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
Auflage
Sprache
Verlagsort
Verlagsgruppe
Zielgruppe
Maße
Höhe: 246 mm
Breite: 155 mm
Gewicht
ISBN-13
978-1-4057-8166-4 (9781405781664)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Klassifikation
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
