[Congressional Record Volume 166, Number 209 (Thursday, December 10, 2020)]
[House]
[Pages H7130-H7131]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                  ORANGE BOOK TRANSPARENCY ACT OF 2019

  Mrs. DINGELL. Madam Speaker, I ask unanimous consent to take from the 
Speaker's table the bill (H.R. 1503) 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, with the 
Senate amendment thereto, and concur in the Senate amendment.
  The Clerk read the title of the bill.
  The SPEAKER pro tempore. The Clerk will report the Senate amendment.
  The Clerk read as follows:
  Senate 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.--

[[Page H7131]]

       (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)''.

  Mrs. DINGELL (during the reading). Madam Speaker, I ask unanimous 
consent to dispense with the reading.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentlewoman from Michigan?
  There was no objection.
  The SPEAKER pro tempore. Is there objection to the original request 
of the gentlewoman from Michigan?
  There was no objection.
  A motion to reconsider was laid on the table.

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