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Author: Ann-Kathrin Lehnhausen Publisher: Springer ISBN: 3658165510 Category : Business & Economics Languages : en Pages : 85
Book Description
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.
Author: Ann-Kathrin Lehnhausen Publisher: Springer ISBN: 3658165510 Category : Business & Economics Languages : en Pages : 85
Book Description
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.
Author: Pierre Kobel Publisher: Springer ISBN: 3319558137 Category : Law Languages : en Pages : 497
Book Description
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.
Author: Pablo Figueroa Publisher: Edward Elgar Publishing ISBN: 1785362615 Category : Business & Economics Languages : en Pages : 758
Book Description
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.
Author: Margherita Colangelo Publisher: ISBN: 9781509965540 Category : Antitrust law Languages : en Pages : 0
Book Description
This book explores the fundamental and inextricable relationship between regulation, intellectual property, competition laws, and public health in prescription drugs 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 anticompetitive 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 debate. 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, emblematic case studies, and policy choices. Pursuant to this rigorous approach, the book provides an original and thought-provoking critique of the challenges of regulating pharmaceutical markets.
Author: Irina Haracoglou Publisher: Edward Elgar Publishing ISBN: 1848440111 Category : Law Languages : en Pages : 272
Book Description
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.
Author: Björn Lundqvist Publisher: Oxford University Press, USA ISBN: 9780198724827 Category : Law Languages : en Pages : 576
Book Description
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: Amalia Athanasiadou Publisher: Kluwer Law International ISBN: 9789403501130 Category : Law Languages : en Pages : 466
Book Description
Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law examines patent settlements between originators and generic pharmaceutical manufacturers under United States (US) antitrust and European Union (EU) competition law. The major focus is on patent settlements involving reverse payments, commonly known as "pay-for-delay" settlements. Reverse payment settlements or "pay-for-delay agreements" 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 on the one hand and the need to preserve innovation incentives for originators and to strengthen the pipeline of life-saving pharmaceuticals on the other hand. This book is one of the first to analyse critically and comparatively how such patent settlements and various other strategies employed by the pharmaceutical industry are scrutinised by US and European courts as well as enforcement authorities, focusing on the applicable legal tests and the main criteria used by courts and enforcement authorities when applying antitrust scrutiny. What's in this book: 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 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. Actavis and subsequent jurisprudence; the decision of Lundbeck v. Commission by the European General Court and the Servier decision of the European Commission; the Roche/Novartis decision 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 and 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 argues that even though patent settlements and other types of potentially exclusionary and abusive conduct change form rapidly, the main criteria for their assessment remain broadly the same. How this will help you: 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. This book is also beneficial to legal counsels, practicing attorneys, competition authorities and judges wishing to have the overview of the current legal standards in both the US and the EU. 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 case law, with the ultimate goal to increase legal certainty on the most controversial aspects of patent settlements in the pharmaceutical industry.
Author: Ann-Kathrin Lehnhausen
Author: Ann-Kathrin Lehnhausen
Author: Pierre Kobel
Author: 
Author: Pablo Figueroa
Author: Roy Levy
Author: Margherita Colangelo
Author: Meir Statman
Author: Irina Haracoglou
Author: Björn Lundqvist
Author: Amalia Athanasiadou