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`Paper No. ___
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`Date Filed: May 3, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`MYLAN PHARMACEUTICALS INC., ACTAVIS LABORATORIES FL, INC.,
`AMNEAL PHARMACEUTICALS LLC, AMNEAL PHARMACEUTICALS OF
`NEW YORK, LLC, DR. REDDY’S LABORATORIES, INC., DR. REDDY’S
`LABORATORIES, LTD., SUN PHARMACEUTICALS INDUSTRIES, LTD.,
`SUN PHARMACEUTICALS INDUSTRIES, INC., TEVA
`PHARMACEUTICALS USA, INC., WEST-WARD PHARMACEUTICAL
`CORP., and HIKMA PHARMACEUTICALS, LLC,
`Petitioner
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`Patent Owner
`________________
`
`Case IPR2016-013321
`________________
`
`Patent No. 8,822,438 B2
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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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`1 Case IPR2016-00853 has been joined with this proceeding.
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`IPR2016-01332
`U.S. Patent 8,822,438
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`I.
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`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 Petitioners 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 Petitioners’ declarations (and related exhibits) that are not
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`cited in any paper in this proceeding, including Petitioners’ petition or 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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`1
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`IPR2016-01332
`U.S. Patent 8,822,438
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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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`2
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`IPR2016-01332
`U.S. Patent 8,822,438
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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 Petitioners 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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`Petitioners’ 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, Petitioners seek to rely on declarations and
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`related exhibits of Dr. Ivan Hofmann, an economist offering his opinions on
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`“aspects of commercial success, from an economic perspective.” See Exh. 1017
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`(Decl. of Hofmann) at ¶ 6 (describing scope and content of declaration). Dr.
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`Hofmann’s declaration in support of the petition (Exh. 1017) does not offer any
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`discussion or analysis of invalidity based on “prior art consisting of patents or
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`printed publications.” Similarly, exhibits he relies upon are not prior art, but
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`instead pertain to commercial aspects of Zytiga and Dr. Hofmann’s economic
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`3
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`IPR2016-01332
`U.S. Patent 8,822,438
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`arguments. See Exhibits 1040, 1041, 1046-1051, 1053-1055, 1057, and 1064-
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`1066. For example, Dr. Hofmann relies on websites for information concerning
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`pharmaceutical product information and sales data (Exhs. 1049 and 1055). None
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`of Dr. Hofmann’s economic analysis falls within the statutorily permissible scope
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`for challenging patent claims “only on the basis of prior art.” 35 U.S.C. § 311(b).
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`Petitioners 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 Hofmann Declaration (Exh. 1017) and related exhibits (Exhs. 1040, 1041,
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`1046-1051, 1053-1055, 1057, and 1064-1066). These exhibits should therefore be
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`stricken as contrary to the governing statute and legally irrelevant under FRE 402.2
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`III. Petitioners’ Exhibits and Expert Declarations That Are Not Cited in
`Their Petition or Reply Brief Are Irrelevant
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`Petitioners should not be permitted to rely on sections of their expert
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`declarations that are not cited in their petition or reply brief. In particular,
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`2 Patent Owner has raised objections on these grounds in Patent Owner’s
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`Objections to Evidence, Paper No. 23, at 1-2.
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`4
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`IPR2016-01332
`U.S. Patent 8,822,438
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`Petitioners filed the expert declaration of Dr. Garnick (Exh. 1002), but never cited
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`to paragraph 30 in the petition or reply brief. Similarly, Petitioners did not cite
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`paragraphs 17-29, or 31 of Dr. McKeague’s reply declaration (Exh. 1091), nor did
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`they cite paragraphs 11-16 or 95 of Dr. Bantle’s reply declaration (Exh. 1097).
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`Petitioners also did not cite paragraphs 5-9, 11-13, 88-90, 92-95, or 119-122 of Dr.
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`Garnick’s reply declaration (Exh. 1104). As a result, these sections of the expert
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`declaration of Dr. Garnick and the reply expert declarations of Drs. Bantle,
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`Garnick, and McKeague are not substantively relied upon for any argument or fact
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`articulated in Petitioners’ petition or reply brief. By definition, this untethered
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`material is irrelevant. Since it is not relied upon in the petition or reply brief, it
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`does not make any fact of consequence in determining this action more or less
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`probable than it would be without it. Fed. R. Evid. 401 and 402. Moreover,
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`permitting Petitioners to rely on such free-standing evidence would be prejudicial,
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`since it would not give proper notice as to how Petitioners intend to use the
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`evidence.3
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` Fed. R. Evid. 403.
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`For the same reason, Petitioners’ Exhibits 1040, 1041, 1046, 1049, 1050,
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`1055, 1064, 1066, 1086, 1089, 1092, 1093-1094, 1100, 1102, 1103, and 1139
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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. 23 at 6-7, and Patent Owner’s Objections to Evidence, Paper
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`No. 63 at 7.
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`5
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`IPR2016-01332
`U.S. Patent 8,822,438
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`should also be stricken. Petitioners did not cite these exhibits in the petition or
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`reply brief, nor are paragraphs of Petitioners’ expert declarations discussing these
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`exhibits cited in the petition or reply brief. Therefore, these exhibits should
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`likewise be excluded on the basis of Fed. R. Evid. 401, 402 and 403.4
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`IV. Petitioners Rely 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 Petitioners that
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`are inadmissible due to lack of authenticity and hearsay. As discussed below,
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`Petitioners have 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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`4 Patent Owner timely objected to these exhibits in Patent Owner’s Objections to
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`Evidence, Paper No. 23 at 6, and Patent Owner’s Objections to Evidence, Paper
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`No. 63 at 6.
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`6
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`IPR2016-01332
`U.S. Patent 8,822,438
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`A. Lack of Authenticity5
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`“To satisfy the requirement of authenticating or identifying an item of
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`evidence, the proponent must produce evidence sufficient to support a finding that
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`the item is what the proponent claims it is.” Fed. R. Evid. 901(a). The Board has
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`held that “[w]hen offering a printout of a webpage into evidence to prove the
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`website’s contents, the proponent of the evidence must authenticate the information
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`from the website . . . .” Neste Oil OYJ v. REG Synthetic Fuels, LLC, IPR2013-
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`00578, slip op. 4 (PTAB Mar. 12, 2015) (Paper 53). For this reason, the Board has
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`required that “[t]o authenticate printouts from a website, the party proffering the
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`evidence must produce some statement or affidavit from someone with knowledge
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`of the website . . . .” EMC Corp. v. Personalweb Techs., LLC, Case IPR2013-
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`00084, slip op. 45-46 (PTAB May 15, 2014) (Paper 64).
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`Here, Petitioners rely on printouts from websites that they have filed as
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`Exhibits 1028, 1048, 1049, 1053, 1055, 1057, 1088, and 1092. However,
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`Petitioners have not provided a sufficient basis to conclude that these exhibits are
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`what Petitioners claim, or that any of these exhibits is self-authenticating under
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`Federal Rule of Evidence 902. Accordingly, Patent Owner maintains its objection
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`5 Patent Owner timely objected to these exhibits in Patent Owner’s Objections to
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`Evidence, Paper No. 23, at 3-5, and Patent Owner’s Objections to Evidence, Paper
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`No. 63, at 3-4.
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`7
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`IPR2016-01332
`U.S. Patent 8,822,438
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`and moves to exclude each of these exhibits under Federal Rule of Evidence
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`901(a).
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`In addition to printouts from websites, Petitioners have filed other exhibits
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`that suffer from a lack of authentication. Patent Owner also moves to exclude
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`Exhibits 1017 [B-1], 1095, 1117, and 1125 on this basis. None of these has been
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`properly authenticated as required by Federal Rule of Evidence 901. Petitioners
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`have failed to provide evidence regarding the origin of these documents and to
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`establish whether the documents are true and correct copies. Exhibit 1017,
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`Attachment B-1, which appears to be a summary table of sales for selected
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`oncology drugs between 2013 and 2014, lacks proper authentication and
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`foundation, as does the purported webpage it cites (Exhibit 1055) as mentioned
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`above. Nowhere do Petitioners describe the circumstances surrounding the
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`preparation of the attachment. Nor have Petitioners provided anyone to vouch for
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`the accuracy of the information found in the document.
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`Exhibit 1095 purports to be a “Clinical Study Report” concerning clinical
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`trials COU-AA-001 and COU-AA-001 EXT, while Exhibit 1117 purports to be a
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`“Clinical Study Report Synopsis” concerning clinical trial COU-AA-BE. Exhibit
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`1125 appears to be a compilation of materials from an FDA workshop concerning
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`prostate cancer. Petitioners have likewise failed to provide evidence regarding the
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`origin of Exhibits 1095, 1117, and 1125, and whether they are true and correct
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`8
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`IPR2016-01332
`U.S. Patent 8,822,438
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`copies containing accurate information. In addition, Exhibit 1095 bears a
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`“Confidential” stamp on each page, while page 4 of Exhibit 1117 contains an
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`annotation of unknown origin, both of which further call into question the
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`authenticity of these exhibits.
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`Petitioners have failed to meet the minimum standards for authenticity
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`required under Fed. R. Evid. 901(a) for the exhibits discussed above. Patent
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`Owner moves to exclude the exhibits on that basis.
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`B. Hearsay6
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`Patent Owner maintains its objection and moves to exclude Exhibits 1055,
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`1088, and 1095 as hearsay under Federal Rules of Evidence 801 and 802. These
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`exhibits contain out-of-court statements by non-parties that Petitioners obviously
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`seek to use to prove the truth of the matter asserted. Dr. Hofmann purports to rely
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`on Exhibits 1055 and 1088 in the context of the objective indicia of
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`nonobviousness, including arguments attempting to minimize the commercial
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`success achieved by Zytiga. Exhibit 1055 purports to be a compilation of global
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`sales for various pharmaceutical products from 2013-2014. This exhibit
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`constitutes hearsay because it meets both of the requirements of Fed. R. Evid. 801:
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`6 Patent Owner timely objected to these exhibits in Patent Owner’s Objections to
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`Evidence, Paper No. 23 at 6, and Patent Owner’s Objections to Evidence, Paper
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`No. 63 at 5-6.
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`9
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`IPR2016-01332
`U.S. Patent 8,822,438
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`it constitutes written statements not made while testifying in the current proceeding
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`(Fed. R. Evid. 801(c)(1)) offered to prove the truth of the matter asserted therein
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`(Fed. R. Evid. 801(c)(2)). See Exhibit 1017 at Attachment B-1 (citing Exhibit
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`1055 for sales data); id. ¶ 38 (citing Exhibit 1017 Attachment B-1); see also
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`Petition, Paper No. 1 at 52 (citing Exhibit 1017 ¶¶ 35-38). Exhibit 1088 purports
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`to be a BTG press release concerning a license to Cougar Biotechnology and is
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`impermissibly offered by Petitioners to prove the date and terms of the license.
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`See Exhibit 1017 ¶ 11 (citing Exhibit 1088).
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`Petitioners do not provide any basis for the Board to conclude that these
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`exhibits fall within any hearsay objection. With no applicable exception, this
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`evidence should be excluded under Rule 802.
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`V. Conclusion
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`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, ¶ 30; 1017; 1017 [B-1]; 1028; 1040; 1041; 1046-1051; 1053-1055;
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`1057; 1064-1066; 1086; 1088; 1089; 1091, ¶¶ 17-29, and 31; 1092-1095; 1097, ¶¶
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`11-16 and 95; 1100, 1102, 1103; 1104 ¶¶ 5-9, 11-13, 88-90, 92-95, and 119-122;
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`10
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`1117; 1125; and 1139.
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`IPR2016-01332
`U.S. Patent 8,822,438
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`
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`Respectfully submitted,
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`
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`Dated: May 3, 2017
`
`/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)
`Bindu Donovan (pro hac vice)
`Paul J. Zegger (Reg. No. 33,821)
`Todd L. Krause (Reg. No. 48,860)
`Alyssa B. Monsen (pro hac vice)
`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
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`11
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`IPR2016-01332
`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 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 3, 2017 by filing this document through the End-to-
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`End System, as well as delivering a copy via electronic mail to counsel of record
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`for the Petitioners at the following addresses:
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`Brandon M. White – bmwhite@perkinscoie.com
`Crystal R. Canterbury – ccanterbury@perkinscoie.com
`Bryan D. Beel – bbeel@perkinscoie.com
`Shannon Bloodworth – sbloodworth@perkinscoie.com
`Emily J. Greb – egreb@perkinscoie.com
`Robert D. Swanson – rswanson@perkinscoie.com
`
`Samuel S. Park – spark@winston.com
`Ryan B. Hauer – rhauer@winston.com
`Jovial Wong – jwong@winston.com
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`
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`Date: May 3, 2017
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`Respectfully submitted,
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`
`/Dianne B. Elderkin/
`Dianne B. Elderkin
`Registration No. 28,598
`Counsel for Patent Owner
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`12
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