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11 February 2013
The Ontario Superior Court of Justice has dismissed a claim by Apotex for unjust enrichment under the Patented Medicines (Notice of Compliance) Regulations.(1)
The decision confirms that:
The Federal Court of Appeal had previously ruled that a claim for unjust enrichment was not available in the federal courts.(2)
Apotex's claim arose from a proceeding under the regulations started by Abbott in relation to lansoprazole (Prevacid). Abbott had already successfully asserted the same patent against Teva.
Abbott had started a proceeding against Apotex under the regulations. As Takeda owned the patent, it was a necessary party. Following a hearing on the merits, but before the Federal Court released the decision, the parties settled the case. Abbott agreed that Apotex could enter the market before patent expiry and Apotex reserved the right to claim damages under Section 8 of the regulations for a specified period of time. The agreement was silent on Apotex advancing a claim for unjust enrichment.
Apotex subsequently commenced proceedings in the Ontario court against Abbott and Takeda seeking, in part, disgorgement of Abbott's revenues or alternatively, profits as a consequence of delay attributable to Abbott. A previous proceeding commenced by Apotex in the Federal Court was discontinued.
Abbott and Takeda moved for partial summary judgment seeking dismissal of the claim for disgorgement based on unjust enrichment. The court identified four issues, resolving them as follows:
"Just like the Apotex claim that was before the Federal Court of Appeal in Eli Lilly, Apotex in this case relies on the same delay, caused by the same invocation of the [r]egulations, as the basis for both its claim under s. 8 and its claim in unjust enrichment. Any equitable rights which might have operated but for the [r]egulations cannot be relied upon because: (a) the statute establishes a scheme for compensation and, as such, common law rights are excluded; and, (b) with irresistible clearness, Parliament intended to eliminate any claim to unjust enrichment."
The decision continues the judicial trend towards restricting the remedies available to generics related to unsuccessful proceedings under the regulations. Without exceptional circumstances, the courts are increasingly reluctant to grant remedies in the face of the "code" laid down in the regulations.
(1) Apotex Inc v Abbott Laboratories Limited, 2013 ONSC 356.
(2) Apotex Inc v Eli Lilly Canada Inc, 2011 FCA 358. Leave to appeal to the Supreme Court of Canada was subsequently denied.
(3) 2012 ONSC 3808.
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