~APANESE BIOTECHNOLOGY

A Comprehensive Study 0/ Government Policy, R & D and Industry

A Comprehensive Study 0/ Government Policy, R & D and Industry

Robert T. Yuan Mark D. Dibner

M

JAPANESEBIOTECHNOLOGY

© Robert T. Yuan and Mark D. Dibner, 1990 Softcover reprint of the hardcover 1 st edition 1990 978-0-333-53148-8

All rights reserved. No reproduction, copy or transmission of this publication may be made without written permission.

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Any person who does any unauthorised act in relation to this publication may be liable to criminal prosecution and civil claims for damage.

First published by MACMILLAN PUBLISHERS LTD, 1990

Distributed by Globe Book Services Ltd BruneI Road, Houndmills Basingstoke, Hants RG21 2XS

British Library Cataloguing in Publication Data

Yuan, Robert T. Japanese Biotechnology 1. Japan. Biotechnology I. Title. II. Dibner, Mark D. (Mark Douglas) 1951-660.60952

ISBN 978-1-349-11764-2 ISBN 978-1-349-11762-8 (eBook) DOI 10.1007/978-1-349-11762-8

C 0 N T E N T S

Contents ......................................................... v

List of Tables and Figures ............................................ vii

F oreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IX

Preface .......................................................... xiii

Exchange Rates .................................................... xv

Chapter 1. Executive Summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Chapter 2. Introduction ............................................. 15

Chapter 3. Government Policy ........................................ 18

Chapter 4. Universities and Research Institutes. . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

Chapter 5. The Japanese Biotechnology Industry . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

Chapter 6. Technology Transfer ....................................... 166

Chapter 7. Finance................................................. 175

Chapter 8. Doing Business in Japan .................................... 181

Chapter 9. COnclusions................................................ 189

List of Organizations and Individuals Visited . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202

Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205

v

Japanese Biotechnology

Appendix A: Guidelines for Recombinant DNA Experiments in Universities and Other

Research Institutes ............................................ 207

Appendix B: MITl's Regulations for Large-Scale Industrial Processes . . . . . . . . . . . . 245

Appendix C: Full Text of Notification of Application Data for Recombinant DNA

Drugs ...................................................... 261

Appendix D: Guidelines for Manufacturing Drugs Etc. by Application of Recombinant

DNA Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 270

Appendix E: Guidelines for the Application of Recombinant DNA Organisms in

Agriculture, Forestry, Fisheries, the Food Industry and Other Related

Industries in Japan. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 286

Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 305

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 315

vi

L IST A N 0

OFT A B L E S F I GUR E S

Table 1. 1989 Japanese Government Budgets for Biotechnology R&D . . . . . . . . . . .. 24

Table 2. Japan Health Sciences Foundation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 28

Table 3. Activities of Science and Technology Agency ........................ 31

Table 4. Budget for Life Sciences Programs of ST A . . . . . . . . . . . . . . . . . . . . . . . . . .32-33

Table 5. 1989 Budget of Research Development Corporation of Japan ........... 36

Table 6. ERA TO Projects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39-40

Table 7. AIST Biotechnology-Related Projects . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 50

Table 8. Budget for MAFF Biotechnology Programs ......................... 57-58

Table 9. 1989 Budget of Government-Industry Research Programs . . . . . . . . . . . . . .. 67

Table 10. Key Researchers at Three Selected Japanese Universities . . . . . . . . . . . . . .. 72

Table 11. Laboratories with Biotechnology-Related Projects, Kyoto University . . . . . . . 73

Table 12. Research at the Institute for Molecular and Cell Biology, Osaka University .. 75-76

Table 13. Research Projects of Biosensor and Bioelectronics Laboratory ........... 79

Table 14. Principal Government Research laboratories Involved in Biotechnology .... 81

Table 15. RIKEN Biotechnology-Related Laboratories, Wako Facility ............. 83-84

Table 16. Research Groups at RIKEN's Tsukuba Life Science Center .. . . . . . . . . . . . 85

Table 17. RIKEN - Division of Life Science Promotion Program Areas ............ 87

Table 18. Frontier Research Program - Bio-Homeostasis Program . . . . . . . . . . . . . . .. 88

Table 19. Tsukuba Research Consortium ................................... 90-91

Table 20. Member Companies of Protein Engineering Research Institute . . . . . . . . . .. 93

Table 21. Organization of Protein Engineering Research Institute ................ 94

Table 22. Organization of Osaka Bioscience Institute . . . . . . . . . . . . . . . . . . . . . . . . .. 96

Table 23. Primary Industry Focus of Japanese Biotechnology Companies - 1989 . . . . .. 111

Table 24. Primary Biotechnology Focus of Japanese Biotechnology Companies - 1989 . 120

vii

Japanese Biotechnology

Figure 1. Organization of Biotechnology within the Japanese Government . . . . . . . . .. 25

Figure 2. Structure of the Ministry of Health and Welfare . . . . . . . . . . . . . . . . . . . . .. 25

Figure 3. Structure of the Science and Technology Agency ..................... 34

Figure 4. Structure of the Ministry of International Trade and Industry . . . . . . . . . . .. 47

Figure 5. Map of Technopolis Areas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 53

Figure 6. Structure of the Ministry of Agriculture, Forestry and Fisheries .......... 55

Vlll

FOREWORD

Japanese Biotechnology is part of a continuing series on international biotechnology. Earlier

volumes have examined biotechnology in Western Europe; Singapore, South Korea and Taiwan;

and the People's Republic of China and Hong Kong.

This study has been supported by:

Office of the Vice-Chancellor for Agricultural Affairs, University of Maryland

N orth Carolina Biotechnology Center

IC2 InstitutelRGK Foundation, Austin, TX

KPMG Peat Marwick, Oakland, CA

Office of Biotechnology, Iowa State University

State of Iowa, Department of Economic Development

State of Maryland, Office of International Trade

University of Iowa

Dr Robert Yuan is Professor of Microbiology at the University of Maryland at College Park,

MD. He is also director of BioTechnology International, a program of the International

Development Management Center. He has done extensive research in molecular biology, which

included appointments at the University of Edinburgh and at the Biozentrum of the University

of Basel, Switzerland. He has also served as First Secretary to the American Embassy in London,

and has carried out aseries of biotechnology assessments in Europe and Asia for the U .S.

International Trade Administration (Biotechnology in Western Europe; Biotechnology in Singapore,

South Korea and Taiwan; and Biotechnology in the People's Republic 01 China and Hong Kong).

He has also carried out a number of private studies for foreign governments and multinational

companies. He is multilingual and is familiar with the culture and customs of many European and

Asian countries.

IX

Japanese Biotechnology

Dr Mark D. Dibner is direetor of the Bioteehnology Information Division of the North

Carolina Bioteehnology Center. He is also Adjunet Associate Professor at Duke University's

Fuqua Sehool of Business, where he teaehes management of teehnology. In addition, he has

served as Chairman of the Couneil of Bioteehnology Centers, anational organization. He holds

a Ph.D. in neurobiology and behavior from Cornell University and an M.B.A. in strategie planning

from Widener University. He has written manyarticles on the bioteehnology industry and has

eonsulted and leetured in the United States and abroad on eommercial bioteehnology. Dr Dibner

is the author of Biotechnology Japan; Biotechnology Guide U.SA.: Companies, Data and Analysis;

and Basic Methods in Molecular Biology.

x

Foreword

BioTechnology International

BioTechnology International (BTI) is a program at the University of Maryland. The objectives

of BTI are:

o to carry out technical and industrial assessments of biotechnology worldwide;

o to organize workshops and symposia to promote the commercialization of biotechnology;

o to assist U .S. biotechnology companies in developing commercial ventures abroad.

BTI has carried out aseries of major biotechnology studies in Asia:

o Biotechnology in the People's Republic of China and Hong Kong (funded by the U.S.

Department of Commerce, the Maryland Office of International Trade, and the College

of Agriculture, University of Maryland, College Park;

o Biotechnology in Asia: A Financial Perspective, in collaboration with Mr Michael Hsu,

president of Asia/Pacific Strategic Bioventures (funded by the U.S. Congressional Office

of Technology Assessment).

In addition, Dr. Yuan, director of BTI, has carried out detailed studies of biotechnology in eleven

countries of Western Europe. BTI helped organize the first conference on Biotechnology in the

Pacific Rim which was held in Singapore on September 1988.

BTI is currently carrying out a study for the Hong Kong government to determine the

feasibility of a biotechnology industry in Hong Kong and a study for the Royal Thai Government

on the commercial opportunities for biotechnology in Thailand. Among other projects, BTI is

involved in the organization of the U.S. and Asian Pacific Biotech Conference '90 to be held in

Houston and focusing on collaboration and commercialization of biotechnology, and a workshop

on the Financing of Biotechnology in the Pacific Rim.

BTI has elose relationships with foreign governments, state economic development agencies,

industrial associations, and biotechnology companies both in the United States and abroad.

Xl

Japanese Biotechnology

Tbc North Carolina Biotechnology Center

Tbe North Carolina Biotechnology Center was established in 1981 to catalyze economic

development in North Carolina through support of biotechnology. Largely funded by the State

of North Carolina, the Center is a private, non-profit corporation. In addition to the Information

Division, other Center programs include grants to universities and small companies, public

education, special focus groups, and economic development.

Tbe Biotechnology Information Division of the North Carolina Biotechnology Center was

started by Dr Dibner in 1986 to compile and make available data on commercial biotechnology -

- in North Carolina, in the United States, and worldwide. Tbrough a multi-faceted approach of

utilizing a commercial biotechnology-oriented library, paper datafiles, in-house computer databases

(on U.S. companies and partnering in biotechnology worldwide) and commercially available

databases, the Division is able to provide information to a variety of users. Reports from the

Division's databases are made available to individuals, companies, organizations, and govemment

agencies on a contractual, cost recovery basis. Oients for larger studies have included the Office

of Technology Assessment, the U.S. Department of Agriculture, the U.S. Environmental

Protection Agency, the National Science Foundation, the Association ofBiotechnology Companies,

and several foreign govemments. Tbe Division has recently created a new database of Japanese

companies working with biotechnology, now ready for client use.

xii

P R E F ACE

This report is one in aseries of technical and industrial assessments of biotechnology in the major

industrialized nations of Western Europe and the Far East. Its objectives are to:

odetermine government policies in support of biotechnology;

o identify principal research laboratories and their activities;

o identify principal companies involved in biotechnology and their activities;

o study the various mechanisms for technology transfer from research laboratories to the

industrial sector;

o provide useful information for those biotechnology companies and organizations interested

in doing business in Japan.

The procedure used in this study closely follows the one established for earlier projects in

Western Europe and Asia. Lists of organizations and individuals were obtained from four

different sources: a) colleagues in the scientific community, b) the American Embassy in Tokyo

and the Tokyo Office of the Maryland Office of International Trade, c) the North Carolina

Biotechnology Center's Japan Database, and d) officials in the Japanese government. These lists

were cross-checked against one another and against published reports and articles. Extensive

reading of published materials and selected briefings occurred prior to the site visits arranged by

the American Embassy in Tokyo. The meetings on-site provided an opportunity to obtain current

documents (some in Japanese) and these documents and notes were used in the preparation of

a preliminary report. More extensive work was required for the preparation of this report, which

was reviewed by the staff of the Science Office and Foreign Commercial Service at the American

Embassy in Tokyo and selected other individuals who are knowledgeable about the state of

Japanese biotechnology. Corrections and comments were incorporated prior to the preparation

of the final report.

xiii

Japanese Biotechnology

The Japan project was carried out over the period from May 1989 to May 1990. It is highly

unusual because it involves the collaboration of diverse institutions, such as the federal

government, universities, state economic development agencies, a private foundation, and a private

financial organization. It could not have been possible without the enthusiastic cooperation of the

Japan Desk at the State Department, the American Embassy in Tokyo, and hosts of Japanese

officials, scientists, and corporate managers.

The authors are particularly indebted to Dr Daniel Hamilton and Ms Diane Plentovich of

BioTechnology International and Mr R. Steven White of the Sumitomo Corporation for their

research and logistical support. The authors would also like to express their gratitude to the

following individuals for their encouragement and generous assistance:

xiv

Dr Kenneth Chern, Japan desk, U.S. Department of State

Mr Genya Chiba, ERATO, Japan Research Development Corporation

Dr Robert Fujimura, Oak Ridge National Laboratory

Mr Michael Grose, Maryland Office of International Trade, Tokyo

Dr Marcus Ingle, International Development Management Center, University of Maryland

Ms Kathryn D. Lindquist, Maryland Office of International Trade

Dr. George Kozmetsky, RGK Foundation, Austin, TX

Mr Robert Ludan, American Embassy, Tokyo

Ms Christina Lowell, KPMG Peat Marwick, Oakland, CA

Dr Kenichi Matsubara, Osaka University

Dr Raymond Miller, Vice-Chancellor for Agricultural Affairs, University of Maryland

Ms Fumiko Shioda, American Embassy, Tokyo

Dr Steven Price, Iowa State University

Dr Henry Miller, U.S. Food and Drug Administration

Dr Raymond Smilor, I~ Institute, Austin, TX

Dr Charles E. Hammer, Jr., North Carolina Biotechnology Center

Ms. Janet Hafer, North Carolina Biotechnology Center

Mr John Sylvester, North Carolina Japan Center

Mr Harold Zassenhaus, Maryland Office of International Trade

E X C H A N G E RAT E S

Because the exchange rate between the Japanese yen and the V.S. dollar has fluctuated in the

past years, in this report we have used the rates listed below.

Year

1980

1981

1982

1983

1984

1985

1986

1987

1988

1989

Yen per US $

226.74

220.54

249.08

237.51

237.52

238.54

168.52

144.64

128.15

137.96

Reference: International Financial Statistics, International Monetary Fund 1989 Yearbook.

xv