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144353cv

ApotexInc.,etal.,v.AcordaTherapeutics,Inc.

UNITEDSTATESCOURTOFAPPEALS
FORTHESECONDCIRCUIT
AugustTerm,2015

(Argued:November12,2015Decided:May16,2016)
DocketNo.144353cv
x
APOTEXINC.,etal.,
PlaintiffsAppellants,
v.
ACORDATHERAPEUTICS,INC.,
DefendantAppellee.
x

Before:

JACOBS,LIVINGSTONandDRONEY,CircuitJudges.

Thisappealconcernstwodistinctquestions:thecircumstancesunder
whichthefilingofacitizenpetitionwiththeFoodandDrugAdministration
providesgroundsforanantitrustclaim,andthescopeoffalseadvertising

liabilityundertheLanhamAct.PlaintiffsApotexIncorporatedandApotex
CorporationappealfromthejudgmentoftheUnitedStatesDistrictCourtforthe
SouthernDistrictofNewYork(Swain,J.)thatgranteddefendantAcorda
Therapeutics,Inc.smotiontodismissplaintiffsShermanActclaimandthat
grantedsummaryjudgmentinfavorofdefendantontheLanhamActclaims
(Torres,J.).Becauseeachoftheseconclusionswassound,weaffirm.
KEITHD.PARR(withJosephN.Froehlich,
ScottB.Feder,HughS.Balsam,JamesT.
Peterka,andAndyJ.Milleronthebrief),
LockeLordLLP,Chicago,Illinois,for
AppellantsApotexIncorporated&Apotex
Corporation.
JOHNW.NIELDS,JR.(withJasonC.
RaofieldandColinP.Watsononthebrief),
Covington&BurlingLLP,Washington,
D.C.forAppelleeAcordaTherapeutics,Inc.
DENNISJACOBS,CircuitJudge:
Thepartiesarerivalmanufacturersoftizanidine,adrugfortreating
spasticity.PlaintiffsApotexIncorporatedandApotexCorporation(collectively
Apotex)allegethatdefendantAcordaTherapeutics,Inc.(Acorda)(i)fileda
shamcitizenpetitionwiththeFoodandDrugAdministration(FDA)tohinder
approvalofApotexscompetingformulationinviolationofSectionTwoofthe
2

ShermanAct,and(ii)violatedtheLanhamActsproscriptiononfalse
advertising.Asrelevanthere,thecompetitionbetweenthemanufacturers
focusedontherelativeefficacyoftabletsorcapsulesincontrollingsomnolence,
oneofthesideeffectsoftizanidine.
TheUnitedStatesDistrictCourtfortheSouthernDistrictofNewYork
(Swain,J.)ruledthatthesimultaneousapprovalbytheFDAofApotexsdrug
applicationanditsdenialofAcordascitizenpetition(raisingconcernsaboutthe
application)wasbyitselfinsufficienttosupportaShermanActclaim.After
discovery,thedistrictcourt(Torres,J.)grantedsummaryjudgmentand
dismissedallofApotexsfalseadvertisingclaimsonthegroundsthat(withthe
exceptionofonegraph)norepresentationwasliterallyfalseorlikelytomislead
consumers;andthat,astothatonegraph,Apotexfailedtoshowthatthefalse
depictionwouldmeaningfullyimpactconsumerspurchasingdecisions.
Apotexappealsbothrulings,arguingthatprecedentfromthisCourt
allowsitsantitrustclaimtosurvivedismissalandthatmaterialissuesoffact
pertinenttoAcordasrepresentationsremainforajurytodecide.Weaffirm
theserulings.

Althoughprecedentsupportsaninferencethatacitizenpetitionisan
anticompetitiveweaponifitattacksarivaldrugapplicationandisdeniedthe
samedaythattheapplicationisapproved,thatinferencehasbeenundercutby
recentFDAguidance.Astofalseadvertising,weagreewiththedistrictcourt
thatnoreasonablejurycouldhavefoundthatAcordamadeliterallyfalseor
misleadingrepresentationsinitsadvertisements,withtheexceptionofasingle
representationthatApotexhasfailedtoshowaffecteddecisionstopurchase.

BACKGROUND
Tizanidinetabletsareusedtotreatspasticity,asymptomofmultiple
sclerosisandParkinsonsdisease.Oneofthetabletsmostcommonsideeffectsis
somnolence:sleepinessordrowsiness.Tizanidinetabletswerefirstmarketedin
theUnitedStatesbyElanPharmaceuticals,Inc.(Elan),underthetradename
Zanaflex.(ElanlatersolditsrightstoAcorda.)
ZanaflextabletswereinitiallyapprovedforsalebytheFDAonNovember
27,1996.InOctober2001,ElansubmittedaNewDrugApplication(NDA)to
theFDAseekingapprovaltomarkettizanidineincapsuleform.Duringits
review,theFDAconcludedthattheabsorptionofthedrugwasdelayedwhen
4

tizanidinecapsulesweretakenwithfood(ratherthanwithout),andthatthe
delaywasassociatedwithamean20percentdecreaseinCmax,thepeakamount
ofthedruginasubjectsbloodstream.Moreimportantly,theFDAfoundthat
[w]henbioequivalenceofthecapsulerelativetothetabletisexaminedunderfed
conditions[i.e.,withfood],thereisadelayinabsorptionandthemeanCmaxfor
thecapsuleisapproximately2/3ofthemeanCmaxforthetablet(Figure1).
JointAppendixat2230(emphasisadded).TheFDAsubsequentlyapproved
ElansNDAonAugust29,2002.
Thesignificanceofthisphenomenon,inplainterms,isthatthefasterthe
drugisabsorbed,themoredrowsythepatientmaybecome,whereastheside
effectmaybereducedifabsorptionisslowed.
WhiletheNDAwaspending,Elanfiledapatentapplicationformethods
ofadministeringtizanidinecapsulestoreducesomnolenceandCmax.Lessthan
amonthaftertheFDAapprovedtheNDA,ElanspatentissuedasUnitedStates
PatentNo.6,455,557(the557patent).Elanthenreceivedpermissiontomarket
itsnewlyapprovedtizanidinecapsulesunderthetradenameZanaflex
Capsules.InJuly2004,AcordaacquiredtherightstoZanaflextabletsand
ZanaflexCapsules;inApril2005,itlaunchedthesaleofZanaflexCapsules.
5

Apotexhadbegunsellingitsgenerictizanidinetabletproductin2004,andwas
oneofabouttencompaniestodoso.AtthetimeAcordabegansellingZanaflex
Capsules,Apotexstizanidinetabletproducthadafivepercentmarketshare.
ZanaflexCapsulesontheopenmarketcarriedanFDAlabelpertaining
bothtotheCapsulesandthetablets.Thepreambletothislabelinvitesdoctorsto
distinguishbetweentabletsandCapsules,andbetweenthedrugwhentaken
withfoodandwithout:
PHARMACOKINETICDIFFERENCESBETWEENZANAFLEX
CAPSULESTMANDZANAFLEXTABLETS:ZANAFLEX
CAPSULESTMARENOTBIOEQUIVALENTTOZANAFLEX
TABLETSINTHEFEDSTATE.THEPRESCRIBERSHOULDBE
THOROUGHLYFAMILIARWITHTHECOMPLEXEFFECTSOF
FOODONTIZANIDINEPHARMACOKINETICS(see
PHARMACOKINETICSandDOSAGEANDADMINISTRATION).
JointAppendixat643.ThePharmacokineticssectionofthelabel,underthe
subheadingPharmacokineticdifferencesbetweenZanaflexCapsulesTMand
ZanaflexTablets,advises(consistentwiththeFDAreviewoftheZanaflex
CapsulesNDA)thatthereisa30percentincreaseinCmaxwhenthetabletsare
administeredwithfood,butthatwhentheCapsulesareadministeredwithfood,
Cmaxdecreasesby20percent.Consequently,themeanCmaxforthe[C]apsule

whenadministeredwithfoodisapproximately2/3stheCmaxforthetablet
whenadministeredwithfood.Id.
Thelabelcontainsagraphthatfiguresinanumberofthefalseadvertising
claims.ReferredtoasFigure1,thegraphistitledMeanTizanidine
Concentrationvs.TimeProfilesforZanaflexTabletsandCapsules(24mg)
UnderFastedandFedConditions.Itdisplaysthemeanplasmatizanidine
concentrationatvarioushoursfromdosing.Thepeakforthecurverepresenting
tizanidinecapsules(takenwithfood)islower,andoccurslaterthanthepeakfor
thecurvechartingconcentrationovertimefortizanidinetablets(takenwith
food).
Thelabelthenexplains,intheDosageandAdministrationsection,that
pharmacokineticdifferencesbetweenthefedandfastedstatemayaffectthe

frequencyandonsetofcertainadverseevents.(Thetextisinthemargin.1)
Somnolenceisexplicitlyidentifiedasoneoftheseadverseevents.2
In2007,ApotexfiledanAbbreviatedNewDrugApplication(ANDA)a
filingthatseeksgenericdrugapprovalforanexistinglicensedmedicationor
approveddruginordertosellgenerictizanidinecapsuleswhichwouldprovide
competitiontoAcordasZanaflexCapsules.IntheANDA,Apotexcertifiedthat
itwasnotencroachingonanyvalidlyclaimedintellectualpropertyrights
becausethe557patentwasinvalid.Inpredictableresponse,Acordafileda
patentinfringementsuitin2007.Afterasevendaybenchtrial,theUnitedStates
DistrictCourtfortheDistrictofNewJersey(Brown,J.)ruledinSeptember2011

1Thesepharmacokineticdifferencesmayresultinclinicallysignificant
differenceswhen[1]switchingadministrationofthetabletbetweenthefedor
fastedstate,[2]switchingadministrationofthecapsulebetweenthefedorfasted
state,[and][3]switchingbetweenthetabletandcapsuleinthefedstate....
Thesechangesmayresultinincreasedadverseeventsordelayed/morerapid
onsetofactivity,dependinguponthenatureoftheswitch.Forthisreason,the
prescribershouldbethoroughlyfamiliarwiththechangesinkineticsassociated
withthesedifferentconditions....JointAppendixat646.
2 TheFDAsMedicalReviewoftheZanaflexCapsulesNDAobserved:The
mostproblematicpotentialsituationisthatofpatientsswitchingfromthe
capsuleformulationtothetabletformulationinthefedstate,wherethereisarisk
of moreseveresideeffectswithexcessivehypertensionandsomnolence.Id.at
2102(emphasisomitted).
8

thatthe557patentwasinvalid.SeeAcordaTherapeuticsInc.v.ApotexInc.,No.
074937(GEBMCA),2011WL4074116,at*27(D.N.J.Sept.6,2011).
Soonafterthatruling,AcordafiledacitizenpetitionwiththeFDAraising
problemswithApotexsANDA.Thecitizenpetitionisameansaffordedbythe
FDAforraisingconcernsaboutproductstheFDAreviews;anyindividualmay
filesuchapetitionconcerningscientificorlegalissuesbeforeorwhilethe
productisonthemarket.See21C.F.R.10.30.Conceptually,citizenpetitions
provideanavenueforpublicinputintothedrugapprovalprocess;butthe
processhasbeenabusedbypharmaceuticalcompaniesthatfilemeritless
petitionsintendedtodelayapprovalssoughtbytheircompetitorsandinhibit
competition.Acordascitizenpetitionobjectedto(1)Apotexsstatementthatits
productwasbioequivalenttoReferenceListedDrugs(RLDs)inthefedstate;and
(2)allegedlymisleadingoruntruestatementsintheproposedlabelforthe
ApotexANDA.
TheFDAdeniedAcordascitizenpetitiononFebruary3,2012.Thatsame
day,theFDAapprovedApotexsANDA.TheShermanActclaimrelies
principallyontheFDAssimultaneousdispositions.

WiththegreenlightfromtheFDA,Apotexlauncheditsproduct.Acorda
counteredwithitsownauthorizedgenericversionofZanaflexCapsules.Apotex
contendsthatinthecourseofAcordasmarketing:(1)itsrepresentatives
misrepresentedtodoctorsthatZanaflexCapsulesreducedCmaxincomparison
withthetabletsandthenimproperlyusedreductioninCmaxasaproxyfora
correspondingdecreaseinsomnolence;and(2)Acordadistributedwritten
promotionalmaterialstothesameeffect.Intotal,Acordasadvertisingefforts
contributedtosalesofmorethan$240millionattributabletoitsversionof
ZanaflexCapsules.
ApotexcommencedthislawsuitinDecember2011,amendingitscomplaint
inFebruary2012toincludetheFDAsdenialofAcordascitizenpetition.Acorda
counteredwithamotiontodismiss,whichthedistrictcourt(Swain,J.)granted
withrespecttotheShermanActclaimanddeniedwithrespecttotheLanham
Actclaims.ThedistrictcourtobservedthatApotexsShermanActclaimrelied
purelyontemporalproximitythedenialofAcordascitizenpetitiononthesame
daytheApotexANDAwasapprovedandconcludedthatwasinsufficientto
stateaclaiminviewofrecentlegislationmakingtherequirementsfordelaying
anANDAapplicationmorestringent:Congress[s]explicitdirectivethatANDA
10

processingshouldnotordinarilybedelayedbyacitizenpetition,coupledwith
itsnarrowingforthegroundsforanysuchdelayandthestatutorynotice
requirement,stronglyunderminesanyinferencethatmeresimultaneityof
ANDAandcitizenpetitiondecisionsisindicativeofthedelayofonebyreasonof
pendencyoftheother.ApotexInc.etal.,v.AcordaTherapeutics,Inc.,No.1:11
cv8803(S.D.N.Y.Feb.7,2013),Doc.45at7(Swain,J.)(ApotexI).Apotex
movedforleavetoamend,butthemotionwasdeniedintheinterestofjudicial
economy.
AfterthecasewasreassignedtoJudgeTorres,Acordasuccessfullymoved
forsummaryjudgmentontheLanhamActclaims.JudgeTorresbeganthe
analysiswiththeprinciplethat:[i]nthecontextofpharmaceuticaldrugs,courts
havegenerallyrejectedLanhamActclaimsbasedonadvertisementsthatmerely
repeatlabelinginformationthathasbeenapprovedbytheFDA.ApotexInc.v.
AcordaTherapeutics,Inc.,No.11cv8803(AT),2014WL5462547,at*3(S.D.N.Y.
Oct.23,2014)(Torres,J.)(ApotexII)(quotingMylanPharms.,Inc.v.Proctor&
GambleCo.,443F.Supp.2d453,460(S.D.N.Y.2006)).Thecourtheldthat
becausemanyoftheallegedlyfalserepresentationswereconsistentwiththe
productlabel,Apotexfailedtoidentifyagenuineissueofmaterialfactwith
11

respecttofalsityofanyofAcordasrepresentations,exceptone.Id.at*5.The
remainingrepresentationwasAcordasplacementofCmaxdataonFigure1,as
towhichthedistrictcourtfoundthatareasonablejurorcoulddeterminethatthe
juxtapositionofthistextandimagecommunicatesaliterallyfalsemessage.Id.
at*8.Nevertheless,theclaimdidnotsurvivebecauseApotexfailedtoidentifya
materialissueoffactastotherepresentationsbearingondecisionstopurchase.
Seeid.at*9.
Apotexappealsbothdecisions.

DISCUSSION
ApotexsShermanActclaimwasdispatchedatthemotiontodismiss
stage,whileitsLanhamActclaimssuccumbedonsummaryjudgment.Ona
motiontodismiss,allfactualallegationsinthecomplaintareacceptedastrue
andallinferencesaredrawnintheplaintiffsfavor.Littlejohnv.CityofN.Y.,
795F.3d297,306(2dCir.2015).Wereviewdenovoadistrictcourtsgrantofa
motiontodismissunderRule12(b)(6).Id.Andwereviewadistrictcourts
denialofleavetoamendforabuseofdiscretion.PresbyterianChurchofSudan
12

v.TalismanEnergy,Inc.,582F.3d244,267(2dCir.2009).
Summaryjudgmentisappropriatewhen,havingresolvedallambiguities
andpermissiblefactualinferencesinfavorofthepartyagainstwhomsummary
judgmentissought,therearenogenuineissuesofmaterialfactindisputeand
themovantisentitledtojudgmentasamatteroflaw.Baezv.JetBlueAirways
Corp.,793F.3d269,273(2dCir.2015).Agenuineissueofmaterialfactexistsif
theevidenceissuchthatareasonablejurycouldreturnaverdictforthe
nonmovingparty.Savinov.CityofN.Y.,331F.3d63,71(2dCir.2003)(quoting
Andersonv.LibertyLobby,Inc.,477U.S.242,248(1986)).Thegrantofsummary
judgmentinfavorofAcordaislikewisesubjecttodenovoreview.SeeBaez,793
F.3dat27374.

I
TheclaimthatAcordasfilingofashamcitizenpetitionconstitutesillegal
monopolizationarisesunderSectionTwooftheShermanAct,whichimposes
liabilityon:[e]verypersonwhoshallmonopolize,orattempttomonopolize...
anypartofthetradeorcommerceamongtheseveral[s]tates....15U.S.C.2.
AcomplaintallegingthatacompetitorfiledashamcitizenpetitionwiththeFDA
13

statesaclaimunderthatsection.SeeInreDDAVPDirectPurchaserAntitrust
Litig.,585F.3d677,694(2dCir.2009).Forthesepurposes,asingleshampetition
maybeanalogizedtoasingleshamlitigation.Asinglelawsuitcanviolate
antitrustlawaslongasitisbothanobjectiveandsubjectivesham.Id.at686.
First,thelawsuitmustbeobjectivelybaselessinthesensethatnoreasonable
litigantcouldrealisticallyexpectsuccessonthemerits....[S]econd...,the
courtshouldfocusonwhetherthebaselesslawsuitconcealsanattemptto
interferedirectlywiththebusinessrelationshipsofacompetitor.ProflReal
EstateInvrs,Inc.v.ColumbiaPicturesIndus.,Inc.,508U.S.49,60(1993)
(emphasisinoriginal)(quotingE.R.R.PresidentsConferencev.NoerrMotor
Freight,Inc.,365U.S.127,144(1961)).BecauseweconcludethatApotexhas
failedtoshowthatAcordascitizenpetitionwasobjectivelybaseless,weaffirm
onthefirstgroundanddonotreachthesecond.
Asrelevanthere,thefactualbasisfortheclaiminDDAVPwasthatthe
shampetitioncausedadelayingenericcompetition,apossibilityreinforcedby
thefactthattheFDAapprovedthegenericdrugonthesamedaythatitrejected
thepetition.585F.3dat694.GiventhesimultaneousgrantoftheANDAand
denialofthecitizenpetition,Apotexarguesthatastraightforwardapplicationof
14

DDAVPjustifiesreversal:thepossibilitythatthepetitionwasasham,andthatit
impactedtheFDAsdecision,issufficientlyplausibletodefeatthemotionto
dismiss.Id.at695.
However,theFDAissuedanewGuidanceforIndustry(Guidance)
explaininghowtheFDAdeterminesifapetitionimplicatesanissueofpublic
health,andhowtheFDAsdecisionmakingprocessisaffectedbythe
simultaneouspendencyofanANDAapplicationandacitizenpetitiondealing
withthesamedrug.Althoughthiscasepartiallyarisesonamotiontodismiss,
wemayproperlytakejudicialnoticeofthisdocument(withoutconverting
Acordasmotiontodismissintoamotionforsummaryjudgment)becausethe
Guidanceispubliclyavailableanditsaccuracycannotreasonablybequestioned.
SeeFED.R.EVID.201(b);Staehrv.HartfordFin.Servs.Grp.,Inc.,547F.3d406,425
(2dCir.2008)(Althoughthegeneralruleisthatadistrictcourtmaynotlook
outsidethecomplaintandthedocumentsattachedtheretoinrulingonaRule
12(b)motiontodismiss,wehaveacknowledgedthatthecourtmayalsoconsider
mattersofwhichjudicialnoticemaybetaken.(quotingKramerv.TimeWarner

15

Inc.,937F.2d767,773(2dCir.1991))).3
TheGuidanceexplains:IfapetitionrequeststhattheAgencytakean
actionrelatedtoaspecificaspectofapendingapplication,wewillconsiderthe
reviewstatusoftheaffectedapplication(s)indeterminingwhetheritwouldbe
appropriatefortheAgencytorespondtotherequesttotaketheactionrequested
inthepetitionwithinthe180daytimeframe.JointAppendixat530(emphasis
added).Suchconsiderationisnecessarybecauseofthedifferingprocedural
rightsofanANDAapplicantandthewriterofacitizenpetition.[T]heAgency
mustgivethe[ANDA]applicantnoticeofanopportunityforahearingon
whethertheapplicationisapprovable,withaspecifictimeframeandprocess
shouldtheapplicantrequestsuchahearing.Id.at531.FDAdecisions
adjudicatingcitizenpetitions,ontheotherhand,aresubjecttoimmediate
reviewbythecourts.Theythereforecarrywiththemnoneoftheprocedural
rightsfortheaffectedapplicantsthatattachtoadecisiontodenyapprovalofan
application.Id.Tobringtheseproceduralarrangementsintosync,theFDA
3Thedocumentcanbeaccessedatthefollowingwebsite:FoodandDrug
Administration,CitizenPetitionsandPetitionsforStayofActionSubjectto
Section505(q)oftheFederalFood,Drug,andCosmeticActGuidancefor
Industry(June8,2011),
http://www.regulations.gov/#!documentDetail;D=FDA2009D00080011.
16

statesthatitispreferablenottoissueadecisiononacitizenpetitionuntilit
issuesadecisiononthecorrespondingANDAapplication.Seeid.(Ifwewere
torespondsubstantivelytoapetitionersrequestregardingtheapprovabilityof
...theapplicationasawhole,such[a]responsecouldinterferewiththestatutory
andregulatoryschemegoverningthereviewofapplicationsandrelated
proceduralrightsofapplicants.).
Althoughitremainsconceivable,notwithstandingtheGuidance,thata
citizenpetitionmightcauseanticompetitivedelay,theGuidancetendsto
underminetheinference(drawninDDAVPandadvocatednowbyApotex)that
whenacitizenpetitionisdeniedsimultaneouslywiththegrantofanANDA
petition,thecitizenpetitionwasashamandananticompetitiveweapon.The
Guidancefavorscontemporaneousadjudicationstosafeguardtheprocedural
rightsofANDAapplicantssuchasApotex.4
4WhileDDAVPwaspendingonappeal,CongresspromulgatedtheFoodand
DrugAdministrationAmendmentsAct(FDAAA),whichprovidesinpartthat
considerationofacitizenpetitionshallnotdelayFDAapprovalofanANDA
unlessadelayisnecessarytoprotectthepublichealth.21U.S.C.
355(q)(1)(A)(ii).IftheFDAdeterminesthatdelayisnecessary,itmustgivenotice
totheapplicantnotlaterthan30daysaftermakingsuch[a]determination
alongwithabriefsummaryofthespecificsubstantiveissuesraisedinthe
petitionwhichformthebasisofthedetermination.Id.(B).However,itisnot
evidentthattheFDAAAhascurbedallabusesofthecitizenpetitionprocess.
17

Apotexhasplednootherfactsfromwhichitcanplausiblybeinferredthat
Acordaspetitionwasasham.Apotexallegesthat,inthepatenttrial,Acorda
falselymischaracterizedtestimonyandscientificevidencerelatingtothe
bioequivalenceofApotexsproduct.ButthatallegationshowsthatApotex
disagreedwiththeargumentsAcordaadvancedinitscitizenpetition(whichis
hardlysurprising),notthattheAcordacitizenpetitionwasasham.5
TheFDAletterrejectingAcordascitizenpetitionreinforcesthis
conclusion.6AlthoughAcordasobjectionstoApotexsANDAbasedon

SeeMichaelCarrier&DarylWander,CitizenPetitions:AnEmpiricalStudy,34
CARDOZOL.REV.249,283(2012)([W]hatisclearisthatthe2007amendmenthas
notbeensuccessfulinachievingitsstatedpurposes....[T]odate,the
amendmenthasnotreducedthenumberofunsuccessful(inotherwords,denied
oressentiallydenied)citizenpetitionsthatappeartobefiledtodelaygeneric
competition.).WecannotforeclosethepossibilitythatShermanActliability
mightbepredicatedonthetimetakenfortheFDAtodecidewhetheracitizen
petitionraisesalegitimatepublichealthconcern.But,forreasonsexplained
below,Apotexhasnotplausiblypledanysuchanticompetitivedelayhere.
5ApotexsassertionsthatAcordafalselymischaracterizedtrialtestimonyand
misrepresentedApotexsbioequivalencestudiesarelegalcontentions,notfactual
allegations,andthereforeneednotbecredited.SeeBellAtl.Corp.v.Twombly,
550U.S.544,555(2007)([O]namotiontodismiss,courtsarenotboundto
acceptastruealegalconclusioncouchedasafactualallegation.(quoting
Papasanv.Allain,478U.S.265,286(1986))).

6Wemayconsiderthisdocumentbecausethepleadingreliesheavilyupon
itstermsandeffect,whichrendersthedocumentintegraltothecomplaint.
Chambersv.TimeWarner,Inc.,282F.3d147,153(2dCir.2002)(quotingIntl
18

bioequivalencelefttheFDAunpersuaded,thegroundsforrejectionwere:(1)
AcordasuseofarithmeticmeanvaluesforCmaxinsteadofgeometricmean
values;and(2)Acordasrelianceonacrossstudycomparison.Nowheredoes
theFDAfindthatAcordamisrepresentedtestimonyintheApotexAcordapatent
litigation.SeeJointAppendixat41617n.5(TheAgencyisnotapartytothat
proceeding,andstatementsmadeinprivatelitigationarenotdirectlyrelevantto
FDAsstatutoryobligationtodeterminetheapprovabilityofApotexsANDA.).
Similarly,withrespecttoAcordaslabelingargument,theFDA
disagree[d]withAcordathattheCmaxofApotexsproductinthefedstate
wasincreasedcomparedtotheRLDs.Id.at420.Apotexelidesthedistinction
betweenargumentsthatfailtomovetheFDAandargumentsthatarefalseand
objectivelybaseless.AstheSupremeCourthascautioned,courtsneedtoresist
theunderstandabletemptationtoengageinposthocreasoningbyconcluding
thatanultimatelyunsuccessfulactionmusthavebeenunreasonableorwithout
foundation.RealEstateInvrs,508U.S.at60n.5(quotingChristiansburg
GarmentCo.v.EqualEmptOpportunityCommn,434U.S.412,42122(1978)).
Accordingly,theobjectivecomponentofApotexsclaimislacking;sothereisno

AudiotextNetwork,Inc.v.Am.Tel.&Tel.Co.,62F.3d69,72(2dCir.1995)).
19

needtoevaluateAcordassubjectivemotivationsinfilingthepetition.
ApotexreliesonInreSuboxoneAntitrustLitig.,64F.Supp.3d665,69091
(E.D.Pa.2014),whichisinapposite.ThedistrictcourtinSuboxoneheldthata
SectionTwoclaimbasedonthefilingofashamcitizenpetitionsurvived
dismissalbecauseofthemanyindiciathatthepetitionwasobjectivelybaseless.
Amongtheindicia:theFDAacknowledgedinitsrulingthatithadnoauthority
tograntmuchof[the]requestedrelief,id.at689;andthecompetitorthatfiled
thecitizenpetitionrequestedthattheFDAinvestigatewhySuboxonetablets
hadbeenwithdrawnfromthemarketeventhoughthecompetitorwas
continuingtoselltheproductatthattime.Id.at690.Itwasthereforeplausibly
pledthatthepetitionwasobjectivelybaselessinthatnoreasonablelitigant
couldhaverealisticallyexpectedsuccessonthemerits.Id.Here,however,the
onlyfactApotexhaspledotherthanthetimingoftheFDAsdecisionon
AcordascitizenpetitionisthatAcordascitizenpetitionwasultimatelyfruitless.7
7ApotexsrelianceonTycoHealthcareGrp.LPv.Mut.Pharm.Co.,762F.3d
1338(Fed.Cir.2014)ismisplaced.TheFederalCircuitfoundadisputedissueof
factastowhetherTycoscitizenpetitionwasobjectivelybaselessbecausethe
FDAsresponsestatedthatthepetitionrelie[d]entirelyonuncorroborated
generalitiesandtheoreticalspeculationandfail[ed]toprovideanyevidenceat
allonakeyissue.Id.at1347.Furthermore,Mutualprovidedanexpertwho
testifiedthatthecitizenpetitionwasbaseless.Seeid.Incontrast,theFDAs
20

Inthealternative,Apotexarguesthatthedistrictcourtsdenialofleaveto
amendtheantitrustclaimwasbasedonamisapplicationoftherulessetforthin
theSouthernDistrictsPilotProjectRegardingCaseManagementTechniquesfor
ComplexCivilCases(PilotRules).However,thedistrictcourtdeniedthe
motiontoamendintheinterestsofjudicialeconomy,notbecauseofApotexs
noncompliancewiththePilotRules.Apotexsoughttoamendinordertocitethe
FDAsfourthannualreporttoCongress,issuedinDecember2012,detailingthe
ineffectivenessoftheFDAAA.Thedistrictcourtfoundthatthisreportwas
availabletoApotexbeforeitsdecisionissueddismissingApotexsclaimsin
February2013,thatAcordaexpresslyreliedontheFDAAAinitsinitialmotionto
dismissApotexsShermanActclaim,andthatApotexbroughttheFDAannual
reporttothedistrictcourtsattentiononlyafterAcordasmotiontodismisswas
adjudicated.BecauseApotexdelayedseekingleavetoincludetheFDAsfourth
annualreportuntilMarch2013,andbecausethegeneralfindingsofthereport
werelargelyimmaterialtoApotexsspecificclaim,thedistrictcourtconcluded
thattheinterestsofjudicialeconomywarranteddenialofApotexsmotion.We

lettertoAcordaprovidednosuchlanguageindicatingthecitizenpetitionwas
whollybaseless,andApotexdidnotpleadanyotherfactsthatwouldindicate
baselesness.
21

haveconsistentlyaffordeddistrictcourtslatitudetodenyleavetoamendonthis
basis.SeeRuffolov.Oppenheimer&Co.,987F.2d129,131(2dCir.1993)
(Whereitappearsthatgrantingleavetoamendisunlikelytobeproductive,
however,itisnotanabuseofdiscretiontodenyleavetoamend.).
Insum,ApotexhasnotstatedaclaimunderSectionTwooftheSherman
Act,andthedistrictcourtdidnotabuseitsdiscretionindenyingApotexleaveto
amend.ThedistrictcourtsdecisiondismissingApotexsantitrustclaimis
affirmed.

II
TheLanhamActsprohibitiononfalseadvertisingstates:
Anypersonwho,onorinconnectionwithanygoodsorservices...
usesincommerce...any...falseormisleadingdescriptionoffact,
orfalseormisleadingrepresentationoffact,which...incommercial
advertisingorpromotion,misrepresentsthenature,characteristics,
qualities,orgeographicoriginofhisorheroranotherpersons
goods,services,orcommercialactivities,shallbeliableinacivil
actionbyanypersonwhobelievesthatheorsheislikelytobe
damagedbysuchact.
15U.S.C.1125(a)(1).Falseadvertisingclaimsbasedonthisprovisocontaintwo
components.

22

First(andobviously),aplaintiffbringingafalseadvertisingclaimmust
showfalsity.Therearetwowaystodothat.First,aplaintiffcandemonstrate
thatthechallengedadvertisementisliterallyfalse,i.e.,falseonitsface.Time
WarnerCable,Inc.v.DIRECTV,Inc.,497F.3d144,153(2dCir.2007).
[C]onsumerdeceptionispresumed,andthecourtmaygrantreliefwithout
referencetotheadvertisements[actual]impactonthebuyingpublic.Id.
(quotingCocaColaCo.v.TropicanaProds.,Inc.,690F.2d312,317(2dCir.1982)).
Thisinquiryrequiresevaluatingthemessageconveyedinfullcontext.Id.at
158(quotingCastrolInc.v.PennzoilCo.,987F.2d939,946(3dCir.1993)).Ifthe
wordsorimages,consideredincontext,necessarilyimplyafalsemessage,the
advertisementisliterallyfalseandnoextrinsicevidenceofconsumerconfusionis
required.Id.Importantly,however,onlyanunambiguousmessagecanbe
literallyfalse,;ifthelanguageorgraphicissusceptibletomorethanone
reasonableinterpretation,theadvertisementcannotbeliterallyfalse.Id.
(quotingNovartisConsumerHealth,Inc.v.Johnson&JohnsonMerckPharms.
Co.,290F.3d578,587(3dCir.2002)).Onekindofliterallyfalseclaimisaclaimof
testprovensuperiority.Thepremiseisthatthedefendantsad[vertisement]
explicitlyorimplicitlyrepresentsthattestsorstudiesproveitsproductsuperior
23

andplaintiffsatisfiesitsburdenbyshowingthatthetestsdidnotestablishthe
propositionforwhichtheywerecited.Castrol,Inc.v.QuakerStateCorp.,977
F.2d57,63(2dCir.1992).
Alternatively,aplaintiffcanshowthattheadvertisement,whilenot
literallyfalse,isneverthelesslikelytomisleadorconfuseconsumers.Time
Warner,497F.3dat153.Suchanimplicitfalsityclaimrequiresacomparisonof
theimpression[leftbythestatement],ratherthanthestatement[itself],withthe
truth.Id.(quotingScheringCorp.v.PfizerInc.,189F.3d218,229(2dCir.1999)).
[W]hereasplaintiffsseekingtoestablishaliteralfalsehoodmustgenerallyshow
thesubstanceofwhatisconveyed,...adistrictcourtmustrelyonextrinsic
evidence[ofconsumerdeceptionorconfusion]tosupportafindingofan
implicitlyfalsemessage.Id.(secondalterationinoriginal)(quotingSchering
Corp.,189F.3dat229).
Falsityalonedoesnotmakeafalseadvertisingclaimviable;[u]ndereither
theory,theplaintiffmustalsodemonstratethatthefalseormisleading
representationinvolvedaninherentormaterialqualityoftheproduct.Id.n.3.
Sucharequirementisessentiallyoneofmateriality,atermexplicitlyusedin
othercircuits.S.C.Johnson&Son,Inc.v.CloroxCo.,241F.3d232,238(2dCir.
24

2001)(quotingNatlBasketballAssnv.Motorola,Inc.,105F.3d841,855(2dCir.
1997)).ThisCourthasdefinedmaterialityaslikelytoinfluencepurchasing
decisions,adefinitioninharmonywithotherCircuitsuseoftheterm.Natl
BasketballAssn,105F.3dat855(quotingAm.Tel.&Tel.Co.v.Winback&
ConserveProgram,Inc.,42F.3d1421,1428n.9(3dCir.1994)).8
AmajorityofApotexsclaimsattackAcordasrepresentationsas
inconsistentwiththeFDAapprovedlabelforZanaflexCapsules.Aprior
questioniswhetherrepresentationsthatarewhollyconsistentwithanFDAlabel

8SeealsoGrubbsv.SheakleyGrp.,Inc.,807F.3d785,798(6thCir.2015)
(definingmaterialinthefalseadvertisingcontextaslikelytoinfluencethe
deceivedconsumerspurchasingdecisions)(quotingAm.CouncilofCertified
PodiatricPhysicians&Surgeonsv.Am.Bd.ofPodiatricSurgery,Inc.,185F.3d
606,613(6thCir.1999));Cashmere&CamelHairMfrs.Inst.v.SaksFifthAve.,
284F.3d302,311(1stCir.2002)(Thematerialitycomponentofafalse
advertisingclaimrequiresaplaintifftoprovethatthedefendantsdeceptionis
likelytoinfluencethepurchasingdecision.)(quotingCloroxCo.P.R.v.Proctor
&GambleCommercialCo.,228F.3d24,33n.6(1stCir.2000));ALPOPetfoods,
Inc.v.RalstonPurinaCo.,913F.2d958,964(D.C.Cir.1990)(notingthatto
succeedonafalseadvertisingclaim,aplaintiffmustshowthatrepresentations
werematerialintheireffectsonbuyingdecisions);Taquinov.Teledyne
MonarchRubber,893F.2d1488,1500(5thCir.1990)(Tosucceed,itmustbe
provedthat...thedeceptionismaterial,inthatitislikelytoinfluencethe
purchasingdecision....);5MCCARTHYONTRADEMARKSANDUNFAIR
COMPETITION27:35(4thed.1996)(Plaintiffmustmakesomeshowingthatthe
defendantsmisrepresentationwasmaterialinthesensethatitwouldhave
someeffectonconsumerspurchasingdecisions.).
25

aresubjecttoLanhamActliability.ThisCourthasyettosohold,althougha
numberofdistrictcourtsinthisCircuithavesensiblyadheredtothisprinciple.9
Weagreewiththesecourtsandnowholdthatrepresentationscommensurate
withinformationinanFDAlabelgenerallycannotformthebasisforLanhamAct
liability.10
SucharulereflectsproperdeferencetotheexpertiseoftheFDAasthe
regulatoryagencyresponsibleforissuingthelabelbyrespectingtheexhaustive
processprecedingtheissuanceofalabel.Am.HomeProds.Corp.v.Johnson&
Johnson,672F.Supp.135,144(S.D.N.Y.1987)(Conner,J.);seealsoSmithkline
Beecham,1996WL280810,at*13.Thisprinciplerightfullyinsulates
pharmaceuticalcompaniesfromliabilitywhentheyengageinFirstAmendment

9SeeMylanPharms.,443F.Supp.2dat460(Castel,J.)(Inthecontextof
pharmaceuticaldrugs,courtshavegenerallyrejectedLanhamActclaimsbased
onadvertisementsthatmerelyrepeatlabelinginformationthathasbeen
approvedbytheFDA.);SmithklineBeechamConsumerHealthcare,L.P.v.
Johnson&JohnsonMerckConsumerPharms.Co.,No.95Civ.7011,1996WL
280810,at*13(S.D.N.Y.May24,1996)(Baer,J.)([T]oenjoinSmithKlineBeecham
fromclaimingthatTAGAMETHBworksfasterthanPEPCIDAConthebasisof
package[labeling],wouldsubstitutethisCourtsdiscretionforthatoftheFDAin
approvingpackage[labeling]foroverthecountermedications.).
10LanhamActliabilitymightariseifanadvertisementusesinformation
containedinanFDAapprovedlabelthatdoesnotcorrespondsubstantiallytothe
label,orotherwiserenderstheadvertisementliterallyorimplicitlyfalse.
26

speechthatisconsistentwiththedirectiveoftheregulatorybodyhaving
oversightofproductlabels.
WehavebeencarefulnottopermitoverextensionoftheLanhamActto
intrudeonFirstAmendmentvalues.Grodenv.RandomHouse,Inc.,61F.3d
1045,1052(2dCir.1995).Accordingly,inordertoavoidchillingspeechthat
oughttobeprotected,Acordasadvertisementscannotformthebasisfor
ApotexsclaimstotheextenttheywereinlinewiththeFDAapprovedlabel.
Apotex,however,goesfurtherandcontendsthatAcordasadvertisements
exceededtheboundariesimposedbytheFDAlabel.EachofApotexsspecific
LanhamActchallengesisnowconsidered.
1.StatementsbyAcordasSalesRepresentatives
Apotexchallengesstatements,attributabletoAcordasalesrepresentatives,
thatpatientstakingZanaflexCapsuleswithfoodenjoythebenefitsofreduced
Cmax,includingdosingflexibilityanddiminishedsomnolence.Representative
samplesofthesesalespitchesincludethefollowing:
Uponlearningoftheabilitytodecreasesomnolence...byusing
ZanaflexCapsules,thedoctorsagreedtogiveitatry.

27

JointAppendixat3072;
Iexplainedto[thedoctor]thatthe[C]apsule[][is]reallyuniquein
thatitcounteractsalotofthedrowsinesswhenyoudoseitwith
food.Hesaidhewouldgivethatatryandseehowwellitworksfor
hispatients.
JointAppendixat3093.
WhenAcordalearnedthatitsrepresentativesmayhavemadeunauthorized
promotionalclaimsforZanaflexCapsules,Acordasheadofsalessenta
memorandumtothesalesteamexplicitlyforbiddingpromotionsthatZanaflex
Capsuleshadfewersideeffectsandlesssedationthanthetablets.
ApotexspecificallyobjectstorepresentationsthatZanaflexCapsules
providemoreflexibilitythantheCapsulescounterpartthetabletsapointon
whichtheFDAlabelissilent.However,statementsthatZanaflexCapsules
reduceCmaxwhentakenwithfoodarefullyconsistentwiththeFDAlabel,as
thedistrictcourtcorrectlyfound,andLanhamActliabilitythereforecannot
attachtothesestatements.SeeApotexII,2014WL5462547,at*5.Totheextent
Apotexchallengesstatementsaboutdosingflexibility,itmisconstruesitsburden.
ItisnotenoughtoshowthatAcordamaderepresentationsabsentfromtheFDA
label;instead,Apotexmustshowthatthesecommentswereinconsistentwiththe

28

FDAlabelinamannersufficienttosupportafalseadvertisingclaim.SeeProcter
&GambleCo.v.ChesebroughPondsInc.,747F.2d114,119(2dCir.1984)
([E]achplaintiffbearstheburdenofshowingthatthechallengedadvertisement
isfalseandmisleading,notmerelythatitisunsubstantiatedbyacceptabletests
orotherproof.(internalcitationsomitted)).Apotexhasadducednoevidence
thatAcordaspromotionofdosingflexibilitywaseitherliterallyfalseorlikelyto
causeconsumerconfusion.
ApotexnextarguesthatAcordassalesrepresentativesusedCmaxasa
proxyforsomnolenceandimproperlyclaimedthatZanaflexCapsulesreduceit.
Critically,Apotexreliesonatestprovensuperiorityargumentthatthe
representationsreliedontestsorstudiesallegedlyprovingthesuperiorityof
ZanaflexCapsules.Thedistrictcourt,however,properlyrejectedliabilityunder
thetestprovensuperioritytheory.
Thetheorycomesintoplayonlywhenthedefendantsad[vertisement]
explicitlyorimplicitlyrepresentsthattestsorstudiesproveitsproductsuperior
....Castrol,977F.2dat63(emphasisadded).Apotexproffersnoevidencethat
salesrepresentativesreferredtotestsorstudieswhentheydiscussedthe
potentialofZanaflexCapsulestoreducesomnolence.Atmost,Acordas
29

representativesusedFigure1(orasimilargraphofpharmacokineticresults)asa
tooltoaidtheirreducedsomnolencepitch.Thereisnorecordevidencethat
Acordarepresentativesusedgraphsofpharmacokineticresultstorepresentthat
ZanaflexCapsulesreducedsomnolence.Consideroneofthestatementsatissue:
TalkedtoDr.Corondanforthefirsttime.Iaskedhimaboutthe
mostcommoncomplaintwithZanaflextabletsandhesaidthe
drowsinessandthenwewenttothegraphandIdiscussedthe
[C]apsules(whichishowIloveacalltoworkout).
JointAppendixat1520.Atnopointinthispassageisitexplicitlystatedor
impliedthatFigure1necessarilyshowsthatZanaflexCapsulesreduce
somnolence;instead,thegraphwasusedasatoolforfurtherdiscussion.The
districtcourtsreasoningonthisissuewassound:[a]tmost,thestatements
suggestthat,duetopharmacokineticdifferencesbetweentheproducts,Zanaflex
[C]apsulescauselesssomnolencethanZanaflextabletswhentakenwithfood.
Thestatementsdonot,bycontrast,explicitlyorimplicitlyrepresent[]thattests
orstudiesprovethatthereislesssomnolencewithZanaflex[C]apsules.
ApotexII,2014WL5462547,at*7(thirdalterationinoriginal)(quotingCastrol,
977F.2dat63).Unabletoidentifyamisrepresentationbasedontestproven
superiority,Apotexislefttofindagenuineissueofmaterialfactonfalsityon

30

someothertheorysomethingithasfailedtodo.Itisimmaterialthatnostudy
hasshownareductioninsomnolenceassociatedwithZanaflexCapsules;
ChesebroughmakesclearthatApotexmustshowfalsity,notmerelyuncertainty.
Moreover,AcordassomnolencerepresentationsfindaharborintheFDAlabel,
whichstatesthatincreasedadverseevents,suchassomnolence,mayoccurwhen
switchingbetweenthetabletsandCapsulesinthefedstate.Reinforcingthis
conclusion,theFDAsmedicalreviewconcludedthatthemostproblematic
situationintermsofexacerbatingsomnolencewasswitchingfromtheCapsules
tothetabletsinthefedstate.Inotherwords,theFDAhasgivensomesupportto
Acordasrepresentations;moreimportantly,however,thereisnoevidencethat
therepresentationsarefalse.Thereisnobasistodisturbthegrantofsummary
judgmentrelatingtoAcordassalesrepresentativesstatements.
2.AcordasPromotionalMaterials
SupplementingrepresentationsbyAcordassalesteamwerewritten
promotionalmaterialsheraldingthebenefitsofZanaflexCapsulesinamanner
Apotexbelieveswasfalseandmisleading.ApotexspecificallyattacksAcordas
gatefoldbrochure,apieceofadvertisingthatAcordadisseminatedinthe
thousands.Thefrontcoverannounces:FlexibleControlinaCapsuledirectly
31

abovetwoimagesofthesunandthemoonwiththewordsDAYandNIGHT
printedunderneath.Thebottomofthefrontcoverurges:ForTreatmentof
SpasticityWhenReliefisMostImportant.ThesecondpagecontainsFigure1
juxtaposedwithrelevantCmaxdata,alongwithadditionaltextatthebottomof
thegraph.Thetextreads:
EffectsandAdverseEventsareDoseRelatedtoPlasmaLevelsof
Tizanidine.

Significantpharmacokineticchangesincludingplasmalevel
differencesoccurwhenadministeringZanaflexCapsulesor
tabletswithfood.
These(pharmacokinetic)differencescanresultinclinically
importantdifferencesineffectivenessandadverseevents.

JointAppendixat332728.SeeAppendixA.
Apotexassertsthatthebrochureismisleadingasawholebecausethesun
andmoonimagery,withthetextunderneaththegraphonpage2ofthe
brochure,deliversthemessagethatZanaflexCapsulesundoubtedlyreduce
Cmaxandsomnolence.
AlthoughAcordaarguesthatitmerelyreprintedthegraphfromtheFDA
labelinitsadvertisements(includingthegatefoldbrochure)Apotexaccuses
Acordaofmanipulationbecausethefollowingtextissuperimposedonthe

32

graph:30%INCREASEFORTABLETS;20%DECREASEFORCAPSULES.
JointAppendixat3258.Apotexarguesthatthegraphic,asawhole,conveysa
falsemessagebecauseFigure1depictsmeantizanidineconcentration,whichis
theaveragedrugconcentrationatdifferentpointsintime,whilethetextrelatesto
Cmaxdata,whichisthemaximumdrugconcentrationatdifferenttimepoints
and,bydefinition,differentfromthemeandrugconcentration.SeeAppendixB.
WiththeexceptionoftheversionofFigure1withsuperimposedtext,
Apotexfailstocreateatriableissueoffactastothefalsityofthebrochure.
Literalfalsitycannotbeshownbecausenounambiguousmessageisconveyedby
theremainderofthebrochure;Apotexarguesthatthepresenceofthesunand
themoonimpliesthatthedrugisequallyeffectiveduringthedayandatnight
andtherebyimpliesefficacyincombatingsomnolence.Thisconclusionis
plausible,butitisnotunambiguous,especiallybecausethecovernevermentions
somnolence.NorhasApotexshownextrinsicevidenceofconsumerconfusion
withrespecttothesunmoonimagery.Apotexreliesoninternalmarketing
statementsfromAcordafocusingonreducedCmaxandsomnolence;but
Acordasmotivationsforlaunchingthegatefoldbrochuredonotconstitute
extrinsicevidenceasrequired.
33

Apotexcontendsthatthedistrictcourterredbyexaminingthebrochurein
isolationwhileignoringthecontextofAcordaslaunchlettersandother
documentsdetailingAcordasmarketingefforts.True,adistrictcourt
evaluatingwhetheranadvertisementisliterallyfalsemustanalyzethemessage
conveyedinfullcontext.TimeWarner,497F.3dat158(quotingPennzoilCo.,
987F.2dat946).Buttherelevantcontextoftheadvertisementistheoverall
messageconveyedbythebrochure.Thedistrictcourtwasnotrequiredto
considerexternalmarketingdocuments.Areviewofthebrochureinitsentirety
doesnotchangetheconclusionreachedhere:thereisnounambiguousmessage
thatZanaflexCapsulesreducesomnolencenorhasApotexprofferedevidenceof
consumerconfusiononthispoint.
AcordasuseoftheversionofFigure1withsuperimposedtext,seenonthe
secondpageofthegatefoldbrochure,raisesacloserissue.
!

Figure1showstheaverageconcentrationforagroupofsubjects
overtimeafterthedrugisadministered(i.e.,themeandrug
concentration);while

Cmaxisthemaximumconcentrationofthedrugthatisreachedina
subject,whichvariesfromsubjecttosubjectandisnotcorrelated
34

withthetimeelapsedfromadministrationofthedrug.
SinceCmaxvaluesarenottimedependent,andFigure1displaysmeandrug
concentrationovertime,Figure1cannotdisplaymeanCMaxvalues.We
thereforeagreewiththedistrictcourtthatareasonablejurorcoulddetermine
thatthejuxtapositionofthistextandimagecommunicatesaliterallyfalse
message.ApotexII,2014WL5462547,at*8.However,falsityisnotenough;
Apotexmustalsoraiseafactualissueastomateriality.Undereithertheory,the
plaintiffmustalsodemonstratethatthefalseormisleadingrepresentation
involvedaninherentormaterialqualityoftheproduct.TimeWarner,497F.3d
at153n.3(emphasisadded).Apotexcontendsthatitisnotrequiredtoshowthat
therelevantmisrepresentationwouldhaveaneffectonconsumerspurchasing
decisions.ThisargumentignoresprecedentfromthisCourtwhichendorsedthat
definitionofmaterialityinlinewiththevastmajorityofoursistercircuits.See
NatlBasketballAssn,105F.3dat855.Apotexcountersthat,whenan
advertisementisliterallyfalse,consumerdeceptionispresumed,andthecourt
maygrantreliefwithoutreferencetotheadvertisements[actual]impactonthe
buyingpublic.TimeWarner,497F.3dat153(alterationinoriginal)(quoting
CocaColaCo.,690F.2dat317).Theargumentconflatesfalsitywithmateriality.
35

Onceliteralfalsityisproved,thereisnorequirementofextrinsicevidence
showingconsumerdeception.ButApotexisnottherebyrelievedoftheburden
ofshowingmateriality,whichrequiresthattheallegedlyfalseormisleading
representationinvolvedaninherentormaterialqualityoftheproduct,id.n.3
i.e.,thattherepresentationwaslikelytoinfluencepurchasingdecisions,Natl
BasketballAssn,105F.3dat855(quotingAm.Tel.&Tel.,42F.3dat1428n.9).
Applyingthematerialitystandard,thedistrictcourtconcludedthat,at
most,Acordaoverstatedtheincreaseinmeantizanidineplasmaconcentration
butthatthisevidenceultimatelydoesnotrevealanythingabouttheimpacton
consumerspurchasingdecisions.ApotexII,2014WL5462547,at*9.This
conclusionwassound;theonlyplausibleeffectattributabletothe
misrepresentationinthegraphwasanexaggerationofthescaleofthemeandrug
concentrationcurves,oranimproperconflationofthemeanCmaxwiththe
highestmeandrugconcentrationforagiventreatment.However,thereisno
recordevidencethatthisinaccuracywoulddissuadeconsumersfrompurchasing
ZanaflexCapsules.Certainly,Apotexhasprovidednone.Apotexsshowingon
thispointconsistsofgeneralizedevidencethatAcordasincreasedsalesof
ZanaflexCapsulesstemmedfromitsadvertisementefforts.Apotexfailstomake
36

thenecessaryshowingthatthespecificmisrepresentationinthegraphicinany
ofAcordasadvertisementswaslikelytoinfluenceconsumerspurchasing
decisions.
TheremainderofApotexsattacksonAcordaspromotionalmaterials
sufferfromacommonflaw:althoughAcordaunquestionablymadestatements
thatwerenotdrawnfromtheFDAlabel,thethrustofChesebroughisthatthis
factisinsufficienttoshowfalsity.Apharmaceuticalcompanyisentitledtomake
advertisingstatementsoutsidethefourcornersofanFDAlabelsolongasnone
ofitsrepresentationsisinconsistentwithit.
Insum,thedistrictcourtcorrectlygrantedsummaryjudgmentonallof
Apotexsfalseadvertisingclaims.
CONCLUSION

Fortheforegoingreasons,weAFFIRMthejudgmentofthedistrictcourt.

37