MARSHALL – A Texas federal jury awarded $20 million in royalties and damages to a German pharmaceutical company April 21 in a patent infringement case involving the makers of the drug Cialis.
The Marshall Division of the Eastern District of Texas found that Indiana-based Eli Lilly & Co. infringed on an existing patent by manufacturing and selling the erectile dysfunction drug Cialis as a treatment for enlarged prostate glands, also known as benign prostatic hyperplasia (BPH). Brookshire Bros., a Texas-based pharmacy, was also named as a defendant in the case.
In December 2010, Eli Lilly had filed a supplemental application with the Food and Drug Administration (FDA) that proposed Cialis as a treatment of BPH, as well as BPH symptoms occurring with erectile dysfunction. In 2011, the FDA approved the supplemental application.
The plaintiff, Germany-based Erfindergemeinschaft UroPep, sued Eli Lilly and Brookshire Bros. in July 2015 for patent infringement of the '124 Patent, which was issued by the United States Patent and Trademark Office in 2014 to UroPep and is titled Use of Phosphordiesterase Inhibitors in the Treatment of Prostatic Diseases.
In a July 2015 complaint, UroPep contended that it had attempted to correspond with Eli Lilly in 2014 to inform them that any application of Cialis to treat BPH would infringe the '124 patent and would require a license, thus granting permission. The complaint stated that Eli Lilly been “placed on actual notice.” After Eli Lilly did not respond, UroPep went on to state in the complaint that “Eli Lilly’s infringement of the 124 Patent has been and continues to be willful.” It also cited Brookshire Bros. for inducing infringement by selling Cialis.
In the trial, Eli Lilly argued that UroPep’s patent for BPH and erectile dysfunction is simply an old Chinese herb once called "horny goat weed," and that the jury should toss out the case. The jury held in favor of UroPep and found that Eli Lilly was unable to prove that the 124 Patent was invalid.