Intellectual Property and Health Technologies


Book Description

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.




Health Technologies and International Intellectual Property Law


Book Description

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.




Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade


Book Description

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.




Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade.


Book Description

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.




Intellectual Property, Medicine and Health


Book Description

Intellectual Property, Medicine and Health examines critical issues and debates in current public health practice and policy, 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.




Health Technologies and International Intellectual Property


Book Description

From the late twentieth century onwards, several global virus transmissions have exposed the lack of a mature legal framework in international public health to provide prompt, concrete and specific guidance during a large-scale emergency. This book brings together international trade law and intellectual property law to show how risk analysis and a precautionary approach should be taken in the intellectual property regime to enable states to issue a compulsory licence of a drug patent in order to enhance access to medicines in a public health emergency.




Intellectual Property, Medicine and Health


Book Description

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.




Patent Law and Intellectual Property in the Medical Field


Book Description

The growing presence of technology has created significant changes within the healthcare industry. With the ubiquity of these technologies, there is now an increasing need for more advanced legal procedures. Patent Law and Intellectual Property in the Medical Field is a pivotal reference source for the latest research in support of developing convergent and interoperable systems to increase awareness and applicability of legal aspects in the medical field. Featuring extensive coverage on relevant areas such as compulsory licensing, parallel importing, and protection law, this publication is an ideal resource for researchers, medical and law professionals, academics, graduate students, and practitioners engaged in medical practice.




Intellectual Property and Emerging Technologies


Book Description

This unique and comprehensive collection investigates the challenges posed to intellectual property by recent paradigm shifts in biology. It explores the legal ramifications of emerging technologies, such as genomics, synthetic biology, stem cell research, nanotechnology, and biodiscovery. Extensive contributions examine recent controversial court decisions in patent law such as Bilski v. Kappos, and the litigation over Myriad's patents in respect of BRCA1 and BRCA2 while other papers explore sui generis fields, such as access to genetic resources, plant breeders' rights, and traditional knowledge. The collection considers the potential and the risks of the new biology for global challenges such as access to health-care, the protection of the environment and biodiversity, climate change, and food security. It also considers Big Science projects such as biobanks, the 1000 Genomes Project, and the Doomsday Vault. The inter-disciplinary research brings together the work of scholars from Australia, Canada, Europe, the UK and the US and involves not only legal analysis of case law and policy developments, but also historical, comparative, sociological, and ethical methodologies. Intellectual Property and Emerging Technologies will appeal to policy-makers, legal practitioners, business managers, inventors, scientists and researchers.




FDA and Intellectual Property Strategies for Medical Device Technologies


Book Description

This book offers comprehensive, easy to understand guidance for medical device technology innovators on how to work through the United States FDA regulatory review process, while also providing insight on the various intellectual property concerns that many medical device innovators face. In the first portion of this book, readers are introduced to important concepts concerning FDA compliance for medical devices, as well as strategies for successfully navigating the FDA regulatory review process. Specifically, the first portion discusses the expansive range of medical devices and then walks through the most common routes to market: the PMA and 510(k) application processes. In the second portion of this book, readers are introduced to the various types of intellectual property rights that are available for medical device technology inventions and innovations, and can explore ways to overcome unique intellectual property challenges faced by many medical device technology innovators. In the third portion of the book, specific strategies are discussed to navigate the interface between the FDA regulatory process and the process of obtaining intellectual property protection. This book also includes a number of descriptive examples, case studies and scenarios to illustrate the topics discussed, and is intended for use by medical device designers, developers and innovators.