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Suggested Citation:"FRONT MATTER." National Research Council. 1997. Intellectual Property Rights and Research Tools in Molecular Biology: Summary of a Workshop Held at the National Academy of Sciences, February 15-16, 1996. Washington, DC: The National Academies Press. doi: 10.17226/5758.
×

Intellectual Property Rights and Research Tools in Molecular Biology

Summary of a Workshop Held at the National Academy of Sciences, February 15–16, 1996

National Research Council

NATIONAL ACADEMY PRESS
Washington, D.C.
1997

Suggested Citation:"FRONT MATTER." National Research Council. 1997. Intellectual Property Rights and Research Tools in Molecular Biology: Summary of a Workshop Held at the National Academy of Sciences, February 15-16, 1996. Washington, DC: The National Academies Press. doi: 10.17226/5758.
×

NATIONAL ACADEMY PRESS
2101 Constitution Ave., N.W. Washington, D.C. 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 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 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 Alberts and Dr. Robert M. White are chairman and vice chairman, respectively, of the National Research Council.

This study was sponsored by the National Research Council Basic Science Fund.

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Copyright 1997 by the National Academy of Sciences. All rights reserved.

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Suggested Citation:"FRONT MATTER." National Research Council. 1997. Intellectual Property Rights and Research Tools in Molecular Biology: Summary of a Workshop Held at the National Academy of Sciences, February 15-16, 1996. Washington, DC: The National Academies Press. doi: 10.17226/5758.
×

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

Suggested Citation:"FRONT MATTER." National Research Council. 1997. Intellectual Property Rights and Research Tools in Molecular Biology: Summary of a Workshop Held at the National Academy of Sciences, February 15-16, 1996. Washington, DC: The National Academies Press. doi: 10.17226/5758.
×

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

Suggested Citation:"FRONT MATTER." National Research Council. 1997. Intellectual Property Rights and Research Tools in Molecular Biology: Summary of a Workshop Held at the National Academy of Sciences, February 15-16, 1996. Washington, DC: The National Academies Press. doi: 10.17226/5758.
×

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

Suggested Citation:"FRONT MATTER." National Research Council. 1997. Intellectual Property Rights and Research Tools in Molecular Biology: Summary of a Workshop Held at the National Academy of Sciences, February 15-16, 1996. Washington, DC: The National Academies Press. doi: 10.17226/5758.
×

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

Suggested Citation:"FRONT MATTER." National Research Council. 1997. Intellectual Property Rights and Research Tools in Molecular Biology: Summary of a Workshop Held at the National Academy of Sciences, February 15-16, 1996. Washington, DC: The National Academies Press. doi: 10.17226/5758.
×

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

Page viii Cite
Suggested Citation:"FRONT MATTER." National Research Council. 1997. Intellectual Property Rights and Research Tools in Molecular Biology: Summary of a Workshop Held at the National Academy of Sciences, February 15-16, 1996. Washington, DC: The National Academies Press. doi: 10.17226/5758.
×

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

Suggested Citation:"FRONT MATTER." National Research Council. 1997. Intellectual Property Rights and Research Tools in Molecular Biology: Summary of a Workshop Held at the National Academy of Sciences, February 15-16, 1996. Washington, DC: The National Academies Press. doi: 10.17226/5758.
×
Suggested Citation:"FRONT MATTER." National Research Council. 1997. Intellectual Property Rights and Research Tools in Molecular Biology: Summary of a Workshop Held at the National Academy of Sciences, February 15-16, 1996. Washington, DC: The National Academies Press. doi: 10.17226/5758.
×
   

Intellectual Property and Openness

 

36

   

References

 

38

5

 

CASE STUDIES

 

40

   

Introduction

 

40

   

Recombinant DNA: A Patented Research Tool, Nonexclusively Licensed with Low Fees

 

40

   

PCR and Taq Polymerase: A Patented Research Tool for Which Licensing Arrangements Were Controversial

 

43

   

Protein and DNA Sequencing Instruments: Research Tools to Which Strong Patent Protection Promoted Broad Access

 

46

   

Research Tools in Drug Discovery: Intellectual Property Protection for Complex Biological Systems

 

48

   

Changes in Biotechnology Strategies

 

50

   

Expressed Sequence Tags (ESTs): Three Models for Disseminating Unpatented Research Tools

 

51

   

The Informational Value Of ESTs Is Rudimentary

 

53

   

The Value of ESTs Could Be Reduced by Limiting Access

 

54

   

The Human Genome Is Finite

 

54

   

The Advent of DNA Sequencing Presents Important Questions About Patentability

 

55

   

References

 

55

6

 

PERSPECTIVES FROM DIFFERENT SECTORS

 

57

   

Introduction

 

57

   

University Research

 

58

   

University Administration

 

59

   

Major Pharmaceutical Company

 

61

   

Attitudes Have Greatly Changed

 

61

   

Commerce and Science: Legitimate, Yet Competing, Interests

 

61

   

Research-Use Exemption Is Practiced as Rational Forbearance

 

63

   

Why Intellectual Property Is Important in Molecular Biology

 

63

   

Small Biotechnology Company

 

64

   

Genvec's Intellectual Property

 

64

   

Role of Venture Capital

 

64

   

Issues in Partnering Biotechnology and Pharmaceutical Firms

 

65

   

Summary

 

66

   

Government

 

66

   

References

 

70

7

 

SUMMARY

 

71

 

 

AGENDA OF THE FEBRUARY 1996 WORKSHOP

 

75

Suggested Citation:"FRONT MATTER." National Research Council. 1997. Intellectual Property Rights and Research Tools in Molecular Biology: Summary of a Workshop Held at the National Academy of Sciences, February 15-16, 1996. Washington, DC: The National Academies Press. doi: 10.17226/5758.
×
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Suggested Citation:"FRONT MATTER." National Research Council. 1997. Intellectual Property Rights and Research Tools in Molecular Biology: Summary of a Workshop Held at the National Academy of Sciences, February 15-16, 1996. Washington, DC: The National Academies Press. doi: 10.17226/5758.
×
Page R2
Suggested Citation:"FRONT MATTER." National Research Council. 1997. Intellectual Property Rights and Research Tools in Molecular Biology: Summary of a Workshop Held at the National Academy of Sciences, February 15-16, 1996. Washington, DC: The National Academies Press. doi: 10.17226/5758.
×
Page R3
Suggested Citation:"FRONT MATTER." National Research Council. 1997. Intellectual Property Rights and Research Tools in Molecular Biology: Summary of a Workshop Held at the National Academy of Sciences, February 15-16, 1996. Washington, DC: The National Academies Press. doi: 10.17226/5758.
×
Page R4
Suggested Citation:"FRONT MATTER." National Research Council. 1997. Intellectual Property Rights and Research Tools in Molecular Biology: Summary of a Workshop Held at the National Academy of Sciences, February 15-16, 1996. Washington, DC: The National Academies Press. doi: 10.17226/5758.
×
Page R5
Suggested Citation:"FRONT MATTER." National Research Council. 1997. Intellectual Property Rights and Research Tools in Molecular Biology: Summary of a Workshop Held at the National Academy of Sciences, February 15-16, 1996. Washington, DC: The National Academies Press. doi: 10.17226/5758.
×
Page R6
Suggested Citation:"FRONT MATTER." National Research Council. 1997. Intellectual Property Rights and Research Tools in Molecular Biology: Summary of a Workshop Held at the National Academy of Sciences, February 15-16, 1996. Washington, DC: The National Academies Press. doi: 10.17226/5758.
×
Page R7
Page viii Cite
Suggested Citation:"FRONT MATTER." National Research Council. 1997. Intellectual Property Rights and Research Tools in Molecular Biology: Summary of a Workshop Held at the National Academy of Sciences, February 15-16, 1996. Washington, DC: The National Academies Press. doi: 10.17226/5758.
×
Page R8
Suggested Citation:"FRONT MATTER." National Research Council. 1997. Intellectual Property Rights and Research Tools in Molecular Biology: Summary of a Workshop Held at the National Academy of Sciences, February 15-16, 1996. Washington, DC: The National Academies Press. doi: 10.17226/5758.
×
Page R9
Suggested Citation:"FRONT MATTER." National Research Council. 1997. Intellectual Property Rights and Research Tools in Molecular Biology: Summary of a Workshop Held at the National Academy of Sciences, February 15-16, 1996. Washington, DC: The National Academies Press. doi: 10.17226/5758.
×
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