Blog Big Molecule Watch November 13, 2020

Genentech Sues Centus Over Proposed Bevacizumab Biosimilar

Yesterday, Genentech, Inc. filed a complaint in the Eastern District of Texas alleging that Centus Biotherapeutics, Ltd., Fujifilm Kyowa Kirin Biologics Co., Ltd., Fujifilm Corp., and Kyowa Kirin Co, Ltd. (collectively, Centus) proposed biosimilar to Genentech’s AVASTIN (bevacizumab) product infringes 10 U.S. patents.  Genentech’s complaint, styled as a Complaint for Patent Infringement and Declaratory Judgment, names four foreign defendants and no U.S. entities.  Because all named defendants are foreign corporations, Genentech alleges that venue is proper in any judicial district and that personal jurisdiction is proper in Texas because the product will be sold in Texas.

Genentech asserts that FDA accepted Centus’s BLA on November 18, 2019 and that parties engaged in the patent dance thereafter.  Genentech alleges that Centus failed to provide required manufacturing information and that Centus’s detailed statements lack detail/contain “only conclusory assertions.”  Genentech asserts that Centus provided Notice of Commercial Marketing on April 24, 2020 indicating that the product would be commercially marketing no earlier than October 21, 2020.  Genentech asserts that it asked Centus on November 9, 2020 whether it would agree to delay launch until final resolution of the litigation but that Centus declined.

Genentech describes the ten asserted patents as covering methods of making bevacizumab, methods of cultivating CHO cells, methods of making recombinant proteins, like bevacizumab, methods of treating cancer with bevacizumab, methods of making recombinant antibodies, like bevacizumab, methods of treating a patient having glioblastoma with a VEGF antagonist, like bevacizumab, methods of increasing the specific productivity of CHO cells that produce exogenous polypeptides, like bevacizumab, and methods for filtrating viruses from compositions comprising recombinant proteins, like bevacizumab.

Genentech seeks findings of infringement, a preliminary and permanent injunction, lost profits, and attorneys’ fees.

 

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