Viagra™’s Patent Invalidated by the Supreme Court of Canada

2012-11-29

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VIAGRA®’SPATENTINVALIDATEDBYTHESUPREMECOURTOFCANADA

GABRIELLEMOISAN*
ROBIC,
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L
AWYERS,PATENTANDTRADE-MARKAGENTS

ThepatentthatcoverstheuseoftheactivemoleculeofViagra®,sildenafilwasthe
subjectofaunanimousdecisionbysevenjudgesoftheSupremeCourtofCanada
onNovember8
th,2012[TevaCanadaLtd.v.PfizerCanadaInc.,2012SCC60].It
consideredthattheCanadianPatent2,163,446wasinvalid,reversingthedecisions
oftheFederalCourtandFederalCourtofAppeal,onthegroundsthatthedescription
oftheinventionwasinsufficientatthedateofpatentfiling,andthereforenotin
compliancewithSection27(3)ofthePatentAct
,whichreads:
Thespecificationofaninventionmust(a)correctlyandfullydescribe
theinventionanditsoperationoruseascontemplatedbythe
inventor.

TheexpirationofthepatentwasexpectedinMay2014,20yearsafterthedateof
filingofthepatentapplication,butthisdecisionwillallowthegenericdrugcompany,
TevaPharmaceuticalIndustries(formerlyNovopharmLimited),toobtainanoticeof
complianceoftheMinistryofhealthandtoenterthemarketnow
4.

Pfizer’spatentdisclosesandclaimstheuseofafamilyofcompoundsforthe
treatmentofmaleimpotence.Intheshortdescriptionof12pages,itisonly
mentionedthat”oneoftheespeciallypreferredcompoundsinducespenileerectionin
impotentmales”,withoutspecifyingtheexactstructureofthecompoundhavingthis
property.Then,intheclaimswrittenin”cascade”,thecompoundisfirstclaimedbya
genericchemicalformula”for260quintillionpossiblecompounds.”Theclaimsend
withclaims6and7,addedafterthefilingoftheapplication,eachcoveringasingle
compound.Claim7coverstheactivedruginViagra™(sildenafil),butnothinginthe
patentindicatesthatitisthemoleculeclaimedinclaim7,whichissildenafil.

CitingtheAZT
[AZTisthecommonnameoftheSupremeCourtJudgementApotex
Inc.C.WellcomeFoundationLtd.,2002SCC77]decisionandincorporatingArticle
27(3)ofthePatentAct,theSupremeCourtheldthatthepatenteehadnotfulfilledits
obligationsunderthequidproquocontractthatappliesaccordingtothePatentAct:
theCanadiangovernmentprovidesamonopolyonaninventionfor20yearson
conditionthattheinventionisnovel,inventive,useful,butalsofullydisclosedatthe

©CIPS,2012.*FromROBIC,LLP,amultidisciplinaryfirmofLawyers,andPatentandTrade-markAgents.Published
intheFall2012(Vol.16,no.3)Newsletterofthefirm.Publication068.154E.

2
dateoffilingoftheapplication,sothatapersonskilledintheartwouldbeableto
reproducetheinventionattheexpiryofthepatent.

IntheAZTdecision,theSupremeCourthadclarifiedthenatureofthismarket:
Apatent,ashasbeensaidmanytimes,isnotintendedasan
accoladeorcivicawardforingenuity.Itisamethodbywhich
inventivesolutionstopracticalproblemsarecoaxedintothepublic
domainbythepromiseofalimitedmonopolyforalimited
time.Disclosureisthequidproquoforvaluableproprietaryrightsto
exclusivitywhichareentirelythestatutorycreatureofthePatentAct.

TheCourtfoundthatdoingmoreteststocheckwhichofthe2compoundsofclaims6
and7wasactiveandrepresentedtheinventiononthedateoffilingofthe
application,didnotallowthepublictouseoftheinventionwiththesamesuccessas
theinventor.Indeed,asmentionedabove,itisnotstatedinthedescriptionthat
sildenafilistheeffectivecompoundandthat”eventhoughaskilledreaderwillknow
that,whenapatentcontainscascadingclaims,theusefulclaimwillusuallybeatthe
endconcerninganindividualcompound,theclaimsinthepatentendedwithtwo
individuallyclaimedcompounds.”Infact,theCourtconsidersthat”Pfizerhadthe
informationneededtodisclosetheusefulcompoundandchosenottoreleaseit”,as
ifPfizerhadwantedto”hide”theirinvention.Followingthisdecision,itbecomeseven
moreimportanttoensurethatyouhavefulldisclosureoftheinventioninthepatent
applicationatthetimeoffiling.
AnotherreasondiscussedbeforetheSupremeCourtwasthelackofdisclosureof
theSoundPredictiondoctrineusedtodemonstratetheutilitywhenitisnotclearfrom
thedescription.ThisreasonwasquicklyrejectedbytheSupremeCourtonthe
groundsthattheutilitywaswelldemonstratedintheapplication,wherePfizerrefers
totests.ItwasthereforenotnecessarytoinvokethedoctrineofSoundPrediction.

Thefinalimpactofthisdecisionisnotyetknown.Indeed,thisdecisionwasmade
underasimplifiedprocedurecalledPMNOC,allowinggenericstoasktheMinisterof
Healthforanoticeofcompliancefortheirgenericproductiftheirallegations
regardingthelackofvalidpatentshavingtheabilitytopreventthemanufacture,sale
oruseoftheinventionhavebeenverified.Thistypeofdecisionisbindingbetween
thepartiestothedispute.Thus,inthiscase,onlyTevashouldgetanoticeof
complianceinlightofthisdecision.Othergenericcompaniesshouldpursueparallel
proceedings.Onlyadecisiononthemerits,wouldinvalidatethepatentandremoveit
fromthePatentRegistry.However,theconclusionofthedecision”thepatentis
invalid”isconfusingandthepatenteesoughttoobtainclarificationsormodifications
regardingtheconclusionofthedecision,pursuanttoArticles76and81oftheRules
ofProcedureoftheSupremeCourt,thepatentshouldnotberemovedfromthe
registry,followingthisdecision.Moreover,inparallelproceedingsinvolvingPfizerand
Apotexforthesamepatent
[FilenumberinfederalcourtT-772-09decisionnotyet
publishedatthetimeofwritingthisarticle],thejudgeoftheFederalCourthassince
notedthatalthoughtheSupremeCourtdecisionwasrenderedinthePMNOC

3
proceedings,thequestionraisedasamatteroflaw,theFederalCourtisboundto
respectandmakethesamedecisionthattheSupremeCourtdid,thatistoallowthe
MinisterofHealthtoissueanoticeofcompliancetoApotexforsildenafil.

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