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21 November 2018
The Federal Court of Canada has refused Pfizer's motion to dismiss an action under the Patented Medicines (Notice of Compliance) (PMNOC) Regulations between Amgen Inc and Pfizer. This is in relation to Pfizer's proposed biosimilar (Nivestym) of Amgen's filgrastim (Neupogen) (2018 FC1078).
Pfizer sought to dismiss the action under Section 6.08 of the PMNOC Regulations, asserting that it was redundant, scandalous, frivolous, vexatious or otherwise an abuse of process. Pfizer based its argument on a decision under the old PMNOC Regulations in which the court found that Apotex's allegation of invalidity was justified (for further details please see "Ontario Superior Court dismisses summary judgment motion in Lansoprazole Section 8 claim"). Amgen's second proceeding against Apotex under the old PMNOC Regulations was summarily dismissed as an abuse of process. Pfizer argued that it was an abuse of the court's process for Amgen to invoke the PMNOC Regulations on that same patent. The court disagreed – holding that the findings from the Apotex application cannot simply be grafted onto the present action as the court in the Apotex application had not conclusively determined the validity of the patent.
As actions that have been commenced under the amended PMNOC Regulations determine different issues than in applications under the old PMNOC Regulations, the action was neither considered to be relitigation nor redundant. Pfizer would require leave from the Federal Court of Appeal to appeal the decision.
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