Table of 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