The Supreme Court of Canada announced today that it has granted leave to appeal to Apotex Inc. from the Federal Court of Appeal (FCA) in the patent case Sanofi-Aventis v. Apotex Inc. (reported here), in which the FCA allowed Sanofi’s action for infringement and dismissed Apotex’s action for impeachment (reported here). At the heart of the dispute is the determination of the validity of the Canadian Patent No. 1,366,777 (the ‘777 Patent) in light of the controversial notion of the promise of the patent. The ‘777 Patent relates to clopidogrel bisulfate, a drug useful in inhibiting platelet aggregation and sold in Canada under the brand name Plavix.
In order to launch a generic version of Plavix in Canada, Apotex applied for a Notice of Compliance, claiming that its version of clopidogrel did not infringe Sanofi’s patent as well as challenging the validity of the ‘777 Patent on several grounds including utility. Sanofi obtained an order prohibiting the issuance of the Notice of Compliance and the order was upheld on appeal and at the Supreme Court (2008 SCC 61).
Subsequently, Apotex commenced an impeachment action in the Federal Court seeking a declaration that the ‘777 Patent was invalid on several grounds including lack of utility. Sanofi countered with an infringement action alleging that Apotex had infringed the ‘777 Patent by importing clopidogrel into Canada and then exporting it from Canada. The two actions were consolidated and the Federal Court found the ‘777 Patent invalid based on lack of utility and obviousness, while dismissing Sanofi’s infringement action (2011 FC 1486). The trial judge ruled that the promise of the patent was neither demonstrated nor soundly predicted as of the filing date of the patent application.
The FCA subsequently reversed the trial judge’s decision, dismissed Apotex’s impeachment action and allowed Sanofi’s action for infringement. The FCA ruled that the promise of the patent is the standard against which the utility of the invention described in the patent is measured. Referring to what was set out in the Olanzapine case, the FCA said that where the inventor does not make an explicit promise of a specific result, the test for utility is a “mere scintilla” of utility. However, where the inventor makes an explicit promise of a specific result, utility will be assessed by reference to the terms of the explicit promise. The FCA held that the Federal Court erred in reading into the ‘777 Patent a promise for use in humans on the basis of inferences, in the absence of language at least as clear and unambiguous as that used to establish the advantages of the selection over the compounds of the genus patent.