On February 12, 2024, Chugai, Genentech, and Hoffmann-La Roche (Roche) filed a motion to voluntarily dismiss CAFC Appeals 24-1111 and 24-1115, appealing the Final Written Decisions (FWDs) in IPR2022-00578 and IPR2022-00579, brought by Celltrion. In those FWDs, the PTAB found all challenged claims of Chugai, Genentech, and Roche's U.S. Patent No. 8,580,264 (claiming methods of treatment), and U.S. Patent No. 10,874,677 (claiming drug delivery devices) unpatentable. Celltrion submitted an aBLA for CT-P47, a proposed biosimilar of Genentech's Actemra® (tocilizumab), in January 2024, following the PTAB August 29, 2023 FWDs finding the patent claims unpatentable.
The Celltrion IPRs are the last pending patent disputes related to an Actemra® biosimilar; all other challenges have settled including seven IPRs filed by Fresenius Kabi related to proposed biosimilar MSB11456 (tocilizumab) (aBLA pending), and a BPCIA litigation filed by Genentech against Biogen and Bio-Thera related to Biogen's approved biosimilar Tofidence" (tocilizumab-bavi).
Roche reported that half-year U.S. 2023 sales of Actemra® were $629M.
The authors would like to thank April Breyer Menon for her contributions to this article.
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