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 Office. 

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 subsequently 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 approved applications to provide certain submissions and 

communications to the Food and Drug Administration 

and the United States Patent and Trademark Office. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Medication Afford5 ability and Patent Integrity Act’’. 


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1 SEC. 2. DISCLOSURE OF INFORMATION. 

2 (a) IN GENERAL.— 

3 (1) IN GENERAL.—Section 505(b) of the Fed4 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

5 355(b)) is amended by adding at the end the fol6 lowing: 

7 ‘‘(7)(A) With respect to any application submitted 

8 under this subsection or approved under subsection (c), 

9 the sponsor of the application or holder of the approved 

10 application shall, for any applicable patent— 

11 ‘‘(i) certify to the Food and Drug Administra12 tion that the information described in subparagraph 

13 (B) that is submitted to the Secretary is complete 

14 and consistent with the information such sponsor or 

15 holder provided to the United States Patent and 

16 Trademark Office and any communications such 

17 sponsor or holder had with the United States Patent 

18 and Trademark Office; and 

19 ‘‘(ii)(I) submit to the United States Patent and 

20 Trademark Office any information material to pat21 entability with respect to such applicable patent that 

22 the sponsor or holder submits to the Food and Drug 

23 Administration, and any communications with the 

24 Food and Drug Administration that are related to 

25 such submissions; and 


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1 ‘‘(II) certify to the United States Patent and 

2 Trademark Office that the information provided 

3 under subclause (I) is complete and consistent with 

4 the information such sponsor or holder provided to 

5 the Food and Drug Administration and any commu6 nications such sponsor or holder had with the Food 

7 and Drug Administration. 

8 ‘‘(B) The information described in this subparagraph 

9 is— 

10 ‘‘(i) any statement or characterization of ana11 lytical or clinical data disclosed by the sponsor of the 

12 application or holder of the approved application 

13 under this section to the United States Patent and 

14 Trademark Office that has been, or will be, sub15 mitted to the Food and Drug Administration to sup16 port the approval of an application under this sec17 tion; 

18 ‘‘(ii) any statement or characterization with re19 spect to an applicable patent, including any state20 ment or characterization of prior art, submitted by 

21 the sponsor of the application or holder of the ap22 proved application to the United States Patent and 

23 Trademark Office in support of patentability; and 

24 ‘‘(iii) other information, as the Secretary or the 

25 Secretary of Commerce may require. 


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1 ‘‘(C) In this paragraph, the term ‘applicable patent’ 

2 means— 

3 ‘‘(i) a patent that— 

4 ‘‘(I) claims a drug that is the subject of an 

5 application described in subparagraph (A), in6 cluding any patent that claims, with respect to 

7 such a drug, a formulation or composition, 

8 method of use, or method of manufacturing; 

9 and 

10 ‘‘(II) is issued, assigned, or licensed to the 

11 sponsor of the application or holder of the ap12 proved application described in subparagraph 

13 (A); 

14 ‘‘(ii) an application for a patent described in 

15 clause (i)(I) that is sought by the sponsor of the ap16 plication or holder of the approved application de17 scribed in subparagraph (A); or 

18 ‘‘(iii) such other patent or application for a pat19 ent as the Secretary determines appropriate. 

20 ‘‘(D)(i) Except as provided in clause (ii), subpara21 graph (A) shall apply with respect to any original applica22 tion submitted under this subsection on or after the date 

23 of enactment of the Medication Affordability and Patent 

24 Integrity Act and to any amendments or supplements to 

25 such original application. 


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1 ‘‘(ii) In the case of an application submitted before 

2 the date of enactment of the Medication Affordability and 

3 Patent Integrity Act, the requirements of subparagraph 

4 (A) apply with respect to— 

5 ‘‘(I) any applicable patent issued on or after 

6 such date of enactment; and 

7 ‘‘(II) in the case of an applicable patent issued 

8 before such date of enactment, only to submissions 

9 and communications described in clauses (i) and (ii) 

10 of subparagraph (A) made on or after such date of 

11 enactment.’’. 

12 (2) CONDITION FOR APPROVAL.—Section 

13 505(d)(6) of the Federal Food, Drug, and Cosmetic 

14 Act (21 U.S.C. 505(d)(6)) is amended by inserting 

15 ‘‘, or the sponsor failed to comply with a require16 ment of subsection (b)(7)(A)(i)’’ after ‘‘subsection 

17 (b)’’. 

18 (b) BIOLOGICAL PRODUCT APPLICATIONS.—Section 

19 351(a)(2) of the Public Health Service Act (42 U.S.C. 

20 262(a)(2)) is amended by adding at the end the following: 

21 ‘‘(F)(i) With respect to any application submitted 

22 under this subsection or biological product licensed under 

23 this subsection, the sponsor of the application or holder 

24 of the licensure shall, for any applicable patent— 


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1 ‘‘(I) certify to the Food and Drug Administra2 tion that the information described in clause (ii) that 

3 is submitted to the Secretary is complete and con4 sistent with the information such sponsor or holder 

5 provided to the United States Patent and Trade6 mark Office and any communications such sponsor 

7 or holder had with the United States Patent and 

8 Trademark Office; and 

9 ‘‘(II)(aa) submit to the United States Patent 

10 and Trademark Office any information material to 

11 patentability with respect to such applicable patent 

12 that the sponsor or holder submits to the Food and 

13 Drug Administration, and any communications with 

14 the Food and Drug Administration that are related 

15 to such submissions; and 

16 ‘‘(bb) certify to the United States Patent and 

17 Trademark Office that the information provided 

18 under item (aa) is complete and consistent with the 

19 information such sponsor or holder provided to the 

20 Food and Drug Administration and any communica21 tions such sponsor or holder had with the Food and 

22 Drug Administration. 

23 ‘‘(ii) The information described in this clause is— 

24 ‘‘(I) any statement or characterization of ana25 lytical or clinical data disclosed by the sponsor of the 


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1 application or holder of the approved application 

2 under this section to the United States Patent and 

3 Trademark Office that has been, or will be, sub4 mitted to the Food and Drug Administration to sup5 port the approval of an application under this sec6 tion; 

7 ‘‘(II) any statement or characterization with re8 spect to an applicable patent, including any state9 ment or characterization of prior art, submitted by 

10 the sponsor of the application or holder of the ap11 proved application to the United States Patent and 

12 Trademark Office in support of patentability; and 

13 ‘‘(III) other information, as the Secretary or 

14 the Secretary of Commerce may require. 

15 ‘‘(iii) In this subparagraph, the term ‘applicable pat16 ent’ means— 

17 ‘‘(I) a patent— 

18 ‘‘(aa) with respect to which a reference 

19 product sponsor could reasonably assert a claim 

20 of patent infringement, if a person not licensed 

21 by the reference product sponsor engaged in the 

22 making, using, offering to sell, selling, or im23 porting into the United States of a biological 

24 product that relies on such patent; and 


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1 ‘‘(bb) that is issued, assigned, or exclu2 sively licensed to the sponsor of the application 

3 or holder of the licensure described in clause 

4 (i); 

5 ‘‘(II) an application for a patent described in 

6 subclause (I)(aa) that is sought by the sponsor of 

7 the application or holder of the licensure described 

8 in clause (i); or 

9 ‘‘(III) such other patent or application for a 

10 patent as the Secretary determines appropriate. 

11 ‘‘(iv)(I) Except as provided in subclause (II), clause 

12 (i) shall apply with respect to any original application sub13 mitted under this subsection on or after the date of enact14 ment of the Medication Affordability and Patent Integrity 

15 Act and to any amendments or supplements to such origi16 nal application. 

17 ‘‘(II) In the case of an application submitted under 

18 this subsection before the date of enactment of the Medi19 cation Affordability and Patent Integrity Act, the require20 ments of clause (i) apply with respect to— 

21 ‘‘(aa) any applicable patent issued on or after 

22 such date of enactment; and 

23 ‘‘(bb) in the case of an applicable patent issued 

24 before such date of enactment, only to submissions 

25 and communications described in subclauses (I) and 


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1 (II) of clause (i) made on or after such date of en2 actment. 

3 ‘‘(v) Notwithstanding subparagraph (C), the Sec4 retary may not approve an application for a biological 

5 product if the sponsor of such application is out of compli6 ance with the requirements of clause (i)(I) with respect 

7 to such application.’’. 

8 (c) ENFORCEMENT.— 

9 (1) FDA ENFORCEMENT.—Section 301 of the 

10 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

11 331) is amended by adding at the end the following: 

12 ‘‘(jjj) A failure to comply with a requirement of sec13 tion 505(b)(7) of this Act or section 351(a)(2)(F) of the 

14 Public Health Service Act.’’. 

15 (2) DEFENSE AGAINST PATENT INFRINGEMENT

16 ACTIONS.— 

17 (A) IN GENERAL.—Chapter 28 of title 35, 

18 United States Code, is amended by adding at 

19 the end the following: 

20 ‘‘§ 274. Non-disclosure defense to infringement of 

21 drug patent 

22 ‘‘A person shall be entitled to a defense under section 

23 282(b) in an action asserting infringement of an applica24 ble patent (as defined in paragraph (7)(B) of section 

25 505(b) of the Federal Food, Drug, and Cosmetic Act (21 


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1 U.S.C. 355(b)) or subparagraph (F)(ii) of section 

2 351(a)(2) of the Public Health Service Act (42 U.S.C. 

3 262(a)(2))) if the owner or predecessor owner of the appli4 cable patent violated paragraph (7)(A) of such section 

5 505(b) or subparagraph (F)(i) of such section 351(a)(2) 

6 with respect to the applicable patent by negligently or in7 tentionally failing to disclose any information required to 

8 be disclosed pursuant to such paragraph (7)(A) or such 

9 subparagraph (F)(i).’’. 

10 (B) TECHNICAL AND CONFORMING AMEND11 MENT.—The table of sections for chapter 28 of 

12 title 35, United States Code, is amended by 

13 adding at the end the following: 

‘‘274. Non-disclosure defense to infringement of drug patent.’’. 

Æ 


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