Beware of Overclaiming, Federal Court Of Canada Warns

2005-01-01

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BEWAREOFOVERCLAIMING,FEDERALCOURTOFCANADAWARNS

By
AlexandraSteele*
LEGERROBICRICHARD,Lawyers
ROBIC,Patent&TrademarkAgents
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INTRODUCTION
TheApplicant’sapplicationforawritofprohibitionpreventingtheCanadian
MinisterofNationalHealthandWelfarefromissuingaNoticeofCompliance
totheRespondentinrespectofanti-depressionmedicationwasdenied,the
CourthavingruledthattheRespondent’sallegationsthattheproposeddrug
wouldnotinfringetheApplicant’spatentsweresufficient.[Biovail
PharmaceuticalsInc.etalv.MinisterofNationalHealthandWelfareatal,
[2005]F.C.J.No.7,HarringtonJ.,January6,2005]
BACKGROUND
ThiscaserelatestothePatentedMedicines(NoticeofCompliance)
Regulations,SOR/93-133(“NOCRegulations”).
WhenagenericdrugmanufacturerwishestoobtainaNoticeofCompliance
(“NOC”),itcan,insteadoffilingaNewDrugSubmission,compareits
proposeddrugtoanexistingdrug.Inthepresentcase,theApplicant,Biovail,
hadobtainedaNOCforitsanti-depressiondrugWellbutrin®SRandthe
Respondent,Novopharm,compareditsproposeddrug,alsoforthetreatment
ofdepression,toBiovail’sWellbutrin®SRdrug.
BiovailhadpreviouslyfiledalistofitspatentsrelatingtoWellbutrin®SR
pursuanttotheNOCRegulations.InaccordancewithsaidNOCRegulations,
NovopharmhadnoalternativebuttofileaNoticeofAllegation(“NOA”)in
respectofallofBiovail’sdisclosedpatents,failingwhichtheMinisterof
NationalHealthandWelfare(“Minister”)wouldnotissueaNOC.InitsNOA,

©LEGERROBICRICHARD,2005.
*LawyerwiththelawfirmLEGERROBICRICHARD,g.p.andofthepatentandtrademark
agencyfirmROBIC,g.p.Publication142.173.

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Novopharmalleged,inrespectofBiovail’spatents,thatitsproposeddrugdid
notinfringesaidpatents,andthatthepatentswerenotvalid.Biovailinturn
filedanapplicationtotheFederalCourtofCanadaforawritofprohibitionto
preventtheMinisterfromissuingaNOCtoNovopharm.
Asinallcasesrelatingtopatents,theCourtmustfirstinterpretthepatent(s)in
suittodeterminethescopeoftheinvention.TheCourtwillthendecide
whetherthefirstdrugmanufacturer’sapplicationforawritofprohibitionis
substantiated.ItshouldbenotedthatinsuchNOCproceedings,theCourt’s
findingofinfringementand/orinvaliditydoesnotconstituteresjudicata.A
patenteeisthereforealwaysfreetolitigatea“regular”patentinfringement
actionagainstthegenericdrugmakerifthelatterisallowedto
commercializethegenericdrug.
THEFACTS
Biovail’sdrugcontainsaningredient,HPMC,whichservesinthereleaseofthe
medicine;Novopharm’sproposeddrugcontainsadifferentingredient,HPC,
aderivativeofHPMCthatservesthesamepurpose.Initsapplicationforawrit
ofprohibition,BiovailarguedthatNovopharm’sNOAwasinsufficientandthat
theproposedgenericdrugwouldinfringeitspatents.Novopharminaddition
allegedthatBiovail’spatentswereinvalid.
TheCourtthereforehadtodecidethefollowing:“Theonlyquestioniswhether
theCourtshouldgrantanorderprohibitingtheMinisterfromissuing
NovopharmaNOCuntilaftertheexpirationofoneorbothofthetwo
underlyingpatents”.Inotherwords,iftheCourtfoundthepatentstobevalid
and
infringed,thenaNOCcannotissue.However,iftheCourtfoundthatthe
patentsarenotinfringedor
invalid,thenaNOCmaybeissuedto
Novopharm.

THEFEDERALCOURTJUDGEMENT
JusticeHarringtonbeganhisanalysisbyinterpretingthepatentsinsuit,in
accordancewiththeteachingsoftheSupremeCourtofCanada
concerningtheproperwaytoconstruepatentclaims(FreeWorldTrustv.
Électro-SantéInc.,[2000]2S.C.R.1024andWhirlpoolCorp.v.CamcoInc.,
[2000]2S.C.R.1067).
Inrespectofthefirstpatent,theCourtwasaskedtodeterminewhether
HPMC,thesubstanceusedbyBiovailforthecontrolledreleaseofthe
medicine,wasessentialtotheworkingoftheinvention,orifavariantcould

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besubstitutedwithoutmakinganymaterialdifference.Afterhearingthe
expertevidenceoftheparties,theCourtconcludedthatHPMC,the
substancedescribedinBiovail’sfirstpatent,wasanessentialelementofthe
inventionandthatnovariant,suchasHPCusedinNovapharm’sdrug,had
beencontemplatedbytheinventor.TheCourtruledthataliteral
interpretationoftheclaimsexcludedHPCasapermissiblevariant,andin
addition,theintentoftheinventorshowedthatHPMCwasessentialand
therefore,allvariantswouldfalloutsideoftheclaims.TheCourtruledthatthe
firstBiovailpatentwouldnotbeinfringedifaNOCwasissuedtoNovopharm.
JusticeHarringtonthereforeconcludedthatBiovail’sassertionthatthe
allegationsofNovopharm’sNOAinrespectofthatpatentwereinsufficient
shouldfail.
Inrespectofthesecondpatent,whichrelatedgenerallytoachemical
compositionallowingthereleaseoftheactiveingredientsofthedrug,
NovopharmhadallegedinitsNOAthatnotonlywasthispatentnotinfringed,
butalsothatthepatentwassobroadinscopethatitwasinvalid.TheCourt,
inordertoconstruetheclaimsinaninformedandpurposiveway,referredto
thedisclosure.JusticeHarrington,withtheassistanceoftheexpertevidence,
concludedhattheinventorintendedonlyonemeansofreleaseofthe
medicine,namelythrough“anosmoticpressuresystem”.Theprocess
describedinNovopharm’sdrugsubmissionwasa“hydrogelprocess”which,
accordingtoJusticeHarrington,andalloftheexperts,wasacompletely
differentsystemthantheonedescribedinthepatentandtherefore,Biovail’s
secondpatentwasnotinfringed.
However,theCourtalsoruledthatiftheclaimsweretobeinterpretedmore
broadly,i.e.thatNovopharm’s“hydrogelprocess”couldbeincludedin
Biovail’s“osmoticprocess”,thenBiovail’ssecondpatentwouldbeinvalidfor
“covetousclaiming”.JusticeHarringtonwrites:“Iftheinventorclaimsmore
thanheshould,heloseseverything.Hisfencesmustbeclearlyplacedinorder
togivethenecessarywarningandhemustnotfenceinanypropertythatis
nothisown.[…]Thedisclosureteachesusnothingaboutsustainedrelease
throughahydrogelprocess,theprocesstobeusedbyNovopharm.”
Inlightofitsfindings,theCourtdismissedBiovail’sapplicationforawritof
prohibition,withcosts.
CONCLUSION
AlthoughthisdecisionrelatestotheparticularsofaNOCproceeding,the
Court’sthoroughapplicationoftheSupremeCourtteachingsisofmuch
interesttopatentagentsandattorneysalike.Patentconstructionisofthe

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utmostimportanceandtheCourtswillnothesitatetoconsiderapatent
unenforceableifitsclaimsaretoobroadinscope.
AsstatedbytheSupremeCourtofCanada:“Theclaimsaretobereadinan
informedandpurposivewaytopermitafairnessandpredictabilityandto
definethelimitsofthemonopoly.Ingenuityofthepatentliesnotinthe
identificationofthedesiredresultbutinteachingoneparticularmeansto
achieveit.Theclaimscannotbestretchedtoallowthepatenteeto
monopolizeanythingthatachievesthedesiredresult”(FreeWorldTrustv.
Électro-SantéInc.,[2000]2S.C.R.1024,paragraphs31-32).

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