製薬業における技術革新、競争と特許法 Pharmaceutical Innovation, Competition and Patent Law : A Trilateral Perspective

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製薬業における技術革新、競争と特許法<br>Pharmaceutical Innovation, Competition and Patent Law : A Trilateral Perspective

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製薬業における技術革新、競争と特許法
Pharmaceutical Innovation, Competition and Patent Law : A Trilateral Perspective

Drexl, Josef (EDT)/ Lee, Nari (EDT)

ウェブストア価格 ¥38,738（本体¥35,217）
Edward Elgar Publishing Ltd（2013/07発売）
外貨定価 UK£ 126.00
ポイント 352pt

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製本 Hardcover:ハードカバー版／ページ数 352 p.
言語 ENG
商品コード 9780857932457
DDC分類 346.0486

基本説明

Contributors to this book - academics, judges and practitioners from Europe, US and Japan - explore pharmaceutical industry's life cycle management strategies in the context of competition and patent laws.

Full Description

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.

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