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 receive the 30-month stay under paragraph (3)(C), as applicable; for purposes of paragraphs (3)(C) and (3)(E) and subsections (j)(5)(D)(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) or subsection (b)(1) 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)), 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 that claims a drug that was approved under this subsection before the date of enactment of the Reforming Evergreening and Manipulation that Extends Drug Years Act, or, with respect to a covered patent (as described in paragraph (2)) that claims a drug approved under this subsection on or after the date of enactment of such Act, 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 (b)(1) or (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)) 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 that claims a drug that was approved under subsection (c) before the date of enactment of the Reforming Evergreening and Manipulation that Extends Drug Years Act, or, with respect to a covered patent (as described in subsection (c)(2)) that claims a drug approved under subsection (c) on or after the date of enactment of such Act, after action for patent infringement.