Federal Court Of Appeal Considers Scope Of Abuse Of Process Under Amended PM(NOC) Regulations

Under the former Patented Medicines (Notice of Compliance) Regulations (the "Former Regulations"), section 6 applications only served to determine whether the generic's allegations of non-infringement or invalidity were justified so as to allow the Minister to issue a Notice of Compliance ("NOC") to the generic. Once a patentee was unsuccessful in a section 6 application against one generic, that patentee effectively lost the right to use section 6 in respect of all subsequent generics who provided the same allegation due to, among other things, the doctrine of abuse of process.

Despite being unsuccessful in an application pursuant to section 6 of the Former Regulations, a patentee nevertheless retained the right to commence a patent infringement action against the same generic in respect of the same patent and drug to finally determine the issues of patent validity and infringement.

Under the amended Patented Medicines (Notice of Compliance) Regulations (the "Amended Regulations"), the proceeding contemplated by section 6 was converted from an application to an action for patent infringement, with the typical procedural safeguards associated with an action, including documentary and oral discovery and viva voce evidence presented at a trial.

In Pfizer Canada Inc. v. Amgen Inc., 2019 FCA 249, the Federal Court of Appeal (the "Court") considered the differences between actions under section 6 of the Amended Regulations and applications under the Former Regulations. In the appeal, the issue was whether the procedural changes to section 6 allowed a patentee to commence a section 6 action under the Amended Regulations despite a previously unsuccessful section 6 application under the Former Regulations.

The Court dismissed Pfizer's appeal, affirming Prothonotary Milczynski's decision allowing Amgen's section 6 action under the Amended Regulations to proceed as against Pfizer.

Background and Prior Proceedings

Amgen Inc. and Amgen Canada Inc. (collectively, "Amgen") market two biologic drugs, Neupogen and Neulasta, and have listed Canadian Letters Patent No. 1,341,537 (the "537 Patent") in connection with these products on the Patent Register.

Pfizer Canada Inc. ("Pfizer") intended to market a biosimilar drug to Neupogen and filed a new drug submission with the Minister of Health seeking a NOC for its product. On March 7, 2018, Pfizer served a Notice of Allegation ("NOA") on Amgen with respect to the 537 Patent. In response, Amgen brought an...