Apotex Inc. v. Pfizer Canada Inc., 2014 FCA 250

This decision relates to two appeals that were heard together and the reasons apply to both. The decision set out the parties’ positions and then noted the standard of review for the issues. In particular, patent construction is a question of law, which is assessed on a standard of correctness. Whether utility has been established, either demonstrated or predicted, is a question of fact to be reviewed for a palpable and overriding error, and sufficiency of disclosure is a mixed question of fact and law and therefore is reviewed for a palpable and overriding error unless there is an error of law.

The Court of Appeal noted “[t]he promise doctrine will hold an inventor to an elevated standard only where a clear and unambiguous promise has been made. Where the validity of a patent is challenged on the basis of an alleged unfulfilled promise, the patent will be construed in favour of the patentee where it can reasonably be read by the skilled person as excluding this promise.” The Court of Appeal then determined that the Application Judge correctly construed the promise of the patent, noting that while a promise can appear in the specification provided that the language is clear and explicit, there was no error in the Judge acknowledging that statements that are not in the claim should not be presumed to be promises.

The Court of Appeal addressed a number of alleged promises. Apotex argued that any given promise must be construed as an overarching promise, but the Court of Appeal indicated that there was no support in the jurisprudence for this argument.

The Court of Appeal also addressed abuse of process, stare decisis and comity in light of an apparent concession made with respect to the promise in previous proceedings under the Patented Medicines (Notice of Compliance) Regulations. The Court of Appeal dismissed these arguments. Both appeals were dismissed with costs.