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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.gov 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

CC

CIT CSR FIC

NIMH

NCCAM

NIGMS

NCI

NIEHS

NCMHD

NIDDK

NCRR

NIDCR

NEI

NIDCD

NHGRI NHLBI

NIDA NICHD NIBIB NIAMS

NIA NIAAA NIAID


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 www.pay.gov y.gov ((likee PayPal) y ) Faster means of getting materials for corporate R&D


How To Find Technologies • NIH/FDA Licensing Opportunities – iPhone app pp http://itunes.apple.com/us/app/nih-ott-licensing-opportunities/id401257307?mt=8#

– Searchable database http://www.ott.nih.gov/search

– Technologies RSS Feed http://www.ott.nih.gov/rss

– Neglected Diseases http://www.ott.nih.gov/nd

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

– Federal Register http://www.gpo.gov/fdsys/browse/collection.action?collectionCode=FR

• CRADA Opportunities RSS Feed http://www.ott.nih.gov/rss/cradarss.xml


NIH: Products Products, Partners & Public Health since 1887

• NIH Information: www.nih.gov • Office of Technology Transfer: www.ott.nih.gov


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