On September 24, 2026, the USPTO Director issued a decision explaining the denial of institution of PGR2026-00039, filed by Biocon against Regeneron’s U.S. Patent No. 12,168,036 (“the ’036 patent”). BiologicsHQ previously reported that the Director denied institution on August 6, 2026, in a bulk order and noted that an opinion was forthcoming (previously reported Biocon Announces Launch of EYLEA^® Interchangeable Biosimilar Yesafili™ While PGR Denied Institution).

Biocon requested PGR of claims 1–38 of Regeneron’s ’036 patent, titled “Methods for Treating Angiogenic Eye Disorders with High Doses of VEGF Receptor Fusion Proteins,” and filed a motion seeking joinder to PGR2025-00085, a PGR filed by Alvotech challenging the same patent.

The Director denied institution because Biocon’s PGR was filed outside the nine-month post-patent issuance statutory deadline for PGR. The ’036 patent issued on December 17, 2024. Alvotech filed its PGR on September 17, 2025, and institution in the Alvotech PGR was granted on March 3, 2026. Biocon filed its PGR on April 2, 2026, within one month of institution in the Alvotech PGR, but more than nine months after issuance of the ’036 patent. The Director found that Biocon’s PGR was barred by 35 U.S.C. § 321(c) and that 37 C.F.R. § 42.222(b), which addresses the deadline for requests for joinder, could not override the statutory filing deadline for PGR petitions.

The Director noted that parties seeking joinder in a PGR should consider filing the PGR and motion for joinder before a decision on institution in the lead case, given the limited time frame for filing a PGR.

Regeneron reported EYLEA^® (aflibercept) 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 and related patent developments, please visit BiologicsHQ.

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