Pharmaceuticals Biotechnology & the Law

Pharmaceuticals Biotechnology and the Law is the definitive guide to the law in Europe relating to pharmaceuticals, biotechnology and their related areas such as medical devices.

Written by one of the country's leading patent and regulatory lawyers (Trevor Cook, Bird & Bird), this is the only text which comprehensively covers the wide variety of legal and regulatory issues which surround these industry sectors.

The book examines the background to, and the impact of, the law affecting this area. The text is primarily written from the perspective of European Community law, although in those relatively few areas where this is not harmonised it is written from the perspective of English law.

The book has been comprehensively updated if not re-written to take account of the enormous amount of development in the field since publication of the first edition in 1991.

Virtually every single regulatory framework addressed is completely new or radically updated since then and for example, only two of the materials in the appendix date back to the first edition (e.g., pricing transparency and contained use).

Entire areas of law have developed since then, such as regulatory data, which is accorded three chapters of coverage within the book. The field has also seen the introduction of the EPC 2000, the biotechnology directive and the maturing of biotechnology patenting, which was in its infancy at the time of the first edition. From these developments has come a raft of case law which is cross-referred to throughout.

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 WHEN SECURING AUTHORISATION TO MARKET;
5. Patents for Chemicals, Pharmaceuticals and Agrochemicals;
6. Patents and Biotechnology - Issues of General Application;
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;
11. Securing Marketing Authorisations for Medicinal Products;
12. Regulatory Controls on Medicinal Products and Medical Devices;
PART III - ISSUES THAT ARISE AFTER SECURING AUTHORISATION TO MARKET;
13. Regulatory Control of Life Sciences Products other than Medicinal Products or Medical Devices;
14. Pharmaceutical Trade Marks;
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 Imports;
17. Regulatory Data Protection - General Considerations;
18. Regulatory Data Protection of Medicinal Products in the European Community, Market Exclusivity for Medicinal Products and the Confidentiality of Data as to Medicinal Products;
19. Regulatory Data Protection other than for Medicinal Products in the European Community and the Confidentiality of Data as to Such Products;
20. Patents, Generics and Competition Law;
APPENDICES;
Appendix 1 - EC Materials on Regulation of Medicinal Products;
Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems;
Council Regulation 141/2000/EC of 16 December 1999 on orphan medicinal products;
Council Directive 2001/20/EC of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use;
Council Directive 2001/82/EC of 6 November 2001 on the Community code relating to veterinary medicinal products;
Council Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use;
Council Regulation 726/2004/EC of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency;
Council Regulation 1901/2006/EC of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004;
Council Regulation 1394/2007/EC of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004; Appendix 2 - EC Materials on Genetic Manipulation;
Council Directive 90/219/EC of 23 April 1990 on the contained use of genetically modified micro-organisms; Council Directive 2001/18/EC of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC;
Appendix 3 - EC Materials on Life Science Specific Patent Measures; Council Regulation 1768/92/EC of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products;
Council Regulation 1610/96/EC of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products;
Council Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions;