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It Takes Two to Tango: Lessons Learned for Both Innovator and Generic Drug Manufacturers

2013-12-09

ROBIC,LLPwww.robic.ca
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ITTAKESTWOTOTANGO:LESSONSLEARNEDFORBOTHINNOVATORAND
GENERICDRUGMANUFACTURERS

JASONMOSCOVICI*
ROBIC,
LLP
L
AWYERS,PATENT&TRADEMARKAGENTS

InanadministrativeproceedingbeforetheFederalCourtofCanadaforan
applicationtoprohibittheMinisterofHealthfromissuingamarketapproval(Noticeof
Compliance)toCobaltPharmaceuticalsCompanyforagenericversionofthe
contraceptivedrug“YAZ”,knowninCanadaasaPM(NOC)proceeding,theFederal
CourtstudiedtheapplicabilityandvalidityoftwoofBayerPharma
Aktiengesellschaft’spatents,CA2,382,426and2,179,728,relatingtoadrospirenone
+ethinylestradiolcombinationbirthcontrolproduct.Thisdecisionconfirmedtwo
importantprinciplesrelevanttobothinnovatorandgenericpatentpracticeinCanada
[BayerInc.v.CobaltPharmaceuticalsCompany,2013FC1061,October22,2013,
Hughes].

NOCProceedings

InCanada,theownerofapatentrelatingtoadrugproductcanrequestthatsaid
patentbelistedonaregistermanagedbytheMinisterofHealth,inassociationwitha
medicinalingredientalreadyapprovedforsaleinCanada.Agenericdrug
manufacturerwhowishestomanufactureandselladrugproductcontainingthis
medicinalingredientwouldthenhavetoaddressthevalidityand/orapplicabilityof
anysuchlistedpatent,inwhatisreferredtoasaNoticeofAllegation(NOA).This
stepneedstobecompletedbeforetheMinisterofHealthcanissueamarketing
authorizationforsaidgenericdrug,bywayofaNoticeofCompliance(NOC).

WhenservedwithanNOA,aninnovatordrugcompanythenhastheopportunityto
fileforanapplicationbeforetheCourts,seekingtoprohibittheMinisterofHealth
fromissuinganNOCtoagenericdrugcompanyfortheremainderofthelifeofany
suchlistedpatents.

Accordingly,suchanapplicationwasbroughtbyBayerPharmaAktiengesellschaft
(hereinafter“Bayer”)inresponsetoanNOAthatwasfiledbyCobaltPharmaceuticals

©CIPS,2014.*LawyerwithROBIC,LLP,amultidisciplinaryfirmoflawyers,andpatentandtrade-markagents.
Publishedunderthetitle”LessonsLearnedforBothInnovatorandGenericDrugManufacturers”in
Canada(January2014),28:1WorldIntellectualPropertyReport41-42.Publication142.289.

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Company(hereinafter“Cobalt”),withrespecttoBayer’sCA2,382,426(‘426)and
2,179,728(‘728)patents.OnDecember8th2011,CobaltservedBayeritsNOA,
statingthatithasappliedformarketapprovaltodistributegenericversionsofBayer’s
brandname“YAZ”birthcontroltablets,comprisingof3mgdrospirenone+20mg
ethinylestradiolintabletform,fororaladministration.Insuchaproceeding,the
fundamentalissuetobetriediswhethertheallegationsofnon-infringementand
invaliditymadebythegenericmanufacturerinitsNOAarejustified.Cobaltalleged
thatitsproductwillnotinfringeeitherofthe‘426or‘728patentsandthattheclaims
areinvalid.TheCourtallowedtheapplicationwithrespecttothe‘426patent,but
dismisseditasitconcernspatent‘728.

The‘426patent

TheburdentoprovethatCobalt’sallegationsofinvalidityandnon-infringementare
notjustifiedvestswithBayer.Theaddedlayerofdifficultyinthisreversaloftheonus
isthatitisuptothePlaintiff,Bayer,toproveinfringementwithrespecttoadrugthat
haseithernotbeenmanufacturedyet,orhasnotbeendistributedforsale.Assuch,
despiteamotionitbroughttocompelCobalttoproducesamples,whichCobalt
refusedandtheCourtdidnotcompelitdotoso,Cobalthadadducedonlyalimited
amountofevidencewithrespecttoitsproduct:thatitwillcontain3mgof
drospirenoneandthatitwasformulatedwitha“sprayon”technique.TheCourthad
toaddressCobalt’snon-infringementandinvalidityallegationswiththeevidencethat
wasonrecord.

Amongstotherarguments,Cobaltarguedthattheclaimsatissuearedirectedtoa
contraceptiveproductwherethedrospirenoneis“micronized”.Bayerarguedthatthe
patentwasnotrestrictedinthiswayandappliedtoanyformofdrospirenonehaving
rapiddissolutioncharacteristics.TheCourtstudiedthedescriptionofthepatent,as
wellasthesubmissionsfromtheparties,toconstruetheclaims.TheCourtfoundthat
theclaimswerenottoberestrictedtoa“micronized”tablet,butwererestrictedin
respecttocertaindissolutionparameters.Thisiswhyitisimportanttoalwaysput
yourbestfootforward.SinceCobaltrefusedtoprovidesampletabletsanddidnot
provideanyinformationasitconcernsthedissolutionparametersofitsproduct,the
CourtconcludedthatCobalt’sNOAwasinsufficientandtheallegationsofnon-
infringementwerethereforenotjustified.

TheCourtthenstudiedthevalidityofthepatentwithrespecttoobviousness,inutility,
overbreadth,ambiguityandlackofsoundprediction.Theinventiveconceptwas
determinedtobe“anoralcontraceptivecomprisedofacombinationofdrospirenone
andethinylestradiol,thedrospirenonemaybeprovidedinmicronizedorotherrapidly
dissolvingformwithoutanentericcoat”.NoneofCobaltallegationsastoinvalidity
werefoundtobejustified.

Therefore,aprohibitionorderwasissuedagainstCobaltforthe‘426patent.

The‘728patent

Asitconcernsthe‘728patent,Cobaltarguednon-infringement,claimingamethodof
medicaltreatment(prohibitedinCanada),doublepatenting,obviousness,dose
equivalency(anon-infringementargument),aswellasinutilityandsoundprediction.
Theclaimsrelatedtoadosageofdrospirenone,thehighestdosagebeinga“dose
equivalentof0.075mg(75µg)ofgestodene”.Cobaltarguedthatthe“dose
equivalent”cannotbecalculatedaccurately,ormoreprecisely,ifitcouldbe
calculated,itwouldresultinapproximately2mgofdrospirenone,andtherefore
Cobalt’sproductwouldnotinfringebecauseitcontainsaround3mgdrospirenone.
TheCourtconstruedtheclaimsandfoundthatsinceCobalt’sproductwillcontain3
mgofdrospirenone,andtheclaimsrelatetoa“maximumoronly”dosage(either2
mgofdrospirenoneoranindeterminateamountofdrospirenone),Cobalt’sproduct
wouldthereforenotinfringeanyclaimsatissue.

NotwithstandingCobalt’sargumentsrelatingtodoublepatenting,obviousness,
inutilityandsoundprediction,aninterestingdebatearosewithrespecttotheclaiming
ofamethodformedicaltreatment,since“claims1,2,6,7and8,arealldirectedto
theuse,inoraldosageform,forcontraceptionforafemaleofacertainage,ofa
compositiondrugwithtwoactivecomponents;anestrogenandagestagen.”

Initsstudyoftheclaims,theCourtdeterminedthatallclaimsareclearlyexpressedin
termsof“useforacontraceptive”.Allclaimsexceptclaim8provideforarangeof
dosagesforoneorbothoftheestrogenandgestagencomponents.Submissions
weremadewithrespecttothefactthatcommerciallyspeaking,the“productsaresold
intheformofakitcontainingtabletsoffixeddosagestobeusedinadailyregimen”.

TheCourtreiteratedhoweverthatitisnotimportanthowtheproductissold,butwhat
theclaimssay.Allclaimsatissueare“useclaims”andwerenotproductclaims.
Asidefromclaim8,allotherclaimsthatwerestudiedrelatedtotheuseasa
“contraceptiveofatwo-componentdrugwitheachcomponenttobeselectedfroma
choiceofcomponents,andwitheachcomponenttobefurnishedatadosagewithina
rangeofdosages”.Assuch,theseclaimswerenot:“propersubjectmatterfora
Canadianpatent,astheydonotclaimavendibleproduct;theyprovideforachoice
tobemadebythoseprescribingorprovidingcontraceptivedrugstochoosebetween
avarietyofcomponentsandavarietyofdosageranges”.OnlyClaim8survivedfor
beingdirectedtoasingledosageofeachoftwocompounds.

Cobalt’sallegationsofinvalidityandnon-infringementwerethereforefoundtobe
justified.

Sincehalfthebattlewaswon,Bayerwasentitledtorecoverone-halfofitscostsfrom
Cobalt.

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Conclusion

Initsdecision,theCourtreiteratedtwoimportantprinciplesrelevanttoCanadian
NOCpractice.ThefirstrevolvesaroundputtingyourbestfootforwardinyourNOA.
Withrespectthe‘426patent,Cobaltdidnotprovideproductsamples,nordidit
provideanyevidenceastothedissolutionparametersofitstablets.Assuch,an
unsubstantiatedallegationofnon-infringement,withoutanythingmore,isinsufficient
tosupportanassertionofnon-infringement.Apartymakingsuchanallegation
shouldadvancesufficientevidenceinsupportofitsNOA.Whileitiscorrectthatthe
burdenofprovingthatagenericmanufacturer’sallegationsofnon-infringementare
notjustifiedvestswiththeInnovator,thisdeterminationiscontingentuponwhetheror
nottheallegationsmadebythegenericmanufacturerweresufficientlysubstantiated
tobeginwith.

Secondly,asitconcernstheInnovator,howyoucommercializeaproductwillnotbe
takenintoaccountwhenaCourtisconstruingtheclaimsofyourpatent.Inother
words,“whatdotheclaimssay”?Iftheclaimsatissuearedirectedtothe“use”,the
factthatyourproductissoldasakitcannotthenbereliedontoescapearejection
forclaimingamethodofmedicaltreatment.

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transfertsdetechnologies;commerceélectronique,distributionetdroitdesaffaires;
marquage,publicitéetétiquetage;poursuite,litigeetarbitrage;vérificationdiligenteet
audit.ROBIC,agroupoflawyersandofpatentandtrademarkagentsdedicatedsince
1892totheprotectionandthevalorizationofallfieldsofintellectualproperty:patents,
industrialdesignsandutilitypatents;trademarks,certificationmarksandindications
oforigin;copyrightandentertainmentlaw,artistsandperformers,neighbouring
rights;computer,softwareandintegratedcircuits;biotechnologies,pharmaceuticals
andplantbreeders;tradesecrets,know-how,competitionandanti-trust;licensing,
franchisingandtechnologytransfers;e-commerce,distributionandbusinesslaw;
marketing,publicityandlabelling;prosecutionlitigationandarbitration;duediligence.
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