Canada’s Intellectual Property Firm

Amgen not precluded from asserting patent under current PMNOC Regulations even though unsuccessful under old PMNOC Regulations

The Federal Court of Canada has refused Pfizer’s motion to dismiss an action under the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) between Amgen and Pfizer in relation to Pfizer’s proposed biosimilar (NIVESTYM) of Amgen’s filgrastim (NEUPOGEN): 2018 FC 1078. Pfizer sought to dismiss the action under section 6.08 of the PMNOC Regulations, asserting that the action is redundant, scandalous, frivolous or vexatious or is otherwise an abuse of process. Pfizer’s argument was based on a decision under the old PMNOC Regulations in which the Court found that Apotex’s allegation of invalidity was justified (as previously reported). Amgen’s second proceeding against Apotex under the old PMNOC Regulations was summarily dismissed as an abuse of process.  Pfizer argued on this motion that it is 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 on to the present action as the Court in the Apotex application had not conclusively determined the validity of the patent. As actions commenced under the amended PMNOC Regulations determine different issues than in applications under the old PMNOC Regulations, the action was neither relitigation nor redundant. Pfizer would require leave from the Federal Court of Appeal to appeal the decision.