Eli Lilly throws SCOTUS hail mary in Cialis patent infringement fight

supreme court
Eli Lilly is hoping the U.S. Supreme Court can overturn a $20 million infringment loss for its embattled erectile dysfunction drug Cialis. (Pixabay)

Looking at a future swarming with generic challengers, Eli Lilly’s Cialis is already feeling the burden on its global sales. Now, after Cialis’ $20 million patent infringement loss in benign prostatic hyperplasia (BPH), the drugmaker is taking the fight to the Supreme Court.

Lilly petitioned (PDF) the court this week to reconsider a federal court opinion invalidating Cialis’ BPH patent stemming from a challenge in 2011 by Erfindergemeinschaft Uropep GBR (EUG), a group Lilly called a “shadowy non-practicing entity based in Germany.”

Lilly claimed the German company’s competing patent, which swept district and federal courts of appeal, represented a “particularly egregious example of functional claiming,” a challenge the company said violated SCOTUS precedent.

The EUG patent stemmed from a 1997 patent application claiming exclusivity to treat BPH through an enzyme inhibitor, a category Cialis falls under. In the initial court ruling, Lilly was ordered to pay royalties to EUG for sales of Cialis used to treat BPH.

Lilly’s last-ditch effort to protect Cialis’ only remaining exclusive indication comes after a troubled couple years for the ED drug. Patent losses in the U.S. and Europe and the ensuing wave of generics have rung the death knell for its blockbuster status. 

RELATED: Top 10 U.S. patent losses of 2017 -  Cialis

In 2018, Cialis posted a 20% dip in global sales to $1.85 billion, driven by the drug’s loss of U.S. and European patent protection in late 2018 and 2017, respectively. Cialis sales were hit particularly hard in Europe, where revenue dropped 25% on the year. In 2016, Cialis cleared $2.47 billion worldwide.

For the first quarter of this year, sales figures were even more dire: Cialis posted a little more than $308 million worldwide—a 38% drop from the previous year. And this time, the U.S. took the worst hit, with sales diving to $143 million—a 54% drop.

RELATED: Eli Lilly's new launches step up in time to fill the growing Cialis gap

Even with Cialis on the ropes, Lilly has posted nearly across-the-board increases in its pharma portfolio, driven by star diabetes drug Trulicity’s booming sales.

In the first quarter, Lilly posted $5.09 billion in global pharma sales, a 3% increase from the previous year, driven by growing uptake, the company said. Lilly CEO David Ricks told investors the company’s portfolio saw 7% growth in the quarter—13%, in fact, if you didn’t consider Cialis and its huge decline.

The drugmaker's two largest revenue increases, by far, were tied to the diabetes duo Trulicity and Jardiance, which posted 30% and 35% growth in the quarter, respectively. Trulicity appears poised for even more success after a November outcomes trial showed the drug significantly cut the rate of heart attack, stroke and cardiovascular death in about 69% of treated patients.

Suggested Articles

Post-Tesaro buyout, don’t expect GlaxoSmithKline to spring for more commercial-stage oncology products anytime soon.

Already a fast-growing blockbuster, Novo Nordisk's injectable Ozempic won a major heart-helping FDA nod that could bode well for its oral sibling.

Bayer's new Vitrakvi for tumors with NTRK gene fusions is meeting skepticism in England and Germany, where cost watchdogs on Friday rejected it.