Alexion and Amgen Settle IPRs Over SOLIRIS (eculizumab)

Alexion Pharmaceuticals’ SOLIRIS (eculizumab) is approved in the U.S. for the treatment of paroxysmal nocturnal hemoglobinuria (PHN), atypical hemolytic uremic syndrome (aHUS), myasthenia gravis (gMG), and neuromyelitis optica spectrum disorder (NMOSD).  Amgen’s ABP 959 is a biosimilar to SOLIRIS undergoing clinical trials with a phase 3 clinical trial initiated earlier this year in patients with PNH.  As of June 2020, this study is recruiting participants.

We previously reported Amgen’s effort to invalidate Alexion’s patents directed to SOLIRIS (Nos. 9,725,504, 9,718,880, and 9,732,149, the “SOLIRIS patents”) using three inter partes reviews (IPR2019-00739, IPR2019-00740, and IPR2019-00741, the “eculizumab IPRs”).  The SOLIRIS patents are directed to eculizumab or methods of use to treat PHN and set to expire March 15, 2027.  The hearing for the eculizumab IPRs was originally scheduled for June 1, 2020 but on May 27, 2020 the hearing was postponed to June 16, 2020 to facilitate settlement.

On May 29, 2020, Alexion filed an 8-K with the Securities And Exchange Commission stating that Alexion and Amgen entered into a settlement and license agreement regarding the eculizumab IPRs.  While the agreement remains confidential, Alexion announced that Amgen agreed to file a motion to terminate each of the eculizumab IPRs and Alexion granted Amgen a non-exclusive, royalty-free, license under U.S. patents and patent applications related to eculizumab to make, have made, use, import, have imported, sell, have sold, offer for sale, have offered for sale, distribute, and have distributed in or for the U.S., an eculizumab product as of March 1, 2025. The same day as the 8-K filing, Amgen and Alexion filed a joint motion to terminate the eculizumab IPRs and the PTAB terminated the proceedings on June 1, 2020.