[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1503 Reported in House (RH)]
<DOC>
Union Calendar No. 25
116th CONGRESS
1st Session
H. R. 1503
[Report No. 116-47]
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.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
March 5, 2019
Ms. Kelly of Illinois introduced the following bill; which was referred
to the Committee on Energy and Commerce
May 2, 2019
Additional sponsors: Mr. Ruiz, Mr. Rush, Mr. Pallone, Mrs. Dingell, Ms.
Eshoo, Mr. Kennedy, Ms. Matsui, Mrs. Craig, Ms. Clarke of New York, Mr.
Van Drew, Mr. Walden, Ms. Schakowsky, and Ms. Mucarsel-Powell
May 2, 2019
Reported with an amendment, committed to the Committee of the Whole
House on the State of the Union, and ordered to be printed
[Strike out all after the enacting clause and insert the part printed
in italic]
[For text of introduced bill, see copy of bill as introduced on March
5, 2019]
_______________________________________________________________________
A BILL
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 one 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 one 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.
Union Calendar No. 25
116th CONGRESS
1st Session
H. R. 1503
[Report No. 116-47]
_______________________________________________________________________
A BILL
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.
_______________________________________________________________________
May 2, 2019
Reported with an amendment, committed to the Committee of the Whole
House on the State of the Union, and ordered to be printed