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Products, Partners & Public Health: C Commercializing i li i New N Technologies From Intramural NIH Steven M. Ferguson Deputy Director, Director Licensing & Entrepreneurship NIH Office of Technology Transfer HHS Email: sf8h@nih go

In biomedical research, research we’d like to think that all roads will eventually l d to lead t Bethesda‌

NIH – U.S. U S National Medical Research Agency • • • •

Annual budget of $ 30.9 billion (FY12) 10% of funding for intramural research , intramural scientists / 18,000 , staff / 2,000 , projects p j 6,000 325,000 extramural scientists /50,000 grants / 3,000 organizations • Basic & clinical research discoveries • Partners P commercialize i li into i products d

The National Institutes of Health 27 Institutes and Centers NLM NINR NINDS

















National Institutes of Health Support pp off Biomedical Research to Benefit Public Health

• Funding

• Clinical Trials

• Training

• Inventions

• Basic Research

• Policies

Why NIH Intramural Research Programs Are Attractive For Commercial Licensors • Novel, fundamental research discoveries • “Supermarket” for research tools y available for basic or • Collaborations ggenerally clinical (applied) studies • Selected projects in early clinical development • Licensees do $6B in annual sales

Goals For Intramural NIH Technology Transfer Programs • Benefit the public health • Utilize IP appropriately as incentive for commercial development p of technologies g • Attract new R&D resources • Obtain public return on public investment • Stimulate Stim late economic development de elopment

Future Commercial Products Licensable From Several Sources • Intramural Research (from the NIH Office of Technology Transfer) p • Universityy Grantee Research ((from specific university technology transfer offices) • SBIR and STTR Programs (from small business awardees) • New SBIR –TT TT Program (combines SBIR award & intramural license agreement)

Intramural NIH Basic & Clinical Research Collaborations

Intramural NIH Research Collaboration Mechanisms • Material Transfer Agreement (MTA) - non-profit • Cooperative Research And Development Agreement (CRADA) - for-profit • Clinical Trial Agreement • Specialized Development Services • Training Programs y collaborations • Informal “official duty”

CRADA - Cooperative Research and Development Agreement • Collaboration between Government lab & outside party • Government provides expertise, equipment & materials • Collaborator C ll b provides id same andd possibly ibl money • Provides Collaborator with right to elect exclusive option to new inventions

Industry Interactions With NIH Intramural Scientists • Collaborations should be “official duty” projects • Informal -- uncompensated p • Formal (CRADAs, CTAs) -- uncompensated

• Financial Fi i l support from f company is i to institution i i i only l • Public-Private-Partnerships via FNIH • Lab funding (under CRADA) • Royalty income under licenses (shared with inventors)

Technology Licensing At NIH

NIH Product Licensing Principles • • • • •

Granting only the appropriate scope of rights Permit research uses Preference for non or partial exclusivity S ifi d fields Specified fi ld off use Enforceable benchmarks

Typical Types Of Royalties In NIH Intramural Licenses • Execution Royalty • Minimum Mi i Annual A l Royalty R lt (regardless ( dl off the th amount of Net Sales • Earned Royalties (fixed % of Net Sales) y • Benchmark Royalties • Patent Costs • Equity (?)

Typical Factors Influencing Royalty Rate Negotiations • St Stage off Development D l t • Type of Product • Market Value of Product • Uniqueness of Materials

• S Scope off P Patent t t Coverage • Market Timing • “Content” in Final Product • Public Health

Research Products Licensed From NIH

Typical i l Researchh Products d License i (Commercialization) • • • • • •

Non-exclusive Non exclusive Materials provided (patented or unpatented) S ll firms Smaller fi predominate d i t as licensees li High earned royalty rates Low upfront costs Products: CHAPS, antisera, mabs

Typical i l Researchh Products d License i (Internal Use) • • • • • •

Non-exclusive Materials provided / screening use permitted No reachh through h h to products d Larger firms predominant Paid-up term licenses or annual fees Products: muscarinic receptors

Diagnostic & Therapeutic Products Licensed From NIH

Typical i l Vaccine, i Diagnostic i i Or O Therapeutic License • • • • • •

Exclusive if required for development Most major pharma or biotech have at least one D t il d development Detailed d l t plan l with ith benchmarks b h k Preference for capable small firms CRADA research separate from license U.S. manufacturing for U.S. product sales

Typical T i l Vaccine, V i Diagnostic Di ti Or O Therapeutic p License ((Cont.)) • • • • • •

Substantial upfront p fees Moderate earned royalties Appropriate benchmark payments Share sublicensing payments “White Knight” (public benefit) provisions Monitor pperformance of licensee

Old NIH ““Homerun”” Licensed Older i d Products • • • • • •

Abbott BMS BMS Schering GlaxoSKB Roche

HIVAB ((AIDS Test Kit)) Videx (ddI) Taxol (paclitaxel) Fludara (fludarabine) Havrix (hepatitis A) ( ) Hivid (ddC)

M More R Recentt Product P d t Approvals A l • • • • • • •

Angiotech Genzyme Isis Medimmune Millennium Biogen Idec Amgen

Taxus (paclitaxel-eluting stents) Thyrogen (rTSH) Vitravene (antisense CMV) Synagis (RSV mab) Velcade (myeloma drug) Zevalin (NHL I131 mab) Kepivance i (KGF) ( )

AcuTect AIDS Test Kit Beaucage Reagent BRCA1 Diagnostic Certiva Certiva CHAPS Fludara Fecolator Havrix ImmunoWELL® Matrigel® Invasion Chamber Mirakelle NeuTrexin® ParaSightF PixCell Soluble Interleukin-2 Receptor Squirrel Free Seed Saver Synagis Taxol® Thyrogen TransProbe Thyrogen TransProbe-1® 1® Videx® Vitravene

NIH Licensing Portfolio > 600 products developed to date ((25 vaccines and therapeutics) p ) Over 84% licenses – non-exclusive Over 86% licenses – U.S. firms O Over 52% li licenses – small ll companies i Annual Sales Byy Licensees – nearlyy $6B

NIH Technology Portfolio • 351 invention disclosures per year (FY11) • ~3500 total p pending/issued g patents p (131 U.S. Patents issued FY11) • ~1300+ 1300+ active ti li licenses (197 executed t d FY11) • $ $96.9 million in royalties y collected FY11 • 68 CRADAs executed FY11

Pilot Program In FY12: E Express Start-up St t Li License Agreements A t For Small Companies p • Up to 50 employees, in business up to 5 years with raised i d capital i l up to $5M $ • For vaccine, drugs or other therapeutics • 1 year option agreement for $2K • Convertible to exclusive license with heavily deferred financial terms • Financial terms pre pre-set set

New In FY11: SBIR-Technology gy Transfer (TT) Contract Awards • Pilot study from National Cancer Institute (NCI) and the h NIH Offi Office off Technology h l Transfer f (OTT) (O ) • Out-licensing bundles with SBIR funding to move inventions from intramural NIH to the market g at NIST • Pilot is based on the successful pprogram • In FY11, two SBIR-TT “Requests For Proposals” (RFPs) were guaranteed funding & published • Program is being expanded to other NIH SBIR offices

C ll b ti Collaborations on SBIR-TT SBIR TT Contracts C t t  NIH labs can collaborate under many different formats p y can exchange g knowledge g with the NIH researcher  Company  Company can utilize fixed asset resources at NIH Company p y cannot contact NIH researchers pprior to contract award p y cannot rely y on the NIH lab to pperform the majority j y Company of the effort being proposed for the SBIR contract Company cannot fund work in NIH lab using SBIR money under a CRADA

The SBIRSBIR TT Internal Use License • “Royalty-free, non-exclusive” internal use license ggiven with SBIR-TT award pperiod • SBIR-TT research completed without infringement of NIH patents • Internal R & D allowed using the invention, but not sales of the final commercial product

The SBIR-TT Commercialization License • Need to develop NIH invention into a commercial product that benefits the public • Commercialization license required to sell product (if issued IP claims) and/or requested (if only pending claims) • Commercialization license also required for each SBIR-TT Phase II topic • License terms are negotiable

• • • • •

For internal use license agreements Select materials for licensing from on-line catalog Clickable license agreement (with terms) available Payments y e s made de through oug www.p ((likee PayPal) y ) Faster means of getting materials for corporate R&D

How To Find Technologies • NIH/FDA Licensing Opportunities – iPhone app pp

– Searchable database

– Technologies RSS Feed

– Neglected Diseases

– Rare Diseases http://www ott nih gov/rd

– Federal Register

• CRADA Opportunities RSS Feed

NIH: Products Products, Partners & Public Health since 1887

• NIH Information: • Office of Technology Transfer:


Products, Partners & Public Health: C ilii N Commercializing New TechnologiesFromIntramuralNIH Technologies From IntramuralNIH Steven M....

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