Genentech, Hoffmann-La Roche, and Biogen have settled their BPCIA litigation against Dr. Reddy’s Laboratories (“DRL”) and Fresenius Kabi. As we previously reported, Genentech, Hoffmann-La Roche, and Biogen filed a complaint in the U.S. District Court for the District of New Jersey in November 2023, alleging that DRL’s proposed rituximab biosimilar…
On February 12, 2024, Chugai, Genentech, and Hoffmann-La Roche filed a motion for voluntary dismissal of their appeals of the PTAB’s Final Written Decisions in IPR2022-00578 and IPR2022-00579. The appeals concerned IPRs filed by Celltrion where the PTAB found all challenged claims of U.S. Patent Nos. 8,580,264 and 10,874,677 were…
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)…
As we previously reported, in July 2023 Genentech, Inc., Hoffmann-LaRoche, Inc., and Chugai Pharmaceutical Co., Ltd. (collectively, “Genentech”) filed BPCIA litigation against Biogen MA Inc. and Bio-Thera Solutions, Ltd. in the District of Massachusetts, asserting that Biogen sought FDA approval “to commercialize ‘BIIB800,’ a proposed biosimilar to Genentech’s drug Actemra®…
On August 29, 2023, the PTAB issued final written decisions in IPR2022-00578 and IPR2022-00579, filed by Celltrion on two patents related to tocilizumab — U.S. Patent Nos. 8,580,264 and 10,874,677, owned by Chugai Seiyaku Kabushiki Kaisa, Genentech, Inc, and Hoffmann La Roche, Inc. The ’264 patent claims are directed to…
Yesterday, Genentech, Inc., Hoffmann-LaRoche, Inc., and Chugai Pharmaceutical Co., Ltd. (“Genentech”) filed BPCIA litigation against Biogen MA Inc. and Bio-Thera Solutions, Ltd. in the District of Massachusetts. In its Complaint, Genentech asserts that Biogen is seeking FDA approval “to commercialize ‘BIIB800,’ a proposed biosimilar to Genentech’s drug Actemra® (tocilizumab).” Genentech…
The U.S. Patent Trials & Appeals Board (Board) recently issued an Order granting Celltrion’s motion to submit supplemental information in its IPR (2022-00578) against U.S. Pat. No. 8,580,264, owned by Chugai Seiyaku Kabushiki Kaisa, Genentech, Inc, and Hoffmann La Roche, Inc. As we previously reported, this is one of two…
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…