Fresh From the Bench: Latest Precedential Patent Cases
CASE OF THE WEEK
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.
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.
Editors:
Nika Aldrich, IP Litigation Group Leader, Schwabe
Jason A. Wrubleski, Shareholder