Federal Court Of Appeal Of Canada Dismisses Patent Validity Appeal Relating To Macitentan Drug

On November 9, 2023, the Federal Court of Appeal (FCA) issued its decision in Sandoz Canada Inc. v Janssen Inc., 2023 FCA 221, dismissing an appeal relating to a decision of the Federal Court (FC) that dismissed allegations by the appellant, Sandoz Canada Inc. (Sandoz), that Canadian Patent No. 2,659,770 (the Patent) was invalid on various grounds.

Last year, in Janssen Inc. v Sandoz Canada Inc., 2022 FC 715, the FC found that Sandoz had failed to establish that the claims of the Patent were invalid for obviousness, lack of utility, overbreadth, or insufficiency, as previously reported by E-TIPS® Newsletter here.

On appeal, Sandoz addressed only the lack of utility argument.  The issue on appeal was whether the FC applied the incorrect legal test for sound prediction by failing to consider the requirement for a “prima facie reasonable inference of utility”.  Sandoz acknowledged that the FC did not err simply in failing to state that the threshold for a sound prediction is a prima facie reasonable inference of utility.  However, Sandoz urged the FCA to infer that the FC failed to apply this threshold because, it said, the evidence could not support it.

The FCA held that the FC’s failure to cite the wording “a prima facie reasonable inference of utility” when applying the threshold for sound prediction was not remarkable and did not amount to an error of law.  Sandoz cited factual findings made by the FC in support of its position that the FC applied a lower threshold for sound prediction.  The FCA dismissed Sandoz’s argument, finding that the threshold was not high and it was up to the FC to weigh the evidence and decide whether the threshold for a sound prediction had been met.  Further, the FCA noted that Sandoz itself did not explicitly refer to this wording in its written argument before the FC, and therefore it was not surprising that the FC did not use this wording.

The FCA dismissed the appeal with costs.

Summary By: Victoria Di Felice