Paper No. ___
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`Date Filed: May 5, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
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`WOCKHARDT BIO AG,
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`Petitioner
`
`v.
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`JANSSEN ONCOLOGY, INC.,
`Patent Owner
`________________
`
`Case IPR2016-01582
`________________
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`Patent No. 8,822,438 B2
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`
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`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64(C)
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`
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`Date Filed: May 5, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`WOCKHARDT BIO AG,
`
`Petitioner
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`Patent Owner
`________________
`
`Case IPR2016-01582
`________________
`
`Patent No. 8,822,438 B2
`
`
`
`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64(C)
`
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2016-01582
`Patent No. 8,822,438
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`I.
`
`Introduction
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`Patent Owner Janssen Oncology, Inc. moves pursuant to 37 C.F.R. §
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`42.64(c) to exclude three categories of evidence submitted by Petitioner in this
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`matter. In particular, Patent Owner hereby moves to exclude:
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`1. Expert declarations and exhibits that are outside the scope of the “prior
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`art consisting of patents or printed publications” permitted by 35 U.S.C. § 311(b);
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`2. Sections of Petitioner’s declarations (and related exhibits) that are not
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`cited in any paper in this proceeding, including Petitioner’s petition and reply brief,
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`since this disconnected evidence should be excluded as irrelevant and prejudicial
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`under Fed. R. Evid. 401, 402 and 403; and
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`3. Exhibits that lack authenticity or violate the hearsay rule. Such exhibits
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`should be excluded under Fed. R. Evid. 901(a) and Fed. R. Evid. 801 and 802.
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`These grounds for exclusion are discussed below. As a preliminary matter,
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`the Federal Rules of Evidence govern the admissibility of evidence submitted in
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`the context of inter partes review proceedings before the Patent Trial and Appeal
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`Board (the “Board”). See 37 C.F.R. § 42.62(a) (“[e]xcept as otherwise provided in
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`this subpart, the Federal Rules of Evidence shall apply to a proceeding”). A
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`motion to exclude evidence before the board is a two-step process: (1) a party
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`must timely serve written objections to the challenged evidence (37 C.F.R. §
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`42.64(b)(1) (“Any objection to evidence submitted during a preliminary
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`
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`proceeding must be filed within ten business days of the institution of the trial.
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`Once a trial has been instituted, any objection must be filed within five business
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`days of service of evidence to which the evidence is directed. The objection must
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`identify the grounds for the objection with sufficient particularity to allow
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`correction in the form of supplemental evidence.”)); and (2) a party must preserve
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`its objection by filing a motion to exclude (37 C.F.R. § 42.64(c) (“A motion to
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`exclude evidence must be filed to preserve any objection”)). As noted below,
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`Patent Owner timely raised the objections underlying the basis for the present
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`motion.
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`Under Fed. R. Evid. 401, evidence is relevant if: (a) it has any tendency to
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`make a fact more or less probable than it would be without the evidence; and (b)
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`the fact is of consequence in determining the action. Irrelevant evidence is not
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`admissible. Fed. R. Evid. 402. In addition, relevant evidence may be excluded if
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`its probative value is substantially outweighed by unfair prejudice. Fed. R. Evid.
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`403.
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`Rules 802-807 of the Federal Rules of Evidence govern the admissibility of
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`hearsay, which Rule 801 defines as “a statement that: (1) the declarant does not
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`make while testifying at the current trial or hearing; and (2) the party offers in
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`evidence to prove the truth of the matter asserted in the statement.” Fed. R. Evid.
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`3
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`
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`801(c). Absent the applicability of an exception to the rule against hearsay, it is not
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`admissible. Fed. R. Evid. 802.
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`Admissible evidence must also be authenticated. Fed. R. Evid. 901. “To
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`satisfy the requirement of authenticating or identifying an item of evidence, the
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`proponent must produce evidence to support a finding that the item is what the
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`proponent claims it is.” Fed. R. Evid. 901(a).
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`As discussed below, exhibits filed by Petitioner fail to meet one or more of
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`these evidentiary standards and should be excluded.
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`II.
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`Petitioner’s Attempt to Cancel the ’438 Patent Claims on the Basis of
`Commercial Success Evidence Is Barred by Statute
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`The grounds for requesting cancelation to patent claims in an IPR are clear
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`and unambiguous. Under 35 U.S.C. § 311(b), a petitioner may request cancellation
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`of a claim “only on the basis of prior art consisting of patents or printed
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`publications.” Contrary to the statute, Petitioner seeks to rely on declarations and
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`related exhibits of Dr. Robert Stoner, an economist offering his opinions on
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`“aspects of commercial success, from an economic perspective.” Exh. 1077
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`(Stoner Decl.) ¶ 6 (describing scope and content of declaration). Dr. Stoner’s
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`declaration in support of the petition (Exh. 1077) does not offer any discussion or
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`analysis of invalidity based on “prior art consisting of patents or printed
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`publications.” Similarly, exhibits he relies upon are not prior art, but instead
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`pertain to commercial aspects of Zytiga and Dr. Stoner’s economic arguments. See
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`4
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`
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`Exhs. 1048-1076, 1078 and 1080. For example, Dr. Stoner relies on various
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`investment research reports commenting on the market for Zytiga (Exhs. 1057,
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`1060-61, 1067-73), an article on “Patent Valuation” (Exh. 1059), and various
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`websites and industry sources for information on Zytiga sales and market share
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`(e.g., Exhs. 1056, 1074, and 1080). None of Dr. Stoner’s economic analysis falls
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`within the statutorily permissible scope for challenging patent claims “only on the
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`basis of prior art.” 35 U.S.C. § 311(b).
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`Petitioner will no doubt argue that evidence of commercial success can be
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`relevant to the issue of obviousness or non-obviousness of a patent claim. But that
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`misses the point. Congress has by statute expressly limited the grounds upon
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`which a petitioner can seek cancellation of patent claims in an IPR. 35 U.S.C. §
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`311(b). And those grounds do not include economic analysis going to commercial
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`success of the patented invention. Accordingly, there is no permissible basis for
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`the Stoner Declaration (Exh. 1077) and related exhibits (Exhs. 1048-1076, 1078,
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`1080). These exhibits should therefore be stricken as contrary to the governing
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`statute and legally irrelevant under FRE 402.1
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`1 Patent Owner has raised objections on these grounds in Patent Owner’s
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`Objections to Evidence, Paper No. 34 at 1-3.
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`5
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`III. Petitioner’s Exhibits and Expert Declarations That Are Not Cited By
`Petitioner Are Irrelevant
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`Petitioner should not be permitted to rely on sections of its expert
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`declarations that are not cited in its petition or reply brief. Petitioner did not cite
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`paragraphs 46-57, 106, 117, or 119-123 of Dr. Godley’s declaration (Exh. 1002) or
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`paragraphs 13-22, 24-32, or 72 of Dr. Stoner’s declaration (Exh. 1077). Similarly,
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`Petitioner did not cite 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 (Exh. 1104) or paragraphs 5-10, 12,
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`15-19, 27-30, 37, 39-41, or 43 of Dr. Stoner’s reply declaration (Exh. 1103).
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`Petitioner also did not cite paragraphs 17-33, 36, 38-41, 43-49, 51-53, or 56-61 of
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`Dr. McKeague’s reply declaration (Exh. 1106). As a result, these sections of the
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`expert declarations of Dr. Godley and Dr. Stoner and the reply declarations of Drs.
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`Godley, McKeague, and Stoner are not substantively relied upon for any argument
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`or fact articulated in Petitioner’s petition or reply brief. By definition, this
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`untethered material is irrelevant. Since it is not relied upon in the petition or reply
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`brief, it does not make any fact of consequence in determining this action more or
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`less probable than it would be without it. Fed. R. Evid. 401 and 402. Moreover,
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`permitting Petitioner to rely on such free-standing evidence would be prejudicial,
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`6
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`since it would not give proper notice as to how Petitioner intends to use the
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`evidence.2
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` Fed. R. Evid. 403.
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`For the same reason, Petitioner’s Exhibits 1013, 1048, 1050, 1051, 1053-
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`1055, 1059, 1066, 1067, 1073-1076, 1080, 1082, 1084, 1086, 1093, 1094, 1107-
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`1114, and 1116-1119 should also be stricken. In particular, none of these exhibits
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`are cited in Petitioner’s petition or reply, nor are paragraphs of Petitioner’s expert
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`declarations discussing these exhibits cited in the petition or reply brief. Further,
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`Exhibits 1082 and 1086 are not cited in any of the accompanying declarations, let
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`alone the petition or reply. Therefore these exhibits should likewise be excluded
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`on the basis of Fed. R. Evid. 401, 402 and 403.3 See Microsoft Corp. v. Parallel
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`Networks Licensing, LLC, IPR2015-00485, Paper 81 at 24 (Aug. 11, 2016)
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`(excluding exhibits not cited in the papers).
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`2 Patent Owner timely objected to these exhibits in its Patent Owner’s Objections
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`to Evidence, Paper No. 34 at 7-8 and Patent Owner’s Objections to Evidence,
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`Paper No. 60 at 6-7.
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`3 Patent Owner timely objected to these exhibits in Patent Owner’s Objections to
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`Evidence, Paper No. 34 at 7-8 and Patent Owner’s Objections to Evidence, Paper
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`No. 60 at 5-6.
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`7
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`IV. Petitioner Relies Upon Exhibits That Are Inadmissible Due to Lack of
`Authenticity and Hearsay
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`Patent Owner objects and moves to exclude exhibits filed by Petitioner that
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`are inadmissible due to lack of authenticity and hearsay. As discussed below,
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`Petitioner has filed exhibits that consist of printouts from various websites and
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`documents from other sources, without providing the requisite showing of
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`authenticity required by the Federal Rules of Evidence. Other exhibits run afoul of
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`the hearsay rule.
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`A. Lack of Authenticity4
`“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, Paper 53 at 4 (Mar. 12, 2015). For this reason, the Board has required that
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`“[t]o authenticate printouts from a website, the party proffering the evidence must
`
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`4 Patent Owner timely objected to these exhibits in its Patent Owner’s Objections
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`to Evidence, Paper No. 34 at 4-6, and Patent Owner’s Objections to Evidence,
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`Paper No. 60 at 2-4.
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`8
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`
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`produce some statement or affidavit from someone with knowledge of the website
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`. . . .” EMC Corp. v. Personalweb Techs., LLC, IPR2013-00084, Paper 64 at 45-46
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`(May 15, 2014).
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`Here, Petitioner relies on printouts from websites that it has filed as Exhibits
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`1050, 1063, 1065, 1066, 1069, 1074, 1087, 1094, 1100, 1102, 1109, 1112, and
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`1116. However, Petitioner has not provided a sufficient basis to conclude that
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`these exhibits are what Petitioner claims, or that any of these exhibits is self-
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`authenticating under Federal Rule of Evidence 902. Petitioner may assert that Dr.
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`Stoner authenticated Exhibits 1050, 1053, 1063, 1065, 1066, 1069, 1074, and 1087
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`in his opening declaration. Exh. 1077 ¶ 5. However, Dr. Stoner merely made a
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`blanket assertion that “[e]ach of these Exhibits is publicly available, or derived
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`from documents that are publicly available, and is a true and correct copy of the
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`documents cited.” Exh. 1077 ¶ 5. Accordingly, Patent Owner maintains its
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`objection and moves to exclude each of these exhibits under Federal Rule of
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`Evidence 901(a).
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`In addition to printouts from websites, Petitioner has filed other exhibits that
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`suffer from a lack of authentication. Patent Owner also moves to exclude Exhibits
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`1034, 1057, 1060-1061, 1067, 1068, 1070-1073, 1080, 1114, 1119, and
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`Attachments B-1 and B-2 of Exhibit 1077 on this basis. None of these has been
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`properly authenticated as required by Federal Rule of Evidence 901. Petitioner has
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`9
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`
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`failed to provide appropriate evidence regarding the origin of these documents and
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`to establish whether the documents are true and correct copies of what they are
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`purported to be. Exhibit 1077, Attachment B1, which appears to be a summary
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`table of the ’438 file history, and Exhibits 1077, Attachment B2 and 1080,5 which
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`appear to be summary tables of sales for selected oncology drugs between 2013
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`and 2015, lack proper authentication and foundation. Petitioner nowhere describes
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`the circumstances surrounding the preparation of each of the attachments and
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`exhibits. Nor has Petitioner provided anyone to vouch for the accuracy of the
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`information found in the documents. Exhibit 1034 is purported to be the
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`“Taxotere® Prescribing Information” from 2004, (Petition, Paper No. 4, at iv), but
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`this exhibit likewise lacks proper authentication and foundation at least because the
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`circumstances surrounding the preparation and the accuracy of the “Taxotere®
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`Prescribing Information” have not been established, including the purported 2004
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`date. See TRW Automotive U.S. LLC v. Magna Elecs. Inc., IPR2014-01348, Paper
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`25 at 5-12 (Jan. 15, 2016) (granting motion to exclude alleged prior art publication
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`on authenticity grounds). Exhibits 1057, 1060-1061, 1067, 1068, and 1070-1073,
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`which appear to be financial analyst reports, similarly suffer from a lack proper
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`authentication and foundation. Here too, Petitioner has not set forth the
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`5 Attachment B-2 of Exhibit 1077 cites to Exhibit 1081 but it appears a citation to
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`Exhibit 1080 was intended.
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`10
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`circumstances surrounding the preparation of each of the documents. Nor has
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`Petitioner provided a basis for establishing the accuracy of the information found
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`in each of the documents. Exhibit 1114 appears to be excerpts of a book
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`concerning intellectual property, but Petitioner has not provided evidence regarding
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`the origin of the document, or whether it is a true and correct copy. For example,
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`Exhibit 1114 does not include bibliographic information from which authenticity or
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`date of publication might be discerned. Exhibit 1119 purports to be a “Clinical
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`Study Report,” and lacks proper authentication and foundation at least because the
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`circumstances surrounding its preparation have not been explained, and the
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`accuracy of the information therein has not been established. Exhibit 1119 also
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`contains a “Confidential” stamp at the bottom of each page that calls into question
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`its authenticity.
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`Petitioner may assert that Dr. Stoner authenticated Exhibits 1057, 1060-61,
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`1067, 1068, 1070-1073, and 1080 in his opening declaration. Exh. 1077 ¶ 5.
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`However, as mentioned above Dr. Stoner merely made a blanket assertion that
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`“[e]ach of these Exhibits is publicly available, or derived from documents that are
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`publicly available, and is a true and correct copy of the documents cited.” Exh.
`
`1077 ¶ 5.
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`11
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`
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`Petitioner has failed to meet the minimum standards for authenticity required
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`under Fed. R. Evid. 901(a) for the exhibits discussed above. Patent Owner moves
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`to exclude the exhibits on that basis.
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`B. Hearsay6
`Patent Owner maintains its objection and moves to exclude Exhibits 1057,
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`1060-61, 1065, 1067-1073, 1080, 1087, 1100, 1102, and 1109 under Federal Rules
`
`of Evidence 801 and 802. These exhibits contain out-of-court statements by non-
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`parties that Petitioner obviously seeks to use to prove the truth of the matter
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`asserted, and are therefore inadmissible hearsay. See, e.g., Standard Innovation
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`Corp. v. Lelo, Inc., IPR2014-00148, Paper 41 at 13-15 (Apr. 23, 2015) (excluding
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`purported dates on exhibits as hearsay when offered to prove the date of
`
`publication).
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`Petitioner and its expert, Dr. Stoner, purport to rely on this evidence in the
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`context of the objective indicia of nonobviousness, including arguments attempting
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`to minimize the commercial success achieved by Zytiga. Exhibits 1057, 1060-
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`1061, 1065, and 1067-1073 appear to be investment analyst reports. The contents
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`of these exhibits constitute hearsay because they meet both of the requirements of
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`6 Patent Owner timely objected to these exhibits in its Patent Owner’s Objections
`
`to Evidence, Paper No. 34 at 7 and Patent Owner’s Objections to Evidence, Paper
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`No. 60 at 5.
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`12
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`Fed. R. Evid. 801: they are written statements not made while testifying in the
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`current proceeding (Fed. R. Evid. 801(c)(1)), and they are being offered to prove
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`the truth of the matter asserted therein (Fed. R. Evid. 801(c)(2)). See Stoner Decl.,
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`Exhibit 1077 ¶ 35 (citing Exhibits 1057 and 1060 for analysis of Zytiga market
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`share and demand); id. ¶¶ 54, 56, 58 (citing Exhibits 1057, 1060, 1061, 1065, and
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`1067-1073 regarding the relative positioning of Zytiga and Xtandi in the
`
`marketplace); see also Petition, Paper No. 1 at 60 (citing Stoner Decl., Exhibit
`
`1077, ¶¶ 33-35) and 63 (citing Stoner Decl., Exhibit 1077, ¶¶ 54-58). In addition,
`
`Exhibit 1080 purports to be compilations of revenue and sales figures for
`
`pharmaceutical products from 2012-2015. Exhibit 1080 constitutes impermissible
`
`hearsay as it constitutes written statements not made while testifying in the current
`
`proceeding (Fed. R. Evid. 801(c)(1)) offered to prove the truth of the matter
`
`asserted therein (Fed. R. Evid. 801(c)(2)). See Stoner Decl., Exhibit 1077
`
`Attachment B-2 (citing Exhibit 10807 regarding the gross sales, units sold, and
`
`average sales prices for three oncology drugs); see also Stoner Decl., Exhibit 1077
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`¶¶ 56-57 (citing Stoner Decl., Exhibit 1077, Attachment B-2), Petition, Paper No. 1
`
`at 63 (citing Exhibit 1077 ¶¶ 54-58).
`
`
`7 As noted Exhibit 1077 Attachment B-2 cites Exhibit 1081, but it appears a
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`citation to Exhibit 1080 was intended.
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`
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`13
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`
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`Exhibit 1087 purports to be a BTG press release concerning a license to
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`Cougar Biotechnology and is impermissibly offered by Petitioner to prove the date
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`and terms of the license. See Stoner Reply Decl., Exhibit 1103 ¶ 23 (citing Exhibit
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`1087); see also Reply, Paper No. 54 at 26 (citing Stoner Reply Decl., Exhibit 1103
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`¶¶ 21-26). Exhibit 1100 purports to be a blog entry by Cancer Research UK and is
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`improperly relied on for double-hearsay statements attributed to Dr. Ian Judson for
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`the truth of the matter asserted. Stoner Reply Decl., Exhibit 1103 ¶ 24, at page 23
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`(citing Exhibit 1100); see also Reply, Paper No. 54 at 26 (citing Stoner Reply
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`Decl., Exhibit 1103 ¶¶ 21-26). Exhibit 1102 purports to be an ICR webpage
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`concerning development of abiraterone acetate and is similarly offered to prove the
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`truth of the matter asserted. Stoner Reply Decl., Exhibit 1103 ¶ 24, at page 23-24
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`(citing Exhibit 1102); see also Reply, Paper No. 54 at 26 (citing Stoner Reply
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`Decl., Exhibit 1103 ¶¶ 21-26). Exhibit 1109 purports to be a ClinicalTrials.gov
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`entry concerning an abiraterone acetate clinical trial, bearing an exhibit stamp from
`
`another IPR proceeding, offered to prove the truth of the matter asserted. Stoner
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`Reply Decl., Exhibit 1103 ¶¶ 30, 39 (citing Exhibit 1109).
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`Petitioner does not provide any basis for the Board to conclude that these
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`exhibits fall within any hearsay exception. With no applicable exception, this
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`evidence should be excluded under Rule 802.
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`14
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`V. Conclusion
`For the foregoing reasons, Patent Owner Janssen Oncology, Inc. respectfully
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`requests that the Board exclude the following evidence from the trial in this matter:
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`Exhibits 1002 ¶¶ 46-57, 106, 117, and 119-123; 1013; 1034; 1048-1076; 1077,
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`including but not limited to, ¶¶ 13-22, 24-32, and 72; 1078, 1080; 1082; 1084;
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`1086; 1087; 1093; 1094; 1100; 1102; 1103 ¶¶ 5-10, 12, 15-19, 27-30, 37, 39-41,
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`and 43; 1104 ¶¶ 3-4, 6-7, 9-13, 15, 17-19, 28, 31, 37-38, 40, 42, 44, 46, and 48;
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`1106 ¶¶ 17-33, 36, 38-41, 43-49, 51-53, and 56-61; 1107-1114; and 1116-1119.
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`15
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`Dated: May 5, 2017
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`Respectfully Submitted,
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`By: /Dianne B. Elderkin/
`Dianne B. Elderkin (Reg. No. 28,598)
`delderkin@akingump.com
`Barbara L. Mullin (Reg. No. 38,250)
`bmullin@akingump.com
`Ruben H. Munoz (Reg. No. 66,998)
`rmunoz@akingump.com
`AKIN GUMP STRAUSS HAUER &
`FELD LLP
`Two Commerce Square
`2001 Market Street, Suite 4100
`Philadelphia, PA 19103
`Tel: (215) 965-1200
`Fax: (215) 965-1210
`
`David T. Pritikin (pro hac vice)
`dpritikin@sidley.com
`Bindu Donovan (pro hac vice)
`bdonovan@sidley.com
`Paul Zegger (Reg. No. 33,821)
`pzegger@sidley.com
`Todd Krause (Reg. No. 48,860)
`tkrause@sidley.com
`Alyssa B. Monsen (pro hac vice)
`amonsen@sidleyaustin.com
`SIDLEY AUSTIN LLP
`787 Seventh Avenue
`New York, NY 10019
`Tel.: (212) 839-5300
`Fax: (212) 839-5599
`ZytigaIPRTeam@sidley.com
`Counsel for Patent Owner
`
`16
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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 Motion to Exclude Evidence Pursuant to 37 C.F.R. § 42.64(C) was served
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`on counsel of record on May 5, 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 Petitioner and Patent Co-Owner at the 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
`Ralph W. Powers III – tpowers-PTAB@skgf.com
`
`Anthony C. Tridico - anthony.tridico@finnegan.com
`Jennifer H. Roscetti - jennifer.roscetti@finnegan.com
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`Date: May 5, 2017
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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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`17
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