MDL Panel Grants Transfer of Aflibercept BPCIA Case

As we previously reported, on January 11, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) moved to establish a multi-district litigation (“MDL”) for its aflibercept BPCIA litigation, and to transfer its case against Amgen, Inc. (“Amgen”) to the Northern District of West Virginia under 28 U.S.C. § 1407.  The litigation consists of six actions—one against Amgen, pending in the Central District of California, and five pending in the Northern District of West Virginia (assigned to Chief Judge Thomas S. Kleeh) against Mylan/Biocon, Celltrion, Formycon, and two against Samsung Bioepis.

On February 2, 2024, Samsung Bioepis, Celltrion, and Formycon filed a joint opposition to Regeneron’s motion.  Amgen filed a separate opposition brief the same day.

On April 11, 2024, the Judicial Panel on Multidistrict Litigation (“JPML”) determined that the actions involve “common questions of fact and that centralization in the Northern District of West Virginia will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation.”  The JPML noted that Regeneron alleges that the defendants “infringed a common set of thirteen U.S. patents covering Regeneron’s ophthalmic drug, EYLEA®, by submitting aBLAs and seeking to market their follow-on biologic products.”  The panel noted that the ʼ865 patent, one of the thirteen patents, has been held valid and infringed by Judge Kleeh after trial in the action again Mylan.

The defendants had argued that centralization was not appropriate because there were many non-overlapping patents against each defendant, including those involving manufacturing methods, raising different invalidity and non-infringement defenses.  Defendants also asserted that their manufacturing methods are confidential, and because defendants are competitors to one another, that “special discovery protections will be necessary” if the case were centralized.  The JPML rejected those arguments as not persuasive.  The JPML noted that, despite potential variations in defenses among defendants, it is “[m]ore efficient to allow a single court to construe the patents at issue and to decide whether injunctive relief is warranted.”

The JPML ordered transfer of the case against Amgen to the Northern District of Virginia for “coordinated or consolidated pretrial proceedings” before Chief Judge Thomas S. Kleeh.


Stay tuned to Big Molecule Watch for more updates on these litigations.