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COMMITTEE ON INTELLECTUAL PROPERTY RIGHTS AND RESEARCH TOOLS IN MOLECULAR BIOLOGY
REBECCA EISENBERG, (Chair),
University of Michigan Law School, Ann Arbor, Michigan
WILLIAM R. BRINKLEY,
Baylor College of Medicine, Houston, Texas
WILLIAM T. COMER,
SIBIA, La Jolla, California
BARBARA J. MAZUR,
E.I. du Pont de Nemours & Company, Wilmington, Delaware
LITA L. NELSEN,
Massachusetts Institute of Technology, Cambridge, Massachusetts
GERALD M. RUBIN,
University of California, Berkeley, California
SIDNEY G. WINTER JR.,
Wharton School of Business, Philadelphia, Pennsylvania
National Research Council Staff
JANET E. JOY, Study Director
ROBIN SCHOEN, Staff Officer
NORMAN GROSSBLATT, Editor
JEFFREY PECK, Project Assistant
BOARD ON BIOLOGY
MICHAEL T. CLEGG (Chair),
University of California, Riverside, California
JOHN C. AVISE,
University of Georgia, Athens, Georgia
DAVID EISENBERG,
University of California, Los Angeles, California
GERALD D. FISCHBACH,
Harvard Medical School, Cambridge, Massachusetts
DAVID J. GALAS,
Darwin Molecular Corporation, Bothell, Washington
DAVID V. GOEDDEL,
Tularik, Inc., South San Francisco, California
ARTURO GOMEZ-POMPA,
University of California, Riverside, California
COREY S. GOODMAN,
University of California, Berkeley, California
BRUCE R. LEVIN,
Emory University, Atlanta, Georgia
OLGA F. LINARES,
Smithsonian Tropical Research Institute, Miami, Florida
ELLIOTT M. MEYEROWITZ,
California Institute of Technology, Pasadena, California
ROBERT T. PAINE,
University of Washington, Seattle Washington
DANIEL SIMBERLOFF,
Florida State University, Tallahassee, Florida
ROBERT R. SOKAL,
State University of New York, Stony Brook, New York
SHIRLEY M. TILGHMAN,
Princeton University, Princeton, New Jersey
Staff
ERIC A. FISCHER, Director, Board On Biology
BOARD ON HEALTH SCIENCES POLICY
JOHN D. STOBO (Chair),
Johns Hopkins University School of Medicine
BARUCH S. BLUMBERG,
Fox Chase Cancer Center
ENRIQUETA C. BOND,
The Burroughs Wellcome Fund
C. THOMAS CASKEY,
Merck & Co., Inc.
DAVID R. CHALLONER,
University of Florida
DEBORAH COTTON,
Harvard Medical School
MARK R. CULLEN,
Yale University School of Medicine
RUTH R. FADEN,
Johns Hopkins School of Hygiene and Public Health
ADA SUE HINSHAW,
University of Michigan
THOMAS INUI,
Harvard Medical School
RICHARD J. JOHNS,
Johns Hopkins University School of Medicine
JUDITH H. LAROSA,
Tulane University School of Public Health and Tropical Medicine
ROBERT I. LEVY,
Wyeth-Ayerst Research
BERNARD LO,
University of California, San Francisco School of Medicine
RICHARD A. MERRILL,
University of Virginia School of Law
GLORIA ELIZABETH SARTO,
University of New Mexico School of Medicine
FLOSSIE WONG-STAAL,
University of California, San Diego
JAMES H. WYCHE,
Brown University
Institute of Medicine Staff
VALERIE P. SETLOW, Director,
Division of Health Sciences Policy
VIRTUAL COMMISSION ON INTELLECTUAL PROPERTY RIGHTS
JOHN D. STOBO (Chair),
Johns Hopkins University School of Medicine, Baltimore, Maryland
SHIRLEY M. TILGHMAN,
Princeton University, Princeton, New Jersey
MICHAEL T. CLEGG,
University of California, Riverside, California
GERALD D. FISCHBACH,
Harvard Medical School, Boston, Massachusetts
WILLIAM HUBBARD JR.,
Hickory Corners, Michigan
MARY LAKE POLAN,
Stanford University School of Medicine, Stanford, California
National Research Council Staff
PAUL GILMAN, Executive Director
SOLVEIG PADILLA, Administrative Assistant
Preface
Although controversy over intellectual property has been a recurring phenomenon in research science, the terms of controversy have shifted in recent years as patenting has become a more familiar part of the landscape. Whereas in an earlier era we might have asked whether intellectual property is fundamentally inconsistent with the norms of research science, today we are likely to ask more nuanced questions about what sorts of research discoveries should be patented and about how proprietary research tools should be disseminated in the research community so as to preserve the benefits of intellectual property while minimizing interference with the progress of science.
In March 1993, in the wake of a controversy over patent applications filed by the National Institutes of Health (NIH) on anonymous cDNA fragments (ESTs), the National Research Council's Commission on Life Sciences (CLS) and the Institute of Medicine (IOM) jointly held a workshop to discuss both specific concerns raised by the NIH patent application and broader issues arising from the patenting of discoveries in the biomedical sciences. Participants at that workshop concluded that a study on intellectual property, technology transfer, and conflict of interest in molecular biology might help resolve some of the issues. In October 1994, NIH director Harold Varmus met with the council of the National Academy of Sciences to discuss how the scientific community should respond to various constraints on the use of research tools and, in particular, to the terms set by Human Genome Sciences for access to its private EST database. In July 1995, the CLS and IOM formed the Committee on Intellectual Property and Research Tools in Molecular Biology to organize a workshop to examine the impact of intellectual property protection on the development of and access to research
tools in molecular biology, with attention to the perspectives of universities, government agencies, and private firms.
The workshop was held at the National Academy of Sciences on February 15–16, 1996. Over 100 people attended, coming from academic institutions, industry, and government agencies that sponsor research in molecular biology. The workshop was organized in three sessions. The first consisted of invited papers presenting legal, economic, and sociological perspectives on the topic of intellectual property protection for research tools. The second session consisted of a series of panel discussions of five case studies chosen to illustrate different strategies for managing intellectual property rights in different types of research tools. The third session consisted of presentations of different perspectives from academic institutions (representing both research scientists and technology transfer professionals), industry (representing both small biotechnology companies and major pharmaceutical companies), and government.
This report summarizes the workshop sessions and examines the common themes that emerged. The variety of circumstances presented in the case studies cautions against facile generalizations about ideal practices for protection of research tools in molecular biology. Nonetheless, some themes emerged that might provide useful insights for those concerned with how best to manage intellectual property rights in research tools in molecular biology.
All of the members of the organizing committee gave generously of their time in planning the workshop, identifying speakers, chairing workshop sessions, and reviewing drafts of the report. Francis Collins, director of the National Center for Human Genome Research at NIH and Maxwell Cowan, Vice President and Chief Scientific Officer of the Howard Hughes Medical Institute, met with the committee in advance of the workshop and gave extremely helpful comments and suggestions. The workshop speakers deserve special thanks for the time and thought they put into the workshop. Janet Joy provided essential staff support, both in the planning stages and in drafting the report of the workshop, with the assistance of Jeff Peck. Bob Cook-Deegan provided thoughtful guidance in shaping the final report, and Robin Schoen joined the committee in its planning meeting. Norman Grossblatt edited the proceedings. Last but by no means least, financial support for the workshop came from the National Research Council Basic Science Fund, the Academy Industry Program (AIP) of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine, and the National Institutes of Health.
Rebecca S. Eisenberg, Chair