Filed on behalf of: Par Pharmaceutical, Inc.
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`Entered: February 28, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
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`PAR PHARMACEUTICAL, INC.
`Petitioner
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`v.
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`NOVARTIS AG
`Patent Owner
`_______________________
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`
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`Case IPR2016-01479
`U.S. Patent No. 9,006,224
`_______________________
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`Before LORA M. GREEN, CHRISTOPHER L. CRUMBLEY, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
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`PETITIONER’S OBJECTIONS TO PATENT OWNER’S EVIDENCE
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`Entered: February 28, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
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`PAR PHARMACEUTICAL, INC.
`Petitioner
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`v.
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`NOVARTIS AG
`Patent Owner
`_______________________
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`
`
`Case IPR2016-01479
`U.S. Patent No. 9,006,224
`_______________________
`
`Before LORA M. GREEN, CHRISTOPHER L. CRUMBLEY, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
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`
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`PETITIONER’S OBJECTIONS TO PATENT OWNER’S EVIDENCE
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`
`
`Case IPR2016-01479
`U.S. Patent No. 9,006,224
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`Under 37 C.F.R. § 42.64(b)(1), Petitioner Par Pharmaceutical, Inc.
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`(“Petitioner”) submits the following objections to evidence submitted by Patent
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`Owner Novartis AG (“Patent Owner”). Petitioner’s objections apply equally to
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`Patent Owner’s reliance on this evidence in any subsequently-filed documents or
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`further proceedings in this matter. These objections are timely, having been filed
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`and served within ten business days of the institution of the trial.
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`Notwithstanding these objections, Petitioner expressly reserves the right to
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`rely on any evidence submitted by Patent Owner, including on the ground that such
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`evidence constitutes a party admission.
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`Objections
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`Exhibit 2001 (Kulke Decl.)
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`Petitioner objects to this document as inadmissible hearsay under FRE 801
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`and 802 that does not fall under any exceptions, including those of FRE 803, 804,
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`805, or 807, and as improper expert testimony under FRE 702, 703, and 37 C.F.R.
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`§ 42.65, to the extent it impermissibly acts as a conduit for hearsay, including the
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`hearsay objected to herein, and does not rely on the kinds of facts or data that
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`experts in the relevant field would reasonably rely on in forming an opinion on the
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`subject without providing the underlying facts, data, and other required disclosures.
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`Petitioner objects to this document for lack of foundation and lack of
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`personal knowledge, as improper expert testimony under FRE 702, 703, and 37
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`1
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`Case IPR2016-01479
`U.S. Patent No. 9,006,224
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`C.F.R. § 42.65, and as improper lay testimony under FRE 701, to the extent it
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`offers testimony in areas outside of Dr. Kulke’s area of expertise or fails to
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`properly provide the underlying facts, data, and other required disclosures,
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`including but not limited to the portions at paragraphs 5 and 89-96 purporting to
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`address whether the FDA approval and the underlying clinical trial data from the
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`RADIANT-3 clinical trial would have been unexpected to a person of ordinary
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`skill as of November 2005.
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`Exhibits 2003 (Seeley) and 2021 (Remington’s)
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`Petitioner objects to these documents under FRE 106 (completeness), as the
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`documents are incomplete and only include select portions of larger documents
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`that in fairness ought to be considered in connection with these exhibits.
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`To the extent Patent Owner relies on these exhibits for the truth of the matter
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`asserted, Petitioner objects to them as inadmissible hearsay under FRE 801 and
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`802 that does not fall under any exceptions, including FRE 803, 804, 805, or 807.
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`Exhibit 2016 (Novartis Press Release)
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`Petitioner objects to this document as not properly authenticated under FRE
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`901 because Patent Owner has not presented any evidence that the document is
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`authentic nor that the document is self-authenticating under FRE 902.
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`Petitioner objects to this as inadmissible hearsay under FRE 801 and 802
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`that does not fall under any exceptions, including FRE 803, 804, 805, or 807.
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`2
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`Case IPR2016-01479
`U.S. Patent No. 9,006,224
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`Exhibits 2017 (Ritchel) and 2018 (WHO)
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`Petitioner objects to these documents as inadmissible hearsay under FRE
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`801 and 802 that does not fall under any exceptions, including those of FRE 803,
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`804, 805, or 807.
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`Petitioner objects to these documents under FRE 106 (completeness), as the
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`documents are incomplete and only includes select portions of larger documents
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`that in fairness ought to be considered in connection with these exhibits.
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`Exhibits 2024 (Ratain Trial Tr. I), 2025 (Ratain Trial Tr. II), and 2026
`(Ratain Dep. Tr.)
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`Petitioner objects to these documents as inadmissible hearsay under FRE
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`801 and 802 that does not fall under any exceptions, including FRE 803, 804, 805,
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`or 807.
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`Petitioner objects to these documents under FRE 106 (completeness), as the
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`documents are incomplete and only include select portions of larger documents
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`that in fairness ought to be considered in connection with these exhibits.
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`Exhibits 2010 (Pazdur), 2011 (Kouvaraki), 2015 (Margolin), 2019 (Gemzar®
`Prescribing Information 2005), 2022 (Yao), 2027 (Dancey 2005), and 2028
`(Duran 2006)
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`Petitioner objects to these documents under FRE 401 and 402, as the
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`documents do not have a tendency to make the facts for which they are offered any
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`more or less probable than those facts would otherwise be.
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`Petitioner objects to these documents under FRE 403, as any probative value
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`3
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`Case IPR2016-01479
`U.S. Patent No. 9,006,224
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`is substantially outweighed by a danger of unfair prejudice, confusing the issues,
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`wasting time, and needlessly presenting cumulative evidence.
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`To the extent Patent Owner relies on the contents of these exhibits for the
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`truth asserted, Petitioner objects to these documents as inadmissible hearsay under
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`FRE 801 and 802 that does not fall under any exceptions, including FRE 803, 804,
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`805, or 807.
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`Exhibits 2005 (Laughlin Cancer Glossary), 2008 (Motzer), 2012 (Delaunoit),
`2013 (Kulke 2003), 2014 (Kulke 2004), 2020 (Kulke 1999), and 2023 (Kola &
`Landis)
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`To the extent Patent Owner relies on the contents of these exhibits for the
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`truth asserted, Petitioner objects to them as hearsay not falling under any
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`exception. These exhibits contain out of court statements by non-parties, but
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`Patent Owner does not provide any basis for the PTAB to conclude that they fall
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`within any hearsay objection.
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`Dated: February 28, 2017
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`Respectfully submitted,
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`By: /Daniel G. Brown/
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`Daniel G. Brown (Reg. No. 54,005)
`Latham & Watkins LLP
`885 Third Avenue
`New York, NY 10022-4834
`212.906.1200; 212.751.4864 (Fax)
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`Counsel for Petitioner
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`4
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`Case IPR2016-01479
`U.S. Patent No. 9,006,224
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), I certify that on this 28th day of
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`February, 2017, a copy of Petitioner’s Objections to Patent Owner’s Evidence
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`was served by electronic mail on Patent Owner’s lead and backup counsel at the
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`following email addresses:
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`Nicholas N. Kallas (Reg. No. 31,530)
`Raymond R. Mandra (Reg. No. 34,382)
`Fitzpatrick, Cella, Harper & Scinto
`1290 Avenue of the Americas
`New York, NY 10104-3800
`ZortressAfinitorIPR@fchs.com
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`By: /Daniel G. Brown/
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`Daniel G. Brown (Reg. No. 54,005)
`Latham & Watkins LLP
`885 Third Avenue
`New York, NY 10022-4834
`212.906.1200; 212.751.4864 (Fax)
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`Counsel for Petitioner
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