[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1503 Engrossed Amendment Senate (EAS)]
<DOC>
In the Senate of the United States,
December 7, 2020.
Resolved, That the bill from the House of Representatives (H.R.
1503) entitled ``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.'', do pass with the
following
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.--
(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)''.
Attest:
Secretary.
116th CONGRESS
2d Session
H.R. 1503
_______________________________________________________________________
AMENDMENT