Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests

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Publisher :
ISBN 13 :
Total Pages : 376 pages
Book Rating : 4.:/5 (19 download)

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Book Synopsis Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests by : National Institutes of Health (U.S.). Secretary's Advisory Committee on Genetics, Health, and Society

Download or read book Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests written by National Institutes of Health (U.S.). Secretary's Advisory Committee on Genetics, Health, and Society and published by . This book was released on 2010 with total page 376 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Gene Patents and Collaborative Licensing Models

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Publisher : Cambridge University Press
ISBN 13 : 0521896738
Total Pages : 517 pages
Book Rating : 4.5/5 (218 download)

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Book Synopsis Gene Patents and Collaborative Licensing Models by : Geertrui van Overwalle

Download or read book Gene Patents and Collaborative Licensing Models written by Geertrui van Overwalle and published by Cambridge University Press. This book was released on 2009-06-11 with total page 517 pages. Available in PDF, EPUB and Kindle. Book excerpt: The cost of patent licenses needed to design a new genetic test or treatment may ultimately prevent research projects getting started, as individual components are protected by different patent owners. This book examines legal measures which might be used to solve the problem of fragmentation of patents in genetics.

The Troubled Dream of Genetic Medicine

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Publisher : JHU Press
ISBN 13 : 9780801883255
Total Pages : 272 pages
Book Rating : 4.8/5 (832 download)

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Book Synopsis The Troubled Dream of Genetic Medicine by : Keith Wailoo

Download or read book The Troubled Dream of Genetic Medicine written by Keith Wailoo and published by JHU Press. This book was released on 2006-05-29 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: Winner of the History of Science category of the Professional and Scholarly Publishing Awards given by the Association of American Publishers Why do racial and ethnic controversies become attached, as they often do, to discussions of modern genetics? How do theories about genetic difference become entangled with political debates about cultural and group differences in America? Such issues are a conspicuous part of the histories of three hereditary diseases: Tay-Sachs, commonly identified with Jewish Americans; cystic fibrosis, often labeled a "Caucasian" disease; and sickle cell disease, widely associated with African Americans. In this captivating account, historians Keith Wailoo and Stephen Pemberton reveal how these diseases—fraught with ethnic and racial meanings for many Americans—became objects of biological fascination and crucibles of social debate. Peering behind the headlines of breakthrough treatments and coming cures, they tell a complex story: about different kinds of suffering and faith, about unequal access to the promises and perils of modern medicine, and about how Americans consume innovation and how they come to believe in, or resist, the notion of imminent medical breakthroughs. With Tay-Sachs, cystic fibrosis, and sickle cell disease as a powerful backdrop, the authors provide a glimpse into a diverse America where racial ideologies, cultural politics, and conflicting beliefs about the power of genetics shape disparate health care expectations and experiences.

Assessing Genetic Risks

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Publisher : National Academies Press
ISBN 13 : 0309047986
Total Pages : 353 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Assessing Genetic Risks by : Institute of Medicine

Download or read book Assessing Genetic Risks written by Institute of Medicine and published by National Academies Press. This book was released on 1994-01-01 with total page 353 pages. Available in PDF, EPUB and Kindle. Book excerpt: Raising hopes for disease treatment and prevention, but also the specter of discrimination and "designer genes," genetic testing is potentially one of the most socially explosive developments of our time. This book presents a current assessment of this rapidly evolving field, offering principles for actions and research and recommendations on key issues in genetic testing and screening. Advantages of early genetic knowledge are balanced with issues associated with such knowledge: availability of treatment, privacy and discrimination, personal decision-making, public health objectives, cost, and more. Among the important issues covered: Quality control in genetic testing. Appropriate roles for public agencies, private health practitioners, and laboratories. Value-neutral education and counseling for persons considering testing. Use of test results in insurance, employment, and other settings.

The Ethics of Patenting DNA

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Publisher :
ISBN 13 :
Total Pages : 132 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis The Ethics of Patenting DNA by : Nuffield Council on Bioethics

Download or read book The Ethics of Patenting DNA written by Nuffield Council on Bioethics and published by . This book was released on 2002 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt: This paper questions whether the application of the patent system to DNA sequences achieves its goals of stimulating innovation for the public good and rewarding people for useful new inventions. Even if DNA sequences are considered eligible for patenting, they must also be novel, inventive, and useful. The application of these criteria has not been stringently applied. In future, patents asserting rights over DNA sequences should become the exception rather than the norm.

Reaping the Benefits of Genomic and Proteomic Research

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Publisher : National Academies Press
ISBN 13 : 0309100674
Total Pages : 189 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Reaping the Benefits of Genomic and Proteomic Research by : National Research Council

Download or read book Reaping the Benefits of Genomic and Proteomic Research written by National Research Council and published by National Academies Press. This book was released on 2006-04-09 with total page 189 pages. Available in PDF, EPUB and Kindle. Book excerpt: The patenting and licensing of human genetic material and proteins represents an extension of intellectual property (IP) rights to naturally occurring biological material and scientific information, much of it well upstream of drugs and other disease therapies. This report concludes that IP restrictions rarely impose significant burdens on biomedical research, but there are reasons to be apprehensive about their future impact on scientific advances in this area. The report recommends 13 actions that policy-makers, courts, universities, and health and patent officials should take to prevent the increasingly complex web of IP protections from getting in the way of potential breakthroughs in genomic and proteomic research. It endorses the National Institutes of Health guidelines for technology licensing, data sharing, and research material exchanges and says that oversight of compliance should be strengthened. It recommends enactment of a statutory exception from infringement liability for research on a patented invention and raising the bar somewhat to qualify for a patent on upstream research discoveries in biotechnology. With respect to genetic diagnostic tests to detect patient mutations associated with certain diseases, the report urges patent holders to allow others to perform the tests for purposes of verifying the results.

Intellecual Property Rights and High Quality Genetic Testing

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Publisher :
ISBN 13 :
Total Pages : 0 pages
Book Rating : 4.:/5 (137 download)

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Book Synopsis Intellecual Property Rights and High Quality Genetic Testing by : Geertrui Van Overwalle

Download or read book Intellecual Property Rights and High Quality Genetic Testing written by Geertrui Van Overwalle and published by . This book was released on 2012 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Over the last years, the patenting of genetic tests sparked significant interest worldwide. Newspapers commented on patent cases and, quite often, portrayed patents as a negative story. The commotion surrounding the current patent framework for genetic testing is hardly surprising. Although patents on human genes and diagnostics are not novel, patents on genes for diagnostics are indeed a rather special combination. And although licensing has become daily routine in genetics to gain access to patented technology, the emergence of patent clusters and the restrictive licensing behaviour of some patent proprietors has been experienced as quite disturbing. In an attempt to provide a better understanding of the contentious patent issues at stake in genetic testing, the present contribution first surveys the current legal framework for patenting genetic tests, thus sketching the patent regime from a patent holder's perspective. The paper then examines strategies to gain freedom to operate in the genetic field, thus zooming in on the patent landscape from a patent user's perspective. Generally speaking, genetic testing relates to identifying changes in chromosomes, genes, or proteins to find changes that are associated with inherited disorders. More narrowly, medical genetic testing aims at probing genetic material for disease associated geno or karyotypes (medical applications of cytogenetics, DNA & biochemical tests). The present contribution focuses, even more specifically, on medical genetic DNA/RNA testing, and reviews patent and licensing issues related to genes and diagnostic methods and tools from an international and European perspective, illustrated with a concrete, real life example, namely the well known BRCA-case dealing with diagnostic testing for early onset breast and ovarian cancer based on the genes BRCA1 and BRCA2. The paper concludes that the impasses identified and the criticism voiced is not always directed to the existence of the patent system as such, but rather to some excesses in the exercise of patent rights and the unrestrained behaviour of individual patent owners, in an effort to maximize profit. It is hoped that the new compulsory license for public health will address undesirable effects and unreasonable behaviour from patent holders in an adequate manner, thanks to its preventive and dissuading effect towards patent holders applying (extremely) restrictive licensing policies. It is also to be expected that new models of collaborative licensing may contribute to facilitating access to genetic testing when clusters of patents are rendering access to genetic testing technology too complex and uncertain.

Patents in the Knowledge-Based Economy

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Publisher : National Academies Press
ISBN 13 : 0309167183
Total Pages : 352 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Patents in the Knowledge-Based Economy by : National Research Council

Download or read book Patents in the Knowledge-Based Economy written by National Research Council and published by National Academies Press. This book was released on 2003-08-11 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume assembles papers commissioned by the National Research Council's Board on Science, Technology, and Economic Policy (STEP) to inform judgments about the significant institutional and policy changes in the patent system made over the past two decades. The chapters fall into three areas. The first four chapters consider the determinants and effects of changes in patent "quality." Quality refers to whether patents issued by the U.S. Patent and Trademark Office (USPTO) meet the statutory standards of patentability, including novelty, nonobviousness, and utility. The fifth and sixth chapters consider the growth in patent litigation, which may itself be a function of changes in the quality of contested patents. The final three chapters explore controversies associated with the extension of patents into new domains of technology, including biomedicine, software, and business methods.

Diagnostic Molecular Pathology

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Publisher : Academic Press
ISBN 13 : 0128229934
Total Pages : 846 pages
Book Rating : 4.1/5 (282 download)

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Book Synopsis Diagnostic Molecular Pathology by : William B. Coleman

Download or read book Diagnostic Molecular Pathology written by William B. Coleman and published by Academic Press. This book was released on 2023-10-27 with total page 846 pages. Available in PDF, EPUB and Kindle. Book excerpt: Diagnostic Molecular Pathology: A Guide to Applied Molecular Testing, Second Edition assembles a group of experts to discuss the molecular basis and mechanisms of major human diseases and disease processes and how the molecular features of disease can be harnessed to develop practical molecular tests for disease detection, diagnosis and prognosis. The book explains how molecular tests are utilized in the treatment of patients in personalized medicine, highlights new technologies and approaches of applied molecular pathology, and discusses how this discovery-based research yields new and useful biomarkers and tests. As it is essential to stay up-to-date on new molecular diagnostics in this changing field, this book covers critically important areas in the practice of personalized medicine and reflects our understanding of the pathology, pathogenesis and pathophysiology of human disease. Includes new material on mass spectrometry for infectious diseases, microbiome, homology-directed repair for PARPi, whole genome sequencing for constitutional testing, and much more Provides insights on the value of the molecular test in comparison to traditional methods, which include speed, precision, sensitivity and clinical impacts for the patient Focuses on the menu of molecular diagnostic tests available in modern molecular pathology or clinical laboratories that can be applied to disease detection, diagnosis and classification in the clinical workup of a patient Explains how molecular tests are utilized to guide the treatment of patients in personalized medicine (guided therapies) and for the prognostication of disease

An Introduction to Ethical, Safety and Intellectual Property Rights Issues in Biotechnology

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Publisher : Academic Press
ISBN 13 : 0128092513
Total Pages : 394 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis An Introduction to Ethical, Safety and Intellectual Property Rights Issues in Biotechnology by : Padma Nambisan

Download or read book An Introduction to Ethical, Safety and Intellectual Property Rights Issues in Biotechnology written by Padma Nambisan and published by Academic Press. This book was released on 2017-06-21 with total page 394 pages. Available in PDF, EPUB and Kindle. Book excerpt: An Introduction to Ethical, Safety and Intellectual Property Rights Issues in Biotechnology provides a comprehensive look at the biggest technologies that have revolutionized biology since the early 20th century, also discussing their impact on society. The book focuses on issues related to bioethics, biosafety and intellectual property rights, and is written in an easy-to-understand manner for graduate students and early career researchers interested in the opportunities and challenges associated with advances in biotechnology. Important topics covered include the Human Genome Project, human cloning, rDNA technology, the 3Rs and animal welfare, bioterrorism, human rights and genetic discrimination, good laboratory practices, good manufacturing practices, the protection of biological material and much more. Full of relevant case studies, practical examples, weblinks and resources for further reading, this book offers an essential and holistic look at the ways in which biotechnology has affected our global society. Provides a comprehensive look at the ethical, legal and social implications of biotechnology Discusses the global efforts made to resolve issues Incorporates numerous case studies to more clearly convey concepts and chart the development of guidelines and legislation regulating issues in biotechnology Takes a straightforward approach to highlight and discuss both the benefits and risks associated with the latest biotechnologies

Inherited Susceptibility to Cancer

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Publisher : Cambridge University Press
ISBN 13 : 9780521563406
Total Pages : 480 pages
Book Rating : 4.5/5 (634 download)

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Book Synopsis Inherited Susceptibility to Cancer by : William D. Foulkes

Download or read book Inherited Susceptibility to Cancer written by William D. Foulkes and published by Cambridge University Press. This book was released on 1998-06-28 with total page 480 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many cancers, both common and rare, are known to have a hereditary predisposition and advances in genetics have clarified the risks and in some cases the mechanisms of cancer developing in an individual. First published in 1998, this important contribution to the literature of cancer genetics covers all the key issues, reviewing both the technology behind genetic risk assessment and the ethical dilemmas it poses. It is divided into two parts. The first deals with ethical, legal and social issues. The second systematically outlines current knowledge of the inheritance patterns of many different cancer types, both from a site-by-site perspective and for special groups. This authoritative volume will be of interest to oncologists, physicians and surgeons in other specialities and to health professionals in the areas of primary care, counselling and cancer risk assessment.

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

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Publisher : WIPO
ISBN 13 : 9280523082
Total Pages : 259 pages
Book Rating : 4.2/5 (85 download)

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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.

The Role of NIH in Drug Development Innovation and Its Impact on Patient Access

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Publisher : National Academies Press
ISBN 13 : 0309498511
Total Pages : 103 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis The Role of NIH in Drug Development Innovation and Its Impact on Patient Access by : National Academies of Sciences, Engineering, and Medicine

Download or read book The Role of NIH in Drug Development Innovation and Its Impact on Patient Access written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-01-27 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.

Genetics, Health, and Society

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Publisher : Emerald Group Publishing
ISBN 13 : 1783505680
Total Pages : 336 pages
Book Rating : 4.7/5 (835 download)

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Book Synopsis Genetics, Health, and Society by : Brea L. Perry

Download or read book Genetics, Health, and Society written by Brea L. Perry and published by Emerald Group Publishing. This book was released on 2015-07-16 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume focuses on critical issues surrounding the intersection of genetics, health, and society. It provides a critical examination of sociological and biomedical approaches to genomics, including strengths and limitations of each perspective.

The Genealogy of a Gene

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Publisher : MIT Press
ISBN 13 : 0262028662
Total Pages : 349 pages
Book Rating : 4.2/5 (62 download)

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Book Synopsis The Genealogy of a Gene by : Myles W. Jackson

Download or read book The Genealogy of a Gene written by Myles W. Jackson and published by MIT Press. This book was released on 2015-02-20 with total page 349 pages. Available in PDF, EPUB and Kindle. Book excerpt: The history of the CCR5 gene as a lens through which to view such issues as intellectual property, Big Pharma, personalized medicine, and race and genomics. In The Genealogy of a Gene, Myles Jackson uses the story of the CCR5 gene to investigate the interrelationships among science, technology, and society. Mapping the varied “genealogy” of CCR5—intellectual property, natural selection, Big and Small Pharma, human diversity studies, personalized medicine, ancestry studies, and race and genomics—Jackson links a myriad of diverse topics. The history of CCR5 from the 1990s to the present offers a vivid illustration of how intellectual property law has changed the conduct and content of scientific knowledge, and the social, political, and ethical implications of such a transformation. The CCR5 gene began as a small sequence of DNA, became a patented product of a corporation, and then, when it was found to be an AIDS virus co-receptor with a key role in the immune system, it became part of the biomedical research world—and a potential moneymaker for the pharmaceutical industry. When it was further discovered that a mutation of the gene found in certain populations conferred near-immunity to the AIDS virus, questions about race and genetics arose. Jackson describes these developments in the context of larger issues, including the rise of “biocapitalism,” the patentability of products of nature, the difference between U.S. and European patenting approaches, and the relevance of race and ethnicity to medical research.

The Changing Face of US Patent Law and Its Impact on Business Strategy

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Publisher : Edward Elgar Publishing
ISBN 13 : 1781007853
Total Pages : 257 pages
Book Rating : 4.7/5 (81 download)

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Book Synopsis The Changing Face of US Patent Law and Its Impact on Business Strategy by : D.R. Cahoy

Download or read book The Changing Face of US Patent Law and Its Impact on Business Strategy written by D.R. Cahoy and published by Edward Elgar Publishing. This book was released on 2013-01-01 with total page 257 pages. Available in PDF, EPUB and Kindle. Book excerpt: 'Daniel Cahoy and Lynda Oswald have brought together some of the country's most prominent patent scholars outside the legal discipline. From the LeahySmith America Invents Act to recent court cases from the Supreme Court and the Federal Circuit, this timely, informative and well-edited volume examines the latest changes in US patent law and their impact on business strategy. The book is a must-read for anybody who wants to learn more deeply about the ever-increasing role of patents in the business environment.' Peter K. Yu, Drake University Law School, US Within the complex global economy, patents function as indispensable tools for fostering and protecting innovation. This fascinating volume offers a comprehensive perspective on the US patent system, detailing its many uses and outlining several critical legislative, administrative and judicial reforms that impact business strategy. The expert contributors to this book provide an overview of how the US patent system functions today and describe how recent changes affect firms and individual inventors. Topics discussed include the drivers of intellectual property policy; recent revisions to the patent application process in terms of the new first-to-file regime, inequitable conduct, and allowable subject matter; and changes to patent enforcement and infringement related to the Federal Circuit's special role and post-grant review. Contributors address recent legislation such as the 2011 America Invents Act, which enacted some of the most significant patent reforms in decades. This examination of the US patent system highlights some of the most important issues for business. It will serve as an important tool for both policymakers and business leaders, and will also interest students and professors of business and management studies, innovation studies and business law.

Biotechnology and the Patent System

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Publisher : A E I Press
ISBN 13 : 9780844742564
Total Pages : 116 pages
Book Rating : 4.7/5 (425 download)

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Book Synopsis Biotechnology and the Patent System by : Claude E. Barfield

Download or read book Biotechnology and the Patent System written by Claude E. Barfield and published by A E I Press. This book was released on 2007 with total page 116 pages. Available in PDF, EPUB and Kindle. Book excerpt: American patent law has reached an unprecedented crossroads, prodded by a landmark Supreme Court decision this spring and the prospect of sweeping new federal legislation this fall. At this critical time, Biotechnology and the Patent System: Balancing Innovation and Property Rights provides a timely look at the complex issues involved in making patent law for cutting-edge high-tech industries such as the biotechnology and computer software sectors.