Regeneron v. Mylan BPCIA Aflibercept Litigation Update: Claim Construction Order and Stipulation to Narrow the Case for June 2023 Trial

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.

On April 19, the Court issued a claim construction order construing seven terms from the claims of the four patents still being asserted in the case.  The Court adopted Mylan’s proposed constructions for six of the seven disputed terms, and adopted Regeneron’s proposed construction for the remaining term.  The following day, on April 20, Mylan moved for summary judgment of noninfringement or invalidity of certain claims in U.S. Patent Nos. 10,888,601, 11,084,865, 11,253,572, and 11,104,715.

Under the Court’s scheduling order for the case, 7 days after issuance of the claim construction order, Regeneron was required to identify three patents and no more than 25 total claims that it would assert at the upcoming trial.  On April 27, 2023, Regeneron filed a stipulation that narrowed the asserted claims in the case to the following:

  • U.S. Patent No. 10,888,601: Claims 11, 19, and 27;
  • U.S. Patent No. 11,084,865: Claims 4, 7, 9, 11, and 14-18; and
  • U.S. Patent No. 11,253,572: Claims 6, 7, 12, 13, 18, 19, 22, 23, and 25.

In the same stipulation, Regeneron stated that it “does not oppose summary judgment as to the following claims,” under the Court’s claim constructions, subject to its “rights of appeal concerning claim construction”:

  • U.S. Patent No. 11,104,715:  Non-infringement of Claims 2-3, 6, 12-14, and 16
  • U.S. Patent No. 10,888,601:  Invalidity of Claims 5-6 and 9
  • U.S. Patent No. 11,253,572:  Invalidity of claims 1-5, 8-11, 14, and 26-28

Regeneron also stated that it “opposes summary judgment with respect to all other bases and all other claims that are the subject of Mylan’s motion, and will file an opposition to Mylan’s motion accordingly.”

Finally, on April 28, 2023, the court granted Mylan’s motion to amend its Answer and Counterclaims to “add a declaratory judgment counterclaim of no lost profits or injunctive relief with respect to certain patents,” particularly patents that Regeneron had initially asserted in the litigation but did not select for trial.  Mylan filed its motion in December 2022, after the expedited schedule was ordered and Regeneron narrowed the asserted patents to six.  According to Mylan, the “unselected patents. . . have been effectively dismissed without prejudice and/or not prosecuted to judgment in good faith under the Biologics Price Competition and Innovation Act,” and thus the available remedies with respect to those patents should be limited under the BPCIA.

Stay tuned to Big Molecule Watch for additional updates on this case.