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Intellectual property – Patents –Medicines – Following prohibition order under Patented Medicines (Notice of Compliance) Regulations, SOR 93/133, patent in question declared invalid in patent action – Whether s. 8 of the Regulations provides for compensation for a generic company which has been kept out of the market by a NOC prohibition order where it is determined that the relevant claims of the patent which are the basis for the order are invalid - Whether the underlying application for the prohibition order should be dismissed? Whether the federal court of appeal made other fundamental errors of law in affirming the refusal to dismiss the NOC prohibition applications substantially for the reasons of the motion judge?


In 2001, Pharmascience Inc. (“Pharmascience”), a generic drug manufacturer, submitted a notice of allegation to the Minister of Health to obtain a notice of compliance (“NOC”) to market its generic version of ramipril, a drug used in the treatment of hypertension. The Respondents (collectively,“Aventis”) brought a motion to prohibit the Minister of Health from issuing a NOC to Pharmascience. The court rejected Pharmascience’s allegation that the claims of the ‘206 patent were invalid for double patenting and granted the prohibition order until after the expiry of the ‘206 patent. Pharmascience filed a second notice of allegation, asserting that the ‘206 patent was invalid on several different grounds. The court held that the allegation of invalidity had been finally determined in the first application and that issue estoppel precluded Pharmascience from making further allegations of invalidity and issued a second prohibition order.

In 2007, Aventis commenced an infringement action against Apotex Inc. and Novopharm Limited, two other generic manufacturers, arising from their sales of ramipril in Canada. Claims 1,2,3,6 and 12, the same claims that were relevant in the Pharmascience NOC litigation, were found to be invalid and of no force and effect. As a result of this finding in 2009, Pharmascience again asked the Minister for a NOC to market its ramipril capsules. The Minister’s position was that as not all of the claims of the ‘206 patent were declared invalid, it could not be considered “expired” and refused to issue the NOC. Pharmascience brought a motion to set aside the two orders of prohibition and to dismiss their underlying applications granted by the federal court in the NOC litigation.