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On December 22, 2020, the Federal Court issued its decision
holding that section 8.2 of the
Patented Medicines (Notice
of Compliance) Regulations (
PMNOC Regulations)
does not impose a limitation period either the same as or
comparable to the 45-day limitation period for commencing an action
under subsection 6(1):
Merck v Sandoz and
Pharmascience, 2020 FC 1180.
Background
Merck commenced actions pursuant to subsection 6(1) of
the
PMNOC Regulations against Sandoz and
Pharmascience after each served a notice of allegation (NOA) in
respect of the patents listed against
Merck s
JANUVIA (
sitagliptin).
Three months later, Merck commenced an action against each
VISTITAN (
Allergan Inc v Alberta (Justice and
Solicitor General), 2021 ABCA 32.
Alberta Health concluded that VISTITAN was interchangeable with
LUMIGAN RC on the basis that LUMIGAN RC had previously been listed
as interchangeable with another Allergan bimatoprost product with
the same concentration as
VISTITAN:
LUMIGAN (
0.03%
bimatoprost).
On judicial review (reported
here), the reviewing Court agreed that Alberta Health s
decision was unreasonable, but the judicial review was nonetheless
dismissed as not pertaining to the most final or recent decision on
interchangeability. The Court concluded that Allergan ought to have
sought judicial review of Alberta Health s later decision on
Allergan s resubmission for LUMIGAN RC, which the Court