EHF18270
`
`S.L.C.
`
`AMENDMENT NO.llll
`
`Calendar No.lll
`
`Purpose: To prevent the inter partes review process for chal-
`lenging patents from diminishing competition in the
`pharmaceutical industry and with respect to drug inno-
`vation.
`
`IN THE SENATE OF THE UNITED STATES—115th Cong., 2d Sess.
`
`S. 974
`
`To promote competition in the market for drugs and biologi-
`cal products by facilitating the timely entry of lower-
`cost generic and biosimilar versions of those drugs and
`biological products.
`
`Referred to the Committee on llllllllll and
`ordered to be printed
`
`Ordered to lie on the table and to be printed
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`AMENDMENT intended to be proposed by Mr. HATCH
`
`Viz:
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`After section 4, add the following:
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`SEC. 5. PREVENTING THE INTER PARTES REVIEW PROCESS
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`FOR CHALLENGING PATENTS FROM DIMIN-
`
`ISHING COMPETITION
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`IN THE PHARMA-
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`CEUTICAL INDUSTRY AND WITH RESPECT TO
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`DRUG INNOVATION; PREVENTING THE MA-
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`NIPULATIVE AND DECEPTIVE USE OF INTER
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`PARTES REVIEW.
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`(a) SHORT TITLE.—This section may be cited as the
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`10
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`‘‘Hatch-Waxman Integrity Act of 2018’’.
`
`Dr. Reddy’s Laboratories, Inc. v. Celgene Corp.
`IPR2018-01504
`Exhibit 2030, Page 1
`
`
`
`S.L.C.
`
`AMENDMENT NO.llll
`
`Calendar No.lll
`
`Purpose: To prevent the inter partes review process for chal-
`lenging patents from diminishing competition in the
`pharmaceutical industry and with respect to drug inno-
`vation.
`
`IN THE SENATE OF THE UNITED STATES—115th Cong., 2d Sess.
`
`S. 974
`
`To promote competition in the market for drugs and biologi-
`cal products by facilitating the timely entry of lower-
`cost generic and biosimilar versions of those drugs and
`biological products.
`
`Referred to the Committee on llllllllll and
`ordered to be printed
`
`Ordered to lie on the table and to be printed
`
`AMENDMENT intended to be proposed by Mr. HATCH
`
`Viz:
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`1
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`2
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`3
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`4
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`5
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`6
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`7
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`8
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`9
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`After section 4, add the following:
`
`SEC. 5. PREVENTING THE INTER PARTES REVIEW PROCESS
`
`FOR CHALLENGING PATENTS FROM DIMIN-
`
`ISHING COMPETITION
`
`IN THE PHARMA-
`
`CEUTICAL INDUSTRY AND WITH RESPECT TO
`
`DRUG INNOVATION; PREVENTING THE MA-
`
`NIPULATIVE AND DECEPTIVE USE OF INTER
`
`PARTES REVIEW.
`
`(a) SHORT TITLE.—This section may be cited as the
`
`10
`
`‘‘Hatch-Waxman Integrity Act of 2018’’.
`
`Dr. Reddy’s Laboratories, Inc. v. Celgene Corp.
`IPR2018-01504
`Exhibit 2030, Page 1
`
`
`
`EHF18270
`
`S.L.C.
`
`2
`(b) BRAND NAME DRUGS.—Section 505(b)(2) of the
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`Federal Food, Drug, and Cosmetic Act (21 U.S.C.
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`355(b)(2)) is amended—
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`(1) in subparagraph (A)(iv), by striking ‘‘and’’
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`at the end;
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`(2) in subparagraph (B), by striking the period
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`at the end and inserting ‘‘; and’’; and
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`(3) by adding at the end the following:
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`‘‘(C) in each certification required under sub-
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`paragraph (A) with respect to a patent, a certifi-
`
`cation that—
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`‘‘(i) neither the applicant nor any party in
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`privity 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
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`‘‘(ii) in making the certification required
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`under subparagraph (A), the applicant is not
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`relying in whole or in part on any decision
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`issued by the Patent Trial and Appeal Board in
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`an inter partes review or post-grant review
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`under chapter 31 or 32, respectively, of title 35,
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`United States Code.’’.
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`Dr. Reddy’s Laboratories, Inc. v. Celgene Corp.
`IPR2018-01504
`Exhibit 2030, Page 2
`
`
`
`EHF18270
`
`S.L.C.
`
`3
`(c) GENERIC DRUGS.—Section 505(j)(2)(A) of the
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`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 certifi-
`
`cation that—
`
`‘‘(I) neither the applicant nor any
`
`party in privity 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, re-
`
`spectively, of title 35, United States Code;
`
`and
`
`‘‘(II) in making the certification re-
`
`quired under clause (vii), the applicant is
`
`not relying in whole or in part on any deci-
`
`sion issued by the Patent Trial and Appeal
`
`Board in an inter partes review or post-
`
`grant review under chapter 31 or 32, re-
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`24
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`25
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`Dr. Reddy’s Laboratories, Inc. v. Celgene Corp.
`IPR2018-01504
`Exhibit 2030, Page 3
`
`
`
`EHF18270
`
`S.L.C.
`
`4
`spectively, of
`
`Code.’’; and
`
`title 35, United States
`
`(4) in the flush text following clause (ix), as
`
`added by paragraph (3), by striking ‘‘(viii)’’ and in-
`
`serting ‘‘(ix)’’.
`
`(d) BIOSIMILAR DRUGS; EVALUATION BY THE SEC-
`
`RETARY.—Section 351(k) of the Public Health Service Act
`
`(42 U.S.C. 262(k)) is amended—
`
`(1) in paragraph (2)(A)(iii)—
`
`(A) in subclause (I), by striking ‘‘and’’ at
`
`the end;
`
`(B) in subclause (II), by striking the pe-
`
`riod at the end and inserting ‘‘; and’’; and
`
`(C) by adding at the end the following:
`
`‘‘(III) with respect to any patent
`
`that is, or that could be, included on
`
`a list of patents under subsection
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`(l)(3)(A)(i), shall
`
`include a certifi-
`
`cation that neither the applicant nor
`
`any party in privity with the applicant
`
`has filed, or will file, a petition to in-
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`stitute inter partes review or post-
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`grant review of that patent under
`
`chapter 31 or 32, respectively, of title
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`35, United States Code.’’; and
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`24
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`25
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`Dr. Reddy’s Laboratories, Inc. v. Celgene Corp.
`IPR2018-01504
`Exhibit 2030, Page 4
`
`
`
`EHF18270
`
`S.L.C.
`
`5
`(2) in paragraph (3)—
`
`(A) in subparagraph (A)(ii), by striking
`
`‘‘and’’ at the end;
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`(B) in subparagraph (B), by striking the
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`period at the end and inserting ‘‘; and’’; and
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`(C) by adding at the end the following:
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`‘‘(C) the Secretary determines that the ap-
`
`plication fully complies with the requirements
`
`under paragraph (2)(A)(iii).’’.
`
`(e) PREVENTING THE MANIPULATIVE AND DECEP-
`
`TIVE USE OF INTER PARTES REVIEW.—Section 10(b) of
`
`the Securities Exchange Act of 1934 (15 U.S.C. 78j(b))
`
`is amended—
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`(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 de-
`
`vice 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
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`‘‘(B) the person, or an affiliate of the person,
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`during the 180-day period beginning on the date
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`that is 90 days before the date on which the person
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`23
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`24
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`25
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`Dr. Reddy’s Laboratories, Inc. v. Celgene Corp.
`IPR2018-01504
`Exhibit 2030, Page 5
`
`
`
`EHF18270
`
`S.L.C.
`
`6
`files the petition described in subparagraph (A), en-
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`gages in a short sale of any publicly traded security
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`of the owner of the patent that is the subject of the
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`petition.’’.
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`2
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`Dr. Reddy’s Laboratories, Inc. v. Celgene Corp.
`IPR2018-01504
`Exhibit 2030, Page 6
`
`
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