I 
116TH CONGRESS 
1ST SESSION H. R. 1503 
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 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act regard-
ing 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 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) PATENTS.—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 to read as follows: 
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‘‘(iii)(I) When patent information submitted under 
subsection (b) or (c) respecting a drug included on the 
list is to be published by the Secretary, the Secretary shall, 
in revisions made under clause (ii), include such informa-
tion for such drug. 
‘‘(II) The Secretary— 
‘‘(aa) shall include on the list, from such patent 
information respecting a drug, drug substance (in-
cluding active ingredient) patents, drug product (in-
cluding formulation and composition) patents, and 
method of use patents; and 
‘‘(bb) may choose to include on the list addi-
tional patent information respecting the drug. 
‘‘(III) The Secretary shall not include on the list any 
patent to the extent such patent claims a device that is 
used for the delivery of the drug. Notwithstanding the pre-
ceding sentence, the Secretary may require (under other 
applicable provisions of law) the holder of the approved 
application for a drug to submit, for purposes other than 
the list under this paragraph, patent information respect-
ing a device that is used for the delivery of the drug.’’. 
(b) 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: 
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‘‘(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 (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 (iii) or (iv) of paragraph (5)(F) of 
this subsection; 
‘‘(IV) section 505A; 
‘‘(V) section 505E; or 
‘‘(VI) section 527(a).’’. 
(c) 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 promptly notify 
the Secretary in writing if either of the following occurs: 
‘‘(I) The Patent Trial and Appeals Board issues 
a decision that a patent for such drug is invalid. 
‘‘(II) A court issues a decision from which no 
appeal may be taken that a patent for such drug is 
invalid. 
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‘‘(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 clause (iv) or (v) of para-
graph (5)(B) 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. 
(d) 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) review the types of patent information that 
should be included on the list under section 
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507(j)(7) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(j)(7)); and 
(2) report to the Congress on the results of 
such review, including any recommendations about 
the types of patent information that should be in-
cluded on or removed from such list. 
Æ 
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