On December 21, 2020, Congress passed a second COVID-19 stimulus bill. Buried among the 5500 pages of the 900 billion dollar relief package was legislation updating procedures for the Purple Book of licensed biologic products and products that have been evaluated for biosimilarity or interchangeability.
Unlike the Orange Book for small molecules, the enacting legislation of the Purple Book (the BPCIA) did not require reference product sponsors to provide FDA with lists of patents protecting approved products. That remains the case after the current updates to 42 USC § 262(k). However, the statute now adds a new paragraph 9 of subsection (k) that requires reference product sponsors to provide FDA with copies of any patent lists within 30 days of when they were first provided to biosimilar applicants as part of the "patent dance." Likewise, FDA must be updated within 30 days of any subsequent or supplemental list of patents provided to a biosimilar challenger. While the enacting legislation indicates that the patent holder "shall" provide this information to FDA, no consequences are specified for failing to comply.
Additional updates to the Purple Book in the stimulus bill include a mandate that FDA publish a text-searchable list of all approved biologic and biosimilar products within 180 days of enactment. The publication must include the following information about each approved biologic product: (a) nonproprietary name; (b) date of licensure and application number; (c) licensure and marketing status; and (d) exclusivity periods. FDA must update the publication every 30 days, including with any patent lists provided to FDA as part of the patent dance discussed above.
It remains to be seen how FDA will implement the new requirements in practice. Stay tuned for further updates as new regulations from FDA will likely be promulgated in the near future.
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