The Purple Book Continuity Act

January 8, 2021 – Article

The Congress passed and President on December 22 signed into law the “Further Extension of Continuing Appropriations Act, 2021”; despite its name it was chock full of goodies having nothing to do the nation’s need for a budget to pay its bills. One of the unrelated measures was the “Purple Book Continuity Act of 2019” (aka H.R. 1520). While the official text hasn’t been released yet, the Act’s content can be gleaned from the House report on H.R. 1520. The Act requires the FDA within 180 days to create in electronic format a searchable compendium of all licensed biologic products containing the license number, its date of approval, the marketing or license status. It requires updates every 30 days to include newly licensed products in the preceding 30 days. The FDA is also required to list each exclusivity period for a listed product that is applicable and has not expired.  If a product’s license was withdrawn for safety, purity, or potency reasons the product must be removed from the list with notice published in the Federal Register.

Of interest is the provision that requires product sponsors who engage in the patent dance to provide the number and expiration date of each patent listed by the sponsor in either original list or any supplemental list to the FDA which then must be added to the Purple Book. In addition, it requires the FDA to solicit from the public what type of information should be added or deleted from the list and provide an evaluation of the comments as to the information to be added or removed from the list. 

While the statute is benign it may represent but the first stage in modifications of the patent enforcement provisions for biologics. Stay tuned for future developments.