Competition And Patent Law In The Pharmaceutical Sector

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.

Editors --Contributors --Foreword --Preface --Pharmaceutical Patents and Competition Issues --What Is Going on in National Systems?

A comprehensive analysis of European competition law and intellectual property law issues affecting the pharmaceutical and biotechnology sectors, offering both theoretical and practical perspectives.

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.

What is the efficacy of Competition Law in regard to scrutinizing strategic patenting practices and evergreening in the pharmaceutical sector under the arrangements of Patent law? The book is a comprehensive study of the pharmaceutical sector in relation to consumer protection whilst considering the excessive price affliction on the availability of affordable health services. It focuses on anti-competitive agreements like cartels, parallel pricing, predatory pricing by pharmaceutical companies including other aspects under competition law, and patients being fettered by patents under intellectual property laws. Drugs being an essential commodity have been part of unfair-trade practices and its implication is leading to extensive price discrimination on a global level. It is a comparative analysis of the implementation of laws in different jurisdictions for the availability of drugs at fair prices, which will include the legal hurdles in the promotion and adoption of low-cost generic drugs by various jurisdictions. The line where fair profits end and the extortion in the name of innovation and exclusivity rights start is a bleak one. This book is aimed at finding that balance that encourages innovation in the pharmaceutical sector as well as makes these innovative drugs affordable and available for common man's use with the efficacy of Competition Law in place. The primary objective of this book is to highlight the capitalist approach of pharmaceutical companies in defeating the larger public interest and the discrepancies of law leading to ethical misconduct.

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.

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.

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