Paper No. ___
`Filed on April 11, 2018
`
`Filed on behalf of Breckenridge Pharmaceutical, Inc.,
`
`
`By:
`Daniel R. Evans
`devans@merchantgould.com
`(404) 954-5061
`
`
`
`
`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
`____________
`
`
`
`
`PETITIONER'S OBJECTIONS TO EVIDENCE SUBMITTED BY
`NOVARTIS PHARMACEUTICALS CORPORATION WITH THE
`PATENT OWNER RESPONSE
`
`
`Filed on April 11, 2018
`
`Filed on behalf of Breckenridge Pharmaceutical, Inc.,
`
`
`By:
`Daniel R. Evans
`devans@merchantgould.com
`(404) 954-5061
`
`
`
`
`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
`____________
`
`
`
`
`PETITIONER'S OBJECTIONS TO EVIDENCE SUBMITTED BY
`NOVARTIS PHARMACEUTICALS CORPORATION WITH THE
`PATENT OWNER RESPONSE
`
`
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Petitioner Breckenridge
`
`Pharmaceutical, Inc. ("Breckenridge" or "Petitioner"), hereby submits its
`
`objections to certain evidence that Patent Owner Novartis Pharmaceuticals Corp.
`
`("Novartis" or "Patent Owner") submitted in connection with IPR2017-01592.
`
`These objections are being filed within five business days of Patent Owner's
`
`Response. These objections are being made without prejudice to Breckenridge's
`
`ability to use such exhibits or to recall or remove any objections at a later date.
`
`
`
`Exhibits 2004-2005, 2006, 2007, 2009-2016, 2023-2025, 2028-2030, 2032, 2034-
`2040, 2046-2051, 2056-2059, 2061-2063, 2065, 2069, 2071-2077, 2082, 2083,
`2085, 2089-2091, 2095-2101
`Breckenridge objects to the aforementioned exhibits under FRE 4021 for
`
`lack of relevance, since these exhibits fail to provide any evidence relating to
`
`Novartis' positions in this matter. Breckenridge further objects to these exhibits
`
`under FRE 403, since any minimal relevance possessed by these exhibits is greatly
`
`outweighed by their potential for undue prejudice, confusion, and a waste of
`
`judicial resources. For the same reasons Breckenridge objects to these exhibits
`
`
`
`1 As used herein, "FRE" refers to the Federal Rules of Evidence.
`
`
`
`1
`
`
`
`under FRE 702 and 703, as well as 37 C.F.R. §§ 42.22(a)(2), 42.104(b)(2) and
`
`(b)(5), and 35 U.S.C. § 311(b).2
`
`Breckenridge further objects to the aforementioned exhibits under FRE 802
`
`and 37 C.F.R § 42.61(c) as impermissible hearsay to the extent Novartis is
`
`attempting to rely on the substance of any of the documents for the truth of the
`
`matter asserted therein.
`
`
`
`Exhibits 2001, 2002, 2017-2022, 2024, 2026, 2054, 2081
`
`Breckenridge objects to the aforementioned exhibits under 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 since
`
`these exhibits were not cited in the Patent Owner's Response. Breckenridge objects
`
`to any attempt to rely on these documents in any manner, whether in an expert
`
`declaration or in subsequent briefing, as untimely and improper incorporation by
`
`reference.
`
`Breckenridge further objects to the aforementioned exhibits under FRE 402
`
`for lack of relevance, since these exhibits fail to provide any evidence supporting
`
`Novartis' positions in this matter and are therefore irrelevant. Breckenridge further
`
`
`
`2 As used herein, "CFR" refers to the Code of Federal Regulations.
`
`
`
`2
`
`
`
`objects to these exhibits under FRE 403, since any minimal relevance possessed by
`
`these exhibits is greatly outweighed by their potential for undue prejudice,
`
`confusion, and a waste of judicial resources. For the same reasons Breckenridge
`
`objects to these exhibits under FRE 702 and 703, as well as 37 C.F.R. §§
`
`42.22(a)(2), 42.104(b)(2) and (b)(5), and 35 U.S.C. § 311(b).
`
`Breckenridge further objects to the aforementioned exhibits under FRE 802
`
`and 37 C.F.R § 42.61(c) as impermissible hearsay to the extent Novartis is
`
`attempting to rely on the substance of any of the documents for the truth of the
`
`matter asserted therein.
`
`
`
`Exhibits 2003, 2006, 2017-2021, 2045, 2052-2055, 2064, 2066, 2067, 2068, 2086-
`2088
`
`Breckenridge objects to the aforementioned exhibits under FRE 402 for lack
`
`of relevance, since these exhibits fail to provide any evidence supporting Novartis'
`
`claims and defenses in this matter and are therefore irrelevant. Breckenridge
`
`further objects to the aforementioned exhibits under FRE 402 as not relevant to any
`
`of Novartis' positions in this matter because Novartis has failed to demonstrate that
`
`the documents were publicly available prior to the priority date of the patent at
`
`issue in this matter.
`
`
`
`3
`
`
`
`Breckenridge further objects to these exhibits under FRE 403, since any
`
`minimal relevance possessed by these exhibits is greatly outweighed by their
`
`potential for undue prejudice, confusion, and a waste of judicial resources. For the
`
`same reasons Breckenridge objects to these exhibits under FRE 702 and 703, as
`
`well as 37 C.F.R. §§ 42.22(a)(2), 42.104(b)(2) and (b)(5), and 35 U.S.C. § 311(b).
`
`Breckenridge further objects to the aforementioned exhibits under FRE 802
`
`and 37 C.F.R § 42.61(c) as impermissible hearsay to the extent Novartis is
`
`attempting to rely on the substance of any of the documents for the truth of the
`
`matter asserted therein.
`
`
`
`Exhibits 2008, 2020-2021, 2031, 2033, 2041, 2044, 2045, 2054-2055, 2060, 2066,
`2067, 2078, 2079, 2084, 2086-2088
`
`
`Breckenridge objects to the aforementioned exhibits under FRE 901 because
`
`Novartis has failed to provide sufficient evidence that these documents are
`
`authentic. Novartis has similarly failed to provide sufficient evidence
`
`demonstrating that the aforementioned exhibits are self-authenticating under the
`
`Federal Rules of Evidence.
`
`Breckenridge further objects to the aforementioned exhibits under FRE 402
`
`for lack of relevance, since these exhibits fail to provide any evidence supporting
`
`Novartis' positions in this matter and are therefore irrelevant. Breckenridge further
`4
`
`
`
`
`
`objects to these exhibits under FRE 403, since any minimal relevance possessed by
`
`these exhibits is greatly outweighed by their potential for undue prejudice,
`
`confusion, and a waste of judicial resources. For the same reasons Breckenridge
`
`objects to these exhibits under FRE 702 and 703, as well as 37 C.F.R. §§
`
`42.22(a)(2), 42.104(b)(2) and (b)(5), and 35 U.S.C. § 311(b).
`
`Breckenridge further objects to the aforementioned exhibits under FRE 802
`
`and 37 C.F.R § 42.61(c) as impermissible hearsay to the extent Novartis is
`
`attempting to rely on the substance of any of the documents for the truth of the
`
`matter asserted therein.
`
`
`
`Exhibits 2026, 2060, 2078, 2084
`
`Breckenridge objects to the aforementioned exhibits under FRE 106 and
`
`1002 for lack of completeness and failure to comply with the best evidence rule.
`
`Each of these documents appears to be missing large portions of the document, and
`
`in some instances, the entirety of the document, and therefore fail to satisfy the
`
`requirements of FRE 106 and 1002.
`
`Breckenridge further objects to the aforementioned exhibits under FRE 402
`
`for lack of relevance, since these exhibits fail to provide any evidence supporting
`
`Novartis' claims and defenses in this matter and are therefore irrelevant.
`
`
`
`5
`
`
`
`Breckenridge further objects to these exhibits under FRE 403, since any minimal
`
`relevance possessed by these exhibits is greatly outweighed by their potential for
`
`undue prejudice, confusion, and a waste of judicial resources. For the same reasons
`
`Breckenridge objects to these exhibits under FRE 702 and 703, as well as 37
`
`C.F.R. §§ 42.22(a)(2), 42.104(b)(2) and (b)(5), and 35 U.S.C. § 311(b).
`
`Breckenridge further objects to the aforementioned exhibits under FRE 802
`
`and 37 C.F.R § 42.61(c) as impermissible hearsay to the extent Novartis is
`
`attempting to rely on the substance of any of the documents for the truth of the
`
`matter asserted therein.
`
`
`
`Exhibits 2001, 2002, 2017-2022, 2026, 2070, 2080, 2081, 2092
`
`Breckenridge objects to the aforementioned exhibits under FRE 802 and 37
`
`C.F.R § 42.61(c) as impermissible hearsay because such documents contain out of
`
`court statements, are being asserted for the truth of the matter therein, and do not
`
`fall within any valid hearsay exception.
`
`Breckenridge further objects to the aforementioned exhibits under FRE 402
`
`for lack of relevance, since these exhibits fail to provide any evidence supporting
`
`Novartis' positions in this matter and are therefore irrelevant. Breckenridge further
`
`objects to these exhibits under FRE 403, since any minimal relevance possessed by
`
`
`
`6
`
`
`
`these exhibits is greatly outweighed by their potential for undue prejudice,
`
`confusion, and a waste of judicial resources. For the same reasons Breckenridge
`
`objects to these exhibits under FRE 702 and 703, as well as 37 C.F.R. §§
`
`42.22(a)(2), 42.104(b)(2) and (b)(5), and 35 U.S.C. § 311(b).
`
`
`
`Exhibits 2001, 2017-2021, 2080, 2092
`
`Breckenridge objects to the aforementioned exhibits under FRE 702 and 703
`
`as improper expert testimony and for an improper basis for expert testimony.
`
`Novartis has failed to provide sufficient evidence that the declarant in each of these
`
`exhibits is properly considered an expert in the field of the subject matter discussed
`
`therein.
`
`Breckenridge further objects to the aforementioned exhibits under FRE 402
`
`for lack of relevance, since these exhibits fail to provide any evidence supporting
`
`Novartis' claims and defenses in this matter and are therefore irrelevant.
`
`Breckenridge further objects to these exhibits under FRE 403, since any minimal
`
`relevance possessed by these exhibits is greatly outweighed by their potential for
`
`undue prejudice, confusion, and a waste of judicial resources. For the same reasons
`
`Breckenridge objects to these exhibits under 37 C.F.R. §§ 42.22(a)(2),
`
`42.104(b)(2) and (b)(5), and 35 U.S.C. § 311(b).
`
`
`
`7
`
`
`
`Breckenridge further objects to the aforementioned exhibits under FRE 802
`
`and 37 C.F.R § 42.61(c) as impermissible hearsay to the extent Novartis is
`
`attempting to rely on the substance of any of the documents for the truth of the
`
`matter asserted therein.
`
`
`
`Exhibit 2027, 2093, 2094
`
`Breckenridge objects to the aforementioned transcripts under FRE 402, 403,
`
`702, 703, 37 C.F.R. §§ 42.22(a)(2), 42.104(b)(2) and (b)(5), and 35 U.S.C. §
`
`311(b). Much of the referenced testimony is irrelevant, unduly prejudicial,
`
`confusing, duplicative, based on speculation, improper counsel testimony, lacking
`
`foundation, and based on improper an improper form of the question.
`
`
`
`Exhibit 2001
`
`Breckenridge objects to Exhibit 2001, the Expert Declaration of Dr. Howard
`
`Burris, III under FRE 802 as hearsay not fitting within any valid exception.
`
`Breckenridge further objects to this declaration under FRE 402, 403, 702, 703 and
`
`37 CFR § 42.65 as irrelevant, confusing, a waste of judicial resources, more
`
`prejudicial than probative, and improper expert testimony because Novartis has
`
`failed to demonstrate that Dr. Burris is properly considered an expert in the matters
`
`
`
`8
`
`
`
`discussed therein, and therefore the disclosed opinions do not have any relevance
`
`to the ultimate question at issue. Breckenridge further objects to portions of Exhibit
`
`2001 as follows:
`
`Paragraphs 1-100: Breckenridge objects to the aforementioned paragraphs
`
`because they are not referenced in the Patent Owner's Response. Breckenridge
`
`opposes any attempt to rely on such information as untimely and improper
`
`incorporation by reference.
`
`Paragraphs 3-8, 43-46, 53, 58, 69, 71, 76, 77: Breckenridge objects to the
`
`aforementioned paragraphs under FRE 402, 403, 602, 702, 703, and 37 CFR §
`
`42.65 as irrelevant, confusing, a waste of judicial resources, more prejudicial than
`
`probative, lacking foundation, and improper expert testimony because these
`
`paragraphs fail to cite any support for the assertions made therein.
`
`Paragraphs 31, 32, 33, 35, 37, 66: Breckenridge objects to the
`
`aforementioned paragraphs under FRE 402 as not relevant to any of Novartis'
`
`positions in this matter because the assertions made therein rely on documents
`
`which Novartis has failed to demonstrate were publicly available prior to the
`
`priority date of the patent at issue in this matter. As a result, Novartis has failed to
`
`show that the statements in the referenced paragraphs have any bearing on this
`
`matter, and are therefore irrelevant under FRE 402.
`
`
`
`9
`
`
`
`Paragraph 34: Breckenridge objects to the aforementioned paragraph under
`
`FRE 901 because the statements made therein rely on documents which Novartis
`
`has failed to demonstrate are authentic. Novartis has similarly failed to provide
`
`sufficient evidence demonstrating that the aforementioned documents are self-
`
`authenticating under the Federal Rules of Evidence.
`
`Paragraphs 30-37, 66, 75, 78, 79, 87-90, 92, 98: Breckenridge objects to
`
`the aforementioned paragraphs under FRE 402 and 403 because the statements
`
`made therein rely on irrelevant and unduly prejudicial documents. For the same
`
`reasons Breckenridge objects to these paragraphs under FRE 702 and 703, as well
`
`as 37 C.F.R. §§ 42.22(a)(2), 42.104(b)(2) and (b)(5), and 35 U.S.C. § 311(b).
`
`Paragraphs 20-28: Breckenridge objects to the aforementioned paragraphs
`
`as improper expert testimony under FRE 702 and 703 and for lack of knowledge
`
`under FRE 602, as they are statements of law which the declarant is not qualified
`
`to provide.
`
`
`
`Exhibit 2080
`
`Breckenridge objects to Exhibit 2080, the Expert Declaration of Dr. Krishna
`
`Komanduri under FRE 802 as hearsay not fitting within any valid exception.
`
`Breckenridge further objects to this declaration under FRE 402, 403, 702, 703 and
`
`
`
`10
`
`
`
`37 CFR § 42.65 as irrelevant, confusing, a waste of judicial resources, more
`
`prejudicial than probative, and improper expert testimony because Novartis has
`
`failed to demonstrate that Dr. Komanduri is properly considered an expert in the
`
`matters discussed therein, and therefore the disclosed opinions do not have any
`
`relevance to the ultimate question at issue. Breckenridge further objects to portions
`
`of Exhibit 2080 as follows:
`
`Paragraphs 1-33, 41, 55: Breckenridge objects to the aforementioned
`
`paragraphs because they are not referenced in the Patent Owner's Response.
`
`Breckenridge opposes any attempt to rely on such information as untimely and
`
`improper incorporation by reference.
`
`Paragraphs 10, 15, 30-55: Breckenridge objects to the aforementioned
`
`paragraphs under FRE 402, 403, 602, 702, 703, and 37 CFR § 42.65 as irrelevant,
`
`confusing, a waste of judicial resources, more prejudicial than probative, lacking
`
`foundation, and improper expert testimony because Novartis has failed to
`
`demonstrate that Dr. Komanduri is a person of ordinary skill in the art.
`
`Paragraph 15: Breckenridge objects to the aforementioned paragraph under
`
`FRE 402, 403, 602, 702, 703, and 37 CFR § 42.65 as irrelevant, confusing, a waste
`
`of judicial resources, more prejudicial than probative, lacking foundation, and
`
`
`
`11
`
`
`
`improper expert testimony because these paragraphs fail to cite any support for the
`
`assertions made therein.
`
`Paragraphs 34, 35: Breckenridge objects to the aforementioned paragraphs
`
`under FRE 402 as not relevant to any claim or defense in this matter because the
`
`assertions made therein rely on documents which Novartis has failed to
`
`demonstrate were publicly available prior to the priority date of the patent at issue
`
`in this matter. As a result, Novartis has failed to show that the statements in the
`
`referenced paragraphs have any bearing on this matter, and are therefore irrelevant
`
`under FRE 402.
`
`Paragraphs 10, 34-39, 46, 50, 54: Breckenridge objects to the
`
`aforementioned paragraphs under FRE 402 and 403 because the statements made
`
`therein rely on irrelevant and unduly prejudicial documents. For the same reasons
`
`Breckenridge objects to these paragraphs under FRE 702 and 703, as well as 37
`
`C.F.R. §§ 42.22(a)(2), 42.104(b)(2) and (b)(5), and 35 U.S.C. § 311(b).
`
`Paragraphs 17, 18, 23, 30-32, 35, 36: Breckenridge objects to the
`
`aforementioned paragraphs as improper expert testimony under FRE 702 and 703
`
`and for lack of knowledge under FRE 602, as they are statements of law which the
`
`declarant is not qualified to provide.
`
`
`
`
`
`12
`
`
`
`Exhibit 2092
`
`Breckenridge objects to Exhibit 2092, the Expert Declaration of Dr. Howard
`
`Burris, III under FRE 802 as hearsay not fitting within any valid exception.
`
`Breckenridge further objects to this declaration under FRE 402, 403, 702, 703 and
`
`37 CFR § 42.65 as irrelevant, confusing, a waste of judicial resources, more
`
`prejudicial than probative, and improper expert testimony because Novartis has
`
`failed to demonstrate that Dr. Burris is properly considered an expert in the matters
`
`discussed therein, and therefore the disclosed opinions do not have any relevance
`
`to the ultimate question at issue. Breckenridge further objects to portions of Exhibit
`
`2092 as follows:
`
`Paragraphs 1-34, 36-41, 43, 47, 48, 53, 54, 61, 62, 71, 118-120, 137, 154,
`
`219, 220, 222, 223, 239, 251, 267, 268, 272, 279-281, 286, 287, 300, 302, 306:
`
`Breckenridge objects to the aforementioned paragraphs because they are not
`
`referenced in the Patent Owner's Response. Breckenridge opposes any attempt to
`
`rely on such information as untimely and improper incorporation by reference.
`
`Paragraphs 1-16, 42, 46, 47, 48, 54, 99, 104, 105, 110, 144, 148, 188, 189,
`
`196, 214, 219, 220, 222, 225, 234, 237, 251, 256, 257, 259, 260, 266-268, 278-280,
`
`287-290, 293, 297, 300-303: Breckenridge objects to the aforementioned
`
`paragraphs under FRE 402, 403, 602, 702, 703, and 37 CFR § 42.65 as irrelevant,
`
`
`
`13
`
`
`
`confusing, a waste of judicial resources, more prejudicial than probative, lacking
`
`foundation, and improper expert testimony because these paragraphs fail to directly
`
`cite any support for the assertions made therein.
`
`Paragraphs 44, 50, 51, 52, 57, 58, 85, 86, 160, FN12, 164, FN16, FN17,
`
`213, 217, 226: Breckenridge objects to the aforementioned paragraphs under FRE
`
`402 as not relevant to any claim or defense in this matter because the assertions
`
`made therein rely on documents which Novartis has failed to demonstrate were
`
`publicly available prior to the priority date of the patent at issue in this matter. As a
`
`result, Novartis has failed to show that the statements in the referenced paragraphs
`
`have any bearing on this matter, and are therefore irrelevant under FRE 402.
`
`Paragraphs 55-57, 106, 111, 141, 145, FN9, FN12, 164, 167, FN16, FN17,
`
`192, 198, 199, 213, 218, 226, 276, 282, 283, 296: Breckenridge objects to the
`
`aforementioned paragraph under FRE 901 because the statements made therein
`
`rely on documents which Novartis has failed to demonstrate are authentic. Novartis
`
`has similarly failed to provide sufficient evidence demonstrating that the
`
`aforementioned documents are self-authenticating under the Federal Rules of
`
`Evidence.
`
`Paragraphs 44, 45, 49, 50-60, 85, 86, 103, 106, 111, 121, 124-126, 128-
`
`137, 140, 141, 145, 146, FN9, 149-152, FN11, 160, 164, 167, FN12, 175-177, 179,
`
`
`
`14
`
`
`
`183-187, 190-192, 195, 197-199, 203-205, 210, 212, 213, 217, 218, 221, 226-229,
`
`231, 233, 236, 242, 255, FN16, FN17, 273, 276, 282, 283, 294, 295, 296:
`
`Breckenridge objects to the aforementioned paragraphs under FRE 402 and 403
`
`because the statements made therein rely on irrelevant and unduly prejudicial
`
`documents. For the same reasons Breckenridge objects to these paragraphs under
`
`FRE 702 and 703, as well as 37 C.F.R. §§ 42.22(a)(2), 42.104(b)(2) and (b)(5), and
`
`35 U.S.C. § 311(b).
`
`Paragraphs 1-16, 27-41, 66-70: Breckenridge objects to the aforementioned
`
`paragraphs as improper expert testimony under FRE 702 and 703 and for lack of
`
`knowledge under FRE 602, as they are statements of law and ultimate conclusions
`
`of law which the declarant is not qualified to provide.
`
`Paragraphs 145, FN7, FN11, 154, 160, 173, 186, FN18, 208, 217:
`
`Breckenridge objects to the aforementioned paragraphs under 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 since
`
`these paragraphs rely on documents not cited in Patent Owner's Response.
`
`Breckenridge objects to any attempt to rely on these documents as untimely and
`
`improper incorporation by reference.
`
`Paragraphs 55, 57, 106, 111, 192: Breckenridge objects to the
`
`aforementioned paragraphs as improper expert testimony and having an improper
`
`
`
`15
`
`
`
`basis for expert testimony because they rely on documents that fail to meet the
`
`completeness and best evidence requirements of FRE 106 and 1002.
`
`
`
`Dated: April 11, 2018
`
`
`
`/Daniel R. Evans/
`Daniel R. Evans
`Registration No. 55,868
`Lead Counsel for Petitioner
`MERCHANT & GOULD P.C.
`191 Peachtree Street, NE, Suite 3800
`Atlanta, GA 30303
`(404) 954-5061
`
`
`
`
`16
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the foregoing Petitioner's Objections
`
`to Evidence Submitted By Novartis Pharmaceuticals Corporation with its Response
`
`filed on April 4, 2018 for IPR2017-01592 was served on April 11, 2018 by sending
`
`it via email to Patent Owner's counsel identified below.
`
`Nicholas N. Kallas
`Fitzpatrick, Cella, Harper & Scinto
`1290 Avenue of the Americas
`New York, NY 10104-2100
`NKallas@fchs.com
`ZortressAfinitorIPR@fchs.com
`
`Dated: April 11, 2018
`
`
`
`/Daniel R. Evans/
`Daniel R. Evans
`Registration No. 55,868
`Lead Counsel for Petitioner
`MERCHANT & GOULD P.C.
`191 Peachtree Street, NE, Suite 3800
`Atlanta, GA 30303
`(404) 954-5061
`
`
`
`
`
`
`
`
`
`
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