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[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1503 Referred in Senate (RFS)]

<DOC>
116th CONGRESS
  1st Session
                                H. R. 1503

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                              May 9, 2019

     Received; read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 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 
2019''.

SEC. 2. ORANGE BOOK.

    (a) Submission of Patent Information for Brand Name Drugs.--
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) 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--
            ``(A) full reports of investigations which have been made 
        to show whether or not such drug is safe for use and whether 
        such drug is effective in use;
            ``(B) a full list of the articles used as components of 
        such drug;
            ``(C) a full statement of the composition of such drug;
            ``(D) a full description of the methods used in, and the 
        facilities and controls used for, the manufacture, processing, 
        and packing of such drug;
            ``(E) such samples of such drug and of the articles used as 
        components thereof as the Secretary may require;
            ``(F) specimens of the labeling proposed to be used for 
        such drug;
            ``(G) any assessments required under section 505B; and
            ``(H) patent information, with respect to each patent for 
        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, and consistent with the 
        following requirements:
                    ``(i) The applicant shall file with the application 
                the patent number and the expiration date of--
                            ``(I) any patent which claims the drug for 
                        which the applicant submitted the application 
                        and is a drug substance (including active 
                        ingredient) patent or a drug product (including 
                        formulation and composition) patent; and
                            ``(II) any patent which claims the method 
                        of using such drug.
                    ``(ii) If an application is filed under this 
                subsection for a drug and a patent of the type 
                described in clause (i) which claims such drug or a 
                method of using such drug is issued after the filing 
                date but before approval of the application, the 
                applicant shall amend the application to include such 
                patent information.
Upon approval of the application, the Secretary shall publish the 
information submitted under subparagraph (H). The Secretary shall, in 
consultation with the Director of the National Institutes of Health and 
with representatives of the drug manufacturing industry, review and 
develop guidance, as appropriate, on the inclusion of women and 
minorities in clinical trials required by subparagraph (A).''.
    (b) Conforming Changes to Requirements for Subsequent Submission of 
Patent Information.--Section 505(c)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)(7)) is amended--
            (1) by inserting after ``the patent number and the 
        expiration date of any patent which'' the following: ``fulfills 
        the criteria in subsection (b) and'';
            (2) by inserting after the first sentence the following: 
        ``Patent information that is not the type of patent information 
        required by subsection (b) shall not be submitted.''; and
            (3) by inserting after ``could not file patent information 
        under subsection (b) because no patent'' the following: ``of 
        the type required to be submitted in subsection (b)''.
    (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 each exclusivity period that is applicable and has not 
concluded under--
            ``(I) clause (ii), (iii), or (iv) of subsection (c)(3)(E) 
        of this section;
            ``(II) clause (iv) or (v) of paragraph (5)(B) of this 
        subsection;
            ``(III) clause (ii), (iii), or (iv) of paragraph (5)(F) of 
        this subsection;
            ``(IV) section 505A;
            ``(V) section 505E; or
            ``(VI) section 527(a).''.
    (d) Removal of Invalid Patents.--
            (1) In general.--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)(i) The holder of an application approved under subsection (c) 
for a drug on the list shall notify within 14 days the Secretary in 
writing if either of the following occurs:
            ``(I) The Patent Trial and Appeals Board issues a decision 
        from which no appeal has been or can be taken that a patent for 
        such drug is invalid.
            ``(II) A court issues a decision from which no appeal has 
        been or can be taken that a patent for such drug is invalid.
    ``(ii) The holder of an approved application shall include in any 
notification under clause (i) a copy of the decision described in 
subclause (I) or (II) of clause (i).
    ``(iii) The Secretary shall remove from the list any patent that is 
determined to be invalid in a decision described in subclause (I) or 
(II) of clause (i)--
            ``(I) promptly; but
            ``(II) not 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) that such 
        patent was invalid.''.
            (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 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 the Congress an evaluation of such 
        comments, including any recommendations about the types of 
        patent information that should be included on or removed from 
        such list.

SEC. 3. GAO REPORT TO CONGRESS.

    (a) In General.--Not later than 1 year 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 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)), including an analysis and evaluation of the types of 
patents included in such list and the claims such patents make about 
the products they claim.
    (b) Contents.--The Comptroller General shall include in the report 
under subsection (a)--
            (1) data on the number of--
                    (A) patents included in the list published under 
                paragraph (7) of section 505(j) of the Federal Food, 
                Drug and Cosmetic Act (21 U.S.C. 355(j)), that claim 
                the active ingredient or formulation of a drug in 
                combination with a device that is used for delivery of 
                the drug, together comprising the finished dosage form 
                of the drug; and
                    (B) claims in each patent 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;
            (2) data on the date of inclusion in the list under 
        paragraph (7) of such section 505(j) for all patents under such 
        list, as compared to patents that claim a method of using the 
        drug in combination with a device;
            (3) an analysis regarding the impact of including on the 
        list under paragraph (7) of such section 505(j) certain types 
        of patent information for drug product applicants and approved 
        application holders, including an analysis of whether--
                    (A) the listing of the patents described in 
                paragraph (1)(A) delayed the market entry of one or 
                more drugs approved under such section 505(j); and
                    (B) not listing the patents described in paragraph 
                (1)(A) would delay the market entry of one or more such 
                drugs; and
            (4) recommendations about which kinds of patents relating 
        to devices described in paragraph (1)(A) should be submitted to 
        the Secretary of Health and Human Services for inclusion on the 
        list under paragraph (7) of such section 505(j) and which 
        patents should not be required to be so submitted.

            Passed the House of Representatives May 8, 2019.

            Attest:

                                             CHERYL L. JOHNSON,

                                                                 Clerk.
```