Canada’s Intellectual Property Firm

Federal Court of Appeal dismisses appeal of first trial decision under the amended PMNOC Regulations

Authored byUrszula Wojtyra

UPDATE: On July 9, 2021, the Supreme Court of Canada denied Amgen’s leave to appeal (see article here). 

On November 3, 2020, the Federal Court of Appeal heard and dismissed the appeal of the first trial decision under the amended Patented Medicines (Notice of Compliance) Regulations: Amgen v Pfizer, 2020 FCA 188. Amgen had appealed the trial decision, previously reported here, which held obvious the asserted claims of Canadian Patent No. 1,341,537, relating to filgrastim (Amgen’s NEUPOGEN and Pfizer’s biosimilar product NIVESTYM).

The Court of Appeal found that the trial judge had a correct understanding of the legal factors to be considered and applied in the test for obviousness, which is flexible and must be applied contextually to the facts and circumstances of each claim. The Court of Appeal further held that the trial judge had not committed any palpable and overriding error in concluding as he had, and that the Court of Appeal would have reached the same result if it were to apply the legal test for obviousness to the evidence as if it were a court of first instance.

Any appeal by Amgen would require the grant of leave by the Supreme Court of Canada.

Should you have any questions, please do not hesitate to contact a member of the Pharmaceutical Litigation group.

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