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Vol 23 No 7 July/August 2018

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Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law


ISBN13: 9789403501130
To be Published: August 2018
Publisher: Kluwer Law International
Country of Publication: The Netherlands
Format: Hardback
Price: £138.00



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.

  • Subjects:
    Competition Law, Intellectual Property Law, Medical Law
    Contents:
    Preface
    List of Abbreviations
    Acknowledgements
    Introduction
    PART I
    Pharma Innovation and Settlements
    CHAPTER 1
    Pharma R&D and Settlements
    PART II
    Pharma Settlements in the US
    CHAPTER 2
    The US Regulatory Framework
    CHAPTER 3
    The US Circuits’ Split on Reverse Payment Settlements
    CHAPTER 4
    FTC v. Actavis
    PART III
    Pharma Settlements in the EU
    CHAPTER 5
    The European Regulatory Framework
    CHAPTER 6
    Delaying Generic Entry in the EU
    Conclusion
    Bibliography
    Table of Cases
    Tables of Statutes & Legislation
    Index

    Series: International Competition Law

    EU State Aid Control of Infrastructure Funding ISBN 9789041190994
    Published July 2018
    Kluwer Law International
    £137.00
    Competition Law in the ASEAN Countries: Regional Law and National Systems ISBN 9789041191021
    Published July 2018
    Kluwer Law International
    £98.00
    Sixty Years of EU State Aid Law and Policy: Analysis and Assessment ISBN 9789041188694
    Published February 2018
    Kluwer Law International
    £126.00
    The EU Leniency Policy: Reconciling Effectiveness and Fairness ISBN 9789041184795
    Published October 2017
    Kluwer Law International
    £104.00
    Directory of EU Case Law on Competition 2nd ed ISBN 9789041183637
    Published August 2017
    Kluwer Law International
    £209.00
    £108.00
    Directory of EC Case Law on State Aids 2nd ed ISBN 9789041167217
    Published June 2016
    Kluwer Law International
    £204.00
    The Role of Economic Analysis in EU Competition Law: The European School 4th ed ISBN 9789041162458
    Published May 2016
    Kluwer Law International
    £154.00
    £124.00
    Competition and State Aid: An Analysis of the EU Practice 2nd ed ISBN 9789041158185
    Published July 2015
    Kluwer Law International
    £152.00
    The Substantive Appraisal of Joint Ventures Under the EU Merger Control Regime ISBN 9789041158161
    Published December 2014
    Kluwer Law International
    £96.00
    EU Competition Law, Regulation and the Internet: The Case of Net Neutrality ISBN 9789041141408
    Published November 2014
    Kluwer Law International
    £108.00
    The Interface between Competition Law, Patents and Technical Stadards ISBN 9789041154187
    Published November 2014
    Kluwer Law International
    £104.00
    Competition Law Enforcement and Compliance across the World: A Comparative Review ISBN 9789041158154
    Published November 2014
    Kluwer Law International
    £116.00
    Standard Essential Patents and Competition Law: A Transatlantic Perspective ISBN 9789041149602
    Published September 2014
    Kluwer Law International
    £96.00
    Competition Law: Comparative Private Enforcement and Collective Redress Across the EU ISBN 9789041145598
    Published March 2014
    Kluwer Law International
    £100.00
    EU Competition Law: Between Public and Private Enforcement ISBN 9789041146779
    Published December 2013
    Kluwer Law International
    £112.00
    £116.00
    Landmark Cases in Competition Law: Around the World in Fourteen Stories ISBN 9789041138439
    Published December 2012
    Kluwer Law International
    £112.00
    Merger Decisions and the Rules of Procedure of the European Community Courts ISBN 9789041136718
    Published December 2011
    Kluwer Law International
    £120.00
    Antitrust Law in Brazil ISBN 9789041136701
    Published December 2011
    Kluwer Law International
    £112.00
    £92.00
    Merger Control Regimes in Emerging Economies: A Case Study on Brazil and Argentina ISBN 9789041134028
    Published January 2011
    Kluwer Law International
    £108.00
    Does EC Merger Control Discriminate Against Small Companies ? ISBN 9789041132611
    Published July 2010
    Kluwer Law International
    £128.00
    The Reform of EC Competition Law: New Challenges ISBN 9789041126924
    Published December 2009
    Kluwer Law International
    £125.00
    Civil Procedure in EU Competition Cases before the English and Dutch Courts ISBN 9789041131928
    Published November 2009
    Kluwer Law International
    £126.00
    An Institutional Assessment of Antitrust Policy: The Latin American Experience ISBN 9789041124784
    Published May 2009
    Kluwer Law International
    £136.00
    £169.00
    EC State Aid Law: Liber Amicorum in Honour Francisco Santaolalla ISBN 9789041127747
    Published October 2008
    Kluwer Law International
    £144.00
    Competition Problems in Liberalized Telecommunications ISBN 9789041127365
    Published June 2008
    Kluwer Law International
    £144.00
    Liner Shipping and EU Competition Law ISBN 9789041127174
    Published May 2008
    Kluwer Law International
    £112.00
    A Practical Guide to National Competition Rules Across Europe 2nd ed ISBN 9789041126078
    Published November 2007
    Kluwer Law International
    £173.00
    Tying and Bundling as A Leveraging Concern Under EC Competition Law ISBN 9789041125750
    Published October 2007
    Kluwer Law International
    £113.00
    Competition Law and Economics: Advances in Competition Policy and Antitrust Enforcement ISBN 9789041126320
    Published September 2007
    Kluwer Law International
    £124.00
    Directory of EC Case Law on Competition ISBN 9789041126566
    Published August 2007
    Kluwer Law International
    Out of print
    Effective Application of EU State Aid Procedures: The Role of National Law and Practice
    Edited by: Paul F. Nemitz
    ISBN 9789041126573
    Published July 2007
    Kluwer Law International
    £124.00
    £124.00
    Private Enforcement of EC Competition Law
    Edited by: Jurgen Basedow
    ISBN 9789041126139
    Published March 2007
    Kluwer Law International
    £128.00
    Competition Rules for the 21st Century: Principles from America's Experience 2nd ed ISBN 9789041124777
    Published September 2006
    Kluwer Law International
    £161.00
    A Concise Guide to the EU Anti-Dumping/ Anti-Subsidies Procedures ISBN 9789041124647
    Published June 2006
    Kluwer Law International
    £100.00
    The EC Merger Control Regulation: Rights of Defence ISBN 9789041125538
    Published June 2006
    Kluwer Law International
    £121.00
    Mergers and Acquisitions: The Industrial Organization Perspective ISBN 9789041124517
    Published March 2006
    Kluwer Law International
    £85.00
    Unfair Competition Law. European Union and Member States ISBN 9789041123299
    Published February 2006
    Kluwer Law International
    £116.00
    Economic Analysis of Vertical Agreements: A Self-Assessment ISBN 9789041123282
    Published July 2005
    Kluwer Law International
    £100.00
    US and EC Oligopoly Control ISBN 9789041122964
    Published June 2004
    Kluwer Law International
    £116.00
    Economic Essays on Australian and New Zealand Competition Law ISBN 9789041119919
    Published April 2003
    Kluwer Law International
    £127.00
    Merger Control in Europe: EU Member States and Accession States 4th ed ISBN 9789041120564
    Published January 2003
    Kluwer Law International
    £123.00
    Limits and Control of Competition with a View to International Harmonization
    Edited by: Jurgen Basedow
    ISBN 9789041119674
    Published November 2002
    Kluwer Law International
    £135.00
    Competition Policy in the Global Trading System ISBN 9789041117588
    Published April 2002
    Kluwer Law International
    £128.00
    International and Comparative Competition Law and Policies ISBN 9789041116437
    Published September 2001
    Kluwer Law International
    £106.00
    M & A in Belgium
    ISBN 9789041115942
    Published May 2001
    Kluwer Law International
    £71.00
    US and EC Oligopoly Control 2nd ed ISBN 9789041125637

    Kluwer Law International
    Publication Abandoned