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ARTICLE · 19 JUNE 2024

Permanent Injunction Issued Preventing Launch Of EYLEA® Biosimilar Yesafili™

On June 11, 2024, the Court in Case No. 1:22-cv-00061 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.) issued a permanent injunction against the launch of Biocon and Mylan's Yesafili™ (aflibercept-jbvf)...

United StatesIntellectual Property

On June 11, 2024, the Court in Case No. 1:22-cv-00061 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.) issued a permanent injunction against the launch of Biocon and Mylan's Yesafili" (aflibercept-jbvf), a recently approved interchangeable biosimilar of Regeneron's EYLEA® (aflibercept) (previously reported FDA Approves First Two Interchangeable EYLEA® Biosimilars – Biocon's Yesafili" (aflibercept-jbvf) and Samsung Bioepis's Opuviz" (aflibercept-yszy)). The permanent injunction comes after the Court's finding in December 2023 that Yesafili" infringed method of treatment claims 4, 7, 9, 11, 14-17 of Regeneron's U.S. Patent No. 11,084,865 (previously reported EYLEA® (aflibercept) and Soliris® (eculizumab) IPR and BPCIA Litigation Updates). In the December 2023 order, the Court also found Yesafili" infringed claims 6 and 25 of U.S. Patent No. 11,253,572 and claims 11 and 19 of U.S. Patent No. 10,888,601, but found those claims invalid. In March 2024, the Court granted summary

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