Blog Big Molecule Watch September 14, 2022

Apotex Files IPR Petition on Aflibercept Patent

Apotex Inc. recently filed an IPR petition, IPR2022-01524, seeking cancellation of claims 1-14 and 26-30 of U.S. Patent No. 11,253,572 assigned to Regeneron Pharmaceuticals, Inc.  The challenged claims generally relate to methods for treating angiogenic eye disorders with a claimed dosing regimen of aflibercept, achieving specific visual acuity results from the treatment, and formulating the aflibercept as an isotonic solution.  Apotex argues that claims 1-5, 8-11, 14 and 26-30 are anticipated and that claims 6, 7, 12 and 13 are obvious.

This IPR petition follows Apotex’s December 2021 filing of IPR petitions challenging two other patents in the same family – U.S. Patent No. 9,254,338 (IPR 2021-00298), and U.S. Patent No. 9,669,069 (IPR 2021-00301).  On February 9, 2022, the PTAB granted institution of both petitions and joined them with previously instituted IPR proceedings filed by Mylan on the same patents:  IPR 2021-00881 and IPR 2021-00880, respectively.  Oral argument in both sets of joined IPRs was held on August 10, 2022.

Stay tuned to BMW for further developments on these IPRs, and check out our PTAB Tracker for information on pending and concluded IPRs on aflibercept and other biosimilar products.

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