Blog Big Molecule Watch April 08, 2019

New BPCIA Complaint: Genentech Seeks to Block Pfizer’s Proposed Bevacizumab Biosimilar

On April 5, 2019, Genentech filed patent infringement and declaratory judgment complaint against Pfizer in the District of Delaware in response to Pfizer’s submission of an aBLA seeking U.S. FDA approval of a biosimilar of Avastin® (bevacizumab).  In the complaint, Genentech alleges infringement of 22 patents, out of a total 31 that Genentech allegedly identified on its § (l)(3)(A) list of patents that it believed it could reasonably assert against Pfizer.

Genentech also alleges violations of the BPCIA’s patent dance procedures by Pfizer, including a failure by Pfizer to provide “other information” describing Pfizer’s manufacturing process, beyond its aBLA.  Accordingly, pursuant to § (l)(9)(C), Genentech also seeks a declaratory judgment of infringement of several of the asserted patents.  In addition, Genentech seeks a declaration that Pfizer failed to comply with § (l)(2)(A) and is therefore enjoined from bringing “an action under section 2201 of title 28 for a declaration of infringement, validity, or enforceability of any patent that claims the biological product [bevacizumab] or use of the biological product [bevacizumab].”

The complaint further alleges that Pfizer served a notice of commercial marketing pursuant to § (l)(8)(A), notifying Genentech of Pfizer’s “intent to begin commercial marketing of its aBLA product as early as July 17, 2019 (180 days from the date of the notice).”

This new litigation has been docketed as Civil Action No. 19-cv-638.  This is the second BPCIA litigation regarding a proposed bevacizumab biosimilar, following Genentech’s case against Amgen regarding Mvasi (bevacizumab-awwb), which too is pending in the District of Delaware, with a trial before Judge Connolly scheduled for July 2020.

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