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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________
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`WOCKHARDT BIO AG
`
`Petitioner
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
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`Patent Owner
`________________________
`
`Case IPR2016-01582
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`U.S. Patent No. 8,822,438
`________________________
`
`
`PETITIONER’S OPPOSITION TO PATENT OWNER’S MOTION TO
`EXCLUDE EVIDENCE
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`Mail Stop "PATENT BOARD"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, Virginia 22313–1450
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`IPR2016-01582
`Wockhardt’s Opposition to Janssen’s Motion to Exclude Evidence
`INTRODUCTION
`
`I.
`
`37 C.F.R. § 42 governs these proceedings, and it “shall be construed to
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`secure the just, speedy, and inexpensive resolution of every proceeding.” § 42.1(b).
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`The “just” requirement mandates that the Board consider all of the evidence
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`introduced by Petitioner Wockhardt Bio AG (“Wockhardt”).
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`II. STANDARD
`As the movant, Patent Owner Janssen ("Janssen") bears the burden of
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`proving that the challenged exhibits are inadmissible. Liberty Mutual Insurance
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`Co. v. Progressive Casualty Insurance Co., CBM2012-00002, Paper 66 at 59
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`(January 23, 2014); 37 C.F.R. §42.20(c). Janssen failed to meet this burden. As a
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`matter of policy, the Board disfavors excluding evidence; “it is better to have a
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`complete record of the evidence submitted by the parties than to exclude particular
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`pieces.” Id. at 60-61.
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`I. Exhibits 1077, 1048-1076, 1078 and 1078 are relevant.
`Janssen alleges that Dr. Stoner’s Declaration (EX1077) and related exhibits
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`(EX1048-EX1076, EX1078, EX1080) are irrelevant and should be excluded
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`because this evidence does not fall within the statutorily permissible scope for
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`challenging patent claims “only on the basis of prior art.” (Janssen Mot. at 5, citing
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`35 U.S.C. § 311(b).) But Janssen’s argument is flawed for two reasons.
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`First Dr. Stoner’s Declaration and the exhibits relied upon by Dr. Stoner
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`(EX1048-EX1076, EX1078, EX1080) are relevant for the purpose of analyzing the
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`
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`1
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`
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`IPR2016-01582
`Wockhardt’s Opposition to Janssen’s Motion to Exclude Evidence
`obviousness of the claims of the ’438 patent. As Janssen correctly points out,
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`commercial success, if it exists, can be relevant to the issue of obviousness of a
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`patent claim. Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299 (Fed. Cir. 2006); see
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`Patent Owner’s Response at 64-68. In this instance, Janssen itself attempted to
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`claim commercial success as an objective indicia of non-obviousness in its Patent
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`Owner’s Response. (Id.) Indeed proper obviousness analysis requires looking at
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`several factors including objective considerations such as commercial success,
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`long felt need, and the failure of others. KSR Int'l Co. v. Teleflex, Inc., 550 U.S.
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`398, 406, (2007) (citing Graham v. John Deere Co. of Kan. City, 383 U.S. 1, 17–
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`18, (1966)). Thus, in accordance with obviousness law and Petitioner’s duty to
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`address any known objective considerations, Dr. Stoner’s declaration and the relied
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`upon exhibits are directed to evaluating whether Zytiga® (abiraterone acetate)
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`enjoys a commercial success that has a nexus to U.S. Patent No. 8,822,438 (the
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`“’438 patent”). (EX1077, ¶ 7.)
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`Janssen overlooks that critically, during prosecution of the ‘438 patent,
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`patentees were only able to overcome compelling prior art rejections based on
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`“commercial showings.” Janssen essentially argues that Wockhardt should have
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`turned a blind eye and not addressed known evidence related to any obviousness
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`analysis of the ’438 patent. But this argument is not grounded in any law. Janssen
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`cannot have it both ways: They cannot attempt to establish non-obviousness with
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`2
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`IPR2016-01582
`Wockhardt’s Opposition to Janssen’s Motion to Exclude Evidence
`evidence of commercial success in the course of prosecuting a patent, and again
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`during an IPR proceeding, but then argue that Wockhardt is prohibited from
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`addressing such, commenting upon, and offering its own evidence on the issue.
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`Second, Exhibits 1077, 1048-1076, 1078, and 1080 should not be excluded
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`because these pieces of evidence post-date the filing date of the ’438 patent, as
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`implied by Janssen. (See Janssen Mot. at 4-5.) Evidence of commercial success (or
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`lack thereof in this instance) expectedly would post-date the filing date of the ’438
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`patent. As explained by Dr. Stoner, his declaration and the supporting exhibits are
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`used to “evaluate the ‘commercial success’ of Zytiga®, including an inquiry as to
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`whether any substantial level of sales can be attributed to the formulations and
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`methods claimed in the ’438 patent, as opposed to other drivers such as feature of
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`the claims that already existed in the prior art, other patent or market exclusivities,
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`or other commercial drivers such as marketing and promotion”—factors that would
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`not be known until after the filing date of the ’438 patent. (EX1077, ¶ 11.)
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`For these reasons Exhibits 1077, 1048-1076, 1078, and 1080 are relevant
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`and should not be excluded from this proceeding.
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`3
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`IPR2016-01582
`Wockhardt’s Opposition to Janssen’s Motion to Exclude Evidence
`II. Portions of Exhibits 1002, 1077, 1103, and 1104 along with Exhibits
`1013, 1048, 1050, 1051, 1053-1055, 1059, 1066, 1067, 1073-1076, 1080,
`1082, 1084, 1086, 1093, 1094, 1107-1114, and 1116-1119 are relevant
`and should not be excluded.
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`Janssen alleges that paragraphs 46-57, 106, 117, and 119-123 of Dr.
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`Godley’s declaration (EX1002), paragraphs 13-22, 24-32, or 72 of Dr. Stoner’s
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`declaration (EX1077), paragraphs 3-4, 6-7, 9-13, 15, 17-19, 28, 31, 37-38, 40, 42,
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`44, 46, or 48 of Dr. Godley’s reply declaration (EX1104), paragraphs 5-10, 12,
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`15-19, 27-30, 37, 39-41, or 43 of Dr. Stoner’s reply declaration (EX1103), and
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`paragraphs 17-33, 36, 38-41, 43-49, 51-53, or 56-61 of Dr. McKeague’s reply
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`declaration (EX1106) are irrelevant. Janssen seems to have performed a text search
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`on Wockhardt’s briefs, and if a paragraph was not expressly cited in a brief,
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`Janssen included it in its motion to exclude as irrelevant—regardless of the
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`substance of those paragraphs. But this approach is flawed for two reasons. First,
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`Janssen’s understanding of the law regarding the relevance of evidence is
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`incorrect. Second, a review shows that these paragraphs are relevant.
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`First, Janssen’s contention—any paragraph of a declaration that is not
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`directly cited in a brief is irrelevant—is legally incorrect. Evidence is relevant if it
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`“has any tendency to make a [material] fact more or less probable than it would be
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`without the evidence,” F.R.E. 401, and the federal rules of evidence set a very low
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`bar for relevance, as recognized by the Federal Circuit and Board alike. OddzOn
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`Prods., Inc. v. Just Toys, Inc., 122 F.3d 1396, 1407 (Fed. Cir. 1997); Laird Techs.,
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`4
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`IPR2016-01582
`Wockhardt’s Opposition to Janssen’s Motion to Exclude Evidence
`Inc. v. GrafTech Int’l Holdings, Inc., Case IPR2014-00025, slip op. at 44 (PTAB
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`Mar. 25, 2015) (Paper at 45). The test for relevance is not whether the challenged
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`evidence was cited or analyzed sufficiently. See First Quality Baby Prods. v.
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`Kimberly-Clark Worldwide, IPR2014-01023, Paper 56 at 35 (Dec. 10, 2015) (a
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`party’s failure to provide necessary analysis “does not negate the relevance of that
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`evidence”). Indeed, it is extremely common for expert declarations to include
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`information that is not directly cited in a party’s brief. Expert declarations almost
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`always include information relevant to the expert’s opinions that are not cited by
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`paragraph number in the brief. Such is the case here. In fact, Janssen’s own expert
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`declarations are replete with paragraphs that are not cited in Janssen’s own
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`Response brief.
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`Second, the challenged paragraphs are indeed relevant and should not be
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`excluded. Janssen seeks to exclude these paragraphs solely because Wockhardt
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`does not explicitly cite to these paragraphs. However, an expert is expected to
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`provide the basis, rationale, and underpinnings for any conclusion reached by the
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`expert. See F.R.E. 702(b). These paragraphs support the analysis and conclusions
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`of Dr. Stoner, Dr. Godley, and Dr. McKeague in their respective declarations, and
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`as contained in the portions of their declarations that were cited in the Petition and
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`Petitioner’s Reply. Contrary to Janssen’s contention, IPR proceedings do not have
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`any requirement that every paragraph of a declaration be expressly cited in a brief.
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`5
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`IPR2016-01582
`Wockhardt’s Opposition to Janssen’s Motion to Exclude Evidence
`See Ericsson v. Intellectual Ventures, IPR2014-00915, Paper 37 at 11 (December
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`7, 2015). Moreover, these paragraphs provide context and support for statements
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`in the other unchallenged and cited paragraphs of the declarations of Dr. Stoner,
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`Dr. Godley, and Dr. McKeague. Thus, these paragraphs are relevant and should not
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`be excluded from this proceeding.
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`Similar to the reasons above, Exhibits 1013, 1048, 1050, 1051, 1053-1055,
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`1059, 1066, 1067, 1073-1076, 1080, 1082, 1084, 1086, 1093, 1094, 1107-1114,
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`and 1116-1119 should not be excluded. EX1013 is used by Dr. Godley in his
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`initial declaration (WCK1002). Exhibits 1048, 1050, 1051, 1053-1055, 1059,
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`1066, 1067, 1073-1076, and 1080 are cited or replied upon by Dr. Stoner in his
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`initial declaration (WCK1077). Exhibits 1093 and 1094 are cited or relied upon by
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`Dr. Godley in his second declaration (WCK1104). Exhibits 1107-1114 are cited in
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`Dr. Stoner’s second declaration (WCK1103). Exhibits 1116-1119 are cited or
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`relied upon by Dr. McKeague in his declaration (WCK1106). Exhibits 1082, 1084
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`and 1086 were presented during the deposition of Dr. Matthew Rettig. Each of
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`these exhibits provides context and support for statements in the other
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`unchallenged and cited paragraphs of the respective declarations, and these
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`exhibits are relevant for assessment of each expert’s credibility.
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`6
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`IPR2016-01582
`Wockhardt’s Opposition to Janssen’s Motion to Exclude Evidence
`III. Exhibits 1050, 1063, 1065, 1066, 1069, 1074, 1087, 1094, 1100, 1102,
`1109, 1112, and 1116, 1034, 1057, 1060-1061, 1067, 1068, 1070-1073,
`1080, 1114, 1119, and Attachments B-1 and B-2 of Exhibit 1077 have
`been authenticated.
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`Janssen moves to exclude the following exhibits based on a lack of
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`authentication: Exhibits 1050, 1063, 1065, 1066, 1069, 1074, 1087, 1094, 1100,
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`1102, 1109, 1112, 1116, 1034, 1057, 1060-1061, 1067, 1068, 1070-1073, 1080,
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`1114, 1119, and Attachments B-1 and B-2 of Exhibit 1077. (See Janssen Mot. at
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`9.) At the outset, Janssen initially objected to all of these exhibits and Wockhardt
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`timely responded to each objection and timely served supplemental evidence
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`authenticating each of these exhibits1. This alone should have been dispositive of
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`the issue. However, Janssen is asking the Board to set a threshold for
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`authentication much higher than required.
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`Rule 901 of the Federal Rules of Evidence explains that evidence is
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`admissible if there is sufficient support to find that the evidence in question is what
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`its proponent claims. Additionally, the burden of proof for authentication is slight.
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`Lexington Ins. Co. v. W. Penn. Hosp, 423 F.3d 318, 329 (3d Cir. 2005). Rule
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`901(b) lists nine examples of authentication techniques, but the list of examples is
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`not intended to be exclusive. Rule 901(a) merely requires that a proponent produce
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`sufficient evidence of authenticity to support a prima facie case that the item is
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`genuine. Rickets v. City of Hartford, 74 F.3d 1397, 1409–11 (2d Cir. 1996). Courts
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`1 Wockhardt files such evidence with the Board with this filing.
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`7
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`IPR2016-01582
`Wockhardt’s Opposition to Janssen’s Motion to Exclude Evidence
`have maintained that a bona fide dispute regarding the authenticity of evidence
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`should be decided by the trier of fact and conflicting evidence goes to weight, not
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`admissibility, as long as some reasonable person could believe that the item is what
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`it is claimed to be. Id. at 1411.
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`Here, Wockhardt has properly authenticated all of the challenged exhibits
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`via declarations and supplemental evidence served to Janssen. The table below
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`shows where each of the challenged exhibits was authenticated:
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`EX1050
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`EX1063
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`EX1065
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`EX1057, EX1060,
`EX1061, EX1066,
`EX1074
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`EX1070, EX1068
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`Stoner Initial Suppl. Decl. (WCK1130), ¶¶ 5
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`Stoner Initial Suppl. Decl., ¶ 10
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`Stoner Initial Suppl. Decl., ¶¶ 4, 7
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`Stoner Initial Suppl. Decl., ¶¶ 4, 7
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`Stoner Initial Suppl. Decl., ¶¶ 7, 8. Additionally
`replacement for EX1070 was also served and now
`filed as Ex.1131.
`
`EX1080
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`Stoner Initial Suppl. Decl., ¶ 12
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`Attachments B-1 and B-
`2 of EX1077
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`EX1067, EX1068,
`EX1071-EX1073
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`Stoner Initial Suppl. Decl., ¶ 13
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`Stoner Initial Suppl. Decl., ¶ 7
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`EX1071-EX1073
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`Stoner Initial Suppl. Decl., ¶¶ 7, 8
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`EX1034
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`EX1094
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`Godley Initial Suppl. Decl. (WCK1129), ¶ 4
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`Godley Second Suppl. Decl. (WCK1123), ¶¶ 4-6
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`8
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`IPR2016-01582
`Wockhardt’s Opposition to Janssen’s Motion to Exclude Evidence
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`EX10872
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`EX1102
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`EX1100
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`EX1114
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`Stoner Second Suppl. Decl. (WCK1124), ¶¶ 4-5
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`Stoner Second Suppl. Decl. (WCK1124), ¶¶ 4, 6
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`Stoner Second Suppl. Decl., (WCK1124), ¶¶ 4, 7
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`Stoner Second Suppl. Decl., (WCK1124), ¶¶ 8, 10,
`and 11. Additionally replacement for EX1114 was
`also served and now filed as Ex.1128.
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`EX11093, EX1112
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`Stoner Second Suppl. Decl., (WCK1124), ¶¶ 12, 13,
`and 15
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`EX1116
`EX11194
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`Kenton Decl. (WCK1125), ¶ 3
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`Kenton Decl., ¶ 6
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`Thus, Wockhardt has met its burden in proving the authenticity of the
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`challenged exhibits. For these reasons, Exhibits 1050, 1063, 1065, 1066, 1069,
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`1074, 1087, 1094, 1100, 1102, 1109, 1112, 1116, 1034, 1057, 1060-1061, 1067,
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`1068, 1070-1073, 1080, 1114, 1119, and Attachments B-1 and B-2 of Exhibit 1077
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`are admissible.
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`IV. Exhibits 1057, 1060-61, 1065, 1067-1073, 1080, 1087, 1100, 1102, and
`1109 should not be excluded based on hearsay.
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`Exhibits 1057, 1060-1061, 1065, 1067-1073, 1080, 1087, 1100, 1102, and
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`1109 should not be excluded on the basis of hearsay. F.R.E. 801(c) defines
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`
`2 Notably, this Exhibit is Janssen’s own document that either Janssen
`generated or contributed to, or at least a document that has been in Janssen’s
`possession, custody, and/or control.
`3 Supra note 2.
`4 Supra note 2.
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`
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`9
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`
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`IPR2016-01582
`Wockhardt’s Opposition to Janssen’s Motion to Exclude Evidence
`“hearsay” as a statement that “a party offers in evidence to prove the truth of the
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`matter asserted in the statement.” It is well established, however, that “[i]f the
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`significance of an offered statement lies solely in the fact that it was made, no issue
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`is raised as to the truth of anything asserted, and the statement is not hearsay.”
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`F.R.E. 801 Advisory Committee’s Notes on Proposed Rules (citing Emich Motors
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`Corp. v. General Motors Corp., 181 F.2d 70 (7th Cir. 1950)).
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`In its Motion to Exclude, Janssen failed to recognize that Exhibits 1057,
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`1060-1061, 1065, 1067-1073, 1080, 1087, 1100, 1102, and 1109 serve a non-
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`hearsay purpose. Wockhardt offered Exhibits 1057, 1060-61, 1065, 1067-1073,
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`1080, 1087, 1100, 1102, and 1109 for what they describe to a POSA, and not for
`
`the truth of the matter asserted therein. The law is well established that the Board
`
`will not exclude evidence that is proffered to show what a POSA would have
`
`known about the relevant field of art. See Liberty Mut. Ins. Co. Petitioner,
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`CBM2012-00010, Final Decision, Paper 59 at 37 (P.T.A.B. Feb. 24, 2014) (“We
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`further agree with Liberty that the articles that are Exhibits 1025-1034 and 1036
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`serve a non-hearsay purpose for which they can be admitted— namely to show
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`what one with ordinary skill in the art would have known about technical features
`
`and developments in the pertinent art.”). Furthermore, Exhibits 1057, 1060-61,
`
`1065, 1067-1073, 1080, 1087, 1100, 1102, and 1109 are not hearsay because they
`
`provide context for the testimony of expert witnesses Dr. Stoner and therefore can
`
`
`
`10
`
`
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`IPR2016-01582
`Wockhardt’s Opposition to Janssen’s Motion to Exclude Evidence
`assist the Board in assessing his credibility. At least for these reasons, Janssen’s
`
`motion to exclude Exhibits 1057, 1060-61, 1065, 1067-1073, 1080, 1087, 1100,
`
`1102, and 1109 as hearsay under FRE 801 is improper and should be denied.
`
`Moreover, Janssen objects to Exhibits 1057, 1060-1061, 1065, and 1067-
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`1073, but correctly characterizes these as investment analyst reports. These
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`documents clearly fall within the exception to the hearsay Rule 803(17), which
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`states: “Market Reports and Similar Commercial Publications. Market quotations,
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`lists, directories, or other compilations that are generally relied on by the public or
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`by persons in particular occupations.” Dr. Stoner relied on these commercial
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`publications as a person in the occupation of consulting in applied business
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`economics. Janssen fails to prove or even argue that the documents are not
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`generally relied on by the public or by persons in Dr. Stoner’s occupational field.
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`Additionally, to the extent that any of the evidence is considered hearsay
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`(and Wockhardt does not concede this), Exhibits 1057, 1060-61, 1065, 1067-1073,
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`1080, 1087, 1100, 1102, and 1109 should not be excluded because experts are
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`permitted to rely on hearsay. Generally, experts are permitted leeway with respect
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`to hearsay evidence: “for example, help to identify, gauge the reliability of, and
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`interpret evidence that would otherwise elude, mislead, or remain opaque to a
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`layperson.” Marvel Characters, Inc. v. Kirby, 726 F.3d 119, 135 (2d Cir. 2013).
`
`Marvel further explains that “such a witness might offer background knowledge or
`
`
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`11
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`IPR2016-01582
`Wockhardt’s Opposition to Janssen’s Motion to Exclude Evidence
`context that illuminates or places in perspective past events.” Id. at 136. Moreover,
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`“an expert is permitted to disclose hearsay for the limited purpose of explaining the
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`basis for his expert opinion.” United States v. Dukagjini, 326 F.3d 45, 58 (2d Cir.
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`2003). This is what Dr. Stoner does here: he is relying on these exhibits, in part, as
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`a basis for his opinion about the ’438 patent.
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`Finally, even if Exhibits 1057, 1060-61, 1065, 1067-1073, 1080, 1087, 1100,
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`1102, and 1109 were hearsay—which they are not— they would nevertheless be
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`admissible under F.R.E. 703. F.R.E. 703 provides that “[a]n expert may base an
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`opinion on facts or data . . . [b]ut if the facts or data would otherwise be
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`inadmissible, the proponent of the opinion may disclose them to the jury only if
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`their probative value in helping the jury evaluate the opinion substantially
`
`outweighs their prejudicial effect.” F.R.E. 703. Janssen has not established that the
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`challenged exhibits will have a prejudicial effect, and, therefore, because these
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`exhibits are probative, they are admissible.
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`Accordingly Exhibits 1057, 1060-61, 1065, 1067-1073, 1080, 1087, 1100,
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`1102, and 1109 should not be excluded.
`
`
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`
`
`
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`12
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`
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`IPR2016-01582
`Wockhardt’s Opposition to Janssen’s Motion to Exclude Evidence
`V. CONCLUSION
`As shown above, Janssen has not met its burden of proving that the
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`challenged exhibits are inadmissible under the Federal Rules of Evidence.
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`Janssen’s Motion to Exclude all challenged exhibits should therefore be denied.
`
`
`Respectfully submitted,
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`
`
`Date: May 12, 2017
`1100 New York Avenue, N.W.
`Washington, DC 20005-3934
`(202) 371-2600
`
`
`___________________________
`Dennies Varughese
`Registration No. 61,868
`Attorney for Petitioner
`
`
`
`13
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`
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`IPR2016-01582
`Wockhardt’s Opposition to Janssen’s Motion to Exclude Evidence
`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e))
`
`The undersigned hereby certifies that the above-captioned "Petitioner’s
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`Opposition to Patent Owner’s Motion to Exclude Evidence," and supporting
`
`Exhibits WCK1123 – WCK1131 were served in its entirety on May 12, 2017, upon
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`the following parties via email:
`
`Dianne B. Elderkin: delderkin@akingump.com
`Barbara L. Mullin: bmullin@akingump.com
`Ruben H. Munoz: rmunoz@akingump.com
`JANS-ZYTIGA@akingump.com
`
`David. T. Pritikin: dpritikin@sidley.com
`Bindu Donovan: bdonovan@sidley.com
`Paul J. Zegger: pzegger@sidley.com
`Todd L. Krause: tkrause@sidley.com
`Alyssa Monsen: amonsen@sidley.com
`ZytigaIPRTeam@sidley.com
`
`Anthony C. Tridico: anthony.tridico@finnegan.com
`Jennifer H. Roscetti: jennifer.roscetti@finnegan.com
`
`STERNE, KESSLER, GOLDSTEIN & FOX PLLC
`
`
`
`Date: May 12, 2017
`1100 New York Avenue, N.W.
`Washington, DC 20005
`(202) 371-2600
`
`
`
` f
`Dennies Varughese
`Registration No. 61,868
`Attorney for Petitioner
`
`
`
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`
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