Substantial amendments to the Patented Medicines (Notice of Compliance) (PMNOC) Regulations came into force on 21 September 2017. This update examines two court decisions which addressed procedure under these amendments.

Genentech, Inc v Pfizer Canada

On 1 March 2018 Prothonotary Aylen ruled that the court lacked jurisdiction to consider a motion under Section 5(3.7) of the PMNOC Regulations to vary confidentiality rules imposed by a party that has served a notice of allegation under Section 5(3.5) until an action has been commenced.(1) Pfizer served eight notices of allegation on Hoffmann La-Roche with respect to Pfizer's new drug submission for its Trazimera product (a biosimilar of Roche's Herceptin (trastuzumab)) and simultaneously imposed confidentiality rules on those documents. Prior to the commencement of actions, Roche and Genentech (the patent owner) had filed a motion/application to vary those rules, which the court dismissed. The court found that in the absence of proceedings, it lacked jurisdiction to consider the motion/application.

Genentech, Inc v Amgen Canada

On 15 March 2018, Aylen dismissed Pfizer's motion to dismiss, adjourn or delay a motion filed by Amgen under Section 6.08 of the PMNOC Regulations, which sought to summarily dismiss Roche and Genentech's action against Amgen, which also concerned patents for Roche's Herceptin.(2) The prothonotary decided as follows:

  • Amgen's motion, on its face, was not bereft of any prospect of success. The prothonotary likened motions under Section 6.08 to those under the former Section 6(5)(b) and motions to strike under Rule 221 of the Federal Court Rules.
  • The prothonotary similarly refused to delay hearing Amgen's motion until after the completion of examinations for discovery. The PMNOC Regulations imposed no temporal restriction on such motions and, based on the schedule proposed by Amgen, Roche and Genentech would have the benefit of full documentary discovery prior to filing their motion materials.
  • The prothonotary refused to extend the 24-month statutory stay as a result of Amgen's motion, as it was not found to amount to misconduct warranting an extension of the stay.

For further information on this topic please contact Abigail Smith at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email ( The Smart & Biggar website can be accessed at


(1) Genentech, Inc v Pfizer Canada, 2018 FC 233.

(2) Genentech, Inc v Amgen Canada, 2018 FC 303.

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