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Pharmaceutical Innovation, Competition and Patent Law

A Trilateral Perspective Edited by Josef Drexl, Director, Max Planck Institute for Innovation and Competition, Munich, Germany and Nari Lee, Hanken School of Economics, Helsinki, Finland
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, the 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.
Extent: 352 pp
Hardback Price: $154.00 Web: $138.60
Publication Date: 2013
ISBN: 978 0 85793 245 7
Availability: In Stock
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  • Law - Academic
  • Biotechnology and Pharmaceutical Law
  • Competition and Antitrust Law
  • Intellectual Property Law
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, the 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.
‘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

‘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
Contributors: R. Arnold, M.A. Bagley, B. Domeij, J. Drexl, R.C. Dreyfuss, C.R. Fackelmann, T. Imura, R. Iseki, N. Lee, R. Moufang, H. Ullrich
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