Alexion has a lot riding on the launch for Ultomiris, its long-acting follow-up to Soliris. But Roche's Chugai says the new med is built on its own patented drug-delivery technology—and it's suing to stop the new launch in its tracks.
Chugai filed a lawsuit in Delaware federal court alleging Alexion deliberately infringed its patent on the technology that cuts Ultomiris' typical dosing to once every eight weeks from Soliris' biweekly schedule. Both drugs are C5 inhibitors designed to treat certain rare diseases.
Chugai developed and patented technology that “extends the half-life of an antibody in blood plasma, thereby improving the duration of time in which the antibody binds and neutralizes target antigens," the lawsuit states.
In fact, the lawsuit claims, Alexion actually tried to license Chugai's technology back in 2012 and 2013.
Alexion’s predecessor Soliris, which patients take weekly for five weeks and then every other week, doesn’t infringe the work, according to Chugai. But the drugmaker says Alexion's eight-week follow-up Ultomiris does.
Both meds are approved to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome, and Soliris boasts additional indications, including neuromyelitis optica spectrum disorder. For its part, Chugai says it’s developing a C5 inhibitor with partners.
Alexion didn’t immediately respond to a request for comment.
Chugai says Alexion's attempt to license the technology shows it knew it would be infringing the patent. And the lawsuit claims an unnamed third-party attorney filed a challenge during Chugai's patent proceedings, and that it believes Alexion hired that attorney.
Chugai’s lawsuit follows another infringement action the company filed against Alexion last year. The company is asking for an injunction to stop the infringement, damages and more.
As for Alexion, the company is counting on Ultomiris to pick up steam as Soliris faces a patent challenge from Amgen. Soliris generated 78% of the company’s sales in the third quarter, and Alexion is continuing its campaign to switch patients over to the long-acting option. Both meds are among the most expensive in the U.S.