Public health, safety, and access to reasonably priced medicine are common policy goals of pharmaceutical regulations. As both the context for innovation and competitive structure change, industry actors dynamically challenge the balance between the incentive for protection and the achievement of those policy goals. Considering the arguments from the perspectives of innovation, competition law and patent law, this book explores the difficult question of balancing protection with access, highlighting the difficulties in harmonization and coordination. The contributors to this book including academics, judges and practitioners from Europe, US and Japan, explore to what extent patent strategies and life-cycle management practices take advantage of patent laws and health-care regulation and disrupt the necessary balance between incentives for innovation and access to affordable medicine and health care. Addressing fundamental questions in the field of pharmaceutical innovation, this book will appeal to scholars and practitioners in intellectual property, competition law and life sciences regulation, as well as pharmaceutical companies and regulators.
Contents: Introduction PART I: PATENT PROTECTION FOR PHARMACEUTICAL METHODS 1. The Patentability of Genetic Diagnostics in U.S. Law and Policy 2. Patentability of Pharmaceutical Innovations - The European Perspective 3. Patentability of Medical Methods in Japan PART II: DATA EXCLUSIVITY AND PATENT TERM EXTENSION - CONVERGENCE OR DIVERGENCE 4. Patent Term Restoration and Non-Patent Exclusivity in the United States 5. Clinical Data, Data Exclusivity and Private Investment Protection in Europe 6. Patent Term Extension in Japan - an Academic and Comparative Perspective 7. Recent United Kingdom Case Law On Supplementary Protection Certificates 8. Patent Term Extension in Japan - Focusing on the Pacif Capsule Decision Apppendix Decision of Japanese Supreme Court, 28 April 2011 PART III: BALANCING INCENTIVES AND COMPETITION IN EUROPE 9. Strategic Patenting by Pharmaceutical Industry - Towards a Concept of Abusive Practices of Protection 10. Anticompetitive Marketing in the Context of Pharmaceutical Switching in Europe 11. AstraZeneca and the EU Sector Inquiry: When Do Patent Filings Violate Competition Law? Index.
