As previously reported in the E-TIPS® newsletter here, Lilly succeeded in obtaining a prohibition order against Mylan in Eli Lilly Canada Inc v Mylan Pharmaceuticals ULC, 2015 FC 17, regarding Mylan’s generic tadalafil (Lilly’s CIALIS®).

Subsequently, in Eli Lilly Canada Inc v Mylan Pharmaceuticals ULC2015 FC 125 (February 2, 2015), de Montigny J dismissed Lilly’s application for a prohibition order until the expiry of Canadian Patent No 2,371,684 (the 684 Patent). The 684 Patent is directed to a unit dosage form of tadalafil, including the use of that unit dosage form for the treatment of erectile dysfunction (ED).

De Montigny J held that Lilly failed to establish that Mylan’s invalidity allegations on the grounds of lack of utility (demonstrated or soundly predicted), anticipation and obviousness were not justified.

De Montigny J also held that the 684 Patent promised that the claimed unit doses of 1 to 20 mg of tadalafil, when administered to patients to treat ED, would be effective and provide an improvement over sildentafil by minimizing significantly or eliminating three side effects expressly described in the patent. He rejected Lilly’s argument that the promise should be construed by focusing on the claims rather than the specification and held that the general rule is that the promise should be construed within the context of the patent as a whole.

De Montigny J found that the study, using a single dose of tadalafil, relied upon by Lilly was insufficient for not using a representative patient population suffering from ED. He also found that the notional skilled person would have no basis to extrapolate the results of this study to the higher doses claimed in the patent. De Montigny J concluded that the promised utility was not demonstrated as of the Canadian filing date. He also held that the promised utility was not soundly predicted, as there was no factual basis for such prediction or articulable and sound line of reasoning from which the desired result could be inferred from such a factual basis.

De Montigny J also concluded that the 684 Patent was anticipated by Canadian Patent No 2,226,784 and was obvious.


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