    [United States Statutes at Large, Volume 134, 116th Congress, 2nd Session]
    [From the U.S. Government Publishing Office, www.gpo.gov]

    Public Law 116-290
    116th Congress

    An Act

    To amend the Federal Food, Drug, and Cosmetic Act regarding the list
    under section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act, and
    for other purposes. <>

    Be it enacted by the Senate and House of Representatives of the
    United States of America in Congress assembled, <>
    SECTION 1. <>  SHORT TITLE.

    This Act may be cited as the ``Orange Book Transparency Act of
    2020''.
    SEC. 2. ORANGE BOOK MODERNIZATION.

    (a) Submission of Patent Information for Brand Name Drugs.--
    (1) In general.--Paragraph (1) of section 505(b) of the
    Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) is
    amended to read as follows:

    ``(b)(1)(A) Any person may file with the Secretary an application
    with respect to any drug subject to the provisions of subsection (a).
    Such persons shall submit to the Secretary as part of the application--
    ``(i) <>  full reports of investigations
    which have been made to show whether such drug is safe for use
    and whether such drug is effective in use;
    ``(ii) <>  a full list of the articles used as
    components of such drug;
    ``(iii) a full statement of the composition of such drug;
    ``(iv) a full description of the methods used in, and the
    facilities and controls used for, the manufacture, processing,
    and packing of such drug;
    ``(v) such samples of such drug and of the articles used as
    components thereof as the Secretary may require;
    ``(vi) specimens of the labeling proposed to be used for
    such drug;
    ``(vii) <>  any assessments required
    under section 505B; and
    ``(viii) the patent number and expiration date of each
    patent for which a claim of patent infringement could reasonably
    be asserted if a person not licensed by the owner of the patent
    engaged in the manufacture, use, or sale of the drug, and that--
    ``(I) claims the drug for which the applicant
    submitted the application and is a drug substance
    (active ingredient) patent or a drug product
    (formulation or composition) patent; or
    ``(II) claims a method of using such drug for which
    approval is sought or has been granted in the
    application.

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    ``(B) If an application is filed under this subsection for a drug,
    and a patent of the type described in subparagraph (A)(viii) is issued
    after the filing date but before approval of the application, the
    applicant shall amend the application to include the patent number and
    expiration date.''.
    (b) Subsequent Submission of Patent Information.--
    (1) <>  In general.--Section 505(c)(2) of
    the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)(2))
    is amended--
    (A) by inserting before the first sentence the
    following: ``Not later than 30 days after the date of
    approval of an application submitted under subsection
    (b), the holder of the approved application shall file
    with the Secretary the patent number and the expiration
    date of any patent described in subsection
    (b)(1)(A)(viii), except that a patent that is identified
    as claiming a method of using such drug shall be filed
    only if the patent claims a method of use approved in
    the application. If a patent described in subsection
    (b)(1)(A)(viii) is issued after the date of approval of
    an application submitted under subsection (b), the
    holder of the approved application shall, not later than
    30 days after the date of issuance of the patent, file
    the patent number and the expiration date of the patent,
    except that a patent that claims a method of using such
    drug shall be filed only if approval for such use has
    been granted in the application.'';
    (B) in the first sentence following the sentences
    added by subparagraph (A), by striking ``which claims
    the drug for which'' and all that follows through ``of
    the drug.'' and inserting ``described in subsection
    (b)(1)(A)(viii).'';
    (C) in the second sentence following the sentences
    added by subparagraph (A), by inserting after ``could
    not file patent information under subsection (b) because
    no patent'' the following: ``of the type for which
    information is required to be submitted in subsection
    (b)(1)(A)(viii)''; and
    (D) by adding at the end the following: ``Patent
    information that is not the type of patent information
    required by subsection (b)(1)(A)(viii) shall not be
    submitted under this paragraph.''.
    (2) Updating list.--Clause (iii) of section 505(j)(7)(A) of
    the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7))
    is amended by striking ``(b) or''.

    (c) Listing of Exclusivities.--Subparagraph (A) of section 505(j)(7)
    of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)) is
    amended by adding at the end the following:
    ``(iv) For each drug included on the list, the Secretary shall
    specify any exclusivity period that is applicable, for which the
    Secretary has determined the expiration date, and for which such period
    has not yet expired, under--
    ``(I) clause (ii), (iii), or (iv) of subsection (c)(3)(E);
    ``(II) clause (iv) or (v) of paragraph (5)(B);
    ``(III) clause (ii), (iii), or (iv) of paragraph (5)(F);
    ``(IV) section 505A;
    ``(V) section 505E;
    ``(VI) section 527(a); or
    ``(VII) subsection (u).''.

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    (d) Orange Book Updates With Respect to Invalidated Patents.--
    (1) Amendment.--Section 505(j)(7) of the Federal Food, Drug,
    and Cosmetic Act (21 U.S.C. 355(j)(7)) is amended by adding at
    the end the following:

    ``(D) <> In the case of a listed drug for
    which the list under subparagraph (A)(i) includes a patent for such
    drug, and any claim of the patent has been cancelled or invalidated
    pursuant to a final decision issued by the Patent Trial and Appeal Board
    of the United States Patent and Trademark Office or by a court, from
    which no appeal has been, 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 under this section--
    ``(i) <>  the holder of such
    approved application shall notify the Secretary, in writing,
    within 14 days of such decision of such cancellation or
    invalidation and request that such patent or patent information,
    as applicable, be amended or withdrawn in accordance with the
    decision issued by the Patent Trial and Appeal Board or a court;
    ``(ii) the holder of such approved application shall include
    in any notification under clause (i) information related to such
    patent cancellation or invalidation decision and submit such
    information, including a copy of such decision, to the
    Secretary; and
    ``(iii) the Secretary shall, in response to a notification
    under clause (i), amend or remove patent or patent information
    in accordance with the relevant decision from the Patent Trial
    and Appeals Board or court, as applicable, except that the
    Secretary shall not remove from the list any patent or patent
    information before the expiration of any 180-day exclusivity
    period under paragraph (5)(B)(iv) that relies on a certification
    described in paragraph (2)(A)(vii)(IV).''.
    (2) <>  Applicability.--Subparagraph
    (D) of section 505(j)(7) of the Federal Food, Drug, and Cosmetic
    Act (21 U.S.C. 355(j)(7)), as added by paragraph (1), applies
    only with respect to a decision described in such subparagraph
    that is issued on or after the date of enactment of this Act.

    (e) Review and Report.--Not later than 1 year after the date of
    enactment of this Act, the Secretary of Health and Human Services,
    acting through the Commissioner of Food and Drugs, shall--
    (1) solicit public comment regarding the types of patent
    information that should be included on, or removed from, the
    list under section 507(j)(7) of the Federal Food, Drug, and
    Cosmetic Act (21 U.S.C. 355(j)(7)); and
    (2) <>  transmit to Congress a summary of
    such comments and actions the Food and Drug Administration is
    considering taking, if any, in response to public comment
    pursuant to paragraph (1) about the types of patent information
    that should be included or removed from such list.

    (f) GAO <> Report to Congress.--
    (1) In general.--Not later than 2 years after the date of
    enactment of this Act, the Comptroller General of the United
    States (referred to in this section as the ``Comptroller
    General'') shall submit to the Committee on Health, Education,
    Labor,

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    and Pensions of the Senate and the Committee on Energy and
    Commerce of the House of Representatives a report on the patents
    included in the list published under section 505(j)(7) of the
    Federal Food, Drug and Cosmetic Act (21 U.S.C. 355(j)(7)) that
    claim an active ingredient or formulation of a drug in
    combination with a device that is used for delivery of such
    drug, including an analysis of such patents and their claims.
    (2) Content.--The Comptroller General shall include in the
    report under paragraph (1)--
    (A) <>  data on--
    (i) the number of patents included in the list
    published under section 505(j)(7) of the Federal
    Food, Drug and Cosmetic Act (21 U.S.C. 355(j)(7))
    that claim the active ingredient or formulation of
    a drug in combination with a device that is used
    for delivery of the drug, and that together claim
    the finished dosage form of the drug; and
    (ii) the number of claims with respect to each
    patent included in the list published under such
    section 505(j)(7) that claim a device that is used
    for the delivery of the drug, but do not claim
    such device in combination with an active
    ingredient or formulation of a drug;
    (B) an analysis of the listing of patents described
    in subparagraph (A)(ii), including the timing of listing
    such patents in relation to patents described in
    subparagraph (A)(i), and the effect listing the patents
    described in subparagraph (A)(ii) has on market entry of
    one or more drugs approved under section 505(j) of the
    Federal Food, Drug, and Cosmetic Act as compared to the
    effect of not listing the patents described in
    subparagraph (A)(ii); and
    (C) <>  recommendations
    about which kinds of patents relating to devices
    described in subparagraph (A)(i) should be submitted to
    the Secretary of Health and Human Services for inclusion
    on the list under section 505(j)(7) of the Federal Food,
    Drug, and Cosmetic Act and which patents should not be
    required to be so submitted in order to reduce barriers
    to approval and market entry.

    (g) Conforming Amendments.--Section 505 of the Federal Food, Drug,
    and Cosmetic Act (21 U.S.C. 355) is amended--
    (1) in subsection (c)(3)(E), by striking ``clause (A) of
    subsection (b)(1)'' each place it appears and inserting
    ``subsection (b)(1)(A)(i)''; and

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    (2) in subsection (j)(2)(A)(vi), by striking ``clauses (B)
    through (F) of subsection (b)(1)'' and inserting ``clauses (ii)
    through (vi) of subsection (b)(1)(A)''.

    Approved January 5, 2021.

    LEGISLATIVE HISTORY--H.R. 1503:
    ---------------------------------------------------------------------------

    HOUSE REPORTS: No. 116-47 (Comm. on Energy and Commerce).
    CONGRESSIONAL RECORD:
    Vol. 165 (2019):
    May 8, considered and passed House.
    Vol. 166 (2020):
    Dec. 7, considered and passed
    Senate, amended.
    Dec. 10, House concurred in Senate
    amendment.