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Intellectual Property Rights In Pharmaceutical Test Data
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Book Synopsis Intellectual Property Rights in Pharmaceutical Test Data by : Adam Buick
Download or read book Intellectual Property Rights in Pharmaceutical Test Data written by Adam Buick and published by Springer Nature. This book was released on 2023-05-12 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book considers the intellectual property protection of clinical test data that has been submitted to governments, in particular through test data exclusivity rights. It focuses on how these intellectual property rights first emerged in the early 1980s, how they have globalised over the past four decades, and what impact they have had upon access to medicine. This book makes a number of significant and original contributions to the literature around the protection of submitted test data. First, the book draws upon the theory of regulatory globalisation to provide an explanation of how intellectual property rights in submitted pharmaceutical test data have become nearly ubiquitous in the legal systems of most major economies. Second, through a comprehensive analysis and synthesis of provisions on the protection of submitted test data in free trade agreements, as well as a comparison of a range of national approaches to the protection of submitted test data, it reveals the broader global regulatory pattern that has given rise to these intellectual property rights. Third, by analysing data on drug approvals in the US, it provides an empirical insight into the impact of test data exclusivity in national pharmaceutical markets. Fourth, the book covers a number of developments regarding test data exclusivity that have occurred as a result of responses to the COVID-19 pandemic, both at the national level as well as at the World Trade Organisation (WTO). This book will appeal to academics researching the intersection of intellectual property and the life sciences, civil society activists working to promote access to medicines, and students (particularly those at the post-graduate level) studying the relationship between intellectual property and medicine.
Book Synopsis Pharmaceutical Test Data Exclusivity by : John C. Todaro
Download or read book Pharmaceutical Test Data Exclusivity written by John C. Todaro and published by Kluwer Law International B.V.. This book was released on 2022-08-12 with total page 250 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data exclusivity gives pharmaceutical companies a limited period of time in which clinical test data are exclusive to the innovator. Internationally, however, aside from prohibition against unfair commercial use, there are no specifics as to how these data are protected; exclusivity is available on a jurisdiction-by-jurisdiction basis. This book, the only one of its kind, provides expert guidance, chapter by chapter, on test data exclusivity rights for pharmaceutical products in twenty-two major markets worldwide. For each jurisdiction, in addition to explaining the available regulatory data protection – including both substantive and formal requirements for approvals and testing, protection of undisclosed data, confidentiality, and enforcement in practice – local experts provide detailed information and guidance on the degree to which test data exclusivity may be achieved in such areas of pharmaceutical research as the following: infectious disease products; paediatrics products; chemical and biological products; agricultural products; animal health products; orphan drugs; and new chemical entities. This book originated from a project conducted by the Pharma Committee of the International Association for the Protection of Intellectual Property (AIPPI), the world’s leading non-profit association dedicated to the development, expansion, and improvement of international and regional treaties and agreements and national laws relating to intellectual property. Many committee members and observers are authors of chapters in this book. An unmatched starting point for innovator pharmaceutical companies and their advisers to evaluate data exclusivity rules and opportunities around the world, this book will be an invaluable resource for IP professionals, governments, non-governmental organizations, and international organizations to promote and share IP laws and practices.
Book Synopsis Access to Medicine Versus Test Data Exclusivity by : Owais H. Shaikh
Download or read book Access to Medicine Versus Test Data Exclusivity written by Owais H. Shaikh and published by Springer. This book was released on 2016-07-25 with total page 269 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explores the concept of test data exclusivity protection for pharmaceuticals. Focusing on Art 39(3) of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) and relevant provisions in selected free trade agreements (FTA) and national laws, it combines normative, historical, comparative and economic analysis of test data exclusivity protection.At the heart of this book is the novel and original Index of Data Exclusivity and Access (IDEAS), which analyzes the effectiveness of test data exclusivity provisions in FTAs and national laws both on the strength of exclusivity as well as on access to medicine. IDEAS provides a framework for the assessment of current test data exclusivity protection standards on the basis of their proximity to Article 39(3) of the TRIPS Agreement, the scope of exclusivity and the flexibilities in FTAs, and subsequently in national laws. This book aims to broaden national and international policy makers’ grasp of the various nuances of test data exclusivity protection. Furthermore, it provides practical recommendations with regard to designing an appropriate legal system with a strong focus on promoting access to medicine for all.
Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Book Synopsis Contemporary Issues in Pharmaceutical Patent Law by : Bryan Mercurio
Download or read book Contemporary Issues in Pharmaceutical Patent Law written by Bryan Mercurio and published by Routledge. This book was released on 2017-02-17 with total page 271 pages. Available in PDF, EPUB and Kindle. Book excerpt: This collection reflects on contemporary and contentious issues in international rulemaking in regards to pharmaceutical patent law. With chapters from both well-established and rising scholars, the collection contributes to the understanding of the regulatory framework governing pharmaceutical patents as an integrated discipline through the assessment of relevant laws, trends and policy options. Focusing on patent law and related pharmaceutical regulations, the collection addresses the pressing issues governments face in an attempt to resolve policy dilemmas involving competing interests, needs and objectives. The common theme running throughout the collection is the need for policy and law makers to think and act in a systemic manner and to be more reflective and responsive in finding new solutions within and outside the patent system to the long-standing problems as well as emerging challenges
Download or read book Negotiating Health written by Pedro Roffe and published by Earthscan. This book was released on 2012 with total page 321 pages. Available in PDF, EPUB and Kindle. Book excerpt: In developing countries, access to affordable medicines for the treatment of diseases such as AIDS and malaria remains a matter of life or death. In Africa, for instance, more than one million children die each year from malaria alone, a figure which could soon be far higher with the extension of patent rules for pharmaceuticals. Previously, access to essential medicines was made possible by the supply of much cheaper generics, manufactured largely by India; from 2005, however, the availability of these drugs is threatened as new WTO rules take effect. Halting the spread of malaria and HIV/AIDS is one of the eight Millennium Goals adopted at the UN Millennium Summit, which makes this a timely and topical book.Informed analysis is provided by internationally renowned contributors who look at the post-2005 world and discuss how action may be taken to ensure that intellectual property regimes are interpreted and implemented in a manner supportive to the right to protect public health and, in particular, to promote access to medicines for all.
Download or read book Negotiating Health written by Pedro Roffe and published by Taylor & Francis. This book was released on 2012-04-27 with total page 314 pages. Available in PDF, EPUB and Kindle. Book excerpt: In developing countries, access to affordable medicines for the treatment of diseases such as AIDS and malaria remains a matter of life or death. In Africa, for instance, more than one million children die each year from malaria alone, a figure which could soon be far higher with the extension of patent rules for pharmaceuticals. Previously, access to essential medicines was made possible by the supply of much cheaper generics, manufactured largely by India; from 2005, however, the availability of these drugs is threatened as new WTO rules take effect. Halting the spread of malaria and HIV/AIDS is one of the eight Millennium Goals adopted at the UN Millennium Summit, which makes this a timely and topical book. Informed analysis is provided by internationally renowned contributors who look at the post-2005 world and discuss how action may be taken to ensure that intellectual property regimes are interpreted and implemented in a manner supportive to the right to protect public health and, in particular, to promote access to medicines for all.
Book Synopsis Pharmaceutical Medicine, Biotechnology and European Law by : Richard Goldberg
Download or read book Pharmaceutical Medicine, Biotechnology and European Law written by Richard Goldberg and published by Cambridge University Press. This book was released on 2000 with total page 279 pages. Available in PDF, EPUB and Kindle. Book excerpt: Lawyers and academics reassess the impact of European law on health care and pharmaceutical law.
Book Synopsis Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade by : World Intellectual Property Organization
Download or read book Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade written by World Intellectual Property Organization and published by WIPO. This book was released on 2013 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Intellectual Property Rights and International Trade by : Shayerah Ilias
Download or read book Intellectual Property Rights and International Trade written by Shayerah Ilias and published by Nova Publishers. This book was released on 2008 with total page 84 pages. Available in PDF, EPUB and Kindle. Book excerpt: Introduction -- Intellectual property rights basics -- Global intellectual property holdings -- Contribution of intellectual property to U.S. economy -- The organized structure of IPR protection -- U.S. trade law -- Issues for Congress.
Book Synopsis Access to Medicines and Vaccines by : Carlos M. Correa
Download or read book Access to Medicines and Vaccines written by Carlos M. Correa and published by Springer Nature. This book was released on 2022 with total page 373 pages. Available in PDF, EPUB and Kindle. Book excerpt: "This book is an outcome of a partnership between the Max Planck Institute (MPI) for Innovation and Competition and the South Centre, which jointly organized a Global Forum on Intellectual Property, Access to Medicine and Innovation in Munich on 9-10 December 2019"--Page v
Book Synopsis Drugs, Patents and Policy by : Bryan Mercurio
Download or read book Drugs, Patents and Policy written by Bryan Mercurio and published by . This book was released on 2018-06-28 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive review of Hong Kong's pharmaceutical patent law that will influence debate and inform public policy.
Book Synopsis Trade Related Aspects of Intellectual Property Rights by : Carlos Maria Correa
Download or read book Trade Related Aspects of Intellectual Property Rights written by Carlos Maria Correa and published by Oxford Commentaries on Interna. This book was released on 2020-07-18 with total page 593 pages. Available in PDF, EPUB and Kindle. Book excerpt: The TRIPS Agreement is the most comprehensive and influential international treaty on intellectual property rights. It brings intellectual property rules into the framework of the World Trade Organization, obliging all WTO Member States to meet minimum standards of intellectual property protection and enforcement. This has required massive changes in some national laws, particularly in developing countries. This volume provides a detailed legal analysis of the provisions of the TRIPS Agreement, as well as elements to consider their economic implications in different legal and socio-economic contexts. This book provides an in depth analysis of the principles and of the substantive and enforcement provisions of the TRIPS Agreement, the most influential international treaty on intellectual property currently in force. It discusses the legal context in which the Agreement was negotiated, the objectives of their proponents and the nature of the obligations it created for the members of the World Trade Organization. In particular, it examines the minimum standards that must be implemented with regard to patents, trademarks, industrial designs, geographical indications, copyright and related rights, integrated circuits, trade-secrets and test data for pharmaceutical and agrochemical products. Trade Related Aspects of Intellectual Property Rights: A Commentary on the TRIPS Agreement elaborates on the interpretation of provisions contained in said Agreement, in the light of the customary principles for the interpretation of international law. The analysis -which is supported by a review of the relevant GATT and WTO jurisprudence- identifies the policy space left to such members to implement their obligations in accordance with their own legal systems and public policy objectives, including in respect of complex issues such as patentability criteria, compulsory licenses, exceptions and limitations to copyright, border measures, injunctive relief and the protection of test data under the discipline of unfair competition.
Book Synopsis Vaccines, Medicines and COVID-19 by : Germán Velásquez
Download or read book Vaccines, Medicines and COVID-19 written by Germán Velásquez and published by Springer Nature. This book was released on 2022-01-01 with total page 129 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book is a collection of research papers on COVID-19 by Germán Velásquez from 2020 and early 2021 that help to answer the question: How can an agency like the World Health Organization (WHO) be given a stronger voice to exercise authority and leadership? The considerable health, economic and social challenges that the world faced at the beginning of 2020 with COVID-19 continued and worsened in many parts of the world in the second-half of 2020 and into 2021. Many of these countries and nations wanted to explore COVID-19 on their own, sometimes without listening to the main international health bodies such as WHO, an agency of the United Nations system with long-standing experience and vast knowledge at the global level and of which all countries in the world are members. In this single volume, the chapters present the progress of thinking and debate — particularly in relation to drugs and vaccines — that would enable a response to the COVID-19 pandemic or to subsequent crises that may arise. Among the topics covered: COVID-19 Vaccines: Between Ethics, Health and Economics Medicines and Intellectual Property: 10 Years of the WHO Global Strategy Re-thinking Global and Local Manufacturing of Medical Products After COVID-19 Rethinking R&D for Pharmaceutical Products After the Novel Coronavirus COVID-19 Shock Intellectual Property and Access to Medicines and Vaccines The World Health Organization Reforms in the Time of COVID-19 Vaccines, Medicines and COVID-19: How Can WHO Be Given a Stronger Voice? is essential reading for negotiators from the 194 member countries of the World Health Organization (WHO); World Trade Organization (WTO) and World Intellectual Property Organization (WIPO) staff participating in these negotiations; academics and students of public health, medicine, health sciences, law, sociology and political science; and intergovernmental organizations and non-governmental organizations that follow the issue of access to treatments and vaccines for COVID-19.
Book Synopsis The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights by : Justin Malbon
Download or read book The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights written by Justin Malbon and published by Edward Elgar Publishing. This book was released on 2014-01-31 with total page 933 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Commentary on the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) provides a detailed textual analysis of TRIPS _ a pivotal international agreement on intellectual property rights. TRIPS sets minimum standards
Book Synopsis Private Patents and Public Health by : Ellen F. M. 't Hoen
Download or read book Private Patents and Public Health written by Ellen F. M. 't Hoen and published by . This book was released on 2016 with total page 181 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Genetic Inventions, Intellectual Property Rights and Licensing Practices Evidence and Policies by : OECD
Download or read book Genetic Inventions, Intellectual Property Rights and Licensing Practices Evidence and Policies written by OECD and published by OECD Publishing. This book was released on 2003-01-21 with total page 112 pages. Available in PDF, EPUB and Kindle. Book excerpt: Few topics in the life sciences today provoke as much debate as the availability of patent protection on "genetic inventions". Some hold that protection is essential to encourage innovation and development of new products. Others argue that patents ...
