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`Filed on behalf of: Par Pharmaceutical, Inc.
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`Entered: May 18, 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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`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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`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 filed by Patent Owner
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`Novartis AG (“Patent Owner”) on May 11, 2017. Petitioner’s objections apply
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`equally to Patent Owner’s reliance on this evidence in any subsequently-filed
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`documents or further proceedings in this matter. These objections are timely,
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`having been filed and served within five business days of Patent Owner’s
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`Response (Paper 17) and accompanying exhibits in this proceeding.
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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 2041 (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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`U.S. Patent No. 9,006,224
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`personal knowledge, as improper expert testimony under FRE 702, 703, and 37
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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 229-239. The declarant is
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`not stated to have expertise with respect to organic or medicinal chemistry or
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`pharmacology.
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`Exhibit 2054 (FDA Guidance)
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`Petitioner objects to this document under FRE 401 and 402, as the document
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`does not have a tendency to make the facts for which it is offered any more or less
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`probable than those facts would otherwise be.
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`Petitioner objects to this document under FRE 403, as any probative value is
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`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 this exhibit for the truth
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`asserted, Petitioner objects to this document 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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`Exhibit 2097 (Wyeth Press Release)
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`Petitioner objects to this document under FRE 401 and 402, as the document
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`Case IPR2016-01479
`U.S. Patent No. 9,006,224
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`does not have a tendency to make the facts for which it is offered any more or less
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`probable than those facts would otherwise be.
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`Petitioner objects to this document under FRE 403, as any probative value is
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`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 this exhibit for the truth
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`asserted, Petitioner objects to this document 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 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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`Exhibits 2044 (Afinitor® Supp. Approval Letter), 2056 (Hidalgo 2006), 2068
`(2013 PDR), 2073 (2016 PDR), 2081 (Sandostatin (octreotide) Approval
`History), 2089 (Sutent® FDA Suppl. Approval Letter), 2098 (Zanosar®
`(streptozocin) Approval History), 2101 (Eisen), 2102 (Pacey), 2103 (Ratain
`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 it is 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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`is substantially outweighed by a danger of unfair prejudice, confusing the issues,
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`U.S. Patent No. 9,006,224
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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 do not fall under any exceptions, including FRE 803, 804,
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`805, or 807.
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`Exhibits 2105 (Ratain Dep. Tr. I) and 2106 (Ratain Dep. Tr. II)
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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. Petitioner further objects to these documents as incomplete under FRE 106
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`as they only include select portions of larger documents that in fairness ought to be
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`considered in connection with these exhibits.
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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)
`daniel.brown@lw.com
`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 Par
`Pharmaceutical, Inc.
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`Dated: May 18, 2017
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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 18th day of May,
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`2017, a copy of Petitioner’s Objections to Patent Owner’s Evidence was served
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`by electronic mail on Patent Owner’s lead and backup counsel at the following
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`email addresses:
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`Nicholas N. Kallas (Reg. No. 31,530)
`Raymond R. Mandra (Reg. No. 34,382)
`Charlotte Jacobsen (pro hac vice)
`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)
`daniel.brown@lw.com
`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 Par
`Pharmaceutical, Inc.
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