On March 2, 2017, the PTAB issued a decision denying Celltrion, Inc.’s (“Celltrion”) request for inter partes review (“IPR”) of claims 1-14 of U.S. Patent No. 7,976,838 related to Genentech’s Rituxan® (rituximab). This denial comes less than a week after the PTAB instituted IPR of U.S. Patent No. 7,820,161, related to the same product, in response to a separate petition filed by Celltrion as discussed in this post.
The challenged claims of the ’838 patent are generally directed to methods of treating rheumatoid arthritis in a patient who experiences an inadequate response to a TNFα-inhibitor by administering an anti-CD20 antibody, such as rituxan, intravenously at certain dosages. Rituximab is an anti-CD20 monoclonal antibody approved for the treatment of non-Hodgkin’s lymphoma, chronic lyphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangitis, and microscopic polyangitis.
The Board denied institution in proceeding IPR2016-01667 filed on August 25, 2016. The real parties-in-interest identified for Petitioner are Celltrion, Celltrion Healthcare Co. Ltd. (“CTHC”), and Teva Pharmaceuticals International GmbH (“Teva”). The only real party-in-interest identified for Patent Owner is Genentech, Inc. The PTAB previously instituted an IPR for certain claims of the ’838 patent on a petition filed by Boehringer Ingelheim. That proceeding (IPR2015-00417) was terminated on October 1, 2015, following a Request for Adverse Judgment by Petitioner. Celltrion also previously filed a petition challenging certain claims of the ’838 patent, IPR2015-01733, on August 14, 2015. Celltrion filed a motion seeking to join that proceeding with IPR2015-0417, but when IPR2015-00417 was terminated by Boehringer Ingelheim (before an institution decision on Celltrion’s petition), Celltrion moved to dismiss the petition in IPR2015-01733 without prejudice.
A complete list of IPRs related to rituximab and other proposed biosimilars can be found in RFEM’s IPR Dashboard.