Alexion Settles Patent Infringement Lawsuits Against Ultomiris for $775M

AstraZeneca_Bodo Marks/picture alliance via Getty

Bodo Marks/picture alliance via Getty

Alexion has agreed to resolve all patent disputes with Chugai Pharmaceutical regarding the prescription drug Ultomiris (ravulizumab) by signing a settlement agreement that will involve a one-time payment of $775 million. 

Under the terms of the deal, Alexion, AstraZeneca's rare disease arm, will pay Chugai $775 million in the second quarter of 2022 in exchange for the Japanese firm withdrawing the patent infringement lawsuits it filed in various courts in Europe, Japan and the U.S. 

In 2016, Alexion questioned the validity of five of Chugai's patents in Europe, four of which were revoked while one remained with the European Patient Office's opposition division. In 2018, Chugai sued Alexion Pharma GK in the Tokyo District Court for Ultomiris, allegedly infringing two of its patents in Japan for undisclosed damages. Alexion challenged the validity of four Japanese patents, and the IP High Court in Japan found the patents invalid. Chugai filed a correction, but the patent office found these invalid. 

In the U.S., Chugai sued Alexion in the Delaware District Court in 2018, alleging that Ultomiris infringes its patent. Chugai then filed a second lawsuit in 2019 in the same court. The two U.S. lawsuits were consolidated in December 2019. 

The settlement agreement covers Chugai's withdrawal of all patent infringement lawsuits in the Tokyo District Court and the U.S. District Court for the District of Delaware. 

"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," commented Marc Dunoyer, the chief executive of Alexion, in a statement. 

Ultomiris is a long-acting C5 complement inhibitor that is given intravenously and works by inhibiting the C5 protein in the terminal complement cascade, a part of the immune system. It is approved in the U.S. to treat adults and children ages one month and up who are diagnosed with paroxysmal nocturnal hemoglobinuria (PNH) and in the same demographic diagnosed with atypical hemolytic uremic syndrome (aHUS). The drug is said to provide up to eight weeks of respite between infusions. Two weeks after the first dose, Ultomiris is given every eight weeks for adults and every four or eight weeks for pediatric patients.

It is not known whether the medication is safe for use in children younger than one month. It is also approved in the EU for adults and children with a bodyweight of at least 10 kgs with aHUS and in Japan for the same demographic. 

With the settlement, a charge will be recorded through Alexion's non-core profit and loss report in the first quarter of 2022. It will not affect AstraZeneca's financial guidance for the year. The amount will also no longer be followed by any more payments from either Alexion or Chugai.

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