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Federal Court of Appeal confirms obviousness finding in section 8 bortezomib action against Teva

Authored byBrandon Heard

As previously reported, the Federal Court granted Teva’s claim for compensation under section 8 of the Patented Medicines (Notice of Compliance) Regulations relating to Teva’s bortezomib product (Janssen markets bortezomib as VELCADE). According to Justice Locke, Teva would not have infringed Patents Nos. 2,203,936 and 2,435,146 because their relevant claims were invalid for obviousness. On November 4, 2019, the Federal Court of Appeal upheld the finding of obviousness, dismissing Millennium Pharmaceuticals and Janssen’s appeal: Millennium Pharmaceuticals v Teva Canada, 2019 FCA 273

The Court of Appeal first found no legal error in the decision below, which applied the correct legal test for obviousness.

The Court of Appeal next found no palpable and overriding error, explaining that “[p]alpable and overriding error is a difficult standard to meet” and that a first-instance court’s reasons must be understood in the “wider context” of the information before that court (e.g. evidence, submissions, issues). The Court of Appeal addressed three specific arguments made by the appellants. First, the trial judge did not improperly employ hindsight in finding “that the selection of components of bortezomib lack inventive ingenuity.” Second, the trial judge did not improperly ignore prior art, but rather “made factual findings about the prior art based on the expert evidence that was before it and evaluated the claimed inventions against that prior art as required by [Apotex Inc. v Sanofi-Synthelabo Canada Inc., 2008 SCC 61].” Third, the existence of evidence which the Court could have used to find in the appellants’ favour does not alone establish palpable and overriding error. “Preferring one line of evidence over another is the exclusive prerogative of the first-instance court,” especially when the court raises “serious concerns about the impartiality of certain expert witnesses.”

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