On March 17, 2022 Alexion, AstraZeneca’s Rare Disease group, reported that it has entered into a settlement agreement with Chugai Pharmaceutical Co., Ltd. (Chugai), resolving all patent disputes between the two companies related to Ultomiris (ravulizumab) (Press release, AstraZeneca, MAR 17, 2022, View Source [SID1234610214]).

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In accordance with the settlement agreement, Alexion and Chugai have taken steps to withdraw patent infringement proceedings filed with US District Court for the District of Delaware and Tokyo District Court.

Marc Dunoyer, Chief Executive Officer, Alexion, said: "With this settlement, we will continue to advance our Ultomiris development programmes in new indications and focus on our mission to transform the lives of people affected by rare diseases."

Financial considerations
Under the terms of the agreement, Alexion will make a single payment of $775m in the second quarter of 2022, for which a charge will be recognised through the non-core P&L in the first quarter of 2022. No further amounts are payable by either party. The settlement does not impact AstraZeneca’s financial guidance for 2022.

Notes

Ultomiris patent proceedings
US
In November 2018, Chugai filed a lawsuit against Alexion in the Delaware District Court alleging that Ultomiris infringes US patent No. 9,890,377 held by Chugai. Upon issuance of US patent No. 10,472,623 in November 2019, Chugai filed a second lawsuit in the same court alleging that Ultomiris also infringes that patent. The two lawsuits were consolidated in December 2019.

Japan
In December 2018, Chugai filed a lawsuit in the Tokyo District Court against Alexion Pharma GK alleging that Ultomiris infringed two Japanese patents (Japanese Patent No. 4954326 and No. 641743) held by Chugai. Chugai’s complaint sought unspecified damages and certain injunctive relief. Also beginning in 2016, Alexion had challenged the validity of four of Chugai’s Japanese patents. The IP High Court in Japan had found these patents invalid. Chugai filed a correction of these patents with the Japanese Patent Office. The Japanese Patent Office found the corrected patents invalid, and Chugai appealed the Patent Office’s decision to the IP High Court in Japan.

Europe
Beginning in 2016, Alexion challenged the validity of five of Chugai’s European patents. One patent was maintained by the Opposition Division of the European Patent Office while four were revoked. Three of the five decisions by the Opposition Division have been appealed to the Boards of Appeal for the European Patent Office.

Ultomiris
Ultomiris (ravulizumab), the first and only long-acting C5 complement inhibitor, offers immediate, complete, and sustained complement inhibition. The medication works by inhibiting the C5 protein in the terminal complement cascade, a part of the body’s immune system. When activated in an uncontrolled manner, the complement cascade over-responds, leading the body to attack its own healthy cells. Ultomiris is administered intravenously every eight weeks or, for paediatric patients less than 20kg, every four weeks, following a loading dose. Ultomiris is approved in the US for the treatment of adults and children (one month of age and older) with PNH; in the EU for adults, as well as for children (with a body weight of 10kg or above) and adolescents with PNH who experience haemolysis with clinical symptom(s) indicative of high disease activity, as well as for individuals who are clinically stable after having been treated with Soliris for at least the past six months; and in Japan as a treatment for adults with PNH. It is also approved in the US for aHUS to inhibit complement-mediated thrombotic microangiopathy in adult and paediatric (one month of age and older) patients, in the EU for the treatment of adults and children with a body weight of at least 10kg with aHUS, as well as in Japan for adults and children with aHUS.