Is Your Medical Treatment Claim More Patentable Now? Hint: A Little

2015-07-22

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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.

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.

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indicationsoforigin;copyrightandentertainmentlaw,artistsandperformers,
neighbouringrights;computer,softwareandintegratedcircuits;
biotechnologies,pharmaceuticalsandplantbreeders;tradesecrets,know-
how,competitionandanti-trust;licensing,franchisingandtechnology
transfers;e-commerce,distributionandbusinesslaw;marketing,publicityand
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®/MD

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