Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) filed a complaint on January 3, 2024, against Samsung Bioepis Co. Ltd. (“Samsung”) in the U.S. District Court for the District of Delaware, alleging infringement of 6 patents under the BPCIA based on Samsung’s submission of an aBLA for SB12, a proposed biosimilar to SOLIRIS (eculizumab).  According to the complaint, eculizumab is a humanized antibody that binds complement protein C5 to block the effects of the complement pathway in patients with paroxysmal nocturnal hemoglobinuria (PNH).  This is the first BPCIA litigation involving a eculizumab biosimilar.

Alexion alleges that Samsung submitted its aBLA for SB12 to the FDA on July 7, 2023 and that same day, also provided Notice of Commercial Marketing pursuant to 42 U.S.C. § 262(l)(8)(A).

Alexion asserts that Samsung’s SB12 biosimilar product will infringe U.S. Patent No. 9,732,149, directed to the antibody eculizumab that is the active compound in SOLIRIS; U.S. Patent No. 9,718,880, directed to compositions containing eculizumab; and U.S. Patent Nos. 9,725,504, 10,590,189, 10,703,809, and 9,447,176, directed to methods of treating patients using eculizumab.  Alexion seeks a judgment and declaration that Samsung has or will infringe the asserted patents, and a preliminary and permanent injunction to stop Samsung from marketing its biosimilar product.

As we previously reported, Samsung filed IPR petitions challenging the validity of 5 of these asserted patents—the ’149, ’880, ’504, ’809, and ’189 patents—and the PTAB recently granted institution on all 5 petitions.

Stay tuned to Big Molecule Watch for more updates on this litigation.

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