On November 17, 2023, Genentech, Inc., Hoffmann-La Roche Inc., and Biogen Inc. (“Plaintiffs”) filed a BPCIA complaint (“Complaint”) against Dr. Reddy’s Laboratories, Inc., Dr. Reddy’s Laboratories SA (“DRL SA”), Dr. Reddy’s Laboratories Ltd., Fresenius Kabi USA, LLC, Fresenius Kabi Swissbiosim Gmbh, and Fresenius Kabi Deutschland GmbH (“Defendants”) in the District of New Jersey, requesting the Court to block Defendants’ “DRL_RI,” a proposed biosimilar of Plaintiffs’ Rituxan^® (rituximab), from entering the United States market.  Genentech, Inc. et al v. Dr. Reddy’s Laboratories, Inc. et al, D.N.J., No. 1:23-cv-22485.  Rituxan^® is approved for various indications including for the treatment of adult patients with rheumatoid arthritis, non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis.  In their complaint, Plaintiffs allege that Defendants infringe fifteen patents related to Rituxan^®, including regarding its therapeutic uses, its administration, its formulation, and the processes by which it is manufactured.

An aBLA for DRL_RI was accepted by the FDA in July 2023 and is currently pending.  There are three other biosimilars of Rituxan^® that have already been approved and launched: Truxima^® (rituximab-abbs), Ruxience^® (rituximab-pvvr), and Riabni™ (rituximab-arrx).  There have previously been several biosimilar litigations against the other biosimilars, all of which settled or were dismissed.  See, e.g., Biogen, Inc. et al v. Sandoz GmbH et al, D.N.J., No. 1:17-cv-13507; Biogen, Inc. et al v. Celltrion Healthcare Co., Ltd., D.N.J., No. 1:18-cv-00574; Biogen, Inc. et al v. Celltrion Healthcare Co., Ltd., D.N.J., No. 1:18-cv-11553; Sanofi-Aventis Deutschland GmbH, et al v. Biogen IDEC, Inc. et al, N.D. Cal., No. 3:08-cv-04909; Sanofi-Aventis Deutschland GmbH, et al v. Biogen IDEC, Inc. et al, N.D. Cal., No. 3:09-cv-04919; Celltrion Healthcare Co., et al v. Biogen, Inc. et al, N.D. Cal., No. 4:18-cv-00276.  

In the Genentech action, of the fifteen asserted patents, nine have not been previously asserted against other Rituxan^® biosimilars.  The “patent dance” (42 U.S.C. § 262(1) outlines the framework) started on or about July 3, 2023 when the biosimilar (i.e., Defendant DRL SA) provided Plaintiffs with its aBLA for DRL_RI.  According to the Complaint, following receipt of the aBLA, Plaintiffs allege that the Defendants did not “meet its obligation to provide” other information that describes the “processes used to manufacture DRL_RI as required” by the BPCIA, and on August 1, 2023, requested Defendants provide the allegedly missing manufacturing information.  Despite the allegedly missing information, on September 1, 2023, Plaintiffs provided Defendants with a 3(A) list of fifteen patents that could reasonably be asserted against the DRL_RI product.  On November 16, 2023, Defendants provided the Plaintiffs a Notice of Commercial Marketing, starting a 180-day clock before the first possible date on which Defendants could market or sell DRL_RI.  Plaintiffs brought suit the day after receiving the Notice of Commercial Marketing on the fifteen patents on the 3(A) list “to preserve all rights.”  Plaintiffs are seeking, inter alia, a declaration of infringement and patent validity, damages and an injunction blocking sales of DRL_RI.

In 2022 Rituxan^® had U.S. sales of almost $1.5B.

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The authors would like to thank April Breyer Menon for her contributions to this article.