Mylan Pharmaceuticals ULC v. Eli Lilly Canada Inc., 2016 FCA 119 

Drug: tadalafil

The Federal Court of Appeal has upheld an earlier decision (2015 FC 17) prohibiting Mylan from obtaining its Notice of Compliance until after the impugned patent expires. Mylan had alleged that Eli Lilly's patent was invalid on the basis of obviousness-type double-patenting and for lack of utility due to no sound prediction.

Three dates were considered as the correct date to assess obviousness-type double patenting: 1) The priority date of the first patent; 2) The priority date of the second patent; or 3) the publication date of the second patent. The Court of Appeal held that the third date is not appropriate. But, the Court of Appeal further held it was not necessary to determine the question of which of these remaining dates is the appropriate one, because on the facts of the case there was no double patenting.

Mylan's sound prediction allegation also failed, but the Court noted that even if it were successful it would not have affected the disposition of the appeal as it would not invalidate all of the claims in issue.