REAPING THE BENEFITS OF Genomic and Proteomic Research

Intellectual Property Rights, Innovation,and Public Health

Committee on Intellectual Property Rights in Genomic and Protein Research and Innovation

Board on Science, Technology, and Economic Policy

Committee on Science, Technology, and Law

Policy and Global Affairs

Stephen A. Merrill and Anne-Marie Mazza, Editors

NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
Washington, D.C. www.nap.edu



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Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health REAPING THE BENEFITS OF Genomic and Proteomic Research Intellectual Property Rights, Innovation,and Public Health Committee on Intellectual Property Rights in Genomic and Protein Research and Innovation Board on Science, Technology, and Economic Policy Committee on Science, Technology, and Law Policy and Global Affairs Stephen A. Merrill and Anne-Marie Mazza, Editors NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 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 study was supported by Contract No. N01-OD-4-2139, between the National Academies and the National Institutes of Health. In addition, the study was supported by Affymetrix Inc., Agilent Technologies, Amgen, Biotechnology Industry Organization, Chiron Foundation, Pfizer Inc., and the Bellagio Center of the Rockefeller Foundation. The views presented in this report are those of the National Research Council Committee on the Intellectual Property Rights in Genomic and Protein Research and Innovation and are not necessarily those of the funding agencies. International Standard Book Number 0-309-10067-4 (Book) International Standard Book Number 0-309-65523-4 (PDF) Library of Congress Control Number 2006921870 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. Copyright 2006 by the National Academy of Sciences. All rights reserved. Printed in the United States of America.

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Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, and 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. Ralph J. Cicerone 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. Wm. 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. Harvey V. Fineberg 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. Ralph J. Cicerone and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health COMMITTEE ON INTELLECTUAL PROPERTY RIGHTS IN GENOMIC AND PROTEIN RESEARCH AND INNOVATION SHIRLEY TILGHMAN (Co-Chair), President, Princeton University, Princeton, NJ RODERICK MCKELVIE (Co-Chair), Partner, Covington & Burling, Washington, DC ASHISH ARORA, Professor, H. John Heinz III School of Public Management, Carnegie Mellon University, Pittsburgh, PA HELEN M. BERMAN, Board of Governors Professor of Chemistry and Chemical Biology, Rutgers University, Piscataway, NJ JOYCE BRINTON, former Director, Office for Technology and Trademark Licensing, Harvard University, Cambridge, MA STEPHEN BURLEY, Chief Scientific Officer, SGX Pharmaceuticals, Inc., San Diego, CA Q. TODD DICKINSON, Vice President and Chief Intellectual Property Counsel, General Electric Co., Fairfield, CT ROCHELLE DREYFUSS, Pauline Newman Professor of Law, New York University School of Law, New York, NY REBECCA S. EISENBERG, Robert and Barbara Luciano Professor of Law, University of Michigan Law School, Ann Arbor, MI CHARLES HARTMAN,1 General Partner, CW Ventures, New York, NY DANIEL KEVLES, Stanley Woodward Professor of History, Yale University, New Haven, CT DAVID KORN, Senior Vice President, Biomedical and Health Sciences Research, Association of American Medical Colleges, Washington, DC GEORGE MILNE, JR., Partner, Radius Ventures, New York, NY RICHARD SCHELLER, Executive Vice President, Research, Genentech, Inc., San Francisco, CA ROCHELLE SEIDE, Partner, Arent Fox PLLC, New York, NY ROBERT WATERSTON, Professor and Gates Chair, Genome Sciences, University of Washington, Seattle, WA NANCY WEXLER, Higgins Professor Neuropsychology, College of Physicians and Surgeons of Columbia University and President, Hereditary Disease Foundation, New York, NY BRIAN WRIGHT, Professor of Agricultural and Resource Economics, University of California, Berkeley, Berkeley, CA 1   Deceased 2/22/05

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Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health Staff STEPHEN A. MERRILL, Study Director ANNE-MARIE MAZZA, Study Director KATHI E. HANNA, Consultant SARA DAVIDSON MADDOX, Editor LAURA SHEAHAN, Program Officer CRAIG SCHULTZ, Senior Research Associate (through August 2005) PATRICIA E. SANTOS, Program Associate (through August 2005) STACEY E. SPEER, Project Associate (through March 2005) ROBERT BERLIN, Christine Mirzayan Science and Technology Fellow (Summer 2005) KAREN BOYD, Christine Mirzayan Science and Technology Fellow (Winter 2005) SARAH ELSON, Christine Mirzayan Science and Technology Fellow (Summer 2005) MARA JEFFRESS, Christine Mirzayan Science and Technology Fellow (Winter 2005) PETER KOZEL, Christine Mirzayan Science and Technology Fellow (Winter 2004) SARA LIGHTBODY, Christine Mirzayan Science and Technology Fellow (Summer 2004) ANNA STAVLA, Christine Mirzayan Science and Technology Fellow (Fall 2004) ELENI ZIKA, Christine Mirzayan Science and Technology Fellow (Summer 2004)

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Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health BOARD ON SCIENCE, TECHNOLOGY, AND ECONOMIC POLICY DALE JORGENSON (NAS) (Chairman), Samuel W. Morris University Professor, Harvard University WILLIAM SPENCER (NAE) (Vice-Chairman), Chairman Emeritus, International SEMATECH M. KATHY BEHRENS, Managing Partner, RS Investments KENNETH FLAMM, Professor and Dean Rusk Chair in International Affairs, LBJ School of Public Affairs, University of Texas-Austin JAMES HECKMAN (NAS), Henry Schultz Distinguished Service Professor of Economics, University of Chicago DAVID MORGENTHALER, Founding Partner, Morgenthaler Ventures MARK B. MYERS, Visiting Executive Professor of Management, The Wharton School, University of Pennsylvania JOSEPH NEWHOUSE (IOM), John D. MacArthur Professor of Health Policy and Management, Director, Division of Health Policy Research and Education, Chair, Committee on Higher Degrees in Health Policy, Harvard University ROGER NOLL, Morris M. Doyle Centennial Professor of Economics, Director, Public Policy Program, Stanford University EDWARD E. PENHOET (IOM), President and Chief Program Officer, Gordon and Betty Moore Foundation WILLIAM RADUCHEL, Chairman and Chief Executive Officer, Ruckus Network JACK SCHULER, Chairman, Ventana Medical Systems, Inc. Staff STEPHEN A. MERRILL, Executive Director CRAIG SCHULTZ, Senior Research Associate (through August 2005)

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Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health COMMITTEE ON SCIENCE, TECHNOLOGY, AND LAW DONALD KENNEDY (NAS/IOM) (Co-Chair), Editor in Chief, Science, President Emeritus and Bing Professor of Environmental Science Emeritus, Stanford University RICHARD A. MERRILL (IOM), (Co-Chair), Daniel Caplin Professor of Law, University of Virginia Law School SHIRLEY S. ABRAHAMSON, Chief Justice, Wisconsin Supreme Court FREDERICK R. ANDERSON, JR., Partner, McKenna, Long & Aldridge LLP MARGARET A. BERGER, Suzanne J. and Norman Miles Professor of Law, Brooklyn Law School ARTHUR I. BIENENSTOCK, Vice Provost and Dean of Research and Graduate Policy, Stanford University PAUL D. CARRINGTON, Professor of Law, Duke University Law School JOE S. CECIL, Project Director, Program on Scientific and Technical Evidence, Division of Research, Federal Judicial Center JOEL E. COHEN (NAS), Abby Rockefeller Mauze Professor and Head, Laboratory of Populations, The Rockefeller University and Columbia University KENNETH W. DAM, Max Pam Professor Emeritus of American and Foreign Law and Senior Lecturer, University of Chicago Law School REBECCA S. EISENBERG, Robert and Barbara Luciano Professor of Law, University of Michigan Law School DAVID J. GALAS, Chancellor and Chief Scientific Officer, Norris Professor of Applied Life Sciences, Keck Graduate Institute of Applied Life Sciences DAVID L. GOODSTEIN, Vice Provost; Professor of Physics and Applied Physics; Frank J. Gilloon Distinguished Teaching and Service Professor, California Institute of Technology SHEILA S. JASANOFF, Pforzheimer Professor of Science and Public Policy Studies, John F. Kennedy School of Government, Harvard University DANIEL J. KEVLES, Stanley Woodward Professor of History, Yale University DAVID KORN (IOM), Senior Vice President for Biomedical and Health Sciences Research, Association of American Medical Colleges ROBERT A. LONERGAN, Vice President and General Counsel, Rohm and Haas PATRICK A. MALONE, Partner, Stein, Mitchell & Mezines RICHARD A. MESERVE (NAE), President, Carnegie Institution of Washington ALAN B. MORRISON, Senior Lecturer, Stanford Law School

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Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health THOMAS D. POLLARD (NAS/IOM), Eugene Higgins Professor, Department of Molecular, Cellular, and Developmental Biology, Yale University CHANNING R. ROBERTSON, Ruth G. and William K. Bowes Professor, Dean of Faculty and Academic Affairs, School of Engineering, Stanford University JONATHAN M. SAMET (IOM), Professor and Chairman, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health FERN M. SMITH, U.S. District Judge (retired), U.S. District Court for the Northern District of California JAMES GUSTAVE SPETH, Dean and Professor in the Practice of Environmental Policy and Sustainable Development, Yale School of Forestry and Environmental Studies SHEILA E. WIDNALL (NAE), Institute Professor, Massachusetts Institute of Technology Staff ANNE-MARIE MAZZA, Director ELIZABETH BRIGGS-HUTHNANCE, Senior Program Associate PATRICIA E. SANTOS, Program Associate (through August 2005) STACY SPEER, Program Associate (through March 2005)

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Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health Preface and Acknowledgments The free exchange and open dissemination of scientific information and the pursuit of basic scientific research has led to remarkable advances in our understanding of biology. This scientific progress, coupled with the protections and information dissemination possibilities offered by a vigorous patent system, has resulted in the development of numerous products—with many more on the horizon—that can be used to diagnose, treat, and cure a variety of diseases. Avoiding a conflict between open dissemination and access to scientific discoveries and the protection of inventors’ rights is critical to furthering scientific progress and enhancing human health. It also is critical that as science evolves, we stop to assess whether the appropriate mechanisms to prevent such a conflict remain in place. This report is just such an assessment—a marker in time that looks at the state of genomic and proteomic research and the current policies and practices promoting or restricting the dissemination of scientific information, tools, and products, and asks, “are there any storms over the horizon?” The original survey data collected for this report, although arguably the best data currently available to address some of the committee’s questions, necessarily reflect a limited snapshot of the current situation. This survey produced some important findings, which the committee took into account in deliberating on its recommendations. Yet in light of a modest response rate and other limitations inherent in survey research, the committee also drew from many other sources of information in addition to its own research, including the presentations of many speakers at its public meetings and workshops, interviews conducted with academic and industry representatives, and informal discussions with colleagues at its members’ own institutions. The report focuses more deliberately on genomics

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Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health because it has a longer scientific and intellectual property history, while proteomics is still in a nascent stage, with patenting activities just gearing up. Based on these many sources of information, the committee offers recommendations intended to foster scientific advances, maintain a strong patent system, and create an environment in which significant contributions can be made to scientific progress and human health. The committee calls on scientists in all sectors to incorporate the norms espoused in this report and urges those who interpret and enforce the patent system to be mindful of the evolving nature of science and the ways in which it continues to challenge our assumptions. The committee gratefully acknowledges the contributions of the following individuals who provided invaluable information and other assistance. Affiliations are at the time of participation in the study: Elena Armandola, European Patent Office; Robert Armitage, Eli Lilly and Company; Alan Bennett, University of California, Davis; Jeremy Berg, National Institutes of Health; David Beyer, Amgen; Sara Boettiger, University of California, Berkley; Charles Caruso, Merck & Co., Inc; Scott Chambers, Patton Boggs LLP; Charlene Cho, University of Chicago; Iain Cockburn, Boston University; Wesley Cohen, Duke University; Francis Collins, National Human Genome Research Institute; Robert Cook-Deegan, Duke University; Kenneth Dam, University of Chicago Law School; Dennis Drayna, National Institutes of Health; Anthony Delcampo, Dana-Farber Cancer Institute; Susan Ehringhaus, Association for American Medical Colleges; George Elliott, U.S. Patent and Trademark Office; Lila Feisse, BIO; Joanna Groden, University of Cincinnati; Corey Goodman, Renovis; Stephen Hansen, American Association for the Advancement of Science; Udo Heinemann, Max Delbrueck Centrum fur Molekulare Medizin; Brian Hicks, Brigham and Women’s Hospital; Stephen Hilgartner, Cornell University; Hans-Rainer Jaenichen, Vossius & Partner; Ester Kepplinger, U.S. Patent and Trademark Office; Hiroki Kitamura, Japanese Patent Office; Robert Kneller, University of Tokyo; Katharine Ku, Stanford University; Stephen Kunin, Oblon & Spivak; Jeffrey Kushan, Sidly, Austin, Brown & Wood LLP; Waldemar Kutt, DG Research, European Commission; Debra Leonard, Weill Medical College of Cornell University; Tim Leshan, National Human Genome Research Institute; Gert Matthijs, Center for Human Genetics; Jon Mertz, University of Pennsylvania; Arie Michelsohn, Finnegan, Henderson, Farabow, Garrett & Dunner; Sadao Nagaoka, Hitotsubashi University; Pauline Newman, U.S. Court of Appeals for the Federal Circuit; John Norvell, National Institute of General Medical Sciences; Frank Orlaudella, Agilent; Marvin Parnes, University of Michigan; Lori Pressman, Consultant; Richard Rodriquez, National Institutes of Health; Mark Rohrbaugh, National Institutes of Health; Tony Rollins, Merck & Co., Inc; Bill Rusconi, Myriad Genetic Laboratories; Christina Sampogna, Organization for Economic Cooperation and Development; Mark Sobel, Association for Molecular Pathology; Jon Soderstrom, Yale University; Melissa Soucy, Georgetown University; Avron Spier, Allon Therapeutics, Inc.; Ashley

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Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health Stevens, Boston University; Edwin Stone, University of Iowa; John Sulston, Wellcome Trust Sanger Institute; Koichi Sumikura, National Graduate Institute for Policy Studies (Japan); Lawrence Sung, University of Maryland; Akiteru Tamura, Japanese Patent Office; Fred Telling, Pfizer; Sandy Thomas, Nuffield Bioethics Council; Sara Vinarov, Quarles & Brady LLP; Shawna Vogel, Massachusetts Institute of Technology; John Walsh, University of Illinois, Chicago; LeRoy Walters, Georgetown University; and Robert Wells, Affymetrix. This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Academies’ Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the process. We wish to thank the following individuals for their review of this report: Robert Armitage, Eli Lilly and Company; Wendy Baldwin, University of Kentucky; Fred Cohen, University of California, San Francisco; Robert Cook-Deegan, Duke University; Deborah Delmer, Rockefeller Foundation; Anthony Ford-Hutchinson, Merck Research Laboratories; Steven Holtzman, Infinity Pharmaceuticals, Inc.; Stephen Kunin, Oblon & Spivak; Lonnie Ingram, University of Florida; Joshua LaBaer, Harvard University; Gilbert Omenn, University of Michigan; Arti Rai, Duke University; James Severson, University of Washington; Sandy Thomas, Nuffield Council on Bioethics; Marie Thursby, Georgia Tech; Phillip Sharp, Massachusetts Institute of Technology; Leroy Walters, Georgetown University; Charles Wilson, Consultant; and Barbara Zehnbauer, Washington University in St. Louis. Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations, nor did they see the final draft of the report before its release. The review of this report was overseen by John Bailar, University of Chicago, and Kenneth Dam, University of Chicago. Appointed by the National Academies, they were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution. We are indebted to the input of the entire committee and thank each member for his or her willingness to wrestle with these complex issues and to put forth what the committee agrees is the best public policy for genomic and proteomic research. We also wish to thank staff and consultants—Stephen Merrill, Anne-Marie Mazza, Kathi Hanna, Craig Schultz, Sara Davidson Maddox, Stacey Speer, Patricia Santos, and a succession of participants in the National Research Council’s Christine Mirzayan Science and Technology Policy Fellowship Pro-

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Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health gram—for their assistance and dedication. We are also indebted to Tim Leshan, Senior Policy Analayst, National Human Genome Research Institute, for his extremely effective liaison between the committee and all of the interested parties at NIH, and to the Rockefeller Foundation’s Bellagio Center for providing an ideal venue in which to explore similarities and differences in approaches to these issues with European and Japanese colleagues. We thank John Walsh and Charlene Cho, University of Illinois, Chicago, and Wesley Cohen, Duke University, for developing and conducting the survey of research scientists that added much to our understanding of intellectual property from the perspective of the biomedical research bench. Finally, we wish to acknowledge one committee member in particular, Charles (Chuck) Hartman. Chuck died suddenly on February 22, 2005, and did not see the final report, although his contributions throughout the committee deliberations helped shape its outcome in innumerable ways. We hope in some way that the report reflects his graciousness, thoughtfulness, and commitment to sound public policy. Shirley Tilghman and Roderick McKelvie

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Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health Contents     SUMMARY   1 1   INTRODUCTION   19      The Push to Patent,   21      Science and Commerce,   24      Patent Issues,   26      Secrecy versus Openness,   27      The Illusory Experimental Use Exemption,   28      Charge to the Committee,   29      Organization of the Report,   31 2   GENOMICS, PROTEOMICS, AND THE CHANGING RESEARCH ENVIRONMENT   32      The Importance of DNA Sequence,   33      The Human Genome Project,   34      Human Genetic Variation,   36      What are Genomics and Proteomics?,   38      The Importance of Protein Structure,   41      Changing Scientific and Clinical Paradigms,   42      Intellectual Property and Commercialization,   43      Scientific Norms and Evolving Science Policies,   49      Summary,   69

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Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health 3   THE U.S. PATENT SYSTEM, BIOTECHNOLOGY AND THE COURTS   70      Fields of Activity,   70      Applicable Law,   75      Conclusions,   99 4   TRENDS IN THE PATENTING AND LICENSING OF GENOMIC AND PROTEIN INVENTIONS AND THEIR IMPACT ON BIOMEDICAL RESEARCH   100      Trends in Patenting Genomic and Protein Inventions,   101      Trends in University Licensing of Genomic and Proteomic Inventions,   116      Effects of Intellectual Property Practices on Research,   119      Sharing Research Materials,   128      Conclusion,   132 5   CONCLUSIONS AND RECOMMENDATIONS   133      Overall Conclusions,   134      Best Practices and Norms for the Scientific Community and Federal Research Sponsors,   135      Adapting the Patent System to the Developing Fields of Genomics and Proteomics,   140      Facilitate Research Access to Patented Inventions Through Licensing and Shielding from Liability for Infringement,   144     REFERENCES         APPENDIXES         A  Biographical Information of Committee and Staff   157     B  Search Algorithms Used to Identify Patents of Interest   169

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Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health List of Boxes, Figures, and Tables BOXES A   Patenting the Oncomouse,   23 B   Birth of the Biotechnology Industry,   47 C   Summary of Principles of the International Strategy Meeting on Human Genome Sequencing,   57 FIGURES 4-1   Number of DNA-based U.S. patents (as of June 30, 2005),   103 4-2   Thirty entities holding the largest number of DNA-based U.S. patents (as of June 30, 2005),   104 4-3   DNA patent trends, 1995-2004,   107 4-4   Protein structure patent trends, 1995-2004,   108 4-5   Protein-protein interactions patent trends, 1995-2004,   108 4-6   Research tools patent trends, 1995-2004,   109 4-7   Molecular pathway patent trends, 1995-2004,   109 4-8   Patent class 536/23.1 (DNA/RNA fragments) application pendency by quarter, 1997-2002,   112 4-9   DNA patents: inventor and assignee country, 1995-2004,   113 4-10   Protein patents: inventor and assignee country, 1995-2004,   113 4-11   Research tools patents: inventor and assignee country, 1995-2004,   114 4-12   Molecular pathway patents: inventor and assignee country, 1995-2004,   114 4-13   Patterns of university licensing of DNA inventions by company type,   118

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Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health TABLES 4-1   Issued U.S. and European patents and patent applications in selected categories of biotechnology inventions, 1995-2005,   106 4-2   Principal assignees of patents by category,   115 4-3   Reasons for not pursuing projects, by research goal and pathway,   124 4-4   Sharing of research materials, by consumer sector and supplier sector,   129 4-5   Average number of adverse effects from not receiving research inputs, academic respondents by research goal and for pathways and industry respondents,   130