PharmSciRN: Pharmaceutical Intellectual Property Protection (Topic)最新文献

{"title":"The Price Tag of 'Pay-for-Delay'","authors":"Robin C. Feldman","doi":"10.2139/ssrn.3846484","DOIUrl":"https://doi.org/10.2139/ssrn.3846484","url":null,"abstract":"In a landmark decision nearly a decade ago, the U.S. Supreme Court opened the door for antitrust suits against brand and generic pharmaceutical companies who engage in collusive settlements to delay the time for the generic to come to market. With these “pay-for-delay” agreements, brand-name companies offer prospective generics some form of compensation in exchange for the generic’s promise not to enter the market until an agreed-upon date. Laying the groundwork for the lawsuit that would eventually lead to the Actavis decision, the Federal Trade Commission (“FTC”) published a study estimating that pay-for-delay agreements cost American consumers $3.5 billion annually, a figure that has been cited repeatedly by scholars and policymakers alike. \u0000To understand the state of pay-for-delay agreements, this Article presents an in-depth examination of the burden that pay-for-delay imposes, both on society at large and on individual patients, and explores the modern legal landscape that has emerged since the Supreme Court’s historic pronouncement. Part I describes pay- for-delay agreements, exploring the literature on the potential harm of such agreements among pharmaceutical competitors. Part II presents a new analysis demonstrating that the cost of pay-for-delay to American consumers is far greater than anyone has recognized, and well beyond the $3.5 billion figure cited by the FTC in 2010. We applied six different methodologies to provide as fair and broad a view as possible. The range of methodologies show that at a minimum, the cost of pay-for-delay settlements on the U.S. population between 2006 and 2017 is $6.2 billion per year—almost double that of the FTC’s estimate. The methodology with the largest result suggests that the cost could be as high as $37.1 billion per year— ten times higher. Part III argues that courts are allowing this costly problem to flourish unchecked. This part reviews pay-for-delay decisions since Actavis, arguing that the courts have failed to properly analyze such cases from the perspective of all three notions inherent in the words “pay,” “for,” and “delay.” Finally, Part IV offers a path forward through the doctrinal haze.","PeriodicalId":128340,"journal":{"name":"PharmSciRN: Pharmaceutical Intellectual Property Protection (Topic)","volume":"22 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126042063","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Taking Action to Topple the Great Wall Around American Pharmaceutical 'Trade Secrets'","authors":"Connor D. Hicks","doi":"10.2139/SSRN.3842489","DOIUrl":"https://doi.org/10.2139/SSRN.3842489","url":null,"abstract":"The Food and Drug Administration is one of the most stringent regulatory bodies in the world. As American consumers continue to ingest more pharmaceuticals yearly, the ingredients within these products are increasingly outsourced. Due to the strict oversight of the FDA, American pharmaceutical companies have moved towards outsourcing the majority of ingredients abroad, specifically to China and India. While these products are consumed by millions of Americans daily, inspection occurs only at import, and the ingredients are then assembled domestically and sold as if they were made entirely in the United States. \u0000 \u0000Because these ingredients come from facilities that are largely under-regulated, this presents a legitimate risk to the health of consumers. Beyond that, the average consumer does not even know, because the companies claim this sourcing information to be protected by “trade secret” and thus not a required disclosure. As China and India gain a larger share of the pharmaceutical market yearly, it is essential that Congress take action to ensure proper oversight of the ingredients in U.S. products and necessary disclosure to the consumer.","PeriodicalId":128340,"journal":{"name":"PharmSciRN: Pharmaceutical Intellectual Property Protection (Topic)","volume":"11 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116873252","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"New Drugs to Tackle Antimicrobial Resistance: Analysis of EU Policy Options","authors":"Priya Sharma, A. Towse","doi":"10.2139/ssrn.2640028","DOIUrl":"https://doi.org/10.2139/ssrn.2640028","url":null,"abstract":"Antimicrobial resistance (AMR) is becoming a major global public health threat, contributing to the growing problem of drug resistance, a naturally occurring consequence of treating infectious diseases with drugs. Recently, AMR has begun to command attention from European policy makers whose focus has moved towards addressing the lack of new drugs in the R&D pipeline of the pharmaceutical industry.In 2009 the EU focused on the need for the development of new antibacterials to fill the pipeline and the need for the introduction of appropriate incentives to stimulate R&D for novel antibiotics. A Report commissioned from the London School of Economics (LSE) examined appropriate ways to stimulate the development of new antibiotics. Its findings, and other material were discussed at a conference in Stockholm in September 2009.The purpose of this paper is to contribute to the discussion that began in Stockholm by presenting policy makers and other relevant stakeholders with a short list of feasible and realistic solutions for Europe to stimulate R&D by attempting to determine the size of the various incentives needed to make the net present value (NPV) for antibiotic development more competitive relative to other therapeutic classes. To do this we selected incentives that have been implemented or discussed in regards to addressing disincentives and market failures in other markets: neglected diseases, orphan drugs, countermeasures against chemical, biological, radiological and nuclear (CBRN) agents, and evidence for paediatric drug use.","PeriodicalId":128340,"journal":{"name":"PharmSciRN: Pharmaceutical Intellectual Property Protection (Topic)","volume":"23 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2010-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123499110","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}