Intellectual Property Rights and Plant Biotechnology

Proceedings of a Forum Held at the National Academy of Sciences,

November 5, 1996,

Washington, D.C.

National Research Council

NATIONAL ACADEMY PRESS
Washington, D.C.
1997



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Intellectual Property Rights and Plant Biotechnology Intellectual Property Rights and Plant Biotechnology Proceedings of a Forum Held at the National Academy of Sciences, November 5, 1996, Washington, D.C. National Research Council NATIONAL ACADEMY PRESS Washington, D.C. 1997

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Intellectual Property Rights and Plant Biotechnology NATIONAL ACADEMY PRESS 2101 Constitution Avenue, NW Washington, DC 20418 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M. Alberts is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. William A. Wulf is acting president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy's purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. William A. Wulf are chairman and vice-chairman, respectively, of the National Research Council. This report was prepared with funds provided by the Office of Energy Research and the Office of Health and Environmental Research of the U.S. Department of Energy under agreement number DE-FG02-94ER61939. International Standard Book Number 0-309-05828-7 Additional copies are available from: National Academy Press, 2101 Constitution Ave., NW , Box 285 , Washington, DC 20055 800-624-6242 ; 202-334-3313 (in the Washington Metropolitan Area) http://www.nap.edu Copyright 1997 by the National Academy of Sciences . All rights reserved. Printed in the United States of America

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Intellectual Property Rights and Plant Biotechnology STEERING COMMITTEE MICHAEL T. CLEGG, Chair, University of California, Riverside ELLIOT M. MEYEROWITZ, California Institute of Technology, Pasadena RONALD R. SEDEROFF, North Carolina State University Science Writer ROBERT POOL, Arlington, Virginia NRC Staff JANET E. JOY, Study Director MARY JANE LETAW, Staff Officer JULIEMARIE GOUPIL, Project Assistant

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Intellectual Property Rights and Plant Biotechnology BOARD ON AGRICULTURE DALE E. BAUMAN, Chair, Cornell University JOHN M. ANTLE, Montana State University SANDRA S. BATIE, Michigan State University MAY R. BERENBAUM, University of Illinois LEONARD S. BULL, North Carolina State University WILLIAM B. DELAUDER, Delaware State College ANTHONY S. EARL, Quarles & Brady Law Firm, Madison, Wisconsin ESSEX E. FINNEY, JR., U.S. Department of Agriculture, Mitchellville, Maryland CORNELIA B. FLORA, Iowa State University GEORGE R. HALLBERG, University of Iowa RICHARD R. HARWOOD, Michigan State University T. KENT KIRK, University of Wisconsin HARLEY W. MOON, Iowa State University WILLIAM L. OGREN, University of Illinois GEORGE E. SEIDEL, JR., Colorado State University JOHN W. SUTTIE, University of Wisconsin JAMES J. ZUICHES, Washington State University NRC Staff MICHAEL J. PHILLIPS, Director SHIRLEY B. THATCHER, Senior Project Assistant

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Intellectual Property Rights and Plant Biotechnology BOARD ON BIOLOGY MICHAEL T. CLEGG, Chair, University of California, Riverside JOHN C. AVISE, University of Georgia, Athens DAVID EISENBERG, University of California, Los Angeles GERALD D. FISCHBACH, Harvard Medical School DAVID J. GALAS, Darwin Technologies, Seattle, Washington DAVID V. GOEDDEL, Tularik, Inc., San Francisco ARTURO GOMEZ-POMPA, University of California, Riverside COREY S. GOODMAN, University of California, Berkeley BRUCE R. LEVIN, Emory University, Atlanta OLGA F. LINARES, Smithsonian Tropical Research Institute, Balboa, Panama ELLIOT M. MEYEROWITZ, California Institute of Technology, Pasadena ROBERT T. PAINE, University of Washington, Seattle RONALD R. SEDEROFF, North Carolina State University DANIEL S. SIMBERLOFF, Florida State University ROBERT R. SOKAL, State University of New York, Stony Brook SHIRLEY M. TILGHMAN, Princeton University RAYMOND L. WHITE, University of Utah, Salt Lake City NRC Staff ERIC A. FISHER, Director * KATHLEEN A. BEIL, Project Assistant * Through December 1996.

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Intellectual Property Rights and Plant Biotechnology COMMISSION ON LIFE SCIENCES THOMAS D. POLLARD, Chair, The Salk Institute for Biological Studies, La Jolla, California FREDERICK R. ANDERSON, Cadwalder, Wickersham and Taft, Washington, D.C. JOHN C. BAILAR III, University of Chicago PAUL BERG, Stanford University JOHN E. BURRIS, Marine Biological Laboratory, Woods Hole, Massachusetts SHARON L. DUNWOODY, University of Wisconsin, Madison URSULA W. GOODENOUGH, Washington University, St. Louis, Missouri HENRY W. HEIKKINEN, University of Northern Colorado, Greeley HANS J. KENDE, Michigan State University, Lansing SUSAN E. LEEMAN, Boston University School of Medicine THOMAS E. LOVEJOY, Smithsonian Institution, Washington, D.C. DONALD R. MATTISON, University of Pittsburgh JOSEPH E. MURRAY, Wellesley Hills, Massachusetts EDWARD E. PENHOET, Chiron Corporation, Emeryville, California EMIL A. PFITZER, Research Institute for Fragrance Materials, Inc., Hackensack, New Jersey MALCOLM C. PIKE, Norris/University of Southern California, Comprehensive Cancer Center, Los Angeles HENRY C. PITOT III, University of Wisconsin, Madison JOHNATHAN M. SAMET, John Hopkins University, Baltimore CHARLES F. STEVENS, The Salk Institute for Biological Studies, La Jolla, California JOHN L. VANDERBERG, Southwest Foundation for Biomedical Research, San Antonio, Texas NRC Staff PAUL GILMAN, Executive Director SOLVEIG M. PADILLA, Administrative Assistant

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Intellectual Property Rights and Plant Biotechnology Preface In 1993 the National Research Council's Board on Biology established a series of fora on biotechnology. The purpose of the discussions is to foster open communication among scientists, administrators, policymakers, and others engaged in biotechnology research, development, and commercialization. The neutral setting offered by the National Research Council is intended to promote mutual understanding among government, industry, and academe and to help develop imaginative approaches to problem solving. For the first forum, held on November 5, 1996, the Board on Biology collaborated with the Board on Agriculture to focus on intellectual property rights issues surrounding plant biotechnology. It was suggested that plant biotechnologies have not developed with the same vigor as might have been expected, given recent progress in molecular biology and by comparison to biomedical biotechnology. It was hoped that a forum could clarify intellectual property issues among research collaborators and potential impacts on advances in plant molecular biology. Participation at the “Forum on Intellectual Property Rights and Plant Biotechnology” by representatives of the U.S. Department of Energy, U.S. Department of Agriculture, National Science Foundation, National Institutes of Health, and U.S. Patent and Trademark Office (PTO) suggests that intellectual property rights issues are important to many federal agencies. Forum participants agreed that exploration of successful technology transfer models would benefit publicprivate research collaborations. Executives from biotechnology firms raised concerns that universities overestimate the value of intellectual property in the mar-

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Intellectual Property Rights and Plant Biotechnology ketplace. Scientists emphasized the need for a research exemption to prevent intellectual property rights from negatively impacting the research environment. Examination of intellectual property rights also has been a focus of other activities of the Board on Biology. In 1993 Harold Varmus, chair of the Board on Biology at that time, headed an effort to discuss sharing of reagents associated with transgenic mice. More recently, the board organized a forum in November 1995 to examine the effects of intellectual property protection on the development, dissemination, and utilization of research tools such as expressed sequence tags and the polymerase chain reaction. It is anticipated that the present forum proceedings will generate further interest in intellectual property rights and other issues of biotechnology. Michael T. Clegg, Chair Board on Biology

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Intellectual Property Rights and Plant Biotechnology Contents  1   OVERVIEW   1  2   SUMMARY OF FORUM PROCEEDINGS   3      Worlds in Collision,   3      Worries in the Laboratory,   7      Commercial Concerns,   12      Technology Transfer,   18      The Future,   22     APPENDIXES       A  Forum Program and Discussion Questions   27     B  Forum Agenda   30     C  Speaker Biographies   32

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