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 findings, it would have reached the same result as the Trial Judge.

Trial decision

As we previously reported, the Trial Judge dismissed Amgen’s action and allowed Pfizer’s counterclaim for a declaration of invalidity: 2020 FC 522. The Trial Judge concluded that the asserted claims were obvious because it was self-evident to try to obtain the claimed recombinant protein.  The evidence favoured Pfizer on all three of the obvious-to-try factors: the Self-Evident Factor, the Extent of Effort Factor, and the Motive Factor. The Trial Judge’s findings included:

  • Blinded evidence. The Trial Judge found that the reliability of Pfizer’s experts was enhanced by their having considered the key prior art – which disclosed the natural protein – before being shown the 537 Patent. The three Pfizer experts independently laid out the same roadmap from the known natural protein to the claimed recombinant protein before having read the patent.
  • Skilled person. The Trial Judge rejected the notion that prior art published by leaders in a field does not inform what was routine and within the capabilities of the person of skill in the art. One of Amgen’s experts had erred by interpreting the person of skill in the art as someone of mediocre skill, rather than someone lacking inventiveness.
  • Properties known. The Trial Judge found that the reason to make the claimed recombinant protein was the known properties of the known natural protein, which distinguished this case from previous obvious-to-try cases involving compounds or combinations that had not been previously made or isolated, and whose properties were therefore not known.

Pfizer was represented by Norton Rose Fulbright Canada LLP at trial and on appeal.

Decisions: Amgen Inc v Pfizer Canada ULC, 2020 FC 522, aff’d 2020 FCA 188