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When a Statement Becomes a Promise: Canadian Federal Court of Appeal Studies “Promise Doctrine” in Celecoxib Patent Utility Finding

2015-01-08

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WHENASTATEMENTBECOMESAPROMISE:CANADIANFEDERALCOURT
OFAPPEALSTUDIES“PROMISEDOCTRINE”INCELECOXIBPATENTUTILITY
FINDING

JASONMOSCOVICI*
ROBIC,
LLP
L
AWYERS,PATENT&TRADEMARKAGENTS

OnOctober30th,2014,theCanadianFederalCourtofAppealdismissedtwoappeals
broughtbyMylanPharmaceuticalsULCandApotexInc.(“Appellants”),heardjointly,
inadecisionthatfurtherclarifiesthe“promisedoctrine”appliedtopatentvalidity
casesinvolvingtheevaluationofutility.TheseappealsfollowedtheFederalCourt’s
grantingofprohibitionordersappliedforbyPfizerCanadaIncandG.D.Searle&Co.
(“Respondents”),aspartofCanada’sNoticeofCompliancemarketapprovalprocess
forpatentedmedicines.TheprohibitionordersprohibittheMinisterofHealthfrom
issuingmarketapprovals(NoticesofCompliance)toAppellantsforgenericversions
ofadrugcontainingCelecoxib,untilexpiryofapatentheldbyRespondents.(Apotex
Inc.v.PfizerCanadaInc.,2014FCA250)

FACTUALBACKGROUND
ThepatentatissueisCanadianpatentNo.2,177,576(“’576”)forCelecoxib,a
moleculethatispartofafamilyofpharmaceuticalnon-steroidalanti-inflammatory
drugs(NSAIDS),usedtohelpreduceinflammation.The`576patentdescribesanew
classofNSAIDcompoundsandclaimsCelecoxibitself,aswellasitsuseina
therapeuticallyeffectiveamount.
Thedescriptionofthe‘576patentalsoaddressesthecommonissueofsideeffects
normallyassociatedwithNSAIDSandstatesthat“(t)hecompoundsareusefulas
anti-inflammatoryagents,suchasforthetreatmentofarthritis,withtheadditional
benefitofhavingsignificantlylessharmfulsideeffects”.Itisalsostatedinthe
descriptionofthispatentthattheselectivityofthepreferredcompoundsusedinthe
patent“mayindicateanabilitytoreducetheincidenceofcommonNSAID-induced
sideeffects”.Inaddition,atleastoneoftheclaimsisdirectedtothepreventionof
colorectalcancer.

©CIPS,2015.*LawyerwithROBIC,LLP,amultidisciplinaryfirmoflawyers,andpatentandtrade-markagents.
Publishedat(2015),29:1WorldIntellectualPropertyReport41-42.Publication142.287.

TheFederalCourtDecisionsandthePromiseDoctrine

AttheFederalCourtlevel,Appellantsallegedthatthepatentdidnotdeliverthe
promisedresultsandisthereforeinvalidforlackofutilityunderCanada`spromise
doctrine.Respondentsarguedthatthepatentdidnotmakepromisesastoany
specificresultsandthatAppellantsarewronginassertingthatthepatentedinvention
promisesto1)treatinflammationinHumans,2)reducesideeffects,and3)prevent
colorectalcancer.
TheFederalCourtjudgesidedwithRespondentsinbothFederalCourtcases.Under
thePatentActR.S.C.,1985,c.P-4,aninventionmustbeuseful.Thethresholdto
meetthisrequirementhasalwaysbeenlow.Thisutilityiseithershowntobe
demonstratedorcanbesoundlypredictedatthepatent’sfilingdate.Assuch,a
patentneedonlyshowmorethana“scintillaofutility”tomeetthisthreshold.

Anexceptiontothisiswhatisreferredtoasthe“promisedoctrine”.Aninventorisnot
requiredtodescribetheparticularutilityofitsinvention,butifapromiseismade
regardingaspecificresult,thentheissuedpatentwillbeheldtothatpromiseinorder
toproveutility.TheFederalCourtJudge,inthiscase,specifiedthatthishigher
standardappliesonlywhereitisclearandunambiguousthatapromisehasindeed
beenmadeandtheCourts,whenstudyingpatentvaliditymatters,havegenerally
favoredsavinganinventionratherthaninvalidatingapatentduetoambiguity.

Initsrepresentations,theAppellantssubmittedthatthepatentlacksutilityintreating
inflammationinhumansspecifically,doesnotreducesideeffectsandlacksutilityin
preventingcolorectalcancer.
Itwasarguedthatatthetimeoffilingofthepatentapplication,onlyareductionof
inflammationinratscouldbedemonstrated.Respondentssubmittedthatonce
properpatentconstructionwasapplied,no“promiseof(the)specificresult”of
treatmentofinflammationinhumansappearsinthe‘576Patent.Respondents
furthersubmittedthatitwasclearthattreatmentonhumanswassoundlypredicted.
TheFederalCourtjudgefoundthatsincethe‘576patentspeakstotreating“a
subject”,thisshouldbeinterpretedbroadlytoincludebothratsandhumansandthat
utilitywasthereforedemonstrated.
Insupportofthepositionthatthepatentlackedutilitybecauseitpromisedreduced
sideeffects,Appellantsarguedthatthedescriptionstatesthatthecompoundsbenefit
fromhavingsignificantlylesssideeffects.Respondentsputforwardthatnosuch
promisecouldbefoundexplicitlyinthepatent,whichalsocontainedstatementsthat
Celecoxib”may”beabletoreducesideeffects.TheFederalCourtjudgeonceagain
sidedwithRespondentsandfoundthatusesthatdonotappearintheclaim
specificationaremerestatementsofadvantage,unlessthereisaclearand
unequivocalpromise.

3
Furthermore,pertainingtothepromiseofutilityforcolorectalcancerspecifically,
Appellantsarguedthatanypromiseoftreatmentforcolorectalcancershouldapplyto
allclaimsfoundinthepatent.TheFederalCourtjudgeheldthatdifferentclaimscan
relatetodifferentpromisesandthatnoteverypromiseneedstobeconstruedas
“overarchingandinherent”toapatent’sinventionandtoeachofitsclaims.Whilethis
promisewasfoundtohavebeenmadeinatleastoneclaim,theFederalCourtjudge
foundthatthisclaimcouldbeseveredfromtherestofthepatent,therebysavingthe
patent.
TheprohibitionorderswerethereforegrantedandtheMinisterofHealthwas
precludedfromissuingmarketapprovalsforgenericversionsofCelecoxibuntil
expiryofthe‘576patent,whichexpiredinNovember2014.
Appellantsappealedthesedecisionsandsincebothappealsfollowedthesamelines
ofreasoning,theywereheardtogether.
TheFederalCourtofAppeal’sAnalysis
TheissueatbarintheseappealsiswhetherornottheFederalCourtproperly
determinedi)thatthepatentdidnotmakepromisesregardingspecifiedresultsand
ii)thattheAppellantsallegationsofinvalidityforfailingtoprovidetheseresultswas
unjustified.
Aspertheapplicablestandardofreviewinsuchmattersunderappeal,theCourt
separateditsanalysisintofivecategories:a)UtilityinTreatingInflammationin
Humans,b)UtilityinReducingSideEffects,c)UtilityinPreventingColorectal
Cancer,d)Insufficiencyofdisclosureande)AbuseofProcess/StareDecisis.Asthis
decisionisnotableforitsanalysisoftheutilityrequirements,wewillonlybe
discussingcategories1to3above.a)UtilityinHumans

Regardingthequestionofthepromiseoftreatinginflammationinhumans,theCourt
foundthatcontrarytoAppellants’representations,therewasnoclearpromiseof
treatmentinhumans.Theclaimsspeakof“subjects”andnounequivocallanguage
foundinthedescriptionrepresentsotherwise.TheCourtwasthereforeoftheopinion
thattheFederalCourtjudgeheldcorrectlythatthepromiseofthepatentdidnot
extendexplicitlytohumans.b)UtilityinReducingSideEffects

Onthequestionofthepromiseofreducedsideeffects,Appellantsarguedthatthe
FederalCourtjudgeerredinstatingthatforthepromisedoctrinetoapply,apromise
needstobeclearlyandunequivocallystatedinthepatent.TheAppellantsput

4
forwardthatthe’576Patentdidinfactpromisereducedsideeffects,whichCelecoxib
doesnotprovide.
TheCourtfoundthattherewasnosucherrorandagreedwiththeFederalCourt
judgethatastatementastoutilityshouldbepresumedtobejustthat,astatement,
unlessthisstatementisunequivocallypresentedasanadvantagethatispartofa
promisedutility.Thenthestatementbecomesapromise.TheCourtagreedthatany
statementsfoundinthedescriptionastothereductionofsideeffectswere
“equivocal”andthereforesincetherewasnoclearpromise,statementsregarding
reductionofsideeffectswerejuststatementsofadvantages,notpromises.
c)UtilityinColorectalCancer

Asbrieflymentionedabove,theCourtagreedthatnotedpromisesshouldnot
necessarilybeinterpretedasapplyingtoalltheclaimsofthepatentbeingconstrued.
Alackofutilityinoneclaimofthe‘576Patentshouldnothavean“automatic”impact
oneveryotherclaim.Anyclaimnotmeetinganexplicitpromisecanbeseveredfrom
therestofthepatent,therebysavingthevalidityofthepatent.TheCourtagreedwith
theFederalCourtJudgethatbyandlarge,anypromisefoundinapatentshouldnot
bereadasapplyingtoeachandeveryoneofthepatent’sclaims.TheCourt
recognizedthatcertainpromisesmaybeoverarchingwhileatthesametime,thereis
nothingtosupporttheallegationthateverypromisemustextendtoeachclaim.

Theappealwasthereforedismissedandthevalidityofthe‘576patentwasupheld.

Conclusion
Thisdecisionisrelevantforitsdiscussionoftheprinciplesapplicabletotheanalysis
ofpatentutility,moreparticularlyrelatingtothe“promisedoctrine”.TheCourt
clarifiedthatthisdoctrineshouldonlybeappliedwhenpromisesareclearlyand
unequivocallybeingmade.Thisisnotanewassessmentofthepromisedoctrinebut
aclarificationontheapplicationofanalreadyestablishedlegalapproach.An
equivocalstatementofadvantagefoundinthedescriptionofthepatent,ifnotalso
foundintheclaimspecification,isessentiallyjustthat:astatementofadvantage.
Furthermore,whileclaimsshouldbeheldtoanypromisesthatmayhavebeenmade,
noteverypromiseappliestoeachclaimandclaimsfailingtomeetanysuchpromise
canbeseveredfromthepatentfornothavingthepromisedutility,therebysavingthe
patent,andtheinvention,frominvalidity.

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