BRIEF—Chugai and Roche file patent infringement lawsuit over Actemra

14 July 2023

Japanese drugmaker Chugai, Roche (the majority owner of Chugai), and Roche unit Genentech have filed a patent infringement lawsuit in the US District Court for the District of Massachusetts.

The action is in response to US biotech major Biogen filing of an abbreviated biologics license application (aBLA) to the US Food and Drug Administration for approval of a biosimilar to immunosuppressive drug Actemra (tocilizumab).

Chugai, Roche and Genentech filed the lawsuit against Biogen together with its business partner Bio-Thera Solutions, which developed biosimilar products subject to Biogen’s aBLA, seeking judgments including infringement of Chugai, Roche, and Genentech’s US patents under the framework of Biologics Price Competition and Innovation Act (BPCIA).

Patents in suit include but not limited to patents related to methods of using tocilizumab in intravenous form, and methods of manufacturing tocilizumab.

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