Title: Second Look at Drug Patents Act of 2019
Policy area: Health

Summary:
Second Look at Drug Patents Act of 2019
This bill addresses the publication of drug patent information.
Drug manufacturers must submit patent information to the U.S. Patent and Trademark Office (USPTO) within 30 days following approval of a new drug application or an abbreviated new drug application. For patents issued after approval of an application, a drug manufacturer must submit the required patent information within 30 days of issuance. The USPTO must publish the patent information and invite requests for patent validity challenges.
The Food and Drug Administration must provisionally list in the Approved Drug Products with Therapeutic Equivalence Evaluations publication (commonly known as the Orange Book) a drug patent submitted to the USPTO in accordance with this bill until the Patent Trial and Appeal Board confirms the patent to be patentable or the patent is not challenged within a specific time frame.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 1617 Introduced in Senate (IS)]

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116th CONGRESS
  1st Session
                                S. 1617

 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

                              May 22, 2019

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 
2019''.

SEC. 2. AMENDMENTS.

    (a) In General.--Section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) is amended--
            (1) in subsection (b)(1), at the end of the fifth sentence, 
        by inserting ``subject to subsection (j)(7)(A)(iii)(II)'' 
        before the period; and
            (2) in subsection (j)(7)(A)(iii)--
                    (A) by striking ``When patent'' and inserting ``(I) 
                When patent'';
                    (B) by inserting ``, subject to subclauses (II) and 
                (III),'' 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 included in its application information 
                about the patent as required under subsection (b)(1).
                    ``(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 the notification described in item (aa).
                    ``(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.
            ``(III) A patent included on the list as described in 
        subclause (II) shall be designated as being provisionally 
        included on such list until either of the following conditions 
        is met:
                    ``(aa) The Patent Trial and Appeal Board of the 
                United States Patent and Trademark Office (referred to 
                in this clause as the `Board') issues a final written 
                decision with respect to an inter partes review of all 
                claims of the patent conducted under chapter 31 of 
                title 35, United States Code, and the Director issues 
                and publishes a certificate confirming those claims to 
                be patentable.
                    ``(bb) Notwithstanding the filing deadlines 
                provided under section 321(c) of title 35, United 
                States Code, no person files a petition for inter 
                partes review of any claim of the patent, with respect 
                to a patent described in subclause (II)(aa), not later 
                than 300 days after the date on which the application 
                is approved under subsection (c), or, with respect to a 
                patent described in subclause (II)(bb), not later than 
                15 months after the date on which the application is so 
                approved.
            ``(IV) With respect to a patent that is included on the 
        list as described in subclause (II), is designated as 
        provisionally included on such list under subclause (III), and, 
        after an inter partes review of the patent conducted under 
        chapter 31 of title 35, United States Code, is subject to a 
        final written decision of the Board and a certificate issued 
        and published by the Director canceling one or more claims of 
        the patent finally determined to be unpatentable, the holder of 
        the approved application, not later than 30 days after the date 
        on which the Director publishes the certificate, shall submit 
        to the Secretary--
                    ``(aa) if that decision and certificate relate to 
                all claims of the patent, a request to remove the 
                patent from the list; and
                    ``(bb) if that decision and certificate do not 
                relate to all claims of the patent, a request to remove 
                the patent information relating to the claim or claims 
                to which that decision and certificate relate from the 
                list.
            ``(V) If, as of the date on which a drug is approved under 
        subsection (c), a complaint has been filed in a district court 
        of the United States challenging the validity of a patent, a 
        patent submitted under subsection (b) or (c) respecting such 
        drug included on the list shall be included on the list until 
        the date on which the court invalidates the patent, if 
        applicable.
            ``(VI) Nothing in this clause shall affect the availability 
        to a first applicant of an exclusivity period pursuant to 
        clause (iv) or (v) of paragraph (5)(B), provided that, at the 
        time that the first applicant submits an application under this 
        subsection containing a certification described in paragraph 
        (2)(A)(vii)(IV), information about the patent is included on 
        the list or is included on the list on a provisional basis.''.
    (b) Effective Date.--The amendments made by subsection (a) shall 
apply only with respect to patents issued after the date of enactment 
of this Act.
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