In a recently released decision (2020 FC 635), Justice O’Reilly held that patent infringement actions taken under section 6(1) of the Patent Medicines (Notice of Compliance) Regulations do not become moot if the action is not heard or decided before the patent(s) at issue expires.

AstraZeneca Canada Inc. and AstraZeneca AB commenced the actions in January 2020 against Sandoz Canada Inc., with respect to Canadian Patent No. 2,402,894 (“894 Patent”).  The trial for the action is scheduled for October 2021.  However, the 894 Patent will expire on March 5, 2021, about seven months before the trial opens.

AstraZeneca brought a motion seeking a preemptive declaration that the action will not be rendered moot by the 894 Patent’s expiry.  Sandoz did not oppose the motion and, indeed, does not appear to have filed any responding motion record.

The Court held that the action would not be moot after the patent’s expiry for two reasons.  Collectively, these outline a preference that matters of substantive patent law (e.g., infringement and validity) should be addressed as part of infringement actions taken under section 6(1) of the Regulations, while actions under section 8 of the Regulations should focus on section 8 damages.

[15]  First, unlike its predecessor, the current regulatory scheme envisages the determination of substantive patent issues within a single proceeding (s 6.01). It would be inconsistent with that intent if substantive issues relating to patents soon to expire would be dealt with differently than those arising in respect of younger ones. For example, it would be incongruous if the determination of the former would depend on the exercise of the Court’s discretion rather than a patentee’s right of action under s 6.

[16]  Second, s 8 actions have typically been confined to damages calculations, leaving substantive patent matters to s 6 proceedings. For example, attempts to re-litigate infringement within a s 8 action have been discouraged: Apotex Inc v Pfizer Canada Inc, 2013 FC 493 at para 26.

Consequently, the possibility of a claim for section 8 damages would be sufficient to avoid an infringement action under the Regulations from becoming moot, with the Court willing to assume that claims for section 8 damages normally follow the dismissal of proceedings taken under section 6(1) of the Regulations.

The Court also noted, as pointed out by AstraZeneca, that certain acts by Sandoz, such as the manufacturing of commercial product before the 894 Patent’s expiry, could result in possible other remedies in addition to the declaration under section 6(1) of the Regulations, including possible damages.  Although this point was not elaborated upon, the Court appeared to accept that actual acts of infringement during the life of the patent would preclude the action from being moot after the patent’s expiry.

The motion was originally scheduled for an oral hearing but the hearing was adjourned by the COVID‑19 Suspension Period.  The motion was instead dealt with in writing only.