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. Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health 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.
This committee, a joint collaboration of the Committee on Science, Technology, and Law and the Science, Technology, Economic Policy Board, reviewed the patenting and licensing of human genetic material and proteins. This represents an extension of intellectual property rights to naturally occurring biological material and scientific information - much of it is well upstream of drugs and other disease therapies. The study documents the types of patents that have been issued/applied for and by whom, the differences in the criteria applied by the U.S. and other major patent offices to the examination of such applications, and to the extent possible, the licensing arrangements for different types of patented materials. In view of substantial evidence that patents play an important role in certain kinds of biomedical innovations, especially the development of therapeutic drugs, the committee carefully considered the impact of its recommendations on investments in R&D and the commercialization of their results.
April 21-22, 2005
New York City, NY
Meeting closed in its entirety
February 11-12, 2005
December 13-17, 2004
October 1-2, 2004
August 5-6, 2004
June 4-5, 2004
February 27-28, 2004
The Committee on Intellectual Property Rights in Genomics and Proteomic Research and Innovation released its report, Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health, on November 17, 2005.
Shirley Tilghman, Co-chair
Roderick McKelvie, Co-Chair
Covington & Burling
H. John Heinz III School of Public Management
Carnegie Mellon University
Helen M. Berman
Board of Governors Professor of Chemistry and Chemical Biology
Office for Technology and Trademark Licensing
Chief Scientific Officer
SGX Pharmaceuticals, Inc.
Q. Todd Dickinson
Vice President and Chief Intellectual Property Counsel
General Electric Co.
Rochelle Cooper Dreyfuss
Pauline Newman Professor of Law
New York University School of Law
Rebecca S. Eisenberg
Robert and Barbara Luciano Professor of Law
University of Michigan Law School
Chuck Hartman (deceased)
Stanley Woodward Professor of History
Senior Vice President
Biomedical and Health Sciences Research
American Association of Medical Colleges
George Milne, Jr.
Executive Vice President, Research
Arent Fox PLLC
Professor and Gates Chair, Genome Sciences
University of Washington
Higgins Professor Neuropsychology, College of Physicians and Surgeons of Columbia University and President, Hereditary Disease Foundation
Professor of Agricultural and Resource Economics
University of California, Berkeley
This project was sponsored by the National Institutes of Health, Affymetrix Inc., Agilent Technologies, Amgen, Biotechnology Industry Organization, Chiron Foundation, Pfizer Inc., and the Bellagio Center of the Rockefeller Foundation.
Stephen A. Merrill, Ph.D.
Director, Board on Science, Technology, and Economic Policy
Anne-Marie Mazza, Ph.D.
Director, Committee on Science, Technology, and Law