Title: Expanding Access to Low-Cost Generics Act of 2019
Policy area: Health

Summary:
Expanding Access to Low-Cost Generics Act of 2019
This bill modifies the 180-day exclusivity period for certain generic drug manufacturers.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 3092 Introduced in Senate (IS)]

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116th CONGRESS
  1st Session
                                S. 3092

 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
          180-day exclusivity period, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           December 18, 2019

 Ms. Smith (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 amend the Federal Food, Drug, and Cosmetic Act with respect to the 
          180-day exclusivity period, and for other purposes.

    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 ``Expanding Access to Low-Cost 
Generics Act of 2019''.

SEC. 2. 180-DAY EXCLUSIVITY PERIOD.

    (a) In General.--Section 505(j)(5)(B)(iv) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B)(iv)) is amended--
            (1) in subclause (I), by striking ``effective on the date 
        that is 180 days after'' and all that follows through the 
        period at the end and inserting the following: ``effective--
                            ``(aa) except as provided in item (bb), on 
                        the date that is 180 days after the date of the 
                        first commercial marketing of the drug 
                        (including the commercial marketing of the 
                        listed drug) by any first applicant; or
                            ``(bb) if, in an infringement action 
                        brought in a district court solely against the 
                        applicant for the application described in this 
                        subclause (or any affiliate of the applicant), 
                        or an action in a district court for a 
                        declaratory judgment brought by that applicant, 
                        with respect to each patent to which a first 
                        applicant had submitted and lawfully maintained 
                        a certification under paragraph 
                        (2)(A)(vii)(IV), the district court decides 
                        that each patent is invalid or not infringed 
                        (including any substantive determination that 
                        there is no cause of action for patent 
                        infringement or invalidity), and the applicant 
                        for the application described in this subclause 
                        meets the requirements under subclause (III), 
                        immediately upon the district court entering 
                        such decision for such applicant.''; and
            (2) by adding at the end the following:
                    ``(III) Applicant requirements.--The requirements 
                under this subclause are that the applicant for the 
                application described in subclause (I)--
                            ``(aa) does not stay the action described 
                        in item (bb) of such subclause;
                            ``(bb) does not agree to be bound by a 
                        judgment as to another applicant; and
                            ``(cc) does not request joinder under 
                        section 42.122 of title 37, Code of Federal 
                        Regulations (or any corresponding similar 
                        regulation or ruling), for any petition that 
                        the applicant may have filed with respect to 
                        the application.''.
    (b) Applicability.--The amendments made by subsection (a) shall 
apply only with respect to an application filed under section 505(j) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) after the 
date of enactment of this Act that identifies a listed drug for which 
no certification under paragraph (2)(A)(vii)(IV) of such section was 
made before such date of enactment.
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