On May 22, 2020, the Federal Court granted a motion seeking an order that the issue of infringement in an action brought pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations (Regulations) would not be moot notwithstanding that the trial was set to proceed after the expiry of the relevant patent.
Sandoz served a Notice of Allegation on AstraZeneca alleging non-infringement, invalidity and ineligibility for listing of AstraZeneca’s patent for saxagliptin tablets (marketed as ONGLYZA), being Canadian Patent No. 2,402,894 (894 Patent). AstraZeneca commenced an action against Sandoz seeking a declaration that Sandoz would infringe the 894 Patent pursuant to subsection 6(1) of the Regulations (the Action).
The 894 Patent expires on March 5, 2021. However, the trial of the Action was scheduled for October 2021. AstraZeneca brought a motion seeking an order confirming that the infringement action would not be rendered moot upon the expiry of the 894 Patent and alternatively, confirming that the Court would exercise its discretion to decide the issue of infringement even if it were moot. The motion was unopposed by Sandoz.
The issue of infringement is not moot upon patent expiry
The Court found that the issue of infringement was not moot even though it would be determined after the patent expires because a decision was relevant to: 1) whether Sandoz was justifiably kept off of the market by the statutory stay; and 2) the issue of remedies.
Deciding the issues of infringement, invalidity, and ineligibility for listing, is relevant to whether the statutory stay imposed during the litigation is justified. This remains a live issue even after the expiry of the 894 Patent.
Additionally, the Court can grant broad remedies to AstraZeneca under the Patent Act if it is successful in obtaining a declaration of infringement. The issue of appropriate remedies also remains a live issue after the expiry of the 894 Patent.
In the alternative, the Court determined that even if the issues were moot, the Court would have exercised its discretion to decide the case.
Postponing the issues to a later section 8 proceeding is not appropriate
The Court considered whether it was appropriate to defer deciding the issues in the Action to a later potential section 8 proceeding. It decided it was not appropriate for two reasons. First, the intent of the regulatory scheme is to determine substantive patent issues within a single proceeding (i.e., under section 6.01 of the Regulations). It would be inconsistent with that intent to treat patents close to expiry differently from newer patents. Second, as section 8 actions are typically related to damages calculations, the Court found that it was more appropriate to decide substantive patent issues within the section 6 action.