Ensuring Access to Generic Medications Act

Subjects: Commerce


<html><body><pre>[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 1128 Introduced in Senate (IS)]

&lt;DOC&gt;






118th CONGRESS
  1st Session
                                S. 1128

   To establish special rules relating to information provided with 
     respect to drug applications concerning method of use patents.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 30, 2023

 Ms. Hassan (for herself and Mr. Braun) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
   To establish special rules relating to information provided with 
     respect to drug applications concerning method of use patents.

    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 ``Ensuring Access to Generic 
Medications Act''.

SEC. 2. SPECIAL RULES RELATING TO METHOD OF USE PATENTS.

    Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355) is amended by adding at the end the following:
    ``(z) Cause of Action Relating to Drug Use Codes.--
            ``(1) In general.--In the case of an application under 
        subsection (b)(2) or (j) of this section or section 351(k) of 
        the Public Health Service Act with respect to which the 
        applicant seeking approval includes in the application a 
        statement that a patent claiming a method of use does not claim 
        a use for the drug that is the subject of such application, as 
        described in subsection (b)(2)(B) or (j)(2)(A)(viii), or in the 
        case of an application under such section 351(k), as otherwise 
        required by the Secretary, the sponsor of the application under 
        subsection (b)(2) or (j) or such section 351(k) described in 
        paragraph (2) may file a civil action in an appropriate 
        district court of the United States against the holder of the 
        approved application for the applicable reference drug or 
        reference product seeking a court order requiring the holder to 
        correct or delete information relating to a use code submitted 
        by the holder of the reference drug or reference product with 
        respect to such patent claiming a method of use, on the ground 
        that such use code--
                    ``(A) does not correspond to a patent that claims 
                the reference drug or reference product for which the 
                application was approved;
                    ``(B) does not correspond to a patent that claims 
                an approved method of using the reference drug or 
                reference product; or
                    ``(C) is overly broad or otherwise inaccurate or 
                inappropriate.
            ``(2) Rule of construction.--Nothing in this subsection 
        shall be construed to affect the application of subsection 
        (j)(5)(C)(ii).
            ``(3) Definition.--For purposes of paragraph (1), the term 
        `use code' means the information relating to a patent claiming 
        a method of using a drug that is approved under section 505 of 
        this Act or under section 351 of the Public Health Service Act, 
        as applicable, based upon information submitted by the drug 
        sponsor or holder of the approved application or licensure 
        pursuant to section 314.53(c)(2)(ii)(P)(3) of title 21, Code of 
        Federal Regulations (or any successor regulations).''.
                                 &lt;all&gt;
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