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Chugai, Genentech, and Hoffmann-La Roche Dismiss Appeals of Actemra® Patent IPR Final Written Decisions

by Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.
February 20, 2024

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.

For more information about these and other biosimilar patent disputes, visit BiologicsHQ.

 

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The authors would like to thank April Breyer Menon for her contributions to this article.

    Methodology

    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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