Publisher's Synopsis
Pharmaceuticals Biotechnology and the Law is the definitive guide to the law in Europe relating to pharmaceuticals, biotechnology and their related areas such as medical devices. Written by leading patent and regulatory lawyer, this is the only text which comprehensively covers the wide variety of legal and regulatory issues which surround these industry sectors. This new expanded edition covers the numerous changes in EU legislation that has affected many areas of life sciences, some of which are now the subject of an entirely new legal framework, and captures a substantial body of new CJEU case law in just about every area of life sciences. What's new: This new expanded edition covers the numerous changes in EU legislation that has affected many areas of life sciences, some of which are now the subject of an entirely new legal framework, and captures a substantial body of new CJEU case law in just about every area of life sciences. * Patents - new case law including the SPC regime for de facto patent extension, second medical uses, the experimental use and regulatory review defences, and in the patenting of stem cell related inventions and inventions relating to plant breeding * Data exclusivity - taking account of new official guidance, and case law (including decisions of the Commission, the EMA and its Committees) as to medicinal products, and new statutory frameworks for most other types of life sciences products that benefit from data exclusivity * Coverage of new official guidance and case law in relation to orphan medicinal product exclusivity, and clinical trial transparency * Developments in trade marks, parallel trade and competition law in so far as these concern life sciences products * New legislation relevant to clinical trials, and official guidance and new case law as to clinical trial transparency; * Regulatory frameworks for life sciences products - including new legislation as to food and feed, cosmetics, plant protection and biocidal products and amended legislation as to medicinal products
