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
