[116th Congress Public Law 290]
[From the U.S. Government Publishing Office]



[[Page 134 STAT. 4889]]

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. <<NOTE: Jan. 5, 2021 -  [H.R. 1503]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Orange Book 
Transparency Act of 2020.>> 
SECTION 1. <<NOTE: 21 USC 301 note.>>  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) <<NOTE: Reports.>>  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) <<NOTE: List.>>  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) <<NOTE: Assessments.>>  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.

[[Page 134 STAT. 4890]]

    ``(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) <<NOTE: Deadlines.>>  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).''.

[[Page 134 STAT. 4891]]

    (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, <<NOTE: Determination.>> 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) <<NOTE: Notification. Deadline.>>  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) <<NOTE: 21 USC 355 note.>>  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) <<NOTE: Summary.>>  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) <<NOTE: Analysis.>>  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,

[[Page 134 STAT. 4892]]

        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) <<NOTE: Data.>>  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) <<NOTE: Analysis.>>  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) <<NOTE: Recommenda- tions.>>  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

[[Page 134 STAT. 4892]]

            (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.

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