FDA’s Purple Book provides a searchable database of licensed biological products and includes the patent information provided to biosimilar applicants during the BPCIA patent dance. As we previously reported, a patent list for Regeneron’s EYLEA (aflibercept) was added to the Purple Book in April 2022. That original list contained 29 patents, including the 24 patents that Regeneron later asserted against Mylan in a BPCIA lawsuit filed in August 2022. As of the Purple Book’s April 2023 update, Regeneron has listed 17 additional patents for Eylea.
Under the Biological Product Patent Transparency Act, a biologic license holder that has already provided a patent-dance list to a biosimilar applicant must supplement that list with newly issued patents within 30 days of issuance, and then within 30 days of that is required to notify FDA of the additional patents for inclusion in the Purple Book. The new patents added to the Purple Book for Eylea all issued since April 2022, and include U.S. Nos. 11,299,532; 11,306,135; 11,332,771; 11,433,186; 11,439,758; 11,459,373; 11,459,374; 11,472,861; 11,478,588; 11,485,770; 11,505,593; 11,548,932; 11,555,176; 11,559,564; 11,577,025; D961,376; and D961,377.
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