Roche and AstraZeneca settle yearslong patent battle over Ultomiris — report
Roche’s Chugai unit and AstraZeneca’s Alexion have settled a yearslong patent battle over the latter’s Ultomiris — a rare blood disorder treatment designed to succeed Alexion’s blockbuster Soliris, according to reports.
The settlement was filed under seal on Monday, Bloomberg Law and Law 360 reported, and the terms are currently unknown. Alexion declined to comment on the case, while Chugai wasn’t available as of press time.
The trouble dates back to 2018 (before Ultomiris was approved) when Chugai filed a complaint against Alexion alleging that the company used its patented antibody recycling technology to create the drug. The technology, Chugai says, could be used to extend the half-life of an antibody in the blood, and “improve the function of C5 inhibiting antibodies, including those used to treat rare blood diseases like PNH and aHUS.”
Like its predecessor Soliris, Ultomiris is a C5 inhibitor — but while Soliris is dosed every two weeks during the maintenance period, Ultomiris can be taken every eight weeks. It snagged its first approval in paroxysmal nocturnal hemoglobinuria (PNH), a rare but life-threatening blood disease, in December 2018. Less than a year later, it picked up a second approval for atypical hemolytic uremic syndrome (aHUS), a disease that can cause progressive injury to vital organs via damage to the walls of blood vessels and blood clots.
Soliris and Ultomiris were key elements in AstraZeneca’s $39 billion Alexion buyout last summer. The latter raked in $688 million in 2021, according to recently released Q4 results.
In its 2018 complaint, Chugai argued that Alexion knew of the alleged patent infringement because the company made “multiple inquiries regarding obtaining a license to Chugai’s antibody technology patents” in 2012 and 2013.
“Despite knowing that Chugai did not give Alexion permission to use Chugai’s recycling technology, and despite knowing that Chugai patented its recycling technology, Alexion knowingly incorporated Chugai’s technology into its ALXN1210 product anyway. Alexion’s conduct amounts to a willful disregard of Chugai’s patent rights,” the complaint states.