Medication Affordability and Patent Integrity Act

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

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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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