How to Treat a Regimen: Federal Court of Canada Clarifies Case Law on Patentable Subject Matter, Dosage Regimes and Methods of Medical Treatment
ROBIC,LLPwww.robic.ca
info@robic.com
MONTREAL1001Square-Victoria-BlocE-8thFloor
Montreal,Quebec,CanadaH2Z2B7
Tel.:+1514987-6242Fax:+1514845-7874QUEBEC2828LaurierBoulevard,Tower1,Suite925
Quebec,Quebec,CanadaG1V0B9
Tel.:+1418653-1888Fax.:+1418653-0006
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.
ROBIC,LLPwww.robic.ca
info@robic.com
MONTREAL1001Square-Victoria-BlocE-8thFloor
Montreal,Quebec,CanadaH2Z2B7
Tel.:+1514987-6242Fax:+1514845-7874QUEBEC2828LaurierBoulevard,Tower1,Suite925
Quebec,Quebec,CanadaG1V0B9
Tel.:+1418653-1888Fax.:+1418653-0006
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
ROBIC,LLPwww.robic.ca
info@robic.com
MONTREAL1001Square-Victoria-BlocE-8thFloor
Montreal,Quebec,CanadaH2Z2B7
Tel.:+1514987-6242Fax:+1514845-7874QUEBEC2828LaurierBoulevard,Tower1,Suite925
Quebec,Quebec,CanadaG1V0B9
Tel.:+1418653-1888Fax.:+1418653-0006
3
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
ROBIC,LLPwww.robic.ca
info@robic.com
MONTREAL1001Square-Victoria-BlocE-8thFloor
Montreal,Quebec,CanadaH2Z2B7
Tel.:+1514987-6242Fax:+1514845-7874QUEBEC2828LaurierBoulevard,Tower1,Suite925
Quebec,Quebec,CanadaG1V0B9
Tel.:+1418653-1888Fax.:+1418653-0006
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].
ROBIC,LLPwww.robic.ca
info@robic.com
MONTREAL1001Square-Victoria-BlocE-8thFloor
Montreal,Quebec,CanadaH2Z2B7
Tel.:+1514987-6242Fax:+1514845-7874QUEBEC2828LaurierBoulevard,Tower1,Suite925
Quebec,Quebec,CanadaG1V0B9
Tel.:+1418653-1888Fax.:+1418653-0006
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.
Pourdesservicesdeconseilsdansledomainedelapropriétéintellectuelleetdestechnologiesdel’informationetdes
communications(incluantlesservicesd’agentsdebrevetsetdemarquesdecommerce)demêmequedesservicesjuridiques.
ROBIC,ungrouped’avocatsetd’agentsdebrevetsetdemarquesdecommercevouédepuis1892àlaprotectionetà
lavalorisationdelapropriétéintellectuelledanstouslesdomaines:brevets,dessinsindustrielsetmodèlesutilitaires;
marquesdecommerce,marquesdecertificationetappellationsd’origine;droitsd’auteur,propriétélittéraireet
artistique,droitsvoisinsetdel’artisteinterprète;informatique,logicielsetcircuitsintégrés;biotechnologies,
pharmaceutiquesetobtentionsvégétales;secretsdecommerce,know-howetconcurrence;licences,franchiseset
transfertsdetechnologies;commerceélectronique,distributionetdroitdesaffaires;marquage,publicitéet
étiquetage;poursuite,litigeetarbitrage;vérificationdiligenteetaudit.ROBIC,agroupoflawyersandofpatentand
ROBIC,LLPwww.robic.ca
info@robic.com
MONTREAL1001Square-Victoria-BlocE-8thFloor
Montreal,Quebec,CanadaH2Z2B7
Tel.:+1514987-6242Fax:+1514845-7874QUEBEC2828LaurierBoulevard,Tower1,Suite925
Quebec,Quebec,CanadaG1V0B9
Tel.:+1418653-1888Fax.:+1418653-0006
6
trademarkagentsdedicatedsince1892totheprotectionandthevalorizationofallfieldsofintellectualproperty:
patents,industrialdesignsandutilitypatents;trademarks,certificationmarksandindicationsoforigin;copyrightand
entertainmentlaw,artistsandperformers,neighbouringrights;computer,softwareandintegratedcircuits;
biotechnologies,pharmaceuticalsandplantbreeders;tradesecrets,know-how,competitionandanti-trust;licensing,
franchisingandtechnologytransfers;e-commerce,distributionandbusinesslaw;marketing,publicityandlabelling;
prosecutionlitigationandarbitration;duediligence.
®/MD
COPYRIGHTER
TM/MC
IDEASLIVEHERE
®/MD
ILATOUTDEMÊMEFALLUL’INVENTER!
®/MD
LAMAÎTRISEDESINTANGIBLES
®/MD
LEGERROBICRICHARD
®/MD
NOSFENÊTRESGRANDESOUVERTESSURLEMONDEDESAFFAIRES
®/MD
PATENTER
®/MD
ou«R»
®/MDstylisé
ROBIC®/
MD
OustyliséROBIC++++
®/MDstylisé
ouROBIC+DROIT+AFFAIRES+SCIENCES+ARTS
®/MDstylisé
ouROBIC+LAW+BUSINESS+SCIENCE+ART
®/MDstylisé
THETRADEMARKERGROUP
TM/MC
TRADEMARKER
TM/MC
VOSIDÉESÀLAPORTÉEDUMONDE,DESAFFAIRESÀLAGRANDEURDELAPLANÈTE
®/MD
YOURBUSINESSISTHEWORLDOFIDEAS;OURBUSINESSBRINGSYOURIDEASTOTHEWORLD
®/MD
MarquesdecommercedeROBIC,
S.E.N.C.R.L.poursesservicesdeconseilsdansledomainedelapropriétéintellectuelleet
destechnologiesdel’informationetdescommunications(incluantlesservicesd’agentsdebrevetsetdemarquesde
commerce)demêmequesesservicesjuridiques
**************************************************************************************************
Forservicespertainingtointellectualproperty,technologyandcommunicationlawandrelatedmatters(includingpatentand
trade-markagencyservices)aswellaslegalservices.
ROBIC,ungrouped’avocatsetd’agentsdebrevetsetdemarquesdecommercevouédepuis1892àlaprotectionetà
lavalorisationdelapropriétéintellectuelledanstouslesdomaines:brevets,dessinsindustrielsetmodèlesutilitaires;
marquesdecommerce,marquesdecertificationetappellationsd’origine;droitsd’auteur,propriétélittéraireet
artistique,droitsvoisinsetdel’artisteinterprète;informatique,logicielsetcircuitsintégrés;biotechnologies,
pharmaceutiquesetobtentionsvégétales;secretsdecommerce,know-howetconcurrence;licences,franchiseset
transfertsdetechnologies;commerceélectronique,distributionetdroitdesaffaires;marquage,publicitéet
étiquetage;poursuite,litigeetarbitrage;vérificationdiligenteetaudit.ROBIC,agroupoflawyersandofpatentand
trademarkagentsdedicatedsince1892totheprotectionandthevalorizationofallfieldsofintellectualproperty:
patents,industrialdesignsandutilitypatents;trademarks,certificationmarksandindicationsoforigin;copyrightand
entertainmentlaw,artistsandperformers,neighbouringrights;computer,softwareandintegratedcircuits;
biotechnologies,pharmaceuticalsandplantbreeders;tradesecrets,know-how,competitionandanti-trust;licensing,
franchisingandtechnologytransfers;e-commerce,distributionandbusinesslaw;marketing,publicityandlabelling;
prosecutionlitigationandarbitration;duediligence.
®/MD
COPYRIGHTER
TM/MC
ROBIC,LLPwww.robic.ca
info@robic.com
MONTREAL1001Square-Victoria-BlocE-8thFloor
Montreal,Quebec,CanadaH2Z2B7
Tel.:+1514987-6242Fax:+1514845-7874QUEBEC2828LaurierBoulevard,Tower1,Suite925
Quebec,Quebec,CanadaG1V0B9
Tel.:+1418653-1888Fax.:+1418653-0006
7
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
THETRADEMARKERGROUP
TM/MC
TRADEMARKER
TM/MC
VOSIDÉESÀLAPORTÉEDUMONDE,DESAFFAIRESÀLAGRANDEURDELAPLANÈTE
®/MD
YOURBUSINESSISTHEWORLDOFIDEAS;OURBUSINESSBRINGSYOURIDEASTOTHEWORLD
®/MD
Trade-marksofROBIC,
LLPforitsservicespertainingtointellectualproperty,technologyandcommunicationlawandrelated
matters(includingpatentandtrade-markagencyservices)aswellaslegalservices