[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1503 Engrossed Amendment Senate (EAS)]

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                  In the Senate of the United States,

                                                      December 7, 2020.
    Resolved, That the bill from the House of Representatives (H.R. 
1503) entitled ``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.'', do pass with the 
following

                               AMENDMENT:

             Strike all after the enacting clause and insert the 
      following:

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)''.

            Attest:

                                                             Secretary.
116th CONGRESS

  2d Session

                               H.R. 1503

_______________________________________________________________________

                               AMENDMENT