Canada PM(NOC) Decision: Federal Court Judge Criticizes 'Very Sketchy' Disclosure In A CIALIS Patent

On February 2, 2015 Justice de Montigny of the Federal Court released his judgment and reasons in Eli Lilly Canada Inc. v. Mylan Pharmaceuticals ULC, 2015 FC 125, dismissing Lilly's application for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Mylan until the expiry of Canadian Patent No. 2,371,684 (the "'684 Patent"). The '684 Patent claims a dosage form of tadalafil and its use to treat erectile dysfunction ("ED"). This decision is the second in a series of three prohibition applications by Lilly relating to its tadalafil patents.

The use of tadalafil for the treatment of ED was claimed in the earlier '784 Patent which was the subject of a prohibition application summarized in a January 26, 2015 post on snIP/ITs. In contrast to that decision, Justice de Montigny took a harder stance on the promised utility of the '684 Patent. He noted that the patent made several explicit statements promising particular results, and that this promised utility was neither disclosed nor soundly predicted on the filing date. Justice de Montigny ultimately found that Mylan's allegations of invalidity on the basis of lack of utility, anticipation and obviousness were justified.

Utility

Lilly submitted that the '684 Patent promises that the claimed dosage forms will be effective in the treatment of ED and will have a better side effect profile than sildenafil, an earlier ED drug. Mylan argued that the '684 Patent goes far beyond Lilly's construction and promises that the claimed doses will minimize three specific side effects to insignificant levels.

Justice de Montigny preferred Mylan's construction, noting that the ambitious and explicit statements throughout the patent promise much more than a marginal improvement over sildenafil. He observed that reading down the promise in accordance with Lilly's construction would "fly in the face of the clear language of the '648 Patent".

Justice de Montigny further held that, as of the filing date, this promised utility had not been demonstrated. He noted that the only study comparing the occurrence of one of the side effects showed...

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