Cook: Pharmaceuticals Biotechnology and the Law 3rd Ed (eBook)

Contents

Part I – Introduction and overview;

Chapter 1 Introduction;

Chapter 2 Regulatory, tort and competition law in life sciences;

Chapter 3 Intellectual property in life sciences;

Chapter 4 Agreements in life sciences;

Part II – Issues that arise before securing authorisation to market;

Chapter 5 Patents for chemicals, pharmaceuticals and medical;

Chapter 6 Patents and biotechnology – issues of general;

Chapter 7 Biotechnology patents – ethical, variety and source issues;

Chapter 8 The Experimental use defence to patent infringement;

Chapter 9 Regulation of early-stage biotechnology and life sciences research;

Chapter 10 Testing medicinal and other products on animals and

on humans, and clinical trial transparency;

Chapter 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;

Chapter 12 Regulatory controls on medicinal products and medical devices once on the market;

Chapter 13 Regulatory control of life sciences products other than

medicinal products or medical devices;

Chapter 14 Pharmaceutical trade marks and other naming considerations;

Chapter 15 Using supplementary protection certificates to provide

extended patent type protection for pharmaceuticals and agrochemicals to compensate for regulatory delay;

Chapter 16 Free movement of goods and parallel trade, especially

within the European Union;

Chapter 17 Data exclusivity – general considerations;

Chapter 18 Regulatory exclusivities for medicinal products in the

European Union, including data exclusivity and orphan medicinal products exclusivity;

Chapter 19 Data exclusivity other than for medicinal products in

the European Union and the confidentiality of data as to

such products;

Chapter 20 Patents, generics and competition law;

Index