Eli Lilly Canada Inc. v. Apotex Inc., 2023 FCA 125 (Tadalafil*)

Justice Gleason; Justice Rivoalen; Justice de Montigny - 2023-06-02

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In the Federal Court Decision [see 2020 FC 816], the Judge addressed the merits of the action and counterclaims and concluded that the asserted claims of the 684 Patent were invalid on the grounds of anticipation and obviousness. The Judge stated that, if she was wrong in her assessment of the validity of the patent and if the asserted claims were valid, Lilly had met their burden to establish infringement and were entitled to elect between damages and accounting of profits. ... For the reasons set out below, I would dismiss the appeals with costs. ... As is apparent from the discussion that follows, even if I were to accept the appellants’ proposed inventive concept, which now is “a minimization or elimination of flushing as compared to larger doses of tadalafil”, this appeal must nonetheless be dismissed. ... Indeed, the Judge found that the routine work carried on by the person skilled in the art included identifying the dose range and any side effects. The Judge repeatedly stated that, as part of identifying the dose range, the person skilled in the art identifies “side effect occurrences” or the doses that best balance efficacy, safety and tolerability.

Decision relates to:


Canadian Intellectual Property