Obtained a victory in a patent invalidation action related to the Soliris® use patent

Lee & Ko’s IP Practice Group represented Samsung Bioepis in a patent invalidation action involving Soliris®, a treatment for paroxysmal nocturnal hemoglobinuria, and obtained a winning decision for the client. Soliris® is a rare-disease treatment developed by Alexion Pharmaceuticals (“Alexion”) in the United States, and is a ultra-high-price medicine with annual medication costs reaching KRW 0.5 billion. Two patents were registered for Soliris®,a composition patent that expired in 2015 and a use patent. Samsung Bioepis filed an invalidation action on the use patent last June.

In this invalidation action, Lee & Ko argued that the patent’s priority claim should be denied and that its novelty and inventive step are also denied in view of the prior art. The Intellectual Property Trial and Appeal Board (the “IPTAB”) agreed and found that the use patent should be invalidated.

Samsung Bioepis had completed phase III clinical trials on its biosimilar product of Soliris® in October 2021 and applied for marketing approval with the Ministry of Food and Drug Safety in July 2022. The win at the IPTAB now paves the way for Samsung Bioepis to potentially launch its biosimilar this year.