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.