On September 9, 2025, the District Court for the Northern District of West Virginia entered a Stipulation and Order dismissing all claims and counterclaims in view of a settlement agreement between Sandoz, Inc. (“Sandoz”) and Regeneron Pharmaceuticals, Inc. (“Regeneron”) resolving the BPCIA litigation regarding Sandoz’s aflibercept biosimilar, ENZEEVU (aflibercept-abzv). According…
We previously reported that South Korean biopharmaceutical company Alteogen submitted its Marketing Authorization Application to the European Medicines Agency (“EMA”) for ALT-L9, what has since been named EYLUXVI. EYLUXVI is a proposed biosimilar to Regeneron’s EYLEA (aflibercept). Alteogen had previously announced clinical results demonstrating similarity between EYLUXVI and EYLEA. On…
On July 14, 2025 Fresenius filed two IPR petitions challenging Regeneron’s patents related to aflibercept. Regeneron has not asserted that Fresenius infringes either of these patents in district court litigation; however, there are a number of district court actions against other parties related to the patents challenged in Fresenius’s IPRs….
On June 17, 2025, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed another complaint against Amgen Inc. (“Amgen”) under the BPCIA, alleging that Amgen’s aflibercept biosimilar, PAVBLU®, infringes U.S. Patent No. 12,331,099 (“the ’099 patent”). The ’099 patent issued on the same day, with claims generally directed to a stable liquid ophthalmic formulation…
Earlier this month, a Patent Trial and Appeal Board (“PTAB”) panel denied institution of two petitions that were filed separately by Samsung Bioepis (IPR2025-00176) and Formycon (IPR2025-00233) for inter partes review (“IPR”) of Regeneron’s U.S. Patent No. 11,084,865 (the “’865 patent”). The ’865 patent issued on August 10, 2021 and is…
On May 15, 2025, a jury returned a verdict finding Amgen Inc. (“Amgen”) liable for antitrust violations and awarding Regeneron Pharmaceuticals, Inc. (“Regeneron”) over $400 million in damages. As we reported previously, Regeneron filed its antitrust lawsuit in 2022 in the U.S. District Court for the District of Delaware, alleging…
On April 18, 2025, Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration has issued a complete response letter regarding the supplemental Biologics License Application for EYLEA HD (aflibercept). The supplemental application is for the addition of extended dosing intervals (up to every 24 weeks) of EYLEA HD injection…
On April 22, 2025, the U.S. District Court for the Northern District of West Virginia entered a Stipulation and Order Vacating Permanent Injunction and Dismissing All Claims and Counterclaims with Prejudice in In re: Aflibercept Patent Litigation (MDL No.: 1:24-md-3103). The stipulation had been filed the day before by Plaintiff…
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…
On March 5, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s entry of a preliminary injunction preventing Celltrion, Inc. (“Celltrion”) from launching CT-P42, its aflibercept biosimilar of EYLEA®. As we have previously reported, the Federal Circuit recently…