Review of Granted Compulsory Licences
Legislators recognise that exceptions and limitations may be established to help the achievement of the ultimate goal under patent law. However, exceptions and limitations are made to keep the interest balance between the patentee and the public, including the potential competitors of the patentee. Such interest balance would be obtained when patentees are restrained from asserting their exclusive rights against some acts that have no substitution effects on the patented products and, at the same time, are conducive to the disclosure of and access to the patent to enhance the technological development. This inference is supported by Art. 30 of the TRIPS Agreement, after which limited exceptions can be allowed in patent law provided that they “do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties”.
Global Intellectual Property Law: Chapter 1
Globalization of trade means that intangible informational resources are now produced, bartered and consumed anywhere and everywhere defying jurisdictional borders. Intellectual property has moved into the mainstream of national economic and developmental planning; in the recent past it has also emerged as the central impetus in multilateral trade relations. The authors of this original and progressive textbook trace the evolving remits of intellectual property, which are rapidly expanding to embrace new subject matter and increase the scope of protection. This creates conflicts with current trade, development, cultural, ethical, human rights and economic mores.This book reflects on intellectual property as it stands at the crossroads of these values. It considers the challenges presented by such developments as the commodification of persona, the commons, and life itself. Most significantly perhaps, the book examines the impact of intellectual property on the international stage, especially in respect of trade, development, economics and biological and cultural diversity. It is sure to become an invaluable reference work for scholars and students of intellectual property, international law, public policy, politics, government, human rights and development, as well as legal practitioners.
Practical, legal, and ethical issues in expanded access to investigational drugs.
The authors review the FDA policies and procedures that permit some patients with serious conditions to receive investigational drugs before formal product approval and examine the legal and ethical issues associated with expanded access.