Competition & Intellectual Property Law In The Pharmaceutical Sector

International Competition Law Series Volume 65 Competition and Intellectual Property Law in the Pharmaceutical Sector deals with the apparent contradiction between intellectual property (IP) rights (particularly patents) and competition law, with a focus on the pharmaceutical sector: in its aim to promote innovation and long-term competition, the patent system in fact provides a temporary right to exclude. The book explores the possibility of adjusting patent policies to better account for the trade-off between static and dynamic welfare and minimize the risks of anticompetitive behaviour, which happens with the misuse of patents. This book, the first to deal with this issue on a global basis, tackles the clashes of case law by Courts and antitrust enforcement by competition authorities that undermine the predictability of solutions to this problem and increase the risk of fundamental rights violations and excessive transitional costs for enterprises. Examining the approaches to competition and IP regulation in fourteen leading jurisdictions, the analysis provides a comparative perspective on recent relevant regulations and case law in the pharmaceutical sector. Thirty-one contributions by internationally known experts in both fields – judges in specialized courts, chairmen and board members of national competition authorities, and well-known scholars and practitioners – focus on the salient topics and on the interplay between patent law and competition law, with an insight into the human rights issues that arise. What’s in this book: Among the topics covered are the following: balancing the human right to health with competition law and IP law; patent lifecycle strategies; reverse payment settlements; abusive litigation; damages for patents and antitrust infringements; co-marketing and co-promotion agreements; and the role of the Unified Patent Court. The jurisdictions covered are Brazil, Canada, China, France, Germany, Greece, India, Italy, Japan, the Netherlands, Russia, South Africa, the United Kingdom, and the United States. The book’s ultimate and challenging proposal identifies the pharmaceutical sector as a starting point for reshaping a more procompetitive and harmonized system of regulation. Comparing different systems, the book takes the first step in moving towards a more levelled regulation in the pharmaceutical field. It helps in reducing the lack of uniformity among different legal systems and the clashes of jurisprudence in Court decisions that undermine the predictability of solutions in arising conflicts and increase the risk of violation of Fundamental Rights for individuals and the transitional costs for enterprises. It focuses on IP and competition law related issues and on the interplay between Patent Law and Antitrust Law and Human Rights in the field.

Part I. Pharmaceutical Patents and Competition Issues Chapter 1. The Perspective of Economics The Economics of Competition Law and of Pharmaceutical Patents Avantika Chowdhury & Alexander Gaigl The Procompetitive and Anticompetitive Impact of Patent Settlements Ginevra Bruzzone & Sara Capozzi Originators versus Originators: Competition before the Market and Market Power beyond Dominance Andrea Pezzoli Damages for Patent Infringements: The Interplay of Legal and Economic Perspectives in the Main European Jurisdictions Luigi Prosperetti Chapter 2. The Perspective of Law Balancing the Human Right to Health with the Competition Law and the Intellectual Property Regime Beniamino Caravita di Toritto The Dangers of Settling Patent Litigation Ian S. Forrester Life-Cycle Management Strategies in the Pharmaceutical Patent Sector Giovanni Pitruzzella Pharmaceutical Patents: Competition Law Goes Too Far Robin Jacob What Is in a Name: The Concept of Abuse in Sui Generis Abuse Cristoforo Osti Abuse of litigation, Abuse of Patent and Abuse of Dominance: Where Do We Stand? Gabriella Muscolo Reverse Settlements in the European Union and the United States Damien Geradin, Douglas H. Ginsburg & Graham Safty Co-marketing and Co-promotion Agreements Enrico Adriano Raffaelli The New Unified European Patent Court and a New Patent Law: When a KU is Not a KU Mario Franzosi Part II. What Is Going on in National Systems? Chapter 3. The Perspective from Europe France. Raising Artificial Barriers against Generic Entry: The French Experience Bruno Lasserre Germany. Patent Settlements and Drug Discount Agreements in Light of European and German Antitrust Law Heinz Goddar, Jan Bernd Nordemann & Julian Waiblinger Greece. The Status Quo and the Future of the Balance between Patent Law and Competition Law in the Pharmaceutical Sector in Greece Ioannis Kokkoris & Alexandra Sidossis Italy. The Intersection between Competition Law and Intellectual Property Law: The Public Enforcement Approach Followed by The ICA Filippo Arena & Roberto Chieppa Italy. Abuse of Patent Rights and Abuse of Dominant Position: The Pfizer Case Gustavo Ghidini, Giovanni Cavani & Piera Francesca Piserà Italy. Antitrust Assessment of Co-marketing Agreements: A Diverging Approach between EU and Italy? Mario Siragusa & Pietro Merlino Netherlands. Follow the Dutch? Willem Hoyng & Anne-Claire Hoyng United Kingdom. The Pharmaceutical Sector between Patent Law and Competition Law in the UK Ioannis Kokkoris United Kingdom. IP in the Pharmaceutical Sector in the UK: Some Recent Cases Christopher Floyd United Kingdom. Gaviscon: The Diagnosis and Treatment of Abuse of Dominance – Very Recent Changes in the Private Enforcement of Competition Rules in the UK Gerald Barling & Renella Reumerman Chapter 4. The International Approach Brazil. Competition Policy and Life Cycle Management: The Brazilian Experience Ana Paula Martinez Canada. The Intersection of Canadian Competition and Intellectual Property Law: Developments in the Pharmaceutical Sector Alan Gunderson China.The Development of China Antitrust Law and a Review of the Main Decision on the Pharmaceutical Industry Hermes Pazzaglini India.The Interplay between Competition Law and Intellectual Property in the Indian Pharmaceutical Sector: Deference Is Better than Cure Naval Satarawala Chopra & Yaman Verma Japan. Japan’s Pharmaceutical Industry and the Patent and Non-patent Incentives for Pharmaceutical R&D Toshiko Takenaka Russia. The Interplay of Patents and Competition Law in the Russian Pharmaceutical Sector: An Everlasting State of Transition Alexey Ivanov South Africa. The Intersection between Patent Law and Competition law as It Relates to the Pharmaceutical Sector in South Africa Daryl Dingley United States. Pharmaceutical Antitrust Law in the United States Michael A. Carrier