June 27, 2012

1. Expanding federal intramural technology transfer SBIR TT Program: A new approach to partnering accelerating federal technologies through effective SBIR relationships Clara Asmailformer NIST SBIR Program Manager Senior Technical Advisor, MEP June 27, 2012

2. Federal Technologies with commercial application • Technologies resulting from federal intramural research may have commercial viability but often require additional research that feds will not conduct • That research can at times be appropriate for a small business to undertake • Could be scoped to track the SBIR two-phase structure

3. Goals of the SBIR Program(per legislation) • To increase private sector commercialization of innovations derived from federal R&D • To use small business to meet federal research and development needs • To stimulate small business innovation in technology • To foster and encourage participation by minority and disadvantaged persons in technological innovation

4. SBIR TT • Emphasizes an “increase in private sector commercialization of innovations derived from federal R&D”per legislation • IDENTIFY: Background technology, ie commercially promising federal patents and technologies - and - the research gaps that delay their commercialization • Fund and orient innovations that build upon valuable federal background technology through open competition

5. SBIR TT – IP considerations • Some background technologies are in public domain . • If patented and available*, SBIR award will include a non-exclusive, royalty-free research license (ie, right to use/make only, no right to sell) for duration of ph1 award OR negotiate other terms * no CRADA obligation, no non-fed co-owner • Proposal acts as research plan for license application • Provide the opportunity of a non-exclusive commercialization licenseto the awardee (no deviation from 37 CFR 404) • Rights to all SBIR funded research will be owned by the small business awardee  Gov’t use license reserved • c

6. IP treatment for work performed under SBIR award • Trade Secret If small business chooses to keep research results confidential, Gov’t will hold confidence for 4 years • Patent Protection per 37 CFR 401 If small business chooses to seek patent protection, must disclose invention to agency and small business will own and retain rights … Gov’t use right

7. Typical NIST SBIR TT subtopic includes: • Succinct description of the NIST’s background technology - includes: citations to paper(s), issued patent or application as applicable, any other reference such as ppts, website • Focused description of research that must be conducted to advance NIST technology from bench to market - includes specifications of end goals but not approach • Complete description and extent of NIST’s assets to be made available during SBIR project, ie collaboration on xyz area(s), materials, equipment, facility, …

9. Results so far… Cumulatively: 29 NIST technologies 11 research licenses & 2 commercialization licenses FY08 11 ph1 1 comm lic 2 research lic’s FY09 16 ph1 9 ph2 1 comm lic 9 research lic’s + 1 co-owned patent FY10 2 ph1 2 ph2 1 research lic

10. Prevention of COI Named inventors: • may author subtopics • may not participate in proposal review or selection • may monitor project progress

11. Explicit benefits of SBIR TT approach • Systematically creates spin-outs dedicated to commercialization of federal IP • Engenders the spirit of SBIR by enabling/supporting small business growth and accelerating commercialization • Expands S-W mandated federal technology transfer by providing new tool and channel for marketing • Access to background fed tech enhances the “vetted” credential of SBIR awardee for 3rd party funding

12. Lessons Learned • Press release  trade journals • Launch year mistakes: two separate solicitations … poor techs inventory • Launch year successes: hand pick collaborative fed researchers … predetermined template license language embedded in awards • Follow on years success… word of mouth among fed researchers • Surplus techs  licensing and/or collaboration leads • Manage expectations • SBC re licensing, access to fed researcher • Fed researcher re time commitment • Launch year: devoted ½ of budget to SBIR TT, opened 22 subtopics and only one received no proposals, made 11 SBIR TT awards

13. Other agencies implementing SBIR TT: • NIH (5 institutes) • DOE and NASA working out last minute operations Other agencies exploring SBIR TT: • Army • DOT (FHWA, FAA) • DOEd

14. Clara Asmail Snr Technical Advisor NIST MEP 301 975 2339 asmail@nist.gov

15. Licensing of Gov’t-owned inventions 37 CFR § 404.2   Policy and objective. It is the policy and objective of this subpart to use the patent system to promote the utilization of inventions arising from federally supported research or development. § 404.4   Authority to grant licenses. Federally owned inventions shall be made available for licensing as deemed appropriate in the public interest and each agency shall notify the public of these available inventions. The agencies having custody of these inventions may grant nonexclusive, co-exclusive, partially exclusive, or exclusive licenses thereto under this part. Licenses may be royalty-free or for royalties or other consideration….

16. Contract Management • COTR duties centralized at SBIR Program interfaces with CO, secures mgmt direction for technical monitoring, tracks project compliance with contract, manages invoice payments and modifications, … • COTR relies on technical monitoring of projects by TR at intramural program level allowing for collaboration between researchers to not be impeded by administrative matters TR drafts original subtopic for solicitation, identifies federal resources to be made available to awardee, reviews* proposals, collaborates with awardee according to predetermined & mgmt-approved extent, reviews progress reports and consults with COTR re acceptability *unless named inventor on a patent