Title: Hatch-Waxman Integrity Act of 2018
Policy area: Health

Summary:
Hatch-Waxman Integrity Act of 2018
This bill amends the Federal Food, Drug, and Cosmetic Act and the Securities Exchange Act of 1934 to prevent a generic drug or biosimilar manufacturer from using a specific review process for challenging pharmaceutical drug or biologic patents.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 3738 Introduced in Senate (IS)]

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115th CONGRESS
  2d Session
                                S. 3738

 To amend the Federal Food, Drug, and Cosmetic Act and the Securities 
  Exchange Act of 1934 to prevent the inter partes review process for 
challenging patents from diminishing competition in the pharmaceutical 
 industry and with respect to drug innovation, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           December 11, 2018

 Mr. Hatch (for himself and Mr. Tillis) 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 and the Securities 
  Exchange Act of 1934 to prevent the inter partes review process for 
challenging patents from diminishing competition in the pharmaceutical 
 industry and with respect to drug innovation, and for other purposes.

    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 ``Hatch-Waxman Integrity Act of 
2018''.

SEC. 2. PREVENTING THE INTER PARTES REVIEW PROCESS FOR CHALLENGING 
              PATENTS FROM DIMINISHING COMPETITION IN THE 
              PHARMACEUTICAL INDUSTRY AND WITH RESPECT TO DRUG 
              INNOVATION.

    (a) Brand Name Drugs.--Section 505(b)(2) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(b)(2)) is amended--
            (1) in subparagraph (A)(iv), by striking ``and'' at the 
        end;
            (2) in subparagraph (B), by striking the period at the end 
        and inserting ``; and''; and
            (3) by adding at the end the following:
            ``(C) in each certification required under subparagraph (A) 
        with respect to a patent, a certification that--
                    ``(i) neither the applicant nor any party in 
                privity with, related to, or cooperating with the 
                applicant has filed, or will file, a petition to 
                institute inter partes review or post-grant review of 
                that patent under chapter 31 or 32, respectively, of 
                title 35, United States Code; and
                    ``(ii) in making the certification required under 
                subparagraph (A), the applicant is not relying in whole 
                or in part on any decision issued by the Patent Trial 
                and Appeal Board in an inter partes review or post-
                grant review under chapter 31 or 32, respectively, of 
                title 35, United States Code.''.
    (b) Generic Drugs.--Section 505(j)(2)(A) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(j)(2)(A)) is amended--
            (1) in clause (vii)(IV), by striking ``and'' at the end;
            (2) in clause (viii), by striking the period at the end and 
        inserting ``; and'';
            (3) by inserting after clause (viii), as amended by 
        paragraph (2), the following:
                    ``(ix) in each certification required under clause 
                (vii) with respect to a patent, a certification that--
                            ``(I) neither the applicant nor any party 
                        in privity with, related to, or cooperating 
                        with the applicant has filed, or will file, a 
                        petition to institute inter partes review or 
                        post-grant review of that patent under chapter 
                        31 or 32, respectively, of title 35, United 
                        States Code; and
                            ``(II) in making the certification required 
                        under clause (vii), the applicant is not 
                        relying in whole or in part on any decision 
                        issued by the Patent Trial and Appeal Board in 
                        an inter partes review or post-grant review 
                        under chapter 31 or 32, respectively, of title 
                        35, United States Code.''; and
            (4) in the flush text following clause (ix), as added by 
        paragraph (3), by striking ``(viii)'' and inserting ``(ix)''.
    (c) Biosimilar Drugs; Evaluation by the Secretary.--Section 351(k) 
of the Public Health Service Act (42 U.S.C. 262(k)) is amended--
            (1) in paragraph (2)(A)(iii)--
                    (A) by redesignating subclauses (I) and (II) as 
                items (aa) and (bb), respectively, and adjusting the 
                margins accordingly;
                    (B) in the matter preceding item (aa), as so 
                redesignated, by striking ``An application'' and 
                inserting the following:
                                    ``(I) In general.--An 
                                application'';
                    (C) in subclause (I), as so designated--
                            (i) in item (aa), as so redesignated, by 
                        striking ``and'' at the end;
                            (ii) in item (bb), as so redesignated, by 
                        striking the period at the end and inserting 
                        ``; and''; and
                            (iii) by adding at the end the following:
                                            ``(cc) shall, with respect 
                                        to a patent described in 
                                        subclause (II), include a 
                                        certification that neither the 
                                        applicant nor any party in 
                                        privity with, related to, or 
                                        cooperating with the applicant 
                                        has filed, or will file, a 
                                        petition to institute inter 
                                        partes review or post-grant 
                                        review of the patent under 
                                        chapter 31 or 32, respectively, 
                                        of title 35, United States 
                                        Code.''; and
                    (D) by adding at the end the following:
                                    ``(II) Patent described.--A patent 
                                is described in this subclause if--
                                            ``(aa) the patent covers 
                                        the reference product or a 
                                        method for using the reference 
                                        product; and
                                            ``(bb)(AA) the reference 
                                        product described in item (aa) 
                                        is marked under section 287(a) 
                                        of title 35, United States 
                                        Code; or
                                            ``(BB) there is otherwise 
                                        public notice regarding the 
                                        applicability of the reference 
                                        product described in item 
                                        (aa).''; and
            (2) in paragraph (3)--
                    (A) in subparagraph (A)(ii), by striking ``and'' at 
                the end;
                    (B) in subparagraph (B), by striking the period at 
                the end and inserting ``; and''; and
                    (C) by adding at the end the following:
                    ``(C) the Secretary determines that the application 
                fully complies with the requirements under paragraph 
                (2)(A)(iii).''.

SEC. 3. PREVENTING THE MANIPULATIVE AND DECEPTIVE USE OF INTER PARTES 
              REVIEW.

    Section 10(b) of the Securities Exchange Act of 1934 (15 U.S.C. 
78j(b)) is amended--
            (1) by inserting ``(1)'' after ``(b)''; and
            (2) by adding at the end the following:
    ``(2) For purposes of paragraph (1), a person shall be considered 
to be using a manipulative or deceptive device if--
            ``(A) the person, or an affiliate of the person, files a 
        petition to institute an inter partes review under chapter 31 
        of title 35, United States Code, with respect to a patent; and
            ``(B) the person, or an affiliate of the person, during the 
        180-day period beginning on the date that is 90 days before the 
        date on which the person files the petition described in 
        subparagraph (A), engages in a short sale of any publicly 
        traded security of the owner of the patent that is the subject 
        of the petition.''.
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