As previously reported, on 6 May 2024, the United States District Court for the District of Delaware refused to grant Alexion preliminary 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.
On 14 May 2024, Alexion filed a Notice of Appeal from the Court’s decision denying the preliminary injunction and, on 17 May 2024, Alexion sought an emergency injunction pending the appeal. On 17 June 2024, the Court refused Alexion’s motion for an emergency injunction, finding that there was a substantial question of validity in relation to the patents.
The injunction applications are 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.
SB12 was launched as Epysqli® in Germany, Italy and Spain in 2023 and in Korea in April 2024.