First Trial Decision Under Canada's Amended Patented Medicines (Notice Of Compliance) Regulations Offers Guidance On Key Issues

• Published date: 05 May 2020
• Law Firm: McCarthy Tétrault LLP
• Author: SnIP/ITs Blog, Bohdana Tkachuk, James S.S. Holtom and Fiona Legere
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Food and Drugs Law

Background

Earlier this week, the Federal Court of Canada publicly released Amgen Inc. v. Pfizer Canada ULC, 2020 FC 522, the first trial decision under the amended Patented Medicines (Notice of Compliance) Regulations ("PM(NOC) Regulations"). Prior to 2017, proceedings under Canada's drug patent linkage legislation, the PM(NOC) Regulations, proceeded by summary application with affidavit evidence and cross-examinations out of court. The pre-2017 PM(NOC) Regulations were unique in that judgments operated strictly in personam between the particular parties before the court. Additionally, once a patent challenger had obtained marketing approval from Health Canada, any appeals were considered moot, and the patent owner's sole recourse was to commence a separate action for patent infringement.

In 2017, the PM(NOC) Regulations were amended to provide for full actions. Until this week, no action under the 2017 PM(NOC) Regulations had proceeded through to a trial decision.

The facts of this action were somewhat unique.

First, the plaintiff, Amgen, had previously brought an application under the pre-2017 PM(NOC) Regulations against a different generic and had lost on the basis that the invalidity allegations were justified.¹ In this action, Amgen alleged infringement of the same patent that was previously found invalid in the earlier in personam application.

Second, the patent at issue, Canadian Patent No. 1,341,537 (the "537 Patent"), was also filed and issued under Canada's pre-1989 Patent Act (the "Old Act"). In 1989, Canada's Patent Act was substantially amended, converting Canada from a first-to-invent jurisdiction into a first-to-file jurisdiction. Relevant to this case, under the Old Act, patent applications were not published until the patent was issued.

The 537 Patent covered Amgen's biologic drug product NEUPOGEN, which contained the medicinal ingredient filgrastim. Pfizer wished to market a biosimilar to NEUPOGEN, called NIVESTYM. Pfizer sent Amgen a notice of allegation and Amgen sued for a declaration that, if approved, NIVESTYM would infringe the 537 Patent. Pfizer counterclaimed for a declaration of invalidity. The Court found for Pfizer, holding that the asserted claims were obvious.

Although the Court provided detailed reasons on all the issues in dispute, this blog post will focus on four:

1. Abuse of process/judicial comity in light of the prior application decision;
2. Treatment of "blinded" experts by the Court;
3. Guidance from the Court on the date...