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

otm@uth.tmc.edu 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)500-3369Bruce.D.Butler@uth.tmc.edu

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