[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:
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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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