Chugai settles patent infringement litigation in USA

Japanese drug major Chugai Pharmaceutical (TYO: 4519) announced that, along with majority owner Roche (ROG: SIX) and its biotech subsidiary Genentech (collectively “the companies”) have entered into a settlement agreement with Fresenius Kabi USA, on August 5, 2022 relating to the patent lawsuit filed by the companies on March 19, 2020.

In the lawsuit, the companies alleged that the submission of an Abbreviated New Drug Application (ANDA) by Fresenius for a generic version of Alecensa (alectinib), an ALK inhibitor, anti-cancer agent, to the US Food and Drug Administration infringed Chugai’s patents in the USA (Nos 9,126,931; 9,440,922; 9,365,514 and 10,350,214) under the framework of the Drug Price Competition and Patent Term Restoration Act (known as Hatch-Waxman Act).

In accordance with the settlement agreement, the companies and Fresenius will take steps to withdraw the lawsuit.