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OfficeofTechnologyManagement
ChristineE.Flynn,Ph.D.AssociateDirector,Licensing&NewVentureDevelopment
TechnologyTransfer:Whatisit?
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It’sallaboutgettingfromHERE…..
toHERE
• Process of transferring UTHealth discoveries to the private sector for commercial development
• Link between research and commercialization • Licensing is primary vehicle in academia• Bayh-Dole Act 1980’s
INTELLECTUALPROPERTY!!
WhatisIntellectualProperty(IP)?
Aproductofthemindthathascommercialvalue
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• Patent(plants,utility,design)• Copyright(music,graphics,writtenmatter,software)• Trademarks(name,sound,logo)• Tradesecrets(customerlist,formula,know-how)• Software(maybeincludedinpatentsandcopyrights)• TangibleResearchProperty(biologicalmaterials,
prototypes,databases,devices,equipment)
WhatisaPatent?U.S.Constitution:ArticleI:Section8,
Clause8:• TheCongressshallhavepower…To
promotetheprogressofscienceandusefularts,bysecuringforlimitedtimestoauthorsandinventorstheexclusiverighttotheirrespectivewritingsanddiscoveries.
• …patentlawseekstofosterandrewardinvention…topromotedisclosureofinventions…tostimulatefurtherinvention…andtopermitfreeuseofitemsinthepublicdomain.U.S.SupremeCt.(1979)
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✓
WhatdoesaPatentdo?therighttoexcludeothersfrom“making,using,offeringforsale,orsellingtheinventionthroughouttheU.S.orimportingtheinventionintotheU.S.”foraperiodof20yearsfromthedateoffilingthepatentapplication. (35U.S.C.154(1994)
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✓verses
Copyright
Theexclusiveright,grantedbylaw,tothecreatorofaworktomake,print,publish,perform/recordandotherwisetocontroltheuseofaliterary,dramatic,musical,artistic,orotherwork.Mayincludesoftware.Costisminimal. 6
Trademark
“Words,names,symbol,device,slogan,packagingdesignorcombinationofthesethatservestoidentifyanddistinguishonespecificproductfromothers.Includessound,colorcombinations,orsmell.”Canberegistered.Costcanvary
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IntellectualPropertyProtection
• Patent-20yearsfromfilingofapplication• Copyright-Lifetimeofcreatorplus50years
– HappyBirthday!
• Trademark-20years,extendable• TradeSecret-Forever,ifcareful
Eachprotectionstrategyprovidestheownerwiththeabilitytoexcludeothersfromusingthetechnologyunlesslicensed,foraspecifiedtimeperiod.
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WhoownsIP?TheBoardofRegentsoftheUniversityofTexasSystemownstheIPwhenitis:• createdwithinanemployee’sscopeofemployment;or
• createdonUTSystemtime,orwithuseofUTSystemfacilities/resources;or
• ResultingfromresearchsupportedbyFederalFundsor3rdpartysponsorshiporuniversitygift.
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WhatisaInvention?
• Aninventionisasolutiontoatechnicalproblem• Inventionsareimportant,butnoteverythingimportantisaninvention.
• Aninventionstartswithanidea,butmustbemorethananidea– Conceptionandreductiontopractice
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PatentableInventions?• Someinventionsarepatentableandsomearenot.
– Judicialexceptions:abstractidea,lawofnatureornaturalphenomenon,humans
• IntheU.S.,apatentableinventionmustbeclaimedaseithera
• machine
• acompositionofmatter
• Methodoraprocess
• amanufacture
• Mustbenew,useful,andnon-obvious.11
CanIpatentthis?• Perpetualmotionmachine No• Naturally-occurringcultureofmicroorganisms No• Enrichedorpurecultureofmicroorganisms Yes• HumanGene No• Word-processingapplicationstoredonadisk Yes• Songstoredonadisk No• Genetically-engineeredmouse Yes• Genetically-engineeredhuman No• Anewuseforaspirin Yes?• Medicalorsurgicalprocedure Yes,but• Methodofdoingbusiness Maybe?• Diagnosticassay Maybe?• Algorithm Maybe?
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Justbecauseyoucan?
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WhoisanInventor?• Apersonwhoconceives,producesorcontrivessomethingpreviouslyunknownbytheuseofingenuityorimagination
• Co-inventorsifeachcontributetotheinventiveprocess,evenifunequally
• Notnecessarilyco-inventorifonlyfollowingdirections
• Aco-authorisnotnecessarilyaninventor• Inventorshipisdependentonthespecificclaimsinanapplication
– Co-Inventorshaveequalrights(notasapercentageofcontribution)
• AmatterofLAW14
WhydoIcareaboutIP?
• IPisawaytotranslateyourresearchtothemarketplace—OTMisyourlinktocommercialization,i.e.throughexistingornewbusinesses,investors($$),etc.
• FederalGrantAgenciesrequireIPtobereportednotonlyonyourgrantreport,butthroughouroffice(iEdison)– Bayh-DoleAct1980’s
• Createdenvironmentfortechnologytransferfromuniversities
• Governmentreportingrequirementsforinventionsmadeusingfederalfunds15
HowdoestheIPprocessstart?
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Technology Report Form Copyright Disclosure Form Software Disclosure Form Research Material Form OTM’s disclosure form (left), as well as a wealth of IP related information for inventors, can be found on OTM’s website:
www.uth.tmc.edu/otm
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Discover
Disclose
Search
Protect
Market
License
Manage
TheCommercializationPath
WhatdoesOTMdo?
AssessingtheTechnologyQualitativeassessmentofpotentialproduct• Thetechnologyshouldleadtoauseful,commerciallyvaluable
product• Intellectualpropertyprotection;technologyshouldbeadequately
protected;otherIPmustnotblockthepathtocommercialization• Path-to-market;clearbusinessmodel/strategyforgeneratingprofit• Regulatoryissues• CommercialPartnershipOpportunity• Licensing:Bigcompanyvs.smallcompanyvs.start-upcompany
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WhatadditionalinformationdoweneedtoknowforIPProtection?
• IsthereNovelty/Obviousness• PublicDisclosures?• FundingSources• LicenseAgreements• SponsoredResearchAgreements• MaterialTransferAgreements• SoftwareAgreements• ClinicalTrialAgreements• Inventors’employment
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Manuscripts
Abstracts
Posters
Seminars,includingjobinterviews
WebPostings
Genbank
Conversations
Patents
WhatdoesOTMdo?
Obtainingapatentisexpensive!• Anaverageof$15,000+inlegalfeesjusttofileaUSpatentapplication,$25,000toissue
• Anaverageof3-5yearstoprosecuteaUSpatent
• Anestimated$480,000inlegalfeestofileandmaintainUSandstandardforeignvenues
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Commercialization
• Valuation• Negotiation• ExecutionofAgreements• AgreementManagement
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What’sthebenefittoyou?AtUTHealth,wedistributecashreceivedfromthelicensingofyourIPasfollows:
• Creators 50% • Patentfund/OTM 35% • YourSchool 5%• YourDepartment 5%• YourLaboratory 5%
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WeNeedYourHelp!
• Talktous(asEARLYaspossible)• Confidentiality• Documentation/RecordKeeping• Assistwithsearching
– ScientificLiterature– Patents– Commercialpotential– LicenseeIdentification
• Assistwithpatentprosecution• Assistwithlicensing
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2004 2011
DeviceExample:PortableFluidWarmer
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• 2patentsissuedbytheUSPTO• 1startupcompanyformed:EMITCorporation• FDA510(k)clearancereceivedinFY2011to
marketthedeviceas“HypothermX™HX100”
DisclosetoOTM&FilePatentApp.
ProsecutePatent
1stPatentIssues
PatentMaintenance
Timeline*
LicenseAgreement ProductDevelopment FDAapproval
ProductSales
not to scale *
DeviceExample:PortableFluidWarmer
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Variousfluidwarmerprototypesovertheyears,fromresearchprototypetoFDAapprovedproductforsale
20142012
SoftwareExample:PatientDashboard
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• 1issuedpatentintheUnitedStates• patentspendingintheUnitedStatesand
abroad• 1startupcompanyformed:DecisioHealth• FDA510(k)clearancereceivedinFY2014
DisclosetoOTM&File
App.ProsecutePatentApplications
Timeline*
LicenseAgreement ProductDevelopment FDAapproval
ProductSalesnottoscale*
SoftwareExample:PatientDashboard
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Early prototype:
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FDA approved version:
iPhone™, Android™ Display
Android Tablet™, iPad™ Display
SoftwareExample:PatientDashboard
$5+millionAnnualGrossRevenue$75+millionLicensingRevenue(cumulative)25+NewLicense/OptionAgreementsperYear475+TotalLicense/OptionAgreements(cumulative)1700+Patents/PatentApplications(cumulative)45NewPatentApplicationsFiledEachYear100+ProductsontheMarketPortfolioCompanies(UTHealth)• 51portfoliocompanies(cumulative);31active• Morethan$250Mincapitalraisedtodate• 3companiesIPO/acquiredwithmarketcap>$3B:Volcano,
LifeCell;PLxPharma• Morethan>1300jobscreatedinprivateand3publiccompanies
OTMByTheNumbers
SelectedPortfolioCompanies:
MORE
Information
[email protected] uth.tmc.edu/otm @UTHealth_OTM UTHealth Office of Technology Management
ChristineE.Flynn,Ph.D.AssociateDirector,Licensing&NewVenturesDirector,BiotechnologyCommercializationCenter713-500-3383directChristine.Flynn@uth.tmc.edu
ContactUs:WeareheretohelpYOU!
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BruceD.Butler,Ph.D.VicePresidentforResearchandTechnology
(713)[email protected]
PeterG.Seferian,Ph.D.SeniorPatentManager713-500-3377directPeter.Seferian@uth.tmc.edu
HannahMarmanNelson,Ph.D.Sr.TechnologyLicensingAssociate713-500-3399directHannah.M.Nelson@uth.tmc.edu
Chuan-Yar“Yaya”Lai,Ph.D.TechnologyLicensingAssociate713-500-3384directChuan-Yar.Lai@uth.tmc.edu