A federal jury in Texas awarded $ 20 million in royalties and damages to a German pharmaceutical company on April 21 in a patent infringement case involving drug makers Cialis.
The Marshall Division of the Eastern District of Texas found that Indiana-based Eli Lilly and Co. infringed on an existing patent by manufacturing and selling 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 submitted a supplemental application to the Food and Drug Administration (FDA) that proposed Cialis as a treatment for BPH as well as the symptoms of BPH that occur with erectile dysfunction. In 2011, the FDA approved the supplemental application.
The applicant, Erfindergemeinschaft UroPep, based in Germany, 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 Phosphordisterase Inhibitors in the Treatment of Prostatic Diseases.
In a July 2015 complaint, UroPep argued 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. After Eli Lilly did not respond, UroPep continued to state in the complaint that “Eli Lilly’s violation of patent 124 has been and remains deliberate.” He also cited Brookshire Bros. to induce infringement by selling Cialis.
At the trial, Eli Lilly argued that UroPep’s patent for BPH and Erectile Dysfunction is simply an ancient Chinese herb called “goat’s horny goat”, and that the jury should launch the case. The jury ruled in favor of UroPep and found that Eli Lilly could not prove that patent 124 was invalid.