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ARTICLE · 02 OCTOBER 2021

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PM(NOC) Regulations: Fourth Year Following Major Amendments

September 21, 2021 marked the fourth anniversary of the significant amendments to the Patented Medicines Regulations.

CanadaIntellectual Property

September 21, 2021 marked the fourth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations  (Regulations). This article provides an update on activities in the fourth year following the amendments, including new actions and a wave of Court decisions, both on the merits and procedural (see our prior first, second and third anniversary updates).

Status of actions under the Regulations

In the period of September 21, 2020 to September 21, 2021, approximately 29 sets 1 (43 total) of actions were started. This is a drop from the last two years (49 in 2019-2020 and 35 in 2018-2019).

Of the approximately 186 actions started since the amendments, the majority were resolved before a decision on the merits (114, in grey below), 19 actions were pursued to a decision on the merits, with the majority of actions dismissed (13, in red below). Appeals are pending from 18 actions; one trial decision was affirmed on appeal.

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The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.

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