The COVID-19 relief and spending bill signed into law on December 27, 2020, includes a provision – Division BB, Title III, Subtitle C, Section 325[1] – that adds a new paragraph 9 to 42 U.S.C. §262(k) requiring the U.S. Food & Drug Administration (“FDA”) to provide more information to the public about patented biological products. This information includes:
- a list of each biological product, by nonproprietary name, for which a biologics license is in effect;
- the date of licensure and the application number;
- the licensure status and, as available, the marketing status; and
- exclusivity periods.
The FDA has 180 days from the enactment of the paragraph to make this information available to the public in its Database of Licensed Biological Products, or “Purple Book,” and the FDA is required to revise the list every 30 days. Prior to enactment of this provision, the Purple Book, unlike the Orange Book for small molecules, did not contain any patent information.
As part of the “patent dance” for biosimilar approval, a reference biologic product sponsor provides a biosimilar applicant with patent information regarding the reference product. The new paragraph now requires that the sponsor provide this information to the FDA within 30 days of the date the information is provided to the biosimilar applicant. The FDA is required to include this patent information when it revises the Purple Book every 30 days. The FDA is also required to publish any subsequent or supplemental list of patents provided to a biosimilar applicant.
Notably missing are any consequences for reference sponsors for failure to provide this information to the FDA. Stay tuned for updates on how FDA implements these new requirements and whether the FDA promulgates any new regulations for providing the information.
[1] The text of the bill is available at: https://rules.house.gov/sites/democrats.rules.house.gov/files/BILLS-116HR133SA-RCP-116-68.pdf. Section 325 begins on page 2125 of Division BB (page 4592 of the PDF).