[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3812 Introduced in House (IH)]

<DOC>






116th CONGRESS
  1st Session
                                H. R. 3812

   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
             approval of abbreviated new drug applications.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 17, 2019

Mr. McKinley (for himself and Mr. Welch) introduced the following bill; 
       which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
             approval of abbreviated new drug applications.

    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 ``Reforming Evergreening and 
Manipulation that Extends Drug Years Act'' or the ``REMEDY Act''.

SEC. 2. AMENDMENTS TO ANDA APPROVAL PROVISION.

    (a) In General.--Section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) is amended--
            (1) in subsection (c)(3)(C), by inserting ``in the case of 
        a certification with respect to a patent that claims a drug 
        substance (and not in the case of a certification with respect 
        to a patent that claims a drug product or method of use for a 
        drug, except that, in the case of a patent that claims a drug 
        substance and a drug product or method of use, this 
        subparagraph shall apply, but only to the extent the patent 
        claims a drug substance),'' after ``immediately unless,''; and
            (2) in subsection (j)(5)(B)(iii), by inserting ``in the 
        case of a certification with respect to a patent that claims a 
        drug substance (and not in the case of a certification with 
        respect to a patent that claims a drug product or method of use 
        for a drug, except that, in the case of a patent that claims a 
        drug substance and a drug product or method of use, this clause 
        shall apply, but only to the extent the patent claims a drug 
        substance),'' after ``immediately unless,''.
    (b) Orange Book Updates With Respect to Invalidated Patents.--
            (1) In general.--Section 505(j)(7)(A) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)(A)) is amended by 
        adding at the end the following:
            ``(iv) In the case of a listed drug for which the list 
        under clause (i) includes a patent that claims the drug or a 
        use for such drug, and where the Under Secretary of Commerce 
        for Intellectual Property and Director of the United States 
        Patent and Trademark Office has cancelled any claim of the 
        patent relating to such drug or such use pursuant to a 
        determination by the Patent Trial and Appeal Board in an inter 
        partes review conducted under chapter 31 of title 35, United 
        States Code, or a post-grant review conducted under chapter 32 
        of that title, and any such cancellation, if appealed, has been 
        upheld upon appeal, the holder of the applicable approved 
        application shall notify the Secretary of such cancellation, 
        and the revisions required under clause (iii) shall include 
        striking the patent from the list with respect to such drug.''.
            (2) No effect on first applicant exclusivity period.--
        Section 505(j)(5)(B)(iv)(I) is amended by adding at the end the 
        following: ``This subclause shall apply even if a patent is 
        stricken from the list under paragraph (7)(A), pursuant to the 
        second sentence of clause (iii) of such paragraph, provided 
        that, at the time that the first applicant submitted an 
        application under this subsection containing a certification 
        described in paragraph (2)(A)(vii)(IV), the patent that was the 
        subject of such certification was included in such list with 
        respect to the listed drug.''.
                                 <all>