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Pharmaceutical Pay For Delay Reexamined
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Book Synopsis Pharmaceutical 'Pay-for-Delay' Reexamined by : Laura Karas
Download or read book Pharmaceutical 'Pay-for-Delay' Reexamined written by Laura Karas and published by . This book was released on 2020 with total page 16 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Supreme Court ruled in FTC v. Actavis that a delay in generic entry may be anticompetitive when part of a patent settlement that includes a large and otherwise unjustified value transfer to the generic company, termed a reverse payment patent settlement, or “pay-for-delay.” Following Actavis, drug companies have limited the size of reverse payments and have fashioned settlement terms that include more discreet categories of compensation to generic companies. In light of the fact that such settlements retain the potential for anticompetitive effects, the apparent size of the reverse payment may no longer be a useful gauge of the legality of pay-for-delay deals. In this article, we argue that convoluted settlements in the post-Actavis landscape that camouflage value transfers from brand-name to generic companies necessitate a shift in the focus of antitrust scrutiny to the existence of any restriction on generic entry together with a category of patent less likely to survive a challenge. We conclude with a discussion of pay-for-delay bills in the 116th Congress and propose several reforms to deter pay-for-delay behavior.
Book Synopsis Pay-for-Delay: How Drug Company Pay-Offs Cost Consumers Billions by :
Download or read book Pay-for-Delay: How Drug Company Pay-Offs Cost Consumers Billions written by and published by DIANE Publishing. This book was released on 2010 with total page 16 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts and Competition Policy Publisher : ISBN 13 : Total Pages :184 pages Book Rating :4.:/5 (327 download)
Book Synopsis Pay to Delay by : United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts and Competition Policy
Download or read book Pay to Delay written by United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts and Competition Policy and published by . This book was released on 2010 with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis A Brief Introduction to Competition Concerns in 'Pay-for-Delay' Settlement Agreements Between Brand-Name and Generic Drug Companies by : Rudolph J.R Peritz
Download or read book A Brief Introduction to Competition Concerns in 'Pay-for-Delay' Settlement Agreements Between Brand-Name and Generic Drug Companies written by Rudolph J.R Peritz and published by . This book was released on 2013 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Antitrust authorities in both the United States and Europe have expressed deep concern over settlements of antitrust cases in the pharmaceutical sector, settlements involving “reverse payments” from plaintiffs to defendants, large sums paid by branded pharmaceutical companies to generic competitors in exchange for promises to stay off the market. Such “pay-for-delay” settlements have proliferated in the United States since federal circuit courts of appeals have found them unproblematic despite the Federal Trade Commission's persistently strong position that they violate the antitrust laws. These cases arise at the intersection of three statutory regimes seeking to promote innovation, three clusters of doctrine and policy that have interacted only to reach impasse: the Patent Act, the 1984 amendment to the Food, Drug, and Cosmetic Act, and finally the Sherman Anti-Trust Act. Antitrust is a late comer to the fierce competition over patented drugs, competition that permeates the approval process in the Food & Drug Administration [the FD , competition that is restrained by these pay-for-delay settlement agreements. To set the stage, we begin with the Patent Act and its relationship to the FDA approval process. The story of pay-for-delay settlements then proceeds to the settlement agreements and their antitrust implications. We conclude that the best solution in these antitrust cases would be adoption of the FTC's approach of presumptive illegality. Together with an amendment proposed to fix the food and drug act, the presumptive illegality of pay-for-delay settlements under the antitrust laws would make the market for pharmaceuticals more price competitive, open weak patents to serious challenge, and as a result save consumers billions of dollars annually without taking from branded drug companies legitimately earned incentives to engage in research and development.
Author :United States Congress Publisher :Createspace Independent Publishing Platform ISBN 13 :9781978279537 Total Pages :184 pages Book Rating :4.2/5 (795 download)
Book Synopsis Pay to Delay by : United States Congress
Download or read book Pay to Delay written by United States Congress and published by Createspace Independent Publishing Platform. This book was released on 2017-10-15 with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pay to delay: are patent settlements that delay generic drug market entry anticompetitive? : hearing before the Subcommittee on Courts and Competition Policy of the Committee on the Judiciary, House of Representatives, One Hundred Eleventh Congress, first session, June 3, 2009.
Book Synopsis Regulation, Innovation and Competition in Pharmaceutical Markets by : Margherita Colangelo
Download or read book Regulation, Innovation and Competition in Pharmaceutical Markets written by Margherita Colangelo and published by Bloomsbury Publishing. This book was released on 2023-04-20 with total page 257 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explores the fundamental and inextricable relationship between regulation, intellectual property, competition law, and public health in pharmaceutical markets, examining their interconnections and the delicate balance between the various interests and policy goals at stake. Although pharmaceutical markets are heavily regulated and subject to close antitrust scrutiny, there is a constant requirement for existing rules and policies to tackle a number of persistent, complex issues. The variety of anti-competitive practices occurring in this sector, the worrying rise in drug prices, and major, far-reaching concerns over the accessibility of medicines are sources of frequent controversy in academic and policy debates. Understanding the unique features and dynamics of the pharmaceutical industry requires a tailored and multifaceted approach. The study is enhanced by the adoption of a comparative perspective, tracing convergence and divergence between EU and US systems through the analysis of relevant applicable rules, significant cases, and policy choices. Pursuant to this rigorous approach, the book provides an original and thought-provoking critique of the challenges of regulating pharmaceutical markets.
Book Synopsis Competition Law and Policy in the Japanese Pharmaceutical Sector by : Akira Negishi
Download or read book Competition Law and Policy in the Japanese Pharmaceutical Sector written by Akira Negishi and published by Springer Nature. This book was released on 2022-02-08 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the first book published that focuses on competition law and policy in the Japanese pharmaceutical sector. It consists of chapters written and edited by academics who research the industry from various perspectives, including economics, competition law, pharmaceutical regulations, and intellectual property law. Competition policies involving pharmaceutical products attract attention from academics and policymakers worldwide. The pharmaceutical industry is regulated by drug laws that vary from country to country and are affected by differing practices and industrial structures. The book begins by examining drug regulations and trade practices in the industry that are peculiar to Japan and its healthcare system. It then presents the Japanese Antimonopoly Act and cases involving it, and discussions of current competition law issues in the Japanese pharmaceutical industry. The book also discusses innovation and intellectual property and economic analyses of pharmaceutical regulations and drug discovery. The chapters include comparative studies on Japanese regulations vs. those in the European Union and the United States. Japan is one of the biggest pharmaceutical markets in the world. With this in mind, the book provides “one-stop shopping” for anyone interested in pharmaceutical regulations in the country. Covering the basics but extending to in-depth explorations of complex problems, this book appeals not only to students and academics, pharmaceutical companies and regulators, but also to those dealing with real-world policy issues that encompass competition policy, intellectual property, and pharmaceutical regulation. Chapter 11 is available open access under a Creative Commons Attribution 4.0 International License via link.springer.com
Book Synopsis The Economics of US Healthcare: Competition, Innovation, Regulation, and Organizations by :
Download or read book The Economics of US Healthcare: Competition, Innovation, Regulation, and Organizations written by and published by Stigler Center. This book was released on 2023-05-01 with total page 244 pages. Available in PDF, EPUB and Kindle. Book excerpt: This eBook was born out of a general diagnosis that the US healthcare sector is not only one of the most studied industries in economics but also one of the areas where the field can make the most progress. Indeed, the American healthcare industry has many features that are particularly attractive to economists. It is one of (if not the) largest sectors of the US economy, accounting for almost 20% of the national Gross Domestic Product and employing tens of millions of workers. Firms range from large conglomerates to small providers, and there is strong government-private sector interaction, with federal, state, and local governments shaping policy. The industry also has many failures, is undergoing tremendous change, and produces a wealth of data (even if not always perfectly formatted). The field, however, is far from saturated. Healthcare is such a complex and intricate sector, one where details matter so much that it is almost its own subfield of economics. These high barriers to entry prevent scholars from researching healthcare topics and weaken the cross-pollination of ideas, an increasing hallmark of many other areas. This is problematic, not the least, because any major advances in healthcare economics literally save lives (and billions of dollars). This project aimed to help lower these barriers and kick-start broader collaborations.
Book Synopsis Antitrust Policy in Health Care Markets by : Roger D. Blair
Download or read book Antitrust Policy in Health Care Markets written by Roger D. Blair and published by Cambridge University Press. This book was released on 2022-10-31 with total page 529 pages. Available in PDF, EPUB and Kindle. Book excerpt: Health care costs in the United States are much higher than in other countries. These cost differences can be explained in part by a lack of competition in the United States. Some markets, such as pharmaceuticals and medical equipment, have elements of monopoly. Other markets, such as health insurance, have elements of monopsony. Many other markets may be subject to collusion on prices, such as generic drugs, or wages, such as the nurse labor market. Lawful monopoly and monopsony are beyond the reach of antitrust laws, but collusion is not. When appropriate, vigorous antitrust enforcement challenging anticompetitive conduct can aid in reducing health care costs. This book addresses monopoly, monopsony, cartels of sellers and buyers, horizontal and vertical merger policy, and antitrust enforcement through private suits as well as the efforts of the antitrust Agencies. The authors demonstrate how enforcing antitrust laws can ultimately promote competition and reduce health care costs.
Book Synopsis The Antitrust Enterprise by : Herbert HOVENKAMP
Download or read book The Antitrust Enterprise written by Herbert HOVENKAMP and published by Harvard University Press. This book was released on 2009-06-30 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: After thirty years, the debate over antitrust's ideology has quieted. Most now agree that the protection of consumer welfare should be the only goal of antitrust laws. Execution, however, is another matter. The rules of antitrust remain unfocused, insufficiently precise, and excessively complex. The problem of poorly designed rules is severe, because in the short run rules weigh much more heavily than principles. At bottom, antitrust is a defensible enterprise only if it can make the microeconomy work better, after accounting for the considerable costs of operating the system. The Antitrust Enterprise is the first authoritative and compact exposition of antitrust law since Robert Bork's classic The Antitrust Paradox was published more than thirty years ago. It confronts not only the problems of poorly designed, overly complex, and inconsistent antitrust rules but also the current disarray of antitrust's rule of reason, offering a coherent and workable set of solutions. The result is an antitrust policy that is faithful to the consumer welfare principle but that is also more readily manageable by the federal courts and other antitrust tribunals.
Book Synopsis EU Law of Competition and Trade in the Pharmaceutical Sector by : Pablo Figueroa
Download or read book EU Law of Competition and Trade in the Pharmaceutical Sector written by Pablo Figueroa and published by Edward Elgar Publishing. This book was released on 2019 with total page 758 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a systematic analysis of the law and practice of EU competition and trade in the pharmaceutical sector. Authored by leading private practitioners, economists, scholars and high-level officials at competition regulators, this work provides valuable insider knowledge on the application of law and policies to the pharmaceutical industry. The work contains extensive commentary on the legislation and the latest case law and administrative precedents in this sector, at both EU and national level, including certain significant jurisdictions (e.g., the US, China). Coverage of various key developments includes the recent pay-for-delay antitrust investigations, the perennial issues around parallel trade, and an examination of mergers among pharmaceutical companies and medical devices manufacturers. In addition to the legal analysis, it offers vital economic and business perspectives to ensure that the reader has the full range of tools with which to prepare for cases and conduct transactions within the pharmaceutical industry.
Download or read book Drug Wars written by Robin Feldman and published by Cambridge University Press. This book was released on 2017-06-09 with total page 165 pages. Available in PDF, EPUB and Kindle. Book excerpt: While the shockingly high prices of prescription drugs continue to dominate the news, the strategies used by pharmaceutical companies to prevent generic competition are poorly understood, even by the lawmakers responsible for regulating them. In this groundbreaking work, Robin Feldman and Evan Frondorf illuminate the inner workings of the pharmaceutical market and show how drug companies twist health policy to achieve goals contrary to the public interest. In highly engaging prose, they offer specific examples of how generic competition has been stifled for years, with costs climbing into the billions and everyday consumers paying the price. Drug Wars is a guide to the current landscape, a roadmap for reform, and a warning of what is to come. It should be read by policymakers, academics, patients, and anyone else concerned with the soaring costs of prescription drugs.
Book Synopsis Disease Control Priorities, Third Edition (Volume 6) by : King K. Holmes
Download or read book Disease Control Priorities, Third Edition (Volume 6) written by King K. Holmes and published by World Bank Publications. This book was released on 2017-11-06 with total page 1027 pages. Available in PDF, EPUB and Kindle. Book excerpt: Infectious diseases are the leading cause of death globally, particularly among children and young adults. The spread of new pathogens and the threat of antimicrobial resistance pose particular challenges in combating these diseases. Major Infectious Diseases identifies feasible, cost-effective packages of interventions and strategies across delivery platforms to prevent and treat HIV/AIDS, other sexually transmitted infections, tuberculosis, malaria, adult febrile illness, viral hepatitis, and neglected tropical diseases. The volume emphasizes the need to effectively address emerging antimicrobial resistance, strengthen health systems, and increase access to care. The attainable goals are to reduce incidence, develop innovative approaches, and optimize existing tools in resource-constrained settings.
Book Synopsis Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade by : World Intellectual Property Organization
Download or read book Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade written by World Intellectual Property Organization and published by WIPO. This book was released on 2013 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.
Book Synopsis Pharmaceuticals, Corporate Crime and Public Health by : Graham Dukes
Download or read book Pharmaceuticals, Corporate Crime and Public Health written by Graham Dukes and published by Edward Elgar Publishing. This book was released on 2014-06-27 with total page 419 pages. Available in PDF, EPUB and Kindle. Book excerpt: The pharmaceutical industry exists to serve the community, but over the years it has engaged massively in corporate crime, with the public footing the bill. This readable study by experts in medicine, law, criminology and public health documents the pr
Book Synopsis Patents in the Knowledge-Based Economy by : National Research Council
Download or read book Patents in the Knowledge-Based Economy written by National Research Council and published by National Academies Press. This book was released on 2003-08-11 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume assembles papers commissioned by the National Research Council's Board on Science, Technology, and Economic Policy (STEP) to inform judgments about the significant institutional and policy changes in the patent system made over the past two decades. The chapters fall into three areas. The first four chapters consider the determinants and effects of changes in patent "quality." Quality refers to whether patents issued by the U.S. Patent and Trademark Office (USPTO) meet the statutory standards of patentability, including novelty, nonobviousness, and utility. The fifth and sixth chapters consider the growth in patent litigation, which may itself be a function of changes in the quality of contested patents. The final three chapters explore controversies associated with the extension of patents into new domains of technology, including biomedicine, software, and business methods.
Book Synopsis Federal Public Land and Resources Law by : George Cameron Coggins
Download or read book Federal Public Land and Resources Law written by George Cameron Coggins and published by . This book was released on 2002 with total page 1272 pages. Available in PDF, EPUB and Kindle. Book excerpt: This casebook is an authoritative introduction to the study of public land and resources law. Case studies, case notes, and examples illustrate points under consideration. Thought-provoking questions generate classroom discussion and hone students' legal reasoning. Representative topics include authority on public lands, wildlife resource, preservation, resource, and history of public land law.
