The Supreme Court of Canada rejects the promise doctrine and confirms the correct approach for utility determination

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TheSupremeCourtofCanadarejectsthepromise
doctrineandconfirmsthecorrectapproachforutility
determination

DanièleEthier1
ROBIC,LLP
BiochemistandPatentAgentinCanadaandintheUnitedStates,Partner

InaunanimousdecisionpublishedonJune30th2017(AstraZenecaCanadav.
ApotexInc.i),theSupremeCourtofCanada(SCC)decidedthatthepromise
doctrinewasnotthecorrectmethodofdeterminingwhethertheutilityrequirement
undersection2ofthePatentActwasmet.
Thefacts
AstraZenecaappealedtotheSCC,arguingthatitspatentNo.2,139,653(“the653
patent”)claimingopticallypuresaltsofomeprazole,includingesomeprazolea
protonpumpinhibitor(PPI),wasimproperlyinvalidatedforlackofutilityonthe
basisofthepromisedoctrine.AstraZenecaarguedthatthepromisedoctrinewas
anextra-statutoryrequirementofutilitywithnofoundationinthePatentActorthe
PatentjurisprudenceoftheSCC.
ThePatentActandthepromisedoctrine
Section2ofthePatentActstatesthat“aninventionmeansanynewanduseful
art,process,machine,manufacture,compositionofmatteroranynewanduseful
improvementandintheartprocessmachine,manufactureorcompositionof
matter”.
ThepromisedoctrinewasdevelopedandappliedbyFederalcourtsovertheyears
inseveralcasestodeterminewhethertheutilityrequirementundersection2ofthe
PatentActwasmet.

©CIPS,20171FromROBIC,LLP,amultidisciplinaryfirmofLawyers,andPatentandTrade-markAgents.Published
intheWinter2016(Vol.20,no.1)Newsletterofthefirm.Publication068.202F.

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Inthedecision,theSCChassummarizedthepromisedoctrineasfollows:
[29]Wherethespecificationdoesnotpromiseaspecificresult,
noparticularlevelofutilityisrequired;a“merescintilla”ofutilitywill
suffice.However,wherethespecificationsetsoutanexplicit
“promise”,utilitywillbemeasuredagainstthatpromise:Consolboard;
PfizerCanadaInc.v.Canada(MinisterofHealthii).
[31]ThePromiseDoctrine(…)directscourtstoreadboththe
claimsandthedisclosuretoidentifypotentialpromises,ratherthan
theclaimsalone,eveninanabsenceofambiguityintheclaims.After
aprocessofidentifyingpromises,thedoctrineequatesthefulfillment
ofthesepromises(bydemonstrationorsoundprediction)withthe
requirementins.2thataninventionbeuseful.Thedoctrinethen
goesontoprovidethatifanyoneofthepromisesisnotfulfilled,then
theutilityrequirementins.2isnotmetandthepatent,initsentirety,
isinvalid.

TheFederalCourtdecisions
Applyingthepromisedoctrine,theFederalCourtfoundthatthe‘653patent
containedanexplicitpromiseofimprovedpharmacokineticandmetabolic
propertieswhichwasnotdemonstratednorsoundlypredictedasofthefilingdate.
TheFederalCourtalsofoundthatthe‘653patentcontainedapromiseofutilityfor
useasPPIwhichwassoundlypredictedasofthefilingdate.Nonetheless,the
FederalCourtinvalidatedtheentirepatentforlackofutilityundersection2ofthe
PatentActonthebasisthatthe‘653patent“promisedmorethanitcould
provide”.ThisdecisionwasupheldbytheFederalCourtofAppeal,whichaffirmed
thatthepromisedoctrinewasthecorrectmethodtodeterminewhethertheutility
requirementofsection2ofthePatentActhasbeenmet.
TheSupremeCourtdecision
Initsjudgement,theSCCaddressedthefollowingtwoissues:1)Whatisthe
correctapproachfordeterminingwhethertheutilityrequirementofsection2ofthe
PatentActismetand2)Wasthe‘653patentclaimingopticallypuresaltsof
omeprazoleusefulwithinthemeaningofsection2ofthePatentActatthefiling
date.
1)Approachfordeterminingwhethertheutilityrequirementofsection2ofthe
PatentActismet
TheSCCconcludedthatthepromisedoctrinewasnotthecorrectmethodof
determiningwhethertheutilityrequirementundersection2ofthePatentActwas
met.JusticeRowe,writingforthemajorityfoundthatthepromisedoctrinewas

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unsoundandincongruentwithboththewordsandschemeofthePatentActand
wastooonerousforrequiringthatanypromisedutilitydisclosedinapatentbe
demonstratedorsoundlypredictedatthetimeoffilinginorderforapatenttobe
valid.
Inthedecision,theSCCprovidesguidanceonthecorrectmethodfordetermining
whetherthesubjectmatterofapatentisusefulinasenseofsection2ofthePatent
Act.Thiscorrectapproachisarticulatedinparagraphs55and56ofthedecision
(emphasisadded):
[55]TheActdoesnotprescribethedegreeorquantumofusefulness
required,orthateverypotentialuseberealized–ascintillaofutilitywilldo.
Asingleuserelatedtothenatureofthesubject-matterissufficient,andthe
utilitymustbeestablishedbyeitherdemonstrationorsoundpredictionasof
thefilingdate(AZTiii,atpara.56).
[56]Theutilityrequirementservesaclearpurpose.Toavoidgranting
patentsprematurely,andtherebylimitingpotentiallyusefulresearchand
developmentbyothers,thecaselawhasimposedarequirementthatan
invention’susefulnessbedemonstratedorsoundlypredictedatthetimeof
application,ratherthanatsomelaterpoint.Thisensurespatentsarenot
grantedwheretheuseoftheinventionisspeculative.Whatmattersisthat
aninvention“beuseful,inthesensethatitcarriesoutsomeusefulknown
objective”andisnotmerelya“laboratorycuriositywhoseonlypossible
claimtoutilityisasastartingmaterialforfurtherresearch”(ReApplication
ofAbitibiCo.(1982)iv,atpara.91).
AccordingtotheSCC,thereisnorequirementtofulfilleverypotentialuserecited
inapatentforthepatenttobevalid.Asingleuse-ascintillaofutilityrelatedtothe
subject-matterofthepatentissufficient.Whileascintillaofutilitywilldo,theSCC
alsoclearlystatedthisutilitymustbeestablishedbydemonstrationorsound
predictionatthetimeoftheapplication.
1)Wasthe‘653patentclaimingopticallypuresaltsofomeprazoleusefulwithin
themeaningofsection2ofthePatentActatthefilingdate
Applyingthecorrectmethodfordeterminingwhetherthesubjectmatterofapatent
isusefulinasenseofsection2ofthePatentAct,theSCCfoundthattheuseof
opticallypuresaltsofomeprazoleasPPIwasappropriatelyrelatedtothesubject-
matterofthepatentandthatthisusewassoundlypredictedatthefilingdate.The
SCCfoundthatthissinglesoundlypredictedusewassufficienttomeettheutility
requirementundersection2ofthePatentActanddeclaredthe‘653patenttobe
valid.

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Conclusion
TheSCCdecisionhaseffectivelyputCanada’sPatentLawinstepwith
internationalstandards.Itwillbeinterestingtoseehowthisdecisionwillimpact
ongoingandfuturelitigation,especiallyinthepharmaceuticalfield.WhiletheSCC
rejectedthepromisedoctrineforgood,itisimportanttonotethattheSCChasre-
affirmedthattheutilityofaclaimedinventionmustbedemonstratedorsoundly
predictedatthetimeofapplicationratherthanatsometimelaterinthefuture.
Patenteescan’tthereforerelyondataobtainedafterthefilingdatetomeetthe
utilityrequirementofSection2ofthePatentAct.Inthisregard,includingdata
showingthatanaloguesand/orvariantspossessutilityintheapplicationatthetime
offilingwillhelpestablishingthatutilitywasdemonstratedorsoundlypredictedat
thetimeofthefilingandwillincreasethelikelihoodofsecuringbroaderclaimsin
Canada.

©CIPS2017iAstraZenecaCanadav.ApotexInc.2017SCC31iiConsolboard;PfizerCanadaInc.v.Canada(MinisterofHealth),2008FCA108,[2009]1F.C.R.
253(Ranbaxy)iiiApotexInc.v.WellcomeFoundationLtd.,2002SCC77,[2002]4S.C.R.153ivReApplicationofAbitibiCo.(1982),62C.P.R.(2d)81,(PatentAppealBoardandCommissioner
ofPatents)