Isolating Genes is no Longer Sufficient to get a Patent in the United States

2013-12-09

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ISOLATINGGENESISNOLONGERSUFFICIENTTOGETAPATENTINTHE
UNITEDSTATES*
ROBIC,
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AWYERS,PATENTANDTRADE-MARKAGENTS
OnJune13th2013,theSupremeCourtoftheUnitedStatereversedtwodecadesof
UnitedStatesPatentOffice(USPTO)pastpracticeanddelivereditslongawaited
decisionintheMyriadcase(AssociationforMolecularPathologyv.MyriadGenetics.
Inc.).MyriadistheholderofmultiplepatentspertainingtotheBRCA1andBRCA2
genesandtheirapplications.TheinventorsoftheMyriadpatentsdeterminedthe
exactlocationandnucleotidesequenceoftheBRCA1andBRCA2genesalongwith
thefactthatcertainmutationsintheBRCA1andBRCA2genesconsiderably
increasebreastorovariancancerrisk.TheAssociationforMolecularPathology
(AMP)broughtasuitagainstMyriadseekingadeclarationthatsomeofMyriad’s
patentsareinvalidfornon-statutorysubject-matter.

Inaunanimousdecision,theSupremeCourtpartiallyreversedtheFederalCircuit
priordecisionandruledthat:·Isolatedhumangenesfallunderthelawsofnatureandarenotpatent
eligiblesubject-matter.TheSupremeCourttookthepositionthatthe
chemicalchangesresultingfromtheisolationofagenewerenotsufficientto
renderanisolatedgenepatentable.
·SyntheticallymadecomplementaryDNAmolecules(cDNA)comprising
codingonlyDNA-segments(exons)areeligibletopatentprotection.The
SupremeCourttookthepositionthatcDNAsarenotnaturallyoccurringsince
non-codingDNAsegments(introns)presentingenesmustbeomittedin
ordertoobtaincDNAs.

AftertheSupremeCourtdecisionwasrendered,AmbryGeneticsannouncedthatit
wouldbeginofferingBRCAtesting.Myriadrespondedbyfilingalawsuitagainst
AmbryGeneticsforinfringingMyriad’spatentclaimsdirectedtoBRCAanalysis.Inits
submissions,Myriadarguedthatitwasstilltheholderofmorethan500validclaims.
ItisimportanttopointthattheonlyissuebeforetheSupremeCourtwaswhether
claimsdirectedtoisolatedgeneswereeligibleforpatentprotection.TheSupreme
CourtdidnotruleonMyriad’sgenetestingclaims.

TheSupremeCourtwascarefulinidentifyingwhatwasnotaffectedbyitsdecision.
Morespecificallythedecisionstatesthat:
“Thiscase,itisimportanttonote,doesnotinvolvemethodclaims,patentsonnew
applicationsofknowledgeabouttheBRAC1andBRCA2genes,orthepatentability

©CIPS,2013.*FromROBIC,LLP,amultidisciplinaryfirmofLawyers,andPatentandTrade-markAgents.Published
intheFall2013(Vol.17,no.2)Newsletterofthefirm.Publication068.167E.

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ofDNAinwhichtheorderofnaturallyoccurringnucleotideshasbeenaltered”
(emphasisadded).
InapriorFederalCircuitdecision,certainmethodclaimsdirectedtoidentificationof
cancertherapeuticagentswereheldtobeeligibletopatentprotectionwhileother
methodclaimsdirectedtocomparingoranalyzingDNAsequencesandincludingno
transformativestepsweredeterminednottobeeligibletopatentprotection.

IntheAmbrylitigation,MyriadistakingthepositionthatwhiletheSupremeCourt
invalidatedasmallnumberofclaims,MyriadisstilltheholderofsyntheticDNAand
methodofuseclaimsthatwerenotaffectedbytheFederalCircuitandSupreme
Courtdecisions.ThevalidityofMyriad’sBRCA1and2patentswillmostlikelybe
revisitedsinceAmbryisseekingadeclaratoryjudgmentthatMyriad’spatentsare
invalidandnotinfringedandthatMyriadhasviolatedU.S.antitrustlawsthroughbad
faithenforcementofthesepatents.
Whatisnext?

OnthesamedaytheSupremeCourtdecisionwasdelivered,theUSPTOissueda
memoranduminstructingpatentexaminerstorejectproductclaimsdrawnsolelyto
naturallyoccurringnucleicacidsandfragmentstherefor,whetherisolatedornot.The
memorandumalsostatedthatcDNAandman-madevariantswillcontinuetobe
patenteligiblewhileclaimsdirectedtomethodsinvolvingnaturallyoccurringnucleic
acidsmaygiverisetoeligibilityissuesunderthecurrentrules.

Interestingly,theMyriaddecisionandtheUSPTOmemorandumaresilentonhow
claimsdirectedtoisolatednaturallyoccurringbiomolecules,otherthangenes,should
beconsidered.BasedonthepositiontakenbytheSupremeCourt,thereisa
possibilitythatclaimsdirectedonlytoisolatednaturallyoccurringbiomoleculesmay
notbeeligibletopatentprotectionintheUS.
WhileisolatedgenescontinuetobepatentableinmanycountriesincludingCanada,
patenteesshouldcarefullyreviewtheirpatentportfoliosinordertoaddclaimsthat
aremorelikelytomeetthethresholdforeligiblepatentsubject-matterintheUnited
States.Patenteesshouldconsideraddingclaimsdirectedtonovelapplications,
cDNAandmodifiedvariantsofthegenesifpossible

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