Agricultural Biotechnology and Intellectual Property Rights in China: An FAS and USDA Perspective

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_at_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
• USDAs Animal and Plant Health Inspection
  Service, Biotechnology Regulatory Service
• USDAs Plant Variety Protection Office
• USDAs Agricultural Research Service, Office of
  Technology Transfer

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An Overview of Biotech Products in China

• largest market (gt 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.

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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

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Challenges for Biotech Products in China II.
Business Practices

• Constraints on Foreign Direct Investment for
  biotech industries
• Trademarks (first to file system in China)

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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?

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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

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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

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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)

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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