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June 18 2018
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.
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.
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:
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(1) Genentech, Inc v Pfizer Canada, 2018 FC 233.
(2) Genentech, Inc v Amgen Canada, 2018 FC 303.
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