Published Intellectual Property Rights Associated with Plants

Transcription

1 Published 1989 Intellectual Property Rights Associated with Plants

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3 Intellectual Property Rights Associated with Plants Section I. Policy Issues Relating to Proprietary Rights Editors B. E. Caldwell and J. A. Schillinger Section II. An Evaluation of the Issues, Challenges, and Opportunities Related to Plant Patenting Editors J. H. Barton, C. O. Qualset, D. N. Duvick, and R. F Barnes Steering Committee C. O. Qualset and D. N. Duvick, cochairs R. F Barnes, J. H. Barton, R. L. Lower, R. K. Perrin, L. J. Raines, H. L. Shands, H. Silverstein, and S. B. Williams, Jr. P. J. Fitzgerald, ex officio Editor-In-Chief CSSA Editor-In-Chief ASA Editor-In-Chief SSSA C. W. Stuber G. H. Heichel D. E. Kissel Managing Editor s. H. Mickelson Associate Editor-at-Large Annette J. Tallard ASA Special Publication Number 52 Crop Science Society of America, Inc. American Society of Agronomy, Inc. Soil Science Society of America, Inc. Madison, Wisconsin, USA. 1989

4 Cover Design: Patricia Jeffson Crop Science Society of America, Inc. American Society of Agronomy, Inc. Soil Science Society of America, Inc. 677 South Segoe Road, Madison, WI 53711, USA Copyright 1989 by the Crop Science Society of America, Inc. American Society of Agronomy, Inc. Soil Science Society of America, Inc. ALL RIGHTS RESERVED UNDER THE U.S. COPYRIGHT LAW OF 1978 (P.L ) Any and all uses beyond the limitations of the "fair use" provision of the law require written permission from the publisher(s) and/or the author(s); not applicable to contributions prepared by officers or employees of the U.S. Government as part of their official duties. Second Printing 1991 Library of Congress Cataloging-in-Publication Data Intellectual property rights associated with plants. (ASA special publication; no. 52) Comprised in part of papers presented at a workshop held Jan. 31-Feb. 3, 1989, in Anaheim, Calif. 1. Plants, Cultivated-United States-Varieties-Patents Congresses. I. Caldwell, B. E. (Billy E.) II. Crop Science Society of America. III. Series. SI.A453 no s [ ] [KF3133.P53] 630 s [ ] ISBN Printed in the United States of America. iv

5 CONTENTS Foreword Contributors... vii ix Section I. Policy Issues Relating to Proprietary Rights Preface Overview and Status of Plant Proprietary Rights, Robert J. Jondle... 2 The Seed Trade's View on Proprietary Rights, William T. Schapaugh... 3 Bioethics-Impact of Proprietary Rights on Public Research Goals, A. David Kline A Congressional View on Proprietary Rights, William A. Stiles, Jr Specific Issues on Proprietary Rights, William H. Tallent Intellectual Property Rights-Industry/University Agreements, Victor L. Lechtenberg... 7 Proprietary Rights-Private Industry, Roger A. Kleese Section II. An Evaluation of the Issues, Challenges, and Opportunities Related to Plant Patenting Preface Part A. Background on Biological and Statutory Bases of Intellectual Property Rights Related to Plants Plant Breeding, Crop Cultivars, and the Nature of Genetic Variability, Fredrick A. Bliss Intellectual Property Protection and Plants, Sidney B. Williams, Jr. and Kenneth A. Weber Patenting Genes that Encode Agriculturally Important Traits, Stephen A. Bent Protecting Plant Germplasm: Alternatives to Patent and Plant Variety Protection, Jeffrey L. Ihnen and Robert J. Jondle Issues and Challenges in the Administration of the Patent Law with Regard to Plants by the Patent and Trademark Office, Charles F. Warren Issues and Challenges in the Administration of the Plant Variety Protection Act, Kenneth H. Evans and Eldon E. Taylor v

6 Part B. Plant Patenting Workshop Report 1 An Evaluation of the Issues, Challenges, and Opportunities Related to Plant Patenting, Executive Summary Workshop Rationale Implications of Plant Patenting for Science, Technology, and Agriculture, Orville G. Bentley Workshop Summary Report Appendix 1 Workshop Program: An Evaluation of the Issues, Challenges, and Opportunities Related to Plant Patenting Appendix 2 List of Participants Appendix 3 Work Group Organization Appendix 4 Proposed Educational Program on Intellectual Property Rights for Plants vi

7 FOREWORD Plant varieties (cultivars, see Editor's note) have been patentable in the USA since the Plant Patent Act of 1930, which allowed patenting of asexually propagated varieties. Since 1970, sexually propagated varieties could be protected under the Plant Variety Protection Act. Processes in plant breeding have been protected under utility patents for many years, but it was not until the modern era of biotechnology that organisms-including microorganisms, plants, and animals-could be protected by utility patents. Landmark decisions include the U.S. Supreme Court case (1980) Diamond v. Chakrabarty and the U.S. Patent and Trademark Office (1985) action Ex Parte Hibberd, which permitted patents on organisms, traits, and genes. Understandably, these recent developments and the explosion in technology to manipulate genes by molecular means have raised a number of questions about the interpretation and application of the U.S. Code dealing with patents, including the Plant Variety Protection Act of The environment for research and development (R & D) in crop improvement is changing rapidly, both in public and private sectors. In the public sector, plant breeding continues but with a dramatic shift in staffing to reflect development and adoption of new technologies-molecular plant breeding is a near-reality. At the same time, the dynamics of private sector R&D encourage infusion of venture capital into biotechnology and various degrees of concentration and vertical integration in the seed development and marketing industry. Public-private relationships also are evolving, from the traditionally free distribution of public germplasm to the private sector, to more restricted releases, including licensing agreements. Public institutions are exploring opportunities to recover costs of R&D and to generate income for student training through patenting of processes, plant genes and gene systems, and varieties. All of these factors, and more, have caused a great deal of uncertainty and uneasiness among scientists, research managers, public and private variety development organizations, farmers, and consumers. The Crop Science Society of America (CSSA) provided a forum for discussion and debate of plant breeders' rights in 1963 [A.A. Hanson and M.G. Weiss (ed.) Plant breeders' rights. ASA Spec. Publ. 3. ASA, CSSA, Madison, WI] and variety protection in 1968 [R.V. Frakes (program chair) Variety protection by plant patents and other means. CSSA Technical Series 1. CSSA, Madison, WI] as these topics became important to developers of crop varieties. The CSSA continued this dialogue at its annual meeting in 1988, results of which are published in the first section ofthis special publication. During that symposium, it became clear that additional review and discussion was needed to clarify existing policy and practice of proprietary protection as it exists in the USA and how it may impact upon public and private plant breeding, international trade, the sharing of genetic resources, and the public good. vii

8 The CSSA was joined by its sister societies, the American Society of Agronomy and the Soil Science Society of America as well as the American Agricultural Economics Association and the American Society for Horticultural Science in sponsoring an evaluation workshop 31 Jan. to 3 Feb The workshop was supported in part by a grant from the USDA. The second section of this special publication is devoted to invited papers presented during the workshop on the biological bases for crop variety development and the legal bases for the various options for proprietary protection of plants and the Workshop Report. Weare pleased with the great interest in the whole field of intellectual property rights, and hope that this publication will stimulate further developments in legal and practical aspects of proprietary protection of plants. Especially needed is an expanded educational effort. To that end we are confident that the papers included in this special publication will be widely used. We thank the authors and editors for their efforts in producing this publication. Calvin O. Qualset, president Crop Science Society of America Edward C. A. Runge, president American Society of Agronomy John J. Mortvedt, president Soil Science Society of America Editor's note: The terms variety and cultivar are considered to be synonymous; which term used depends on an authors' preference, and in some instances, on legal requirements. viii

9 CONTRIBUTORS Stephen A. Bent Fredrick A. Bliss Kenneth H. Evans Partner, Foley & Lardner, Schwartz, Jeffery, Schwaab, Mack, Blumenthal & Evans, Alexandria, VA Department of Pomology, University of California, Davis, CA Plant Variety Protection Commissioner, Plant Variety Protection Office, USDA, Beltsville, MD Jeffrey L. Ihnen Robbins & Laramie, Washington, DC Robert J. Jondle Bioscience Advisor, Robbins & Laramie, Washington, DC Roger A. Kleese Formerly, Vice President, Plant Research and Development, Molecular Genetics, Inc. Currently, President, Plant Science Research, Inc., Minnetonka, MN A. David Kline Professor and Chair, Department of Philosophy, Iowa State University, Ames, IA Victor L. Lechtenberg William T. Schapaugh William A. Stiles, Jr. Associate Director, Agricultural Experiment Station, Purdue University, West Lafayette, IN Executive Vice President, American Seed Trade Association, Washington, DC Staff Director, House Agriculture Committee, Subcommittee on Department Operations, Research, and Foreign Agriculture, Washington, DC William H. Tallent Assistant Administrator, USDA-ARS, Washington, DC Eldon E. Taylor Charles F. Warren Plant Variety Senior Examiner, Plant Variety Protection Office, USDA, Beltsville, MD Supervisory Patent Examiner, Examining Group 180, Biotechnology, U.S. Patent and Trademark Office, Washington, DC Kenneth A. Weber Townsend and Townsend, San Francisco, CA Sidney B. Williams, Jr. Associate Patent Counsel, The UpJohn Company, Patents and Trademarks, Kalamazoo, MI ix