[Congressional Record Volume 166, Number 206 (Monday, December 7, 2020)]
[Senate]
[Pages S7242-S7243]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SA 2693. Mr. McCONNELL (for Mr. Alexander) proposed an amendment to
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; as follows:
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
[[Page S7243]]
(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)''.
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