Blog Big Molecule Watch July 11, 2022

Mylan Files New IPR Petitions on Aflibercept Patents

Mylan recently filed two IPR petitions seeking cancellation of various claims of patents assigned to Regeneron relating to dosing regimens for EYLEA® (aflibercept): IPR2022-01225 challenging claims 1, 3-11, 13-14, 16-24, and 26 of U.S. Patent No. 10,130,681, and IPR2022-01226 challenging claims 1-9, 34-39, 41-43, and 45 of U.S. Patent No. 10,888,601.  The challenged claims generally relate to methods for treating angiogenic eye disorders with a certain dosing regimen of a VEGF antagonist.  Mylan argues that the claims are invalid as anticipated and obvious in view of the prior art.

These two new IPR petitions follow Mylan’s filings in May 2021 of two IPR petitions on two other patents in the same family – U.S. Patent No. 9,669,069 (IPR 2021-00880), and U.S. Patent No. 9,254,338 (IPR 2021-00881).  On November 10, 2021, the PTAB granted institution of both petitions, which are now pending before the PTAB. Oral argument is scheduled for August 10, 2022 for both IPRs.

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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