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How to Treat a Regimen: Federal Court of Canada Clarifies Case Law on Patentable Subject Matter, Dosage Regimes and Methods of Medical Treatment

2015-07-22

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HOWTOTREATAREGIMEN:FEDERALCOURTOFCANADACLARIFIES
CASELAWONPATENTABLESUBJECTMATTER,DOSAGEREGIMESAND
METHODSOFMEDICALTREATMENT

JASONMOSCOVICI*
ROBIC,
LLP
L
AWYERS,PATENT&TRADEMARKAGENTS

OnDecember22nd,2014,theFederalCourtofCanadaallowedAbbvie
BiotechnologyLtd.’s(“Abbvie”)appealandrequestforjudicialreviewofthe
CommissionerofPatents(“Commissioner”)refusaltograntAbbvieapatenton
CanadianPatentApplicationNo.2,385,745(the‘745Application).Abbviecontested
theCommissioner’sfindingsthattheclaimsofthe‘745Applicationwerenot
patentablesubjectmatterunderCanada’sPatentAct[RSC1985,cP-4;“theAct”]
forbeingdirectedtomethodsofmedicaltreatment.[AbbvieBiotechnologyLtd.v.
Canada(AttorneyGeneral),2014FC1251,FC1251;“Abbvie”]

The‘745Application
Briefly,the‘745patentapplicationrelatedtotheuseofHUMIRA®,aknowndrug
commonlyusedforthetreatmentofautoimmunediseaseslikerheumatoidarthritis.
AbbvieisalreadytheownerofapatentforHUMIRA®andin2002,filedthe‘745
application,claimingtheuseofHUMIRA®forthetreatmentofautoimmunediseases,
inafixeddosageamountofthedrug(apreloadedsyringecontaining40mg)andon
afixedschedule(everytwoweeks,orbi-weekly).
GeneralProhibition
InCanada,claimsdirectedtoamethodofmedicaltreatmentarenotpatentable
subjectmatter.Thisrestrictionfindsitsoriginsintheinterpretationofthedefinitionof
inventionintheAct,aswellasfromaSupremeCourtofCanada’sdecision
[TennesseeEastmanCovCommissionerofPatents,[1974]SCR111],whichfound
thatclaimstotheexecutionofaprofessionalskillarenotinventionsandtherefore
cannotbepatented.

©CIPS,2015.*LawyerofROBIC,LLP,amultidisciplinaryfirmoflawyers,patentandtrade-markagents.Published
underthetitleCanadaCourtClarifiesLawonPatentableSubjectMatter,DosageRegimesand
TreatmentMethod(2015),29:4WorldIntellectualPropertyReport39-41.Publication142.300.

2
Inthelifesciences,thiswasinterpretedasmeaningthatclaimsthatinterferedwith
theabilityofaphysiciantoexerciseskillorjudgmentwhenprescribingacertaindrug
orprovidingacertaintreatmentarenotpatentable,specificallywhensuchaclaim
wouldeffectivelycovertheuseofaknowncompound/treatmentforapurposethat
wasalreadyestablishedbypractice.
Canadiancaselawhasalsodistinguishedbetweenclaimstodosagesanddosage
regimesthataremadetoavendibleproduct,whicharepatentable,andclaimsthat
relatetotheexerciseofaprofessionalskillorjudgment,whicharen’t.

TheCommissioner’sAnalysis
Priortothisappeal,theCommissioner,whencommentingthePatentOffice’sfinal
decisionnottograntthe‘745patent,foundthattheclaimsweredirectedtoamethod
ofmedicaltreatmentsinceaphysician’sskillandjudgmentwasaffectedwhen
prescribingadrugproductalreadyhavingafixeddosageregimen.Itfoundthatthis
lineofreasoningwasconsistentwithitsinterpretationoftherelevantcaselaw,as
wellasa“new”practicenoticeadoptedbytheCanadianIntellectualPropertyOffice
whichstatedthat“inventionspreventingphysiciansfromexercisingtheirskilland
judgmentinusingaknowncompoundforanestablishedpurposeeffectivelycovera
methodofmedicaltreatment”.Thenoveltyornon-obviousnessofthealleged
inventionwasnotatissue.
WhileitwasarguedbyAbbviethatthepresenceofafixeddosageregimeremoved
thepossibilityofaphysicianhavingtoexerciseanyskillandjudgmentinthefirst
place,theCommissionerinterpretedthecaselawasestablishingthatthesimple
presenceofafixeddosageandadosagescheduleisnotalwayssufficienttoescape
thescopeofwhatisconsideredamethodofmedicaltreatment.TheCommissioner
didnotagreethattherestrictionofaphysician’sabilitytoexerciseskillandjudgment
islimitedonlytoclaimsthatcoverarangeofdosesordoseintervalsandassuch,
refusedtograntthepatent.
TheCourt’sDecision
i)Theparties’positions
TheAppellant,Abbvie,submittedthattheCommissionerappliedthewrongdefinition
of“methodofmedicaltreatment”anddidnotconsiderormisinterpretedestablished
caselawthatdealtwiththeinterpretationof“invention”asfoundintheAct.

Abbviealsosubmittedthatthepatentclearlyprovidesforafixeddosageatafixed
intervalandthatnoskillorjudgmentneedstobeexercisedbyaprofessional:“the
patentdoesnotrestrictmethodsofmedicaltreatmentortheskillandjudgmentofthe

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physician,becausenoskillorjudgmentisneededtobeexercisedwithintheclaim.”
[Abbvie,atpara.3]

Abbviefurthersubmittedthat“thefocusshouldratherbeonwhetherthatchoice[to
usetheinvention]isrestrictedbytheclaims.Thechoicesmadeandtheskilland
judgmentexercisedoutsidetheclaimsofthepatent(i.e.,whendeterminingwhether
theparticulardrugshouldbeprescribedandusedassetoutintheclaim)arenot
restricted.”[Abbvie,atpara.52]

AbbviealsoarguedthattheCommissioner’sdecisionreflectsitsintenttoimplement
achangeofpolicy[CanadianIntellectualPropertyOffice[CIPO]document,
ExaminationPracticeRespectingMedicalUses,PN2013-14,datedJune10,2013]
andthatthisnewpolicyattemptstocreateanewexclusionthatwasnotbasedon
theAct:“inventionspreventingphysiciansfromexercisingtheirskillandjudgmentin
usingaknowncompoundforanestablishedpurposeeffectivelycoveramethodof
medicaltreatment”.
Inreturn,theAttorneyGeneralofCanada(the“Respondent”)submittedthatthe
Commissioneridentifiedandappliedthecorrectlegaltestsandthatthe
Commissioner’sfindingthattheclaimswerenotpatentablesubjectmatterisa
findingoffact,shouldthereforebereviewedunderthestandardof“reasonableness”
andthatdeferenceisowedtotheCommissionerwhohasaspecificexpertiseinthis
field.
Furthermore,theRespondentalsoallegedthatsincetheclaimsincludebi-weekly
dosageregimesitisthereforenotsimplya“vendibleproduct”.Itfurthersubmitted
thatanyclaimthatincludesadosage(fixed,rangeorotherwise)restrictsa
physician’sabilitytoexerciseitsownskillandjudgmentandthereforeseeksto
patentamethodofmedicaltreatment.
TheRespondentalsoputforwardthatHUMIRA®wasalreadypatentedandwas
alreadyinasyringe.Theonlydifferencenowbeingthe40mgfixedamountandthe
bi-weeklydosage.Thiselementtherefore:“addsthe“howandwhen”and“fencesin”
theprescribingpractice.Ifphysiciansmustdecidenottoprescribeitbecause40mg
bi-weeklyisnotappropriateforthepatient,this“fencesin”theprescribingpractice”
[Abbvie,atpara.74].

ii)TheCourt’sAnalysis
Onappealforjudicialreview,aCourtmustfirstdetermineifthefirstdecision
renderedbytheCommissionerwascorrectorreasonabledependingonthe
applicablestandardofreview.Iftheappropriatestandardis“reasonability”,thenthe
issueisiftheCommissioner’sdecisioniswithintherangeofpossible,defensible
outcomes.Ifthestandardofreviewiscorrectness,thenitneedstobedeterminedif
theCommissionerappliedthecorrectdefinitionofinventionundertheActand

4
correctlyinterpretedthattheclaimsweredirectedtowardsa“methodofmedical
treatment”.
Afterrepresentationsfrombothparties,theCourtreviewedtheCommissioner’s
decisionusingthe“correctness”standard”,sincethescopeofthepatentablesubject
matterispurelyaquestionoflaw,havingtodowiththestatutorylimitationsofwhat
consistsofpatentablesubjectmatter,andwhatdoesnot.Sincethefactswerenotin
dispute,thematterbecomespurelyaquestionoflaw,ormoreparticularly,the
correctapplicationofthislaw:“[T]heonlyissueistheCommissioner’sinterpretation
ofpatentablesubjectmatter,andmorespecifically,thescopeoftheprohibitionon
methodsofmedicaltreatment””[Abbvie,atpara.48

TheRespondentallegedthatsinceHUMIRA®wasalreadypreviouslyavailableand
thatthe‘745applicationsimplyaddedasyringewithaspecificdosageofthedrug
anddosingschedule,thatthisboxedinthemedicalprofessionalandinterferedwith
thephysician’sprescribinghabitsornormalexerciseofskillandjudgment.
TheCourtfoundthatthedistinctionshouldnotbewhetherornotapatentclaimsa
dosageordosagerangebutiftheclaimscontainarestrictionwithregardstoa
professional’suseofskillorjudgment.Ifthereisnosuchrestriction,theinventionis
avendibleproduct:“aclaimdirectedtotheexerciseofprofessionalskillorjudgmentis
notpatentable.However,aclaimwhichdoesnotrestrict,orinterfere
with,orotherwiseengageprofessionalskillorjudgment–includinga
claimforafixeddosageandorafixeddosagescheduleorinterval-
isnotimpermissiblesubjectmatterwherethereisnoevidenceto
contradictthatclaimeddosage”[Abbvie,atpara.114].

Therefore,theCourtfoundthatthecaselawhasbeenconsistenttotheeffectthata
claimdirectedtotheexerciseofaprofessionalskillisnotpatentable.Furthermore,if
aclaimisbeingmadetoavendibleproduct,evaluationoftheskillandjudgment
requiredtoprescribetheproductneedstobemade:
“thedistinctionisnotsimplywhetherornotthepatentclaimsa
dosagerange.Theissueiswhethertheclaimscontainwithinthem
therestrictiononchoice–i.e.,whethertheyrestricttheuseofskill.A
dosagerangesignalsthattheexerciseofskillisbeingmonopolized.
However,ifthereisnorangeclaimed,thereisnoattemptto
monopolizetheexerciseofskillsincenoneisneeded.”[Abbvie,at
para.61]

TheCourtfoundthatthereisnothingtosuggestthatabi-weeklydosageisnot“fixed
andprecise”andthatfurtherskillandjudgmentwouldneedtobeexercisedwhen
prescribingtheproduct.Assuch“claimstofixeddosagesandscheduleswhichdo
notinvolveanyprofessionaldecision-makinghavebeenacceptedaspatentable”
[Abbvie,atpara.112].

5
Conversely,justbecauseaclaiminvolvesafixeddosageandscheduledoesnot
makeitautomaticallypatentable.Evidencemaybepresentedthatshowsthat
additionalskillandjudgmentarestillinfactneeded.

TheCourtultimatelyfoundthatAbbvie’sreadingandunderstandingofthecaselaw
wascorrectanddemonstratesthat“thepresentclaimisforavendibleproduct.It
doesnotrestrictthephysician’schoiceorskillthatwouldbereliedonattheoutsetto
determinewhetherthatvendibleproductshouldorshouldnotbeprescribed.The
caselawhasestablishedthatauseclaimmaybeavendibleproduct.”[Abbvie,at
para.115]
SincetheCommissionerhadalreadydeterminedthattheclaimsatissuewerenovel
andnotobvious,andthatonlytheissueofpatentablesubjectmatterremained,the
CourtfoundthattherewasnothingleftforthePatentOfficetoexamineandordered
theCommissionertoallowtheclaimstoissuetopatent.

Conclusion
Thisdecisionclarifieswhatwasanongoingdebateregardingthepatentabilityof
certainclaimscontainingdosageregimesinCanada.Contrarytothepractice
adoptedbytheCanadianIntellectualPropertyOffice,theCourtfoundthatclaims
containingsuchdosageregimensaren’talwaysautomaticallyconsideredmethodsof
medicaltreatmentandcanbeallowable.Morespecifically,theCourtfoundthatthe
presenceofaspecificdosageregimenthatprovidesthe“howandwhen”forthe
administrationofadrugproductdoesnotautomatically“fencein”theskilland
judgmentofamedicalpractitionerandisthereforeallowableonacasebycase
basis.Itthereforeremainstobeseenhowthisdecisionwillaffectdaytoday
prosecutionofpatentapplicationscontainingsimilarlywordedclaimsandwhat
argumentswouldneedtobeprovidedtofurtherdistinguishadosageregimenthat
“fencesin”apractitioner’sexerciseofskillandjudgment,fromonethatdoesn’tlikein
thepresentcase.

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