Federal Court Of Appeal Upholds First Trial Judgment Under New PM(NOC) Regulations

• Published date: 20 November 2020
• Subject Matter: Intellectual Property, Litigation, Mediation & Arbitration, Patent, Trials & Appeals & Compensation
• Law Firm: Norton Rose Fulbright Canada LLP
• Author: Mr Orestes Pasparakis, Mark Davis, Daniel Daniele, Paul Jorgensen and Kassandra Shortt

The Federal Court of Appeal has upheld the first trial judgment under the new Patented Medicines (Notice of Compliance) Regulations. In Amgen Inc v Pfizer Canada ULC, 2020 FCA 188, the Court dismissed Amgen's appeal from the Federal Court's decision declaring certain claims in Amgen's Canadian Patent No. 1,341,537 (537 Patent) invalid for obviousness. The action related to Pfizer's filgrastim biosimilar drug.

Appeal decision

The Court of Appeal found that the Trial Judge applied the correct approach to obviousness, noting that it requires a flexible approach and must be applied in context to the facts and circumstances of each claim. The Trial Judge's conclusion was consistent with the views of the experts he preferred and the principles in the governing jurisprudence. The Court of Appeal further found that, viewing the evidence in light of the Trial Judge's credibility...