Federal Court of Appeal upholds prohibition application dismissal under s. 6(5)(b) of the NOC Regulations

Bayer Inc. et al., v. Fresenius Kabi Canada Ltd., 2016 FCA 13

Bayer appealed the dismissal of its application for a prohibition order against Fresenius in respect of the drug moxifloxacin hydrochloride. Prothonotary Lafrenière dismissed the application under s. 6(5)(b) of the Patented Medicines (Notice of Compliance) Regulations on the basis that Fresenius’ product monograph for moxifloxacin did not infringe or induce infringement (see 2015 FC 388).

The Federal Court dismissed Bayer’s Rule 51 motion from the Prothonotary’s order (see 2015 FC 797). Bayer appealed that decision to the Federal Court of Appeal. On the Rule 51 motion, the Federal Court did not interfere with the Prothonotary’s decision. Therefore, the Federal Court of Appeal could only intervene if the decision of the Federal Court was arrived at on a wrong basis or was plainly wrong.

Justice Stratas, writing for the Federal Court of Appeal, dismissed the appeal.

On the motion below, the Federal Court had set out the applicable principles on the law of inducement. The parties did not dispute those principles and so the decision could not have been arrived at on a wrong basis. According to the Federal Court of Appeal, the decision on appeal was not plainly wrong because:

[11] At paragraphs 53 of its reasons and following, the Federal Court applied these principles to the facts before it. In our view, in doing so, it was not plainly wrong. It found as a factual matter that the product monograph in question does not instruct or direct that Fresenius’ product is to be co-administered or co-administered with 0.9% sodium chloride (at paragraphs 59-61). It also found that a general reference to sodium chloride in the product monograph was obligatory and fell short of inducement (at paragraphs 64-65). That was a factually-suffused finding in circumstances where the Federal Court had instructed itself properly on the principles relating to inducement.

In obiter, Justice Stratas noted that it may be time for a shift from the present standard of review on appeals from Rule 51 motions to the standard set out in Housen v Nikolaisen, 2002 SCC 33, which required a “palpable and overriding error” to overturn factually suffused findings. However, he found this was not quite the appeal to make that shift given the Court had not received full argument on the point.

The Court of Appeal’s decision is available here.