Tadalafil - USA

On Oct 10, 2018, Federal Circuit upheld (Rule 36 Judgment) a $20 million verdict against Eli Lilly & Co. for marketing erectile dysfunction drug Cialis.

Previously, plaintiff Erfindergemeinschaft UroPep GbR sued Eli Lilly and Company for infringement of U.S. Patent No. 8,791,124. Claim 1 of the ’124 patent is to a method of administering an effective amount of a compound known as an inhibitor of the enzyme phosphodiesterase (“PDE”) V, in order to treat the condition of benign prostatic hyperplasia (“BPH”). UroPep alleged that Lilly induced infringement of claim 1 by marketing and selling the drug Cialis for the treatment of BPH. Lilly denied infringement and asserted various invalidity defenses. After a trial, a jury found the ’124 patent infringed and not invalid. The jury awarded damages in the amount of $20 million. The evidence at trial showed that Lilly made approximately $704.3 million in sales of Cialis attributable to the BPH indication between October 9, 2014 (the date on which Lilly was notified of UroPep’s patent), and April 16, 2017 (the day before the beginning of the trial). Then pursuant to Rules 50(b) and 59, Fed. R. Civ. P., Lilly moved for judgment as a matter of law or, in the alternative, a new trial. Court denied the motion in Aug 2017.