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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>
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