The Orange Book Transparency Act of 2020, which was signed into law by President Trump on January 5, 2021, clarifies the types of patent and exclusivity-related information to be listed in the Orange Book and codifies certain existing agency regulations relating to New Drug Application (“NDA”) holders’ obligation to submit and/or provide updated relevant patent information to the Food and Drug Administration for listing in the Orange Book.

Key Amendments

  1. The Orange Book Act clarifies the types of patents NDA holders must list in the Orange Book. 21 U.S.C. § 355(b)(1) currently requires submission of patent information for “any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug.” The Orange Book Act amends that language to require submission of patent information for patents that claim the drug substance (active ingredient), the drug product (formulation or composition), or a method of use that is included in the application (i.e., a method of use that corresponds with an approved indication/use code). See Amendment to Section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355(b)(1)). Patent information for all other patents—e.g., patents that cover unapproved uses—“shall not be submitted.” See Amendment to Section 505(c)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355(c)(2)). This codifies the existing regulation 21 C.F.R. § 314.53(b).
  2. The Orange Book Act specifies NDA holders’ obligation to submit relevant patent information for the Orange Book listing no later than 30 days after the date of approval or, if the patent has not yet been issued at the time of approval, no later than 30 days after the date of issuance of the patent. See Amendment to Section 505(c)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355(c)(2)). This codifies the existing regulations 21 C.F.R. § 314.53(d)(1)-(3).
  3. The Orange Book Act requires NDA holders to notify the FDA within 14 days of a PTAB or court decision cancelling or invalidating any claim of the listed patent “from which no appeal has been taken or can be taken, if the holder of the applicable application approved under subsection (c) determines that a patent for such drug, or any patent information for such drug no longer meets the listing requirements…” See Amendment to Section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355(j)(7)). This codifies the existing regulations, which require NDA holders “to promptly notify FDA” for removal of an Orange Book-listed patent, for example, “if there has been a judicial finding of invalidity for a listed patent, from which no appeal has been or can be taken.” 21 C.F.R. § 314.53(f)(2)(i). It provides clarity to the existing regulation by replacing “promptly notify FDA” with a requirement to notify FDA within 14 days. The FDA would then remove the invalidated patent from the Orange Book “promptly” but not prior to the expiration of any 180-day exclusivity applicable for an ANDA filer whose paragraph IV certification was based on invalidity of the patent. See Amendment to Section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355(j)(7)). This new section applies prospectively to any decisions “issued on or after the date of enactment of this Act.” See Id.
  4. The Orange Book Act additionally requires that the FDA “shall specify [in the Orange Book] any exclusivity period that is applicable, for which the Secretary has determined the expiration date, and for which such period has not yet expired,” including the 180-day exclusivity period for first-to-file applicants. See Amendment to Section 505(j)(7)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355(j)(7)).

The Orange Book Act does not provide a separate enforcement section; thus, the liabilities for failing to comply with the newly added requirements are governed by the currently existing regulations, statutes and case law.