Bevacizumab Litigation Update: Pfizer Answers Genentech’s Complaint and Genentech Moves to Dismiss Counterclaims

On April 29, 2019, Pfizer answered Genentech’s complaint alleging infringement of 22 patents based on Pfizer’s submission of an aBLA seeking U.S. FDA approval of a biosimilar of Avastin® (bevacizumab).  In its answer, Pfizer denied Genentech’s allegations of patent infringement and violations of the BPCIA’s patent dance procedures.  Pfizer also made counterclaims seeking declaratory judgement of invalidity and noninfringement of each of the 22 patents identified in Genentech’s complaint, and unenforceability of U.S. Patent No. 6,407,213 due to inequitable conduct during prosecution of the patent.

On May 20, 2019, Genentech moved to moved to dismiss Pfizer’s counterclaims.  Genentech argued that the declaratory judgement counterclaims are barred by the BPCIA because during the patent dance Pfizer did not produce its entire aBLA and also did not comply with the requirement to produce “such other information that describes the process or processes used to manufacture” the proposed biosimilar product.  Genentech also argued that Pfizer’s validity challenges should be “stricken or dismissed with prejudice” because they “challenge validity and unenforceability on grounds broader than what was disclosed” during the patent dance.  Finally, Genentech argued that Pfizer did not adequately plead inequitable conduct during prosecution of the ’213 patent.

On June 3, 2019, Pfizer responded to Genentech’s motion to dismiss.  Pfizer argued that Genentech’s motion is “based largely on unsupportable interpretations of the BPCIA” and “raises factual issues that cannot be properly resolved on a motion to dismiss.”  In particular, Pfizer argued that Genentech “point[s] to no statutory text or legislative history to support” the argument that Pfizer should be limited to invalidity arguments identified during the patent dance, and that Genentech’s “position defies common sense and fairness and cannot be squared with the careful balance of the parties’ interests that Congress designed.”  Pfizer also argued that it adequately pled inequitable conduct during prosecution of the ’213 patent.

We will continue to monitor this litigation.  Stay tuned to Big Molecular Watch for further updates.