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`Filed on behalf of: Par Pharmaceutical, Inc.
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`Served: August 29, 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
`v.
`NOVARTIS AG
`Patent Owner
`_______________________
`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 ENTERED AT DR. RATAIN’S
`DEPOSITION
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`Case IPR2016-01479
`U.S. Patent No. 9,006,224
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`Pursuant to the parties’ agreement at the deposition of Dr. Mark Ratain on
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`August 28, 2017 and under 37 C.F.R. § 42.64(a), Petitioner Par Pharmaceutical,
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`Inc. (“Petitioner”) submits the following objections to evidence entered by Patent
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`Owner Novartis AG (“Patent Owner”) on August 28, 2017. Petitioner’s objections
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`apply 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 served the day following the deposition, as the parties agreed on the
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`record.
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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 2107
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`Petitioner objects to this document under FRE 401, 402, and 703, as the
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`document does 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. This exhibit relates to
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`treatments for diabetes. As such, Ex. 2107 is not relevant to any issue in this IPR
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`proceeding and is not the type of document upon which a person of ordinary skill
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`in the art at the time of the invention would rely. Further, Ex. 2107 published after
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`the November 21, 2005 priority date of the ’224 patent and is not a document upon
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`Case IPR2016-01479
`U.S. Patent No. 9,006,224
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`which a person of ordinary skill in the art at the time would have relied.
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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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`Petitioner further objects to this document under 37 C.F.R. § 42.53(d)(5)(ii)
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`for failing to be limited to the scope of the direct testimony.
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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 2108
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`Petitioner objects to this document under FRE 401, 402, and 703, as the
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`document does 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. This exhibit relates to
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`treatments for diabetes. As such, Ex. 2108 is not relevant to any issue in this IPR
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`proceeding and is not the type of document upon which a person of ordinary skill
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`in the art at the time of the invention would rely. Further, Ex. 2108 published after
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`the November 21, 2005 priority date of the ’224 patent and is not a document upon
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`which a person of ordinary skill in the art at the time would have relied.
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`Petitioner objects to this document under FRE 403, as any probative value is
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`Case IPR2016-01479
`U.S. Patent No. 9,006,224
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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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`Petitioner further objects to this document under 37 C.F.R. § 42.53(d)(5)(ii)
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`for failing to be limited to the scope of the direct testimony.
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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 2109
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`Petitioner objects to this document under FRE 401, 402, and 703, as the
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`document does 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. This exhibit relates to
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`clinical tumors in patients and not to preclinical tumor models. As such, Ex. 2109
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`is not relevant to preclinical tumor models and is not the type of document upon
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`which a person of ordinary skill in the art at the time of the invention would rely.
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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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`Petitioner further objects to this document under 37 C.F.R. § 42.53(d)(5)(ii)
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`for failing to be limited to the scope of the direct testimony.
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`Case IPR2016-01479
`U.S. Patent No. 9,006,224
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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 2110
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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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`Petitioner further objects to this document under 37 C.F.R. § 42.53(d)(5)(ii)
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`for failing to be limited to the scope of the direct testimony.
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`Further, Patent Owner has presented no evidence that Ex. 2110 was publicly
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`available prior to November 21, 2005, and this is not the type of document on
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`which a person of ordinary skill in the art would have relied on the time.
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`Dated: August 29, 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)
`daniel.brown@lw.com
`Latham & Watkins LLP
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`Case IPR2016-01479
`U.S. Patent No. 9,006,224
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`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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`5
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`Case IPR2016-01479
`U.S. Patent No. 9,006,224
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`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. § 42.6(e), I certify that on this 2 9th day of August,
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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)
`
`Counsel for Petitioner Par
`Pharmaceutical, Inc.
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