`Filed: August 11, 2015
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`AMNEAL PHARMACEUTICALS LLC and PAR PHARMACEUTICAL, INC.
`
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`
`Patent Owner
`
`________________
`
`Case IPR2015-00545
`
`Patent 8,589,182
`________________
`
`JAZZ PHARMACEUTICALS, INC.’S OBJECTIONS TO
`EVIDENCE SUBMITTED DURING THE PRELIMINARY
`PROCEEDING PURSUANT TO 37 C.F.R. § 42.64(b)(1)
`
`
`
`
`
`
`
`
`
`
`
`Case IPR2015-00545
`Patent 8,589,182
`Patent Owner’s Objections
`
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Patent Owner Jazz Pharmaceuticals,
`
`Inc. objects as follows to the admissibility of evidence submitted during the
`
`preliminary proceeding:
`
`Evidence
`AMN1007 at
`¶¶ 21, 47, 50,
`160, and any
`other paragraph
`addressing the
`public
`accessibility/
`availability of
`AMN1003-1006
`
`Objections
`FRE 602: No evidence supports a finding that Dr. Valuck has
`
`personal knowledge of the public accessibility/availability of the
`
`Advisory Committee Art (AMN1003-1006).
`
`FRE 702: Dr. Valuck’s assertions regarding the alleged public
`
`accessibility/availability of AMN1003-1006 are improper expert
`
`testimony at least because: (1) Dr. Valuck is not qualified as an
`
`expert on the subject of public accessibility/availability; (2) Dr.
`
`Valuck’s specialized knowledge is not helpful to the trier of fact
`
`to understand or determine the public accessibility/availability
`
`of AMN1003-1006; and (3) Dr. Valuck’s testimony regarding
`
`the alleged public accessibility/availability of AMN1003-1006
`
`is not based on sufficient facts or data and is not the product of
`
`reliable principles and methods reliably applied by Dr. Valuck.
`
`AMN1028
`
`FRE 802: The exhibit is inadmissible hearsay if it is offered to
`
`prove the truth of the matter asserted therein, including, but not
`
`
`
`Case IPR2015-00545
`Patent 8,589,182
`Patent Owner’s Objections
`
`
`Evidence
`
`Objections
`limited to, any alleged public accessibility/availability of
`
`AMN1003-1006.
`
`FRE 901: Petitioners have not produced evidence sufficient to
`
`support a finding that the exhibit is what Petitioners claim it is.
`
`Date: August 11, 2015
`
`
`
`Respectfully submitted,
`
`By: /F. Dominic Cerrito (Reg. No. 38,100)/
` F. Dominic Cerrito (Reg. No. 38,100)
` 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
`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.
`
`
`
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`AMNEAL PHARMACEUTICALS LLC and PAR PHARMACEUTICAL, INC.
`
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`
`Patent Owner
`
`________________
`
`Case IPR2015-00545
`
`Patent 8,589,182
`________________
`
`CERTIFICATE OF SERVICE
`
`
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), the undersigned hereby certify that JAZZ
`
`PHARMACEUTICALS, INC.’S OBJECTIONS TO EVIDENCE SUBMITTED
`
`DURING THE PRELIMINARY PROCEEDING was served on August 11, 2015
`
`by filing this document through the Patent Review Processing System, as well as e-
`
`mailing a copy to mruedy@meiplaw.com and smaddox@meiplaw.com.
`
`Date: August 11, 2015
`
`
`
` Respectfully submitted,
`
`By: /F. Dominic Cerrito (Reg. No. 38,100)/
` F. Dominic Cerrito (Reg. No. 38,100)
` 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
`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.