No more promises: Supreme Court of Canada finds that the “promise doctrine” is not a correct method for determining the utility of a patent
ROBIC,LLPwww.robic.cainfo@robic.com
MONTREAL1001Square-VictoriaBlocE-8thFloorMontreal,Quebec,CanadaH2Z2B7Tel.:+1514987-6242Fax:+1514845-7874
QUEBECLeDeltaBuilding2875LaurierBoulevard,Delta3–suite700Quebec,Quebec,CanadaG1V2M2Tel.:+1418653-1888Fax.:+1418653-0006
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.
2
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.
3
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
4
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.
5
6
Pourdesservicesdeconseilsdansledomainedelapropriétéintellectuelleetdes
technologiesdel'informationetdescommunications(incluantlesservicesd’agents
debrevetsetdemarquesdecommerce)demêmequedesservicesjuridiques.
ROBIC,ungrouped’avocatsetd’agentsdebrevetsetdemarquesde
commercevouédepuis1892àlaprotectionetàlavalorisationdelapropriété
intellectuelledanstouslesdomaines:brevets,dessinsindustrielsetmodèles
utilitaires;marquesdecommerce,marquesdecertificationetappellations
d’origine;droitsd’auteur,propriétélittéraireetartistique,droitsvoisinsetde
l’artisteinterprète;informatique,logicielsetcircuitsintégrés;biotechnologies,
pharmaceutiquesetobtentionsvégétales;secretsdecommerce,know-howet
concurrence;licences,franchisesettransfertsdetechnologies;commerce
électronique,distributionetdroitdesaffaires;marquage,publicitéet
étiquetage;poursuite,litigeetarbitrage;vérificationdiligenteetaudit.ROBIC,
agroupoflawyersandofpatentandtrademarkagentsdedicatedsince1892to
theprotectionandthevalorizationofallfieldsofintellectualproperty:patents,
industrialdesignsandutilitypatents;trademarks,certificationmarksand
indicationsoforigin;copyrightandentertainmentlaw,artistsandperformers,
neighbouringrights;computer,softwareandintegratedcircuits;
biotechnologies,pharmaceuticalsandplantbreeders;tradesecrets,know-
how,competitionandanti-trust;licensing,franchisingandtechnology
transfers;e-commerce,distributionandbusinesslaw;marketing,publicityand
labelling;prosecutionlitigationandarbitration;duediligence.®/MD
COPYRIGHTERTM/MC
IDEASLIVEHERE®/MD
ILATOUTDEMÊMEFALLUL’INVENTER!®/MD
LAMAÎTRISEDESINTANGIBLES®/MD
LEGERROBICRICHARD®/MD
NOSFENÊTRESGRANDESOUVERTESSURLEMONDEDESAFFAIRES®/MD
PATENTER®/MD
ou«R»®/MDstylisé
ROBIC®/MD
7
OustyliséROBIC++++®/MDstylisé
ouROBIC+DROIT+AFFAIRES+SCIENCES+ARTS®/MDstylisé
ouROBIC+LAW+BUSINESS+SCIENCE+ART®/MDstylisé
THETRADEMARKERGROUPTM/MC
TRADEMARKERTM/MC
VOSIDÉESÀLAPORTÉEDUMONDE,DESAFFAIRESÀLAGRANDEURDE
LAPLANÈTE®/MD
YOURBUSINESSISTHEWORLDOFIDEAS;OURBUSINESSBRINGSYOUR
IDEASTOTHEWORLD®/MD
MarquesdecommercedeROBIC,S.E.N.C.R.L.poursesservicesdeconseilsdansle
domainedelapropriétéintellectuelleetdestechnologiesdel’informationetdes
communications(incluantlesservicesd’agentsdebrevetsetdemarquesde
commerce)demêmequesesservicesjuridiques
*************************************************************************************************
*
Forservicespertainingtointellectualproperty,technologyandcommunicationlaw
andrelatedmatters(includingpatentandtrade-markagencyservices)aswellas
legalservices.
ROBIC,ungrouped’avocatsetd’agentsdebrevetsetdemarquesde
commercevouédepuis1892àlaprotectionetàlavalorisationdelapropriété
intellectuelledanstouslesdomaines:brevets,dessinsindustrielsetmodèles
utilitaires;marquesdecommerce,marquesdecertificationetappellations
d’origine;droitsd’auteur,propriétélittéraireetartistique,droitsvoisinsetde
l’artisteinterprète;informatique,logicielsetcircuitsintégrés;biotechnologies,
pharmaceutiquesetobtentionsvégétales;secretsdecommerce,know-howet
concurrence;licences,franchisesettransfertsdetechnologies;commerce
électronique,distributionetdroitdesaffaires;marquage,publicitéet
étiquetage;poursuite,litigeetarbitrage;vérificationdiligenteetaudit.ROBIC,
agroupoflawyersandofpatentandtrademarkagentsdedicatedsince1892to
theprotectionandthevalorizationofallfieldsofintellectualproperty:patents,
industrialdesignsandutilitypatents;trademarks,certificationmarksand
indicationsoforigin;copyrightandentertainmentlaw,artistsandperformers,
8
neighbouringrights;computer,softwareandintegratedcircuits;
biotechnologies,pharmaceuticalsandplantbreeders;tradesecrets,know-
how,competitionandanti-trust;licensing,franchisingandtechnology
transfers;e-commerce,distributionandbusinesslaw;marketing,publicityand
labelling;prosecutionlitigationandarbitration;duediligence.®/MD
COPYRIGHTERTM/MC
IDEASLIVEHERE®/MD
ILATOUTDEMÊMEFALLUL’INVENTER!®/MD
LAMAÎTRISEDESINTANGIBLES®/MD
LEGERROBICRICHARD®/MD
NOSFENÊTRESGRANDESOUVERTESSURLEMONDEDESAFFAIRES®/MD
PATENTER®/MD
orstylizedR®/MD
ROBIC®/MD
orstylizedROBIC++++®/MD
orstylizedROBIC+DROIT+AFFAIRES+SCIENCES+ARTS®/MD
orstylizedROBIC+LAW+BUSINESS+SCIENCE+ART®/MD
THETRADEMARKERGROUPTM/MC
TRADEMARKERTM/MC
VOSIDÉESÀLAPORTÉEDUMONDE,DESAFFAIRESÀLAGRANDEURDE
LAPLANÈTE®/MD
YOURBUSINESSISTHEWORLDOFIDEAS;OURBUSINESSBRINGSYOUR
IDEASTOTHEWORLD®/MD
9
Trade-marksofROBIC,LLPforitsservicespertainingtointellectualproperty,
technologyandcommunicationlawandrelatedmatters(includingpatentandtrade-
markagencyservices)aswellaslegalservices