WORLD TRADE WT/DS114/1
ORGANIZATION IP/D/11
G/L/221
12January 1998
(98-0059)
Original: English
CANADA -PATENT PROTECTION OF
PHARMACEUTICAL PRODUCTS
Request forConsultations bytheEuropean Communities
Thefollowing communication, dated 19December 1997, fromthePermanent Delegation of
theEuropean Commission tothePermanent Mission ofCanada andtotheDispute Settlement Body,
iscirculated inaccordance withArticle 4.4oftheDSU.
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Pursuant toArticle 4oftheUnderstanding onRules andProcedures Governing theSettlement
ofDisputes (DSU), Article 64oftheAgreement onTrade-Related Aspects ofIntellectual Property
Rights (TRIPs Agreement) inconjunction withArticle XXII oftheGeneral Agreement onTariffs and
Trade 1994(GATT 1994), werequest consultations onbehalf oftheEuropean Communities andtheir
Member States withtheGovernment ofCanada regarding theprotection ofinventions intheareaof
pharmaceuticals under therelevant provisions oftheCanadian implementing legislation (inparticular
thePatent Act)inrelation toitsobligations under theTRIPs Agreement.
Byvirtue oftheTRIPs Agreement, Members oftheWorld Trade Organisation (WTO) are
required toprovide:
- forpatent protection without discrimination astothefieldoftechnology (Article 27.1
oftheTRIPs Agreement);
- thatpatents confer ontheirowners theexclusive righttoprevent thirdparties nothaving
theowner ’sconsent from, among others, theactsofmaking andusing thepatented
product (Article 28oftheTRIPs Agreement);
- foratermofprotection ofaperiod of20years counted fromthefiling date(Article 33
oftheTRIPs Agreement).
Under Canadian patent legislation, however, athirdpartymay,without theconsent ofthepatent
holder, useapatented invention to:
- carry outexperiments andtestsrequired (proof ofsafety andbio-equivalency) toobtain
marketing approval ofthecopyofaninnovative medicine before theexpiration ofthe
relevantpatentinordertoensuremarketaccessimmediatelyfollowingthepatentexpiry;
- manufacture andstockpile patented products foraperiod ofuptosixmonths before
patent expiry forsaleafterexpiry.
./.WT/DS114/1
IP/D/11
G/L/221
Page2
IntheviewoftheEuropean Communities andtheirMember States, Canada ’spatent legislation
isnotcompatible withCanada ’sobligations under theTRIPs Agreement, since itdoesnotprovide
forthefullprotection ofpatented pharmaceutical inventions fortheentire duration ofthetermof
protection asforeseen under Articles 27.1, 28and33oftheTRIPs Agreement.
Welookforward toreceiving yourreplytothepresent request forconsultations andtoagreeing
onamutually acceptable dateonwhich these consultations canbeheld.
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