丸善雄松堂株式会社
学術情報ソリューション事業部
法律情報営業部

〒160-0002
東京都新宿区四谷坂町10-10
Tel: 03-3357-1435
Fax: 03-3357-2805

ご注文に際して

個人情報保護方針

コーポレートサイト

書影

医薬品、バイオテクノロジーに関する欧州・英国法 第3版

Pharmaceuticals Biotechnology and the Law, 3rd Edition

Trevor Cook

1 vol. lxxviii, 748 p. Hard., 2016年6月刊

Butterworths (LexisNexis), GBR. ISBN: 9781405781664

¥82,491

在庫あり

医薬品、バイオ技術、ライフサイエンス商品の開発・承認・流通の各段階において適用されるEU(および英国)の広範な法規制を解説。第一人者として知られるCook弁護士による解説書。

□補充的保護証明書(SPC)制度 □幹細胞や植物育種に関する特許 □試験的使用や規制機関審査による抗弁 □試験データの独占的利用(data exclusivity) □希少医薬品(orphan product)や臨床試験データの透明性に関する新判例やガイダンス □ライフサイエンス商品に関する競争法、平行輸入、商標法 □食品、飼料、化粧品、植物新種、殺生物剤(バイオサイド)等に関する規制 等

【Table of Contents】

PART I - INTRODUCTION AND OVERVIEW

1. Introduction

2. Regulatory, Tort and Competition Law in Life Sciences

3. Intellectual Property in Life Sciences

4. Agreements in Life Sciences

PART II - ISSUES THAT ARISE BEFORE SECURING AUTHORISATION TO MARKET

5. Patents for Chemicals, Pharmaceuticals and Medical Treatment

6. Patents and Biotechnology - Issues of General Application, Particularly as to Products of Nature

7. Biotechnology Patents - Ethical, Variety and Source Issues

8. The Experimental Use Defence to Patent Infringement

9. Regulation of Early Stage Biotechnology and Life Sciences Research

10. Testing Medicinal and Other Products on Animals and on Humans, and Clinical Trial Transparency

11. Securing Marketing Authorisations for Medicinal Products and Placing Medical Devices on the Market

PART III - ISSUES THAT ARISE AFTER PLACING A LIFE SCIENCES PRODUCT ON THE MARKET

12. Regulatory Controls on Medicinal Products and Medical Devices Once on the Market

13. Regulatory Control of Life Sciences Products Other Than Medicinal Products or Medical Devices

14. Pharmaceutical Trade Marks and Other Naming Considerations

15. Using Supplementary Protection Certificates to Provide Extended Patent Type Protection for Pharmaceuticals and Agrochemicals to Compensate for Regulatory Delay

16. Free Movement of Goods and Parallel Trade, Especially within the European Union

17. Data Exclusivity – General Considerations

18. Regulatory Exclusivities for Medicinal Products in the European Union, including Data Exclusivity and Orphan Medicinal Products Exclusivity

19. Data Exclusivity Other Than for Medicinal Products in the European Union and the Confidentiality of Data as to Such Products

20. Patents, Generics and Competition Law