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Two procedural decisions relating to HERCEPTIN under the amended PMNOC Regulations: confidentiality rules cannot be varied until action commenced; motion to dismiss may be brought prior to completion of examinations for discovery

As previously reported, substantial amendments to the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) came into force on September 21, 2017. The following reports on two court decisions addressing procedure under these amendments.

On March 1, 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 the person who served the notice of allegation under section 5(3.5) until an action has been commenced: Genentech, Inc. v Pfizer Canada, 2018 FC 233. Pfizer served eight Notices of Allegation on Roche with respect to Pfizer’s New Drug Submission for its TRAZIMERA product (a biosimilar of Hoffmann La-Roche’s HERCEPTIN (trastuzumab)), and simultaneously imposed confidentiality rules on those documents. Prior to the commencement of actions, Roche and Genentech (the patent owner) filed a “motion/application” to vary those rules. The Court dismissed the motion/application, finding that in the absence of proceedings, it lacked jurisdiction to consider Roche and Genentech’s “motion/application”.

On March 15, 2018, Prothonotary Aylen dismissed Roche’s motion to dismiss, adjourn, or delay a motion by Amgen under section 6.08 of the PMNOC Regulations seeking to summarily dismiss Roche and Genentech’s action against Amgen, which also relates to patents for Roche’s HERCEPTIN (trastuzumab):Genentech, Inc. v Amgen Canada, 2018 FC 303. The Prothonotary decided as follows:

  • Amgen’s motion, on its face, was not bereft of any prospect of success. She likened motions under section 6.08 to those under former section 6(5)(b) and motions to strike under Rule 221 of the Federal Court Rules.

  • She 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.

  • Lastly, she 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 extension of the stay.