Intellectual Property and Health Technologies Balancing Innovation and the Public's Health Joanna T. Brougher, Esq., MPH At first glance, ownership of intellectual property seems straightforward: the control over an invention or idea. But with the recent explosion of new scientific discoveries poised to transform public health and healthcare systems, costly and lengthy patent disputes threaten both to undermine the attempts to develop new medical technologies and to keep potentially life-saving treatments from patients who need them. Intellectual Property and Health Technologies grounds readers in patent law and explores how scientific research and enterprise are evolving in response. Geared specifically to the medical disciplines, it differentiates among forms of legal protection for inventors such as copyrights and patents, explains their limits, and argues for balance between competing forces of exclusivity and availability. Chapters delve into the major legal controversies concerning medical and biotechnologies in terms of pricing, markets, and especially the tension between innovation and access, including: The patent-eligibility of genes The patent-eligibility of medical process patents The rights and roles of universities and inventors The balancing of access, innovation, and profit in drug development The tension between biologics, small-molecule drugs, and their generic counterparts International patent law and access to medicine in the developing world As these issues continue to shape and define the debate, Intellectual Property and Health Technologies enables professionals and graduate students in public health, health policy, healthcare administration, and medicine to understand patent law and how it affects the development of medical technology and the delivery of medicine.

The global transmission of infectious diseases has fuelled the need for a more developed legal framework in international public health to provide prompt and specific guidance during a large-scale emergency. This book develops a means for States to take advantage of the flexibilities of compulsory licensing in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which promotes access to medicines in a public health emergency. It presents the precautionary approach (PA) and the structure of risk analysis as a means to build a workable reading of TRIPS and to help States embody the flexibilities of intellectual property (IP). The work investigates the complementary roles of the World Health Organization (WHO) and the World Trade Organization (WTO) in order to promote the harmonisation of the precautionary approach in relation to the patenting of crucial pharmaceutical products. By bringing together international trade law and intellectual property law Phoebe Li demonstrates how through the use of risk analysis and the precautionary approach, States can still comply with their legal obligations in international law, while exercising their sovereignty right in issuing a compulsory licence of a drug patent in an uncertain public health emergency. This book will be of great interest to students and academics of medical and healthcare law, intellectual property law, international trade law, and human rights law.

Intellectual Property, Medicine and Health examines critical issues and debates, including access to knowledge and medicinal products, human rights and development, innovations in life technologies and the possibility for ethical frameworks for intellectual property law and its application in public health. The second edition accounts for recent and in some areas extensive developments in this dynamic and fast-moving field. This edition brings together new and updated examples and analysis in competition and regulation, gene-related inventions and biotechnology, as well as significant cases, including Novartis v Union of India.

WIPO Re:Search aims to catalyze the development of medical products for neglected tropical diseases, malaria and tuberculosis through innovative research partnerships and knowledge sharing.

The global transmission of infectious diseases has fuelled the need for a more developed legal framework in international public health to provide prompt and specific guidance during a large-scale emergency. This book develops a means for States to take advantage of the flexibilities of compulsory licensing in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which promotes access to medicines in a public health emergency. It presents the precautionary approach (PA) and the structure of risk analysis as a means to build a workable reading of TRIPS and to help States embody the flexibilities of intellectual property (IP). The work investigates the complementary roles of the World Health Organization (WHO) and the World Trade Organization (WTO) in order to promote the harmonisation of the precautionary approach in relation to the patenting of crucial pharmaceutical products. By bringing together international trade law and intellectual property law Phoebe Li demonstrates how through the use of risk analysis and the precautionary approach, States can still comply with their legal obligations in international law, while exercising their sovereignty right in issuing a compulsory licence of a drug patent in an uncertain public health emergency. This book will be of great interest to students and academics of medical and healthcare law, intellectual property law, international trade law, and human rights law.

This study seeks to reinforce the understanding of the interplay between the distinct policy domains of health, trade and intellectual property, and of how they affect medical innovation and access to medical technologies. The second edition comprehensively reviews new developments in key areas since the initial launch of the study in 2013.

This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.