“Object Clause” Under the Microscope: the Federal Court of Appel Interprets a Common Patent Expression

2012-06-11

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“OBJECTCLAUSE”UNDERTHEMICROSCOPE:THEFEDERALCOURTOF
APPEALINTERPRETSACOMMONPATENTEXPRESSION

A.SASHAMANDY*
ROBIC,
LLP
L
AWYERS,PATENTANDTRADE-MARKAGENTS

Whatmeaningshouldbegiventoparagraphsorsentencesinapatentspecification
thatdescribethe“objectoftheinvention”?Doessuchastatementhaveanybearing
ontheutilityofaninvention?ThesewereamongsomeofthequestionstheFederal
CourtofAppealofCanadahadtograpplewithinMylanPharmaceuticalsULCv.
AstraZenecaCanadaInc.
1,whichwasrenderedonApril11,2012.

Thiscaseisimportanttopatentpractitionersandagentsbecauseitprovides
guidanceonhowthesecommonstatementsmaybeinterpretedbythecourts,and
thusindirectlyguidespractitionersonhowtheyshouldbedraftedtobeginwith.The
casemayalsointerestthosepatentlitigatorswhomaywishtoscrutinizesuch
statementsinfuturecasesinlightoftheCourt’sreasons.

Facts
Inthepharmaceuticalindustry,MylanPharmaceuticalsiswhatisknownasa
“generic”becauseitmanufacturesgenericdrugs.Veryoften,thesegenericdrugs
arereplicasofpopular,patenteddrugsmadeby“innovators”,suchas
pharmaceuticalcompanieslikeAstraZeneca.Thedevelopmentoftheseinnovative
or“brandname”drugsbycompanieslikeAstraZenecaofteninvolvesyearsof
research,experimentation,andclinicaltrials.Whenaninnovativedrugfinallyenters
themarket,itschemicalcompositionisusuallyalreadypatented.

Initslandmarkdecision
2,theSupremeCourtofCanadaexplainedasfollowsthe
procedurebywhichamanufacturerofgenericdrugsmayplaceitsproductinthe
market:[13]Theprocedureunderthe[PatentedMedicinesNoticeof
ComplianceRegulations,or“NOCRegulations”]pursuanttowhich
amanufacturerofdrugsmayapplytotheMinisterofHealthfora

©CIPS,2012.*LawyerandJuniorEngineer,A.SashaMandyisamemberofROBIC,LLP,afirmoflawyers,and
patentandtrademarkagents.PublishedintheJune2012issueoftheWorldIntellectualProperty
Report.Publication142.265.
12012FCA109.2ApotexInc.v.Sanofi‑SynthelaboCanadaInc.,[2008]3S.C.R.265,2008SCC61.

noticeofcomplianceiswellknown.Amanufacturer
,usuallya
genericmanufacturer,wishestocompareitsdrugwiththatofa
patentholder[…].Thegenericmanufacturer’spurposeisto
establishthesafetyandefficacyofitsdrugforthepurposesof
securingmarketingapprovalfromtheMinister.Theprocessof
comparisonsavesthegenericcompetitortimeandresources.
However,theMinisterwillnotissueanoticeofcomplianceunless
thepatentonthecomparatordrughasexpired,isinvalid,orthe
generic’sproductwillnototherwiseinfringethepatent.Thusthe
NOCRegulationscreateaconnectionbetweengovernment
approvaltomarketagenericdrugandtheissueofpatentvalidity
andinfringement.
[14]Section5(1)(b)oftheNOCRegulationsstatesthatthegeneric
manufacturer,initssubmissionforanoticeofcompliance,may
allegethatthepatenthasexpired,isnotvalidorwillnotbe
infringed.ThepatentholdermaythenapplytotheFederalCourt
foranorderprohibitingtheMinisterfromissuinganoticeof
compliancetothegenericmanufactureruntilafterexpirationofthe
patentthatisthesubjectofthenoticeofallegation.Thecourtwill
granttheprohibitionorderifitfindsthattheallegationofinvalidity,
expiryornon-infringementisnotjustified.Ifitfindstheallegation
justified,itwilldismisstheapplicationforprohibitionandthe
Ministermaythenissueanoticeofcompliancetothegeneric
manufacturerifallotherrequirementsaremet.
[15]TheNOCRegulationsdonotprovideguidanceabouthowan
allegationof“notvalid”asstatedins.5(1)(b)(iii)istobeconsidered
anddeterminedbythecourt.Forthispurpose,referencemustbe
madetotherelevantversionofthePatentAct.
Inthepresentcase,Mylanfiledforanoticeofcompliancetosellitsversionofthe
medicineanastrozoleinCanada.AstraZenecaownsCanadianpatent1,337,420
(420patent)relatingtothecompoundanastrozole,whichexpiresinOctober,2012.
Oneeffectiveuseofanastrozolecanbeasaninhibitoroftheenzymearomatase.
AsexplainedbytheCourt,“anaromataseinhibitorblockstheconversionof
androgenstoestrogens,whichreducestheavailabilityofcirculatingestrogensinthe
body.Thereductionofestrogenshasparticularsignificanceforthetreatmentof
formsofbreastcancerthatdependonestrogenfortheirgrowth.”

Initssubmission,Mylanallegedthatisversionofanastrozolewouldnotinfringethe
420patentbecausethepatentwasinvalidfor,interalia,lackingutility.Attrial,
JusticeRennieoftheFederalCourtdisagreed,andgrantedanorderprohibitingthe
MinisterofHealthfromissuingaNoticeofCompliancetoMylantosellitsversionof
anastrozoleuntilafterthe420patentexpires.Mylanappealedthisdecisiontothe
FederalCourtofAppeal,arguingthatonesentenceinthespecificationofthepatent

constitutesapromisethatwasnotdemonstratedat
thetimeoftheinvention,and
theinventionthereforelackedutility.
Judgement

Thespecificationofthe420patentcontainsthefollowingparagraph:
Avarietyofcompoundspossessingaromataseinhibitoryactivityis
known,ofwhichthemostimportantclinicallyisaminogluthethimide
[AG].[AG],however,hasthedrawbackthatitaffectsotheraspects
ofsteroidmetabolism,withtheconsequencethatitsuseisoften
associatedwithundesirableside-effects.Itisaparticularobjectof
thepresentinventiontoprovidearomataseinhibitorycompounds
withfewerundesirablesideeffectsthan[AG].(Emphasisfromthe
decision)
Mylanfocuseditsutilityargumentontheunderlined“object”clause.Draftersof
patentswilloftenuseexpressionssuchas“anobjectofthepresentinventionis…”
toexpressagoaloranobjectiveofthesolutionprovidedbytheinvention.Therisk,
ofcourse,isthatacourtmightinterpretsuchaclauseasaspecificpromiseofthe
invention,whichmustbedemonstratedoratleastbesoundlypredictedatthetime
offilingofthepatentapplication.
Indeed,Mylanarguedexactlythat.ForMylan,theclause“constitutesapromisethat
anastrozolehasfewerundesirablesideeffectsthanAG,thefirstaromataseinhibitor
tobeusedinthetreatmentofbreastcancer.”Sincetheinventorscouldnot
demonstrateatthetimethepatentapplicationwasfiledthatanastrozoleproduced
fewersideeffectsthanAG,andsincethisutilitywasnotdisclosedinthe
specification,theinventionlacksutility.
AstraZenecacounteredthattheobjectoftheinventionrefersto“theforward-looking
oraspirationalaimoftheinvention.”Thedisputedsentence“merelylookstothe
futureattainment”ofthegoalofreducingundesirablesideeffects.Alternatively,
AstraZenecaarguesthatthepatentdidmeettheallegedpromise.Anastrozoleisa
selectiveenzymeinhibitor,andthusproducesfewerundesirablesideeffectsthat
AG.
TheFederalCourtofAppealframedtheissuebeforeitasthus:
Itwillberecalledthatthequestioniswhetherthewords“objectof
thepresentinvention”meanthatanastrozoleproducesfewer
effectsthanAG,asMylanargues,orwhether,asAstraZeneca
says,itmeansthatthisiswhattheinventionaimstodo,without
promisingthatithassucceeded.

TheCourtfirstaddressedMylan’sobjectionthatJusticeRenniereliedtooheavilyon
aparticulardictionarydefinitionoftheword“object”,whenitshouldhaveinterpreted

thewordinthecontextofpatentlaw.Mylancited
otherauthorities3where,according
toMylan,thecourthadreliedonthe“object”clausestodefinethescopeofthe
invention.TheCourtfoundthatJusticeRennieproperlyconstruedtheterm“object”
inlightofthepatentasawhole,andinviewoftheevidencebeforehim.

Secondly,Mylanarguedthattheword“provide”inthedisputedsentenceshould,in
lightofthepatentasawholeandtheuseof“provide”inotherareasofthepatent,
beinterpretedasapromise.Again,theCourtdisagreed.

Thirdly,Mylanpleadthatapersonofordinaryskillintheart(aPOSITA)would
understandtheobjectclausetobeapromisethatanastrozoleisanaromatase
enzymeinhibitorthatcausesfewersideeffects.MylanarguedthatJusticeRennie
overlookedcrucialexperttestimonyinthisregard.Oncemore,theCourtdidnot
agree,holdingthatJusticeRenniecommittednoreversibleerrorincomingtohis
conclusionsregardingtheexperttestimonyonfile.

TheCourtthereforerejectedMylan’sappeal,withcosts.

Conclusion

Thiscaseshouldhelppatentdrafterstobetterunderstandanduse“objectclauses”.
Generally,suchclauseswillnotbeinterpretedbythecourtasaparticularpromise
thatmustbemetforthepatenttobeconsidereduseful.Still,itshouldbenotedthat
theobjectclausemayhavesomebearingonhowthecourtsassessissuesother
thanutility,suchasdeterminingthescopeoftheinvention.Patentpractitioners
wouldalsodowelltoheedthiswarningfromtheCourt:
Patentsarenotrequiredtocontainaclausedescribingtheobject
oftheinvention.Whentheydo,themeaningoftheobjectclause
dependsonthespecificcontext,includingthewordingofthe
particularclauseinquestionanditsrelationshiptotherestofthe
patent.

Thus,theCourtleavesopenthepossibilitythatanobjectclausecanbeinterpreted
asapromise.Insuchasituation,thepatenteewouldbewisetogivethispromise
thesupportrequiredtodemonstrateitsutility.

3AmfacFoodsInc.v.IrvingPulp&Paper,Ltd.(1986),12C.P.R.(3d)193(F.C.A.)at199.

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