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ARTICLE · 18 JULY 2023

Genentech Files BPCIA Complaint Against Biogen Regarding Tocilizumab

Goodwin Procter LLP
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The asserted patents cover various processes, methods of treatment, antibody subtypes, and compositions.

United StatesIntellectual Property
Elaine Blais
Elaine Blais

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

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