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`Paper No. ___
`Date Filed: Feb. 2, 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 1003, 1009, 1013, 1014, 1020, 1032-1034, 1041, 1042, 1044, 1047-1080,
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`Attachments B-1 and B-2 of Exhibit 1077, and portions of Exhibit 1002, which
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`were submitted by Petitioner Wockhardt Bio AG (“Wockhardt”) during the
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`preliminary phase of 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 ten business days of the institution decision
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`issued by the Board on January 19, 2017. Paper No. 29. Janssen’s objections
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`provide notice to Wockhardt that Janssen may move to exclude these exhibits
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`under 37 C.F.R. § 42.64(c).
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`Exhibits 1048-1078 and 1080 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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`In his declaration (Exhibit 1077), Wockhardt’s declarant Dr. Stoner states that his
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`testimony is directed to the “evaluat[ion of] aspects of commercial success, from
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`an economic perspective, as it pertains to Zytiga® (abiraterone acetate) and the
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`1
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`IPR2016-01582
`U.S. Patent 8,822,438
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`U.S. Patent No. 9,822,438 Patent” (hereinafter, “the ’438 Patent”). 1 Thus, Exhibit
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`1077, as well as Exhibits 1048-1076, 1078 and 1080 cited therein, do not pass the
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`test of relevant evidence under Federal Rule of Evidence 401 because they do not
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`pertain to “prior art consisting of patents or printed publications” as required by the
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`statute governing inter partes reviews. As such, these exhibits are not admissible
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`under Federal Rule of Evidence 402.
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`Exhibits 1042, 1047-1051, 1053, 1054, 1056-1057, 1059-1074, 1076 and 1080
`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 1042, 1047-1051, 1053, 1054, 1056-1057, 1059-1074, 1076 and 1080
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`post-date the priority date of the patent under review in this proceeding. As such,
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`Exhibits 1042, 1047-1051, 1053, 1054, 1056-1057, 1059-1074, 1076 and 1080 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.
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`1 Exhibit 1077 (Declaration of Robert D. Stoner, Ph.D.) at ¶ 7 (describing
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`scope and content of declaration).
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`2
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`IPR2016-01582
`U.S. Patent 8,822,438
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`As a separate basis for excluding Exhibits 1047, 1057, 1060, 1061, 1065-
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`1073 and 10802 to the extent that Wockhardt relies on these exhibits to support its
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`positions regarding commercial success under the Graham factors,3 Janssen objects
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`under Federal Rule of Evidence 402 for the additional reason that evidence related
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`to XTANDI®, or comparisons between XTANDI® and ZYTIGA®, are not
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`relevant to the commercial success of ZYTIGA®.
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`As a separate basis for excluding Exhibits 1049, 1063 and 1064 to the extent
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`Wockhardt relies on Exhibits 1049, 1063 and 1064 to support its position regarding
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`2 Although Dr. Stoner states that the data reflected in Attachment B-2 to his
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`Declaration was obtained from Exhibit “WCK1081: IMS Health Data” (Ex. 1077
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`(Declaration of Robert D. Stoner, Ph.D.) at Attachment B-2), it appears that Dr.
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`Stoner intended to cite to Exhibit WCK1080 because Dr. Stoner described Exhibit
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`1080 as “IMS Health Data, 2012-2015” (id. at ¶9), and Wockhardt did not submit
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`an Exhibit WCK1081 with its Petition (see id.; Paper 4 (Petition) at p. i-viii). In
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`the event, Dr. Stoner intended to cite to Exhibit WCK1081, Janssen reserves its
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`right to object to this exhibit for all relevant grounds, including Wockhardt’s failure
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`to produce this exhibit in a timely manner.
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`3 See Paper 4 (Petition) at p. 62-63, and Ex. 1077 (Declaration of Robert D.
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`Stoner, Ph.D.) at ¶¶ 54-58.
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`3
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`IPR2016-01582
`U.S. Patent 8,822,438
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`unexpected results and commercial success under the Graham factors, 4 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 dosing information of JEVTANA®, which was not available until
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`after the priority date of the patent under review in this proceeding, is not relevant
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`to what was known in the art before the ’438 Patent.
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`Exhibits 1048-1050, 1053, 1054, 1063, 1065, 1066, 1069, 1074 and 1076 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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`4 See Paper 4 (Petition) at p. 53, 61, and Ex. 1077 (Declaration of Robert D.
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`4
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`Stoner, Ph.D.) at ¶ 47.
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`IPR2016-01582
`U.S. Patent 8,822,438
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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 1048-1050, 1053, 1054, 1063, 1065, 1066,
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`1069, 1074 and 1076. Wockhardt, however, has not brought forth sufficient
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`evidence to support a finding that these exhibits are what Wockhardt claims, or that
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`any of these exhibits is self-authenticating under Federal Rule of Evidence 902;
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`therefore, Janssen objects to the admissibility of each of these exhibits under
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`Federal Rule of Evidence 901(a). Furthermore, in addition to being
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`unauthenticated printouts of websites, Exhibits 1048-1050, 1053 and 1054 are also
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`incomplete and Janssen additionally objects to these exhibits under Federal Rule of
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`Evidence 106.
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`Exhibits 1034, 1057, 1060-1062, 1067, 1068, 1070-1073, 1080 and Attachments
`B-1 and B-2 of Exhibit 1077 Lack Authentication
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`Janssen objects to Exhibits 1034, 1057, 1060-1062, 1067, 1068, 1070-1073,
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`1080 and Attachments B-1 and B-2 of Exhibit 1077 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, Attachments B-1
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`and B-2 of Exhibit 1077, which appears to be a summary of prosecution filings for
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`5
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`IPR2016-01582
`U.S. Patent 8,822,438
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`the ’438 Patent, and a summary table of the sales for select oncology drugs in 2013
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`and 2014, respectively, lack proper authentication and foundation at least because
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`the circumstances surrounding the preparation of the attachments have not been
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`explained, and the accuracy of the information found therein has not been
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`established.
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`Exhibits 1009, 1032, 1033, 1041, 1059, 1060, 1067, 1070, 1073, 1075 and 1080
`are Incomplete
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`Janssen objects to Exhibits 1009, 1032, 1033, 1041, 1059, 1060, 1067, 1070,
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`1073, 1075 and 1080 under Federal Rule of Evidence 106 because these exhibits
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`appear to be excerpts of larger documents or books.
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`Exhibits 1042, 1048-1051, 1053-1054, 1056-1057, 1059-1076, 1078 and 1080 are
`More Prejudicial than Probative
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`Janssen objects to Exhibits 1042, 1048-1051, 1053-1054, 1056-1057, 1059-
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`1076, 1078 and 1080 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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`6
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`IPR2016-01582
`U.S. Patent 8,822,438
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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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`the Petition.
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`Exhibits 1048-1050, 1054, 1057, 1060-1061, 1063, 1065-1074, 1076 and 1080
`are Hearsay
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`Janssen objects to Exhibits 1048-1050, 1054, 1057, 1060-1061, 1063, 1065-
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`1074, 1076 and 1080 under Federal Rules of Evidence 801 and 802. These
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`exhibits contain out-of-court statements by non-parties that Wockhardt apparently
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`seeks to use to prove the truth of the matter asserted, and Wockhardt does not
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`provide any basis for the Patent Trial and Appeal Board to conclude that they fall
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`within any hearsay exception.
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`Exhibits 1003, 1013, 1014, 1020, 1044, 1047, 1048, 1050-1057, 1059-1062, 1064,
`1066-1076, and 1078-1080 Are Irrelevant
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`Janssen objects to the use of Exhibits 1003, 1013, 1014, 1020, 1044, 1047,
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`1048, 1050-1057, 1059-1062, 1064, 1066-1076, and 1078-1080 under Federal
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`Rules of Evidence 401, 402, and 403. In particular, these exhibits are not
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`substantively relied on, or even cited, in the Petition. Accordingly, the
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`aforementioned exhibits do not appear to make any fact of consequence in
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`IPR2016-01582
`U.S. Patent 8,822,438
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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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`Paragraphs 28, 46-57, 106, 117 and 119-123 of Exhibit 1002 and Paragraphs
`13-22, 24-32, 60-62 and 72 of Exhibit 1077 are Irrelevant
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`In addition, Janssen objects to the use of paragraphs 28, 46-57, 106, 117 and
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`119-123 of Exhibit 1002 and Paragraphs 13-22, 24-32, 60-62 and 72 of Exhibit
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`1077 under Federal Rules of Evidence 401, 402, and 403. In particular, these
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`paragraphs are not substantively relied on, or even cited, in the Petition.
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`Accordingly, the aforementioned paragraphs of Exhibit 1002 and 1077 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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`Further, permitting reference to or reliance on these paragraphs from the
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`declarations of Dr. Godley and Dr. Stoner in other submissions of Wockhardt
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`would also be impermissible, misleading, irrelevant, and unfairly prejudicial to
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`Janssen. To the extent Wockhardt attempts to rely on or submit this
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`aforementioned portions of Exhibit 1002 or Exhibit 1077 in the future as evidence
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`in support of new substantive positions, doing so would be untimely, in violation of
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`the applicable rules governing this proceeding, and unfairly prejudicial to Janssen.
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`IPR2016-01582
`U.S. Patent 8,822,438
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`Respectfully submitted,
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`Date: February 2, 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)
`Bindu Donovan (pro hac vice)
`Todd L. Krause (Reg. No. 48,860)
`Paul J. Zegger (Reg. No. 33,821)
`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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`9
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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 February 2, 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
`Christopher M. Gallo - cgallo-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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`10
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`Date: February 2, 2017
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