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Contents 1. INTRODUCTION 1 2. CONTEXT = Commercial Stakes and the IPR Factor ................................................... Intellectual Property Rights in the United States and Japan 11 Intellectual Property Issues Raised by Biotechnology 15 3. THE EXPERIENCE OF U.S. FIRMS IN JAPAN ..... Jananese Case Law ................................................. Genentech and T-PA .................................................. ....17 ....17 .. 20 4. JAPAN'S GROWING PRESENCE IN THE UNITED STATES 24 Strategies of Japanese Companies 24 Japanese Corporate Involvement in U.S. Academic Research 27 Japanese Corporate Experience with U.S. Patent Litigation 29 EPO: Amgen vs. Genetics Institute and Chugai 32 5. FUTURE PROSPECTS AND POLICY CONSIDERATIONS FOR THE UNITED STATES .................. Bilateral Issues.................................... International Patent Harmonization ... Trade-related Issues............................ 12 ~ at.. ~ ~ ti mn Competitive Implications for U.S. Biotechnology IX .34 .34 .36 .38 .40 .41