Tadalafil - Canada

On Nov 04, 2016, Federal Court of Appeal in Apotex Inc. v Eli Lilly Canada Inc, 2016 dismissed the appeal relating to double patenting & sufficiency of Canadian Patent No. 2,226,784 (784 Patent). The Court of Appeal had previously considered the issue of double patenting of this patent with a different generic company, Mylan.

The double-patenting issue in the tadalafil (CIALIS) cases concerns two of Lilly’s patents. The earlier patent, Canadian Patent No. 2,181,377 (377 Patent), claims tadalafil and the use of tadalafil in the treatment of various disorders, but not treatment of ED specifically. The later patent, '784 claims the use of tadalafil for the treatment of ED. Mylan and Apotex both alleged that the later patent was invalid for obviousness-type double-patenting over the earlier one.

Apotex also argued that in the court below, Gleason J erred in law when she found that the disclosure of the later patent was sufficient. The FCA held that application of the legal test for sufficiency of disclosure to the facts of the case is a question of mixed fact and law, reviewable on the standard of palpable and overriding error. The FCA refused to revisit Gleason J’s preference for the evidence of Lilly’s experts on this issue and dismissed the appeal.