Patents related to Regeneron's EYLEA (aflibercept) were
recently added to the Purple Book. Under the Biological Product
Patent Transparency Act, signed into law December 27, 2020 and
codified at 42 U.S.C. § 262(k)(9), patents must be submitted
to the FDA for listing in the Purple Book during the "Patent
Dance" under the BPCIA. Specifically, within thirty (30) days
after the reference product sponsor (RPS) has submitted a list of
patents that could reasonably be asserted against the biosimilar
manufacturer under § 262(l)(3)(A), the RPS must provide the
list of patents and their expiry dates to FDA.
Regeneron listed twenty-nine patents in connection with EYLEA,
four of which do not expire until 08/18/2040 (U.S. Nos. 11,053,280,
11,104,715, 11,174,283, and 11,186,625). Although there are
multiple aflibercept biosimilars currently under development, all
have yet to receive FDA approval. Regeneron's recent Purple
Book listing presumably comes as part of a Patent Dance
