In the Senate of the United States, 
December 7, 2020. 
Resolved, That the bill from the House of Representa-
tives (H.R. 1503) entitled ‘‘An Act to amend the Federal 
Food, Drug, and Cosmetic Act regarding the list under sec-
tion 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 Trans-
parency 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:
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by the owner of the patent engaged in the manufac-
ture, use, or sale of the drug, and that— 
‘‘(I) claims the drug for which the applicant 
submitted the application and is a drug sub-
stance (active ingredient) patent or a drug prod-
uct (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 subpara-
graph (A)(viii) is issued after the filing date but before ap-
proval of the application, the applicant shall amend the ap-
plication to include the patent number and expiration 
date.’’. 
(b) SUBSEQUENT SUBMISSION OF PATENT INFORMA-
TION.— 
(1) IN GENERAL.—Section 505(c)(2) of the Fed-
eral 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 appli-
cation shall file with the Secretary the patent
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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 sub-
section (b)(1)(A)(viii) is issued after the date of 
approval of an application submitted under sub-
section (b), the holder of the approved applica-
tion 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 sen-
tences added by subparagraph (A), by striking 
‘‘which claims the drug for which’’ and all that 
follows through ‘‘of the drug.’’ and inserting ‘‘de-
scribed in subsection (b)(1)(A)(viii).’’; 
(C) in the second sentence following the sen-
tences added by subparagraph (A), by inserting 
after ‘‘could not file patent information under 
subsection (b) because no patent’’ the following:
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‘‘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 pat-
ent 
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;
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‘‘(V) section 505E; 
‘‘(VI) section 527(a); or 
‘‘(VII) subsection (u).’’. 
(d) ORANGE BOOK UPDATES WITH RESPECT TO IN-
VALIDATED PATENTS.— 
(1) AMENDMENT.—Section 505(j)(7) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
355(j)(7)) is amended by adding at the end the fol-
lowing: 
‘‘(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 invali-
dated 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 appli-
cation approved under subsection (c) determines that a pat-
ent for such drug, or any patent information for such drug, 
no longer meets the listing requirements under this sec-
tion— 
‘‘(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 accord-
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ance 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) in-
formation related to such patent cancellation or in-
validation decision and submit such information, in-
cluding a copy of such decision, to the Secretary; and 
‘‘(iii) the Secretary shall, in response to a notifi-
cation 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 infor-
mation before the expiration of any 180-day exclu-
sivity period under paragraph (5)(B)(iv) that relies 
on 
a 
certification 
described 
in 
paragraph 
(2)(A)(vii)(IV).’’. 
(2) APPLICABILITY.—Subparagraph (D) of sec-
tion 505(j)(7) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(j)(7)), as added by para-
graph (1), applies only with respect to a decision de-
scribed 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