New Developments in Biotechnology: Patenting LifeÑSpecial ...

[Pages:36]New Developments in Biotechnology: Patenting Life--Special Report April 1989

NTIS order #PB89-196612

Recommended Citation: U.S. Congress, Office of Technology Assessment, New Developments in Biotechnology: Patenting Life--Special Report, OTA-BA-370 (Washington, DC: U.S. Government Printing Office, April 1989).

Library of Congress Catalog Card Number 88-600596

For sale by the Superintendent of Documents U.S. Government Printing Office, Washington, DC 20402-9325

(order form can be found in the back of this report.)

Foreword

Since the discovery of recombinant DNA technology in the early 1970s, biotechnology has become an essential tool for many researchers and industries. The potential of biotechnology has spurred the creative genius of inventors seeking to improve the Nation's health, food supply, and environment. In 1980, the Supreme Court ruled that a living micro-organism could be patented. Subsequently, the U.S. Patent and Trademark Office held that certain types of plant and animal life constituted patentable subject matter.

This special report is the fifth in a series of OTA studies being carried out under an assessment of "New Developments in Biotechnology," requested by the House Committee on Energy and Commerce and the House Committee on Science, Space, and Technology. This report reviews U.S. patent law as it relates to the patentability of micro-organisms, cells, plants, and animals; as well as specific areas of concern, including deposit requirements and international considerations. The report includes a range of options for congressional action related to the patenting of animals, intellectual property protection for plants, and enablement of patents involving biological material.

The first publication in OTA's assessment of "New Developments in Biotechnology" was Ownership of Human Tissues and Cells, the second was Public Perceptions of Biotechnology, the third was Field-Testing Engineered Organisms, and the fourth was U.S. Investment in Biotechnology. OTA was assisted in preparing this study by a panel of advisors, a workshop group, and reviewers selected for their expertise and diverse points of view on the issues covered by the assessment. OTA gratefully acknowledges the contribution of each of these individuals. As with all OTA reports, responsibility for the content of the special report is OTA's alone. The special report does not necessarily constitute the consensus or endorsement of the advisory panel, the workshop group, or the Technology Assessment Board.

u JOHN H. GIBBONS Director

New Developments in Biotechnology Advisory Panel

Bernadine P. Healy, Panel Chair The Cleveland Clinic Foundation

Cleveland, OH

Timothy B. Atkeson Steptoe & Johnson Washington, DC

David Blumenthal Brigham and Women's Hospital Corp. Cambridge, MA

Hon. Edmund G. Brown, Jr. Reavis & McGrath Los Angeles, CA

Nancy L. Buc Weil, Gotshal & Manges Washington, DC

Mark F. Cantley Concertation Unit for Biotechnology

in Europe Brussels, Belgium

Alexander M. Capron University of Southern California Los Angeles, CA

Jerry D. Caulder Mycogen Corp. San Diego, CA

Lawrence I. Gilbert University of North Carolina Chapel Hill, NC

Conrad A. Istock The University of Arizona Tucson, AZ

Edward L. Korwek Hogan & Hartson Washington, DC

Sheldon Krimsky Tufts University Medford, MA

Joshua Lederberg The Rockefeller University New York, NY

William E. Marshall Pioneer Hi-Bred International, Inc. Johnston, IA

Ronald L. Meeusen Sandoz Crop Protection Corp. Palo Alto, CA

Robert B. Nicholas McDermott, Will & Emery Washington, DC

Eric J. Stanbridge University of California, Irvine Irvine, CA

James M. Tiedje Michigan State University East Lansing, MI

Kunio Toriyama Nat. Fed. of Agri. Coop. Assn. of Japan Tokyo, Japan

Pablo D.T. Valenzuela Chiron Corp. Emery vine, CA

Thomas E. Wagner Ohio University Athens, OH

Richard Krasnow Institute for International Education Washington, DC

NOTE: OTA is grateful for the valuable assistance and thoughtful critiques provided by the Advisory Panel members. The views expressed in this OTA report, however, are the sole responsibility of the Office of Technology Assessment.

iv

OTA Project Staff New Developments in Biotechnology: Patenting Life

Roger C. Herdman, Assistant Director, OTA Health and Life Sciences Division

Gretchen S. Kolsrud, Biological Applications Program Manager

Gary B. Ellis, Project Director

Kevin W. O'Connor, Study Director and Legal Analyst

Robyn Y. Nishimi, Analyst Luther Val Giddings, Analyst1 Blake M. Cornish, Research Analyst2

Editor Bart Brown, Baltimore, MD

Support Staff Sharon Kay Oatman, Administrative Assistant Lori B. Idian, Secretary/Word Processing Specialism

Contractors American Type Culture Collection, Rockville, MD Baruch A. Brody, Baylor College of Medicine, Houston TX

John Kinsman, La Valle, WI William H. Lesser, Cornell University, Ithaca, NY

David J. Maki, Seed & Berry, Seattle, WA R.J. Patterson& Associates, Inc., Research Triangle Park, NC

Robbins & Laramie, Washington, DC Bernard E. Rollin, Colorado State University, Fort Collins, CO

Sandra R. Segal, Washington, DC Jane Stein, Washington, DC

Acknowledgment to Other OTA Staff Michael J. Phillips, Senior Associate, Food and Renewable Resources Program

Gladys B. White, Analyst, Biological Applications Program IT~()@ January 1989.

2Though May 1988.

Contents

Chapter

l. Summary, Policy Issues, and Options for Congressional Action . . . . . . . . . . . . . . . . . . . . . . 3 2. Introduction and Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 3. Intellectual Property . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ......................00.. 37 4. Patenting of Micro-Organisms and Cells ...... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 5. Intellectual Property and Plants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 6. Patenting of Animals-Scientific and Regulatory Considerations . . . . . . . . . . . . . . . . . . . . . 93 7. Patenting of Animals--Economic Considerations . . . . . . . . . . . . . . . . . . . . .. .. ... ... ... ..115 8. Patenting of Animals-Ethical Considerations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ....127 9. Deposit Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141 10. International Protection for Micro-Organisms, Plants, and Animals . ..................155

Appendix

A. Selected Sections, 35 United States Code, Patents . . . . . . . . . . . ........................169 B. Patents: Questions and Answers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ................172 C. Proposed Rules on Deposit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ....................174 D. Participants, OTA Workshop on Federal Regulation and Animal Patents . . . . . . . . . . ....178 E. List of Contractor Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..................179 F. Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...,..,........180 G. List of Acronyms and Glossary of Terms, . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ............183 Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ....191

vi

Chapter 1

Summary, Policy Issues, and Options for Congressional Action

"Last month the government granted its first patent on something that can look you in the eye. Is this small step for a mouse a giant leap backward or forward for mankind?"

The New Republic, May 23, 1988.

CONTENTS

Page

INTELLECTUAL PROPERTY. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Patents . . . . . . . . . . . . .. . . . . . . . . . . . ........0 . . . . . . . . . . . . . . . . 0 . . . . . . . . . . . . . . . . . . . . .4 Copyrights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Trademarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Trade Secrets. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Plant Variety Protection . . . . . . . . . .. .. .. .. .. .. .. .. .. .. ... ... ... ..$.. . . . . . . . . . . . . . . 7

PATENTING OF MICRO-ORGANISMS AND CELLS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 The Chakrabarty Case.... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Post-Chakrabarty Events and Trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

INTELLECTUAL PROPERTY PROTECTION AND PLANTS . . . . . . . . . . . . . . . . . . . . . . 9 Plant Patent Act of 1930.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Plant Variety Protection Act of 1970. . . . . . . . . . . . . . . . . . .. .. .. . .. .. .. .. . . . . . . . . . 10

Utility Patents for Plants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ..... 11

Comparison of Different Forms of Plant Intellectual Property Protection . . . . . . . . . . . . . 11 PATENTING OF ANIMALS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Producing Transgenic Animals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ........ 12 Species Barriers and Species Integrity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Federal Regulation and Animal Patents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Economic Considerations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Ethical Considerations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..+ 17 DEPOSIT Considerations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

INTERNATIONAL PROTECTION FOR MICRO-ORGANISMS, PLANTS, AND ANIMALS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

International Agreements and Laws of Other Countries . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 POLICY ISSUES AND OPTIONS FOR CONGRESSIONAL ACTION . . . . . . . . . . . . . . . 22

Box

Box

Page

l-A. Patenting of Animals: Nine Applications for European Patents. . . . . . . . . . . . . . . . . . . 23

Figures

Figure

Page

l-1. Patents Issues in Biotechnology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...... . . . . . . . . . . . 3

l-2. Figures, Mousetrap and Mouse Patents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Tables

Table

Page

l-l. Comparison, Utility Patents and Plant Patents . . . . . . ............... . . . . . . . . . . . . . 12

l-2. Comparison, Utility Patents and Plant Variety Protection Certificates. . . . . . . . . . . . . . 12

l-3. Advantages of Mice for Research in Gene Transplantation. . . . . . . . . . . . . . . . . . . . . . . 14

l-4. Arguments For and Against Patenting Transgenic Animals. . . . . . . . . . . . . . . . . . . . . . . 18

l-5. Fees, Deposit for Patent Purposes.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

l-6. International Agreements and Biotechnology Patents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

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