IB 
Union Calendar No. 25 
116TH CONGRESS 
1ST SESSION H. R. 1503 
[Report No. 116–47] 
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. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 5, 2019 
Ms. KELLY of Illinois introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
MAY 2, 2019 
Additional sponsors: Mr. RUIZ, Mr. RUSH, Mr. PALLONE, Mrs. DINGELL, Ms. 
ESHOO, Mr. KENNEDY, Ms. MATSUI, Mrs. CRAIG, Ms. CLARKE of New 
York, Mr. VAN DREW, Mr. WALDEN, Ms. SCHAKOWSKY, and Ms. 
MUCARSEL-POWELL 
MAY 2, 2019 
Reported with an amendment, committed to the Committee of the Whole 
House on the State of the Union, and ordered to be printed 
[Strike out all after the enacting clause and insert the part printed in italic] 
[For text of introduced bill, see copy of bill as introduced on March 5, 2019] 
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Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Orange Book Trans-
parency Act of 2019’’. 
SEC. 2. ORANGE BOOK. 
(a) SUBMISSION OF PATENT INFORMATION FOR BRAND 
NAME DRUGS.—Paragraph (1) of section 505(b) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) is 
amended to read as follows: 
‘‘(b)(1) Any person may file with the Secretary an ap-
plication with respect to any drug subject to the provisions 
of subsection (a). Such persons shall submit to the Secretary 
as part of the application— 
‘‘(A) full reports of investigations which have 
been made to show whether or not such drug is safe 
for use and whether such drug is effective in use; 
‘‘(B) a full list of the articles used as components 
of such drug; 
‘‘(C) a full statement of the composition of such 
drug; 
‘‘(D) a full description of the methods used in, 
and the facilities and controls used for, the manufac-
ture, processing, and packing of such drug; 
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‘‘(E) such samples of such drug and of the arti-
cles used as components thereof as the Secretary may 
require; 
‘‘(F) specimens of the labeling proposed to be 
used for such drug; 
‘‘(G) any assessments required under section 
505B; and 
‘‘(H) patent information, with respect to each 
patent for which a claim of patent infringement could 
reasonably be asserted if a person not licensed by the 
owner engaged in the manufacture, use, or sale of the 
drug, and consistent with the following requirements: 
‘‘(i) The applicant shall file with the appli-
cation the patent number and the expiration 
date of— 
‘‘(I) any patent which claims the drug 
for which the applicant submitted the appli-
cation and is a drug substance (including 
active ingredient) patent or a drug product 
(including formulation and composition) 
patent; and 
‘‘(II) any patent which claims the 
method of using such drug. 
‘‘(ii) If an application is filed under this 
subsection for a drug and a patent of the type 
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described in clause (i) which claims such drug or 
a method of using such drug is issued after the 
filing date but before approval of the applica-
tion, the applicant shall amend the application 
to include such patent information. 
Upon approval of the application, the Secretary shall pub-
lish the information submitted under subparagraph (H). 
The Secretary shall, in consultation with the Director of 
the National Institutes of Health and with representatives 
of the drug manufacturing industry, review and develop 
guidance, as appropriate, on the inclusion of women and 
minorities in clinical trials required by subparagraph 
(A).’’. 
(b) CONFORMING CHANGES TO REQUIREMENTS FOR 
SUBSEQUENT SUBMISSION
OF PATENT INFORMATION.— 
Section 505(c)(2) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(j)(7)) is amended— 
(1) by inserting after ‘‘the patent number and 
the expiration date of any patent which’’ the fol-
lowing: ‘‘fulfills the criteria in subsection (b) and’’; 
(2) by inserting after the first sentence the fol-
lowing: ‘‘Patent information that is not the type of 
patent information required by subsection (b) shall 
not be submitted.’’; and 
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(3) by inserting after ‘‘could not file patent in-
formation under subsection (b) because no patent’’ the 
following: ‘‘of the type required to be submitted in 
subsection (b)’’. 
(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 each exclusivity period that is applicable and 
has not concluded under— 
‘‘(I) clause (ii), (iii), or (iv) of subsection 
(c)(3)(E) of this section; 
‘‘(II) clause (iv) or (v) of paragraph (5)(B) of 
this subsection; 
‘‘(III) clause (ii), (iii), or (iv) of paragraph 
(5)(F) of this subsection; 
‘‘(IV) section 505A; 
‘‘(V) section 505E; or 
‘‘(VI) section 527(a).’’. 
(d) REMOVAL OF INVALID PATENTS.— 
(1) IN GENERAL.—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: 
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‘‘(D)(i) The holder of an application approved under 
subsection (c) for a drug on the list shall notify within 14 
days the Secretary in writing if either of the following oc-
curs: 
‘‘(I) The Patent Trial and Appeals Board issues 
a decision from which no appeal has been or can be 
taken that a patent for such drug is invalid. 
‘‘(II) A court issues a decision from which no 
appeal has been or can be taken that a patent for 
such drug is invalid. 
‘‘(ii) The holder of an approved application shall in-
clude in any notification under clause (i) a copy of the deci-
sion described in subclause (I) or (II) of clause (i). 
‘‘(iii) The Secretary shall remove from the list any 
patent that is determined to be invalid in a decision de-
scribed in subclause (I) or (II) of clause (i)— 
‘‘(I) promptly; but 
‘‘(II) not 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) that such patent was invalid.’’. 
(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-
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scribed in such subparagraph that is issued on or 
after the date of enactment of this Act. 
(e) REVIEW AND REPORT.—Not later than one year 
after the date of enactment of this Act, the Secretary of 
Health and Human Services, acting through the Commis-
sioner of Food and Drugs, shall— 
(1) solicit public comment regarding the types of 
patent information that should be included on 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 the Congress an evaluation of 
such comments, including any recommendations 
about the types of patent information that should be 
included on or removed from such list. 
SEC. 3. GAO REPORT TO CONGRESS. 
(a) IN GENERAL.—Not later than one year after the 
date of enactment of this Act, the Comptroller General of 
the United States (referred to in this section as the ‘‘Comp-
troller General’’) shall submit to 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)), including an analysis and evaluation of 
the types of patents included in such list and the claims 
such patents make about the products they claim. 
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(A) the listing of the patents described in 
paragraph (1)(A) delayed the market entry of 
one or more drugs approved under such section 
505(j); and 
(B) not listing the patents described in 
paragraph (1)(A) would delay the market entry 
of one or more such drugs; and 
(4) recommendations about which kinds of pat-
ents relating to devices described in paragraph (1)(A) 
should be submitted to the Secretary of Health and 
Human Services for inclusion on the list under para-
graph (7) of such section 505(j) and which patents 
should not be required to be so submitted. 
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Union Calendar No. 25 
116TH CONGRESS 
1ST SESSION 
H. R. 1503 
[Report No. 116–47] 
A BILL 
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. 
MAY 2, 2019 
Reported with an amendment, committed to the Com-
mittee of the Whole House on the State of the Union, 
and ordered to be printed 
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