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Patent Settlements In The Pharmaceutical Industry Under Us Antitrust And Eu Competition Law
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Book Synopsis Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law by : Amalia Athanasiadou
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.
Book Synopsis Competition and Patent Law in the Pharmaceutical Sector by : Giovanni Pitruzzella
Download or read book Competition and Patent Law in the Pharmaceutical Sector written by Giovanni Pitruzzella and published by Kluwer Law International. This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Editors --Contributors --Foreword --Preface --Pharmaceutical Patents and Competition Issues --What Is Going on in National Systems?
Book Synopsis Competition in the Pharmaceutical Marketplace by : United States. Congress. Senate. Committee on the Judiciary
Download or read book Competition in the Pharmaceutical Marketplace written by United States. Congress. Senate. Committee on the Judiciary and published by . This book was released on 2002 with total page 56 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Competition Law and IP Rights in Pharmaceuticals and Biotechnology by : Björn Lundqvist
Download or read book Competition Law and IP Rights in Pharmaceuticals and Biotechnology written by Björn Lundqvist and published by Oxford University Press, USA. This book was released on 2031-05-30 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive analysis of European competition law and intellectual property law issues affecting the pharmaceutical and biotechnology sectors, offering both theoretical and practical perspectives.
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 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.
Book Synopsis Blocking Patents in European Competition Law by : Angelika S. Murer
Download or read book Blocking Patents in European Competition Law written by Angelika S. Murer and published by Kluwer Law International B.V.. This book was released on 2021-12-03 with total page 386 pages. Available in PDF, EPUB and Kindle. Book excerpt: In practice and jurisprudence in European competition law, it is especially difficult to define the boundaries of patent abuse as an offence. In this thoroughly researched book, the author answers the question of when and how an application for a blocking patent can amount to an abuse of a dominant position under Article 102 TFEU. Drawing on legal literature and European Union (EU) case law, the presentation analyses a constellation of blocking patenting strategies and proposes potential remedies where abuse is involved. With detailed descriptions of the characteristics of potentially abusive and non-abusive behaviour regarding applications for blocking patents, the book provides the following and more: a comprehensive analysis of the case law of the EU courts on the abuse of a dominant position in cases which involve intellectual property rights; insights on how patenting strategies affect competition with a particular focus on the application of blocking patents; an overview of the developments in doctrine and practice which led to the current understanding of the seemingly conflictual goals of competition and intellectual property law; and insights on the difficulties of defining relevant markets and establishing whether an undertaking holds a dominant position. The book illustrates the mechanisms of blocking patenting strategies with examples from the pharmaceutical industry because blocking strategies have particular relevance in applying for patents in that context. A test scheme for analysing the application of a blocking patent under Article 102 TFEU is included. Additionally, the book provides an outlook on the topic of patents and shortages of supply in light of the COVID pandemic. Practitioners and policymakers requiring an understanding of the conceptual framework of the abuse concept within EU competition law and how it relates to patent strategies will welcome this invaluable book. They will not only be able to set the conduct of applying for blocking patents into the Article 102 TFEU context but also have decisive tools to approach questions on the intersection of patent law and competition law in the EU.
Book Synopsis Pharmaceutical Industry Antitrust Handbook by :
Download or read book Pharmaceutical Industry Antitrust Handbook written by and published by American Bar Association. This book was released on 2009 with total page 484 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Studies on Competition and Antitrust Issues in the Pharmaceutical Industry by : Ann-Kathrin Lehnhausen
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 85 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.
Book Synopsis Competition Law and Patents by : Irina Haracoglou
Download or read book Competition Law and Patents written by Irina Haracoglou and published by Edward Elgar Publishing. This book was released on 2008-01-01 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is an incredibly interesting book on an increasingly pertinent topic. . . the book is succinctly written and provides a comprehensive overview of EU law. . . providing a really useful analysis of the European cases concerned with the imposition of a duty to deal in relation to intellectual property. . . This book is a thoroughly enjoyable read, and perhaps because of its brevity the author retains her focus on the central issues being examined. I found it to be engaging and thought provoking. Jane Nielsen, Competition and Consumer Law Journal The book caters for various groups ranging from those with a general interest in competition law, patent law and/or biopharmaceuticals, to students who want to understand how competition and intellectual property work in practice (or to understand the interface between the two policies), and from practitioners and policymakers to people within the biopharmaceutical industry itself. Journal of Intellectual Property Rights Using the example of research tools in biopharmaceutical research and innovation, this book examines the complexities of the relationship between two fundamental areas of law and policy intellectual property rights and competition law. It addresses a question that is certain to become paramount in other industries also: how to strike the balance between initial and follow-on innovation so as to ensure that access to essential research tools (or other fundamental elements to follow-on innovation) is not impeded. The book concludes by suggesting how competition law could be used to complement the patent balance. Competition Law and Patents caters for various groups ranging from those with a general interest in competition law, patent law and/or biopharmaceuticals, to students who want to understand how competition and intellectual property work in practice (or to understand the interface between the two policies), and from practitioners and policymakers to people within the biopharmaceutical industry itself.
Book Synopsis EU Competition Law and Pharmaceuticals by : Wolf Sauter
Download or read book EU Competition Law and Pharmaceuticals written by Wolf Sauter and published by Edward Elgar Publishing. This book was released on 2022-11-15 with total page 325 pages. Available in PDF, EPUB and Kindle. Book excerpt: This timely book discusses the application of the EU competition rules to pharmaceuticals, covering the prohibitions on anticompetitive agreements and abuse of dominance, and merger control. It carefully considers the balance between competition and innovation, as well as between competition and regulation, and concludes that competition and regulation are not alternatives, but complementary, and that novel ways of taking into account risk and real innovation through competition assessments have been developed.
Book Synopsis Antitrust in Pharmaceutical Markets & Geographical Rules of Origin by : Pierre Kobel
Download or read book Antitrust in Pharmaceutical Markets & Geographical Rules of Origin written by Pierre Kobel and published by Springer. This book was released on 2017-09-20 with total page 497 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book gathers international and national reports from across the globe on key questions in the field of antitrust and intellectual property. The first part discusses the application of competition law in the pharmaceutical sector, which continues to be a focus for anti-trust authorities around the world. A detailed international report explores the extent to which the application of the competition rules in the pharmaceutical sector should be affected by the specific characteristics of those products and markets (including consumer protection rules, the need to promote innovation, the need to protect public budgets, and other public interest considerations). It provides an excellent comparative study of this complex subject, which lies at the interface between competition law and intellectual property law. The second part of the book gathers contributions from various jurisdictions on the topic of “What rules should govern claims by suppliers about the national or geographic origin of their goods or services?” This section presents an international report, which offers an unparalleled comparative analysis of this topic, bringing together common themes and contrasting the various national provisions dealing with indications of origin, amongst other things. The book also includes the resolutions passed by the General Assembly of the International League of Competition Law (LIDC) following a debate on each of these topics, which include proposed solutions and recommendations. The LIDC is a long-standing international association that focuses on the interface between competition law and intellectual property law, including unfair competition issues.
Book Synopsis IP and Antitrust by : Herbert Hovenkamp
Download or read book IP and Antitrust written by Herbert Hovenkamp and published by Aspen Publishers. This book was released on 2009-12-18 with total page 2096 pages. Available in PDF, EPUB and Kindle. Book excerpt: The leading reference that focuses on the intersection of the areas of IP and antitrust enables you to factor antitrust considerations into the drafting and review of intellectual property licensing arrangements, maximizing the commercial value of intellectual property rights, and minimizing antitrust risks. IP and Antitrust: An Analysis of Antitrust Principles Applied to Intellectual Property Law, Second Edition is a two-volume reference that focuses on the intersection of the areas of IP and antitrust. While intellectual property licensing arrangements are typically pro-competitive, antitrust concerns may nonetheless arise. Licensing arrangements raise concerns under the antitrust laws if they are likely to adversely affect the prices, quantities, qualities or varieties of goods and services -- either currently or potentially available. The Justice Department's rekindled interest in intellectual property licensing arrangements now requires that companies factor antitrust considerations into the drafting and review of intellectual property licensing arrangements. Thus, licensing agreements involving intellectual property must now be drafted with two considerations in mind: maximizing the commercial value of intellectual property rights, and minimizing antitrust risks IP and Antitrust is the first comprehensive resource that fully examines intellectual property from an antitrust perspective, to help you steer clear of unexpected problems. It provides a sophisticated discussion of intellectual property law not currently available in the antitrust treatises on the market today, including Areeda and Hovenkamp's Antitrust Law treatise.
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 Pharmaceutical Innovation, Competition and Patent Law by : Josef Drexl
Download or read book Pharmaceutical Innovation, Competition and Patent Law written by Josef Drexl and published by Edward Elgar Publishing. This book was released on 2013-01-01 with total page 347 pages. Available in PDF, EPUB and Kindle. Book excerpt: Public health, safety and access to reasonably priced medicine are common policy goals of pharmaceutical regulations. As both the context for innovation and competitive structure change, industry actors dynamically challenge the balance between the incentive for protection and the achievement of those policy goals. Considering the arguments from the perspectives of innovation, competition law and patent law, this book explores the difficult question of balancing protection with access, highlighting the difficulties in harmonization and coordination. The contributors to this book, including academics, judges and practitioners from Europe, the US and Japan, explore to what extent patent strategies and life-cycle management practices take advantage of patent laws and health-care regulation and disrupt the necessary balance between incentives for innovation and access to affordable medicine and health care. Addressing fundamental questions in the field of pharmaceutical innovation, this book will appeal to scholars and practitioners in intellectual property, competition law and life sciences regulation, as well as pharmaceutical companies and regulators.
Book Synopsis Pharmaceutical Patents by : Florian Aerts
Download or read book Pharmaceutical Patents written by Florian Aerts and published by Nova Science Publishers. This book was released on 2013 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Although brand-name pharmaceutical companies routinely procure patents on their innovative medications, such rights are not self-enforcing. Brand-name firms that wish to enforce their patents against generic competitors must therefore commence litigation in the federal courts. Such litigation ordinarily terminates in either a judgement of infringement, which typically blocks generic competition until such time as the patent expires, or a judgement that the patent is invalid or not infringed, which typically opens the market to generic entry. This book introduces and analyses innovation and competition policy issues associated with pharmaceutical patent litigation settlements. It begins with a review of pharmaceutical patent litigation procedures under the Hatch-Waxman Act, then introduces the concept of reverse payment settlements, and analyses the status of reverse payment settlements under antitrust laws, and discusses congressional issues and possible alternatives.
Book Synopsis After the Damages Directive by : Andrea Biondi
Download or read book After the Damages Directive written by Andrea Biondi and published by Kluwer Law International B.V.. This book was released on 2022-01-11 with total page 973 pages. Available in PDF, EPUB and Kindle. Book excerpt: International Competition Law Series [ICLS], Volume 89 Designed to deter anticompetitive conduct and to ensure full compensation for loss and damage caused by competition infringements, the Antitrust Damages Directive has become a crucial factor in companies’ risk management planning. This first book of its kind offers a comparative overview, practical and authoritative, of the implementation and application of private enforcement rules in each EU Member State as well as in the post-Brexit United Kingdom, covering legislation and case law to date. For leading jurisdictions where practice is already well developed, there are more detailed chapters, with perspectives of judges, competition authorities, practitioners, and economists. The contributors – all experts in the use of EU competition law in their respective jurisdictions – cover the provisions of the Directive in detail, including the following: requirement of full compensation; rules preventing overcompensation; court’s power to estimate damages that cannot be precisely quantified; joint and several liability for infringing undertakings; coordination between public and private enforcement; provisions related to passing-on; certain rules on admissibility of evidence; rules on limitation periods; and consensual dispute resolution. In its detailed explanations of shared best practices and its highlighting of opportunities for convergence, the book provides much-needed insight into judicial practice and thinking, the economic approaches and strategies relevant to damages, and the coordination between public and private enforcement. These expert views will prove invaluable for practitioners wishing to see how the law and practice might evolve in their own jurisdictions, as well as into the problems that have arisen or might arise in the future.
