The Biological Product Patent Transparency (BPPT) section of the Consolidated Appropriations Act of 2021 requires FDA to publish patent lists provided by reference product sponsors (i.e., biologics license application (BLA) holders) to FDA for certain licensed biological products. Specifically, a reference product sponsor is required to provide to FDA, as described in section 351(k)(9)(A)(iii) of the PHS Act, the list of patents and corresponding expiry dates (also referred to as the “initial list”), not later than 30 days after the reference product sponsor has provided the initial list to a 351(k) applicant under section 351(l)(3)(A) or (l)(7) of the PHS Act. The reference product sponsor is also required to provide to FDA any subsequent or supplemental lists, and their corresponding expiry dates, within 30 days of the provision of such lists to a 351(k) applicant under section 351(l)(3)(A) or (l)(7) of the PHS Act. Pursuant to section 351(k)(9)(A)(iii) of the PHS Act, FDA shall include this information in the published list and revise it on a monthly basis to include any additional initial lists and any updates from subsequent or supplemental lists.

FDA’s role in publishing patent information is ministerial, and FDA does not consider the applicability of patents to a biosimilar product (e.g., validity, enforceability, or potential infringement) in publishing the information described in section 351(k)(9) of the PHS Act, nor in FDA’s review of a 351(k) BLA or supplement to a 351(k) BLA. For additional information regarding Purple Book listing requirements, see FAQ 5. For detailed information regarding submission processes for initial and updated patent information, see FAQ 6 and FAQ 7, respectively.

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