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.

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

What are the normative foundations of competition law? That is the question at the heart of this book. Leading scholars consider whether this branch of law serves just one or more than one goal, and if it serves to protect unfettered competition as such, how this goal relates to other objectives such as the promotion of economic welfare. The book brings together contributions on the relevance of different welfare standards, on the concept of 'freedom to compete' and on distributional fairness as a goal of competition law. Moreover, it discusses the relationship to other legal goals such as mar.

Examining the relationship between intellectual property and competition law with a particular focus on European law, this book highlights areas emerging new frontiers.

This new Sixth Edition of a major work by the well-known competition law team at Van Bael & Bellis in Brussels brings the book up to date to take account of the many developments in the case law and relevant legislation that have occurred since the Fifth Edition in 2010. The authors have also taken the opportunity to write a much-extended chapter on private enforcement and a dedicated section on competition law in the pharmaceutical sector. As one would expect, the new edition continues to meet the challenge for businesses and their counsel, providing a thoroughly practical guide to the application of the EU competition rules. The critical commentary cuts through the theoretical underpinnings of EU competition law to expose its actual impact on business. In this comprehensive new edition, the authors examine such notable developments as the following: important rulings concerning the concept of a restriction by object under Article 101; the extensive case law in the field of cartels, including in relation to cartel facilitation and price signalling; important Article 102 rulings concerning pricing and exclusivity, including the Post Danmark and Intel judgments, as well as standard essential patents; the current block exemption and guidelines applicable to vertical agreements, including those applicable to the motor vehicle sector; developments concerning online distribution, including the Pierre Fabre and Coty rulings; the current guidelines and block exemptions in the field of horizontal cooperation, including the treatment of information exchange; the evolution of EU merger control, including court defeats suffered by the Commission and the case law on procedural infringements; the burgeoning case law related to pharmaceuticals, including concerning reverse payment settlements; the current technology transfer guidelines and block exemption; procedural developments, including in relation to the right to privacy, access to file, parental liability, fining methodology, inability to pay and hybrid settlements; the implementation of the Damages Directive and the first interpretative rulings. As a comprehensive, up-to-date and above all practical analysis of the EU competition rules as developed by the Commission and EU Courts, this authoritative new edition of a classic work stands alone. Like its predecessors, it will be of immeasurable value to both business persons and their legal advisers.

Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.

Pharmaceuticals is a large, high-growth, globalized, & innovation intensive industry. Pharmaceuticals has long been a stronghold of the European industry, & it still provides by far the largest contribution to the European trade balance in high-technology, R&D intensive sectors. However, it is now a diffused perception that the European pharmaceutical industry is losing ground vis-a-vis the U.S. Against this background, the Report examines the competitive position of the European pharmaceutical companies & industries, & compares them with the pharmaceutical companies & industries in other parts of the world, particularly the U.S. Charts, tables & graphs.

This book explores the fundamental and inextricable relationship between regulation, intellectual property, competition law, and public health in pharmaceutical 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 anti-competitive 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 debates. 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, significant cases, and policy choices. Pursuant to this rigorous approach, the book provides an original and thought-provoking critique of the challenges of regulating pharmaceutical markets.

Through a collaboration among twenty legal scholars from North America, Europe and Asia, this book presents an international consensus on the use of patent remedies for complex products such as smartphones, computer networks, and the Internet of Things. This title is also available as Open Access on Cambridge Core.

In this revised and much expanded second edition David Ashton provides a comprehensive review of the EU damages directive (Directive 2014/104/EU) and its implementation, bringing the book up to date with the latest advances in EU Competition Law damages actions. This edition also features insights from practising lawyers on national developments in over 10 countries across Europe and an updated, separately authored, chapter on the quantification of loss. This book will provide practising lawyers and scholars alike with a clear, well-structured and updated guide to EU Competition Law Damages.