No more promises: Supreme Court of Canada finds that the “promise doctrine” is not a correct method for determining the utility of a patent

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NOMOREPROMISES:SUPREMECOURTOFCANADAFINDSTHATTHE
“PROMISEDOCTRINE”ISNOTACORRECTMETHODFORDETERMININGTHE
UTILITYOFAPATENT

JASONMOSCOVICI*
ROBIC,LLP
LAWYERS,PATENT&TRADEMARKAGENTS

OnJune30,2017,theSupremeCourtofCanadaallowedanappealbyAstraZeneca
ofadecisionthatfoundthatitsCanadianpatent(the653patent)wasinvalidforlack
ofutilityunderanapplicationofCanada`s“PromiseDoctrine”,asPatent653
promisedmorethanwhatthepatentcouldprovide.Thisisalandmarkdecisionin
Canada,astheSupremeCourtofCanadahasessentiallydoneawaywitha
controversialandoftencontesteddoctrinethatwaspreviouslyappliedtotheanalysis
ofthedisclosureofapatentandtheutilityoftheinventiondescribedtherein.[
AstraZenecaCanadaInc.v.ApotexInc.,2017SCC36]

The653Patent

AstraZeneca`s653patentclaimedopticallypuresaltsofthe(-)enantiomerof
omeprazole,knownas“esomeprazole”.Esomeprazoleisusedinthemitigationof
gastricacidandacidrefluxrelatedailments(a“PPI”).

TheConflict

Apotexsoughttosellagenericversionofesomeprazoleand,afterseekingmarket
approvalfromHealthCanada(bywayofan“NoticeofCompliance”or“NOC”)and
afterbattlingwithAstraZenecaunderCanada`sPatentedMedicinesNoticeof
Compliance1administrativeprocess(“PMNOC”);which,briefly,allowsforaPatent
holdertoblocktheissuanceofanNOCtoagenericmanufactureriftheycanshow
thatthegenericdrugwouldinfringeonapatentthatislistedonaregistermanaged
byHealthCanada.AstraZenecachallengedApotexviathisPMNOCprocessbutthe
CourtsidedwithApotex.

©CIPS,2017.*OfROBIC,LLP,afirmoflawyers,patentandtrademarkagents.PublishedunderthetitleNoMore
Promises:CanadaDumpsDoctrineJudgingPatentUtility,(2017)31:10WorldIntellectualProperty
Report43-44.Publication064.320.1PatentedMedicines(NoticeofCompliance)Regulations,SOR/93-133.

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AnNOCwasthereforegrantedtoApotexandonceApotexbegantosellitsgeneric
versionofesomeprazole,AstraZenecasueddirectlyforpatentinfringement.Apotex
counterclaimedallegingthe653patentwasinvalid.

Attrial,theCourtfoundthatwhilethe653patentmetthecriteriafornoveltyandnon-
obviousness,thepatentlackedutilityunderanapplicationofthe“PromiseDoctrine”,
becauseit“promisedmorethatitcouldprovide”,anditwasthereforedeclared
invalid.

AstraZenecaappealedarguingthattheCourterredinitsapplicationofthePromise
Doctrine.Theappealwasdismissed.

PromiseDoctrine

Attrial,theCourtsanalysisofutilitywasbasedontwopropositions:1)that“an
allegedpatentsatisfiestherequirementofutilityif,fromtheperspectiveoftheskilled
personasofthefilingdate,itsutilityisdemonstrated,or[…]issoundlypredicted”;2)
thatthe“promiseofthepatent”wascentraltothisutilityanalysis.

TheCourtfoundthatthe653patentcontainedatleasttwopromisesofutility:i)
usefulasaPPI(reducetheamountofacidinthestomach)andii)improved
propertiesgivinganoverallimprovedtherapeuticprofile(workforawiderrangeof
patients).Itwasthissecondpromisethatwasfoundtobeneitherdemonstratednor
soundlypredictedatthefilingdateofthepatent.Assuch,aspertheapplicationof
thePromiseDoctrine,theCourtdeclaredtheentirepatentinvalid,eventhoughthe
firstpromisewasmet.ThisanalysiswasheldbytheFederalCourtofappeal,who
confirmedthatthePromiseDoctrinewasappliedcorrectly,andthatthisdoctrine’s
applicationfordeterminingutilitywas“settledlaw”.

PositionoftheParties

BeforetheSupremeCourtofCanada,AstraZenecaarguedthatthepatentshould
nothavebeeninvalidatedbyadoctrinerequirementforutility,whichis“extra-
statutory”.Inotherwords,AstraZeneca`spositionisthatthePromiseDoctrinehas
nofoundationinthePatentAct2(“Act”)andthatthelawofpatentsis“wholly
statutory”.

ApotexarguedthattheuseofthePromiseDoctrineissettledlawandthatthe
Court`sapplicationofthisdoctrinewascorrectlyapplied:“ThePromiseDoctrine
merelyrequiresapatenteetobeheldtowhatisdisclosedinthepatent[…]Astra
2PatentAct,RCS1985,cP-4.

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Zeneca`spatentspecificationcontainedonepromisethatwasneitherdemonstrated
norsoundlypredictedatthetimeitwasfiled”.

SupremeCourtFinding

TheSupremeCourthadtodecideontwoissues:i)isthePromiseDoctrineacorrect
approachindeterminingifaninventionis“useful”aspertheAct?Andii)wasthe
subjectmatterthatwasthesubjectofthe653patent“useful”atthefilingdateofthe
patent?

TheSupremeCourtofCanadafoundthatthePromiseDoctrineisincorrectand
shouldnotbeusedinthedeterminationofutilityundertheAct.
TheSupremeCourtofCanadabaseditsdecisiononitsreadingofsection2ofthe
Act,whichisthesourceoftheutilityrequirementforaninvention.Aninventionisa
“newandusefulart,process,machine,manufactureorcompositionofmatter”.
Usefulnessisthereforeapre-conditiontopatentability.

TheCourtshavepreviouslyansweredthequestion“usefulforwhat”withthepromise
thatthepatentmakes.Therefore,previouscaselawwastotheeffectthat“ifa
patentee`spatentapplicationpromisesaspecificutility,onlyifthatpromiseisfulfilled,
cantheinventionhavetherequisiteutility”.Furthertothis,theFederalCourtof
Appealhadalsopreviouslyheldthat“wherethespecificationdoesnotpromisea
specificresult,noparticularlevelofutilityisrequired;amerescintillaofutilitywill
suffice.However,wherethespecificationsetsoutanexplicitpromise,utilitywillbe
measuredagainstthatpromise”

Therefore,thepromisedoctrineinvolvesidentifyinganypromisesintheentire
specificationofthepatent(claims+disclosure)andtheSupremeCourtofCanada
foundthatthisprocessisunsoundandis“incongruentwithboththewordsandthe
schemeofthePatentAct”.TheSupremeCourtofCanadafoundthattheAct
establishesthesysteminwhichaninventorisgrantedrightstoaninventionandthe
Actalsodefineswhatkindofinventionbenefitsfromthissystem.TheSupremeCourt
ofCanada`sreadingoftheActissuchthatonceaninventionhasbeenidentifiedand
canqualifyforpatentprotection,itneedstobeproperydisclosed:“apatenteemust
describetheinventionwithsufficientlycompleteandaccuratedetailsaswillenablea
workman,skilledinthearttowhichtheinventionrelates,toconstructorusethat
invention[..]”.TheSupremeCourtfoundthatoneneedstodifferentiatethe
requirementthataninventionbe“useful”,asperthedefinitionofinventionintheAct,
andtherequirementtodisclosethisinvention(enablement).Oneisaconditiontothe
existenceofaninvention,theotherisaconditiontoprotectingthisinventionviaa
patent.

TheSupremeCourtfoundthatthePromisedoctrinetakesthissecondcriteria,thatof
enablement,andimproperlyimporteditintotheanalysisofutilitysuchthat“any
discloseduse[hadto]bedemonstratedorsoundlypredictedatthetimeoffiling”and

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that“ifthatisnotdonesuccessfully,theentirepatentisinvalid,asthepre-condition
ofpatentability-aninventionunder[…]theAct-hasnotbeenfulfilled”.

TheSupremeCourtofCanadaalsofoundthatthedefinitionofinventionspeaksto
“useful”subjectmatter.Therefore,asingleuseshouldmakeaninventionusefuland
notmeetingthe“promises”ofmultipleuses,whenoneusehasbeenestablished,
waspunitiveandwasbaselessundertheAct:

“Toinvalidateapatentsolelyonthebasisofanunintentionaloverstatementofeven
asingleusewilldiscourageapatenteefromdisclosingfully,whereassuchdisclosure
istotheadvantageofthepublic.ThePromiseDoctrineinitsoperationisinconsistent
withthepurposeofs.27(3)oftheActwhichcallsonaninventorto“fullydescribethe
inventionanditsoperationoruse”.Thus,thePromiseDoctrineunderminesakey
partoftheschemeoftheAct;itisnotgoodlaw.”

TheCorrectApproachtoUtility

Asperitsanalysis,theSupremeCourtfoundthatthetypeofutilitythatisapre-
cursortoaninventionisonethatappliestothe“subjectmatter”oftheinventionand
theinventionitselfneedstobecapableofbeingusedasaninventivesolutiontoa
practicalproblem.Assuch,theSupremeCourtsetoutthefollowingtest,oranalysis:
“First,courtsmustidentifythesubject-matteroftheinventionasclaimedinthe
patent.Second,courtsmustaskwhetherthatsubject-matterisuseful—isitcapable
ofapracticalpurpose(i.e.anactualresult)?”Theapplicationoftheutilityrequirement
avoidsinventionsthatarespeculativeandpreventspatentingof“fanciful,speculative
orinoperableinventions”.

Utilityofthe653Patent

Regardingthesecondissue,thatis,wastheinventionofthe653Patentuseful,the
CourtfoundthatthesubjectmatterwassoundlypredictedtobeusefulasaPPI,and
undertheSupremeCourt`sanalysisofutilityabove,thiswassufficienttobeuseful
undertheAct.

Conclusion

ThisdecisionclosesacontroversialbridgetheCourtshaveusedinthepastthat
linked“usefulness”ofaninventiontoproperdisclosureorenablementofapatent.In
declaringthepromisedoctrine“incorrectinlaw”,theSupremeCourtofCanadahas
effectivelyclarifiedthepathtoaproperapproachtodeterminingutility.Itofcourse
remainstobeseenhowtheCourtswillnowusethisguidanceinfuturepatent
impeachmentcases.

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