Genentech And Partners Voluntarily Dismiss IPR Appeals Related To Genentech's ACTEMRA® (Tocilizumab)

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 either anticipated by or obvious over the prior art. The '264 and '677 patents are directed to methods of treatment and drug delivery using tocilizumab. Genentech et al. state in their motion that they "have determined not to pursue further their appeals of the PTAB's Final Written Decisions."

In January 2024, Celltrion announced it had completed its submission of a BLA for CT-P47, Celltrion's biosimilar of Genentech's ACTEMRA^® (tocilizumab), an interleukin-6 receptor antagonist indicated for treatment of adult rheumatoid arthritis, juvenile idiopathic polyarthritis, and systemic juvenile idiopathic arthritis. Genentech has not yet filed a BPCIA complaint against Celltrion in relation to Celltrion's tocilizumab biosimilar.

As we previously reported, in July 2023, Genentech, Chugai, and Hoffmann-La Roche filed a BPCIA complaint against Biogen and Bio-Thera in connection with their submission of a BLA for their own tocilizumab biosimilar BIIB800, but that complaint was dismissed a few months later pursuant to the parties' settlement agreement.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.