`Filed: March 10, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`PAR PHARMACEUTICAL, INC., WOCKHARDT BIO AG, and
`AMNEAL PHARMACEUTICALS LLC,
`
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`
`Patent Owner
`
`________________
`
`Case IPR2015-005541
`Patent 7,668,730
`________________
`
`
`
`PATENT OWNER’S NOTICE REGARDING
`NEW ARGUMENTS AND EVIDENCE IN PETITIONERS’ REPLY
`
`
`
`
`
`
`1 Case IPR2015-01818 has been joined with this proceeding.
`
`
`
`
`
`IPR2015-00554
`Patent 7,668,730
`
`Pursuant to the Board’s March 3, 2016 e-mail, Patent Owner Jazz
`
`Pharmaceuticals, Inc. (“Jazz”) identifies the following arguments and evidence
`
`raised for the first time in Petitioners’ Reply filed on February 19, 2016 (Paper 46)
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`to which Jazz had no opportunity to respond or address:
`
`1. With the exception of two sentences, Pages 2-4, under the section
`
`entitled “FDA was required to make Exs. 1004-1006 available to the public prior
`
`to or at the ACM, and there is no evidence that FDA violated the law,” contain
`
`new arguments and evidence alleging that Exs. 1004-1006 were publicly available.
`
`Petitioners rely on Ex. 1057 (along with new arguments about how this new
`
`exhibit relates to previously submitted evidence), which was available to
`
`Petitioners but not cited or mentioned in the Petition or supporting declarations.
`
`The two unchallenged sentences in this section are: on page 2, “Jazz argues there
`
`is insufficient evidence to conclude that Exs. 1004-1006 would have been available
`
`from FDA’s website prior to the critical date. Response at 12-13.”; and on page 3,
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`“The FACA requires that ‘documents which were made available to or prepared
`
`for or by each advisory committee shall be made available for public inspection.’
`
`5 U.S.C. app. 2 § 10(b) (2001) (emphasis added).”
`
`2.
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`Page 4, under the section entitled “Ex. 1003 further corroborates the
`
`availability of Exs. 1004-1006 at the ACM,” contains new arguments alleging that
`
`Exs. 1004-1006 were publicly available. Petitioners rely on Ex. 1003 at 12, 179,
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`
`
`
`
`
`
`
`
`IPR2015-00554
`Patent 7,668,730
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`
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`284, 330, and 342, which were available to Petitioners but not cited or mentioned
`
`
`
`in the Petition or supporting declarations, for statements allegedly related to the
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`availability of Exs. 1004-1006.
`
`3.
`
`Page 5, lines 5-11, beginning with the word “Following,” and ending
`
`with “See id.,” contains new arguments regarding alleged updates of links only in
`
`Ex. 1017, which lead to links in Ex. 1018, which lead to further links in Ex. 1019.
`
`The new arguments regarding the alleged updates to Ex. 1017 could have been, but
`
`were not, mentioned in the Petition or supporting declarations.
`
`
`
`
`
`
`
`
`
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`- 2 -
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`
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`
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`Date: March 10, 2016
`
`
`
`
`
`
`
`
`
`
`IPR2015-00554
`Patent 7,668,730
`
`Respectfully submitted,
`
`By: /F. Dominic Cerrito (Reg. No. 38,100)/
` F. Dominic Cerrito (Reg. No. 38,100)
` Eric C. Stops (Reg. No. 51,163)
` Evangeline Shih (Reg. No. 50,170)
` Frank C. Calvosa (Reg. No. 69,064)
`QUINN EMANUEL URQUHART &
`SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`General Tel: (212) 849-7000
`Fax: (212) 849-7100
`nickcerrito@quinnemanuel.com
`ericstops@quinnmemanuel.com
`evangelineshih@quinnemanuel.com
`frankcalvosa@quinnemanuel.com
`
`John V. Biernacki
`Reg. No. 40,511
`JONES DAY
`North Point
`901 Lakeside Avenue
`Cleveland, Ohio 44114
`General Tel: (216) 586-3939
`Direct Tel: (216) 586-7747
`Fax: (216) 579-0212
`jvbiernacki@jonesday.com
`
`Attorneys for Jazz Pharmaceuticals, Inc.
`
`
`
`- 3 -
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`AMNEAL PHARMACEUTICALS LLC, PAR PHARMACEUTICAL, INC. and
`WOCKHARDT BIO AG,
`
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`
`Patent Owner
`
`________________
`
`Case IPR2015-005542
`Patent 7,668,730
`________________
`
`
`
`CERTIFICATE OF SERVICE
`
`
`
`
`
`
`2 Case IPR2015-01818 has been joined with this proceeding.
`
`
`
`
`
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`
`
`
`
`
`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), the undersigned hereby certifies that
`
`PATENT OWNER’S NOTICE REGARDING NEW ARGUMENTS AND
`
`EVIDENCE IN PETITIONERS’ REPLY was served on March 10, 2016 by filing
`
`this document through the Patent Review Processing System, as well as e-mailing
`
`a copy to bradford.frese@arentfox.com, richard.berman@arentfox.com,
`
`janine.carlan@arentfox.com, and PCGallagher@duanemorris.com.
`
`Date: March 10, 2016
`
`
`
`
`
`
`
`
` Respectfully submitted,
`
`By: /F. Dominic Cerrito (Reg. No. 38,100)/
` F. Dominic Cerrito (Reg. No. 38,100)
` QUINN EMANUEL URQUHART &
` SULLIVAN, LLP
` 51 Madison Avenue, 22nd Floor
` New York, NY 10010
` General Tel: (212) 849-7000
`Fax: (212) 849-7100
`nickcerrito@quinnemanuel.com
`
`Lead Counsel for
`Jazz Pharmaceuticals, Inc.
`
`
`
`- 2 -
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