Balancing Efficiency And Compressed Timelines: Two Years Into The Amended Patented Medicines (Notice Of Compliance) Regulations

The September 21, 2017 amendments to the PMNOC Regulations brought significant change to litigation involving patented medicines in Canada. Perhaps most notably, (i) infringement actions replaced applications for prohibition orders, (ii) eliminating dual litigation and (iii) guaranteeing patentees a right of appeal even if the Minister of Health issues a Notice of Compliance. The amendments introduced documentary and oral examinations for discovery at the interlocutory stage and viva voce testimony at trial, but maintained the 24-month period to complete the proceedings.

The first trials of actions brought under the amended Regulations are scheduled for early 2020. As these cases work their way to trial, the Court has been called on to examine a number of interlocutory issues unique to actions under the Regulations, including rights of confidentiality and the test for striking a claim as frivolous and vexatious.

Prohibition on Joinder

One provision that has received noteworthy attention is the new section restricting joinder of actions. Section 6.02 of the Regulations prohibits joinder with any other action unless it relates to the submission at issue in that given action, or an action brought in relation to a Certificate of Supplementary Protection if the patent set out in that CSP is in issue. The Regulatory Impact Analysis Statement issued with the Regulations explains that the rationale for the prohibition is to restrict the number of issues in dispute and facilitate resolution within the 24-month statutory stay period1.

While in principle prohibiting joinder may facilitate resolution within 24 months, it can also place a heavy burden on innovators served with NOAs from multiple generics by requiring the innovator to litigate concurrently the same or similar issues in multiple proceedings. While this issue existed prior to the amendments, the added workload of an action, including document production and examinations for discovery, heightens the concern. At the same time, the ability of a later generic to challenge a patent whose validity was upheld in earlier proceedings is muted. That is, where the court has declared a patent valid in an action, comity dictates considerably more deference to findings made in a full action on infringement and validity. This is in contrast to findings made in thesummary proceedings in applications under the former Regulations as to whether allegations were justified in order to determine simply whether the...