Since the amendments to the PM(NOC)
Regulations in 2017, both generic and brand side
litigants have struggled with the question of whether the second
person's Notice of Allegation governs the issues in the
proceeding, or the Statement of Defence. The Federal Court of
Appeal has answered in this week's decision in Sunovion Pharmaceuticals Canada Inc v Taro
Pharmaceuticals Inc: it is the Statement of Defence.
This grey area arose because the amendments shifted the
proceedings under the Regulations from
applications to actions. As Justice Locke wrote for the Federal
Court of Appeal, the pre-2017 Regulations
“contemplated an application by a ‘first person'
for an Order prohibiting the Minister of Health from issuing a
notice of compliance, in which the first person bore the burden of
establishing that the allegations made in the NOA [Notice of
Allegation] were not justified.” A proceeding by way of
application meant there were no pleadings and the Notice
