A PATENT SYSTEM FOR THE 21ST CENTURY

Stephen A. Merrill, Richard C. Levin, and Mark B. Myers, Editors

Committee on Intellectual Property Rights in the Knowledge-Based Economy

Board on Science, Technology, and Economic Policy

Policy and Global Affairs Division

NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES

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



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A Patent System for the 21st Century A PATENT SYSTEM FOR THE 21ST CENTURY Stephen A. Merrill, Richard C. Levin, and Mark B. Myers, Editors Committee on Intellectual Property Rights in the Knowledge-Based Economy Board on Science, Technology, and Economic Policy Policy and Global Affairs Division NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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A Patent System for the 21st Century 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. NASW-99037, Task Order 103, between the National Academy of Sciences and the National Aeronautics and Space Administration, and by the U.S. Department of Commerce, Andrew W. Mellon Foundation, Center for the Public Domain, Pharmacia Corporation, Merck & Company, Procter & Gamble, and IBM. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the views of the organizations or agencies that provided support for the project. International Standard Book Number 0-309-08910-7 (Book) International Standard Book Number 0-309-50610-7 (PDF) Library of Congress Control Number TK Limited copies are available from: Board on Science, Technology, and Economic Policy National Research Council 500 Fifth Street, N.W. Washington, DC 20001 Phone: 202-334-2200 Fax: 202-334-1505 Additional copies of this report are available from 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 2004 by the National Academy of Sciences. All rights reserved. Printed in the United States of America Companion volume: Patents in the Knowledge-Based Economy, edited by Wesley M. Cohen and Stephen A. Merrill, studies patent quality, litigation, and patenting and licensing in biotechnology, software, and the business methods. The cover design incorporates original illustration from the following U.S. patents issued over a nearly 160-year period: U.S. Patent 6,506,554; Core structure of gp41 from the HIV envelope glycoprotein; Chan, David C. (Brookline, MA); Fass, Deborah (Cambridge, MA); Lu, Min (New York, NY); Berger, James M., (Cambridge, MA); Kim, Peter S. (Lexington, MA); Granted January 14, 2003. U.S. Patent 6,423,583; Methodology for electrically induced selective breakdown of nanotubes; Avouris, Phaedon (Yorktown Heights, NY); Collins, Philip G. (Ossining, NY); Martel, Richard (Peekskill, NY); Granted July 23, 2003. U.S. Patent 6,313,562; Microelectromechanical ratcheting apparatus; Barnes, Stephen M. (Albuquerque, NM); Miller, Samuel L. (Albuquerque, NM); Jensen, Brian D. (Albuquerque, NM); Rodgers, M. Steven (Albuquerque, NM); Burg, Michael S., (Albuquerque, NM); Granted November 6, 2001. U.S. Patent 821,393; Flying machine; Wright, Orville (Dayton, OH) and Wright, Wilbur (Dayton, OH); Granted May 22, 1906. U.S. Patent 223,898; Electric lamp; Edison, Thomas A. (Menlo Park, NJ); Granted January 27, 1880. U.S. Patent 4750; Improvement in sewing machines; Howe, Jr., Elias, (Cambridge, MA); Granted September 10, 1846.

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A Patent System for the 21st Century 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. Bruce M. 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. 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. Bruce M. Alberts and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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A Patent System for the 21st Century Committee on Intellectual Property Rights in the Knowledge-Based Economy Board on Science, Technology, and Economic Policy Richard C. Levin, Co-chair President Yale University Mark B. Myers, Co-chair Visiting Executive Professor of Management The Wharton School University of Pennsylvania John H. Barton George E. Osborne Professor of Law Emeritus Stanford University Law School Robert Blackburn Vice President and Chief Patent Counsel Chiron Corporation and Distinguished Scholar Berkeley Center for Law and Technology Wesley Cohen Professor of Economics and Management Fuqua School of Business Duke University Frank Collins Senior Vice President for Research ZymoGenetics Rochelle Cooper Dreyfuss Pauline Newman Professor of Law New York University School of Law Bronwyn H. Hall Professor of Economics University of California, Berkeley Eugene Lynch Judge (ret.) U.S. District Court for the Northern District of California Daniel P. McCurdy President & CEO ThinkFire, Ltd. Gerald J. Mossinghoff Senior Counsel Oblon, Spivak, McClelland, Maier & Neustadt, P.C. (until December 2003) Gail K. Naughton Dean, School of Business San Diego State University Richard R. Nelson George Blumenthal Professor of International and Public Affairs Columbia University

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A Patent System for the 21st Century James Pooley Partner Milbank, Tweed, Hadley & McCloy LLP William J. Raduchel Great Falls, Virginia Pamela Samuelson Chancellor’s Professor of Law and Information Management and Director, Berkeley Center for Law and Technology University of California, Berkeley Liaisons with Other NRC Programs Science, Technology and Law Program David Korn Senior Vice President for Biomedical and Health Sciences Research Association of American Medical Colleges National Cancer Policy Board Pilar Ossorio Assistant Professor of Law and Medical Affairs University of Wisconsin Law School Staff Stephen A. Merrill Project Director Craig Schultz Research Associate Camille Collett Project Associate (until September 2002) George Elliott U.S. Department of Commerce Science and Technology Fellow (from September 2000 through September 2001) Russell Moy Senior Program Officer (from June 2002) Aaron Levine NRC Intern (Summer 2003) Peter Kozel NRC Intern (Winter-Spring 2004)

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A Patent System for the 21st Century Board on Science, Technology, and Economic Policy Dale Jorgenson, Chair Samuel W. Morris University Professor Harvard University Bill Spencer, Vice Chair Chairman Emeritus International SEMATECH M. Kathy Behrens Managing Director for Medical Technology RS Investments Kenneth Flamm Professor and Dean Rusk Chair in International Affairs LBJ School of Public Affairs University of Texas-Austin Bronwyn H. Hall Professor of Economics University of California, Berkeley James Heckman Henry Schultz Distinguished Service Professor of Economics University of Chicago Richard C. Levin President Yale University David Morgenthaler Founding Partner Morgenthaler Ventures Mark B. Myers Visiting Executive Professor of Management The Wharton School University of Pennsylvania Roger Noll Morris M. Doyle Centennial Professor of Economics Director, Public Policy Program Stanford University Edward E. Penhoet Director, Science and Higher Education Programs Gordon and Betty Moore Foundation William J. Raduchel Great Falls, Virginia Jack Schuler Chairman of the Board of Directors Ventana Medical Systems, Inc. Alan Wm. Wolff Managing Partner Dewey Ballantine

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A Patent System for the 21st Century Staff Stephen A. Merrill Executive Director Charles Wessner Deputy Director Russell Moy Senior Program Officer Sujai Shivakumar Program Officer Craig Schultz Research Associate McAlister Clabaugh Program Associate David Dierksheide Program Associate Amy Przybocki Financial Associate

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A Patent System for the 21st Century Acknowledgments Our committee’s study of the patent system was a much more ambitious undertaking than we anticipated at its outset, and we have many people to thank for their contributions to its completion. First, through eight meetings, two conferences, numerous report drafts, and preparation of the response to reviewers’ comments, the members of the committee not only provided thoughtful individual contributions but also successfully bridged differences in professional training and experience to reach a common understanding and consensus recommendations. One committee member, Gerald Mossinghoff, resigned on December 1, 2003, as this report was being revised before submission to the National Research Council review process. He played a very active and constructive role in the deliberations of the committee and provided comments on a preliminary report draft. We regret not having the benefit of his advice in the final stage of writing. More than 150 people assisted the committee’s deliberations in a variety of ways—conducting and reporting on research, speaking at conferences, presenting views at open meetings of the committee, and providing other valuable information through communications with staff. Their contributions were indispensable to the committee’s work, and they are listed in Appendix B of the report. Although self-initiated, the study as a whole or activities within it have attracted diverse support from government agencies, foundations, and corporations. The National Aeronautics and Space Administration sponsored the project as part of its program support of the Board on Science, Technology, and Economic Policy (STEP) from 1999 to 2003. The Andrew W. Mellon Foundation was principal sponsor of the conference Intellectual Property Rights: How Far Should They Be Extended? as well as of the commissioned research activities that followed it. A supplemental Mellon contribution will help to support dis-

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A Patent System for the 21st Century semination of the results of the project. A grant from the Center for the Public Domain enabled the project to develop a web site dedicated to intellectual property issues across the National Academies and supported other activities. The web site (http://ip.nationalacademies.org) has been an indispensable part of our efforts to keep the community of interested people informed of our progress and an avenue for them to express their views. The U.S. Department of Commerce, through its Technology Administration, sponsored a conference on university patenting and licensing. Several corporations—Pharmacia, Merck and Co., Procter and Gamble, and IBM—provided unrestricted funds. Finally, the U.S. Patent and Trademark Office (USPTO) paid the salary of a senior patent examining supervisor who, under the Commerce Department’s Science and Technology Fellowship Program, worked full-time with the staff and committee from September 2000 through September 2001. The USPTO also provided data and suggested factual corrections to the prepublication version of this report at our request. We are very grateful to these sponsors and contributors. At the outset of the study phase of this project, we were encouraged to consult other National Research Council boards and committees with an interest in intellectual property policy and relevant technical and legal expertise. The committee extended invitations to three program units to select a volunteer to serve in a liaison capacity, contributing to framing the study and participating in its fact-finding phrase but not deliberating on nor assuming responsibility for the committee’s findings and recommendations. Two units accepted STEP’s invitation. David Korn of the Association of American Medical Colleges represented the Science, Technology, and Law Program and Pilar Ossorio of the University of Wisconsin law faculty represented the National Cancer Policy Board of the Institute of Medicine. Both actively participated in a number of panel meetings, helped to focus the inquiry in its early stages, and provided useful information to the committee. We are grateful to them for their assistance, especially as they were not able to see the project through to its conclusion. 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 Research Council’s 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 deliberative process. We wish to thank the following individuals for their review of this report: Robert Armitage, Eli Lilly & Co. David Beier, Amgen, Inc. Q. Todd Dickinson, Howrey, Simon, Arnold & White Raoul Drapeau, Products Concepts Co.

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A Patent System for the 21st Century David Forney, Motorola, Inc. (ret.) Dominique Guellec, European Patent Office Donald Grant Kelley, Intellectual Asset Management Assoc., LLC Katharine Ku, Stanford University Roderick McKelvie, Fish & Neave Robert Merges, University of California, Davis, Law School Steven Odre, Amgen, Inc. Arti Rai, Duke University Law School F. M. Scherer, Harvard University emeritus Carl Shapiro, University of California, Berkeley Anthony Siegman, Stanford University emeritus Although the reviewers 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 Gilbert Omenn, University of Michigan, and Joe Cecil, Federal Judicial Center. Appointed by the National Research Council, they were responsible for ensuring 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. Our most profound thanks are reserved for STEP’s executive director, Stephen Merrill, and his excellent staff. Steve made a prodigious personal effort to assist the committee even as he continued to manage the office and supervise a number of other projects. We are grateful that he took responsibility for writing the first drafts of everything and impressed by how patiently he integrated the comments, suggestions, and substitute prose of committee members and outside reviewers. His good sense and evenhandedness prevailed throughout our committee’s lively and often contentious internal debates, which persisted until the final draft was sent to the printer. Craig Schultz provided superb research, production, and administrative support throughout the project. He created the National Academies’ intellectual property web site and produced on CD-ROM the conference proceedings as well as the research collection and the final report. The success of our conferences, workshops, and public hearings is a tribute to his organizational and personal skills. During the crucial first year of our deliberations the committee had the benefit of the experience, detailed knowledge, and good sense of George Elliott, on leave from the USPTO as a Commerce science and technology fellow with the National Academies. To the extent that our report reflects some understanding of the details of the patent examination process and life of examiners, George is responsible. He is responsible neither for our errors of fact nor the flaws in our recommendations.

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A Patent System for the 21st Century As co-chairs, it has been a pleasure to work with such a talented committee that represented such diverse professional backgrounds and points of view. Everyone on the committee gained a broader appreciation of the field from our encounter with one another. It was no small task to achieve consensus, but despite initial disagreements that were often deep, we worked hard to find common ground. We hope that our recommendations, which have stood the test of fierce internal debate and intense external review, prove useful in encouraging the innovation upon which our nation’s economic strength depends. Richard C. Levin President Yale University   Mark B. Myers Visiting Executive Professor of Management The Wharton School University of Pennsylvania

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A Patent System for the 21st Century Contents     EXECUTIVE SUMMARY   1 1   INTRODUCTION   9 2   SIX REASONS TO PAY ATTENTION TO THE PATENT SYSTEM   18      Introduction,   18      Reasons the Patent System Merits Attention,   19      Preserve America’s Capacity to Innovate,   19      Substantial Changes in Patent Policy,   21      Expanded Patenting of Research Tools and Discoveries,   25      Surge in Patent-Related Activity,   28      Varied Roles and Uncertain Benefits of Patents,   35      Increasing Costs,   38 3   SEVEN CRITERIA FOR EVALUATING THE PATENT SYSTEM   39      Patents and Innovation,   39      Evaluation Criteria,   41      Accommodating New Technologies,   42      Ensuring High-Quality Patents,   46      Disseminating Technical Information,   63      Ensuring the Timeliness and Containing the Costs of Decisions,   65      Accessing Technologies for Research and Development,   70      Reducing Redundancies and Inconsistences Among National Patent Systems,   77      Maintaining a Level Field Among Rights Holders,   78      Summary,   79

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A Patent System for the 21st Century 4   SEVEN RECOMMENDATIONS FOR A 21ST-CENTURY PATENT SYSTEM   81      Preserve a Flexible, Unitary, Open-Ended Patent System,   83      Reinvigorate the Non-Obviousness Standard,   87      Non-Obviousness and Business Method Inventions,   87      Non-Obviousness and Gene Sequence-Related Inventions,   91      Institute a Post-Grant Open Review Procedure,   95      Process,   97      Issues and Outcomes,   101      Strengthen USPTO Capabilities,   103      Personnel,   104      Electronic Processing,   105      Analytical Capability,   105      Financial Resources,   107      Shield Some Research Uses of Patented Inventions from Infringement Liability,   108      Limit the Subjective Elements of Patent Litigation,   117      Willful Infringement and Enhanced Damages,   118      Best Mode Defense,   120      Inequitable Conduct Defense,   121      Harmonize the U.S., European, and Japanese Patent Examination Systems,   123      First-to-Invent Versus First-to-File Priority,   124      Grace Period,   127      Best Mode Requirement,   127      Prior Art,   127      Application Publication,   128      Other Issues,   128     REFERENCES   130     ACRONYMS   138     LAW CASES CITED   140     APPENDIXES     A   A PATENT PRIMER, Stephen A. Merrill and George C. Elliott   143 B   CONTRIBUTORS   155 C   COMMITTEE AND STAFF BIOGRAPHIES   162