Is Your Medical Treatment Claim More Patentable Now? Hint: A Little
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
ISYOURMEDICALTREATMENTCLAIMMOREPATENTABLENOW?HINT:A
LITTLE
G
ABRIELLEMOISAN*
ROBIC,
LLP
L
AWYERS,PATENTANDTRADE-MARKAGENTS
Inthepharmaceuticalfield,whenboththemoleculeandtheuseareknownandthe
inventionisonlyabouttheadministrationmodeorthedosagerange,itmightbe
difficulttogetapatentinCanada.
Infact,ThePatentActdefinesan“invention”insection2as:
anynewandusefulart,process,machine,manufactureor
compositionofmatter,oranynewandusefulimprovementinanyart,
process,machine,manufactureorcompositionofmatter.
Caselawhasexcludedmedicalmethodsoftreatmentonthehumanoranimalbody
fromthisdefinition,onthegroundsthattheywerenotprocessesandthattheywould
compromisetheworkofhealthcareprofessionalsandthereforewouldalso
compromisethepatientcare.Moreparticularly,claimswhichdescribeanactivestep
ofsurgeryorofadministrationand/orprovideatherapeuticbenefitarerejected,
whereasclaimsdirectedtocosmeticordiagnosticmethods,orrelatedtonatural
statesconsiderednonpathologicallikepregnancy,baldness,wrinklesandageing
areallowed.
Theseclaimshadtobereplacedwithuseclaims,withoutanystepofadministration:
·UseofproductXfortreatingdiseaseY;
·UseofproductXforthemanufactureofamedicamentfortreatingdiseaseY;
·ProductXfortreatingdiseaseY.
However,whentheclaimsdescribeadosagerangeorarangeofadministration,
theyarerejectedifahealthcareprofessionalmustnotonlydecidewhetherornotto
prescribeatreatmenttoapatient(“what”),butmustalsoexerciseprofessional
judgement(“how”:whatdosage,forhowlong,accordingtothepatient’sprofileand
hisresponsetotreatment).Caselawrequiresthatthedosageandthecalendarof
administrationbefixed.Toobtainpatentableclaims,sometimesmanyclaimsmust
bedrafted,eachwithaspecificdosageandcalendar,suchas:
Claim1:10mgfor10days,then20mgfor5days
©CIPS,2015.*FromROBIC,LLP,amultidisciplinaryfirmofLawyers,andPatentandTrade-markAgents.Published
intheSpring2015(Vol.18,no.4)Newsletterofthefirm.Publication068.194E.
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
Claim2:10mgfor5days,then20mgfor10days.
InthejudgementofJanuary20th2015ofAbbVieBiotechnologyLtdv.Canada[2014
FC1251],theFederalCourtoverturnedtheCommissioner’sdecisiontorejectthe
patentapplication2,385,745onthegroundsthattheclaimsweredirectedtowards
methodsoftreatment,withanindeterminateperiodofadministration,andordered
ratherthattheclaimsbeamendedtobecomepatentablebeforebeingsenttothe
examiner.ThepatentwasissuedFebruary17th2015withthefollowingclaim13,in
theformofuseandanadministrationeverytwoweeks:
13.Useofanisolatedhumananti-TNFαantibodywhereinsaid
antibody(a)comprisesalightchainvariableregion(LCVR)
comprisingaCDR3domaincomprisingtheaminoacidsequenceof
SEQIDNO:3,aCDR2domaincomprisingtheaminoacidsequence
ofSEQIDNO:5,andaCDR1domaincomprisingtheaminoacid
sequenceofSEQIDNO:7;and(b)comprisesaheavychain
variableregion(HCVR)comprisingaCDR3domaincomprisingthe
aminoacidsequenceofSEQIDNO:4,aCDR2domaincomprising
theaminoacidsequenceofSEQIDNO:6,andaCDR1domain
comprisingtheaminoacidsequenceofSEQIDNO:8;inthe
manufactureofamedicamentfortreatinganarthriticdiseaseoran
inflammatoryboweldiseaseinahumansubject,whereinsaid
medicamentisadaptedforsubcutaneousadministrationandwherein
thedosageis40mgaccordingtoacontinuousschedulehavingan
everyotherweekdosingintervalof14days.
TheCIPOhaspreparedpracticenoticePN2015-012
[http://www.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03916.html]for
examinersfollowingtheFederalCourt’sdecisionandalsoprovidedsomeexamples
[http://www.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03919.html].Ifthe
claim’spurposeistoanswerthe“what”,asinwhatisneededtotreatapatient(a
compound,amolecule,acomposition,aformulation,adosingunit,asub-population
ofpatients,adistinctpopulationofpatients),it’spatentable.Iftheclaim’spurpose
answersthe“how”,andinformsthemedicalprofessionalastohowtotreatthe
patient(adosagerange,alarge/vagueadministrationcalendar)requiringbothhis
professionalskillsandjudgement,theclaimisnotpatentable.
Inconclusion,theclaimmustdescribetheuseofasaleableandisolatableproductas
muchaspossible.Thepatentagentcommunitywelcomesthisdecisionwithrelief,
sinceagrowingnumberofinventionsconsistpreciselyinnewdosagesand/or
administrationcalendars,anditisunfortunatetoseetheseinventionsbeprotected
allaroundtheworld,yetnotinCanada.Thisdecisionrepresentsastepintheright
direction.
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
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
Pourdesservicesdeconseilsdansledomainedelapropriété
intellectuelleetdestechnologiesdel’informationetdescommunications
(incluantlesservicesd’agentsdebrevetsetdemarquesdecommerce)
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
COPYRIGHTER
TM/MC
IDEASLIVEHERE
®/MD
ILATOUTDEMÊMEFALLUL’INVENTER!
®/MD
LAMAÎTRISEDESINTANGIBLES
®/MD
LEGERROBICRICHARD
®/MD
NOSFENÊTRESGRANDESOUVERTESSURLEMONDEDESAFFAIRES
®/MD
PATENTER
®/MD
ou«R»
®/MDstylisé
ROBIC®/
MD
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
OustyliséROBIC++++
®/MDstylisé
ouROBIC+DROIT+AFFAIRES+SCIENCES+ARTS
®/MDstylisé
ouROBIC+LAW+BUSINESS+SCIENCE+ART
®/MDstylisé
THETRADEMARKERGROUP
TM/MC
TRADEMARKER
TM/MC
VOSIDÉESÀLAPORTÉEDUMONDE,DESAFFAIRESÀLAGRANDEURDE
LAPLANÈTE
®/MD
YOURBUSINESSISTHEWORLDOFIDEAS;OURBUSINESSBRINGSYOUR
IDEASTOTHEWORLD
®/MD
MarquesdecommercedeROBIC,S.E.N.C.R.L.poursesservicesde
conseilsdansledomainedelapropriétéintellectuelleetdes
technologiesdel’informationetdescommunications(incluantles
servicesd’agentsdebrevetsetdemarquesdecommerce)demême
quesesservicesjuridiques
*************************************************************************************************
*
Forservicespertainingtointellectualproperty,technologyand
communicationlawandrelatedmatters(includingpatentandtrade-mark
agencyservices)aswellaslegalservices.
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,
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
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
COPYRIGHTER
TM/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
THETRADEMARKERGROUP
TM/MC
TRADEMARKER
TM/MC
VOSIDÉESÀLAPORTÉEDUMONDE,DESAFFAIRESÀLAGRANDEURDE
LAPLANÈTE
®/MD
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
YOURBUSINESSISTHEWORLDOFIDEAS;OURBUSINESSBRINGSYOUR
IDEASTOTHEWORLD®/MD
Trade-marksofROBIC,LLPforitsservicespertainingtointellectual
property,technologyandcommunicationlawandrelatedmatters
(includingpatentandtrade-markagencyservices)aswellaslegal
services