Patented medicines regulations -
No implied limitation period in
section 8.2

17 February 2021

In the recently issued decision, Merck Sharp & Dohme Corp. v. Sandoz Canada Inc. (2020 FC 1180) Justice Southcott confirmed that a 45-day limitation period does not apply to actions commenced under s. 8.2 of the Patented Medicines (Notice of Compliance) Regulations (the "Regulations").



Section 8.2 was added to the Regulations in September 2017. It allows a patentee or a first person under the Regulations to commence a quia timet action for infringement in response to a Notice of Allegation (NOA), with respect to a patent that is not the subject of the NOA or that is not listed on the Patent Register.

In Merck v Sandoz, the Plaintiffs commenced patent infringement actions under s. 6(1) in respect of three patents for sitagliptin listed on the Patent Register which were addressed in the NOAs served by the Defendants. Pursuant to section 6(1) of the Regulations, a patent owner or first person who is served a NOA by a second person has 45 days within which to bring an action against the second person.

More than four months after receiving the NOAs, the Plaintiffs also filed Statements of Claim commencing actions pursuant to s. 8.2 of the Regulations (the "s. 8.2 actions") against the same Defendants for infringement of Canadian Patent No. 2,518,435, which was not listed on the Patent Register or addressed in the NOAs.

In response, each Defendant brought a motion seeking an order for summary judgment or, alternatively, an order to strike out the Statement of Claim in the s. 8.2 actions. The Defendants took the position that s. 8.2 imposes a 45-day limitation period upon service of the NOAs, same as for actions commenced under s. 6(1), which had expired by the time the s 8.2 actions were commenced.

The Plaintiffs' main submissions highlighted the clear differences in the language of s. 8.2 and s. 6(1). From the Plaintiffs' standpoint, if the legislature intended to include a limitation period, it would have done so as it had done for other provisions under the Regulations. The Defendants primarily argued that the language of s. 8.2 should be read down to include such a 45-day limitation to advance infringement actions enforcing unlisted patents within the 24-month statutory stay resulting from s. 6(1). Without this time limitation, the Defendants argued, pending s. 8.2 actions "may frustrate the market entry of generics" and its legislative purpose.

The Court considered the text and legislative purpose of s. 8.2 as well as the Regulatory Impact Analysis Statement in determining that the legislature intended for s. 8.2 actions to proceed outside and independently of the regime created by the Regulations. The only impact of the Regulations on s. 8.2 actions is to remove the barriers to quia timet actions normally imposed under common law. Accordingly, the legislative purpose underlying the Regulations does not require s. 8.2 actions to be subject to a 45-day limitation period.

The Court also held that the 45-day limitation period is a function of the intention of the 24-month statutory stay (i.e., "to bring the litigation to conclusion expeditiously"), which only applies to actions commenced under s. 6(1) and not to s. 8.2 actions. Moreover, given the notice function of NOAs and the breadth of information provided within them, the Court accepted that the since a NOA and the information required to be provided with a NOA are directed to patent(s) specifically addressed in the NOA, a first person would not be similarly prepared to launch a s. 8.2 action within 45 days as with s. 6(1) actions.

As a result, the Court properly concluded that s. 8.2 of the Regulations does not impose a limitation period, and granted partial summary judgement to the Plaintiffs dismissing the Defendants' limitation defences.


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