On September 11, 2015, the Federal Court dismissed Eli Lilly’s application for a prohibition Order against Apotex’s generic versions of CIALIS and ADCIRCA: Eli Lilly Canada Inc v Apotex Inc, 2015 FC 1016. Eli Lilly asserted Canadian Patent No. 2,379,948, which claims certain formulations of tadalafil. Justice Gleason determined that “in the rather unique circumstances of this case,” the application was not an abuse of process, even though Justice de Montigny had ruled earlier this year that Mylan’s allegation that the 948 patent was invalid for obviousness was justified: Eli Lilly Canada Inc v Mylan Pharmaceuticals ULC, 2015 FC 178 (as reported here). The Court found that Eli Lilly would be severely prejudiced if the application against Apotex was dismissed and Eli Lilly later proved successful in its appeal of Justice de Montigny’s decision (which was unlikely to be dismissed for mootness). The Court noted that Apotex could have avoided the cost and inconvenience of the application by agreeing to a stay pending the appeal.
Apotex’s allegations of non-infringement and obviousness were, however, found to be justified. On non-infringement, the Court determined that the identity and amounts of excipients in Apotex’s formulations put them outside the claims of the 948 patent. On obviousness, the Court rejected Eli Lilly’s argument that Apotex’s expert evidence should be struck because the inventive concept in the expert’s affidavit differed from that set out in the notice of allegation (NOA). Eli Lilly was not prejudiced, as it had cross-examined the expert and had not contested the admissibility of the evidence until oral argument. More fundamentally, determination of the inventive concept is a matter of construction and so need not be raised in an NOA. The Court then found, largely for the same reasons as Justice de Montigny, that the formulations claimed in the 948 patent would have been obvious to try.
Apotex’s allegation of inutility was found not to be justified. The testing done by Eli Lilly was sufficient to establish the promised utility. The Court held that data demonstrating utility need not be referenced in the 948 patent. In doing so, the Court referred to and differed with the recent decision of Justice Roy in Laboratoires Servier v Apotex Inc , 2015 FC 108, at para. 211 (as reported here) in favour of the “weight of authority” holding that disclosure in the patent is not required to demonstrate utility.
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