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.

Contents: Introduction Nari Lee and Josef Drexl PART I: PATENT PROTECTION FOR PHARMACEUTICAL METHODS 1. The Patentability of Genetic Diagnostics in US Law and Policy Rochelle C. Dreyfuss 2. Patentability of Pharmaceutical Innovations: The European Perspective Rainer Moufang 3. Patentability of Medical Methods in Japan Nari Lee PART II: DATA EXCLUSIVITY AND PATENT TERM EXTENSION: CONVERGENCE OR DIVERGENCE 4. Patent Term Restoration and Non-Patent Exclusivity in the US Margo A. Bagley 5. Clinical Data, Data Exclusivity and Private Investment Protection in Europe Christian R. Fackelmann 6. Patent Term Extension in Japan: An Academic and Comparative Perspective Ryoko Iseki 7. Recent UK Case Law on Supplementary Protection Certificates Richard Arnold 8. Patent Term Extension in Japan: Focusing on the Pacif Capsule Decision Toshiaki Imura PART III: BALANCING INCENTIVES AND COMPETITION IN EUROPE 9. Strategic Patenting by the Pharmaceutical Industry: Towards a Concept of Abusive Practices of Protection Hanns Ullrich 10. Anticompetitive Marketing in the Context of Pharmaceutical Switching in Europe Bengt Domeij 11. AstraZeneca and the EU Sector Inquiry: When Do Patent Filings Violate Competition Law? Josef Drexl Index

'In sum, the book is well written, interesting and very topical. It is written by very knowledgeable lawyers, which is reflected in the high quality of the articles. . . I recommend this book, not only for academics but for practicing lawyers as well. Many of the contributions contain valuable ''take home messages'', which should be taken into account in the discussions.' --Marcus Norrgard, International Review of Intellectual Property and Competition Law'This is an intriguing selection of topical essays addressing fundamental questions of pharmaceutical innovation. It is comprised of a high-profile list of contributors, including academics, judges and practitioners from the U.S., Europe and Japan, who ''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 medicines and health care''. . . This is an enjoyable, readable and interesting book containing thorough studies of ''hot'' legal issues in the pharma sector converging in an decisive era for pharmaceutical innovation. It ought to be found in any library that has reserved space for pharma-, IP- or competition law-related literature.' --Jur. Dr. Timo Minssen, European Competition Law Review