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`Paper No. ___
`Date Filed: Apr. 26, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`________________
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`MYLAN PHARMACEUTICALS INC., ACTAVIS LABORATORIES FL, INC.,
`AMNEAL PHARMACEUTICALS LLC, AMNEAL PHARMACEUTICALS OF
`NEW YORK, LLC, DR. REDDY’S LABORATORIES, INC., DR. REDDY’S
`LABORATORIES, LTD., SUN PHARMACEUTICALS INDUSTRIES, LTD.,
`SUN PHARMACEUTICALS INDUSTRIES, INC., TEVA
`PHARMACEUTICALS USA, INC., WEST-WARD PHARMACEUTICAL
`CORP., and HIKMA PHARMACEUTICALS, LLC,
`Petitioner,
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`Patent Owner.
`
`________________
`Case IPR2016-013321
`Patent 8,822,438 B2
`________________
`
`
`PATENT OWNER’S OBJECTIONS TO EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64(b)(1)
`
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`1 Case IPR2017-00853 has been joined with this proceeding.
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`
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`IPR2016-01332
`U.S. Patent 8,822,438
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`Pursuant to 37 C.F.R. § 42.64(b)(1), Patent Owner Janssen Oncology, Inc.
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`(“Janssen”) objects under the Federal Rules of Evidence to the admissibility of
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`Exhibits 1013, 1022, 1025, 1026, 1031, 1047, 1078, 1080, 1085, 1086, 1088, 1089,
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`1091–1125, 1129-1134, and 1138-1141, which were submitted by Petitioners
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`Mylan Pharmaceuticals Inc., Actavis Laboratories FL, Inc., Amneal
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`Pharmaceuticals LLC, Amneal Pharmaceuticals of New York, LLC, Dr. Reddy’s
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`Laboratories, Inc., Dr. Reddy’s Laboratories, Ltd., Sun Pharmaceuticals Industries,
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`Ltd., Sun Pharmaceuticals Industries, Inc., Teva Pharmaceuticals USA, Inc., West-
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`Ward Pharmaceutical Corp., and Hikma Pharmaceuticals, LLC, (“Petitioners”) in
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`support of Petitioners’ Reply in this inter partes review.
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`Janssen’s objections are timely under 37 C.F.R. § 42.64(b)(1) because they
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`are being filed and served within five business days of service of evidence in
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`support of Petitioners’ Reply. Paper No. 55(filed Apr. 19, 2017). Janssen’s
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`objections provide notice to Petitioners that Janssen may move to exclude these
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`exhibits under 37 C.F.R. § 42.64(c).
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`Exhibits 1086, 1088, 1089, 1092-1096, 1102, 1117, 1119, 1123, 1124, 1131-1133,
`1138, 1139, 1141, Paragraphs 113 and 118 of Exhibit 1104, and Paragraphs 25,
`30, 41, and 43 of Exhibit 1134 are Irrelevant
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`Under 35 U.S.C. § 311(b), a petitioner may request cancellation of a patent
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`claim “only on the basis of prior art consisting of patents or printed publications.”
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`Exhibits 1086, 1088, 1089, 1092-1096, 1102, 1117, 1119, 1123, 1124, 1131-1133,
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`1
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`IPR2016-01332
`U.S. Patent 8,822,438
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`1138, 1139, and 1141 post-date the priority date of the patent under review in this
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`proceeding. As such, Exhibits 1086, 1088, 1089, 1092-1096, 1102, 1117, 1119,
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`1123, 1124, 1131-1133, 1138, 1139, and 1141 do not pass the test of relevant
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`evidence under Federal Rule of Evidence 401 and are thus not admissible under
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`Federal Rule of Evidence 402.
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`As a separate basis for excluding Exhibits 1131-1133 and Paragraphs 113
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`and 118 of Ex. 1104, to the extent Petitioners rely on these exhibits to support their
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`positions regarding long-felt need or skepticism under the Graham factors, Janssen
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`objects under Federal Rule of Evidence 402 for the additional reason that evidence
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`related to the purported “survival benefit” of XTANDI® and “successful[]
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`develop[ment]” of an mCRPC therapy, which was not available until after the
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`priority date of the patent under review in this proceeding, is not relevant to what
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`was known in the art before the ’438 patent.
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`As a separate basis for excluding Exhibit 1138 and Paragraph 25 of Exhibit
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`1134, to the extent Petitioners rely on these exhibits to support their position
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`regarding what was known in the art, Janssen objects under Federal Rule of
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`Evidence 402 for the additional reason that evidence related to the dosing
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`information of JEVTANA®, which was not available until after the priority date of
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`the patent under review in this proceeding, is not relevant to what was known in
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`the art before the ’438 Patent.
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`2
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`IPR2016-01332
`U.S. Patent 8,822,438
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`As a separate basis for excluding Paragraphs 30, 41, and 43 of Exhibit 1134,
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`to the extent that Petitioners rely on Paragraphs 30, 41, and 43 of Exhibit 1134 to
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`support their positions regarding commercial success under the Graham factors,
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`Janssen objects under Federal Rule of Evidence 402 for the additional reason that
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`evidence related to XTANDI® or JEVTANA®, or comparisons between
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`ZYTIGA® and XTANDI® and/or JEVTANA®, are not relevant to the commercial
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`success of ZYTIGA®.
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`Exhibits 1088, 1089, 1092-1094, and 1141 Lack Authentication
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`“To satisfy the requirement of authenticating or identifying an item of
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`evidence, the proponent must produce evidence sufficient to support a finding that
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`the item is what the proponent claims it is.” Fed. R. Evid. 901(a). The Board has
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`held that “[w]hen offering a printout of a webpage into evidence to prove the
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`website’s contents, the proponent of the evidence must authenticate the information
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`from the website . . . .” Neste Oil OYJ v. REG Synthetic Fuels, LLC, IPR2013-
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`00578, slip op. 4 (PTAB Mar. 12, 2015) (Paper 53). For this reason, the Board has
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`required that “[t]o authenticate printouts from a website, the party proffering the
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`evidence must produce some statement or affidavit from someone with knowledge
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`of the website . . . .” EMC Corp. v. Personalweb Techs., LLC, Case IPR2013-
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`00084, slip op. 45-46 (PTAB May 15, 2014) (Paper 64).
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`3
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`IPR2016-01332
`U.S. Patent 8,822,438
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`In this proceeding, Petitioners rely on printouts from websites that they have
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`introduced into the record as Exhibits 1088, 1089, 1092-1094, and 1141.
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`Petitioners, however, have not brought forth sufficient evidence to support a
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`finding that these exhibits are what Petitioners claim, or that any of these exhibits
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`is self-authenticating under Federal Rule of Evidence 902; therefore, Janssen
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`objects to the admissibility of each of these exhibits under Federal Rule of
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`Evidence 901(a). Furthermore, in addition to being unauthenticated printouts of
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`websites, Exhibits 1093 and 1094 are also incomplete and Janssen additionally
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`objects to these exhibits under Federal Rule of Evidence 106.
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`Exhibits 1095, 1117, and 1125 Lack Authentication
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`Patent Owner objects to Exhibits 1095, 1117, and 1125 at least because they
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`have not been authenticated as required by Federal Rule of Evidence 901.
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`Petitioners have failed to provide evidence regarding the origin of these documents
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`and to establish whether the documents are true and correct copies. For example,
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`Exhibits 1095, 1117 and 1125 lack proper authentication and foundation at least
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`because the circumstances surrounding their preparation have not been explained,
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`and the accuracy of the information found therein has not been established. In
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`addition, Exhibit 1095 contains a “Confidential” stamp at the bottom of each page
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`and page 4 of Exhibit 1117 contains an annotation of unknown origin, both of
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`which call into question the authenticity of these exhibits.
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`4
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`IPR2016-01332
`U.S. Patent 8,822,438
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`Exhibits 1105, 1111, 1118, and 1119 are Incomplete
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`Patent Owner objects to Exhibits 1105, 1111, 1118, and 1119 under Federal
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`Rule of Evidence 106 because these exhibits appear to be excerpts of larger
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`documents or books.
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`Exhibits 1086, 1088, 1089, 1092-1096, 1102, 1117, 1119, 1123, 1124, 1130, 1131-
`1133, 1138-1141, Paragraphs 113 and 118 of Exhibit 1104, and Paragraphs 25,
`30, 41, and 43 of Exhibit 1134 are Irrelevant are More Prejudicial than
`Probative
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`Patent Owner objects to Exhibits 1086, 1088, 1089, 1092-1096, 1102, 1117,
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`
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`1119, 1123, 1124, 1130, 1131-1133, 1138-1141, Paragraph 113 and 118 of Exhibit
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`1104, and Paragraphs of 25, 30, 41, and 43 of Exhibit 1134 at least because they
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`are not relevant to this proceeding as required by Federal Rule of Evidence 402, or,
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`alternatively, because any probative value of these documents is substantially
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`outweighed by the danger of confusing the issues under Federal Rule of Evidence
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`403. Specifically, these exhibits are not relevant to this proceeding and are of little
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`probative value because they are not “prior art consisting of patents or printed
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`publications” as required by 35 U.S.C. § 311(b) but contain highly prejudicial
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`statements related to what was known in the art after the invention of the ’438
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`patent was made that confuse the issues raised in the Reply.
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`Exhibits 1088, 1089, 1092-1095, 1117, and 1125 are Hearsay
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`Patent Owners object to Exhibits 1088, 1089, 1092-1095, 1117, and 1125
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`under Federal Rules of Evidence 801 and 802. These exhibits contain out-of-court
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`5
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`IPR2016-01332
`U.S. Patent 8,822,438
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`statements by non-parties that Petitioners apparently seek to use to prove the truth
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`of the matter asserted, and Petitioners do not provide any basis for the Patent Trial
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`and Appeal Board to conclude that they fall within any hearsay exception.
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`Exhibits 1013, 1022, 1025, 1026, 1031, 1047, 1078, 1080, 1086, 1088, 1089,
`1092-1096, 1098–1103, 1105, 1106, 1108–1125, 1129-1133, and 1138-1141 Are
`Irrelevant
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`
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`Patent Owner objects to the use of Exhibits 1013, 1022, 1025, 1026, 1031,
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`1047, 1078, 1080, 1086, 1088, 1089, 1092-1096, 1098–1103, 1105, 1106, 1108–
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`1125, 1129-1133, and 1138-1141 under Federal Rules of Evidence 401, 402, and
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`403. In particular, Exhibits 1013, 1022, 1025, 1026, 1031, 1047, 1078, 1080,
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`1088, 1092-1096, 1098–1103, 1105, 1106, 1108–1125, 1129-1133, 1138, 1140, and
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`1141 are not substantively relied on, or even cited, in the Petitioners’ Reply,2
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`whereas Exhibits 1086, 1089, 1139 are not cited in either the Petitioners’ Reply or
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`any of the accompany declarations to Petitioners’ Reply. Accordingly, the
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`aforementioned exhibits do not appear to make any fact of consequence in
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`determining the action more or less probable than it would be without them and are
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`thus irrelevant and not admissible.
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`2 These exhibits were cited in at least one of the declarations submitted with
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`Petitioners’ Reply.
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`6
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`IPR2016-01332
`U.S. Patent 8,822,438
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`Paragraphs 17-29, 31, and 40-43 of Exhibit 1091, Paragraphs 11-16, and 95 of
`Exhibit 1097, and Paragraphs 5-9, 11-13, 88-90, 92-95, and 119-122 of Exhibit
`1104 Are Irrelevant
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`
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`In addition, Patent Owner objects to the use of Paragraphs 17-29, 31, and
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`40-43 of Exhibit 1091, Paragraphs 11-16, and 95 of Exhibit 1097, and Paragraphs
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`5-9, 11-13, 88-90, 92-95, and 119-122 of Exhibit 1104 under Federal Rules of
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`Evidence 401, 402, and 403. In particular, these paragraphs are not substantively
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`relied on, or even cited, in the Petition. Accordingly, the aforementioned
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`paragraphs of Exhibits 1091, 1097 and 1104 do not appear to make any fact of
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`consequence in determining the action more or less probable than it would be
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`without those paragraphs and are thus irrelevant and not admissible. Further,
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`permitting reference to or reliance on these paragraphs from the declarations of
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`Drs. McKeague, Bantle and Garnick in other submissions of Petitioners would also
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`be impermissible, misleading, irrelevant, and unfairly prejudicial to Patent Owner.
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`To the extent Petitioners attempt to rely on or submit these aforementioned
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`paragraphs of Exhibits 1091, 1097 and 1104 in the future as evidence in support of
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`new substantive positions, doing so would be untimely, in violation of the
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`applicable rules governing this proceeding, and unfairly prejudicial to Patent
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`Owner.
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`7
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`IPR2016-01332
`U.S. Patent 8,822,438
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`Exhibits 1097 and 1104 Are Outside the Scope of Response and Petition
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`Patent Owner objects to Exhibits 1097 and 1104 in their entirety as well as
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`the supporting exhibits as outside the scope of Patent Owner’s Response and
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`Petitioners’ Petition under 37 C.F.R. § 42.223, 37 C.F.R. § 42.23(b), and Office
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`Patent Trial Practice Guide, Part II, § I (77 Fed. Reg. 48756, 48767 (Aug. 14,
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`2012)). These declarations and exhibits are not properly in reply to issues raised in
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`Patent Owner’s Response, but rather “raise a new issue or belatedly present
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`evidence . . . necessary to make out a prima facie case for the . . . unpatentability of
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`an original . . . claim,” and/or constitute “new evidence that could have been
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`presented in a prior filing.” Office Trial Practice Guide, 77 Fed. Reg. 48756, 48767
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`(Aug. 14, 2012). Petitioners now attempt to bring forth arguments belatedly,
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`which Patent Owner has no opportunity to rebut under the rules, and no time to
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`request relief to address under the schedule of the proceeding. As such, they are
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`improper and should not be considered by the Board.
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`8
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`IPR2016-01332
`U.S. Patent 8,822,438
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`Exhibits 1085, 1098, 1099, 1102, 1106 and 1107 Are Outside the Scope of
`Response and Petition3
`Petitioners object to Exhibits 1085, 1098, 1099, 1102, 1106, and 1107 under
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`37 C.F.R. § 42.223, 37 C.F.R. 42.23(b), and Office Patent Trial Practice Guide,
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`Part II, § I (77 Fed. Reg. 48756, 48767 (Aug. 14, 2012)).
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`Petitioners advance no position that may form a proper basis for the belated
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`submission of Exhibits 1085, 1098, 1099, 1102, 1106, and 1107. This new
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`evidence is prejudicial and irrelevant to any issue properly raised in this
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`proceeding under FRE 402, FRE 403, and 37 C.F.R. § 42.61. These exhibits are
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`used by Petitioners to present new invalidity theories and arguments in an effort to
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`make out a prima facie case of unpatentability, raise new issues, or belatedly
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`present evidence which are either inapposite or could have been submitted with the
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`Petition, not with the Reply.
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`3 Further, Petitioners have not cited Exhibits 1086, 1088, 1089, 1092-1096,
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`1098–1103, 1105, 1106, 1108–1125, 1129-1133, and 1138-1141 in their Reply. To
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`the extent Petitioners’ declarants rely on this evidence to present new invalidity
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`theories and arguments that Petitioners have incorporated by reference, Patent
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`Owner objects to their use as improper.
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`9
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`Respectfully submitted,
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`/Dianne B. Elderkin/
`Dianne B. Elderkin (Lead Counsel)
`Reg. No. 28,598
`Barbara L. Mullin (Back-up Counsel)
`Reg. No. 38,250
`Ruben H. Munoz (Back-up Counsel)
`Reg. No. 66,998
`AKIN GUMP STRAUSS HAUER
`& FELD LLP
`Two Commerce Square
`2001 Market Street, Suite 4100
`Philadelphia, PA 19103
`Tel.: (215) 965-1340
`Fax: (215) 965-1210
`
`David T. Pritikin (pro hac vice)
`Bindu Donovan (pro hac vice)
`Todd L. Krause
`Reg. No. 48,860
`Paul J. Zegger
`Reg. No. 33,821
`Alyssa Monsen (pro hac vice)
`SIDLEY AUSTIN LLP
`787 Seventh Avenue
`New York, NY 10019
`Tel.: (212) 839-5300
`Fax: (212) 839-5599
`
`Counsel for Patent Owner
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`10
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`IPR2016-01332
`U.S. Patent 8,822,438
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`Date: April 26, 2017
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`IPR2016-01332
`U.S. Patent 8,822,438
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing PATENT
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`OWNER’S OBJECTIONS TO EVIDENCE PURSUANT TO 37 C.F.R. §
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`42.64(b)(1) was served on counsel of record on April 26, 2017 by filing this
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`document through the End-to-End System, as well as delivering a copy via
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`electronic mail to counsel of record for the Petitioners at the following addresses:
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`Brandon M. White – bmwhite@perkinscoie.com
`Crystal R. Canterbury – ccanterbury@perkinscoie.com
`Bryan D. Beel – bbeel@perkinscoie.com
`Shannon Bloodworth – sbloodworth@perkinscoie.com
`Emily J. Greb – egreb@perkinscoie.com
`Robert D. Swanson – rswanson@perkinscoie.com
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`Samuel S. Park – spark@winston.com
`Ryan B. Hauer – rhauer@winston.com
`Jovial Wong – jwong@winston.com
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`Respectfully submitted,
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`By: /Dianne B. Elderkin/
`Dianne B. Elderkin
`Registration No. 28,598
`Counsel for Patent Owner
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`Date: April 26, 2017
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`11
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