Henney IPRinChina

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

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

FAS and USDA on Biotech and China: 

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

An Overview of Biotech Products in China: 

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.

Challenges for Biotech Products in China: I. Regulatory: 

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

Challenges for Biotech Products in China: II. Business Practices: 

Challenges for Biotech Products in China: II. Business Practices Constraints on Foreign Direct Investment for biotech industries Trademarks (first to file system in China)

Challenges for Biotech products in China: III. IPR: 

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?

The Interface of Regulatory and IPR issues: I : 

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

The Interface of Regulatory and IPR Issues: II: 

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

FAS Action on Regulatory and IPR Issues: I. Structure: 

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)

FAS and USDA Action on Regulatory and IPR Issues: II. Fora: 

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