On August 18, 2021, Fresenius Kabi USA, LLC and Fresenius Kabi SwissBioSim GmbH (collectively, “Fresenius”) filed Petitions for Inter Partes Review of U.S. Patent No. 10,874,677 (IPR 2021-01336) and U.S. No. 5,80,264 (IPR 2021-01288) .  The ‘264 patent claims are directed to methods of treating rheumatoid arthritis patients using a fixed dose of 162 mg of tocilizumab, an anti-IL-6R antibody.  Fresenius asserts that claims 1-3 and 6-11 of the ‘264 patent are invalid as anticipated or obvious.  The ‘677 patent claims are directed to a subcutaneous administration device for delivery of a fixed dose of 162 mg of tocilizumab, and Fresenius contends that claims 1-8 are invalid as anticipated or obvious.  The ‘264 patent is assigned to Chugai Seiyaku Kabushiki Kaisa, Hoffmann La-Roche Inc., and Genentech, Inc., while the ‘677 patent is assigned to Chugai Seiyaku Kabushiki Kaisa, and Hoffman-La Roche Inc. A decision on institution in IPRs 2021-01288 and -01336 is expected no later than February 2022.

Fresenius had also filed Petitions on June 28, 2021 for Inter Partes Review of U.S. No. 7,521,052 (IPR 2021-01024) and U.S. Patent No. 10,744,201 (IPR 2021-01025).  The ‘052 patent has only one claim, directed to a method of treating rheumatoid arthritis by administering an effective amount of an anti-IL-6R antibody and an effective amount of methotrexate, and Fresenius contends that the claim is invalid as anticipated or obvious.  The ‘201 patent claims are generally directed to methods of increasing the likelihood of achieving, or methods for achieving, an American College of Rheumatology (ACR) 70 response in a rheumatoid arthritis patient by administration of an intravenous 8 mg/kg dose of tocilizumab and oral methotrexate at 10-25 mg.  Fresenius contends that claims 1-15 of the ‘201 patent are invalid as anticipated or obvious.  The ‘052 and ‘264 patents are both assigned to Chugai Seiyaku Kabushiki Kaisa.  A decision on institution in IPRs 2021-01024 and -01025 is expected no later than January 2022.