Genentech, Roche, and Biogen filed a Complaint on November 17 against Dr. Reddy’s Laboratories (“DRL”) and Fresenius in the U.S. District Court for the District of New Jersey, alleging infringement of 15 patents under the BPCIA based on DRL’s submission of an aBLA for DRL_RI, a proposed biosimilar of RITUXAN (rituximab) and DRL’s provision of Notice of Commercial Marketing with respect to the same. This is the third infringement suit under the BPCIA concerning a proposed biosimilar of RITUXAN. Genentech previously sued Sandoz on December 21, 2017 and Celltrion and Teva on January 12, 2018. Both cases were dismissed in December 2018, after the parties filed stipulations of dismissal stating that they had entered into settlement agreements. Since then several rituximab biosimilars have launched in the United States, including Celltrion’s TRUXIMA (rituximab-abbs), Pfizer’s RUXIENCE (rituximab-pvvr), and Amgen’s RIABNI (rituximab-arrx).
Genentech’s Complaint states that Plaintiffs are informed and believe that Fresenius has “entered into an exclusive license agreement with Dr. Reddy’s to commercialize Rituximab in the US.” They further allege that DRL submitted its aBLA prior to April 21, 2023 seeking approval for a RITUXAN biosimilar labeled with all the various indications for RITUXAN. Genentech’s Complaint states that DRL provided its aBLA to Plaintiffs on or about July 3, 2023, but did not “meet its obligation to provide ‘other information that describes the process or processes used to manufacture’ DRL_RI as required” by the BPCIA. Despite this alleged deficiency, Genentech provided its 3(A) list to DRL. According to the Complaint, thereafter, on November 16, 2023, DRL provided its Notice of Commercial Marketing. Plaintiffs brought “suit on all fifteen patents on Plaintiffs’ Patent List, out of an abundance of caution, to preserve all rights.” Twelve of the patents are directed to methods of manufacture and the remaining three patents claim methods of treatment.
Genentech’s Complaint seeks a declaration of infringement, a declaration that the patents are valid and enforceable, damages, an award for an accounting of damages, a declaration of willful infringement and a trebling of damages, and preliminary and permanent injunctions.
Stay tuned to Big Molecule Watch for more updates on this litigation.