Download or read book Legislative and Regulatory Responses to the Ftc Study on Barriers to Entry in the Pharmaceutical Marketplace written by United States. Congress and published by Createspace Independent Publishing Platform. This book was released on 2018-02-15 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt: Legislative and regulatory responses to the FTC study on barriers to entry in the pharmaceutical marketplace : hearing before the Committee on the Judiciary, United States Senate, One Hundred Eighth Congress, first session, June 17, 2003.
Download or read book Legislative and Regulatory Responses to the FTC Study on Barriers to Entry in the Pharmaceutical Marketplace written by United States Senate and published by . This book was released on 2020-03-11 with total page 122 pages. Available in PDF, EPUB and Kindle. Book excerpt: Legislative and regulatory responses to the FTC study on barriers to entry in the pharmaceutical marketplace: hearing before the Committee on the Judiciary, United States Senate, One Hundred Eighth Congress, first session, June 17, 2003.
Download or read book Legislative and Regulatory Responses to the FTC Study on Barriers to Entry in the Pharmaceutical Marketplace written by United States. Congress. Senate. Committee on the Judiciary and published by . This book was released on 2003 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Legislative and Regulatory Responses to the FTC Study on Barriers to Entry in the Pharmaceutical Marketplace Hearing Before the Committee on the United States Senate One Hundred Eighth Congress First Session written by and published by . This book was released on 2003 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Legislative and Regulatory Responses to the FTC Study on Barriers to Entry in the Pharmaceutical Marketplace written by United States. Congress. Senate. Committee on the Judiciary and published by . This book was released on 2003 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book LEGISLATIVE AND REGULATORY RESPONSES TO THE FTC STUDY ON BARRIERS TO HEARING S HRG 108 250 COMMITTEE ON THE JUDICIARY UNITED ST written by and published by . This book was released on 2004* with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law written by Amalia Athanasiadou and published by Kluwer Law International B.V.. This book was released on 2018-08-14 with total page 520 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reverse payment settlements or “pay-for-delay agreements” between originators and generic drug manufacturers create heated debates regarding the balance between competition and intellectual property law. These settlements touch upon sensitive issues such as timely generic entry and access to affordable pharmaceuticals and also the need to preserve innovation incentives for originators and to strengthen the pipeline of life-saving pharmaceuticals. This book is one of the first to critically and comparatively analyse how such patent settlements and various other strategies employed by the pharmaceutical industry are scrutinised by both United States (US) and European courts and enforcement authorities, and to discuss the applicable legal tests and the main criteria used for their assessment. The book’s ultimate objective is to provide guidance to the pharmaceutical industry regarding the types of patent settlements, strategies and conduct which may be problematic from US antitrust and European Union (EU) competition law perspectives and to assist practitioners in structuring settlements which are both efficient and compliant. To this end, an exhaustive legal analysis of some of the most controversial issues regarding pharmaceutical patent settlements is provided, including: – the lengthy split among US Circuit Courts on the issue of pay-for-delay settlements, its resolution by the US Supreme Court in FTC v. Actavisand subsequent jurisprudence; – the decision of Lundbeck v. Commissionby the European General Court and the Servier decision of the European Commission; – the Roche/Novartisdecision of the European Court of Justice and the most important decisions by National Competition Authorities on pharma patent settlements in the EU; – an overview of other types of strategies such as product-hopping and product reformulations, no-authorised generic commitments, problematic side-deals, mechanisms affecting generic substitution; – the rejection of the “scope of the patent” test in both the US and the EU and the balancing of patent law and antitrust law considerations in the prevailing applicable tests; – the benefits of settlements and the main criteria for assessing their legitimacy under US antitrust and EU competition law. The analysis provides concrete examples of both illegitimate and legitimate settlements and strategies, emphasising on conduct that falls within a grey zone and on the circumstances and criteria under which such conduct could be deemed problematic from an antitrust perspective. This book will serve as a valuable guide for pharmaceutical companies wishing to minimise the risk of engaging in conduct that could potentially infringe US antitrust and EU competition law. It further aims to save courts and enforcement agencies and also practitioners and academics considerable time and resources by providing an exhaustive analysis of the relevant caselaw, with the ultimate goal to increase legal certainty on the most controversial aspects of patent settlements in the pharmaceutical industry.
Download or read book Legislative and Executive Calendar written by United States. Congress. Senate. Committee on the Judiciary and published by . This book was released on with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book H R 1706 the Protecting Consumer Access to Generic Drugs Act of 2009 written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Commerce, Trade, and Consumer Protection and published by . This book was released on 2012 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Making Medicines Affordable written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-03-01 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.
Download or read book Strategy Predation and Antitrust Analysis written by Steven C. Salop and published by . This book was released on 1981 with total page 772 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Pharmaceutical Industry written by Roy Levy and published by DIANE Publishing. This book was released on 1999 with total page 226 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Generic drug entry prior to patent expiration an FTC study written by and published by DIANE Publishing. This book was released on 2002 with total page 129 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The United States Patents Quarterly written by and published by . This book was released on 2010 with total page 1172 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Evolving IP Marketplace written by Suzanne Michael and published by DIANE Publishing. This book was released on 2011-05 with total page 309 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report recommends improvements to two areas of patent law policies affecting how well a patent gives notice to the public of what technology is protected and remedies for patent infringement. The report provides valuable insights on how courts can reform the patent system to best serve consumers. It recognizes that patents play a critical role in encouraging innovation, but it also observes that some strategies by patent holders risk distorting competition and deterring innovation. This is especially true for activity driven by poor patent notice, and by remedies that do not align the compensation received by patent holders for infringement with the economic value of their patented inventions. This is a print on demand report.
Download or read book Studies on Competition and Antitrust Issues in the Pharmaceutical Industry written by Ann-Kathrin Lehnhausen and published by Springer. This book was released on 2016-11-14 with total page 95 pages. Available in PDF, EPUB and Kindle. Book excerpt: This publication examines how drug originator manufacturers manage to shield their products from competition. It characterizes the pharmaceutical industry in detail and analyzes actions that violate antitrust laws in the USA and/or the European Union. The publication examines, for example, pay-for-delay strategies, market foreclosure, resale price maintenance, but also mergers and acquisitions, while taking into account market specificities such as the unique research and development process. The study explains why drug prices sometimes remain at elevated levels even after the drug’s patent protection has expired. Knowing the characteristics of such anticompetitive strategies helps customers such as health insurance companies to develop effective counter-strategies.
Download or read book Corporate Crime in the Pharmaceutical Industry Routledge Revivals written by John Braithwaite and published by Routledge. This book was released on 2013-10-08 with total page 451 pages. Available in PDF, EPUB and Kindle. Book excerpt: First published in 1984, this book examines corporate crime in the pharmaceutical industry. Based on extensive research, including interviews with 131 senior executives of pharmaceutical companies in the United States, the United Kingdom, Australia, Mexico and Guatemala, the book is a major study of white-collar crime. Written in the 1980s, it covers topics such as international bribery and corruption, fraud in the testing of drugs and criminal negligence in the unsafe manufacturing of drugs. The author considers the implications of his findings for a range of strategies to control corporate crime, nationally and internationally.
