Bill C-9 an Act to Amend the Patent Act and the Food and Drugs Act – A Humanitarian Initiative

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BILLC-9ANACTTOAMENDTHEPATENTACTANDTHEFOODANDDRUGSACT-
AHUMANITARIANINITIATIVE

ZhenWong*
LEGERROBICRICHARD
,L.L.P.
Lawyers,PatentandTrademarkAgents
CentreCDPCapital
1001Square-Victoria–BlocE–8thFloor
Montreal,Quebec,CanadaH2Z2B7
Tel.(514)9876242–Fax(514)8457874
www.robic.ca–info@robic.com

OnMay14th,2004,BillC-9entitledAnActtoamendthePatentActandthe
FoodandDrugsAct(JeanChrétien’spledgetoAfrica)(“BillC-9”)received
assent.
ThisActwascreatedinordertoallowthemanufactureanduseofa
patenteddrugforthepurposeofexportationtodevelopingandleast
developedcountriesafflictedbydiseasessuchasHIV/AIDS,tuberculosis,
malariaandotherepidemics.
TheCanadianPatentAct,aspresentlyinforce,doesnotincludeany
provisionswhichallowathirdpartytoimport,manufacture,useorsella
patentedinventionformedicinewithoutalicencewhileexemptingthatparty
frominfringingthepatentcoveringtheinvention.
ExemptionsunderBillC-9aregrantedonlyforhumanitarianandnon-
commercialreasons.Sections21.01to21.2ofBillC-9establishcriteriathatan
applicantmustmeetandtheprocedurestobefollowedwhenfilingan
applicationunderthisstatute.
Subjecttocertainconditions,BillC-9grantspowertotheCommissionerof
Patentstoauthorizeapersonorentitytomanufactureoruseapatented
inventionsolelyforpurposesdirectlyrelatedtothemanufactureofthe
pharmaceuticalproducttobesoldforexporttoacountryorWTOmember
thatislistedinanyofschedulesIItoIVofBillC-9.
Todate,sections21.01to21.2applytospecificpharmaceuticalproducts
whicharedefinedinscheduleIbytheirdosageform,theirstrengthandtype
ofadministration.About56pharmaceuticalproductsarelisted.Thecountries




























































CIPS,2004.
*OfLEGERROBICRICHARD,L.L.P.,amultidisciplinaryfirmoflawyers,andpatentandtrademark
agents.PublishedintheSummer2004issue(Vol.8,No.3)issueofourNewsletter.Publication
068.062E.

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towhichtheproductscanbeexportedarelistedinschedulesIItoIVofBillC-
9.About50countriesarelisted.Itshouldbenotedthatthesesectionsinclude
provisionsallowingtheGovernorinCounciltoamendschedulesItoIV.
Eachapplicationshouldinclude:
-thenameofthepharmaceuticalproducttobe
manufacturedandsoldforexportundertheauthorization;

-informationwithrespecttotheversionofthe
pharmaceuticalproducttobemanufacturedandsoldfor
exportundertheauthorization;
-themaximumquantityofthepharmaceuticalproductto
bemanufacturedandsoldforexportunderthe
authorization;
-foreachpatentedinventiontowhichtheapplication
relates,thenameofthepatenteeoftheinventionand
thenumber,asrecordedatthepatentoffice,ofthe
issuedpatentinrespecttothatinvention;
-thenameofthecountryorWTOmembertowhichthe
pharmaceuticalproductistobeexported;and
-thenameofthegovernmentalpersonorentity,orthe
personorentitypermittedbythegovernmentofthe
importingcountry,towhichtheproductistobesold.
ItshouldalsobenotedthatanauthorizationgrantedunderBillC-9isvalidfor
aperiodoftwoyearsbeginningonthedayonwhichtheauthorizationis
granted.Furthermore,theuseofapatentedinventionundersuchan
authorizationisnotexclusiveandnon-transferableunlesstheholderofthe
authorizationissold,assignedorotherwisetransferred.

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