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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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`WOCKHARDT BIO AG
`Petitioner
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`v.
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`JANSSEN ONCOLOGY, INC.,
`Patent Owner
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`________________
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`Case IPR2016-01582
`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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`IPR2016-01582
`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 1004, 1009-1011, 1016, 1017, 1019, 1025, 1026, 1033, 1034, 1063, 1082,
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`1084, 1086, 1087, 1090-1094, 1096, 1098, 1100-1105, 1107-1114, 1116-1119 and
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`1122, which were submitted by Petitioner Wockhardt Bio AG (“Wockhardt”) in its
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`Petitioner’s Reply.
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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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`Wockhardt’s Reply on April 19, 2017. Paper No. 54. Janssen’s objections provide
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`notice to Wockhardt that Janssen may move to exclude these exhibits under 37
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`C.F.R. § 42.64(c).
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`Exhibits 1082, 1091, 1092, 1094, 1096, 1100, 1102, 1107-1111, 1116-1119,
`Paragraphs 13, 14, 42 and 43 of Exhibits 1103 and 1122, and Paragraph 48 of
`Exhibit 1104 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 1082, 1091, 1092, 1094-1096, 1100, 1102, 1107-1111, and 1116-1119
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`post-date the priority date of the patent under review in this proceeding. As such,
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`Exhibits 1082, 1091, 1092, 1094-1096, 1100, 1102, 1107-1111, and 1116-1119 do
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`not pass the test of relevant evidence under Federal Rule of Evidence 401 and are
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`thus not admissible under Federal Rule of Evidence 402. As a separate basis for
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`1
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`IPR2016-01582
`U.S. Patent 8,822,438
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`excluding paragraphs 13 and 14 of Exhibits 1103 and 1122, to the extent that
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`Wockhardt relies on these exhibits to support its positions regarding commercial
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`success under the Graham factors, Janssen objects under Federal Rule of Evidence
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`402 for the additional reason that evidence related to XTANDI®, or comparisons
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`between XTANDI® and ZYTIGA®, are not relevant to the commercial success of
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`ZYTIGA®.
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`As a separate basis for excluding paragraphs 42 and 43 of Exhibits 1103 and
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`1122 and paragraph 48 of Exhibit 1104, to the extent Wockhardt relies on these
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`exhibits to support its position regarding unexpected results and commercial
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`success under the Graham factors, Janssen objects under Federal Rule of Evidence
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`402 for the additional reason that evidence related to the dosing information of
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`JEVTANA®, which was not available until after the priority date of the patent
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`under review in this proceeding, is not relevant to what was known in the art
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`before the ’438 Patent.
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`Exhibits 1087, 1094, 1100, 1102, 1109, 1110, 1112, 1116 and 1118 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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`IPR2016-01582
`U.S. Patent 8,822,438
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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 this proceeding, Wockhardt relies on printouts from websites that it has
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`introduced into the record as Exhibits 1087, 1094, 1100, 1102, 1109, 1110, 1112,
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`1116 and 1118. Wockhardt, however, has not brought forth sufficient evidence to
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`support a finding that these exhibits are what Wockhardt claims, or that any of
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`these exhibits is self-authenticating under Federal Rule of Evidence 902; therefore,
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`Janssen objects to the admissibility of each of these exhibits under Federal Rule of
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`Evidence 901(a).
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`Exhibits 1114 and 1119 Lack Authentication
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`Janssen objects to Exhibits 1114 and 1119 at least because they have not
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`been authenticated as required by Federal Rule of Evidence 901. Wockhardt has
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`failed to provide evidence regarding the origin of these documents and to establish
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`whether the documents are true and correct copies. For example, Exhibit 1114
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`lacks the bibliographic information from which Janssen can discern the
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`authenticity, as well as its date of publication. Exhibit 1119 lacks proper
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`IPR2016-01582
`U.S. Patent 8,822,438
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`authentication and foundation at least because the circumstances surrounding its
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`preparation have not been explained, and the accuracy of the information found
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`therein has not been established. In addition, Exhibit 1119 contains a
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`“Confidential” stamp at the bottom of each page that calls into question its
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`authenticity.
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`Exhibits 1090 and 1114 are Incomplete
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`Janssen objects to Exhibits 1090 and 1114 under Federal Rule of Evidence
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`106 because these exhibits appear to be excerpts of larger documents or books.
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`Exhibits 1082, 1091, 1092, 1094, 1096, 1100, 1102, 1107-1111, and 1116-1119 are
`More Prejudicial than Probative
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`Janssen objects to Exhibits 1082, 1091, 1092, 1094,1096, 1100, 1102, 1107-
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`1111, and 1116-1119 at least because they are not relevant to this proceeding as
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`required by Federal Rule of Evidence 402, or, alternatively, because any probative
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`value of these documents is substantially outweighed by the danger of confusing
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`the issues under Federal Rule of Evidence 403. Specifically, these exhibits are not
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`relevant to this proceeding and are of little probative value because they are not
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`“prior art consisting of patents or printed publications” as required by 35 U.S.C. §
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`311(b) but contain highly prejudicial statements related to what was known in the
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`art after the invention of the ’438 Patent was made that confuse the issues raised in
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`4
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`the Petition.
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`IPR2016-01582
`U.S. Patent 8,822,438
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`Exhibits 1087, 1094, 1100, 1102, 1109, 1110, 1112, 1116, 1118 and 1119
`are Hearsay
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`Janssen objects to Exhibits 1087, 1094, 1100, 1102, 1109, 1110, 1112, 1116,
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`1118 and 1119 under Federal Rules of Evidence 801 and 802. These exhibits
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`contain out-of-court statements by non-parties that Wockhardt apparently seeks to
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`use to prove the truth of the matter asserted, and Wockhardt does not provide any
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`basis for the Patent Trial and Appeal Board to conclude that they fall within any
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`hearsay exception.
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`Exhibit 1107 is an Improper Summary
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`Janssen objects to Exhibit 1107 under Federal Rule of Evidence 1006 as an
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`improper summary which fails to provide the original data or information
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`underlying the figures and tables disclosed in the exhibit.
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`Exhibits 1004, 1009-1011, 1016, 1017, 1019, 1025, 1026, 1033, 1034, 1063, 1082,
`1084, 1086, 1087, 1091-1094, 1098, 1100, 1101, 1105, 1107-1114 and 1116-1119
`Are Irrelevant
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`Janssen objects to the use of Exhibits 1004, 1009-1011, 1016, 1017, 1019,
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`1025, 1026, 1033, 1034, 1063, 1082, 1084, 1086, 1087, 1091-1094, 1098, 1100,
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`1101, 1105, 1107-1114 and 1116-1119 under Federal Rules of Evidence 401, 402,
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`and 403. In particular, Exhibits 1004, 1009-1011, 1016, 1017, 1019, 1025, 1026,
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`1033, 1034, 1063, 1084, 1087, 1091-1094, 1100, 1101, 1107-1114 and 1116-1119
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`5
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`IPR2016-01582
`U.S. Patent 8,822,438
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`are not substantively relied on, or even cited, in Wockhardt’s Reply1, whereas
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`Exhibits 1082, 1086, 1098 and 1105 are not cited in either the Reply or any of the
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`accompanying declarations. Accordingly, the aforementioned exhibits do not
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`appear to make any fact of consequence in determining the action more or less
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`probable than it would be without them and are thus irrelevant and not admissible.
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`Paragraphs 5-10, 12, 15-19, 27-30, 37, 39-41 and 43 of Exhibit 1103,
`Paragraphs 3, 4, 6, 7, 9-13, 15, 17-19, 28, 31, 32, 37, 38, 40, 42, 44, 46, and 48 of
`Exhibit 1104, and Paragraphs 17-33, 36, 38-41, 43-49, 51-53 and 56-61 of
`Exhibit 1106 are Irrelevant
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`In addition, Janssen objects to the use of paragraphs 5-10, 12, 15-19, 27-30,
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`37, 39-41 and 43 of Exhibit 1103, paragraphs 3, 4, 6, 7, 9-13, 15, 17-19, 28, 31, 32,
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`37, 38, 40, 42, 44, 46, and 48 of Exhibit 1104, and paragraphs 17-33, 36, 38-41,
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`43-49, 51-53 and 56-61 of Exhibit 1106 under Federal Rules of Evidence 401, 402,
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`and 403. In particular, these paragraphs are not substantively relied on, or even
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`cited, in the Reply. Accordingly, the aforementioned paragraphs of Exhibits 1103,
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`1104 and 1106 do not appear to make any fact of consequence in determining the
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`action more or less probable than it would be without them and are thus irrelevant
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`and not admissible. Further, permitting reference to or reliance on these
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`paragraphs from the declarations of Dr. Stoner, Dr. Godley and Dr. McKeague in
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`1 These exhibits were cited in at least one of the declarations submitted with
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`Wockhardt’s Reply.
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`IPR2016-01582
`U.S. Patent 8,822,438
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`other submissions of Wockhardt would also be impermissible, misleading,
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`irrelevant, and unfairly prejudicial to Janssen. To the extent Wockhardt attempts to
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`rely on or submit the aforementioned portions of Exhibits 1103, 1104 or 1106 in
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`the future as evidence in support of new substantive positions, doing so would be
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`untimely, in violation of the applicable rules governing this proceeding, and
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`unfairly prejudicial to Janssen. Janssen further objects to Exhibits 1103, 1104 and
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`1106 to the extent they rely on exhibits that are objected to herein.
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`Respectfully submitted,
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`Date: April 26, 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
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`David T. Pritikin (pro hac vice)
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`Bindu Donovan (pro hac vice)
`Todd L. Krause (Reg. No. 48,860)
`Paul J. Zegger (Reg. No. 33,821)
`Alyssa B. Monsen (pro hac vice)
`SIDLEY AUSTIN LLP
`787 Seventh Avenue
`New York, NY 10019
`Tel.: (212) 839-5300
`Fax: (212) 839-5599
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`Counsel for Patent Owner
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`8
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`IPR2016-01582
`U.S. Patent 8,822,438
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`IPR2016-01582
`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 Petitioner and Patent Co-Owner at the
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`following addresses:
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`Dennies Varughese - dvarughe-PTAB@skgf.com
`Deborah A. Sterling - dsterlin-PTAB@skgf.com
`Lestin L. Kenton Jr. – lkenton-PTAB@skgf.com
`Ralph W. Powers III – tpowers-PTAB@skgf.com
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`Anthony C. Tridico - anthony.tridico@finnegan.com
`Jennifer H. Roscetti - jennifer.roscetti@finnegan.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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