An Overview of NIH An Overview of NIH Licensing Licensing

Mojdeh Bahar, J.D., M.A.Mojdeh Bahar, J.D., M.A.Technology Licensing SpecialistTechnology Licensing SpecialistOffice of Technology TransferOffice of Technology TransferNational Institutes of HealthNational Institutes of HealthU.S. Department of Health & Human ServicesU.S. Department of Health & Human Services

FLC Eastern ShoreMarch 12, 2008

NIH MissionNIH Mission

To uncover new knowledge To uncover new knowledge that will lead to improved that will lead to improved

public healthpublic health

Office of Technology TransferOffice of Technology Transfer

Located in the Office of Intramural Located in the Office of Intramural Research which is in the Office of the Research which is in the Office of the Director, NIHDirector, NIH

Director: Mark Rohrbaugh, Ph.D., J.D. Director: Mark Rohrbaugh, Ph.D., J.D.

Staff of ~65 persons – Ph.D., J.D., M.B.A.Staff of ~65 persons – Ph.D., J.D., M.B.A.

14 patent contract firms14 patent contract firms

Technology Development at the Technology Development at the Institutes and CentersInstitutes and Centers

Offices in Institutes and CentersOffices in Institutes and Centers Technology Development CoordinatorsTechnology Development Coordinators Work closely with scientistsWork closely with scientists Provide scientific and programmatic input into licensing Provide scientific and programmatic input into licensing

and patenting decisions by OTTand patenting decisions by OTT Negotiate Collaborative Agreements, CTAs, MTAsNegotiate Collaborative Agreements, CTAs, MTAs Royalties flow back to support further researchRoyalties flow back to support further research

OTT GoalsOTT Goals Benefit the public healthBenefit the public health

Utilize IPR appropriately as incentive for Utilize IPR appropriately as incentive for commercial development of technologiescommercial development of technologies

Attract new R&D resourcesAttract new R&D resources

Obtain return on public investmentObtain return on public investment

Stimulate economic developmentStimulate economic development

NIH/FDA Intramural Portfolios NIH/FDA Intramural Portfolios (2007)(2007)

419 invention disclosures 419 invention disclosures

117 U.S. patents issued 117 U.S. patents issued

3,400+ total pending/issued patents3,400+ total pending/issued patents

264 licenses executed 264 licenses executed

1300+ active licenses 1300+ 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 CRADAs222 active CRADAs

NIH/FDA Intramural PortfoliosNIH/FDA Intramural Portfolios

~200 products developed to date ~200 products developed to date (24 vaccines and therapeutics)(24 vaccines and therapeutics)

Over 79% licenses – non-exclusiveOver 79% licenses – non-exclusive

Over 85% licenses – U.S. firmsOver 85% licenses – U.S. firms

NIH Licensed ProductsNIH 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 Characteristics of the NIH Intramural Research Program “Pipeline”Research Program “Pipeline”

Novel, fundamental research discoveriesNovel, fundamental research discoveries Research Tools Research Tools CRADA partnerships for basic or clinical studiesCRADA partnerships for basic or clinical studies Selected products in early clinical studiesSelected products in early clinical studies Licensees do over $4.7 billion in salesLicensees do over $4.7 billion in sales

Patenting PolicyPatenting PolicySeek patent protection if:Seek patent protection if:

facilitates availability of the technology for preventive, diagnostic, facilitates availability of the technology for preventive, diagnostic, therapeutic, or other commercial usetherapeutic, or other commercial use

further research and development is necessary to realize the further research and development is necessary to realize the technology’s primary usetechnology’s primary use

commercial or public health value of the technology warrants the commercial or public health value of the technology warrants the expenditure of fundsexpenditure of funds

research has a practical utility or a reasonable expectation of future research has a practical utility or a reasonable expectation of future practical utilitypractical utility

Do Do notnot seek patent protection if: seek patent protection if:

Commercialization and technology transfer can best be accomplished Commercialization and technology transfer can best be accomplished without patent protectionwithout patent protection

NIH Product Licensing PrinciplesNIH Product Licensing Principles

Granting only the appropriate scope of rightsGranting only the appropriate scope of rights

Permit research usesPermit research uses

Preference for non or partial exclusivityPreference for non or partial exclusivity

Specified fields of useSpecified fields of use

Enforceable milestones and benchmarksEnforceable milestones and benchmarks

Maximize development of products for the Maximize development of products for the public healthpublic health

Ensure appropriate return on public investmentEnsure appropriate return on public investment

NIH License TypesNIH License Types Exclusive Patent Exclusive Patent

CommercializationCommercialization

Non-exclusive Patent Non-exclusive Patent CommercializationCommercialization

Non-exclusive Patent Non-exclusive Patent Internal UseInternal Use

Commercial Evaluation Commercial Evaluation LicenseLicense

Biological Material Biological Material CommercializationCommercialization

Biological Material Biological Material Internal UseInternal Use

Interference or Interference or Dispute SettlementDispute Settlement

Inter-institutionalInter-institutional

Marketing EffortsMarketing Efforts

SynapseSynapse™™: Our new technology matching tool: Our new technology matching tool http://www.ott.nih.gov/synapsehttp://www.ott.nih.gov/synapse

Pipeline to Partnerships (P2P): virtual space for NIH licensees and NIHPipeline to Partnerships (P2P): virtual space for NIH licensees and NIHSBIR/STTR awardees to showcase technology and product development for SBIR/STTR awardees to showcase technology and product development for an audience of potential strategic partners and investors. an audience of potential strategic partners and investors.

http://www.ott.nih.gov/p2phttp://www.ott.nih.gov/p2p

Rare Diseases and Conditions Page: A listing of technologies related to rare Rare Diseases and Conditions Page: A listing of technologies related to rare diseases or conditions available for commercial licensing are listed under the diseases or conditions available for commercial licensing are listed under the related disease or condition. related disease or condition.

http://http://www.ott.nih.gov/rarediseaseswww.ott.nih.gov/rarediseases

OTT/NIH ContactsOTT/NIH Contacts

NIHNIH http://www.nih.govhttp://www.nih.gov

OTTOTT http://www.ott.nih.govhttp://www.ott.nih.gov

Science. Ideas. Breakthroughs.