The Federal Court has held that the “related right of action” for infringement of unlisted patents under section 8.2 of the Patented Medicines (Notice of Compliance) Regulations (Regulations) is not subject to the 45-day limitation period familiar to patentees asserting infringement of listed patents under subsection 6(1).
Merck Canada Inc. and Merck Sharp & Dohme Corp. (the Plaintiffs) are involved in litigation under the Regulations against Sandoz Canada Inc. and Pharmascience Inc. (the Defendants) regarding proposed generic versions of the drug JANUVIA (sitagliptin).
The Plaintiffs initially brought infringement actions under subsection 6(1) in respect of three patents listed against JANUVIA. These actions were commenced within 45 days of receiving each generic notice of allegation (NOA), as expressly required by subsection 6(1).
After the 45-day period had expired, the Plaintiffs commenced infringement actions in respect of the proposed generics under section 8.2 of the Regulations. In these “related” quia timet-type actions, the Plaintiffs asserted a fourth patent that was not listed on the patent register.
The Defendants moved to have the section 8.2 actions dismissed or struck on the basis that they are subject to the same 45-day limitation period set out in subsection 6(1) of the Regulations.
No 45-day limitation period: section 8.2 removes barriers to quia timet actions
Focusing on the text of the provision, the Plaintiffs argued that unlike subsection 6(1), section 8.2 does not contain an express limitation period. The Defendants argued that section 8.2 requires the related action to be commenced “on receipt” of an NOA, and that this suggested immediacy.
The Court considered the text, context and legislative purpose of the provision and agreed with the Plaintiffs that there was no reason to read down section 8.2 to include a 45-day limitation period.
The Regulatory Impact Analysis Statement (RIAS) supported that section 8.2 was intended to eliminate common law barriers to quia timet actions for specific patents before the generic enters the market. The Court noted that “prior to the 2017 regulatory amendments, the common law prohibited such actions … except in exceptional circumstances”. Section 8.2 permits these actions to be brought based on the NOA.
The Court therefore dismissed the Defendants’ motion, granted summary judgment on the limitations issue in favour of the Plaintiffs, and dismissed the Defendants’ limitation defence.
Link to decision: Merck Sharp & Dohme Corp v Sandoz Canada Inc, 2020 FC 1180