Samsung recently filed the following IPR petitions challenging all claims of four patents assigned to Alexion relating to SOLIRIS (eculizumab): IPR2023-00998, challenging claims 1-3 of U.S. Patent No. 9,718,880; IPR2023-00999, challenging claims 1-10 of U.S. Patent No. 9,725,504; IPR2023-01069, challenging claims 1-8 of U.S. Patent No. 10,590,189; and IPR2023-01070, challenging claims 1-29 of U.S. Patent No. 10,703,809.  The challenged claims generally relate to pharmaceutical dosages of eculizumab and methods for treating paroxysmal nocturnal hemoglobinuria with eculizumab. Samsung argues that all claims are invalid as obvious and/or anticipated by prior art references.

Samsung also recently filed IPR2023-01103, challenging all claims of U.S. Patent No. 10, 961,307, assigned to Janssen, with 34 claims relating to methods for treating ulcerative colitis with ustekinumab.  Samsung argues that all claims are invalid as obvious and/or anticipated by prior art references.

Stay tuned to BMW for future developments on these IPRs, and check out our PTAB Tracker for information on pending and concluded IPRs on other biosimilar products.

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