Eli Lilly v. Apotex

Drug: atomoxetine

In this proceeding under the NOC Regulations, the Court found all of Apotex’ allegations to be unjustified. However, the proceeding was dismissed for mootness, as the patent at issue had been found invalid in rem, in an impeachment action.

The Court considered Apotex’ allegations of obviousness and anticipation and found that they were not justified.

The Court then considered the issue of utility. The Court found that in its evidence, Apotex had focussed on the allegation of a lack of sound prediction. However, the Court held that Lilly asserted that the patent demonstrated utility. Lilly tendered as evidence a report and the published version of a clinical trial study as exhibits to an expert affidavit. Apotex sought to challenge the admission of the study on the basis of hearsay; however, Apotex did not seek to file reply evidence or cross-examine Lilly’s witnesses on a challenge to the study’s reliability or sufficiency. Apotex also argued that the study and its data are not referenced in the patent.

The Court held that where a patentee maintains that it can demonstrate the utility of its invention, its disclosure obligation is limited to the provision of a full description of invention and the means to work it. It is only when the patentee relies on sound prediction that it is required to disclose in the patent the factual data upon which the prediction is based and the sound line of reasoning followed to support it. The Court agreed that because Lilly was relying on an assertion of demonstrated utility, it had no obligation to put the study in the patent. Furthermore, Apotex’ evidence pointing to the absence of the study in the patent is not capable of rebutting the statutory presumption of validity. Thus, the allegation of inutility fails because Apotex elected not to meet Lilly’s assertion of demonstrated utility head on.

However, in an impeachment action involving Novopharm, the patent at issue in this case was declared to be invalid (summarized here). The Court held that, because of the intervening determination that the patent is invalid, the application must be dismissed on the basis of mootness. The Court held that Lilly could defend any s.8 claim brought by Apotex on the basis of an argument that “dismissed by the Court hearing the application” in s.8 ofthe NOC Regulations means a dismissal on the merits of the application and not simply for mootness.