This report of a workshop organized by the Committee on Japan, with assistance from the Office of Japan Affairs, brings together some of the highlights of the discussions. Chaired by Dr. Hubert Schoemaker, Chairman and CEO of Centocor, the workshop was designed to provide a forum to examine the experiences of U.S. firms with the IPR environment for biotechnology in Japan, to discuss the implications of the growing presence of Japanese firms in the United States, and to evaluate future prospects and policy implications for the United States. The report was reviewed by the workshop panelists, who offered many useful insights, but it is not a consensus document.

Contents

• COMMITTEE ON JAPAN
• INTELLECTUAL PROPERTY RIGHTS AND U.S.-JAPAN COMPETITION IN BIOTECHNOLOGY
• OFFICE OF JAPAN AFFAIRS
  • Staff
• Preface
• 1. Introduction
• 2. Context
  • COMMERCIAL STAKES AND THE IPR FACTOR
  • INTELLECTUAL PROPERTY RIGHTS IN THE UNITED STATES AND JAPAN
  • INTELLECTUAL PROPERTY ISSUES RAISED BY BIOTECHNOLOGY
• 3. The Experience of U.S. Firms in Japan
  • JAPANESE CASE LAW
  • GENENTECH AND T-PA
• 4. Japan’s Growing Presence in the United States
  • STRATEGIES OF JAPANESE COMPANIES
  • JAPANESE CORPORATE INVOLVEMENT IN U.S. ACADEMIC RESEARCH
  • JAPANESE CORPORATE EXPERIENCE WITH U.S. PATENT LITIGATION
  • EPO: AMGEN VS. GENETICS INSTITUTE AND CHUGAI
• 5. Future Prospects and Policy Considerations for the United States
  • BILATERAL ISSUES
  • INTERNATIONAL PATENT HARMONIZATION
  • TRADE-RELATED ISSUES
  • REGULATION
  • COMPETITIVE IMPLICATIONS FOR U.S. BIOTECHNOLOGY

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. Frank Press 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 achievement of engineers. Dr. Robert M. White 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. Stuart Bondurant is acting 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. Frank Press and Dr. Robert M. White are chairman and vice-chairman, respectively, of the National Research Council.