Certificates of supplementary protection : one year later

CERTIFICATESOFSUPPLEMENTARYPROTECTION:ONEYEARLATER

DANIÈLEÉTHIERANDAMÉLIECÔTÉ*
ROBIC,LLP
LAWYERS,PATENTANDTRADEMARKAGENTS

SinceSeptember21,2017,anewCertificateofSupplementaryProtection(hereafterreferredto
asa”CSP”)Regimehasbeenimplementedwhichmayallowpatentholderstoreceiveupto2
yearsofadditionalpatentprotectionforapprovedmedicines.Inthepastyear,severalCSP
applicationshavebeensubmittedandreviewed,whichgivesusinsightastohowthisadditional
protectionisgrantedandhowtheCSPregulationsareinterpretedbyHealthCanada.

THECSPSCHEMEANDELIGIBILITY

TheCSPregimewasimplementedtocompensatepatentholdersfortimespentinresearchand
developmentfordrugscontainingpatentedmedicinalingredients.ACSPmayallowapatentholder
tobenefitfromuptotwoadditionalyearsofpatentprotectionontheapprovedmedicinalingredient
orcombinationofmedicinalingredients.

OnceaCanadianpatentisgranted,apatentholderormanufacturercanapplyforaCSPifallof
thefollowingconditionsaremet:
•ThepatentisinforceandisbasedonanapplicationwhichwasfiledinCanadaafterOctober
1,1989†;

•Thepatentrelatestothesamemedicinalingredientoracombinationofthesamemedicinal
ingredientscontainedinamedicineforhumanorveterinaryuse‡;

•Thefirstmarketingauthorization(i.e.noticeofcompliance)forthemedicinalingredientora
combinationwasissuedafterSeptember21,2017§;

•TheapplicationformarketauthorizationwasfiledinCanadawithin1year(or2yearsforthe
firstyearofapplicationoftheCSPscheme)afterthedateonwhichthefirstequivalent
applicationwassubmittedinacountryoftheEuropeanUnion,theUnitedStates,Australia,
SwitzerlandorJapan;

•NootherCSPhasbeengrantedforthemedicinalingredientoracombinationofthesame
medicinalingredients**;

©CIPS,2018.
*DanièleEthierisapartner,biochemistandCanadianpatentagentandAmélieCôtéisanarticlingstudent
workingatROBIC,LLP,afirmoflawyers,patentandtrademarkagents.†PatentAct,RSC1985,cP-4,s.106(1)a)andb);CertificateofSupplementaryProtectionRegulations,SOR/2017-165,s.3(1).‡CertificateofSupplementaryProtectionRegulations,SOR/2017-165,s.3(2).§PatentAct,RSC1985,cP-4,s.106(1)c.**Id.,s.106(1)e).

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•Theapplicableregulatorytaxesarepaid;and

•TheCSPApplicationisfiledwithHealthCanadawithin120daysfromthelaterof(i)thefirst
marketauthorizationofthemedicinalproduct;or(ii)thegrantofthepatent††.

Aswillbeseenbelow,failuretomeetanyoneoftheconditionsabovemayresultintheCSP
applicationbeingrefused.

SUMMARYOFPASTAPPLICATIONS

HealthCanadamaintainsaRegisterwhichincludesinformationfromCSPsandCSPapplications.
AsofOctober26,2018,twenty-sixCSPapplicationswerefiled,fifteenCSPsweregrantedand
threeapplicationshavebeenrejected.

CSPapplication900001wasthefirstCSPapplicationfiledandwasrejectedbecausethemarket
approvalwasissuedpriortoSeptember21,2017.Therefore,theconditionsofsection106(1)cof
thePatentActwerenotmet.

BasedontheinformationprovidedbyHealthCanada,CSPapplication900011wasrejected
becausethemarketauthorizationforthedrugwasnotthefirstmarketingapprovalasrequiredby
thePatentActandtheCertificateofSupplementaryProtectionRegulations.Apriorapprovalwas
issuedforaprescribedvariationofthemedicinalingredient.Inthiscase,thevariationwasapost-
translationmodificationofthemedicinalingredient(pegylationand/orglycosylation).

CSPapplication900006withrespecttothedrugSHINGRIX®wasrejectedbecausetheclaimsof
thepatentdidnotcontainaneligiblepatentclaim.Theclaimsinthepatentinquestionaredirected
totheuseofacompositioncomprisingagEantigenandaselectedadjuvanttomakeavaccine.
Accordingtothecourtdocuments,theCSPapplicationwasrejectedonthegroundsthattheclaims
aredirectedtoaformulationcomprisingmedicinalandnon-medicinalingredients.Accordingtothe
CSPRegulations,onlypatentcontainingclaimsforthemedicinalingredients,combinationsofthe
medicinalingredient,usesandprocessesformakingsameareeligibleforaCSP‡‡.

TheApplicantforCSPApplicationNumber900006recentlyappliedforajudicialreviewoftheir
refusedapplication§§.TheApplicantessentiallyclaimsthattheMinistermisinterpretedtheCSP
regimeinfindingthatadjuvantsarenotmedicinalingredients***.Thedeterminationofthecourthas
yettobemade.Nonetheless,beingthefirstreviewofadecisionmadebytheHealthCanada
underthesenewregulations,thedecisionwillhopefullyclarifytheextentandlimitsofthisnewCSP
regime.

IMPORTANCEOFFULFILLINGTHECONDITIONS

CSPsallowpatentholderstobenefitfromanadditionalprotectionfortheirpatenteddrugs.To
benefitfromthisrecentregime,itishowevercrucialthattheCSPApplicationfulfillallofthe
††Id.,s.106(3);CertificateofSupplementaryProtectionRegulations,SOR/2017-165,s.6(2).‡‡SeeFederalCourtNoticeofApplicationNo.T-1603-18:https://www.robic.ca/publications/federal-court-glaxosmithkline-biological-s-minister-health/§§Id.***Id.,para.34.

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conditionssetoutinthePatentActandtheCertificateofSupplementaryProtectionRegulations.
Ascanbeseenfromthecasesdiscussedabove,failingtoproperlyensurethatalltheeligibility
conditionsaremetmayresultintherefusaloftheCSPapplication.Ourteamofexpertscanhelp
youstrategicallycoordinateyourpatentsandCSPapplications,allwhileensuringthatregulatory
measuresaremet.Weinviteyoutocontactusforadditionalinformation.