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WHYGENESMUSTREMAINELIGIBLEFORPATENTING
ByKevinNoonan
Inthegenepatentingdebate,asinwar,truthhasbeenthefirstcasualty.Whetherit'spublicitycampaignsbythe
AmericanCivilLibertiesUnionwithcleverbuttonsdeclaring"Donotpatentmygenes"orhyperbolicrhetoric,
polemichasquicklyreplacedintegrityinanefforttoinfluencepublicopinion(bothathomeandabroad).

Agreatdealoftheantigenepatentingargumentisbasedonfaultypremises,incorrectscience,andastudiedlackof
appreciationofpatentlawasithasbeenapplied,interalia,topatenteligibilityfornaturalproducts.Sinceany
rationaldebateisonlyasgoodastheinformationitisbasedupon,itisusefultoaddressthemoreflagrant
inaccuraciesspoutedbythosewhoopposegenepatenting.Since"thetruthshallsetyoufree,"therearesome
fundamentaltruthsthatmustbeconsideredwhendiscussinggenepatents.Theseinclude:

RaceandGenetics
Forcenturies,humansocietieshave
dividedpopulationgroupsinto
separateraces.Whilethereisno
scientificbasisforthis,people
unquestioninglyacceptthese
classificationsasfact.

"Genesareaproductofnature":Thefacts
Patentsclaiminggenesdonotclaimproductsofnature.Thesimpledistinctionisthatgeneclaimsrecitethatthe
genesare"isolated,"andthislimitationontheirscope(aswellasthe13thAmendmenttotheU.S.Constitution)
prohibitthescenariothatapatentholdermayonedayringyourdoorbellandaskforaroyaltyfromyoubecauseyour
liveris"using"apatentedgene.Moreimportantly,noonewouldwanttoownanyindividualperson'sgenes:ithas
beenknownformorethanfortyyearsthatanyparticularcopyofageneinanindividualinapopulationislikelyto
containatleastonepolymorphismthatdoesorcould(undertherightenvironmentalconditions)affectitsfunction.
RecentreportsfromJ.CraigVenteronthecompletesequenceofhumandiploidgenomicDNA(hisown)detected
morethan4millionnucleotidevariants,includinganextraordinaryamountofgeneticvariationthatcouldaffect
geneexpressionandgeneproductsinunpredictableways.
Moreover,andmoresignificantly,humangenesastheyexistinhumanchromosomesarephysicallyandchemically
differentfromgenes(really,isolatednucleicacids)asclaimedintheoverwhelmingmajorityofsocalled"gene
patents."Geneshavebeendescribed,properly,astheinstructionsforproducingproteins.Ageneencodestheamino
acidsequenceofaproteininalinearsequenceof3basetripletcodonsthatcorrespondinlinearordertotheamino
acidsequenceoftheprotein.However,inhumans(andalmostallothermulticellularorganisms)almostallgenes
areinterruptedby"junk"DNAthatdoesnotencodeprotein(oratleastdoesnotencodethesameproteinthatthe
geneencodes).Theentiregene,junkandcodingsequence,istranscribedintoRNAbythecellandthenthejunk
piecesare"splicedout,"leavingthecodingsequence(termedamessengerRNAormRNA)thatisusedtoproduce
theprotein.Scientiststakeadvantageofthisprocesstoclonegenes,byisolatingthemRNAandconvertingitintoa
DNAmoleculecalledcomplementaryDNA(cDNA),whichiswhatiscloned,sequenced,andpatented.cDNAdoes
notexistinnature,andmustbecreatedbymanusingchemicalandbiologicaltechniques.Thehallmarkofwhatthe
SupremeCourthasdeclaredispatenteligibleis"anythingunderthesunmadebyman."ThecDNAcopiesofgenes
thatformthebasisforhumangenepatentingare"madebyman"andnotproductsofnaturebecausetheydonot
existinnaturepriortobeingsynthesizedinatesttubebyascientist.Ifwearehonestindefiningwhatareactually
"productsofnature,"thentheymustbydefinitionbeproducedbynature.cDNAmoleculesarenot.

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"Genesareproductsofnature":Thelaw
Thelegalargumentthat"productsofnature"arenotpatenteligibleprovestoomuch,becauseifgenesarenot
patentablethenmanyothernaturalproductscannotbe,either.Thisincludesforexamplevariousantibiotics,and
anynumberofproductsisolatedfromcrudeoil,plants,animals,andevenhumans.Ifgenesarenotpatenteligible,
basedonthefactthattheyareproductsofnature,thenthepatentincentivecannotexistforthese"productsof
nature,"either.IfisolatedhumanDNAisnotpatenteligible,thereisnoprincipledreasonwhymanyother"natural
products,"suchasantibodies,antibiotics,antisenseandsmallinterferingRNAs(siRNAs),hormones,metabolites,
andproteinsshouldbe.Importantly,alsoincludedinanysuch"naturalproducts"patentingbanwouldbebiologic
drugs,i.e.,thosedrugsbasedon"naturallyoccurring"humanproteins.Indeed,proteinslikehumanBloodClotting
FactorsVIIIandIX,insulin,humangrowthhormone,erythropoietin,tissueplasminogenactivator,andall
monoclonalantibodiesare"isolated"insubstantiallyhomogeneousform,arestructurallyunchangedfromtheir
sourcesinbloodandotherbodilyfluids,andarelessalteredthanthecDNAsthatarethesubjectoftheclaimsto
isolatedhumanDNAinvalidatedbythedistrictcourt.Theseconsiderationsarealsowhythedistinctionsdrawnin
theDepartmentofJustice'sbrieftotheFederalCircuitisbadscience,badlawandbadpolicy,inviewoftheexpected
importanceofbiologicdrugsintheyearstocome.

Thereisnobindinglegalprecedentthatmandatesthatnaturalproductsareineligibleforpatenting.Onthe
contrary,theprevailingprecedent,Diamondv.Chakrabarty,mandatespatenteligibilitytoanythingthatisa

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"nonnaturallyoccurringmanufactureorcompositionofmatteraproductofhumaningenuity,"thatis"not
nature'shandiwork,but[theinventors']own."IsolatedDNA(aswellastheseotherexamplesofnaturalproducts)
fallssquarelywithinthisrubric.
"Genesarepartofa'commons.'"
Ironically,genesandgenepatentingwereoriginallyassailedascreatinga"tragedyoftheanticommons,"because
private"ownership"thereofwouldimpedegeneticresearch.Infact,ashasbeenshownbymultiplestudiesoverthe
past10years,genepatentinghasdonenosuchthing.Indeed,everyreportonthesubject,whetherfromtheUnited
States1,Germany2,Australia3orJapan4,hasfoundthat"patentthickets"5orthe"anticommons"6rarelyaffectsthe
researchofacademicscientists.Inaddition,theincentiveforgenepatentingmotivatedprivatecompanies,most
notablyCeleraandHumanGenomeSciences,tocompetewiththefederallyfundedeffortstosequencethehuman
genome.Thiscompetitionacceleratedtheseeffortsandproducedsequenceinformationmorerapidlythananyone
expected.Iftheseeffortsprovidedgeneticinformationthatcanbeusedtoaddresshumandiseaseoneday,one
month,oroneyearearlierthanitwouldhavebeenproducedotherwise,whocansaytheincentiveisinsufficient?
"Genepatentinginhibitsgeneticresearch."
Infact,averygoodcasecanbemadethattheoppositeistrue.Thisisduetoanotherdistinctionglossedoverby
thoseopposedtogenepatenting:geneticinformationisn'tpatented(despitethedistrictcourt'sconceitthatitcould
distinguishclaimedDNAfromotherbiologicalproductsforbeing"thephysicalembodimentof[genetic]
information").Patentlawrequiresthatclaimsbesupportedbyawrittendescriptionsufficienttoenabletheskilled
workertomakeandusetheinvention.Forgenes,thishasmeantthatthegeneticsequenceisdisclosedinalmostall
genepatents.Thisinformationcanbeusedforanynumberofpurposes,includingsequencecomparisons(which
canbeperformedwithout"isolating"agene),detectinggeneticpolymorphisms,andavarietyofotherscientific
endeavorsbothbeforeandafterapatentgrants,withoutriskofinfringement.
Perhapsthebestindicatorthat"inhibitingbasicresearch"hasnotbeenaconsequenceofpermittingpatentson
humangenesistheextenttowhichbasicresearchhasbeenperformedontheBRCA1orBRCA2genes,famously
patentedbytheUniversityofUtahandlicensedbyMyriadGenetics.Thenumberofresearchreportsinpublic
databasesreflectingongoingbasicscientificresearchinpeerreviewedscientificjournalsonthesegenesisalmost
10,000:asimpledatabase(PubMed)searchof"brca1orbrca2"resultedin7,855publications.IfeitheroftheBRCA
patentsweretohavehadachillingeffectonbasicresearch,theexpectationwouldbethatthenumberofscientific
researchreportswouldhavedeclinedinthefaceofpatentinfringementliability.Onthecontrary,thenumberof
suchpublicationshassteadilyincreasedeachyear,whichispreciselywhatwouldbeexpectedifthesepatentshad
nosignificanteffectonbasicscientificresearch.
Whatthesepatentsdo,ofcourse,ispreventcommercialactivityi.e.,usingthepatentedisolatedhumanDNAor
performingthepatentedmethodsforprofit.Thisisalegitimateexerciseofthepatentgrant.
"Wedon'tneedgenepatentsresearcherswilldoitanyway."
Withregardtobasicgeneticresearch,thisistrueitisthecorollarytothepreviouspoint,thatgenepatentsdon't
inhibitgeneticresearch.However,thereisavastgapbetweenidentifyingageneticpolymorphismrelatedtoa
disease,oridentifyingagenethatencodesausefulprotein,anddevelopingaclinicallyvalidatedtestorproducinga
commercialbiologicdrugproduct,andthatiswherebiotechnologycompaniescomein.Ofcourse,withoutthe
prospectofpatentprotection,investorsareunlikelytoprovidethefundingneededbystartupbiotechnology
companiestodevelopcommercialembodimentsoftheseinventions.Andinviewofthecomplexitiesof
biotechnologyproducts,otheravenuestradesecretsandregulatorydataexclusivitybeingjusttwomayenable
companiestokeeptheir"monopoly"muchlongerthanthetermofagenepatent.Thiswouldproducethekindof
unfetteredrightin(undisclosed)geneticinformationthatopponentsofgenepatentingwronglyassertexiststoday.
"Genepatentinginhibitsinnovation."
Itiseasytoforgettodaythebasisforgenepatentinginthepast.Anynumberofbiologicdrugshavebeendeveloped
that,accordingtoarecentFederalTradeCommissionreport,"haveimprovedmedicaltreatments,reducedsuffering,
andsavedthelivesofmanyAmericans."Thesedrugsweredevelopedbycompaniesthatisolatedthegenesencoding
them,includingerythropoietin,humangrowthhormone,interferon,bloodclottingFactorsVIIIandXI,human
insulin,tissueplasminogenactivator,andahostofothers.Thepatentincentivewasinstrumentalinsupporting
investmentinthesecompaniesandindevelopingabiotechnologyindustryintheU.S.thathasbeenaworldleader
for25years.Asanyonewhofollowedthedebateonfollowonbiologicswillrecognize,theneedforpatent
protectiontoattractinvestmentinwhatremainsafundamentallyriskyindustryhasnotdiminished.Patentpolicies
abroadalreadypermitthosecountriesto"freeride"onAmericaninnovation.Whyshouldweadopttheirfailed
policieshere?Andwhowillcreatethenextgenerationofdrugsbasedonbiotechnologyifwedo?
Unfortunately,mostoftheseargumentsmisconstruethefundamentalsocietalbenefitconferredbythepatent
systemnotincentivestoinnovate,andnotevenincentivestocommercialize,buttherequirementsfordisclosure
thatarefundamentaltothepatentgrant.Theplaintiffsfatallyoverreachedinseekingtoinvalidatethepatentsin
suit,andtheU.S.DistrictCourt'sdecision,ifupheldbytheFederalCircuitorSupremeCourt,islikelytohave
unintendedandseriouslynegativeconsequences.Thepatentsatissue,directedtoisolatedhumanDNAencoding
BRCA1andBRCA2,representonlythebeginningofaneraofpersonalizedmedicinethatwillbecharacterizedby
understanding,andutilizing,geneticdifferencesthatimpactbothanindividual'spropensityforsuccumbingto
diseasesanddisordersaswellasmakingadeterminationofthebesttherapeuticinterventionsandtreatmentsfor
addressingthem.Patentsinthisareaareneededtopromoteexpeditiousdisclosureofthegeneticbasesforsuch
diagnosticandtherapeuticapproachestohumandiseasewithoutthem,alternativemeansofprotectingsuch
discoveries,forexamplebyholdingthemastradesecrets,willbecomemoreattractive.Patenteligibilityofisolated
humanDNApromotesnotonlydisclosureoftheDNAitself(andtheproteinsencodedthereby)butalsothebest
modeformakingandusingtheisolatedhumanDNAandrelatedmethods.Evenshouldthebasicgenetic
informationbeavailableelsewhere,failuretopatentalsomeansfailuretorequirefulldisclosure,andtheattendant
suppressionofinformationwouldaffectthedevelopmentofreliabledrugsanddiagnosticmethods(orworse,permit
privatecompaniestoholdsuchinformationindefinitely).Suchanoutcomewouldbeadversetothepublicinterest
andcontrarytothesoundpublicpolicyunderlyingthePatentAct.

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KevinE.Noonan,PhD,JD,isapatentattorneyandfounderofpatentdocs.org.

1.Walshetal.,2003,"ScienceandtheLaw:WorkingThroughthePatentProblem,"Science299:1020).
2.Straus,2002,GeneticInventions,IntellectualPropertyRightsandLicensingPractices.
3.Nicoletal.,2003,PatentsandMedicalBiotechnology:AnEmpiricalAnalysisofIssuesFacingtheAustralian
Industry,CentreforLaw&Genetics,OccasionalPaper6.
4.Nagaoka,2006,"AnEmpiricalAnalysisofPatentingandLicensingPracticeofResearchToolsfromThree
Perspectives,"presentedinOECDConferenceinResearchUseofPatentedInventions,Madrid).
5.Shapiro,2001,"NavigatingthePatentThicket:CrossLicenses,PatentPools,andStandardSetting,"In:
InnovationPolicyandtheEconomy1:11950.
6.Heller&Eisenberg,1998,"CanPatentsDeterInnovation?TheAnticommonsinBiomedicalResearch,"Science
280:698701.

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