blg disclosure submission and management · disclosure submission & management ownership of...
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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.