Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law PDF Download
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Author: Amalia Athanasiadou Publisher: Kluwer Law International B.V. ISBN: 9403501146 Category : Law Languages : en Pages : 349
Book Description
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: Amalia Athanasiadou Publisher: Kluwer Law International B.V. ISBN: 9403501146 Category : Law Languages : en Pages : 349
Book Description
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: Herbert HOVENKAMP Publisher: Harvard University Press ISBN: 9780674038820 Category : Law Languages : en Pages : 392
Book Description
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.
Author: Ashish Bharadwaj Publisher: Springer ISBN: 981131232X Category : Law Languages : en Pages : 350
Book Description
This open access edited book captures the complexities and conflicts arising at the interface of intellectual property rights (IPR) and competition law. To do so, it discusses four specific themes: (a) policies governing functioning of standard setting organizations (SSOs), transparency and incentivising future innovation; (b) issue of royalties for standard essential patents (SEPs) and related disputes; (c) due process principles, procedural fairness and best practices in competition law; and (d) coherence of patent policies and consonance with competition law to support innovation in new technologies. Many countries have formulated policies and re-oriented their economies to foster technological innovation as it is seen as a major source of economic growth. At the same time, there have been tensions between patent laws and competition laws, despite the fact that both are intended to enhance consumer welfare. In this regard, licensing of SEPs has been debated extensively, although in most instances, innovators and implementers successfully negotiate licensing of SEPs. However, there have been instances where disagreements on royalty base and royalty rates, terms of licensing, bundling of patents in licenses, pooling of licenses have arisen, and this has resulted in a surge of litigation in various jurisdictions and also drawn the attention of competition/anti-trust regulators. Further, a lingering lack of consensus among scholars, industry experts and regulators regarding solutions and techniques that are apposite in these matters across jurisdictions has added to the confusion. This book looks at the processes adopted by the competition/anti-trust regulators to apply the principles of due process and procedural fairness in investigating abuse of dominance cases against innovators.
Author: Steven Anderman Publisher: OUP Oxford ISBN: 9780199589951 Category : Law Languages : en Pages : 0
Book Description
Examining the relationship between intellectual property and competition law with a particular focus on European law, this book highlights areas emerging new frontiers.
Author: Ioannis Kokkoris Publisher: Kluwer Law International B.V. ISBN: 9041126929 Category : Law Languages : en Pages : 626
Book Description
This book represents a fresh approach to EC competition law - one that is of singular value in grappling with the huge economic challenges we face today. As a critical analysis of the law and options available to European competition authorities and legal practitioners in the field, it stands without peer. It will be greatly welcomed by lawyers, policymakers and other interested professionals in Europe and throughout the world.
Author: Robin Feldman Publisher: Cambridge University Press ISBN: 131673949X Category : Law Languages : en Pages : 165
Book Description
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: Thomas K. Cheng Publisher: Oxford University Press ISBN: 0192671766 Category : Law Languages : en Pages : 545
Book Description
This book proposes an approach to the patent-competition interface for developing countries. It puts forward a theoretical framework after canvassing relevant policy considerations and examines the many reasons why patent protection is not essential for generating innovation incentives in developing countries. These include the tendency of the patent system to overcompensate innovators, the availability of other appropriation mechanisms for innovators to monetize their innovations, and the lack of appropriate technological capacity in many developing countries to take advantage of the incentives generated by the patent system. It also argues that developing countries with a small population need not pay heed to the impact of their patent system on the incentives of foreign innovators. It then proposes a classification of developing countries into production countries, technology adaptation countries, and proto-innovation countries and argues that dynamic efficiency considerations take on different meanings for developing countries depending on their technological capacities. For the vast majority of developing countries bereft of meaningful innovation capacity, foreign technology transfer is the main vehicle for technological progress. The chief dynamic policy consideration for these countries is hence incentives for technology transfer instead of innovation incentives. There are three main means of voluntary technology transfer: importation of technological goods, foreign direct investment, and technology licensing. Competition law regulation of patent exploitation practices interacts with these three means of technology transfer in different ways and an appropriate approach to the patent-competition interface for these countries needs to take these into account. Distilling all these considerations, the book proposes a development stage-specific approach to the patent-competition interface for developing countries. The approach is then applied to a number of patent exploitation practices, including unilateral refusal to deal, patent tying, excessive pricing for pharmaceuticals, reverse payment settlements, and restrictive licensing practices.
Author: René Barents Publisher: Kluwer Law International B.V. ISBN: 9403511028 Category : Law Languages : en Pages : 1308
Book Description
This new edition of an immensely useful book follows the same proven format as its predecessors, updates its analysis of case law with hundreds of new decisions by the courts of the European Union (EU), and thus remains the quickest source of reference for practitioners working with EU State aid matters. Following a highly organized sequence of subject headings, it presents extracts from all judgments and orders of both the Court of Justice and the General Court of the EU on the Treaty on the functioning of the European Union (TFEU) rules on State aids. All the relevant case law of both courts until the end of 2018 is covered. There is a new chapter on legal protection and additional material on the concept of State aid, advantages for undertakings, selectivity, forms of State aid, procedures and unlawful aids. With this book practitioners will quickly find relevant paragraphs and full citations regarding all issues raised by Articles 107–109 TFEU, including the following and much more: territorial scope of State aids; Article 107(1) EC and WTO Agreements; conditions for categorizing a national measure as State aid; free movement of goods; undertakings; private versus public investment; justification of selective measures; interstate trade and competition; tax measures; restructuring aids; procedural aspects; and locus standi of trade associations. In many areas, the extracts relate to points of the judgments which are not or only partially covered in official summaries. For accessibility of this case law, this updated edition of the preeminent analysis of EU State aid case law has no peers. Practitioners in this key area of EU competition law will find this book indispensable.
Author: Amalia Athanasiadou
Author: Amalia Athanasiadou
Author: Giovanni Pitruzzella
Author: Herbert HOVENKAMP
Author: 
Author: Ashish Bharadwaj
Author: Steven Anderman
Author: Ioannis Kokkoris
Author: Robin Feldman
Author: Thomas K. Cheng
Author: René Barents