Regeneron v. Mylan – Update on Aflibercept BPCIA Litigation

As we have previously reported, Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding on an expedited schedule, with a two-week trial scheduled to begin on June 12, 2023, in the Northern District of West Virginia.

On April 20th, both parties filed motions for summary judgment.  Regeneron requested summary judgment of nonobviousness on U.S. Patent No. 11,084,865, asserted by Regeneron.  Mylan requested summary judgment with respect to certain aspects of Regeneron’s infringement allegations regarding U.S. Patent Nos. 11,104,715 (which Regeneron recently stipulated to not assert at trial); 11,084,865; 10,888,601; and 11,253,572.  On June 6th, the Court denied both motions for summary judgment, finding that “genuine disputes regarding material facts exist in this case, to the extent that summary judgment for either party is inappropriate under Rule 56 of the Federal Rules of Civil Procedure.”  The Court further denied two related motions to strike evidence and arguments, one filed by each party, and Mylan’s further motion to defer summary judgment as moot in light of the denials of summary judgment.

Separately on June 6th, the Court granted Regeneron’s motion for judgment on the pleadings and denied Mylan’s second motion to amend its pleadings.  Regeneron had previously filed a motion for judgment on the pleadings in response to arguments of inequitable conduct set forth by the defendant, arguing that Mylan did not provide sufficient support for their argument.  The Court ruled in Regeneron’s favor, finding that Mylan had failed to sufficiently plead the intent element of inequitable conduct and further that “[e]ven if Mylan had satisfied intent, Mylan’s allegations also fail because the cited statements were attorney argument” rather than a genuine misrepresentations of fact.  Concurrently, the Court denied Mylan’s second motion to amend its pleadings, finding that the motion for amendments proposed by Mylan would be “prejudicial to Regeneron due to its untimeliness and the volume of new allegations proposed.”