On March 14, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s denial of a preliminary injunction against Amgen Inc. (“Amgen”) in the ongoing aflibercept BPCIA litigation.
On October 1, 2024, the district court denied Regeneron’s motion for a preliminary injunction against Amgen on the grounds that Regeneron had failed to establish a likelihood of success in showing that Amgen infringed the asserted claims of U.S. Patent No. 11,084,865 (“’865 patent”). The claims at issue are directed to an ophthalmic formulation with, among other elements, “a vascular endothelial growth factor (VEGF) antagonist” and a “buffer.” Amgen had argued that the “VEGF antagonist” and “buffer” limitations are separate components, whereas Regeneron asserted that a “VEGF antagonist” can also satisfy the claimed “buffer” limitation. The district court construed the claims to require that the “VEGF antagonist” be a separate component from the claimed “buffer,” relying on the Federal Circuit’s decision in Becton, Dickinson & Co. v. Tyco Healthcare Grp., LP, 616 F.3d 1249, 1254–55 (Fed. Cir. 2010), holding that “[w]here a claim lists elements separately, the clear implication of the claim language is that those elements are distinct components of the patented invention.” Applying that construction, the district court denied Regeneron’s motion because Amgen’s product does not contain a separate “buffer.”
On appeal, the Federal Circuit addressed the district court’s claim construction analysis. The Federal Circuit agreed that the Becton rule applies, and therefore the asserted claims patent require that the claimed VEGF antagonist and buffer be separate and distinct components. As the Federal Circuit explained, “to overcome Becton, there must be evidence that shows that the impliedly distinct components, instead, can be satisfied by a single component.” The court found insufficient evidence to overcome Becton, because the claim language used different units of measurement for the two components at issue, the specification consistently described the “VEGF antagonist plus a distinct buffer component,” and the specification did not describe any example of a “single component performing both functions (e.g., a self-buffering protein).” The Federal Circuit also held that “the district court did not need to consider the extrinsic evidence given the overwhelming evidence in the intrinsic record,” and that it was “reasonable for the district court to determine” that the extrinsic evidence supported Amgen’s contention that “self-buffering proteins were not well known.” Accordingly, the Federal Circuit held that Regeneron did not establish a likelihood of success on the merits of its infringement allegations because Amgen’s product does not contain a separate buffer, and, thus, there was a substantial question of noninfringement.
As we have previously reported, the Federal Circuit recently affirmed preliminary injunctions against Celltrion, Samsung, and Formycon.
Stay tuned to Big Molecule Watch as we continue to monitor key developments in ongoing BPCIA litigations and the biosimilars market.