Reaping the Benefits of Genomic and Proteomic Research

Reaping the Benefits of Genomic and Proteomic Research
Author: National Research Council
Publisher: National Academies Press
Total Pages: 189
Release: 2006-04-09
Genre: Science
ISBN: 0309100674

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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.

Reaping the Benefits of Genomic and Proteomic Research

Reaping the Benefits of Genomic and Proteomic Research
Author: National Research Council
Publisher:
Total Pages: 188
Release: 2006-03-09
Genre:
ISBN: 9780309383929

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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.

A Patent System for the 21st Century

A Patent System for the 21st Century
Author: National Research Council
Publisher: National Academies Press
Total Pages: 186
Release: 2004-10-01
Genre: Science
ISBN: 0309089107

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The U.S. patent system is in an accelerating race with human ingenuity and investments in innovation. In many respects the system has responded with admirable flexibility, but the strain of continual technological change and the greater importance ascribed to patents in a knowledge economy are exposing weaknesses including questionable patent quality, rising transaction costs, impediments to the dissemination of information through patents, and international inconsistencies. A panel including a mix of legal expertise, economists, technologists, and university and corporate officials recommends significant changes in the way the patent system operates. A Patent System for the 21st Century urges creation of a mechanism for post-grant challenges to newly issued patents, reinvigoration of the non-obviousness standard to quality for a patent, strengthening of the U.S. Patent and Trademark Office, simplified and less costly litigation, harmonization of the U.S., European, and Japanese examination process, and protection of some research from patent infringement liability.

Evolution of Translational Omics

Evolution of Translational Omics
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 354
Release: 2012-09-13
Genre: Science
ISBN: 0309224187

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Technologies collectively called omics enable simultaneous measurement of an enormous number of biomolecules; for example, genomics investigates thousands of DNA sequences, and proteomics examines large numbers of proteins. Scientists are using these technologies to develop innovative tests to detect disease and to predict a patient's likelihood of responding to specific drugs. Following a recent case involving premature use of omics-based tests in cancer clinical trials at Duke University, the NCI requested that the IOM establish a committee to recommend ways to strengthen omics-based test development and evaluation. This report identifies best practices to enhance development, evaluation, and translation of omics-based tests while simultaneously reinforcing steps to ensure that these tests are appropriately assessed for scientific validity before they are used to guide patient treatment in clinical trials.

Biotechnology & Genetic Engineering Reviews

Biotechnology & Genetic Engineering Reviews
Author: Stephen Harding
Publisher: Nottingham University Press
Total Pages: 439
Release: 2010-05-01
Genre: Science
ISBN: 1904761917

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Containing more than a dozen original, major review articles from authors published in leading journals and covering important developments in industrial, agricultural, and medical applications of biotechnology, this newest edition from the well-established hardcover review series focuses primarily on the genetic manipulation of organisms. Covering issues ranging from gene expression and genetic regulations to plant bioreactors and enzymatic processing, this reference will benefit students in the fields of biochemistry, genetics, molecular biology, and pharmaceutical sciences.

Stifling Or Stimulating

Stifling Or Stimulating
Author: United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts, the Internet, and Intellectual Property
Publisher:
Total Pages: 132
Release: 2008
Genre: Medical
ISBN:

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Genomic medicine

Genomic medicine
Author: Great Britain: Parliament: House of Lords: Science and Technology Committee
Publisher: The Stationery Office
Total Pages: 652
Release: 2009-07-07
Genre: Political Science
ISBN: 9780108444500

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Volume 1 Report also available (ISBN 9780108444517). Genomic medicine has developed from the sequencing of the human genome

Governing Digitally Integrated Genetic Resources, Data, and Literature

Governing Digitally Integrated Genetic Resources, Data, and Literature
Author: Jerome H. Reichman
Publisher: Cambridge University Press
Total Pages: 679
Release: 2016-05-19
Genre: Law
ISBN: 1316380998

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The free exchange of microbial genetic information is an established public good, facilitating research on medicines, agriculture, and climate change. However, over the past quarter-century, access to genetic resources has been hindered by intellectual property claims from developed countries under the World Trade Organization's TRIPS Agreement (1994) and by claims of sovereign rights from developing countries under the Convention on Biological Diversity (CBD) (1992). In this volume, the authors examine the scientific community's responses to these obstacles and advise policymakers on how to harness provisions of the Nagoya Protocol (2010) that allow multilateral measures to support research. By pooling microbial materials, data, and literature in a carefully designed transnational e-infrastructure, the scientific community can facilitate access to essential research assets while simultaneously reinforcing the open access movement. The original empirical surveys of responses to the CBD included here provide a valuable addition to the literature on governing scientific knowledge commons.

Managing University Intellectual Property in the Public Interest

Managing University Intellectual Property in the Public Interest
Author: National Research Council
Publisher: National Academies Press
Total Pages: 118
Release: 2011-03-28
Genre: Science
ISBN: 0309161118

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Thirty years ago federal policy underwent a major change through the Bayh-Dole Act of 1980, which fostered greater uniformity in the way research agencies treat inventions arising from the work they sponsor. Before the Act, if government agencies funded university research, the funding agency retained ownership of the knowledge and technologies that resulted. However, very little federally funded research was actually commercialized. As a result of the Act's passage, patenting and licensing activity from such research has accelerated. Although the system created by the Act has remained stable, it has generated debate about whether it might impede other forms of knowledge transfer. Concerns have also arisen that universities might prioritize commercialization at the expense of their traditional mission to pursue fundamental knowledge-for example, by steering research away from curiosity-driven topics toward applications that could yield financial returns. To address these concerns, the National Research Council convened a committee of experts from universities, industry, foundations, and similar organizations, as well as scholars of the subject, to review experience and evidence of the technology transfer system's effects and to recommend improvements. The present volume summarizes the committee's principal findings and recommendations.