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Biotechnology and IPR in China: An FAS persepctive
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Biotechnology and IPR in China: An FAS persepctive

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  • Hi. I’m Michael Henney of the Foreign Agricultural Service – FAS.
    I’m happy to be able to talk to you today about the role that FAS plays in the marketing of biotech products in China.
  • Structurally speaking, there are a number of offices and people in FAS and USDA who work together on ag. biotech issues with China.

Transcript

  • 1. Agricultural Biotechnology and Intellectual Property Rights in China: An FAS and USDA Perspective Michael Henney U.S. Department of Agriculture Foreign Agricultural Service June 26, 2007 Michael.Henney@fas.usda.gov
  • 2. FAS and USDA on Biotech and China • FAS, Office of Scientific and Technical Affairs, New Technologies and Production Methods Branch • FAS, Office of Country and Regional Affairs, China Desk • FAS Beijing • USDA’s Animal and Plant Health Inspection Service, Biotechnology Regulatory Service • USDA’s Plant Variety Protection Office • USDA’s Agricultural Research Service, Office of Technology Transfer
  • 3. An Overview of Biotech Products in China • largest market (> 30%) for U.S.- produced soybeans, greater than $2.5 billion FY2006 • emerging market for U.S-produced corn • domestic production of cotton • potential domestic production of rice, etc.
  • 4. Challenges for Biotech Products in China: I. Regulatory • Biosafety regulatory system – lack of synchrony between U.S. and Chinese biosafety approvals • infrequent meetings of National Biosafety Committee • extensive in-country biosafety testing required • requirement for approval in country of origin prior to application submission – no clearly established policy on stacked event biotech products – growing interest to develop capacities for detection testing
  • 5. Challenges for Biotech Products in China: II. Business Practices • Constraints on Foreign Direct Investment for biotech industries • Trademarks (first to file system in China)
  • 6. Challenges for Biotech products in China: III. IPR • Currently no ability to patent biotech products, only processes • requirement for disclosure of source of genetic material in patent application • 1978 UPOV convention for Plant Variety Protection • Lack of IPR enforcement?
  • 7. The Interface of Regulatory and IPR issues: I • Blurred lines between responsibilities – government officials vs. academy, university and institute faculty – basic researchers, product developers, biosafety researchers, risk assessors, National Biosafety Committee members sometimes all the same people
  • 8. The Interface of Regulatory and IPR Issues: II • Concern about management of information and materials required for application submission – seed for biosafety testing, PVP testing and reference material for detection testing – protocols for detection testing – data on product development, molecular information
  • 9. FAS Action on Regulatory and IPR Issues: I. Structure • FAS work with U.S. Patent and Trademark Office on overarching IPR issues • U.S. Embassy Beijing IPR Task Force (coordination on all IPR issues) • FAS Beijing IPR office (run through Ag. Trade Office) • Regular Coordination with Stakeholders (e.g.- Crop Life China Industry Group)
  • 10. FAS and USDA Action on Regulatory and IPR Issues: II. Fora • High-Level Biotechnology Working Group (BWG) and Technical Working Group (TWG) on biotech regulatory and trade policy issues (with Chinese Ministry of Agriculture, others) • Joint Committee on Cooperation in Agriculture (JCCA) • U.S.–China Joint Commission on Commerce and Trade (JCCT), IPR Working Group