119-s2658

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 2658 Introduced in Senate

    (IS) ]

<DOC>

119th CONGRESS
 1st Session
 S. 2658

 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

 August 1, 2025

Ms. Hassan (for herself and Mr. Hawley) 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.

 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 ``Medication Affordability and Patent 
Integrity Act''.

SEC. 2. DISCLOSURE OF INFORMATION.

    (a) In General.--

    (1) In general.--

Section 505

    (b) of the Federal Food, Drug, 
 and Cosmetic Act (21 U.S.C. 355

    (b) ) is amended by adding at the 
 end the following:
 ``

    (7)
        (A) With respect to any application submitted under this 
subsection or approved under subsection
            (c) , the sponsor of the 
application or holder of the approved application shall, for any 
applicable patent--
 ``
            (i) certify to the Food and Drug Administration that the 
 information described in subparagraph
        (B) that is submitted to 
 the Secretary is, to the best knowledge of the sponsor or 
 holder, consistent with the information such sponsor or holder 
 provided to the United States Patent and Trademark Office and 
 any communications such sponsor or holder had with the United 
 States Patent and Trademark Office; and
 ``
            (ii) 
            (I) 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 information the Food 
 and Drug Administration provided in response; and
 ``
            (II) certify to the United States Patent and Trademark 
 Office that the submission under subclause
            (I) , to the best 
 knowledge of the sponsor or holder, includes all information 
 material to patentability, and is consistent with the 
 information such sponsor or holder provided to the Food and 
 Drug Administration and any communications such sponsor or 
 holder had with the Food and Drug Administration.
 ``
        (B) The information described in this subparagraph is limited to 
information that is material to patentability, as defined in 
regulations promulgated by the United States Patent and Trademark 
Office, and that is--
 ``
            (i) any statement or characterization of analytical data 
 set forth in the chemistry, manufacturing, and controls section 
 of a new drug application disclosed by the sponsor of the 
 application or holder of the approved application under this 
 section to the United States Patent and Trademark Office that 
 has been, or will be, submitted to the Food and Drug 
 Administration to support the approval of an application under 
 this section;
 ``
            (ii) any statement or characterization with respect to an 
 applicable patent, including any statement or characterization 
 of prior art, submitted by the sponsor of the application or 
 holder of the approved application to the United States Patent 
 and Trademark Office in support of patentability; or
 ``
            (iii) other information, as the Secretary or the 
 Secretary of Commerce may by regulation require.
 ``
            (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) , including 
 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 approved 
 application described in subparagraph
        (A) ;
 ``
            (ii) an application for a patent described in clause
            (i) 
            (I) that is sought by the sponsor of the application or 
 holder of the approved application described in subparagraph
        (A) ; or
 ``
            (iii) such other patent or application for a patent as 
 the Secretary or the Secretary of Commerce may by regulation 
 require.
 ``
            (D) 
            (i) Except as provided in clause
            (ii) , subparagraph
        (A) shall 
apply with respect to any original application 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.
 ``
            (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 only 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.
 ``
        (E) The United States Patent and Trademark Office shall, as 
necessary, update its applicable regulations or establish new 
procedures to ensure that any information that the sponsor or holder of 
the application has submitted to or received from the Food and Drug 
Administration and that is submitted to the United States Patent and 
Trademark Office to fulfill the requirements of subparagraph
        (A) , and 
that would not otherwise be submitted to the United States Patent and 
Trademark Office, shall remain subject to application protections for 
trade secret or confidential information or financial information as if 
the information were held by the Food and Drug Administration.''.

    (2) Inclusion of certifications in application.--

Section 505

    (b)

    (1)
        (A) of the Federal Food, Drug, and Cosmetic Act (21 
 U.S.C. 355

    (b)

    (1)
        (A) ) is amended--
        (A) in clause
            (vii) , by striking ``and'' at the 
 end;
        (B) in clause
            (viii) 
            (II) , by striking the period 
 and inserting ``; and''; and
            (C) by adding at the end the following:
 ``
            (ix) with respect to each patent listed in the 
 application pursuant to clause
            (viii) that is an applicable 
 patent (as defined in paragraph

    (7)
            (C) ), the certifications 
 required under clauses
            (i) and
            (ii) 
            (II) of paragraph

    (7)
        (A) .''.

    (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--
 ``
            (I) certify to the Food and Drug Administration that the 
 information described in clause
            (ii) that is submitted to the 
 Secretary is, to the best knowledge of the sponsor or holder, 
 consistent with the information such sponsor or holder provided 
 to the United States Patent and Trademark 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 provided in response; and
 ``

    (bb) certify to the United States Patent and Trademark 
 Office that the submission under item

    (aa) , to the best 
 knowledge of the sponsor or holder, includes all information 
 material to patentability and is consistent with the 
 information such sponsor or holder provided to the Food and 
 Drug Administration and any communications such sponsor or 
 holder had with the Food and Drug Administration.
 ``
            (ii) The information described in this clause is limited to 
information that is material to patentability, as defined in 
regulations promulgated by the United States Patent and Trademark 
Office, and that is--
 ``
            (I) any statement or characterization of analytical data 
 set forth in the chemistry, manufacturing, and controls section 
 in a biological product license application disclosed by the 
 sponsor of the application or holder of the approved 
 application under this section to the United States Patent and 
 Trademark Office that has been, or will be, submitted to the 
 Food and Drug Administration to support the approval of an 
 application under this section;
 ``
            (II) any statement or characterization with respect to an 
 applicable patent, including any statement or characterization 
 of prior art, submitted by the sponsor of the application or 
 holder of the approved application to the United States Patent 
 and Trademark Office in support of patentability; or
 ``
            (III) other information, as the Secretary or the 
 Secretary of Commerce may by regulation require.
 ``
            (iii) In this subparagraph, the term `applicable patent' means--
 ``
            (I) a patent that--
 ``

    (aa) claims a biological product that is the 
 subject of an application described in clause
            (i) , 
 including any patent that claims, with respect to such 
 biological product, a formulation or composition, 
 method of use, or method of manufacturing; and
 ``

    (bb) is issued, assigned, or exclusively 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 or Secretary of Commerce may by regulation 
 require.
 ``
            (iv) 
            (I) Except as provided in subclause
            (II) , clause
            (i) shall 
apply with respect to any original application 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.
 ``
            (II) In the case of an application submitted under this 
subsection before the date of enactment of the Medication Affordability 
and Patent Integrity Act, the requirements of clause
            (i) apply only 
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
            (II) of clause
            (i) made on or 
 after such date of enactment.
 ``
            (v) 
            (I) Any information that the sponsor of the application or 
holder of the licensure has submitted to or received from the Food and 
Drug Administration that is submitted to the United States Patent and 
Trademark office to fulfill the requirements of clause
            (i) shall remain 
subject to application protections for trade secret or confidential 
information or financial information as if the information were held by 
the Food and Drug Administration.
 ``
            (II) The United States Patent and Trademark Office shall, as 
necessary, update its applicable regulations or create new procedures 
to ensure compliance with subclause
            (I) for information submitted under 
this subparagraph.''.
            (c) Enforcement.--

    (1) FDA enforcement.--

Section 301

    (q)

    (1) of the Federal 
 Food, Drug, and Cosmetic Act (21 U.S.C. 331

    (q)

    (1) ) is amended--
        (A) in clause
        (B) , by striking ``; or'' and 
 inserting a semicolon;
        (B) in clause
            (C) , by striking the period and 
 inserting ``; or''; and
            (C) by adding at the end the following:
 ``
            (D) to submit the certification required under 

section 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:
``

Sec. 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 applicable patent (as defined in 
paragraph

    (7)
            (C) of 

section 505

    (b) of the Federal Food, Drug, and 
Cosmetic Act (21 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 applicable 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 intentionally failing to disclose any information required to be 
disclosed pursuant to such paragraph

    (7)
        (A) or such subparagraph
        (F)
            (i) .''.
        (B) Technical and conforming amendment.--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.''.
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