On March 4, 2021, the Federal Court of Appeal of Canada (FCA) issued its decision in Apotex Inc. v. Janssen Inc., 2021 FCA 45, further clarifying the test for obviousness to try in patent litigation proceedings.

Apotex Inc. (Apotex) appealed the Federal Court’s decision, which prohibited the Minister of Health from granting a notice of compliance for Apotex’s version of a generic drug product marketed by Janssen Inc. While a second decision following amendments to the Patented Medicines (Notice of Compliance) Regulations found that the relevant patent was invalid for obviousness, the FCA proceeded with Apotex’s moot appeal due to its potential relevance on Apotex’s claim for damages.

On the issue of obviousness to try, the FCA distinguished this case from Hospira Healthcare Corporation v. Kennedy Trust for Rheumatology Research, 2020 FCA 30 (previously reported on by the E-TIPS® Newsletter here), where the Federal Court had treated “more or less self-evident that what is being tried ought to work” as a requirement and conducted an inadequate examination of at least one other relevant factor. The FCA held that the Federal Court in the present case considered the relevant factors of obviousness to try and that it was open to the Federal Court to conclude that although the combination of relevant components may have been “worth trying”, it “was not obvious to try”.

In addition, the FCA maintained the view that “more or less self-evident that it ought to work” should be treated as a factor in the obviousness to try analysis, rather than as a requirement. The FCA noted that this interpretation seems most consistent with what the Supreme Court of Canada intended in its decision in Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61.

The FCA concluded that the Federal Court did not err in its findings and dismissed Apotex’s appeal with costs.

Summary By: Steffi Tran


21 03 31

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