1. Commercializing USDA Innovations Via Public-Private Partnerships June Blalock Coordinator, Technology Licensing Program USDA, Agricultural Research Service Office of Technology Transfer djb@ars.usda.gov

2. Overview  Quick review of Federal technology transfer legislation  Summary of USDA technology transfer goals and policies  Role of private sector technology transfer partners  Factors affecting agricultural biotechnology partnerships

3. U.S. Technology Transfer Legislation  Bayh-Dole Act, 1980  Stevenson-Wydler Act, 1980  Federal Technology Transfer Act, 1986  National Technology Transfer and Advancement Act, 1996  Technology Transfer Commercialization Act, 2000

4. 37 CFR 404.2 “It is the policy and objective of (this regulation) to use the patent system to promote the utilization of inventions arising from federally supported research or development.”

5. 37 CFR 404.2, paraphrased A federally owned invention should be protected when a private sector partner is needed to achieve technology transfer AND that partner requires some scope of exclusivity to protect the capital investments needed to commercialize the invention.

6. USDA Technology Transfer Goals  Use the patent system to facilitate technology transfer  Provide an incentive for investments by the private sector  Support small business enterprises and entrepreneurs  Support investments by U.S. businesses in international markets

7. USDA Technology Transfer Policies  Patenting decisions are based on technology transfer requirements.  USDA does not require licenses for research only use of USDA inventions.  Most licenses are exclusive or partially exclusive.  Exclusive licenses for protected plant varieties reserve the right to make the licensed varieties available to third parties for research and breeding.  Scientists are promoted based on the IMPACT of their research.

8. Role of Private Sector Partners in Transferring Public Sector Innovations  Make investments in the development and marketing of licensed products and services  Make licensed products and services widely available  Provide the complementary assets required for commercialization; e.g., manufacturing facilities, marketing and distribution capacity, investment capital, product registration expertise

9. Selected USDA Technology Transfer Data for FY 2003  Active CRADAs229  U.S. patent applications filed60  U.S. patents issued64  Active patent licenses270  Licenses generating earned royalty income56  Total license revenues$2.3 million  Median earned royalty income$3,102

10. Examples of Licensed USDA Technologies U.S. Patent No. 6,261,790, “Monoclonal antibodies and antibody cocktail for detection of prion protein as an indication of transmissible spongiform encephalopathies” U.S. Patent No. 5,689,054, “Low phytic acid mutants and selection thereof” U.S. Patent No. 5,676,994,”Non-separable starch-oil compositions” and U.S. Patent No. 5,882,713, “Non- separable compositions of starch and water- immiscible organic materials” U.S. Patent No. 5,705,030, “Fiber and fiber products produced from feathers” U.S. Patent No. 6,083,498, “Chemical attractants for yellowjackets and paper wasps”

11. Factors Affecting the “Partnership Value” of Agricultural Biotechnology Innovations  Consumer acceptance of agbiotech products  Industry consolidation  Biosafety regulations and liabilities  International trade agreements and enforcement  IPR availability, enforcement and freedom to operate  Advances in tools and technology

12. Complementary Assets Required for Agbiotech Innovations  Facilities for propagation/seed increase and field trials  Access to markets and distribution capacity  Expertise in local biosafety regimes  Technical expertise in variety selection, trait stability, product QC  Investment capital