Author : Giovanni Pitruzzella
Publisher : Kluwer Law International
Page : 0 pages
File Size : 15,64 MB
Release : 2016
Category : Antitrust law
ISBN : 9789041159274
Editors --Contributors --Foreword --Preface --Pharmaceutical Patents and Competition Issues --What Is Going on in National Systems?
Author : Amalia Athanasiadou
Publisher : Kluwer Law International B.V.
Page : 349 pages
File Size : 47,27 MB
Release : 2018-08-14
Category : Law
ISBN : 9403501146
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 : Nada Bodiroga-Vukobrat
Publisher : Springer
Page : 405 pages
File Size : 38,56 MB
Release : 2019-08-02
Category : Law
ISBN : 3030164659
This book gathers scientific contributions on comprehensive approaches to personalized medicine. In a systematic and clear manner, it provides extensive information on the methodological, technological, and clinical aspects of high-throughput analytics, nanotechnology approaches, microbiota/human interactions, in-vitro fertilization and preimplantation, and various diseases like cancer.Moreover, the book analyzes the social and legal aspects of social security systems, healthcare systems and EU law – e.g. the role of solidarity, regulatory possibilities and obstacles, justice and equality, privacy/disclosure of data, and the right to know – from an interdisciplinary perspective. Lastly, it explores the economical and ethical context in the fields of business models, intellectual property issues, the patient/physician relationship, and price discrimination.
Author : Herbert HOVENKAMP
Publisher : Harvard University Press
Page : 392 pages
File Size : 32,2 MB
Release : 2009-06-30
Category : Law
ISBN : 9780674038820
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 : Van Bael & Bellis
Publisher : Kluwer Law International B.V.
Page : 1618 pages
File Size : 17,25 MB
Release : 2021-03-01
Category : Law
ISBN : 9041154051
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.
Author : Thomas K. Cheng
Publisher : Oxford University Press
Page : 545 pages
File Size : 21,64 MB
Release : 2022-01-15
Category : Law
ISBN : 0192857355
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 : Ariel Ezrachi
Publisher : Bloomsbury Publishing
Page : 1061 pages
File Size : 43,35 MB
Release : 2014-09-04
Category : Law
ISBN : 1782254803
This book is the fourth edition of a highly practical guide to the leading cases in European Competition Law. It explores the application of Article 101 TFEU, Article 102 TFEU and the European Merger Regulation, as well as the public and private enforcement of Competition Law. In addition, it reviews the intersection between Competition Law and Intellectual Property Rights and the application of Competition Law to State action. Each chapter outlines the relevant laws, regulations and guidelines for each topic. Within this framework, cases are reviewed in summary form, accompanied by analysis and commentary. Endorsements: 'This book should be in the library of every competition law practitioner and academic. The summary of cases is first class. But what makes it really stand out is the quality of the commentary and the selection of the material which includes not only the most important European judgements and decisions but also some of the leading cases from the US and European Member States.'Ali Nikpay, Gibson, Dunn & Crutcher LLP, Former Senior Director, Office of Fair Trading 'The study of EU Competition law requires the analysis and understanding of a number of increasingly complex European Commission and European Court decisions. Through the provision of case summaries, excerpts from the important passages and concise commentary linking these decisions to other key case law and Commission documents, this unique and impressive book, now in its fourth edition, provides the student and practitioner of EU competition law with an extremely clear and useful introduction to these leading decisions' Dr Kathryn McMahon, Associate Professor, School of Law, University of Warwick 'The Guide is an invaluable tool for both students and practitioners. It provides a compact overview on the fundamental cases and highlights the essential problems in a clear and sharp analysis.' Dr Christoph Voelk, Antitrust Practice Group, McDermott, Will & Emery LLP 'This book is especially valuable to competition law specialists in Europe and abroad who are interested in the jurisprudence and policy of the European Union and its member states. Familiarity with the European regime is essential for proficiency in competition law today, and this volume provides an excellent foundation.' William E Kovacic, Global Competition Professor of Law and Policy, George Washington University Law School, Former Chairman, US Federal Trade Commission
Author : C. Bradford Biddle
Publisher : Cambridge University Press
Page : 379 pages
File Size : 25,70 MB
Release : 2019-06-27
Category : Business & Economics
ISBN : 1108426751
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.
Author : Pablo Figueroa
Publisher : Edward Elgar Publishing
Page : 733 pages
File Size : 11,96 MB
Release : 2019
Category : Business & Economics
ISBN : 1785362615
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 : Enrico Bonadio
Publisher : Bloomsbury Publishing
Page : 448 pages
File Size : 27,18 MB
Release : 2022-06-30
Category : Law
ISBN : 1509944907
This collection of essays highlights the sometimes absurd outcomes which an unjustified overprotection of intellectual property (IP) may lead to. It collects and comments on a series of IP disputes which have taken the notion of IP protection to extremes. From individuals being sued for hundreds of thousands of dollars for sharing a playlist, to sports spectators being arrested for wearing the 'wrong' dresses, passing through granting patents for inventions obtained by misappropriating traditional knowledge, and trademark protection of merely descriptive signs, this book brings together a broad range of examples from across the IP spectrum where protection and enforcement have been used or threatened on unreasonable and/or untenable grounds. The aim of the book is to criticise these excesses precisely because they harm IP; and because they contribute to creating an environment where more and more people are led to 'hate' IP, and view it as a protectionist regime which discourages creativity in innovation and ends up safeguarding the owners of monopolistic rights which restrict trade, competition and people's freedom. This is not, therefore, a book against IP, it is instead a call for change and an attempt to 'save' IP through critiquing its excesses and preventing such a fascinating area of law from continuing to be an easy target for criticism. The book includes a foreword by Jason Mazzone, Albert E Jenner Jr Professor of Law at the University of Illinois, USA.
