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ARTICLE · 22 DECEMBER 2023

EYLEA® (Aflibercept) IPR And BPCIA Litigation Updates

Venable LLP
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There has been a flurry of activity relating to proposed EYLEA® (aflibercept) biosimilars in November, starting with a BPCIA litigation against Celltrion's proposed biosimilar CT-P42...

United StatesIntellectual Property
Damineh Morsali, Ph.D.
Damineh Morsali, Ph.D.
Robert S. Schwartz, Ph.D.
Robert S. Schwartz, Ph.D.

There has been a flurry of activity relating to proposed EYLEA® (aflibercept) biosimilars in November, starting with a BPCIA litigation against Celltrion's proposed biosimilar CT-P42 filed on November 8, 2023, Case No. 1:23-cv-00089 (N.D.W.Va.) (see BPCIA Litigation Related to Proposed EYLEA® Biosimilar CT-P42 Filed).This was the second BPCIA litigation filed by Regeneron related to a proposed EYLEA® biosimilar, coming over a year after the case relating to Biocon's M710 aflibercept biosimilar (see Case No. 1:22-cv-00061 (N.D.W.Va.), pending).

SB15 (aflibercept) – Samsung Bioepis

On November 17, 2023, the PTAB granted institution of Samsung Bioepis's IPR2023-00884, challenging Regeneron's U.S. Patent No. 11,253,572 directed at "Use of VEGF antagonist to treat angiogenesis eye disorders." The granted petition included challenges to method of treatment claims as anticipated and obvious over the prior art.

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