IP Law Daily, PATENT—Fed. Cir.: Preliminary injunction affirmed barring German company’s sale of biosimilar eye medication, (Jan 30, 2025)

By Kevin M. Finson

An injunction was properly issued because the court had personal jurisdiction over the defendant and the defendant failed to raise a substantial question of patent invalidity in its attack on the patent owner’s likelihood of success on the merits.

A German pharmaceutical company failed to show any error in a district court decision granting a preliminary injunction against the company’s sale of a biosimilar biologic eye treatment product, the U.S. Court of Appeals for the Federal Circuit has held. A West Virginia district court had personal jurisdiction to issue the injunction due to the company’s demonstrated intent to sell, through a third party, the infringing product within the court’s geographic jurisdiction. The court also did not err in finding that the German company had not raised a substantial question of the invalidity of the asserted patent due to obviousness-type double patenting (Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., No. 24-2009 (Fed. Cir. Jan. 29, 2025)).

Regeneron Pharmaceuticals, Inc. (Regeneron) was the owner of U.S. Patent No. 11,084,865 (the ’865 patent), which claimed in part an FDA-approved aflibercept biologic product, EYLEA®, used in the treatment of certain eye conditions. Regeneron brought suit for infringement and obtained a preliminary injunction against Formycon AG, (Formycon), a competing pharmaceutical company based in Germany, which had sought to market its own FDA approved biosimilar product, FYB203. Formycon appealed the issuance of the preliminary injunction.

Personal jurisdiction. Formycon argued that the district court lacked personal jurisdiction over it because it had no contacts with West Virginia, but would instead be hiring a marketer/distributor who would eventually control sales in the United States and who may or may not conduct any business in West Virginia.

The Federal Circuit determined that it was clear from documents in the record, including a map of markets to be targeted, that Formycon intended to direct the sale of its products into both West Virginia and the rest of the United States. The court found no error in the trial court’s determination that it possessed personal jurisdiction over Formycon.

Injunction. Formycon argued that the district court erred in finding that it had not raised a substantial question of the invalidity of the asserted patent due to obviousness-type double patenting (ODP) and in determining that there was a substantial nexus between Formycon’s conduct and the irreparable harm cited by Regeneron.

Referring to reasoning explained in a related precedential decision the panel issued contemporaneously, the Federal Circuit found that the ’865 patent did not merely optimize on an earlier, expired, patent but instead represented patentable improvements and that Formycon’s direction of marketing the proposed biosimilar product would cause irreparable harm by price erosion, even if that was carried out directly by a marketer/distributor hired by Formycon rather than by Formycon itself.

The Federal Circuit affirmed the district court’s issuance of the preliminary injunction.

The Case is Nos. 24-2009, 24-2019, 24-2156.

Judge: Taranto, R.

Attorneys: David I. Berl (Williams & Connolly LLP) for Regeneron Pharmaceuticals, Inc. Shaun Van Horn (Fish & Richardson P.C.) for Formycon AG. William Adams (Quinn Emanuel Urquhart & Sullivan, LLP) for Mylan Pharmaceuticals Inc.

Companies: Regeneron Pharmaceuticals, Inc.; Formycon AG; Mylan Pharmaceuticals Inc.; Amgen USA, Inc.; Biocon Biologics, Inc.; Celltrion, Inc.; Samsung Bioepis Co., Ltd.; Amgen Inc.

Cases: Patent FedCirNews WestVirginiaNews