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Action under amended PMNOC Regulations not rendered moot by patent expiry

On May 22, 2020, the Federal Court held that an action under the amended Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) relating to saxagliptin (ONGLYZA) would not be rendered moot by the relevant patent’s expiry before trial: AstraZeneca Canada Inc v Sandoz Canada Inc, 2020 FC 635.

In the underlying action, AstraZeneca seeks a declaration under section 6(1) of the PMNOC Regulations that Sandoz’s generic saxagliptin product would infringe Canadian Patent No. 2,402,894 (894 patent). Sandoz defended, alleging that the 894 patent is invalid, not infringed and ineligible for listing on the Patent Register.  The trial was scheduled for October 2021.  As the patent will expire in March 2021, AstraZeneca moved for an Order confirming the action will not be rendered moot upon patent expiry and in the alternative, asking the Court to exercise its discretion to hear the case even if moot.  Sandoz did not oppose the motion.

Issue of infringement not rendered moot by patent’s expiry

The Court found that the issue of infringement was not rendered moot by the expiry of the 894 patent. Per the Court, the declaration sought by AstraZeneca “will be of more than theoretical interest after the expiry of the patent”:

  • A 24-month stay was imposed on Sandoz when AstraZeneca commenced the action. The issue of infringement is relevant to whether Sandoz was justifiably kept off the market by that stay.
  • On granting a declaration under section 6(1), the Court may grant the plaintiff any remedy available under the Patent Act, and damages may be appropriate if Sandoz is found to have begun commercial manufacture of infringing product pre-expiry.
  • Although the issues in dispute could theoretically be resolved in a later section 8 proceeding, such proceedings are typically limited to calculating damages, and the current regulatory scheme envisages the determination of substantive patent issues within a single proceeding (per section 6.01).

Even if moot, Court would exercise its discretion to hear the proceeding

The Court further held that even if the proceeding were rendered moot by the patent’s expiry, the Court would exercise its discretion to nonetheless hear it:

  • If not resolved in the section 6(1) action, the issues in the proceeding may have to be determined in a later section 8 proceeding in any event.
  • It would be more efficient and economical to resolve the issues in dispute within the section 6(1) action already underway than in a later proceeding.
  • The Court would not encroach on the legislature’s role by deciding the issues in the action even if they were technically moot.

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