On April 2, 2026, Biocon filed a petition for post-grant review (“PGR”) challenging Regeneron’s U.S. Patent No. 12,168,036 (“the ’036 patent”), which is directed to methods for treating angiogenic eye disorders using high doses of VEGF receptor fusion proteins.

The petition, PGR2026-00039, seeks review of claims 1-38 of the ’036 patent and requests joinder with Alvotech’s previously filed PGR2025-00085, which was instituted by the PTAB without an opinion in March 2026. Biocon states that its petition is substantively identical to Alvotech’s petition, with modifications limited to party-specific information and procedural requirements.

The ’036 patent relates to formulations of EYLEA^® (aflibercept) for treating angiogenic eye disorders, including age-related macular degeneration and diabetic macular edema. Biocon challenges the claims on multiple grounds, including obviousness and lack of written description under 35 U.S.C. § 112.

Alvotech’s PGR2025-00085 remains pending before the Board.

Regeneron reported EYLEA^® U.S. sales of $2.75 billion and EYLEA^® HD U.S. sales of $1.64 billion in FY2025.

For more information about these and other biosimilars, please visit BiologicsHQ.

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