Pharmaceuticals Biotechnology and the Law

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Description
Although the period between the third edition of this book and the second is very much less than that between the second and first editions, the degree of rewriting and expansion necessitated by amending legislation and by new case law in the seven years since the second edition has been considerable. However, the overall structure of the legal and regulatory framework that is specific to life sciences in the European Union has remained largely unchanged during that time, allowing the structure of the second edition to be retained, although some chapters have been renamed to reflect changes in emphasis and many have undergone, in addition to the updating and extensive rewriting to which all have been subject, some rearrangement and refocusing. Thus, issues surrounding the disclosure of clinical data are now addressed in Chapter 9, in the same chapter as clinical trials, rather than in Chapter 18, along with data exclusivity; Chapter 6 has been refocused on to the 'product of nature' issue as encountered in biotechnology patenting as well those aspects of the Biotechnology Directive that are not discussed in Chapter 7; and much discussion of the products of biotechnology now takes place in Chapter 5, reflecting the fact that the most important therapeutic biotechnological products today are monoclonal antibodies, which are not found in nature (even though they are often defined by reference to products that are found in nature) and which raise, from a patent point of view, issues that tend to be more akin to those encountered with small molecules than do the first generation of biotechnology products.
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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 Treatment
Chapter 6    Patents and Biotechnology - Issues of General Application, Particularly as to Products
                       of Nature
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 Medical and Other Products on Animals and on Humans, and Clinical Trial
                      Transparency
Chapter 11  Securing Marketing Authorisations for Medical 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 Control on Medical 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 Regulatroy 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 Medical Products in the European Union and the
                       Confidentiality of Data as to such Products
Chapter 20  Patents, Generics and Competition Law
Index
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Author Details
Trevor Cook
Partner, Wilmer Cutler Pickering Hale and Dorr LLP
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