Eu Competition Law And Pharmaceuticals PDF Download
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Author | : Wolf Sauter |
Publisher | : Edward Elgar Publishing |
Total Pages | : 325 |
Release | : 2022-11-15 |
Genre | : Law |
ISBN | : 1802204415 |
Download EU Competition Law and Pharmaceuticals Book in PDF, ePub and Kindle
This timely book discusses the application of the EU competition rules to pharmaceuticals, covering the prohibitions on anticompetitive agreements and abuse of dominance, and merger control. It carefully considers the balance between competition and innovation, as well as between competition and regulation, and concludes that competition and regulation are not alternatives, but complementary, and that novel ways of taking into account risk and real innovation through competition assessments have been developed.
Author | : Amalia Athanasiadou |
Publisher | : Kluwer Law International B.V. |
Total Pages | : 520 |
Release | : 2018-08-14 |
Genre | : Law |
ISBN | : 9403501146 |
Download Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law Book in PDF, ePub and Kindle
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 | : Pablo Figueroa |
Publisher | : Edward Elgar Publishing |
Total Pages | : 758 |
Release | : 2019 |
Genre | : Business & Economics |
ISBN | : 1785362615 |
Download EU Law of Competition and Trade in the Pharmaceutical Sector Book in PDF, ePub and Kindle
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 | : Björn Lundqvist |
Publisher | : Oxford University Press, USA |
Total Pages | : 576 |
Release | : 2031-05-30 |
Genre | : Law |
ISBN | : 9780198724827 |
Download Competition Law and IP Rights in Pharmaceuticals and Biotechnology Book in PDF, ePub and Kindle
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 | : Pierre Kobel |
Publisher | : Springer |
Total Pages | : 499 |
Release | : 2017-09-20 |
Genre | : Law |
ISBN | : 3319558137 |
Download Antitrust in Pharmaceutical Markets & Geographical Rules of Origin Book in PDF, ePub and Kindle
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 | : Claudia Desogus |
Publisher | : |
Total Pages | : 0 |
Release | : 2011 |
Genre | : Drugs |
ISBN | : 9789400001473 |
Download Competition and Innovation in the EU Regulation of Pharmaceuticals Book in PDF, ePub and Kindle
This book deals with parallel trade of pharmaceuticals from a law and economics perspective. Traditionally, restrictions to parallel trade were regarded negatively because they ran against the rules of the EU internal market. However, in recent judgments (Bayer, Glaxo, and Syfait), EU courts questioned some of the legal principles underpinning the EU policy on parallel trade in the field of pharmaceuticals. This shift suggested that there might be scope for improvement of such policy. However, how and to what extent this change should be performed remained partially unclear. Through the analysis of the impact that parallel trade of pharmaceuticals has on consumer welfare, both in a static and in a dynamic sense, this book examines whether the current legal approach to parallel trade of pharmaceuticals reflects the findings of economic theory, whether it should change, and, if so, on what basis this adjustment should take place. The analysis not only provides a policy assessment, but also offers some insights on one of the issues debated within the process of modernization of EU competition law: how judges should integrate economic reasoning in the antitrust assessment of corporate practices. The book will be particularly useful both for practitioners and legal scholars who want deepen their understanding of the EU pharmaceutical market and of the most recent EU judicial developments in that field, as well as of their implications for EU competition law in a 'modernized' context.
Author | : Giovanni Pitruzzella |
Publisher | : Kluwer Law International |
Total Pages | : 0 |
Release | : 2016 |
Genre | : Antitrust law |
ISBN | : 9789041159274 |
Download Competition and Patent Law in the Pharmaceutical Sector Book in PDF, ePub and Kindle
Editors --Contributors --Foreword --Preface --Pharmaceutical Patents and Competition Issues --What Is Going on in National Systems?
Author | : Leigh Hancher |
Publisher | : |
Total Pages | : 27 |
Release | : 2015 |
Genre | : |
ISBN | : |
Download A Dose of Competition Book in PDF, ePub and Kindle
In the pharmaceuticals sector there is an inherent tension between intellectual property rights and antitrust. This paper examines this tension over the past 10 years since modernisation of EU competition law. It looks at three types of problems: (i) restrictions on parallel imports; (ii) abuse of administrative procedure; and (iii) pay for delay cases. This overview shows that the European Commission is now especially active in areas (ii) and (iii) and generally relies on a more formalistic approach of finding restrictions by object instead of using economic arguments to demonstrate restrictions by effect. The by object approach is supported by the EU Courts. Also, the molecule (active ingredient) is often regarded as the relevant product market, facilitating a finding of dominance. Some national competition authorities have followed in the footsteps of the Commission but on the whole they are less active, for instance on pay for delay. This may be because the EU Courts have yet to rule on this type of case. For pharmaceutical companies the net result is that they cannot assume their intellectual property rights will stand in the way of a finding of antitrust infringement and their behaviour will be scrutinised closely.
Author | : Van Bael & Bellis |
Publisher | : Kluwer Law International B.V. |
Total Pages | : 1618 |
Release | : 2021-03-01 |
Genre | : Law |
ISBN | : 9041154051 |
Download Competition Law of the European Union Book in PDF, ePub and Kindle
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 | : Ann-Kathrin Lehnhausen |
Publisher | : Springer |
Total Pages | : 95 |
Release | : 2016-11-14 |
Genre | : Business & Economics |
ISBN | : 3658165510 |
Download Studies on Competition and Antitrust Issues in the Pharmaceutical Industry Book in PDF, ePub and Kindle
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.