Tadalafil – USA

On May 18, 2017 a Texas federal judge entered a $20 million judgment against Eli Lilly & Co. for infringing Germany-based company Erfindergemeinschaft UroPep’s patent. The ruling, which was handed down at the US District Court for the Eastern District of Texas Marshall Division, came after a jury verdict that Eli Lilly was liable for infringement.

The patent involved is US patent number 8,791,124 owned by UroPep. It covers treatment of prostatic disease and is titled “Use of phosphodiesterase inhibitors in the treatment of prostatic diseases.” UroPep sued Eli Lilly in July 2015, alleging infringement of patent ’124 based on marketing of Eli Lilly’s drug Cialis (Tadalafil) for benign prostatic hyperplasia (BPH). Asserted claim 1 of the '124 patent recites a method "for prophylaxis or treatment of benign prostatic hyperplasia comprising administering to a person in need thereof an effective amount of an inhibitor of phosphodiesterase (PDE) V," excluding certain specified compounds.

In a decision of Mar 03, 2017 Court denied all motions for summary judgment (invalidity based on anticipation, indefiniteness & non-infringement) requested by Eli Lilly. According to the ruling, the jury found that Eli Lilly failed to prove the patent invalid on grounds of anticipation, obviousness, lack of adequate written description, and lack of enablement.