On July 6, 2018, the Federal Court dismissed the first motion brought under section 6.08 of the newly-amended Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court’s public reasons were released July 30, 2018. The moving party, Amgen Canada Inc. (Amgen), was seeking an order dismissing the Plaintiffs’ action in respect of two of the patents in suit on the ground that the action is redundant, scandalous, frivolous or vexatious or is otherwise an abuse of process. Amgen contended that it was plain and obvious that the Plaintiffs’ infringement allegations had no chance of success.

Norton Rose Fulbright Canada LLP represented the Plaintiffs, Genentech, Inc. and Hoffmann-La Roche Limited.


Amgen is seeking Health Canada’s approval to market a biosimilar version of HERCEPTIN® for the same indications as HERCEPTIN®.  The Plaintiffs commenced an action against Amgen seeking a declaration that the making, constructing, using or selling of Amgen’s biosimilar would infringe four patents. Amgen brought a motion to dismiss the action in respect of two of the patents, Canadian Patents No. 2,376,596 (596 Patent) and 2,407,556 (556 Patent). Amgen argued that the Plaintiffs’ allegations that Amgen would induce infringement of the 596 Patent and the 556 Patent were clearly futile.

Motion to dismiss under section 6.08

This was the first motion to dismiss brought under section 6.08 of the newly-amended Regulations. The Court found, however, that the jurisprudence under section 6(5)(b) of the previous Regulations – which had essentially the same language as section 6.08 – was applicable.

Therefore, as set out in the section 6(5)(b) case law, dismissing an action under section 6.08 remains an extraordinary remedy. The moving party bears the onus of demonstrating that the claim is so clearly futile that it has not the slightest chance of success. The Court is to determine whether the plaintiff raises an arguable case. In doing so, the Court  is not to embark on anything resembling a trial of the action in order to evaluate the strength of either party’s case.

The Court found that it should exercise a heightened level of caution in dismissing actions under the newly-amended Regulations, as – unlike the previous Regulations – if the action is dismissed, the plaintiff may be precluded from suing for patent infringement if the proposed product comes to market.

The Court also observed that, because the newly-amended Regulations provide for discovery, in cases that – like this one – concern induced infringement of use claims, there may be many key documents in addition to the proposed product monograph.

An arguable case of induced infringement

The Court found that it was not plain and obvious that the Plaintiffs’ allegations of induced infringement had no chance of success. With respect to the 596 Patent, the Court found that the parties had engaged in legal and factual disputes during the motion. The Court determined that it was at least arguable that Amgen would exert the requisite influence leading to direct infringement of the 596 Patent by physicians and patients. With respect to the 556 Patent, the Court determined that there was a debatable issue regarding claims construction and that the Plaintiffs had otherwise raised an arguable case of induced infringement.


Genentech, Inc. and Hoffmann-La Roche Limited v Amgen Canada Inc., 2018 FC 694