[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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