DisclosureSubmission&Management

OwnershipofIntellectualProperty

Asisstandardpracticeamongacademicinstitutions,BaylorCollegeofMedicineownsintellectualpropertydevelopedbyitsfaculty,staff,andstudents.Collegepersonnelarestronglyencouragedtoeducatethemselvesonthecollege’spoliciesregardingintellectualpropertyownershipanddisposition.TheCollege’spolicy20.8.01:Research:InventionsandPatents(Baylorloginrequired)describesthesepoliciesintheirentirety,butkeyclausesassociatedwiththePatentPolicyareasfollows:

• AssignmentofIntellectualPropertyRights(SectionII.A.):“BaylorIntellectualPropertyisandshallberegardedastheproprietarypropertyoftheCollege,ownedandcontrolledsolelybytheCollege,andallrightstheretoshallbedeterminedandadministeredbytheCollegeasprovidedinthisPolicy.Asaconditionoftheirappointment,employmentorenrollmentby,orworkingattheCollege,oruseoffacilitiesmadeavailablebyorthroughtheCollege,orinconsiderationforthecompensationorotherbenefitsreceivedfromorthroughtheCollege(includingtheuseoffacilities),allCollegePersonnelareobligatedtoassignandconvey,anddoherebyassignandconveytotheCollege,allBaylorIntellectualPropertyDevelopedbythem.”

• DefinitionofIntellectualProperty(SectionX.):“IntellectualProperty”shallmeanInventions,know-how,tradesecrets,technology,researchdataandnotes,CopyrightableWorks,trademarks,servicemarks,andtradenames.”

• DefinitionofInvention(SectionX.):“Invention”shallmeanandinclude,withoutlimitation,anydevelopment,discovery,creation,improvementorotheradvancewhetherdevelopedasaproductofmentalprocessesorasaresultofscientificinvestigationandexperimentation,andwhethernotreducedtowriting.Inventionsshallincludebywayofexample,butnotbywayoflimitation:drugs,methodsofhealingorpromotingthehealingarts,chemicalorbiologicalprocessesormethods,genesequences,genetherapy,celllines,vectors,organisms,combinationsofmatter,computersoftware,electricalormechanicaldevices,andelectricalcircuits.Theforegoingexamplesshallnotinanywaylimitthescopeofthisdefinition(SectionXofthePatentPolicy).”

TheBayhDoleActandtheRiseofAcademicTechnologyCommercialization:In1980,Congresspassedanactoflegislationthatmadefundamentalchangestotheownershipandmanagementofintellectualpropertyresultingfromfederallyfundedinventions.TheBayhDoleActenabledrecipientsoffederalresearchfundstoelecttitletoinventionsdevelopedwithfederalfunding.Universities,smallbusinessesandnon-profitorganizationsthatreceivefederalresearchfundswerenowabletodirectthecommercializationoffederally-fundedinventions.PriortopassageoftheBayhDoleAct,thevastmajorityoffederally-fundedinventionswerenotleveragedanddevelopedbythecommercialsector.Thepublicfundsresearchwiththeexpectationthatitwillleadtothedevelopmentofnewproductsandservicesthatbenefitsociety,yetpriortoBayhDole,itsimplywasn’thappening.

ThepassageofBayh-Doleunleashedawaveofcommercializationactivityatatacademicinstitutionsacrossthecountryandspurredthegrowthanddevelopmentofuniversitytechnologytransfer.SincethebeginningoftheBayh-Doleera,U.S.universitieshavegeneratedover4,000start-upcompaniesand153newFDAapprovedvaccines,drugsand/ornewindicationsforexistingdrugswerediscoveredthroughresearchconductedintheuniversitysetting(source:AssociationofUniversityTechnologyManagers).ItisnotanexaggerationtostatethattheBayh-DoleActsingularlyspurredthegrowthanddevelopmentofthebiotechnologyindustryintheUnitedStates.ThesuccessoftheActhasspawnedsimilarlegislationinnumerousforeigncountries,includingmostofthedevelopedworld’smajoreconomies.

MajorprovisionsoftheBayh-DoleActinclude:

o Recipientsoffederalfunds,includinguniversitiesandsmallbusinesses,canelecttitletofederally-fundedinnovations.

o Universitiesareencouragedtocommercializeinventionsdevelopedwithfederalresearchfunding,andarespecificallyencouragedtoworkwithsmallbusinesses.

o Universitiesmustshareaportionoftheircommercializationrevenuewiththeinventorsofthelicensedtechnology.

o Althoughuniversitiesarepermittedtolicensefederally-fundedinventionstocommercialthirdparties,thefederalgovernmentretainsanon-exclusivelicensetopracticetheinventionintheinterestsoftheU.S.governmentthroughouttheworld.

o Thefederalgovernmentretainsmarch-inrights,meaningitcanstepinandpotentiallydirectactivitiesrelatedtocommercializationoffederally-fundedinventions.

Whattodisclose?Whentodisclose?Howtodisclose?

• Whattodisclose?Ifyouhavedevelopedatechnologythatsolvesoraddressesanunmetneed,youshoulddisclosethetechnologytotheBaylorLicensingGroup.Examplesoftechnologiesthatarefrequentlydisclosedincludetherapeuticcompositionsandmethods,vaccines,devices,diagnostics,softwareandsmartphoneapplications,educationalmaterials,aswellasresearchtoolssuchasknockoutmice,antibodies,vectors,andcelllinesthathavebeenengineeredtohavespecialcharacteristics.Note:Forthepurposeofthissection,theterms“technology”and“invention”maybeusedinterchangeably.

• Whentodisclose?Ifthetechnologyisonethatmayrequirethepreparationandfilingofapatentin

ordertobesuccessfullycommercialized(thisgroupwouldgenerallyincludetherapeuticcompositionsandmethods,medicaldevices,andsomediagnostics),itisimportanttodisclosethetechnologypriortoanypublicpresentationordisclosureofit.Publicdisclosurecantakeavarietyofforms,includingmeetingabstracts,oralpresentations,andonlineandprintpublications.Manymeetingabstractsarepublishedonlinewellinadvanceofthescientificmeetingorconference,makingitimperativetodisclosetheinventiontoBLGpriortoanydescriptionoftheinventionappearingonline.Ideally,we’dstronglyliketoavoidthescenarioofa“rush”patentfilingtotrytobeatonlinepublicationofanabstract,especiallyifthereareaspectsoftheinventionthathaven’tbeendevelopedordescribed,suchthatweendupfilinganapplicationthatmaynotadequatelycaptureandclaimimportantaspectsoftheinvention.

ThereasonthatyoushoulddiscloseyourtechnologytoBLGpriortoanypublicdisclosureoftheinventionislinkedtothefactthattheabilitytopatenttheinventioninmostcountriesintheworldispermanentlylostoncetheinventionispubliclydisclosed.Mostcountriesintheworldhavearequirementforabsolutenoveltyinorderforaninventiontobepatentable.TheUnitedStatesdoesrepresentanexceptiontothispractice,suchthatapatentapplicationcanbefiledwithinoneyearofthedateoftheinitialpublicdisclosure–thisisknownasthe“graceperiod.”However,itisimportanttostressthatitistoyouradvantage,andtothecollege’s,tofileanapplicationbeforeanypotentialpatentabilityrightsarelostthroughapublicdisclosure.

Howtodisclose?SubmittingyourdisclosureisasimpleprocessthatyoucandousingBLG’sonlinedisclosuresubmissionapplication,availablehere:ttps://blg.research.bcm.edu,oronthefrontpageoftheBaylorLicensingGroupwebsite.

Beforegettingstarted,you’llneedthefollowinginformation:

• Thenamesofthecontributorstothetechnology/invention,theircontact

information(iftheyareBCMpersonnel,theyaresearchablewiththedisclosuresubmissionapplication),andtheirrespectivepercentagecontributiontothetechnology.

• Theidentitiesofanyfundingsourcesthatwereusedtosupportthedevelopmentofthetechnology,includinggrantnumbers.BLGhasreportingobligationstothefederalgovernment,andtootherfundingagencies(CPRIT,forexample),suchwemusthavegrantnumbersassociatedwiththedisclosure.

• Adescriptionofthetechnology:Youmayattachmanuscripts,abstracts,posters,orotherdocumentsthatdescribethetechnologythatyouhavedeveloped;or,youmaychoosetowriteadescription.

• Publicdisclosureofthetechnology/invention:Ifthetechnology/inventionhasbeendescribedinapublishedmanuscript,abstract,poster,orotherformat,pleaseattachacopyofthatdocument.Priorpublicdisclosureofaninventioncanimpactpatentabilityofyourinvention.

• Thirdpartyuseofthetechnology/invention:Hastheinventionbeenofferedforsaleorusetoanythirdpartyoutsideofyourlaboratory?Ifthiswasdonethroughanagreementwithathirdparty,wewouldneedtoseeacopyofthatagreement.

Onceyouhavetherequiredinformationin-hand,submittingthedisclosureshouldrequireverylittletime.Oncetheinformationissubmitted,youandtheotherBCMcontributorswillbeaskedtosubmitelectronicsignatures.BLGwillcoordinateobtainingsignaturesfromanynon-BCMdevelopers.OncethedisclosurehasbeensubmittedandtransferredtotheBLGdatabase,youwillreceiveanemailconfirmationandyourdepartmentchairwillbenotifiedaswell.

DisclosureManagement:WhatHappenstoYourDisclosure?

Followingsubmissionofthecompleteddisclosure,itwillbeassignedtoaBLGprojectmanager,whowillworkwithyoutodeterminetheappropriatecommercializationstrategy.EachBLGprojectmanagerisresponsibleformanagingdisclosuresfromaportfolioofdepartments.AlistofprojectmanagersandthedepartmentsforwhichtheyareresponsibleisavailableontheBLGwebsite.

• Thetypicalworkflowofthedisclosuremanagementprocessissummarizedin“LifeCycleofanInventionDisclosure”graphic.Theindividualstepsinthisprocessaredescribedindetailinthisguide(marketingandlicensingactivities,forexample),butthisgraphicservestoprovideaschematicoverviewoftheentireprocessbeginningwiththesubmissionofadisclosureandendingwiththesuccessfulexecutionofalicenseagreementoradecisiontoclosethefileandceaselicensingandmarketingactivities.

• InventionDisclosureAnalysis:Elements&Purpose.OnceyourdisclosureisassignedtoyourBLGprojectmanager,theywillinitiatetheprocessofcoordinatingthedevelopmentofanInventionDisclosureAnalysis(IDA)foryourdisclosure.TheIDAisintendedtoprovidethefacultymemberwithananalysisoffactorsthatthecommercialprospectsofthedisclosedtechnologyanditwillprovideacommercializationrecommendationalongwitharationalefortherecommendation.TheIDAisnotintendedtobeanexhaustiveanalysisofthedisclosure,butisintendedtobeavehicletoprovidehigh-qualityfeedbacktothePIwithinareasonabletimeframeaftersubmission.TheIDAprocesswillbeinitiatedwhentheBLGprojectmanagerhasreceivedsufficientinformationonthetechnologytoconductanevaluation.MembersoftheBLGinternteamwillassistBLGprojectmanagerswiththecollectionofpriorartandmarketinformationthatisrelevanttotheinventionbeinganalyzed.

ElementsofatypicalIDAwillinclude:

§ Adescriptionofthetechnologybeingevaluated.

§ Citationsofpriorartinthescientificandpatentliteraturethatarerelevanttothe

invention,alongwithcitationofspecificlanguage/passagesinthereferencesthatmayreaduponaspectsoftheinvention.

§ Adescriptionofthecommercialmarketassociatedwiththeinvention,whichmay

containalistofcompanies/productsthatareactiveintherelevantmarket,and/ordescriptionsofcompetingtechnologies.

§ Identificationofanyencumbrancesthatmayimpactourabilitytocommercializethedisclosedtechnology.Suchencumbrancesmightconsistofobligationstothirdpartiesthatariseviapreviouslysignedagreements,suchasMTAsorSRAs.

§ Acommercializationplan,whichmayresultinadecisiontopreparemarketing

materialsandbeginmarketingtheinventiontopotentiallicensees,and/ortoprepareandfileapatentapplication.Alternatively,wemaydecidethattheinventionhasalreadybeensubstantiallydisclosedinthepriorartandwemayelectnottofileapatentortomarketittoindustry.Eachtechnologywillbedifferent,andthecommercializationplanforeachonewillbedifferentaswell.

TypicalCommercializationFactors&StrategiesforDifferentTypesofInventions

EachtechnologydisclosedtoBLGwillbeexaminedonitsownmerits,buttherearesomegeneralfactorsthatimpactthecommercializationprospects,andourdecisionsaroundthem,fordifferentclassesoftechnologies:

• TherapeuticMethodsandNewUsesforExistingCompounds:Inorderforatherapeuticmethodtobeofinteresttoapotentiallicensee,theywilltypicallywishtoseeproof-of-

conceptdatafromarelevantanimalmodelsystem.Ifthetherapeuticmethodinvolvestheuseofacompound/moleculethisisownedbyathirdpartyandnotBCM,thenthelikely(andinmostcases,theonly)prospectforalicenseewillbetheownerofthecompound.Therehasbeenmuchfocusandemphasisondevelopingnewusesforexistingcompounds.Foracompoundthathasalreadybeenthroughtheregulatoryapprovalprocessandhasbeenprovensafeforuseinhumans,therearesoundreasonstoinvestigatenewusesforitfromapatientcarestandpoint.But,fromacommercializationstandpoint,thecompanythatownsthecompoundwillbetheprimarybeneficiaryofanynewmethodofuseforsuchacompoundthatisdevelopedbyanacademicPI.

IfanacademicPIdevelopsanewmethodofuseforanoff-patent,non-proprietaryFDA-approvedcompound,itisoftenverydifficulttoattractacompanytolicensesuchatechnologybecausethecompounditselfisnolongerprotectable,andenforcinginfringementaroundanewmethodofuseforanon-proprietarycompoundischallengingatbest,particularlyifthenewmethodofusecanbeachievedvia“off-label”useoftheapproveddrug.

Technologiesinvolvingnoveltherapeuticmethodsthatarenotassociatedwithsomesortofproprietarymoleculeorcompoundareverytoughtosuccessfullycommercialize.Theremustsomeaspectofthedataassociatedwiththenewmethodthatisextraordinaryinsomerespecttohavearealisticshotatgarneringcommercialinterest.

Therearecasesinwhichanewtherapeuticmethodisdevelopedusinganexistingcompound,butarouteexistsbywhichpotentiallyproprietaryderivativescanbedeveloped.Weoftenwillelecttofileapatentapplicationunderthesecircumstances,providedthatthePIhasaplaninplacetodevelopandenablesuchderivatives,andprovidedthatthereisindeedarealprospectfordevelopingderivativesthathavenotbeendescribedorclaimedbyathirdparty.Wewilluseoutsidepatentcounseltoguidestrategy.

• TherapeuticCompoundsorMolecules:Whenwereceiveadisclosurethatdescribesa

potentiallyproprietarycompositionofmatter,ourinitialfocuswillbetodeterminewhetherthemoleculeisindeednovelandproprietary,orwhetheritisbaseduponaknowncompositionormolecularscaffold.Wewillalsobeinterestedindeterminingthedegreetowhichderivativescanbemade,claimed,andtested.Ifatallpossible,wewouldprefertofileapatentapplicationoncethecompounds/moleculeshavebeentestedinanappropriateanimalmodelsystem,sothatwecanclaimboththecompound(s)andmethodsfortheiruseintreatingdisease.

• DrugTargets:Disclosuresbasedongeneticorbiochemicalevidencethatagene/protein

constitutesarouteforthedevelopmentofatherapeutic(a“target”),butlackinganydescriptionofamoleculethatinteractswithandimpactstheactivityofthetargetareextremelydifficulttosuccessfullycommercialize.Wedonotfilepatentapplicationsondisclosuresthatdescribedrugtargetswithoutadescriptionofamoleculethatinteractswithit.Nordowefilepatentswithclaimsdirectedtoscreeningmethodsbecausescreeningmethodclaimsareverydifficulttopoliceforinfringementandcompanieswon’tlicensescreeningmethodpatents.Wecannotobtainpatentclaimstoamoleculethatinteractswithatargetwithoutprovidinganenabledexampleofsuchamolecule.Thereislegalprecedentaroundthisissue(UniversityofRochesterv.G.D.Searle&Co.,358F.3d916(Fed.Cir.2004).

Inthishigh-profilecase,thecourtruledthatapatentheldbytheUniversityofRochesterthatclaimedinhibitorstotheCox-2enzymewithoutactuallyprovidinganexampleofsuchaninhibitorwasinvalid.

Itisverydifficulttofindacommercialpartnerifallwehavetoofferisatargetwithoutamolecule.Onceinformationaboutatargetispublished,anythirdpartycanusethatinformationtodevelopascreenandisolateamolecule.Ifyouhavedevelopeddataonatargetthatyoubelieveisproprietary,youmaywishtopursuecollaborativeroutestodevelopamoleculethatinteractswithyourtarget.TheBCMCenterforDrugDiscoverymaybeabletohelpyouidentifycollaborativeroutestoisolateamoleculethatinteractswithyourtarget.

• DiagnosticTests/Biomarkers:Thekeyquestiontoanswerregardingthecommercial

prospectsofadiagnostictestorbiomarkeris:“Howwilltheinformationgainedfromthistestinformthepatient’shealthcareprofessionalandchangethecourseoftreatment?”Ifthetestdoesn’tchangethepatient’scourseoftreatmentorclinicaloutcome,thenitscommercialprospectsareprobablyinsignificant.Ifindeedthediagnostictestdoeschangethecourseoftreatment,thenthefocusoftheevaluationwillshifttotheidentificationofaspectsofthetestthatareproprietary(novelsequences,antibodies,reactionconditions,etc.).

Additionally,arecentcasedecidedbytheSupremeCourt(Mayov.Prometheus)heldthatmeasurementofametaboliteandtheuseofthatmeasurementtoguidetreatmentdidnotconstituteapatentableinventionbecausethetestrevolvedaroundmeasurementofametaboliteexistinginthenaturalstatewithoutanytransformativestep.Theoutcomeofthiscasehasthrownpatentswithclaimsdirectedtodiagnosticmethodsintoastateofconfusion,andcompanieshavebecomemorehesitanttolicensediagnostictechnologies.

BecauseofBaylor’sextraordinarystrengthinthegeneticsofrarediseases,particularlyneurologicaldisorders,wedoreceivedisclosuresofdiagnostictestsfortheseraredisorders.Ourcurrentpracticeistorarely,ifever,patentdiagnosticteststoraregeneticdisorders.Thetargetmarketsandpatientpopulationsareoftenverysmallwithlimitedcommercialprospects.Additionally,patientaccesstothesetestshasbecomeaprominentissueviatheactivityofpatientadvocacygroups,suchthattheexclusivityassociatedwithpatentingthetestmayruncountertothefocusofadvocacygroupswhodesirebroaddisseminationofsuchtests.

• MedicalDevices:Ourevaluationofthecommercialprospectsassociatedwithamedicaldevicetechnologywillrevolvearoundobtaininganswerstothefollowingquestions?

o Isthedevicedesigntechnicallyfeasible?Doesaprototypeofthedeviceexist?Aretheremeanstodevelop/testtheprototype?

o Ifaprototypehasbeendeveloped,hasitbeentestedinanappropriateanimalmodelsystem?

o Isthedevicenovel&proprietary?Doesthedevicerepresentanincrementalimprovementofanexistingdeviceapproach,orisitanewdesign?Easeofworkaroundmaybeasignificantissueifthedeviceismoreincrementalvs.completelynovel.

o Howdoesthedevicedifferfromothercurrentsolutionsforthesameapplication?Howdoesthenewdevicestackupagainstthe“goldstandard”?

o Isthedevicetechnicallyfeasible?o Doesthedevicedependonorinterfacewithothertechnologies/devicesinorderto

beused?Doesthedevicerequiresoftwaretowork?Ifso,whoownstheseotherrequiredtechnologies?

o Isthedevicecost-effective?Canitproduceanimprovedpatientoutcomeatalowercostthanothercurrentsolutionsonthemarket?

• ResearchTools:Researchtooltechnologiesincludetangiblematerialssuchasmouse

models,celllinesthathavebeenengineeredorselectedtohavespecializedcharacteristics,expressionvectors,bacterialstrains,etc.Ifthetoolthatyou’vedevelopedispopularwithyouracademiccolleagues,thereisagoodprobabilitythatitmaybeofinteresttoscientistsinindustryaswell.Wedon’tpatentresearchtools–thegoalofresearchtoollicensingistopromotethebroadadoptionanduseofthetoolviaanon-exclusivelicensingstrategy.Companieswillreadilypayforaccesstoresearchtoolsthatwilladdvaluetotheirresearchprograms.Licensingatoolsavesthecompanythetimeandresourcesthatitwouldhavetocommitifitweretodecidetoindependentlydevelopthesame(orasimilar)tool.

Apeer-reviewedpublicationthatdescribestheuseofatoolisoftenthebestrouteformarketingatooltoindustry.Wefrequentlycoordinateourmarketingeffortstocoincidewithpublicationofmanuscriptthatdescribesthetool.

• Software/SmartPhoneApplications:Softwaretechnologiesarefrequentlyprotectedby

registrationwiththeU.S.CopyrightOfficevs.filingapatentapplication.Thesoftwaredevelopmentcycleistypicallyveryfast,whereasthepatentprosecutionprocesstakesyears,andbythetimethatapatentissues,theclaimsmaynolongerberelevanttothecurrentversionofthesoftware.Registeringthecodewiththecopyrightofficeisgenerallythepreferredrouteforprotectingasoftwareapplicationagainstpotentialthirdpartyinfringement.Theremaybecasesinwhichthesoftwareisbuiltaroundaproprietaryalgorithmthatmaywarrantpatentprotection,butthisisgenerallytheexceptionandnottherule.

Intermsofcommercialprospects,ourevaluationwillfocusontheaspectsofthesoftwarethatdifferentiateitfromcompetingsoftwareapplications.Whatfeaturesandcapabilitiesdoesthesoftwareapplicationhavethatotherslack?

Inrecentyears,we’vebegunreceivingdisclosuresfromsmartphoneapplications.WeareencouragedtoseethesenewdigitalinnovationsfromtheBCMresearchandclinicalcommunities.However,mostoftheseappstendtobeofinteresttoveryspecializednichemarkets,andgenerallydon’trepresentsignificantcommercialopportunities.TheyareoftenbestdisseminatedonmarketingchannelssuchasiTunes.Therehasbeenactivediscussionaboutdifferentstrategiestocommercializesmartphoneappsintheacademictechnologytransfercommunity,andwearealsoexploringandconsideringsuitablesolutionsforhealthcarerelatedappsdevelopedatBCM.