NIH TECHNOLOGY TRANSFER Mark L. Rohrbaugh, Ph.D., J.D. Director Office of Technology Transfer National Institutes of Health U.S. Department of Health & Human Services RCN, Oslo 22 June 2006

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

Importance of Global Health Research Humanitarian Objectives Globalization of Health Problems and their Relevance to Domestic Health Economic Development and Political Stability

CSR NCMHD NIGMS NLM FIC NCCAM NIBIB The National Institutes of Health 27 Institutes and Centers NIDCDNHGRI NHLBI NIDCR NINR NINDS NEI NCI NIA NIMH NIAID NIDA NIEHS NIDDK NIAMS NIAAA CC NICHD NCRR CIT

Extramural Research Over 80% of the NIH budget Over 46,000 grant and contract awards annually 35,000 Extramural researchers (mostly universities) Over 3,000 organizations

Extramural Research Resources Databases – long-term health surveys, genomics Grants and Contracts Repositories – Reagents, tissues and Compound databases Screening – In Vitro and Animal models Pharmacology and Toxicology testing Formulation and Manufacturing Clinical Research Lab Technology Clinical Trials

Intramural Research Approximately 10% of NIH Budget More than 2,000 active projects More than 6,000 scientists Breakthrough Technologies/Therapies

Technology Transfer at NIH  Office of Technology Transfer  Patenting, Licensing, Monitoring, Policy  Offices in Institutes and Center  Technology Development Coordinators  Collaborative Agreements, CTAs, MTAs  Royalties flow back to ICs

Collaborating with NIH Scientists Material Transfer Agreements Clinical Trial Agreements CRADAs

CRADA -- Cooperative Research and Development Agreement Collaboration between Government lab and outside party Government provides expertise, equipment, materials Collaborator provides same and possibly money Provides Collaborator with right to elect exclusive option to new inventions

NIH Office of Technology Transfer Patenting and Licensing New Inventions

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

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

License Characteristics By law, licensing of NIH inventions must favor small US businesses with US manufacturing requirement (for US product sales) 84% licenses – non-exclusive 86% licenses – U.S. firms 52% licenses – small companies

Selected FDA Approved Products Vitravene Isis antisense (CMV) Zevalin Coulter/IDEC radioimmunotherapy NHL Velcade Millennium therapeutic for MM Angiotech Taxus Express paclitaxel-eluting stent Merck Gardasilvaccine for HPV

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 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  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 

Portfolio  2500 patents pending and issued  More than 1500 active licenses  Cooperative Research and Development Agreements (CRADAs)  1612 CRADAs executed FY88-05 to350 companies  240 CRADAs still active  About 200 products (including research tools) on the market, 24 FDA approved to date  FY05 $98M royalties  Licensees do over $4.7 billion in sales

Recent Int’l License Approaches  ddI – PROTEIN, S.A. de C.V., MEXICO  Conjugated Meningococcal Vaccine – PATH and WHO, produced in India for distribution in Sub-Saharan Africa, Latin America, Caribbean, Middle East, Eastern Europe and Asia  Conjugated vaccine against typhoid fever to the International Vaccine Institute (IVI) based in Korea and to be produced in partnership with a public institution in Indonesia and a private entity in India for distribution in Southeast Asia  Human-Bovine Rotavirus Vaccine proposed multi-licensing approach (9 institutions in India, China, Brazil, and the US)  Vericella-Zoster virus vaccine (chicken pox, shingles): Vacsera (Egypt)  Thymosin β4 to promote hair growth: Panacea (India) and Lee’s Pharmaceuticals (Hong-Kong, China)

OTT has already transferred technologies to, or has negotiations in process with:  Brazil  China  Egypt  India  Indonesia  Korea  Mexico  South Africa  Tunisia

NIH Contacts NIHhttp:// OTThttp://ott.od.nih.govhttp://ott.od.nih.gov Clinical Trials CRISPhttp://crisp.cit.nih.govhttp://crisp.cit.nih.gov PubMed PubChem Science. Ideas. Breakthroughs.