Paper No. ___
`Date Filed: January 23, 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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`AMERIGEN PHARMACEUTICALS LIMITED and
`ARGENTUM PHARMACEUTICALS LLC
`Petitioners
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`v.
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`JANSSEN ONCOLOGY, INC.,
`Patent Owner
`________________
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`Case IPR2016-002861
`Patent 8,822,438 B2
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`________________
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`PATENT OWNER’S OBJECTIONS TO EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64(b)(1)
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`1 Case IPR2016-01317 has been joined with this proceeding.
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`Date Filed: January 23, 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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`AMERIGEN PHARMACEUTICALS LIMITED and
`ARGENTUM PHARMACEUTICALS LLC
`Petitioners
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`Patent Owner
`________________
`
`Case IPR2016-002861
`Patent 8,822,438 B2
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`________________
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`PATENT OWNER’S OBJECTIONS TO EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64(b)(1)
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`1 Case IPR2016-01317 has been joined with this proceeding.
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`IPR2016-00286
`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 and 37 C.F.R. Part 42 to
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`the admissibility of Exhibits 1074-1075, 1077, 1083-1095, 1097-1149, 1150-1156,
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`1160-1163, 1165-1173, and 1175-1190, on which Petitioners Amerigen
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`Pharmaceuticals Limited and Argentum Pharmaceuticals LLC rely in support of
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`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. 60 (filed Jan. 16, 2017). 2 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 1074, 1085, 1086, 1089, 1099, 1107, 1109-1111, 1115, 1118, 1119, 1128-
`1137, 1139-1142, 1146, 1149, 1150, 1151, 1153, 1165, 1168, 1170, 1173, 1181, and
`1187 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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`2 As explained in the sections that follow, a significant number of exhibits on
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`which Petitioners rely were not timely filed or served, and Patent Owner objects to
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`the admission of those exhibits as untimely.
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`1
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`IPR2016-00286
`U.S. Patent 8,822,438
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`Exhibits 1074, 1085, 1086, 1089, 1099, 1107, 1109-1111, 1115, 1118, 1119, 1128-
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`1137, 1139-1142, 1146, 1149, 1150, 1151, 1153, 1165, 1168, 1170, 1173, 1181, and
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`1187 post-date the priority date of the patent under review in this proceeding. As
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`such, these Exhibits do not pass the test of relevant evidence under Federal Rule of
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`Evidence 401 and are thus not admissible under Federal Rule of Evidence 402.
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`Furthermore, in addition to being irrelevant to this proceeding under Federal
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`Rule of evidence 402, Patent Owner objects to Exhibits 1074, 1085, 1086, 1089,
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`1107, 1109-1111, 1115, 1118, 1119, 1128-1137, 1139-1142, 1146, 1149, 1150,
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`1151, 1153, 1165, 1168, 1170, 1173, 1181, and 1187 alternatively because any
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`probative value of these documents is substantially outweighed by the danger of
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`confusing the issues under Federal Rule of Evidence 403. Specifically, these
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`exhibits are not relevant to this proceeding and are of little probative value because
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`they are not “prior art consisting of patents or printed publications” as required by
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`35 U.S.C. § 311(b). Instead, these exhibits contain highly prejudicial statements
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`related to what was known in the art after the invention of U.S. Patent No.
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`8,822,438 (the “’438” patent) was made that confuse the issues raised in the
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`Petition and the Patent Owner’s Response.
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`2
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`IPR2016-00286
`U.S. Patent 8,822,438
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`Exhibits 1088, 1128, 1130, 1139, 1140, 1166, and 1187 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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`In support of their Reply, Petitioners rely on printouts from websites that
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`they have introduced into the record as Exhibits 1088, 1128, 1130, 1139, 1166, and
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`1187. 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 these exhibits are self-
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`authenticating under Federal Rule of Evidence 902; therefore, Janssen objects to
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`the admissibility of these exhibits under Federal Rule of Evidence 901(a).
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`Janssen also objects to the admissibility of Exhibit 1140 for lack of
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`authentication. Exhibit 1140 appears to be a manuscript of an article titled
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`3
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`IPR2016-00286
`U.S. Patent 8,822,438
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`“Therapeutic management of bone metastasis in prostate cancer: an update.”
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`However, this document provides no indication that this represents the final, as
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`published, copy of the article. Therefore, Janssen objects to the admissibility of
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`Exhibit 1140 under Federal Rule of Evidence 901(a).
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`Exhibits 1092, 1094, 1097-1149, 1150, 1151, 1153-1156, 1160-1163, 1165-1173,
`and 1175-1190 Are Untimely
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`Under the Rules governing this proceeding, a late action will not be excused
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`unless there is good cause or upon a showing that it is in the interest of justice to
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`do so. See 37 C.F.R. § 42.5(c)(3). Petitioners’ Reply to Janssen’s Patent Owner
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`Response was due on January 16, 2017. Petitioners, however, failed to file and
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`serve accompanying exhibits 1092, 1094, 1097-1149, 1150, 1151, 1153-1156,
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`1160-1163, 1165-1173, and 1175-1190 until 5:37 a.m. and 5:44 a.m., respectively,
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`on the following day, January 17, 2017. Janssen, therefore, objects to the
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`admissibility of each of these exhibits as untimely, and prejudicial to Janssen.
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`Exhibits 1074, 1075, 1077, 1083, 1084, 1087, 1088, 1090, 1097-1108, 1110, 1115-
`1120, 1126, 1127, 1131, 1138, 1140-1151, 1153-1156, 1160-1163, 1165-1169,
`1171-1186, and 1190 Are Irrelevant
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`Patent Owner objects to the admissibility of Exhibits 1074, 1075, 1077,
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`1083, 1084, 1087, 1088, 1090, 1097-1108, 1110, 1115-1120, 1126, 1127, 1131,
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`4
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`IPR2016-00286
`U.S. Patent 8,822,438
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`1138, 1140-1151, 1153-1156, 1160-1163, 1165-1169, 1171-1186, and 1190 under
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`Federal Rules of Evidence 401, 402, and 403. In particular, Exhibits 1074, 1075,
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`1077, 1083, 1084, 1087, 1088, 1090, 1097-1108, 1110, 1115-1120, 1126, 1127,
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`1131, 1138, 1140-1151, 1153-1156, 1160-1163, 1165-1169, 1171-1186, and 1190
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`are not relied upon, or even cited, in 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
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`they are thus irrelevant and not admissible.
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`Portions of Exhibits 1091 and 1093 and 1152 in its Entirety Are Irrelevant
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`Patent Owner objects to the use of paragraphs 23-29, 32-34, 42, 44-46 and
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`paragraphs 72-74 of Exhibit 1091, paragraph 13 of Exhibit 1093, and 1152 in its
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`entirety under Federal Rules of Evidence 401, 402, and 403. In particular, these
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`paragraphs and exhibits are not substantively relied upon, or even cited, in the
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`Reply. Accordingly, the aforementioned paragraphs and exhibits do not appear to
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`make any fact of consequence in determining the action more or less probable than
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`it would be without them and are thus irrelevant and not admissible.
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`5
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`IPR2016-00286
`U.S. Patent 8,822,438
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`Exhibits 1091, 1093, 1095, and 1152 Are Outside the Scope of Response and
`Petition
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`Patent Owner objects to Exhibits 1091, 1093, 1095 and 1152 in their entirety
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`as well as the supporting exhibits as outside the scope of Patent Owner’s Response
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`and 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 an
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`original…claim,” and/or constitute “new evidence that could have been presented
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`in a prior filing.” Office Trial Practice Guide, 77 Fed. Reg. 48756, 48767 (Aug.
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`14, 2012). Petitioners now attempt to bring forth arguments belatedly, which
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`Patent Owner has no opportunity to rebut under the rules, and no time to request
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`relief to address under the schedule of the proceeding. As such, they are improper
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`and should not be considered by the Board.
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`Further, Patent Owner objects to Exhibits 1091, 1093, 1095 and 1152 under
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`37 C.F.R. § 42.6(a)(3) , 37 C.F.R. § 42.65, Fed. R. Evid. 705, and Office Patent
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`Trial Practice Guide, Part II, § I (77 Fed. Reg. 48756, 48763 (Aug. 14, 2012)) for
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`failing to disclose with specificity the underlying facts or data relied upon in the
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`6
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`IPR2016-00286
`U.S. Patent 8,822,438
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`affidavits of Petitioners’ experts and for incorporating by reference exhibits cited in
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`their entirety.
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`Exhibits 1074, 1075, 1077, 1083-1086, 1088-1090, 1097-1151, 1153-1156, 1160-
`1163, and 1165-1187 Are Outside the Scope of Response and Petition
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`Petitioners object to Exhibits 1074, 1075, 1077, 1083-1086, 1088-1090,
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`1097-1151, 1153-1156, 1160-1163, and 1165-1187 under 37 C.F.R. § 42.223, 37
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`C.F.R. 42.23(b), and Office Patent Trial Practice Guide, Part II, § I (77 Fed. Reg.
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`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 1074, 1075, 1077, 1083-1086, 1088-1090, 1097-1151,
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`1153-1156, 1160-1163, and 1165-1187. This new evidence is prejudicial and
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`irrelevant to any issue properly raised in this proceeding under FRE 402, FRE 403,
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`and 37 C.F.R. § 42.61. These exhibits are used by Petitioners to present new
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`invalidity theories and arguments in an effort to make out a prima facie case of
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`unpatentability, raise new issues, or belatedly present evidence which are either
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`inapposite or could have been submitted with the Petition, not with the Reply.
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`In addition, Patent Owner objects to portions of Petitioners’ Reply on the
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`basis of 37 C.F.R. § 42.6(a)(3) for incorporating by reference significant portions
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`of cited exhibits including, but not limited to, Exhibits 1093 and 1095.
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`7
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`IPR2016-00286
`U.S. Patent 8,822,438
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`Respectfully submitted,
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`Date: January 23, 2017
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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)
`dpritikin@sidley.com
`Bindu Donovan (pro hac vice)
`bdonovan@sidley.com
`Paul J. Zegger (Reg. No. 33,821)
`pzegger@sidley.com
`Todd Krause (Reg. No. 48,860)
`tkrause@sidley.com
`Isaac Olson (pro hac vice)
`iolson@sidley.com
`Alyssa B. Monsen (pro hac vice)
`amonsen@sidley.com
`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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`8
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`IPR2016-00286
`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. § 42.64(b)(1) was served on
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`counsel of record on January 23, 2017 by filing this document through the End-to-
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`End System, as well as delivering a copy via electronic mail to counsel of record
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`for the Petitioners and Patent Co-Owner at the following addresses:
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`William Hare - bill@miplaw.com
`Gabriela Materassi - materassi@miplaw.com
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`Teresa Stanek Rea - TRea@Crowell.com
`Shannon M. Lentz - SLentz@Crowell.com
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`Anthony C. Tridico - anthony.tridico@finnegan.com
`Jennifer H. Roscetti - jennifer.roscetti@finnegan.com
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`Date: January 23, 2017
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`Respectfully submitted,
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`/Dianne B. Elderkin /
`Dianne B. Elderkin
`Registration No. 28,598
`Counsel for Patent Owner
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`9
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