On 6 May 2024, by order unsealed on 10 May 2024, the United States District Court for the District of Delaware refused to grant Alexion injunctive relief against Samsung Bioepis for alleged infringement of claims of two Alexion patents relating to methods for treating paroxysmal nocturnal hemoglobinuria (PNH) (US 10590189) and atypical haemolytic uremic syndrome (aHUS) (US 9447176) with eculizumab. The patents are due to expire on 8 September 2027 and 22 August 2032, respectively.
The PI application was part of the BPCIA litigation commenced by Alexion on 3 January 2024 alleging infringement of 6 patents relating to Samsung Bioepis’ aBLA for SB12, its biosimilar to Alexion’s Soliris® (eculizumab). The litigation is ongoing.
Alexion also filed proceedings on 19 March 2024 against Samsung Bioepis (and Amgen) in the Hamburg Local Division of the UPC seeking provisional measures in relation to EP 3 167 888 (method of treating PNH).
SB12 was launched as Epysqli® in Germany, Italy and Spain in 2023 and in Korea in April 2024.