1. Government Funded Inventions Mark L. Rohrbaugh, Ph.D., J.D. Acting Director Office of Technology Transfer National Institutes of Health

2. Office of Technology Transfer Evaluates, Protects, Markets, Licenses and Monitors the Use of Intellectual Property Generated by Intramural Scientists at NIH to Advance the Health of the Public. Lead Agency for Technology Transfer at US Department of Health and Human Services (DHHS).

3. The Credo Funding for Basic Research Publication and Dissemination of Findings Access to Research Tools Appropriate Patenting Strategic Licensing Education of Scientists

4. Government Funded Inventions The Bayh-Dole Act governs University can retain title Government has residual rights

5. Goals of the Bayh-Dole Act Utilization Commercialization – economic activity Free competition and enterprise Public availability Prevent nonuse or unreasonable use

6. If University Elects Title University can patent and license University retains royalties Prohibition on assignment

7. If University Declines Title -- Inventor Can Seek It University requests on behalf of inventor NIH grants/denies request If granted, inventor can patent, license, and retain royalties Government has residual interests

8. What Are the Government’s Residual Rights? Utilization Reporting U.S. Manufacturing Requirement Government Use License March-in

9. Research Tools: A Special Category

10. Properties of Research Tools Useful lifecycle is generally short Does not require significant R&D Generally does not require IP incentive to make/use Desire broad access and availability

11. Examples of Research Tools Animal Models Cell Lines Bulk DNA Sequences Drug Targets Clones/Cloning Tools Libraries Software Databases Lab Techniques Antibody Reagents

12. NIH Director’s Working Group on Research Tools Convened (1997) Members from academia, industry, not-for-profit Inquired into access problems encountered by NIH-funded scientists Issued four recommendations (1998) Guidelines for NIH funding recipients

13. Principles and Guidelines Adopted after Public Comment Applicable to Funding Recipients Internal Practices will be Consistent Call for Other Institutions to Adopt

14. Principles for Recipients of NIH Funds Academic Freedom and Publication Appropriate Implementation of Bayh-Dole Dissemination of NIH-Funded Tools Minimize Impediments to the Research Enterprise

15. Guidelines for Implementing the Principles Importing tools into NIH-funded research Disseminating tools developed with NIH funds Uniform one-page MTA proposed Strategic licensing to achieve balance

16. Guidelines for Implementing the Principles Importing Tools Into NIH-Funded Research -- preserve distribution of future tools -- ensure agreements with third parties are consistent

17. Guidelines for Implementing the Principles Disseminating Tools Developed with NIH Funds Avoid reach-through Avoid exclusive internal use

18. Guidelines for Implementing the Principles Disseminating Tools Developed With NIH Funds -- simple letter agreement -- non-exclusive internal use -- license to distributor -- repository

19. Guidelines for Implementing the Principles Simple Letter Agreement uniform one-page MTA can be modified not for 100% of the transactions scientists will ask for it

20. Guidelines for Implementing the Principles Use Strategic Licensing to Achieve Balance

21. NIH License Policy Non-exclusive where possible Exclusive when necessary Ensure appropriate scope Ensure expeditious development Ensure continuing availability of tools

22. The Toll-Road Analogy Prefer Freeways to promote Research Tool (RT) use Willing to Accept Occasional Tolls Avoid Tollbooth Gridlock with patents on RTs

23. Status of the Principles/Guidelines Period of Implementation Intramural and Extramural Implementation Term of Award for grants and contracts Request for Comments on implementation of Principles and Guidelines (September 2000)

24. FFI http://ott.od.nih.gov/http://ott.od.nih.gov/ Office of Technology Transfer http://www.bioinfo.com/http://www.bioinfo.com/ Biotech. Information Institute http://www.wipo.org/http://www.wipo.org/ WIPO http://www.uspto.gov/http://www.uspto.gov/ USPTO http://www.autm.net/index_ie.htmlhttp://www.autm.net/index_ie.html AUTM