Celltrion, Inc. (“Celltrion”) filed a petition with the Patent Trial and Appeal Board (“PTAB”) on August 15, 2016 for inter partes review (“IPR”) of U.S. Patent No. 7,820,161 (“the ’161 patent”) related to Genentech’s Rituxan® (rituximab).  On February 24, 2017, the PTAB issued a decision instituting review of claims 1–3, 5–7, and 9–11 of the ’161 patent.  The challenged claims of the ’161 patent are directed to a method for treating rheumatoid arthritis by administering more than one intravenous dose of a therapeutically effective amount of rituximab and administering methotrexate.

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 proceeding is IPR2016-01614. The real party-in-interest identified for Petitioner is Celltrion, Inc.  The real parties-in-interest identified for Patent Owner are Genentech, Inc. and Biogen, Inc.  The PTAB previously instituted an IPR for certain claims of the ’161 patent (claims 1, 2, 5, 6, 9, and 10) on a petition filed by Boehringer Ingelheim. That proceeding (IPR2015-00415) 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 ’161 patent, IPR2015-01744, on August 17, 2015.  Celltrion filed a motion seeking to join that proceeding with IPR2015-0415, but when IPR2015-00415 was terminated by Boehringer Ingelheim (before an institution decision on Celltrion’s petition), Celltrion moved to dismiss the petition in IPR2015-01744 without prejudice.  Celltrion currently has a separate petition for IPR pending for U.S. Patent No. 7,967,838.  A decision on institution in that proceeding is expected shortly.

A complete list of IPRs related to rituximab and other proposed biosimilars can be found in RFEM’s IPR Dashboard.