Paper No. ____
`Date Filed: June 28, 2018
`
`Filed On Behalf Of:
`Novartis Pharmaceuticals Corporation
`
`By:
`Nicholas N. Kallas
`NKallas@fchs.com
`ZortressAfinitorIPR@fchs.com
`(212) 218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`BRECKENRIDGE PHARMACEUTICAL, INC.,
`
`Petitioner,
`
`v.
`
`NOVARTIS PHARMACEUTICALS CORPORATION,
`
`Patent Owner.
`
`Case IPR2017-01592
`Patent No. 8,410,131
`
`PATENT OWNER’S OBJECTIONS UNDER 37 C.F.R. § 42.64 TO
`EVIDENCE SUBMITTED BY PETITIONER WITH ITS REPLY
`
`
`Date Filed: June 28, 2018
`
`Filed On Behalf Of:
`Novartis Pharmaceuticals Corporation
`
`By:
`Nicholas N. Kallas
`NKallas@fchs.com
`ZortressAfinitorIPR@fchs.com
`(212) 218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`BRECKENRIDGE PHARMACEUTICAL, INC.,
`
`Petitioner,
`
`v.
`
`NOVARTIS PHARMACEUTICALS CORPORATION,
`
`Patent Owner.
`
`Case IPR2017-01592
`Patent No. 8,410,131
`
`PATENT OWNER’S OBJECTIONS UNDER 37 C.F.R. § 42.64 TO
`EVIDENCE SUBMITTED BY PETITIONER WITH ITS REPLY
`
`
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Patent Owner Novartis Pharmaceuticals
`
`Corporation (“Novartis”) objects to Exhibit 1159 (Second Declaration of Allan J.
`
`Pantuck, M.D. in support of Inter Partes Review of U.S. Patent 8,410,131), filed
`
`with Petitioner’s Breckenridge Pharmaceutical, Inc. (Petitioner) Reply on June 21,
`
`2018, on the grounds set forth below.
`
`In this paper, a reference to “F.R.E.” means the Federal Rules of Evidence, a
`
`reference to “C.F.R.” means the Code of Federal Regulations, and “the ’131
`
`Patent” means U.S. Patent No. 8,410,131. All objections under F.R.E. 802
`
`(hearsay) and 37 C.F.R § 42.61(c) (hearsay) apply to the extent Petitioner relies on
`
`the exhibit identified in connection with that objection for the truth of the matters
`
`asserted therein. Novartis’s objections to Petitioner’s Exhibit 1159 are without
`
`prejudice to Novartis’s reliance on or discussion of that exhibit in Novartis’s
`
`papers in this proceeding.
`
`Novartis’s objections are as follows:
`
`Novartis objects to Exhibit 1159 under F.R.E. 802 (hearsay), F.R.E. 402
`
`(relevance), F.R.E. 403 (confusing, waste of time), F.R.E. 702 (improper expert
`
`testimony), F.R.E. 703 (bases for expert opinion), and 37 C.F.R. § 42.65, as Dr.
`
`Pantuck’s scientific, technical, or other specialized knowledge will not help the
`
`trier of fact to understand the evidence or to determine a fact in issue, the
`
`testimony is not based on sufficient facts or data, is not the product of reliable
`
`1
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`
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`principles and methods, and the principles and methods have not been reliably
`
`applied to the facts of this case.
`
`Novartis objects to Exhibit 1159 under F.R.E. 802 (hearsay), F.R.E. 402
`
`(relevance), F.R.E. 403 (confusing, waste of time), F.R.E. 702 (improper expert
`
`testimony), F.R.E. 703 (bases for expert opinion), and 37 C.F.R. § 42.65, as Dr.
`
`Pantuck’s testimony is not based on an analysis of the prior art as a whole. Exhibit
`
`1159 ¶¶ 72-75, 185, 214, 240, 261, and 302 rely on a review of SciFinder® search
`
`results and references identified from that search that do not reflect the prior art as
`
`a whole.
`
`Novartis objects to Exhibit 1159 under 35 U.S.C. § 312(a)(3), 37 C.F.R. §§
`
`42.65 and 42.104(b)(5), F.R.E. 702 (improper expert testimony), F.R.E. 402
`
`(relevance), and F.R.E. 403 (confusing, waste of time) for failing to identify with
`
`particularity the underlying facts and data on which the opinion is based. Exhibit
`
`1159 ¶¶ 72-73, 75, 83, 101-103, 131-146, 226-249, 259-262, 273-276, 278, 282-
`
`287, 299, 326-382 fail to cite any support at all, include statements that do not cite
`
`any support, or include statements that are not supported by the cite(s) provided;
`
`and Exhibit 1159 ¶¶ 4, 70, 73, 81, 82, 85, 86, 87, 88, 100, 117, 215, 240, 261, 277,
`
`302 cite to entire articles, book chapters or other references without identifying
`
`which aspects of those references are relied upon.
`
`2
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`
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`Novartis objects to Exhibit 1159 under F.R.E. 402 (relevance), F.R.E. 403
`
`(confusing, waste of time), 35 U.S.C. § 312(a)(3), and 37 C.F.R. §§ 42.22(a)(2),
`
`42.24(a), 42.104(b), and 42.105. Exhibit 1159 ¶¶ 1-71, 74, 76-82, 84-100, 104-
`
`130, 147-225, 250-258, 263-272, 277, 279-281, 288, 300-325, and 283 are not
`
`cited in Petitioner’s Reply; and Exhibit 1159 ¶¶ 134-146, 226-249, 326-333, 334-
`
`340, 341-376, 377-382 are not specifically identified or discussed in detail in
`
`whole or in part in Petitioner’s Reply. Any attempt by Petitioner to rely on these
`
`paragraphs to establish unpatentability is improper and untimely and will constitute
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`an improper incorporation by reference under 37 C.F.R. § 42.6(a)(3) or attempt to
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`circumvent the word count limits for petitions under 37 C.F.R. § 42.24(a).
`
`Novartis also objects to Exhibit 1159 ¶¶ 131-133, 136-138, 140-145, 146,
`
`226-249, 261-262, 273-275, 276 to the extent that these paragraphs recite
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`arguments that have not been made in any detail in Petitioner’s Reply. Any
`
`attempt by Petitioner to rely on the arguments in these paragraphs to establish
`
`unpatentability is improper and untimely and will constitute an improper
`
`incorporation by reference under 37 C.F.R. § 42.6(a)(3) or attempt to circumvent
`
`the word count limits for petitions under 37 C.F.R. § 42.24(a). In particular,
`
`Exhibit 1159 contains arguments that are not made in any detail in Petitioner’s
`
`Reply: ¶¶ 131-133 (citing references in support of opinion that the
`
`immunosuppressive activity of temsirolimus was comparable with rapamycin); ¶¶
`
`3
`
`
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`136-138 (discussion of the experimental protocol in Weckbecker); ¶¶ 140-145
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`(arguments and citing references in support of opinion that Novartis’s statements
`
`support Dr. Pantuck’s opinions); ¶ 146 (arguments that the ’131 Patent supports
`
`Pantuck’s opinions); ¶¶ 226-249 (arguments and citing references, including
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`reliance on Schuler (Exhibit 1008), Sedrani (Exhibit 1020) and Cottens WO ‘010
`
`(Exhibit 1026), regarding a class of rapamycin derivatives; details of the Wasik
`
`experiments; arguments and citing references in support of opinion regarding the
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`distinction between the properties of everolimus, cyclosporin, and tacrolimus;
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`argument against using Majewski to support Dr. Burris’s opinion; and reliance on
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`other various parts of Wasik (Exhibit 1002)); ¶¶ 261-262 (arguments regarding
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`Beirer (Exhibit 1133) and arguments that POSA need not understand the
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`mechanism of action of mTOR inhibitors given development of mTOR inhibitors);
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`¶ 273 (arguments and citing references in support of opinion that a POSA would
`
`have understood the immunosuppressive activity of temsirolimus to be comparable
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`to the immunosuppressive activity of rapamycin); ¶¶ 274-275 (arguments and
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`citing references in support of opinion that the immunosuppressive effect of
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`temsirolimus disappears based on the dosing schedule); and ¶ 276 (argument
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`regarding the distinction between the properties of everolimus, cyclosporin, and
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`tacrolimus).
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`4
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`
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`Novartis objects to Exhibit 1159 under F.R.E. 702 (improper expert
`
`testimony), F.R.E. 703 (bases for expert opinion), F.R.E. 402 (relevance) and
`
`F.R.E. 403 (confusing, waste of time). Exhibit 1159 ¶¶ 4, 18-162, and 164-383
`
`include expert opinion based on (i) documents that are inadmissible under at least
`
`37 C.F.R. §§ 42.22(a)(2), 42.61(c) (hearsay), 42.104(b)(2) and (b)(5), F.R.E. 802
`
`(hearsay), F.R.E. 402 (relevance), F.R.E. 403 (confusing, waste of time, needlessly
`
`presenting cumulative evidence), F.R.E. 702 (improper expert testimony), F.R.E.
`
`703 (bases for expert opinion), and F.R.E. 901 (authentication); (ii) documents that
`
`are stamped with dates after the February 19, 2001 priority date of the ’131 Patent,
`
`the October 17, 2001 priority date of the ’131 Patent, or the February 18, 2002
`
`application date of the ’131 Patent; (iii) documents that were not published until
`
`after the February 19, 2001 priority date of the ’131 Patent, the October 17, 2001
`
`priority date of the ’131 Patent, or the February 18, 2002 application date of the
`
`’131 Patent; (iv) documents for which Petitioner has not provided evidence to
`
`prove were published before the February 19, 2001 priority date of the ’131 Patent,
`
`the October 17, 2001 priority date of the ’131 Patent, or the February 18, 2002
`
`application date of the ’131 Patent; and/or (v) documents that are not relevant to
`
`any issue in this IPR proceeding and/or not the type of documents upon which a
`
`person of ordinary skill in the art at the time of invention would rely.
`
`5
`
`
`
`Novartis objects to Exhibit 1159 under F.R.E. 106 (completeness); Exhibit
`
`1159 ¶¶ 46-65, 217, and 247 include expert opinion based on documents that are
`
`incomplete under at least under F.R.E. 106 (completeness). Exhibit 1159 ¶¶ 4, 83,
`
`84, 108, 110, 111, 114, 134, 135, 141, 299, 304, 347 include expert opinion based
`
`on misleading or incomplete excerpts of Dr. Burris’s deposition testimony (Exhibit
`
`1126), and omit portions of answers or follow up questions that in fairness ought to
`
`be considered in connection with Exhibit 1126, including for Exhibit 1159 ¶ 110,
`
`Dep. Tr. 85:10-86:22, 88:8-89:10, 89:20-90:3, 97:1-98.1; for Exhibit 1159 ¶ 111,
`
`Dep. Tr. 254:6-255:8; for Exhibit 1159 ¶ 134, Dep. Tr. 57:22-58:3; for Exhibit
`
`1159 ¶ 135, Dep. Tr. 31:10-32:18; for Exhibit 1159 ¶ 304, Dep. Tr. 239:6-240:7,
`
`246:5-17; for Exhibit 1159 ¶ 347, Dep. Tr. 31:10-32:18. Exhibit 1159 ¶¶ 299, 307,
`
`308, 309, 312, 313, 317, 318, 321, 324 include expert opinion based on misleading
`
`or incomplete excerpts of Dr. Komanduri’s deposition testimony (Exhibit 1127),
`
`and omit portions of answers or follow up questions that in fairness ought to be
`
`considered in connection with Exhibit 1127, including for Exhibit 1159 ¶ 299, Dep
`
`Tr. 59:12-61:24; for Exhibit 1159 ¶¶ 307-308, Dep. Tr. 28:7-19; for Exhibit 1159 ¶
`
`312, Dep Tr. 37:3-38:5; for Exhibit 1159 ¶ 313, Dep. Tr. 12:8-15; for Exhibit 1159
`
`¶ 318, Dep. Tr. 74:7-17, 97:23-98:18; for Exhibit 1159 ¶ 321, Dep. Tr. 74:7-17,
`
`77:5-78:21, 79:18-80:22, 81:10-82:23, 87:4-9, 87:22-88:6. Exhibit 1159 ¶ 4
`
`includes expert opinion based on a misleading cite to Dr. Burris’s first trial
`
`6
`
`
`
`testimony (Exhibit 1129). And, Exhibit 1159 ¶¶ 4, 79, 107, 185, 344, 345 include
`
`expert opinion based on misleading or incomplete excerpts of Dr. Burris’s second
`
`trial testimony (Exhibit 1130), and omit portions of answers or follow up questions
`
`that in fairness ought to be considered in connection with Exhibit 1130, including
`
`for Exhibit 1159 ¶¶ 79, 107, 185, 344, and 345, Trial. Tr. 520:4-531:9.
`
`Novartis objects to Exhibit 1159 under 37 C.F.R. §§ 42.22(a)(2),
`
`42.104(b)(2) and (b)(5), 35 U.S.C. § 311(b), F.R.E. 702 (improper expert
`
`testimony), F.R.E. 703 (bases for expert opinion), F.R.E. 402 (relevance), and
`
`F.R.E. 403 (confusing, waste of time). Exhibit 1159 ¶¶ 23, 31, 32, 34, 40, 52, 53,
`
`55, 58, 146, 167, 169, 197, 246 n. 43, 267, 293, 355, 356, 357, and 374 rely on the
`
`disclosures of the ’131 Patent, which is not prior art under 35 U.S.C. § 102 nor are
`
`the disclosures in the ’131 Patent an admission of the disclosures of the prior art.
`
`Novartis objects to Exhibit 1159 under F.R.E. 702 (improper expert
`
`testimony), F.R.E. 703 (bases for expert opinion), F.R.E. 402 (relevance), and
`
`F.R.E. 403 (confusing, waste of time). Exhibit 1159 ¶¶ 64, 65, 67, 68, 75, 77, 79,
`
`144, 148, 150, 151, 154, 178, 180, 182, 183, 184, 185, 187, 189, 190, 192, 193,
`
`194, 195, 196, 198, 199, 214, 220, 222, 225, 227, 228, 229, 230, 231, 233, 234,
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`235, 236, 237, 238, 239, 240, 241, 242, 243, 244, 245, 246, 247, 248, 249, 250,
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`252, 253, 254,255, 257, 258, 260, 261, 262, 265, 266, 267, 269, 276, 282, 283,
`
`284, 285, 286, 287, 291, 292, 293, 296, 300, 303, 322, 324, 331, 332, 333, 337,
`
`7
`
`
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`339, 352, 366, 370, 373, 375, 379, 382 are not relevant to any issue in this IPR
`
`proceeding because they cite references that relate to the field of
`
`immunosuppression and/or transplantation and/or are in a separate field of
`
`endeavor and/or are not pertinent to the entire problem solved by the ’131 Patent.
`
`Novartis objects to Exhibit 1159 under F.R.E. 702 (improper expert
`
`testimony), F.R.E. 703 (bases for expert opinion), F.R.E. 402 (relevance) and
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`F.R.E. 403 (confusing, waste of time). Exhibit 1159 ¶¶ 64, 65, 67, 68, 75, 77, 79,
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`144, 148, 150, 151, 154, 178, 180, 182, 183, 184, 185, 187, 189, 190, 192, 193,
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`194, 195, 196, 198, 199, 214, 220, 222, 225, 227, 228, 229, 230, 231, 233, 234,
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`235, 236, 237, 238, 239, 240, 241, 242, 243, 244, 245, 246, 247, 248, 249, 250,
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`252, 253, 254,255, 257, 258, 260, 261, 262, 265, 266, 267, 269, 276, 282, 283,
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`284, 285, 286, 287, 291, 292, 293, 296, 300, 303, 322, 324, 331, 332, 333, 337,
`
`339, 352, 366, 370, 373, 375, 379, 382 are improper because the declarant is not
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`stated to have expertise with respect to immunosuppression and/or transplantation,
`
`or related fields.
`
`In addition, Novartis objects to Exhibit 1159 to the extent Petitioners rely on
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`it to establish any element of their prima facie case against claims 1-3 and 5-9 of
`
`the ’131 Patent (other than evidence used for the limited purposes of describing the
`
`state of the art or reinforcing the meaning of a prior art reference that appears in
`
`Grounds 1, 2, 3 4, or 5). See In re NuVasive, 841 F.3d 966, 972-73 (Fed. Cir.
`
`8
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`
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`2016) (Board abused its discretion by relying on portion of prior art reference that
`
`was first identified by petitioner in its reply; that portion of the reference did not
`
`merely describe the state of the art, but instead was the sole prior art disclosure of
`
`disputed claim elements relied upon by the Board); Genzyme Therapeutic Prods.
`
`Limited Partnership v. Biomarin Pharms. Inc., 825 F.3d 1360, 1368 (Fed. Cir.
`
`2016) (parties should move to exclude a reference not cited in instituted grounds).
`
`Novartis similarly objects to Petitioner’s reliance on any 2000-series exhibit (or
`
`any other Exhibit that is not a reference in Grounds 1, 2, 3, 4, or 5) for the same
`
`reasons.
`
`Dated: June 28, 2018
`
`/Nicholas N. Kallas/
`Nicholas N. Kallas
`Registration No. 31,530
`Lead Counsel for Patent Owner
`FITZPATRICK, CELLA, HARPER
`& SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel. 212-218-2100
`
`9
`
`
`
`CERTIFICATE OF SERVICE
`
`I certify that a copy of the foregoing Patent Owner’s Objections Under 37
`
`C.F.R. § 42.64 To Evidence Submitted By Petitioner With Its Reply was served on
`
`June 28, 2018 by causing it to be sent by email to counsel for Petitioner at the
`
`following email addresses:
`
`Daniel R. Evans (devans@merchantgould.com)
`
`Jeffrey D. Blake (jblake@merchantgould.com)
`
`Melissa M. Hayworth (mhayworth@merchantgould.com)
`
`Dated: June 28, 2018
`
`/Nicholas N. Kallas/
`Nicholas N. Kallas
`Registration No. 31,530
`Lead Counsel for Patent Owner
`FITZPATRICK, CELLA, HARPER
`& SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel. 212-218-2100
`
`10
`
`
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