On January 9, 2024, the PTAB issued final written decisions in IPR2022-01225 and IPR2022-01226, filed by Mylan on two Regeneron patents directed to dosing of aflibercept — U.S. Patent Nos. 10,130,681 and 10,888,601.  The PTAB ruled that all challenged claims of the ’681 patent (claims 1, 3-11, 13, 14, 16-24, and 26) and the ’601 patent (claims 1-9, 34-39. 41-43, and 45) are invalid as anticipated by the same prior art reference.

As we previously reported, Celltrion and Samsung also filed IPR petitions challenging claims of the ’681 and ’601 patents.  Celltron’s IPR2023-00532, challenging claims of ’681 patent, had been joined with Mylan’s IPR2022-01255.  Celltrion’s IPR2023-00533 and Samsung’s IPR2023-0566, both challenging claims of the ‘601 patent, had been joined with Mylan’s IPR2022-01226.  Samsung’s IPR2023-00442, challenging claims of the ‘681 patent, remains pending before the PTAB.

Check out our PTAB Tracker for information on pending and concluded IPRs on alibercept and other biosimilar products.

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