Genentech and Dr. Reddy’s Settle BPCIA Rituximab Litigation

Genentech, Hoffmann-La Roche, and Biogen have settled their BPCIA litigation against Dr. Reddy’s Laboratories (“DRL”) and Fresenius Kabi.   As we previously reported, Genentech, Hoffmann-La Roche, and Biogen filed a complaint in the U.S. District Court for the District of New Jersey in November 2023, alleging that DRL’s proposed rituximab biosimilar to RITUXAN, DRL_RI, infringed 15 patents.   The parties entered into a joint stipulation last week, dismissing all claims.  The court then ordered the case dismissed.

This was the third BPCIA litigation involving a rituximab biosimilar, following cases against Sandoz and Celltrion which were dismissed in 2018 after the parties reached settlements in their respective cases.