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[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1503 Enrolled Bill (ENR)]

        H.R.1503

                     One Hundred Sixteenth Congress

                                 of the

                        United States of America

                          AT THE SECOND SESSION

           Begun and held at the City of Washington on Friday,
            the third day of January, two thousand and twenty

                                 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.
    ``(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).''.
    (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, 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
        (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)''.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.
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