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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.
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.
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, 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.
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.
This comprehensive book provides a detailed survey and practical examination of a wide range of legal and regulatory topics in HealthTech. Key features include: • Analysis of the impact of emerging innovations on the accessibility, efficiency and quality of healthcare and its effects on healthcare providers • Examination of artificial intelligence, blockchain and digital identity applications in healthcare, alongside associated regulatory challenges • Guidance on the financial requirements of healthcare start-ups at different stages of growth and various collaboration and partnership models in the HealthTech market • Discussion of the major regulatory questions affecting the HealthTech industry, from data protection, public procurement and product liability, to the regulation of medical devices, intellectual property and advertising.
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.
Distinguished economists, political scientists, and legal experts discuss the implications of the increasingly globalized protection of intellectual property rights for the ability of countries to provide their citizens with such important public goods as basic research, education, public health, and environmental protection. Such items increasingly depend on the exercise of private rights over technical inputs and information goods, which could usher in a brave new world of accelerating technological innovation. However, higher and more harmonized levels of international intellectual property rights could also throw up high roadblocks in the path of follow-on innovation, competition and the attainment of social objectives. It is at best unclear who represents the public interest in negotiating forums dominated by powerful knowledge cartels. This is the first book to assess the public processes and inputs that an emerging transnational system of innovation will need to promote technical progress, economic growth and welfare for all participants.
As technological developments multiply around the globeâ€"even as the patenting of human genes comes under serious discussionâ€"nations, companies, and researchers find themselves in conflict over intellectual property rights (IPRs). Now, an international group of experts presents the first multidisciplinary look at IPRs in an age of explosive growth in science and technology. This thought-provoking volume offers an update on current international IPR negotiations and includes case studies on software, computer chips, optoelectronics, and biotechnologyâ€"areas characterized by high development cost and easy reproducibility. The volume covers these and other issues: Modern economic theory as a basis for approaching international IPRs. U.S. intellectual property practices versus those in Japan, India, the European Community, and the developing and newly industrializing countries. Trends in science and technology and how they affect IPRs. Pros and cons of a uniform international IPRs regime versus a system reflecting national differences.
Millions of people around the world do not have access to the medicines they need to treat disease or alleviate suffering. Strict patent regimes introduced following the establishment of the World Trade Organization in 1995 interfere with widespread access to medicines by creating monopolies that keep medicines prices well out of reach for many. 0The AIDS crisis in the late nineties brought access to medicines challenges to the public?s attention, when millions of people in developing countries died from an illness for which medicines existed, but were not available or affordable. Faced with an unprecedented health crisis ? 8,000 people dying daily ? the public health community launched an unprecedented global effort that eventually resulted in the large-scale availability of low-priced generic HIV medicines. 0But now, high prices of new medicines - for example, for cancer, tuberculosis and hepatitis C - are limiting access to treatment in low-, middle and high-income countries alike. Patent-based monopolies affect almost all medicines developed since 1995 in most countries, and global health policy is now at a critical juncture if the world is to avoid new access to medicines crises. 0This book discusses lessons learned from the HIV/AIDS crisis, and asks whether actions taken to extend access and save lives are exclusive to HIV or can be applied more broadly to new global access challenges.