Statement on Policies and Practices Governing Data and Materials Sharing and Intellectual Property in Stem Cell Science

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1 StatementonPoliciesandPracticesGoverning DataandMaterialsSharingandIntellectual PropertyinStemCellScience PREAMBLE Tensionisincreasingbetweenfairlynewandpervasivepoliciesandpracticesgoverning dataandmaterialssharingandintellectualpropertyinscience( proprietarystructures ), andnormsofopennessandfreeexchange.whileintellectualpropertyrights(ipr)can bringprivateinvestmentintoareasunderfundedbygovernmentsandhelpbridgegaps betweenscientificinventionordiscoveryandusefultechnologies,somenewandemerging policiesandpracticesriskslowinginnovationinresearchanddevelopment(r&d)and skewingattentiontowardlargemarkets,tothedisadvantageofsmallmarkets,suchas thoseforrarediseasesandinsomeemergingeconomies.thisisofconcern,asonecentral goalofthelifesciencesistoimproveglobalhealth:oursharedhumanityandthepotential forbiologicalknowledgetobenefitallpeoplecreatethisobligation.further,theselfregulatorystructureswithinscientificcommunities,asmuchasthelegalinstitutionswe consciouslyerectforscience,shouldberesponsivetothisgoal. Whiletheproprietarydilemmascurrentlyfacedinstemcellscienceconfoundmanyifnot allareasofcuttingedgelifescience,theyareespeciallypronouncedinthefieldofstemcell research.first,thetree likeshapeofcellulardifferentiationmakesthefieldespecially pronetoiprholdingsthatcanfunctionastollboothstobroadareasofwork,creatinga dragoninvestmentandslowingdownbasicresearch.second,theconsequencesofsuch slowingareespeciallysevereinthestemcellfield,wherenovelcelllines,reagentsand relatedtechnologiesfunctionasplatformsforbroadareasoffollow onwork.third,the competitiontostakeoutaggressivepatentpositionsisaccentuatedinthecurrentcontext ofcompetitivenationalinnovationpoliciesfeaturingstemcellscience. Itshouldbenotedthatourresearchanddeliberationsfocusedprimarilyonhuman pluripotentstemcells(embryonicstemcells ESCs,andinducedpluripotentstemcells ipscs),andtheirderivatives,ratherthantissuespecificstemcells,inpartbecausethe abilitytoderivehumanpluripotentstemcellsisrelativelynewandbecauseofthe considerableexcitementthesecellshavegenerated(politicalaswellasscientific),butalso becausetheiroriginsandverynaturecreatespecialproblemsrelatingtoipr.indeed,the pluripotencyofescsandipscsisamajorissueintermsofutilityandoverlappingpatent claims.however,itisquitelikelythatmanyofourdeliberationsandrecommendations couldequallyapplytotissuespecificstemcells,whetherthesearefetal,umbilicalcord blood,oradultinorigin.weencouragethoseworkingontheseotherstemcelltypesto consideradoptingsimilarmeasurestothoseproposedhereandtocontributetocommon resourcesfordataandmaterials.

2 Humanpluripotentstemcellscienceisayoungfield,butonethathasalreadyprogressed frominitialinventiontoenrollingthefirstsubjectinaclinicaltrial.thisrapidprogresshas occurredinthepubliceye,againstabackgroundofsignificantmoraldisagreementwithin andacrossnations,andwithinacomplexregulatoryenvironmenthostingapatchworkof divergentandoftenconflictingresponses.furthermore,withitsgreatpotentialtoadvance bothbasicandtranslationalscience,stemcellresearchhasbecomeafocusofnational economic,innovationandcompetitivenessstrategies.andfinally,thoughmanyfieldsof sciencehavereachedasimilarpointintheirdevelopment,nowisthetimeinstemcell scienceforthesortsofcollectivereflectionandactionproposedherein. Thisstatementhasbenefitedfromtheinputofaninternationalgroupofstemcell scientists,scholarsofiprandinnovation,ethicists,lawyers,physicians,and representativesfromfundingbodies,governmentalbodies,industry,andscientific journals.inthisstatement,wemakeseveralrecommendationstoaddressthechallenges raisedbyproprietarypracticesandpoliciesinstemcellresearchinawaythatpromotes bothscientificinnovationandthepublicgood.admittedly,wedonotaddressallissues facedbystakeholdersinthisarena;wehavetriedtotargetchallengesfacedbymultiple stakeholdersandforwhichwecoulddevelopconcreteandactionablerecommendations. Wealsoacknowledgethatsomeofthemostimportantwaystoalignstemcellresearch withthegoalofglobaljusticepertainlesstoipr,andmoretothekindsofresearch questionsthatareasked,andthesortsofprojectsthatfindfunding. Whilewedonot,byourconstitution,representtheviewsandinterestsofallthevaried stakeholdersinthestemcellscienceenterprise,wedohopethisstatementwill nonethelesshelptoarticulatethekindsofglobalobligationsweshareinthestudyof biologywritlarge,andhowthoseobligationsmaybehonoredinthefieldofstemcell science.wealsohopethattheserecommendationswillhelpstimulateabroaderdialogue amongcommunities,scientists,patients,ethicists,regulators,andothersabouthow proprietarypracticesandpoliciesinstemcellresearchcanbestservetheglobalpublic interest.

3 Recommendation1a.Establishacentralhubforaccessingglobalstemcell registryinformation StatementoftheProblem Datasharingisacriticalfactorintheprogressionofstemcellscience;thoughcurrently, sharingishamperedbythebehaviorofindividualscientistsandlaboratories,thespeed withwhichthefieldismoving,andbyfragmentationofdataacrosslocal,regionaland nationalregistriesandbanks,andtherelatedbarrierstoknowledgeofandaccesstothis disparatesetofresources.inpartduetothespeedwithwhichthefieldismoving,many celllinesarebeingderivedandcharacterized,thoughnotalllinesarebeingpublishedin theliterature,evenintheacademicsector.furthermore,usefulcelllinescreatedfrom humanmaterials(especiallythosecreatedwithpublicfunds)andtheirassociateddata shouldbedistributedandusedwidely,constrainedonlybythewishesofthematerials donors. Recommendation Apubliclyavailablecentralhuborinformationportalforaccessingglobalstemcellregistry informationshouldbeestablishedandmaintainedasaresourceforandservicetothe community,easingaccesstoinformationandreducingbarrierstosharing.theglobalhub forstemcellregistryinformationshouldenhanceandcreatelinkagesbetweenandbuild uponexistingefforts(e.g.,thenihhumanembryonicstemcellregistry,theinternational StemCellRegistryattheUniversityofMassachusetts,theEuropeanHumanEmbryonic StemCellRegistry). Agoodmodelforsuchalinkedresourceisthenetworkofthreepubliclyfundeddatabases usedfordnasequencedata,proteindata,andotherbiologicalinformation:genbankatthe NationalCenterforBiotechnologyInformation(NCBI;Bethesda,Maryland,USA);EMBL BankattheEuropeanBioinformaticsInstitute(EBI;Hinxton,UK);andtheCenterfor InformationBiologyandDNADataBankofJapan(Mishima,Japan).Eachofthethree groupscollectsaportionofthetotaldata,andallnewandupdateddatabaseentriesare exchangedbetweenthegroupsonadailybasis.thusthefunding,physicalsecurity, transparentoperationandcollectiveownershipofthedatabaseasawholeisassuredmore securelythanifitwerelocatedinasingleplace.datainthepublicdatabasesarefreeto anyonetoread,todownloadandanalyzewithoutrestriction,includingforcommercialuse, andinthecontextofclearrulesforappropriateaccessandattribution. Databases,suchastheseandothers[e.g.,theKyotoEncyclopediaofGenesandGenomes (KEGG)]haveprovedsuccessfulforanumberofreasons.First,therewascollaboration amongstakeholders(journals,fundingagencies,governments)andthedevelopmentof incentivesforparticipation(e.g.,priorityrulesandtheneedforacommondatabaseagainst whichtocomparenewlydiscoveredsequences).databaseoperatorsnegotiatedwithmajor scientificjournalstoestablishdatabaseaccessionsasarequirementforpublication.this

4 becamestandardpracticeinthefieldasotherjournalsfollowedsuit,andassuredopen accesstoresearchresults.inthesameway,provisionofstemcellinformationtotheglobal Huboroneofitsconstituentregistriescouldbemadeaconditionforgrantsand publications;alternatively,itcouldbeleftvoluntarywithincentivestocontribute.thegoal isasuccessfuldataresource,asmeasuredbyhowcomprehensive,complete,andaccessible itis. The linking functionoftheglobalhubwillrequirecoordinationandcooperationacross manyorganizations,alongwitharobustprogrammingefforttoallowthehubtousefully drawfromdiversedatabasesandresources.agreementstostoredatainastandardformat acrossdatabaseswillbecrucialtosuccess.atminimum,theglobalhubshouldinclude informationoncelllines(includingthosewithspecificmutations,thosecreatedfor screening/discoverypurposes,thosewithpotentialmedicalutility,etc.),andany associatedattributes(suchascharacterizationdataandprovenanceinformation)thatcan begleanedfromavailablesources;researchtools(reagents,technologiesandmethods); and,publicationinformation(vialinkstopubmedandtherelevantjournals).forthesorts ofdatathatshouldbeavailableforcelllines,proposedandevolvingstandardsshouldbe consulted(e.g.,theinternationalstemcellbankinginitiative sconsensusguidancefor BankingandSupplyofHumanEmbryonicStemCellLinesforResearchPurposes),butshould includeaccessionnumbersforrelatedmaterials,aswellassuchinformationasdonor ethnicity,hlaphenotype,sex,availableclinicalhistoryandinformedconsentdetails, includinganyrestrictionsputontheuseofthecells.agreementonaminimumdataset(for bothcharacterizationandprovenance)forcelllinesincludedintheassociateddatabases willmaximizetheutilityoftheresource. Recommendation1b.Establishacentralhubforaccessinginformationabout stemcellpatents StatementoftheProblem Manyresearchinstitutions,privateentities,andindividualshaveobtainedpatentsrelevant tostemcellresearchanditsapplication.thesepatentshavebeenstudiedbyindividual groupsofscholars.someofthemainconclusionsfromthatbodyofscholarshiparethat(1) thepublicdatabasesofpatentsareoftendifficulttosearch,andcanbeoutofdate,and incomplete;(2)despitegenerallysimilarlegalcriteria,theoutcomesofpatentexamination indifferentpatentjurisdictionsarequitedifferent;(3)iprarecopiousandatomizedintoa profusionofpatentswithoverlappingclaims;and(4)nooneiscuratingtheglobalbodyof patentdata.thishascreatedasituationinwhichevenadiligentstemcellresearcheror entitythatwishestorespectiprwillfaceconsiderableuncertaintyandenormouscostsif theytrytosurveytheiprlandscape.everyonesufferswhenthereisnomapforanew researcharea,andindividualexplorersareinnopositiontodothemappingandhaveno incentivetosatisfytheneedsofotherstakeholders.

5 Recommendation WeproposethecreationofanInformationResourceforStemCellIntellectualProperty Rights(IPRResource)thatwouldfunctionasafield specifichubtolinkandbuildon existingresources,suchasthepatentlandscapingeffortsofthejapanpatentofficeandthe UKIntellectualPropertyOffice,andacademicefforts,includingworkoftheStanford ProgramonStemCellsinSociety.TheIPRResourcewouldlinkallrelevantfacetsofstem celliprandrepresentasearchabledatabaseofprimarypatentdata,i.e.,patentsandpatent applications(e.g.,drawingonthenewlyonlineuspatentapplicationinformationretrieval system,privatepatentcompilingservices,etc.),andbelinkedtosecondaryresources,such asrelatedacademicpublications(viapubmed,andincludingbothscientificmanuscripts andthoseonstemcellipr),celllineinformation,etc.[thepublic SectorIntellectual Property Resource for Agriculture (PIPRA) and the DatabaseofGenotypesandPhenotypes (dbgap)representpartialmodelsforthis.] AswiththeGlobalHub,the linking functionoftheiprresourcewillrequirecoordination andcooperationacrossmanyorganizations,alongwitharobustprogrammingeffortto allowthehubtousefullydrawfromdiversedatabasesandresources.the building functionoftheiprresourcewillrequirestaff,andthedevelopmentandmaintenanceof thesetofdocumentsthatarenotbeingcapturedbyexistingresourcesthatcouldfeedinto ahub(e.g.,informationfrompatentofficesnotcoveredbysearchablepatentdatabases). Staffwillalsobeneededtosearchforandcaptureavailablelicensingandassignment information(i.e.,scanningthetradepress,securitiesandexchangecommissionfilings, companyannualreports,etc.),andscholarlyliteraturethatpresentsfirstlevelanalysisof theevolvinglandscapeofstemcellpatents(e.g.,landscaping).thereis,ofcourse,a languageproblemthatwillneedtobeaddressed,aspatents,governmentdocuments,and academicliteraturearenotwritteninasingle,commonlanguageglobally.theremayalso bearoleintheiprresourceforawiki typecomponent,whereinscholarsandother expertsinthefielddeveloppatentdigestsforselectedtechnologies,orotherwisehelp curatetheresource. Aresourcesuchastheoneproposedherewillrequirebothchampionsandfunding.We envisionaninternationalconsortiumofpublicandprivatefundingpartners,withinterests inscience,innovationandequitableaccesstoinformation. Recommendation2.Encourage,supportandcoordinateinternationalhuman stemcellbanksandhumantissueandcellrepositories StatementoftheProblem Manyindividuallabsinacademiadonothavethecapacitytosharecelllinesbroadly; however,normsofopensciencepresumebroadcirculationofdataandmaterials,inpartto reproduceresultsasabasictenetofscience.inaddition,consentdocumentssignedby tissuedonorsfrequentlyrefertobenefitsforparticularcommunities,andusuallyfor

6 generalpublicorsocietalbenefit.currently,manyhumanpluripotentstemcelllinesare beingderivedinlaboratoriesaroundtheworld,thoughnormsaroundstoringandsharing theselinesareunsettled.amongalltheindividualpartiesusingexistingbanks,thereare duplicatedlegalnegotiations,especiallyaroundmaterialtransferagreements(mtas),and duplicatedinvestigationsofprovenancethatdelaythesharingofmaterials.differing operatingproceduresandendusesacrossresearchandclinicaldomainsalsocreate challenges.furthermore,thescientificenterpriseisdevelopinginthedirectionofdesiring toacquireincreasinglevelsofmedicalinformationassociatedwiththetissuesusedto derivecelllines,andwemayneednew,internationallycoordinatedmechanismstodeal withemergingissuesrelatedtoinformedconsentandprivacy. Recommendation a.currenthumanpluripotentstemcellbankingefforts(e.g.,ukstemcellbank)already addresssomeofthechallengesofmaterialssharingandshouldbeencouraged,funded,and coordinatedinternationally. b.existingcellbanksandrepositoriesshouldcoordinatewithregardtostandards,and networkacrossnationalboundariesanddiseasecommunities;thiscouldhavesynergiesin enhancingaccessforthegeneralresearchanddevelopmentcommunity.whilenot necessarilyglobalinscope,awell networkedinternationalsetofcellbanksand repositoriescouldquicklyandefficientlydistributeexistingandnewlygeneratedhuman stemcelllinesofcommoninterest.inadditiontostemcellbanks,banksofhumantissueor differentiatedcells(e.g.,skinfibroblastcells)couldalsoprovidecellstothestemcell communitythatcouldbereprogrammedandcirculatedinasimilarfashiontoprovidea comparablelevelofaccess.cellandtissuebanks,overtime,developexpertisethatcanbe usedtodevelopstandards,suchasincellcultureandstoragemethods,andcoordinate practicesofdata,cellandtissuedistribution(seetheinternationalstemcellbanking Initiative sconsensusguidanceforbankingandsupplyofhumanembryonicstemcelllines forresearchpurposes). c.importantly,andinadditiontocirculatingmaterialswithintheresearchcommunity, manybankingeffortsalsomanageprovenanceinformationrelatedtothehumanmaterials theybank.thispracticeshouldbeadoptedandcoordinatedacrosscellbanksand repositories,asprovenanceinvestigationsandfindingsfacilitatethecriticalfunctionof ensuringthatconsentforresearchusesattheprocurementstageishonoredasr&dare pursuedwiththeresultingstemcelllines. d.giventhecostsofmaintainingsuchbanks,theseeffortscouldencompass,initially,a smallsetofwell characterizedhumanipsclines.theselectionofparticularcelllines shouldbejustifiedandtransparent.forexample,acriterionforinclusionofcelllinescould seekabalancebetweenhowpopulartheselinesareintheacademiccommunityversus howapplicabletheyareforparticulartherapeuticefforts,anddeliberationonthisbalance

7 shouldbepublicallyavailable.anotherrelevantcriterionmaybethelevelofconstrainton theuseofacelllinebasedontheconsentobtainedatthetimeofmaterialsprocurement. Recommendation3.Developandinstituteincentivesfordataandmaterials sharingthroughpublication,participationininformationhubs,andother mechanisms StatementoftheProblem Inarapidlyexpandingfieldwithnumerouspublicationsreportingonresearchinvolving stemcells,itcanbedifficulttoaccesscertaintypesofdata(e.g.,cellcharacterizationdata), andsuchdataareoftennoteasilycomparableacrosspublications.moreover,thereis concernabouttheefficientsharingofmaterials,especiallyinaninternationalandoften competitiveenvironment.currently,therearedisincentivestoearlypublicationand distribution,especiallyinindustry:competitionisrestrictingdataandmaterialssharing bothwithinandacrossacademiaandindustry;thereisalackofvehiclesforpublishing certaintypesofdata(especiallynegativedata);and,thereisareluctancetodistribute materialsafterpublication.recommendations1and2areconcernedwiththe establishmentandoperationofcentralinformationhubsandcellbankstohelpameliorate theseproblems.however,theutilityofthesehubsandbanksisdependentonthe participationofscientists,researchinstitutions,fundersandgovernments. Recommendation a.funders,researchinstitutionsandjournalsshouldencourageandsupportthe establishmentofrelevantdatabasesand/or hubs wherethesedonotalreadyexist,and whereandwhentheydo,insistonthedepositionofdata,withreleaseon(orinaspecified timeafter)publication.thereisacomparablemodelsuccessfullyusedbythetop20 clinicaljournals(e.g.,nejm,lancet,blood),begunbytheusnationalinstitutesofhealthin 2000:ClinicalTrials.gov.Thissitefeatures90,000clinicaltrialrecords.Trialaimsand designmustberegisteredbeforeanyresultswillbepublished.otherrelevantexamples includetheminimuminformationaboutamicroarrayexperiment(miame)standards, whichdescribethedatadeemednecessarytoevaluateandreproduceapublished experiment,andtowhichover50journalsholdmicroarray basedpapersasaconditionof publication;thebermudaprinciples,whichreinforcedtheexistinggenomedatabases;and databasesandbiomaterialrepositoriesformodelorganisms e.g.,themouseresourcesat thejacksonlaboratory,thekomprepositoryoftheknockoutmouseproject,flybase(for Drosophila),WormBase(forCaenorhabditiselegans).Manyscientistsarealreadyusedto dealingwiththeseandsimilarrepositories,andrecognizethebenefitsofsubmittingdata andmaterials,theadvantagestheygiveinefficiencyandcostofdistribution,andtheadded valuetheserepositoriesprovidetotherelevantcommunities. b.fundingbodiesandjournalsshouldinsistthatsufficientinformationisprovidedon

8 methodsin(orassociatedwith)apublication,toallowotherresearcherstoevaluateand replicatepublishedexperiments.intheeventthatitisdiscoveredpost publicationthat insufficientmethodologyaccompaniedamanuscript,thereshouldbemechanismstoadd thisinformationinawaythatitislinkedtothepaper,viaamechanismsimilarto corrigendaanderrata,perhapsasamendments. c.regulatorybodies,researchinstitutions,fundingbodies,companies,andjournalsshould developaconsistentpolicyforsharingdataandmaterialspostpublication.supportfor theseactivitiesshouldbeitemizedinresearchgrants,andmechanismsshouldbe implementedtomonitorcompliancewiththepolicy. d.atthetimeofsubmissionforpublication,fundersandjournalsshouldinquireand researchersshouldsharewhetheranyusefulnegativedataweregeneratedinthecourseof aproject.ifso,thisinformationshouldalsobemadeavailableinpublications,as supplementarydataorasanaccessionnumbertoaresearchinformationdatabaseorhub. Mechanismsmayberequiredtoensurethatnegativedatahavebeenobtainedinarigorous manner,whichmayimposeanunfairburdenonjournalsandreviewers.itistherefore recognisedthatadditionalincentiveandsupportmechanismsmayneedtobedeveloped. e.scientistsandcliniciansshouldadvisejournalsandfundersonappropriatestandardsfor datacompletenessandnormsofbehaviourthatshouldbeincorporatedintoguidelinesor rules. Recommendation4.Exploreoptionsforformalcollaborativenetworks,patent brokering,andformationofpatentpoolswhenthosemechanismsforcollective managementofintellectualpropertycanmovethefieldforward Statementoftheproblem CopiousIP,includingpatents,hasaccumulated.Collectiveactioncouldbetakentoreduce transactioncostsandbureaucraticfrictionthatcanintrudeonmarketmechanismsto advancestemcellr&danditsearlyclinicalapplications.theprofusionofpatentssignals thatindividualresearchinstitutionsarehedgingtheirbets,seekingpatentrightsasa matterofcourse,intheunlikelyeventthatoneofthesepatentswillresultinahuge financialpayoff,buttherebycreatingacultureofpervasivepatentinfringementmarriedto apotentialoptionforprosecutingselectedinfringementlater.theresultisabroadshadow ofuncertaintyaboutfreedomtodoresearchandpursueapplications.anotherresultis likelytobeunder investmentinnewfirms,highbarrierstoentryfornewinnovators,and slowerprogressforthefieldthanifindividualresearchinstitutionsweremoreconstrained andtargetedintheirseekingofpatentrights.noonecanmoveaheadwithoutfearoflater encounteringlawsuitsbypatent owners,andyetmanyofthekeypatentsareheldby researchinstitutionswithpublicmissions.

9 Collectiveresources,suchascellbanksandregistries;centralhubs,suchasthoseproposed elsewhereinthisdocument;andconsistentpoliciesamongresearchinstitutionsand funderscanreducesomefriction.itseemslikely,however,thatsomeformofcollective managementofaccumulatediprmayalsobeneeded.ofnote,therecentusnational ResearchCouncilreporton ManagingUniversityIntellectualPropertyinthePublic Interest makesclearthatthemissionsofcreatingknowledgeanddisseminating knowledgeneedtoguidethepatentingandlicensingpoliciesofuniversitiesandnonprofit researchinstitutions. Recommendation Intellectualpropertyrelevanttostemcellresearchhasseveralfeaturesincommonwith othertechnologies,butsomefeaturesthataredistinctive.manypatentshavebeengranted indifferentcountriesandmultinationalpatentjurisdictions(suchastheeuropeanpatent Office).TheaccumulationofIPRiscommonforanemergingtechnology,andsince1998, thishasbeenoccurringinhumanpluripotentstemcellresearchanditsapplications. Themainchallengeinformingcollectiveresourcesisusuallytherecognitionbyacritical massofthestakeholdersthataparticularproblemworthsolvingoraparticular opportunityworthexploitingexists.thefrequencyoflaboratoriesandcompanies encounteringdelaysandblockagesmayberisingfastenough,inatleastsomedomainsof stemcellresearch,tomobilizeaconsensusthattheemergingiprproblemsneedtobe addressed.theiprsurroundingipscsinparticularareaccumulatingrapidly,thepatent holdersarediverseandnumerous,andnewpatentsareemergingonacomplexpatent landscape.thetimemayberipeforcollectiveactiontoensurethatr&dproceedsapace, andwithlesscongestionorfrictionthanislikelytobepossiblewithoutsuchcoordinated action. ThereareseveraloptionsfordisposingoftheaccumulatedIPRinawaythatbenefitsall parties.theinformationresourceforstemcellintellectualpropertyshouldexplore optionsforcollectivemanagementofipr,andidentifyareasinwhichpatentpools, formallyconstructedsemi commons,etc.,maybewarranted. Options PatentPools.Formalpatentpoolsareonepossiblesolutiontoreducingtransactioncosts aroundparticularapplicationsorstandards(thismayincludeipscs).patentpoolsrequire acollectionofissuedpatentsthatpatentholdersagreeto pool, meaningthattheyhavea formalcontractualagreementtonotenforcethepatentsagainstoneanotheroragainst otherslicensedbythepool.apoolrequiresvalidpatents,agatekeepingfunctionto determinewhatbelongsordoesnotbelonginthepool,awaytovalueandreturnrevenues forpatentsinthepool,andsufficientcommoninterestsamongthepatent holderstobe sustained.

10 Threefactorsmaymakeitdifficultforaformalpatentpooltoemergeinstemcellresearch: (1)theclaimsinpatentsneedtobevalid,yetitappearsthatoverlappingclaimsexistand thatmanybroadandsweepingclaimshavebeengranted,assuch,invalidclaimswould needtobeweededoutbyre examinationorlegalanalysis,andonlypatentswithvalid claimsthatcanwithstandlegalchallengeshouldenterthepool;(2)theinterestsof universities,nonprofitresearchinstitutions,smallfirms,andlargefirmsusingthepatented inventionsmaynotbeinsufficientalignmenttosupportapool,andyetallthoseentities holdpatents;(3)thevaluationofthepatentsinthepoolcanbevexing,aspatentsmayhave verydifferentvaluebuttheremaybenoconsensusaboutperceivedrelativevalue,and disagreementovertheformulatoallocaterewardsforuse.patentpoolscouldnonetheless emergebutwilllikelyincludeonlyasmallfractionofthepatentrightsthathavebeen grantedtodateandintheforeseeablefuture. Use nowpay latersemicommons.anothermodelforcollectivemanagementofipr involvesasetofrulesdesignedandenforcedbystakeholders,throughanetworkof agreements.someagreementsmaybeinformal,butasubsetofrulesandpracticesneedsto bewrittenandformal.theformationofnormsandpracticesaroundipriseasierwhen thereisasmallnumberofresearchfunders,butinstemcellresearch,theemergenceofthe fieldfromsmallcompanies,individualuniversitiesandfundingbystategovernments withintheus,andmanyregionalandnationalgovernmentsinternationally,butwithouta dominantfundingorganization,hasledtoanunusuallyintenseproblemofresearch coordination,coupledtoaprofusionofiprheldbydisparateactorswithdivergent interests.thedevelopmentofasemicommonsmaybeawaytoaddressthis. Patentbrokers.Shortofaformalpatentpool,ifpatent holdershavegenerallysimilar licensingstrategies,collectionsofpatentsmanagedbyaneutralarbitercouldemerge.a patentsupermarket doesnotrequireastronggatekeepertovetthepatentsenteringa formalpool,butonlyabrokertocollectpatentsavailabletopotentiallicenseestobemade availableonstandardterms.aroyalty clearinghouse canconsolidateandsimplifythe transactionsofincrementalroyaltypaymentsforsuchstandardtermlicenses. Collaborativenetworks.Onepromisingstrategyistoreducetransactioncostsby eliminatingpatentsthatareneverenforced,licensingexistingpatentsonnonexclusive termsexceptwhenexclusivityisneededtoinduceinvestmentinproductdevelopment,and generallyclearingouttheaccumulatedunderbrushofiprdetritus.theseactionsrequire changesinpolicyamongindividualstakeholdersinthefield,andarelikelytoemergeonly ifthereareexplicitnormsarticulatedbythoseengagedinstemcellresearch.

11 Recommendation5.Adoptlicensingpracticesandpatentpoliciesthatpromote fair,reasonable,andnondiscriminatory(equitable)accesstoknowledgeand healthcareapplications StatementoftheProblem Webelievethatlicensingpracticesinthebiologicalandbiomedicalsciencesshouldreflect thegoalofglobaljustice,borneoutofahumandignitycommontoallandauniversal commitmenttoreducesuffering.intellectualpropertyisnotsimplyaprivatematter:in additiontoitsobviousbenefitsandconsequencesforownersandusers(licensedornot),it providesframeworksvariablyincentivizinginventionandwritingsinaccordancewith societalaims,backedbythepowerofthestate.likerealproperty,itsstate backedpower toexcludemustnecessarilybeaccompaniedbyawarenessofitssocialcontextandutility, andreasonablelimitsonitsuseintheformofobligationstowardsothers.withresearch usinghumanmaterials,thecaseforrequiringbroadsocialbenefitarguablybecomeseven stronger.finally,thealtruismofdonorsandthecommitmentsmadetoethicsreview bodies,fundersandothers,requirethatinstitutionallicensesmatchanyintentionforsocial goodpromisedbyresearchers. Recommendation Theethicalimportanceofpromotingaccesstoknowledgeandmedicinesthroughgood licensingpracticesisself evident.accordingly,statementsinthisveinmadebyanumberof professionalsocietiesmustbenotmerelyaffirmedbutalsoimplemented.thesestatements include,butarenotlimitedto, InthePublicInterest:NinePointstoConsider, endorsedby theassociationofuniversitytechnologymanagers;theintellectualpropertyprovisionsof theinternationalsocietyforstemcellresearch(isscr)guidelinesfortheconductof HumanEmbryonicStemCellResearch;andtheSocialJusticeprovisionsoftheISSCR GuidelinesfortheClinicalTranslationofStemCells. a.inparticular,anylicensingongovernment fundedstemcellinventionsmust: Reserveresearchrightsfornon profitinstitutions; PromoteR&Donandaccesstotechnologiesthatcanhelpmeetcriticalhealthneedsin bothdevelopinganddevelopednations.thiscanbefacilitatedthroughtheuseof, whereverpossible,negotiatedglobalaccesstermsandjurisdictionalandfield of use limitations; Usenon exclusivelicensingofplatformtechnologiesandtechnologiesofbroad ancillaryutilitythatareinstrumentaltothedevelopmentofthefield;and, Ensurethatdataandmaterialsareavailabletogovernmentandacademicresearchers withaminimumofdelay. Licensingofprivatelyfundedstemcellinventionsshouldalsoconsidertheabove recommendations. b.technologytransferofficesingovernment fundedresearchinstitutionsshouldmake

12 publictheirstemcellipr,includingtheirgeographicscopeandlicensinghistory(including whererightshavebeenreservedornon assertclauseshavebeenused),inorderto promotetransparencyandgreateruseofstemcelltechnologies.thiscouldbedoneeasily andinexpensivelywiththeiprresourceproposedelsewhereintheserecommendations. c.patentofficesandkeypolicymakersshouldreassesswhetherthecurrentstandardsfor grantingstemcellpatentsareappropriate,givenboththepowerofbroadplatformpatents toblockr&d,andtheproliferationofpatentsthatcancreateuncertaintyand fragmentationinthepatentlandscape.

13 SteeringCommittee: SarahChan,BSc(Hons),LLB,MA(Health CareEthicsandLaw) DeputyDirector&ResearchFellowin BioethicsandLaw InstituteforScience,EthicsandInnovation SchoolofLaw,UniversityofManchester PeterJDonovan,PhD Professor,DepartmentsofBiological ChemistryandDevelopmental&CellBiology Co Director,Sue&BillGrossStemCellCenter UniversityofCalifornia Irvine RuthFaden,PhD,MPH PhilipFranklinWagleyProfessorof BiomedicalEthics ExecutiveDirector,JohnsHopkinsBerman InstituteofBioethics Professor,DepartmentofHealthPolicy& Management,SchoolofPublicHealth Professor,DepartmentofMedicine TheJohnsHopkinsUniversity JohnHarris,FMedSci,BA,DPhil LordAllianceProfessorofBioethics Director,InstituteforScience, EthicsandInnovation SchoolofLaw UniversityofManchester RobinLovell Badge,PhD,FMedSci,FRS Head,DivisionofDevelopmentalGenetics, MRCNationalInstituteforMedicalResearch DivisionofDevelopmentalGenetics MRCNationalInstituteforMedicalResearch DebraJHMathews,PhD,MA AssistantDirectorforSciencePrograms, JohnsHopkinsBermanInstituteofBioethics AssistantProfessor,DepartmentofPediatrics TheJohnsHopkinsUniversity AlanRegenberg,MBe BioethicsResearchManager,JohnsHopkins BermanInstituteofBioethics TheJohnsHopkinsUniversity JulianSavulescu,BMedSci,MB,BS,MA, PhD UehiroChairinPracticalEthics Director,OxfordUehiroCentreforPractical Ethics UniversityofOxford DavidWinickoff,JD Co Director,Science,Technology,andSociety Center,UniversityofCaliforniaBerkeley AssociateProfessorofBioethicsandSociety UniversityofCalifornia Berkeley

14 ExecutiveCommittee: RobertCook Deegan,MD Director,IGSPCenterforGenomeEthics,Law&Policy DukeUniversity GregoryGraff,PhD AssistantProfessor,DepartmentofAgriculturalandResourceEconomics ColoradoStateUniversity AuroraPlomer,BA,MA,LLB,PhD ChairinLawandBioethics,DirectorofSIBLE,SchoolofLaw,UniversityofSheffield Director,SheffieldInstituteofBiotechnologyLawandEthics UniversityofSheffield KrisSaha,PhD PostdoctoralFellow,WhiteheadInstituteforBiomedicalResearch,MIT ScienceTechnologyandSocietyFellow,KennedySchoolofGovernment HarvardUniversity ChristopherScott Director,ProgramonStemCellsinSociety,CenterforBiomedicalEthics,StanfordUniversity President/CEO,TheStemCellAdvisors JohnSulston,PhD Chair,InstituteofScience,Ethics,andInnovation UniversityofManchesterSchoolofLaw UniversityofManchester PatrickTaylor,JD Fellow,Petrie FlomCenterforHealthLawPolicy,BiotechnologyandBioethics,HarvardLawSchool AssistantClinicalProfessor,HarvardMedicalSchool StaffScientist,Children shospital,boston,ma

15 HinxtonGroupMembers: ElonaBaum,JD(Observer*) GeneralCounsel CaliforniaInstituteofRegenerativeMedicine LauraBiron,PhD GreenwallFellowinBioethicsandHealthPolicy,JohnsHopkinsBermanInstituteofBioethics TheJohnsHopkinsUniversity TaniaBubela,PhD AssistantProfessor,SchoolofPublicHealth UniversityofAlberta,Canada FrancescaCesari,PhD(Observer*) SeniorEditor Nature HaidanChen,PhD PostDoctoralResearchFellow,CenterforSTS ZhejiangUniversity,China JorgeContreras,JD Director,IntellectualPropertyProgram,SchoolofLaw WashingtonUniversityinSt.Louis IshanDasgupta ResearchProgramCoordinator,JohnsHopkinsBermanInstituteofBioethics TheJohnsHopkinsUniversity MatthewDeCamp,MD,PhD GreenwallFellowinBioethicsandHealthPolicy,JohnsHopkinsBermanInstituteofBioethics FellowinGeneralInternalMedicine TheJohnsHopkinsUniversity RichardGold,SJD Professor,McGillUniversityFacultyofLaw President,InnovationPartnership SørenHolm,BA,MA,MD,PhD,DrMedSci Chair,CenterforSocialEthicsandPolicy,UniversityofManchester ProfessorofMedicalEthics,UniversityofOslo JimHoulihan,PhD(Observer*) HeadofInnovationPolicy UKIntellectualPropertyOffice

16 RyuichiIda,LLB,LLM ProfessorofInternationalLaw,KyotoUniversityGraduateSchoolofLaw Member,ExpertPanelonBioethics,CouncilforScienceandTechnologyPolicy,Japan Member,Bioethics&BiosafetyCommittee,MinistryofEducation,Culture,Sport,Science& Technology,Japan KazutoKato,PhD AssociateProfessorofScienceCommunicationandBioethics,InstituteofResearchinHumanities, GraduateSchoolofBiostudies KyotoUniversity AnnabelleLever,PhD WellcomeInterdisciplinaryResearchFellow,InstituteofScience,Ethics,andInnovation UniversityofManchester JacobLeveridge(Observer*) BiomedicalEthics&MedicalHumanitiesAdviser WellcomeTrust ReinhardMerkel,Prof,Dr InstitutfürKriminalwissenschaften UniversitätHamburg DianneNicol,LLM,PhD Professor UniversityofTasmania,Australia AmandaOdell West,PhD LecturerinLaw,SchoolofLaw UniversityofManchester BeverlyAPurnell,PhD SeniorEditor ScienceMagazine MahendraRao,MD,PhD VicePresident,StemCellsatInvitrogen AdjunctProfessor,BuckInstituteofAgeResearch VicePresident,MedicineatLifeTechnologies BrockReeve,MPhil,MBA ExecutiveDirector,HarvardStemCellInstitute HarvardUniversity MarkRohrbaugh,PhD,JD(Observer*) Director,OfficeofTechnologyTransfer

17 NationalInstitutesofHealth MarkSheehan,PhD,MA BRCEthicsFellow,TheEthoxCentre JamesMartinResearchFellowintheProgramontheEthicsoftheNewBiosciences OxfordUniversity GlynStacey,PhD HeadofDivisionofCellBiologyandImaging,NationalInstituteforBiologicalStandardsandControl Director,TheUKStemCellBank JeremySugarman,MD,MPH,MA HarveyMMeyerhoffProfessorofBioethicsandMedicine DeputyDirectorforMedicine,JohnsHopkinsBermanInstituteofBioethics TheJohnsHopkinsUniversity DieterTreichel,PhD PatentandStart upmanager MaxPlanckInnovation FanyiZeng,MD,PhD Professor,AssociateDirector,ShanghaiInstituteofMedicalGenetics,ShanghaiStemCellInstitute ShanghaiJiaoTongUniversity,China *ObserversparticipatedintheHinxtonGroupmeetingasinterestedparties,butareunabletoformally endorsetheconsensusstatementduetotheirprofessionalpositions

18 Funders Wewouldliketogratefullyacknowledgethegeneroussupportoftheinstitutionsfundingthiswork: