Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., Appeal Nos. 2024-1965, -1966, -2082, -2083 (Fed. Cir. Jan. 29, 2025)

Our Case of the Week is a 31-page decision that touches on a variety of issues, including personal jurisdiction, obviousness-type double patenting, written description, enablement, and more—all arising from a preliminary injunction issued by a district court in a case that focused on abbreviated Biologics License Applications filed with the FDA. We primarily discuss the personal jurisdiction issues here, but mention additional issues below, and recommend thorough study of the case for professionals who deal with these issues.

Regeneron holds a Biologics License Application for EYLEA®, a therapeutic product that contains the fusion protein aflibercept. Several companies filed abbreviated Biologics License Applications (aBLA) for generic versions of EYLEA®, including Mylan—and, relevant here, Samsung Bioepis Co., Ltd. (SB), a company based in South Korea. Regeneron filed lawsuits against them. Several, including suits filed against Mylan and SB, were filed in the Northern District of West Virginia. Others were eventually consolidated by the Judicial Panel on Multidistrict Litigation, and all were consolidated to the West Virginia forum. That court granted a preliminary injunction to Regeneron, prohibiting SB from offering for sale or selling in the United States the subject of their aBLAs.

SB challenged, with the argument that the district court lacked personal jurisdiction. As noted, SB is based in South Korea. It has no facilities or employees in the U.S., is not registered to do business in West Virginia, does not currently do business with entities in West Virginia, and has not designated an agent for service of process in West Virginia. SB also had no plans to pursue direct business in West Virginia after its application was approved: The South Korean firm did not intend to distribute, market, or sell its product in the U.S. Instead, it entered into a development and commercialization agreement with a U.S. company, pursuant to which that company would handle marketing and sales in the United States.

The district court found it had personal jurisdiction at the preliminary injunction stage, and the Federal Circuit affirmed. The Court relied largely on its decision in Acorda Therapeutics Inc. v. Mylan Pharms. Inc., 817 F.3d 755 (Fed. Cir. 2016), which involved similar facts but with regard to an ANDA as opposed to an aBLA. The Court stated the following: SB had filed an application with the FDA that confirmed its plan to engage in real-world marketing of its drug within the U.S.; it had served Regeneron with a Notice of Commercial Marketing; it had engaged several manufacturing, testing, labeling, and/or packaging partners in the U.S.; and it had entered into its distribution agreement to commercialize its drug in the U.S. Pursuant to that agreement, SB retained significant involvement in Biogen’s U.S. commercialization activities through various contractually established mechanisms. These efforts were nationwide in character. Thus, even though there was no specific plan to market or sell in West Virginia, that state had not been excluded from these plans. All this was sufficient to infer personal jurisdiction over SB in West Virginia.

As noted, the Court issued a variety of other decisions relating to obviousness-type double-patenting and requirements under Section 112. We make note of one distinction regarding the interplay between these doctrines. The district court had found against SB with respect to its double-patenting argument—a decision the Federal Circuit affirmed. One of the limitations that was not clear from the prior patent addressed whether a VEGF trap be “glycosylated.” SB argued the later patent had failed to satisfy written description and enablement requirements, based on the “glycosylated” limitation. But the Court called attention to a critical distinction: “The ODP [obviousness-type double patenting] analysis is focused on the earlier patent’s claims, and what a relevant artisan would find obvious based on them, whereas the written-description analysis is focused on what is disclosed in the specification.” That distinction was critical here, and sufficient to find the patent was both not subject to obviousness, but also satisfied the written description requirement based on the same claim term.

The opinion can be found here.

By Nika Aldrich

ALSO THIS WEEK

Apple Inc. v. Gesture Technology Partners, LLC, Appeal Nos. 2023-1501, -1554 (Fed. Cir. Jan. 27, 2025)

In cross-appeals from a decision from the PTAB in an inter partes review proceeding, the Federal Circuit for the first time confirmed that an IPR may be brought against an expired patent. The patentee, Gesture, had argued the Supreme Court had foreclosed post-expiration IPRs through language it had used to describe the length of time of the patent grant in Oil States Energy Svcs., LLC v. Greene’s Energy Grp., LLC, 584 U.S. 325 (2018). The Federal Circuit rejected this argument, and held that IPRs may be brought as long as rights in the patent can be exercised—i.e., as long as an infringement case can be brought for past damages. The Court also affirmed that most of the claims of the patent-at-issue were invalid; and, with respect to Apple’s cross-appeal, held the final claim, which the PTAB had found not invalid, was actually invalid as obvious.

The opinion can be found here.

By Nika Aldrich

This article summarizes aspects of the law. This article does not constitute legal advice. For legal advice regarding your situation, you should contact an attorney.