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 Federal 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 
application with respect to any drug subject to the provi-
sions 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 compo-
nents 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; 
‘‘(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 ap-
plication and is a drug substance (includ-
ing active ingredient) patent or a drug 
product (including formulation and com-
position) 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 
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 appli-
cation, the applicant shall amend the applica-
tion 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 Cos-
metic 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 
(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 Cos-
metic 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 Sec-
retary shall specify each exclusivity period that is applica-
ble 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 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(j)(7)) is amended by adding at the end the fol-
lowing: 
‘‘(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 
occurs: 
‘‘(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 
decision 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-
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 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 1 year 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 
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 eval-
uation of the types of patents included in such list and 
the claims such patents make about the products they 
claim.
(b) CONTENTS.—The Comptroller General shall in-
clude in the report under subsection (a)— 
(1) data on the number of— 
(A) patents included in the list published 
under paragraph (7) of section 505(j) of the 
Federal Food, Drug and Cosmetic Act (21 
U.S.C. 355(j)), that claim the active ingredient 
or formulation of a drug in combination with a 
device that is used for delivery of the drug, to-
gether comprising the finished dosage form of 
the drug; and 
(B) claims in each patent that claim a de-
vice 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; 
(2) data on the date of inclusion in the list 
under paragraph (7) of such section 505(j) for all 
patents under such list, as compared to patents that 
claim a method of using the drug in combination 
with a device; 
(3) an analysis regarding the impact of includ-
ing on the list under paragraph (7) of such section 
505(j) certain types of patent information for drug
product applicants and approved application holders, 
including an analysis of whether— 
(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 paragraph (7) of such section 505(j) and 
which patents should not be required to be so sub-
mitted. 
Passed the House of Representatives May 8, 2019. 
Attest: 
Clerk.
116TH CONGRESS 
1ST SESSION 
H. R. 1503 
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.