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.
- 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).
- 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.
- 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.
- 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.
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This Mayer Brown article provides information and comments on legal issues and developments of interest. The foregoing is not a comprehensive treatment of the subject matter covered and is not intended to provide legal advice. Readers should seek specific legal advice before taking any action with respect to the matters discussed herein.