Patentability Inegibility in Canada

2015-12-21

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

PATENTABILITYINELIGIBILITYINCANADA

LOUIS-PIERREGRAVELLEANDJUSTINFREEDIN*
ROBIC,
LLP
L
AWYERS,PATENT&TRADEMARKAGENTS

Inmanyjurisdictions,thenotionofstatutorysubjectmatterorpatentableinventionsis
evolving.Arguably,thereareanumberoffactorsinfluencingthisevolution,including
theincreaseinlitigationintheUnitesStatesfuelledinpartby“non-practicing
entities”.Canadahasbeenanactiveparticipantinthisevolution,evidencedbya
numberofnotablecausesandthechangingpracticeadoptedbytheCanadian
IntellectualPropertyOffice(CIPO).Thoughperhapsinspiredbydevelopmentsin
foreignjurisdictions,Canada’spositiononpatentableinventionshasbeencentered
oninterpretingthemeaningof“invention”asdefinedintheCanadianPatentAct
1.

Section2oftheActsetsoutthatapatenteligible“invention”isanyneworusefulart,
process,machine,manufactureorcompositionofmatter,oranyimprovement
thereon.Thismustbereadinconjunctionwithsection27(8)oftheActwhich
excludesfrompatentabilityanymerescientificprincipleorabstracttheorem.
Althoughthestatutorydefinitionof“invention”hasremainedunchangedsince1923
2,
developmentsintheCanadianrequirementsforpatenteligibilityhaveinvolved
reconsideringthenotionsof“art,process,machine,manufactureorcompositionof
matter”inlightofnewtypesoftechnologies.
ComputerImplementedInventionsandSoftware
InCanada,computerimplementedinventionsmaybeclaimedintermsofhardware
componentsandintermsofamethod.
Thepatenteligibilityofacomputerimplementedmethodessentiallyhingeson
whetherornotitfallswithinthedefinitionof“art”.Acasethatstillprovidesguidance
todaynotwithstandingitsageisLawsonv.Canada(CommissionerofPatents)
3,
whereitwasheldthat”artisanactorseriesofactsperformedbysomephysical

©CIPS,2015*FromROBIC,LLP,amultidisciplinaryfirmofLawyers,andPatentandTrade-markAgents.Postedon
LinkedInon2015-08-03.TheauthorswouldliketothankErikaPaapeandLaurenceBourget-Merlefor
theirvaluedinputPublication62.70.
1RSC,1985,c.P-4[Act]2S.C.1923,c.23,s.2(c)3Lawsonv.Canada(CommissionerofPatents),(1970)62CPR101(ExCt)[Lawson]

2
agentuponsomephysicalobjectandproducinginsuchobjectsomechangeof
eithercharacterorcondition”.InthelandmarkFederalCourtofAppealdecision
regardingAmazon.com’s“one-click”onlineorderingtechnology
4,40yearslater,the
Courtaffirmedthatthedefinitionof“art”mustmeetthreeimportantelementsoutlined
inProgressiveGames,Inc.v.Canada(CommissionerofPatents)
5:“i)itmustnotbe
adisembodiedideabuthaveamethodofpracticalapplication;ii)itmustbeanew
andinventivemethodofapplyingskillandknowledge;andiii)itmusthavea
commerciallyusefulresult.”Thisdefinitiondoesnotrequireanimpactonthephysical
world,asLawsondid.

Inordertoevaluatewhetherornotaclaimedinventionfallswithinthedefinitionof
“art”,onefirsthastoidentifywhattheinventionactuallyis.InAmazon.com,theCourt
statedthattheproperapproachistoperformapurposiveconstructionoftheclaims.
ThenotionofpurposiveconstructionwasdiscussedintheSupremeCourtdecisions
FreeWorldTrust
6andWhirlpool7in2000.Purposiveconstructioninvolves
determiningwhatapersonofreasonableskillintheartwouldunderstandthe
claimedinventiontobe,uponreadingthedisclosureinthepatentapplicationusing
generalknowledgeavailabletohimatthetimethepatentapplicationwaspublished.
AccordingtoFreeWorldTrustandWhirlpool,onemustidentifytheessential
elementsofaclaimbyassessingthenatureoftheclaimedinventioninlightofwhat
isdescribedinthedisclosureofthepatentapplication.Thereisapresumptionthat
theelementsinaclaimareessential,soinorderforanelementtobeconsidered
non-essential,itmustbeshownthatuponpurposiveconstructionoftheclaims,the
elementwasclearlynotintendedtobeessential,orthattheelementcouldbe
substitutedwithoutaffectingthefunctionoftheinvention.AsnotedinAmazon.com,
suchanapproachallowslookingbeyondtheliterallanguageoftheclaiminorderto
assesswhetherornottheunderlyinginventionisinfactdirectedtopatentable
subjectmatter.
8

TwoyearsaftertheAmazon.comdecisionwasrendered,CIPOissuedtwopractice
noticestoguideExaminersinassessingthepatentabilityofcomputerimplemented
inventions.
9Althoughnotbinding,thesepracticenoticesprovideinsightintohow
Examinersarecurrentlyhandlingapplicationsrelatingtocomputerimplemented
inventions.

4Amazon.comv.AttorneyGeneralofCanadaetal,2011FCA328,97C.P.R.(4th)171(F.C.A.)
[Amazon.com]
5ProgressiveGames,Inc.v.Canada(CommissionerofPatents),1999CanLII8921(FC),177F.T.R.
241(T.D.)atpara.16,aff’d(2000),2000CanLII16519(FCA),9C.P.R.(4th)479(F.C.A.).
6FreeWorldTrustv.ÉlectroSantéInc.,2000SCC66[FreeWorldTrust]7WhirlpoolCorp.v.CamcoInc.,2000SCC67[Whirlpool]8Paragraph44Amazon.9Canada,CanadianIntellectualPropertyOffice,ExaminationPracticeRespectingPurposive
Construction-PN2013-02,(Ottawa:CIPO2013);ExaminationPracticeRespectingComputer-
ImplementedInventions-PN2013-03,(Ottawa:CIPO2013),online:CIPO
http://www.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03628.html.

3
InfollowingwiththeAmazon.comdecision,thepracticenoticesexplainthatthe
combinationofessentialelementsofaclaim,asdeterminedbypurposive
construction,mustbedirectedtopatentablesubjectmatter.However,seemingly
contrarytotheprinciplesofpurposiveconstructionoutlinedinFreeWorldTrustand
Whirpool,thepracticenoticesessentiallyinstructExaminerstoperformapurposive
constructionoftheclaimsbytakingaproblem-solutionapproach.Examinersare
directedtolooknotonlyatthelanguageintheclaims,butalsointheapplicationasa
wholeinordertoidentifytheproblemandtheessentialelementsofthesolution.
Accordingly,noteveryelementhavingamaterialeffectonoperationisnecessarily
essentialtoanidentifiedsolution.Someelementscanbeconsideredtobe
superfluous,ormerelydefinethecontextorenvironmentofaspecificworking
embodimentnotwithstandingthelimitationsappearingintheclaim.Conversely,
someessentialelementsoftheidentifiedsolutioncanbemissingfromtheclaim,in
whichcasetheclaimscanberejectedforlackofutility.

Accordingtothepracticenotices,agoodindicationthataclaimisdirectedto
statutorysubjectmatterisifacomputerisfoundtobeanessentialelementofa
construedclaim.Inassessingwhetheracomputerisessential,theExaminerwill
havetodeterminewhetherthecomputerisinfactessentialtocarryoutthesolution,
orifitismerelyaconvenienceorafterthought.
Thepracticenoticesfurtherexplainthatonepossibleapproachtodeterminethe
essentialityofhardwareistoconsiderwhetherthecomputercanbevariedor
substitutedwithouthavingamaterialeffectontheoperationoftheinvention.For
example,ifaninventionteachesusingacomputertoperformcertaincalculations
accordingtoanequation,thecalculationscouldfeasiblybeperformedbyahuman
instead.Althoughtheuseofacomputerwouldexpeditethecalculations,thesame
resultswouldbeachievedifperformedbyahuman.Insuchascenario,thecomputer
wouldnotbeconsideredessential.
Stillaccordingtothepracticenotices,anothergoodindicationthattheinventionis
directedtopatentablesubjectmatterisifitisatechnicalsolutiontoatechnical
problem.Forexample,iftheproblemisacomputerproblem(e.g.aproblemwiththe
operationofacomputer),thesolutioncannotbecarriedoutwithoutthepresenceofa
computer,andtherefore,theclaimedcomputerorhardwarecomponentswouldbe
consideredessential.
Thus,thecurrenttrendofCanadianExaminersistoevaluatewhetherthecomputer
hardwareinaclaimisessentialtotheoperationoftheinvention.Otherwise,the
computercanbethoughtofasanarbitraryvehicleforcarryingoutanabstractor
disembodiedideawhichwouldotherwisebeprohibitedsubject-matterunderthe
CanadianPatentAct.

4
AccordingtoCIPO’s2013-2014AnnualReport,intheyearsfollowingthe2011
Amazon.comdecision,thenumberofcomputer-relatedpatentsgrantedbythe
CanadianPatentOfficehasincreased.
10However,trendsinrecentdecisionsfrom
thePatentAppealBoard(PAB)seemtoindicatethatthecourtsaretakingamore
restrictiveapproach.Infact,between2006and2009,theAmazonpatentapplication
wasonly1outof7applicationsinthedomainofcomputer-relatedinventionsbrought
beforethePABinwhichtheExaminer’srejectionforlackofpatentablesubject
matterwasupheld
11.Between2012and2014(i.e.theyearsfollowingthe
Amazon.comdecision)theExaminer’srejectionwasupheldin5outof12cases.12

BusinessMethods
ThepatenteligibilityofbusinessmethodsisstillagrayareainCanadianpatentlaw
asthereisverylittlerelevantjurisprudence.Thesubjectwas,however,discussed
recentlyinAmazon.com,wheretheCourtconfirmedthatthereisnoCanadiancase
thatsupportsthepropositionthatbusinessmethodsarenotpatenteligible,noris
thereanystatutoryorregulatoryprohibition.Whilethisopensthedoortothe
possibilityofbusinessmethodsbeingpatenteligibleinCanada,itisnotan
unequivocalconfirmationthattheyareindeedpatenteligible.

TheprinciplesestablishedinAmazon.comdo,however,bringsomeclaritytothe
requirementsofapatenteligiblebusinessmethodclaim.Althoughthecourtshave
yettodefinea“businessmethod”,anymethodclaim,whetherqualifiedasabusiness
methodornot,mustmeetthecriteriaofapatentable“art”inordertobepatent
eligible.TheCourt’sdiscussiononthenotionofpatentable“art”inAmazon.comcan
thusserveasguidanceforunderstandingtherequirementsforabusinessmethod
claim.

10http://www.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03865.html11Examiner’srejectionupheldinAmazon.com’sApplication(2009),CD1290(P.A.B.,Commr.);
Examiner’srejectionreversedinIndexSystems,Inc.’sApplication(2006),CD1266(P.A.B.,Commr.);
NorthernLightTechnologyGroupInc.’sApplication(2006),CD1265(P.A.B.,Commr.);Diamonds.net
LLC’sApplication(2006),CD1272(P.A.B.,Commr.);SydneyH.Belzberg’sApplication(2007),CD
1274(P.A.B.,Commr.);OrangePersonalCommunicationsServicesLtd.’sApplication(2007),CD
1277(P.A.B.,Commr.);ToyotaJidoshaKabushikiKaisha’sApplication(2008),CD1286(P.A.B.,
Commr.).
12Examiner’srejectionupheldinDeroyalBusinessSystems,LLC’sApplication(2013),CD1338
(P.A.B.,Commr.);FairIsaacCorporation’sApplication(2013),CD1339(P.A.B.,Commr.);IGT’s
Application(2013),CD1346(P.A.B.,Commr.);CantorFitzgerald,L.P.’sApplication(2013),CD1355
(P.A.B.,Commr.);FinancialEngines,Inc.’sApplication(2014),CD1373(P.A.B.,Commr.);Examiner’s
rejectionreversedinNavigationTechnologiesCorporation’sApplication(2012),CD1332(P.A.B.,
Commr.);PitneyBowesInc.’sApplication(2013),CD1334(P.A.B.,Commr.);ProgressiveCasualty
InsuranceCompany’sApplication(2013),CD1336(P.A.B.,Commr.);PitneyBowesInc.’sApplication
(2013),CD1337(P.A.B.,Commr.);RPXCorporation’sApplication(2013),CD1341(P.A.B.,Commr.);
Weyerhaeuser’sApplication(2013),CD1345(P.A.B.,Commr.);ProgressiveCasualtyInsurance
Company’sApplication(2013),CD1349(P.A.B.,Commr.).

Asdiscussedabove,theCourtstatedthatamethodclaimmustmeetthepractical
applicationrequirementforittomeettherequirementsofapatentable“art”.The
methodmustsatisfya“physicality”requirementinthatitincludessomethingwitha
physicalexistenceorsomethingthatmanifestsadiscernableeffectorchange.An
involvementofacomputermaynotsatisfythephysicalityrequirementiftheonly
inventiveandessentialelementisanalgorithmorformula.However,ifthealgorithm
orformulaisoneofanumberofessentialelementsinanovelcombination,the
practicalapplicationrequirementmaybesatisfied.

GenePatents
Inthedomainofbiotechnology,itisawell-establishedprincipleinCanadathatlower
lifeformsarepatentable,whilehigherlifeformsarenot(althoughthecourtshave
shiedawayfromprovidingdefinitionsto“lower”and“higher”lifeforms).Thisprinciple
wasdiscussedintheSupremeCourt’sHarvardCollege
13decision,whichconcerned
HarvardCollege’spatentapplicationforagenetically-modifiedcancer-pronemouse
(“oncomouse”).TheCourtaffirmedthatclaimstoageneticallymodifiedgeneinthe
mousewereallowable.Claimstothemouseitself,however,werepatent-ineligible
becauseamammaldoesnotfallunderthecategoriesof“manufacture”or
“compositionofmatter”inthestatutorydefinitionof“invention”.Implicitly,several
othertypesofclaimspresentinHarvardCollege’spatentapplicationcanbe
understoodasbeingpatent-eligiblebecausetheywereneithercontestednor
rejectedbytheCourt.Theseclaimsincludeclaimsto:atransgeniccellculture,a
somaticcellculturederivedfromatransgenicmammal,amethodofproducinga
transgenicmammal,amethodoftestingusingsuchmammal,andtheuseofsuch
mammalinamethodoftesting.
ThepatentabilityofgenesandcellsestablishedinHarvardwasfurtherconfirmedin
Monsantov.Schmeiser
14,wheretheSupremeCourtheldthatclaimstoanherbicide
resistantgeneandcellwerepatentable.Theplantswhichcontainedthegeneand
cellwerethemselvesunpatentable,becauseplantsfallunderthedefinitionofa
higherlifeform.However,claimstothegeneorcellweresufficienttoprotectthe
plant.Thisisbecauseclaimstoageneorcellcanbeinfringedeveniftheiruse
occurswithinahigherlifeform.Thismeansthatcultivatingplantscontaininga
patentedgeneorcellcouldresultininfringement,eventhoughtheplantisnotitself
patented.
Thoughthecourtestablishedthathigherandlowerlifeformsdifferinpatent
eligibility,itwasleftuptothePatentOfficetodeterminethedistinctionbetweena

13Harvardcollegev.Canada(CommissionerofPatents)2002SCC76,[2002]4SCR45,21CPR
(4th)417.
14MonsantoCanadaIncvSchmeiser,[2004]1SCR902,2004SCC34,31C.P.R.(4th)161(S.C.C.)

6
higherlifeformandalowerlifeform.AccordingtotheManualofPatentOffice
Practice(MOPOP),thePatentOfficegenerallyconsiderslowerlifeformstobe
unicellular,whilehigherlifeformsaremulticellular.However,multicellularlifeforms
areconsideredtobehigherlifeformsatanystageoftheirdevelopment.
15This
meansthatanycellwhichhasthepotentialtodevelopintoamulticellularlifeform
(suchasafertilizedeggoratotipotentcell,forexample)isalsoconsideredbythe
PatentOfficetobeahigherlifeformandthuspatentineligible.

MethodsofMedicalTreatmentandPharmaceuticalCompositions

MethodsofmedicaltreatmentarenotpatentableinCanada.Althoughnotexplicitly
prohibitedbytheCanadianPatentAct,thecourtsareclearthatsuchclaimsare
directedtonon-statutorysubjectmatterandthuscannotbeprotected.Meaningful
protectioncanbeobtained,however,iftheclaimsaredirectedtomedicalusesor
pharmaceuticalcompositions,inasmuchastheycannotbeequatedtomethodsof
medicaltreatment.Protectioncanalsobeobtainedfordiagnosticmethods,aslong
astheclaimsfallwithinthedefinitionofapatentable“art”

InLawson
16,itwasestablishedthatonecannotobtainanexclusivepropertyor
privilegeinaprofessionalskill.Essentially,professionalskilldoesnotrelatetotrade,
industry,orcommerceandshouldthereforenotbesubjecttoamonopolyunderthe
PatentAct.Thisprinciplewasappliedinthecontextofasurgicalmethodin
TennesseeEastmanCo.v.Commissionerofpatents
17,wheretheSupremeCourt
tookthepositionthatamethodofmedicaltreatmentisneitheran“art”nora
“process”andthereforedoesnotsatisfythestatutorydefinitionof“invention”.

Indiscussingtheprohibitionofmethodsofmedicaltreatment,thecourtshavebeen
clearthatthisprohibitionisnotintendedtocoversubstancesusedinthesemethods,
norisitintendedtocoverprocessesforcreatingsaidsubstances.
18Assuch,medical
useclaimsandpharmaceuticalcompositionsdofallunderthestatutorydefinitionof
inventionandarepatentable,inasmuchastheycannotbeequatedtomedical
methods,andaslongastheymeettheotherrequirementsofpatentability.

Thereisafinelinebetweenamedicaluseclaimandmethodofmedicaltreatment.In
orderforaclaimtobetreatedasapatentablemedicaluse,theprofessionalskilland
judgementofamedicalpractitionercannotbeessentialtotheclaim.Aswas

15CanadianIntellectualPropertyOffice,PatentOffice:ManualofPatentOfficePractice(1998Edition:
lastupdatedJuly2015)at17.02.01[MOPOP]
16Lawsonat11117TennesseeEastmanCo.vcommissionerofpatents[1974]SCR111[TennesseeEastman];affirmed
byShellOilandApotexv.Wellcome200221C.p.r.4th499(s.c.c.)andNovartisPharmaceuticals
CanadaIncv.CobaltPharmaceuticalsCompany,2013FC985,440FTR1atpara70-101,endorsed
bythisCourtat2014FCA17,459N.R.17
18TennesseeEastman,supranote14atpara118.

7
discussedinMerck&Co.v.Apotex19,iftheclaimsaredirectedtotheuseofa
vendibleproductandcanbedistinguishedfromtheworkofaphysicianwhich
requirestheexerciseofskillandjudgement,TennesseeEastmandoesnotapply.
JusticeHughesinNovartisPharmaceuticalsCanadainc.v.CobaltPharmaceuticals
Co.
20alsoconfirmedthataproperclaimshouldbedirectedtoavendibleproduct
includingasubstancewhichisintendedforthetreatmentofamedicalcondition.

Practicallyspeaking,claimstotheuseofacapsuleortabletinspecificdosagesfor
treatingaconditionaregenerallyconsideredpatenteligible.Thesetypesofclaims
relatetoavendibleproduct,anddonotrequiretheexerciseofskillandjudgementof
physicians.Conversely,thepatenteligibilityofclaimsdirectedtotheuseofarange
ofdosagesoradosageregimenfortreatingaconditionislessclear.Ingeneral,
claimsdefiningspecificdosagesoraspecificdosageregimen(suchasaspecific
administrationschedule)arepatentablesincetheclaimsdonotrequiretheexercise
ofskillandjudgementofphysicians.However,claimsdirectedtotheuseofa
medicationinarangeofdosagesfortreatingaconditionmaybeconsideredpatent
ineligiblebecauseprofessionalskillandjudgementmayberequiredinordertoselect
theappropriatedosagefromtherange.What’smore,suchclaimscouldinterferewith
aphysician’sprofessionaljudgementorskillandcouldthereforebeethically
questionableandahazardtopublichealth.AswasnotedinJanssenInc.v.Mylan
Pharmaceuticals,“theconcernwithpatentingadosageregimenisthatthephysician
maybepreventedfromexercisingskillandjudgmentinusingaknowncompoundfor
anestablishedpurposeabsentalicencefromthepatentee.”
21

Assuch,aproperclaimcouldbestructuredas:“thesubstanceXforthetreatmentof
Y”,“thesubstanceXintheformofa5mgtabletforthetreatmentofY”,“useofthe
substanceXfor4weeksat8mg/dayforthetreatmentofY”or“useofadosage
formulationof70mgofthesubstanceX,onceaweek,totreatY”.Animproperclaim
couldbestructuredas:“theuseofsubstanceXinadosagerangebetween5mgand
10mgforthetreatmentofY”or“useofa10mgdosageunitofthesubstanceXto
treatYforabout3to5weeks”.
Itshouldbenoted,however,thatthemereinclusionofadosagerangeorregimenin
amedicaluseclaimdoesnotnecessarilyequatetheclaimtoamethodofmedical
treatment.Amorethoroughanalysisisrequiredinordertodeterminewhetherornot
theclaiminterfereswithorrequirestheprofessionalskillofaphysician.
22

Inanefforttoguideexaminersinexaminingclaimscontainingdosageregimensor
dosageranges,CIPOissuedapracticenoticerespectingmedicalusesin2013,

19Merck&Co.v.Apotex(2005),2005FC755,41CPR(4th)35(FC)20NovartisPharmaceuticalsCanadainc.v.CobaltPharmaceuticalsCo.(2005),43CPR(4th)81(F.C.)21JanssenInc.vMylanPharmaceuticalsULC,2010FC1123,376FTR311atparas51[Janssen]22AbbVieBiotechnologyLtd.v.Canada(AttorneyGeneral)2014FC1251

8
followedbyrevisedpracticenoticein2015.23Examinersaredirectedtoapplya
purposiveconstructionoftheclaimsusingaproblem-solutionapproach.As
discussedearlierinthecontextofcomputer-implementinventions,thisexerciseis
generallycarriedoutbyconsideringthespecificationasawholetoidentifythe
problemfacedbytheinventor,andtheessentialelementsrequiredforthesuccessful
resolutionoftheproblem.
Therevisedpracticenoticeessentiallydirectsexaminerstolookforsituationswhere
dosagerangesorregimensareessentialtoaclaim.Whenadosagerangeor
regimenisnotpresentorisnotessentialtoaclaim,theclaimwillgenerallybe
consideredamedicaluseclaimandthuspatenteligible.Accordingtothepractice
notice,suchclaimsteachapractitioner“what”tousetotreatamedicalcondition,
ratherthan“how”totreatthemedicalcondition.
Whenitisfoundthatadosagerangeorregimenisanessentialelementinaclaim,
theclaimmaybedirectedtounpatentablesubjectmatter.InfollowingJanssen,the
revisedpracticenoticestatesthatifthedosagerangeorregimenisessentialtoa
claimencompassingtheuseofaknowncompoundinanestablishedtreatment,then
theclaimmaycoveramethodofmedicaltreatment.FollowingApotexInc.v.
WellcomeFoundationLtd.
24,therevisedpracticenoticestatesthatiftheessential
elementonlyinstructsamedicalprofessional“how”(i.e.howandwhen)totreata
patientratherthan“what”tousetotreatthepatient,thereisanimplicationthatthe
claimmustencompasstheuseofaknowncompoundinanestablishedtreatment.In
suchascenario,inordertodeterminewhethertheclaimequatestoamethodof
medicaltreatment,itmustbedeterminedthattheessentialelementprevents,
interfereswithorrequirestheprofessionalskillofaphysician.

Therevisedpracticenoticegoesontoprovidetwoexamplesofelementsthatpoint
toalimitationofaphysician’sprofessionalskillorjudgement:(1)detaileddosage
schedulesencompassingarange;and(2)arangeofpotentialdosagesthatapatient
mayreceive.Incontrast,thefollowingelementsareprovidedasexamplesof
elementswhichdonotlimitaphysician’sprofessionalskill:afixeddosage;afixed
dosageregimen;apatientsub-population;andaparticularadministrationsite.

AccordingtotheMOPOP,methodsfordiagnosingdiseasearenotconsideredtobe
methodsofmedicaltreatmentbecausetheydonotinvolveastepofsurgeryor
provideapracticaltherapeuticbenefit.
25Medicaldiagnosticmethodsaretherefore
notsubjecttothesameprohibitionasmethodsofmedicaltreatment,however
diagnosticmethodsraisetheirownpatentabilityissues,particularlyinviewofthe
Amazon.comdecision.Asisthecasewithcomputer-implementedinventions,the

23PN2013-04ExaminationPracticeRespectingMedicalUsespublishedonJune10,2013,revisedby
PN2015-01RevisedExaminationPracticeRespectingMedicalUsespublishedMarch18,2015.
24ApotexInc.vWellcomeFoundationLtd.,[2002]4SCR153,2002SCC77,21CPR(4th)499.25MOPOPat12.05.02and17.02.03

9
patenteligibilityofamedicaldiagnosticmethodessentiallyhingesonwhetherthe
essentialelementsofaclaimfallwithinthestatutorydefinitionof“art”.

ApracticenoticeissuedbyCIPOin2015guidesexaminersinassessingthepatent
eligibilityofmedicaldiagnosticmethods.
26Aswithcomputer-implementedinventions
andmedicaluses,examinersaredirectedtotakeaproblem-solutionapproachto
construetheclaimsandidentifyitsessentialelements.Theproblemcanbegenerally
identifiedasa“dataacquisitionproblem”(i.e.howtoidentify,detect,ormeasurethe
presenceorquantityofXinasample)ora“dataanalysisproblem”(i.e.howX
correlatestoaconditionY).Thesolutioncanbeidentifiedastheelementsorsetof
elementsessentialtoresolvetheidentifiedproblem.

Accordingtothepracticenotice,ifaphysicalstepofdataacquisitionisfoundtobe
anessentialelementoftheconstruedclaim,theclaimislikelydirectedtostatutory
subjectmatter.However,iftheessentialelementsaredisembodied,suchasifthey
simplyinvolveamentalprocess,lackphysicality,orhavenopracticalapplication,
thentheclaimislikelyunpatentable.Therefore,iftheessentialelementsofaclaim
aremerelyassociatedwiththeanalysisorsignificanceofacquireddata,thenthe
claimislikelyunpatentable.
Conclusion
Asisthecaseinmanyotherjurisdictions,theCanadianpositiononpatentable
subjectmatterisstillinastateofchange.Severalimportantcauseshaveprompted
CIPOtoupdateitspractice,butit’slikelythatthispracticewillcontinuetochangeas
theevolutioninpatentablesubjectmatterprogresses.Inthemeantime,theMOPOP
andthepracticenoticesprovidevaluableinsightintohowCanadianexaminerstreat
inventionsthatborderonpatentablesubjectmatter,andshouldaidpractitionersin
preparingapplicationsaccordingly.

26PN2015-02PatentNotice:ExaminationPracticeRespectingMedicalDiagnosticMethodspublished
onJune29,2015