S. 2620

119 S2620 IS: Reforming Evergreening and Manipulation that Extends Drug Years Act
 U.S. Senate
 2025-07-31
 text/xml
 EN
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  II
  119th CONGRESS
  1st Session
  S. 2620
  IN THE SENATE OF THE UNITED STATES
  July 31, 2025
  Mr. Durbin  (for himself and  Mr. Cassidy ) 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 approval
  of abbreviated new drug applications.
1.
Short title
This Act may be cited as the   Reforming Evergreening and Manipulation that Extends Drug Years Act   or the   REMEDY Act  .
2.
Amendments to ANDA approval provisions
Section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) is amended—
(1)
in subsection (c)(2) by adding at the end the following:  With respect to a drug approved on or after the date of enactment of the  Reforming Evergreening and Manipulation that Extends Drug Years Act , when a holder of an approved application first files information under this paragraph with respect to one or more patents described in subsection (b)(1)(A)(viii), the holder shall select one such patent with respect to which the owner or licensee may be eligible for the thirty-month period under paragraph (3)(C) or subsection (j)(5)(B)(iii), as applicable; for purposes of paragraphs (3)(C) and (3)(E)(ii) and subsections (j)(5)(B)(iii) and (j)(5)(F)(ii), such patent shall be referred to as the  covered patent . The selection of such covered patent may not be changed or amended. ;
(2)
in subsection (c)(3)(C)—
(A)
in the matter preceding clause (i)—
(i)
by striking  an action is brought for infringement  and all that follows through the period at the end of the first sentence and inserting  with respect to a drug approved under this subsection before the date of enactment of the  Reforming Evergreening and Manipulation that Extends Drug Years Act , an action is brought for infringement of any patent that is the subject of the certification and for which information was submitted to the Secretary under paragraph (2) before the date on which the application (excluding an amendment or supplement to the application) was submitted, or, with respect to a drug approved under this subsection on or after the date of enactment of the  Reforming Evergreening and Manipulation that Extends Drug Years Act , an action is brought for infringement of the covered patent (as described in paragraph (2)) that is the subject of the certification and for which information was submitted to the Secretary under paragraph (2) before the date on which the application (excluding an amendment or supplement to the application) was submitted. ; and
(ii)
by striking  an action is brought before  and inserting  an action with respect to a patent or a covered patent, as applicable, is brought before ; and
(B)
in clause (i), by striking  decides that the patent  and inserting  decides that the patent or the covered patent, as applicable ;
(3)
in the second sentence of subsection (c)(3)(E)(ii), by inserting  with respect to any patent for which the requirements are met for the thirty-month period described in subparagraph (C)  after  action for patent infringement ;
(4)
in subsection (j)(5)(B)(iii)—
(A)
in the matter preceding subclause (I)—
(i)
by striking  an action is brought for infringement  and all that follows through the period at the end of the first sentence and inserting  with respect to a drug approved under subsection (c) before the date of enactment of the  Reforming Evergreening and Manipulation that Extends Drug Years Act , an action is brought for infringement of any patent that is the subject of the certification and for which information was submitted to the Secretary under subsection (c)(2) before the date on which the application (excluding an amendment or supplement to the application), which the Secretary later determines to be substantially complete, was submitted, or, with respect to a drug approved under subsection (c) on or after the date of enactment of the  Reforming Evergreening and Manipulation that Extends Drug Years Act , an action is brought for infringement of the covered patent (as described in subsection (c)(2)) that is the subject of the certification and for which information was submitted to the Secretary under subsection (c)(2) before the date on which the application (excluding an amendment or supplement to the application), which the Secretary later determines to be substantially complete, was submitted. ; and
(ii)
by striking  an action is brought before  and inserting  an action with respect to a patent or a covered patent, as applicable, is brought before ; and
(B)
in subclause (I), by striking  decides that the patent  and inserting  decides that the patent or covered patent, as applicable, ; and
(5)
in the second sentence of subsection (j)(5)(F)(ii), by inserting  with respect to any patent for which the requirements are met for the thirty-month period described in subparagraph (B)(iii),  after  action for patent infringement .