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.
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‘‘(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 sub-
section (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 informa-
tion 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).’’.
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(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) deter-
mines 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,
H. R. 1503—4 
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 pub-
lished 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 combina-
tion 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 Serv-
ices for inclusion on the list under section 505(j)(7) of 
the Federal Food, Drug, and Cosmetic Act and which pat-
ents 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 sub-
section (b)(1)’’ each place it appears and inserting ‘‘subsection 
(b)(1)(A)(i)’’; and
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(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.