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 further asserts that “Bio-Thera manufactures BIIB800 for Biogen…and will participate in the importation of BIIB800 in to the United States.”

Genentech’s Complaint includes a summary of the parties interactions during the “patent dance.”  Specifically, Genentech asserts that the parties engaged in the “patent dance” but that Biogen failed to provide “such other information that describes the process or processes used to manufacture the biological process that is the subject of [its] application.”  Genentech also alleges that Biogen’s detailed statements “lacked the level of detail required by” the BPCIA.  Genentech alleges that it “has been forced to assess Biogen’s infringement based on incomplete information” but “has reason to believe that the manufacture, use, sale, or offer for sale, or importation of BIIB800 has or will infringe U.S. Patent Nos. 7,332,289; 7,521,052; 8,398,980; 8,512,983; 8,574,869; 8,734,800; 9,714,293; 9,902,777; 10,017,732; 10,336,983; 10,501,769; 10,662,237; 10,676,710; 10,744,201; 10,829,732; 10,982,003; 11,021,728; 11,078,294; 11,136,610; and 11,377,678.”  The asserted patents cover various processes, methods of treatment, antibody subtypes, and compositions.

Genentech seeks a judgement of infringement, “statutory relief under 35 U.S.C. §271(e)(4)(D), including but not limited to a permanent injunction,” “damages in the form of lost profits but in no event less than a reasonable royalty,” judgment that the infringement has been willful and enhancement of damages, an accounting of any damages, a preliminary and permanent injunction, a declaration that the case is exceptional and an award of attorneys’ fees, costs and expenses, and any other just and proper relief.  Genentech has also demanded a jury trial.

This is the first BPCIA tocilizumab litigation brought by Genentech.  Genentech and Fresenius entered into a settlement agreement in October 2022 relating to Fresenius’s tocilizumab biosimilar, in relation to IPRs filed by Fresenius, but Genentech had not filed a BPCIA complaint.

Stay tuned to Big Molecule Watch for updates on the case.

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