I 
118TH CONGRESS 
1ST SESSION H. R. 5429 
To require sponsors of drug applications and holders of approved applications 
to provide certain submissions and communications to the Food and 
Drug Administration and the United States Patent and Trademark Of-
fice. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 13, 2023 
Ms. KUSTER (for herself and Mrs. HARSHBARGER) introduced the following 
bill; which was referred to the Committee on Energy and Commerce, and 
in addition to the Committee on the Judiciary, for a period to be subse-
quently determined by the Speaker, in each case for consideration of such 
provisions as fall within the jurisdiction of the committee concerned 
A BILL 
To require sponsors of drug applications and holders of ap-
proved applications to provide certain submissions and 
communications to the Food and Drug Administration 
and the United States Patent and Trademark Office. 
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 ‘‘Medication Afford-
ability and Patent Integrity Act’’. 
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‘‘(C) In this paragraph, the term ‘applicable patent’ 
means— 
‘‘(i) a patent that— 
‘‘(I) claims a drug that is the subject of an 
application described in subparagraph (A), in-
cluding any patent that claims, with respect to 
such a drug, a formulation or composition, 
method of use, or method of manufacturing; 
and 
‘‘(II) is issued, assigned, or licensed to the 
sponsor of the application or holder of the ap-
proved application described in subparagraph 
(A); 
‘‘(ii) an application for a patent described in 
clause (i)(I) that is sought by the sponsor of the ap-
plication or holder of the approved application de-
scribed in subparagraph (A); or 
‘‘(iii) such other patent or application for a pat-
ent as the Secretary determines appropriate. 
‘‘(D)(i) Except as provided in clause (ii), subpara-
graph (A) shall apply with respect to any original applica-
tion submitted under this subsection on or after the date 
of enactment of the Medication Affordability and Patent 
Integrity Act and to any amendments or supplements to 
such original application. 
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‘‘(ii) In the case of an application submitted before 
the date of enactment of the Medication Affordability and 
Patent Integrity Act, the requirements of subparagraph 
(A) apply with respect to— 
‘‘(I) any applicable patent issued on or after 
such date of enactment; and 
‘‘(II) in the case of an applicable patent issued 
before such date of enactment, only to submissions 
and communications described in clauses (i) and (ii) 
of subparagraph (A) made on or after such date of 
enactment.’’. 
(2) 
CONDITION
FOR
APPROVAL.—Section 
505(d)(6) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 505(d)(6)) is amended by inserting 
‘‘, or the sponsor failed to comply with a require-
ment of subsection (b)(7)(A)(i)’’ after ‘‘subsection 
(b)’’. 
(b) BIOLOGICAL PRODUCT APPLICATIONS.—Section 
351(a)(2) of the Public Health Service Act (42 U.S.C. 
262(a)(2)) is amended by adding at the end the following: 
‘‘(F)(i) With respect to any application submitted 
under this subsection or biological product licensed under 
this subsection, the sponsor of the application or holder 
of the licensure shall, for any applicable patent— 
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‘‘(I) certify to the Food and Drug Administra-
tion that the information described in clause (ii) that 
is submitted to the Secretary is complete and con-
sistent with the information such sponsor or holder 
provided to the United States Patent and Trade-
mark Office and any communications such sponsor 
or holder had with the United States Patent and 
Trademark Office; and 
‘‘(II)(aa) submit to the United States Patent 
and Trademark Office any information material to 
patentability with respect to such applicable patent 
that the sponsor or holder submits to the Food and 
Drug Administration, and any communications with 
the Food and Drug Administration that are related 
to such submissions; and 
‘‘(bb) certify to the United States Patent and 
Trademark Office that the information provided 
under item (aa) is complete and consistent with the 
information such sponsor or holder provided to the 
Food and Drug Administration and any communica-
tions such sponsor or holder had with the Food and 
Drug Administration. 
‘‘(ii) The information described in this clause is— 
‘‘(I) any statement or characterization of ana-
lytical or clinical data disclosed by the sponsor of the 
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application or holder of the approved application 
under this section to the United States Patent and 
Trademark Office that has been, or will be, sub-
mitted to the Food and Drug Administration to sup-
port the approval of an application under this sec-
tion; 
‘‘(II) any statement or characterization with re-
spect to an applicable patent, including any state-
ment or characterization of prior art, submitted by 
the sponsor of the application or holder of the ap-
proved application to the United States Patent and 
Trademark Office in support of patentability; and 
‘‘(III) other information, as the Secretary or 
the Secretary of Commerce may require. 
‘‘(iii) In this subparagraph, the term ‘applicable pat-
ent’ means— 
‘‘(I) a patent— 
‘‘(aa) with respect to which a reference 
product sponsor could reasonably assert a claim 
of patent infringement, if a person not licensed 
by the reference product sponsor engaged in the 
making, using, offering to sell, selling, or im-
porting into the United States of a biological 
product that relies on such patent; and 
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‘‘(bb) that is issued, assigned, or exclu-
sively licensed to the sponsor of the application 
or holder of the licensure described in clause 
(i); 
‘‘(II) an application for a patent described in 
subclause (I)(aa) that is sought by the sponsor of 
the application or holder of the licensure described 
in clause (i); or 
‘‘(III) such other patent or application for a 
patent as the Secretary determines appropriate. 
‘‘(iv)(I) Except as provided in subclause (II), clause 
(i) shall apply with respect to any original application sub-
mitted under this subsection on or after the date of enact-
ment of the Medication Affordability and Patent Integrity 
Act and to any amendments or supplements to such origi-
nal application. 
‘‘(II) In the case of an application submitted under 
this subsection before the date of enactment of the Medi-
cation Affordability and Patent Integrity Act, the require-
ments of clause (i) apply with respect to— 
‘‘(aa) any applicable patent issued on or after 
such date of enactment; and 
‘‘(bb) in the case of an applicable patent issued 
before such date of enactment, only to submissions 
and communications described in subclauses (I) and 
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(II) of clause (i) made on or after such date of en-
actment. 
‘‘(v) Notwithstanding subparagraph (C), the Sec-
retary may not approve an application for a biological 
product if the sponsor of such application is out of compli-
ance with the requirements of clause (i)(I) with respect 
to such application.’’. 
(c) ENFORCEMENT.— 
(1) FDA ENFORCEMENT.—Section 301 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
331) is amended by adding at the end the following: 
‘‘(jjj) A failure to comply with a requirement of sec-
tion 505(b)(7) of this Act or section 351(a)(2)(F) of the 
Public Health Service Act.’’. 
(2) DEFENSE AGAINST PATENT INFRINGEMENT 
ACTIONS.— 
(A) IN GENERAL.—Chapter 28 of title 35, 
United States Code, is amended by adding at 
the end the following: 
‘‘§ 274. Non-disclosure defense to infringement of 
drug patent 
‘‘A person shall be entitled to a defense under section 
282(b) in an action asserting infringement of an applica-
ble patent (as defined in paragraph (7)(B) of section 
505(b) of the Federal Food, Drug, and Cosmetic Act (21 
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U.S.C. 355(b)) or subparagraph (F)(ii) of section 
351(a)(2) of the Public Health Service Act (42 U.S.C. 
262(a)(2))) if the owner or predecessor owner of the appli-
cable patent violated paragraph (7)(A) of such section 
505(b) or subparagraph (F)(i) of such section 351(a)(2) 
with respect to the applicable patent by negligently or in-
tentionally failing to disclose any information required to 
be disclosed pursuant to such paragraph (7)(A) or such 
subparagraph (F)(i).’’. 
(B) TECHNICAL AND CONFORMING AMEND-
MENT.—The table of sections for chapter 28 of 
title 35, United States Code, is amended by 
adding at the end the following: 
‘‘274. Non-disclosure defense to infringement of drug patent.’’. 
Æ 
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