On April 12, 2024, the Federal Circuit dismissed CAFC Appeal No. 24-1402 and Cross-Appeal No. 24-1405 for lack of jurisdiction following its February 22, 2024 order directing Regeneron and Mylan / Biocon to show cause why the appeals of the District Court’s December 27, 2023 decision finding claims 4, 7, 9, 11, 14-17 of U.S. Patent No. 11,084,865 were valid and infringed and 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 were invalid and infringed in Case No. 1:22-cv-00061 (N.D.W. Va.) (See EYLEA^® (aflibercept) and Soliris^® (eculizumab) IPR and BPCIA Litigation Updates) should not be dismissed for lack of jurisdiction.  Following the Court’s show cause order, the parties agreed that the Federal Circuit lacked jurisdiction because the District Court decision did not resolve all of the claims at issue in the litigation, which is related to Mylan / Biocon’s proposed EYLEA^® (aflibercept) biosimilar M710.

On March 8, 2024, the N.D.W. Va. District Court granted Mylan / Biocon’s motion for summary judgment of noninfringement due to disclaimer of Regeneron U.S. Patent Nos. 10,406,226, 10,464,992, and 10,857,205.  In April 2023, Regeneron, following a Markman hearing and decision, stipulated to summary judgment of non-infringement of claims 2-3, 6, 12-14, and 16 of Regeneron U.S. Patent No. 11,104,715 and invalidity of claims 5-6 and 9 of Regeneron U.S. Patent No. 10,888,601 and claims 1-5, 8-11, 14, and 26-28 of Regeneron U.S. Patent No. 11,253,572.  However, because Regeneron asserted infringement of 24 patents in the N.D.W. Va. litigation, which Mylan and Biocon have claimed are all invalid and not infringed, decisions on numerous patent claims are still pending.

There are several pending aBLAs for EYLEA^® biosimilars, including Biocon (Mylan) / Momenta’s M710 accepted in October 2021; Celltrion’s CT-P42 accepted in June 2023; Formycon / Klinge Biopharma’s FYB203, accepted in August 2023; Amgen’s ABP 938, accepted in October 2023; and Samsung Bioepis’s SB15, submitted on an undisclosed date.  The parties are all involved in ongoing BPCIA litigations related to their proposed biosimilars.

EYLEA^®‘s U.S. sales were reported to be approximately $5.9 billion in 2023.

We continue to monitor EYLEA^® biosimilar litigations and will provide updates when available.  For more information on EYLEA^® and other biologic patent disputes, please visit BiologicsHQ.

 

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