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.

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.

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

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.

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.

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.