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