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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5429 Introduced in House (IH)]
<DOC>
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.
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 complete and 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 communications with
the Food and Drug Administration that are related to such
submissions; and
``(II) certify to the United States Patent and Trademark
Office that the information provided under subclause (I) is
complete and 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--
``(i) any statement or characterization of analytical or
clinical data 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; and
``(iii) other information, as the Secretary or the
Secretary of Commerce may 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 determines appropriate.
``(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 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.''.
(2) Condition for approval.--Section 505(d)(6) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 505(d)(6)) is
amended by inserting ``, or the sponsor failed to comply with a
requirement of subsection (b)(7)(A)(i)'' after ``subsection
(b)''.
(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 complete and 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, and any communications with
the Food and Drug Administration that are related to such
submissions; and
``(bb) certify to the United States Patent and Trademark
Office that the information provided under item (aa) is
complete and 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--
``(I) any statement or characterization of analytical or
clinical data 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; and
``(III) other information, as the Secretary or the
Secretary of Commerce may require.
``(iii) In this subparagraph, the term `applicable patent' means--
``(I) a patent--
``(aa) with respect to which a reference product
sponsor could reasonably assert a claim of patent
infringement, if a person not licensed by the reference
product sponsor engaged in the making, using, offering
to sell, selling, or importing into the United States
of a biological product that relies on such patent; and
``(bb) that 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 determines appropriate.
``(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 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) Notwithstanding subparagraph (C), the Secretary may not
approve an application for a biological product if the sponsor of such
application is out of compliance with the requirements of clause (i)(I)
with respect to such application.''.
(c) Enforcement.--
(1) FDA enforcement.--Section 301 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at
the end the following:
``(jjj) A failure to comply with a requirement of 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)(B) 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.''.
<all>
Introduced in House
Introduced in House
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.
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.
Referred to the Subcommittee on Health.
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