Preliminary Injunction Against Amgen’s EYLEA® Biosimilar Pavblu™ Denied

On September 23, 2024, Regeneron’s motion for a preliminary injunction against the commercial launch of Amgen’s EYLEA^® (aflibercept) biosimilar Pavblu™ (aflibercept-ayyh) was denied in Case No. 1:24-cv-00039 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.).  The Order is currently sealed. Regeneron filed a notice of appeal on the same day the Order issued.

This outcome is a departure from previous decisions related to the same patent, Regeneron’s U.S. Patent No. 11,084,865 (“the ’865 patent”).  In June 2024, the same Court granted preliminary injunctions based on the potential infringement of the ’865 patent for three other EYLEA^® biosimilars: Samsung Bioepis’s Opuviz™ (aflibercept-yszy) (Case Nos. 1:23-cv-00094 (N.D.W. Va.), 1:23-cv-00106 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)), Formycon’s Ahzantive^® (aflibercept-mrbb) (Case Nos. 1:23-cv-00097 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)), and Celltrion’s CT-P42 (aflibercept) (Case Nos. 1:23-cv-00089 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)) (previously reported Preliminary Injunctions Issued Preventing Launch of EYLEA Biosimilars).  The N.D.W. Va. Court also entered a permanent injunction against Biocon and Mylan’s Yesafili™ (aflibercept-jbvf) (Case Nos. 1:22-cv-00061 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)) after a trial finding that Yesafili™ infringes claims 4, 7, 9, 11, and 14-17 of the ’865 patent and that those claims are valid (previously reported Permanent Injunction Issued Preventing Launch of EYLEA^® Biosimilar Yesafili™; EYLEA^® (aflibercept) and Soliris^® (eculizumab) IPR and BPCIA Litigation Updates).

Numerous appeals are ongoing related to the aforementioned injunctions, including Samsung Bioepis’s CAFC Appeal Nos. 24-1965 24-1966, 24-2082, and 24-2083; Formycon’s 24-2009, 24-2019, and 24-2156; Celltrion’s 24-2058 and 24-2147; and Biocon / Mylan’s 24-2002.

Regeneron reported EYLEA^® sales of $5.72 billion in 2023.

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The author would like to thank April Breyer Menon for her contributions to this article.