Cook, Trevor 　著

内容

目次

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 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 SECURING AUTHORISATION TO 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 Medical Products in the European Union, including Data Exclusivity and Orphan Medical 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