EIIF18628
`
`S.L.C.
`
`115TI1 (X)NGRESS
`2d Si<]SSION
`
`s.
`
`To aiTiend th(5 Federal F^jod, Dnig, and Cosmetic Act and the Se(;rn'ities
`Excliaiig'e Act of 1934 to prevent the inter ])artes review process for
`cliallenging' ])atents fi'orn diminishing competition in the ])har'macentical
`industry and with res])e(!t to drug innovation, and foi‘ other puiposes.
`
`IN THE SENATE OP THE UNITED STATES
`
`Air. Hatch (for himself and Air. Tibias) introduced the following bill; which
`was road twice and referred to the Committee on
`
`A BILL
`To amend the Federal Pood, Drug, and Cosmetic Act and
`the Securities Exchange Act of 1934 to prevent the
`inter partes review process for cliallenging patents ti'om
`diminishing competition in the pharmaceutical industty
`and with respect to drug innovation, and for other pur
`poses.
`
`1
`2
`
`Be it enacted hy the Senate and House of Representa-
`tives of the United States of America in Congress assembled,
`
`3 SECTION 1. SHORT TITLE.
`4
`This Act may be cited as the “Hatch-Waxman Integ-
`5 rityActof 2018”.
`
`IPR2018-01714
`Celgene Ex. 2003, Page 1
`
`
`
`S.L.C.
`
`115TI1 (X)NGRESS
`2d Si<]SSION
`
`s.
`
`To aiTiend th(5 Federal F^jod, Dnig, and Cosmetic Act and the Se(;rn'ities
`Excliaiig'e Act of 1934 to prevent the inter ])artes review process for
`cliallenging' ])atents fi'orn diminishing competition in the ])har'macentical
`industry and with res])e(!t to drug innovation, and foi‘ other puiposes.
`
`IN THE SENATE OP THE UNITED STATES
`
`Air. Hatch (for himself and Air. Tibias) introduced the following bill; which
`was road twice and referred to the Committee on
`
`A BILL
`To amend the Federal Pood, Drug, and Cosmetic Act and
`the Securities Exchange Act of 1934 to prevent the
`inter partes review process for cliallenging patents ti'om
`diminishing competition in the pharmaceutical industty
`and with respect to drug innovation, and for other pur
`poses.
`
`1
`2
`
`Be it enacted hy the Senate and House of Representa-
`tives of the United States of America in Congress assembled,
`
`3 SECTION 1. SHORT TITLE.
`4
`This Act may be cited as the “Hatch-Waxman Integ-
`5 rityActof 2018”.
`
`IPR2018-01714
`Celgene Ex. 2003, Page 1
`
`
`
`EriP18(i28
`
`S.L.O.
`
`2
`1 SEC. 2. PREVENTING THE INTER PARTES REVIEW PROCESS
`
`2
`
`3
`
`FOR CHALLENGING PATENTS FROM DIMIN-
`
`ISHING COMPETITION IN THE PHARMA-
`
`CEUTICAL INDUSTRY AND WITH RESPECT TO
`
`4
`5
`DRUG INNOVATION.
`6
`(a) Brand Name Drugs.—Section 505(b)(2) of the
`7 Federal Food, Drug, and Cosmetic Act (21 U.S.(
`8 355(b)(2)) is amended—
`9
`(1) in subparagraph (A)(iv), by striking “and
`n
`10
`at the end;
`11
`(2) in subpa,ragTaph, (B), by striking the period
`12
`at the end and inserting
`u ; and”; and
`13
`(3) by adding at tlie end the following:
`14
`(C) in each eei'tification requiivd under sub-
`15
`paragraph (A) with respect to a, patent, a certifi
`16
`cation that—
`17
`u (i) neither' the applicant nor' any party in
`18
`pr'hity with, related to, or cooperating vith the
`19
`applicant ha,s filed
`or- will file, a petition to in
`stitute inter partes I'ewew or' post-grant review
`20
`21
`of that pa,tent under chapter 31 or 32, I'espec-
`tivel}^, of title 35, United States Code; and
`22
`“(ii) in making the certification I'equii'ed
`under subparagraph (A), the applicant is not
`relying in whole
`on a,ny decision
`issued b^'' the Patent Trial and Appea,l Board in
`
`J.
`
`23
`
`24
`25
`26
`
`IPR2018-01714
`Celgene Ex. 2003, Page 2
`
`
`
`EIIF18()28
`
`S.L.d
`
`3
`an inter pai'tes I'eview or post-gT'a,nt review
`under chapter 31 or 32, respectwely, of title 35,
`United States Code.”.
`(b) Generic Drugs.—Section 505(,i)(2)(A) of the
`5 Federal Food, Drug, and Cosmetic Act (21 U.S.C.
`6 355 Ci) (2) (A)) is amended-^
`(1) in clause (vii)(IV), by striking “and” at the
`
`1 2 3 4
`
`end;
`
`(2) in clause (viii), by striking the period at the
`end and inseiding and”;
`(3) b.y inserting after clause (viii), as amended
`b.y paragraph (2), the following:
`(ix) in each certification required under
`clause (wi) with respect to a patent, a ceitifi-
`cation that—
`i i (I) neither the applicant nor any
`parly in privity with, r'dated to, or- cooper-
`ating with the applicant has filed. or will
`file, a petition to institute inter' par'tes r'e-
`view or post-gr'ant review of that patent
`under' chapter 31 or 32, r'espeetively, of
`title 35, United States Code; and
`(. i
`(II) in making the cer'tifrcatiori re
`quired under clause (Ui), the a,]:)plicant is
`not relGng in whole or in part on ari}^ deci-
`
`7 8
`
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`IPR2018-01714
`Celgene Ex. 2003, Page 3
`
`
`
`EIIP18628
`
`S.L.C.
`
`1
`
`2 3 4
`
`4
`sion issued the Patent Ti-ial and AppeaJ.
`Board in an inter partes re’Ndew or post-
`grant review under chapter 31 or 32, re-
`35, United States
`spectively,
`Code.”; and
`(4) in the flush text following clause (ix), as
`added bj'' paragraph (3), b.y striking
`ii (viii)” and in-
`serting “(ix)”.
`(c) Biosimilar Drugs; EvaijUation by the Sec-
`■Section 351 (k) of the Public Health Sendee Act
`10 RETARY.
`11 (42 U.S.C. 262(k)) is ainended
`12
`(I) in paragraph (2) (A) (hi)—
`(A) by redesignating subelauses (I) and
`13
`(II) as items (aa) and (bb), respective^, and
`14
`15
`adjusting the m,argins accordingi^s
`(B) in the matter preceding item (aa), as
`16
`7 y
`so I'edesignated, by striking “An application
`17
`and insei'ting the following:
`18
`(I) In general.—^An. applica-
`19
`a
`20
`21
`22
`23
`
`tion”;
`(C) in subclause (I)
`(i) in item (aa), as so redesignated, b}^
`striking “and yy
`at the end;
`
`5
`
`6 7
`
`8 9
`
`IPR2018-01714
`Celgene Ex. 2003, Page 4
`
`
`
`EHF18628
`
`S.1..C.
`
`p;0
`(ii) in item (bb), as so redesignated,
`by striking the period at the end and in-
`i i ; and”; and
`(iii) by adding at the end the fol-
`mg:
`
`i i
`
`(cc) shall, with respect to a,
`patent desci'ibed in subclanse
`(II), include a
`certification that:
`neithei' the applicant nor any
`party in privity with., related to,
`or coopei'ating with the a-pplicant
`has filed, or will file, a petition to
`institute inter' partes review oi'
`post-grant review of the patent
`under chapter 31 or 32,
`lively, of title 35, United States
`Code.”; and
`(U) b_y ailding at the end the following:
`(II) Patent described.—
`patent is described in this subclause
`if-
`
`(i
`
`i c
`
`(aa) the patent comrs the
`reference pi'oduct or a method
`for using the refei'ence product;
`
`cU.1.1
`
`1
`
`2 3
`
`4
`5
`6
`
`7 8
`
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`IPR2018-01714
`Celgene Ex. 2003, Page 5
`
`
`
`E11F18628
`
`S.li.G.
`
`6
`
`I'eference
`u (bb)(AA)
`pi'ochict desci'ibecl in item (aa) is
`marked under section ‘287(a) of
`United States Code; oi‘
`(BB) there
`is othenvise
`public notice regai'ding the appli-
`eabilit.y of the I'eference pi-oduct
`described in item (aa).”; and
`(2) in paragraph (3)—
`(A) in subpai-agraph (A)(ii), by stiikin
`... A ’ ’
`at
`he end;
`(B) in subparagraph (B), by sti-ilcing the
`period at: the end a,nd inseiding “; and”; and
`(C) by adding at the end the following;
`(Cl) the Secretary determines that the ap
`plication fully complies with the requirements
`under paragraph (2)(A)(iii).”.
`
`.O'
`
`1
`2
`
`3 4 5
`
`6
`
`7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`
`18 SEC. 3. PREVENTING THE MANIPULATIVE AND DECEPTIVE
`19
`USE OF INTER PARTES REVIEW.
`Section 10(b) of the Securities Exchange Act of 1934
`20
`21 (15 U.S.C. 78j(b)) is amended—
`(1) by inserting “(1)” after “(b)”; and
`22
`(2) b}'' adding at the end the following:
`
`23
`
`IPR2018-01714
`Celgene Ex. 2003, Page 6
`
`
`
`EIJP]8()28
`
`S.L.d
`
`7
`1
`“(2) For purposes of paragraph (1), a person shall
`2 be considered to be using a manipuhitive or deceptive de-
`3 vice if'—
`4
`
`U
`
`(A) the pei'son, oi- an affiliate of the person,
`files a, petition to institute a,n inter pa;it,es reAoew
`under clniptei' 31 of title 35, United States Code,
`with respect to a patent; and
`(B) the person, or an. affiliate of the pei'son,
`a
`during the 180-(h\y period beginning on the date
`that is 90 days before the date on which the person
`files the petition described in subparagi'aph (A), en
`gages in a short sale of any publicly traded security
`of the owner' of the patent that is the subject of the
`petition.”.
`
`5 6 7 8
`
`9
`10
`11
`12
`13
`14
`
`IPR2018-01714
`Celgene Ex. 2003, Page 7
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
