Roche settles lawsuit claiming AstraZeneca's Ultomiris infringes delivery patent

Roche has decided to close out a patent infringement lawsuit against AstraZeneca centering on the latter company's newly acquired rare disease drug Ultomiris.

Roche’s Chugai Pharmaceutical and AZ’s Alexion Pharmaceuticals inked a deal to end a lawsuit claiming Alexion unlawfully used Chugai's patented drug-delivery technology to reduce the dosing frequency for blockbuster Ultomiris, a filing in Delaware federal court shows.

The terms of the settlement remain unknown, and Chugai declined a Fierce Pharma request for comment. The two companies proposed to close the case Monday ahead of a long-delayed trial.

Chugai filed the Delaware lawsuit in November 2018 and followed that with another suit of the same nature in Tokyo. The patent at issue here features a technology that could extend the half-life of an antibody drug like Ultomiris in the blood, “thereby improving the duration of time in which the antibody binds and neutralizes target antigens,” according to the lawsuit.

RELATED: Roche's Chugai claims Alexion co-opted its patented tech in building Ultomiris

The Japanese subsidiary of Roche argued that Alexion knew it would be infringing the patent because the U.S. rare disease player had tried to license the technology back in 2012 and 2013.

Alexion developed Ultomiris as a follow-on drug to the highly successful Soliris with a convenience improvement. While Soliris is dosed every two weeks after the loading doses, Ultomiris is given every eight weeks during maintenance. Both drugs are C5 inhibitors approved for certain rare diseases, and Ultomiris is under FDA priority review for an important expansion into the autoimmune neuromuscular disorder of generalized myasthenia gravis.

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The two drugs, especially newer Ultomiris, are the centerpiece of AZ’s $39 billion acquisition of Alexion in July 2021 as part of the pharma giant's push into rare diseases and immunology. During the ensuing months of the year, the two meds together collected $2.56 billion in sales for AZ, with $688 million coming from Ultomiris.

That C5 franchise has lately started to face some challenges. These include Apellis’ C3 inhibitor Empaveli in paroxysmal nocturnal hemoglobinuria, Argenx’s FcRn inhibitor Vyvgart in generalized myasthenia gravis, as well as two late-stage candidates from UCB.