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PTAB Institutes Two Additional Samsung Bioepis IPRs Against Alexion’s Soliris® (eculizumab)

Dec 20, 2023

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.