Regeneron v. Mylan – Update on Aflibercept BPCIA Litigation

As we 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, less than a year from Regeneron’s filing of its complaint in August 2022.  The Court’s scheduling order, issued in October 2022, required Regeneron to immediately identify six patents for the June trial from among the 24 patents originally listed in Regeneron’s Complaint.  The scheduling order also required that within 7 days of the Court’s claim construction order, Regeneron must further limit the issues for the trial to three patents and no more than 25 claims.  The court held a claim construction hearing on January 24, 2023, but has not yet issued a claim construction order.

On April 10, 2023, Mylan filed a motion to modify the scheduling order and require Regeneron to immediately narrow the scope of the proceedings to three patents and 12 claims, even without a claim construction order.  On April 14, 2023, the Court denied Mylan’s motion.  Mylan argued that there was good cause to modify the scheduling order because, with the limited time remaining before trial, adhering to the original scheduling order is “unworkable” and would result in “wasteful pretrial activities” such as motions and preparations related to patents and claims that will not ultimately be addressed at trial.  In response, Regeneron argued that it has already “voluntarily narrowed the trial to four patents” and that it has “scrupulously adhered” to the scheduling order while Mylan has “flouted” it, including missing deadlines for expert reports.  Regeneron further argued that if it is required to narrow the patents ahead of schedule, Mylan should be required to narrow the defenses it will present at trial.  The Court rejected Mylan’s argument that immediate narrowing of the case is necessary and that the scheduling order should be modified.  The Court also rejected Mylan’s request for an emergency status conference “to assess the feasibility of proceeding to trial on June 12th.”

Separately, in March 2023, Mylan also filed a motion to compel Regeneron to produce documents from a lawsuit that the U.S. Department of Justice brought under the anti-Kickback Statute against Regeneron in the District of Massachusetts regarding Regeneron’s sales of Eylea.  The motion, Regeneron’s response, and the Court’s order granting the motion were filed under seal, but after the Court ordered Regeneron to produce the requested documents, Regeneron moved to extend the production deadline in order to provide time to prepare the documents and to comply with the protective order in the Massachusetts case.  That second motion, along with Mylan’s response provided information regarding the nature of Mylan’s motion to compel. In particular, Mylan requested, and the Court ordered Regeneron to produce, “all pleadings and discovery,” from DOJ’s lawsuit against Regeneron, along with all documents that Regeneron produced or received in discovery during the DOJ lawsuit.  In an order addressing Regeneron’s motion, the Court required Regeneron to substantially complete production of the documents by the original deadline, but allowed three additional days to fully complete production and implemented procedures for Regeneron to comply with the protective order in the DOJ case for production of documents that had been designated confidential by parties unaffiliated with Regeneron.