CIALIS® Patent Survives Validity Challenge On Appeal

Last year we wrote about a trilogy of Federal Court decisions relating to Eli Lilly's erectile dysfunction (ED) drug CIALIS® (tadalafil). While Lilly was successful in obtaining a prohibition order in the first proceeding, its latter two applications were dismissed. Mylan appealed the first order, and the Federal Court of Appeal (FCA) recently released its decision in Mylan Pharmaceuticals ULC v. Eli Lilly Canada Inc., 2016 FCA 119 dismissing Mylan's appeal.

The FCA's decision affirms the view that obviousness and obviousness-type double patenting validity challenges require distinct analyses, and that a patent's disclosure cannot be referenced to vary the scope or ambit of its claims where those claims are unambiguous.