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.
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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.
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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.