[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 4253 Introduced in Senate (IS)]

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116th CONGRESS
  2d Session
                                S. 4253

 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
                 listing of patents in the Orange Book.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 21, 2020

Mrs. Murray (for herself and Mr. Cornyn) 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 
                 listing of patents in the Orange Book.

    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 ``Second Look at Drug Patents Act of 
2020''.

SEC. 2. AMENDMENTS.

    Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355) is amended--
            (1) in subsection (b)(1), in the fifth sentence, by 
        inserting ``, subject to the conditions under subsection 
        (j)(7)(A)(iii)(II) being met'' before the period;
            (2) in subsection (c)(2), at the end of the third sentence, 
        by inserting ``subject to the conditions under subsection 
        (j)(7)(A)(iii)(II) being met'' before the period; and
            (3) in subsection (j)(7)(A)(iii)--
                    (A) by striking ``When patent'' and inserting ``(I) 
                When patent'';
                    (B) by inserting ``, subject to subclause (II),'' 
                after ``, include''; and
                    (C) by adding at the end the following:
            ``(II) The Secretary shall include patent information on 
        the list pursuant to subclause (I) if the following conditions 
        are met:
                    ``(aa) If the patent has been issued as of the date 
                on which the application is approved under subsection 
                (c), the sponsor, within 30 days of the date of such 
                approval, shall submit to the Under Secretary of 
                Commerce for Intellectual Property and Director of the 
                United States Patent and Trademark Office (referred to 
                in this clause as the `Director') a notification that 
                the sponsor has filed with the Secretary information 
                about the patent as required under subsection (b)(1) or 
                (c)(2), as applicable.
                    ``(bb) If the patent is issued after the date on 
                which the application is approved under subsection (c), 
                the sponsor, not later than 30 days after the date on 
                which the patent is issued, shall submit to the 
                Director a notification that the sponsor has filed with 
                the Secretary information about the patent as required 
                under subsection (c)(2).
                    ``(cc) Upon receipt of a notification under item 
                (aa) or (bb), as applicable, the Director shall 
                publish, not later than 30 days of such receipt, in the 
                Official Gazette of the United States Patent and 
                Trademark Office, and on an internet website that the 
                Director shall establish, maintain, and operate, a 
                notification with respect to the patent, requesting 
                that any person that is eligible to file a request 
                described in section 311(b) of title 35, United States 
                Code, file such a request.''.
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