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Patent Claims for Biologics in Canada: it’s a Question of Function

2014-04-08

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PATENTCLAIMSFORBIOLOGICSINCANADA:IT’SAQUESTIONOF
FUNCTION

J
ASONMOSCOVICI*
ROBIC,LLP
L
AWYERS,PATENT&TRADEMARKAGENTS

OnJanuary17
th2014,inararepatentinfringementcaseinvolvingarelativelynew
classofdrugproductsknownas”biologics”,theFederalCourtofCanadaupheldthe
validityofapatentownedbyAbbVieDeutschlandGmbH&Co.KG(“AbbVie),relating
tohumanantibodies,andfoundthatsaidpatentwasinfringedbyJanssenInc’s
(“Janssen”)STELARA®humanantibodydrugtreatmentforpsoriasis[AbbVie
Corporationetal.v.JanssenInc.,2014FC55,January17th2014,Hughes].

BiologicDrugs
Biologicsareproductsmadefrombiologicalprocesseswhicharemanufacturedfrom
theuseofanimalsormicroorganisms.Forexample:antibodies,hormonesandgene
therapyproducts.Theseproductsareregulatedinasimilarwayasotherclassesof
drugsinCanada,areconsideredpatentablesubjectmatter,andarerarelythe
subjectofinfringementproceedingssuchasinthepresentcase.

ThePatent
Janssen’sSTELARA®drugproductinvolvestheuseofahumanantibody,derived
fromtransgenicmice,forthetreatmentofpsoriasis.AbbVieallegedthatthisproduct
waswithinthescopeoftheprotectiongrantedbyclaims143and222ofitsCanadian
2,365,281patent(‘281),whicharedirectedtohumanantibodiesbinding(orhaving
anaffinityfor)aproteinknownasIL-12,alsoforthetreatmentofpsoriasis.These
claimsweredraftedsoastobefunctionallydefinedbyatleasttheirbindingaffinities,
bindingpartnersandpotencies.
Anexamplefoundinthedescriptionof‘281describedtheresultsofahumantest
subjectwhohadbeensufferingfrompsoriasisatthetimethestudywasconducted
andwhoreportedanoverallimprovementinhisskinconditionafterreceivingthe
“AbbVieTreatment”claimedinthispatent.

©CIPS,2014.*LawyerwithROBIC,LLP,amultidisciplinaryfirmoflawyers,andpatentandtrade-markagents.
Publishedat(2014),28:4WorldIntellectualPropertyReport6-7.Publication142.293.

2
Followingitsstudyofthepatent,theCourtconstruedtherelevantclaimsasbeingi)
directedtotheusehumanantibodies,howevercreated,ii)whichantibodiesbindand
dissociatefromIL-12;iii)atadefined“stickinessoraffinity”,iv)whichantibodieshave
adefinedminimumpotency,v)totreatpsoriasis.

Infringement
Ontheissueofinfringement,JanssenessentiallyconcededthatsincetheCourt’s
constructioncoveredhumanantibodiesthataremadebyanymethod,therefore
includingatransgenicmousemethod,theirSTELARA®productwouldfallwithinthe
scopeoftheclaims,subjecttoanassessmentofthestickiness(affinity)andpotency
oftheantibodies.AbbViehadconductedsuchtestsanditwasestablishedthatthe
STELARA®antibodywaswithinthescopeoftheclaimedaffinityandpotency.
Assuch,theCourtfoundthatJanssen’sSTELARA®productinfringedclaims143
and222ofthe‘281patent.
Invalidity
Onceinfringementwasestablished,theCourtthenstudiedthequestionofthe
allegedinvalidityofpatent‘281.Janssenhadarguedthattheclaimswereobviousin
lightofthepriorart,butthemaingroundofcontentionwasthatthescopeofthe
claimsdirectedtohumanantibodieswereallegedlytoobroadandcoveredmorethan
whatwasactuallyinvented,orwhatcouldbeproperlyclaimed.

Onthequestionofobviousness,thecourtaskeditself“what,ifany,arethe
differencesbetweenthePriorArtandtheInventionClaimed”?Theanswerwasthe
differencebetween“hopeandcertainty”.Ofthepriorartcited,theexpertswerein
agreementthat:“beforetheinventionwasmade,therewasahopethat,amongthe
“soup”ofcytokinesinthehumanbody,ifanantigenwasfoundtobindtooneor
moreofthem,thencertainhumandiseasesmightbetreatable”.

Theinventiveconceptof‘281was,withreferencetotheantibodies,thatifa
particularcytokinewasboundbyanantigenwithcertainproperties,psoriasiswould
betreatable.TheCourtdidnotagreethatthisconceptwas“selfevident”,asJanssen
argued,anddistinguishedthe“worthatry”approach,fromtheCanadian“moreor
lessself-evident”one,statingthatAbbviemayhavegottenlucky,butthatdoesnot
maketheinventionwasself-evidentwithrespecttothepriorartandtherefore
obvious.
Concerningtheallegedbroadnessoftheclaims,Janssenarguedthattheclaims
exceededthescopeoftheinvention,asonlyonespecificantibodywasallegedto
havebeenspecificallydescribedinthepatent,whileanyantibodybindingIL-2was
beingclaimed.Theclaimsweredraftedusingfunctionallanguage,thatis,the
inventionwasdescribedonthebasiscertainfunctionalcharacteristics,which

3
Janssenargueddidnotdescribe,norprovideguidance,astothestructureofthe
antibodies.
TheuseoffunctionallanguageinpatentclaimsisanallowablepracticeinCanada,
soaslongasthoseclaimsdon’t“merelyrelatetoadesiredresult”.Forexample,
simplyclaiming“anelixirforcuringbaldness”,wouldbeinsufficientunlessfurther
characteristicsofthiselixirareprovided.Inthepresentcase,theCourtfoundthat,
contrarytoJanssen’arguments,AbbViewasnotclaimingallantibodiesthattreat
psoriasis:
theremaybemanywaystotreatpsoriasis,butAbbVie’swayisto
haveanantibodythatdoessobybindingtoIL-12withatleastacertain
levelofstickinessandpotency“,Thatisverydifferentfromsaying-we
haveaparticularantibody(J695),andweputitintopeople,andit
treatstheirpsoriasis;therefore,wewantapatentclaiminganyantibody
thatdoesthat.

Furthermore,Janssendidnotprovideevidenceof“non-working”or“non-useful”
antibodiesthatwouldfallwithinthescopeoftheclaims.TheCourtreiteratedthat
thereisnouniversalruleorprinciplethatcanbeappliedtotheissueofover-breadth.
Thefactthatadescriptioncontainsonlyoneortwoworkingexamplesdoesnot
precludeclaimingeverythingthathasthesamefunction,anddoingsodoesnot
makeaclaimindeterminate.Apatenteecanthereforevalidlyclaimmorethanthe
embodimentsthatarespecificallydisclosedinthespecification.Functionallanguage
isthereforepermissibleincaseswherethespecificationandtheclaimsprovide
exclusioncriteriafornon-usefulentities(forexample,tocarveoutnon-workinganti-
bodies),aswelladequatesupportandguidancetoapersonversedintheart.

Conclusion
TheCourtwasthereforeoftheopinionthattheclaimsatissuewerevalidand
infringed.AbifurcationorderwasinplacesotheCourtdidnotprovideguidanceasto
damages;however,onFebruary13
th2014,JanssenfiledaNoticeofAppealandit
thereforeremainstobeseenhowtheFederalCourtofAppealwillsidewithregards
tothismatter.
Notwithstandingappeal,Canadiancaselawhassofarconsistentlybeentotheeffect
thatfunctionallanguageinclaimdraftingispermissible,ifwhatisbeingclaimedis
notmerelyadesiredresult.Itisclear,atleastatthetimeofwritingofthepresent
article,thattheseprinciplesaretransposabletothefieldof“biologics”,wherethe
subjectmatter,asitrelatestoantibodies,canvalidlybedefinedbytheiraffinityand
potencycharacteristics.

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industrialdesignsandutilitypatents;trademarks,certificationmarksandindications
oforigin;copyrightandentertainmentlaw,artistsandperformers,neighbouring
rights;computer,softwareandintegratedcircuits;biotechnologies,pharmaceuticals
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