[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1503 Enrolled Bill (ENR)]
H.R.1503
One Hundred Sixteenth Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Friday,
the third day of January, two thousand and twenty
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.
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
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)''.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.