On 18 July 2018 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) (for further details please see "Teva succeeds in Section 8 bortezomib action"). According to Justice Locke, Teva would not have infringed Patents 2,203,936 and 2,435,146 because their relevant claims were invalid for obviousness. On 4 November 2019 the Federal Court of Appeal upheld the finding of obviousness, dismissing Millennium Pharmaceuticals' and Janssen's appeal.(1)
First, the Court of Appeal found no legal error in the decision of the Federal Court, which had applied the correct legal test for obviousness.
Second, the Court of Appeal 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 (eg, evidence, submissions and issues). The Court of Appeal addressed three specific arguments made by the appellants. First, the trial judge had not improperly employed hindsight in finding "that the selection of components of bortezomib lack inventive ingenuity". Second, the trial judge had not improperly ignored 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 did not in itself 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".
Endnotes
(1) Millennium Pharmaceuticals v Teva Canada, 2019 FCA 273.
This article was first published by the International Law Office, a premium online legal update service for major companies and law firms worldwide. Register for a free subscription.
