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X0*?@8ʚ;Sk8ʚ;g4MdMd3  0Lppp@ <4!d!d w 0T 3 <4dddd w 0T 3 <4BdBd w 0T 3  Kh___PPT2001D<4X9___PPT10 6___PPT9t/ 0X@? %JHeHWTop non-US Recipients of NIH Grant Funds by Country (cum. avg  02- 05)*HH: w Australia $85.2M/year Canada $46.6M/year UK $40.7M/year China $ 4.3M/year France $ 3.8M/year Germany $ 2.0M/year ,ZwZw$XhThe law that started it all& the Bayh-Dole Act (1980)55  Universities can own, manage & profit from inventions made using federal funds Univ tech transfer offices established (not required) New university mission: commercialization (alongside traditional education & research mandates)  Irrational exuberance ensues& .startups/spin-outs, job creation, fame & fortune for everyone!EZEO1Universities & Gov. Labs Transfer Technology to:22(Facilitate commercialization of research results for the public good (VERY important to NIH) Reward, retain, and recruit scientists Induce closer ties to industry Promote economic growth (preferable locally/regionally! A key mandate for many universities) Generate income (not so important to NIH-any royalty $ is  icing on the cake ; VERY IMPORTANT TO UNIVERSITIES).oP9 3+U#Government Tech Transfer Definition$$(:  Technology transfer is the process by which existing knowledge, facilities or capabilities developed under federal research and development funding are utilized to fulfill public and private needs. Can be a simple process or can be very complex: NIH s prefers the KISS (=keep it simple stupid) mantra Through the TT process federal labs share the benefits of the national investment in R&D with society ZZ173fV"National Institutes of Health(One of the world s premier biomedical research centers//engine for biomedical research & innovation 27 Institutes, Centers and Divisions (ICDs) FY2006 budget of ~$29B; intramural budget ~$3B Extramural (univ., hospitals, etc.) = 60,000 awards to 3,000 organiz./year) Intramural (on campus) = 18,000 employees; 5,000 MDs and PhDs; 2000+ intramural R&D projects Collaborate w/ public and private sector scientists Technologies & inventions available for licensing.iZfZif>>-b NIH Intramural Patent Principles,!( (*(Generally, NIH will NOT Patent if: No further R&D is needed (ex. Research Tools) Low Public Health Priority and/or lack of commercial interest Patenting will hinder technology transfer/access to inventions Generally, NIH will Patent if: High Public Health Priority (even if there isn t commercial interest) Patenting will Facilitate access to technology Necessary for Investments in R&D #Z0ZZZ0ZZ   %NIH Licensing PrinciplesPublic Health Benefits = top goal of licensing program NIH expects speedy Commercial Development by Licensees NIH grants only the Appropriate Scope of Rights within license agreement (e.g. specified fields of use and benchmarks) NIH tries to optimize number of New Products (= non-exclusive licensing is preferred) NIH insists that Technology remains available for its own Research Use; also Licensees must permit research uses by others NIH is willing to be creative for orphan/neglected diseases and deals done with developing countries NIH negotiates for a Financial Return (& the bottom line isn t so important. Really!!)&rP7*;&NIH Portfolio = Early-Stage(0Novel, fundamental research discoveries  Supermarket for research tools; few drug or near-product candidates >1500 active licenses; >2000 issued or pending patents Product sales by licensees exceed $3B/yr NIH royalties $100M in FY2005 ~200 technologies on the market Only 15 are vaccines or therapeutics >80% of Licenses are Non-Exclusive (note: this is exactly the opposite of what happens in academia) Only 2 to 3 of 27 NIH Institutes are in the  black for TT income vs. TT costs in a given year PP P%PPJ%*` %b*aQ hNIH  Homerun Licensed Products: Few and Far Between55$Abbott HIV AB (AIDS Test Kit) BMS Videx (ddI) BMS Taxol (paclitaxel) Schering Fludara (fluarabine) GSK Havrix (hepatitis A) Roche Hivid (ddC)U=YNIH TT and e-ResearchWe utilize several technology matching and related web-based tools Synapse"! Pipelines to Partnerships (P2P) Dedicated Neglected disease and Rare Disease  available technologies web sites (includes NIH & non-NIH inventions) We love CAMBIA s wonderful Patent Lens database (www.patentlens.org) Reality unlike Universities we rarely seek to license or commercialize software or informatics tools No copyright protection is available for  government works Most of our databases, software solutions and bioinformatics tools to could be categorized as  Research Tools Easiest to make these technologies freely available in the public domain (we probably should use the Creative Commons Attribution-Noncommercial-Sharealike license instead of simply dumping everything on the web) CP PeP P PC"e  >! >[WNIH Strategy for Ensuring Accessibility and Affordability of Gene/DNA-based DiagnosticsXX 02Publish (place in public domain) Execute 10 non-exclusive licenses for human disease gene/diagnostic-type inventions Give limited field(s) of use and include mandatory sub-licensing provisions in exclusive licenses Developed  Best Practices guidance document for use by Grantees** \;NIH Best Practices for the Licensing of Genomic Inventions << Include provisions for mandatory sublicensing by exclusive licensees Avoid direct licensing to virtual developers Negotiate and execute  narrow exclusive licenses for specific indications, technology platforms or fields of use and/or territories if exclusivity is needed Include developmental milestones/benchmarks & performance-based royalty payments Monitor & enforce terms|Z|]dAUTM White Paper: In the Public Interest: Nine Points to Consider in Licensing University Technologyee A sensible, thoughtful & balanced approach that might just work! Some overlap with NIH Best Practices Technology-neutral (however diagnostic tests are specifically mentioned) Signed by big name universities (big in research, big in reputation and big in royalty income) Endorsed by AUTM and AAMC (so far) Just released 3/6/2007 partially a response to recent negative press ( The Kept University,  The Trouble with Tech Transfer and criticism of Bayh-Dole Act)P ^!In the Public Interest Highlights"" Reserve the right to practice licensed inventions for research and education use for non-profits and gov orgs Licenses should NOT hinder clinical research, professional education and training, use by public authorities or independent validation of test results Licensing of a single gene for a diagnostic may be counterproductive Avoid broad exclusive licenses; only give those rights necessary to encourage commercial development Ensure broad access to research tools BnPPPneo_@Options for Other Government Agencies & Universities to ConsiderAA"Adopt NIH best practices for licensing of inventions such as: Non-exclusive licensing whenever possible Limit exclusive licensing to products that will not be commercialized without period of exclusivity Adhere to White Paper recommendations from  In the Public Interest: Nine Points to Consider in Licensing University Technology Consider adding BiOS-complaint license options (see www.cambia.org) and other open source-type licenses to agreement toolbox F>>*] <$ 0R )Measures of Biomedical TT Program Success**(qTraditional Metrics Employee Invention Reports Patents filed/issued Licenses Royalty income # start-ups/spin-outs(^^ Mission-Specific Metrics 1st-in-kind drugs and vaccines Hospitalization rates Mortality rates Orphan Drug Status Patients Quality of LifeBr oS <NIH-Derived Commercial Product Case Studies with New Metrics== Success Stories web page http://ott.od.nih.gov/about_nih/success_stories.html Example: Synagis: Helping Infants and Parents Breathe Easier Given to Congress, NIH leadership and the public to demonstrate Value of TT in achieving NIH mission Public benefit of TT Positive outcomes of NIH research Take focus away from $ (modest royalty income for NIH) and shine a spotlight on true Public Health Impact Given to potential collaborators and licensees PR/marketing toolzPuP@PPAP6?@A4- v 0M`For more NIH information([Technology Transfer Office, NHGRI Building 12A Room 1033 tel: (301) 402-2537/ (301) 594-2235 fax: (301) 402-9722 e-mail: cdriscol@mail.nih.gov http://www.genome.gov NHGRI technologies technology transfer information sources electronic mail links to staff http://ott.od.nih.gov All NIH technologies On-line technology transfer training module"ZqZZ[ZZAZ"qYA  J9@]B! 0|" 0# 0/p)+a!c"  0` 33PP` 3333` ___MMM` 13` 333fpKNāvI` j@v۩ῑ΂H` Q_{>?" dd@,??d@ d* n2@`7``2 n?" dd@   @@``PR    @ ` ` p>>L0    (  |F b " `Y  <H3 "iVn F    T43 d" F    <l 3 "PZ F    T1 d"`| F    N1 "b2< F    <1 "BqI F    C x1 ?d?"y F     61  "P` 1  T Click to edit Master title style! !$   01  "  1  RClick to edit Master text styles Second level Third level Fourth level Fifth level!     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Driscoll Director, Technology Transfer Office National Human Genome Research Institute National Institutes of Health (NIH)K  0 (  \  Technology Transfer Policies and Practice at the U.S. National Institutes of Health E-Research Conference Surfers Paradise, Australia July 11, 2007:V @U$0AB  s *޽h ? 33f3f3y___PPT10Y+D=' ( = @B +Q  0L0 PH (  ~  s * 3  P`  3  ~  s *pK3  PpI 3     `xF3  ??3 *Direct funding numbers only; does not include  sub grant/ indirect funding streams from primary granteesm mH  0޽h ? 3333___PPT10i.X+D=' ( = @B +  0L0  (  ~  s *h(  P`  (  x  c $@(     (    s *Ч(  0 0 (  @Z v  C NA6BayhDole_naturebiotech2006` v   THO  ??  /Senators Birch Bayh (D-IN) & Robert Dole (R-KS)0 20H  0޽h ? 33PP___PPT10i.h` =+D=' ( = @B +G  0L0 VNp(    02   N ,$?$x  c $T2  P`  2  x  c $2  p  2  H  0޽h ? ̙33y___PPT10Y+D=' ( = @B +  0L0  0(  x  c $LJs 00  s x  c $$Ks   s H  0޽h ? 33PP___PPT10i.:+D=' ( = @B +B 0L0 QI (    6  p@ `XP___PPT92*  University TT programs provide: Service functions (invention eval./patenting; handling of MTAs, collab. 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