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:
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.
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.
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.
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.
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.
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 2006-03-09 with total page 188 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.
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.
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.
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
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.
Download or read book Diagnostic Molecular Pathology written by William B. Coleman and published by Academic Press. This book was released on 2023-10-18 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
Download or read book The Impact of Human Gene Patents on Innovation and Access written by Christopher M. Holman and published by . This book was released on 2013 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: In 2005, an article in the highly influential journal Science reported that roughly 20% of human genes are patented. This figure has been widely cited and at times over-interpreted. For example, a popular science fiction author warns the public that their bodies are "owned" by someone else. A bill was introduced in Congress in 2007 that would essentially seek to ban the patenting of DNA. The bill appears motivated in part by a perception that one-fifth of our genes are owned by somebody else, that these owners can do whatever they want with these genes, and that there is "nothing that we can do to stop them" (presumably short of banning the patenting of DNA). While clearly many US patents have issued that reference human genetic sequences, the actual scope of exclusivity varies dramatically from claim-to-claim as dictated by the actual claim language. Many patents restrict only some very narrow use of the genetic sequence, others are much broader - none cover actual human genes as they exist in their native state. And it should go without saying that none confer actual ownership of human beings, or allow a patent owner to do "whatever it wants" with another person's genes. In light of the hyperbole and high interest currently surrounding human gene patents, and in an attempt to assess the true impact of these patents, I conducted a search to identify and analyze all instances where a patent relating to a human gene was asserted in a lawsuit. The results suggest that the impact of human gene patents has been felt primarily in the context of biotechnology-derived protein therapeutics, i.e., biologics, the most important fruit of the biotechnology revolution. The impact on genetic testing and assess to research tools has been relatively modest, with some notable exceptions. Furthermore, lawsuits are being filed at a decreasing frequency over time, and it appears that only three human gene patent litigations are currently pending. Two involve patents relating to the production of recombinant erythropoietin, an important biologic drug; these patents claim priority to applications filed in the early 1980s. The third is best characterized as a contract dispute, wherein the licensor of a research tool patent alleges that a licensee has exceeded the scope of its license; this case has been stayed pending the outcome of a court-ordered arbitration of the underlying contractual dispute. The article concludes with a discussion of some policy implications to be drawn from the results of this survey.
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 330 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.
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.
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.
Download or read book Genes and Ingenuity written by Australia. Law Reform Commission and published by Virago Press. This book was released on 2004 with total page 690 pages. Available in PDF, EPUB and Kindle. Book excerpt: Report of an inquiry concerned with two broad issues: the patenting of genetic materials and technologies, and the exploitation of these patents and the distinction that can and possibly should be made between discoveries and inventions when referring to claims over genetic sequences.
