II 

118TH CONGRESS 

1ST SESSION S. 2780 

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 SENATE OF THE UNITED STATES 

SEPTEMBER 13, 2023 

Ms. HASSAN (for herself and Mr. BRAUN) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

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’’. 

6 SEC. 2. DISCLOSURE OF INFORMATION. 

7 (a) IN GENERAL.— 


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1 (1) IN GENERAL.—Section 505(b) of the Fed2 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

3 355(b)) is amended by adding at the end the fol4 lowing: 

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

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

7 the sponsor of the application or holder of the approved 

8 application shall, for any applicable patent— 

9 ‘‘(i) certify to the Food and Drug Administra10 tion that the information described in subparagraph 

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

12 and consistent with the information such sponsor or 

13 holder provided to the United States Patent and 

14 Trademark Office and any communications such 

15 sponsor or holder had with the United States Patent 

16 and Trademark Office; and 

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

18 Trademark Office any information material to pat19 entability with respect to such applicable patent that 

20 the sponsor or holder submits to the Food and Drug 

21 Administration, and any communications with the 

22 Food and Drug Administration that are related to 

23 such submissions; and 

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

25 Trademark Office that the information provided 


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1 under subclause (I) is complete and consistent with 

2 the information such sponsor or holder provided to 

3 the Food and Drug Administration and any commu4 nications such sponsor or holder had with the Food 

5 and Drug Administration. 

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

7 is— 

8 ‘‘(i) any statement or characterization of ana9 lytical or clinical data disclosed by the sponsor of the 

10 application or holder of the approved application 

11 under this section to the United States Patent and 

12 Trademark Office that has been, or will be, sub13 mitted to the Food and Drug Administration to sup14 port the approval of an application under this sec15 tion; 

16 ‘‘(ii) any statement or characterization with re17 spect to an applicable patent, including any state18 ment or characterization of prior art, submitted by 

19 the sponsor of the application or holder of the ap20 proved application to the United States Patent and 

21 Trademark Office in support of patentability; and 

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

23 Secretary of Commerce may require. 

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

25 means— 


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1 ‘‘(i) a patent that— 

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

3 application described in subparagraph (A), in4 cluding any patent that claims, with respect to 

5 such a drug, a formulation or composition, 

6 method of use, or method of manufacturing; 

7 and 

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

9 sponsor of the application or holder of the ap10 proved application described in subparagraph 

11 (A); 

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

13 clause (i)(I) that is sought by the sponsor of the ap14 plication or holder of the approved application de15 scribed in subparagraph (A); or 

16 ‘‘(iii) such other patent or application for a pat17 ent as the Secretary determines appropriate. 

18 ‘‘(D)(i) Except as provided in clause (ii), subpara19 graph (A) shall apply with respect to any original applica20 tion submitted under this subsection on or after the date 

21 of enactment of the Medication Affordability and Patent 

22 Integrity Act and to any amendments or supplements to 

23 such original application. 

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

25 the date of enactment of the Medication Affordability and 


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1 Patent Integrity Act, the requirements of subparagraph 

2 (A) apply with respect to— 

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

4 such date of enactment; and 

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

6 before such date of enactment, only to submissions 

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

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

9 enactment.’’. 

10 (2) CONDITION FOR APPROVAL.—Section 

11 505(d)(6) of the Federal Food, Drug, and Cosmetic 

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

13 ‘‘, or the sponsor failed to comply with a require14 ment of subsection (b)(7)(A)(i)’’ after ‘‘subsection 

15 (b)’’. 

16 (b) BIOLOGICAL PRODUCT APPLICATIONS.—Section 

17 351(a)(2) of the Public Health Service Act (42 U.S.C. 

18 262(a)(2)) is amended by adding at the end the following: 

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

20 under this subsection or biological product licensed under 

21 this subsection, the sponsor of the application or holder 

22 of the licensure shall, for any applicable patent— 

23 ‘‘(I) certify to the Food and Drug Administra24 tion that the information described in clause (ii) that 

25 is submitted to the Secretary is complete and conVerDate Sep 11 2014 03:36 Sep 14, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S2780.IS S2780

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1 sistent with the information such sponsor or holder 

2 provided to the United States Patent and Trade3 mark Office and any communications such sponsor 

4 or holder had with the United States Patent and 

5 Trademark Office; and 

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

7 and Trademark Office any information material to 

8 patentability with respect to such applicable patent 

9 that the sponsor or holder submits to the Food and 

10 Drug Administration, and any communications with 

11 the Food and Drug Administration that are related 

12 to such submissions; and 

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

14 Trademark Office that the information provided 

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

16 information such sponsor or holder provided to the 

17 Food and Drug Administration and any communica18 tions such sponsor or holder had with the Food and 

19 Drug Administration. 

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

21 ‘‘(I) any statement or characterization of ana22 lytical or clinical data disclosed by the sponsor of the 

23 application or holder of the approved application 

24 under this section to the United States Patent and 

25 Trademark Office that has been, or will be, subVerDate Sep 11 2014 03:36 Sep 14, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S2780.IS S2780

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1 mitted to the Food and Drug Administration to sup2 port the approval of an application under this sec3 tion; 

4 ‘‘(II) any statement or characterization with re5 spect to an applicable patent, including any state6 ment or characterization of prior art, submitted by 

7 the sponsor of the application or holder of the ap8 proved application to the United States Patent and 

9 Trademark Office in support of patentability; and 

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

11 the Secretary of Commerce may require. 

12 ‘‘(iii) In this subparagraph, the term ‘applicable pat13 ent’ means— 

14 ‘‘(I) a patent— 

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

16 product sponsor could reasonably assert a claim 

17 of patent infringement, if a person not licensed 

18 by the reference product sponsor engaged in the 

19 making, using, offering to sell, selling, or im20 porting into the United States of a biological 

21 product that relies on such patent; and 

22 ‘‘(bb) that is issued, assigned, or exclu23 sively licensed to the sponsor of the application 

24 or holder of the licensure described in clause 

25 (i); 


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

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

3 the application or holder of the licensure described 

4 in clause (i); or 

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

6 patent as the Secretary determines appropriate. 

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

8 (i) shall apply with respect to any original application sub9 mitted under this subsection on or after the date of enact10 ment of the Medication Affordability and Patent Integrity 

11 Act and to any amendments or supplements to such origi12 nal application. 

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

14 this subsection before the date of enactment of the Medi15 cation Affordability and Patent Integrity Act, the require16 ments of clause (i) apply with respect to— 

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

18 such date of enactment; and 

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

20 before such date of enactment, only to submissions 

21 and communications described in subclauses (I) and 

22 (II) of clause (i) made on or after such date of en23 actment. 

24 ‘‘(v) Notwithstanding subparagraph (C), the Sec25 retary may not approve an application for a biological 


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1 product if the sponsor of such application is out of compli2 ance with the requirements of clause (i)(I) with respect 

3 to such application.’’. 

4 (c) ENFORCEMENT.— 

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

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

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

8 ‘‘(jjj) A failure to comply with a requirement of sec9 tion 505(b)(7) of this Act or section 351(a)(2)(F) of the 

10 Public Health Service Act.’’. 

11 (2) DEFENSE AGAINST PATENT INFRINGEMENT

12 ACTIONS.— 

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

14 United States Code, is amended by adding at 

15 the end the following: 

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

17 drug patent 

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

19 282(b) in an action asserting infringement of an applica20 ble patent (as defined in paragraph (7)(B) of section 

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

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

23 351(a)(2) of the Public Health Service Act (42 U.S.C. 

24 262(a)(2))) if the owner or predecessor owner of the appli25 cable patent violated paragraph (7)(A) of such section 


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1 505(b) or subparagraph (F)(i) of such section 351(a)(2) 

2 with respect to the applicable patent by negligently or in3 tentionally failing to disclose any information required to 

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

5 subparagraph (F)(i).’’. 

6 (B) TECHNICAL AND CONFORMING AMEND7 MENT.—The table of sections for chapter 28 of 

8 title 35, United States Code, is amended by 

9 adding at the end the following: 

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

Æ 


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