An Overview of NIH Licensing Mojdeh Bahar, J.D., M.A. Technology Licensing Specialist Office of Technology Transfer National Institutes of Health U.S. Department of Health & Human Services FLC Eastern Shore March 12, 2008

NIH Mission To uncover new knowledge that will lead to improved public health

Office of Technology Transfer ? Located in the Office of Intramural Research which is in the Office of the Director, NIH ? Director: Mark Rohrbaugh, Ph.D., J.D. ? Staff of ~65 persons – Ph.D., J.D., M.B.A. ? 14 patent contract firms

Technology Development at the Institutes and Centers Offices in Institutes and Centers Offices in Institutes and Centers Technology Development Coordinators Technology Development Coordinators Work closely with scientists Work closely with scientists Provide scientific and programmatic input into licensing and patenting decisions by OTT Provide scientific and programmatic input into licensing and patenting decisions by OTT Negotiate Collaborative Agreements, CTAs, MTAs Negotiate Collaborative Agreements, CTAs, MTAs Royalties flow back to support further research Royalties flow back to support further research

OTT Goals Benefit the public health Benefit the public health Utilize IPR appropriately as incentive for commercial development of technologies Utilize IPR appropriately as incentive for commercial development of technologies Attract new R&D resources Attract new R&D resources Obtain return on public investment Obtain return on public investment Stimulate economic development Stimulate economic development

NIH/FDA Intramural Portfolios (2007) 419 invention disclosures 419 invention disclosures 117 U.S. patents issued 117 U.S. patents issued 3,400+ total pending/issued patents 3,400+ total pending/issued patents 264 licenses executed 264 licenses executed active licenses active licenses $87.7 million in royalties collected $87.7 million in royalties collected 44 CRADAs executed (NIH only) 44 CRADAs executed (NIH only) 222 active CRADAs 222 active CRADAs

NIH/FDA Intramural Portfolios ~200 products developed to date (24 vaccines and therapeutics) Over 79% licenses – non-exclusive Over 85% licenses – U.S. firms

NIH Licensed Products AcuTect  AIDS Test Kit Alfaxan ® injectable anaesthetic for cats/dogs Apodasi  (ddI) Beaucage Reagent BIOMAX Multi-Blot Kit BRCA1 Diagnostic Certiva  CHAPS Gardasil® Generic ddI delayed-release capsules Fludara ® Fecolator Havrix ® ImmunoWELL ® Kepivance  KLEPTOSE ® (betacyclodextrin) Matrigel ® Invasion Chamber Mirakelle  NeoTect  NeuTrexin ® Ocuvite ® PreserVision  ParaSight F  Parvovirus B19 enzyme immunoassay PathVysion  Prezista™ HER-2 DNA Probe Kit PixCell  Soluble Interleukin-2 Receptor SPORANOX ® oral solution Squirrel Free  capsaicin-treated birdseed Synagis  Taxol ® TAXUS  coronary stent system Thyrogen  TWINRIX ® TransProbe-1 ® Velcade  Videx ® Vitravene  ZENAPAX ® ZEVALIN 

Characteristics of the NIH Intramural Research Program “Pipeline” ? Novel, fundamental research discoveries ? Research Tools ? CRADA partnerships for basic or clinical studies ? Selected products in early clinical studies ? Licensees do over $4.7 billion in sales

Patenting Policy 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 Product Licensing Principles ? 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 License Types ? Exclusive Patent Commercialization ? Non-exclusive Patent Commercialization ? Non-exclusive Patent Internal Use ? Commercial Evaluation License ? Biological Material Commercialization ? Biological Material Internal Use ? Interference or Dispute Settlement ? Inter-institutional

Marketing Efforts Synapse™: Our new technology matching tool Pipeline to Partnerships (P2P): virtual space for NIH licensees and NIH SBIR/STTR awardees to showcase technology and product development for an audience of potential strategic partners and investors Rare Diseases and Conditions Page: A listing of technologies related to rare diseases or conditions available for commercial licensing are listed under the related disease or condition

OTT/NIH Contacts NIHhttp:// OTThttp:// Science. Ideas. Breakthroughs.