Product-by-Process Claims in Canada: Useful of Useless?

2013-07-02

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PRODUCT-BY-PROCESSCLAIMSINCANADA:USEFULORUSELESS?
A
.SASHAMANDY*
ROBIC,
LLP
L
AWYERS,PATENT&TRADEMARKAGENTS

Whathappenswhenadrugmanufacturerattemptstoclaimaknownmedicinaldrug
madeaccordingtoanewandnon-obviousprocess?Shouldsuchaclaimbe
interpretedascoveringtheknowndrugitself,irrespectiveofhowit’sproduced?Or,
shouldtheclaiminsteadbeinterpretedascoveringtheknowndrug,providedthatitis
madeaccordingtotheprocess?ThesewerethemainquestionstheFederalCourt
hadtograpplewithinBayerInc.v.CobaltPharmaceuticalsCompany2013FC573,
whichwasrenderedonMay29,2013.
Thisdecisionisimportanttobothgenericandinnovativepharmaceuticaldrug
manufacturersbecauseitprovidesguidanceonhowthesetypesofclaims,knownas
“product-by-process”claims,aretobeinterpretedinCanada.Thedecisionmayalso
serveasacautionarytaletothosepatentagentswhodraftpatentapplicationsinthis
field.Remembertoincludeordescribevariantsofanelementoftheclaimsifyou
wanttheCourttoconstruetheelementasnon-essential.

Facts
Inthepharmaceuticalindustry,Cobaltiswhatisknownasa“generic”becauseit
manufacturesgenericdrugs.Veryoften,thesegenericdrugsarereplicasofpopular,
patenteddrugsmadeby“innovators”,suchaspharmaceuticalcompanieslikeBayer.
Thedevelopmentoftheseinnovativeor“brandname”drugsbycompanieslikeBayer
ofteninvolvesyearsofresearchandclinicaltrials.Whenaninnovativedrugfinally
entersthemarket,itschemicalcompositionisusuallyalreadypatented.

Initslandmarkdecision[ApotexInc.v.Sanofi
‑SynthelaboCanadaInc.,2008SCC
61],theSupremeCourtofCanadaexplainedasfollowstheprocedurebywhicha
manufacturerofgenericdrugsmayplaceitsproductintheCanadianmarketplace:
[13]Theprocedureunderthe[PatentedMedicinesNoticeof
ComplianceRegulations,or“NOCRegulations”]pursuanttowhicha
manufacturerofdrugsmayapplytotheMinisterofHealthforanotice
ofcomplianceiswellknown.Amanufacturer,usuallyageneric
manufacturer,wishestocompareitsdrugwiththatofapatentholder

©CIPS,2013.*MemberofROBIC,LLP,afirmoflawyers,patentandtrademarkagents.Publishedinthe(July2013),
27:7issueofWorldIntellectualPropertyReport.Publication142.277.

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[…].Thegenericmanufacturer’spurposeistoestablishthesafety
andefficacyofitsdrugforthepurposesofsecuringmarketing
approvalfromtheMinister.Theprocessofcomparisonsavesthe
genericcompetitortimeandresources.However,theMinisterwillnot
issueanoticeofcomplianceunlessthepatentonthecomparator
drughasexpired,isinvalid,orthegeneric’sproductwillnot
otherwiseinfringethepatent.ThustheNOCRegulationscreatea
connectionbetweengovernmentapprovaltomarketagenericdrug
andtheissueofpatentvalidityandinfringement.
[14]Section5(1)(b)oftheNOCRegulationsstatesthatthegeneric
manufacturer,initssubmissionforanoticeofcompliance,may
allegethatthepatenthasexpired,isnotvalidorwillnotbeinfringed.
ThepatentholdermaythenapplytotheFederalCourtforanorder
prohibitingtheMinisterfromissuinganoticeofcompliancetothe
genericmanufactureruntilafterexpirationofthepatentthatisthe
subjectofthenoticeofallegation.Thecourtwillgranttheprohibition
orderifitfindsthattheallegationofinvalidity,expiryornon-
infringementisnotjustified.Ifitfindstheallegationjustified,itwill
dismisstheapplicationforprohibitionandtheMinistermaythen
issueanoticeofcompliancetothegenericmanufacturerifallother
requirementsaremet.
[15]TheNOCRegulationsdonotprovideguidanceabouthowan
allegationof“notvalid”asstatedins.5(1)(b)(iii)istobeconsidered
anddeterminedbythecourt.Forthispurpose,referencemustbe
madetotherelevantversionofthePatentAct[…].

Inthepresentcase,Cobaltfiledforanoticeofcompliance(NOC)tosellitsversionof
theoralcontraceptivecommercializedbyBayerunderthenameYASMIN®.Thedrug
containsdrospirenoneastheactivemedicinalingredient.Bayerappliedforapatent
claimingaprocessforproducingdrospirenone,andthepatentwasgrantedin2005
asCanadianpatent2,261,137(137patent).ThepatentissettoexpireinApril,2017.

Inthepresentcase,CobaltallegedthatitwasentitledtoaNOConthegroundsthat
itsproductdidnotinfringeclaim13ofthe137patent(theonlyclaiminissue),and
becausethe137patentwasinvalidbecausetheclaimedprocesswasobvious.

Claim13ofthe137isa“product-by-process”claim(i.e.aclaimforaproductwhichis
producedaccordingtoaprocess).Itrelatesto“Aproductpreparedaccordingtothe
processofclaim12”,wheretheproductcontainsdrospirenonewithoutacertain
percentageofcontaminants.
Bayerarguedthatclaim13isapureproductclaim,andthatitshouldbereadasif
thewords“preparedaccordingtotheprocessofclaim12”werenotwritten.Inother
words,Bayerarguedthatclaim13coversanyproductcontainingtherecited

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percentageofdrospirenonewithoutthecontaminants,regardlessoftheprocessby
whichsuchaproductwasmanufactured.Bayerfurtherarguedthattheprocessof
claim13doesnotrequirethepresenceofaparticularsaltduringtheoxidationstage.
BayerpleadsuchanargumentinanattempttocoverCobalt’sprocessformakingits
versionofthedrug,whichdoesnotemploythesaltasanoxidizingagent.

Judgement

InPM(NOC)proceedings,Cobaltneededtoonlypresentsufficientevidencetogive
itsallegationsofnon-infringement“anairofreality”.Onceitsatisfiedthisonus,the
burdenshiftedtoBayertoprovethatCobalt’sallegationsofnon-infringementare
unjustified.JusticeO’ReillyoftheFederalCourtthereforedealtfirstwithBayer’s
submissions.
Withrespecttoclaimconstruction(i.e.howclaim13shouldbeinterpreted),Bayer
arguedthatclaim13isreallyaproductclaim.ItreliedonadecisionoftheSupreme
CourtofCanadafromthe1950sforthisinterpretation.JusticeO’Reillydidnotagree
withtheirunderstandingofthatcase:[18]Hoffman-LaRoche(theSupremeCourtdecision)tellsusthata
newpatentcannotbeobtainedforaknowncompoundevenifanew
processhasbeendiscoveredformakingit.Accordingly,claimsfora
productmadebyaparticularprocessshouldbeassessedasifthey
wereclaimsfortheproductaloneandshouldbeupheldonlyifthe
productisnew.Inotherwords,anewprocessformakinganold
compounddoesnotjustifyanewpatentforthatsamecompound.

Therefore,theCourtdidnotacceptBayer’sargumentthatclaim13shouldbe
interpretedtocoveranyproductcontainingdrospirenonewithoutthecontaminants.It
heldthatclaim13clearlyandexpresslyincorporatestheprocessdescribedinclaim
12.
WithrespecttoBayer’sargumentthattheprocessofclaim13couldbepracticed
withouttherecitedsaltasanoxidizingagent,theCourtdisagreedandfoundthatthis
elementwasessentialtotheprocess.Infindingthesalttobeanessentialelement,
theCourtwasstatingthatanycompetitor’sprocesswouldneedtohavethiselement
inordertoinfringeclaim13.Here,theCourtprovidedguidancetopatentagentsas
tohowspecificationsshouldbedraftedsoastospecificallylistordescribevariantsof
elements:[33]Theonlymetalsaltsmentionedinthepatentasbeingsuitable
alternativestochromiumarerutheniumsalts.Asmentioned,
rutheniumsaltsarespecificallyincludedinClaims1,5,6and11.No
alternativesarecited,andthereisnoreferencetothepossibilitythat
othermetalsaltsmightwork.Thepatent’sdisclosurealsocontains
numerousreferencestoruthenium.Thereisonlyonepassagethat
couldbereadasadmittingofanalternativetoruthenium.

Finally,BayerhadtheburdenofshowingthatCobalt’sallegationofnon-infringement
wasunjustified.TheevidenceshowedthattheprocessusedbyCobalttomakeits
versionofdrospirenonedidnotemploytherecitedsaltofclaim13ofthe137patent.
SincetheprocessusedbyCobaltdidnotincludeanessentialelementofclaim13,
theCourtfoundthatCobalt’sprocessisnon-infringingandthatBayerfailedto
dischargeitsburden.
TheCourtthereforedismissedBayer’sapplicationforanorderprohibitingthe
issuanceofaNOC,withcosts.
Conclusion

Thiscaseillustratesthatproduct-by-processclaimsarenotalwayseasytoenforce.
Thiscaseshowsthatsuchclaimsareusuallyfoundtobeinvalidunlesstheyrelateto
aproductwhichisitselfnew.
Thismaybesurprisingtomanydrugmanufacturers,whichoftenincludethesetypes
ofclaimsintheirprocesspatentsasanafterthought,andthinkthattheseclaimswill
protectagainstacompetitormakingthesameproduct.Itmaythusbeprudentfor
thesemanufacturerstoverifywhethertheirCanadianprocesspatentsactually
protecttheproductbeingproduced.

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