1. Technology Transfer: The NIH Experience Steven M. Ferguson, CLP Deputy Director, Licensing & Entrepreneurship Email: sf8h@nih.gov Office of Technology Transfer National Institutes of Health U.S. Department of Health & Human Services NIH Office of Technology TransferScience. Ideas. Breakthroughs.1

2. What Does This Mean? Movement of information, materials, and technologies from the research laboratories to the commercial enterprise To support further research and develop new products to improve public health Technology Transfer NIH Office of Technology Transfer2Science. Ideas. Breakthroughs.

3. Technology Transfer Supports Agency Mission NIH Mission: To uncover new knowledge that will lead to improved public health NIH Office of Technology Transfer3Science. Ideas. Breakthroughs.

4. Basic Biomedical Research in Support of the Public Health Funding Training Basic Research Clinical Trials Inventions Policies National Institutes of Health NIH Office of Technology Transfer4Science. Ideas. Breakthroughs.

5. Engine for Research and Innovation Premier biomedical research institution in the United States 2009 Annual Budget: $30.5 billion Basic & clinical research discoveries Partners commercialize into products National Institutes of Health NIH Office of Technology Transfer5Science. Ideas. Breakthroughs.

6. Global Perspective for Health Research & Technology Transfer at Federal Labs NIH Office of Technology Transfer6 Humanitarian Objectives Humanitarian Objectives Globalization of Health Problems and Their Relevance to Domestic Health Globalization of Health Problems and Their Relevance to Domestic Health Economic Development and Political Stability Economic Development and Political Stability Science. Ideas. Breakthroughs.

7. Supporting Research Worldwide Over 80% of the NIH budget Over 50,000 awards annually 325,000 extramural researchers (mostly universities) Over 3,000 research organizations Extramural Research NIH Office of Technology Transfer7Science. Ideas. Breakthroughs.

8. Intramural Research Biomedical Research and Training Approximately 10 % of NIH budget More than 2,000 active projects More than 6,000 scientists Collaborative research Patent/License technologies NIH Office of Technology Transfer8Science. Ideas. Breakthroughs.

9. Development and Transfer Activity Intramural Research (from the NIH Office of Technology Transfer) University Grantee Research (from specific university technology transfer offices) SBIR and STTR Programs (from small business awardees) Future Commercial Products Licensable From Several Sources NIH Office of Technology Transfer9Science. Ideas. Breakthroughs.

10. Benefit the public health & well-being Utilize IPR appropriately as incentive for commercial development of technologies Attract new R&D resources Obtain return on public investment Stimulate economic development Goals For Federal Intramural Technology Transfer NIH Office of Technology Transfer10Science. Ideas. Breakthroughs.

11. Technology Transfer at Federal Intramural Labs NIH Office of Technology Transfer11Science. Ideas. Breakthroughs. Evaluate inventions for patenting Work closely with inventors Manage patent & invention portfolio Identify commercial partners & negotiate licenses & collaboration agreements Manage relationships with commercial partners

12. Novel, fundamental research discoveries Research tools CRADA partnerships for basic or clinical studies Selected products in early clinical studies Licensees do nearly $6 billion annually in sales Characteristics of the NIH Intramural Research Program “Pipeline” NIH Office of Technology Transfer12Science. Ideas. Breakthroughs.

13. NIH/FDA Intramural Portfolios (FY-2009) NIH Office of Technology Transfer13Science. Ideas. Breakthroughs. 353 invention disclosures 110 U.S. patents issued 215 licenses executed 1,400+ active licenses $91.2 million in royalties collected

14. 77 CRADAs executed (NIH only) 365 active CRADAs (NIH only) ~600 products developed to date (25 FDA approved) $1B in royalties collected to date NIH Office of Technology Transfer 14Science. Ideas. Breakthroughs. NIH/FDA Intramural Portfolios (FY-2009)

15. Seek patent protection if: facilitates availability of the technology for preventive, diagnostic, therapeutic, or other commercial use further research and development is necessary to realize the technology’s primary use commercial or public health value of the technology warrants the expenditure of funds research has a practical utility or a reasonable expectation of future practical utility Do not seek patent protection if: Commercialization and technology transfer can best be accomplished without patent protection NIH Patenting Principles NIH Office of Technology Transfer15Science. Ideas. Breakthroughs.

16. Granting only the appropriate scope of rights Permit research uses Preference for non- or partial exclusivity Specified fields of use Enforceable milestones and benchmarks Maximize development of products for the public health Ensure appropriate return on public investment NIH Product Licensing Principles NIH Office of Technology Transfer16Science. Ideas. Breakthroughs.

17. Synagis® Taxol® Velcade® Videx® Vitravene® Zenapax® Zevalin® Therapeutics Didanosine Fludara® Hivid® Kepivance® NeuTrexin® Prezista® Sporanax® NIH Licensed Products NIH Office of Technology Transfer17Science. Ideas. Breakthroughs.

18. NIH Licensed Products Vaccines Certiva® Cervarix® Gardasil® Havrix® Hepatyrix® LYMErix™ RotaShield® Twinrix® NIH Office of Technology Transfer18Science. Ideas. Breakthroughs.

19. Diagnostics AcuTect® BRACAnalysis® HIV Test Kits NeoTect® NIH Licensed Products Parvovirus B19 Immunoassay PathVysion® HER-2 DNA Probe Kit Pathway® Her-2/neu (4B5) Thyrogen® NIH Office of Technology Transfer19Science. Ideas. Breakthroughs.

20. NIH Licensed Products Consumer Products Devices/ Instrumentation/ Software Research Reagents Veterinary Products We invite you to view the Product Showcase at our website to learn more about these licensed products, as well as many others not listed in the preceding slides. Look for this icon on our homepage. NIH Office of Technology Transfer20Science. Ideas. Breakthroughs.

21. Collaboration between Government lab and outside party Government provides expertise, equipment, materials Collaborator provides same and possibly money Provides Collaborator with right to elect option to exclusive license to new inventions CRADA – Cooperative Research and Development Agreement NIH Office of Technology Transfer21Science. Ideas. Breakthroughs.

22. Examples of Products Developed Under NIH CRADAs NIH Office of Technology Transfer22Science. Ideas. Breakthroughs.

23. NIH Marketing Efforts OTT Licensing Opportunities – Searchable database http://www.ott.nih.gov/http://www.ott.nih.gov/search – Technologies RSS Feed http://www.ott.nih.gov/rss – Federal Register http://www.gpoaccess.gov/fr/advanced.html CRADA Opportunities RSS Feed http://www.ott.nih.gov/rss/cradarss.xml NIH Office of Technology Transfer23Science. Ideas. Breakthroughs.

24. NIH Marketing Efforts Interactive Technology Transfer Metrics http://www.ott.nih.gov/ttmetrics/ NIH Lights Up The World http://www.ott.nih.gov/gis/ Pipeline to Partnerships (P2P) http://www.ott.nih.gov/p2p/ Product Development Pipeline http://www.ott.nih.gov/productpipeline/ Product Showcase http://www.ott.nih.gov/productshowcase/ NIH Office of Technology Transfer24Science. Ideas. Breakthroughs.

25. For Additional Information on NIH and OTT NIH http://www.nih.gov OTT http://www.ott.nih.gov NIH Office of Technology Transfer25Science. Ideas. Breakthroughs.