Predicting Patent Utility For a Useful Drug: Federal Court of Canada Invalidates Patent For Esomeprazole

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PREDICTINGPATENTUTILITYFORAUSEFULDRUG:FEDERALCOURTOF
CANADAINVALIDATESPATENTFORESOMEPRAZOLE

J
ASONMOSCOVICI*
ROBIC,
LLP
L
AWYERS,PATENT&TRADEMARKAGENTS

OnJuly2,2014,theFederalCourtofCanadafoundthatASTRAZENECA
AKTIEBOLAG’spatentforesomeprazole(registrationnumber2,139,653,orsimply
“the‘653patent”)wasinvalidfornotmeetingthedeclaredpromisedutility.Thisisa
landmarkrulingthatclarifiesthehottopicissueof“properdisclosure”inthecontext
ofpatentutilityandsoundpredictioninCanada(AstrazenecaCanadaInc.v.Apotex
inc,2014FC638;ASTRAZENECAAKTIEBOLAGandASTRAZENECACANADA
INCarecollectivelyreferredtohereinas“ASTRAZENECA”)

FactualBackground
Briefly,the‘653patentcoversaformofesomeprazolethatwasbeingsoldinCanada
byASTRAZENECACANADAINC.asNEXIUM®,amedicationrecognizedasbeing
usefulforthetreatmentofgastrointestinalconditionssuchasacidreflux.APOTEX
INC.(“APOTEX”)soughttomarketagenericformofthisdrugandappliedtothe
MinisterofHealthforaNoticeofCompliance(“NOC”).AspartoftheCanadiandrug
approvalprocess,anInnovatorcompanycanapplytothecourtstoobtaina
prohibitionorderagainstanygenericseekingmarketapprovalforadrugforwhich
thereisacorrespondingpatentlistedonHealthCanada’spatentregister(knownas
an“NOCproceeding”).Thisapplicationforaprohibitionorderwasappliedforby
ASTRAZENECAforesomeprazole,onaccountofthe’653patent,whichwas
dismissed.APOTEXthereforeobtaineditsNOCforesomeprazoleandstartedselling
thedruginCanada.ASTRAZENECAthensuedfordirectinfringementofthe‘653
patent.
InitsDefenceandCounterclaim,APOTEXchallengedthevalidityofthe‘653patent
forlackofnovelty,obviousnessandforfailingtomeettheclaimedpromise,which
ultimatelyturnsontheinterpretationofthefollowingstatementfoundinthe
descriptionofthepatent:“Itisdesirabletoobtaincompoundswithimprovedpharmacokinetic
andmetabolicpropertieswhichwillgiveanimprovedtherapeutic

©CIPS,2014.*OfROBIC,LLP,amultidisciplinaryfirmoflawyers,patentandtrade-markagents.Publishedinthe
October2014issueoftheWorldIntellectualPropertyReport.Publication142.285.

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2
profilesuchasalowerdegreeofinterindividualvariation.The
presentinventionprovidessuchcompounds,whicharenovelsaltsof
singleenantiomersofomeprazole(emphasisadded)”[Astrazeneca
CanadaInc.v.Apotexinc,2014FC638,para3.]

ASTRAZENECAcontendedthattheunderlinedstatementwasa“hopedfor”
advantageandthatthecompound“may”havetheimprovedtherapeuticprofile
describedtherein.ASTRAZENECAarguedthatuseoftheterm“will”wasnota
promiseinthiscontextandthat,whenonelooksatthepatentasawhole,the
expression“improvedtherapeuticprofile”needstobereadasagoalandnota
promise.TheCourtfoundthatASTRAZENECA’sinterpretationisinconsistentwith
theprincipleofpatentutilityinCanada,whichwewilldelveintoinmoredetailbelow.

Inresponse,APOTEXputforwardthatasimple,plainreadingofthepatentshould
beinterpretedasmakingthepromiseofanimprovedtherapeuticprofile.TheCourt
foundthat,consideringtheprinciplesapplicableinthecontextofdeterminingutility
basedonthepromisefoundinthepatent,patent‘653promisesan”improved
therapeuticprofile”,andthatthispromisewasnotkept.

PreliminaryIssues1)StandingofASTRAZENECAAKTIEBOLAG

Beforedelvingintotheinterpretationandassessmentofthevalidityofthe‘653
patent,ApotexarguedthatASTRAZENECACANADAINC.lackedstandingand
couldnotactasPlaintiff.AsperthePatentAct(R.S.C.,1985,c.P-4),apatent
infringerisliable”tothepatentee”(inthiscase,ASTRAZENECAAKTIEBOLAG)and
to“allpersonsclaimingunderthepatentee”.Apotexarguedthatthereisnoexpress
licensebetweenASTRAZENECACANADAandASTRAZENECAAKTIEBOLAG,
whoistheactualpatentee.TheCourtfoundthatASTRAZENECACANADAhad
standing,asithadbeensellingNexium®inCanadafor13yearsandtherefore,there
musthavebeenanimpliedrecognitionofarightbetweenthetwo.TheCourt
thereforefoundthattheterm”personsclaimingunder”istobeinterpretedbroadly
andincludesASTRAZENECACANADA.2)PreclusionfromContestingInvalidityandAbuseofProcess

Interestingly,APOTEXalsoputforwardthatwhatASTRAZENECAhadarguedinthe
previousNOCproceedingshouldhavesomebearing,orlegaleffect,onthis
impeachment/infringementproceeding.ASTRAZENECAshouldthereforebe
precludedfrom“re-litigating”thesameissuesthatwerealreadyexaminedintheprior
NOCcase.TheCourtbrieflydistinguishedNOCproceedingsfrominfringementor
impeachmentproceedingsandconfirmedthattheirstatusissettledinlaw:adecision
foundinanNOCproceedingisnotbindinginaninfringementaction.However,prior

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caselawhasrecognizedsituationsthatcouldgiverisetoanestoppelinorderto
preventapartyfromre-litigatingcertainfactualorlegalissuesthatwerealready
previouslydecided.Nevertheless,theCourtfoundthat,sincetheevidentiaryrecord
wasnotsufficientlysimilarbetweenbothcases,theestoppeldoctrinedoesnotapply
andtheeffectofanNOCproceedingisnotresjudicataforaninfringementand
validitycaseinvolvingthesamepatent.
APOTEXalsoarguedthatthepositiontakenbyASTRAZENECAinthisinfringement
casewasdifferentthantheonetakenintheNOCproceeding,whichisanabuseof
process.APOTEXallegedthatASTRAZENECAputforwardcontradictoryarguments
withregardstothepromise/utilityofthepatent,andthenon-obviousnessofthe
invention.Whilecontradictory,theCourtdidnotconsiderthesearguments“abusive”.

Inutility,Promise,PredictionandProperDisclosure

Whilethenoveltyandnon-obviousnessofthe‘653patentwascontestedby
APOTEX,itwastheissueofutility,orthepromisedutility,thatbecamedeterminative
fortheevaluationofthevalidityofthe‘653patent;andwhetherornotthedisclosure
ofthispromisedutilitycouldbesoundlypredicted.

Thedemonstrationofutilityreliesonwhetherornot,atthedateoffiling,thereis
proofthatthepatentworkedaspromised.Ifthisutilitywasnotdemonstratedbefore
filingofapatent,itcanbe“soundlypredicted”aspartofathreeparttestsetoutby
theSupremeCourtofCanadainApotexIncvWellcomeFoundationLtd,2002SCC
77thatis:
“(1)theremustbeafactualbasisforthepredictionofutility,(2)the
inventormusthaveatthedateofthepatentapplicationanarticulable
andsoundlineofreasoningfromwhichthedesiredresultcanbe
inferredfromthefactualbasis,and(3)theremustbeproper
disclosure.”

Inthiscontext,thecourtsummarizedthepromisesof‘653asbeing:“(1)useasaPPI
(protonpumpinhibitor);and(2)animprovedtherapeuticprofilesuchasalower
degreeofinterindividualvariation.”[Id,para214.]

Withregardstothefirstpromise,thecourtfoundthatitwassoundlypredicted.
However,itisthesecondpromisethatwasfoundtobeneitherdemonstratednor
soundlypredicted.
TheCourtanalyzedthequestionofproperdisclosureunderthelightof“unsettled”
caselaw.TheCourt’sreadingofthiscaselawsuggestedthattherequirementfor
properor“heightened”disclosureshouldbelimitedonlytocaseswherethecontext
revolvesaround“newuse”patents.Sincethe‘653patentisnotanewusepatent,
APOTEX’ssubmissionsregardingimproperdisclosureofstudiesmadebyAstra
Zenecawerenotrelevant.

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TheCourtwasthereforeoftheviewthat:
“thereisnoenhanceddisclosurerequirementinallsoundpredictioncases.
UtilityanddisclosurearetreatedseparatelyunderthePatentAct,and
consequently,shouldbetreatedseparatelyinthejurisprudenceaswell”[Id,
para160].

Findingthattherewasnoenhanceddisclosurerequirement,theCourtthen
proceededtoapplythelegaltestsrelatingtothedemonstrationandsoundprediction
ofutilityforthepromisesmadein‘653.Itconcludedthatthepromiseofan“Improved
TherapeuticProfile”wasstillnotdemonstrated.Theevidencepresentedshowedthat
thestudiesmadebyASTRAZENECAwerelimitedindataand“couldnotformthe
basisforasoundpredictionofutilitythatextrapolatesacrossanentirepatient
population”[Id,para194].Therefore,thesestudiesdidnotdemonstratenorsoundly
predictthepromiseofanimprovedtherapeuticprofile.Patent‘653wasinvalidatedfor
lackofutility.
CONCLUSION
Inconclusion,whilethisdecisionisinterestingwithregardstotheassessmentbythe
Courtofthepromisedutilityforadrugthatwasrecognizedinpracticeasbeinguseful
andeffective,theCourt’sstudyofthedisclosurerequirementforanevaluationof
soundpredictionclarifies,atleastfornow,whatwasanongoingissuefordebate:
thereisno“enhanceddisclosure”requirementforthedeterminationofasound
predictionofutility,unlessitisforanewusepatent.Nevertheless,useofplainwords
canhaveplainmeaningsinthecontextofidentifyingthispromisedutility.Itis
thereforealwaysprudenttonotpromisemorethanyoucandeliver.

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