Part I Technology Transfer Policy Considerations and Country/Regional 13

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1 V List of Contributors XI 1 Defining the Future: Emerging Issues in Biotechnology, Intellectual Property Rights and Technology Transfer 1 Prabuddha Ganguli, Ben Prickril, and Rita Khanna 1.1 Introduction Historical Evolution of Intellectual Property Regime in Biotechnology Issue of Patentability of Gene Sequences, Antibodies, Early-Stage Technology/Platform and Insufficient Support for Claims Scope of Patent Claims Institutional Arrangements for Technology Transfer Policy Issues and Challenges 8 Part I Technology Transfer Policy Considerations and Country/Regional 13 2 Technology Transfers in Europe within the Life Sciences 15 Jacques Warcoin 2.1 Biology and the Development of Technology Transfers Involvement of Public Bodies Initial Contacts Non-Disclosure Agreements Preliminaries to Negotiations for a Technical Transfer Agreement Memorandum of Understanding or Letter of Intent Material Transfer Agreements Founder Contracts in Technology Transfers The Technology Transfer Agreement Contract Itself Ownership of the Rights Subject Matter of the Contract Domains Territory 27 Technology Transfer in Biotechnology. A Global Perspective. Edited by Prabuddha Ganguli, Rita Khanna, and Ben Prickril Copyright ª 2009 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim ISBN:

2 VI 2.14 Know-How Financial Considerations Financial Clauses Improvements Rights of First Refusal Circulation of Contracts Antistacking Clause Various Clauses Conclusions 34 3 Technology Transfer at the National Institutes of Health 35 Mark L. Rohrbaugh and Brian R. Stanton 3.1 Introduction Technology Transfer Legislation Impact of Bayh Dole and Stevenson Wydler Acts Growth of Technology Transfer in Government and Academic Laboratories NIH Efforts to Transfer Technology Globally International Technology Transfer by Publicly Funded Research Organizations Patent Harmonization and Access to Medicines Final Notes on the Global Expansion of Bayh Dole-Type Intellectual Property Regimes 57 4 Current Intellectual Property Management Situation in Japan 59 Yukiko Nishimura and Katsuya Tamai 4.1 Introduction IP-Related Government Measures and Projects Life Sciences/Biotechnology-Related Projects Medical Patent/Patentability Policies related to University Industry CollaborationIncorporation of National Universities 70 5 Technology Transfer in China 79 Jianyang Yu 5.1 Introduction Overview Technology Import Importing Sources and Industry Dissemination Biotechnology Technology Export Government Policy Legal Protection of Technology in China 84

3 VII Patent Protection Patent Filing and Prosecution Patent Enforcement Patent Enforcement Data Strategic Considerations Trade Secret Protection Contractual Protection Protection under the Anti-Unfair Competition Law Criminal Sanctions Strategic Considerations Other Forms of Protection Technology Transfer in China Technology Import and Export Contract Law Import and Export Regulations Technology Import and Export: Government Regulations Three Categories Technology Prohibited to Import or Export Technology Restricted to Import or Export Technology Free to Import or Export License and Registration Certificate Technology as Investment Legal Liabilities and Judicial Review Import or Export of Dual-Use Technologies Technology Import and Export: Important Issues Definition of Technology Contract Forms of Contract Content of Contract Technology Supplying Party s Obligations Confidentiality and Contract Term Restrictive Clauses Taxation Governing Law Dispute Resolution Statute of Limitations Conclusions 99 6 Technology Transfer in Latin-America 101 Claudia Ines Chamas 6.1 Introduction Academia, Industry and Technology Transfers Support Structures for Investments in Biotechnology Policies for Marketing Biotechnological Knowledge Conclusions and Final Remarks 119

4 VIII Part II Perspectives from Different Participants/Players Technology Transfer in Agricultural Biotechnology: Impact of Applied Plant Sciences on Industry 123 Marc Cornelissen and Michiel M. van Lookeren Campagne 7.1 Introduction Historical Perspective First-Generation Crops New Innovation Wave Third Innovation Wave Market Development Overwhelming Success Full Potential Not Reached Future Developments Technology Transfer Through Open Innovation Platforms as a Key to Success Introduction Need for Innovative Raw Materials as a Driving Force Intensification of Coordination and Communication Involvement of Society Responsible Industry Common Interests Open Innovations Platforms Coordinator Role in Industry Opportunities for Academia and Start-Ups Key Factor: Technology Transfer Specifics of Technology Transfer in Agricultural Biotechnology and Their Consequences Introduction Transition Points Transfer to Agricultural Biotechnology Downstream from Agricultural Biotechnology To End-Consumers Expression of Traits Technology Transfer and Start-Up Companies in Agricultural Biotechnology Introduction Less-Favorable Prospects Stimulatory Measures Future Introduction Diversification and Specialization Evolution in R&D Shifts in National Budgets 138

5 IX The Stimulating Government Self-Sustaining Process Technology Transfer Issues in Biotechnology: The Industry Point of View 141 Florent Gros 8.1 Introduction Diversity of Legal Frameworks Intellectual Property Dangers Industry Out-Licensing Prospects Industry In-Licensing Practices Challenges Related to Biotechnology Experimental-Use Exemptions How Essential are Patented Genes? Biodiversity Convention Industry Motivation Driving R&D Investments A Quarter Century of Technology Transfer in US Universities and Research Institutions 161 Lita Nelsen 9.1 Introduction Enabling Legislation Public Purpose of Bayh Dole Returns and Economic Development Start-Up Companies and Entrepreneurship Lessons Learned in a Quarter Century of Technology Transfer Expectations in Setting Up a Program Licensing Income Building a Program Takes Time and Money Culture Change Defining the Mission Setting the Ground Rules: Policies and Practices Conflicts of Interest Talent Conclusions Technology Transfer Issues in Biotechnology: The Future of Global Health Networks 173 Gerald T. Keusch and Ashley J. Stevens 10.1 Introduction Knowledge for All Knowledge Sequestration New Research Models 175

6 X 10.5 Changing Role of Patents in Academic Research Triple Helix and Economic Impact of the New Paradigm Contributions of Public Sector Research to New Drug Discovery Spread of the New Paradigm Worldwide Role of Patents in the Academic Mission Patents and Publishing Patents and the Power to Dictate the Terms of Development Patents versus Licensing Managing IP in Research Networks Conclusions 182 Part III New Frontiers Biotechnology in the Midst of a Global Transformation 185 G. Steven Burrill 11.1 Introduction Healthcare Financing Environment Signs of Growth in Mergers and Acquisitions Now Part of the Industry Scene Deal Making Slows Slightly Weak Initial Public Offering (IPO) Market Does Not Deter Hopefuls Venture Capital: Deals Continue to Flow Technology Transfer in Biotechnology: International Framework and Impact 195 Carlos M. Correa 12.1 Introduction International Framework for Technology Transfer Transfer of Technology to LDCs Favoring the Transfer Technology to Developing Countries Transferring Agro-Biotechnologies Transfer of Biotechnology for Industrial Production Conclusions 208 References 209 Index 211