Eli Lilly petitions SCOTUS in $20m Cialis suit
Eli Lilly has asked the US Supreme Court to reconsider a lower court’s ruling which ordered the drugmaker to pay Germany-based Erfindergemeinschaft UroPep $20 million for patent infringement.
On Wednesday, June 5, Eli Lilly filed its petition for a writ of certiorari, asking the Supreme Court to overturn the US Court of Appeal for the Federal Circuit’s decision to uphold “a non-practicing entity’s audacious attempt to obtain patent protection for a new use of petitioner’s drug”.
UroPep had sued Eli Lilly in July 2015, alleging infringement of US patent number 8,791,124, which covers treatment of prostatic disease.
In 2001, Eli Lilly sought Food and Drug Administration (FDA) approval for Cialis (tadalafil), a drug to treat erectile dysfunction. The FDA approved Cialis for this use in 2008.
Shortly after seeking approval for Cialis to treat erectile dysfunction, Eli Lilly proposed evaluating tadalafil as a new treatment for benign prostatic hyperplasia (BPH), a noncancerous increase in the size of the prostate gland.
In 2010, Eli Lilly filed a supplemental application, proposing Cialis for the treatment of BPH. The supplemental application was approved in 2011.
According to Eli Lilly: “A few months later, respondent—a shadowy non-practicing entity based in Germany—filed the patent application that ultimately became the patent at issue here [‘124], claiming priority to an application from 1997.”
UroPep claimed that the sale of Cialis for BPH required a licence to the ’124 patent, which covers a method of treating BPH through an enzyme inhibitor, a category Cialis falls under.
In 2017, the US District Court for the Eastern District of Texas, Marshall Division, concluded that Eli Lilly had infringed the ‘124 patent, and ordered Eli Lilly to pay $20 million.
Last year, in October, the Federal Circuit affirmed the district court’s ruling, in a move that Eli Lilly claims was a “particularly egregious example of purely functional claiming that preempts future discoveries". Functional claiming is where a claim merely recites the invention by what it does rather than by what it is.
“After gradually chipping away at this court’s rule against functional claiming, the Federal Circuit has now seemingly dispensed with that rule altogether,” claimed Eli Lilly in its petition.
Without the Supreme Court’s intervention, “patent trolls and others across industries will be able to use broad functional language to claim what others either have discovered or will discover on their own”, warned the drug maker.
According to the petition, the Federal Circuit’s decision presents an important question about the lawful scope of patents across various industries.
Eli Lilly concluded: “This case is an excellent vehicle for resolving that question, and it warrants the court’s review.”
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