Two Kicks at the Same Can: Respecting Prior Judgements Involving Pharmaceutical Patents in Canada

2013-01-02

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TWOKICKSATTHESAMECAN:RESPECTINGPRIORJUDGEMENTS
INVOLVINGPHARMACEUTICALPATENTSINCANADA
A.
SASHAMANDY*
ROBIC,
LLP
L
AWYERS,PATENT&TRADEMARKAGENTS

Whathappenswhenapatentedmedicinaldrugisdeemednon-obviousinone
judgment,butisthenlaterdeemedtobeobviousinanotherjudgment,both
judgmentscomingfromthesamecourt?Howmuchdeference,ifany,dojudgesof
thiscourtoweeachother?Isthepatenteddrugobviousornot?Thesewerethemain
questionstheFederalCourtofAppealofCanadahadtograpplewithinApotexInc.v.
AllerganInc.2012FCA308whichwasrenderedonNovember23,2012.

Thisdecisionisimportantcertainlytobothgenericandinnovativepharmaceutical
drugmanufacturersbecauseitprovidesguidanceonhowdifferentlitigations,inthe
PM(NOC)context(seebelow),concerningthesamepatenteddrugshouldbe
treated.Thedecisionmayalsointerestthosepatentlitigatorswhopracticeinthisfield
becauseitelaboratesonthedoctrineofjudicialcomityinPM(NOC)proceedings.

Facts
Inthepharmaceuticalindustry,Apotexiswhatisknownasa“generic”becauseit
manufacturesgenericdrugs.Veryoften,thesegenericdrugsarereplicasofpopular,
patenteddrugsmadeby“innovators”,suchaspharmaceuticalcompanieslike
Allergan.Thedevelopmentoftheseinnovativeor“brandname”drugsbycompanies
likeAllerganofteninvolvesyearsofresearchandclinicaltrials.Whenaninnovative
drugfinallyentersthemarket,itschemicalcompositionisusuallyalreadypatented.

Initslandmarkdecision[ApotexInc.v.Sanofi
‑SynthelaboCanadaInc.,[2008]3
S.C.R.265,2008SCC61],theSupremeCourtofCanadaexplainedasfollowsthe
procedurebywhichamanufacturerofgenericdrugsmayplaceitsproductinthe
Canadianmarketplace:[13]Theprocedureunderthe[PatentedMedicinesNoticeof
ComplianceRegulations,or“NOCRegulations”]pursuanttowhicha
manufacturerofdrugsmayapplytotheMinisterofHealthforanotice
ofcomplianceiswellknown.Amanufacturer,usuallyageneric
manufacturer,wishestocompareitsdrugwiththatofapatentholder

©CIPS,2013.*OfROBIC,LLP,afirmoflawyers,patentandtrademarkagents.Publishedat
(January2013),27:1WorldIntellectualPropertyReport.Publication142.271.

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

Inthepresentcase,Apotexfiledforanoticeofcompliance(NOC)tosellitsversion
ofthedrugcommercializedunderthenameCOMBIGAN®.Thedrugisacombination
drugcontainingthemedicinalingredientsbrimonidineandtimololinsolution,andis
usedinthetreatmentofglaucoma.Allerganappliedforapatentclaimingthe
chemicalcompositionofthedrug,andthepatentwasgrantedin2005asCanadian
patent2,440,764(764patent).ThepatentissettoexpireinApril,2023.

Priortothepresentcase,the764patenthadalreadybeenthesubjectofanother
NOClitigation.InAllerganInc.v.Canada(Health)andSandozCanadaInc.2011FC
1316(Sandoz),theFederalCourtofCanadadismissedSandoz’allegationthatthe
764patentwasinvalidforobviousness,andgrantedanorderprohibitingtheissuance
ofaNOCtoSandoz.
Inthepresentcase,Apotexalleged,interalia,thatitwasentitledtoaNOConthe
groundsthatthe764patentwasinvalidbecausetheclaimedchemicalcomposition
wasobvious.Attrial,JusticeHughesoftheFederalCourtagreed.However,Justice
HughesstillgrantedanorderprohibitingtheissuanceoftheNOC.Inhisjudgment,
JusticeHughesvoicedconcernsaboutthedoctrineofcomityinthecontextofNOC

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proceedings,andaskedforguidancefromtheFederalCourtofAppealonthisissue.
Remarkably,JusticeHughesissuedtheorderforprohibitionbecause“Theonly
practicalwaytogetthematterbeforetheCourtofAppealisformetogranttheOrder
forprohibitioninthelikelyexpectationthatApotexwillappeal.”

ItwasthusthatthiscasecamebeforetheFederalCourtofAppeal,whichaddressed
thequestionsofcomity,anddecidedwhethertheclaimeddrugwasobviousornot.

Judgement
Doctrineofcomity
TheFederalCourtofAppealexplainsthedoctrineofcomityasfollows:
Thisdoctrineissometimesdescribedasamodifiedformofstare
decisis,i.e.horizontalratherthanvertical[…].Staredecisisrequires
judgestofollowbindinglegalprecedentsfromhighercourts.
Althoughnotbindinginthesameway,thedoctrineofcomityseeksto
preventthesamelegalissuefrombeingdecideddifferentlyby
membersofthesameCourt,therebypromotingcertaintyinthelaw
[…].
Asamanifestationoftheprincipleofstaredecisis,theprincipleof
judicialcomityonlyappliestodeterminationsoflaw.Ithasno
applicationtofactualfindings.

Whilesuchhorizontallegalprecedents“arepersuasiveandshouldbegiven
considerableweight”,theFederalCourtisnotboundtofollowthemblindly,andcan
departfromtheseprecedentswhere“ajudgeisconvincedthatthepriordecisionis
wrongandcanadvancecogentreasonsinsupportofthisview”.TheCourtofAppeal
furtherstatesthatsuchdeparturesshouldberare.

Inthecaseathand,thedoctrineofcomityapplieswithrespecttothetwodiffering
opinionsastowhatconstitutestheinventiveconceptoftheclaimeddrug.InSandoz,
theFederalCourtconstruedtheclaimstodeterminethattheinventiveconceptisthe
drug’simprovedsafetyprofile.ThesameCourtsubsequentlyconcludedthatthe
inventionwasnotobvious.Incontrast,JusticeHughesconstruedthesameclaims
differently,anddeterminedthattheinventiveconceptmustbeconstruedinlightof
certainpromisesmentionedinthedescription.Hethenconcludedthattheinvention
wasobvious.
Thedoctrineofcomityisraisedinthiscasetoanswerthefollowingquestion:should
JusticeHugheshaveappliedthesameinventiveconceptconstruedbyhiscolleague
inSandoz?Yes,accordingtotheCourtofAppeal.

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Inaunanimousdecision,theCourtofAppealfirstrebukedJusticeHughesforthe
mannerinwhichthisappealreachedtheCourt:“Asnotedearlier,thepartieswere
entitledtohavetheirdisputesettledonthemeritsandtheFederalCourtjudgeby
issuingaformaljudgmentthatwascontrarytotheconclusionsthathereachedonthe
merits,failedinhistask.”
AccordingtotheCourtofAppeal,construingapatentinordertodeterminethe
inventiveconceptgivesrisetoadeterminationoflaw,towhichdeferenceisowed
underthedoctrineofcomity.UnlessJusticeHugheshadestablishedthatthe
constructionoftheinventiveconceptinSandozwaswrong,orhadciteddistinct
evidencewhichcompelledhimtoreachadifferentconclusion,heshouldhavestruck
tothesameinventiveconcept:ItfollowsthatunlesstheFederalCourtjudgecoulddemonstratethat
CramptonJ.’sconstructionofthepatentinordertodeterminethe
inventiveconceptwaswrongorthatdistinctevidenceadducedbefore
himcompelledhimtoreachadifferentconclusion,itwouldhave
beenpreferableforhimtoadheretoit.

However,giventhattherearenowtwodifferinginterpretationsoftheinventive
conceptofthesameinvention,theCourtofAppealtookituponitselftoresolvethis
discrepancy.
Obviousness
InapplyingtheobviousanalysisdevelopedbytheSupremeCourtofCanadainthe
Sanofi[ApotexInc.v.Sanofi-SynthelaboCanadaInc.,2008SCC61,[2008]3S.C.R.
265]decision,theCourtofAppealfocusedonsteptwo,whichteachesto“identifythe
inventiveconceptoftheclaiminquestionorifthatcannotreadilybedone,construe
it.”
JusticeHugheslookedtothedescriptiontoseewhatthepatentpromisestodeliver,
andfoundthatthesepromisesconstitutedtheinventiveconcept.InSandoz,onthe
otherhand,theCourtlookedattheresultsoftheclinicaltrialdescribedinthepatent
andfoundthattheimprovedsafetyprofiledemonstratedbythetrialwastheinventive
concept.InsidingwiththeinventiveconceptidentifiedinSandoz(i.e.theimproved
safetyprofile),theCourtofAppealreiteratedafundamentalprincipalofclaim
construction:ApotexhasnotbeenabletoprovideanyjustificationfortheFederal
Courtjudge’snarrowreadingofthepatent.Inholdingthatthe
inventiveconceptisrestrictedtowhatisstatedinparagraph1ofthe
patent,theFederalCourtjudgereadthisparagraphinisolation.
Claimconstructionmustbeconductedinlightofthepatentasa
whole.

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TheinventiveconceptoftheclaimeddrugwasboileddownbytheCourtofAppealas
follows:“[…]Theclaimedcompositioncombinesbrimonidineandtimololintoanew
chemicallystableformulationwhichwhenadministeredBID[twicedaily]hasa
superiorsafetyprofilerelativetobrimonidineadministeredTID[thricedaily].”

TheCourtofAppealthenassessedthethirdandfourthstepsoftheSanofitestby
identifyingthedifferencebetweentheinventiveconceptandthepriorart,andfinally
bydeterminingwhetherthesedifferencesconstitutedobviousstepsforaperson
skilledintheart.TheCourtofAppealfoundthattheimprovedsafetyprofile,the
inventiveconceptoftheclaimeddrug,hadnotbeenshowntobeobvious.

Theappealwasdismissed,andApotexcannotthereforeobtainitssought-afternotice
ofcompliance.
Conclusion

Thiscaseillustratesthatthedoctrineofcomitycanbeadouble-edgedsword.

Onetheonehand,andasoccurredinthiscase,apharmaceuticalinnovatorwho
succeedsinobtainingaprohibitionorderagainstagenericinaNOCcontextwill
probablyobtainprohibitionordersagainstsubsequentgenericsraisingthesame
validityarguments.Indeed,thiscasemayevendiscouragethesegenericsfromeven
tryingtoraisethesesamearguments.
Ontheotherhand,ifagenericassertstheinvalidityofapatenteddrugandisableto
obtainaNOC,thenthedoctrineofcomityshouldresultinanyfuturegenericbeing
abletoraisethesameinvalidityargumentsandalsoobtainaNOCforthesame
patenteddrug.Lucrativedrugswhosepatentsstillhavemanyyearsbeforeexpiry
mayprovetobeaparticularlytemptingtarget.

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