2021年6月25日 All day
The Biological Product Patent Transparency (BPPT) amendments to 42 U.S.C. 262(k) of the Biologics Price Competition and Innovation Act (BPCIA) will take effect.
Q5: What Purple Book listing requirements were added by the Biological Product Patent Transparency section of the Consolidated Appropriations Act of 2021 enacted December 27, 2020?
A5:The Biological Product Patent Transparency (BPPT) section of the legislation requires that, by 180 days after enactment (June 25, 2021), FDA publish and make available to the public in a searchable, electronic format a list of biological products, by nonproprietary name, for which a biologics license under section 351(a) or 351(k) of the Public Health Service Act (PHS Act) is in effect; the date of licensure of the marketing application and the application number; and the licensure status and, if available, marketing status. The BPPT section also requires that FDA revise the list every 30 days to include any additional products licensed under section 351(a) or 351(k) of the PHS Act. In addition, for each biological product on the list, the BPPT section requires that the Purple Book list each reference product exclusivity period and each first interchangeable exclusivity period for which FDA has determined such biological product to be eligible and for which such period has not concluded.
The BPPT section also requires publication in the Purple Book of 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 the list of patents and corresponding expiry dates (referred to here 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. FDA will begin publishing patent lists in the Purple Book not later than 180 days after the date of enactment (June 25, 2021), or when FDA has received any such lists from reference product sponsors, whichever is later. FDA subsequently will revise the list on a monthly basis to include any additional initial lists and any updates from subsequent or supplemental lists.