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ARTICLE · 14 MAY 2013

Authorized Generics In The Hypothetical World Of Generic Damages

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Canada, as in other jurisdictions, links drug marketing approval with patent rights.

CanadaIntellectual Property
Christopher Van Barr
Christopher Van Barr
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Canada, as in other jurisdictions, links drug marketing approval with patent rights. Innovative drug manufacturers may list relevant patents against their drugs. Such listing may then trigger a temporary, but automatic, stay of regulatory approval for other manufacturers' generic versions of these drugs. A consequence of delaying generic market entry is that innovators are subject to potential liability for the generic's damages where the statutory stay was unwarranted. In order to quantify these generic damages, the Court will create a "hypothetical world" in which the generic manufacturer was not prevented from entering the market.

Late in 2012, almost 20 years after this linkage scheme was first put in place, the Federal Court issued its first judgement quantifying generic damages. On November 2, 2012, the Federal Court awarded Apotex Inc. $215,529,129 in damages against Sanofi-Aventis in connection with Apotex's attempts to market a generic version of Sanofi's

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