RARE Daily

AstraZeneca Reaches Settlement with Chugai over Ultomiris Patent Dispute

March 18, 2022

Alexion, AstraZeneca’s Rare Disease group, said it will pay Chugai Pharmaceutical $775 million to settle patent disputes between the two companies related to Ultomiris, its long-acting C5 complement inhibitor.

As part of the settlement, Alexion and Chugai said they are withdrawing patent infringement proceedings filed with U.S. District Court for the District of Delaware and Tokyo District Court.

In 2016, Alexion challenged the validity of five of Chugai’s European patents. The European Patent Office revoked four of those patents and Chugai appealed the decision. Alexion took similar actions in Japan to challenge four Chugai patents there.

In November 2018, Chugai filed a lawsuit against Alexion in the Delaware District Court alleging that Ultomiris infringes on a patent Chugai held. When Chugai secured an additional patent, in November 2019, it filed a second lawsuit in the same court alleging that Ultomiris also infringes that patent. The two lawsuits were consolidated in December 2019.

In December 2018, Chugai filed a lawsuit in the Tokyo District Court against Alexion Pharma GK alleging that Ultomiris infringed two Japanese patents Chugai held. Chugai’s complaint sought unspecified damages and certain injunctive relief.

“With this settlement, we will continue to advance our Ultomiris development programs in new indications and focus on our mission to transform the lives of people affected by rare diseases,” said Marc Dunoyer, CEO of Alexion.

Under the terms of the agreement, Alexion will make a single payment of $775 million in the second quarter of 2022, for which a charge will be recognized through the non-core P&L in the first quarter of 2022.

No further amounts are payable by either party. AstraZeneca said the settlement does not impact its financial guidance for 2022.

Photo: Marc Dunoyer, CEO of Alexion

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