WorldWideScience

Sample records for arv drug patents

  1. Patent Pooling for Promoting Access to Antiretroviral Drugs (ARVs) - A Strategic Option for India.

    Science.gov (United States)

    Satyanarayana, Kanikaram; Srivastava, Sadhana

    2010-01-19

    The current HIV/AIDS scenario in India is quite grim with an estimated 2.4 million people living with HIV/AIDS (PLHA) in 2008, just behind South Africa and Nigeria. The anti-retroviral drugs (ARVs) remain the main stay of global HIV/AIDS treatment. Over 30 ARVs (single and FDCs) available under six categories viz., NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), Protease inhibitors, the new Fusion inhibitors, Entry inhibitors-CCR5 co-receptor antagonists and HIV integrase strand transfer inhibitors. The major originator companies for these ARVs are: Abbott, Boehringer Ingelheim (BI), Bristol-Myers Squibb (BMS), Gilead, GlaxoSmithKline (GSK), Merck, Pfizer, Roche, and Tibotec. Beginning with zidovidine in 1987, all the drugs are available in the developed countries. In India, about 30 ARVs are available as generics manufactured by Aurobindo, Hyderabad, Andhra Pradesh; Cipla Limited, Goa; Emcure Pharmaceuticals, Pune, Maharashtra; Hetero Drugs, Hyderabad, Andhra Pradesh; Macleods Pharmaceuticals, Daman; Matrix Laboratories, Nashik, Maharashtra; Ranbaxy, Sirmour, Himachal Pradesh; and Strides Arcolab, Bangalore, Karnataka. The National AIDS Control Organization (NACO) set up in 1992 by the Govt. of India provides free ARVs to HIV positive patients in India since 2004. The drugs available in India include both single drugs and FDCs covering both first line and second line ARVs. Even while there are claims of stabilization of the disease load, there is still huge gap of those who require ARVs as only about 150,000 PLHA receive the ARVs from the Govt. and other sources. Access to ARVs therefore is still a cause of serious concern ever since India became fully Trade Related Aspects of Intellectual Property Rights (TRIPS)-complaint in 2005. Therefore, the Indian pharmaceutical companies cannot make generics for those for drugs introduced post-2005 due to product patent regime. Other concerns include heat stable

  2. Designing ARVs Patent Pool Up to Trade & Policy Evolutionary Dynamics.

    Science.gov (United States)

    Dionisio, Daniele; Racalbuto, Vincenzo; Messeri, Daniela

    2010-01-19

    Patent pools for second and third-line Fixed Dose Combination (FDC) antiretroviral drugs (ARVs) should not be delayed as they are instrumental to urgent public health needs in the under-served markets.Nonetheless, multinational originator companies still seem to perceive patent pooling for ARVs as a minefield that would offer the generic competitors lots of deeply exploitable opportunities, to the detriment of patent owner's rights.This paper analyses the brand industry concerns, while looking for a strategy up to a really equitable and free world market, without any discrimination between end-users in wealthy and resource-limited countries.This strategy would urge partnerships between originator companies first to make newer FDC ARVs quickly available and allow patent pool agreements with generic counterparts to be negotiated straight afterwards.The patent pool strategy highlighted in this paper would assert the primacy of health over for-profit policies, while aligning with the 61(st) WHO's Assembly recommendations and G7, G8 and World Trade Organisation's warnings and pledges against trade protectionism.

  3. Do national drug policies influence antiretroviral drug prices? Evidence from the Southern African Development community.

    Science.gov (United States)

    Liu, Yao; Galárraga, Omar

    2017-03-01

    The efficacy of low- and middle-income countries’ (LMIC) national drug policies in managing antiretroviral (ARV) pharmaceutical prices is not well understood. Though ARV drug prices have been declining in LMIC over the past decade, little research has been done on the role of their national drug policies. This study aims to (i) analyse global ARV prices from 2004 to 2013 and (ii) examine the relationship of national drug policies to ARV prices. Analysis of ARV drug prices utilized data from the Global Price Reporting Mechanism from the World Health Organization (WHO). Ten of the most common ARV drugs (first-line and second-line) were selected. National drug policies were also assessed for 12 countries in the South African Development Community (SADC), which self-reported their policies through WHO surveys. The best predictor of ARV drug price was generic status—the generic versions of 8 out of 10 ARV drugs were priced lower than branded versions. However, other factors such as transaction volume, HIV prevalence, national drug policies and PEPFAR/CHAI involvement were either not associated with ARV drug price or were not consistent predictors of price across different ARV drugs. In the context of emerging international trade agreements, which aim to strengthen patent protections internationally and potentially delay the sale of generic drugs in LMIC, this study shines a spotlight on the importance of generic drugs in controlling ARV prices. Further research is needed to understand the impact of national drug policies on ARV prices.

  4. Evolution of antiretroviral drug costs in Brazil in the context of free and universal access to AIDS treatment.

    Science.gov (United States)

    Nunn, Amy S; Fonseca, Elize M; Bastos, Francisco I; Gruskin, Sofia; Salomon, Joshua A

    2007-11-13

    Little is known about the long-term drug costs associated with treating AIDS in developing countries. Brazil's AIDS treatment program has been cited widely as the developing world's largest and most successful AIDS treatment program. The program guarantees free access to highly active antiretroviral therapy (HAART) for all people living with HIV/AIDS in need of treatment. Brazil produces non-patented generic antiretroviral drugs (ARVs), procures many patented ARVs with negotiated price reductions, and recently issued a compulsory license to import one patented ARV. In this study, we investigate the drivers of recent ARV cost trends in Brazil through analysis of drug-specific prices and expenditures between 2001 and 2005. We compared Brazil's ARV prices to those in other low- and middle-income countries. We analyzed trends in drug expenditures for HAART in Brazil from 2001 to 2005 on the basis of cost data disaggregated by each ARV purchased by the Brazilian program. We decomposed the overall changes in expenditures to compare the relative impacts of changes in drug prices and drug purchase quantities. We also estimated the excess costs attributable to the difference between prices for generics in Brazil and the lowest global prices for these drugs. Finally, we estimated the savings attributable to Brazil's reduced prices for patented drugs. Negotiated drug prices in Brazil are lowest for patented ARVs for which generic competition is emerging. In recent years, the prices for efavirenz and lopinavir-ritonavir (lopinavir/r) have been lower in Brazil than in other middle-income countries. In contrast, the price of tenofovir is US$200 higher per patient per year than that reported in other middle-income countries. Despite precipitous price declines for four patented ARVs, total Brazilian drug expenditures doubled, to reach US$414 million in 2005. We find that the major driver of cost increases was increased purchase quantities of six specific drugs: patented lopinavir

  5. Evolution of antiretroviral drug costs in Brazil in the context of free and universal access to AIDS treatment.

    Directory of Open Access Journals (Sweden)

    Amy S Nunn

    2007-11-01

    Full Text Available Little is known about the long-term drug costs associated with treating AIDS in developing countries. Brazil's AIDS treatment program has been cited widely as the developing world's largest and most successful AIDS treatment program. The program guarantees free access to highly active antiretroviral therapy (HAART for all people living with HIV/AIDS in need of treatment. Brazil produces non-patented generic antiretroviral drugs (ARVs, procures many patented ARVs with negotiated price reductions, and recently issued a compulsory license to import one patented ARV. In this study, we investigate the drivers of recent ARV cost trends in Brazil through analysis of drug-specific prices and expenditures between 2001 and 2005.We compared Brazil's ARV prices to those in other low- and middle-income countries. We analyzed trends in drug expenditures for HAART in Brazil from 2001 to 2005 on the basis of cost data disaggregated by each ARV purchased by the Brazilian program. We decomposed the overall changes in expenditures to compare the relative impacts of changes in drug prices and drug purchase quantities. We also estimated the excess costs attributable to the difference between prices for generics in Brazil and the lowest global prices for these drugs. Finally, we estimated the savings attributable to Brazil's reduced prices for patented drugs. Negotiated drug prices in Brazil are lowest for patented ARVs for which generic competition is emerging. In recent years, the prices for efavirenz and lopinavir-ritonavir (lopinavir/r have been lower in Brazil than in other middle-income countries. In contrast, the price of tenofovir is US$200 higher per patient per year than that reported in other middle-income countries. Despite precipitous price declines for four patented ARVs, total Brazilian drug expenditures doubled, to reach US$414 million in 2005. We find that the major driver of cost increases was increased purchase quantities of six specific drugs

  6. Effect of Antiretroviral Drug (arved) on the Kidney in Albino Rat ...

    African Journals Online (AJOL)

    African studies on effect of antiretroviral drugs on the kidney are limited resulting to scanty information on the safety of these drugs. This study was therefore designed to evaluate the effects of antiretroviral drugs arved®, on creatinine, urea, potassium and sodium ions as well as histological effect on the kidney. A total of fifty ...

  7. Anaesthesia and ARV

    African Journals Online (AJOL)

    Adele

    As more and more HIV infected patients gain access to antiretroviral medication, this drug class and its patients have gained particular significance for anaesthetists. This paper offers an overview of antiretrovirals (ARV) with a specific focus on the implications for anaesthetic management. The four main classes of ARV's are ...

  8. The potential of AR-V7 as a therapeutic target.

    Science.gov (United States)

    Uo, Takuma; Plymate, Stephen R; Sprenger, Cynthia C

    2018-03-01

    The androgen receptor variant AR-V7 is gaining attention as a potential predictive marker for as well as one of the resistance mechanisms to the most current anti-androgen receptor (AR) therapies in castration-resistant prostate cancer (CRPC). Accordingly, development of next-generation drugs that directly or indirectly target AR-V7 signaling is urgently needed. Areas covered: We review proposed mechanisms of drug resistance in relation to AR-V7 status, the mechanisms of generation of AR-V7, and its transcriptome, cistrome, and interactome. Pharmacological agents that interfere with these processes are being developed to counteract pan AR and AR-V7-specific signaling. Also, we address the current status of the preclinical and clinical studies targeting AR-V7 signaling. Expert opinion: AR-V7 is considered a true therapeutic target, however, it remains to be determined if AR-V7 is a principal driver or merely a bystander requiring heterodimerization with co-expressed full-length AR or other variants to drive CRPC progression. While untangling AR-V7 biology, multiple strategies are being developed to counteract drug resistance, including selective blockade of AR-V7 signaling as well as inhibition of pan-AR signaling. Ideally anti-AR therapies will be combined with agents preventing activation and enrichment of AR negative tumor cells that are otherwise depressed by AR activity axis.

  9. Patents associated with high-cost drugs in Australia.

    Directory of Open Access Journals (Sweden)

    Andrew F Christie

    Full Text Available Australia, like most countries, faces high and rapidly-rising drug costs. There are longstanding concerns about pharmaceutical companies inappropriately extending their monopoly position by "evergreening" blockbuster drugs, through misuse of the patent system. There is, however, very little empirical information about this behaviour. We fill the gap by analysing all of the patents associated with 15 of the costliest drugs in Australia over the last 20 years. Specifically, we search the patent register to identify all the granted patents that cover the active pharmaceutical ingredient of the high-cost drugs. Then, we classify the patents by type, and identify their owners. We find a mean of 49 patents associated with each drug. Three-quarters of these patents are owned by companies other than the drug's originator. Surprisingly, the majority of all patents are owned by companies that do not have a record of developing top-selling drugs. Our findings show that a multitude of players seek monopoly control over innovations to blockbuster drugs. Consequently, attempts to control drug costs by mitigating misuse of the patent system are likely to miss the mark if they focus only on the patenting activities of originators.

  10. Patents associated with high-cost drugs in Australia.

    Science.gov (United States)

    Christie, Andrew F; Dent, Chris; McIntyre, Peter; Wilson, Lachlan; Studdert, David M

    2013-01-01

    Australia, like most countries, faces high and rapidly-rising drug costs. There are longstanding concerns about pharmaceutical companies inappropriately extending their monopoly position by "evergreening" blockbuster drugs, through misuse of the patent system. There is, however, very little empirical information about this behaviour. We fill the gap by analysing all of the patents associated with 15 of the costliest drugs in Australia over the last 20 years. Specifically, we search the patent register to identify all the granted patents that cover the active pharmaceutical ingredient of the high-cost drugs. Then, we classify the patents by type, and identify their owners. We find a mean of 49 patents associated with each drug. Three-quarters of these patents are owned by companies other than the drug's originator. Surprisingly, the majority of all patents are owned by companies that do not have a record of developing top-selling drugs. Our findings show that a multitude of players seek monopoly control over innovations to blockbuster drugs. Consequently, attempts to control drug costs by mitigating misuse of the patent system are likely to miss the mark if they focus only on the patenting activities of originators.

  11. Herbal drug patenting in India: IP potential.

    Science.gov (United States)

    Sahoo, Niharika; Manchikanti, Padmavati; Dey, Satya Hari

    2011-09-01

    Herbal drugs are gaining worldwide prominence due to their distinct advantages. Developing countries have started exploring the ethnopharmacological approach of drug discovery and have begun to file patents on herbal drugs. The expansion of R&D in Indian herbal research organizations and presence of manufacturing units at non-Indian sites is an indication of the capability to develop new products and processes. The present study attempts to identify innovations in the Indian herbal drug sector by analyzing the patenting trends in India, US and EU. Based on key word and IPC based search at the IPO, USPTO, Esp@cenet and WIPO databases, patent applications and grant in herbal drugs by Indian applicants/assignees was collected for the last ten years (from 1st January 2001 to 31st October 2010). From this collection patents related to human therapeutic use only were selected. Analysis was performed to identify filing trends, major applicants/assignees, disease area and major plant species used for various treatments. There is a gradual increase in patent filing through the years. In India, individual inventors have maximum applications and grants. CSIR, among research organizations and Hindustan Unilever, Avesthagen, Piramal Life Science, Sahajanand Biotech and Indus Biotech among the companies have the maximum granted patents in India, US and EU respectively. Diabetes, cancer and inflammatory disorders are the major areas for patenting in India and abroad. Recent patents are on new herbal formulations for treatment of AIDS, hepatitis, skin disorders and gastrointestinal disorders. A majority of the herbal patents applications and grants in India are with individual inventors. Claim analysis indicates that these patents include novel multi-herb compositions with synergistic action. Indian research organizations are more active than companies in filing for patents. CSIR has maximum numbers of applications not only in India but also in the US and EU. Patents by research

  12. Price Reversal Pattern of ARV Drugs: A Transaction-Cost Approach Digression

    Directory of Open Access Journals (Sweden)

    Frank LORNE

    2015-05-01

    Full Text Available A price reversal pattern of ARV drugs was noted across lower and middle income countries in that the lower-income countries have higher prices relative to higher-income countries based on a 2008-2009 Summary Report by World Health Organization. The transaction costs affecting AVR drug pricing can be broadly classified into two kinds: One between the final users and the opinion/knowledge experts, and the other between the opinion/knowledge experts and the manufacturers. Economist’s version of price discrimination needs to be modified by including transaction costs. Transaction costs also point to institution creditability factors that will affect NGO procurement.

  13. Biomarkers and biometric measures of adherence to use of ARV-based vaginal rings.

    Science.gov (United States)

    Stalter, Randy M; Moench, Thomas R; MacQueen, Kathleen M; Tolley, Elizabeth E; Owen, Derek H

    2016-01-01

    Poor adherence to product use has been observed in recent trials of antiretroviral (ARV)-based oral and vaginal gel HIV prevention products, resulting in an inability to determine product efficacy. The delivery of microbicides through vaginal rings is widely perceived as a way to achieve better adherence but vaginal rings do not eliminate the adherence challenges exhibited in clinical trials. Improved objective measures of adherence are needed as new ARV-based vaginal ring products enter the clinical trial stage. To identify technologies that have potential future application for vaginal ring adherence measurement, a comprehensive literature search was conducted that covered a number of biomedical and public health databases, including PubMed, Embase, POPLINE and the Web of Science. Published patents and patent applications were also searched. Technical experts were also consulted to gather more information and help evaluate identified technologies. Approaches were evaluated as to feasibility of development and clinical trial implementation, cost and technical strength. Numerous approaches were identified through our landscape analysis and classified as either point measures or cumulative measures of vaginal ring adherence. Point measurements are those that give a measure of adherence at a particular point in time. Cumulative measures attempt to measure ring adherence over a period of time. Approaches that require modifications to an existing ring product are at a significant disadvantage, as this will likely introduce additional regulatory barriers to the development process and increase manufacturing costs. From the point of view of clinical trial implementation, desirable attributes would be high acceptance by trial participants, and little or no additional time or training requirements on the part of participants or clinic staff. We have identified four promising approaches as being high priority for further development based on the following measurements

  14. The association between ARV and TB drug resistance on TB treatment outcome among Kazakh TB/HIV patients.

    Science.gov (United States)

    Mishkin, Kathryn; Alaei, Kamiar; Alikeyeva, Elmira; Paynter, Christopher; Aringazina, Altyn; Alaei, Arash

    2018-02-26

    TB drug resistance poses a serious threat to the public health of Kazakhstan. This paper presents findings related to TB treatment outcome and drug resistant status among people coinfected with HIV and TB in Kazakhstan. Cohort study using data were provided by the Kazakhstan Ministry of Health's National Tuberculosis Program for 2014 and 2015. Chi-square and logistical regression were performed to understand factors associated with drug resistant TB status and TB treatment outcome. In bivariate analysis, drug resistant status was significantly associated with year of TB diagnosis (p=0.001) viral load (p=0.03). TB treatment outcome was significantly associated with age at diagnosis (p=01), ARV treatment (p <0.0001), and TB drug resistant status (p=0.02). In adjusted analysis, drug resistance was associated with increased odds of successful completion of treatment with successful result compared to treatment failure (OR 6.94, 95% CI: 1.39-34.44) CONCLUSIONS: Our results suggest that being drug resistant is associated with higher odds of completing treatment with successful outcome, even when controlling for receipt of ARV therapy. Copyright © 2018. Published by Elsevier Ltd.

  15. HIV status disclosure and ARV adherence among patients attending ...

    African Journals Online (AJOL)

    HIV status disclosure and ARV adherence among patients attending Jomo Kenyatta University comprehensive care clinic. ... Failure to daily intake of Anti Retrovirals (ARV) not only prevents treatment failure but may also lead to viral development of resistance to the drugs. The fact that HIV is mainly sexually transmitted ...

  16. HIV/AIDS drugs for Sub-Saharan Africa: how do brand and generic supply compare?

    Directory of Open Access Journals (Sweden)

    Colleen V Chien

    Full Text Available BACKGROUND: Significant quantities of antiretroviral drugs (ARVs to treat HIV/AIDS have been procured for Sub-Saharan Africa for the first time in their 20-year history. This presents a novel opportunity to empirically study the roles of brand and generic suppliers in providing access to ARVs. METHODOLOGY/PRINCIPAL FINDINGS: An observational study of brand and generic supply based on a dataset of 2,162 orders of AIDS drugs for Sub-Saharan Africa reported to the Global Price Reporting Mechanism at the World Health Organization from January 2004-March 2006 was performed. Generic companies supplied 63% of the drugs studied, at prices that were on average about a third of the prices charged by brand companies. 96% of the procurement was of first line drugs, which were provided mostly by generic firms, while the remaining 4%, of second line drugs, was sourced primarily from brand companies. 85% of the generic drugs in the sample were manufactured in India, where the majority of the drugs procured were ineligible for patent protection. The remaining 15% was manufactured in South Africa, mostly under voluntary licenses provided by brand companies to a single generic company. In Sub-Saharan African countries, four first line drugs in the dataset were widely patented, however no general deterrent to generic purchasing based on a patent was detected. CONCLUSIONS/SIGNIFICANCE: Generic and brand companies have played distinct roles in increasing the availability of ARVs in Sub-Saharan Africa. Generic companies provided most of the drugs studied, at prices below those charged by brand companies, and until now, almost exclusively supplied several fixed-dose combination drugs. Brand companies have supplied almost all second line drugs, signed voluntary licenses with generic companies, and are not strictly enforcing patents in certain countries. Further investigation into how price reductions in second line drugs can be achieved and the cheapest drugs can

  17. Patents Associated with High-Cost Drugs in Australia

    OpenAIRE

    Christie, Andrew F.; Dent, Chris; McIntyre, Peter; Wilson, Lachlan; Studdert, David M.

    2013-01-01

    Australia, like most countries, faces high and rapidly-rising drug costs. There are longstanding concerns about pharmaceutical companies inappropriately extending their monopoly position by "evergreening" blockbuster drugs, through misuse of the patent system. There is, however, very little empirical information about this behaviour. We fill the gap by analysing all of the patents associated with 15 of the costliest drugs in Australia over the last 20 years. Specifically, we search the patent...

  18. The US Food and Drug Administration's tentative approval process and the global fight against HIV.

    Science.gov (United States)

    Chahal, Harinder Singh; Murray, Jeffrey S; Shimer, Martin; Capella, Peter; Presto, Ryan; Valdez, Mary Lou; Lurie, Peter G

    2017-12-01

    In 2004, the US government began to utilize the Food and Drug Administration's (USFDA) tentative approval process (tFDA) as a basis to determine which HIV drugs are appropriate to be purchased and used in resource-constrained settings. This process permits products that are not approved for marketing in the US, including medicines with active patents or marketing restrictions in the US, to be purchased and distributed in resource-constrained settings. Although the tFDA was originally intended to support the United States' President's Emergency Plan for AIDS Relief (PEPFAR), the USFDA list has become a cornerstone of international HIV programmes that support procurement of ARVs, such as the World Health Organization and the Global Fund to Fight AIDS, Tuberculosis, and Malaria. Our objective in this article is to help the global HIV policy makers and implementers of HIV programmes better understand the benefits and limitations of the tFDA by providing an in-depth review of the relevant legal and regulatory processes. USFDA's dedicated tFDA process for ARVs used by the PEPFAR programme has a wide impact globally; however, the implementation and the regulatory processes governing the programme have not been thoroughly described in the medical literature. This paper seeks to help stakeholders better understand the legal and regulatory aspects associated with review of ARVs under the tFDA by describing the following: (1) the tFDA and its importance to global ARV procurement; (2) the regulatory pathways for applications under tFDA for the PEPFAR programme, including modifications to applications, review timelines and costs; (3) the role of US patents, US marketing exclusivity rights, and the Medicines Patents Pool in tFDA; and (4) an overview of how applications for PEPFAR programme are processed through the USFDA. We also provide a case study of a new ARV, tenofovir alafenamide fumarate (TAF), not yet reviewed by USFDA for PEPFAR use. In this paper, we describe the

  19. [The patents game. Generic and biosimilar drugs].

    Science.gov (United States)

    Villamañán, E; González, D; Armada, E; Ruano, M; Álvarez-Sala, R; Herrero, A

    2016-01-01

    The protection provided by patents on medicines has a limited duration. The expiry of patents expiration allows copies of the drugs to be released, competing with original. At first, they were identical to the original, known as generic drugs, but in recent years, due to the marketing of biological therapies and the expiry of many of their patents, biosimilar drugs have also emerged. These are not exact copies of the original, but, like generic drugs, biosimilar drugs have to demonstrate equivalence to the reference drugs in quality, safety and efficacy. Nevertheless, despite their importance and contribution to sustainability of health system, doctors are sometimes unaware of differences between them, and their impact in terms of clinical and economic effects. An attempt is made to review and clarify certain aspects often unknown by physicians, despite their involvement in their use. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

  20. Equity in access to ARV drugs in Malawi

    African Journals Online (AJOL)

    2007-05-01

    May 1, 2007 ... included):'We found that financial resources are not regarded as .... The dangers implied in this statement are obvious. ..... Mwansambo, A., & Chizimba, R. (2004) Consolidated report on equity in access to ARVs. Lilongwe:.

  1. knowledge and attitudes towards the use of arvs among adults

    African Journals Online (AJOL)

    To assess knowledge and attitudes towards the use of ARV drugs among adults in Dodoma urban district ... male and female respectively interviewed were aware of ARVs. Also ... Sub-Saharan Africa is the most severely affected ... Tanzania, it has been estimated that more than ... support unique to those who fall sick and.

  2. Scientific Prediction and Prophetic Patenting in Drug Discovery.

    Science.gov (United States)

    Curry, Stephen H; Schneiderman, Anne M

    2015-01-01

    Pharmaceutical patenting involves writing claims based on both discoveries already made, and on prophesy of future developments in an ongoing project. This is necessitated by the very different timelines involved in the drug discovery and product development process on the one hand, and successful patenting on the other. If patents are sought too early there is a risk that patent examiners will disallow claims because of lack of enablement. If patenting is delayed, claims are at risk of being denied on the basis of existence of prior art, because the body of relevant known science will have developed significantly while the project was being pursued. This review examines the role of prophetic patenting in relation to the essential predictability of many aspects of drug discovery science, promoting the concepts of discipline-related and project-related prediction. This is especially directed towards patenting activities supporting commercialization of academia-based discoveries, where long project timelines occur, and where experience, and resources to pay for patenting, are limited. The need for improved collaborative understanding among project scientists, technology transfer professionals in, for example, universities, patent attorneys, and patent examiners is emphasized.

  3. Vulnerable infected populations and street markets for ARVs: Potential implications for PrEP rollout in the USA.

    Science.gov (United States)

    Kurtz, Steven P; Buttram, Mance E; Surratt, Hilary L

    2014-04-01

    Widespread diversion of antiretroviral (ARV) medications to illicit markets has recently been documented among indigent patients in South Florida. The recent approval of ARVs for pre-exposure prophylaxis (PrEP) has the potential to broaden these illicit markets, as high-risk individuals seek ARVs without a prescription or medical supervision. Nonadherence among diverters and unsupervised use of ARVs for treatment or PrEP increase risks of treatment failure, drug resistance, and disease transmission. We report the scope of ARV diversion among substance-using men who have sex with men in South Florida. Structured interviews (N = 515) queried demographics, HIV status, mental distress, substance dependence, and sexual risks. HIV-positive participants answered questions about medical care, treatment, and ARV adherence and diversion. Median age was 39. Of 46.4% who were HIV-positive, 79.1% were prescribed ARVs. Of these, 27% reported selling/trading ARVs. Reasons for diversion were sharing/trading with friends, sale/trade for money/drugs, and sale/trade of unused medications. ARV diverters, compared to nondiverters, were more likely to be substance dependent (74.5% vs. 58.7%, p = 0.046) and have traded sex for money/drugs (60.8% vs. 32.6%, p increased risks of treatment failure, disease transmission, and PrEP failure should be carefully considered in developing policy and behavioral supports to scaling up treatment as prevention and PrEP.

  4. Social arv

    DEFF Research Database (Denmark)

    Ploug, Niels

    Formålet med forskningsprogrammet om social arv har været at bidrage med ny viden om forhold, der har afgørende betydning for de sociale forskelle i Danmark. Denne sammenfatning giver et overblik over de væsentligste resultater fra undersøgelserne af den sociale arv set i et livsløbsperspektiv og...... på den sociale arv i forbindelse med daginstitutioner, skole og uddannelse samt sundhed. Det ser ud til, at de kulturelle forhold – forstået som den påvirkning der finder sted mellem mennesker i deres løbende omgang med hinanden – spiller en betydelig rolle i forklaringen af sociale forskelle...

  5. Preferred supplier contracts in post-patent prescription drug markets.

    Science.gov (United States)

    Blankart, Carl Rudolf; Stargardt, Tom

    2016-02-22

    In recent years, the expiration of patents for large drug classes has increased the importance of post-patent drug markets. However, previous research has focused solely on patent drug markets. In this study, the authors evaluate the influence of preferred supplier contracts, the German approach to tendering, in post-patent drug markets using a hierarchical market share attraction model. The authors find that preferred supplier contracts are a powerful strategic instrument for generic manufacturers in a highly competitive environment. They quantify the effects of signing a preferred supplier contract and show that brand-name manufacturers are vulnerable to tendering. Therefore, brand-name manufacturers should readjust their strategies and consider including preferred supplier contracts in their marketing mix. In addition, the authors employ a simulation to demonstrate that a first-mover advantage might be gained from signing a preferred supplier contract. Furthermore, their results can be used as a blueprint for decision makers in the pharmaceutical industry to assess the market share effects of different contracting strategies regarding preferred supplier contracts.

  6. Buccoadhesive drug delivery systems--extensive review on recent patents.

    Science.gov (United States)

    Pathan, Shadab A; Iqbal, Zeenat; Sahani, Jasjeet K; Talegaonkar, Sushma; Khar, Roop K; Ahmad, Farhan J

    2008-01-01

    Peroral administration of drugs, although most preferred by both clinicians and patients has several disadvantages such as hepatic first pass metabolism and enzymatic degradation within the GI tract, that prohibit oral administration of certain classes of drugs especially peptides and proteins. Consequently, other absorptive mucosae are considered as potential sites for administration of these drugs. Among the various transmucosal routes studied the buccal mucosa offers several advantages for controlled drug delivery for extended period of time. The mucosa is well supplied with both vascular and lymphatic drainage and first-pass metabolism in the liver and pre-systemic elimination in the gastrointestinal tract is avoided. The area is well suited for a retentive device and appears to be acceptable to the patient. With the right dosage form, design and formulation, the permeability and the local environment of the mucosa can be controlled and manipulated in order to accommodate drug permeation. Buccal drug delivery is thus a promising area for continued research with the aim of systemic and local delivery of orally inefficient drugs as well as feasible and attractive alternative for non-invasive delivery of potent protein and peptide drug molecules. Extensive review pertaining specifically to the patents relating to buccal drug delivery is currently available. However, many patents e.g. US patents 6, 585,997; US20030059376A1 etc. have been mentioned in few articles. It is the objective of this article to extensively review buccal drug delivery by discussing the recent patents available. Buccal dosage forms will also be reviewed with an emphasis on bioadhesive polymeric based delivery systems.

  7. How drug life-cycle management patent strategies may impact formulary management.

    Science.gov (United States)

    Berger, Jan; Dunn, Jeffrey D; Johnson, Margaret M; Karst, Kurt R; Shear, W Chad

    2016-10-01

    Drug manufacturers may employ various life-cycle management patent strategies, which may impact managed care decision making regarding formulary planning and management strategies when single-source, branded oral pharmaceutical products move to generic status. Passage of the Hatch-Waxman Act enabled more rapid access to generic medications through the abbreviated new drug application process. Patent expirations of small-molecule medications and approvals of generic versions have led to substantial cost savings for health plans, government programs, insurers, pharmacy benefits managers, and their customers. However, considering that the cost of developing a single medication is estimated at $2.6 billion (2013 dollars), pharmaceutical patent protection enables companies to recoup investments, creating an incentive for innovation. Under current law, patent protection holds for 20 years from time of patent filing, although much of this time is spent in product development and regulatory review, leaving an effective remaining patent life of 7 to 10 years at the time of approval. To extend the product life cycle, drug manufacturers may develop variations of originator products and file for patents on isomers, metabolites, prodrugs, new drug formulations (eg, extended-release versions), and fixed-dose combinations. These additional patents and the complexities surrounding the timing of generic availability create challenges for managed care stakeholders attempting to gauge when generics may enter the market. An understanding of pharmaceutical patents and how intellectual property protection may be extended would benefit managed care stakeholders and help inform decisions regarding benefit management.

  8. Social opdrift - social arv

    DEFF Research Database (Denmark)

    Ejrnæs, Morten; Gabrielsen, G.; Nørrung, Per

    "Social opdrift - social arv" stiller på flere måder spørgsmål ved begrebet social arv. Bogen konkluderer blandt andet, at langt de fleste børn, der opvokser i en socialt belastet familie, bliver velfungerende voksne. Professionelle, der møder socialt belastede familier, har derfor et stort ansvar....... Naturligvis skal der tages hånd om udsatte børn, men det kræver samtidig stor opmærksomhed at sørge for, at fokuseringen på den sociale arv ikke tager overhånd, så det bliver en selvopfyldende profeti."Social opdrift - social" arv viser, hvordan forskningsresultater er blevet fremlagt på en måde, som har...... medvirket til at skabe en skæv opfattelse af, at forældrenes problemer er hovedårsag til børns sociale problemer. I selvstændige analyser vises, hvordan data, der normalt bruges som "bevis" for den sociale arvs betydning, tydeligt illustrerer, at det er en undtagelse, at børn får sociale problemer af samme...

  9. Patents and access to drugs in developing countries: an ethical analysis.

    Science.gov (United States)

    Sterckx, Sigrid

    2004-05-01

    More than a third of the world's population has no access to essential drugs. More than half of this group of people live in the poorest regions of Africa and Asia. Several factors determine the accessibility of drugs in developing countries. Hardly any medicines for tropical diseases are being developed, but even existing drugs are often not available to the patients who need them. One of the important determinants of access to drugs is the working of the patent system. This paper first maps out some facts about the global patent regime that has emerged as a consequence of the conclusion of the WTO-TRIPs Agreement in 1994. Attempts to construct a moral justification of the patent system have been based on three grounds: natural rights, distributive justice, and utilitarian arguments. This paper examines to what extent and on which grounds drug patents can be justified. The final section looks at the so-called 'Doha Declaration on the TRIPs Agreement and Public Health', which was adopted by the WTO Ministerial Conference two years ago, recognising the primacy of public health over the interests of patent proprietors.

  10. 'Government Patent Use': A Legal Approach To Reducing Drug Spending.

    Science.gov (United States)

    Kapczynski, Amy; Kesselheim, Aaron S

    2016-05-01

    The high cost of patent-protected brand-name drugs can strain budgets and curb the widespread use of new medicines. An example is the case of direct-acting antiviral drugs for the treatment of hepatitis C. While prices for these drugs have come down in recent months, they still create barriers to treatment. Additionally, prescribing restrictions imposed by insurers put patients at increased risk of medical complications and contribute to transmission of the hepatitis C virus. We propose that the federal government invoke its power under an existing "government patent use" law to reduce excessive prices for important patent-protected medicines. Using this law would permit the government to procure generic versions of patented drugs and in exchange pay the patent-holding companies reasonable royalties to compensate them for research and development. This would allow patients in federal programs, and perhaps beyond, to be treated with inexpensive generic medicines according to clinical need-meaning that many more patients could be reached for no more, and perhaps far less, money than is currently spent. Another benefit would be a reduction in the opportunity for companies to extract monopoly profits that far exceed their risk-adjusted costs of research and development. Project HOPE—The People-to-People Health Foundation, Inc.

  11. "To patent or not to patent? the case of Novartis' cancer drug Glivec in India".

    Science.gov (United States)

    Gabble, Ravinder; Kohler, Jillian Clare

    2014-01-06

    Glivec (imatinib mesylate), produced by the pharmaceutical company Novartis, is prescribed in the case of chronic myeloid leukemia, one of the most common blood cancers in eastern countries. After more than a decade of legal battles surrounding its patentability, the Supreme Court of India gave its final decision on April 1st of 2013, rejecting the appeal of the Swiss giant drug manufacturer. In 2006, the Indian Patent Office first refused Glivec's patent under Section 3(d) of the Indian Patent Act arguing that it was only a modified version of an existing drug, Imatinib, and therefore that the drug was not innovative. Novartis replied filing legal challenges against the Indian government but the final verdict in April of 2013 ends the battle. Indeed, the Supreme Court stated that even if the bioavailability of the drug was improved, it did not demonstrate enhanced efficacy and that Glivec was not patentable. The research primarily focused on journal, newspaper and magazine articles relevant to the time frame of the lawsuit (from 1994 to 2013) as well as news searches through Google, Factiva, ProQuest, PubMed, and YouTube where press articles from court verdicts were obtained by using the following keywords: "India", "Novartis", "Glivec", "Patent", "Novartis Case", and "Supreme Court of India". The data sources were interpreted and analyzed according to the authors' own prior knowledge and understanding of the exigencies of the TRIPS Agreement. This case illuminates how India is interpreting international law to fit domestic public health needs. The Novartis case arguably sets an important precedent for the global pharmaceutical industry and ideally will help improve access to lifesaving medicines in the developing world by demanding that patient health needs supersede commercial interests. The Supreme Court of India's decision may affect the interpretation of the article of the TRIPS Agreement, which states members shall be free to determine the appropriate method

  12. Scope of claim coverage in patents of fufang Chinese herbal drugs: Substitution of ingredients

    Directory of Open Access Journals (Sweden)

    Tian Jiaher

    2011-08-01

    Full Text Available Abstract Herbal ingredients in a Chinese fufang prescription are often replaced by one or several other herbal combinations. As there have been very few Chinese herbal patent infringement cases, it is still unclear how the Doctrine of Equivalents should be applied to determine the scope of 'equivalents' in Chinese fufang prescriptions. Case law principles from cases in other technical areas such as chemical patents and biological drug patents can be borrowed to ascertain a precise scope of a fufang patent. This article summarizes and discusses several chemical and biopharmaceutical patent cases. In cases where a certain herbal ingredient is substituted by another herb or a combination of herbs, accused infringers are likely to relate herbal drug patents to chemical drug patents with strict interpretation whereas patent owners may take advantage of the liberal application of Doctrine of Equivalence in biopharmaceutical patents by analogizing the complex nature of herbal drugs with biological drugs. Therefore, consideration should be given to the purpose of an ingredient in a patent, the qualities when combined with the other ingredients and the intended function. The scope of equivalents also depends on the stage of the prior art. Moreover, it is desirable to disclose any potential substitutes when drafting the application. Claims should be drafted in such a way that all foreseeable modifications are encompassed for the protection of the patent owner's intellectual property.

  13. The impact of South Korea's new drug-pricing policy on market competition among off-patent drugs.

    Science.gov (United States)

    Kwon, Hye-Young; Kim, Hyungmin; Godman, Brian; Reich, Michael R

    2015-01-01

    A new pricing policy was introduced in Korea in April 2012 with the aim of strengthening competition among off-patent drugs by eliminating price gaps between originators and generics. Examine the effect of newly implemented pricing policy. Retrospectively examining the effects through extracting from the National Health Insurance claims data a 30-month panel dataset (January 2011-June 2013) containing consumption data in four major therapeutic classes (antihypertensives, lipid-lowering drugs, antiulcerants and antidepressants). Proxies for market competition were examined before and after the policy. The new pricing policy did not enhance competition among off-patent drugs. In fact, price dispersion significantly decreased as opposed to the expected change. Originator-to-generic utilization increased 6.12 times (p = 0.000) after the new policy. The new pricing policy made no impact on competition among off-patent drugs. Competition in the off-patent market cannot be enhanced unless both supply and demand side measures are coordinated.

  14. Patents and the Global Diffusion of New Drugs.

    Science.gov (United States)

    Cockburn, Iain M; Lanjouw, Jean O; Schankerman, Mark

    2016-01-01

    Analysis of the timing of launches of 642 new drugs in 76 countries during 1983–2002 shows that patent and price regulation regimes strongly affect how quickly new drugs become commercially available in different countries. Price regulation delays launch, while longer and more extensive patent rights accelerate it. Health policy institutions and economic and demographic factors that make markets more profitable also speed up diffusion. The estimated effects are generally robust to controlling for endogeneity of policy regimes with country fixed effects and instrumental variables. The results highlight the important role of policy choices in driving the diffusion of new innovations.

  15. Competitive intelligence and patent analysis in drug discovery.

    Science.gov (United States)

    Grandjean, Nicolas; Charpiot, Brigitte; Pena, Carlos Andres; Peitsch, Manuel C

    2005-01-01

    Patents are a major source of information in drug discovery and, when properly processed and analyzed, can yield a wealth of information on competitors activities, R&D trends, emerging fields, collaborations, among others. This review discusses the current state-of-the-art in textual data analysis and exploration methods as applied to patent analysis.: © 2005 Elsevier Ltd . All rights reserved.

  16. [Data-mining characteristics of adverse drug reactions and pharmacovi-gilance of Chinese patent drugs including Aconitum herbs].

    Science.gov (United States)

    Zhang, Xiao-Meng; Li, Fan; Zhang, Bing; Chen, Xiao-Fen; Piao, Jing-Zhu

    2018-01-01

    The common Aconitum herbs in clinical application mainly include Aconiti Radix(Chuanwu), Aconiti Kusnezoffii Radix(Caowu) and Aconiti Lateralis Radix Praeparaia(Fuzi), all of which have toxicity. Therefore, the safety of using Chinese patent drugs including Aconitum herbs has become an hot topic in clinical controversy. Based on the data-mining methods, this study explored the characteristics and causes of adverse drug reactions/events (ADR/ADE) of the Chinese patent drugs including Aconitum, in order to provide pharmacovigilance and rational drug use suggestions for clinical application. The detailed ADR/ADE reports about the Chinese patent drugs including Aconitum herbs were retrieved in the domestic literature databases since 1984 to now. The information extraction and data-mining were conducted based on the platforms of Microsoft office Excel 2016, Clementine 12.0 and Cytoscape 3.3.0. Finally, 78 detailed ADR/ADE reports involving a total of 30 varieties were included. 92.31% ADR/ADE were surely or likely led by the Chinese patent drugs including Aconitum, mostly involving multiple system/organ damages with good prognosis, and even 1 case of death. The incidence of included ADRs/ADEs was associated with various factors such as the patient idiosyncratic, drug toxicity, as well as clinical medication. The patient age was most closely related to ADR/ADEs, and those aged from 60 to 69 were more easily suffered from the ADRs/ADEs of Chinese patent drugs including Aconitum. The probability of ADR/ADEs for the drugs including Chuanwu or Caowu was greater than that of Fuzi, and the using beyond the instructions dose was the most important potential safety hazard in the clinical medication process. For the regular and characteristics of ADR/ADEs led by Chinese patent drugs including Aconitum, special attention shall be paid to the elder patients or with the patients with allergies; strictly control the dosage and course of treatment, strengthen the safety medication

  17. Androgen Receptor Variant AR-V9 Is Coexpressed with AR-V7 in Prostate Cancer Metastases and Predicts Abiraterone Resistance.

    Science.gov (United States)

    Kohli, Manish; Ho, Yeung; Hillman, David W; Van Etten, Jamie L; Henzler, Christine; Yang, Rendong; Sperger, Jamie M; Li, Yingming; Tseng, Elizabeth; Hon, Ting; Clark, Tyson; Tan, Winston; Carlson, Rachel E; Wang, Liguo; Sicotte, Hugues; Thai, Ho; Jimenez, Rafael; Huang, Haojie; Vedell, Peter T; Eckloff, Bruce W; Quevedo, Jorge F; Pitot, Henry C; Costello, Brian A; Jen, Jin; Wieben, Eric D; Silverstein, Kevin A T; Lang, Joshua M; Wang, Liewei; Dehm, Scott M

    2017-08-15

    Purpose: Androgen receptor (AR) variant AR-V7 is a ligand-independent transcription factor that promotes prostate cancer resistance to AR-targeted therapies. Accordingly, efforts are under way to develop strategies for monitoring and inhibiting AR-V7 in castration-resistant prostate cancer (CRPC). The purpose of this study was to understand whether other AR variants may be coexpressed with AR-V7 and promote resistance to AR-targeted therapies. Experimental Design: We utilized complementary short- and long-read sequencing of intact AR mRNA isoforms to characterize AR expression in CRPC models. Coexpression of AR-V7 and AR-V9 mRNA in CRPC metastases and circulating tumor cells was assessed by RNA-seq and RT-PCR, respectively. Expression of AR-V9 protein in CRPC models was evaluated with polyclonal antisera. Multivariate analysis was performed to test whether AR variant mRNA expression in metastatic tissues was associated with a 12-week progression-free survival endpoint in a prospective clinical trial of 78 CRPC-stage patients initiating therapy with the androgen synthesis inhibitor, abiraterone acetate. Results: AR-V9 was frequently coexpressed with AR-V7. Both AR variant species were found to share a common 3' terminal cryptic exon, which rendered AR-V9 susceptible to experimental manipulations that were previously thought to target AR-V7 uniquely. AR-V9 promoted ligand-independent growth of prostate cancer cells. High AR-V9 mRNA expression in CRPC metastases was predictive of primary resistance to abiraterone acetate (HR = 4.0; 95% confidence interval, 1.31-12.2; P = 0.02). Conclusions: AR-V9 may be an important component of therapeutic resistance in CRPC. Clin Cancer Res; 23(16); 4704-15. ©2017 AACR . ©2017 American Association for Cancer Research.

  18. Product-line extensions and pricing strategies of brand-name drugs facing patent expiration.

    Science.gov (United States)

    Hong, Song Hee; Shepherd, Marvin D; Scoones, David; Wan, Thomas T H

    2005-01-01

    This study proposed an alternative to brand loyalty as the explanation for the continued price rigidity of patent-expired brand-name prescription drugs despite the increase in market entry of generic drugs facilitated by the 1984 Drug Price Competition and Patent Term Restoration Act. Study hypotheses were to test (1) whether market entries of new-product extensions are associated with market success of original brand-name drugs before generic drug entry, and (2) whether original brand-name drugs exhibit price rigidity to generic entry only when they are extended. The design is a retrospective follow-up study for the prescription drug brands that lost their patents between 1987 and 1992. The drug brands were limited to nonantibiotic, orally administered drugs containing only 1 active pharmaceutical ingredient. Information on patent expiration, entry of a product extension, and market success were determined from the U.S. Food and Drug Administration.s Orange Book, First DataBank, and American Druggist, respectively. Market success was defined as whether an original drug brand was listed in the top 100 prescriptions most frequently dispensed before facing generic entry. Product-line extension was defined as the appearance of another product that a company introduces within the same market after its existing product. Drug prices were average wholesale prices from the Drug Topics Red Book. The relationship between product-line extension and market success was examined using a logistic regression analysis. The price rigidity to entry was tested using a panel regression analysis. A total of 27 drug brands lost their patents between 1987 and 1992. Drug brands that achieved market success were 16 times more likely to be extended than were those that did not (OR=16, 95% confidence interval, 2.12-120.65). The price rigidity to entry existed in drug brands with extensions (beta=2.65%, P new product-line extension introduced for an original brand helps the original price be

  19. Social arv

    DEFF Research Database (Denmark)

    Jensen, Bente

    Denne publikation er det første arbejdspapir/rapport i serien om forskningsprojektet "Handlekompetence i pædagogisk arbejde med socialt udsatte børn og unge - indsats og effekt (HPA-projektet). Social arv og det deraf afledte begreb om 'udsatte børn', som er det samfundsproblem, der danner rammen...... om HPA-projektets intervenstionsdel og -analyser er ikke et entydigt begreb. Formålet med papiret er derfor at indkredse diskussionen om social arv set som reproduktion af ulighed og på den baggrund belyse relevante indikatorer som kan tjene som baggrundvariable i studiet af effekter i relation til...... samfundets institutionelle mulighder for at skabe fornyelse på det sociale område gennem social intervention...

  20. [How much does the backlog on drug patents cost for health in Brazil?

    Science.gov (United States)

    Jannuzzi, Anna Haydée Lanzillotti; Vasconcellos, Alexandre Guimarães

    2017-08-21

    The backlog in processing patent applications in Brazil has persisted since the enactment of Law 9,279/1996, when the country resumed granting patents on drugs. The agencies responsible for granting such patents, namely the Brazilian National Patent and Trademark Office (INPI) and the Brazilian National Health Surveillance Agency (Anvisa) cite technical and administrative reasons for the backlog. However, little research has focused on the economic impacts for health due to the inefficiency of the Brazilian patent system. The current study thus proposes a methodology to estimate the extent to which government procurement of medicines is burdened by the backlog in drug patent applications. According to the results, a total of more than BRL 14 million (USD 4.5 million) is spent unnecessarily per year by the Federal Government on just one antiretroviral drug due to the extension of the respective patent's life. Measures to resolve this situation are urgently needed in the three branches of government. These include hiring more staff for the INPI, analysis of bills of law under review in the two houses of the Brazilian Congress to amend the Industrial Property Law, and ruling on direct class action claims of unconstitutionality to suppress the legal mechanisms that allow extending the life of patents.

  1. “To patent or not to patent? the case of Novartis’ cancer drug Glivec in India”

    Science.gov (United States)

    2014-01-01

    Background Glivec (imatinib mesylate), produced by the pharmaceutical company Novartis, is prescribed in the case of Chronic Myeloid Leukemia, one of the most common blood cancers in eastern countries. After more than a decade of legal battles surrounding its patentability, the Supreme Court of India gave its final decision on April 1st of 2013, rejecting the appeal of the Swiss giant drug manufacturer. In 2006, the Indian Patent Office first refused Glivec’s patent under Section 3(d) of the Indian Patent Act arguing that it was only a modified version of an existing drug, Imatinib, and therefore that the drug was not innovative. Novartis replied filing legal challenges against the Indian government but the final verdict in April of 2013 ends the battle. Indeed, the Supreme Court stated that even if the bioavailability of the drug was improved, it did not demonstrate enhanced efficacy and that Glivec was not patentable. Methods The research primarily focused on journal, newspaper and magazine articles relevant to the time frame of the lawsuit (from 1994 to 2013) as well as news searches through Google, Factiva, ProQuest, PubMed, and YouTube where press articles from court verdicts were obtained by using the following keywords: “India”, “Novartis”, “Glivec”, “Patent”, “Novartis Case”, and “Supreme Court of India”. The data sources were interpreted and analyzed according to the authors’ own prior knowledge and understanding of the exigencies of the TRIPS Agreement. Results This case illuminates how India is interpreting international law to fit domestic public health needs. Conclusions The Novartis case arguably sets an important precedent for the global pharmaceutical industry and ideally will help improve access to lifesaving medicines in the developing world by demanding that patient health needs supersede commercial interests. The Supreme Court of India’s decision may affect the interpretation of the article of the TRIPS Agreement

  2. Sustainability of ARV provision in developing countries: challenging a framework based on program history

    Directory of Open Access Journals (Sweden)

    Thiago Botelho Azeredo

    Full Text Available Abstract The provision of ARVs is central to HIV/AIDS programs, because of its impact on the course of the disease and on quality of life. Although first-line treatments costs have declined, treatment-associated expenses are steeper each year. Sustainability is therefore an important variable for the success of treatment programs. A conceptual framework on sustainability of ARV provision was developed, followed by data collection instruments. The pilot study was undertaken in Brazil. Bolivia, Peru and Mozambique, were visited. Key informants were identified and interviewed. Investigation of sustainability related to ARV provision involved implementation and routinization events of provision schemes. Evidence of greater sustainability potential was observed in Peru, where provision is implemented and routinized by the National HIV/AIDS program and expenditures met by the government. In Mozambique, provision is dependent on donations and external aid, but the country displays a great effort to incorporate ARV provision and care in routine healthcare activities. Bolivia, in addition to external dependence on financing and management of drug supply, presents problems regarding implementation and routinization. The conceptual framework was useful in recognizing events that influence sustainable ARV provision in these countries.

  3. An Overview On Various Approaches And Recent Patents On Gastroretentive Drug Delivery Systems.

    Science.gov (United States)

    Kumar, Manoj; Kaushik, Deepak

    2018-03-08

    Drugs having absorption window in the stomach or upper small intestine has restricted bioavailability with conventional dosage forms. The gastric residence time of these dosage forms is usually short and they do not show drug release for prolonged period of time. To avoid these problems and to enhance the bioavailability and gastric retention time of these drugs, controlled drug delivery systems with prolonged gastric retention time are currently being developed. This review highlights the various pharmaceutical approaches for gastroretention such as floating drug delivery systems, mucoadhesive systems, high density systems, expandable and swelling systems, superporous hydrogels systems, magnetic systems, ion exchange resin system and recent patents filed or granted for these approaches. Recently some patents are also reported where a combination of various approaches are being employed to achieve very effective gastroretention. The various patent search sites were used to collect and analyze the information on gastroretentive drug delivery systems. The present study provides valuable information, advantages, limitations and future outlook of various gastroretentive drug delivery systems. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  4. Towards universal ARV access: Achievements and challenges in ...

    African Journals Online (AJOL)

    Information on staff training, vacancy rates and funding allocations for the ARV roll-out was obtained from official government reports. Projections were made of expected new ARV enrolments for 2008 and 2009 and compared with goals set by the National Strategic Plan (NSP) to achieve universal access to ARVs by 2011.

  5. Cyclodextrins improving the physicochemical and pharmacological properties of antidepressant drugs: a patent review.

    Science.gov (United States)

    Diniz, Tâmara Coimbra; Pinto, Tiago Coimbra Costa; Menezes, Paula Dos Passos; Silva, Juliane Cabral; Teles, Roxana Braga de Andrade; Ximenes, Rosana Christine Cavalcanti; Guimarães, Adriana Gibara; Serafini, Mairim Russo; Araújo, Adriano Antunes de Souza; Quintans Júnior, Lucindo José; Almeida, Jackson Roberto Guedes da Silva

    2018-01-01

    Depression is a serious mood disorder and is one of the most common mental illnesses. Despite the availability of several classes of antidepressants, a substantial percentage of patients are unresponsive to these drugs, which have a slow onset of action in addition to producing undesirable side effects. Some scientific evidence suggests that cyclodextrins (CDs) can improve the physicochemical and pharmacological profile of antidepressant drugs (ADDs). The purpose of this paper is to disclose current data technology prospects involving antidepressant drugs and cyclodextrins. Areas covered: We conducted a patent review to evaluate the antidepressive activity of the compounds complexed in CDs, and we analyzed whether these complexes improved their physicochemical properties and pharmacological action. The present review used 8 specialized patent databases for patent research, using the term 'cyclodextrin' combined with 'antidepressive agents' and its related terms. We found 608 patents. In the end, considering the inclusion criteria, 27 patents reporting the benefits of complexation of ADDs with CDs were included. Expert opinion: The use of CDs can be considered an important tool for the optimization of physicochemical and pharmacological properties of ADDs, such as stability, solubility and bioavailability.

  6. Abuse of antiretroviral drugs combined with addictive drugs by ...

    African Journals Online (AJOL)

    Reports of the use of antiretroviral drugs (ARVs) to produce a highly addictive drug called nyaope or whoonga are of major concern as ARVs are easily accessible in sub-Saharan Africa, including to pregnant women. Use of illicit drugs by pregnant women may result in serious adverse effects in their infants. We have ...

  7. ORIGINAL ARTICLES Prevalence of drug-drug interactions of ...

    African Journals Online (AJOL)

    2008-02-02

    Feb 2, 2008 ... Table II. Frequency of level 2 interactions between ARVs and the other drugs. Interacting ARVs and other drugs. N. %*. Didanosine + ketoconazole. 1. 0.91. Didanosine + ofloxacin. 1. 0.91. Didanosine + ciprofloxacin. 2. 1.82. Didanosine + iraconazole. 3. 2.73. Didanosine + ketoconazole. 2. 1.82. Efavirenz ...

  8. Detection of AR-V7 mRNA in whole blood may not predict the effectiveness of novel endocrine drugs for castration-resistant prostate cancer.

    Science.gov (United States)

    Takeuchi, Takumi; Okuno, Yumiko; Hattori-Kato, Mami; Zaitsu, Masayoshi; Mikami, Koji

    2016-01-01

    A splice variant of androgen receptor (AR), AR-V7, lacks in androgen-binding portion and leads to aggressive cancer characteristics. Reverse transcription-polymerase chain reactions (PCRs) and subsequent nested PCRs for the amplification of AR-V7 and prostate-specific antigen (PSA) transcripts were done for whole blood of patients with prostate cancer and male controls. With primary reverse transcription PCRs, AR-V7 and PSA were detected in 4.5% and 4.7% of prostate cancer, respectively. With nested PCRs, AR-V7 messenger RNA (mRNA) was positive in 43.8% of castration-sensitive prostate cancer and 48.1% of castration-resistant prostate cancer (CRPC), while PSA mRNA was positive in 6.3% of castration-sensitive prostate cancer and 18.5% of CRPC. Whole-blood samples of controls showed AR-V7 mRNA expression by nested PCR. Based on multivariate analysis, expression of AR-V7 mRNA in whole blood was not significantly correlated with clinical parameters and PSA mRNA in blood, while univariate analysis showed a correlation between AR-V7 mRNA and metastasis at initial diagnosis. Detection of AR-V7 mRNA did not predict the reduction of serum PSA in patients with CRPC following abiraterone and enzalutamide administration. In conclusion, AR-V7 mRNA expression in normal hematopoietic cells may have annihilated the manifestation of aggressiveness of prostate cancer and the prediction of the effectiveness of abiraterone and enzalutamide by the assessment of AR-V7 mRNA in blood.

  9. Driving a decade of change: HIV/AIDS, patents and access to medicines for all.

    Science.gov (United States)

    Hoen, Ellen 't; Berger, Jonathan; Calmy, Alexandra; Moon, Suerie

    2011-03-27

    Since 2000, access to antiretroviral drugs to treat HIV infection has dramatically increased to reach more than five million people in developing countries. Essential to this achievement was the dramatic reduction in antiretroviral prices, a result of global political mobilization that cleared the way for competitive production of generic versions of widely patented medicines.Global trade rules agreed upon in 1994 required many developing countries to begin offering patents on medicines for the first time. Government and civil society reaction to expected increases in drug prices precipitated a series of events challenging these rules, culminating in the 2001 World Trade Organization's Doha Declaration on the Agreement on Trade-Related Aspects of Intellectual Property Rights and Public Health. The Declaration affirmed that patent rules should be interpreted and implemented to protect public health and to promote access to medicines for all. Since Doha, more than 60 low- and middle-income countries have procured generic versions of patented medicines on a large scale.Despite these changes, however, a "treatment timebomb" awaits. First, increasing numbers of people need access to newer antiretrovirals, but treatment costs are rising since new ARVs are likely to be more widely patented in developing countries. Second, policy space to produce or import generic versions of patented medicines is shrinking in some developing countries. Third, funding for medicines is falling far short of needs. Expanded use of the existing flexibilities in patent law and new models to address the second wave of the access to medicines crisis are required.One promising new mechanism is the UNITAID-supported Medicines Patent Pool, which seeks to facilitate access to patents to enable competitive generic medicines production and the development of improved products. Such innovative approaches are possible today due to the previous decade of AIDS activism. However, the Pool is just one of a

  10. Driving a decade of change: HIV/AIDS, patents and access to medicines for all

    Science.gov (United States)

    2011-01-01

    Since 2000, access to antiretroviral drugs to treat HIV infection has dramatically increased to reach more than five million people in developing countries. Essential to this achievement was the dramatic reduction in antiretroviral prices, a result of global political mobilization that cleared the way for competitive production of generic versions of widely patented medicines. Global trade rules agreed upon in 1994 required many developing countries to begin offering patents on medicines for the first time. Government and civil society reaction to expected increases in drug prices precipitated a series of events challenging these rules, culminating in the 2001 World Trade Organization's Doha Declaration on the Agreement on Trade-Related Aspects of Intellectual Property Rights and Public Health. The Declaration affirmed that patent rules should be interpreted and implemented to protect public health and to promote access to medicines for all. Since Doha, more than 60 low- and middle-income countries have procured generic versions of patented medicines on a large scale. Despite these changes, however, a "treatment timebomb" awaits. First, increasing numbers of people need access to newer antiretrovirals, but treatment costs are rising since new ARVs are likely to be more widely patented in developing countries. Second, policy space to produce or import generic versions of patented medicines is shrinking in some developing countries. Third, funding for medicines is falling far short of needs. Expanded use of the existing flexibilities in patent law and new models to address the second wave of the access to medicines crisis are required. One promising new mechanism is the UNITAID-supported Medicines Patent Pool, which seeks to facilitate access to patents to enable competitive generic medicines production and the development of improved products. Such innovative approaches are possible today due to the previous decade of AIDS activism. However, the Pool is just one of

  11. Glycogen synthase kinase-3 inhibitors suppress the AR-V7-mediated transcription and selectively inhibit cell growth in AR-V7-positive prostate cancer cells.

    Science.gov (United States)

    Nakata, Daisuke; Koyama, Ryokichi; Nakayama, Kazuhide; Kitazawa, Satoshi; Watanabe, Tatsuya; Hara, Takahito

    2017-06-01

    Recent evidence suggests that androgen receptor (AR) splice variants, including AR-V7, play a pivotal role in resistance to androgen blockade in prostate cancer treatment. The development of new therapeutic agents that can suppress the transcriptional activities of AR splice variants has been anticipated as the next generation treatment of castration-resistant prostate cancer. High-throughput screening of AR-V7 signaling inhibitors was performed using an AR-V7 reporter system. The effects of a glycogen synthase kinase-3 (GSK3) inhibitor, LY-2090314, on endogenous AR-V7 signaling were evaluated in an AR-V7-positive cell line, JDCaP-hr, by quantitative reverse transcription polymerase chain reaction. The relationship between AR-V7 signaling and β-catenin signaling was assessed using RNA interference. The effect of LY-2090314 on cell growth in various prostate cancer cell lines was also evaluated. We identified GSK3 inhibitors as transcriptional suppressors of AR-V7 using a high-throughput screen with an AR-V7 reporter system. LY-2090314 suppressed the reporter activity and endogenous AR-V7 activity in JDCaP-hr cells. Because silencing of β-catenin partly rescued the suppression, it was evident that the suppression was mediated, at least partially, via the activation of β-catenin signaling. AR-V7 signaling and β-catenin signaling reciprocally regulate each other in JDCaP-hr cells, and therefore, GSK3 inhibition can repress AR-V7 transcriptional activity by accumulating intracellular β-catenin. Notably, LY-2090314 selectively inhibited the growth of AR-V7-positive prostate cancer cells in vitro. Our findings demonstrate the potential of GSK3 inhibitors in treating advanced prostate cancer driven by AR splice variants. In vivo evaluation of AR splice variant-positive prostate cancer models will help illustrate the overall significance of GSK3 inhibitors in treating prostate cancer. © 2017 Wiley Periodicals, Inc.

  12. The ARV roll out and the disability grant: a South African dilemma?

    Science.gov (United States)

    de Paoli, Marina Manuela; Mills, Elizabeth Anne; Grønningsaeter, Arne Backer

    2012-02-16

    Prior to the antiretroviral (ARV) drug roll out in 2004, people living with HIV (PLHIV) in South Africa received disability grants when they were defined as "AIDS-sick". In the absence of available and effective medication, a diagnosis of AIDS portended disability. The disability grant is a critical component of South Africa's social security system, and plays an important role in addressing poverty among PLHIV. Given the prevalence of unemployment and poverty, disability grants ensure access to essential resources, like food, for PLHIV. Following the ARV roll out in South Africa, PLHIV experienced improved health that, in turn, affected their grant eligibility. Our aim is to explore whether PLHIV reduced or stopped treatment to remain eligible for the disability grant from the perspectives of both PLHIV and their doctors. A mixed-methods design with concurrent triangulation was applied. We conducted: (1) in-depth semi-structured interviews with 29 PLHIV; (2) in-depth semi-structured interviews with eight medical doctors working in the public sector throughout the Cape Peninsula; (3) three focus group discussions with programme managers, stakeholders and community workers; and (4) a panel survey of 216 PLHIV receiving ARVs. Unemployment and poverty were the primary concerns for PLHIV and the disability grant was viewed as a temporary way out of this vicious cycle. Although loss of the disability grant significantly affected the well-being of PLHIV, they did not discontinue ARVs. However, in a number of subtle ways, PLHIV "tipped the scales" to lower the CD4 count without stopping ARVs completely. Grant criteria were deemed ad hoc, and doctors struggled to balance economic and physical welfare when assessing eligibility. It is crucial to provide sustainable economic support in conjunction with ARVs in order to make "positive living" a reality for PLHIV. A chronic illness grant, a basic income grant or an unemployment grant could provide viable alternatives when the

  13. Impact of the trade-related aspects of intellectual property rights (TRIPS) agreement on India as a supplier of generic antiretrovirals.

    Science.gov (United States)

    Babovic, Sonja; Wasan, Kishor M

    2011-03-01

    This is a commentary on how the trade-related aspects of intellectual property rights (TRIPS) agreement has impacted India as a supplier of generic antiretrovirals (ARVs). We provide a systematic review of the issues related to the TRIPS agreement that affects India. This includes discussion around (a) the legal landscape underpinning India as a supplier of generic ARVs; (b) supply of second-line ARVs; and (c) the future of generic drug production in India. The proclamation into force of TRIPS-compliant intellectual property law in India is likely to affect its position as a supplier of affordable ARVs, especially drugs brought to market after 2005. Currently, mechanisms exist for the generic production of almost all ARVs in India, including second-line drugs; however, the manufacture of these drugs by generic pharmaceutical companies may require additional market incentives. Compulsory licensing may emerge as an additional mechanism by which India can provide affordable versions of patented drugs to Least Developed Countries (LDCs). Copyright © 2010 Wiley-Liss, Inc.

  14. Antiretroviral Drug Use in a Cross-Sectional Population Survey in Africa: NIMH Project Accept (HPTN 043).

    Science.gov (United States)

    Fogel, Jessica M; Clarke, William; Kulich, Michal; Piwowar-Manning, Estelle; Breaud, Autumn; Olson, Matthew T; Marzinke, Mark A; Laeyendecker, Oliver; Fiamma, Agnès; Donnell, Deborah; Mbwambo, Jessie K K; Richter, Linda; Gray, Glenda; Sweat, Michael; Coates, Thomas J; Eshleman, Susan H

    2017-02-01

    Antiretroviral (ARV) drug treatment benefits the treated individual and can prevent HIV transmission. We assessed ARV drug use in a community-randomized trial that evaluated the impact of behavioral interventions on HIV incidence. Samples were collected in a cross-sectional survey after a 3-year intervention period. ARV drug testing was performed using samples from HIV-infected adults at 4 study sites (Zimbabwe; Tanzania; KwaZulu-Natal and Soweto, South Africa; survey period 2009-2011) using an assay that detects 20 ARV drugs (6 nucleoside/nucleotide reverse transcriptase inhibitors, 3 nonnucleoside reverse transcriptase inhibitors, and 9 protease inhibitors; maraviroc; raltegravir). ARV drugs were detected in 2011 (27.4%) of 7347 samples; 88.1% had 1 nonnucleoside reverse transcriptase inhibitors ± 1-2 nucleoside/nucleotide reverse transcriptase inhibitors. ARV drug detection was associated with sex (women>men), pregnancy, older age (>24 years), and study site (P < 0.0001 for all 4 variables). ARV drugs were also more frequently detected in adults who were widowed (P = 0.006) or unemployed (P = 0.02). ARV drug use was more frequent in intervention versus control communities early in the survey (P = 0.01), with a significant increase in control (P = 0.004) but not in intervention communities during the survey period. In KwaZulu-Natal, a 1% increase in ARV drug use was associated with a 0.14% absolute decrease in HIV incidence (P = 0.018). This study used an objective, biomedical approach to assess ARV drug use on a population level. This analysis identified factors associated with ARV drug use and provided information on ARV drug use over time. ARV drug use was associated with lower HIV incidence at 1 study site.

  15. Comprehensive Quantitative Analysis of 32 Chemical Ingredients of a Chinese Patented Drug Sanhuang Tablet

    OpenAIRE

    Hau-Yee Fung; Yan Lang; Hing-Man Ho; Tin-Long Wong; Dik-Lung Ma; Chung-Hang Leung; Quan-Bin Han

    2017-01-01

    Sanhuang Tablet (SHT) is a Chinese patented drug commonly used for the treatment of inflammations of the respiratory tract, gastrointestinal tract, and skin. It contains a special medicinal composition including the single compound berberine hydrochloride, extracts of Scutellariae Radix and Rhei Radix et Rhizoma, as well as the powder of Rhei Radix et Rhizoma. Despite advances in analytical techniques, quantitative evaluation of a Chinese patented drug like SHT remains a challenge due to the ...

  16. Patent protection strategies

    Directory of Open Access Journals (Sweden)

    Himanshu Gupta

    2010-01-01

    Full Text Available It is widely recognized that the pharmaceutical industry faces serious financial challenges. Large numbers of blockbuster drugs are losing patent protection and going generic. The pipeline of new drugs is too sparse to fill the gap and generate a platform for future growth. Moreover, many of the new products are biologics with much narrower target patient populations and comparatively higher prices relative to traditional pharmaceuticals. So now the time has come for pharmaceutical scientists to have a better understanding of patent fundamentals. This need is illustrated by analyses of key scientific and legal issues that arose during recent patent infringement cases involving Prozac, Prilosec, and Buspar. Facing this scenario, the pharmaceutical industry has moved to accelerate drug development process and to adopt at the same time different strategies to extend the life time of the patent monopoly to provide the economic incentives and utilizing it for drug discovery and development. This review covers the need of patent protection and various strategies to extend the patent.

  17. Natural products against cancer: A comprehensive bibliometric study of the research projects, publications, patents and drugs

    Directory of Open Access Journals (Sweden)

    Jian Du

    2014-01-01

    Full Text Available Objectives: To analyze multi-source data including awards, publications, patents and drugs, and try to draw the whole landscape of the research and development community in the area of natural products (NPs against cancer. Materials and Methods: Awards, publications, patents and drugs data from National Institute of Health/Natural Science Foundation of China (NIH/NSFC, PubMed, Derwent Innovation Index and Cortellis were collected. Bibliometric methodologies and technology are used to investigate publications/patents/drugs, their contents and relationships. Results: NIH and NSFC respectively demonstrated a stable and sustained expenditure growth in this area. The number of publications is continuously increasing. Yet the annual patent applications worldwide and FDA drug approvals were little changed or not obviously fluctuated in 2003-2013. USA and several Asia-pacific countries/territories are important contributing powers. We described the evolution of major research topics by those MeSH Major Topics indexed in PubMed with the largest growth range in three intervals, and analyzed hot research topics in the recent 10 years which include NPs or NPs derivatives, cell line/animal model, laboratory technologies and activation mechanisms. Conclusions: China published the most publications and received the most patent applications, but drug discovery performance is no better than USA and Japan. Research on anti-neoplastic structures and compounds originated from Chinese traditional medicine (TCM, medicinal plants, herbal medicine and marine NPs are major research topics in the recent 10 years. There still exits translational gap between basic research and drug discovery. Translational research should be undertaken to strengthen the applicability of NPs.

  18. Antiretroviral Drug Use in a Cohort of HIV-Uninfected Women in the United States: HIV Prevention Trials Network 064.

    Directory of Open Access Journals (Sweden)

    Iris Chen

    Full Text Available Antiretroviral (ARV drug use was analyzed in HIV-uninfected women in an observational cohort study conducted in 10 urban and periurban communities in the United States with high rates of poverty and HIV infection. Plasma samples collected in 2009-2010 were tested for the presence of 16 ARV drugs. ARV drugs were detected in samples from 39 (2% of 1,806 participants: 27/181 (15% in Baltimore, MD and 12/179 (7% in Bronx, NY. The ARV drugs detected included different combinations of non-nucleoside reverse transcriptase inhibitors and protease inhibitors (1-4 drugs/sample. These data were analyzed in the context of self-reported data on ARV drug use. None of the 39 women who had ARV drugs detected reported ARV drug use at any study visit. Further research is needed to evaluate ARV drug use by HIV-uninfected individuals.

  19. (ARV) treatment training programme

    African Journals Online (AJOL)

    Winnie

    Keywords:ARV, training, evaluation, HIV, health care provider. RÉSUMÉ .... workers, adequate laboratory facilities for measuring viral load and .... questionnaire guide, the head of unit of the ART ...... begins its scale-up programme. Some of ...

  20. Drug delivery via porous silicon: a focused patent review.

    Science.gov (United States)

    Kulyavtsev, Paulina A; Spencer, Roxanne P

    2017-03-01

    Although silicon is more commonly associated with computer chips than with drug delivery, with the discovery that porous silicon is a viable biocompatible material, mesoporous silicon with pores between 2 and 50 nm has been loaded with small molecule and biomolecule therapeutics and safely implanted for controlled release. As porous silicon is readily oxidized, porous silica must also be considered for drug delivery applications. Since 2010, only a limited number of US patents have been granted, primarily for ophthalmologic and immunotherapy applications, in contrast to the growing body of technical literature in this area.

  1. New drugs or alternative therapy to blurring the symptoms of fibromyalgia-a patent review.

    Science.gov (United States)

    Oliveira, Marlange A; Guimarães, Adriana G; Araújo, Adriano A S; Quintans-Júnior, Lucindo J; Quintans, Jullyana S S

    2017-10-01

    Fibromyalgia (FM) is a musculoskeletal condition characterized by chronic widespread pain, tenderness and often accompanied by other comorbid conditions such as depression, anxiety, chronic fatigue, among others. Now, we aimed to survey the recent patents describing new drugs or alternative therapy for FM. Areas covered: This review covers the therapeutic patents published between 2010 and 2017 from specialized search databases (WIPO, DERWENT, INPI, ESPANET and USPTO) that report the discovery of new drugs or pharmacologic alternative for the treatment of FM. Expert opinion: New therapeutic substances have been proposed in the last seven years. At least as it has been found in our survey, most are still in the pre-clinical phase of the study, and its clinical applicability is unclear. However, other therapeutic approaches were found in patents such as well-established drugs in the market in combination or drug repositioning that combines the 'new analgesic' effects with the old side effects. Hence, it is a safe approach for pharmaceutical market, but poorer to patients who need a radical innovation. So, there is the emerging need for further studies on the safety and efficacy of such therapeutic measures and the search for improvement of side effects, as well as the development of new drugs that are unorthodox for different FM symptoms.

  2. HIV Genetic Diversity and Drug Resistance

    Science.gov (United States)

    Santos, André F.; Soares, Marcelo A.

    2010-01-01

    Most of the current knowledge on antiretroviral (ARV) drug development and resistance is based on the study of subtype B of HIV-1, which only accounts for 10% of the worldwide HIV infections. Cumulative evidence has emerged that different HIV types, groups and subtypes harbor distinct biological properties, including the response and susceptibility to ARV. Recent laboratory and clinical data highlighting such disparities are summarized in this review. Variations in drug susceptibility, in the emergence and selection of specific drug resistance mutations, in viral replicative capacity and in the dynamics of resistance acquisition under ARV selective pressure are discussed. Clinical responses to ARV therapy and associated confounding factors are also analyzed in the context of infections by distinct HIV genetic variants. PMID:21994646

  3. Dual Therapy Treatment Strategies for the Management of Patients Infected with HIV: A Systematic Review of Current Evidence in ARV-Naive or ARV-Experienced, Virologically Suppressed Patients.

    Science.gov (United States)

    Baril, Jean-Guy; Angel, Jonathan B; Gill, M John; Gathe, Joseph; Cahn, Pedro; van Wyk, Jean; Walmsley, Sharon

    2016-01-01

    We reviewed the current literature regarding antiretroviral (ARV)-sparing therapy strategies to determine whether these novel regimens can be considered appropriate alternatives to standard regimens for the initial treatment of ARV-naive patients or as switch therapy for those patients with virologically suppressed HIV infection. A search for studies related to HIV dual therapy published from January 2000 through April 2014 was performed using Biosis, Derwent Drug File, Embase, International Pharmaceutical Abstracts, Medline, Pascal, SciSearch, and TOXNET databases; seven major trial registries, and the abstracts of major conferences. Using predetermined criteria for inclusion, an expert review committee critically reviewed and qualitatively evaluated all identified trials for efficacy and safety results and potential limitations. Sixteen studies of dual therapy regimens were critiqued for the ARV-naive population. Studies of a protease inhibitor/ritonavir in combination with the integrase inhibitor raltegravir or the nucleoside reverse transcriptase inhibitor lamivudine provided the most definitive evidence supporting a role for dual therapy. In particular, lopinavir/ritonavir or darunavir/ritonavir combined with raltegravir and lopinavir/ritonavir combined with lamivudine demonstrated noninferiority to standard of care triple therapy after 48 weeks of treatment. Thirteen trials were critiqued in ARV-experienced, virologically suppressed patients. The virologic efficacy outcomes were mixed. Although overall data regarding toxicity are limited, when compared with standard triple therapy, certain dual therapy regimens may offer advantages in renal function, bone mineral density, and limb fat changes; however, some dual combinations may elevate lipid or bilirubin levels. The potential benefits of dual therapy regimens include reduced toxicity, improved tolerability and adherence, and reduced cost. Although the data reviewed here provide valuable insights into the

  4. Como pesquisar o perfil patentário de um fármaco: o caso Efavirenz How to determine the patent profile of a drug: a case study of Efavirenz

    Directory of Open Access Journals (Sweden)

    Jaqueline Mendes Soares

    2010-01-01

    Full Text Available The importance of the patent system for researchers, especially in chemistry and related areas, is undeniable. In this context, this work aims at guiding the search in major search engines of patents, in order to map the patents related to a specific chemical compound and identify the material that each patent document protects. In this case study, it was performed a search for the drug efavirenz to demonstrate how to conduct a literature search in patents databases and to map patent applications at national and international levels.

  5. Drugs for dengue: a patent review (2010-2014).

    Science.gov (United States)

    Beesetti, Hemalatha; Khanna, Navin; Swaminathan, Sathyamangalam

    2014-11-01

    Almost half the global population is estimated to be at risk of contracting dengue infection. Of the 400 million infections estimated to occur annually, 4 million can be potentially life-threatening leading to vascular leakage and shock. The only treatment available to severe dengue patients is fluid replacement therapy and supportive care. A drug for treating dengue is an urgent need. This article endeavors to provide an overview of the experimental dengue drugs being developed around the world as reflected in the recent patent literature spanning the last few years (2010-2014). Dengue drug development is essentially in its infancy and currently hobbled by multiple factors including a poor understanding of the molecular mechanism of severe disease and lack of reliable small animal model for preclinical drug evaluation. More intense R&D coupled to setting up product development partnerships to facilitate the efficient movement of a drug molecule from the laboratory to the clinic is needed to make antiviral therapy for dengue a reality in the coming future.

  6. Application of nanohydrogels in drug delivery systems: recent patents review.

    Science.gov (United States)

    Dalwadi, Chintan; Patel, Gayatri

    2015-01-01

    Nanohydrogel combines the advantages of hydrogel and nano particulate systems. Similar to the hydrogel and macrogel, nanohydrogel can protect the drug and control drug release by stimuli responsive conformation or biodegradable bond into the polymer networks. Nanohydrogel has drawn huge interest due to their potential applications, such as carrier in target-specific controlled drug delivery, absorbents, chemical/biological sensors, and bio-mimetic materials. Similar to the nanoparticles, stimuli responsive nanohydrogel can easily be delivered in the liquid form for parenteral drug delivery application. This review highlights the methods to prepare nanohydrogel based on natural and synthetic polymers for diverse applications in drug delivery. It also encompasses the drug loading and drug release mechanism of the nanohydrogel formulation and patents related to the composition and chemical methods for preparation of nanohydrogel formulation with current status in clinical trials.

  7. AR-v7 protein expression is regulated by protein kinase and phosphatase

    Science.gov (United States)

    Li, Yinan; Xie, Ning; Gleave, Martin E.; Rennie, Paul S.; Dong, Xuesen

    2015-01-01

    Failure of androgen-targeted therapy and progression of castration-resistant prostate cancer (CRPC) are often attributed to sustained expression of the androgen receptor (AR) and its major splice variant, AR-v7. Although the new generation of anti-androgens such as enzalutamide effectively inhibits AR activity, accumulating pre-clinical and clinical evidence indicates that AR-v7 remains constitutively active in driving CRPC progression. However, molecular mechanisms which control AR-v7 protein expression remain unclear. We apply multiple prostate cancer cell models to demonstrate that enzalutamide induces differential activation of protein phosphatase-1 (PP-1) and Akt kinase depending on the gene context of cancer cells. The balance between PP-1 and Akt activation governs AR phosphorylation status and activation of the Mdm2 ubiquitin ligase. Mdm2 recognizes phosphorylated serine 213 of AR-v7, and induces AR-v7 ubiquitination and protein degradation. These findings highlight the decisive roles of PP-1 and Akt for AR-v7 protein expression and activities when AR is functionally blocked. PMID:26378044

  8. Research on Fairing design and CFD Analysis of Submarine Pipeline Inspection ARV

    Directory of Open Access Journals (Sweden)

    Jin Xiaojian

    2017-01-01

    Full Text Available Along with the fast development of the ocean exploitation, the cost-effective requirement of autonomous & remotely operated vehicle (ARV, which can perform more complicated missions such as the oil exploitation and the inspection of the submarine pipeline is more urgent. The submarine pipeline inspection ARV can help us better understand, protect and efficiently utilize them for human welfare. Fairing design of a new detection ARV are introduced in this paper. In order to select an appropriate thruster that will achieve the required speed of the ARV, the ANSYS-CFX tools are used to predicted the drag force. The CFD results reveal the distribution of velocity and pressure values of the ARV. In order to verify the CFD modeling process, a towed body was developed and analyzed, compared against the corresponding physical test data.

  9. Dual Therapy Treatment Strategies for the Management of Patients Infected with HIV: A Systematic Review of Current Evidence in ARV-Naive or ARV-Experienced, Virologically Suppressed Patients.

    Directory of Open Access Journals (Sweden)

    Jean-Guy Baril

    Full Text Available We reviewed the current literature regarding antiretroviral (ARV-sparing therapy strategies to determine whether these novel regimens can be considered appropriate alternatives to standard regimens for the initial treatment of ARV-naive patients or as switch therapy for those patients with virologically suppressed HIV infection.A search for studies related to HIV dual therapy published from January 2000 through April 2014 was performed using Biosis, Derwent Drug File, Embase, International Pharmaceutical Abstracts, Medline, Pascal, SciSearch, and TOXNET databases; seven major trial registries, and the abstracts of major conferences. Using predetermined criteria for inclusion, an expert review committee critically reviewed and qualitatively evaluated all identified trials for efficacy and safety results and potential limitations.Sixteen studies of dual therapy regimens were critiqued for the ARV-naive population. Studies of a protease inhibitor/ritonavir in combination with the integrase inhibitor raltegravir or the nucleoside reverse transcriptase inhibitor lamivudine provided the most definitive evidence supporting a role for dual therapy. In particular, lopinavir/ritonavir or darunavir/ritonavir combined with raltegravir and lopinavir/ritonavir combined with lamivudine demonstrated noninferiority to standard of care triple therapy after 48 weeks of treatment. Thirteen trials were critiqued in ARV-experienced, virologically suppressed patients. The virologic efficacy outcomes were mixed. Although overall data regarding toxicity are limited, when compared with standard triple therapy, certain dual therapy regimens may offer advantages in renal function, bone mineral density, and limb fat changes; however, some dual combinations may elevate lipid or bilirubin levels.The potential benefits of dual therapy regimens include reduced toxicity, improved tolerability and adherence, and reduced cost. Although the data reviewed here provide valuable

  10. Promosi Kesehatan Nola Pender Berpengaruh Terhadap Pengetahuan dan Kepatuhan ODHA Minum ARV

    Directory of Open Access Journals (Sweden)

    Tuti Asrianti Utami

    2017-05-01

    Full Text Available The success rate of ARV therapy depends on the adherence of HIV-AIDS patients in ARV treatment. The purpose of this study was to analyze the effect of NolaPender health promotion to improve the knowledge and adherence of PLWHA (People living with HIV-AIDS with ARV in SintCarolus Health Service (SCHS and Persahabatan General Hospital (PGH. This study used a Pre-Post test Quasi Eksperimantal Non Equivalent Control Group and a total sample of 90 respondents were recruited through the use of consecutive sampling with inclusion criteria where 45 respondents served as intervention group in SCHS and the remaining as control group in PGH from May-June 2016. The result showed most respondents were in the late adulthood stage (36-55 years old, male, having advanced education, working, exposed to counseling service, having family support as well as peer group support, easy in reaching health service and with health insurance. NolaPender health promotion increased the knowledge of ARV (mean score pre intervention was 5.31 to post intervention 7.04, and improving the adherence of taking ARV from moderate to good adherence as many as 51.1%. There was an effect of Nola Pender health promotion using booklet to respondents’ knowledge (p-value=0.000 from 13.3% to 91.1% and also effect of knowledge improvement of ARV to the adherence of taking ARV, with the support from peer group from 30.2% to 87.2%. The study recommends to continue this program of Nola Pender health promotion for PLWHA taking ARV in a structured and well planned system.

  11. Patented drug extension strategies on healthcare spending: a cost-evaluation analysis.

    Science.gov (United States)

    Vernaz, Nathalie; Haller, Guy; Girardin, François; Huttner, Benedikt; Combescure, Christophe; Dayer, Pierre; Muscionico, Daniel; Salomon, Jean-Luc; Bonnabry, Pascal

    2013-01-01

    Drug manufacturers have developed "evergreening" strategies to compete with generic medication after patent termination. These include marketing of slightly modified follow-on drugs. We aimed to estimate the financial impact of these drugs on overall healthcare costs and also to examine the impact of listing these drugs in hospital restrictive drug formularies (RDFs) on the healthcare system as a whole ("spillover effect"). We used hospital and community pharmacy invoice office data in the Swiss canton of Geneva to calculate utilisation of eight follow-on drugs in defined daily doses between 2000 and 2008. "Extra costs" were calculated for three different scenarios assuming replacement with the corresponding generic equivalent for prescriptions of (1) all brand (i.e., initially patented) drugs, (2) all follow-on drugs, or (3) brand and follow-on drugs. To examine the financial spillover effect we calculated a monthly follow-on drug market share in defined daily doses for medications prescribed by hospital physicians but dispensed in community pharmacies, in comparison to drugs prescribed by non-hospital physicians in the community. Estimated "extra costs" over the study period were €15.9 (95% CI 15.5; 16.2) million for scenario 1, €14.4 (95% CI 14.1; 14.7) million for scenario 2, and €30.3 (95% CI 29.8; 30.8) million for scenario 3. The impact of strictly switching all patients using proton-pump inhibitors to esomeprazole at admission resulted in a spillover "extra cost" of €330,300 (95% CI 276,100; 383,800), whereas strictly switching to generic cetirizine resulted in savings of €7,700 (95% CI 4,100; 11,100). Overall we estimated that the RDF resulted in "extra costs" of €503,600 (95% CI 444,500; 563,100). Evergreening strategies have been successful in maintaining market share in Geneva, offsetting competition by generics and cost containment policies. Hospitals may be contributing to increased overall healthcare costs by listing follow-on drugs in

  12. A patent extension proposal to end the underrepresentation of women in clinical trials and secure meaningful drug guidance for women.

    Science.gov (United States)

    Hathaway, Cynthia

    2012-01-01

    Historically, women have been systematically excluded from or underrepresented in human clinical trials of new drugs. Due to fundamental physiological differences between women and men with regard to how drugs work in the human body, testing of drugs in men alone can both deny women the full benefit of a drug and cause them to suffer from increased adverse side effects. Attempts to reform drug development law and agency practices to resolve this problem have met with only partial success. Proposed herein is a patent term extension and for studies in women, modeled upon the pediatric patent term extension, but with several key differences intended to reduce the cost to the public and fund auxiliary programs to address off-patent medicines as well. Such an extension would incentivize this research and provide meaningful guidance to women and their physicians.

  13. Patents and nanomedicine.

    Science.gov (United States)

    Bawa, Raj

    2007-06-01

    Big pharma's business model, which relies on a few blockbusters to generate profits, is clearly broken. Patent expiration on numerous blockbusters in recent years is already altering the drug landscape. Drug companies are also facing other challenges that necessitate development and implementation of novel R&D strategies, including those that focus on nanotechnology and miniaturization. Clearly, there is enormous excitement and expectation regarding nanomedicine's potential impact. However, securing valid and defensible patent protection will be critical. Although early forecasts for nanomedicine commercialization are encouraging, there are numerous bottlenecks as well. One of the major hurdles is an emerging thicket of patent claims, resulting primarily from patent proliferation as well as continued issuance of surprisingly broad patents by the US Patent and Trademark Office (PTO). Adding to this confusion is the fact that the US National Nanotechnology Initiative's widely cited definition of nanotechnology is inaccurate and irrelevant from a nanomedicine perspective. It is also the cause of the inadequate patent classification system that was recently unveiled by the PTO. All of this is creating a chaotic, tangled patent landscape in various sectors of nanomedicine where the competing players are unsure of the validity and enforceability of numerous issued patents. If this trend continues, it could stifle competition and limit access to some inventions. Therefore, reforms are urgently needed at the PTO to address problems ranging from poor patent quality and questionable examination practices to inadequate search capabilities, rising attrition, poor employee morale and a skyrocketing patent application backlog. Only a robust patent system will stimulate the development of commercially viable nanomedicine products that can drastically improve a patient's quality of life and reduce healthcare costs.

  14. Social arv og ulighed

    DEFF Research Database (Denmark)

    Jensen, Bente

    2017-01-01

    Artiklen søger at komme tættere på spørgsmål om hvordan dagtilbud kan gøre en forskel for social udsatte børn ved for det første at indkredse forskning om dagtilbuds betydning set i relation til en social arv- og ulighedsproblematik. For det andet belyses eksempler fra dansk interventionsforskning...

  15. Prevalence of possible drug-drug interactions between antiretroviral agents in different age groups in a section of the private health care sector setting in South Africa.

    Science.gov (United States)

    Katende-Kyenda, N L; Lubbe, M S; Serfontein, J H P; Truter, I

    2008-08-01

    The chronic nature of human immunodeficiency virus (HIV) infection requires lifelong highly active antiretroviral (ARV) therapy (HAART) to continuously suppress HIV-1 viral replication, thus reducing morbidity and mortality. HAART is restricted by complex dosing, drug-drug interactions (DDIs) and toxicities. To determine the prevalence of possible DDIs between ARV drugs in different age groups in a section of the private primary health care sector in South Africa. A quantitative, retrospective drug utilization review was performed on 47 085 ARV prescriptions claimed through a national medicine claims database during 2006. Possible DDIs identified were classified according to a clinical significance rating as described by Tatro [Drug Interaction Facts 2005. St Louis, MO: Facts and Comparisons (2005)]. The total number of patients who received prescriptions that were claimed through the medicine claims database was 275 424, of whom 25.11% were males, 28.28% were females and the gender of 46.61% patients was unknown. Of the total number of patients, 3.27% were HIV patients of which an average of 5.23 +/- 3.86 ARV prescriptions (n = 47 085) per patient were claimed for representing 4.73% of the total number of prescriptions claimed during the study period (N = 993 804). HIV patients received an average of 2.36 +/- 0.61 ARVs per prescription. Only 4.95% of the prescriptions had one ARV medicine item, 56.04% two, 37.10% three, 1.75% four and 6 years and 12 and 60 years with patients <40 years and < or =60 years having the highest number of DDIs and patients older than 60 years the lowest. The majority of DDIs between the ARVs presented in significance levels 2 and 4. The most important interactions were between: indinavir (IDV) and ritonavir (n = 199); efavirenz (EFV) and lopinavir/ritonavir (n = 65) and EFV and IDV (n = 60) all interacting at level 2. The importance of using drug utilization study as an identification tool to provide insight into the prescribing and

  16. Fixed-Dose Combination Drug Approvals, Patents and Market Exclusivities Compared to Single Active Ingredient Pharmaceuticals.

    Science.gov (United States)

    Hao, Jing; Rodriguez-Monguio, Rosa; Seoane-Vazquez, Enrique

    2015-01-01

    Fixed-dose combinations (FDC) contain two or more active ingredients. The effective patent and exclusivity life of FDC compared to single active ingredient has not been assessed. Trends in FDA approved FDC in the period 1980-2012 and time lag between approval of FDC and single active ingredients in the combination were assessed, and the effective patent and exclusivity life of FDC was compared with their single active ingredients. New molecular entities (NMEs), new therapeutic biologics license applications (BLAs) and FDC data were collected from the FDA Orange Book and Drugs@FDA. Analysis included FDC containing one or more NMEs or BLAs at first FDA approval (NMEs-FDC) and only already marketed drugs (Non-NMEs-FDC). Descriptive, Kruskal-Wallis and Wilcoxon Rank Sum analyses were performed. During the study period, the FDA approved 28 NMEs-FDC (3.5% of NMEs) and 117 non-NMEs-FDC. FDC approvals increased from 12 in the 1980s to 59 in the 2000s. Non-NMEs-FDC entered the market at a median of 5.43 years (interquartile range 1.74, 10.31) after first FDA approval of single active ingredients in the combination. The Non-NMEs-FDC entered the market at a median of 2.33 years (-7.55, 2.39) before approval of generic single active ingredient. Non-NME-FDC added a median of 9.70 (2.75, 16.24) years to the patent and exclusivity life of the single active ingredients in the combination. FDC approvals significantly increased over the last twenty years. Pharmaceutical companies market FDC drugs shortly before the generic versions of the single ingredients enter the market extending the patent and exclusivity life of drugs included in the combination.

  17. Fixed-Dose Combination Drug Approvals, Patents and Market Exclusivities Compared to Single Active Ingredient Pharmaceuticals.

    Directory of Open Access Journals (Sweden)

    Jing Hao

    Full Text Available Fixed-dose combinations (FDC contain two or more active ingredients. The effective patent and exclusivity life of FDC compared to single active ingredient has not been assessed.Trends in FDA approved FDC in the period 1980-2012 and time lag between approval of FDC and single active ingredients in the combination were assessed, and the effective patent and exclusivity life of FDC was compared with their single active ingredients.New molecular entities (NMEs, new therapeutic biologics license applications (BLAs and FDC data were collected from the FDA Orange Book and Drugs@FDA. Analysis included FDC containing one or more NMEs or BLAs at first FDA approval (NMEs-FDC and only already marketed drugs (Non-NMEs-FDC. Descriptive, Kruskal-Wallis and Wilcoxon Rank Sum analyses were performed.During the study period, the FDA approved 28 NMEs-FDC (3.5% of NMEs and 117 non-NMEs-FDC. FDC approvals increased from 12 in the 1980s to 59 in the 2000s. Non-NMEs-FDC entered the market at a median of 5.43 years (interquartile range 1.74, 10.31 after first FDA approval of single active ingredients in the combination. The Non-NMEs-FDC entered the market at a median of 2.33 years (-7.55, 2.39 before approval of generic single active ingredient. Non-NME-FDC added a median of 9.70 (2.75, 16.24 years to the patent and exclusivity life of the single active ingredients in the combination.FDC approvals significantly increased over the last twenty years. Pharmaceutical companies market FDC drugs shortly before the generic versions of the single ingredients enter the market extending the patent and exclusivity life of drugs included in the combination.

  18. Patented drug extension strategies on healthcare spending: a cost-evaluation analysis.

    Directory of Open Access Journals (Sweden)

    Nathalie Vernaz

    Full Text Available BACKGROUND: Drug manufacturers have developed "evergreening" strategies to compete with generic medication after patent termination. These include marketing of slightly modified follow-on drugs. We aimed to estimate the financial impact of these drugs on overall healthcare costs and also to examine the impact of listing these drugs in hospital restrictive drug formularies (RDFs on the healthcare system as a whole ("spillover effect". METHODS AND FINDINGS: We used hospital and community pharmacy invoice office data in the Swiss canton of Geneva to calculate utilisation of eight follow-on drugs in defined daily doses between 2000 and 2008. "Extra costs" were calculated for three different scenarios assuming replacement with the corresponding generic equivalent for prescriptions of (1 all brand (i.e., initially patented drugs, (2 all follow-on drugs, or (3 brand and follow-on drugs. To examine the financial spillover effect we calculated a monthly follow-on drug market share in defined daily doses for medications prescribed by hospital physicians but dispensed in community pharmacies, in comparison to drugs prescribed by non-hospital physicians in the community. Estimated "extra costs" over the study period were €15.9 (95% CI 15.5; 16.2 million for scenario 1, €14.4 (95% CI 14.1; 14.7 million for scenario 2, and €30.3 (95% CI 29.8; 30.8 million for scenario 3. The impact of strictly switching all patients using proton-pump inhibitors to esomeprazole at admission resulted in a spillover "extra cost" of €330,300 (95% CI 276,100; 383,800, whereas strictly switching to generic cetirizine resulted in savings of €7,700 (95% CI 4,100; 11,100. Overall we estimated that the RDF resulted in "extra costs" of €503,600 (95% CI 444,500; 563,100. CONCLUSIONS: Evergreening strategies have been successful in maintaining market share in Geneva, offsetting competition by generics and cost containment policies. Hospitals may be contributing to increased

  19. Patented Drug Extension Strategies on Healthcare Spending: A Cost-Evaluation Analysis

    Science.gov (United States)

    Vernaz, Nathalie; Haller, Guy; Girardin, François; Huttner, Benedikt; Combescure, Christophe; Dayer, Pierre; Muscionico, Daniel; Salomon, Jean-Luc; Bonnabry, Pascal

    2013-01-01

    Background Drug manufacturers have developed “evergreening” strategies to compete with generic medication after patent termination. These include marketing of slightly modified follow-on drugs. We aimed to estimate the financial impact of these drugs on overall healthcare costs and also to examine the impact of listing these drugs in hospital restrictive drug formularies (RDFs) on the healthcare system as a whole (“spillover effect”). Methods and Findings We used hospital and community pharmacy invoice office data in the Swiss canton of Geneva to calculate utilisation of eight follow-on drugs in defined daily doses between 2000 and 2008. “Extra costs” were calculated for three different scenarios assuming replacement with the corresponding generic equivalent for prescriptions of (1) all brand (i.e., initially patented) drugs, (2) all follow-on drugs, or (3) brand and follow-on drugs. To examine the financial spillover effect we calculated a monthly follow-on drug market share in defined daily doses for medications prescribed by hospital physicians but dispensed in community pharmacies, in comparison to drugs prescribed by non-hospital physicians in the community. Estimated “extra costs” over the study period were €15.9 (95% CI 15.5; 16.2) million for scenario 1, €14.4 (95% CI 14.1; 14.7) million for scenario 2, and €30.3 (95% CI 29.8; 30.8) million for scenario 3. The impact of strictly switching all patients using proton-pump inhibitors to esomeprazole at admission resulted in a spillover “extra cost” of €330,300 (95% CI 276,100; 383,800), whereas strictly switching to generic cetirizine resulted in savings of €7,700 (95% CI 4,100; 11,100). Overall we estimated that the RDF resulted in “extra costs” of €503,600 (95% CI 444,500; 563,100). Conclusions Evergreening strategies have been successful in maintaining market share in Geneva, offsetting competition by generics and cost containment policies. Hospitals may be contributing to

  20. Promosi Kesehatan Nola Pender Berpengaruh Terhadap Pengetahuan dan Kepatuhan ODHA Minum ARV

    OpenAIRE

    Tuti Asrianti Utami

    2017-01-01

    The success rate of ARV therapy depends on the adherence of HIV-AIDS patients in ARV treatment. The purpose of this study was to analyze the effect of NolaPender health promotion to improve the knowledge and adherence of PLWHA (People living with HIV-AIDS) with ARV in SintCarolus Health Service (SCHS) and Persahabatan General Hospital (PGH). This study used a Pre-Post test Quasi Eksperimantal Non Equivalent Control Group and a total sample of 90 respondents were recruited through the use of c...

  1. Expression of Genes for Drug Transporters in the Human Female Genital Tract and Modulatory Effect of Antiretroviral Drugs.

    Directory of Open Access Journals (Sweden)

    Karolin Hijazi

    Full Text Available Anti-retroviral (ARV -based microbicides are one of the strategies pursued to prevent HIV-1 transmission. Delivery of ARV drugs to subepithelial CD4+ T cells at concentrations for protection is likely determined by drug transporters expressed in the cervicovaginal epithelium. To define the role of drug transporters in mucosal disposition of topically applied ARV-based microbicides, these must be tested in epithelial cell line-based biopharmaceutical assays factoring the effect of relevant drug transporters. We have characterised gene expression of influx and efflux drug transporters in a panel of cervicovaginal cell lines and compared this to expression in cervicovaginal tissue. We also investigated the effect of dapivirine, darunavir and tenofovir, currently at advanced stages of microbicides development, on expression of drug transporters in cell lines. Expression of efflux ABC transporters in cervical tissue was best represented in HeLa, Ect1/E6E7 and End1/E6E7 cell lines. Expression of influx OCT and ENT transporters in ectocervix matched expression in Hela while expression of influx SLCO transporters in vagina was best reflected in VK2/E6E7 cell line. Stimulation with darunavir and dapivirine upregulated MRP transporters, including MRP5 involved in transport of tenofovir. Dapivirine also significantly downregulated tenofovir substrate MRP4 in cervical cell lines. Treatment with darunavir and dapivirine showed no significant effect on expression of BCRP, MRP2 and P-glycoprotein implicated in efflux of different ARV drugs. Darunavir strongly induced expression in most cell lines of CNT3 involved in cell uptake of nucleotide/nucleoside analogue reverse transcriptase inhibitors and SLCO drug transporters involved in cell uptake of protease inhibitors. This study provides insight into the suitability of cervicovaginal cell lines for assessment of ARV drugs in transport kinetics studies. The modulatory effect of darunavir and dapivirine on

  2. Expression of Genes for Drug Transporters in the Human Female Genital Tract and Modulatory Effect of Antiretroviral Drugs.

    Science.gov (United States)

    Hijazi, Karolin; Cuppone, Anna M; Smith, Kieron; Stincarelli, Maria A; Ekeruche-Makinde, Julia; De Falco, Giulia; Hold, Georgina L; Shattock, Robin; Kelly, Charles G; Pozzi, Gianni; Iannelli, Francesco

    2015-01-01

    Anti-retroviral (ARV) -based microbicides are one of the strategies pursued to prevent HIV-1 transmission. Delivery of ARV drugs to subepithelial CD4+ T cells at concentrations for protection is likely determined by drug transporters expressed in the cervicovaginal epithelium. To define the role of drug transporters in mucosal disposition of topically applied ARV-based microbicides, these must be tested in epithelial cell line-based biopharmaceutical assays factoring the effect of relevant drug transporters. We have characterised gene expression of influx and efflux drug transporters in a panel of cervicovaginal cell lines and compared this to expression in cervicovaginal tissue. We also investigated the effect of dapivirine, darunavir and tenofovir, currently at advanced stages of microbicides development, on expression of drug transporters in cell lines. Expression of efflux ABC transporters in cervical tissue was best represented in HeLa, Ect1/E6E7 and End1/E6E7 cell lines. Expression of influx OCT and ENT transporters in ectocervix matched expression in Hela while expression of influx SLCO transporters in vagina was best reflected in VK2/E6E7 cell line. Stimulation with darunavir and dapivirine upregulated MRP transporters, including MRP5 involved in transport of tenofovir. Dapivirine also significantly downregulated tenofovir substrate MRP4 in cervical cell lines. Treatment with darunavir and dapivirine showed no significant effect on expression of BCRP, MRP2 and P-glycoprotein implicated in efflux of different ARV drugs. Darunavir strongly induced expression in most cell lines of CNT3 involved in cell uptake of nucleotide/nucleoside analogue reverse transcriptase inhibitors and SLCO drug transporters involved in cell uptake of protease inhibitors. This study provides insight into the suitability of cervicovaginal cell lines for assessment of ARV drugs in transport kinetics studies. The modulatory effect of darunavir and dapivirine on expression of drug

  3. DBC1 promotes castration-resistant prostate cancer by positively regulating DNA binding and stability of AR-V7.

    Science.gov (United States)

    Moon, Sue Jin; Jeong, Byong Chang; Kim, Hwa Jin; Lim, Joung Eun; Kwon, Ghee Young; Kim, Jeong Hoon

    2018-03-01

    Constitutively active AR-V7, one of the major androgen receptor (AR) splice variants lacking the ligand-binding domain, plays a key role in the development of castration-resistant prostate cancer (CRPC) and anti-androgen resistance. However, our understanding of the regulatory mechanisms of AR-V7-driven transcription is limited. Here we report DBC1 as a key regulator of AR-V7 transcriptional activity and stability in CRPC cells. DBC1 functions as a coactivator for AR-V7 and is required for the expression of AR-V7 target genes including CDH2, a mesenchymal marker linked to CRPC progression. DBC1 is required for recruitment of AR-V7 to its target enhancers and for long-range chromatin looping between the CDH2 enhancer and promoter. Mechanistically, DBC1 enhances DNA-binding activity of AR-V7 by direct interaction and inhibits CHIP E3 ligase-mediated ubiquitination and degradation of AR-V7 by competing with CHIP for AR-V7 binding, thereby stabilizing and activating AR-V7. Importantly, DBC1 depletion suppresses the tumorigenic and metastatic properties of CRPC cells. Our results firmly establish DBC1 as a critical AR-V7 coactivator that plays a key role in the regulation of DNA binding and stability of AR-V7 and has an important physiological role in CRPC progression.

  4. Affordability and availability of off-patent drugs in the United States—the case for importing from abroad: observational study

    Science.gov (United States)

    Gupta, Ravi; Bollyky, Thomas J; Cohen, Matthew; Ross, Joseph S

    2018-01-01

    Abstract Objectives To evaluate whether off-patent prescription drugs at risk of sudden price increases or shortages in the United States are available from independent manufacturers approved in other well regulated settings around the world. Design Observational study. Setting Off-patent drugs in the USA and approved by the Food and Drug Administration, up to 10 April 2017. Study cohort Novel tablet or capsule prescription drugs approved by the FDA since 1939 that were no longer protected by patents or other market exclusivity and had up to three generic versions. Main outcome measures Number of additional manufacturers that had obtained approval from any of seven non-US regulators with similar standards (European Medicines Agency (European Union), HealthCanada (Canada), Therapeutic Goods Association (Australia), Medsafe (New Zealand), Swissmedic (Switzerland), Medicines Control Council (South Africa), and the Israel Health Ministry). Association with drug characteristics including US orphan drug designation for drugs treating rare diseases, World Health Organization essential medicine designation, treatment area, drug product complexity (that is, with attributes that could complicate establishing bioequivalence or manufacturing), and total Medicaid spending in 2015. Results Of 170 eligible study drugs, more than half (109, 64%) had at least one manufacturer approved by a non-US regulator and 32 (19%) had four or more. Among 44 (26%) drugs with no FDA approved generic versions, 21 (48%) were available from at least one manufacturer approved by one of the seven non-US regulators, and two (5%) by four or more manufacturers. Across all drugs and regulators (including the FDA), 66 (39%) drugs were available from four or more total manufacturers. Of 109 drugs with at least one non-US regulator approved manufacturer, 12 (11%) were approved for patients with rare diseases and 29 (27%) were WHO designated essential medicines; only 12 (11%) were complex products that might

  5. Antiretroviral drug resistance: A guide for the southern African clinician

    African Journals Online (AJOL)

    Both private and public sector see a bewildering clinical array of patients taking failing antiretroviral (ARV) regimens. We intend this article to provide a practical guide to help clinicians understand and manage ARV drug resistance in an African context. ARV resistance is a rapidly evolving field, requiring expertise in dealing ...

  6. [Expert consensus on prescription comment of Chinese traditional patent medicine for promoting the rational use of drugs in Beijing].

    Science.gov (United States)

    Jin, Rui; Zhao, Kui-Jun; Guo, Gui-Ming; Zhang, Bing; Wang, Yu-Guang; Xue, Chun-Miao; Yang, Yi-Heng; Wang, Li-Xia; Li, Guo-Hui; Tang, Jin-Fa; Nie, Li-Xing; Zhang, Xiang-Lin; Zhao, Ting-Ting; Zhang, Yi; Yan, Can; Yuan, Suo-Zhong; Sun, Lu-Lu; Feng, Xing-Zhong; Yan, Dan

    2018-03-01

    With the growth of number of Chinese patent medicines and clinical use, the rational use of Chinese medicine is becoming more and more serious. Due to the complexity of Chinese medicine theory and the uncertainty of clinical application, the prescription review of Chinese patent medicine always relied on experience in their respective, leading to the uncontrolled of clinical rational use. According to the traditional Chinese medicine (TCM) theory and characteristics of the unique clinical therapeutics, based on the practice experience and expertise comments, our paper formed the expert consensus on the prescription review of Chinese traditional patent medicine for promoting the rational use of drugs in Beijing. The objective, methods and key points of prescription review of Chinese patent medicine, were included in this expert consensus, in order to regulate the behavior of prescription and promote rational drug use. Copyright© by the Chinese Pharmaceutical Association.

  7. Supply chain solutions to improve the distribution of antiretroviral drugs (ARVs to clinics in rural areas: A case study of the QwaQwa district

    Directory of Open Access Journals (Sweden)

    Mamolise Mokheseng

    2017-10-01

    Full Text Available This article serves as a case study based on research that was performed in the QwaQwa district in the Free State Province where the distribution of ARVs to the regional Manapo hospital, as well as between the hospital and its peripheral clinics, was interrupted and inconsistent due to problems in the supply chain. An unreliable and interrupted ARV supply chain creates the risk of virus reactivation and eventual patient mortality. The objectives of the study were to explore the problems experienced with the ARV distribution practices at the Manapo hospital, and to recommend ways in which the distribution of ARVs can be improved so that patients can receive an uninterrupted supply. The nature of the topic researched dictated the use of mainly the quantitative research method. The main problems identified include: Wrong and no uniform practice of ordering stock by the hospital and the clinics; lack of reliable, structured transportation from the depot to the hospital; as well as poor inventory management and poor overall communication. Recommendations to address the problems include: Implementing a supply chain planning and design process; improving inventory management and warehousing practices; implementing more effective and reliable distribution and transportation processes; as well as improving supply chain coordination and overall communication.

  8. Patent extension policy for paediatric indications: an evaluation of the impact within three drug classes in a state Medicaid programme.

    Science.gov (United States)

    Nelson, Richard E; McAdam-Marx, Carrie; Evans, Megan L; Ward, Robert; Campbell, Benjamin; Brixner, Diana; Lafleur, Joanne

    2011-05-01

    The Food and Drug Administration Modernization Act (FDAMA) of 1997, Best Pharmaceuticals for Children Act (BPCA) of 2002 and Pediatric Research Equity Act of 2007 provide an extended period of 6 months of marketing exclusivity (i.e. patent extension) to prescription drug manufacturers that conduct paediatric studies. Branded drugs in the statin, ACE inhibitor and selective serotonin reuptake inhibitor (SSRI) classes were three of many classes with drugs granted patent extensions. We estimated the cost impact of the 6-month exclusivity extension policy on the Utah Medicaid drug programme by comparing actual costs to projected costs had the 6-month exclusivity extension not been granted for these drugs and thus less expensive generic alternatives been available sooner. Using these results, we then projected the cost impact of this policy on Medicaid programmes in the US during the 18 months following patent expiration. The Utah Medicaid prescription claims obtained for statins, ACE inhibitors and SSRIs included reimbursement amount, number of units dispensed, days supplied, date of service and drug strength. Actual expenditures for each drug were calculated for the 6 months before and 12 months after generic availability. The percentage difference between the brand name prescription reimbursement amount to Medicaid in the last 2 months of the 6-month extension and the generic prescription reimbursement amount to Medicaid in the first 2 months following exclusivity expiration was then calculated for each drug. This was done using data from the 5 months surrounding the exclusivity expiration by regressing the log-transformed Utah Medicaid reimbursement amount on an indicator for patent expiration, controlling for number of units, volume of sales, month filled and strength. This was used to estimate what the initial generic prescription price would have been without the 6-month patent extension and what costs would have been in the 18 months following the original

  9. Performance comparison of two androgen receptor splice variant 7 (AR-V7) detection methods.

    Science.gov (United States)

    Bernemann, Christof; Steinestel, Julie; Humberg, Verena; Bögemann, Martin; Schrader, Andres Jan; Lennerz, Jochen K

    2018-01-23

    To compare the performance of two established androgen receptor splice variant 7 (AR-V7) mRNA detection systems, as paradoxical responses to next-generation androgen-deprivation therapy in AR-V7 mRNA-positive circulating tumour cells (CTC) of patients with castration-resistant prostate cancer (CRPC) could be related to false-positive classification using detection systems with different sensitivities. We compared the performance of two established mRNA-based AR-V7 detection technologies using either SYBR Green or TaqMan chemistries. We assessed in vitro performance using eight genitourinary cancer cell lines and serial dilutions in three AR-V7-positive prostate cancer cell lines, as well as in 32 blood samples from patients with CRPC. Both assays performed identically in the cell lines and serial dilutions showed identical diagnostic thresholds. Performance comparison in 32 clinical patient samples showed perfect concordance between the assays. In particular, both assays determined AR-V7 mRNA-positive CTCs in three patients with unexpected responses to next-generation anti-androgen therapy. Thus, technical differences between the assays can be excluded as the underlying reason for the unexpected responses to next-generation anti-androgen therapy in a subset of AR-V7 patients. Irrespective of the method used, patients with AR-V7 mRNA-positive CRPC should not be systematically precluded from an otherwise safe treatment option. © 2018 The Authors BJU International © 2018 BJU International Published by John Wiley & Sons Ltd.

  10. Influence of the method of optimizing adjustments of ARV-SD on attainable degree of system stability. Vliyaniye metoda optimizatsii nastroyek ARV-SD na dostizhimuyu stepen ustoychivosti sistemy

    Energy Technology Data Exchange (ETDEWEB)

    Gruzdev, I.A.; Trudospekova, G.Kh.

    1983-01-01

    An examination is made of the efficiency of the methods of successive and simultaneous optimization of adjustments of ARV-SD (ARV of strong action) of several PP. It is shown that with the use of the method of simultaneous optimization for an idealized model of complex EPS, it is possible to attain absolute controllability of the degree of stability.

  11. Affordability and availability of off-patent drugs in the United States-the case for importing from abroad: observational study.

    Science.gov (United States)

    Gupta, Ravi; Bollyky, Thomas J; Cohen, Matthew; Ross, Joseph S; Kesselheim, Aaron S

    2018-03-19

    To evaluate whether off-patent prescription drugs at risk of sudden price increases or shortages in the United States are available from independent manufacturers approved in other well regulated settings around the world. Observational study. Off-patent drugs in the USA and approved by the Food and Drug Administration, up to 10 April 2017. Novel tablet or capsule prescription drugs approved by the FDA since 1939 that were no longer protected by patents or other market exclusivity and had up to three generic versions. Number of additional manufacturers that had obtained approval from any of seven non-US regulators with similar standards (European Medicines Agency (European Union), HealthCanada (Canada), Therapeutic Goods Association (Australia), Medsafe (New Zealand), Swissmedic (Switzerland), Medicines Control Council (South Africa), and the Israel Health Ministry). Association with drug characteristics including US orphan drug designation for drugs treating rare diseases, World Health Organization essential medicine designation, treatment area, drug product complexity (that is, with attributes that could complicate establishing bioequivalence or manufacturing), and total Medicaid spending in 2015. Of 170 eligible study drugs, more than half (109, 64%) had at least one manufacturer approved by a non-US regulator and 32 (19%) had four or more. Among 44 (26%) drugs with no FDA approved generic versions, 21 (48%) were available from at least one manufacturer approved by one of the seven non-US regulators, and two (5%) by four or more manufacturers. Across all drugs and regulators (including the FDA), 66 (39%) drugs were available from four or more total manufacturers. Of 109 drugs with at least one non-US regulator approved manufacturer, 12 (11%) were approved for patients with rare diseases and 29 (27%) were WHO designated essential medicines; only 12 (11%) were complex products that might be more complicated to import. The highest numbers of drugs were indicated

  12. Production of peptides as generic drugs: a patent landscape of octreotide.

    Science.gov (United States)

    Sabatino, Giuseppina; Guryanov, Ivan; Rombecchi, Andrea; Zanon, Jacopo; Ricci, Antonio; Cabri, Walter; Papini, Anna Maria; Rovero, Paolo

    2016-01-01

    New low-cost strategies and enhancement of the already described methods to manufacture peptide molecules on an industrial scale are highly requested, particularly for peptides such as octreotide, which, along with goserelin and leuprolide, dominate the global peptide market. A number of patents related to the production of octreotide can be found, concerning both solution and solid-phase synthesis. Thus, there is a need to revise the existing synthetic approaches in order to organize them in a more comprehensible way. The octreotide patent landscape could help improvement of the methods for manufacturing of octreotide in industrial scale, leading to the appearance of innovative approaches. The pharmaceutical value of octreotide can be seen from its high market percentage among other peptide drugs. The complex chemical structure of octreotide represents the main challenge for its industrial production. Two synthetic steps are crucial in the preparation of octreotide: (i) threoninol attachment or on resin formation working in solid-phase and (ii) disulphide bond formation to achieve cyclic structure. Analysis of various patents filed to date allows us to see the trend in simplification of the synthetic approaches from the labor intensive syntheses in solution to the more versatile and rapid solid-phase methods.

  13. Supply chain solutions to improve the distribution of antiretroviral drugs (ARVs) to clinics in rural areas: A case study of the QwaQwa district

    OpenAIRE

    Mokheseng, Mamolise; Horn, Gideon S.; Klopper, Aileen G.

    2017-01-01

    This article serves as a case study based on research that was performed in the QwaQwa district in the Free State Province where the distribution of ARVs to the regional Manapo hospital, as well as between the hospital and its peripheral clinics, was interrupted and inconsistent due to problems in the supply chain. An unreliable and interrupted ARV supply chain creates the risk of virus reactivation and eventual patient mortality. The objectives of the study were to explore the problems e...

  14. Oral manifestations of anemia in HIV/AIDS patients without ARV treatment

    Directory of Open Access Journals (Sweden)

    Wahyu Hidayat

    2017-03-01

    Full Text Available Abstract Introduction: Acquired immunodeficiency syndrome (AIDS is  a set of symptoms caused by decreases of the immune system that was infected by human immunodeficiency virus (HIV. Blood disorders often found in patient with HIV and associated with HIV infection. Mostly found disorders is anemia of chronic disease. The prevalence of anemia in HIV/AIDS patients reaches 70%. Oral manifestations of anemia are atrophy of the papillae on tongue, glossodynia, pallor, angular cheilitis, glossitis, aphthous ulcers/erosive lesions, candidiasis, and geographic tongue. There are many publications that uses anemia as indicator to determine the prognosis of HIV infection, thus the description of oral manifestation of anemia in the non-ARV HIV/AIDS patients is a necessity. The purpose of this study was to describe the oral manifestation of anemia in the non-ARV HIV/AIDS patients. Methods: The methods used were purposive random sampling. Samples were new HIV/AIDS patients who have not got antiretroviral (ARV treatment. The study included 40 patients in Teratai Clinic Hasan Sadikin Hospital Bandung. Results: Oral manifestations of anemia were found amongst non-ARV HIV/AIDS patients, which were candidiasis in  37 patients, glossodynia in 28 patients, glossitis in 10 patients, and angular cheilitis in 1 patient. Conclusion: From the study found that oral manifestations of anemia that found in non-ARV HIV/AIDS patients were candidiasis, glossodynia, glossitis and angular cheilitis. HIV/AIDS patients with anemia needed to treat more intensive for better prognosis and quality of life. Keywords: Anemia, HIV/AIDS, Candidiasis, Glossitis, Glossodynia

  15. Patent indicators: a window to pharmaceutical market success.

    Science.gov (United States)

    Guo, Yang; Hu, Yuanjia; Zheng, Mingli; Wang, Yitao

    2013-07-01

    Pharmaceutical success in the market is the best reward for pharmaceutical investors undergoing the lengthy, costly and risky process of pharmaceutical Research and Development (R&D). Drugs with high market revenues trigger fierce competition between pharmaceutical enterprises, as is demonstrated by the increasing Mergers & Acquisitions (M&A) cases focusing on seizing the best-selling products. On the other hand, patents, as the best shield for innovative drugs against generic drugs, become a powerful weapon for pharmaceutical enterprises to win the substantial returns generated by market exclusivity. Patents seem to be directly responsible for the commercial success of new medicines. In this context, it is of great significance to find out the empirical associations between pharmaceutical commercial success and patents. By comprehensively analysing 127 drugs marketed in the USA and their 621 American patents, this article identifies the evidence to link various patent indicators with pharmaceutical sales in actual market.

  16. Prevalence and predictors of traditional medicine utilization among persons living with AIDS (PLWA) on antiretroviral (ARV) and prophylaxis treatment in both rural and urban areas in South Africa.

    Science.gov (United States)

    Hughes, G D; Puoane, T R; Clark, B L; Wondwossen, T L; Johnson, Q; Folk, W

    2012-01-01

    Previous studies have reported that majority of antiretroviral (ARV) treatment-naïve patients use traditional medicine (TM). Given that TM use is ubiquitous in South Africa especially for chronic conditions, there is a potential for ARV non-adherence and serious drug interactions among patients with HIV/AIDs who use TM. The motivating factors for TM use in HIV/AIDS patients on ARV and prophylaxis treatment have not been well defined in South Africa. This study aimed to investigate the prevalence, facilitators, predictors, and types of TM used among persons living with HIV/AIDS on antiretroviral treatment. The study was a cross-sectional survey which involved 100 participants enrolled at ARV clinics in two South African provinces. Univariate and bivariate analyses were performed to assess the relationships between variables and potential predictors of TM. Sixteen percent of participants on ARV reported TM use. Seventy-nine percent used TM prior to a diagnosis of HIV. Participants were more likely to use TM if they were from a rural province, female, older, unmarried, employed, had limited education, or were HIV-positive for less than five years. TM users reported utilizing herbal or medicinal mixtures that were claimed to heal all conditions. This study provides insights into the treatment modalities selected by patients with HIV/AIDS in South Africa who are receiving ARV. This study revealed that less than 20% of participants co-used TM and ARV. However, close to 80% of participants utilize TM before contracting HIV, which is in keeping with approximate estimates by the WHO.

  17. International patenting in ophthalmology: An analysis of its structure and relevance for the development of drugs and diagnostics

    Directory of Open Access Journals (Sweden)

    Hermann AM Mucke

    2008-10-01

    Full Text Available Hermann AM Mucke, Peter Mucke, Eva MuckeHM Pharma Consultancy, Vienna, AustriaAbstract: While investigative ophthalmologists access peer-reviewed journals as part of their daily routine, and while they regularly visit scientific congresses, they rarely peruse patent documents as an information source. Among the reasons for this negligence are the incompatibility of patent search algorithms with those known from journal databases, a legalistic and frequently redundant language, and misconceptions about the nature of the patenting system. Here we present key data and analyses from the ophthalmology module of a patent database system that we are developing to address some of these problems. We show that international patent applications consistently reflect developer interest in the ocular drug and diagnostics field; that they are technically focused lead indicators of developments that frequently feature in peer-reviewed patenting only much later; and that patenting targets are well aligned with the unmet therapeutic needs of populations in industrialized countries. Most applications (74%–78% in years since 2006 are supported with experimental data, and most (on average, 80%–90% faced at least one objection to patentability during their initial stage of examination. In contrast to the peer-reviewed scenery that is highly diverse, the corresponding patenting arena shows a pronounced focus on the United States.Keywords: ophthalmology, eye diseases, iontophoresis, intellectual property, patents as topic, bibliographic databases

  18. Loss of Subcellular Lipid Transport Due to ARV1 Deficiency Disrupts Organelle Homeostasis and Activates the Unfolded Protein Response*

    Science.gov (United States)

    Shechtman, Caryn F.; Henneberry, Annette L.; Seimon, Tracie A.; Tinkelenberg, Arthur H.; Wilcox, Lisa J.; Lee, Eunjee; Fazlollahi, Mina; Munkacsi, Andrew B.; Bussemaker, Harmen J.; Tabas, Ira; Sturley, Stephen L.

    2011-01-01

    The ARV1-encoded protein mediates sterol transport from the endoplasmic reticulum (ER) to the plasma membrane. Yeast ARV1 mutants accumulate multiple lipids in the ER and are sensitive to pharmacological modulators of both sterol and sphingolipid metabolism. Using fluorescent and electron microscopy, we demonstrate sterol accumulation, subcellular membrane expansion, elevated lipid droplet formation, and vacuolar fragmentation in ARV1 mutants. Motif-based regression analysis of ARV1 deletion transcription profiles indicates activation of Hac1p, an integral component of the unfolded protein response (UPR). Accordingly, we show constitutive splicing of HAC1 transcripts, induction of a UPR reporter, and elevated expression of UPR targets in ARV1 mutants. IRE1, encoding the unfolded protein sensor in the ER lumen, exhibits a lethal genetic interaction with ARV1, indicating a viability requirement for the UPR in cells lacking ARV1. Surprisingly, ARV1 mutants expressing a variant of Ire1p defective in sensing unfolded proteins are viable. Moreover, these strains also exhibit constitutive HAC1 splicing that interacts with DTT-mediated perturbation of protein folding. These data suggest that a component of UPR induction in arv1Δ strains is distinct from protein misfolding. Decreased ARV1 expression in murine macrophages also results in UPR induction, particularly up-regulation of activating transcription factor-4, CHOP (C/EBP homologous protein), and apoptosis. Cholesterol loading or inhibition of cholesterol esterification further elevated CHOP expression in ARV1 knockdown cells. Thus, loss or down-regulation of ARV1 disturbs membrane and lipid homeostasis, resulting in a disruption of ER integrity, one consequence of which is induction of the UPR. PMID:21266578

  19. Community attitudes toward rationing ARVs: a qualitative study of justice and equity.

    Science.gov (United States)

    Rennie, Stuart

    2006-12-01

    Medical rationing of anti-retroviral therapies (ARVs) may conflict with the right to health, but rationing is nevertheless a reality in developing countries. In this article, which is based on a poster presentation at the conference, Stuart Rennie presents the preliminary findings of a study on community attitudes towards rationing ARVs in the Democratic Republic of Congo (DRC).

  20. Arved Viirlaid teises kaanonis / Jüri Talvet

    Index Scriptorium Estoniae

    Talvet, Jüri, 1945-

    2002-01-01

    Arved Viirlaid 80. Ka tema juubeliks ilmunud ingliskeelsest luulekogust "Selected poems" (tlk. Taimi Ene Moks ja R. W. Stedingh). Ilmunud ka kogumikus: Talvet, Jüri. Tõrjumatu äär. Tartu : Ilmamaa, 2005, lk. 417-420, pealk.: Teises Kaanonis: Viirlaiu luule inglise keeles

  1. 75 FR 34749 - Determination of Regulatory Review Period for Purposes of Patent Extension; BYSTOLIC; U.S. Patent...

    Science.gov (United States)

    2010-06-18

    ... and FDA-2008-E-0267] Determination of Regulatory Review Period for Purposes of Patent Extension; BYSTOLIC; U.S. Patent Nos. 5,759,580 and 6,545,040 AGENCY: Food and Drug Administration, HHS. ACTION... determination because of the submission of applications to the Director of Patents and Trademarks, Department of...

  2. [Systematic review on methodology of randomized controlled trials of post-marketing Chinese patent drugs for treatment of type 2 diabetes].

    Science.gov (United States)

    Ma, Li-xin; Wang, Yu-yi; Li, Xin-xue; Liu, Jian-ping

    2012-03-01

    Randomized controlled trial (RCT) is considered as the gold standard for the efficacy assessment of medicines. With the increasing number of Chinese patent drugs for treatment of type 2 diabetes, the methodology of post-marketing RCTs evaluating the efficacy and specific effect has become more important. To investigate post-marketing Chinese patent drugs for treatment of type 2 diabetes, as well as the methodological quality of post-marketing RCTs. Literature was searched from the books of Newly Compiled Traditional Chinese Patent Medicine and Chinese Pharmacopeia, the websites of the State Food and Drug Administration and the Ministry of Human Resources and Social Security of the People's Republic of China, China National Knowledge Infrastructure Database, Chongqing VIP Chinese Science and Technology Periodical Database, Chinese Biomedical Database (SinoMed) and Wanfang Data. The time period for searching ran from the commencement of each database to August 2011. RCTs of post-marketing Chinese patent drugs for treatment of type 2 diabetes with intervention course no less than 3 months. Two authors independently evaluated the research quality of the RCTs by the checklist of risk bias assessment and the data collection forms based on the CONSORT Statement. Independent double data-extraction was performed. The authors identified a total of 149 Chinese patent drugs for treatment of type 2 diabetes. According to different indicative syndromes, the Chinese patent drugs can be divided into the following types, namely, yin deficiency and interior heat (n=48, 32%), dual deficiency of qi and yin (n=58, 39%) and dual deficiency of qi and yin combined with blood stasis (n=22, 15%). A total of 41 RCTs meeting the inclusion criteria were included. Neither multicenter RCTs nor endpoint outcome reports were found. Risk bias analysis showed that 81% of the included studies reported randomization for grouping without sequence generation, 98% of these studies did not report

  3. [The impact of the androgen receptor splice variant AR-V7 on the prognosis and treatment of advanced prostate cancer].

    Science.gov (United States)

    Thelen, P; Taubert, H; Duensing, S; Kristiansen, G; Merseburger, A S; Cronauer, M V

    2018-01-25

    A recently discovered mechanism enabling prostate cancer cells to escape the effects of endocrine therapies consists in the synthesis of C-terminally truncated, constitutively active androgen receptor (AR) splice variants (AR-V). Devoid of a functional C-terminal hormone/ligand binding domain, various AR-Vs are insensitive to therapies targeting the androgen/AR signalling axis. Preliminary studies suggest that AR-V7, the most common AR-V, is a promising predictive tumour marker and a relevant selection marker for the treatment of advanced prostate cancer. This review critically outlines recent advances in AR-V7 diagnostics and presents an overview of current AR-V7 targeted therapies. © Georg Thieme Verlag KG Stuttgart · New York.

  4. HIV Drug Resistance-Associated Mutations in Antiretroviral Naïve HIV-1-Infected Latin American Children

    Directory of Open Access Journals (Sweden)

    Luis E. Soto-Ramirez

    2010-01-01

    Full Text Available Our goal was to describe the presence of HIV drug resistance among HIV-1-infected, antiretroviral (ARV naïve children and adolescents in Latin America and to examine resistance in these children in relation to drug exposure in the mother. Genotyping was performed on plasma samples obtained at baseline from HIV-1-infected participants in a prospective cohort study in Brazil, Argentina, and Mexico (NISDI Pediatric Study. Of 713 HIV-infected children enrolled, 69 were ARV naïve and eligible for the analysis. At enrollment, mean age was 7.3 years; 81.2% were infected with HIV perinatally. Drug resistance mutations (DRMs were detected in 6 (8.7%; 95% confidence interval 3.1–18.2% ARV-naïve subjects; none of the mothers of these 6 received ARVs during their pregnancies and none of the children received ARV prophylaxis. Reverse transcriptase mutations K70R and K70E were detected in 3 and 2 subjects, respectively; protease mutation I50 V was detected in 1 subject. Three of the 6 children with DRMs initiated ARV therapy during followup, with a good response in 2. The overall rate of primary drug resistance in this pediatric HIV-infected population was low, and no subjects had more than 1 DRM. Mutations associated with resistance to nucleoside reverse transcriptase inhibitors were the most prevalent.

  5. Patent ductus arteriosus

    Science.gov (United States)

    ... Drugs & Supplements Videos & Tools About MedlinePlus Show Search Search MedlinePlus GO GO About MedlinePlus Site Map FAQs Customer Support Health Topics Drugs & Supplements Videos & Tools Español You Are Here: Home → Medical Encyclopedia → Patent ductus arteriosus URL of this page: //medlineplus.gov/ ...

  6. Patent urachus repair

    Science.gov (United States)

    ... Drugs & Supplements Videos & Tools About MedlinePlus Show Search Search MedlinePlus GO GO About MedlinePlus Site Map FAQs Customer Support Health Topics Drugs & Supplements Videos & Tools Español You Are Here: Home → Medical Encyclopedia → Patent urachus repair URL of this page: //medlineplus.gov/ ...

  7. Challenges confronting health care workers in government's ARV ...

    African Journals Online (AJOL)

    Challenges confronting health care workers in government's ARV rollout: rights and responsibilities. ... Potchefstroom Electronic Law Journal/Potchefstroomse Elektroniese Regsblad ... Unless the rights of HCWs are recognised and their needs adequately addressed, the best laid plans of government will be at risk.

  8. Problems Associated With Substandard And Counterfeit Drugs In ...

    African Journals Online (AJOL)

    Problems Associated With Substandard And Counterfeit Drugs In Developing Countries: A Review Article On Global Implications Of Counterfeit Drugs In The Era Of Anti-Retroviral (ARVS) Drugs In A Free Market Economy.

  9. Histone demethylase JMJD1A promotes alternative splicing of AR variant 7 (AR-V7) in prostate cancer cells.

    Science.gov (United States)

    Fan, Lingling; Zhang, Fengbo; Xu, Songhui; Cui, Xiaolu; Hussain, Arif; Fazli, Ladan; Gleave, Martin; Dong, Xuesen; Qi, Jianfei

    2018-05-15

    Formation of the androgen receptor splicing variant 7 (AR-V7) is one of the major mechanisms by which resistance of prostate cancer to androgen deprivation therapy occurs. The histone demethylase JMJD1A (Jumonji domain containing 1A) functions as a key coactivator for AR by epigenetic regulation of H3K9 methylation marks. Here, we describe a role for JMJD1A in AR-V7 expression. While JMJD1A knockdown had no effect on full-length AR (AR-FL), it reduced AR-V7 levels in prostate cancer cells. Reexpression of AR-V7 in the JMJD1A-knockdown cells elevated expression of select AR targets and partially rescued prostate cancer cell growth in vitro and in vivo. The AR-V7 protein level correlated positively with JMJD1A in a subset of human prostate cancer specimens. Mechanistically, we found that JMJD1A promoted alternative splicing of AR-V7 through heterogeneous nuclear ribonucleoprotein F (HNRNPF), a splicing factor known to regulate exon inclusion. Knockdown of JMJD1A or HNRNPF inhibited splicing of AR-V7, but not AR-FL, in a minigene reporter assay. JMJD1A was found to interact with and promote the recruitment of HNRNPF to a cryptic exon 3b on AR pre-mRNA for the generation of AR-V7. Taken together, the role of JMJD1A in AR-FL coactivation and AR-V7 alternative splicing highlights JMJD1A as a potentially promising target for prostate cancer therapy.

  10. Wnt Drug Discovery: Weaving Through the Screens, Patents and Clinical Trials

    Directory of Open Access Journals (Sweden)

    Benjamin Lu

    2016-09-01

    Full Text Available The Wnt signaling pathway is intricately involved in many aspects of development and is the root cause of an increasing number of diseases. For example, colorectal cancer is the second leading cause of death in the industrialized world and aberration of Wnt signaling within the colonic stem cell is the cause of more than 90% of these cancers. Despite our advances in successfully targeting other pathways, such as Human Epidermal Growth Factor Receptor 2 (HER2, there are no clinically relevant therapies available for Wnt-related diseases. Here, we investigated where research activities are focused with respect to Wnt signaling modulators by searching the United States Patent and Trade Office (USPTO for patents and patent applications related to Wnt modulators and compared this to clinical trials focusing on Wnt modulation. We found that while the transition of intellectual property surrounding the Wnt ligand-receptor interface to clinical trials is robust, this is not true for specific inhibitors of β-catenin, which is constitutively active in many cancers. Considering the ubiquitous use of the synthetic T-cell Factor/Lymphoid Enhancer Factor (TCF/Lef reporter system and its success in identifying novel modulators in vitro, we speculate that this model of drug discovery does not capture the complexity of in vivo Wnt signaling that may be required if we are to successfully target the Wnt pathway in the clinic. Notwithstanding, increasingly more complex models are being developed, which may not be high throughput, but more pragmatic in our pursuit to control Wnt signaling.

  11. Antiretroviral purchasing and prescription practices in Mexico: constraints, challenges and opportunities.

    Science.gov (United States)

    Chaumont, Claire; Bautista-Arredondo, Sergio; Calva, Juan José; Bahena-González, Roberto Isaac; Sánchez-Juárez, Gerda Hitz; González de Araujo-Muriel, Arturo; Magis-Rodríguez, Carlos; Hernández-Ávila, Mauricio

    2015-01-01

    This study examines the antiretroviral (ARV) market characteristics for drugs procured and prescribed to Mexico's Social Protection System in Health beneficiaries between 2008 and 2013, and compares them with international data. Procurement information from the National Center for the Prevention and the Control of HIV/AIDS was analyzed to estimate volumes and prices of key ARV. Annual costs were compared with data from the World Health Organization's Global Price Reporting Mechanism for similar countries. Finally, regimens reported in the ARV Drug Management, Logistics and Surveillance System database were reviewed to identify prescription trends and model ARV expenditures until 2018. Results show that the first-line ARV market is concentrated among a small number of patented treatments, in which prescription is clinically adequate, but which prices are higher than those paid by similar countries. The current set of legal and structural options available to policy makers to bring prices down is extremely limited. Different negotiation policies were not successful to decrease ARV high prices in the public health market. The closed list approach had a good impact on prescription quality but was ineffective in reducing prices. The Coordinating Commission for Negotiating the Price of Medicines and other Health Supplies also failed to obtain adequate prices. To maximize purchase efficiency, policy makers should focus on finding long-term legal and political safeguards to counter the high prices imposed by pharmaceutical companies.

  12. Nuclear-specific AR-V7 Protein Localization is Necessary to Guide Treatment Selection in Metastatic Castration-resistant Prostate Cancer.

    Science.gov (United States)

    Scher, Howard I; Graf, Ryon P; Schreiber, Nicole A; McLaughlin, Brigit; Lu, David; Louw, Jessica; Danila, Daniel C; Dugan, Lyndsey; Johnson, Ann; Heller, Glenn; Fleisher, Martin; Dittamore, Ryan

    2017-06-01

    Circulating tumor cells (CTCs) expressing AR-V7 protein localized to the nucleus (nuclear-specific) identify metastatic castration-resistant prostate cancer (mCRPC) patients with improved overall survival (OS) on taxane therapy relative to the androgen receptor signaling inhibitors (ARSi) abiraterone acetate, enzalutamide, and apalutamide. To evaluate if expanding the positivity criteria to include both nuclear and cytoplasmic AR-V7 localization ("nuclear-agnostic") identifies more patients who would benefit from a taxane over an ARSi. The study used a cross-sectional cohort. Between December 2012 and March 2015, 193 pretherapy blood samples, 191 of which were evaluable, were collected and processed from 161 unique mCRPC patients before starting a new line of systemic therapy for disease progression at the Memorial Sloan Kettering Cancer Center. The association between two AR-V7 scoring criteria, post-therapy prostate-specific antigen (PSA) change (PTPC) and OS following ARSi or taxane treatment, was explored. One criterion required nuclear-specific AR-V7 localization, and the other required an AR-V7 signal but was agnostic to protein localization in CTCs. Correlation of AR-V7 status to PTPC and OS was investigated. Relationships with survival were analyzed using multivariable Cox regression and log-rank analyses. A total of 34 (18%) samples were AR-V7-positive using nuclear-specific criteria, and 56 (29%) were AR-V7-positive using nuclear-agnostic criteria. Following ARSi treatment, none of the 16 nuclear-specific AR-V7-positive samples and six of the 32 (19%) nuclear-agnostic AR-V7-positive samples had ≥50% PTPC at 12 weeks. The strongest baseline factor influencing OS was the interaction between the presence of nuclear-specific AR-V7-positive CTCs and treatment with a taxane (hazard ratio 0.24, 95% confidence interval 0.078-0.79; p=0.019). This interaction was not significant when nuclear-agnostic criteria were used. To reliably inform treatment selection

  13. The Demand for Antiretroviral Drugs in the Illicit Marketplace: Implications for HIV Disease Management Among Vulnerable Populations.

    Science.gov (United States)

    Tsuyuki, Kiyomi; Surratt, Hilary L; Levi-Minzi, Maria A; O'Grady, Catherine L; Kurtz, Steven P

    2015-05-01

    The diversion of antiretroviral medications (ARVs) has implications for the integrity and success of HIV care, however little is known about the ARV illicit market. This paper aimed to identify the motivations for buying illicit ARVs and to describe market dynamics. Semi-structured interviews (n = 44) were conducted with substance-involved individuals living with HIV who have a history of purchasing ARVs on the street. Grounded theory was used to code and analyze interviews. Motivations for buying ARVs on the illicit market were: to repurchase ARVs after having diverted them for money or drugs; having limited access or low quality health care; to replace lost or ruined ARVs; and to buy a back-up stock of ARVs. This study identified various structural barriers to HIV treatment and ARV adherence that incentivized ARV diversion. Findings highlight the need to improve patient-provider relationships, ensure continuity of care, and integrate services to engage and retain high-needs populations.

  14. Sub therapeutic drug levels among HIV/TB co-infected patients ...

    African Journals Online (AJOL)

    Daniel W. Gunda

    2016-11-01

    Nov 1, 2016 ... NVP based regimen was associated with sub-therapeutic drug levels on uni- ... a number of important challenges including induction of sub- therapeutic levels of .... ARV plasma levels in the univariate model with p-values less than 0.05 .... clearance of ARVs.56 This may be one of the explanations that.

  15. Patent protection for microbial technologies.

    Science.gov (United States)

    Sherkow, Jacob S

    2017-11-01

    Microbial technologies often serve as the basis of fundamental research tools in molecular biology. These present a variety of ethical, legal and social issues concerning their patenting. This commentary presents several case studies of these issues across three major microbiological tools: CRISPR, viral vectors and antimicrobial resistance drugs. It concludes that the development of these technologies-both scientifically and commercially-depend, in part, on the patent regime available for each, and researchers' willingness to enforce those patents against others. © FEMS 2017. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  16. Patent urachus repair - slideshow

    Science.gov (United States)

    ... Drugs & Supplements Videos & Tools About MedlinePlus Show Search Search MedlinePlus GO GO About MedlinePlus Site Map FAQs Customer Support Health Topics Drugs & Supplements Videos & Tools Español You Are Here: Home → Medical Encyclopedia → Patent urachus repair - series—Normal anatomy URL of this ...

  17. Are biosimilars patentable?

    Science.gov (United States)

    Rolfe, Damian; Parker, Jayson; Morgan, Max

    2016-08-01

    This paper explores whether, and under what circumstances, a biosimilar approved in the United States under the Biologics Price Competition and Innovation Act (hereafter 'BPCIA') can be patented. The possibility that a biosimilar product could have meaningful patent protection arises from specific requirements for biosimilarity under the BPCIA, which account for the fact that manufacturing processes of biologics are inherently imprecise. The requirements for biosimilar approval may provide sufficient leeway to a biosimilar applicant to patent structural or formulation differences that provide non-clinical but business-relevant advantages over the reference molecule, such as improved shelf-life or ease of manufacture, without compromising clinical biosimilarity. Examination of the BPCIA and related Acts, Food and Drug Administration (FDA) guidance papers, case law, patent database searching, and relevant scholarly articles. Legislative and regulatory requirements for the approval of a biosimilar under the BPCIA are focused on clinical results and allow a degree of leeway for differences to exist between a biosimilar's structure and non-clinical components and those of the biosimilar's reference molecule. This leeway can be exploited to provide the biosimilar with potentially patentable business-relevant advantages over its reference product while maintaining clinical biosimilarity to the reference product.

  18. Androgen receptor and its splice variant, AR-V7, differentially regulate FOXA1 sensitive genes in LNCaP prostate cancer cells.

    Science.gov (United States)

    Krause, William C; Shafi, Ayesha A; Nakka, Manjula; Weigel, Nancy L

    2014-09-01

    Prostate cancer (PCa) is an androgen-dependent disease, and tumors that are resistant to androgen ablation therapy often remain androgen receptor (AR) dependent. Among the contributors to castration-resistant PCa are AR splice variants that lack the ligand-binding domain (LBD). Instead, they have small amounts of unique sequence derived from cryptic exons or from out of frame translation. The AR-V7 (or AR3) variant is constitutively active and is expressed under conditions consistent with CRPC. AR-V7 is reported to regulate a transcriptional program that is similar but not identical to that of AR. However, it is unknown whether these differences are due to the unique sequence in AR-V7, or simply to loss of the LBD. To examine transcriptional regulation by AR-V7, we have used lentiviruses encoding AR-V7 (amino acids 1-627 of AR with the 16 amino acids unique to the variant) to prepare a derivative of the androgen-dependent LNCaP cells with inducible expression of AR-V7. An additional cell line was generated with regulated expression of AR-NTD (amino acids 1-660 of AR); this mutant lacks the LBD but does not have the AR-V7 specific sequence. We find that AR and AR-V7 have distinct activities on target genes that are co-regulated by FOXA1. Transcripts regulated by AR-V7 were similarly regulated by AR-NTD, indicating that loss of the LBD is sufficient for the observed differences. Differential regulation of target genes correlates with preferential recruitment of AR or AR-V7 to specific cis-regulatory DNA sequences providing an explanation for some of the observed differences in target gene regulation. Copyright © 2014 Elsevier Ltd. All rights reserved.

  19. The Impact of HIV/AIDS and ARV Treatment on Worker Absenteeism: Implications for African Firms

    Science.gov (United States)

    Habyarimana, James; Mbakile, Bekezela; Pop-Eleches, Cristian

    2010-01-01

    We characterize medium and long-run labor market impacts of HIV/AIDS and ARV treatment using unique panel data of worker absenteeism and information from an AIDS treatment program at a large mining firm in Botswana. We present robust evidence of an inverse-V shaped pattern in worker absenteeism around the time of ARV treatment inception.…

  20. Determinants of adherence to antiretroviral drugs among people living with HIV/AIDS in the Ife-Ijesa zone of Osun state, Nigeria

    Directory of Open Access Journals (Sweden)

    Muhammed O. Afolabi

    2009-04-01

    Method: 120 subjects who received ARV drugs at a federal government-designated ART site located within the Obafemi Awolowo University Teaching Hospital complex, (OAUTHC, Ile-Ife, and a community-based non-governmental organisation, Living Hope Care (LIHOC, Ilesa, from February to May 2006 were serially recruited and studied. Relevant data were collected using an interviewer-administered, patient medication adherence questionnaire. Focus group discussions were also held among the subjects to further elicit qualitative information on factors influencing adherence to ART. Results: The age of participants ranged from 21 to 65 years with a mean age of 40.2 + 10.3 years. Participants had been on ARV drugs for a period ranging between three and 60 months. The overall adherence rate in the study population was 44%. 66% of participants who accessed ARV drugs from LIHOC, Ilesa, had good adherence while only 14% of participants who accessed ARV drugs from OAUTHC, Ile-Ife, had good adherence. Participants with good adherence did not pay funds for the preliminary ARV eligibility investigations and they were also offered regular adherence counselling. These facilities were barely available in the group with poor adherence. Demographic factors such as age, gender and marital status did not seem to have any significant association with adherence level (p > 0.05. Conclusion: The level of adherence was high in a cohort of PLWHA accessing ARV drugs in Ilesa while it was low among PLWHA receiving ART in Ife. The most important reasons for this difference were lack of funds for investigations and poor psycho-social counselling.

  1. Factors affecting adherence to short-course ARV prophylaxis for preventing mother-to-child transmission of HIV in sub-Saharan Africa: a review and lessons for future elimination.

    Science.gov (United States)

    Colombini, Manuela; Stöckl, Heidi; Watts, Charlotte; Zimmerman, Cathy; Agamasu, Enyonam; Mayhew, Susannah H

    2014-01-01

    Despite the biomedical potential to eliminate vertical HIV transmission, drug adherence to short regimens is often sub-optimal. To inform future programmes, we reviewed evidence on the factors influencing maternal and infant drug adherence to preventing MTCT drug regimens at delivery in sub-Saharan Africa. A literature review yielding 14 studies on adherence to drug regimes among HIV-positive pregnant women and mothers in sub-Saharan Africa was conducted. Rates of maternal adherence to preventive drug regimens at time of delivery varied widely across sites between 35 and 93.5%. Factors most commonly associated with low adherence to antiretroviral therapy (ARV) prophylaxis for preventing MTCT at the health system level include giving birth at home, quality and timing of HIV testing and counselling, and late distribution of nevirapine (NVP). Socio-demographic and demand-side factors include fear of stigma, lack of male involvement, fear of partner's reaction to disclosure, few antenatal (ANC) visits, young age and lack of education. With the implementation of the newly published WHO guidelines recommending triple-drug ARV regimen during pregnancy and breastfeeding for all women with HIV, it is important that women are able to adhere to recommended drug regimens. Service improvements should include clear and timely communication with women about the benefits of combined regimens and greater emphasis on patient confidentiality. Efforts must be made to help women overcome barriers that reduce adherence, such as financial logistical challenges, social stigma and women's fear of violence.

  2. Patent landscape of neglected tropical diseases: an analysis of worldwide patent families.

    Science.gov (United States)

    Akinsolu, Folahanmi Tomiwa; de Paiva, Vitor Nobre; Souza, Samuel Santos; Varga, Orsolya

    2017-11-14

    "Neglected Tropical Diseases" (NTDs) affect millions of people in Africa, Asia and South America. The two primary ways of strategic interventions are "preventive chemotherapy and transmission control" (PCT), and "innovative and intensified disease management" (IDM). In the last 5 years, phenomenal progress has been achieved. However, it is crucial to intensify research effort into NTDs, because of the emerging drug resistance. According to the World Health Organization (WHO), the term NTDs covers 17 diseases, namely buruli ulcer, Chagas disease, dengue, dracunculiasis, echinococcosis, trematodiasis, human African trypanosomiasis, leishmaniasis, leprosy, lymphatic filariasis, onchocerciasis, rabies, schistosomiasis, soil-transmitted helminthes, taeniasis, trachoma, and yaws. The aim of this study is to map out research and development (R&D) landscape through patent analysis of these identified NTDs. To achieve this, analysis and evaluation have been conducted on patenting trends, current legal status of patent families, priority countries by earliest priority years and their assignee types, technological fields of patent families over time, and original and current patent assignees. Patent families were extracted from Patseer, an international database of patents from over 100 patent issuing authorities worldwide. Evaluation of the patents was carried out using the combination of different search terms related to each identified NTD. In this paper, a total number of 12,350 patent families were analyzed. The main countries with sources of inventions were identified to be the United States (US) and China. The main technological fields covered by NTDs patent landscape are pharmaceuticals, biotechnology, organic fine chemistry, analysis of biological materials, basic materials chemistry, and medical technology. Governmental institutions and universities are the primary original assignees. Among the NTDs, leishmaniasis, dengue, and rabies received the highest number of

  3. Decoding Patent Information Using Patent Maps

    OpenAIRE

    Liu, Chen-Yuan; Yang, James Chingyu

    2008-01-01

    Patent information is a derivative product from the legal patent system. This information, which includes patent applications, patent descriptions, patent gazettes, patent abstracts, and patent data, is prepared in exact compliance with the regulations and specifications of the patent acts. Patent information, different from other published circulating information, is legally well protected. For convenience, this study classifies patent information into bibliographic and numeric data to creat...

  4. Past, present and future of pharmaceutical patents under Korea-US Trade Agreement.

    Science.gov (United States)

    Shin, Yoon Suk

    2016-07-01

    The introduction of substance patents in 1987 was viewed with apprehension as it was believed that the system would only reinforce the domination of the technology of advanced countries based on the trade agreement between Korea and the USA. However, substance patents provided the Korean pharmaceutical industry with the driving force required to develop new substances, and the Korean pharmaceutical industry has been constantly improving its research and development capability. The patent-approval linkage system was implemented according to the Korea-US Free Trade Agreement in 2015. The system comprises the following: registering the drugs in the Green List, notifying the listed patent and marketing approval holders about the application for generic marketing approval, patent holder's request for staying generic sales and first generic exclusivity. Korean generic companies are expected to have opportunities that enable them to challenge the global market by accumulating experience of designing of generic products, making patent challenges and strategically developing of new drugs or incrementally modified drugs through the linkage system.

  5. Study on the Application of Chinese Patent Drug and Chinese Formula of Rabdosia Rubescens

    Science.gov (United States)

    Peng, Mengfan; Liu, Baosong; Mao, Mingsan

    2018-01-01

    Rabdosia rubescens contais many active ingredients such as terpenoids, flavonoids, polysaccharides and organic acids. Modern research has proved that Rabdosia rubescens has the effect of heat-clearing and detoxicating, antibacterial and anticancer, promoting blood circulation to arrest pain and anti-tumor. It is used in the treatment of sore throat, rheumatoid arthritis and various kinds of cancer. The clinical application of Rabdosia rubescens is restricted in the fat-soluble components, and the solubility of water solubility is ignored. The application of prescriptions, Chinese patent drug and food therapy of Rabdosia rubescens are less and fragmented. This paper inquires relevant literature, the application of Rabdosia rubescens in prescription, Chinese patent medicine and food therapy was reviewed, in order to make Rabdosiae rubescens play a greater role in the relevant area. On the basis of make the best use of everything, to promote the innovation and development of Chinese medicine and services to the people in our country.

  6. Evergreening, patent challenges, and effective market life in pharmaceuticals.

    Science.gov (United States)

    Hemphill, C Scott; Sampat, Bhaven N

    2012-03-01

    Observers worry that generic patent challenges are on the rise and reduce the effective market life of drugs. A related concern is that challenges disproportionately target high-sales drugs, reducing market life for these "blockbusters." To study these questions, we examine new data on generic entry over the past decade. We show that challenges are more common for higher sales drugs. We also demonstrate a slight increase in challenges over this period, and a sharper increase for early challenges. Despite this, effective market life is stable across drug sales categories, and has hardly changed over the decade. To better understand these results, we examine which patents are challenged on each drug, and show that lower quality and later expiring patents disproportionately draw challenges. Overall, this evidence suggests that challenges serve to maintain, not reduce, the historical baseline of effective market life, thereby limiting the effectiveness of "evergreening" by branded firms. Copyright © 2012 Elsevier B.V. All rights reserved.

  7. Religious coalition opposes gene patents.

    Science.gov (United States)

    James, J S

    1995-05-19

    The biotechnology industry is concerned about a coalition of mainstream religious leaders, working with Jeremy Rifkin of the Foundation of Economic Trends, who oppose the patenting of human and animal life forms, body parts, and genes. The coalition called a press conference on May 18 to ask the government to prohibit the current patenting practices for genetic engineering. The biotechnology industry argues that patents indicate that a company's research tool has significant value, and encourages capitalists to invest their dollars in the development of new treatments for diseases. They also argue that the 29 biotech drugs that are on the market have been developed as a result of patents on genes. Although most business leaders are united in opposing restrictions, many scientists are divided, citing both religious and scientific reasons.

  8. Text mining patents for biomedical knowledge.

    Science.gov (United States)

    Rodriguez-Esteban, Raul; Bundschus, Markus

    2016-06-01

    Biomedical text mining of scientific knowledge bases, such as Medline, has received much attention in recent years. Given that text mining is able to automatically extract biomedical facts that revolve around entities such as genes, proteins, and drugs, from unstructured text sources, it is seen as a major enabler to foster biomedical research and drug discovery. In contrast to the biomedical literature, research into the mining of biomedical patents has not reached the same level of maturity. Here, we review existing work and highlight the associated technical challenges that emerge from automatically extracting facts from patents. We conclude by outlining potential future directions in this domain that could help drive biomedical research and drug discovery. Copyright © 2016 Elsevier Ltd. All rights reserved.

  9. Antiretroviral drug expenditure, pricing and judicial demand: an analysis of federal procurement data in Brazil from 2004–2011

    Science.gov (United States)

    2014-01-01

    Background Previous studies have described expenditures for antiretroviral (ARV) medicines in Brazil through 2005. While prior studies examined overall expenditures, they have not have analyzed drug procurement data in order to describe the role of court litigation on access and pricing. Methods ARV drug procurement from private sector sources for the years 2004–2011 was obtained through the general procurement database of the Brazilian Federal Government (SIASG). Procurement was measured in Defined Daily Doses (DDD) per 1000 persons-under-treatment per day. Expenditures and price per DDD were calculated and expressed in U.S. Dollars. Justifications for ARV purchases were examined in order to determine the relationship between health litigation and incorporation into Brazil’s national treatment guidelines. Results Drug procurement of ARVs from private sources underwent marked expansion in 2005, peaked in 2009, and stabilized to 2008 levels by 2011. Expenditures followed procurement curves. Medications which were procured for the first time after 2007 cost more than medicines which were introduced before 2007. Judicial actions initially resulted in purchases of newer medications for a select number of patients in Brazil but ultimately expanded availability to a larger population through incorporation into the national treatment guidelines. Conclusions Drug procurement and expenditures for ARVs in Brazil varied between 2004–2011. The procurement of some drugs from the private sector ceased after public manufacturers started producing them locally. Judicial demand has resulted in the incorporation of newer drugs into the national treatment guidelines. In order for the AIDS treatment program to remain sustainable, efforts should be pursued to reduce prices through generic drugs, price negotiation and other public health flexibilities such as compulsory licensing. PMID:24735589

  10. In Situ Detection and Quantification of AR-V7, AR-FL, PSA, and KRAS Point Mutations in Circulating Tumor Cells.

    Science.gov (United States)

    El-Heliebi, Amin; Hille, Claudia; Laxman, Navya; Svedlund, Jessica; Haudum, Christoph; Ercan, Erkan; Kroneis, Thomas; Chen, Shukun; Smolle, Maria; Rossmann, Christopher; Krzywkowski, Tomasz; Ahlford, Annika; Darai, Evangelia; von Amsberg, Gunhild; Alsdorf, Winfried; König, Frank; Löhr, Matthias; de Kruijff, Inge; Riethdorf, Sabine; Gorges, Tobias M; Pantel, Klaus; Bauernhofer, Thomas; Nilsson, Mats; Sedlmayr, Peter

    2018-03-01

    Liquid biopsies can be used in castration-resistant prostate cancer (CRPC) to detect androgen receptor splice variant 7 (AR-V7), a splicing product of the androgen receptor. Patients with AR-V7-positive circulating tumor cells (CTCs) have greater benefit of taxane chemotherapy compared with novel hormonal therapies, indicating a treatment-selection biomarker. Likewise, in those with pancreatic cancer (PaCa), KRAS mutations act as prognostic biomarkers. Thus, there is an urgent need for technology investigating the expression and mutation status of CTCs. Here, we report an approach that adds AR-V7 or KRAS status to CTC enumeration, compatible with multiple CTC-isolation platforms. We studied 3 independent CTC-isolation devices (CellCollector, Parsortix, CellSearch) for the evaluation of AR-V7 or KRAS status of CTCs with in situ padlock probe technology. Padlock probes allow highly specific detection and visualization of transcripts on a cellular level. We applied padlock probes for detecting AR-V7, androgen receptor full length (AR-FL), and prostate-specific antigen (PSA) in CRPC and KRAS wild-type (wt) and mutant (mut) transcripts in PaCa in CTCs from 46 patients. In situ analysis showed that 71% (22 of 31) of CRPC patients had detectable AR-V7 expression ranging from low to high expression [1-76 rolling circle products (RCPs)/CTC]. In PaCa patients, 40% (6 of 15) had KRAS mut expressing CTCs with 1 to 8 RCPs/CTC. In situ padlock probe analysis revealed CTCs with no detectable cytokeratin expression but positivity for AR-V7 or KRAS mut transcripts. Padlock probe technology enables quantification of AR-V7, AR-FL, PSA, and KRAS mut/wt transcripts in CTCs. The technology is easily applicable in routine laboratories and compatible with multiple CTC-isolation devices. © 2017 American Association for Clinical Chemistry.

  11. Modeling HIV/AIDS drug price determinants in Brazil: is generic competition a myth?

    Science.gov (United States)

    Meiners, Constance; Sagaon-Teyssier, Luis; Hasenclever, Lia; Moatti, Jean-Paul

    2011-01-01

    Brazil became the first developing country to guarantee free and universal access to HIV/AIDS treatment, with antiretroviral drugs (ARVs) being delivered to nearly 190,000 patients. The analysis of ARV price evolution and market dynamics in Brazil can help anticipate issues soon to afflict other developing countries, as the 2010 revision of the World Health Organization guidelines shifts demand towards more expensive treatments, and, at the same time, current evolution of international legislation and trade agreements on intellectual property rights may reduce availability of generic drugs for HIV care. Our analyses are based on effective prices paid for ARV procurement in Brazil between 1996 and 2009. Data panel structure was exploited to gather ex-ante and ex-post information and address various sources of statistical bias. In-difference estimation offered in-depth information on ARV market characteristics which significantly influence prices. Although overall ARV prices follow a declining trend, changing characteristics in the generic segment help explain recent increase in generic ARV prices. Our results show that generic suppliers are more likely to respond to factors influencing demand size and market competition, while originator suppliers tend to set prices strategically to offset compulsory licensing threats and generic competition. In order to guarantee the long term sustainability of access to antiretroviral treatment, our findings highlight the importance of preserving and stimulating generic market dynamics to sustain developing countries' bargaining power in price negotiations undertaken with originator companies.

  12. Modeling HIV/AIDS drug price determinants in Brazil: is generic competition a myth?

    Directory of Open Access Journals (Sweden)

    Constance Meiners

    Full Text Available BACKGROUND: Brazil became the first developing country to guarantee free and universal access to HIV/AIDS treatment, with antiretroviral drugs (ARVs being delivered to nearly 190,000 patients. The analysis of ARV price evolution and market dynamics in Brazil can help anticipate issues soon to afflict other developing countries, as the 2010 revision of the World Health Organization guidelines shifts demand towards more expensive treatments, and, at the same time, current evolution of international legislation and trade agreements on intellectual property rights may reduce availability of generic drugs for HIV care. METHODS AND FINDINGS: Our analyses are based on effective prices paid for ARV procurement in Brazil between 1996 and 2009. Data panel structure was exploited to gather ex-ante and ex-post information and address various sources of statistical bias. In-difference estimation offered in-depth information on ARV market characteristics which significantly influence prices. Although overall ARV prices follow a declining trend, changing characteristics in the generic segment help explain recent increase in generic ARV prices. Our results show that generic suppliers are more likely to respond to factors influencing demand size and market competition, while originator suppliers tend to set prices strategically to offset compulsory licensing threats and generic competition. SIGNIFICANCE: In order to guarantee the long term sustainability of access to antiretroviral treatment, our findings highlight the importance of preserving and stimulating generic market dynamics to sustain developing countries' bargaining power in price negotiations undertaken with originator companies.

  13. Novel Junction-specific and Quantifiable In Situ Detection of AR-V7 and its Clinical Correlates in Metastatic Castration-resistant Prostate Cancer.

    Science.gov (United States)

    Zhu, Yezi; Sharp, Adam; Anderson, Courtney M; Silberstein, John L; Taylor, Maritza; Lu, Changxue; Zhao, Pei; De Marzo, Angelo M; Antonarakis, Emmanuel S; Wang, Mindy; Wu, Xingyong; Luo, Yuling; Su, Nan; Nava Rodrigues, Daniel; Figueiredo, Ines; Welti, Jonathan; Park, Emily; Ma, Xiao-Jun; Coleman, Ilsa; Morrissey, Colm; Plymate, Stephen R; Nelson, Peter S; de Bono, Johann S; Luo, Jun

    2018-05-01

    Androgen receptor splice variant 7 (AR-V7) has been implicated in resistance to abiraterone and enzalutamide treatment in men with metastatic castration-resistant prostate cancer (mCRPC). Tissue- or cell-based in situ detection of AR-V7, however, has been limited by lack of specificity. To address current limitations in precision measurement of AR-V7 by developing a novel junction-specific AR-V7 RNA in situ hybridization (RISH) assay compatible with automated quantification. We designed a RISH method to visualize single splice junctions in cells and tissue. Using the validated assay for junction-specific detection of the full-length AR (AR-FL) and AR-V7, we generated quantitative data, blinded to clinical data, for 63 prostate tumor biopsies. We evaluated clinical correlates of AR-FL/AR-V7 measurements, including association with prostate-specific antigen progression-free survival (PSA-PFS) and clinical and radiographic progression-free survival (PFS), in a subset of patients starting treatment with abiraterone or enzalutamide following biopsy. Quantitative AR-FL/AR-V7 data were generated from 56 of the 63 (88.9%) biopsy specimens examined, of which 44 were mCRPC biopsies. Positive AR-V7 signals were detected in 34.1% (15/44) mCRPC specimens, all of which also co-expressed AR-FL. The median AR-V7/AR-FL ratio was 11.9% (range 2.7-30.3%). Positive detection of AR-V7 was correlated with indicators of high disease burden at baseline. Among the 25 CRPC biopsies collected before treatment with abiraterone or enzalutamide, positive AR-V7 detection, but not higher AR-FL, was significantly associated with shorter PSA-PFS (hazard ratio 2.789, 95% confidence interval 1.12-6.95; p=0.0081). We report for the first time a RISH method for highly specific and quantifiable detection of splice junctions, allowing further characterization of AR-V7 and its clinical significance. Higher AR-V7 levels detected and quantified using a novel method were associated with poorer response to

  14. Analysis of clinical drug-drug interaction data to predict uncharacterized interaction magnitudes between antiretroviral drugs and co-medications.

    Science.gov (United States)

    Stader, Felix; Kinvig, Hannah; Battegay, Manuel; Khoo, Saye; Owen, Andrew; Siccardi, Marco; Marzolini, Catia

    2018-04-23

    Despite their high potential for drug-drug-interactions (DDI), clinical DDI studies of antiretroviral drugs (ARVs) are often lacking, because the full range of potential interactions cannot feasibly or pragmatically be studied, with some high-risk DDI studies also ethically difficult to undertake. Thus, a robust method to screen and to predict the likelihood of DDIs is required.We developed a method to predict DDIs based on two parameters: the degree of metabolism by specific enzymes such as CYP3A and the strength of an inhibitor or inducer. These parameters were derived from existing studies utilizing paradigm substrates, inducers and inhibitors of CYP3A, to assess the predictive performance of this method by verifying predicted magnitudes of changes in drug exposure against clinical DDI studies involving ARVs.The derived parameters were consistent with the FDA classification of sensitive CYP3A substrates and the strength of CYP3A inhibitors and inducers. Characterized DDI magnitudes (n = 68) between ARVs and co-medications were successfully quantified meaning 53%, 85% and 98% of the predictions were within 1.25-fold (0.80 - 1.25), 1.5-fold (0.66 - 1.48) and 2-fold (0.66 - 1.94) of the observed clinical data. In addition, the method identifies CYP3A substrates likely to be highly or conversely minimally impacted by CYP3A inhibitors or inducers, thus categorizing the magnitude of DDIs.The developed effective and robust method has the potential to support a more rational identification of dose adjustment to overcome DDIs being particularly relevant in a HIV-setting giving the treatments complexity, high DDI risk and limited guidance on the management of DDIs. Copyright © 2018 American Society for Microbiology.

  15. Google Patents: The global patent search engine

    OpenAIRE

    Noruzi, Alireza; Abdekhoda, Mohammadhiwa

    2014-01-01

    Google Patents (www.google.com/patents) includes over 8 million full-text patents. Google Patents works in the same way as the Google search engine. Google Patents is the global patent search engine that lets users search through patents from the USPTO (United States Patent and Trademark Office), EPO (European Patent Office), etc. This study begins with an overview of how to use Google Patent and identifies advanced search techniques not well-documented by Google Patent. It makes several sug...

  16. Patent holdings of US biotherapeutic companies in major markets.

    Science.gov (United States)

    Sebastian, Teena E; Yerram, Chandra Bindu; Saberwal, Gayatri

    2009-05-01

    In previous studies we examined the (United States, US) patent holdings of 109 largely North American biotech companies developing therapeutics that, in particular, have an interest in discovery stage science. There appears little correlation between the number of patents and the number of products of individual companies. Here we quantified and compared the 103 US-headquartered companies' patent holdings in Australia, Canada, Europe, Japan and the US. The companies demonstrate variable and surprising patterns of patent holdings across these countries or regions. For most companies, patent holdings are not in proportion to the importance of the country as a biotech or pharma market. These results have implications for the patenting strategies of small biotech companies involved in drug discovery.

  17. Tööõnnetuste arv Ida-Virus väheneb / Erika Prave

    Index Scriptorium Estoniae

    Prave, Erika, 1970-

    2004-01-01

    Ilmunud ka: Severnoje Poberezhje, 7. dets. 2004, lk. 3. Tööinspektsiooni viimase üheksa aasta statistikast järeldub, et tööõnnetuste arv on Ida-Virumaal aastatega vähenenud peaaegu poole võrra

  18. Traditional Knowledge and Patent Protection: Conflicting Views On International Patent Standards

    Directory of Open Access Journals (Sweden)

    A Andrzejewski

    2010-12-01

    Full Text Available As diseases continue to spread around the globe, pharmaceutical and biotech companies continue to search for new and better drugs to treat them. Most of these companies have realised that useful compounds for these purposes may be found in the natural resources that indigenous and local communities use. And yet, even though the importance of these biological resources to global health and economic livelihood is well recognised, the legal ownership and control of this traditional knowledge is still very controversial. This article undertakes a comparative analysis of American and European, as well as international legal regulations on patent law and traditional knowledge. Key questions include: What is traditional knowledge? How have the national patent laws of these countries treated the protection of plant variety and plant genetic resources? What are the existing international standards for patents, and what implications do they have for protecting traditional knowledge? And finally, what protection systems are emerging for the future?

  19. AUSTRALIAN COMPETITION AND CONSUMER COMMISSION v PFIZER: EVERGREENING AND MARKET POWER AS A BLOCKBUSTER DRUG GOES OFF PATENT.

    Science.gov (United States)

    Faunce, Thomas

    2015-06-01

    In Australian Competition and Consumer Commission v Pfizer Australia Pty Ltd [2015] FCA 113, the ACCC alleged that Pfizer's "Project LEAP" involved a scheme to lock pharmacists into substituting its generic version of the high sales volume anti-cholesterol drug, patent-expired atorvastatin (Lipitor), which took advantage of a substantial degree of market power for a purpose proscribed by s 46(1)(c) of the Competition and Consumer Act 2010 (Cth). The ACCC also claimed that Pfizer's actions constituted a course of exclusive dealing pursuant to s 47(1)(d) and (e) for the proscribed purpose of lessening competition. Flick J in the Federal Court of Australia, in a judgment heavy with quotations but sparse in reasoning, dismissed the ACCC's Amended Originating Application alleging abuse of market power and ordered the ACCC to pay Pfizer's costs. The ACCC has now appealed the decision. This column explores this case in the context of Pfizer's broader strategies to preserve its income globally from this high sales volume drug in the period following its patent expiration.

  20. Assessment of analytical techniques for characterization of crystalline clopidogrel forms in patent applications

    Directory of Open Access Journals (Sweden)

    Luiz Marcelo Lira

    2014-04-01

    Full Text Available The aim of this study was to evaluate two important aspects of patent applications of crystalline forms of drugs: (i the physicochemical characterization of the crystalline forms; and (ii the procedure for preparing crystals of the blockbuster drug clopidogrel. To this end, searches were conducted using online patent databases. The results showed that: (i the majority of patent applications for clopidogrel crystalline forms failed to comply with proposed Brazilian Patent Office guidelines. This was primarily due to insufficient number of analytical techniques evaluating the crystalline phase. In addition, some patent applications lacked assessment of chemical/crystallography purity; (ii use of more than two analytical techniques is important; and (iii the crystallization procedure for clopidogrel bisulfate form II were irreproducible based on the procedure given in the patent application.

  1. How patent experts create patent breadth

    DEFF Research Database (Denmark)

    Beukel, Karin

    2014-01-01

    Science as an input to patented inventions is a fundamental of economic growth. However, our understanding of how science is transformed into patents is limited. In the present paper I seek to fill this gap by examining the micro-foundations of science-patent transformations. Using an inductive......, grounded theory approach to study the transformation of 12 scientific discoveries into patents I recast the relationship between science and patents: I show it as a particular process that affects patent breadth. Exploiting surplus patent breadth depends on the processes of abstraction and cognitive...... variety, which can be mobilized by patenting experts. The theory is tested using a recently published algebraic interpretive method for examining causal relationships in small-N studies....

  2. How patent experts create patent breadth

    DEFF Research Database (Denmark)

    Beukel, Karin

    2018-01-01

    Science as an input to patented inventions is a fundamental of economic growth. However, our understanding of how science is transformed into patents is limited. In the present paper I seek to fill this gap by examining the micro-foundations of science-patent transformations. Using an inductive......, grounded theory approach to study the transformation of 12 scientific discoveries into patents I recast the relationship between science and patents: I show it as a particular process that affects patent breadth. Exploiting surplus patent breadth depends on the processes of abstraction and cognitive...... variety, which can be mobilized by patenting experts. The theory is tested using a recently published algebraic interpretive method for examining causal relationships in small-N studies....

  3. 21 CFR 314.53 - Submission of patent information.

    Science.gov (United States)

    2010-04-01

    ... procedures and in-process controls for the drug product; such specifications and analytical methods as are... copy, to the Central Document Room, Center for Drug Evaluation and Research, Food and Drug... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Submission of patent information. 314.53 Section...

  4. Comprehensive Quantitative Analysis of 32 Chemical Ingredients of a Chinese Patented Drug Sanhuang Tablet.

    Science.gov (United States)

    Fung, Hau-Yee; Lang, Yan; Ho, Hing-Man; Wong, Tin-Long; Ma, Dik-Lung; Leung, Chung-Hang; Han, Quan-Bin

    2017-01-12

    Sanhuang Tablet (SHT) is a Chinese patented drug commonly used for the treatment of inflammations of the respiratory tract, gastrointestinal tract, and skin. It contains a special medicinal composition including the single compound berberine hydrochloride, extracts of Scutellariae Radix and Rhei Radix et Rhizoma, as well as the powder of Rhei Radix et Rhizoma. Despite advances in analytical techniques, quantitative evaluation of a Chinese patented drug like SHT remains a challenge due to the complexity of its chemical profile. In this study, ultra-high performance liquid chromatography coupled with quadrupole-time-of-flight mass spectrometry (UHPLC-Q-TOF-MS) was used to simultaneously quantify 29 non-sugar small molecule components of SHT (11 flavonoids, two isoflavonoids, one flavanone, five anthraquinones, two dianthranones, five alkaloids, two organic acids and one stilbene). Three major saccharide components, namely fructose, glucose, and sucrose, were also quantitatively determined using high performance liquid chromatography-charged aerosol detector (HPLC-CAD) on an Asahipak NH₂P-50 4E amino column. The established methods were validated in terms of linearity, sensitivity, precision, accuracy, and stability, and then successfully applied to analyze 27 batches of commercial SHT products. A total of up to 57.61% ( w / w ) of SHT could be quantified, in which the contents of the determined non-saccharide small molecules varied from 5.91% to 16.83% ( w / w ) and three saccharides accounted for 4.41% to 48.05% ( w / w ). The results showed that the quality of the commercial products was inconsistent, and only four of those met Chinese Pharmacopoeia criteria.

  5. Comprehensive Quantitative Analysis of 32 Chemical Ingredients of a Chinese Patented Drug Sanhuang Tablet

    Directory of Open Access Journals (Sweden)

    Hau-Yee Fung

    2017-01-01

    Full Text Available Sanhuang Tablet (SHT is a Chinese patented drug commonly used for the treatment of inflammations of the respiratory tract, gastrointestinal tract, and skin. It contains a special medicinal composition including the single compound berberine hydrochloride, extracts of Scutellariae Radix and Rhei Radix et Rhizoma, as well as the powder of Rhei Radix et Rhizoma. Despite advances in analytical techniques, quantitative evaluation of a Chinese patented drug like SHT remains a challenge due to the complexity of its chemical profile. In this study, ultra-high performance liquid chromatography coupled with quadrupole-time-of-flight mass spectrometry (UHPLC-Q-TOF-MS was used to simultaneously quantify 29 non-sugar small molecule components of SHT (11 flavonoids, two isoflavonoids, one flavanone, five anthraquinones, two dianthranones, five alkaloids, two organic acids and one stilbene. Three major saccharide components, namely fructose, glucose, and sucrose, were also quantitatively determined using high performance liquid chromatography-charged aerosol detector (HPLC-CAD on an Asahipak NH2P-50 4E amino column. The established methods were validated in terms of linearity, sensitivity, precision, accuracy, and stability, and then successfully applied to analyze 27 batches of commercial SHT products. A total of up to 57.61% (w/w of SHT could be quantified, in which the contents of the determined non-saccharide small molecules varied from 5.91% to 16.83% (w/w and three saccharides accounted for 4.41% to 48.05% (w/w. The results showed that the quality of the commercial products was inconsistent, and only four of those met Chinese Pharmacopoeia criteria.

  6. Polymorphs and prodrugs and salts (oh my!: an empirical analysis of "secondary" pharmaceutical patents.

    Directory of Open Access Journals (Sweden)

    Amy Kapczynski

    Full Text Available BACKGROUND: While there has been much discussion by policymakers and stakeholders about the effects of "secondary patents" on the pharmaceutical industry, there is no empirical evidence on their prevalence or determinants. Characterizing the landscape of secondary patents is important in light of recent court decisions in the U.S. that may make them more difficult to obtain, and for developing countries considering restrictions on secondary patents. METHODOLOGY/PRINCIPAL FINDINGS: We read the claims of the 1304 Orange Book listed patents on all new molecular entities approved in the U.S. between 1988 and 2005, and coded the patents as including chemical compound claims (claims covering the active molecule itself and/or one of several types of secondary claims. We distinguish between patents with any secondary claims, and those with only secondary claims and no chemical compound claims ("independent" secondary patents. We find that secondary claims are common in the pharmaceutical industry. We also show that independent secondary patents tend to be filed and issued later than chemical compound patents, and are also more likely to be filed after the drug is approved. When present, independent formulation patents add an average of 6.5 years of patent life (95% C.I.: 5.9 to 7.3 years, independent method of use patents add 7.4 years (95% C.I.: 6.4 to 8.4 years, and independent patents on polymorphs, isomers, prodrug, ester, and/or salt claims add 6.3 years (95% C.I.: 5.3 to 7.3 years. We also provide evidence that late-filed independent secondary patents are more common for higher sales drugs. CONCLUSIONS/SIGNIFICANCE: Policies and court decisions affecting secondary patenting are likely to have a significant impact on the pharmaceutical industry. Secondary patents provide substantial additional patent life in the pharmaceutical industry, at least nominally. Evidence that they are also more common for best-selling drugs is consistent with accounts of

  7. Patent and exclusivity status of essential medicines for non-communicable disease.

    Directory of Open Access Journals (Sweden)

    Tim K Mackey

    Full Text Available OBJECTIVE: The threat of non-communicable diseases ("NCDs" is increasingly becoming a global health crisis and are pervasive in high, middle, and low-income populations resulting in an estimated 36 million deaths per year. There is a need to assess intellectual property rights ("IPRs" that may impede generic production and availability and affordability to essential NCD medicines. METHODS: Using the data sources listed below, the study design systematically eliminated NCD drugs that had no patent/exclusivity provisions on API, dosage, or administration route. The first step identified essential medicines that treat certain high disease burden NCDs. A second step examined the patent and exclusivity status of active ingredient, dosage and listed route of administration using exclusion criteria outlined in this study. MATERIALS: We examined the patent and exclusivity status of medicines listed in the World Health Organization's ("WHO" Model List of Essential Drugs (Medicines ("MLEM" and other WHO sources for drugs treating certain NCDs. i.e., cardiovascular and respiratory disease, cancers, and diabetes. We utilized the USA Food and Drug Administration Orange Book and the USA Patent and Trademark Office databases as references given the predominant number of medicines registered in the USA. RESULTS: Of the 359 MLEM medicines identified, 22% (79/359 address targeted NCDs. Of these 79, only eight required in-depth patent or exclusivity assessment. Upon further review, no NCD MLEM medicines had study patent or exclusivity protection for reviewed criteria. CONCLUSIONS: We find that ensuring availability and affordability of potential generic formulations of NCD MLEM medicines appears to be more complex than the presence of IPRs with API, dosage, or administration patent or exclusivity protection. Hence, more sophisticated analysis of NCD barriers to generic availability and affordability should be conducted in order to ensure equitable access to global

  8. Searching bioremediation patents through Cooperative Patent Classification (CPC).

    Science.gov (United States)

    Prasad, Rajendra

    2016-03-01

    Patent classification systems have traditionally evolved independently at each patent jurisdiction to classify patents handled by their examiners to be able to search previous patents while dealing with new patent applications. As patent databases maintained by them went online for free access to public as also for global search of prior art by examiners, the need arose for a common platform and uniform structure of patent databases. The diversity of different classification, however, posed problems of integrating and searching relevant patents across patent jurisdictions. To address this problem of comparability of data from different sources and searching patents, WIPO in the recent past developed what is known as International Patent Classification (IPC) system which most countries readily adopted to code their patents with IPC codes along with their own codes. The Cooperative Patent Classification (CPC) is the latest patent classification system based on IPC/European Classification (ECLA) system, developed by the European Patent Office (EPO) and the United States Patent and Trademark Office (USPTO) which is likely to become a global standard. This paper discusses this new classification system with reference to patents on bioremediation.

  9. Patents, antibiotics, and autarky in Spain.

    Science.gov (United States)

    Romero De Pablos, Ana

    2014-01-01

    Patents on antibiotics were introduced in Spain in 1949. Preliminary research reveals diversification in the types of antibiotics: patents relating to penicillin were followed by those relating to streptomycin, erythromycin and tetracycline. There was also diversification in the firms that applied for patents: while Merck & Co. Incorporated and Schenley Industries Inc. were the main partners with Spanish antibiotics manufacturers in the late 1940s, this industrial space also included many others, such as Eli Lilly & Company, Abbott Laboratories, Chas. Pfizer & Co. Incorporated, and American Cyanamid Company in the mid-1970s. The introduction of these drugs in Spain adds new elements to a re-evaluation of the autarkic politics of the early years of the Franco dictatorship.

  10. Patent office governance and patent system quality

    OpenAIRE

    PICARD, Pierre M.; VAN POTTELSBERGHE DE LA POTTERIE, Bruno

    2011-01-01

    The present paper discusses the role of quality in patent systems from the perspective of patent offices' behavior and organization. After documenting original stylized facts, the paper presents a model in which patent offices set patent fees and the quality level of their examination processes. Various objectives of patent offices' governors are considered. We show that the quality of the patent system is maximal for the patent offices that maximises either the social welfare or its own prof...

  11. Overexpression of nuclear AR-V7 protein in primary prostate cancer is an independent negative prognostic marker in men with high-risk disease receiving adjuvant therapy.

    Science.gov (United States)

    Chen, Xin; Bernemann, Christof; Tolkach, Yuri; Heller, Martina; Nientiedt, Cathleen; Falkenstein, Michael; Herpel, Esther; Jenzer, Maximilian; Grüllich, Carsten; Jäger, Dirk; Sültmann, Holger; Duensing, Anette; Perner, Sven; Cronauer, Marcus V; Stephan, Carsten; Debus, Jürgen; Schrader, Andres Jan; Kristiansen, Glen; Hohenfellner, Markus; Duensing, Stefan

    2018-04-01

    Overexpression of the androgen receptor (AR) splice variant 7 (AR-V7) has recently been reported to be associated with resistance to antihormonal therapy. Herein, we address the question whether tumor cells with AR-V7 expression can be detected at the time of radical prostatectomy, that is, before long-term hormonal manipulation and castration resistance, and what the potential prognostic impact on the biochemical recurrence (BCR)-free survival may be. An anti-AR-V7 antibody was first validated in a training set of prostate cancer specimens by a comparison of AR-V7 protein to AR-V7 mRNA expression. We then analyzed nuclear AR-V7 protein expression in the primary tumors and lymph node metastases from 163 predominantly high-risk patients (cohort I) as well as the primary tumors from patients of a second, consecutive patient cohort (n = 238, cohort II) not selected for any clinicopathological features. Staining results were correlated to patient characteristics and BCR-free patient survival. High nuclear AR-V7 protein expression was detected in approximately 30%-40% of patients in cohort I and II at the time of radical prostatectomy. High baseline expression of nuclear AR-V7 protein was associated with an unfavorable BCR-free survival in the high-risk patient cohort I but not in the unselected consecutive cohort II. Remarkably, AR-V7 was an independent negative prognostic factor in high-risk prostate cancer patients of cohort I who were selected to receive adjuvant treatment. Prostate cancer cells with high nuclear AR-V7 protein expression can be detected in a substantial proportion of tumors at the time of radical prostatectomy. The presence of AR-V7-positive tumor cells is associated with an unfavorable prognosis for BCR-free survival in a high-risk patient cohort including a subgroup of patients selected to receive adjuvant therapy, in which AR-V7 was an independent negative prognosticator. Overexpression of nuclear AR-V7 protein hence identifies a subset of tumors

  12. PEDF as an anticancer drug and new treatment methods following the discovery of its receptors: A patent perspective

    Science.gov (United States)

    Manalo, Katrina B.; Choong, Peter F.M.; Becerra, S. Patricia; Dass, Crispin R.

    2014-01-01

    Background Traditional forms of cancer therapy, which includes chemotherapy, have largely been overhauled due to the significant degree of toxicity they pose to normal, otherwise healthy tissue. It is hoped that use of biological agents, most of which are endogenously present in the body, will lead to safer treatment outcomes, without sacrificing efficacy. Objective The finding that PEDF, a naturally-occurring protein, was a potent angiogenesis inhibitor became the basis for studying the role of PEDF in tumours that are highly resistant to chemotherapy. The determination of the direct role of PEDF against cancer paved the way for understanding and developing PEDF as a novel drug. This review focuses on the patent applications behind testing the anticancer therapeutic effect of PEDF via its receptors as an antiangiogenic agent and as a direct anticancer agent. Conclusions The majority of the PEDF patents describe its and/or its fragments’ antiangiogenic ability and the usage of recombinant vectors as the mode of treatment delivery. PEDF’s therapeutic potential against different diseases and the discovery of its receptors opens possibilities for improving PEDF-based peptide design and drug delivery modes. PMID:21204726

  13. Tööpuudus hiilib kikivarvul Võrumaale / Arved Breidaks

    Index Scriptorium Estoniae

    Breidaks, Arved, 1975-

    2008-01-01

    Võrumaal on töötute arv eelmise aastaga võrreldes tõusma hakanud: mullu suvel maakonnas registreeritud 3,9%-line töötuse määr asendus tänavu juuli lõpus 5,4%-lise töötusega. Lisa: Töötus Võrumaal. Vt. samas: Kuidas iseloomustate olukorda Võrumaa tööjõuturul? Vastavad Martin Arula (AS Toftan), Kaido Mäesalu (AS Suwem), Meelis Munski (AS Semuehitus), Indrek Klampe (OÜ Selista Ehitus), Andres Visanpuu (Võru TÜ)

  14. Melatonin Inhibits Androgen Receptor Splice Variant-7 (AR-V7)-Induced Nuclear Factor-Kappa B (NF-κB) Activation and NF-κB Activator-Induced AR-V7 Expression in Prostate Cancer Cells: Potential Implications for the Use of Melatonin in Castration-Resistant Prostate Cancer (CRPC) Therapy.

    Science.gov (United States)

    Liu, Vincent Wing Sun; Yau, Wing Lung; Tam, Chun Wai; Yao, Kwok-Ming; Shiu, Stephen Yuen Wing

    2017-05-31

    A major current challenge in the treatment of advanced prostate cancer, which can be initially controlled by medical or surgical castration, is the development of effective, safe, and affordable therapies against progression of the disease to the stage of castration resistance. Here, we showed that in LNCaP and 22Rv1 prostate cancer cells transiently overexpressing androgen receptor splice variant-7 (AR-V7), nuclear factor-kappa B (NF-κB) was activated and could result in up-regulated interleukin ( IL ) -6 gene expression, indicating a positive interaction between AR-V7 expression and activated NF-κB/IL-6 signaling in castration-resistant prostate cancer (CRPC) pathogenesis. Importantly, both AR-V7-induced NF-κB activation and IL-6 gene transcription in LNCaP and 22Rv1 cells could be inhibited by melatonin. Furthermore, stimulation of AR-V7 mRNA expression in LNCaP cells by betulinic acid, a pharmacological NF-κB activator, was reduced by melatonin treatment. Our data support the presence of bi-directional positive interactions between AR-V7 expression and NF-κB activation in CRPC pathogenesis. Of note, melatonin, by inhibiting NF-κB activation via the previously-reported MT₁ receptor-mediated antiproliferative pathway, can disrupt these bi-directional positive interactions between AR-V7 and NF-κB and thereby delay the development of castration resistance in advanced prostate cancer. Apparently, this therapeutic potential of melatonin in advanced prostate cancer/CRPC management is worth translation in the clinic via combined androgen depletion and melatonin repletion.

  15. Melatonin Inhibits Androgen Receptor Splice Variant-7 (AR-V7-Induced Nuclear Factor-Kappa B (NF-κB Activation and NF-κB Activator-Induced AR-V7 Expression in Prostate Cancer Cells: Potential Implications for the Use of Melatonin in Castration-Resistant Prostate Cancer (CRPC Therapy

    Directory of Open Access Journals (Sweden)

    Vincent Wing Sun Liu

    2017-05-01

    Full Text Available A major current challenge in the treatment of advanced prostate cancer, which can be initially controlled by medical or surgical castration, is the development of effective, safe, and affordable therapies against progression of the disease to the stage of castration resistance. Here, we showed that in LNCaP and 22Rv1 prostate cancer cells transiently overexpressing androgen receptor splice variant-7 (AR-V7, nuclear factor-kappa B (NF-κB was activated and could result in up-regulated interleukin (IL-6 gene expression, indicating a positive interaction between AR-V7 expression and activated NF-κB/IL-6 signaling in castration-resistant prostate cancer (CRPC pathogenesis. Importantly, both AR-V7-induced NF-κB activation and IL-6 gene transcription in LNCaP and 22Rv1 cells could be inhibited by melatonin. Furthermore, stimulation of AR-V7 mRNA expression in LNCaP cells by betulinic acid, a pharmacological NF-κB activator, was reduced by melatonin treatment. Our data support the presence of bi-directional positive interactions between AR-V7 expression and NF-κB activation in CRPC pathogenesis. Of note, melatonin, by inhibiting NF-κB activation via the previously-reported MT1 receptor-mediated antiproliferative pathway, can disrupt these bi-directional positive interactions between AR-V7 and NF-κB and thereby delay the development of castration resistance in advanced prostate cancer. Apparently, this therapeutic potential of melatonin in advanced prostate cancer/CRPC management is worth translation in the clinic via combined androgen depletion and melatonin repletion.

  16. Quinoxaline derivatives: a patent review (2006--present).

    Science.gov (United States)

    González, Mercedes; Cerecetto, Hugo

    2012-11-01

    Quinoxaline scaffold is included in a large number of therapeutic agents because of its physicochemical properties that make the difference between them and the carbono analogue, naphthalene. This review of patented products presents the quinoxaline heterocycle as part of the structural patent claims from a medicinal chemistry perspective. We centred our discussion in the various drug patent applications of the quinoxaline and its derivatives. The applications are based firstly in the specific enzyme target with very low development in the disease treatment. Only for cancer and antimicrobial agents they were specifically determined but little is mentioned in order to insight in the last development activities.

  17. [Patented photobioreactor to commercial production of new drugs and nutraceuticals from microalgae].

    Science.gov (United States)

    Talbierz, Szymon; Kujawska, Natalia; Latała, Adam

    2012-01-01

    Microalgae - microscopic photosynthetic plants are an inexhaustible source of compounds with potential pharmaceutical applications. However, the development of microalgal biotechnology in particular for the production of new drugs and nutraceuticals has been slowed by the limited growth performance of algae in industrial photobioreactors. This is due to low light intensity, necessary for photosynthesis, which causes growth of algae. Flat-Plate photobioreactor with a solar-tracker system which is reported to protect with the Patent Office of RP enables optimal positioning of culture vessel to the direction of the sun's rays and thus can increase the efficiency of biomass growth (by 30%) and lipid content, compared with photobioreactors without it. The use of the invention in industrial plants can significantly contribute to lower costs and make all the technology more profitable.

  18. Püsiühenduste arv kasvas aastaga poole võrra / Tõnu Vare

    Index Scriptorium Estoniae

    Vare, Tõnu, 1947-

    2005-01-01

    Uuringufirma Point Topic andmetel oli 30. septembri 2004. a. seisuga Interneti püsiühenduste arv maailmas 136,4 miljonit. Diagrammid: Püsiühendustega leibkondade osakaal (%) Euroopas; 512 Kb/s allalaadimiskiirusega püsiühenduse kuutasu (eurodes)

  19. MORBILI PADA ANAK DALAM PENGOBATAN ANTI RETRO VIRAL (ARV

    Directory of Open Access Journals (Sweden)

    Surya Dipta Nugraha

    2016-03-01

    Full Text Available MEASLES IN CHILDREN WITH ANTI RETRO VIRAL (ARV ON TREATMENT ABSTRACT Introduction: Morbili is an acute viral infectious disease caused by a virus transmitted morbili. Morbili is a contagious acute viral infectious disease that is characterized by three stages: catarrhal stage, eruption stage and convalence stage. Another name morbili is measles, measles, or rubeola. Morbili caused by a virus that is classified as Family paramyxovirus, the virus genus morbili contained in nasopharyngeal secretions and blood during the prodromal period until 24 hours after the onset of spots. Case: Patient male, 6 years old, Hindu, Balinese tribe, came with complaints of febris since 5 days ago. Febris is not measured with a thermometer. The heat is felt up and down, getting better with medicine. Complaints red spots felt since 1 day ago. Originally discovered red spots appear in the neck area and then to the face and chest. The incidence of rash accompanied by itching and heat. This complaint is accompanied with nosebleeds 1 day ago, cough with sputum since 5 days ago and the red eye from one day ago. Patients feel the first time such complaints. Having a history of antiretroviral use regularly since 1.5 years old. Keywords: rash, morbili, HIV, antiretroviral drugs.

  20. Problems associated with substandard and counterfeit drugs in developing countries: a review article on global implications of counterfeit drugs in the era of antiretroviral (ARVs) drugs in a free market economy.

    Science.gov (United States)

    Nsimba, Stephen E D

    2008-12-01

    To review the global implications associated with the use of substandard and or counterfeit drugs in developing and may be developed countries. The focus of this review is particularly on antiretroviral (ARVs), antimalarials and other drugs. Review of various literatures through Pub-Med, Medline, Google and Internet search to retrieve and download published materials was done by the author of this review paper. When patients receive a counterfeit medicines, they are subjected to multiple risks. They often suffer more than just an inconvenience; as they become victims of fraud medicines and are all put at risk of adverse effects from unprescribed medicines or substandard ingredients. Additionally, patients may lose confidence in health care professionals including their physician and pharmacist, and potentially modern medicine or the pharmaceutical industry in general. Counterfeit or substandard (poor quality) drugs pose threats to society; not only to the individual in terms of the health side effects experienced, but also to the public in terms of trade relations, economic implications, and the effects on global pandemics. It is vital for suppliers, providers, and patients to be aware of current trends in counterfeiting in order to best prepare for encounters with suspicious products. Furthermore, this is an issue that needs to be continually dealt with on national and international policy levels. Developing countries should try their level best to establish good laboratories for monitoring and checking quality of all pharmaceuticals manufactured locally and those imported or donated to these countries. The Ministries of Health and all stakeholders involved in this issue must ensure that all drugs meet the set or established international standards and national standards. Failure to do so will be to misuse the hard earned forex that is normally borrowed from banks for the procurement and distribution of drugs to its people. Indeed sub-standard medications do more

  1. A novel rudivirus, ARV1, of the hyperthermophilic archaeal genus Acidianus

    DEFF Research Database (Denmark)

    Vestergaard, Gisle Alberg; Häring, Monika; Peng, Xu

    2005-01-01

    Virus ARV1, the first member of the family Rudiviridae infecting hyperthermophilic archaea of the genus Acidianus, was isolated from a hot spring in Pozzuoli, Italy. The rod-shaped virions, 610 +/- 50 nm long and 22 +/- 3 nm wide, are non-enveloped and carry a helical nucleoprotein core, with thr...

  2. Access to antiretroviral drugs and AIDS management in Senegal.

    Science.gov (United States)

    Desclaux, Alice; Ciss, Mounirou; Taverne, Bernard; Sow, Papa S; Egrot, Marc; Faye, Mame A; Lanièce, Isabelle; Sylla, Omar; Delaporte, Eric; Ndoye, Ibrahima

    2003-07-01

    Description and analysis of the Senegalese Antiretroviral Drug Access Initiative (ISAARV), the first governmental highly active antiretroviral therapy (HAART) treatment programme in Africa, launched in 1998. ISAARV was initially an experimental project designed to evaluate the feasibility, efficacy and acceptability of HAART in an African context. It was based on four principles: collective definition of the strategy, with involvement of the health professionals who would be called on to execute the programme; matching the objectives to available means (gradual enrollment according to drug availability); monitoring by several research programmes; and ongoing adaptation of treatment and follow-up according to the latest international recommendations. Persons qualifying for antiretroviral (ARV) therapy are selected on the basis of immunological and clinical criteria, regardless of economic and social considerations. A system of subsidies was created to favor access to ARV. Following the ARV price reductions that occurred in November 2000, 100% subsidies were created for the poorest participants. Optimal adherence was ensured by monthly follow-up by pharmacists and support groups held by social workers and patient associations. The chosen supply and distribution system allowed drug dispensing to be strictly controlled. The ISAARV programme demonstrates that HAART can be successfully prescribed in Africa. This experience has served as the basis for the creation of a national treatment programme in Senegal planned to treat 7000 patients by 2006.

  3. Law-medicine interfacing: patenting of human genes and mutations.

    Science.gov (United States)

    Fialho, Arsenio M; Chakrabarty, Ananda M

    2011-08-01

    Mutations, Single Nucleotide Polymorphisms (SNPs), deletions and genetic rearrangements in specific genes in the human genome account for not only our physical characteristics and behavior, but can lead to many in-born and acquired diseases. Such changes in the genome can also predispose people to cancers, as well as significantly affect the metabolism and efficacy of many drugs, resulting in some cases in acute toxicity to the drug. The testing of the presence of such genetic mutations and rearrangements is of great practical and commercial value, leading many of these genes and their mutations/deletions and genetic rearrangements to be patented. A recent decision by a judge in the Federal District Court in the Southern District of New York, has created major uncertainties, based on the revocation of BRCA1 and BRCA2 gene patents, in the eligibility of all human and presumably other gene patents. This article argues that while patents on BRCA1 and BRCA2 genes could be challenged based on a lack of utility, the patenting of the mutations and genetic rearrangements is of great importance to further development and commercialization of genetic tests that can save human lives and prevent suffering, and should be allowed.

  4. Modeling HIV/AIDS Drug Price Determinants in Brazil: Is Generic Competition a Myth?

    OpenAIRE

    Meiners, Constance; Sagaon-Teyssier, Luis; Hasenclever, Lia; Moatti, Jean-Paul

    2011-01-01

    BACKGROUND: Brazil became the first developing country to guarantee free and universal access to HIV/AIDS treatment, with antiretroviral drugs (ARVs) being delivered to nearly 190,000 patients. The analysis of ARV price evolution and market dynamics in Brazil can help anticipate issues soon to afflict other developing countries, as the 2010 revision of the World Health Organization guidelines shifts demand towards more expensive treatments, and, at the same time, current evolution of internat...

  5. AR-V7 in Peripheral Whole Blood of Patients with Castration-resistant Prostate Cancer: Association with Treatment-specific Outcome Under Abiraterone and Enzalutamide.

    Science.gov (United States)

    Seitz, Anna Katharina; Thoene, Silvia; Bietenbeck, Andreas; Nawroth, Roman; Tauber, Robert; Thalgott, Mark; Schmid, Sebastian; Secci, Ramona; Retz, Margitta; Gschwend, Jürgen E; Ruland, Jürgen; Winter, Christof; Heck, Matthias M

    2017-11-01

    It has been demonstrated that androgen receptor splice variant 7 (AR-V7) expression in circulating tumor cells (CTCs) predicts poor treatment response in metastatic castration-resistant prostate cancer (mCRPC) patients treated with abiraterone or enzalutamide. To develop a practical and robust liquid profiling approach for direct quantification of AR-V7 in peripheral whole blood without the need for CTC capture and to determine its potential for predicting treatment response in mCRPC patients. Whole blood samples from a prospective biorepository of 85 mCRPC patients before treatment initiation with abiraterone (n=56) or enzalutamide (n=29) were analyzed via droplet digital polymerase chain reaction. The association of AR-V7 status with prostate-specific antigen (PSA) response defined by PSA decline ≥50% and with PSA-progression-free survival (PSA-PFS), clinical PFS, and overall survival (OS) was assessed. High AR-V7 expression levels in whole blood were detectable in 18% (15/85) of patients. No patient with high AR-V7 expression achieved a PSA response, and AR-V7 status was an independent predictor of PSA response in multivariable logistic regression analysis (p=0.03). High AR-V7 expression was associated with shorter PSA-PFS (median 2.4 vs 3.7 mo; pAR-V7 expression remained an independent predictor of shorter PSA-PFS (hazard ratio [HR] 7.0, 95% confidence interval [CI] 2.3-20.7; pAR-V7 mRNA levels in whole blood is a simple and promising approach to predict poor treatment outcome in mCRPC patients receiving abiraterone or enzalutamide. We established a method for determining AR-V7 status in whole blood. This test predicted treatment resistance in patients with metastatic castration-resistant prostate cancer undergoing treatment with abiraterone or enzalutamide. Prospective validation is needed before application to clinical practice. Copyright © 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.

  6. Antiretroviral drug supply challenges in the era of scaling up ART in Malawi.

    Science.gov (United States)

    Schouten, Erik J; Jahn, Andreas; Ben-Smith, Anne; Makombe, Simon D; Harries, Anthony D; Aboagye-Nyame, Francis; Chimbwandira, Frank

    2011-07-06

    The number of people receiving antiretroviral treatment (ART) has increased considerably in recent years and is expected to continue to grow in the coming years. A major challenge is to maintain uninterrupted supplies of antiretroviral (ARV) drugs and prevent stock outs. This article discusses issues around the management of ARVs and prevention of stock outs in Malawi, a low-income country with a high HIV/AIDS burden, and a weak procurement and supply chain management system. This system for ARVs, paid for by the Global Fund to Fight AIDS, Tuberculosis and Malaria, and bypassing the government Central Medical Stores, is in place, using the United Nations Children's Fund's (UNICEF's) procurement services. The system, managed by a handful of people who spend limited time on supply management, is characterized by a centrally coordinated quantification based on verified data from all national ART clinics, parallel procurement through UNICEF, and direct distribution to ART clinics. The model worked well in the first years of the ART programme with a single first-line ARV regimen, but with more regimens becoming available (e.g., alternative first-line, second-line and paediatric regimens), it has become more difficult to administer. Managing supplies through a parallel system has the advantage that weaknesses in the national system have limited influence on the ARV procurement and supply chain management system. However, as the current system operates without a central warehouse and national buffer stock capacity, it diminishes the ability to prevent ARV stock outs. The process of ordering ARVs, from the time that estimates are made to the arrival of supplies in health facilities, takes approximately one year. Addressing the challenges involved in maintaining ARVs through an efficient procurement and supply chain management system that prevents ARV stock outs through the establishment of a dedicated procurement team, a central warehouse and/or national buffer stock is a

  7. HIV-1 infection and pregnancy in young women in Brazil: socioeconomic and drug resistance profiles in a cross-sectional study.

    Science.gov (United States)

    Lima, Yanna Andressa Ramos; Reis, Mônica Nogueira Guarda; Cardoso, Ludimila Paula Vaz; Stefani, Mariane Martins Araújo

    2016-07-05

    To describe socioeconomic and antiretroviral (ARV) drug resistance profiles among young pregnant women infected with HIV-1. A public health antenatal programme responsible for screening ∼90 000 pregnant women per year for nine different infectious diseases in Central Western Brazil. 96 young pregnant women (15-24 years) infected with HIV-1. Standard interviews and blood samples were taken at the time of recruitment, at the first medical appointment after confirmation of diagnosis of HIV-1 infection, and before ARV prophylaxis initiation. Clinical and laboratory data were retrieved from medical files. HIV-1 pol gene sequences (entire protease/PR, partial reverse transcriptase/RT) were obtained from plasma RNA. ARV resistance mutations (CPR/Stanford HIV-1; International AIDS Society-USA databases) were identified. The median age was 21 years; most reported pregnancies. Possible heterosexual transmission by an HIV-1 infected partner (17%) and commercial sex work (2%) were reported. The median of CD4 cell count was 526 cells/mm(3); the median viral load was: 10 056 copies/mL in ARV-naïve (48/96) patients and 5881 copies/mL in ARV-exposed (48/96) patients. Two probable seroconversion cases during pregnancy were identified in adolescents. One mother-to-child transmission case (1.0%) was observed. Transmitted drug resistance among ARV-naïve patients was 9.3% (CI 95% 3.3% to 19.6%); secondary drug resistance among ARV-exposed patients was 12.5% (CI 95% 4.7% to 25.6%). Despite high access to antenatal care, the low socioeconomic-educational profiles seen in these young HIV-1-infected women highlight the necessity of improved public health educational and preventive strategies regarding HIV infection and early unplanned pregnancy. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  8. NEW DRUGS NEW TARGETS AND NOVEL ANTIRETROVIRALS

    African Journals Online (AJOL)

    2005-11-02

    Nov 2, 2005 ... Highly active antiretroviral therapy (HAART) has to date been based on use of a triple combination of drugs chosen from three classes of antiretrovirals (ARVs), nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs).

  9. 37 CFR 1.5 - Identification of patent, patent application, or patent-related proceeding.

    Science.gov (United States)

    2010-07-01

    ... UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES General Provisions General Information and Correspondence § 1.5 Identification of patent, patent... benefit of the date of deposit with the United States Postal Service. If the returned correspondence is...

  10. The role of patent and non-patent databases in patent research in universities

    Science.gov (United States)

    Tolstaya, A. M.; Suslina, I. V.; Tolstaya, P. M.

    2017-01-01

    This studies deal with the description and systematization of the popular patent retrieval resources. The importance of the non-patent information when conducting patent research for the intellectual property created in educational and scientific activity of the university is highlighted. The differences in the patent and non-patent information are found out. Based on the databases` analysis the authors conducted the patent research on "Wireless endoscopic capsules" (development of the NRNU MEPhI). This study can be used to facilitate the university work on the new product development in order to improve the efficiency of the process of the commercialization of the intellectual activity results, including the entering the international market.

  11. Drug transporter gene expression in human colorectal tissue and cell lines: modulation with antiretrovirals for microbicide optimization.

    Science.gov (United States)

    Mukhopadhya, Indrani; Murray, Graeme I; Berry, Susan; Thomson, John; Frank, Bruce; Gwozdz, Garry; Ekeruche-Makinde, Julia; Shattock, Robin; Kelly, Charles; Iannelli, Francesco; Pozzi, Gianni; El-Omar, Emad M; Hold, Georgina L; Hijazi, Karolin

    2016-02-01

    The objectives of this study were to comprehensively assess mRNA expression of 84 drug transporters in human colorectal biopsies and six representative cell lines, and to investigate the alteration of drug transporter gene expression after exposure to three candidate microbicidal antiretroviral (ARV) drugs (tenofovir, darunavir and dapivirine) in the colorectal epithelium. The outcome of the objectives informs development of optimal ARV-based microbicidal formulations for prevention of HIV-1 infection. Drug transporter mRNA expression was quantified from colorectal biopsies and cell lines by quantitative real-time PCR. Relative mRNA expression was quantified in Caco-2 cells and colorectal explants after induction with ARVs. Data were analysed using Pearson's product moment correlation (r), hierarchical clustering and principal component analysis (PCA). Expression of 58 of the 84 transporters was documented in colorectal biopsies, with genes for CNT2, P-glycoprotein (P-gp) and MRP3 showing the highest expression. No difference was noted between individual subjects when analysed by age, gender or anatomical site (rectum or recto-sigmoid) (r = 0.95-0.99). High expression of P-gp and CNT2 proteins was confirmed by immunohistochemical staining. Similarity between colorectal tissue and cell-line drug transporter gene expression was variable (r = 0.64-0.84). PCA showed distinct clustering of human colorectal biopsy samples, with the Caco-2 cells defined as the best surrogate system. Induction of Caco-2 cell lines with ARV drugs suggests that darunavir-based microbicides incorporating tenofovir may result in drug-drug interactions likely to affect distribution of individual drugs to sub-epithelial target cells. These findings will help optimize complex formulations of rectal microbicides to realize their full potential as an effective approach for pre-exposure prophylaxis against HIV-1 infection. © The Author 2015. Published by Oxford University Press on behalf of the

  12. The economics of pediatric formulation development for off-patent drugs.

    Science.gov (United States)

    Milne, Christopher-Paul; Bruss, Jon B

    2008-11-01

    Many drugs currently used in children have never been adequately studied in rigorous scientific trials. Although these medications can still be prescribed in the pediatric setting, they are considered "off-label" because they are not specifically approved for use in children. The role of the Economics Working Group (EWG) within the Pediatric Formulation Initiative (PFI) of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is to identify economic barriers and to propose possible mechanisms to create cost-effective and appropriately formulated products for off-patent pediatric drugs and to ensure their distribution and availability. The purpose of this article was to briefly outline the EWG's considerations and recommendations on these topics. Information for this article was gathered from the proceedings of a PFI workshop sponsored by the NICHD, held December 6 and 7, 2005, in Bethesda, Maryland. Other information was based on: the authors' unpublished and published research as well as personal communication with members of the EWG; a comprehensive search of Web sites, publications, and publicly accessible databases of the European Medicines Agency, the US Food and Drug Administration, the Agency for Healthcare Research and Quality, and the NICHD; and the databases and publications available from the Louis Lasagna Library of the Tufts Center for the Study of Drug Development (Boston, Massachusetts). The US Congress has attempted to remedy the lack of incentives to develop pediatric drugs by passing 2 key pieces of legislation. After >10 years, this US pediatric initiative has stimulated a great deal of pediatric drug research, and similar initiatives have been emulated in Europe and proposed in Japan. Although the initiative is generally considered successful in the United States, an incentive gap exists that still hinders pediatric drug development. It results from a series of factors, including: (1) a relatively small

  13. The patents-based pharmaceutical development process: rationale, problems, and potential reforms.

    Science.gov (United States)

    Barton, John H; Emanuel, Ezekiel J

    2005-10-26

    The pharmaceutical industry is facing substantial criticism from many directions, including financial barriers to access to drugs in both developed and developing countries, high profits, spending on advertising and marketing, and other issues. Underlying these criticisms are fundamental questions about the value of the current patent-based drug development system. Six major problems with the patent system are (1) recovery of research costs by patent monopoly reduces access to drugs; (2) market demand rather than health needs determines research priorities; (3) resources between research and marketing are misallocated; (4) the market for drugs has inherent market failures; (5) overall investment in drug research and development is too low, compared with profits; and (6) the existing system discriminates against US patients. Potential solutions fall into 3 categories: change in drug pricing through either price controls or tiered pricing; change in drug industry structure through a "buy-out" pricing system or with the public sector acting as exclusive research funder; and change in development incentives through a disease burden incentive system, orphan drug approaches, or requiring new drugs to demonstrate improvement over existing products prior to US Food and Drug Administration approval. We recommend 4 complementary reforms: (1) having no requirement to test new drug products against existing products prior to approval but requiring rigorous comparative postapproval testing; (2) international tiered pricing and systematic safeguards to prevent flow-back; (3) increased government-funded research and buy-out for select conditions; and (4) targeted experiments using other approaches for health conditions in which there has been little progress and innovation over the last few decades.

  14. 77 FR 26556 - Determination of Regulatory Review Period for Purposes of Patent Extension; EQUIDONE GEL

    Science.gov (United States)

    2012-05-04

    ... of two periods of time: A testing phase and an approval phase. For animal drug products, the testing... Cosmetic Act: July 30, 2010. The applicant claims July 27, 2010, as the date the new animal drug... Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that animal...

  15. 75 FR 75678 - Determination of Regulatory Review Period for Purposes of Patent Extension; STELARA

    Science.gov (United States)

    2010-12-06

    ..., animal drug product, medical device, food additive, or color additive) was subject to regulatory review... or systemic therapy. Subsequent to this approval, the Patent and Trademark Office received a patent...

  16. Dynamic competition in pharmaceuticals. Patent expiry, generic penetration, and industry structure.

    Science.gov (United States)

    Magazzini, Laura; Pammolli, Fabio; Riccaboni, Massimo

    2004-06-01

    This paper investigates patterns of industrial dynamics and competition in the pharmaceutical industry, with particular reference to the consequences of patent expiry in different countries. We focus on the competition at the level of single chemical entities, distinguishing between original brands and generic products. Quarterly data, spanning from July 1987 to December 1998, on sales of pharmaceutical products in four countries (USA, UK, Germany, and France) constitute the basis of our analysis. All the products containing major molecules whose patent expiration date lies between 1986 and 1996 are included in our sample. We show how diffusion of generics is linked to the characteristics of the market and investigate how price dynamics of original products are affected by generic competition. Our empirical investigation shows that the dynamics of drug prices and the competition by generic drugs vary significantly across countries. This heterogeneity notwithstanding, a clear distinction seems to emerge. On the one hand, systems that rely on market-based competition in pharmaceuticals promote a clear distinction between firms that act as innovators and firms that act as imitators after patent expiry. Here, original products enjoy premium prices and exclusivity profits under patent protection, and face fierce price competition after patent expiry. On the other hand, in systems that rely on administered prices, penetration by generic drugs tends to be rather limited. Its descriptive and preliminary nature notwithstanding, our analysis seems to have relevant implications at different levels of generality, especially for Europe.

  17. Early warning indicators for HIV drug resistance in Cameroon during the year 2010.

    Directory of Open Access Journals (Sweden)

    Serge C Billong

    Full Text Available BACKGROUND: Rapid scale-up of antiretroviral therapy (ART in resource-limited settings is accompanied with an increasing risk of HIV drug resistance (HIVDR, which in turn could compromise the performance of national ART rollout programme. In order to sustain the effectiveness of ART in a resource-limited country like Cameroon, HIVDR early warning indicators (EWI may provide relevant corrective measures to support the control and therapeutic management of AIDS. METHODS: A retrospective study was conducted in 2010 among 40 ART sites (12 Approved Treatment Centers and 28 Management Units distributed over the 10 regions of Cameroon. Five standardized EWIs were selected for the evaluation using data from January through December, among which: (1 Good ARV prescribing practices: target = 100%; (2 Patient lost to follow-up: target ≤ 20%; (3 Patient retention on first line ART: target ≥ 70%; (4 On-time drug pick-up: target ≥ 90%; (5 ARV drug supply continuity: target = 100%. Analysis was performed using a Data Quality Assessment tool, following WHO protocol. RESULTS: THE NUMBER OF SITES ATTAINING THE REQUIRED PERFORMANCE ARE: 90% (36/40 for EWI(1, 20% (8/40 for EWI(2; 20% (8/40 for EWI(3; 0% (0/37 for EWI(4; and 45% (17/38 for EWI 5. ARV prescribing practices were in conformity with the national guidelines in almost all the sites, whereas patient adherence to ART (EWI(2, EWI(3, and EWI(4 was very low. A high rate of patients was lost-to-follow-up and others failing first line ART before 12 months of initiation. Discontinuity in drug supply observed in about half of the sites may negatively impact ARV prescription and patient adherence. These poor ART performances may also be due to low number of trained staff and community disengagement. CONCLUSIONS: The poor performance of the national ART programme, due to patient non-adherence and drug stock outs, requires corrective measures to limit risks of HIVDR emergence in Cameroon.

  18. Early warning indicators for HIV drug resistance in Cameroon during the year 2010.

    Science.gov (United States)

    Billong, Serge C; Fokam, Joseph; Nkwescheu, Armand S; Kembou, Etienne; Milenge, Pascal; Tsomo, Zephirin; Dion, Grace Ngute; Aghokeng, Avelin F; Mpoudi, Eitel N; Ndumbe, Peter M; Colizzi, Vittorio; Elat Nfetam, Jean B

    2012-01-01

    Rapid scale-up of antiretroviral therapy (ART) in resource-limited settings is accompanied with an increasing risk of HIV drug resistance (HIVDR), which in turn could compromise the performance of national ART rollout programme. In order to sustain the effectiveness of ART in a resource-limited country like Cameroon, HIVDR early warning indicators (EWI) may provide relevant corrective measures to support the control and therapeutic management of AIDS. A retrospective study was conducted in 2010 among 40 ART sites (12 Approved Treatment Centers and 28 Management Units) distributed over the 10 regions of Cameroon. Five standardized EWIs were selected for the evaluation using data from January through December, among which: (1) Good ARV prescribing practices: target = 100%; (2) Patient lost to follow-up: target ≤ 20%; (3) Patient retention on first line ART: target ≥ 70%; (4) On-time drug pick-up: target ≥ 90%; (5) ARV drug supply continuity: target = 100%. Analysis was performed using a Data Quality Assessment tool, following WHO protocol. THE NUMBER OF SITES ATTAINING THE REQUIRED PERFORMANCE ARE: 90% (36/40) for EWI(1), 20% (8/40) for EWI(2); 20% (8/40) for EWI(3); 0% (0/37) for EWI(4); and 45% (17/38) for EWI 5. ARV prescribing practices were in conformity with the national guidelines in almost all the sites, whereas patient adherence to ART (EWI(2), EWI(3), and EWI(4)) was very low. A high rate of patients was lost-to-follow-up and others failing first line ART before 12 months of initiation. Discontinuity in drug supply observed in about half of the sites may negatively impact ARV prescription and patient adherence. These poor ART performances may also be due to low number of trained staff and community disengagement. The poor performance of the national ART programme, due to patient non-adherence and drug stock outs, requires corrective measures to limit risks of HIVDR emergence in Cameroon.

  19. The lifespan of semiconductor patents by assignee and patent characteristics

    Directory of Open Access Journals (Sweden)

    Chang Shu-Hao

    2017-01-01

    Full Text Available Evaluating the values of patents is critical for both managers and investors. Patent maintenance time is an ideal proxy indicator for evaluating commercial patent value. This study investigated the survival rates of patents in the semiconductor industry by using a survival analysis and incorporated a predictive model for patent maintenance times. The technical characteristics of the patents, the assignee factors, and the statuses of the patents were used as the predictive factors for patent maintenance time. The results revealed a small entity size and the number of assignees are the risk factors that increase the likelihood of the maintenance time of a patent decreasing. The litigation status of a patent and the number of its international patent classifications, claims, forward citations, and assignments were determined to be the protection factors that raise the likelihood of its maintenance time extending. Additionally, substantial differences were noted between small entities and nonsmall entities and between being litigated and not in their effects on the survival rates of patents. This study examined the factors that affect the survival rates of patents and provides a reference for the managers and investors of intellectual property rights to use when assessing technical and commercial patent values.

  20. Lovely but dangerous: The impact of patent citations on patent duration

    OpenAIRE

    Maurseth, Per Botolf

    2001-01-01

    - What is the impact of patent citations on patent renewal behaviour? Patent citations are commonly used as an indicator of technology spillovers. For cited patents therefore, patent citations have a potentially ambiguous impact. On the one hand, patent citations may indicate a scientific breakthrough, a high value of the cited patent and therefore a long survival period. On the other hand, patent citations may indicate competing innovations that render the cited patent obsolete. By discri...

  1. Test Collections for Patent-to-Patent Retrieval and Patent Map Generation in NTCIR-4 Workshop

    OpenAIRE

    Fujii, Atsushi; Iwayama, Makoto; Kando, Noriko

    2004-01-01

    This paper describes the Patent Retrieval Task in the Fourth NTCIR Workshop, and the test collections produced in this task. We perform the invalidity search task, in which each participant group searches a patent collection for the patents that can invalidate the demand in an existing claim. We also perform the automatic patent map generation task, in which the patents associated with a specific topic are organized in a multi-dimensional matrix.

  2. Patenting human genes: Chinese academic articles' portrayal of gene patents.

    Science.gov (United States)

    Du, Li

    2018-04-24

    The patenting of human genes has been the subject of debate for decades. While China has gradually come to play an important role in the global genomics-based testing and treatment market, little is known about Chinese scholars' perspectives on patent protection for human genes. A content analysis of academic literature was conducted to identify Chinese scholars' concerns regarding gene patents, including benefits and risks of patenting human genes, attitudes that researchers hold towards gene patenting, and any legal and policy recommendations offered for the gene patent regime in China. 57.2% of articles were written by law professors, but scholars from health sciences, liberal arts, and ethics also participated in discussions on gene patent issues. While discussions of benefits and risks were relatively balanced in the articles, 63.5% of the articles favored gene patenting in general and, of the articles (n = 41) that explored gene patents in the Chinese context, 90.2% supported patent protections for human genes in China. The patentability of human genes was discussed in 33 articles, and 75.8% of these articles reached the conclusion that human genes are patentable. Chinese scholars view the patent regime as an important legal tool to protect the interests of inventors and inventions as well as the genetic resources of China. As such, many scholars support a gene patent system in China. These attitudes towards gene patents remain unchanged following the court ruling in the Myriad case in 2013, but arguments have been raised about the scope of gene patents, in particular that the increasing numbers of gene patents may negatively impact public health in China.

  3. Litigation-proof patents: avoiding the most common patent mistakes

    National Research Council Canada - National Science Library

    Goldstein, Larry M

    2014-01-01

    "Litigation-Proof Patents: Avoiding the Most Common Patent Mistakes explains the principles of excellent patents, presents the ten most common errors in patents, and details a step-by-step method for avoiding these common errors...

  4. How Patent Function Integration with R&D Influence the Value of Patents

    DEFF Research Database (Denmark)

    Beukel, Karin; Valentin, Finn

    Patent strategies are endogenous to firm appropriability. However, to what extent does firm’s R&D teams’ engagement with patent experts influence the value of patents? We estimate the relationship between firm’s R&D use of patent functions on patent value in Biotech firms. Controlling...... for characteristics of scientific team, firm effects, and other patent value indicators, we find that having a firm specific (in-house) internal patent function is a driver of patent value. In addition, we find that the way in which patent functions create patent value differs dependent on whether the firm has...... internal patent function or not. In-house patent functions create value through narrow patents, whereas, firms with no in-house patent function create valuable patents by the use of broader scoped patents. Our results point to a strong effect of firm specific patent functions, but also explain how firms...

  5. Adherence to ARV medication in Romanian young adults: self-reported behaviour and psychological barriers

    NARCIS (Netherlands)

    Dima, A.L.; Schweitzer, A.M.; Diaconiţă, R.; Remor, E.; Wanless, R.S.

    2013-01-01

    Adherence to antiretroviral (ARV) treatment during adolescence and young adulthood is a significant clinical issue for the current management of the HIV/AIDS epidemic in Romania. Understanding patients' own perceptions of their adherence behaviours and related psychological barriers is instrumental

  6. 76 FR 24034 - Determination of Regulatory Review Period for Purposes of Patent Extension; CONVENIA

    Science.gov (United States)

    2011-04-29

    ... an exemption under section 512(j) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S... G) in dogs. Subsequent to this approval, the Patent and Trademark Office received a patent term...

  7. CX4945 suppresses the growth of castration-resistant prostate cancer cells by reducing AR-V7 expression.

    Science.gov (United States)

    Deng, Chuangzhong; Chen, Jieping; Guo, Shengjie; Wang, Yanjun; Zhou, Qianghua; Li, Zaishang; Yang, Xingping; Yu, Xingsu; Zhang, Zhenfeng; Zhou, Fangjian; Han, Hui; Yao, Kai

    2017-08-01

    The aberrant expression of casein kinase 2 (CK2) has been reported to be involved in the tumorigenesis and progression of prostate cancer. The inhibition of CK2 activity represses androgen-dependent prostate cancer cells by attenuating the androgen receptor (AR) signaling pathway. In this study, we examined the effect of CK2 inhibition in castration-resistant prostate cancer (CRPC) cells, in which AR variants (ARVs) play a predominant role. A newly synthetic CK2 selective inhibitor CX4945 was utilized to study the effect of CK2 inhibition in CRPC cells by CCK8 assay and colony formation assay. Protein and mRNA levels of full-length AR (AR-FL) and AR-V7 were determined by qPCR and western blot, respectively. The nuclear translocation of p50 and p65 was assessed to reflect the activity of the NF-κB pathway. CX4945 reduced the proliferation of CRPC cells in a dose-dependent and time-dependent manner. AR-V7 rather than AR-FL was downregulated by CX4945 in both the mRNA and protein level. Furthermore, CX4945 could restore the sensitivity of CRPC cells to bicalutamide. The analysis of possible mechanisms demonstrated that the inhibition of CK2 diminished the phosphorylation of p65 at ser529 and thus attenuated the activity of the NF-κB pathway. The inhibition of CK2 by CX4945 can repress the viability of CRPC cells and restore their sensitivity to anti-androgen therapy by suppressing AR-V7. This finding presents a potential option for the treatment of prostate cancer, especially CRPC.

  8. Patent Assessment Quality

    DEFF Research Database (Denmark)

    Burke, Paul F.; Reitzig, Markus

    2006-01-01

    The increasing number of patent applications worldwide and the extension of patenting to the areas of software and business methods have triggered a debate on "patent quality". While patent quality may have various dimensions, this paper argues that consistency in the decision making on the side...... of the patent office is one important dimension, particularly in new patenting areas (emerging technologies). In order to understand whether patent offices appear capable of providing consistent assessments of a patent's technological quality in such novel industries from the beginning, we study the concordance...... of the European Patent Office's (EPO's) granting and opoposition decisions for individual patents. We use the historical example of biotech patens filed between 1978 until 1986, the early stage of the industry. Our results indicate that the EPO shows systematically different assessments of technological quality...

  9. Patent first, ask questions later: morality and biotechnology in patent law.

    Science.gov (United States)

    Bagley, Margo A

    2003-12-01

    This Article explores the U.S. "patent first, ask questions later" approach to determining what subject matter should receive patent protection. Under this approach, the U.S. Patent and Trademark Office (USPTO or the Agency) issues patents on "anything under the sun made by man," and to the extent a patent's subject matter is sufficiently controversial, Congress acts retrospectively in assessing whether patents should issue on such interventions. This practice has important ramifications for morally controversial biotechnology patents specifically, and for American society generally. For many years a judicially created "moral utility" doctrine served as a type of gatekeeper of patent subject matter eligibility. The doctrine allowed both the USTPO and courts to deny patents on morally controversial subject matter under the fiction that such inventions were not "useful." The gate, however, is currently untended. A combination of the demise of the moral utility doctrine, along with expansive judicial interpretations of the scope of patent-eligible subject matter, has resulted in virtually no basis on which the USTPO or courts can deny patent protection to morally controversial, but otherwise patentable, subject matter. This is so despite position statements by the Agency to the contrary. Biotechnology is an area in which many morally controversial inventions are generated. Congress has been in react-mode following the issuance of a stream of morally controversial biotech patents, including patents on transgenic animals, surgical methods, and methods of cloning humans. With no statutory limits on patent eligibility, and with myriad concerns complicating congressional action following a patent's issuance, it is not Congress, the representative of the people, determining patent eligibility. Instead, it is patent applicants, scientific inventors, who are deciding matters of high public policy through the contents of the applications they file with the USTPO. This Article

  10. Patenting Nanomedicines Legal Aspects, Intellectual Property and Grant Opportunities

    CERN Document Server

    Souto, Eliana B

    2012-01-01

    "Patenting Nanomedicines: Legal Aspects, Intellectual Property and Grant Opportunities" focuses on the fundamental aspects of Patenting Nanomedicines applied in different "Drug Delivery and Targeting Systems". The promoters of new findings in this field of research are numerous and spread worldwide; therefore, managing intellectual property portfolios, and the acquisition and exploitation of new knowledge face several contingency factors. Today, the scientific community is discussing issues of economic outcomes in the field of Nanomedicines. Major concerns include questions

  11. Toward a normalized clinical drug knowledge base in China-applying the RxNorm model to Chinese clinical drugs.

    Science.gov (United States)

    Wang, Li; Zhang, Yaoyun; Jiang, Min; Wang, Jingqi; Dong, Jiancheng; Liu, Yun; Tao, Cui; Jiang, Guoqian; Zhou, Yi; Xu, Hua

    2018-04-04

    In recent years, electronic health record systems have been widely implemented in China, making clinical data available electronically. However, little effort has been devoted to making drug information exchangeable among these systems. This study aimed to build a Normalized Chinese Clinical Drug (NCCD) knowledge base, by applying and extending the information model of RxNorm to Chinese clinical drugs. Chinese drugs were collected from 4 major resources-China Food and Drug Administration, China Health Insurance Systems, Hospital Pharmacy Systems, and China Pharmacopoeia-for integration and normalization in NCCD. Chemical drugs were normalized using the information model in RxNorm without much change. Chinese patent drugs (i.e., Chinese herbal extracts), however, were represented using an expanded RxNorm model to incorporate the unique characteristics of these drugs. A hybrid approach combining automated natural language processing technologies and manual review by domain experts was then applied to drug attribute extraction, normalization, and further generation of drug names at different specification levels. Lastly, we reported the statistics of NCCD, as well as the evaluation results using several sets of randomly selected Chinese drugs. The current version of NCCD contains 16 976 chemical drugs and 2663 Chinese patent medicines, resulting in 19 639 clinical drugs, 250 267 unique concepts, and 2 602 760 relations. By manual review of 1700 chemical drugs and 250 Chinese patent drugs randomly selected from NCCD (about 10%), we showed that the hybrid approach could achieve an accuracy of 98.60% for drug name extraction and normalization. Using a collection of 500 chemical drugs and 500 Chinese patent drugs from other resources, we showed that NCCD achieved coverages of 97.0% and 90.0% for chemical drugs and Chinese patent drugs, respectively. Evaluation results demonstrated the potential to improve interoperability across various electronic drug systems

  12. Patentability of inventions under the Nigeria's patents and designs act

    African Journals Online (AJOL)

    Patentability of inventions under the Nigeria's patents and designs act: an examination. ... AFRICAN JOURNALS ONLINE (AJOL) · Journals · Advanced Search · USING ... The Nigerian Patent Registry refuses patent applications for Software or ...

  13. Mixed WTO ruling on generic drug development.

    Science.gov (United States)

    Elliott, R

    2000-01-01

    On 17 March 2000, the World Trade Organization upheld the provision in Canada's patent laws that allows generic drug manufacturers to develop (but not sell) their cheaper versions of patented medicines before the 20-year patients expire. The decision prevents pharmaceutical companies from enjoying market monopolies beyond their patent terms, avoiding what would otherwise be even lengthier delays in the sale of cheaper, generic drugs in Canada. This decision is of significance not only to Canada, but also to other WTO member countries and to all individuals who use pharmaceutical products. However, the decision is not all positive: the WTO also ruled that Canada is violating international agreements by letting generic manufacturers stockpile their versions of patented drugs before patents expire. This article explains the issues, the arguments, and the decision.

  14. Biocompatible Synthetic and Semi-synthetic Polymers - A Patent Analysis.

    Science.gov (United States)

    Ranganathan, Balu; Miller, Charles; Sinskey, Anthony

    2018-01-01

    Bioengineering has come of ages by setting up spare parts manufacturing units to be used in human body such as invasive implants and interventional controlled drug delivery in vivo systems. As a matter of fact patients on basis of their fiscal strength have the option to undergo prophylactic tactical manoeuvre for longer life spans. In this sphere of invasive implants, biocompatible polymer implants are a state of the art cutting edge technology with outstanding innovations leading to number of very successful start-up companies with a plethora of patent portfolios. From 2000 onwards, patent filings and grants for biocompatible polymers are expanding. Currently definition of biocompatibility is quite ambiguous with respect to the use of FDA approved polymeric materials. This article analysed patent portfolios for the trend patterns of prolific biocompatible polymers for capitalization and commercialization in the forthcoming years. Pair Bulk Data (PBD) portal was used to mine patent portfolios. In this patent preliminary analysis report, patents from 2000 to 2015 were evaluated using 317(c) filings, grants and classifications data for poly(vinyl alcohol) (PVA), poly(glycolic acid) (PGA), poly(hydroxyalkanoates) (PHAs) and poly(lactic acid) (PLA). This patent portfolio preliminary analysis embarks into patent analysis for New Product Development (NPD) for corporate R&D investment managerial decisions and on government advocacy for federal funding which is decisive for developmental advances. An in-depth patent portfolio investigation with return of investment (RoI) is in the pipeline. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  15. International patent applications for non-injectable naloxone for opioid overdose reversal: Exploratory search and retrieve analysis of the PatentScope database.

    Science.gov (United States)

    McDonald, Rebecca; Danielsson Glende, Øyvind; Dale, Ola; Strang, John

    2018-02-01

    : Exploratory search and retrieve analysis of the PatentScope database. Drug Alcohol Rev 2017;00:000-000]. © 2017 Australasian Professional Society on Alcohol and other Drugs.

  16. Compulsory patent licensing and local drug manufacturing capacity in Africa

    Science.gov (United States)

    2014-01-01

    Abstract Africa has the highest disease burden in the world and continues to depend on pharmaceutical imports to meet public health needs. As Asian manufacturers of generic medicines begin to operate under a more protectionist intellectual property regime, their ability to manufacture medicines at prices that are affordable to poorer countries is becoming more circumscribed. The Doha Declaration on the TRIPS Agreement and Public Health gives member states of the World Trade Organization (WTO) the right to adopt legislation permitting the use of patented material without authorization by the patent holder, a provision known as “compulsory licensing”. For African countries to take full advantage of compulsory licensing they must develop substantial local manufacturing capacity. Because building manufacturing capacity in each African country is daunting and almost illusory, an African free trade area should be developed to serve as a platform not only for the free movement of goods made pursuant to compulsory licences, but also for an economic or financial collaboration towards the development of strong pharmaceutical manufacturing capacity in the continent. Most countries in Africa are in the United Nations list of least developed countries, and this allows them, under WTO law, to refuse to grant patents for pharmaceuticals until 2021. Thus, there is a compelling need for African countries to collaborate to build strong pharmaceutical manufacturing capacity in the continent now, while the current flexibilities in international intellectual property law offer considerable benefits. PMID:24700981

  17. "It's important to take your medication everyday okay?" An evaluation of counselling by lay counsellors for ARV adherence support in the Western Cape, South Africa.

    Science.gov (United States)

    Dewing, S; Mathews, C; Schaay, N; Cloete, A; Louw, J; Simbayi, L

    2013-01-01

    There is growing interest in standard care programmes for antiretroviral (ARV) adherence support. In South Africa, individual counselling following ARV initiation is a main strategy for supporting adherence in the public sector. Egan's client-centred "Skilled Helper" counselling model is the predominant model used in HIV counselling in this context. This study evaluated counselling delivered by lay ARV adherence counsellors in Cape Town in terms of adherence to Egan's model. Thirty-eight transcripts of counselling sessions with non-adherent patients were analysed based on the methods of content analysis. These sessions were conducted by 30 counsellors. Generally counsellors' practice adhered neither to Egan's model nor a client-centred approach. Inconsistent with evidence-based approaches to counselling for ARV adherence support, counsellors mainly used information-giving and advice as strategies for addressing clients' non-adherence. Recommendations for improving practice are made. The question as to how appropriate strategies from developed countries are for this setting is also raised.

  18. A Case Study of Pharmaceutical Pricing in China: Setting the Price for Off-Patent Originators.

    Science.gov (United States)

    Hu, Shanlian; Zhang, Yabing; He, Jiangjiang; Du, Lixia; Xu, Mingfei; Xie, Chunyan; Peng, Ying; Wang, Linan

    2015-08-01

    This article aims to define a value-based approach to pricing and reimbursement for off-patent originators using a multiple criteria decision analysis (MCDA) approach centered on a systematic analysis of current pricing and reimbursement policies in China. A drug price policy review was combined with a quantitative analysis of China's drug purchasing database. Policy preferences were identified through a MCDA performed by interviewing well-known academic experts and industry stakeholders. The study findings indicate that the current Chinese price policy includes cost-based pricing and the establishment of maximum retail prices and premiums for off-patent originators, whereas reference pricing may be adopted in the future. The literature review revealed significant differences in the dissolution profiles between originators and generics; therefore, dissolution profiles need to be improved. Market data analysis showed that the overall price ratio of generics and off-patent originators was around 0.54-0.59 in 2002-2011, with a 40% price difference, on average. Ten differentiating value attributes were identified and MCDA was applied to test the impact of three pricing policy scenarios. With the condition of implementing quality consistency regulations and controls, a reduction in the price gap between high-quality off-patent products (including originator and generics) seemed to be the preferred policy. Patents of many drugs will expire within the next 10 years; thus, pricing will be an issue of importance for off-patent originators and generic alternatives.

  19. Patent medicine vendors are major providers antimalaria treatment

    African Journals Online (AJOL)

    pre-intervention value (5.5% versus 3.6%; p>0.05) and significantly lower than the post training values. (p<0.001). ... Profit was the core factor underlying the negative practices among the patent medicine vendors. .... Give cheaper drugs.

  20. Factors contributing to antiretroviral drug adherence among adults living with HIV or AIDS in a Kenyan rural community.

    Science.gov (United States)

    Kioko, Mary T; Pertet, Anne M

    2017-07-31

    Antiretroviral (ARV) adherence of ≥ 95% is recommended for suppressing HIV. However, studies have shown that the ≥ 95% recommended level is rarely achieved. This cross-sectional community-based study sought to assess factors contributing to ARV drug adherence among adults living with HIV or AIDS. The study was conducted in a rural community in Machakos County, Kenya. The questions used for the study were adapted from the Patient Medicine Adherence Questionnaire (PMAQ), a tool grounded in the Health Belief Model. Adherence to ARV was measured using self-reports and pill counts. The perception social support was measured with a 5-point Likert scale, whereas the type and the number of side effects experienced were recorded using 'yes' and 'no' questions. We used the chi-square test to test associations and binary logistic regression to assess factors explaining dose adherence to ARV. The levels of adherence of 86% using self-reports were significantly higher (p < 0.001) than the pill count of 58.6%. The immediate family was rated high in providing social support (3.7 ± 0.6) followed by social support groups (3.1 ± 0.8). A binary logistic regression analysis was conducted to predict ARV adherence (adherent, non-adherent) using social support, side effects and marital status as explanatory variables. The Wald criterion demonstrated that marital status (p = 0.019) and burden of side effects (p ≤ 0.001) made a significant contribution to the prediction of ARV adherence. The burden of side effects and being a divorcee are primary predictors of ARV adherence.

  1. Deuterated drugs; updates and obviousness analysis.

    Science.gov (United States)

    Timmins, Graham S

    2017-12-01

    The pharmacokinetics and/or toxicity of many known drugs can be modified by selective deuteration, an area of significant commercial interest and scientific and regulatory progress. Areas covered: This review firstly discusses recent developments in deuterated drugs including the FDA approval of deutetrabenazine. Secondly, it discusses 35 U.S.C. §103 'obviousness' as it relates to recent patent prosecution, and also to Inter Partes Review (IPR). IPR is a new post-award review of patentability under §102 or §103, two IPR petitions upon deuterated drugs have been instituted and included §103 arguments. Finally, an extended analysis of §103 obviousness based upon the practices of major pharmaceutical companies is provided, that supports rather late priority dates, while §102 is also discussed. Expert opinion: The total value of transactions involving deuterated drugs is close to $5 billion. While the importance of §103 'obviousness' rejections remains in patent applications under current prosecution, IPR of issued patents is developing and will affect likely affect §103 interpretations in this area. However, patents are still issuing with later priority dates, and further litigation will likely occur.

  2. Exploring sets of molecules from patents and relationships to other active compounds in chemical space networks

    Science.gov (United States)

    Kunimoto, Ryo; Bajorath, Jürgen

    2017-09-01

    Patents from medicinal chemistry represent a rich source of novel compounds and activity data that appear only infrequently in the scientific literature. Moreover, patent information provides a primary focal point for drug discovery. Accordingly, text mining and image extraction approaches have become hot topics in patent analysis and repositories of patent data are being established. In this work, we have generated network representations using alternative similarity measures to systematically compare molecules from patents with other bioactive compounds, visualize similarity relationships, explore the chemical neighbourhood of patent molecules, and identify closely related compounds with different activities. The design of network representations that combine patent molecules and other bioactive compounds and view patent information in the context of current bioactive chemical space aids in the analysis of patents and further extends the use of molecular networks to explore structure-activity relationships.

  3. Secondary patents in the pharmaceutical industry: missing the wood for the trees?

    Science.gov (United States)

    Kiran, Saritha; Kulkarni, Mohan

    2018-03-01

    The critics of the Innovator pharmaceutical industry allege that secondary patents are trivial modifications over the primary patent, which extend its term and delay the entry of the generics in the market place. The protagonists regard secondary patents a result of continuous research and development (R&D), which help them introduce and protect new, differentiated products. Areas covered: The areas covered are Product life cycle management (PLCM), Drug approval process, Orange book (OB) listed patents, US patent data. Expert opinion: Our analysis of the patents and products of four innovators viz., AstraZeneca, Takeda, Eisai and Wyeth in the field of proton pump inhibitors (PPI's) and Merck and Pfizer in the field of Statins shows that secondary patents help innovators sustain competition against other innovators in the specific product segment. The number of secondary patents listed in OB per NCE depends on the innovators interest in exploiting the NCE, the success of R & D effort and product lifecycle management strategy in the wake of market competition. Market entry decisions of innovators are strategic rather than a mere fallout of the secondary patents granted. Entry of another innovator is more unpredictable and hurts the first entrant more vis a vis the entry of generics who can enter the market when the patents protecting a product are no more enforceable, and hence more predictable. Generic entry in the field of PPI's shows that the term of the primary patent is not extended by the secondary patents.

  4. Uncharted territories of the patent-restoration due-diligence challenge.

    Science.gov (United States)

    Gaudry, Kate S

    2011-01-01

    The innovation and development incentives offered by the patent system are mitigated if a substantial portion of the patent term is lost while obtaining product approval through the Food and Drug Administration (FDA). The Drug Price Competition and Patent Restoration Act was enacted to return some of the lost patent term to the patentee. However, any person can petition the FDA, contending that the patentee did not act with due diligence in seeking FDA approval of the product during the regulatory review period. A successful challenge will reduce the restored term, such that the patentee is not compensated for time lost due to his own non-diligent actions. While the current due-diligence regulations provide a vague and flexible standard, earlier drafts of the regulations and FDA responses to comments provide insight as to the types of factors the FDA is likely to consider when assessing an applicant's diligence. A due-diligence petition has only been filed three times, and in none of these cases did the FDA issue a decision based on substantive diligence matters. Still, detailed examination of these petitions is also instructive in predicting the success of due-diligence challenges. Statute-imposed maximums and applicants' own incentives to act diligently may minimize the utility of the due-diligence challenges in some contexts. However, in other contexts, I propose that these petitions offer a feasible approach towards limiting pharmaceutical monopolies.

  5. ONC201 Targets AR and AR-V7 Signaling, Reduces PSA, and Synergizes with Everolimus in Prostate Cancer.

    Science.gov (United States)

    Lev, Avital; Lulla, Amriti R; Ross, Brian C; Ralff, Marie D; Makhov, Petr B; Dicker, David T; El-Deiry, Wafik S

    2018-05-01

    Androgen receptor (AR) signaling plays a key role in prostate cancer progression, and androgen deprivation therapy (ADT) is a mainstay clinical treatment regimen for patients with advanced disease. Unfortunately, most prostate cancers eventually become androgen-independent and resistant to ADT with patients progressing to metastatic castration-resistant prostate cancer (mCRPC). Constitutively activated AR variants (AR-V) have emerged as mediators of resistance to AR-targeted therapy and the progression of mCRPC, and they represent an important therapeutic target. Out of at least 15 AR-Vs described thus far, AR-V7 is the most abundant, and its expression correlates with ADT resistance. ONC201/TIC10 is the founding member of the imipridone class of small molecules and has shown anticancer activity in a broad range of tumor types. ONC201 is currently being tested in phase I/II clinical trials for advanced solid tumors, including mCRPC, and hematologic malignancies. There has been promising activity observed in patients in early clinical testing. This study demonstrates preclinical single-agent efficacy of ONC201 using in vitro and in vivo models of prostate cancer. ONC201 has potent antiproliferative and proapoptotic effects in both castration-resistant and -sensitive prostate cancer cells. Furthermore, the data demonstrate that ONC201 downregulates the expression of key drivers of prostate cancer such as AR-V7 and downstream target genes including the clinically used biomarker PSA (KLK3). Finally, the data also provide a preclinical rationale for combination of ONC201 with approved therapeutics for prostate cancer such as enzalutamide, everolimus (mTOR inhibitor), or docetaxel. Implications: The preclinical efficacy of ONC201 as a single agent or in combination, in hormone-sensitive or castration-resistant prostate cancer, suggests the potential for immediate clinical translation. Mol Cancer Res; 16(5); 754-66. ©2018 AACR . ©2018 American Association for Cancer

  6. Exploration of Global Trend on Biomedical Application of Polyhydroxyalkanoate (PHA): A Patent Survey.

    Science.gov (United States)

    Ponnaiah, Paulraj; Vnoothenei, Nagiah; Chandramohan, Muruganandham; Thevarkattil, Mohamed Javad Pazhayakath

    2018-01-30

    Polyhydroxyalkanoates are bio-based, biodegradable naturally occurring polymers produced by a wide range of organisms, from bacteria to higher mammals. The properties and biocompatibility of PHA make it possible for a wide spectrum of applications. In this context, we analyze the potential applications of PHA in biomedical science by exploring the global trend through the patent survey. The survey suggests that PHA is an attractive candidate in such a way that their applications are widely distributed in the medical industry, drug delivery system, dental material, tissue engineering, packaging material as well as other useful products. In our present study, we explored patents associated with various biomedical applications of polyhydroxyalkanoates. Patent databases of European Patent Office, United States Patent and Trademark Office and World Intellectual Property Organization were mined. We developed an intensive exploration approach to eliminate overlapping patents and sort out significant patents. We demarcated the keywords and search criterions and established search patterns for the database request. We retrieved documents within the recent 6 years, 2010 to 2016 and sort out the collected data stepwise to gather the most appropriate documents in patent families for further scrutiny. By this approach, we retrieved 23,368 patent documents from all the three databases and the patent titles were further analyzed for the relevance of polyhydroxyalkanoates in biomedical applications. This ensued in the documentation of approximately 226 significant patents associated with biomedical applications of polyhydroxyalkanoates and the information was classified into six major groups. Polyhydroxyalkanoates has been patented in such a way that their applications are widely distributed in the medical industry, drug delivery system, dental material, tissue engineering, packaging material as well as other useful products. There are many avenues through which PHA & PHB could be

  7. Patents in INIS

    International Nuclear Information System (INIS)

    Scheel, H.; Breitfeld, B.

    1983-01-01

    Proceeding from the INIS rules for collecting, characterizing, and making available patent documents, results of an analysis are presented, which concern timeliness, origin, and classification of patents according to the INIS subject categories and the International Patent Classification. GDR's capabilities for SDI services and retrospective searches are outlined taking into account patents. For a selected subject area (IPC G21) the coverage of patents announced by INIS was found to be about 30%

  8. Nanotechnology and patents in agriculture, food technology, nutrition and medicine - advantages and risks: worldwide patented nano- and absorber particles in food nutrition and agriculture.

    Science.gov (United States)

    Benckiser, Gero

    2012-12-01

    The keywords nanotechnology, super absorber, agriculture, nutrition, and food technology exhibited 28,149 positive matches under more than 68 million patents worldwide. A closer look at the first 500 nanotechnology, agriculture, nutrition and biotechnology related patents, published during 2011-2012, unveiled that 64% are parts of machines and control devices while about 36% comprise metal oxides, fertilizers, pesticides and drugs, which are compounds and often applied in combination with inorganic or organic super absorbing polymeric structures. The latter compounds are in the focus of this special issue.

  9. Modern evaluation of patents

    Science.gov (United States)

    Ignat, V.

    2016-08-01

    The number of patents is not so important as the market value. The market value is especially important for licensing of patents, make-or-buy decisions for technology procurement, corporate finance. Patents can be used as collateral for financing. Patents and credit approvals: without patents only 46% and with patents 54%. The value share of knowledge-based components to industrial products already reached 50% and it is still rising. OECD called these developments under the slogan "knowledge economy”. German Norm-DIN 77100 provides a working method for monetary evaluation of a patent. The value of a patent arises from its use. A patent can be used to protect or to earn licensing revenues. An evaluation expertise is required in areas, such as marketing, finance, R & D and strategic planning. As an indicator of the value of a patent is often used the number of citations. The number of a patent citation refers to its meaning and value. Other indicators would be: size of the patent family, validity of the patent, result of objections against patent application, number and quality of claims. The analysis of 9.000 patents resulted that only 7.2% worth over 10 million euro and 68% below 1 million euro. The cost method: it is considered the cost that would be incurred for the development and patenting of a similar invention. The market method: are used the prices that have been achieved in comparable with recently transactions. The Income method: the potential reward is measured, which can arise from a patent. The evaluation will be in the following areas: legal status, technology, market conditions, finance and strategy. Each question relates to a different parameter of a value.

  10. Current Energy Patents

    International Nuclear Information System (INIS)

    Kelly, R.C.

    1982-01-01

    Current Energy Patents (CEP) provides abstracting and indexing coverage of the international patent literature, including patent applications, that concerns any aspect of energy production, conservation, and utilization

  11. Cross-Border Patent Disputes: Unified Patent Court or International Commercial Arbitration?

    OpenAIRE

    Alba Betancourt, Ana

    2016-01-01

    Currently, the enforcement of a patent that is registered in several countries involves the risk of getting different and conflicting decisions from the national courts. In 2013, 25 European countries entered in an agreement that aims to homogenise the patent system by creating the European patent with unitary effect and a Unified Patent Court (UPC). This article focuses on the UPC, which aims to have a single court proceeding for cross-border patent conflicts. Does the UPC system represent a...

  12. Nanocarriers for the Effective Treatment of Cervical Cancer: Research Advancements and Patent Analysis.

    Science.gov (United States)

    Akhtar, Nida; Pathak, Kamla

    2018-04-02

    Cervical cancer being the cancer of cervix is caused by the aberrant cell growth that acquires an ability to spread/ invade to other body parts as well. It has been reported to be the second most commonest cause of death and cancer as well among women. Based on the severity of the disease, treatment aspect needs to be explored more in order to overcome the limitations acquired by conventional treatment. Recently, nanocarriers based drug delivery systems including liposomes, nanofibres, metallic NPs, polymeric NPs, dendrimers, polymeric micelles, antibody-drug conjugates etc. have been explored to target and treat cervical cancer. This review highlights numerous recent research and patent reports as well on nanocarriers based systems. Patents viz US, EP and WIPO have been retrieved using sites www.uspto.gov/patft and www.freepatentsonline.com to collect literature on nanocarriers. Various research reports and patents revealed nanocarriers to be effective in treating cervical cancer and these carriers are observed to be safer than the conventional treatment. Nanocarriers results in transforming drug distribution that can overpower drug resistance. Further, nanocarriers based drug delivery systems can particularly target drugs to cellular, subcellular and tissue sites. By enhancing the drug's bioavailability at the desired site, these systems result in therapeutic benefits like enhanced safety and efficacy. Also, in combination with other treatment approaches like radiation, photothermal and gene therapy, nanocarriers are reported to be quite effective and can define novel strategies to combat cervical cancer. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  13. Enforcement costs: some humanitarian alternatives to stronger patent rights.

    Science.gov (United States)

    Trotter, Andrew

    2012-01-01

    Diseases that cause comparatively few problems in developed countries kill millions of people in the Third World each year. In many cases, people die because they cannot afford the medication needed to save their lives. In others, there are simply no drugs available because there are no wealthy western patients to justify pharmaceutical companies investing in a cure. This reveals a deep-seated problem within the patent system and the pharmaceutical industry that emphasises markets and profits at the expense of health and global welfare. Global efforts have seen substantial improvements in access to medicines in isolated areas, but with international agreements driving towards stronger patent protection and the expiry date for the TRIPS grace period fast approaching, it is time to consider alternatives which will allow the patent system to work for the humanitarian cause rather than against it. This paper considers two such problems in the patent system and pharmaceutical industry - prohibitive pricing and misdirected incentives - to offer a mode of regulation and enforcement that will support both a viable pharmaceutical industry and the human right to health and medication.

  14. Teaching Chemistry Students How To Use Patent Databases and Glean Patent Information

    Science.gov (United States)

    MacMillan, Margy; Shaw, Lawton

    2008-07-01

    Patent literature is an important source of chemical information that is often neglected by chemical educators. This paper describes an effort to teach chemistry students how to use patent databases to search for information on applied chemical technology related to the manufacture of industrial and specialty chemicals. Students in a second-year-level organic chemistry class were shown how to search patent literature as part of a group research paper assignment that involved determining the feasibility of starting an industrial chemical operation to manufacture a given industrial chemical. Students who were assigned high value or specialty chemicals were most likely to cite patent literature in their final papers. Students who were assigned plastics or bulk commodity chemicals were less likely to cite patents. It is suggested that students made choices about the usefulness of patent literature and that patents were most useful when current patents existed and provided the patent owner a competitive advantage. For plastics or commodity chemicals, manufacturing technologies tend to be mature and are well described by more accessible information sources. Suggestions are made for effective introduction of patent literature instruction into upper-level chemistry courses.

  15. A guide of patent map

    International Nuclear Information System (INIS)

    1999-12-01

    This book introduces application and characteristic of patent information, types of patent information data and research of patent information, arrangement of patent information and patent map, analysis of patent information, necessity, writing period arrangement way of patent map, cases of patent map on selection of task of research and development, system of research and development and application, examples of PM such as MAP by year, application, technique, Inventor, and claim point map and computerization like data arrangement of PM patent, collection of analysis range and item analysis of patent, cases and written reports on patent analysis.

  16. Discrimination in the patent system: evidence from standard-essential patents

    NARCIS (Netherlands)

    de Rassenfosse, G.; Raiteri, E.; Bekkers, R.N.A.

    2017-01-01

    This paper tests for traces of discrimination against foreigners in the patent prosecution process. It focuses on the case of China and looks specifically at patent applications declared as essential to a technological standard, so called standard-essential patents. The identification strategy

  17. Patent cliff mitigation strategies: giving new life to blockbusters.

    Science.gov (United States)

    Kakkar, Ashish Kumar

    2015-01-01

    With several blockbuster drugs on the brink of another significant patent expiry cliff, innovator pharmaceutical firms are at risk of losing billions of dollars in sales to generic competition. With issues such as staggering R&D costs, reduced productivity and increasing governmental emphasis on pharmacoeconomics, timely planning and implementation of product lifecycle management strategies is becoming indispensable. A variety of strategies designed to mitigate the post-patent expiry revenue loss exist. These approaches range from fairly straightforward measures, such as strategic price cuts and launching own or authorized generics, to complex and lengthy ones, such as new formulations and indications that require companies to reinvent their pharmaceuticals. As patent expiries loom and product pipelines continue to remain thin, proactive planning for generic entry will be critical for pharma companies to drive growth and earnings in a sustainable manner.

  18. 76 FR 36548 - Determination of Regulatory Review Period for Purposes of Patent Extension; METVIXIA

    Science.gov (United States)

    2011-06-22

    ... 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670... (human drug product, animal drug product, medical device, food additive, or color additive) was subject... physician's office when other therapies are considered medically less appropriate. Subsequent to this...

  19. Profil Lipodistrofi dan Dislipidemia pada Pasien Prepubertas dengan HIV yang Mendapat Terapi ARV di Rumah Sakit Cipto Mangunkusumo

    Directory of Open Access Journals (Sweden)

    Yessi Yuniarti

    2016-11-01

    Kesimpulan. Prevalensi lipodistrofi dan dislipidemia cukup tinggi pada pasien prepubertas dengan HIV yang mendapatkan terapi ARV. Mayoritas subyek yang mengalami lipodistrofi memiliki massa lemak tubuh, TLK triceps dan subscapular yang normal.

  20. Of Remedies and Poisons: Recreational Use of Antiretroviral Drugs ...

    African Journals Online (AJOL)

    In itself, this is seen to be a barrier to adherence for many of their patients whose medication is traded to, or stolen by, drug dealers. Independent anecdotal evidence is emerging about this trade, though there has been little hard data verifying the existence of a recreational market for ARVs. While there are rumours that ...

  1. Vietnamese Women's Struggle to Access Antiretroviral Drugs in a Context of Free Treatment

    DEFF Research Database (Denmark)

    Nguyen, Nam Thi Thu; Rasch, Vibeke; Bygbjerg, Ib Christian

    2013-01-01

    This qualitative study aims to explore how HIV positive women living in a northern province of Vietnam experience seeking antiretroviral (ARV) treatment in the public health system, and how they address obstacles encountered along the way. Despite the fact that antiretroviral drugs were freely pr...

  2. Economic Justification of Patents and Exceptions to Patentability

    DEFF Research Database (Denmark)

    Nordberg, Ana

    2012-01-01

    The present article is the conclusion of a review of economic justifications for patent rights conducted with the objective of determining whether such arguments are per se capable of sustaining the existence of a different patentability regime for inventions of methods for treatment and diagnostic...... methods (art.53 (c) European Patent Convention). It starts by exploring the normative background and summarily describes the different types of claims allowed under the current legal framework and their differences. The following sections will describe and apply the main economic arguments sustaining...... patent rights inventions of methods for treatment and diagnostic methods. These reasoning will be later confronted with contra-arguments. This piece will finalize with the formulation of conclusions extracted from the previous debate, inter-alia that economic reasoning does not per se sustain...

  3. A functional, genome-wide evaluation of liposensitive yeast identifies the "ARE2 required for viability" (ARV1) gene product as a major component of eukaryotic fatty acid resistance.

    Science.gov (United States)

    Ruggles, Kelly V; Garbarino, Jeanne; Liu, Ying; Moon, James; Schneider, Kerry; Henneberry, Annette; Billheimer, Jeff; Millar, John S; Marchadier, Dawn; Valasek, Mark A; Joblin-Mills, Aidan; Gulati, Sonia; Munkacsi, Andrew B; Repa, Joyce J; Rader, Dan; Sturley, Stephen L

    2014-02-14

    The toxic subcellular accumulation of lipids predisposes several human metabolic syndromes, including obesity, type 2 diabetes, and some forms of neurodegeneration. To identify pathways that prevent lipid-induced cell death, we performed a genome-wide fatty acid sensitivity screen in Saccharomyces cerevisiae. We identified 167 yeast mutants as sensitive to 0.5 mm palmitoleate, 45% of which define pathways that were conserved in humans. 63 lesions also impacted the status of the lipid droplet; however, this was not correlated to the degree of fatty acid sensitivity. The most liposensitive yeast strain arose due to deletion of the "ARE2 required for viability" (ARV1) gene, encoding an evolutionarily conserved, potential lipid transporter that localizes to the endoplasmic reticulum membrane. Down-regulation of mammalian ARV1 in MIN6 pancreatic β-cells or HEK293 cells resulted in decreased neutral lipid synthesis, increased fatty acid sensitivity, and lipoapoptosis. Conversely, elevated expression of human ARV1 in HEK293 cells or mouse liver significantly increased triglyceride mass and lipid droplet number. The ARV1-induced hepatic triglyceride accumulation was accompanied by up-regulation of DGAT1, a triglyceride synthesis gene, and the fatty acid transporter, CD36. Furthermore, ARV1 was identified as a transcriptional of the protein peroxisome proliferator-activated receptor α (PPARα), a key regulator of lipid homeostasis whose transcriptional targets include DGAT1 and CD36. These results implicate ARV1 as a protective factor in lipotoxic diseases due to modulation of fatty acid metabolism. In conclusion, a lipotoxicity-based genetic screen in a model microorganism has identified 75 human genes that may play key roles in neutral lipid metabolism and disease.

  4. Patents for Soldiers

    Science.gov (United States)

    2016-06-10

    PATENTS FOR SOLDIERS A thesis presented to the Faculty of the U.S. Army Command and General Staff College in partial fulfillment...COVERED (From - To) AUG 2015 – JUNE 2016 4. TITLE AND SUBTITLE Patents for Soldiers 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM...protection of an innovative idea; that is, a patent . A Soldier’s pursuit of patents provides the Army with tangible and intangible benefits. There are on

  5. Patents for critical pharmaceuticals: the AZT case.

    Science.gov (United States)

    Ackiron, E

    1991-01-01

    Patents and other statutory types of market protections are used in the United States to promote scientific research and innovation. This incentive is especially important in research intensive fields such as the pharmaceutical industry. Unfortunately, these same protections often result in higher monopoly pricing once a successful product is brought to market. Usually this consequence is viewed as the necessary evil of an incentive system that encourages costly research and development by promising large rewards to the successful inventor. However, in the case of the AIDS drug Zidovudine (AZT), the high prices charged by the pharmaceutical company owning the drug have led to public outcry and a re-examination of government incentive systems. This Note traces the evolution of these incentive programs--the patent system, and, to a lesser extent, the orphan drug program--and details the conflicting interests involved in their development. It then demonstrates how the AZT problem brings the interest of providing inventors with incentives for risky innovative efforts into a sharp collision with the ultimate goal of such systems: ensuring that the public has access to the resulting products at a reasonable price. Finally, the Note describes how Congress and the courts have attempted to resolve these problems in the past, and how they might best try to solve the AZT problem in the near future.

  6. [The Glivec® case: the first example of a global debate on the drug patent system].

    Science.gov (United States)

    Moital, Inês; Bosch, Fèlix; Farré, Magí; Maddaleno, Mariano; Baños, Josep-E

    2014-01-01

    To describe the sequence of events involving the Glivec® case in India and to analyze the opinions generated in distinct settings. We performed a systematic search for articles concerning the imatinib (Glivec®) patent in India. We selected those sources that described the events, decisions of the authorities involved, and press and scientific opinions. Dates and arguments presented by the involved parties were clearly identified. Of 886 documents initially obtained, we selected 40 documents published between 2003 and 2013. Most of them were press news and commentaries. The process lasted 7 years, starting in 2006 when the Indian Patent Office rejected the patent application filed by Novartis. It ended in 2013 when the Indian Supreme Court upheld this decision. It was argued that the Indian Patent Law would facilitate access to medicines in the Third World and the final decision has received support by the general population. Although the court's final decision has been supported by several institutions, an objective analysis should also take into account the arguments of the pharmaceutical companies and other entities. The Glivec® case gave rise to an intense debate on the appropriateness of international standards on patents, their applicability and how they should be adopted in each country. This case, as well as other cases, should serve to stimulate reflection on the international patent system and to achieve scenarios in which the health of the poorest populations is protected but also balanced against intellectual property protection and innovation. Copyright © 2014 SESPAS. Published by Elsevier Espana. All rights reserved.

  7. Economic evaluation of weekends-off antiretroviral therapy for young people in 11 countries.

    Science.gov (United States)

    Tierrablanca, Luis Enrique; Ochalek, Jessica; Ford, Deborah; Babiker, Ab; Gibb, Diana; Butler, Karina; Turkova, Anna; Griffin, Susan; Revill, Paul

    2018-02-01

    To analyze the cost effectiveness of short-cycle therapy (SCT), where patients take antiretroviral (ARV) drugs 5 consecutive days a week and have 2 days off, as an alternative to continuous ARV therapy for young people infected with human immunodeficiency virus (HIV) and taking efavirenz-based first-line ARV drugs. We conduct a hierarchical cost-effectiveness analysis based on data on clinical outcomes and resource use from the BREATHER trial. BREATHER is a randomized trial investigating the effectiveness of SCT and continuous therapy in 199 participants aged 8 to 24 years and taking efavirenz-based first-line ARV drugs in 11 countries worldwide. Alongside nationally representative unit costs/prices, these data were used to estimate costs and quality adjusted life years (QALYs). An incremental cost-effectiveness comparison was performed using a multilevel bivariate regression approach for total costs and QALYs. Further analyses explored cost-effectiveness in low- and middle-income countries with access to low-cost generic ARV drugs and high-income countries purchasing branded ARV drugs, respectively. At 48 weeks, SCT offered significant total cost savings over continuous therapy of US dollar (USD) 41 per patient in countries using generic drugs and USD 4346 per patient in countries using branded ARV drugs, while accruing nonsignificant total health benefits of 0.008 and 0.009 QALYs, respectively. Cost-effectiveness estimates were similar across settings with access to generic ARV drugs but showed significant variation among high-income countries where branded ARV drugs are purchased. SCT is a cost-effective treatment alternative to continuous therapy for young people infected with HIV in countries where viral load monitoring is available.

  8. AR-V7 in circulating tumor cells cluster as a predictive biomarker of abiraterone acetate and enzalutamide treatment in castration-resistant prostate cancer patients.

    Science.gov (United States)

    Okegawa, Takatsugu; Ninomiya, Naoki; Masuda, Kazuki; Nakamura, Yu; Tambo, Mitsuhiro; Nutahara, Kikuo

    2018-06-01

    We examined whether androgen receptor splice variant 7 (AR-V7) in circulating tumor cell(CTC)clusters can be used to predict survival in patients with bone metastatic castration resistant-prostate cancer (mCRPC) treated with abiraterone or enzalutamide. We retrospectively enrolled 98 patients with CRPC on abiraterone or enzalutamide, and investigated the prognostic value of CTC cluster detection (+ v -) and AR-V7 detection (+ v -) using a CTC cluster detection - based AR-V7 mRNA assay. We examined ≤50% prostate-specific antigen (PSA) responses, PSA progression-free survival (PSA-PFS), clinical and radiological progression-free survival (radiologic PSF), and overall survival (OS). We then assessed whether AR-V7 expression in CTC clusters identified after On-chip multi-imaging flow cytometry was related to disease progression and survival after first-line systemic therapy. All abiraterone-treated or enzalutamide-treated patients received prior docetaxel. The median follow-up was 20.7 (range: 3.0-37.0) months in the abiraterone and enzalutamide cohorts, respectively. Forty-nine of the 98 men (50.0%) were CTC cluster (-), 23 of the 98 men (23.5%) were CTC cluster(+)/AR-V7(-), and 26 of the 98 men (26.5%) were CTC cluster(+)/AR-V7(+). CTC cluster(+)/AR-V7(+) patients were more likely to have EOD ≥3 at diagnosis (P = 0.003), pain (P = 0.023), higher alkaline phosphatase levels (P cluster(+), CTC cluster(+)/AR-V7(-), and ALP >UNL were independently associated with a poor PSA-PFS, radiographic PFS, and OS in abiraterone-treated patients and enzalutamide-treated patients. The CTC clusters and AR-V7-positive CTC clusters detected were important for assessing the response to abiraterone or enzalutamide therapy and for predicting disease outcome. © 2018 Wiley Periodicals, Inc.

  9. Truth and falsity of patent

    International Nuclear Information System (INIS)

    Park, Gum Jin

    2006-10-01

    This book describes the process of the effect to build the business of patent strongly in difficult situation. The titles of this contents are finally, lawsuit if formed, the task of patent application introduction of tasks of patent negotiation, negotiation with Fujitsu, Mitsubishi, Oki and NEC, amalgamation between LG semiconductor and Hyundai Electronic Industry, life in incorporated company, current condition of application for a patent, the method to process strategy patent, how to make strong patent and effective negotiation strategy for a patent and strategy of patent application.

  10. Comprehension and application of patent information

    International Nuclear Information System (INIS)

    Lee, Sang Nam

    2004-05-01

    This book gives descriptions of conception of patent information such as the meaning, characteristic, function, investigation and map of patent information, pro-patent period and patent strategy of the business. It also deals with comprehension of patent information like publication of nations, patent document, patent procedure in Korea, patent procedure in Japan, the U.S, and Europe, article and function of patent document, patent information survey such as writing of search keyword, procedure of the survey and search site of other countries, patent analysis and patent map.

  11. Data anonymization patent landscape

    Directory of Open Access Journals (Sweden)

    Mirjana Pejić Bach

    2017-01-01

    Full Text Available The omnipresent, unstoppable increase in digital data has led to a greater understanding of the importance of data privacy. Different approaches are used to implement data privacy. The goal of this paper is to develop a data anonymization patent landscape, by determining the following: (i the trend in data anonymization patenting, (ii the type of technical content protected in data anonymization, (iii the organizations and countries most active in patenting data anonymization know-how; and (iv the topics emerging most often in patent titles. Patents from the PatSeer database relating to data anonymization from 2001 to 2015 were analyzed. We used the longitudinal approach in combination with text mining techniques to develop a data anonymization patent landscape. The results indicated the following. The number of single patent families is growing with a high increase after 2010, thus indicating a positive trend in the area of patenting data anonymization solutions. The majority of patenting activities relate to the G Physics section. Organizations from the USA and Japan assigned the majority of patents related to data anonymization. The results of text mining indicate that the most often used word in titles of data anonymization patents are “anonym*, “method”, “data” and “system”. Several additional words that indicated the most frequent topics related to data anonymization were: “equipment”, “software”, “protection”, “identification”, or “encryption”, and specific topics such as “community”, “medical”, or “service”.

  12. A Functional, Genome-wide Evaluation of Liposensitive Yeast Identifies the “ARE2 Required for Viability” (ARV1) Gene Product as a Major Component of Eukaryotic Fatty Acid Resistance*

    Science.gov (United States)

    Ruggles, Kelly V.; Garbarino, Jeanne; Liu, Ying; Moon, James; Schneider, Kerry; Henneberry, Annette; Billheimer, Jeff; Millar, John S.; Marchadier, Dawn; Valasek, Mark A.; Joblin-Mills, Aidan; Gulati, Sonia; Munkacsi, Andrew B.; Repa, Joyce J.; Rader, Dan; Sturley, Stephen L.

    2014-01-01

    The toxic subcellular accumulation of lipids predisposes several human metabolic syndromes, including obesity, type 2 diabetes, and some forms of neurodegeneration. To identify pathways that prevent lipid-induced cell death, we performed a genome-wide fatty acid sensitivity screen in Saccharomyces cerevisiae. We identified 167 yeast mutants as sensitive to 0.5 mm palmitoleate, 45% of which define pathways that were conserved in humans. 63 lesions also impacted the status of the lipid droplet; however, this was not correlated to the degree of fatty acid sensitivity. The most liposensitive yeast strain arose due to deletion of the “ARE2 required for viability” (ARV1) gene, encoding an evolutionarily conserved, potential lipid transporter that localizes to the endoplasmic reticulum membrane. Down-regulation of mammalian ARV1 in MIN6 pancreatic β-cells or HEK293 cells resulted in decreased neutral lipid synthesis, increased fatty acid sensitivity, and lipoapoptosis. Conversely, elevated expression of human ARV1 in HEK293 cells or mouse liver significantly increased triglyceride mass and lipid droplet number. The ARV1-induced hepatic triglyceride accumulation was accompanied by up-regulation of DGAT1, a triglyceride synthesis gene, and the fatty acid transporter, CD36. Furthermore, ARV1 was identified as a transcriptional of the protein peroxisome proliferator-activated receptor α (PPARα), a key regulator of lipid homeostasis whose transcriptional targets include DGAT1 and CD36. These results implicate ARV1 as a protective factor in lipotoxic diseases due to modulation of fatty acid metabolism. In conclusion, a lipotoxicity-based genetic screen in a model microorganism has identified 75 human genes that may play key roles in neutral lipid metabolism and disease. PMID:24273168

  13. 37 CFR 1.710 - Patents subject to extension of the patent term.

    Science.gov (United States)

    2010-07-01

    ... of Patent Term Extension of Patent Term Due to Regulatory Review § 1.710 Patents subject to extension... primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes...

  14. Patent border wars: defining the boundary between scientific discoveries and patentable inventions.

    Science.gov (United States)

    Holman, Christopher M

    2007-12-01

    Drawing an appropriate boundary between unpatentable natural phenomena and patentable inventions is crucial in preventing the patent laws from unduly restricting access to fundamental scientific discoveries. Some would argue that, particularly in the U.S., patents are being issued that purport to claim a novel product or process but that, in effect, encompass any practical application of a fundamental biological principle. Examples include gene patents, which Congress is considering banning, and patents relating to biological correlations and pathways, such as the patents at issue in the headline-grabbing LabCorp v. Metabolite and Ariad v. Eli Lilly litigations. In view of the mounting concern, it seems likely that Congress and/or the courts will address the issue, and perhaps substantially shift the boundary.

  15. Patenting Nanomedicine in Europe:

    DEFF Research Database (Denmark)

    Nordberg, Ana

    Patenting Nanomedicine in Europe: Applying the ‘medical methods exception’ to emerging technologies is based on the authors PhD dissertation, defended in March 2014, at the University of Copenhagen. The book debates restrictions on the patentability of medical methods in European Patent Law....... The main question addressed is whether it is viable and advisable the reinterpretation, reformulation or replacement of Article 53 (c) EPC – a provision restricting the patenting of medical methods. The subject is approached by reference to emerging technologies, and using nanomedicine innovation...... as example and point of departure. Nanotechnology inventions blur the lines between patentable subject matter and what may fall under the exception from patentability. It is a good example of how in recent years, emerging technologies have been challenging the patent system and exposing the need for re...

  16. Patent Keyword Extraction Algorithm Based on Distributed Representation for Patent Classification

    Directory of Open Access Journals (Sweden)

    Jie Hu

    2018-02-01

    Full Text Available Many text mining tasks such as text retrieval, text summarization, and text comparisons depend on the extraction of representative keywords from the main text. Most existing keyword extraction algorithms are based on discrete bag-of-words type of word representation of the text. In this paper, we propose a patent keyword extraction algorithm (PKEA based on the distributed Skip-gram model for patent classification. We also develop a set of quantitative performance measures for keyword extraction evaluation based on information gain and cross-validation, based on Support Vector Machine (SVM classification, which are valuable when human-annotated keywords are not available. We used a standard benchmark dataset and a homemade patent dataset to evaluate the performance of PKEA. Our patent dataset includes 2500 patents from five distinct technological fields related to autonomous cars (GPS systems, lidar systems, object recognition systems, radar systems, and vehicle control systems. We compared our method with Frequency, Term Frequency-Inverse Document Frequency (TF-IDF, TextRank and Rapid Automatic Keyword Extraction (RAKE. The experimental results show that our proposed algorithm provides a promising way to extract keywords from patent texts for patent classification.

  17. Used, Blocking and Sleeping Patents

    DEFF Research Database (Denmark)

    Torrisi, Salvatore; Gambardella, Alfonso; Giuri, Paola

    2016-01-01

    This paper employs data from a large-scale survey (InnoS&T) of inventors in Europe, the USA, and Japan who were listed in patent applications filed at the European Patent Office with priority years between 2003 and 2005. We provide evidence regarding the reasons for patenting and the ways in which...... patents are being utilized. A substantial share of patents is neither used internally nor for market transactions, which confirms the importance of strategic patenting and inefficiency in the management of intellectual property. We investigate different types of unused patents—unused blocking patents...... and sleeping patents. We also examine the association between used and unused patents and their characteristics such as family size, scope, generality and overlapping claims, technology area, type of applicant, and the competitive environment from where these patents originate. We discuss our results...

  18. Invention note and patent note

    International Nuclear Information System (INIS)

    Chang, Sung Su

    1997-09-01

    This book deals with origin of invention and term related patent and invention, making idea, brain storming, 10 laws of invention skill, attitude of inventors, invention order, making good inventions, patent system, preparation of application, procedure and method of patent, management of patent, patent and trademark office, patent lawyer, copyright, new intellectual property right, industrial property right, trademark, invasion of industrial property right, patent, Judgment, preparation of items, application of industrial property right and effect of inventor and related people.

  19. How Important are Noncorporate Patents?

    DEFF Research Database (Denmark)

    Schneider, Cédric

    2011-01-01

    This article analyses the innovative performances of noncorporate inventors using patent citations data from the European Patent Office. The results show that inventions patented outside an established corporate framework are on average less ‘important’ than corporate patents, but with large...... variations across technology classes. Patents applied for by independent inventors, start-ups and corporate firms are of comparable ‘quality’ in emerging technologies. The results also highlight that in these fields noncorporate patents are more ‘radical’ than corporate patents....

  20. Pharmacokinetic, Pharmacogenetic, and Other Factors Influencing CNS Penetration of Antiretrovirals

    Directory of Open Access Journals (Sweden)

    Jacinta Nwamaka Nwogu

    2016-01-01

    Full Text Available Neurological complications associated with the human immunodeficiency virus (HIV are a matter of great concern. While antiretroviral (ARV drugs are the cornerstone of HIV treatment and typically produce neurological benefit, some ARV drugs have limited CNS penetration while others have been associated with neurotoxicity. CNS penetration is a function of several factors including sieving role of blood-brain and blood-CSF barriers and activity of innate drug transporters. Other factors are related to pharmacokinetics and pharmacogenetics of the specific ARV agent or mediated by drug interactions, local inflammation, and blood flow. In this review, we provide an overview of the various factors influencing CNS penetration of ARV drugs with an emphasis on those commonly used in sub-Saharan Africa. We also summarize some key associations between ARV drug penetration, CNS efficacy, and neurotoxicity.

  1. Pre-empted Patents, Infringed Patents and Firms’ Participation in Markets for Technology

    DEFF Research Database (Denmark)

    Grimpe, Christoph; Hussinger, Katrin

    2014-01-01

    In recent years, firms have increasingly contributed to and been confronted with a patent landscape characterized by numerous but marginal inventions, overlapping claims and patent fences. As a result, firms risk their patent applications to be pre-empted or to be infringed upon by rivals. While...... patents on firms’ engagement in in- and cross-licensing. Based on a sample of more than 1100 German manufacturing firms our results show that firms engage in in-licensing as a reaction to pre-empted patents and in cross-licensing if their protected IP was infringed upon. However, these effects vary...

  2. Diuretics with carbonic anhydrase inhibitory action: a patent and literature review (2005 - 2013).

    Science.gov (United States)

    Carta, Fabrizio; Supuran, Claudiu T

    2013-01-01

    The benzothiadiazines and high ceiling diuretics (hydrochlorothiazide, hydroflumethiazide, quinethazone, metolazone, chlorthalidone, indapamide, furosemide and bumetanide) contain primary sulfamoyl moieties acting as zinc-binding groups in the metalloenzyme carbonic anhydrase (CA, EC 4.2.1.1). These drugs are widely used clinically and were recently shown to weakly inhibit isoforms CA I and II, but to possess stronger activity against isoforms involved in other important pathologies, for example, obesity, cancer, epilepsy and hypertension. The class of clinically used diuretics, with CA inhibitory properties, is the main topic of the review. A patent literature review covering the period from 2005 to 2013 is presented. This section presents an overview of the patent literature in the sulfonamide diuretic field. Most of the patents deal with the combination of diuretic sulfonamide CA inhibitors with other agents useful in the management of cardiovascular diseases and obesity. Such combinations exert a better therapeutic activity compared to similar diuretics that do not inhibit CAs, raising the question of the polypharmacological and drug repositioning effects of these old drugs. These effects seem to be due to the potent inhibition of such drugs against CA isoforms present in kidneys and blood vessels, which explain both the blood pressure lowering effects as well as organ-protective activity of the drugs. An explanation of these data is provided by the fact that inhibition of the renal CAs leads to a large increase of the nitrite excretion in urine, suggesting that renal CAs are involved in nitrite reabsorption in humans. Important lessons for the drug design of sulfonamide CA inhibitors (CAIs) can be drawn from these data.

  3. In which developing countries are patents on essential medicines being filed?

    Science.gov (United States)

    Beall, Reed F; Blanchet, Rosanne; Attaran, Amir

    2017-06-26

    This article is based upon data gathered during a study conducted in partnership with the World Intellectual Property Organization on the patent status of products appearing on the World Health Organization's 2013 Model List of Essential Medicines (MLEM). It is a statistical analysis aimed at answering: in which developing countries are patents on essential medicines being filed? Patent data were collected by linking those listed in the United States and Canada's medicine patent registers to corresponding patents in developing countries using two international patent databases (INPADOC and Derwent) via a commerical-grade patent search platform (Thomson Innovation). The respective supplier companies were then contacted to correct and verify our data. We next tallied the number of MLEM patents per developing country. Spearman correlations were done to assess bivariate relationships between variables, and a multivariate regression model was developed to explain the number of MLEM patents in each country using SPSS 23.0. A subset of 20 of the 375 (5%) products on the 2013 MLEM fit our inclusion criteria. The patent estate reports (i.e., the global list of patents for a given drug) varied greatly in their number with a median of 48 patents (interquartile range [IQR]: 26-76). Their geographic reach had a median of 15% of the developing countries sampled (IQR: 8-28%). The number of developing countries covered appeared to increase with the age of the patent estate (r = .433, p = 0.028). The number of MLEM patents per country was significantly positively associated with human development index (HDI), gross domestic income (GDI) per capita, total healthcare expenditure per capita, population size, the Rule of Law Index, and average education level. Population size, GDI per capita, and healthcare expenditure (in % of national expenditure) were predictors of the number of MLEM patents in countries (p = 0.001, p = 0.001, p = 0.009, respectively). Population

  4. Patent cliff and strategic switch: exploring strategic design possibilities in the pharmaceutical industry

    OpenAIRE

    Song, Chie Hoon; Han, Jeung-Whan

    2016-01-01

    Extending the period of the market exclusivity and responding properly to the recent agglomeration of patent expiries are pivotal to the success of pharmaceutical companies. Declining R&D productivity, rising costs of commercialization, near-term patent expirations for many top-selling drugs are forcing companies to adopt new systems to introduce innovative products to market and to focus on strategies that increase the returns from the existing product portfolio. This systematic review explo...

  5. Identification of BKCa channel openers by molecular field alignment and patent data-driven analysis

    Directory of Open Access Journals (Sweden)

    Yaseen Gigani

    2016-01-01

    Full Text Available In this work, we present the first comprehensive molecular field analysis of patent structures on how the chemical structure of drugs impacts the biological binding. This task was formulated as searching for drug structures to reveal shared effects of substitutions across a common scaffold and the chemical features that may be responsible. We used the SureChEMBL patent database, which provides search of the patent literature using keyword-based functionality, as a query engine. The extraction of data of the BKCa channel openers and aligning them for molecular field similarity with newly designed structures did provide a probable validation method with accurate values. Therefore, in an attempt to increase the true positives, we report a procedure that functions on a multiple analyses modeled on molecular field similarity and common sub-structural search with consensus scoring and high confidence values to obtain greater accuracy during conventional virtual screening.

  6. Managing the patent thicket and maximizing patent lifetime in vaccine technology.

    Science.gov (United States)

    Mertes, Maria M M; Stötter, Gerd

    2010-10-01

    Patents are exclusive rights for a limited period of time that are granted to provide an incentive for innovation and in exchange for the public disclosure of an invention. Patenting in the medical field, especially in the field of human vaccine technologies, is full of pitfalls, because the products that finally access the market are often covered by a multitude of exclusive IP rights. This commentary gives an overview on obstacles in vaccine patenting and how to overcome them, and intends to provide a patenting guideline for researchers.

  7. Patent Races and Market Value

    DEFF Research Database (Denmark)

    Czarnitzki, Dirk; Hussinger, Katrin; Leten, Bart

    Patent races are models of strategic interactions between firms competing to develop an invention. The winning firm secures a patent, protecting the invention from imitation. This paper tests the assumption made about the reward structure in patent races, both in discrete and complex industries. We...... identify patent race winners using detailed information from the patent examination reports at the European Patent Office (EPO). Estimates of a market value equation featuring large, R&D-intensive U.S., European and Japanese firms, show that if firms win patent races, their market value increases...... significantly. We further show that the gain in market value is significantly larger for patent race winners in discrete industries than for firms in complex industries....

  8. ARV Re-Entry Module Aerodynmics And Aerothermodynamics

    Science.gov (United States)

    Scheer, Heloise; Tran, Philippe; Berthe, Philippe

    2011-05-01

    Astrium-ST is the prime contractor of ARV phase A and is especially in charge of designing the Reentry Module (RM). The RM aeroshape has been defined following a trade-off. High level system requirements were derived with particular attention paid on minimum lift-over-drag ratio, trim incidence, centre-of-gravity lateral off-set and box size, volumetric efficiency, attitude at parachute deployment, flight heritage and aeroheating. Since moderate cross-range and thus L/D ratio were required, the aeroshape trade-off has been performed among blunt capsule candidates. Two front- shield families were considered: spherical (Apollo/ARD/Soyuz type) and sphero-conical (CTV type) segment front-shield. The rear-cone angle was set to 20° for internal pressurized volume and accommodation purposes. Figures of merit were assessed and a spherical front- shield of ARD type with a 20° rear-cone section was selected and proposed for further investigations. Maximum benefits will be taken from ARD flight heritage. CFD and WTT campaigns plans will be presented including preliminary results.

  9. US patent interferences vs. international first-to-file patent systems, and current GATT problems

    International Nuclear Information System (INIS)

    Parkhurst, R.W.; Serbinowski, P.A.

    1991-01-01

    Simultaneous superconductivity research activities by different entities have resulted in numerous US patent applications, some of which may claim identical inventions and thus likely will be involved in interference proceedings in the US Patent and Trademark Office to determine which inventors are entitled to priority of invention and the resulting US patent. The determination in an interference proceeding of what inventors were the first-to-invent a patentable invention is contrasted with the patent systems in the rest of the world where the first inventor to file his patent application automatically gains priority. This issue and other aspects of US patent law are the subjects of criticism of US patent law and practice in the current Uruguay round of talks on the General Agreement on Trade and Tariffs (GATT). Interesting aspects of each of these subjects will be discussed

  10. The pharmaceutical sector, patents and access to medicines in the South

    Directory of Open Access Journals (Sweden)

    Xabier Barrutia Etxebarría

    2003-12-01

    Full Text Available This article deals with the lack of access to drug treatments experienced by the poor in the economic South. First, it studies the extraordinarily profitable pharmaceutical industry, whose research forgets about the illnesses typical of the South, given its greatbusiness and market concentration in the countries of the North, where marketing is decisive. Then, it deals with the relationship between the high prices of medicines and a patent system which is greatly strengthened by the rules of the WTO and which clasheswith people’s right to health, as revealed by the case of HIV-AIDS treatment in the countries of the South. The paper concludes by underscoring the need for an active intervention by the public sector, both at a national and international level, which wouldlimit the patents on drugs and promote research on the forgotten diseases.

  11. Strategic management and utilization of patents

    International Nuclear Information System (INIS)

    Kim, Gyeong Go; Yun, Gwon Jun

    1993-11-01

    This book deals with why does management of patents need?, system of management of patents with function and site of management of patents and system and composition, what does management of patents department do?, task like technical development, management regulation, patent information, management of patents in small business with technical development of small business, how does business manage the patents in real, introduction of management of patents in the U.S, Europe, Japan, and Korea, and management of patents as strategic management.

  12. Spreadsheet Patents

    DEFF Research Database (Denmark)

    Borum, Holger Stadel; Kirkbro, Malthe Ettrup; Sestoft, Peter

    2018-01-01

    This technical report gives a list of US patents and patent applications related to spreadsheet implementation technology. It is intended as a companion to the monograph Spreadsheet Implementation Technology (Peter Sestoft, MIT Press 2014), and substantially extends and updates an appendix from...

  13. Discrimination against foreigners in the patent system : evidence from standard-essential patents

    NARCIS (Netherlands)

    de Rassenfosse, G.; Raiteri, E.; Bekkers, R.N.A.

    This paper tests for traces of discrimination against foreign firms in the patent prosecution process. It focuses on the case of China and looks specifically at patent applications declared as essential to a technological standard. The choice of standard-essential patents (SEPs) is particularly

  14. Prediction of phenotypic susceptibility to antiretroviral drugs using physiochemical properties of the primary enzymatic structure combined with artificial neural networks

    DEFF Research Database (Denmark)

    Kjaer, J; Høj, L; Fox, Z

    2008-01-01

    OBJECTIVES: Genotypic interpretation systems extrapolate observed associations in datasets to predict viral susceptibility to antiretroviral drugs (ARVs) for given isolates. We aimed to develop and validate an approach using artificial neural networks (ANNs) that employ descriptors...

  15. US Photovoltaic Patents, 1988--1990

    Energy Technology Data Exchange (ETDEWEB)

    1991-12-01

    This document contains US patents on terrestrial photovoltaic (PV) power applications, including systems, components, and materials, as well as manufacturing and support functions. The patent entries in this document were issued from 1988 through 1990. The entries were located by searching USPA, the data base of the US Patent Office. The final search retrieved all patents under the class ``Batteries, Thermoelectric and Photoelectric`` and the subclasses ``Photoelectric,`` ``Testing,`` and ``Applications.`` The search also located patents that contained the words ``photovoltaic(s)`` or ``solar cell(s)`` and their derivatives. A manual search of the patents in the Solar Energy Research Institute (SERI) patent file augmented the data base search. After the initial list was compiled, most of the patents on the following subjects were excluded: space photovoltaic technology, use of the photovoltaic effect for detectors and subjects only peripherally concerned with photovoltaics. Some patents on these three subjects were included when it appeared that those inventions might be of use in terrestrial PV power technologies.

  16. Effect of antiretroviral drug (arved) on hepatic enzymes in albino rats ...

    African Journals Online (AJOL)

    ... with very little or no laboratory monitory, limited attention has been given to side effects ... A total of fifty two (52) albino rats were randomly divided into four groups ... The mean value of ALT activity for the drug in dose dependent manner was ...

  17. Between pharmaceutical patents and European patients: is a compromise still possible?

    Science.gov (United States)

    Garattini, Livio; Padula, Anna

    2017-10-01

    Pharmaceutical regulation has always attempted to balance the public health objective to make safe and effective drugs available for patients while providing commercial incentives through patents. Here we discuss whether it is still possible to find a balance between the incentives on the supply side and the regulatory framework on the demand side. Areas covered: The current regulatory framework on pharmaceutical exclusivity has been harshly criticized by many experts, arguing about whether it is still fit for public purposes and needs. Here we envisage a different scenario without 'revolutionizing' the whole present system. The main radical change should concern the present management of pharmaceutical patents by introducing a specific agency dedicated to them. Secondly, specific pharmaceutical patents could be restricted to compounds for one (or more) declared indication(s). Thirdly, pharmaceutical patents should be kept only for compounds that start a first clinical trial within five years from the granting date. Expert opinion: We think it is time to reconsider the regulation of pharmaceutical patents in the light of their relevance in terms of public health. New models of enhancing research investments are required for long-term sustainability of public pharmaceutical expenditure and the EU can still play a leading role.

  18. Patent Searching for Librarians and Inventors.

    Science.gov (United States)

    Wherry, Timothy Lee

    Information on patents is provided for librarians and laypersons requiring an understanding of the system and the processes involved. Chapter 1 discusses successful patents; terms and concepts; patent types; copyright; trademark; requirements; patent examiners; patent pending; expiration; patentee and assignee; and reissued patents. Chapter 2…

  19. DOE Patents Available for Licensing

    International Nuclear Information System (INIS)

    Stuber, C.

    1981-01-01

    DOE Patents Available for Licensing (DOE PAL) provides abstracting and indexing coverage of the DOE patent literature, including patent applications, that concerns any apsect of energy production, conservation, and utilization. The citations are arranged by subject category. DOE is prepared to grant exclusive or nonexclusive, revocable licenses under DOE-owned US patents and patent applications in accordance with the provisions of 10CFR781

  20. Research method of nuclear patent information

    International Nuclear Information System (INIS)

    Mo Dan; Gao An'na; Sun Chenglin; Wang Lei; You Xinfeng

    2010-01-01

    When faced with a huge amount of nuclear patent information, the key to effective research include: (1) Choose convenient way to search, quick access to nuclear technology related patents; (2) To overcome the language barrier, analysis the technical content of patent information; (3) Organize the publication date of retrieved patent documents, analysis the status and trends of nuclear technology development; (4) Research the patented technology of main applicants; (5) Always pay attention to the legal status of patent information, free use the invalid patents, at the same time avoid the patent infringement. Summary, patent information is important to obtain the latest technical information source, and the research work of patent information is a comprehensive understanding and mastery way for advanced nuclear technology. (authors)

  1. US Photovoltaic Patents, 1988--1990

    Energy Technology Data Exchange (ETDEWEB)

    1991-12-01

    This document contains US patents on terrestrial photovoltaic (PV) power applications, including systems, components, and materials, as well as manufacturing and support functions. The patent entries in this document were issued from 1988 through 1990. The entries were located by searching USPA, the data base of the US Patent Office. The final search retrieved all patents under the class Batteries, Thermoelectric and Photoelectric'' and the subclasses Photoelectric,'' Testing,'' and Applications.'' The search also located patents that contained the words photovoltaic(s)'' or solar cell(s)'' and their derivatives. A manual search of the patents in the Solar Energy Research Institute (SERI) patent file augmented the data base search. After the initial list was compiled, most of the patents on the following subjects were excluded: space photovoltaic technology, use of the photovoltaic effect for detectors and subjects only peripherally concerned with photovoltaics. Some patents on these three subjects were included when it appeared that those inventions might be of use in terrestrial PV power technologies.

  2. Technology Clusters Exploration for Patent Portfolio through Patent Abstract Analysis

    Directory of Open Access Journals (Sweden)

    Gabjo Kim

    2016-12-01

    Full Text Available This study explores technology clusters through patent analysis. The aim of exploring technology clusters is to grasp competitors’ levels of sustainable research and development (R&D and establish a sustainable strategy for entering an industry. To achieve this, we first grouped the patent documents with similar technologies by applying affinity propagation (AP clustering, which is effective while grouping large amounts of data. Next, in order to define the technology clusters, we adopted the term frequency-inverse document frequency (TF-IDF weight, which lists the terms in order of importance. We collected the patent data of Korean electric car companies from the United States Patent and Trademark Office (USPTO to verify our proposed methodology. As a result, our proposed methodology presents more detailed information on the Korean electric car industry than previous studies.

  3. Cross-Border Patent Disputes: Unified Patent Court or International Commercial Arbitration?

    Directory of Open Access Journals (Sweden)

    Ana Alba Betancourt

    2016-04-01

    Full Text Available Currently, the enforcement of a patent that is registered in several countries involves the risk of getting different and conflicting decisions from the national courts. In 2013, 25 European countries entered in an agreement that aims to homogenise the patent system by creating the European patent with unitary effect and a Unified Patent Court (UPC. This article focuses on the UPC, which aims to have a single court proceeding for cross-border patent conflicts. Does the UPC system represent an advantage compared to the current litigation system? The paper argues that it does and explores what it considers to be the two main advantages of a UPC over the current system of cross-border litigation of patents: the ability to drag several conflicts to a single procedure and the neutrality of the decision makers. These advantages are consequently compared to the characteristics of arbitration. Then, an explanation is provided with regards to how the UPC system is going to work in terms of jurisdiction, preliminary injunctions, the choice of law and enforcement of decisions, comparing those same procedural aspects to arbitration. The article finds that arbitration involves many of the same advantages (as compared to the UPC and that the procedural issues studied in both means are, so too, similar. Therefore, arbitration represents a viable alternative to the UPC when it comes to reducing the risks in solving cross-border patent conflicts.

  4. The Coordination of Independently-Owned Vacuum Tube Patents in the Alleged Early Radio Patent Thicket

    DEFF Research Database (Denmark)

    Howells, John; Ron D, Katznelson

    -examines the legal trajectories and entrepreneurial exploitation of these patents with a focus on vacuum tube technology where Fleming’s diode patent ‘overlapped’ with earlier prior art and, dependent on court decisions, with later commercial implementations of De Forest’s triode patents. We show, by means...... of the relevant historical record, patent claims, litigation records and other relevant law, how the ‘overlapping’ patent rights were resolved by the courts and by the immunity of suppliers to the Government from patent infringement liability. We trace the cross-licensing agreements between the different radio...

  5. Análisis de Minimización de Costo e Impacto Presupuestario del Tratamiento ARV con Abacavir/Lamivudina para el VIH/SIDA en México.

    Science.gov (United States)

    Rely, Kely; Martínez Valverde, Silvia; Salinas Escudero, Guillermo

    2013-12-01

    In Mexico, health authorities have raised reach the total of people living with HIV/ AIDS who need treatment have access to it, with the proper use of the best ARV therapies. Evaluate health spending would mean the management of patients with HIV/AIDS with the first-line therapy of abacavir/lamivudine with respect to tenofovir/emtricitabine and lamivudine-zidovudine. A literature review was conducted to seek evidence from clinical studies that demonstrated similar efficacy of ARV treatment between abacavir-lamivudine medications compared with other options. To calculate the incremental cost between these treatments, there was a Budget Impact Analysis and a pharmacoeconomic model was constructed to estimate the economic benefits by increasing its market share. Increased market penetration of abacavir/lamivudine represent a save of $ 44.8 million for the National Health System in Mexico during the years 2012-2017, without compromising the quality and effectiveness of treatment. Furthermore, this increase in market share with abacavir-lamivudine, the National Health System could get an additional benefit to deal on average 5.197 with HIV patients by 5 years with ARV therapies in Mexico. The use of abacavir/lamivudine in ARV treatment of patients with HIV/AIDS is a cost saving for the Mexican health System, which leads to a potential reduction in resources of US$44.8 million in treatment costs in the five projected years. Copyright © 2013 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  6. 77 FR 26557 - Determination of Regulatory Review Period for Purposes of Patent Extension; FERAHEME

    Science.gov (United States)

    2012-05-04

    ... human drug product FERAHEME (ferumoxytol). FERAHEME is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. Subsequent to this approval, the Patent and...

  7. Optimal patent policies: A survey

    DEFF Research Database (Denmark)

    Poulsen, Odile

    2002-01-01

    This paper surveys some of the patent literature, in particular, it focuses on optimal patent policies. We compare two situations. The first where the government only has a single policy tool to design the optimal patent policy, namely the optimal patent length. In the second situation......, the government uses two policy tools, the optimal breadth and length. We show that theoretical models give very different answers to what is the optimal patent policy. In particular, we show that the optimal patent policy depends among othet things on the price elasticity of demand, the intersectoral elasticity...... of research outputs as well as the degree of compettition in the R&D sector. The actual law on intellectual property, which advocates a unique patent length of 20 years is in general not supported by theoretical models....

  8. Vitamin E derivatives: a patent review (2010 - 2015).

    Science.gov (United States)

    Koufaki, Maria

    2016-01-01

    The vitamin E family consists of four tocopherols and four tocotrienols. α-Tocopherol is the most studied member of this family for its antioxidant and non-antioxidant properties, while tocotrienols have attracted recent research interest. The structural motifs of the vitamin E family and specifically the chroman moiety, are amenable to various modifications in order to improve their bioactivities towards numerous therapeutic targets. This review includes the patent literature from 2010 - 2015 related to vitamin E derivatives and it is focused on 2-, 5- or 6-substituted chroman analogues. The patent search was performed using Reaxys® and esp@cenet. The chroman moiety of vitamin E is a privileged structure and an essential pharmacophore which inspired organic chemists to synthesize new analogues with improved bioactivities. Modifications at the 2- and 5- positions of the chroman ring resulted in very interesting active compounds in cellular and animal models of diseases related to oxidative stress. More recent publications and patents reported 6-substituted chromans as anticancer agents in vitro and in vivo. Additionally, an emerging interest is observed towards the use of vitamin E analogues incorporated in drug delivery systems and for medical imaging as contrast agents or fluorescent probes.

  9. Alienation from the Objectives of the Patent System: How to Remedy the Situation of Biotechnology Patent.

    Science.gov (United States)

    Jiang, Li

    2018-03-12

    Some fundamental biotechnologies hold unprecedented potential to eradicate many incurable diseases. However, in absence of regulations, the power of patent makes the future use of some important biotechnology in few institution's hands. The excessive patents restrict researcher access to the fundamental technologies. It generates concerns and complaints of deteriorating the public health and social welfare. Furthermore, intellectual curiosities, funding, respect among colleagues etc., rather than patents, are the real motivations driving a major ground-breaking discoveries in biotechnology. These phenomena reveal that some biotechnology patents are alienated from the purpose of patent system. Therefore, it is necessary to take some approaches to stop over-patenting these fundamental biotechnology inventions. This article proposes a model regulatory framework for controlling biotechnology patent alienating from the purpose of patent system.

  10. The use of non-steroidal anti-inflammatory drugs for patent ductus arteriosus closure in preterm infants.

    Science.gov (United States)

    Benitz, William E; Bhombal, Shazia

    2017-10-01

    Over the last four decades, non-steroidal anti-inflammatory drugs have been widely used to induce closure of the patent ductus arteriosus (PDA) in preterm infants. Evidence to support this practice is lacking, despite performance of >50 randomized trials. The credibility of those trials may have been compromised by high rates of open treatment in controls, era of study prior to advent of modern practices, or inclusion of insufficient numbers of very immature infants. Meta-analyses show little impact of those factors on main conclusions. Essentially all trials reporting important long-term outcomes (other than mortality) initiated treatment within five days after birth, so no evidence regarding later treatment is available. Accruing clinical experience suggests that long-term outcomes are not compromised, and may be improved, with non-interventional management strategies. Future studies to identify preterm infants at greatest risk of potential harm from a persistent PDA, particularly after the second postnatal week, are urgently needed. Copyright © 2017 Elsevier Ltd. All rights reserved.

  11. Can patents prohibit research? On the social epistemology of patenting and licensing in science.

    Science.gov (United States)

    Biddle, Justin B

    2014-03-01

    A topic of growing importance within philosophy of science is the epistemic implications of the organization of research. This paper identifies a promising approach to social epistemology--nonideal systems design--and uses it to examine one important aspect of the organization of research, namely the system of patenting and licensing and its role in structuring the production and dissemination of knowledge. The primary justification of patenting in science and technology is consequentialist in nature. Patenting should incentivize research and thereby promote the development of knowledge, which in turn facilitates social progress. Some have disputed this argument, maintaining that patenting actually inhibits knowledge production. In this paper, I make a stronger argument; in some areas of research in the US--in particular, research on GM seeds--patents and patent licenses can be, and are in fact being, used to prohibit some research. I discuss three potential solutions to this problem: voluntary agreements, eliminating patents, and a research exemption. I argue against eliminating patents, and I show that while voluntary agreements and a research exemption could be helpful, they do not sufficiently address the problems of access that are discussed here. More extensive changes in the organization of research are necessary.

  12. 77 FR 4509 - Patent Public Advisory Committee Public Hearings on the Proposed Patent Fee Schedule

    Science.gov (United States)

    2012-01-30

    ... patent fees. The publication of that Notice will open a comment window through which the public may...-P-2012-0002] Patent Public Advisory Committee Public Hearings on the Proposed Patent Fee Schedule... Trademark Office (USPTO) may set or adjust by rule any patent or trademark fee established, authorized, or...

  13. Patenting Human Genes in Europe

    DEFF Research Database (Denmark)

    Minssen, Timo

    2017-01-01

    In accordance with the concept of the book and the assigned scope of the contribution, this chapter describes the European law with respect to the patent-eligibility of isolated DNA sequences. This chapter will further include a brief comparison with recent developments from the US and Australia....... It will, however, not focus on the important debates regarding the patent-eligibility of other biological material, diagnostic methods patents (as data aggregators) or abstract ideas which will be addressed by other contributions. Moreover, the analysis will merely concentrate on patent-eligibility. Other...... patentability requirement will only be briefly touched upon in the discussion part. The paper starts out in section 1.5.2 by discussing the patent-eligibility of isolated human DNA sequences on the European national level and under the Biotechnology Directive. Then the patent-eligibility of isolated human DNA...

  14. US photovoltaic patents: 1991--1993

    Energy Technology Data Exchange (ETDEWEB)

    Pohle, L

    1995-03-01

    This document contains US patents on terrestrial photovoltaic (PV) power applications, including systems, components, and materials as well as manufacturing and support functions. The patent entries in this document were issued from 1991 to 1993. The entries were located by searching USPA, the database of the US Patent Office. The final search retrieved all patents under the class ``Batteries, Thermoelectric and Photoelectric`` and the subclasses ``Photoelectric,`` ``Testing,`` and ``Applications.`` The search also located patents that contained the words ``photovoltaic(s)`` or ``solar cell(s)`` and their derivatives. After the initial list was compiled, most of the patents on the following subjects were excluded: space photovoltaic technology, use of the photovoltaic effect for detectors, and subjects only peripherally concerned with photovoltaic. Some patents on these three subjects were included when ft appeared that those inventions might be of use in terrestrial PV power technologies.

  15. Performance of Patenting Firms

    DEFF Research Database (Denmark)

    Madsen, Erik Strøjer; Smith, Valdemar; Nielsen, Anders Østergaard

    2000-01-01

    Most countries focus on industries with high technology and the governments grant subsidies to innovating firms. However, there has been remarkable few studies of the performance of innovative firms or industries. This study examines the performance of patent active firms compared to the non-patenting...... firms within the manufacturing sector in Denmark. Performance is measured both by growth in employment as well as in the return on equity and profit share in turnover. The results suggest that differences in performance of patenting and non-patenting firms are very small, which questions the political...

  16. Foreign patent documentation and information research

    International Nuclear Information System (INIS)

    Wang Tongsheng; Wu Xianfeng; Liu Jia; Cao Jifen; Song Tianbao; Feng Beiyuan; Zhang Baozhu

    2014-01-01

    Patent documentations are important scientific and technical documentations, which gather legal information, technical information and economic information together. According to WIPO forecasts, making full use of patent documentation can save 40% of research funding and 60% of the study period. Foreign patent documentations are the world's most valuable patent documentations, and many original technologies that have significant influence are first disclosed in foreign patent documentation. Studying and making use of foreign patent documentations can improve our starting point of scientific and technological innovation, and reduce the research investment. This paper analyzes foreign patent documentation and, combining with the actual development of nuclear technology in our country, makes specific recommendations for patent documentation research. (authors)

  17. Patents, Inducement Prizes, and Contestant Strategy

    DEFF Research Database (Denmark)

    Davis, Jerome; Davis, Lee N.

    2006-01-01

    Debate over the merits of patents versus inducement prizes has tended to ignore the signaling roles of patents, and totally ignores the impact of patent signaling on prize contests. This paper asks: How does patent signaling affect the strategic choices of firms considering entering prize contests......? First, we consider contests that do not allow patenting, then contests that do. If patenting is not allowed, we argue, patent-holders, both internal and external to the contest, can adversely impact prize contests by claiming prize winner violation of their patents, and suing for damages. The likelihood...... of such challenges being made can deter entry, particularly in contests requiring large sunk costs. Furthermore, the firm's decisionmaking process will discriminate against entering prize contests and favor R&D projects with patentable outcomes. Together, these problems may circumscribe any future wider role...

  18. Increasing the Discovery and Use of Non-Patent Literature (NPL): Scientific Publications in Patent Examination

    OpenAIRE

    F. Loizides; B. Diallo; A. Pollard; A. Mavri

    2017-01-01

    In this work we present findings on non-patent literature use, and specifically scientific publications such as academic articles. We interview patent examiners and observe their prior art searching in order to provide insights into the perceived usage of non-patent literature and produce high level requirements for advancing non-patent literature search tools.

  19. Patenting Nanomedicine in Europe

    DEFF Research Database (Denmark)

    Nordberg, Ana

    This work addresses the question of determining whether reinterpretation, reformulation or replacement of article 53 (c) of the European Patent Convention is viable and advisable. It does so by reference to novel or resurfacing interpretative concerns connected with emerging technologies exemplif......This work addresses the question of determining whether reinterpretation, reformulation or replacement of article 53 (c) of the European Patent Convention is viable and advisable. It does so by reference to novel or resurfacing interpretative concerns connected with emerging technologies...... exemplified by nanomedicine, while considering known interpretative issues and traditional objections to this provision. The debate concerning the patentability of ‘medical methods’ is multi-layered and complex. The ‘medical methods exception’ is a public policy mechanism, intended to introduce flexibility...... in the patent system in order to allow for the protection of core ethical values of society. Nanotechnology inventions blur the lines between patentable subject matter and what may fall under the exception from patentability. It is a good example of how in recent years, emerging technologies have been...

  20. Constructing an Intelligent Patent Network Analysis Method

    Directory of Open Access Journals (Sweden)

    Chao-Chan Wu

    2012-11-01

    Full Text Available Patent network analysis, an advanced method of patent analysis, is a useful tool for technology management. This method visually displays all the relationships among the patents and enables the analysts to intuitively comprehend the overview of a set of patents in the field of the technology being studied. Although patent network analysis possesses relative advantages different from traditional methods of patent analysis, it is subject to several crucial limitations. To overcome the drawbacks of the current method, this study proposes a novel patent analysis method, called the intelligent patent network analysis method, to make a visual network with great precision. Based on artificial intelligence techniques, the proposed method provides an automated procedure for searching patent documents, extracting patent keywords, and determining the weight of each patent keyword in order to generate a sophisticated visualization of the patent network. This study proposes a detailed procedure for generating an intelligent patent network that is helpful for improving the efficiency and quality of patent analysis. Furthermore, patents in the field of Carbon Nanotube Backlight Unit (CNT-BLU were analyzed to verify the utility of the proposed method.

  1. Innovation strategies for generic drug companies: moving into supergenerics.

    Science.gov (United States)

    Ross, Malcolm S F

    2010-04-01

    Pharmaceutical companies that market generic products generally are not regarded as innovators, but rather as companies that produce copies of originator products to be launched at patent expiration. However, many generics companies have developed excellent scientific innovative skills in an effort to circumvent the defense patents of originator companies. More patents per product, in terms of both drug substances (process patents and polymorph patents) and formulations, are issued to generics companies than to companies that are traditionally considered to be 'innovators'. This quantity of issued patents highlights the technical knowledge and skill sets that are available in generics companies. In order to adopt a completely innovative model (ie, the development of NCEs), a generics company would require a completely new set of skills in several fields, including a sufficient knowledge base, project and risk management experience, and capability for clinical data evaluation. However, with relatively little investment, generics companies should be able to progress into the so-called 'supergeneric' drug space - an area of innovation that reflects the existing competencies of both innovative and generics companies.

  2. Environmentally conscious patent histories

    Science.gov (United States)

    Crouch, Dennis D.; Crouch, Henry L.

    2004-02-01

    There is a need for investigators, legislators, and business leaders to understand the magnitude of innovation and discovery in the field of environmentally conscious technologies (ECTs). Knowledge of the "big picture" is important to providing a national and global account of actual environmental stewardship over the last twenty-five years. A recitation of the Environmental Protection Agency (EPA) supported Acts which have been enacted into law reveals one facet of the multifaceted dynamic of environmental consciousness. The popular discussion and debate, as well as partisan lobbying, which created the political forces leading to environmentally conscious legislation is another facet. A third facet is the corporate response to the threats and opportunities predicted by CEO"s and others through environmental scanning. This paper examines changes in environmentally conscious inventive effort by comparing data from United States Patents issued from 1976 through 2003. Patents are useful tool for measuring technological innovation because they are publicly available records of innovative activity. Although not all inventions result in patent applications, the monopoly rights granted on the invention give the inventor a strong incentive to obtain patents on any viable product or process. Among the results, we found a significant increase in patents relating to environmentally conscious products and processes during the period in question. Specifically, a dramatic increase in patent activity was seen for the decade of the 1990"s. Surprisingly, the patenting rate from 2000 to 2003 seems to have stabilized. Additionally public discussion of ECTs appears to have a positive impact on patent filings.

  3. Labor Mobility and Patenting Activity

    DEFF Research Database (Denmark)

    Kaiser, Ulrich; Kongsted, Hans Christian; Rønde, Thomas

    We measure the quantitative importance of labor mobility as a vehicle for the transmission of knowledge and skills across firms. For this purpose we create a unique data set that matches all applications of Danish firms at the European Patent Office to linked employer-employee register data...... for the years 1999-2002. The Danish workforce is split into "R&D workers", who hold a bachelor's or a master's degree in a technical field, and "non{R&D workers". We find that mobile R&D workers ("R&D joiners"') contribute more to patenting activity than immobile R&D workers. Furthermore, R&D workers who have...... previously been employed by a patenting firm ("patent exposed workers") have a larger effect on patenting activity than R&D workers without this experience. Patent exposed R&D joiners constitute the most productive group of workers: for firms that patented prior to 1999, one additional worker of this type...

  4. [High activity antiretroviral therapy change associated to adverse drug reactions in a specialized center in Venezuela].

    Science.gov (United States)

    Subiela, José D; Dapena, Elida

    2016-03-01

    Adverse drug reactions (ADRs) represent the first cause of change of the first-line highly active antiretroviral therapy (HAART) regimen, therefore, they constitute the main limiting factor in the long-term follow up of HIV patients in treatment. A retrospective study was carried out in a specialized center in Lara State, Venezuela, including 99 patients over 18 years of age who had change of first-line HAART regimen due to ADRs, between 2010 and 2013. The aims of this research were to describe the sociodemographic and clinical variables, frequency of ADRs related to change of HAART, duration of the first-line HAART regimen, to determine the drugs associated with ARVs and to identify the risk factors. The ADRs constituted 47.5% of all causes of change of first-line HAART regimen, the median duration was 1.08±0.28 years. The most frequent ADRs were anemia (34.3%), hypersensitivity reactions (20.2%) and gastrointestinal intolerance (13.1%). The most frequent ARV regimen type was the protease inhibitors-based regimen (59.6%), but zidovudine was the ARV most linked to ADRs (41.4%). The regression analysis showed increased risk of ADRs in singles and students in the univariate analysis and heterosexuals and homosexuals in multivariate analysis; and decreased risk in active workers. The present work shows the high prevalence of ADRs in the studied population and represents the first case-based study that describes the pharmacoepidemiology of a cohort of HIV-positive patients treated in Venezuela.

  5. Incentives for orphan drug research and development in the United States.

    Science.gov (United States)

    Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Szeinbach, Sheryl L; Visaria, Jay

    2008-12-16

    The Orphan Drug Act (1983) established several incentives to encourage the development of orphan drugs (ODs) to treat rare diseases and conditions. This study analyzed the characteristics of OD designations, approvals, sponsors, and evaluated the effective patent and market exclusivity life of orphan new molecular entities (NMEs) approved in the US between 1983 and 2007. Primary data sources were the FDA Orange Book, the FDA Office of Orphan Drugs Development, and the US Patent and Trademark Office. Data included all orphan designations and approvals listed by the FDA and all NMEs approved by the FDA during the study period. The FDA listed 1,793 orphan designations and 322 approvals between 1983 and 2007. Cancer was the main group of diseases targeted for orphan approvals. Eighty-three companies concentrated 67.7% of the total orphan NMEs approvals. The average time from orphan designation to FDA approval was 4.0 +/- 3.3 years (mean +/- standard deviation). The average maximum effective patent and market exclusivity life was 11.7 +/- 5.0 years for orphan NME. OD market exclusivity increased the average maximum effective patent and market exclusivity life of ODs by 0.8 years. Public programs, federal regulations, and policies support orphan drugs R&D. Grants, research design support, FDA fee waivers, tax incentives, and orphan drug market exclusivity are the main incentives for orphan drug R&D. Although the 7-year orphan drug market exclusivity provision had a positive yet relatively modest overall effect on effective patent and market exclusivity life, economic incentives and public support mechanisms provide a platform for continued orphan drug development for a highly specialized market.

  6. [Preliminary study on general safe medication regularity of Chinese patent orthopedic medicines based on adverse reaction/event literature analysis].

    Science.gov (United States)

    Wang, Yu-guang; Shi, Xin-yuan; Jin, Rui; Li, Hong-yan; Kong, Xiang-wen; Qiao, Yan-jiang

    2015-03-01

    Chinese patent orthopedic medicines feature complex components, mainly including desperate and toxic herbal pieces, narrow safety window, more clinical contraindications and frequent adverse drug reaction/events (ADR/ADE). To study the general safe medication regularity of Chinese patent orthopedic medicines, define key points in the medication education and ensure rational clinical medication, the authors took 80 types of commonly used Chinese patent orthopedic medicines as the study objects, collect 237 cases from 164 ADR/ADE documents through a system retrieval strategy, make a multidimensional literature analysis to determine the common risk factors for safe and rational medication of Chinese patent orthopedic medicines and establish an ADR/ADE prevention regularity. First, in the aspect of clinical symptoms, skin allergy is the most common ADR/ADE and closely related to the toxic ingredients, particularly accumulated liver or kidney damage caused by some drugs. Second, there are three time nodes in the ADR/ADE occurrence; The ADR/ADE occurred in 30 minutes is closely related to the idiosyncrasy; the ADR/ADE occurred between several months and half a year is related to the drug-induced liver and kidney damages; The most common ADR/ADE was observed within 7 days and predictable according to the pharmacological actions; Third, toxicity is an important factor in the occurrence of ADR/ADE of Chinese patent orthopedic medicines. Fourth, emphasis shall be given to the special medication factors, such as the combination with western medicines and Chinese herbal decoctions, overdose and long-course medication and self-medical therapy. In conclusion, the general ADR/ADE prevention regularity for Chinese patent orthopedic medicines was summarized to provide supports for clinicians in safe and rational medication and give the guidance for pharmacist in medication education.

  7. Decoding gene patents in Australia.

    Science.gov (United States)

    Denley, Adam; Cherry, James

    2014-10-03

    Patents directed to naturally occurring genetic material, such as DNA, RNA, chromosomes, and genes, in an isolated or purified form have been granted in Australia for many years. This review provides scientists with a summary of the gene patent debate from an Australian perspective and specifically reviews how the various levels of the legal system as they apply to patents-the Australian Patent Office, Australian courts, and Australian government-have dealt with the issue of whether genetic material is proper subject matter for a patent. Copyright © 2015 Cold Spring Harbor Laboratory Press; all rights reserved.

  8. The Seductive-Plausibility of Patent Hold-Up Myths — A Flawed Historiography of Patents

    DEFF Research Database (Denmark)

    Howells, John; Katznelson, Ron D

    In previous work we have shown that a flawed historiography of patents continues to be the basis for patent policy advocacy. We set out objective standards of evidence that allegations of development block due to assertion of patents must meet. We show the extent of the errors in the historical...... record in the aircraft, automobile, radio and incandescent lamp technologies. We then evaluate how they measure against the objective standards. We find many simple errors and that an absence of indicia of development block characterise scholarship alleging that assertion of patents blocked development...... of multiple case studies subjected to such standards justifies the rebuttable presumption that “pioneer patents have never blocked development”....

  9. Patenting and the gender gap: should women be encouraged to patent more?

    Science.gov (United States)

    de Melo-Martín, Inmaculada

    2013-06-01

    The commercialization of academic science has come to be understood as economically desirable for institutions, individual researchers, and the public. Not surprisingly, commercial activity, particularly that which results from patenting, appears to be producing changes in the standards used to evaluate scientists' performance and contributions. In this context, concerns about a gender gap in patenting activity have arisen and some have argued for the need to encourage women to seek more patents. They believe that because academic advancement is mainly dependent on productivity (Stuart and Ding in American Journal of Sociology 112:97-144, 2006; Azoulay et al. in Journal of Economic Behavior & Organization 63:599-623, 2007), differences in research output have the power to negatively impact women's careers. Moreover, in the case of patenting activity, they claim that the gender gap also has the potential to negatively affect society. This is so because scientific and technological advancement and innovation play a crucial role in contemporary societies. Thus, women's more limited involvement in the commercialization of science and technology can also be detrimental to innovation itself. Nevertheless, calls to encourage women to patent on grounds that such activity is likely to play a significant role in the betterment of both women's careers and society seem to be based on two problematic assumptions: (1) that the methods to determine women's productivity in patenting activities are an appropriate way to measure their research efforts and the impact of their work, and (2) that patenting, particularly in academia, benefits society. The purpose of this paper is to call into question these two assumptions.

  10. Patent pools: Intellectual property rights and competition.

    NARCIS (Netherlands)

    Rodriguez, V.F.

    2010-01-01

    Patent pools do not correct all problems associated with patent thickets. In this respect, patent pools might not stop the outsider problem from striking pools. Moreover, patent pools can be expensive to negotiate, can exclude patent holders with smaller numbers of patents or enable a group of major

  11. Transporters for Antiretroviral Drugs in Colorectal CD4+ T Cells and Circulating α4β7 Integrin CD4+ T Cells: Implications for HIV Microbicides.

    Science.gov (United States)

    Mukhopadhya, Indrani; Murray, Graeme I; Duncan, Linda; Yuecel, Raif; Shattock, Robin; Kelly, Charles; Iannelli, Francesco; Pozzi, Gianni; El-Omar, Emad M; Hold, Georgina L; Hijazi, Karolin

    2016-09-06

    CD4+ T lymphocytes in the colorectal mucosa are key in HIV-1 transmission and dissemination. As such they are also the primary target for antiretroviral (ARV)-based rectal microbicides for pre-exposure prophylaxis. Drug transporters expressed in mucosal CD4+ T cells determine ARV distribution across the cell membrane and, most likely, efficacy of microbicides. We describe transporters for antiretroviral drugs in colorectal mucosal CD4+ T lymphocytes and compare gene expression with circulating α4β7+CD4+ T cells, which traffic to the intestine and have been shown to be preferentially infected by HIV-1. Purified total CD4+ T cells were obtained from colorectal tissue and blood samples by magnetic separation. CD4+ T cells expressing α4β7 integrin were isolated by fluorescence-activated cell sorting from peripheral blood mononuclear cells of healthy volunteers. Expressions of 15 efflux and uptake drug transporter genes were quantified using Taqman qPCR assays. Expression of efflux transporters MRP3, MRP5, and BCRP and uptake transporter CNT2 were significantly higher in colorectal CD4+ T cells compared to circulating CD4+ T cells (p = 0.01-0.03). Conversely, circulating α4β7+CD4+ T cells demonstrated significantly higher expression of OATPD compared to colorectal CD4+ T cells (p = 0.001). To the best of our knowledge this is the first report of drug transporter gene expression in colorectal CD4+ and peripheral α4β7+CD4+ T cells. The qualitative and quantitative differences in drug transporter gene expression profiles between α4β7+CD4+ T cells and total mucosal CD4+ T cells may have significant implications for the efficacy of rectally delivered ARV-microbicides. Most notably, we have identified efflux drug transporters that could be targeted by selective inhibitors or beneficial drug-drug interactions to enhance intracellular accumulation of antiretroviral drugs.

  12. Biosimilar Drugs for Cancer Emerge

    Science.gov (United States)

    As the patents on widely used biological drugs to treat cancer expire, biosimilar drugs are being developed for the treatment of patients with cancer. You can learn how biosimilars may expand treatment options in this Cancer Currents blog post.

  13. Interactive overlay maps for US Patent (USPTO) data based on International Patent Classifications (IPC)

    NARCIS (Netherlands)

    Leydesdorff, L.; Kushnir, D.; Rafols, I.

    2014-01-01

    We report on the development of an interface to the US Patent and Trademark Office (USPTO) that allows for the mapping of patent portfolios as overlays to basemaps constructed from citation relations among all patents contained in this database during the period 1976-2011. Both the interface and the

  14. Patents - Superconductor materials, processes and devices

    International Nuclear Information System (INIS)

    Test, A.

    1987-01-01

    A patent is a grant by a country to an inventor or his assignee of the right to exclude others for a limited period of time from making, using or selling the patented invention within its territory. It is reported that basic patents have been filed by IBM and the University of Houston to protect a broad range of warm superconducting materials or compounds. It is believed that other researchers are seeking patents to protect related or improved materials, processes and apparatus. Because of the importance of this field and to speed up the patent process, the United States Patent Office is giving, upon request, special expedited status to these patent applications. A survey of Japanese companies shows that more than 1500 patents have been applied for in Japan relating to superconducting materials, compositions, apparatus using superconductors and improvements. It appears that the goal of the Japanese companies is to obtain a patent position in Japan so that they can trade with companies wishing to do business in Japan for rights in other parts of the world

  15. Can this kind of idea be a patent?

    Energy Technology Data Exchange (ETDEWEB)

    Yu, Jae Bok

    2004-08-15

    This book mentions patent such as application, what is patents, patent law, procedure and patent attorney, which includes business idea is patent. Is internet domain name or name-brand? We can make a big money with others idea, the difference among patent, trademark, utility model rights and registration of design, priority system, new weapon in digital period, patent is a knife and a shield, the cost from application to registration, what is hunting of patent information, writing document for patent, patent examination and patent lawyer.

  16. Can this kind of idea be a patent?

    International Nuclear Information System (INIS)

    Yu, Jae Bok

    2004-08-01

    This book mentions patent such as application, what is patents, patent law, procedure and patent attorney, which includes business idea is patent. Is internet domain name or name-brand? We can make a big money with others idea, the difference among patent, trademark, utility model rights and registration of design, priority system, new weapon in digital period, patent is a knife and a shield, the cost from application to registration, what is hunting of patent information, writing document for patent, patent examination and patent lawyer.

  17. 78 FR 31885 - Patent Term Extension

    Science.gov (United States)

    2013-05-28

    ... DEPARTMENT OF COMMERCE Patent and Trademark Office Patent Term Extension ACTION: Proposed collection; comment request. SUMMARY: The United States Patent and Trademark Office (USPTO), as part of its... States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450. Federal Rulemaking Portal...

  18. 78 FR 7759 - Patent Cooperation Treaty

    Science.gov (United States)

    2013-02-04

    ... DEPARTMENT OF COMMERCE Patent and Trademark Office Patent Cooperation Treaty ACTION: Proposed collection; comment request. SUMMARY: The United States Patent and Trademark Office (USPTO), as part of its... States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450. Federal Rulemaking Portal...

  19. 75 FR 20561 - Patent Term Extension

    Science.gov (United States)

    2010-04-20

    ... DEPARTMENT OF COMMERCE Patent and Trademark Office Patent Term Extension ACTION: Proposed collection; comment request. SUMMARY: The United States Patent and Trademark Office (USPTO), as part of its... Officer, Office of the Chief Information Officer, United States Patent and Trademark Office, P.O. Box 1450...

  20. Progress towards novel adenosine receptor therapeutics gleaned from the recent patent literature.

    Science.gov (United States)

    Press, Neil J; Fozard, John R

    2010-08-01

    The principle of treating disease with selective adenosine receptor ligands has been demonstrated with drugs on the market, while the lesser understood receptor subtypes are still being probed with new and drug-like pharmaceutical tools. The field of adenosine receptor research is, therefore, highly important as an emerging and proven point of intervention in disease. From 2008 to 2009, > 120 primary patent applications have claimed adenosine receptor ligands, which we analyze by applicant and target. Particularly significant disclosures are described in detail, paying particular attention to the biological data marshalled to support the case. The first published disclosure of new compounds, compound uses or drug targets is often in the patent literature, which can be difficult to trawl, interpret and verify as it is not subject to peer review. We have critically reviewed this area and share our conclusions regarding progress, trends and identification of early tool compounds or compounds of potential clinical significance ahead of peer-reviewed publication. Adenosine receptor research is a thriving field with continuing claims of exciting new compounds with high specificity and intriguing examples of new uses for such ligands.

  1. Patentability of methods of human enhancement

    DEFF Research Database (Denmark)

    Nordberg, Ana

    2015-01-01

    This article explores how to apply patentability rules to human enhancement, particularly focusing on Article 53(c) of the European Patent Convention (EPC). The global size and value of the cosmetic and wellness market and industry allow for the prediction of considerable market potential for hum...... future evolution and the corresponding public policy choices. This article seeks to provide prospective patentees with guidance and awareness concerning the patentability of methods for human enhancement.......This article explores how to apply patentability rules to human enhancement, particularly focusing on Article 53(c) of the European Patent Convention (EPC). The global size and value of the cosmetic and wellness market and industry allow for the prediction of considerable market potential for human...... enhancement. Patents will be instrumental for companies to protect investment in innovation and tap into this potentially valuable market. The European patent system contains, in Article 53(c) EPC, an exception from patentability for methods for treatment and diagnostic methods. Such rule was created...

  2. Published patent applications and patents from the promoted R + D area

    International Nuclear Information System (INIS)

    Jaeckel, G.; Zierl, I.

    1977-09-01

    The Ministry for Research and Technology of the Federal Republic of Germany has sponsored technological R + D for industrial innovations since 1969. The following compilation includes the published patent applications and patents from all projects which were sponsored up to and including 1973. (orig.) [de

  3. THE ECSTACY OF GOLD Patent Expirations for Trastuzumab, Bevacizumab, Rituximab, and Cetuximab.

    Science.gov (United States)

    Serna-Gallegos, Tasha R; LaFargue, Christopher J; Tewari, Krishnansu S

    2017-11-22

    Fully humanized monoclonal antibodies have revolutionized the treatment of many solid tumors, including breast, lung, colorectal, and ovarian cancer. Among the most widely used monoclonal antibodies in clinical oncology are cetuximab, trastuzumab, rituximab, and bevacizumab. This article will review these four notable monoclonal antibodies, their role in clinical oncology, and the drug patents that are nearing expiration. They are used in both first and second line treatment regimens for multiple common malignancies. With recent patent expirations, pharmaceutical companies involved in biosimilar manufacture are looking to establish ownership over these financial monopolies. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  4. The History of Patenting Genetic Material.

    Science.gov (United States)

    Sherkow, Jacob S; Greely, Henry T

    2015-01-01

    The US Supreme Court's recent decision in Association for Molecular Pathology v. Myriad Genetics, Inc. declared, for the first time, that isolated human genes cannot be patented. Many have wondered how genes were ever the subjects of patents. The answer lies in a nuanced understanding of both legal and scientific history. Since the early twentieth century, "products of nature" were not eligible to be patented unless they were "isolated and purified" from their surrounding environment. As molecular biology advanced, and the capability to isolate genes both physically and by sequence came to fruition, researchers (and patent offices) began to apply patent-law logic to genes themselves. These patents, along with other biological patents, generated substantial social and political criticism. Myriad Genetics, a company with patents on BRCA1 and BRCA2, two genes critical to assessing early-onset breast and ovarian cancer risk, and with a particularly controversial business approach, became the antagonist in an ultimately successful campaign to overturn gene patents in court. Despite Myriad's defeat, some questions concerning the rights to monopolize genetic information remain. The history leading to that defeat may be relevant to these future issues.

  5. Phenotype, Genotype, and Drug Resistance in Subtype C HIV-1 Infection.

    Science.gov (United States)

    Derache, Anne; Wallis, Carole L; Vardhanabhuti, Saran; Bartlett, John; Kumarasamy, Nagalingeswaran; Katzenstein, David

    2016-01-15

    Virologic failure in subtype C is characterized by high resistance to first-line antiretroviral (ARV) drugs, including efavirenz, nevirapine, and lamivudine, with nucleoside resistance including type 2 thymidine analog mutations, K65R, a T69del, and M184V. However, genotypic algorithms predicting resistance are mainly based on subtype B viruses and may under- or overestimate drug resistance in non-B subtypes. To explore potential treatment strategies after first-line failure, we compared genotypic and phenotypic susceptibility of subtype C human immunodeficiency virus 1 (HIV-1) following first-line ARV failure. AIDS Clinical Trials Group 5230 evaluated patients failing an initial nonnucleoside reverse-transcriptase inhibitor (NNRTI) regimen in Africa and Asia, comparing the genotypic drug resistance and phenotypic profile from the PhenoSense (Monogram). Site-directed mutagenesis studies of K65R and T69del assessed the phenotypic impact of these mutations. Genotypic algorithms overestimated resistance to etravirine and rilpivirine, misclassifying 28% and 32%, respectively. Despite K65R with the T69del in 9 samples, tenofovir retained activity in >60%. Reversion of the K65R increased susceptibility to tenofovir and other nucleosides, while reversion of the T69del showed increased resistance to zidovudine, with little impact on other NRTI. Although genotype and phenotype were largely concordant for first-line drugs, estimates of genotypic resistance to etravirine and rilpivirine may misclassify subtype C isolates compared to phenotype. © The Author 2015. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

  6. 37 CFR 1.215 - Patent application publication.

    Science.gov (United States)

    2010-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Patent application publication. 1.215 Section 1.215 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES National Processing Provisions Publication...

  7. Analysis of US patents on spacer grids

    International Nuclear Information System (INIS)

    Kim, Hyung Kyu; Song, Kee Nam; Yoon, Kyung Ho; Kang, Hong Seok; Kim, Hyung Kyu; Jeon, Tae Hyun; Oh, Dong Seok; In, Wang Ki; Bang, Jae Keun; Oh, Seung Eun; Seo, Jeong Min; Lee, Jin Seok; Park, Seong Keun

    1997-06-01

    The total of 137 US patents on spacer grids patented from 1968 through 1993 are analyzed and summarized. Database is constituted with designing the appropriate fields by which each patent can be identified. The fields consist of patent number, inventor, assignee, date of patent, title and major foci of the patent. The major foci are again classified by detailed subjects such as the fretting failure and fuel rod support-related, the strength-related, the fabrication-related as for mechanical subjects, while the cooling performance-related and the pressure drop-related as for thermal-hydraulic one. The 92% of the patents analyzed were issued form nuclear companies of USA, France and Germany. Among the patents dealing with mechanical subjects, the fretting failure and fuel rod support-related is more than the pressure drop-related among the patents of thermal-hydraulic subjects. The number of patents issued from Japan ranks just after Germany i.e., the 4th country. It is thought that much concern as well as investment should be increased in this field, the patent of nuclear components. (author). 2 tabs., 5 figs

  8. Analysis of US patents on spacer grids

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Hyung Kyu; Song, Kee Nam; Yoon, Kyung Ho; Kang, Hong Seok; Kim, Hyung Kyu; Jeon, Tae Hyun; Oh, Dong Seok; In, Wang Ki; Bang, Jae Keun [Korea Atomic Energy Research Institute, Taejon (Korea, Republic of); Oh, Seung Eun; Seo, Jeong Min; Lee, Jin Seok; Park, Seong Keun [Korea Nuclear Fuel Company, Taejon (Korea, Republic of)

    1997-06-01

    The total of 137 US patents on spacer grids patented from 1968 through 1993 are analyzed and summarized. Database is constituted with designing the appropriate fields by which each patent can be identified. The fields consist of patent number, inventor, assignee, date of patent, title and major foci of the patent. The major foci are again classified by detailed subjects such as the fretting failure and fuel rod support-related, the strength-related, the fabrication-related as for mechanical subjects, while the cooling performance-related and the pressure drop-related as for thermal-hydraulic one. The 92% of the patents analyzed were issued form nuclear companies of USA, France and Germany. Among the patents dealing with mechanical subjects, the fretting failure and fuel rod support-related is more than the pressure drop-related among the patents of thermal-hydraulic subjects. The number of patents issued from Japan ranks just after Germany i.e., the 4th country. It is thought that much concern as well as investment should be increased in this field, the patent of nuclear components. (author). 2 tabs., 5 figs.

  9. Analysis of Patent Databases Using VxInsight

    Energy Technology Data Exchange (ETDEWEB)

    BOYACK,KEVIN W.; WYLIE,BRIAN N.; DAVIDSON,GEORGE S.; JOHNSON,DAVID K.

    2000-12-12

    We present the application of a new knowledge visualization tool, VxInsight, to the mapping and analysis of patent databases. Patent data are mined and placed in a database, relationships between the patents are identified, primarily using the citation and classification structures, then the patents are clustered using a proprietary force-directed placement algorithm. Related patents cluster together to produce a 3-D landscape view of the tens of thousands of patents. The user can navigate the landscape by zooming into or out of regions of interest. Querying the underlying database places a colored marker on each patent matching the query. Automatically generated labels, showing landscape content, update continually upon zooming. Optionally, citation links between patents may be shown on the landscape. The combination of these features enables powerful analyses of patent databases.

  10. The diffusion of patented oil and gas technology with environmental uses: A forward patent citation analysis

    International Nuclear Information System (INIS)

    Duch-Brown, Néstor; Costa-Campi, María Teresa

    2015-01-01

    Relevant advances in the mitigation of environmental impact could be obtained by the appropriate diffusion of existing environmental technologies. In this paper, we look at the diffusion of knowledge related to environmental technologies developed within the oil and gas industry. To assess knowledge spillovers from oil and gas inventions as a measure of technology diffusion, we rely on forward patent citations methodology. Results show that there is a strong likelihood that the citing patent will be eventually linked to environmental technologies if the original oil and gas invention has already environmental uses. Moreover, both intra and intersectoral spillovers produce a “turnabout” effect, meaning that citing patents show the opposite quality level of the cited patent. Our results support the idea that more sector-specific environmental policies, with an emphasis on diffusion, would significantly improve the use of environmental technologies developed within the oil and gas industry. -- Highlights: •Knowledge spillovers from oil and gas inventions are of an intrasectoral nature. •Environmental uses in original patents diffuse to patents with environmental uses. •The “turnabout” effect converts low quality patents into high quality citing patents. •Diffusion of oil and gas inventions need more ad hoc instruments

  11. The Academic Advantage: Gender Disparities in Patenting

    Science.gov (United States)

    Sugimoto, Cassidy R.; Ni, Chaoqun; West, Jevin D.; Larivière, Vincent

    2015-01-01

    We analyzed gender disparities in patenting by country, technological area, and type of assignee using the 4.6 million utility patents issued between 1976 and 2013 by the United States Patent and Trade Office (USPTO). Our analyses of fractionalized inventorships demonstrate that women’s rate of patenting has increased from 2.7% of total patenting activity to 10.8% over the nearly 40-year period. Our results show that, in every technological area, female patenting is proportionally more likely to occur in academic institutions than in corporate or government environments. However, women’s patents have a lower technological impact than that of men, and that gap is wider in the case of academic patents. We also provide evidence that patents to which women—and in particular academic women—contributed are associated with a higher number of International Patent Classification (IPC) codes and co-inventors than men. The policy implications of these disparities and academic setting advantages are discussed. PMID:26017626

  12. The academic advantage: gender disparities in patenting.

    Science.gov (United States)

    Sugimoto, Cassidy R; Ni, Chaoqun; West, Jevin D; Larivière, Vincent

    2015-01-01

    We analyzed gender disparities in patenting by country, technological area, and type of assignee using the 4.6 million utility patents issued between 1976 and 2013 by the United States Patent and Trade Office (USPTO). Our analyses of fractionalized inventorships demonstrate that women's rate of patenting has increased from 2.7% of total patenting activity to 10.8% over the nearly 40-year period. Our results show that, in every technological area, female patenting is proportionally more likely to occur in academic institutions than in corporate or government environments. However, women's patents have a lower technological impact than that of men, and that gap is wider in the case of academic patents. We also provide evidence that patents to which women--and in particular academic women--contributed are associated with a higher number of International Patent Classification (IPC) codes and co-inventors than men. The policy implications of these disparities and academic setting advantages are discussed.

  13. The academic advantage: gender disparities in patenting.

    Directory of Open Access Journals (Sweden)

    Cassidy R Sugimoto

    Full Text Available We analyzed gender disparities in patenting by country, technological area, and type of assignee using the 4.6 million utility patents issued between 1976 and 2013 by the United States Patent and Trade Office (USPTO. Our analyses of fractionalized inventorships demonstrate that women's rate of patenting has increased from 2.7% of total patenting activity to 10.8% over the nearly 40-year period. Our results show that, in every technological area, female patenting is proportionally more likely to occur in academic institutions than in corporate or government environments. However, women's patents have a lower technological impact than that of men, and that gap is wider in the case of academic patents. We also provide evidence that patents to which women--and in particular academic women--contributed are associated with a higher number of International Patent Classification (IPC codes and co-inventors than men. The policy implications of these disparities and academic setting advantages are discussed.

  14. The fallacy of Software Patents

    CERN Multimedia

    CERN. Geneva

    2015-01-01

    Software patents are usually used as argument for innovation but do they really promote innovation? Who really benefits from software patents? This talk attempts to show the problems with software patents and how they can actually harm innovation having little value for software users and our society in general.

  15. 37 CFR 1.41 - Applicant for patent.

    Science.gov (United States)

    2010-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Applicant for patent. 1.41 Section 1.41 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES National Processing Provisions Who May Apply for A...

  16. 37 CFR 1.314 - Issuance of patent.

    Science.gov (United States)

    2010-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Issuance of patent. 1.314 Section 1.314 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES National Processing Provisions Allowance and Issue of...

  17. 37 CFR 1.315 - Delivery of patent.

    Science.gov (United States)

    2010-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Delivery of patent. 1.315 Section 1.315 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES National Processing Provisions Allowance and Issue of...

  18. Abbreviated New Drug Applications (ANDAS): Future trend in radiopharmaceuticals

    International Nuclear Information System (INIS)

    Kishore, R.

    1990-01-01

    The Drug Price Competition and Patent Term Restoration Act (commonly called Waxman Hatch Amendment) of 1984, to the Federal Food, Drug, and Cosmetic Act provided for abbreviated new drug applications (ANDAs) if the conditions specified in the Code of Federal Regulations (CFR) Title 21, subsection 312.55 are met. Under this subsection, reports of nonclinical laboratory studies and clinical investigations can be omitted. New drugs approved under these regulations are so called generic drugs as opposed to listed or pioneer (innovator) drugs. As the patents on more and more radiopharmaceuticals reach their expiration, the radiopharmaceutical industry is likely to produce more of these generic versions of innovator drugs. The ANDAs are required to contain information specified under subsections 314.50(a), (b), (d)(1) and (3), (e), and (g)

  19. Patent protection and licensing in microfluidics.

    Science.gov (United States)

    Yetisen, Ali K; Volpatti, Lisa R

    2014-07-07

    Microfluidic devices offer control over low-volume samples in order to achieve high-throughput analysis, and reduce turnaround time and costs. Their efficient commercialisation has implications for biomedical sciences, veterinary medicine, environmental monitoring and industrial applications. In particular, market diffusion of microfluidic laboratory and point-of-care diagnostic devices can contribute to the improvement of global health. In their commercialisation, consultancy and patent protection are essential elements that complement academic publishing. The awareness of knowledge transfer strategies can help academics to create value for their research. The aim of this article is to provide a guidance to (1) overview the terminology in patent law, (2) elucidate the process of filing a patent in the US, EU, Japan and internationally, (3) discuss strategies to licence a patent, and (4) explain tactics to defend a patent in a potential infringement. Awareness of the patent law and rights allows obtaining optimised, valid and valuable patents, while accelerating implementation to market route. Striking a balance between academic publishing, consultancy to industry and patent protection can increase commercial potential, enhance economic growth and create social impact.

  20. 14 CFR 1260.28 - Patent rights.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false Patent rights. 1260.28 Section 1260.28... Provisions § 1260.28 Patent rights. Patent Rights May 2006 As stated at § 1260.136, this award is subject to... “Patent Rights (Small Business Firms and Nonprofit Organizations)” and the following: (a) Where the term...

  1. [Antiretroviral drug supply in Argentina: National Program to Combat Human Retroviruses, AIDS, and STDs].

    Science.gov (United States)

    Colautti, Marisel; Luppi, Irene; Salamano, Mercedes; Traverso, María Luz; Botta, Carina; Palchik, Valeria

    2009-01-01

    To evaluate the supply cycle of antiretroviral (ARV) drugs, overseen by the National Program to Combat Human Retroviruses, AIDS, and STDs, through its order fulfillment indicators, and to obtain input from supply chain stakeholders. A study was carried out from April-September 2005 in the pharmacies of two hospitals in Rosario, Argentina, involving both a quantitative analysis of indicators and secondary sources and a qualitative evaluation using semistructured interviews. The indicators reveal the impact that interruptions in ARV supply stream from the Program (central level) have and the overstocking that takes place at the pharmacies (local level) to manage the shortages. Changes in ARV treatment account for over 50% of the prescriptions. Fulfillments fall short of the reference value. The interviewees shared possible strategies for overcoming the communication gaps between levels, for building-up stock, for guaranteeing availability, and for shortening waiting times; reached informal agreements to deal with the lack of policies and the shortage of staff; acknowledged the challenges facing the jurisdictions (central, intermediate, and local/community); and recognized local efforts to improve management. These challenges could be the starting point for building teams to work on effectively decentralizing the entire supply chain and allowing the Program to fulfill its much-needed oversight role.

  2. Transparency in the pharmaceutical industry - A cost accounting approach to the prices of drugs

    NARCIS (Netherlands)

    Broekhof, Martijn

    2002-01-01

    The WTO TRIPS agreement grants pharmaceutical companies patent rights on new innovative drugs. Patents give these companies the opportunity to charge higher prices for their drugs in order to recover their R&D expenses. For developing countries this is one of the reasons why people in developing

  3. Using Patent Classification to Discover Chemical Information in a Free Patent Database: Challenges and Opportunities

    Science.gov (United States)

    Ha¨rtinger, Stefan; Clarke, Nigel

    2016-01-01

    Developing skills for searching the patent literature is an essential element of chemical information literacy programs at the university level. The present article creates awareness of patents as a rich source of chemical information. Patent classification is introduced as a key-component in comprehensive search strategies. The free Espacenet…

  4. Effect of firm variables on patent price

    Directory of Open Access Journals (Sweden)

    Shyam Sreekumaran Nair

    2012-03-01

    Full Text Available In this study, using singleton patent auction price data from Ocean Tomo, LLC, we analyse the effect of firm variables on patent price. Patents owned by small firms attract higher price than patents owned by large firms, if they engage in multi-country filings. The patents owned by small firms get cited more than the patents owned by large firms. The patents owned by individual inventors attract a higher price than the patents owned by organisations when multi-country filings are not included. We believe that the lack of resources is preventing individual inventors from engaging in multi-country filings and maximising the revenue from their invention. A larger representative data should be used to replicate the results before generalising it.

  5. The Academic Advantage: Gender Disparities in Patenting

    OpenAIRE

    Sugimoto, Cassidy R.; Ni, Chaoqun; West, Jevin D.; Larivi?re, Vincent

    2015-01-01

    We analyzed gender disparities in patenting by country, technological area, and type of assignee using the 4.6 million utility patents issued between 1976 and 2013 by the United States Patent and Trade Office (USPTO). Our analyses of fractionalized inventorships demonstrate that women's rate of patenting has increased from 2.7% of total patenting activity to 10.8% over the nearly 40-year period. Our results show that, in every technological area, female patenting is proportionally more likely...

  6. Patent data mining method and apparatus

    Science.gov (United States)

    Boyack, Kevin W.; Grafe, V. Gerald; Johnson, David K.; Wylie, Brian N.

    2002-01-01

    A method of data mining represents related patents in a multidimensional space. Distance between patents in the multidimensional space corresponds to the extent of relationship between the patents. The relationship between pairings of patents can be expressed based on weighted combinations of several predicates. The user can select portions of the space to perceive. The user also can interact with and control the communication of the space, focusing attention on aspects of the space of most interest. The multidimensional spatial representation allows more ready comprehension of the structure of the relationships among the patents.

  7. Geographic and Temporal Trends in the Molecular Epidemiology and Genetic Mechanisms of Transmitted HIV-1 Drug Resistance: An Individual-Patient- and Sequence-Level Meta-Analysis

    NARCIS (Netherlands)

    S.Y. Rhee (Soo Yoon); J.L. Blanco (Jose Luis); M.R. Jordan (Michael); J. Taylor (Jonathan); P. Lemey (Philippe); V. Varghese (Vici); R.L. Hamers (Raph); S. Bertagnolio (Silvia); M. De Wit (Meike); A.F. Aghokeng (Avelin); J. Albert (Jan); R. Avi (Radko); S. Avila-Rios (Santiago); P.O. Bessong (Pascal O.); J.I. Brooks (James I.); C.A.B. Boucher (Charles); Z.L. Brumme (Zabrina L.); M.P. Busch (Michael P.); H. Bussmann (Hermann); M.L. Chaix (Marie Laure); B.S. Chin (Bum Sik); T.T. D’Aquin (Toni T.); C. de Gascun (Cillian); A. Derache (Anne); D. Descamps (Diane); A.K. Deshpande (Alaka K.); C.F. Djoko (Cyrille F.); S.H. Eshleman (Susan H.); H. Fleury (Hervé); P. Frange (Pierre); S. Fujisaki (Seiichiro); P. Harrigan (Pr); J. Hattori (Junko); A. Holguin (Africa); G.M. Hunt (Gillian M.); H. Ichimura (Hiroshi); P. Kaleebu (Pontiano); D. Katzenstein (David); S. Kiertiburanakul (Sasisopin); J.H. Kim (Jerome H.); S.S. Kim (Sung Soon); Y. Li (Yanpeng); I. Lutsar (Irja); L. Morris (L.); N. Ndembi (Nicaise); K.P. NG (Kee Peng); R.S. Paranjape (Ramesh S.); M.C. Peeters (Marian); M. Poljak (Mario); M.A. Price (Matt A.); M.L. Ragonnet-Cronin (Manon L.); G. Reyes-Terán (Gustavo); M. Rolland (Morgane); S. Sirivichayakul (Sunee); D.M. Smith (Davey M.); M.A. Soares (Marcelo A.); V. Soriano (Virtudes); D. Ssemwanga (Deogratius); M. Stanojevic (Maja); M.A. Stefani (Mariane A.); W. Sugiura (Wataru); S. Sungkanuparph (Somnuek); A. Tanuri (Amilcar); K.K. Tee (Kok Keng); H.-H.M. Truong (Hong-Ha M.); D.A.M.C. van de Vijver (David); N. Vidal (Nicole); C. Yang (Chunfu); R. Yang (Rongge); G. Yebra (Gonzalo); J.P.A. Ioannidis (John); A.M. Vandamme (Anne Mieke); R.W. Shafer (Robert)

    2015-01-01

    textabstractRegional and subtype-specific mutational patterns of HIV-1 transmitted drug resistance (TDR) are essential for informing first-line antiretroviral (ARV) therapy guidelines and designing diagnostic assays for use in regions where standard genotypic resistance testing is not affordable. We

  8. Multimodal actions of the phytochemical sulforaphane suppress both AR and AR-V7 in 22Rv1 cells: Advocating a potent pharmaceutical combination against castration-resistant prostate cancer.

    Science.gov (United States)

    Khurana, Namrata; Kim, Hogyoung; Chandra, Partha K; Talwar, Sudha; Sharma, Pankaj; Abdel-Mageed, Asim B; Sikka, Suresh C; Mondal, Debasis

    2017-11-01

    Prostate cancer (PCa) cells expressing full-length androgen receptor (AR-FL) are susceptible to androgen deprivation therapy (ADT). However, outgrowth of castration-resistant prostate cancer (CRPC) can occur due to the expression of constitutively active (ligand-independent) AR splice variants, particularly AR-V7. We previously demonstrated that sulforaphane (SFN), an isothiocyanate phytochemical, can decrease AR-FL levels in the PCa cell lines, LNCaP and C4-2B. Here, we examined the efficacy of SFN in targeting both AR-FL and AR-V7 in the CRPC cell line, CWR22Rv1 (22Rv1). MTT cell viability, wound-heal assay, and colony forming unit (CFU) measurements revealed that 22Rv1 cells are resistant to the anti-androgen, enzalutamide (ENZ). However, co-exposure to SFN sensitized these cells to the potent anticancer effects of ENZ (PAR-FL and AR-V7 levels, and immunofluorescence microscopy (IFM) depicted decreased AR in both cytoplasm and nucleus with SFN treatment. SFN increased both ubiquitination and proteasomal activity in 22Rv1 cells. Studies using a protein synthesis inhibitor (cycloheximide) or a proteasomal inhibitor (MG132) indicated that SFN increases both ubiquitin-mediated aggregation and subsequent proteasomal-degradation of AR proteins. Previous studies reported that SFN inhibits the chaperone activity of heat-shock protein 90 (Hsp90) and induces the nuclear factor erythroid-2-like 2 (Nrf2) transcription factor. Therefore, we investigated whether the Hsp90 inhibitor, ganetespib (G) or the Nrf2 activator, bardoxolone methyl (BM) can similarly suppress AR levels in 22Rv1 cells. Low doses of G and BM, alone or in combination, decreased both AR-FL and AR-V7 levels, and combined exposure to G+BM sensitized 22Rv1 cells to ENZ. Therefore, adjunct treatment with the phytochemical SFN or a safe pharmaceutical combination of G+BM may be effective against CRPC cells, especially those expressing AR-V7.

  9. 43 CFR 402.10 - Patent.

    Science.gov (United States)

    2010-10-01

    ... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Patent. 402.10 Section 402.10 Public Lands... LANDS IN FEDERAL RECLAMATION PROJECTS Public Lands § 402.10 Patent. When a purchaser has complied fully... and patent and shall state the statutory authority for such liens. The receipt shall be submitted to...

  10. Tracking 20 years of compound-to-target output from literature and patents.

    Directory of Open Access Journals (Sweden)

    Christopher Southan

    Full Text Available The statistics of drug development output and declining yield of approved medicines has been the subject of many recent reviews. However, assessing research productivity that feeds development is more difficult. Here we utilise an extensive database of structure-activity relationships extracted from papers and patents. We have used this database to analyse published compounds cumulatively linked to nearly 4000 protein target identifiers from multiple species over the last 20 years. The compound output increases up to 2005 followed by a decline that parallels a fall in pharmaceutical patenting. Counts of protein targets have plateaued but not fallen. We extended these results by exploring compounds and targets for one large pharmaceutical company. In addition, we examined collective time course data for six individual protease targets, including average molecular weight of the compounds. We also tracked the PubMed profile of these targets to detect signals related to changes in compound output. Our results show that research compound output had decreased 35% by 2012. The major causative factor is likely to be a contraction in the global research base due to mergers and acquisitions across the pharmaceutical industry. However, this does not rule out an increasing stringency of compound quality filtration and/or patenting cost control. The number of proteins mapped to compounds on a yearly basis shows less decline, indicating the cumulative published target capacity of global research is being sustained in the region of 300 proteins for large companies. The tracking of six individual targets shows uniquely detailed patterns not discernible from cumulative snapshots. These are interpretable in terms of events related to validation and de-risking of targets that produce detectable follow-on surges in patenting. Further analysis of the type we present here can provide unique insights into the process of drug discovery based on the data it actually

  11. 37 CFR 1.705 - Patent term adjustment determination.

    Science.gov (United States)

    2010-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Patent term adjustment determination. 1.705 Section 1.705 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES Adjustment and Extension of Patent Term...

  12. Patenting of university and non-university public research organisations in Germany: evidence from patent applications for medical research results.

    Directory of Open Access Journals (Sweden)

    Peter Tinnemann

    Full Text Available BACKGROUND: Patents are one of the most important forms of intellectual property. They grant a time-limited exclusivity on the use of an invention allowing the recuperation of research costs. The use of patents is fiercely debated for medical innovation and especially controversial for publicly funded research, where the patent holder is an institution accountable to public interest. Despite this controversy, for the situation in Germany almost no empirical information exists. The purpose of this study is to examine the amount, types and trends of patent applications for health products submitted by German public research organisations. METHODS/PRINCIPAL FINDINGS: We conducted a systematic search for patent documents using the publicly accessible database search interface of the German Patent and Trademark Office. We defined keywords and search criteria and developed search patterns for the database request. We retrieved documents with application date between 1988 and 2006 and processed the collected data stepwise to compile the most relevant documents in patent families for further analysis. We developed a rationale and present individual steps of a systematic method to request and process patent data from a publicly accessible database. We retrieved and processed 10194 patent documents. Out of these, we identified 1772 relevant patent families, applied for by 193 different universities and non-university public research organisations. 827 (47% of these patent families contained granted patents. The number of patent applications submitted by universities and university-affiliated institutions more than tripled since the introduction of legal reforms in 2002, constituting almost half of all patent applications and accounting for most of the post-reform increase. Patenting of most non-university public research organisations remained stable. CONCLUSIONS: We search, process and analyse patent applications from publicly accessible databases

  13. Percutaneous closure of a large patent ductus arteriosus in a preterm newborn weighing 1400 g without using arterial sheath: an innovative technique.

    Science.gov (United States)

    Garg, Gaurav; Garg, Vishal; Prakash, Amit

    2018-03-01

    Percutaneous closure of patent ductus arteriosus is well established in infants weighing >5 kg, but data regarding outcome of preterm especially very low birth weight infants is minimal. Although surgical ligation of patent ductus arteriosus is the preferred and well-accepted modality of treatment after failure of drug therapy in preterm infants, it has also got its own demerits in such a small and fragile subset. Device closure in infants weighing closure of large patent ductus arteriosus. Percutaneous closure of patent ductus arteriosus was done successfully and the infant was discharged on room air with a weight of 1.8 kg. We present here an innovative technique in which successful patent ductus arteriosus device closure was done in a 1.4-kg infant without using arterial sheath.

  14. Canada ordered to implement WTO ruling against "stockpiling" of generic drugs.

    Science.gov (United States)

    Elliott, R

    2000-01-01

    In the last issue, we reported on a mixed World Trade Organization (WTO) ruling regarding Canada's patent laws, based on a complaint by the member states of the European Communities (joined by the United States). In March 2000, a WTO Panel accepted the provision in Canada's Patent Act that creates an "early working exception" to patent rights--in other words, that allows a third party to use a patented invention during the term of patent protection, as long as the use is for obtaining regulatory approval of an equivalent product to be sold once the patent expires. This was an important victory from the perspective of allowing earlier access to generic versions of patented drugs.

  15. Therapeutic and cosmetic applications of mangiferin: a patent review.

    Science.gov (United States)

    Telang, Manasi; Dhulap, Sivakami; Mandhare, Anita; Hirwani, Rajkumar

    2013-12-01

    Mangiferin, a natural C-glucoside xanthone [2-C-β-D-glucopyranosyl-1, 3, 6, 7-tetrahydroxyxanthone], is abundantly present in young leaves and stem bark of the mango tree. The xanthonoid structure of mangiferin with C-glycosyl linkage and polyhydroxy components contributes to its free radical-scavenging ability, leading to a potent antioxidant effect as well as multiple biological activities. An extensive search was carried out to collect patent information on mangiferin and its derivatives using various patent databases spanning all priority years to date. The patents claiming therapeutic and cosmetic applications of mangiferin and its derivatives were analyzed in detail. The technology areas covered in this article include metabolic disorders, cosmeceuticals, multiple uses of the same compound, miscellaneous uses, infectious diseases, inflammation, cancer and autoimmune disorders, and neurological disorders. Mangiferin has the potential to modulate multiple molecular targets including nuclear factor-kappa B (NF-κB) signaling and cyclooxygenase-2 (COX-2) protein expression. Mangiferin exhibits antioxidant, antidiabetic, antihyperuricemic, antiviral, anticancer and antiinflammatory activities. The molecular structure of mangiferin fulfils the four Lipinski's requisites reported to favor high bioavailability by oral administration. There is no evidence of adverse side effects of mangiferin so far. Mangiferin could thus be a promising candidate for development of a multipotent drug.

  16. Entrepreneurial patent management in pharmaceutical startups.

    Science.gov (United States)

    Holgersson, Marcus; Phan, Tai; Hedner, Thomas

    2016-07-01

    Startups fill an increasingly important role as innovators in the pharmaceutical industry, and patenting is typically central to their success. This article aims to explore patent management in pharmaceutical startups. The results show that startups need to deal with several challenges related to patenting and an 'entrepreneurial' approach to patent management is called for. Resource constraints, venture capital provision, exits and other conditions and events must be readily considered in the patent management process to build a successful pharmaceutical venture, something that could benefit the pharmaceutical industry as a whole. Copyright © 2016 Elsevier Ltd. All rights reserved.

  17. Hybrid Underwater Vehicle: ARV Design and Development

    Directory of Open Access Journals (Sweden)

    Zhigang DENG

    2014-02-01

    Full Text Available The development of SMU-I, a new autonomous & remotely-operated vehicle (ARV is described. Since it has both the characteristics of autonomous underwater vehicle (AUV and remote operated underwater vehicle (ROV, it is able to achieve precision fix station operation and manual timely intervention. In the paper the initial design of basic components, such as vehicle, propulsion, batteries etc. and the control design of motion are introduced and analyzed. ROV’s conventional cable is replaced by a fiber optic cable, which makes it available for high-bandwidth real-time video, data telemetry and high-quality teleoperation. Furthermore, with the aid of the manual real-time remote operation and ranging sonar, it also resolves the AUV’s conflicting issue, which can absolutely adapt the actual complex sea environment and satisfy the unknown mission need. The whole battery system is designed as two-battery banks, whose voltages and temperatures are monitored through CAN (controller area network bus to avoid battery fire and explosion. A fuzzy-PID controller is designed for its motion control, including depth control and direction control. The controller synthesizes the advantage of fuzzy control and PID control, utilizes the fuzzy rules to on-line tune the parameters of PID controller, and achieves a better control effect. Experiment results demonstrate to show the effectiveness of the test-bed.

  18. Emergency transcatheter closure of patent ductus arteriosus complicated by severe pneumonia in infants

    International Nuclear Information System (INIS)

    Huang Xiyong; Xiao Yunbin; Chen Zhi; Wang Xiang; Wang Xun

    2014-01-01

    Objective: To evaluate the efficacy and safety of emergency transcatheter occlusion of patent ductus arteriosus associated with severe pneumonia in infants. Methods: During the period from Oct. 2011 to May 2012, 12 infants with patent ductus arteriosus complicated by severe pneumonia were admitted to the hospital. The infants had repeated episodes of pneumonia together with heart failure. Emergency transcatheter occlusion of patent ductus arteriosus was carried out in all infants. After the treatment the use of anti-bacterial drugs and cardiac stimulants was kept on. Routine examinations of blood and urine were made 24 hours after the management. Two-dimensional and color Doppler echocardiography, chest radiograph and electrocardiogram were performed at 24 hours, 1, 3, and 6 months after the surgery. The results were analyzed. Results: After emergency transcatheter closure, all patients recovered fully at the time of discharge. No intervention-related major complications occurred during short-term follow-up period. Conclusion: For the treatment of patent ductus arteriosus associated with severe pneumonia in infants, emergency transcatheter occlusion therapy is effective and safe. Optimal surgery time together with proper perioperative management is the key to ensure a successful operation. (authors)

  19. Automated Patent Categorization and Guided Patent Search using IPC as Inspired by MeSH and PubMed.

    Science.gov (United States)

    Eisinger, Daniel; Tsatsaronis, George; Bundschus, Markus; Wieneke, Ulrich; Schroeder, Michael

    2013-04-15

    Document search on PubMed, the pre-eminent database for biomedical literature, relies on the annotation of its documents with relevant terms from the Medical Subject Headings ontology (MeSH) for improving recall through query expansion. Patent documents are another important information source, though they are considerably less accessible. One option to expand patent search beyond pure keywords is the inclusion of classification information: Since every patent is assigned at least one class code, it should be possible for these assignments to be automatically used in a similar way as the MeSH annotations in PubMed. In order to develop a system for this task, it is necessary to have a good understanding of the properties of both classification systems. This report describes our comparative analysis of MeSH and the main patent classification system, the International Patent Classification (IPC). We investigate the hierarchical structures as well as the properties of the terms/classes respectively, and we compare the assignment of IPC codes to patents with the annotation of PubMed documents with MeSH terms.Our analysis shows a strong structural similarity of the hierarchies, but significant differences of terms and annotations. The low number of IPC class assignments and the lack of occurrences of class labels in patent texts imply that current patent search is severely limited. To overcome these limits, we evaluate a method for the automated assignment of additional classes to patent documents, and we propose a system for guided patent search based on the use of class co-occurrence information and external resources.

  20. Geographic and temporal trends in the molecular epidemiology and genetic mechanisms of transmitted HIV-1 drug resistance: an individual-patient- and sequence-level meta-analysis

    NARCIS (Netherlands)

    Rhee, Soo-Yon; Blanco, Jose Luis; Jordan, Michael R.; Taylor, Jonathan; Lemey, Philippe; Varghese, Vici; Hamers, Raph L.; Bertagnolio, Silvia; Rinke de Wit, Tobias F.; Aghokeng, Avelin F.; Albert, Jan; Avi, Radko; Avila-Rios, Santiago; Bessong, Pascal O.; Brooks, James I.; Boucher, Charles A. B.; Brumme, Zabrina L.; Busch, Michael P.; Bussmann, Hermann; Chaix, Marie-Laure; Chin, Bum Sik; D'Aquin, Toni T.; de Gascun, Cillian F.; Derache, Anne; Descamps, Diane; Deshpande, Alaka K.; Djoko, Cyrille F.; Eshleman, Susan H.; Fleury, Herve; Frange, Pierre; Fujisaki, Seiichiro; Harrigan, P. Richard; Hattori, Junko; Holguin, Africa; Hunt, Gillian M.; Ichimura, Hiroshi; Kaleebu, Pontiano; Katzenstein, David; Kiertiburanakul, Sasisopin; Kim, Jerome H.; Kim, Sung Soon; Li, Yanpeng; Lutsar, Irja; Morris, Lynn; Ndembi, Nicaise; Ng, Kee Peng; Paranjape, Ramesh S.; Peeters, Martine; Poljak, Mario; Price, Matt A.; Ragonnet-Cronin, Manon L.; Reyes-Terán, Gustavo; Rolland, Morgane; Sirivichayakul, Sunee; Smith, Davey M.; Soares, Marcelo A.; Soriano, Vincent V.; Ssemwanga, Deogratius; Stanojevic, Maja; Stefani, Mariane A.; Sugiura, Wataru; Sungkanuparph, Somnuek; Tanuri, Amilcar; tee, Kok Keng; Truong, Hong-Ha M.; van de Vijver, David A. M. C.; Vidal, Nicole; Yang, Chunfu; Yang, Rongge; Yebra, Gonzalo; Ioannidis, John P. A.; Vandamme, Anne-Mieke; Shafer, Robert W.

    2015-01-01

    Regional and subtype-specific mutational patterns of HIV-1 transmitted drug resistance (TDR) are essential for informing first-line antiretroviral (ARV) therapy guidelines and designing diagnostic assays for use in regions where standard genotypic resistance testing is not affordable. We sought to

  1. The A to Z of pharmaceutical cocrystals: a decade of fast-moving new science and patents.

    Science.gov (United States)

    Almarsson, Örn; Peterson, Matthew L; Zaworotko, Michael

    2012-07-01

    From aspirin to zoledronic acid, pharmaceutical cocrystals emerged in the past decade as a promising new weapon in the arsenal of drug development. Resurgence of interest in multicomponent crystal compositions has led to significant advances in the science of cocrystal design and discovery. These advances have built upon crystal engineering, which provides a deep understanding of supramolecular interactions between molecules that govern crystal packing and physicochemical properties of crystalline materials. Concomitantly, the patent landscape of pharmaceutical cocrystals developed rapidly in the last decade. This review presents a broad survey of patents issued in the area of pharmaceutical cocrystals. In addition, the review contains analyses of key patents in the area involving compositions and methodologies. Along the way, the main events of the past decade representing a renaissance of cocrystals of pharmaceutical materials are chronicled. Future directions in the area are discussed in light of key pending patent applications and recent publications of seminal interest.

  2. High HIV-1 Diversity and Prevalence of Transmitted Drug Resistance Among Antiretroviral-Naive HIV-Infected Pregnant Women from Rio de Janeiro, Brazil.

    Science.gov (United States)

    Delatorre, Edson; Silva-de-Jesus, Carlos; Couto-Fernandez, José Carlos; Pilotto, Jose H; Morgado, Mariza G

    2017-01-01

    Antiretroviral (ARV) resistance mutations in human immunodeficiency virus type 1 (HIV-1) infection may reduce the efficacy of prophylactic therapy to prevent mother-to-child transmission (PMTCT) and future treatment options. This study evaluated the diversity and the prevalence of transmitted drug resistance (TDR) in protease (PR) and reverse transcriptase (RT) regions of HIV-1 pol gene among 87 ARV-naive HIV-1-infected pregnant women from Rio de Janeiro, Brazil, between 2012 and 2015. The viral diversity comprised HIV-1 subtypes B (67.8%), F1 (17.2%), and C (4.6%); the circulating recombinant forms 12_BF (2.3%), 28/29_BF, 39_BF, 02_AG (1.1% each) and unique recombinants forms (4.5%). The overall prevalence of any TDR was 17.2%, of which 5.7% for nucleoside RT inhibitors, 5.7% for non-nucleoside RT inhibitors, and 8% for PR inhibitors. The TDR prevalence found in this population may affect the virological outcome of the standard PMTCT ARV-regimens, reinforcing the importance of continuous monitoring.

  3. Patent Law for Computer Scientists

    Science.gov (United States)

    Closa, Daniel; Gardiner, Alex; Giemsa, Falk; Machek, Jörg

    More than five centuries ago the first patent statute was passed by the Venetian senate. It already had most of the features of modern patent law, recognizing the public interest in innovation and granting exclusive right in exchange for a full disclosure. Some 350 years later the industrial revolution led to globalisation. The wish to protect intellectual property on a more international level evolved and supranational treaties were negotiated. Patent laws are still different in many countries, however, and inventors are sometimes at a loss to understand which basic requirements should be satisfied if an invention is to be granted a patent. This is particularly true for inventions implemented on a computer. While roughly a third of all applications (and granted patents) relate, in one way or another, to a computer, applications where the innovation mainly resides in software or in a business method are treated differently by the major patent offices. The procedures at the USPTO, JPO and EPO and, in particular, the differences in the treatment of applications centring on software are briefly explained. In later sections of this book, a wealth of examples will be presented. The methodology behind the treatment of these examples is explained.

  4. Can voluntary pooled procurement reduce the price of antiretroviral drugs? a case study of Efavirenz.

    Science.gov (United States)

    Kim, Sung Wook; Skordis-Worrall, Jolene

    2017-05-01

    : A number of strategies have aimed to assist countries in procuring antiretroviral therapy (ARV) at lower prices. In 2009, as the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) commenced a voluntary pooled procurement scheme, however, the impact of the scheme on ARV prices remains uncertain. This study aims to estimate the effect of VPP on drug prices using Efavirenz as a case study. This analysis uses WHO Global price report mechanism (GPRM) data from 2004 to 2013. Due to the highly skewed distribution of drug Prices, a generalized linear model (GLM) was used to conduct a difference-in-difference estimation of drug price changes over time. These analyses found that voluntary pooled procurement reduced both the ex-works price of generic Efavirenz and the incoterms price by 16.2 and 19.1%, respectively ( P <  0.001) in both cases). The year dummies were also statistically significant from 2006 to 2013 ( P <  0.001), indicating a strong decreasing trend in the price of Efavirenz over that period. Voluntary pooled procurement significantly reduced the price of 600 mg generic Efavirenz between 2009 and 2013. Voluntary pooled procurement therefore offers a potentially effective strategy for the reduction in HIV drug prices and the improvement of technical efficiency in HIV programming. Further work is required to establish if these findings hold also for other drugs. © The Author 2017. Published by Oxford University Press in association with The London School of Hygiene and Tropical Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  5. 76 FR 72000 - Patent, Trademark & Copyright Acts

    Science.gov (United States)

    2011-11-21

    ... DEPARTMENT OF THE INTERIOR Geological Survey Patent, Trademark & Copyright Acts AGENCY: U.S... Consultants, 1255 Roberts Boulevard NW., Suite 200, Kennesaw, GA 30144, on U.S. Patent Application Serial No. 12/133,666, and a divisional patent application to be filed shortly at the Patent and Trademark...

  6. Patent cliff and strategic switch: exploring strategic design possibilities in the pharmaceutical industry.

    Science.gov (United States)

    Song, Chie Hoon; Han, Jeung-Whan

    2016-01-01

    Extending the period of the market exclusivity and responding properly to the recent agglomeration of patent expiries are pivotal to the success of pharmaceutical companies. Declining R&D productivity, rising costs of commercialization, near-term patent expirations for many top-selling drugs are forcing companies to adopt new systems to introduce innovative products to market and to focus on strategies that increase the returns from the existing product portfolio. This systematic review explores various strategic and tactical management approaches by synthesizing the relevant literature and practical examples on patent expiration strategies. It further discusses how the mix of competition policies and strategic instruments can be used to maintain declining revenue streams from the blockbuster business model of the pharmaceutical industry. The review provides a comprehensive overview of the research on various strategies, offers both theoretical and practical guidelines for strategy transformation that companies can use to prolong the market exclusivity, and identifies knowledge gaps that needed to be addressed in order to improve efficiency in policy design.

  7. 78 FR 51177 - Notice of Intent To Grant Partially Exclusive Patent License; ICAP Patent Brokerage, LLC

    Science.gov (United States)

    2013-08-20

    ... DEPARTMENT OF DEFENSE Department of the Navy Notice of Intent To Grant Partially Exclusive Patent License; ICAP Patent Brokerage, LLC AGENCY: Department of the Navy, DoD. ACTION: Notice. SUMMARY: The Department of the Navy hereby gives notice of its intent to grant to ICAP Patent Brokerage, LLC, a revocable...

  8. 78 FR 72872 - Notice of Intent To Grant Partially Exclusive Patent License; ICAP Patent Brokerage, LLC

    Science.gov (United States)

    2013-12-04

    ... DEPARTMENT OF DEFENSE Department of the Navy Notice of Intent To Grant Partially Exclusive Patent License; ICAP Patent Brokerage, LLC AGENCY: Department of the Navy, DoD. ACTION: Notice. SUMMARY: The Department of the Navy hereby gives notice of its intent to grant to ICAP Patent Brokerage, LLC, a revocable...

  9. 48 CFR 970.2703 - Patent rights.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Patent rights. 970.2703 Section 970.2703 Federal Acquisition Regulations System DEPARTMENT OF ENERGY AGENCY SUPPLEMENTARY REGULATIONS DOE MANAGEMENT AND OPERATING CONTRACTS Patents, Data, and Copyrights 970.2703 Patent rights. ...

  10. Beyond Invention: Patent as Knowledge Law

    OpenAIRE

    Madison, Michael

    2017-01-01

    The decision of the Supreme Court of the United States in Bilski v. Kappos, concerning the legal standard for determining patentable subject matter under the American Patent Act, is used as a starting point for a brief review of historical, philosophical, and cultural influences on subject matter questions in both patent and copyright law. The article suggests that patent and copyright law jurisprudence was constructed initially by the Court with explicit attention to the relationship between...

  11. 48 CFR 970.2702-3 - Patent indemnity.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Patent indemnity. 970.2702... SUPPLEMENTARY REGULATIONS DOE MANAGEMENT AND OPERATING CONTRACTS Patents, Data, and Copyrights 970.2702-3 Patent indemnity. (a) Contracting officers must use the clause at 970.5227-6, Patent Indemnity—Subcontracts to...

  12. The ethics of patenting human embryonic stem cells.

    Science.gov (United States)

    Chapman, Audrey R

    2009-09-01

    Just as human embryonic stem cell research has generated controversy about the uses of human embryos for research and therapeutic applications, human embryonic stem cell patents raise fundamental ethical issues. The United States Patent and Trademark Office has granted foundational patents, including a composition of matter (or product) patent to the Wisconsin Alumni Research Foundation (WARF), the University of Wisconsin-Madison's intellectual property office. In contrast, the European Patent Office rejected the same WARF patent application for ethical reasons. This article assesses the appropriateness of these patents placing the discussion in the context of the deontological and consequentialist ethical issues related to human embryonic stem cell patenting. It advocates for a patent system that explicitly takes ethical factors into account and explores options for new types of intellectual property arrangements consistent with ethical concerns.

  13. Drug discovery and the impact of the safe harbor provision of the Hatch- Waxman Act.

    Science.gov (United States)

    Goodson, Susanne H

    2010-01-01

    Many facets of drug discovery involve the use of patented materials and methods, subjecting the researcher to potential liability from infringement of the underlying patents. Enacted in 1984, the Hatch-Waxman Act established a “safe harbor” for activities that would otherwise constitute infringement of a patented invention, if those activities were “solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products”. This article examines the major court decisions interpreting the scope of the safe harbor and their application to various activities in drug development.

  14. Developing a Systematic Patent Search Training Program

    Science.gov (United States)

    Zhang, Li

    2009-01-01

    This study aims to develop a systematic patent training program using patent analysis and citation analysis techniques applied to patents held by the University of Saskatchewan. The results indicate that the target audience will be researchers in life sciences, and aggregated patent database searching and advanced search techniques should be…

  15. Assessing the impact of a food supplement on the nutritional status and body composition of HIV-infected Zambian women on ARVs.

    Science.gov (United States)

    Zulu, Rodah M; Byrne, Nuala M; Munthali, Grace K; Chipeta, James; Handema, Ray; Musonda, Mofu; Hills, Andrew P

    2011-09-21

    Zambia is a sub-Saharan country with one of the highest prevalence rates of HIV, currently estimated at 14%. Poor nutritional status due to both protein-energy and micronutrient malnutrition has worsened this situation. In an attempt to address this combined problem, the government has instigated a number of strategies, including the provision of antiretroviral (ARV) treatment coupled with the promotion of good nutrition. High-energy protein supplement (HEPS) is particularly promoted; however, the impact of this food supplement on the nutritional status of people living with HIV/AIDS (PLHA) beyond weight gain has not been assessed. Techniques for the assessment of nutritional status utilising objective measures of body composition are not commonly available in Zambia. The aim of this study is therefore to assess the impact of a food supplement on nutritional status using a comprehensive anthropometric protocol including measures of skinfold thickness and circumferences, plus the criterion deuterium dilution technique to assess total body water (TBW) and derive fat-free mass (FFM) and fat mass (FM). This community-based controlled and longitudinal study aims to recruit 200 HIV-infected females commencing ARV treatment at two clinics in Lusaka, Zambia. Data will be collected at four time points: baseline, 4-month, 8-month and 12-month follow-up visits. Outcome measures to be assessed include body height and weight, body mass index (BMI), body composition, CD4, viral load and micronutrient status. This protocol describes a study that will provide a longitudinal assessment of the impact of a food supplement on the nutritional status of HIV-infected females initiating ARVs using a range of anthropometric and body composition assessment techniques. Pan African Clinical Trial Registry PACTR201108000303396.

  16. 48 CFR 31.205-30 - Patent costs.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Patent costs. 31.205-30....205-30 Patent costs. (a) The following patent costs are allowable to the extent that they are incurred... patent application where title or royalty-free license is to be conveyed to the Government. (b) General...

  17. A Moral Economy of Patents: Case of Finnish Research Universities' Patent Policies

    Science.gov (United States)

    Kauppinen, Ilkka

    2014-01-01

    The primary objective of this paper is to demonstrate the usefulness of the concept of moral economy for higher education studies through a study of Finnish research universities' patent policies. Patent policies not only stimulate the commercialization of research, they also set norms for behavior and aim to clarify how to distribute rights and…

  18. 48 CFR 35.012 - Patent rights.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Patent rights. 35.012 Section 35.012 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION SPECIAL CATEGORIES OF CONTRACTING RESEARCH AND DEVELOPMENT CONTRACTING 35.012 Patent rights. For a discussion of patent rights, see...

  19. The problem with repurposing: Is there really an alternative to Big Pharma for developing new drugs for multiple sclerosis?

    Science.gov (United States)

    Giovannoni, Gavin; Baker, David; Schmierer, Klaus

    2015-01-01

    If it is not feasible to develop licensed drugs to the stage that they can actually be prescribed for a new indication, can we justify, either ethically or economically, the undertaking of proof-of-concept studies using off-patent medications? Without a financial incentive it is very difficult to repurpose off patent drugs for a new indication. Therefore, we need a political solution to allow the repurposing of off-patent drugs by other stakeholders or Big Pharma. Copyright © 2014 Elsevier B.V. All rights reserved.

  20. Confidential patent application with an example of preparation

    Directory of Open Access Journals (Sweden)

    Obrad T. Čabarkapa

    2013-12-01

    Full Text Available In order that the invention solving a technical problem receives a patent protection, it is necessary to file a patent application. For the protection of confidential inventions which are important for defense and national security, a confidential patent application[1] must be filed. A confidential patent application is an important and complex document, the parts of which are,  in principle, exposed in an established order. For the preparation of patent applications, it is necessary to engage experts with higher education, primarily in the technical field the invention relates to. The contents of the patent application is a basis for examining whether the application meets the requirements for patentability and whether the right to patent protection is achieved. Besides theoretical discussions on patent application, the paper gives a short version of an example of an application regarding a protected confidential invention. Introduction The basic condition for the exercise of patent protection is filing a patent application, the test procedure and, eventually, depending on the test results - the recognition or rejection of the patent. The paper gives a description of all parts of the patent application on an example of a confidential invention already patented. The content of the confidential patent application The confidential patent application for confidential invention protection consists of the following parts: The application for a patent; description of the invention; the claims (indication of what is new and what is required to be protected by patenting; abstract (short summary of the invention  and a draft of the invention (to which the description and the claims are referred. The application for a patent The application for patent is filed on Form P-1 and a request for the petty patent on Form MP-1. The data entered in the file is, for example: the applicant; the lawyer; the name of the invention in Serbian and English; the inventor

  1. Short communication: cheminformatics analysis to identify predictors of antiviral drug penetration into the female genital tract.

    Science.gov (United States)

    Thompson, Corbin G; Sedykh, Alexander; Nicol, Melanie R; Muratov, Eugene; Fourches, Denis; Tropsha, Alexander; Kashuba, Angela D M

    2014-11-01

    The exposure of oral antiretroviral (ARV) drugs in the female genital tract (FGT) is variable and almost unpredictable. Identifying an efficient method to find compounds with high tissue penetration would streamline the development of regimens for both HIV preexposure prophylaxis and viral reservoir targeting. Here we describe the cheminformatics investigation of diverse drugs with known FGT penetration using cluster analysis and quantitative structure-activity relationships (QSAR) modeling. A literature search over the 1950-2012 period identified 58 compounds (including 21 ARVs and representing 13 drug classes) associated with their actual concentration data for cervical or vaginal tissue, or cervicovaginal fluid. Cluster analysis revealed significant trends in the penetrative ability for certain chemotypes. QSAR models to predict genital tract concentrations normalized to blood plasma concentrations were developed with two machine learning techniques utilizing drugs' molecular descriptors and pharmacokinetic parameters as inputs. The QSAR model with the highest predictive accuracy had R(2)test=0.47. High volume of distribution, high MRP1 substrate probability, and low MRP4 substrate probability were associated with FGT concentrations ≥1.5-fold plasma concentrations. However, due to the limited FGT data available, prediction performances of all models were low. Despite this limitation, we were able to support our findings by correctly predicting the penetration class of rilpivirine and dolutegravir. With more data to enrich the models, we believe these methods could potentially enhance the current approach of clinical testing.

  2. METRICS DEVELOPMENT FOR PATENTS.

    Science.gov (United States)

    Veiga, Daniela Francescato; Ferreira, Lydia Masako

    2015-01-01

    To develop a proposal for metrics for patents to be applied in assessing the postgraduate programs of Medicine III - Capes. From the reading and analysis of the 2013 area documents of all the 48 areas of Capes, a proposal for metrics for patents was developed to be applied in Medicine III programs. Except for the areas Biotechnology, Food Science, Biological Sciences III, Physical Education, Engineering I, III and IV and Interdisciplinary, most areas do not adopt a scoring system for patents. The proposal developed was based on the criteria of Biotechnology, with adaptations. In general, it will be valued, in ascending order, the deposit, the granting and licensing/production. It will also be assigned higher scores to patents registered abroad and whenever there is a participation of students. This proposal can be applied to the item Intellectual Production of the evaluation form, in subsection Technical Production/Patents. The percentage of 10% for academic programs and 40% for Masters Professionals should be maintained. The program will be scored as Very Good when it reaches 400 points or over; Good, between 200 and 399 points; Regular, between 71 and 199 points; Weak up to 70 points; Insufficient, no punctuation. Desenvolver uma proposta de métricas para patentes a serem aplicadas na avaliação dos Programas de Pós-Graduação da Área Medicina III - Capes. A partir da leitura e análise dos documentos de área de 2013 de todas as 48 Áreas da Capes, desenvolveu-se uma proposta de métricas para patentes, a ser aplicada na avaliação dos programas da área. Constatou-se que, com exceção das áreas Biotecnologia, Ciência de Alimentos, Ciências Biológicas III, Educação Física, Engenharias I, III e IV e Interdisciplinar, a maioria não adota sistema de pontuação para patentes. A proposta desenvolvida baseou-se nos critérios da Biotecnologia, com adaptações. De uma forma geral, foi valorizado, em ordem crescente, o depósito, a concessão e o

  3. Orphan drug: Development trends and strategies

    Directory of Open Access Journals (Sweden)

    Aarti Sharma

    2010-01-01

    Full Text Available The growth of pharma industries has slowed in recent years because of various reasons such as patent expiries, generic competition, drying pipelines, and increasingly stringent regulatory guidelines. Many blockbuster drugs will loose their exclusivity in next 5 years. Therefore, the current economic situation plus the huge generic competition shifted the focus of pharmaceutical companies from the essential medicines to the new business model - niche busters, also called orphan drugs. Orphan drugs may help pharma companies to reduce the impact of revenue loss caused by patent expiries of blockbuster drugs. The new business model of orphan drugs could offer an integrated healthcare solution that enables pharma companies to develop newer areas of therapeutics, diagnosis, treatment, monitoring, and patient support. Incentives for drug development provided by governments, as well as support from the FDA and EU Commission in special protocols, are a further boost for the companies developing orphan drugs. Although there may still be challenges ahead for the pharmaceutical industry, orphan drugs seem to offer the key to recovery and stability within the market. In our study, we have compared the policies and orphan drug incentives worldwide alongwith the challenges faced by the pharmaceutical companies. Recent developments are seen in orphan drug approval, the various drugs in orphan drug pipeline, and the future prospectives for orphan drugs and diseases.

  4. A Database of EPO-Patenting Firms in Denmark

    DEFF Research Database (Denmark)

    Nielsen, Anders Østergaard

    1998-01-01

    The first section gives a brief introduction of the basic stages to be observed by the patent applicant from idea to the patent is granted. Section two presents three examples of how patents are registered in the online patent database INPADOC. Section three accounts for the initial analysis...... of the existing patent stock issued to firms with domicile in Denmark. Sections four and five report the basic characteristics of the EPO-patent sample and the procedures for linking the patent statistics to accounting data at the firm level, and finally they present the basic properties of the resulting database...

  5. Digital pathology: A systematic evaluation of the patent landscape.

    Science.gov (United States)

    Cucoranu, Ioan C; Parwani, Anil V; Vepa, Suryanarayana; Weinstein, Ronald S; Pantanowitz, Liron

    2014-01-01

    Digital pathology is a relatively new field. Inventors of technology in this field typically file for patents to protect their intellectual property. An understanding of the patent landscape is crucial for companies wishing to secure patent protection and market dominance for their products. To our knowledge, there has been no prior systematic review of patents related to digital pathology. Therefore, the aim of this study was to systematically identify and evaluate United States patents and patent applications related to digital pathology. Issued patents and patent applications related to digital pathology published in the United States Patent and Trademark Office (USPTO) database (www.uspto.gov) (through January 2014) were searched using the Google Patents search engine (Google Inc., Mountain View, California, USA). Keywords and phrases related to digital pathology, whole-slide imaging (WSI), image analysis, and telepathology were used to query the USPTO database. Data were downloaded and analyzed using the Papers application (Mekentosj BV, Aalsmeer, Netherlands). A total of 588 United States patents that pertain to digital pathology were identified. In addition, 228 patent applications were identified, including 155 that were pending, 65 abandoned, and eight rejected. Of the 588 patents granted, 348 (59.18%) were specific to pathology, while 240 (40.82%) included more general patents also usable outside of pathology. There were 70 (21.12%) patents specific to pathology and 57 (23.75%) more general patents that had expired. Over 120 unique entities (individual inventors, academic institutions, and private companies) applied for pathology specific patents. Patents dealt largely with telepathology and image analysis. WSI related patents addressed image acquisition (scanning and focus), quality (z-stacks), management (storage, retrieval, and transmission of WSI files), and viewing (graphical user interface (GUI), workflow, slide navigation and remote control). An

  6. Digital pathology: A systematic evaluation of the patent landscape

    Directory of Open Access Journals (Sweden)

    Ioan C. Cucoranu

    2014-01-01

    Full Text Available Introduction: Digital pathology is a relatively new field. Inventors of technology in this field typically file for patents to protect their intellectual property. An understanding of the patent landscape is crucial for companies wishing to secure patent protection and market dominance for their products. To our knowledge, there has been no prior systematic review of patents related to digital pathology. Therefore, the aim of this study was to systematically identify and evaluate United States patents and patent applications related to digital pathology. Materials and Methods: Issued patents and patent applications related to digital pathology published in the United States Patent and Trademark Office (USPTO database (www.uspto.gov (through January 2014 were searched using the Google Patents search engine (Google Inc., Mountain View, California, USA. Keywords and phrases related to digital pathology, whole-slide imaging (WSI, image analysis, and telepathology were used to query the USPTO database. Data were downloaded and analyzed using the Papers application (Mekentosj BV, Aalsmeer, Netherlands. Results: A total of 588 United States patents that pertain to digital pathology were identified. In addition, 228 patent applications were identified, including 155 that were pending, 65 abandoned, and eight rejected. Of the 588 patents granted, 348 (59.18% were specific to pathology, while 240 (40.82% included more general patents also usable outside of pathology. There were 70 (21.12% patents specific to pathology and 57 (23.75% more general patents that had expired. Over 120 unique entities (individual inventors, academic institutions, and private companies applied for pathology specific patents. Patents dealt largely with telepathology and image analysis. WSI related patents addressed image acquisition (scanning and focus, quality (z-stacks, management (storage, retrieval, and transmission of WSI files, and viewing (graphical user interface (GUI

  7. Patents and Innovation: Friends or Foes?

    OpenAIRE

    Lévêque, François

    2007-01-01

    Over 2 million patents are currently in force in the EU and in the USA. Do they testify innovation is blockaded for they restrict freedom in research or do they give evidence innovation is flourishing for patent law provides incentives to invent new products and processes? In other terms do patents freeze or spur innovation? The question arises for massive anecdotal evidence shows the patent system may have turned on its head, e.g., USPTO and EPO examiners spend less than 30 hours pe...

  8. Frequency of etiological factors leading to patent ductus arteriosus

    International Nuclear Information System (INIS)

    Waheed, I.; Shahbaz, A.

    2013-01-01

    Background: Patent Ductus Arteriosus (PDA) is developing as major problem in our society. Many studies in Pakistan has been done to analyze the efficacy of surgical procedures but no one tried to find the frequency of factors leading to this problem. Objective: The purpose of this study was to find out the frequency of factors leading to patent ductus arteriosus in children presented at Punjab Institute of Cardiology. Method: A cross sectional study was conducted on 242 patients of PDA who already have been treated during the year 2006 - 2007. They were interviewed on their regular follow up visits. Their operative information was gathered from their files. Results: Mean age of children at time of treatment was 6.12 + 5.203 years. Out of 242 children, there were more female (62.8%) as compared to male (37.2%). In this study, 17.8% children inherited the disease from their close relatives and 105 (43.4%) mothers had some infectious problems during pregnancy. 103 (42.6%) mothers used antibiotics or other drugs during pregnancy. 11 (4.5%) children had Down syndrome. One hundred and thirty seven (56.61%) children had premature birth. Conclusion: Female gender, preterm birth, infection during pregnancy, mother's exposure to drugs and smoking, low birth weight may be etiological factors for development of PDA. (author)

  9. The problem and solution of enterprise patent application

    International Nuclear Information System (INIS)

    Li Dabo; Yang Xiaoqing

    2010-01-01

    Recently, the situation of Chinese patent application is pleasant, but there are still some hiding disquiets. For the most enterprises, the passion of current patent application may not be derived from the internal motility but mainly derived by the government policy. Because of the shortage of related knowledge on patent, there are still some problems for our enterprises, such as blurring the scope of patent application and failing the organization of the documents of patent application which causing the patent cannot be applied timely. In some cases, the patent cannot obtain the effective protection even if it has been applied and obtained the authorization successfully. For such problems, we should enhance the cooperation between enterprises and agency organizations and build a patent engineer group which should participate in the whole R and D process and can prepare the documents of the patent application effectively and timely. What's more, we should inhibit the phenomena of infringement of patent rights and use 'existing technique' effectively by the methods of document retrieval. (authors)

  10. The PHACS SMARTT Study: Assessment of the Safety of In Utero Exposure to Antiretroviral Drugs

    Directory of Open Access Journals (Sweden)

    Russell Barrett Van Dyke

    2016-05-01

    Full Text Available The Surveillance Monitoring for ART Toxicities (SMARTT cohort of the Pediatric HIV/AIDS Cohort Study (PHACS includes over 3500 HIV-exposed but uninfected (HEU infants and children at 22 sites in the U.S. including Puerto Rico. The goal of the study is to determine the safety of in utero exposure to antiretrovirals (ARV and to estimate the incidence of adverse events. Domains being assessed include metabolic, growth and development, cardiac, neurological, neurodevelopmental, behavior, language, and hearing. SMARTT employs an innovative trigger-based design as an efficient means to identify and evaluate adverse events. Participants who met a predefined clinical or laboratory threshold (trigger undergo additional evaluations to define their case status. After adjusting for birth cohort and other factors, there was no significant increase in the likelihood of meeting overall case status (case in any domain with exposure to combination ARVs (cARV, any ARV class, or any specific ARV. However, several individual ARVs were significantly associated with case status in individual domains, including zidovudine for a metabolic case, first trimester stavudine for a language case, and didanosine plus stavudine for a neurodevelopmental case. We found an increased rate of preterm birth with first trimester exposure to protease inhibitor-based cARV. Although there was no overall increase in congenital anomalies with first trimester cARV, a significant increase was seen with exposure to atazanavir, ritonavir, and didanosine plus stavudine. Tenofovir exposure was associated with significantly lower mean whole-body bone mineral content in the newborn period and a lower length and head circumference at 1 year of age. With neurodevelopmental testing at 1 year of age, specific ARVs (atazanavir, ritonavir-boosted lopinavir, nelfinavir, and tenofovir were associated with lower performance, although all groups were within the normal range. No ARVs or classes were

  11. [Allergic reaction to patent blue dye in breast surgery - case report].

    Science.gov (United States)

    Maranhão, Marcius Vinícius M; Nóbrega, Dyluzia Kelly Amaral da; Anunciação, Carlos Eduardo Caiado; Maia, Barbara de Alcântara Brito; Mariano, Paulo Virgílio Dantas

    2016-01-01

    We present a case of allergic reaction to patent blue in a patient who underwent excision of sentinel lymph node associated with segmental breast resection. About 20minutes after the dye injection, the patient developed hypotension (BP=70×30mmHg) associated with increased heart frequency. The patient was treated successfully with decreased inspired fraction of inhaled anesthetic and fluid replacement. At the end of the procedure, she presented with bluish urticarial - like plaques on the head, neck, upper limbs, and trunk; hydrocortisone was then used. The patient recovered uneventfully and was discharged from the PACU two hours after the end of surgery without skin changes, and was discharged from hospital on the morning after surgery. The incidence of allergic reactions with the use of patent blue is far superior to the hypersensitivity reactions seen with anesthetic and adjuvant drugs. Therefore, the anesthesiologist must be aware of cardiovascular instability associated with skin changes during the use of patent blue, for early diagnosis and appropriate treatment of this hypersensitivity reaction to this dye. Copyright © 2014 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.

  12. Allergic reaction to patent blue dye in breast surgery - case report.

    Science.gov (United States)

    Maranhão, Marcius Vinícius M; da Nóbrega, Dyluzia Kelly Amaral; Anunciação, Carlos Eduardo Caiado; Maia, Barbara de Alcântara Brito; Mariano, Paulo Virgílio Dantas

    2016-01-01

    We present a case of allergic reaction to patent blue in a patient who underwent excision of sentinel lymph node associated with segmental breast resection. About 20min after the dye injection, the patient developed hypotension (BP=70×30mmHg) associated with increased heart frequency. The patient was treated successfully with decreased inspired fraction of inhaled anesthetic and fluid replacement. At the end of the procedure, she presented with bluish urticarial-like plaques on the head, neck, upper limbs, and trunk; hydrocortisone was then used. The patient recovered uneventfully and was discharged from the PACU 2h after the end of surgery without skin changes, and was discharged from hospital on the morning after surgery. The incidence of allergic reactions with the use of patent blue is far superior to the hypersensitivity reactions seen with anesthetic and adjuvant drugs. Therefore, the anesthesiologist must be aware of cardiovascular instability associated with skin changes during the use of patent blue, for early diagnosis and appropriate treatment of this hypersensitivity reaction to this dye. Copyright © 2014 Sociedade Brasileira de Anestesiologia. Published by Elsevier Editora Ltda. All rights reserved.

  13. Decoding Gene Patents in Australia

    OpenAIRE

    Denley, Adam; Cherry, James

    2015-01-01

    Patents directed to naturally occurring genetic material, such as DNA, RNA, chromosomes, and genes, in an isolated or purified form have been granted in Australia for many years. This review provides scientists with a summary of the gene patent debate from an Australian perspective and specifically reviews how the various levels of the legal system as they apply to patents—the Australian Patent Office, Australian courts, and Australian government—have dealt with the issue of whether genetic m...

  14. 77 FR 26018 - Determination of Regulatory Review Period for Purposes of Patent Extension; Victoza

    Science.gov (United States)

    2012-05-02

    ... exercise to improve glycemic control in adults with type 2 diabetes mellitus. Subsequent to this approval...] Determination of Regulatory Review Period for Purposes of Patent Extension; Victoza AGENCY: Food and Drug... regulatory review period for Victoza and is publishing this notice of that determination as required by law...

  15. An economic assessment of patent settlements in the pharmaceutical industry.

    Science.gov (United States)

    Dickey, Bret; Orszag, Jonathan; Tyson, Laura

    2010-01-01

    This article demonstrates that in recent years, patent settlements between branded and generic manufacturers involving "reverse payments" from branded manufacturers to generic manufacturers have received close antitrust scrutiny, driven by concerns that such settlements harm consumers by delaying the entry of lower-priced generic drugs. The authors note that such settlements will be a focus of the Obama Administration's antitrust enforcement policy, yet there is a growing consensus among the courts that such settlements are anticompetitive only under narrow sets of circumstances. In this article, the authors present an analytical framework for evaluating the competitive effects of patent settlements, including those involving reverse payments, and demonstrate that these settlements can benefit consumers. Thus, the authors conclude that while continued scrutiny of such settlements is important, broad brush treatments are inappropriate and only a more individualized evaluation can correctly determine the competitive effects of a particular settlement agreement.

  16. Effect of Contemporary Social Environment, Drug Abuse and ...

    African Journals Online (AJOL)

    Effect of Contemporary Social Environment, Drug Abuse and Cultism on the Health of ... This health situation comes as results of substance abuse which these ... the patent medicine stores, from hard drugs like (marijuana, cannabis) or others ...

  17. Patent portfolio management: literature review and a proposed model.

    Science.gov (United States)

    Conegundes De Jesus, Camila Kiyomi; Salerno, Mario Sergio

    2018-05-09

    Patents and patent portfolios are gaining attention in the last decades, from the called 'pro-patent era' to the recent billionaire transactions involving patent portfolios. The field is growing in importance, both theoretically and practically and despite having substantial literature on new product development portfolio management, we have not found an article relating this theory to patent portfolios. Areas covered: The paper develops a systematic literature review on patent portfolio management to organize the evolution and tendencies of patent portfolio management, highlighting distinctive features of patent portfolio management. Interview with IP manager of three life sciences companies, including a leading multinational group provided relevant information about patent portfolio management. Expert opinion: Based on the systematic literature review on portfolio management, more specifically, on new product development portfolio theory, and interview the paper proposes the paper proposes a reference model to manage patent portfolios. The model comprises four stages aligned with the three goals of the NPD portfolio management: 1 - Linking strategy of the Company's NPD Portfolio to Patent Portfolio; 2 - Balancing the portfolio in buckets; 3 - Patent Valuation (maximizing valuation); 4 - Regularly reviewing the patent portfolio.

  18. Evidence on the cost of breast cancer drugs is required for rational decision making.

    Science.gov (United States)

    Berghuis, Anne Margreet Sofie; Koffijberg, Hendrik; Terstappen, Leonardus Wendelinus Mathias Marie; Sleijfer, Stefan; IJzerman, Maarten Joost

    2018-01-01

    For rational decision making, assessing the cost-effectiveness and budget impact of new drugs and comparing the costs of drugs already on the market is required. In addition to value frameworks, such as the American Society of Clinical Oncology Value Framework and the European Society of Medical Oncology-Magnitude of Clinical benefit Scale, this also requires a transparent overview of actual drug prices. While list prices are available, evidence on treatment cost is not. This paper aims to synthesise evidence on the reimbursement and costs of high-cost breast cancer drugs in The Netherlands (NL). A literature review was performed to identify currently reimbursed breast cancer drugs in the NL. Treatment costs were determined by multiplying list prices with the average length of treatment and dosing schedule. Comparing list prices to the estimated treatment cost resulted in substantial differences in the ranking of costliness of the drugs. The average mean treatment length was unknown for 11/31 breast cancer drugs (26.2%). The differences in the 15 highest-cost drugs were largest for Bevacizumab, Lapatinib and everolimus, with list prices of €541, €158, €1,168 and estimated treatment cost of €174,400, €18,682 and €31,207, respectively. The lowest-cost (patented) targeted drug is €1,818 more expensive than the highest-cost (off-patent) generic drug according to the estimated drug treatment cost. A lack of evidence on the reimbursement and cost of high-cost breast cancer drugs complicates rapid and transparent evidence synthesis, necessary to focus strategies aiming to limit the increasing healthcare costs. Interestingly, the findings show that off-patent generics (such as paclitaxel or doxorubicin), although substantially cheaper than patented drugs, are still relatively costly. Extending standardisation and increasing European and national regulations on presenting information on costs per cancer drug is highly recommended.

  19. Patents: Recent Trends and Puzzles

    OpenAIRE

    Zvi Griliches

    1989-01-01

    This paper reviews the historical data on patenting in the United States with special reference to the last 20 years and their potential relation, if any, to the recent productivity slowdown. Two Points are made: Patents are not a "constant-yardstick" indicator of either inventive input or output. Moreover, they are "produced" by a governmental agency which goes through its own budgetary and inefficiency cycles. The paper shows that the appearance of an absolute decline in patenting in the 19...

  20. Regulatory challenges in developing long-acting antiretrovirals for treatment and prevention of HIV infection.

    Science.gov (United States)

    Arya, Vikram; Au, Stanley; Belew, Yodit; Miele, Peter; Struble, Kimberly

    2015-07-01

    To outline some of the regulatory challenges inherent to the development of long-acting antiretrovirals (ARVs) for the treatment or prevention of HIV infection. Despite advances in drug development that have reduced ARV dosing to once daily, suboptimal drug adherence remains an obstacle to successful HIV treatment. Further, large randomized trials of once daily oral ARVs for preexposure prophylaxis (PrEP) have shown that drug adherence correlates strongly with prophylactic effect and study outcomes. Thus, the prospect of developing long-acting ARVs, which may mitigate drug adherence issues, has attracted considerable attention lately. Because of their pharmacokinetic properties, the development of long-acting ARVs can present novel regulatory challenges. Chief among them is determining the appropriate dosing regimen, the need for an oral lead-in, and whether existing data with an approved oral agent, if available, can be leveraged for a treatment or prevention indication. For PrEP, because validated biomarkers are lacking, additional nonclinical studies and evaluation of tissue concentrations in multiple compartments may be necessary to identify optimal dosages. Study design and choice of controls for registrational trials of new long-acting PrEP agents might also prove challenging following the availability of an oral PrEP drug.

  1. In-depth research of domestic nuclear patent information

    International Nuclear Information System (INIS)

    Mo Dan; Gao Anna; Li Dongbin; Lu Yanjia; Ren Chao

    2014-01-01

    Based on the domestic patent information, combined with examples, this article makes an in-depth discussion on the domestic nuclear patent information. The author puts forward for the patent information research, the appropriate retrieval of patent documents is the basis,and the correct quantitative statistical analysis of patent documents is the key, and in-depth qualitative analysis of patent documents is the core. It is expected to provide information support and guarantee for the technical innovation and scientific research personnel in the nuclear field through in-depth study of domestic nuclear information. (authors)

  2. Inventing around Edison’s Incandescent Lamp Patent

    DEFF Research Database (Denmark)

    Howells, John; Katznelson, Ron D.

    ’s ‘898 patent. Third, by analysis of forward citation to these patents we show that regardless of these inventions’ commercial viability in the incandescent lamp market, some became important prior art for new technological fields and some laid the groundwork for the later successful substitute...... for Edison’s carbon filament. Fourthly, we show that the recent view that Edison’s patent gave the patent holder General Electric (GE) a dominant position in the incandescent lamp market is incorrect: we show that besides commercially-successful invention around the claims of this patent, data for GE...

  3. Inventing around Edison’s incandescent lamp patent

    DEFF Research Database (Denmark)

    Howells, John; Ron D, Katznelson

    ’s ‘898 patent. Third, by analysis of forward citation to these patents we show that regardless of these inventions’ commercial viability in the incandescent lamp market, some became important prior art for new technological fields and some laid the groundwork for the later successful substitute...... for Edison’s carbon filament. Fourthly, we show that the recent view that Edison’s patent gave the patent holder General Electric (GE) a dominant position in the incandescent lamp market is incorrect: we show that besides commercially-successful invention around the claims of this patent, data for GE...

  4. Evaluating patent portfolios by means of multicriteria analysis

    Directory of Open Access Journals (Sweden)

    Xiaolu Wang

    2011-06-01

    Full Text Available Valuation of intangible assets is a complex topic where traditional methodologies are not always successful. Nevertheless, intangible assets, like patents, have become of great importance to companies, as their value is considered to be relevant economic and strategic information, so it is necessary to evaluate firms’ patent portfolios. The present research introduces an extended goal programming model to calculate the relative importance of the patents of companies in a patent pool. This information may be useful for patent valuation as well as for management purposes. The proposed multicriteria methodology has been applied to the 19 companies in the MPEG2 patent pool, with a total of 770 valid patents, using 7 criteria to obtain a composite measure of the relative position of the firms in the patent pool.RESUMENLa valoración de activos intangibles constituye un área compleja donde los métodos tradicionales no siempre obtienen buenos resultados. Sin embargo, los activos intangibles, entre ellos las patentes, han ganado importancia en las empresas, de forma que el cálculo de su valor se ha convertido en una cuestión estratégica en muchos casos. Este hecho requiere que las empresas valoren la cartera de patentes en su conjunto. La presente investigación presenta un modelo extendido de programación por metas y su aplicación para el cálculo de la importancia relativa de las patentes. Este modelo puede resultar importante tanto para la valoración de las patentes como para la gestión empresarial. La metodología multicriterio propuesta ha sido aplicado a 19 empresas en el sector de las patentes del formato MPEG2, con un total de 770 patentes válidas, y utilizando 7 criterios con el objetivo de obtener una medida compuesta de la posición relativa de las empresas en el conjunto de patentes.

  5. Effect of the economic crisis on the production of immunology patents managed through the Patent Cooperation Treaty agreement from 2004-2011.

    Science.gov (United States)

    Campos, Elena; Campos, Adolfo

    2015-07-01

    To determine the evolution of patents in immunology, as a result of research and innovation in the years 2004-2011. The search for patents published internationally in immunology was made by using the SCOPUSTM database. SCOPUS gives information about over 23 million patents. The extracted data from patents were: inventors and applicants; their nationalities; sections, classes and subclasses of the International Patent Classification. 89 countries. Data have been obtained from the database SCOPUS. It has been used for the international patent classification. Patents by country, Productive sectors, Productive areas. A total of 17,281 patents were applied for immunology during 2004-2011 of which 16,811 were from 30 Organisation for Economic Cooperation and Development countries, and 5326 from 28 countries in the European Union. These patents were granted in 89 countries and 13,699 of them were submitted by researchers from only one country. Private entities applied for 62.45% of all patents, universities 17.48%, hospitals 3.40% and public research organisations and private applicants applied for the rest. The university that made more applications was the University of California with 315 and the company was Genentech Inc. (US) with 302. The reduction in the number of applications of international patents in all disciplines of science also affected the area of immunology. Collaboration in immunology between universities, companies and hospitals is hard because their interests are different. It is shown in patent applications that the majority of patents in immunology are applied for by only one entity. Patents in immunology are developed, mainly, in aspects such as medical preparations, peptides, mutation or genetic engineering, therapeutic activity of chemical compounds and analysing materials by determining their chemical or physical properties.

  6. Assessing the impact of a food supplement on the nutritional status and body composition of HIV-infected Zambian women on ARVs

    Directory of Open Access Journals (Sweden)

    Musonda Mofu

    2011-09-01

    Full Text Available Abstract Background Zambia is a sub-Saharan country with one of the highest prevalence rates of HIV, currently estimated at 14%. Poor nutritional status due to both protein-energy and micronutrient malnutrition has worsened this situation. In an attempt to address this combined problem, the government has instigated a number of strategies, including the provision of antiretroviral (ARV treatment coupled with the promotion of good nutrition. High-energy protein supplement (HEPS is particularly promoted; however, the impact of this food supplement on the nutritional status of people living with HIV/AIDS (PLHA beyond weight gain has not been assessed. Techniques for the assessment of nutritional status utilising objective measures of body composition are not commonly available in Zambia. The aim of this study is therefore to assess the impact of a food supplement on nutritional status using a comprehensive anthropometric protocol including measures of skinfold thickness and circumferences, plus the criterion deuterium dilution technique to assess total body water (TBW and derive fat-free mass (FFM and fat mass (FM. Methods/Design This community-based controlled and longitudinal study aims to recruit 200 HIV-infected females commencing ARV treatment at two clinics in Lusaka, Zambia. Data will be collected at four time points: baseline, 4-month, 8-month and 12-month follow-up visits. Outcome measures to be assessed include body height and weight, body mass index (BMI, body composition, CD4, viral load and micronutrient status. Discussion This protocol describes a study that will provide a longitudinal assessment of the impact of a food supplement on the nutritional status of HIV-infected females initiating ARVs using a range of anthropometric and body composition assessment techniques. Trial Registration Pan African Clinical Trial Registry PACTR201108000303396.

  7. Simultaneous invention and the patent law

    DEFF Research Database (Denmark)

    Howells, John

    inventions they often find this to challenge the idea that patent law (which rewards only the first inventor with exclusive rights) is needed to encourage invention and innovation. We review the empirical evidence alleged to show that simultaneous invention is prevalent for important inventions. In general...... is typical of important pioneer inventions in both survey evidence and alleged illustrative cases of simultaneous invention. We show this in the cases of Edison, the Wright brothers, the Selden automobile patent vis a vis Ford, Watt and the steam engine. We then point out that patent law inherently ensures...... that patent protection is not extended to near simultaneous inventions. There remain a number of simultaneous inventions discovered through interference proceedings but we find the number too small to mount a serious challenge to the general operation of patent law....

  8. The European Patent System: Dealing with emerging technologies.

    NARCIS (Netherlands)

    Kica, Evisa; Groenendijk, Nico

    2011-01-01

    In light of recent controversial patent decisions in biotechnology, this article argues that the current European patent examination and opposition procedures do not suffice to balance the patent system These procedures do not provide sufficient guidance for patent examiners to deal effectively with

  9. Trends in worldwide nanotechnology patent applications: 1991 to 2008

    International Nuclear Information System (INIS)

    Dang Yan; Zhang Yulei; Fan Li; Chen Hsinchun; Roco, Mihail C.

    2010-01-01

    Nanotechnology patent applications published during 1991-2008 have been examined using the 'title-abstract' keyword search on esp-cenet 'worldwide' database. The longitudinal evolution of the number of patent applications, their topics, and their respective patent families have been evaluated for 15 national patent offices covering 98% of the total global activity. The patent offices of the United States (USA), People's Republic of China (PRC), Japan, and South Korea have published the largest number of nanotechnology patent applications, and experienced significant but different growth rates after 2000. In most repositories, the largest numbers of nanotechnology patent applications originated from their own countries/regions, indicating a significant 'home advantage.' The top applicant institutions are from different sectors in different countries (e.g., from industry in the US and Canada patent offices, and from academe or government agencies at the PRC office). As compared to 2000, the year before the establishment of the US National Nanotechnology Initiative (NNI), numerous new invention topics appeared in 2008, in all 15 patent repositories. This is more pronounced in the USA and PRC. Patent families have increased among the 15 patent offices, particularly after 2005. Overlapping patent applications increased from none in 1991 to about 4% in 2000 and to about 27% in 2008. The largest share of equivalent nanotechnology patent applications (1,258) between two repositories was identified between the US and Japan patent offices.

  10. Trends in worldwide nanotechnology patent applications: 1991 to 2008

    Science.gov (United States)

    Dang, Yan; Zhang, Yulei; Fan, Li; Chen, Hsinchun; Roco, Mihail C.

    2010-03-01

    Nanotechnology patent applications published during 1991-2008 have been examined using the "title-abstract" keyword search on esp@cenet "worldwide" database. The longitudinal evolution of the number of patent applications, their topics, and their respective patent families have been evaluated for 15 national patent offices covering 98% of the total global activity. The patent offices of the United States (USA), People's Republic of China (PRC), Japan, and South Korea have published the largest number of nanotechnology patent applications, and experienced significant but different growth rates after 2000. In most repositories, the largest numbers of nanotechnology patent applications originated from their own countries/regions, indicating a significant "home advantage." The top applicant institutions are from different sectors in different countries (e.g., from industry in the US and Canada patent offices, and from academe or government agencies at the PRC office). As compared to 2000, the year before the establishment of the US National Nanotechnology Initiative (NNI), numerous new invention topics appeared in 2008, in all 15 patent repositories. This is more pronounced in the USA and PRC. Patent families have increased among the 15 patent offices, particularly after 2005. Overlapping patent applications increased from none in 1991 to about 4% in 2000 and to about 27% in 2008. The largest share of equivalent nanotechnology patent applications (1,258) between two repositories was identified between the US and Japan patent offices.

  11. Development and tuning of an original search engine for patent libraries in medicinal chemistry.

    Science.gov (United States)

    Pasche, Emilie; Gobeill, Julien; Kreim, Olivier; Oezdemir-Zaech, Fatma; Vachon, Therese; Lovis, Christian; Ruch, Patrick

    2014-01-01

    The large increase in the size of patent collections has led to the need of efficient search strategies. But the development of advanced text-mining applications dedicated to patents of the biomedical field remains rare, in particular to address the needs of the pharmaceutical & biotech industry, which intensively uses patent libraries for competitive intelligence and drug development. We describe here the development of an advanced retrieval engine to search information in patent collections in the field of medicinal chemistry. We investigate and combine different strategies and evaluate their respective impact on the performance of the search engine applied to various search tasks, which covers the putatively most frequent search behaviours of intellectual property officers in medical chemistry: 1) a prior art search task; 2) a technical survey task; and 3) a variant of the technical survey task, sometimes called known-item search task, where a single patent is targeted. The optimal tuning of our engine resulted in a top-precision of 6.76% for the prior art search task, 23.28% for the technical survey task and 46.02% for the variant of the technical survey task. We observed that co-citation boosting was an appropriate strategy to improve prior art search tasks, while IPC classification of queries was improving retrieval effectiveness for technical survey tasks. Surprisingly, the use of the full body of the patent was always detrimental for search effectiveness. It was also observed that normalizing biomedical entities using curated dictionaries had simply no impact on the search tasks we evaluate. The search engine was finally implemented as a web-application within Novartis Pharma. The application is briefly described in the report. We have presented the development of a search engine dedicated to patent search, based on state of the art methods applied to patent corpora. We have shown that a proper tuning of the system to adapt to the various search tasks

  12. Patent Value: A Business Perspective for Technology Startups

    OpenAIRE

    Angela de Wilton

    2011-01-01

    In the last year, news headlines have highlighted record patent infringement settlements, multibillion dollar auctions of large corporate patent portfolios, and ongoing patent battles between key technology industry players. Despite this acknowledgment of the significant value of patents for large corporations, many small technology companies are understandably more focused on the near-term costs of obtaining a patent rather than future value. Costs may seem prohibitive to an early stage tech...

  13. AVC/H.264 patent portfolio license

    Science.gov (United States)

    Skandalis, Dean A.

    2006-08-01

    MPEG LA, LLC offers a joint patent license for the AVC (a/k/a H.264) Standard (ISO/IEC IS 14496-10:2004). Like MPEG LA's other licenses, the AVC Patent Portfolio License is offered for the convenience of the marketplace as an alternative enabling users to access essential intellectual property owned by many patent holders under a single license rather than negotiating licenses with each of them individually. The AVC Patent Portfolio License includes essential patents owned by DAEWOO Electronics Corporation; Electronics and Telecommunications Research Institute (ETRI); France Telecom, societe anonyme; Fujitsu Limited; Hitachi, Ltd.; Koninklijke Philips Electronics N.V.; LG Electronics Inc.; Matsushita Electric Industrial Co., Ltd.; Microsoft Corporation; Mitsubishi Electric Corporation; Robert Bosch GmbH; Samsung Electronics Co., Ltd.; Sedna Patent Services, LLC; Sharp Kabushiki Kaisha; Siemens AG; Sony Corporation; The Trustees of Columbia University in the City of New York; Toshiba Corporation; UB Video Inc.; and Victor Company of Japan, Limited. Another is expected also to join as of August 1, 2006. MPEG LA's objective is to provide worldwide access to as much AVC essential intellectual property as possible for the benefit of AVC users. Therefore, any party that believes it has essential patents is welcome to submit them for evaluation of their essentiality and inclusion in the License if found essential.

  14. 77 FR 269 - Matters Related to Patent Appeals

    Science.gov (United States)

    2012-01-04

    ... DEPARTMENT OF COMMERCE United States Patent and Trademark Office Matters Related to Patent Appeals ACTION: Proposed collection; comment request. SUMMARY: The United States Patent and Trademark Office... Matters Related to Patent Appeals comment'' in the subject line of the message. Mail: Susan K. Fawcett...

  15. Patentability aspects of computational cancer models

    Science.gov (United States)

    Lishchuk, Iryna

    2017-07-01

    Multiscale cancer models, implemented in silico, simulate tumor progression at various spatial and temporal scales. Having the innovative substance and possessing the potential of being applied as decision support tools in clinical practice, patenting and obtaining patent rights in cancer models seems prima facie possible. What legal hurdles the cancer models need to overcome for being patented we inquire from this paper.

  16. The Transformation of Science Into Patented Inventions

    DEFF Research Database (Denmark)

    Beukel, Karin

    This paper presents the results of a grounded theory study of the transformation of scientific discoveries into patented inventions. Using an algebraic interpretive approach, the narratives collected during interviews are analyzed as Bayesian inferences and the developed theory is tested. The fin......This paper presents the results of a grounded theory study of the transformation of scientific discoveries into patented inventions. Using an algebraic interpretive approach, the narratives collected during interviews are analyzed as Bayesian inferences and the developed theory is tested....... The findings recast the relationship between science and patents as a process in which the way the transformation of the scientific invention is handled has an effect on the breadth of the patent scope. Unleashing patent scope surplus is dependent on processes related to abstraction and cognitive variety......, which can be mobilized by patent experts with both an in-depth understanding of the scientific discovery, due to their educational background in the life sciences, and capabilities within the legal framework for patenting. More specifically, the findings reveal previously unreported aspects...

  17. The Patentability of Stem Cells in Australia.

    Science.gov (United States)

    Petering, Jenny; Cowin, Prue

    2015-07-01

    The potential therapeutic applications of stem cells are unlimited. However, the ongoing political and social debate surrounding the intellectual property and patenting considerations of stem cell research has led to the implementation of strict legislative regulations. In Australia the patent landscape surrounding stem cells has evolved considerably over the past 20 years. The Australian Patents Act 1990 includes a specific exclusion to the patentability of human beings and of biological processes for their generation. However, this exclusion has received no judicial consideration to date, and so its scope and potential impact on stem cell patents is unclear. Copyright © 2015 Cold Spring Harbor Laboratory Press; all rights reserved.

  18. Idea on patent ; It is high time to stress quality

    International Nuclear Information System (INIS)

    2012-03-01

    This book deals with patent stressing on the quality, which includes from idea to technical business, It's simple to register the computer program, why do patent lawyer appoint the patent attorney's office? construction of patent right range, a good patent and a bad patent, strong patent and weak patent. It doesn't allow for Dus to use as we like, each patent has different value, Let's write technical specifications, advice on talking for invention with a patent attorney's office and what kind of task do intellectual property division do?

  19. 37 CFR 1.14 - Patent applications preserved in confidence.

    Science.gov (United States)

    2010-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Patent applications preserved in confidence. 1.14 Section 1.14 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES General Provisions...

  20. Patent Value: A Business Perspective for Technology Startups

    Directory of Open Access Journals (Sweden)

    Angela de Wilton

    2011-12-01

    Full Text Available In the last year, news headlines have highlighted record patent infringement settlements, multibillion dollar auctions of large corporate patent portfolios, and ongoing patent battles between key technology industry players. Despite this acknowledgment of the significant value of patents for large corporations, many small technology companies are understandably more focused on the near-term costs of obtaining a patent rather than future value. Costs may seem prohibitive to an early stage technology startup. Some software startups question whether patents are relevant to their business. In practice, effective intellectual property (IP strategy and management is dependent on many factors, such as technology or industry sector, size and maturity of the business, technology lifecycle, and the business and market environment. IP strategy must be aligned to business strategy from the outset. By considering IP in the broader context of the overall business plan and the competitive environment, opportunities for generating increased return on R&D investment and added business value through patents or other forms of IP can be recognized early on. This approach ensures that a decision about whether or not to patent is driven by business reasons rather than budget constraints. This article examines the costs and benefits of patents from the perspective of early-stage technology startups and growing businesses, and it provides some general guidance on best practices for developing an IP and patent activity plan and for building a patent portfolio that appropriately supports business objectives.

  1. Trends in worldwide nanotechnology patent applications: 1991 to 2008

    Energy Technology Data Exchange (ETDEWEB)

    Dang Yan, E-mail: ydang@email.arizona.edu; Zhang Yulei, E-mail: ylzhang@email.arizona.edu; Fan Li, E-mail: fanli@email.arizona.edu; Chen Hsinchun, E-mail: hchen@eller.arizona.ed [University of Arizona, Department of Management Information Systems, Eller College of Management (United States); Roco, Mihail C., E-mail: mroco@nsf.go [National Science Foundation (United States)

    2010-03-15

    Nanotechnology patent applications published during 1991-2008 have been examined using the 'title-abstract' keyword search on esp-cenet 'worldwide' database. The longitudinal evolution of the number of patent applications, their topics, and their respective patent families have been evaluated for 15 national patent offices covering 98% of the total global activity. The patent offices of the United States (USA), People's Republic of China (PRC), Japan, and South Korea have published the largest number of nanotechnology patent applications, and experienced significant but different growth rates after 2000. In most repositories, the largest numbers of nanotechnology patent applications originated from their own countries/regions, indicating a significant 'home advantage.' The top applicant institutions are from different sectors in different countries (e.g., from industry in the US and Canada patent offices, and from academe or government agencies at the PRC office). As compared to 2000, the year before the establishment of the US National Nanotechnology Initiative (NNI), numerous new invention topics appeared in 2008, in all 15 patent repositories. This is more pronounced in the USA and PRC. Patent families have increased among the 15 patent offices, particularly after 2005. Overlapping patent applications increased from none in 1991 to about 4% in 2000 and to about 27% in 2008. The largest share of equivalent nanotechnology patent applications (1,258) between two repositories was identified between the US and Japan patent offices.

  2. Uniform interpretation of european patent law with a special view on the creation of a common patent court

    NARCIS (Netherlands)

    Luginbühl, SL

    2009-01-01

    The European Patent Convention (EPC) provides for a common application and examination procedure for European patents. Therefore, European patents are granted on the basis of uniform European law which is applied and interpreted by the EPO, as well as by a great number of national judges and members

  3. 37 CFR 11.9 - Limited recognition in patent matters.

    Science.gov (United States)

    2010-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Limited recognition in patent matters. 11.9 Section 11.9 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE REPRESENTATION OF OTHERS BEFORE THE UNITED STATES PATENT AND TRADEMARK OFFICE...

  4. Patent Keyword Extraction for Sustainable Technology Management

    Directory of Open Access Journals (Sweden)

    Jongchan Kim

    2018-04-01

    Full Text Available Recently, sustainable growth and development has become an important issue for governments and corporations. However, maintaining sustainable development is very difficult. These difficulties can be attributed to sociocultural and political backgrounds that change over time [1]. Because of these changes, the technologies for sustainability also change, so governments and companies attempt to predict and manage technology using patent analyses, but it is very difficult to predict the rapidly changing technology markets. The best way to achieve insight into technology management in this rapidly changing market is to build a technology management direction and strategy that is flexible and adaptable to the volatile market environment through continuous monitoring and analysis. Quantitative patent analysis using text mining is an effective method for sustainable technology management. There have been many studies that have used text mining and word-based patent analyses to extract keywords and remove noise words. Because the extracted keywords are considered to have a significant effect on the further analysis, researchers need to carefully check out whether they are valid or not. However, most prior studies assume that the extracted keywords are appropriate, without evaluating their validity. Therefore, the criteria used to extract keywords needs to change. Until now, these criteria have focused on how well a patent can be classified according to its technical characteristics in the collected patent data set, typically using term frequency–inverse document frequency weights that are calculated by comparing the words in patents. However, this is not suitable when analyzing a single patent. Therefore, we need keyword selection criteria and an extraction method capable of representing the technical characteristics of a single patent without comparing them with other patents. In this study, we proposed a methodology to extract valid keywords from

  5. Wacky Patents Meet Economic Indicators

    DEFF Research Database (Denmark)

    Czarnitzki, Dirk; Hussinger, Katrin; Schneider, Cédric

    2011-01-01

    We investigate whether standard indicators can distinguish between “wacky” patents and a control group. Forward citations are good predictors of importance. However, “wacky” patents have higher originality, generality and citation lags, suggesting that these indicators should be interpreted...

  6. When patents matter: The impact of competition and patent age on the performance contribution of intellectual property rights protection

    NARCIS (Netherlands)

    Maresch, Daniela; Fink, Matthias; Harms, Rainer

    2016-01-01

    The question whether patenting impacts patenting firms' subsequent financial performance is important for technology-oriented companies. However, relevant research has led to contradictory results. We strive to overcome this impasse by introducing innovation competition and patent age as moderators

  7. Firm- and drug-specific patterns of generic drug payments by US medicaid programs: 1991-2008.

    Science.gov (United States)

    Kelton, Christina M L; Chang, Lenisa V; Guo, Jeff J; Yu, Yan; Berry, Edmund A; Bian, Boyang; Heaton, Pamela C

    2014-04-01

    The entry of generic drugs into markets previously monopolized by patented, branded drugs often represents large potential savings for healthcare payers in the USA. Our objectives were to describe and explain the trends in drug reimbursement by public Medicaid programmes post-generic entry for as many drug markets and for as long a time period as possible. The data were the Medicaid State Drug Utilization Data maintained by the Centers for Medicare and Medicaid Services. Quarterly utilization and expenditure data from 1991 to 2008 were extracted for 83 drugs, produced by 229 firms, that experienced initial generic entry between 1992 and 2004. A relative 'price' for a specific drug, firm and quarter was constructed as Medicaid reimbursement per unit (e.g. tablet, capsule or vial) divided by average reimbursement per unit for the branded drug the year before entry. Fixed-effects models controlling for time-, firm- and drug-specific differences were estimated to explain reimbursement. Twelve quarters after generic entry, 18 % of drugs had average per-unit reimbursement less than 50 % of the original branded-drug reimbursement. For each additional firm manufacturing the drug, reimbursement per unit, relative to the pre-generic-entry branded-drug reimbursement, was estimated to fall by 17 (p < 0.01) and 3 (p < 0.01) percentage points for generic and branded-drug companies, respectively. Each additional quarter post-generic entry brought a 2 (p < 0.01) percentage point drop in relative reimbursement. State Medicaid programmes generally have been able to obtain relief from high drug prices following patent expirations for many branded-drug medications by adjusting reimbursement following the expanded competition in the pharmaceutical market.

  8. El Sistema de patentes en Colombia

    Directory of Open Access Journals (Sweden)

    Rafael Viana Barceló

    2014-01-01

    Full Text Available En este documento se realiza un análisis económico del Sistema de Patentes de Colombia. Para ello, se establece el efecto que tienen las patentes concedidas a los inventores foráneos sobre la Inversión Extranjera Directa y el Producto Interno Bruto Nacional, a través de la técnica de regresión de data panel. De igual manera, se identifican los sectores económicos que registran mayores tasas de innovación por parte de los inventores nacionales y extranjeros. Se muestra que el sistema nacional de propiedad intelectual tiene un grado de fortaleza acorde con el resto de países latinoamericanos; para ello, se construye un índice de grado de fortalecimiento de sistema de patente nacional que luego será comparado con el de otros países latinos.Palabras Clave: Sistema de Patentes; Derechos de Propiedad Intelectual; Inversión Directa extranjera; Producto Interno Bruto e innovación tecnológica. The system of patents in ColombiaAbstractIn this document an economic analysis of the System of Patents of Colombia is made. For it, the effect that has the patents granted to the foreign inventors on the Direct Foreign Investment and the Internal Product Gross National, through the technique of regression of data settles down panel. Of equal way, the economic sectors are identified that register greater rates of innovation on the part of the national and foreign inventors.Sample that the national system of intellectual property has a degree of agreed strength with the rest of Latin American countries; for it, an index of degree of fortification of system of national patent is constructed that soon will be compared with the one of other Latin countries.Keywords: System Patent; Rights of Intellectual Property; Foreign Direct Investment; Gross Domestic Product and Technology Innovation.

  9. Exploring gender differences in patenting in Spain

    OpenAIRE

    Elba Mauleón; Cinzia Daraio; Maria Bordons

    2013-01-01

    The under-representation of women in science and technology is a matter of current great concern. Obtaining patent-based indicators by gender is crucial to analyse the situation of women in innovation, identify potential cases of gender inequalities, and support policy measures to promote gender balance. In this article we analyse men and women involvement in Spanish patents applied to the European Patent Office during 1990--2004. At least one female inventor is present in 18% of the patents;...

  10. 37 CFR 1.81 - Drawings required in patent application.

    Science.gov (United States)

    2010-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Drawings required in patent..., DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES National Processing Provisions The Drawings § 1.81 Drawings required in patent application. (a) The applicant for a patent is required to furnish...

  11. Advances in CO2 capture technology: A patent review

    International Nuclear Information System (INIS)

    Li, Bingyun; Duan, Yuhua; Luebke, David; Morreale, Bryan

    2013-01-01

    Highlights: ► Timely updates on carbon capture technologies: More than 1000 patents on solvent, sorbent, and membrane. ► More patents on solvent and sorbent compared to membrane. ► Environmental and health concerns exist regarding carbon capture technologies. -- Abstract: Carbon dioxide (CO 2 ) emissions are believed to be a major contributor to global warming. As a consequence, large anthropogenic CO 2 sources worldwide will eventually be required to implement CO 2 capture and storage technologies to control CO 2 emissions. In order to guide the establishment of policies for CO 2 removal, we reviewed the current status of CO 2 capture patents and technologies based on the Espacenet patent database and found that more than 1000 patents have been published on sorbent, solvent, and membrane. More than 60% of these patents were published since the year 2000, and a sharp increase in patent numbers was seen in the last several years; ∼25% patents were published in the last 2 years. Substantially more patents on CO 2 removal and separation technologies are expected in the coming years. Meanwhile, the top four major types of patents, which consist of more than 2/3 of these patents, were patents granted by Japan (JP), United States (US), World Intellectual Property Organization (WO), and China (CN), and approximately half of the patents were JP and US patents. Unfortunately, no current technologies for removing CO 2 from large sources like coal-based power plants exist which satisfy the needs of safety, efficiency, and economy; further enhancement and innovation are much needed.

  12. Online Patent Searching: The Realities.

    Science.gov (United States)

    Kaback, Stuart M.

    1983-01-01

    Considers patent subject searching capabilities of major online databases, noting patent claims, "deep-indexed" files, test searches, retrieval of related references, multi-database searching, improvements needed in indexing of chemical structures, full text searching, improvements needed in handling numerical data, and augmenting a…

  13. Geographic and temporal trends in the molecular epidemiology and genetic mechanisms of transmitted HIV-1 drug resistance: an individual-patient- and sequence-level meta-analysis.

    Science.gov (United States)

    Rhee, Soo-Yon; Blanco, Jose Luis; Jordan, Michael R; Taylor, Jonathan; Lemey, Philippe; Varghese, Vici; Hamers, Raph L; Bertagnolio, Silvia; Rinke de Wit, Tobias F; Aghokeng, Avelin F; Albert, Jan; Avi, Radko; Avila-Rios, Santiago; Bessong, Pascal O; Brooks, James I; Boucher, Charles A B; Brumme, Zabrina L; Busch, Michael P; Bussmann, Hermann; Chaix, Marie-Laure; Chin, Bum Sik; D'Aquin, Toni T; De Gascun, Cillian F; Derache, Anne; Descamps, Diane; Deshpande, Alaka K; Djoko, Cyrille F; Eshleman, Susan H; Fleury, Herve; Frange, Pierre; Fujisaki, Seiichiro; Harrigan, P Richard; Hattori, Junko; Holguin, Africa; Hunt, Gillian M; Ichimura, Hiroshi; Kaleebu, Pontiano; Katzenstein, David; Kiertiburanakul, Sasisopin; Kim, Jerome H; Kim, Sung Soon; Li, Yanpeng; Lutsar, Irja; Morris, Lynn; Ndembi, Nicaise; Ng, Kee Peng; Paranjape, Ramesh S; Peeters, Martine; Poljak, Mario; Price, Matt A; Ragonnet-Cronin, Manon L; Reyes-Terán, Gustavo; Rolland, Morgane; Sirivichayakul, Sunee; Smith, Davey M; Soares, Marcelo A; Soriano, Vincent V; Ssemwanga, Deogratius; Stanojevic, Maja; Stefani, Mariane A; Sugiura, Wataru; Sungkanuparph, Somnuek; Tanuri, Amilcar; Tee, Kok Keng; Truong, Hong-Ha M; van de Vijver, David A M C; Vidal, Nicole; Yang, Chunfu; Yang, Rongge; Yebra, Gonzalo; Ioannidis, John P A; Vandamme, Anne-Mieke; Shafer, Robert W

    2015-04-01

    Regional and subtype-specific mutational patterns of HIV-1 transmitted drug resistance (TDR) are essential for informing first-line antiretroviral (ARV) therapy guidelines and designing diagnostic assays for use in regions where standard genotypic resistance testing is not affordable. We sought to understand the molecular epidemiology of TDR and to identify the HIV-1 drug-resistance mutations responsible for TDR in different regions and virus subtypes. We reviewed all GenBank submissions of HIV-1 reverse transcriptase sequences with or without protease and identified 287 studies published between March 1, 2000, and December 31, 2013, with more than 25 recently or chronically infected ARV-naïve individuals. These studies comprised 50,870 individuals from 111 countries. Each set of study sequences was analyzed for phylogenetic clustering and the presence of 93 surveillance drug-resistance mutations (SDRMs). The median overall TDR prevalence in sub-Saharan Africa (SSA), south/southeast Asia (SSEA), upper-income Asian countries, Latin America/Caribbean, Europe, and North America was 2.8%, 2.9%, 5.6%, 7.6%, 9.4%, and 11.5%, respectively. In SSA, there was a yearly 1.09-fold (95% CI: 1.05-1.14) increase in odds of TDR since national ARV scale-up attributable to an increase in non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance. The odds of NNRTI-associated TDR also increased in Latin America/Caribbean (odds ratio [OR] = 1.16; 95% CI: 1.06-1.25), North America (OR = 1.19; 95% CI: 1.12-1.26), Europe (OR = 1.07; 95% CI: 1.01-1.13), and upper-income Asian countries (OR = 1.33; 95% CI: 1.12-1.55). In SSEA, there was no significant change in the odds of TDR since national ARV scale-up (OR = 0.97; 95% CI: 0.92-1.02). An analysis limited to sequences with mixtures at less than 0.5% of their nucleotide positions—a proxy for recent infection—yielded trends comparable to those obtained using the complete dataset. Four NNRTI SDRMs—K101E, K103N, Y181C, and G190A

  14. Comparing two service delivery models for the prevention of mother-to-child transmission (PMTCT of HIV during transition from single-dose nevirapine to multi-drug antiretroviral regimens

    Directory of Open Access Journals (Sweden)

    Mugwaneza Placidie

    2010-12-01

    Full Text Available Abstract Background Mother-to-child transmission (MTCT of HIV has been eliminated from the developed world with the introduction of multi-drug antiretroviral (md-ARV regimens for the prevention of MTCT (PMTCT; but remains the major cause of HIV infection among sub-Saharan African children. This study compares two service delivery models of PMTCT interventions and documents the lessons learned and the challenges encountered during the transition from single-dose nevirapine (sd-nvp to md-ARV regimens in a resource-limited setting. Methods Program data collected from 32 clinical sites was used to describe trends and compare the performance (uptake of HIV testing, CD4 screening and ARV regimens initiated during pregnancy of sites providing PMTCT as a stand-alone service (stand-alone site versus sites providing PMTCT as well as antiretroviral therapy (ART (full package site. CD4 cell count screening, enrolment into ART services and the initiation of md-ARV regimens during pregnancy, including dual (zidovudine [AZT] +sd-nvp prophylaxis and highly active antiretroviral therapy (HAART were analysed. Results From July 2006 to December 2008, 1,622 pregnant women tested HIV positive (HIV+ during antenatal care (ANC. CD4 cell count screening during pregnancy increased from 60% to 70%, and the initiation of md-ARV regimens increased from 35.5% to 97% during this period. In 2008, women attending ANC at full package sites were 30% more likely to undergo CD4 cell count assessment during pregnancy than women attending stand-alone sites (relative risk (RR = 1.3; 95% confidence interval (CI: 1.1-1.4. Enrolment of HIV+ pregnant women in ART services was almost twice as likely at full package sites than at stand-alone sites (RR = 1.9; 95% CI: 1.5-2.3. However, no significant differences were detected between the two models of care in providing md-ARV (RR = 0.9; 95% CI: 0.9-1.0. Conclusions All sites successfully transitioned from sd-nvp to md-ARV regimens for PMTCT

  15. 75 FR 79382 - Determination of Regulatory Review Period for Purposes of Patent Extension; LIVALO

    Science.gov (United States)

    2010-12-20

    ... Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug... phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the... hyperlipidemia and mixed dyslipidemia as an adjunctive therapy to diet to reduce elevated total cholesterol, low...

  16. Scientometrics of drug discovery efforts: pain-related molecular targets

    Directory of Open Access Journals (Sweden)

    Kissin I

    2015-07-01

    Full Text Available Igor KissinDepartment of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USAAbstract: The aim of this study was to make a scientometric assessment of drug discovery efforts centered on pain-related molecular targets. The following scientometric indices were used: the popularity index, representing the share of articles (or patents on a specific topic among all articles (or patents on pain over the same 5-year period; the index of change, representing the change in the number of articles (or patents on a topic from one 5-year period to the next; the index of expectations, representing the ratio of the number of all types of articles on a topic in the top 20 journals relative to the number of articles in all (>5,000 biomedical journals covered by PubMed over a 5-year period; the total number of articles representing Phase I–III trials of investigational drugs over a 5-year period; and the trial balance index, a ratio of Phase I–II publications to Phase III publications. Articles (PubMed database and patents (US Patent and Trademark Office database on 17 topics related to pain mechanisms were assessed during six 5-year periods from 1984 to 2013. During the most recent 5-year period (2009–2013, seven of 17 topics have demonstrated high research activity (purinergic receptors, serotonin, transient receptor potential channels, cytokines, gamma aminobutyric acid, glutamate, and protein kinases. However, even with these seven topics, the index of expectations decreased or did not change compared with the 2004–2008 period. In addition, publications representing Phase I–III trials of investigational drugs (2009–2013 did not indicate great enthusiasm on the part of the pharmaceutical industry regarding drugs specifically designed for treatment of pain. A promising development related to the new tool of molecular targeting, ie, monoclonal antibodies, for pain treatment has not

  17. Patent Strategy at the Age of High Technology

    Science.gov (United States)

    Aoyama, Hirokazu

    This paper is a summary of the lecture which the author presented at the 5th Hokuriku Workshop for Study of Scientific and Technological Information Activities on the 17th of January in 1986. The author analyzed the present situation and made some suggestions on them ; (1) the role of patent system has shifted from introduction of foreign technologies to independent technological development at the age of high technology, (2) circumstances of rapidly increasing international patent war, particularly patent conflict between U.S. and Japan concerning U.S. ITC, (3) as the service of soft aspects of economy has been closed up, the new business has come to the fore front, and the move to consider technology as a good has been activated, (4) how patent specification should be written, the way of obtaining and protecting patent successfully, (5) basic pattern of patent strategy and what the strategy should be to respond to the enterprises level, (6) present situation of patent information service, effective use of patent maps and information strategy.

  18. The paradigm shift to an “open” model in drug development

    Directory of Open Access Journals (Sweden)

    Regina Au

    2014-12-01

    Full Text Available The rising cost of healthcare, the rising cost for drug development, the patent cliff for Big pharma, shorter patent protection, decrease reimbursement, and the recession have made it more difficult for the pharmaceutical and biotechnology industry to develop drugs. Due to the unsustainable amount of time and money in developing a drug that will have a significant return on investment (ROI it has become hard to sustain a robust pipeline. The industry is transforming its business model to meet these challenges. In essence a paradigm shift is occurring; the old “closed” model is giving way to a new “open” business model.

  19. Role of MRP transporters in regulating antimicrobial drug inefficacy and oxidative stress-induced pathogenesis during HIV-1 and TB infections.

    Science.gov (United States)

    Roy, Upal; Barber, Paul; Tse-Dinh, Yuk-Ching; Batrakova, Elena V; Mondal, Debasis; Nair, Madhavan

    2015-01-01

    Multi-Drug Resistance Proteins (MRPs) are members of the ATP binding cassette (ABC) drug-efflux transporter superfamily. MRPs are known to regulate the efficacy of a broad range of anti-retroviral drugs (ARV) used in highly active antiretroviral therapy (HAART) and antibacterial agents used in Tuberculus Bacilli (TB) therapy. Due to their role in efflux of glutathione (GSH) conjugated drugs, MRPs can also regulate cellular oxidative stress, which may contribute to both HIV and/or TB pathogenesis. This review focuses on the characteristics, functional expression, and modulation of known members of the MRP family in HIV infected cells exposed to ARV drugs and discusses their known role in drug-inefficacy in HIV/TB-induced dysfunctions. Currently, nine members of the MRP family (MRP1-MRP9) have been identified, with MRP1 and MRP2 being the most extensively studied. Details of the other members of this family have not been known until recently, but differential expression has been documented in inflammatory tissues. Researchers have found that the distribution, function, and reactivity of members of MRP family vary in different types of lymphocytes and macrophages, and are differentially expressed at the basal and apical surfaces of both endothelial and epithelial cells. Therefore, the prime objective of this review is to delineate the role of MRP transporters in HAART and TB therapy and their potential in precipitating cellular dysfunctions manifested in these chronic infectious diseases. We also provide an overview of different available options and novel experimental strategies that are being utilized to overcome the drug resistance and disease pathogenesis mediated by these membrane transporters.

  20. Role of MRP Transporters in Regulating Antimicrobial Drug Inefficacy and Oxidative Stress-induced Pathogenesis during HIV-1 and TB Infections

    Directory of Open Access Journals (Sweden)

    Upal eRoy

    2015-09-01

    Full Text Available Multi-Drug Resistance Proteins (MRPs are members of the ATP binding cassette (ABC drug-efflux transporter superfamily. MRPs are known to regulate the efficacy of a broad range of anti-retroviral drugs (ARV used in highly active antiretroviral therapy (HAART and antibacterial agents used in Tuberculus Bacilli (TB therapy. Due to their role in efflux of glutathione (GSH conjugated drugs, MRPs can also regulate cellular oxidative stress, which may contribute to both HIV and/or TB pathogenesis. This review focuses on the characteristics, functional expression, and modulation of known members of the MRP family in HIV infected cells exposed to ARV drugs and discusses their known role in drug-inefficacy in HIV/TB-induced dysfunctions. Currently, nine members of the MRP family (MRP1-MRP9 have been identified, with MRP1 and MRP2 being the most extensively studied. Details of the other members of this family have not been known until recently, but differential expression has been documented in inflammatory tissues. Researchers have found that the distribution, function and reactivity of members of MRP family vary in different types of lymphocytes and macrophages, and are differentially expressed at the basal and apical surfaces of both endothelial and epithelial cells. Therefore, the prime objective of this review is to delineate the role of MRP transporters in HAART and TB therapy and their potential in precipitating cellular dysfunctions manifested in these chronic infectious diseases. We also provide an overview of different available options and novel experimental strategies that are being utilized to overcome the drug resistance and disease pathogenesis mediated by these membrane transporters.

  1. Trends in Decline of Antiretroviral Resistance among ARV-Experienced Patients in the HIV Outpatient Study: 1999–2008

    Directory of Open Access Journals (Sweden)

    Kate Buchacz

    2012-01-01

    Full Text Available Background. Little is known about temporal trends in frequencies of clinically relevant ARV resistance mutations in HIV strains from U.S. patients undergoing genotypic testing (GT in routine HIV care. Methods. We analyzed cumulative frequency of HIV resistance among patients in the HIV Outpatient Study (HOPS who, during 1999–2008 and while prescribed antiretrovirals, underwent GT with plasma HIV RNA >1,000 copies/mL. Exposure ≥4 months to each of three major antiretroviral classes (NRTI, NNRTI and PI was defined as triple-class exposure (TCE. Results. 906 patients contributed 1,570 GT results. The annual frequency of any major resistance mutations decreased during 1999–2008 (88% to 79%, P=0.05. Resistance to PIs decreased among PI-exposed patients (71% to 46%, P=0.010 as exposure to ritonavir-boosted PIs increased (6% to 81%, P<0.001. Non-significant declines were observed in resistance to NRTIs among NRTI-exposed (82% to 67%, and triple-class-resistance among TCE patients (66% to 41%, but not to NNRTIs among NNRTI-exposed. Conclusions. HIV resistance was common but declined in HIV isolates from subgroups of ARV-experienced HOPS patients during 1999–2008. Resistance to PIs among PI-exposed patients decreased, possibly due to increased representation of patients whose only PI exposures were to boosted PIs.

  2. Applying patent information to tracking a specific technology

    Directory of Open Access Journals (Sweden)

    Chen-Yuan Liu

    2007-10-01

    Full Text Available Patents in general contain much novel technological information. This paper demonstrates that the usage of patent analysis can facilitate a unique scheme for tracking technology development. In this paper, the walking technique of the Japanese biped robot is tracked as an example. The searching method of the FI (file index and F-term classification system developed by JPO (Japan Patent Office was employed in this study, where all the related patent data were searched from the IPDL (Intellectual Property Digital Library. This study investigated an important technique applied to the humanoid biped robot that imitates the walking behavior of the human beings on two legs. By analyzing the patent information obtained, the relative research capabilities, technical strengths, and patent citation conditions among patent competitors were compared. Furthermore, a formulated technical matrix of patent map is established in this paper to indicate that the ZMP (Zero Moment Point control means is the main technology to achieve stabilized walking control of the humanoid biped robot. This study also incorporates relevant academic journal findings and industrial information. Results presented herein demonstrate that patents can function not only as a map for tracking a technology trajectory, but also as a guide to the main development of a new technology in years to come.

  3. Fundamentals of patenting and licensing for scientists and engineers

    National Research Council Canada - National Science Library

    Ma, M. Y. (Matthew Y.)

    2009-01-01

    ... ...28 3.2 Types of Patents...28 3.3 Patent Dates ...29 viiviii Fundamentals of Patenting and Licensing for Scientists and Engineers 3.4 Eligibility of Priority Date ...30 3.5 Patentability ...32...

  4. The Patent Literature As A Shortcut To Identify Knowledge Suppliers

    DEFF Research Database (Denmark)

    Søberg, Peder Veng

    patents which decreases the time span between a patent is filed and its value can be evaluated when searching the patent literature. A potential benefit thereof could be that the patent literature could become relevant in order to identify potential knowledge suppliers.......The present paper explores characteristics of valuable patents that have been subject to litigation which resulted in some of the largest fines to patent infringers reported in history. The valuable patents are compared with less valuable patents in order to identify new methods of evaluating...

  5. The gene patent controversy on Twitter: a case study of Twitter users' responses to the CHEO lawsuit against Long QT gene patents.

    Science.gov (United States)

    Du, Li; Kamenova, Kalina; Caulfield, Timothy

    2015-08-25

    The recent Canadian lawsuit on patent infringement, filed by the Children's Hospital of Eastern Ontario (CHEO), has engendered a significant public debate on whether patenting genes should be legal in Canada. In part, this public debate has involved the use of social networking sites, such as Twitter. This case provides an opportunity to examine how Twitter was used in the context of this gene patent controversy. We collected 310 English-language tweets that contained the keyword "gene patents" by using TOPSY.com and Twitter's built-in search engine. A content analysis of the messages was conducted to establish the users' perspectives on both CHEO's court challenge and the broader controversy over the patenting of human DNA. More specifically, we analyzed the users' demographics, geographic locations, and attitudes toward the CHEO position on gene patents and the patentability of human genes in principle. Our analysis has shown that messages tweeted by news media and health care organizations were re-tweeted most frequently in Twitter discussions regarding both the CHEO patent infringement lawsuit and gene patents in general. 34.8% of tweets were supportive of CHEO, with 52.8% of the supportive tweets suggesting that gene patents contravene patients' rights to health care access. 17.6% of the supportive tweets cited ethical and social concerns against gene patents. Nearly 40% of tweets clearly expressed that human genes should not be patentable, and there were no tweets that presented perspectives favourable toward the patenting of human genes. Access to healthcare and the use of genetic testing were the most important concerns raised by Twitter users in the context of the CHEO case. Our analysis of tweets reveals an expectation that the CHEO lawsuit will provide an opportunity to clear the confusion on gene patents by establishing a legal precedent on the patentability of human genes in Canada. In general, there were no tweets arguing in favour of gene patents

  6. 48 CFR 1427.201 - Patent and copyright infringement liability.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Patent and copyright... INTERIOR GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patents and Copyrights 1427.201 Patent and copyright infringement liability. ...

  7. 48 CFR 27.201 - Patent and copyright infringement liability.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Patent and copyright... REGULATION GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patents and Copyrights 27.201 Patent and copyright infringement liability. ...

  8. A study of fuel cell patenting activity in Canada

    International Nuclear Information System (INIS)

    Lee, B.Y.; Sajewycz, M.

    2004-01-01

    'Full text:' A patent application is generally filed shortly after completion of research and development; therefore, patent filing statistics provide insight into the state of innovation of a technology. A study has been conducted on fuel cell patenting activity in Canada. This study examines fuel cell patenting trends between 1989-2003 and specific activity in 2001, identifies the major players in the Canadian fuel cell industry, and examines the patent landscape by fuel cell technology. Our results show that historically, Canadians have been leaders at home and abroad in fuel cell innovation. However, Canadians have recently fallen behind in protecting their patent rights at home, and now rank fourth behind German, American and Japanese fuel cell patent filers in the Canadian patent office. However, our data also shows that a significant number of new Canadian entities have emerged and have been very active filing new patent applications. These new entities as well as established Canadian companies are examined in detail. (author)

  9. Pesticides and the Patent Bargain

    NARCIS (Netherlands)

    Timmermann, C.A.

    2015-01-01

    In order to enlarge the pool of knowledge available in the public domain, temporary exclusive rights (i.e. patents) are granted to innovators who are willing to fully disclose the information needed to reproduce their invention. After the 20-year patent protection period elapses, society should be

  10. 48 CFR 2527.7002 - NSF patent policy.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true NSF patent policy. 2527... CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Disposition of Rights in Inventions 2527.7002 NSF patent policy. As authorized by the National Science Board at its 230th meeting, October 15-16, 1981, the...

  11. Performance of Patenting Firms in Danish Manufacturing

    DEFF Research Database (Denmark)

    Madsen, Erik Strøjer; Smith, Valdemar; Nielsen, Anders Østergaard

    2000-01-01

    Most countries focus on industries with high technology and the governments grant subsidies to innovating firms. However, there has been remarkable few studies of the performance of innovative firms or industries. This study examines the performance of patent active firms compared to the non-patenting...... firms within the manufacturing sector in Denmark. Performance is measured both by growth in employment as well as in the return on equity and profit share in turnover. The results suggest that differences in performance of patenting and non-patenting firms are very small, which questions the political...

  12. Interaction between pharmaceutical companies and physicians who prescribe antiretroviral drugs for treating AIDS

    Directory of Open Access Journals (Sweden)

    Mario Cesar Scheffer

    Full Text Available CONTEXT AND OBJECTIVE: Given that Brazil has a universal public policy for supplying medications to treat HIV and AIDS, the aim here was to describe the forms of relationship between physicians and the pharmaceutical companies that produce antiretrovirals (ARVs. DESIGN AND SETTING: Cross-sectional epidemiological study conducted in the state of São Paulo. METHODS : Secondary database linkage was used, with structured interviews conducted by telephone among a sample group of 300 physicians representing 2,361 professionals who care for patients with HIV and AIDS. RESULTS : Around two thirds (64% of the physicians prescribing ARVs for HIV and AIDS treatment in the state of São Paulo who were interviewed declared that they had some form of relationship with pharmaceutical companies, of which the most frequent were receipt of publications (54%, visits by sales promoters (51% and receipt of small-value objects (47%. CONCLUSIONS: Two forms of relationship between the pharmaceutical industry and physicians who deal with HIV and AIDS can be highlighted: facilitation of professionals' access to continuing education; and antiretroviral drug brand name promotion.

  13. Mobile phone use for a social strategy to improve antiretroviral refill experience at a low-resource HIV clinic: patient responses from Nigeria.

    Science.gov (United States)

    Adetunji, Adedotun A; Muyibi, Sufiyan A; Imhansoloeva, Martins; Ibraheem, Olusola M; Sunmola, Adegbenga; Kolawole, Olubunmi O; Akinrinsola, Oluwasina O; Ojo-Osagie, James O; Mosuro, Olusola A; Abiolu, Josephine O; Irabor, Achiaka E; Okonkwo, Prosper; Adewole, Isaac F; Taiwo, Babafemi O

    2017-05-01

    In sub-Saharan African areas where antiretroviral (ARV) drugs are not available through community pharmacies, clinic-based pharmacies are often the primary source of ARV drug refills. Social pressure is mounting on treatment providers to adjust ARV refill services towards user-friendly approaches which prioritize patients' convenience and engage their resourcefulness. By this demand, patients may be signalling dissatisfaction with the current provider-led model of monthly visits to facility-based pharmacies for ARV refill. Mobile phones are increasingly popular in sub-Saharan Africa, and have been used to support ARV treatment goals in this setting. A patient-centred response to on-going social pressure requires treatment providers to view ARV refill activities through the eyes of patients who are negotiating the challenges of day-to-day life while contemplating their next refill appointment. Using focus groups of five categories of adult patients receiving combination ARV therapy, we conducted this cross-sectional qualitative study to provide insight into modifiable gaps between patients' expectations and experiences of the use of mobile phones in facility-based ARV refill service at a public HIV clinic in Nigeria. A notable finding was patients' preference for harnessing informal social support (through intermediaries with mobile phones) to maintain adherence to ARV refill appointments when they could not present in person. This evolving social support strategy also has the potential to enhance defaulter tracking. Our study findings may inform the development of ARV refill strategies and the design of future qualitative studies on client-provider communication by mobile phones in under-resourced HIV treatment programmes.

  14. Patenting Biotechnological Inventions in Europe

    Directory of Open Access Journals (Sweden)

    Peter Raspor

    2002-01-01

    Full Text Available The patent system has been able to provide the protection for the achievements of different technologies and in that way it has supported further development and growth of the industry where those achievements were implemented. Modern technologies like information technology and biotechnology with genetic engineering that appeared in the 70s have overgrown the frames of the existing patent system because of their exponential development during the last thirty years. Industry that invests a huge amount of money in these technologies, especially in the field of biotechnology, where the results are very uncertain, has started to claim changes in the patent system.

  15. Patent citation network in nanotechnology (1976-2004)

    International Nuclear Information System (INIS)

    Li Xin; Chen Hsinchun; Huang Zan; Roco, Mihail C.

    2007-01-01

    The patent citation networks are described using critical node, core network, and network topological analysis. The main objective is understanding of the knowledge transfer processes between technical fields, institutions and countries. This includes identifying key influential players and subfields, the knowledge transfer patterns among them, and the overall knowledge transfer efficiency. The proposed framework is applied to the field of nanoscale science and engineering (NSE), including the citation networks of patent documents, submitting institutions, technology fields, and countries. The NSE patents were identified by keywords 'full-text' searching of patents at the United States Patent and Trademark Office (USPTO). The analysis shows that the United States is the most important citation center in NSE research. The institution citation network illustrates a more efficient knowledge transfer between institutions than a random network. The country citation network displays a knowledge transfer capability as efficient as a random network. The technology field citation network and the patent document citation network exhibit a less efficient knowledge diffusion capability than a random network. All four citation networks show a tendency to form local citation clusters

  16. Approved Animal Drug Products (Green Book)

    Data.gov (United States)

    U.S. Department of Health & Human Services — On November 16, 1988, the President of the United States signed into law the Generic Animal Drug and Patent Restoration Act (GADPTRA). Among its major provisions,...

  17. Patent circumvention strategy using TRIZ-based design-around approaches

    NARCIS (Netherlands)

    Veldhuijzen van Zanten, J.F.J.; Wits, Wessel Willems; Aoussat, Améziane; Cavallucci, Denis; Trella, Marc

    2013-01-01

    This paper proposes guidelines for a systematic patent circumvention strategy utilizing innovation and TRIZ tools. It focuses on starting from a landscape of patents and claims of an existing patent to create solutions that circumvent this existing patent. Information gathered from various sources

  18. Patent circumvention strategy using TRIZ-based design-around approaches

    NARCIS (Netherlands)

    Veldhuijzen van Zanten, J.F.J.; Wits, Wessel Willems

    2015-01-01

    This paper proposes guidelines for a systematic patent circumvention strategy utilizing innovation and TRIZ tools. It focuses on starting from a landscape of patents and claims of an existing patent to create solutions that circumvent this existing patent. Information gathered from various sources

  19. 76 FR 53885 - Patent and Trademark Resource Centers Metrics

    Science.gov (United States)

    2011-08-30

    ... DEPARTMENT OF COMMERCE United States Patent and Trademark Office Patent and Trademark Resource Centers Metrics ACTION: Proposed collection; comment request. SUMMARY: The United States Patent and... ``Patent and Trademark Resource Centers Metrics comment'' in the subject line of the message. Mail: Susan K...

  20. Drug delivery strategies and systems for HIV/AIDS pre-exposure prophylaxis and treatment.

    Science.gov (United States)

    Nelson, Antoinette G; Zhang, Xiaoping; Ganapathi, Usha; Szekely, Zoltan; Flexner, Charles W; Owen, Andrew; Sinko, Patrick J

    2015-12-10

    The year 2016 will mark an important milestone - the 35th anniversary of the first reported cases of HIV/AIDS. Antiretroviral Therapy (ART) including Highly Active Antiretroviral Therapy (HAART) drug regimens is widely considered to be one of the greatest achievements in therapeutic drug research having transformed HIV infection into a chronically managed disease. Unfortunately, the lack of widespread preventive measures and the inability to eradicate HIV from infected cells highlight the significant challenges remaining today. Moving forward there are at least three high priority goals for anti-HIV drug delivery (DD) research: (1) to prevent new HIV infections from occurring, (2) to facilitate a functional cure, i.e., when HIV is present but the body controls it without drugs and (3) to eradicate established infection. Pre-exposure Prophylaxis (PrEP) represents a significant step forward in preventing the establishment of chronic HIV infection. However, the ultimate success of PrEP will depend on achieving sustained antiretroviral (ARV) tissue concentrations and will require strict patient adherence to the regimen. While first generation long acting/extended release (LA/ER) DD Systems (DDS) currently in development show considerable promise, significant DD treatment and prevention challenges persist. First, there is a critical need to improve cell specificity through targeting in order to selectively achieve efficacious drug concentrations in HIV reservoir sites to control/eradicate HIV as well as mitigate systemic side effects. In addition, approaches for reducing cellular efflux and metabolism of ARV drugs to prolong effective concentrations in target cells need to be developed. Finally, given the current understanding of HIV pathogenesis, next generation anti-HIV DDS need to address selective DD to the gut mucosa and lymph nodes. The current review focuses on the DDS technologies, critical challenges, opportunities, strategies, and approaches by which novel

  1. Patent business guide in a domestic and foreign countries

    International Nuclear Information System (INIS)

    2009-09-01

    This book explains general things on industrial property right, which includes description of industrial property right, types, qualification for application of patent, application guide, on-line application, useful procedure of application, writing methods and samples for application of patents such as design patent and trademarks patent, writing skill and examples for registration, writing ways and examples related examination and writing tips and samples on international application of patent.

  2. Biotechnological Patents Applications of the Deuterium Oxide in Human Health.

    Science.gov (United States)

    da S Mariano, Reysla M; Bila, Wendell C; Trindade, Maria Jaciara F; Lamounier, Joel A; Galdino, Alexsandro S

    2017-01-01

    Deuterium oxide is a molecule that has been used for decades in several studies related to human health. Currently, studies on D2O have mobilized a "Race for Patenting" worldwide. Several patents have been registered from biomedical and technological studies of D2O showing the potential of this stable isotope in industry and health care ecosystems. Most of the patents related to the applications of the deuterium oxide in human health have been summarized in this review. The following patents databases were consulted: European Patent Office (Espacenet), the United States Patent and Trademark Office (USPTO), the United States Latin America Patents (LATIPAT), Patent scope -Search International and National Patent Collections (WIPO), Google Patents and Free Patents Online. With this review, the information was collected on recent publications including 22 patents related to deuterium oxide and its applications in different areas. This review showed that deuterium oxide is a promising component in different areas, including biotechnology, chemistry and medicine. In addition, the knowledge of this compound was covered, reinforcing its importance in the field of biotechnology and human health. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  3. Technology Trends Analysis Using Patent Landscaping

    Directory of Open Access Journals (Sweden)

    Sergey Vsevolodovich Kortov

    2017-09-01

    Full Text Available The article is devoted to the analysis and the choice of the priorities in technology development and, particularly, to the use of patent landscaping as a tool for the study of technology trends. Currently, patent activity indicators are often used for technology foresight and for competitive intelligence as well. Nevertheless, causal relationship between these indicators, on the one hand, and strategic and tactical decisions in the sphere of technological development on meso- and microeconomic level, on the other hand, are not adequately investigated to solve practical tasks. The goal of the work is to systemize the challenges of technology trends analysis, which could be effectively solved on the base of patent landscape analysis. The article analyses the patent landscaping methodology and tools, as well as their use for evaluating the current competitive environment and technology foresight. The authors formulated the generalized classification for the criteria of promising technologies for a selected region. To assess the compliance of a technology with these criteria, we propose a system of corresponding indicators of patenting activity. Using the proposed methodology, we have analysed the patent landscape to select promising technologies for the Sverdlovsk region. The research confirmed the hypothesis of the patent landscapes performance in evaluating such technology indicators as stages of the life cycle stage, universality (applicability in different industries, pace of worldwide development, innovations and science availability in the region and potential possibilities for scientific collaboration with international research institutions and universities. The results of the research may be useful to the wide audience, including representatives small and medium enterprises, large companies and regional authorities for the tasks concerned with the technology trends analysis and technology strategy design

  4. Long-Term Effectiveness of the Zilver PTX Drug-Eluting Stent for Femoropopliteal Peripheral Artery Disease in Patients with No Patent Tibial Runoff Vessels-Results from the Zilver PTX Japan Post-Market Surveillance Study.

    Science.gov (United States)

    Cipollari, Stefano; Yokoi, Hiroyoshi; Ohki, Takao; Kichikawa, Kimihiko; Nakamura, Masato; Komori, Kimihiro; Nanto, Shinsuke; O'Leary, Erin E; Lottes, Aaron E; Saunders, Alan T; Dake, Michael D

    2018-01-01

    To evaluate 2-year results of the Zilver PTX (Cook Medical, Bloomington, Indiana) drug-eluting stent (DES) for femoropopliteal peripheral artery disease (PAD) in patients with no continuous patent infrapopliteal runoff arteries compared with patients with ≥ 1 continuous patent runoff vessels. A retrospective analysis of patients with femoropopliteal PAD enrolled in the Zilver PTX Post-Market Surveillance Study in Japan was performed. There were no exclusion criteria. Outcomes, including freedom from target lesion revascularization (TLR), patency, and clinical benefit, for the no-runoff group (n = 54) were compared with the runoff group (n = 846). The 2 groups were similar in terms of demographics, lesion characteristics, and comorbidities (P > .05). There was a higher incidence of critical limb ischemia in the no-runoff group compared with the runoff group (44.8% vs 19.7%; P < .01). There were 3 amputations (5.6%) in the no-runoff group versus 7 amputations (0.8%) in the runoff group (P = .02). At 2 years, freedom from TLR rates were 81.3% versus 83.8% (P = .87), patency rates were 68.4% versus 70.7% (P = .95), and clinical benefit rates were 73.7% versus 80.0% (P = .16) in the no-runoff versus runoff group, respectively. Results in patients with no continuous patent tibial runoff were favorable through 2 years and similar to results for patients with ≥ 1 continuous patent runoff vessels, indicating that the Zilver PTX DES may be a valid treatment option for patients with these difficult-to-treat lesions. Copyright © 2017 SIR. Published by Elsevier Inc. All rights reserved.

  5. 48 CFR 1327.201 - Patent and copyright infringement liability.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Patent and copyright infringement liability. 1327.201 Section 1327.201 Federal Acquisition Regulations System DEPARTMENT OF COMMERCE GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patents and Copyrights 1327.201 Patent and...

  6. Evaluation of Brazilian biotechnology patent activity from 1975 to 2010.

    Science.gov (United States)

    Dias, F; Delfim, F; Drummond, I; Carmo, A O; Barroca, T M; Horta, C C; Kalapothakis, E

    2012-08-01

    The analysis of patent activity is one methodology used for technological monitoring. In this paper, the activity of biotechnology-related patents in Brazil were analyzed through 30 International Patent Classification (IPC) codes published by the Organization for Economic Cooperation and Development (OECD). We developed a program to analyse the dynamics of the major patent applicants, countries and IPC codes extracted from the Brazilian Patent Office (INPI) database. We also identified Brazilian patent applicants who tried to expand protection abroad via the Patent Cooperation Treaty (PCT). We had access to all patents published online at the INPI from 1975 to July 2010, including 9,791 biotechnology patent applications in Brazil, and 163 PCTs published online at World Intellectual Property Organization (WIPO) from 1997 to December 2010. To our knowledge, there are no other online reports of biotechnology patents previous to the years analyzed here. Most of the biotechnology patents filed in the INPI (10.9%) concerned measuring or testing processes involving nucleic acids. The second and third places belonged to patents involving agro-technologies (recombinant DNA technology for plant cells and new flowering plants, i.e. angiosperms, or processes for obtaining them, and reproduction of flowering plants by tissue culture techniques). The majority of patents (87.2%) were filed by nonresidents, with USA being responsible for 51.7% of all biotechnology patents deposited in Brazil. Analyzing the resident applicants per region, we found a hub in the southeast region of Brazil. Among the resident applicants for biotechnology patents filed in the INPI, 43.5% were from São Paulo, 18.3% were from Rio de Janeiro, and 9.7% were from Minas Gerais. Pfizer, Novartis, and Sanofi were the largest applicants in Brazil, with 339, 288, and 245 biotechnology patents filed, respectively. For residents, the largest applicant was the governmental institution FIOCRUZ (Oswaldo Cruz

  7. Prevailing impact trends in patenting

    DEFF Research Database (Denmark)

    Elsmore, Matthew J.

    2009-01-01

      Patents are at the heart of science and public policy. Getting European patent policy right is a daunting task and involves listening to numerous voices. Part of this process must entail a full understanding of emerging trends that challenge the present system. The challenges are fluid and vary...... from sector to sector. This paper identifies and evaluates key recent developments in patenting which impact upon the European patent system, whichever way it looks. An analysis of these and the underlying causes means we are in a much better position to build an effective policy rearguard.    ...

  8. On Sharks, Trolls, and Other Patent Animals

    DEFF Research Database (Denmark)

    Reitzig, Markus; Henkel, Joachim; Heath, Christopher

    2007-01-01

    Patent trolls (or sharks) are small patent holding individuals or firms who trap R&D intense manufacturers in patent infringement situations in order to receive damage awards for the illegitimate use of their technology. While of great concern to management, their existence and impact for both...... corporate decision makers and policy makers remains to be fully analyzed from an academic standpoint. In this paper we show why patent sharks can operate profitably, why they are of growing concern, how manufacturers can forearm themselves against them, and which issues policy makers need to address. To do...... so, we map international indemnification rules with strategic rationales of small patent-holding firms within a game-theoretical model. Our central finding is that the courts’ unrealistic consideration of the trade-offs faced by inadvertent infringers is a central condition for sharks to operate...

  9. Trends in worldwide nanotechnology patent applications: 1991 to 2008

    OpenAIRE

    Dang, Yan; Zhang, Yulei; Fan, Li; Chen, Hsinchun; Roco, Mihail C.

    2009-01-01

    Nanotechnology patent applications published during 1991?2008 have been examined using the ?title?abstract? keyword search on esp@cenet ?worldwide? database. The longitudinal evolution of the number of patent applications, their topics, and their respective patent families have been evaluated for 15 national patent offices covering 98% of the total global activity. The patent offices of the United States (USA), People?s Republic of China (PRC), Japan, and South Korea have published the larges...

  10. Modification of polysaccharides: Pharmaceutical and tissue engineering applications with commercial utility (patents)

    Energy Technology Data Exchange (ETDEWEB)

    Malviya, Rishabha, E-mail: rishabhamalviya19@gmail.com [Polymer Science Laboratory, Department of Pharmacy, School of Medical & Allied Sciences, Galgotias University, Greator Noida, UP (India); Department of Pharmacy, Uttarkhand Technical University, Dehradun, Uttarkhand (India); Sharma, Pramod Kumar [Polymer Science Laboratory, Department of Pharmacy, School of Medical & Allied Sciences, Galgotias University, Greator Noida, UP (India); Dubey, Susheel Kumar [Siddarth Institute of Pharmacy, Dehradun, Uttarkhand (India)

    2016-11-01

    Polymer modifications open new era for the development of polymers with requisite properties. Use of modified polymers is practically boundless. Different studies focus on biomedical applications of chemically modified polysaccharides. Development and utilization of modified polysaccharides get attention to be used as carrier for pharmaceutical drug delivery as well as tissue engineering scaffolds. Grafted polymer shows better cellular regeneration, signal transmission, diagnostic and imaging material than putative form. This review article aims to discuss various approaches to modify naturally derived polymer and their applications as pharmaceutical drug carrier and as a material for wound dressing and artificial cartilage due to better biophysical cues. Manuscript included various patents based on the applications of modified polymers and techniques used to modify polymers. - Highlights: • Properties of natural polysaccharides can be modulated by modification in their basic backbone. • Polysaccharides can be easily modified using microwave irradiation as compared to conventional closed vessel modification. • Biodegradable and biocompatible nature of modified polymer promotes their use in targeted cellular delivery of pharmaceuticals. • Studies show strong support that biodegradable polymers have ability to modulate cell signaling, cellular attachment, migration, proliferation and differentiation. • Manuscript reveals the fact that various commercial patents have been granted for the use of modified polymer.

  11. Valuing patents on cost-reducing technology: A case study

    NARCIS (Netherlands)

    van Triest, S.P.; van de Vis, Wim

    2007-01-01

    We present an approach for valuing patents on production process improvements. Specifically, we focus on valuing a patent on cost-reducing process improvements from the viewpoint of the patent holding firm. We do this by considering the relevant cash flows that result from owning the patent. The

  12. 37 CFR 11.10 - Restrictions on practice in patent matters.

    Science.gov (United States)

    2010-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Restrictions on practice in patent matters. 11.10 Section 11.10 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE REPRESENTATION OF OTHERS BEFORE THE UNITED STATES PATENT AND...

  13. 37 CFR 1.17 - Patent application and reexamination processing fees.

    Science.gov (United States)

    2010-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Patent application and reexamination processing fees. 1.17 Section 1.17 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES General Provisions Fees...

  14. In-vitro photo-translocation of antiretroviral drug delivery into TZMbl cells

    CSIR Research Space (South Africa)

    Malabi, Rudzani

    2017-01-01

    Full Text Available The objectives of this study are to use femtosecond laser pulses in a photo-translocation system to deliver ARVs into HIV infected TZMbl cells, and to investigate the influence of ARVs and laser on cellular processes using different molecular...

  15. The Battle for Patent Rights in Plant Biotechnology

    DEFF Research Database (Denmark)

    Schneider, Cédric

    2011-01-01

    This paper describes and analyzes the occurrence and extent of oppositions initiated against plant biotechnology patents granted by the European Patent Office (EPO). The opposition mechanism is a legal procedure that allows any third party to challenge the validity of patents awarded by the EPO....... Results indicate that the opposition rate is far greater in plant biotechnology than in other emerging industries. Consistent with theoretical predictions, the empirical findings suggest that opposed patents are disproportionately those that score high on features that proxy for their “value” or “quality......”. In contrast to previous findings, however, the results show that large-volume applicants are more likely to be opposed. Because the boundaries of plant biotech patents are ill-defined, large patent portfolios do not promote cooperative behavior such as licensing or settlements. The analysis rejects...

  16. To succeed with invention and patent which are my own idea

    International Nuclear Information System (INIS)

    Yu, Jae Bok

    1999-07-01

    This book introduces how to invent through various way such as successful story about the effect to invent, conception like everyone can be a inventor and this is invention. This book also explains all of process of patent such as application of patent, patent in Korea, Japan, the U.S and other countries, what is patent information, how to hunt patent, intellectual property right, priority system, international patent application is possible in Korea, other common sense on patent application, patent as a great power and questions and answers on patent.

  17. The patent activity of the Czech R

    Directory of Open Access Journals (Sweden)

    Kučera Zdeněk

    2016-12-01

    Full Text Available An effective knowledge transfer between research institutions and industry is a significant bottleneck in the national innovation system. CR adopted in recent years a series of systemic measures aimed to stimulate the orientation of the R&D organizations towards the generation of knowledge directly applicable in the innovation process and more generally to improve the collaboration of the R&D establishment with the industry. In the majority of programs supporting the applied research patents and industrial designs and utility models are among the anticipated results. The Methodology of the evaluation of R&D organizations implemented in the second half of the last decade brought financial bonuses for the creation of the results in the category of industrial property. Despite of this stimulus CR lags behind the technologically advanced EU countries in the patent activities. The topic of this article is a comparison of the protection of the industrial property rights in the Czech higher education institutions and governmental R&D institutions with selected EU countries. We make use of a couple of quantitative indicators to assess the quality and the technological and the commercial potential of the produced industrial property. Despite a dynamic growth of the patent applications in the CR the number of patent applications relative to the country size is far below the EU-15 average. The Czech research organizations contribute to a higher extent to the number of patent applications then do the analogous institutions in EU-15 countries where the majority of patent applications come from the industrial sphere. The Czech research organizations mainly limit the patent rights to the Czech Republic whereas in the EU-15 countries the opposite is preponderant and only a small fraction of patent applications remains limited to the national environment. Thus the majority of the Czech patents created by research organizations cannot be commercialized on the

  18. 37 CFR 1.720 - Conditions for extension of patent term.

    Science.gov (United States)

    2010-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Conditions for extension of patent term. 1.720 Section 1.720 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES Adjustment and Extension of...

  19. Argonne National Laboratory patent portfolio

    International Nuclear Information System (INIS)

    Huguelet, B.C.

    1976-01-01

    This booklet contains the abstracts of all active U. S. patents on technology items that originated at ANL, the applicability of which is not limited to nuclear reactors. Also listed are the titles of all ANL-originated nuclear-related U. S. patents that are still in force. Selected technology items for which patent applications have been filed and are available for licensing are included in several categories. Categories included in this booklet are as follows: atmospheric and earth sciences; biological and medical sciences; chemistry and chemical engineering; cryogenics and superconductivity; electronics and electrical engineering; energy conversion; measurements and controls; methods and devices; materials and fabrication; physics, accelerators and fusion; and selected nuclear-related technology

  20. Nanotechnology patents in the automotive industry (a quantitative & qualitative analysis).

    Science.gov (United States)

    Prasad, Raghavendra; Bandyopadhyay, Tapas K

    2014-01-01

    The aim of the article is to present a trend in patent filings for application of nanotechnology to the automobile sector across the world, using the keyword-based patent search. Overviews of the patents related to nano technology in the automobile industry have been provided. The current work has started from the worldwide patent search to find the patents on nanotechnology in the automobile industry and classify the patents according to the various parts of an automobile to which they are related and the solutions which they are providing. In the next step various graphs have been produced to get an insight into various trends. In next step, analysis of patents in various classifications, have been performed. The trends shown in graphs provide the quantitative analysis whereas; the qualitative analysis has been done in another section. The classifications of patents based on the solution they provide have been performed by reading the claims, titles, abstract and full texts separately. Patentability of nano technology inventions have been discussed in a view to give an idea of requirements and statutory bars to the patentability of nanotechnology inventions. Another objective of the current work is to suggest appropriate framework for the companies regarding use of nano technology in the automobile industry and a suggestive strategy for patenting of the inventions related to the same. For example, US Patent, with patent number US2008-019426A1 discusses the invention related to Lubricant composition. This patent has been studied and classified to fall under classification of automobile parts. After studying this patent, it is deduced that, the problem of friction in engine is being solved by this patent. One classification is the "automobile part" based while other is the basis of "problem being solved". Hence, two classifications, namely reduction in friction and engine were created. Similarly, after studying all the patents, a similar matrix has been created.

  1. 37 CFR 1.178 - Original patent; continuing duty of applicant.

    Science.gov (United States)

    2010-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Original patent; continuing... Provisions Reissues § 1.178 Original patent; continuing duty of applicant. (a) The application for reissue of... upon reissue of the patent. Until a reissue application is granted, the original patent shall remain in...

  2. Are Patents used to Suppress Useful Technology?

    DEFF Research Database (Denmark)

    Howells, John

    2006-01-01

    of innovation, other than in the trivial sense of excluding third parties from the right to develop the technology covered by the patent? There are many references to this possibility in the management, economic and legal literatures, but two highly-cited papers stand out for grounding their claims of corporate......This article examines the evidence behind claims that innovation is hindered or blocked (termed technology suppression) by corporations' use of patents. In other words, are there ways in which the exploitation of the exclusive development right of the patent can be shown to retard the process...... and the difference between economic monopoly and an exclusive right. It is argued here that what is at issue in this work is the proper function of the patent institution. It is shown early in this paper that the understanding of the patent institution as a system of development prospects makes better sense...

  3. 14 CFR 1214.112 - Patent, data and information matters.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false Patent, data and information matters. 1214... Customers § 1214.112 Patent, data and information matters. (a) Patent and data rights. NASA will not acquire rights to inventions, patents or proprietary data which may be used in, or arise from, activities for...

  4. 45 CFR 650.2 - National Science Foundation patent policy.

    Science.gov (United States)

    2010-10-01

    ... 45 Public Welfare 3 2010-10-01 2010-10-01 false National Science Foundation patent policy. 650.2... FOUNDATION PATENTS § 650.2 National Science Foundation patent policy. As authorized by the National Science... adopted the following statement of NSF patent policy. (a) In accordance with the Bayh-Dole Act and the...

  5. Intellectual Property Strategies of Multinational Companies Patenting in China

    DEFF Research Database (Denmark)

    Wolfram, Pierre; Schuster, Gerd; Brem, Alexander

    2014-01-01

    While global intellectual property trends show a stable rate of worldwide patent applications during the last five years, patent applications in emerging economies strongly increased within the same period. Unless the increasing number of applications in emerging economies, the indigenous legal...... archetypes of the world’s largest patent applicants using the case of China as an empirical context. Using Questel’s professional patent search application Orbit, we build a unique data set of the world’s top patent applicants combining data from the World Intellectual Property Organization and the State...... Intellectual Property Office of China comprising data of about 620.000 patents. Referring to the study of Keupp et al. (2012), we extend previous qualitative studies on patenting strategy archetypes by adding quantitative evidence from a data set of the world’s largest intellectual property owners. Model based...

  6. The backlog issue in patents: A look at the European case

    NARCIS (Netherlands)

    Rodriguez, V.

    2010-01-01

    Backlogs can be caused by an increase in the number of patent applications and patent size. A large number of patents granted could be explained by patent examiners' bonuses, legal and cultural contexts, claim forms, the geographical origin of patents, a firm's experience in patenting, the number of

  7. Patent foramen ovale and migraine attacks: a systematic review.

    Science.gov (United States)

    Lip, Philomena Z Y; Lip, Gregory Y H

    2014-05-01

    Migraine headache and the presence of a patent foramen ovale have been associated with each other, although the precise pathophysiological mechanism(s) are uncertain. The purpose of this systematic review was to identify the extent of patent foramen ovale prevalence in migraineurs and to determine whether closure of a patent foramen ovale would improve migraine headache. An electronic literature search was performed to select studies between January 1980 and February 2013 that were relevant to the prevalence of patent foramen ovale and migraine, and the effects of intervention(s) on migraine attacks. Of the initial 368 articles presented by the initial search, 20 satisfied the inclusion criteria assessing patent foramen ovale prevalence in migraineurs and 21 presented data on patent foramen ovale closure. In case series and cohort studies, patent foramen ovale prevalence in migraineurs ranged from 14.6% to 66.5%. Case-control studies reported a prevalence ranging from 16.0% to 25.7% in controls, compared with 26.8% to 96.0% for migraine with aura. The extent of improvement or resolution of migraine headache attack symptoms was variable. In case series, intervention ameliorated migraine headache attack in 13.6% to 92.3% of cases. One single randomized trial did not show any benefit from patent foramen ovale closure. The data overall do not exclude the possibility of a placebo effect for resolving migraine following patent foramen ovale closure. This systematic review demonstrates firstly that migraine headache attack is associated with a higher prevalence of patent foramen ovale than among the general population. Observational data suggest that some improvement of migraine would be observed if the patent foramen ovale were to be closed. A proper assessment of any interventions for patent foramen ovale closure would require further large randomized trials to be conducted given uncertainties from existing trial data. Copyright © 2014 Elsevier Inc. All rights reserved.

  8. Preliminary analysis of patent trends for magnetic fusion technology

    International Nuclear Information System (INIS)

    Levine, L.O.; Ashton, W.B.; Campbell, R.S.

    1984-02-01

    This study presents a preliminary analysis of development trends in magnetic fusion technology based on data from US patents. The research is limited to identification and description of general patent activity and ownership characteristics for 373 patents. The results suggest that more detailed studies of fusion patents could provide useful R and D planning information

  9. Japan's patent issues relating to life science therapeutic inventions.

    Science.gov (United States)

    Tessensohn, John A

    2014-09-01

    Japan has made 'innovation in science and technology' as one of its central pillars to ensure high growth in its next stage of economic development and its life sciences market which hosts regenerative medicine was proclaimed to be 'the best market in the world right now.' Although life science therapeutic inventions are patentable subject matter under Japanese patent law, there are nuanced obviousness and enablement challenges under Japanese patent law that can be surmounted in view of some encouraging Japanese court developments in fostering a pro-patent applicant environment in the life sciences therapeutic patent field. Nevertheless, great care must be taken when drafting and prosecuting such patent applications in the world's second most important life sciences therapeutic market.

  10. [INDENA SPA company's patent portfolio of Ginkgo biloba preparation].

    Science.gov (United States)

    Wang, Nan; Guo, Kai; Cheng, Xin-min; Liu, Wei

    2015-10-01

    INDENA SPA Company in Italy is a multi-national company that produces and sells plant extracts. Based on its own re- search advantages in the field of Ginkgo biloba preparation, the company protects its own products market effectively through building patent portfolio around the patents of its opponent. Based on the multi-angle analysis for patent portfolio of G. biloba preparation from the aspects of application time, legal status, technical development route, and patent portfolio layout, this article provides technical reference on research and development of G. biloba preparation, and the author suggest that Chinese applicants learn techniques and layout experiences of other patents fully to enhance the level of research and patent protection level.

  11. Patent analysis for competitive technical intelligence and innovative thinking

    Directory of Open Access Journals (Sweden)

    H Dou

    2006-01-01

    Full Text Available Patents are a very useful source of technical information. The public availability of patents over the Internet, with for some databases (eg. Espacenet the assurance of a constant format, allows the development of high value added products using this information source and provides an easy way to analyze patent information. This simple and powerful tool facilitates the use of patents in academic research, in SMEs and in developing countries providing a way to use patents as a ideas resource thus improving technological innovation.

  12. Trends in genetic patent applications: the commercialization of academic intellectual property.

    Science.gov (United States)

    Kers, Jannigje G; Van Burg, Elco; Stoop, Tom; Cornel, Martina C

    2014-10-01

    We studied trends in genetic patent applications in order to identify the trends in the commercialization of research findings in genetics. To define genetic patent applications, the European version (ECLA) of the International Patent Classification (IPC) codes was used. Genetic patent applications data from the PATSTAT database from 1990 until 2009 were analyzed for time trends and regional distribution. Overall, the number of patent applications has been growing. In 2009, 152 000 patent applications were submitted under the Patent Cooperation Treaty (PCT) and within the EP (European Patent) system of the European Patent Office (EPO). The number of genetic patent applications increased until a peak was reached in the year 2000, with >8000 applications, after which it declined by almost 50%. Continents show different patterns over time, with the global peak in 2000 mainly explained by the USA and Europe, while Asia shows a stable number of >1000 per year. Nine countries together account for 98.9% of the total number of genetic patent applications. In The Netherlands, 26.7% of the genetic patent applications originate from public research institutions. After the year 2000, the number of genetic patent applications dropped significantly. Academic leadership and policy as well as patent regulations seem to have an important role in the trend differences. The ongoing investment in genetic research in the past decade is not reflected by an increase of patent applications.

  13. Access to hepatitis C virus treatment: Lessons from implementation of strategies for increasing access to antiretroviral treatment.

    Science.gov (United States)

    Assefa, Yibeltal; Hill, Peter S; Williams, Owain D

    2018-05-01

    At September's 2017 United Nations General Assembly, a state-of-the-art HIV medicine was announced to be made available at just $75 per person per year. There have been a number of strategies that the global AIDS community and countries have utilized to reduce prices and make antiretrovirals (ARVs) accessible for people living with HIV/AIDS. There appears to be an opportunity for the treatment of hepatitis C virus infection using direct-acting antivirals (DAAs) to benefit from the often painful and laboured history of driving down the prices of ARVs. In general, the success of lowering prices for ARVs has stemmed from the politics needed to initially support generic entry into the on-patent market. The use of flexibilities present in the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) have been used to overcome patent barriers, with the use of compulsory licenses and/or the threat of their use as instruments for strengthening the bargaining power in price negotiations. These strategies have been combined with new financing mechanisms that have promoted more effective procurement and price negotiations. Partnership among the different stakeholders has also been critical in this regard. Countries have also invested in their health systems and implemented several strategies to reduce stigma and discrimination to increase access to and improve utilization of ARVs. This article suggests that any future international initiatives to increase access to DAAs can learn from these lessons surrounding price reduction, improved financing, advocacy, as well as health systems strengthening and stigma reduction. Adopting and reconfiguring these strategies will also incur substantial savings in time, money and lives. Crown Copyright © 2018. Published by Elsevier Ltd. All rights reserved.

  14. Access to hepatitis C virus treatment: Lessons from implementation of strategies for increasing access to antiretroviral treatment

    Directory of Open Access Journals (Sweden)

    Yibeltal Assefa

    2018-05-01

    Full Text Available At September’s 2017 United Nations General Assembly, a state-of-the-art HIV medicine was announced to be made available at just $75 per person per year. There have been a number of strategies that the global AIDS community and countries have utilized to reduce prices and make antiretrovirals (ARVs accessible for people living with HIV/AIDS. There appears to be an opportunity for the treatment of hepatitis C virus infection using direct-acting antivirals (DAAs to benefit from the often painful and laboured history of driving down the prices of ARVs. In general, the success of lowering prices for ARVs has stemmed from the politics needed to initially support generic entry into the on-patent market. The use of flexibilities present in the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS have been used to overcome patent barriers, with the use of compulsory licenses and/or the threat of their use as instruments for strengthening the bargaining power in price negotiations.These strategies have been combined with new financing mechanisms that have promoted more effective procurement and price negotiations. Partnership among the different stakeholders has also been critical in this regard. Countries have also invested in their health systems and implemented several strategies to reduce stigma and discrimination to increase access to and improve utilization of ARVs. This article suggests that any future international initiatives to increase access to DAAs can learn from these lessons surrounding price reduction, improved financing, advocacy, as well as health systems strengthening and stigma reduction. Adopting and reconfiguring these strategies will also incur substantial savings in time, money and lives. Keywords: Acces to medicines, Hepatitis C virus, HIV, Antiretrovirals, Direct-acting antivirals

  15. 76 FR 40339 - Patent Prosecution Highway (PPH) Program

    Science.gov (United States)

    2011-07-08

    ... any of the following methods: E-mail: [email protected] . Include ``0651- 0058 comment... Singapore (IPOS), German Patent and Trade Mark Office (DPMA), National Board of Patents and Registration of... being planned with the USPTO: CIPO, SIPO, and the Nordic Patent Institute (NPI). II. Method of...

  16. [Secret drug tribulations and French legislation].

    Science.gov (United States)

    Charlot, Colette

    2002-01-01

    From an official Montpellier prefecture paper of 18th century, we are interested in a secret drug from Provence origin: the Irroë powder. This purgative will pass from "secret" drug status to "patent" drug. It's notoriety will come from its arrival to Paris. The law of 21th germinal year XI, the decret of 25 prairial year XIII and this of 18th 1810 imposed to give the drug composition to an official status; that examined and permit it's sale. This secret will be produce for half century.

  17. Patent quality and incentives at the patent office

    NARCIS (Netherlands)

    Schuett, F.

    2013-01-01

    Patent examination is a problem of moral hazard followed by adverse selection: examiners must have incentives to exert effort, but also to truthfully reveal the evidence they find. I develop a theoretical model to study the design of incentives for examiners. The model can explain the puzzling

  18. Should we definitively abandon prophylaxis for patent ductus arteriosus in preterm new-borns?

    OpenAIRE

    Fanos,Vassilios; Pusceddu,Michele; Dessì,Angelica; Marcialis,Maria Antonietta

    2011-01-01

    Although the prophylactic administration of indomethacin in extremely low-birth weight infants reduces the frequency of patent ductus arteriosus and severe intraventricular hemorrhage, it does not appear to provide any long-term benefit in terms of survival without neurosensory and cognitive outcomes. Considering the increased drug-induced reduction in renal, intestinal, and cerebral blood flow, the use of prophylaxis cannot be routinely recommended in preterm neonates. However, a better unde...

  19. Budget impact analysis of drugs for ultra-orphan non-oncological diseases in Europe.

    Science.gov (United States)

    Schlander, Michael; Adarkwah, Charles Christian; Gandjour, Afschin

    2015-02-01

    Ultra-orphan diseases (UODs) have been defined by a prevalence of less than 1 per 50,000 persons. However, little is known about budget impact of ultra-orphan drugs. For analysis, the budget impact analysis (BIA) had a time horizon of 10 years (2012-2021) and a pan-European payer's perspective, based on prevalence data for UODs for which patented drugs are available and/or for which drugs are in clinical development. A total of 18 drugs under patent protection or orphan drug designation for non-oncological UODs were identified. Furthermore, 29 ultra-orphan drugs for non-oncological diseases under development that have the potential of reaching the market by 2021 were found. Total budget impact over 10 years was estimated to be €15,660 and €4965 million for approved and pipeline ultra-orphan drugs, respectively (total: €20,625 million). The analysis does not support concerns regarding an uncontrolled growth in expenditures for drugs for UODs.

  20. Are the Brookhill-Wilk patents impediments to market growth in cybersurgery?

    Science.gov (United States)

    McLean, T R; Torrance, A W

    2008-03-01

    In the past, many surgeons could practise their craft with little or no knowledge of patent law. But in the world of robotic and computerized surgery, this is increasingly a myopic approach, because the principle means of protecting high-tech surgical instruments is through the application of patent law. The issue is: does the Brookhill-Wilk patent, which covers the performance of remote robotic surgery, impede the growth of cybersurgery? Review of the Brookhill-Wilk patent and relevant law. Patent law, which first took its form in the Middle Ages, attempts to balance the rewarding of innovation with the stifling of market growth. Using US patent law as a model, it would appear that the Brookhill-Wilk patent, a particular example of a medical process patent, could inhibit the growth of cybersurgery, as potential sums of money could be demanded by the patent holder from anyone who practises cybersurgery. However, two recent US Supreme Court cases appear to have seriously undermined the validity of a number of medical process patents, including the Brookhill-Wilk patent. Based on recent changes in patent law, it is not expected that Brookhill-Wilk patent will hinder the growth of cybersurgery.

  1. Patent Foramen Ovale: Is Stroke Due to Paradoxical Embolism?

    Science.gov (United States)

    Ranoux, D.; Cohen, A.; Cabanes, L.; Amarenco, P.; Bousser, M. G.; Mas, J. L.

    1993-01-01

    Background and Purpose: A patent foramen ovale has been reported to be significantly more frequent in young stroke patients than in matched control subjects, and paradoxical embolism has been suggested as the main mechanism of stroke in-this situation. The present study was designed to test this hypothesis. Methods: Sixty-eight consecutive patients under 55 years of age presenting with an ischemic stroke had an extensive workup, including transesophageal echocardiography with contrast. We compared the prevalence of criteria for the diagnosis of paradoxical embolism in patients with and without a patent foramen ovale. Results: A patent foramen ovale was found in 32 patients (47%). A Valsalva-provoking activity was present at stroke onset in six patients with a patent foramen ovale and in eight patients with no patent foramen ovale (X(sup 2)=0.1, nonsignificant). Clinical/radiological features suggestive of an embolic mechanism were not more frequent in patients with a patent foramen ovale. Clinical evidence of deep vein thrombosis was present in one patient with a patent foramen ovale and in none of the others. No occult venous thrombosis was found in a subgroup of patients with a patent foramen ovale and no definite cause for stroke who underwent venography (n=13). Conclusions. Our results do not support the hypothesis that paradoxical embolism is the primary mechanism of stroke in patients with a patent foramen ovale. (Stroke 1993;24:31-34) KEY WORDS e cerebral ischemia e embolism foramen ovale, patent

  2. p38 MAPK inhibitors: a patent review (2012 - 2013).

    Science.gov (United States)

    Bühler, Stefanie; Laufer, Stefan A

    2014-05-01

    The p38 MAPK is a ubiquitous target in the research-based pharmaceutical industry. It plays a decisive role in the regulation of the production of proinflammatory cytokines. Since novel biological therapies have revolutionized the treatment of chronic inflammatory diseases, an intensive global search is underway for small molecules for the same application. Herein, the patents and the corresponding publications of international companies, which focus on the development and identification of a new generation of small-molecule p38 inhibitors, are summarized. The most promising approach is the development of linear binders, which induce a glycine flip at Gly110 of the kinase hinge region by a carbonyl oxygen atom of the respective ligand. The major focus of the patent works was the application of molecules in new indications. Previous applications were in the treatment of rheumatoid arthritis; currently, there are several new applications, including pulmonary diseases, cancer and Alzheimer's disease. Targeting p38 upstream kinases and downstream effectors has also proved to be a very promising step in the development of more effective inhibitors. A further trend is drug combination, applied to a wide range of indications, such as chronic obstructive pulmonary disease and cancer.

  3. Disclosure rules and declared essential patents

    NARCIS (Netherlands)

    Bekkers, R.N.A.; Catalini, C.; Martinelli, Arianna; Righi, C.; Simcoe, T.

    Many standard setting organizations (SSOs) require participants to disclose patents that might be infringed by implementing a proposed standard, and commit to license their “essential” patents on terms that are at least fair, reasonable and non-discriminatory (FRAND). Data from these SSO

  4. 9 CFR 124.20 - Patent term extension calculation.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Patent term extension calculation. 124... OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PATENT TERM RESTORATION Regulatory Review Period § 124.20 Patent term extension calculation. (a) As provided in 37 CFR 1...

  5. Patent prosecution strategies for stem cell related applications.

    Science.gov (United States)

    Kumar, Rajeev; Yeh, Jenny J; Fernandez, Dennis; Hansen, Nels

    2007-09-01

    Stem cell research and the intellectual property derived from it, because of its potential to completely transform health care, demand an especially high level of consideration from business and patent prosecution perspectives. As with other revolutionary technologies, ordinary risks are amplified (e.g., litigation), and ordinarily irrelevant considerations may become important (e.g., heightened level of both domestic and foreign legislative risk). In the first part of this article, general strategies for patent prosecutors such as several prosecution considerations and methods for accelerating patent prosecution process are presented. In the second part, patent prosecution challenges of stem cell-related patents and possible solutions are discussed. In the final part, ethical and public policy issues particular to stem cell-related and other biotechnological inventions are summarized.

  6. Drug policy in United States of America

    OpenAIRE

    Stahl, Edmundo G.; Médico internista, President and Chief Executive Officer, LatAmScience. Florida, USA.

    2009-01-01

    The USA federal prescription drug policies are inconsistent. The federal government regulates the development, production, marketing and safety of prescription drugs in the country through various legal mechanisms as well as private and governmental institutions. Patent laws also play an important role in this process protecting the pharmaceutical industry. The government has no direct mechanism to control prices of prescription drugs nor does it have a policy to cover the whole US popula...

  7. Annotated chemical patent corpus: a gold standard for text mining.

    Directory of Open Access Journals (Sweden)

    Saber A Akhondi

    Full Text Available Exploring the chemical and biological space covered by patent applications is crucial in early-stage medicinal chemistry activities. Patent analysis can provide understanding of compound prior art, novelty checking, validation of biological assays, and identification of new starting points for chemical exploration. Extracting chemical and biological entities from patents through manual extraction by expert curators can take substantial amount of time and resources. Text mining methods can help to ease this process. To validate the performance of such methods, a manually annotated patent corpus is essential. In this study we have produced a large gold standard chemical patent corpus. We developed annotation guidelines and selected 200 full patents from the World Intellectual Property Organization, United States Patent and Trademark Office, and European Patent Office. The patents were pre-annotated automatically and made available to four independent annotator groups each consisting of two to ten annotators. The annotators marked chemicals in different subclasses, diseases, targets, and modes of action. Spelling mistakes and spurious line break due to optical character recognition errors were also annotated. A subset of 47 patents was annotated by at least three annotator groups, from which harmonized annotations and inter-annotator agreement scores were derived. One group annotated the full set. The patent corpus includes 400,125 annotations for the full set and 36,537 annotations for the harmonized set. All patents and annotated entities are publicly available at www.biosemantics.org.

  8. Languages, Fees and the International Scope of Patenting

    DEFF Research Database (Denmark)

    Harhoff, Dietmar; Hoisl, Karin; Van Pottelsberghe de la Potterie, Bruno

    2016-01-01

    Pottelsberghe, 2006; von Graevenitz et al., 2013) and on potential implications of their behaviour for the effectiveness of the patent system. Lately, a number of researchers have started to explore the design of the patent system itself, i.e. the role of fees and costs of patenting (Archontopoulos et al., 2007...

  9. The Effects of Oral Ibuprofen on Medicinal Closure of Patent Ductus Arteriosus in Full-Term Neonates in the Second Postnatal Week.

    Science.gov (United States)

    Alipour, Mohammad Reza; Mozaffari Shamsi, Mansooreh; Namayandeh, Seyedeh Mahdieh; Pezeshkpour, Zohreh; Rezaeipour, Fatemeh; Sarebanhassanabadi, Mohammadtaghi

    2016-08-01

    The arterial ductus is a major communicative pathway which is naturally patent in the fetus, connecting the body of the major pulmonary artery to the descending aorta. Although usually closing on its own, the patent ductus arteriosus (PDA) may remain open in the second postnatal week due to a lack of prompt diagnosis in the initial days of life or an absence of prompt treatment. To prevent the untoward sequelae of patency of the ductus arteriosus, and to avoid invasive surgery at higher ages, the researchers in the present study embarked on determining the effects of oral ibuprofen during the second postnatal week on newborns with patent ductus arteriosus. In this study, 70 neonates aged eight to 14 days, presenting at Khatam-al-Anbia clinic and the NICU ward of Shahid Sadoughi hospital in Yazd, Iran, who were diagnosed with PDA through auscultation of heart murmurs and echocardiography, were randomly assigned to two groups. The experimental group received oral ibuprofen of 10 mg/kg in day 1, 5 mg/kg in day 2, and 5 mg/kg in day 3 administered by their parents. The control group did not receive any drug. Parents were informed of the potential drug complications and side effects and asked to report them to the researchers if any occurred. After intervention, the patent ductus arteriosus was closed in 62.9% of the neonates in the experimental group (35 newborns) who received oral ibuprofen, while it was closed in 54.3% of the control neonates (35 newborns) who did not receive any drug (P = 0.628). No complications were observed in either of the neonatal groups. Our findings showed that administration of oral ibuprofen had no significant effect on the medicinal closure of PDA in full-term neonates during the second postnatal week.

  10. Modeling HIV vaccines in Brazil: assessing the impact of a future HIV vaccine on reducing new infections, mortality and number of people receiving ARV.

    Directory of Open Access Journals (Sweden)

    Maria Goretti P Fonseca

    2010-07-01

    Full Text Available The AIDS epidemic in Brazil remains concentrated in populations with high vulnerability to HIV infection, and the development of an HIV vaccine could make an important contribution to prevention. This study modeled the HIV epidemic and estimated the potential impact of an HIV vaccine on the number of new infections, deaths due to AIDS and the number of people receiving ARV treatment, under various scenarios.The historical HIV prevalence was modeled using Spectrum and projections were made from 2010 to 2050 to study the impact of an HIV vaccine with 40% to 70% efficacy, and 80% coverage of adult population, specific groups such as MSM, IDU, commercial sex workers and their partners, and 15 year olds. The possibility of disinhibition after vaccination, neglecting medium- and high-risk groups, and a disease-modifying vaccine were also considered. The number of new infections and deaths were reduced by 73% and 30%, respectively, by 2050, when 80% of adult population aged 15-49 was vaccinated with a 40% efficacy vaccine. Vaccinating medium- and high-risk groups reduced new infections by 52% and deaths by 21%. A vaccine with 70% efficacy produced a great decline in new infections and deaths. Neglecting medium- and high-risk population groups as well as disinhibition of vaccinated population reduced the impact or even increased the number of new infections. Disease-modifying vaccine also contributed to reducing AIDS deaths, the need for ART and new HIV infections.Even in a country with a concentrated epidemic and high levels of ARV coverage, such as Brazil, moderate efficacy vaccines as part of a comprehensive package of treatment and prevention could have a major impact on preventing new HIV infections and AIDS deaths, as well as reducing the number of people on ARV. Targeted vaccination strategies may be highly effective and cost-beneficial.

  11. An advanced search engine for patent analytics in medicinal chemistry.

    Science.gov (United States)

    Pasche, Emilie; Gobeill, Julien; Teodoro, Douglas; Gaudinat, Arnaud; Vishnykova, Dina; Lovis, Christian; Ruch, Patrick

    2012-01-01

    Patent collections contain an important amount of medical-related knowledge, but existing tools were reported to lack of useful functionalities. We present here the development of TWINC, an advanced search engine dedicated to patent retrieval in the domain of health and life sciences. Our tool embeds two search modes: an ad hoc search to retrieve relevant patents given a short query and a related patent search to retrieve similar patents given a patent. Both search modes rely on tuning experiments performed during several patent retrieval competitions. Moreover, TWINC is enhanced with interactive modules, such as chemical query expansion, which is of prior importance to cope with various ways of naming biomedical entities. While the related patent search showed promising performances, the ad-hoc search resulted in fairly contrasted results. Nonetheless, TWINC performed well during the Chemathlon task of the PatOlympics competition and experts appreciated its usability.

  12. Affordability of adult HIV/AIDS treatment in developing countries: modelling price determinants for a better insight of the market functioning.

    Science.gov (United States)

    Sagaon-Teyssier, Luis; Singh, Sauman; Dongmo-Nguimfack, Boniface; Moatti, Jean-Paul

    2016-01-01

    This study aims to provide a landscape of the global antiretroviral (ARV) market by analyzing the transactional data on donor-funded ARV procurement between 2003 and 2015, and the ARV price determinants. The data were obtained from the Global Price Reporting Mechanism (GPRM) managed by the AIDS Medicines and Diagnostics Service of the WHO, and it consists of information that covers approximately 80% of the total donor-funded adult ARV transactions procurement. ExWorks prices and procured quantities were standardized according to the guidelines in terms of yearly doses. Descriptive statistics on quantities and prices show the main trends of the ARV market. Ordinary least squares estimation was carried out for the whole sample, then stratified according to the type of supplier (originator and generic) and controlled for time and geographical fixed-effects. Given that analyses were carried out on a public dataset on ARV transactional prices from the GPRM, ethics are respected and consent was not necessary. Originator medicines are on average the least expensive in the sub-Saharan Africa region, where at the same time, generic medicines are on average the most expensive. By contrast, originator medicines are the most expensive in Europe and Central Asia, and generic medicines are the least expensive. In fact, the data suggest mixed strategies by ARV suppliers to exploit opportunities for profit maximization and to adapt to the specific conditions of market competition in each region. Our results also suggest that the expiration of patents is not sufficient to boost additional developments in generic competition (at least in the ARV market) and that formal or informal agreements between generic firms may de facto slow down or even reverse long-term trends towards price decreases. Our findings provide an improved understanding of the ARV market that can help countries strengthen policy measures to increase their bargaining power in price negotiations and the use of TRIPS

  13. Nanotechnology strength indicators: international rankings based on US patents

    Science.gov (United States)

    Marinova, Dora; McAleer, Michael

    2003-01-01

    Technological strength indicators (TSIs) based on patent statistics for 1975-2000 are used to analyse patenting of nanotechnology in the USA, and to compile international rankings for the top 12 foreign patenting countries (namely Australia, Canada, France, Germany, Great Britain, Italy, Japan, Korea, the Netherlands, Sweden, Switzerland and Taiwan). As the indicators are not directly observable, various proxy variables are used, namely the technological specialization index for national priorities, patent shares for international presence, citation rate for the contribution of patents to knowledge development and rate of assigned patents for potential commercial benefits. The best performing country is France, followed by Japan and Canada. It is shown that expertise and strength in nanotechnology are not evenly distributed among the technologically advanced countries, with the TSIs revealing different emphases in the development of nanotechnology.

  14. Measuring performance in off-patent drug markets: a methodological framework and empirical evidence from twelve EU Member States.

    Science.gov (United States)

    Kanavos, Panos

    2014-11-01

    This paper develops a methodological framework to help evaluate the performance of generic pharmaceutical policies post-patent expiry or after loss of exclusivity in non-tendering settings, comprising five indicators (generic availability, time delay to and speed of generic entry, number of generic competitors, price developments, and generic volume share evolution) and proposes a series of metrics to evaluate performance. The paper subsequently tests this framework across twelve EU Member States (MS) by using IMS data on 101 patent expired molecules over the 1998-2010 period. Results indicate that significant variation exists in generic market entry, price competition and generic penetration across the study countries. Size of a geographical market is not a predictor of generic market entry intensity or price decline. Regardless of geographic or product market size, many off patent molecules lack generic competitors two years after loss of exclusivity. The ranges in each of the five proposed indicators suggest, first, that there are numerous factors--including institutional ones--contributing to the success of generic entry, price decline and market penetration and, second, MS should seek a combination of supply and demand-side policies in order to maximise cost-savings from generics. Overall, there seems to be considerable potential for faster generic entry, uptake and greater generic competition, particularly for molecules at the lower end of the market. Copyright © 2014. Published by Elsevier Ireland Ltd.

  15. Biological diversity in the patent system.

    Directory of Open Access Journals (Sweden)

    Paul Oldham

    Full Text Available Biological diversity in the patent system is an enduring focus of controversy but empirical analysis of the presence of biodiversity in the patent system has been limited. To address this problem we text mined 11 million patent documents for 6 million Latin species names from the Global Names Index (GNI established by the Global Biodiversity Information Facility (GBIF and Encyclopedia of Life (EOL. We identified 76,274 full Latin species names from 23,882 genera in 767,955 patent documents. 25,595 species appeared in the claims section of 136,880 patent documents. This reveals that human innovative activity involving biodiversity in the patent system focuses on approximately 4% of taxonomically described species and between 0.8-1% of predicted global species. In this article we identify the major features of the patent landscape for biological diversity by focusing on key areas including pharmaceuticals, neglected diseases, traditional medicines, genetic engineering, foods, biocides, marine genetic resources and Antarctica. We conclude that the narrow focus of human innovative activity and ownership of genetic resources is unlikely to be in the long term interest of humanity. We argue that a broader spectrum of biodiversity needs to be opened up to research and development based on the principles of equitable benefit-sharing, respect for the objectives of the Convention on Biological Diversity, human rights and ethics. Finally, we argue that alternative models of innovation, such as open source and commons models, are required to open up biodiversity for research that addresses actual and neglected areas of human need. The research aims to inform the implementation of the 2010 Nagoya Protocol on Access to Genetic Resources and the Equitable Sharing of Benefits Arising from their Utilization and international debates directed to the governance of genetic resources. Our research also aims to inform debates under the Intergovernmental Committee on

  16. 48 CFR 627.203 - Patent indemnification of Government by contractor.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false Patent indemnification of Government by contractor. 627.203 Section 627.203 Federal Acquisition Regulations System DEPARTMENT OF STATE GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Patents 627.203 Patent indemnification of...

  17. Analysing patent landscapes in plant biotechnology and new plant breeding techniques.

    Science.gov (United States)

    Parisi, Claudia; Rodríguez-Cerezo, Emilio; Thangaraj, Harry

    2013-02-01

    This article aims to inform the reader of the importance of searching patent landscapes in plant biotechnology and the use of basic tools to perform a patent search. The recommendations for a patent search strategy are illustrated with the specific example of zinc finger nuclease technology for genetic engineering in plants. Within this scope, we provide a general introduction to searching using two online and free-access patent databases esp@cenet and PatentScope. The essential features of the two databases, and their functionality is described, together with short descriptions to enable the reader to understand patents, searching, their content, patent families, and their territorial scope. We mostly stress the value of patent searching for mining scientific, rather than legal information. Search methods through the use of keywords and patent codes are elucidated together with suggestions about how to search with or combine codes with keywords and we also comment on limitations of each method. We stress the importance of patent literature to complement more mainstream scientific literature, and the relative complexities and difficulties in searching patents compared to the latter. A parallel online resource where we describe detailed search exercises is available through reference for those intending further exploration. In essence this is aimed at a novice patent searcher who may want to examine accessory patent literature to complement knowledge gained from mainstream journal resources.

  18. Transferability and Commercialization of Patent Rights: Economic and Practical Perspectives

    Directory of Open Access Journals (Sweden)

    Haim V. Levy

    2012-01-01

    Full Text Available The transformation of innovation into commercial value depends primarily on appropriate protection of the intellectual property, usually by patents, and efficient pathway(s of its transferability as well as the transfer of the protected knowledge. The key features of patents, from an economic perspective, are that they encompass new knowledge and confer monopoly rights to the owner. The exclusiveness of patent rights is generally conceived as a necessary mechanism to ensure further innovation, stimulate advanced research and facilitate efficient market transactions with patent rights. The patent holder can transfer the technology embodied by way of granting to others a license to use the patented invention in return for a share of the revenues, usually royalties. Patent rights transferability has been proven to be efficient and profitable to the industry as well as beneficial to the welfare of society. The economic and practical perspectives of the transferability and commercialization of patent rights are discussed.

  19. 37 CFR 1.501 - Citation of prior art in patent files.

    Science.gov (United States)

    2010-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Citation of prior art in patent files. 1.501 Section 1.501 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES Ex Parte Reexamination of...

  20. Tracking U.S. biofuel innovation through patents

    International Nuclear Information System (INIS)

    Kessler, Jeff; Sperling, Daniel

    2016-01-01

    We use biofuel patents as a proxy for biofuel innovation. Through use of natural language processing and machine-learning algorithms, we expand patent classification capabilities to better explain the history of biofuels innovation. Results indicate that after the initial establishment of the U.S. biofuel industry, there were two surges in biofuel innovation: 1995–2000, characterized by heavy patenting by 1st generation (food-based) biofuel firms; and 2005–2010, characterized by a second surge of innovation by those same large firms, complemented by a large number of biotechnology firms producing a relatively small number of 2nd generation biofuel patents. Our analysis corroborates the widespread understanding that the first surge in biofuel innovation was linked to innovations in agriculture, and that the second surge of biofuel innovation was driven by demand-pull policies mandating and incentivizing biofuels. But the slow emergence of a 2nd generation cellulose-based biofuels industry, far slower than called for by policy, suggests that technology-push policies more focused on R&D and investment may be needed to accelerate the commercialization of 2nd generation biofuels. - Highlights: • Patenting activity closely corresponds to sociotechnical shifts in biofuel innovation. • The Renewable Fuel Standard likely contributed to the rise in biofuel patenting activity after 2005. • 2nd generation biofuel technology innovation appears lacking compared to 1st generation technologies.