The US Patent Trial and Appeal Board (PTAB) has instituted two more of Samsung Bioepis’ inter partes review (IPR) petitions challenging Alexion’s Soliris® (eculizumab) patent. The IPRs relate to US patent nos. 10,590,189 and 10,703,809 in IPR proceedings IPR2023-01069 and IPR2023-01070 respectively. The patents cover method of treatment claims in treating paroxysmal nocturnal hemoglobinuria (PNH).
On 8 December 2023, PTAB instituted three other Samsung Bioepis petitions against Alexion’s Soliris® patent: US patent nos. 9,725,504, 9,718,880 and 9,732,149. Samsung Bioepis launched Epysqli®, biosimilar to Soliris®, in three European countries on 19 October 2023. Epysqli® was approved by the EMA on 30 May 2023.