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

Dec 8, 2023

The US Patent Trial and Appeal Board (PTAB) has instituted three of Samsung Bioepis’ inter partes reviews (IPR) petitions challenging Alexion’s Soliris® (eculizumab) patent nos. 9,725,504, 9,718,880 and 9,732,149 in IPR proceedings IPR2023-00999, IPR2023-00998 and IPR2023-00933 respectively.  The patents cover method of treatment, pharmaceutical composition and API claims.

Samsung Bioepis recently launched Epysqli®, biosimilar to Soliris®, in three European countries on 19 October 2023. Epysqli® was approved by the EMA on 30 May 2023.