Samsung Bioepis Defeats Emergency Motion for Injunction

Delaware – June 18, 2024 – Cooley successfully defeated an emergency motion for injunction pending appeal for Samsung Bioepis in an ongoing Biologics Price Competition and Innovation Act (BPCIA) litigation related to Samsung’s Soliris (eculizumab) biosimilar drug product. Eculizumab is used primarily to treat paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), life-threatening genetic diseases that cause the breakdown of red blood cells resulting in various medical complications. The Cooley team representing Samsung in the matter includes partners Michelle Rhyu, Daniel Knauss, Jonathan Davies and Orion Armon, along with associates Brianna Patterson and HanByul Chang.

In January 2024, Alexion Pharmaceuticals Inc. and Alexion Pharma International Operations Ltd. (collectively, Alexion) asserted infringement of five patents directed to methods of treating PNH with eculizumab and one patent directed to methods of treating aHUS with the same drug. The litigation is pending before Judge Gregory Williams in the US District Court for the District of Delaware.

Last fall, Cooley successfully secured inter partes review (IPR) institution decisions at the Patent Trial and Appeal Board in all five petitions filed against Alexion’s five PNH patents-in-suit. Alexion sought a preliminary injunction in district court based on one of these patents and the patent-claiming treatments of aHUS. Cooley defeated Alexion’s motion for a preliminary injunction in May 2024, with the court holding that Samsung demonstrated a substantial question of validity for both the PNH and aHUS patents Alexion relied upon in its motion.

On June 18, 2024, Judge Williams denied Alexion’s emergency motion for injunction pending appeal. Alexion reiterated its argument on the PNH patent that, because the references used in the IPRs would not be available at trial, a finding of substantial question of validity could not rely upon the reasoning in the IPRs. In denying Alexion’s emergency motion, the court noted that Alexion had “failed to show that the Court clearly erred and abused its discretion. Specifically, the Court finds that the well-reasoned IPR institution decision raises a substantial question of validity. Injunctions are an equitable remedy, and the Court will not grant an injunction on a patent likely to be invalid.”

Read the opinion

The case is Alexion Pharmaceuticals, Inc. et al. v. Samsung Bioepis Co. Ltd.

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