Book Description
Editors --Contributors --Foreword --Preface --Pharmaceutical Patents and Competition Issues --What Is Going on in National Systems?
Author : Giovanni Pitruzzella
Publisher : Kluwer Law International
Page : 0 pages
File Size : 25,37 MB
Release : 2016
Category : Antitrust law
ISBN : 9789041159274
Editors --Contributors --Foreword --Preface --Pharmaceutical Patents and Competition Issues --What Is Going on in National Systems?
Author :
Publisher : DIANE Publishing
Page : 129 pages
File Size : 34,38 MB
Release : 2002
Category :
ISBN : 1428951938
Author : Amalia Athanasiadou
Publisher : Kluwer Law International B.V.
Page : 349 pages
File Size : 49,95 MB
Release : 2018-08-14
Category : Law
ISBN : 9403501146
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.
Author : Robert O'Donoghue KC
Publisher : Bloomsbury Publishing
Page : 1608 pages
File Size : 37,55 MB
Release : 2020-09-03
Category : Law
ISBN : 1509942963
“A reference book in this area of EU competition law and a must-have companion for academics, enforcers and practitioners alike, as well as EU and national judges.” Judge Nils Wahl, Court of Justice of the European Union This seminal text offers an authoritative and integrated treatment of the legal and economic principles that underpin the application of Article 102 TFEU to the behaviour of dominant firms. Traditional concerns of monopoly behaviour, such as predatory pricing, refusals to deal, excessive pricing, tying and bundling, discount practices and unlawful discrimination are treated in detail through a review of the applicable economic principles, the case law and decisional practice and more recent economic and legal writings. In addition, the major constituent elements of Article 102 TFEU, such as market definition, dominance, effect on trade and applicable remedies are considered at length. The third edition involves a net addition of over 250 pages, with a substantial new chapter on Abuses In Digital Platforms, an extensively revised chapter on standards, and virtually all chapters incorporating substantial revisions reflecting key cases such as Intel, MEO, Google Android, Google Shopping, AdSense, and Qualcomm.
Author : Robin Feldman
Publisher : Cambridge University Press
Page : 165 pages
File Size : 35,86 MB
Release : 2017-06-09
Category : Law
ISBN : 131673949X
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.
Author : Christopher Scott Hemphill
Publisher : Stanford University
Page : 249 pages
File Size : 40,46 MB
Release : 2010
Category :
ISBN :
This dissertation examines the law and economics of generic drug entry, and the problems that arise from specific U.S. regulatory arrangements that govern innovation and competition in the market for patented pharmaceuticals. As Chapter 1 explains, competitive entry by generic drug makers is limited by both patents and industry-specific regulation, which together provide the means for brand-name drug makers to avoid competition and thereby recoup large investments in research, development, and testing. At the same time, the complex rules of the Hatch-Waxman Act furnish a pathway by which generic drug makers may challenge the validity or scope of brand-name patents, with a view to entering the market with a competing product prior to patent expiration. The subsequent chapters examine several aspects of the competitive interaction between brand-name and generic drug makers. Chapter 2 analyzes settlements of patent litigation between brand-name and generic drug makers, in which the brand-name firm pays the generic firm in exchange for delayed market entry. Such pay-for-delay settlements are an important, unresolved question in U.S. antitrust policy. The analysis reveals that the pay-for-delay settlement problem is more severe than has been commonly understood. Several specific features of the Act—in particular, a 180-day bounty granted to certain generic drug makers as an incentive to pursue pre-expiration entry—widen the potential for anticompetitive harm from pay-for-delay settlements, compared to the usual understanding. In addition, I show that settlements are "innovation inefficient" as a means of providing profits and hence ex ante innovation incentives to brand-name drug makers. To the extent that Congress established a preferred tradeoff between innovation and competition when it passed the Act, settlements that implement a different, less competition-protective tradeoff are particularly problematic from an antitrust standpoint. Chapter 3 synthesizes available public information about pay-for-delay settlements in order to offer a new account of the extent and evolution of settlement practice. The analysis draws upon a novel dataset of 143 such settlements. The analysis uncovers an evolution in the means by which a brand-name firm can pay a generic firm to delay entry, including a variety of complex "side deals" by which a brand-name firm can compensate a generic firm in a disguised fashion. It also reveals several novel forms of regulatory avoidance. The analysis in the chapter suggests that, as a matter of institutional choice, an expert agency is in a relatively good position to conduct the aggregate analysis needed to identify an optimal antitrust rule. Chapter 4 examines the co-evolution of increased brand-name patenting and increased generic pre-expiration challenges. It draws upon a second novel dataset of drug approvals, applications, patents, and other drug characteristics. Its first contribution is to chart the growth of patent portfolios and pre-expiration challenges. Over time, patenting has increased, measured by the number of patents per drug and the length of the nominal patent term. During the same period, challenges have increased as well, and drugs are challenged sooner, relative to brand-name approval. The analysis shows that brand-name sales, a proxy for the profitability of the drug, have a positive effect on the likelihood of generic challenge, consistent with the view that patents that later prove to be valuable receive greater ex post scrutiny. The likelihood of challenge also varies by patent type and timing of expiration. Conditional on sales and other drug characteristics, drugs with weaker patents, particularly those that expire later than a drug's basic compound patent, face a significantly higher likelihood of challenge. Though the welfare implications of Hatch-Waxman patent challenge provisions are complicated, these results suggest these challenges serve a useful purpose, in promoting scrutiny of low quality and late-expiring patents.
Author : William M. LANDES
Publisher : Harvard University Press
Page : 449 pages
File Size : 38,24 MB
Release : 2009-06-30
Category : Law
ISBN : 0674039912
This book takes a fresh look at the most dynamic area of American law today, comprising the fields of copyright, patent, trademark, trade secrecy, publicity rights, and misappropriation. Topics range from copyright in private letters to defensive patenting of business methods, from moral rights in the visual arts to the banking of trademarks, from the impact of the court of patent appeals to the management of Mickey Mouse. The history and political science of intellectual property law, the challenge of digitization, the many statutes and judge-made doctrines, and the interplay with antitrust principles are all examined. The treatment is both positive (oriented toward understanding the law as it is) and normative (oriented to the reform of the law). Previous analyses have tended to overlook the paradox that expanding intellectual property rights can effectively reduce the amount of new intellectual property by raising the creators' input costs. Those analyses have also failed to integrate the fields of intellectual property law. They have failed as well to integrate intellectual property law with the law of physical property, overlooking the many economic and legal-doctrinal parallels. This book demonstrates the fundamental economic rationality of intellectual property law, but is sympathetic to critics who believe that in recent decades Congress and the courts have gone too far in the creation and protection of intellectual property rights. Table of Contents: Introduction 1. The Economic Theory of Property 2. How to Think about Copyright 3. A Formal Model of Copyright 4. Basic Copyright Doctrines 5. Copyright in Unpublished Works 6. Fair Use, Parody, and Burlesque 7. The Economics of Trademark Law 8. The Optimal Duration of Copyrights and Trademarks 9. The Legal Protection of Postmodern Art 10. Moral Rights and the Visual Artists Rights Act 11. The Economics of Patent Law 12. The Patent Court: A Statistical Evaluation 13. The Economics of Trade Secrecy Law 14. Antitrust and Intellectual Property 15. The Political Economy of Intellectual Property Law Conclusion Acknowledgments Index Reviews of this book: Chicago law professor William Landes and his polymath colleague Richard Posner have produced a fascinating new book...[The Economic Structure of Intellectual Property Law] is a broad-ranging analysis of how intellectual property should and does work...Shakespeare's copying from Plutarch, Microsoft's incentives to hide the source code for Windows, and Andy Warhol's right to copyright a Brillo pad box as art are all analyzed, as is the question of the status of the all-bran cereal called 'All-Bran.' --Nicholas Thompson, New York Sun Reviews of this book: Landes and Posner, each widely respected in the intersection of law and economics, investigate the right mix of protection and use of intellectual property (IP)...This volume provides a broad and coherent approach to the economics and law of IP. The economics is important, understandable, and valuable. --R. A. Miller, Choice Intellectual property is the most important public policy issue that most policymakers don't yet get. It is America's most important export, and affects an increasingly wide range of social and economic life. In this extraordinary work, two of America's leading scholars in the law and economics movement test the pretensions of intellectual property law against the rationality of economics. Their conclusions will surprise advocates from both sides of this increasingly contentious debate. Their analysis will help move the debate beyond the simplistic ideas that now tend to dominate. --Lawrence Lessig, Stanford Law School, author of The Future of Ideas: The Fate of the Commons in a Connected World An image from modern mythology depicts the day that Einstein, pondering a blackboard covered with sophisticated calculations, came to the life-defining discovery: Time = $$. Landes and Posner, in the role of that mythological Einstein, reveal at every turn how perceptions of economic efficiency pervade legal doctrine. This is a fascinating and resourceful book. Every page reveals fresh, provocative, and surprising insights into the forces that shape law. --Pierre N. Leval, Judge, U.S. Court of Appeals, Second Circuit The most important book ever written on intellectual property. --William Patry, former copyright counsel to the U.S. House of Representatives, Judiciary Committee Given the immense and growing importance of intellectual property to modern economies, this book should be welcomed, even devoured, by readers who want to understand how the legal system affects the development, protection, use, and profitability of this peculiar form of property. The book is the first to view the whole landscape of the law of intellectual property from a functionalist (economic) perspective. Its examination of the principles and doctrines of patent law, copyright law, trade secret law, and trademark law is unique in scope, highly accessible, and altogether greatly rewarding. --Steven Shavell, Harvard Law School, author of Foundations of Economic Analysis of Law
Author : National Research Council
Publisher : National Academies Press
Page : 352 pages
File Size : 13,89 MB
Release : 2003-08-11
Category : Political Science
ISBN : 0309167183
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.
Author : Ellen F. M. 't Hoen
Publisher :
Page : 136 pages
File Size : 28,14 MB
Release : 2009
Category : Agreement on Trade-Related Aspects of Intellectual Property Rights
ISBN : 9789079700066
In The Global Politics of Pharmaceutical Monopoly Power, researcher and global advocate Ellen 't Hoen explains how new global rules for pharmaceutical patenting impact access to medicines in the developing world. The book gives an account of the current debates on intellectual property, access to medicines, and medical innovation, and provides historical context that explains how the current system emerged. This book supports major policy changes in the management of pharmaceutical patents and the way medical innovation is financed in order to protect public health and, in particular, promote access to essential medicines for all. The Open Society Institute provided support to translate this report into Russian.
Author : National Research Council
Publisher : National Academies Press
Page : 186 pages
File Size : 31,92 MB
Release : 2004-10-01
Category : Science
ISBN : 0309089107
The U.S. patent system is in an accelerating race with human ingenuity and investments in innovation. In many respects the system has responded with admirable flexibility, but the strain of continual technological change and the greater importance ascribed to patents in a knowledge economy are exposing weaknesses including questionable patent quality, rising transaction costs, impediments to the dissemination of information through patents, and international inconsistencies. A panel including a mix of legal expertise, economists, technologists, and university and corporate officials recommends significant changes in the way the patent system operates. A Patent System for the 21st Century urges creation of a mechanism for post-grant challenges to newly issued patents, reinvigoration of the non-obviousness standard to quality for a patent, strengthening of the U.S. Patent and Trademark Office, simplified and less costly litigation, harmonization of the U.S., European, and Japanese examination process, and protection of some research from patent infringement liability.