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`Paper No. ___
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`Date Filed: January 30, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
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`AMERIGEN PHARMACEUTICALS LIMITED,
`ARGENTUM PHARMACEUTICALS LLC,
`
`Petitioner
`
`v.
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`JANSSEN ONCOLOGY, INC.,
`Patent Owner
`________________
`
`Case IPR2016-002861
`________________
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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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`1 Case IPR2016-01317 has been joined with this proceeding.
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`
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`IPR2016-00286
`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 four 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. Exhibits that Petitioners belatedly filed in connection with their reply
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`brief and declarations after the January 16, 2016 deadline;
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`3. Sections of Petitioners’ reply declarations (and related exhibits) that are
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`not cited in any paper in this proceeding, including Petitioners’ reply brief, since
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`this disconnected evidence should be excluded as irrelevant and prejudicial under
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`Fed. R. Evid. 401, 402 and 403; and
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`4. 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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`1
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`IPR2016-00286
`U.S. Patent No. 8,822,438
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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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`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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`2
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`IPR2016-00286
`U.S. Patent No. 8,822,438
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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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`801(c). Absent the applicability of an exception to the rule against hearsay, it is
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`not 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. Deforest McDuff, 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 McDuff) at ¶ 6 (describing scope and content of declaration). Neither Dr.
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`McDuff’s declaration in support of the petition (Exh. 1017) nor his reply
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`3
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`U.S. Patent No. 8,822,438
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`declaration (Exh. 1152) offer any discussion or analysis of invalidity based on
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`“prior art consisting of patents or printed publications.” Similarly, exhibits he
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`relies upon are not prior art, but instead pertain to commercial aspects of Zytiga
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`and Dr. McDuff’s economic arguments. See Exhibits 1040-1067 and 1149-1151
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`and 1190. For example, Dr. McDuff relies on various investment research reports
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`commenting on the market for Zytiga (Exhs. 1042-1044, 1056, 1058-1061), an
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`article on “Patent Valuation” (Exh. 1054), and various websites and industry
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`sources for information on Zytiga sales and market share (Exhs. 1045 and 1067).
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`None of Dr. McDuff’s economic analysis falls within the statutorily permissible
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`scope for challenging patent claims “only on the basis of prior art.” 35 U.S.C. §
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`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 McDuff Declaration (Exh. 1017) and related exhibits (Exhs. 1040-1067).
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`Further, any argument Petitioners may offer that the second McDuff Declaration,
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`4
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`IPR2016-00286
`U.S. Patent No. 8,822,438
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`submitted with Petitioners’ Reply, is properly rebuttal evidence is unavailing, as
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`the second McDuff Declaration (Exh. 1152) is not cited in Petitioners’ Reply or
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`any paper filed in this proceeding. See infra Section IV. These exhibits should
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`therefore be stricken as contrary to the governing statute and legally irrelevant
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`under FRE 402.2
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`III. Petitioners’ Failure to File and Serve Exhibits Until After the Deadline
`Warrants Striking of the Late Exhibits.
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`Under the Rules governing this proceeding, a late action will not be excused
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`unless there is good cause or upon a showing that it is in the interest of justice to
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`do so. See 37 C.F.R. § 42.5(c)(3). Here, Petitioners’ Reply to Patent Owner’s
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`Response was due on January 16, 2017. See Jan. 9, 2017 Joint Notice of Change
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`of Due Dates 2, 4 and 5, Paper No. 59. Petitioners filed their Reply brief and four
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`expert declarations on January 16, but just barely - - at 11:59 p.m. However,
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`Petitioners failed to file the exhibits on time. Not until the following day, January
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`17, 2017 at approximately 5:40 a.m., did Petitioners file and serve their reply
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`2 Patent Owner has raised objections on these grounds, in its Preliminary Response,
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`Paper No. 12 at 49-50, 52; in its Request for Reconsideration, Paper No. 16 at 4
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`and 12, n. 2; in its June 14, 2016 Objections to Evidence, Paper No. 17 at 2-3; and
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`in it January 23, 2017 Objections to Evidence, Paper No. 67 at 1-2 and 5-7.
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`5
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`IPR2016-00286
`U.S. Patent No. 8,822,438
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`exhibits. In total, Petitioners filed and served 90 reply exhibits, all of them late.
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`See USPTO Filing Courtesy Notice, Jan. 17, 2017 (Exh. 2126).
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`Petitioners are not entitled to an excusal of their failure to file the exhibits on
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`time. See e.g., Teva Pharmaceuticals USA, Inc. v. Monosol RX, LLC, IPR2016-
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`00281, -00282, Papers 21 and 19 (PTAB May 23, 2016) (Decision Denying
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`Petitioner’s Motions to Change Filing Date). In Teva, petitioner requested that the
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`Board change the filing date of its petitions from December 4, 2015 to December
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`3, 2015, citing “technical issues” encountered during the uploading of the petitions
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`and exhibits. Id. at 3. In particular, petitioner explained that it did not start filing
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`of the petition in IPR282 until 11:11 pm on the day of the deadline and did not
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`receive confirmation of filing until 12:09 am the next day. Id. at 5. The petitioner
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`did not provide service copies of the documents to FedEx® until 3:02 on
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`December 4, 2015. Id. at 5. The Board denied petitioner’s request to change the
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`filing date by one day, stating: “Waiting until the last minute – without
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`explanation – is ill advised and had Petitioner not done so, any alleged delays
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`caused by “technical issues” would have been moot.” Id. at 10. Petitioner claimed
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`that they would be prejudiced unless the filing date were changed. Id. at 13. But
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`the Board concluded that: “Any prejudice to Petitioner was created by Petitioner’s
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`own delay.” Id .
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`6
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`IPR2016-00286
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`Here, Petitioners have not moved for relief for their failure to file and serve
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`their reply exhibits on time, nor have they offered any explanation as to why they
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`missed the January 16, 2016 deadline. Moreover, Petitioners were well aware that
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`the depositions of their four experts were scheduled for January 18, 19, 21 and 23,
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`meaning that the timing between Patent Owner’s receipt of the reply documents
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`and the depositions would be very tight. Whether Petitioners’ filing and service of
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`their reply brief and expert declarations at 11:59 pm on January 16 was by design
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`is unclear. In any event there is no question that the 90 exhibits were not filed and
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`served until after the deadline had passed. Accordingly, the late exhibits should be
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`stricken.3
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`IV. The Sections of Petitioners’ Reply Expert Declarations That Are Not
`Cited in Their Reply Brief Are Irrelevant
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`Petitioners should not be permitted to rely on sections of their reply expert
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`declarations that are not cited in their reply brief. In particular, Petitioners filed the
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`reply expert declaration of Dr. Ratain (Exh. 1091), but never cited to paragraphs
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`3 Petitioners failed to file the following exhibits on time: 1092, 1094, 1097-1149,
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`1150, 1151, 1153-1156, 1160-1163, 1165-1173, and 1175-1190. Patent Owner
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`timely objected to these exhibits in its Patent Owner’s Objections to Evidence,
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`Paper No. 67 at 4.
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`7
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`U.S. Patent No. 8,822,438
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`23-29, 32-34, 42, 44-46 and 72-74. Similarly, Petitioners’ reply brief makes no
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`mention of paragraph 13 of Dr. Dorin’s expert declaration (Exh. 1093). Even more
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`glaring, Petitioners filed a reply expert declaration of Dr. McDuff (Exh. 1152), but
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`then cited to no part of his declaration in their reply brief. As a result, these
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`sections of the expert reports of Dr. Ratain and Dr. Dorin, and the entirety of Dr.
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`McDuff’s expert reply report are not substantively relied upon for any argument or
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`fact articulated in Petitioners’ reply brief. By definition, this untethered material is
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`irrelevant. Since it is not relied upon in the reply brief, it does not make any fact of
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`consequence in determining this action more or less probable than it would be
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`without it. Fed. R. Evid. 401 and 402. Moreover, permitting Petitioners to rely on
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`such free-standing evidence would be prejudicial, since it would not give proper
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`notice as to how Petitioners intend to use the evidence.4 Fed. R. Evid. 403.
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`For the same reason, Petitioners’ Exhibits 1149, 1150, 1151 and 1190 should
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`also be stricken. These are only cited in Dr. McDuff’s reply declaration (Exh.
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`1152). Obviously, since the McDuff reply declaration is not cited in Petitioners’
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`4 Patent Owner timely objected to these exhibits in its Patent Owner’s Objections to
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`Evidence, Paper No. 67 at 5.
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`8
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`IPR2016-00286
`U.S. Patent No. 8,822,438
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`reply, neither are these exhibits. Likewise, the exhibits should be excluded on the
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`basis of Fed. R. Evid. 401, 401 and 403.5
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`V.
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`Petitioners Rely Upon Numerous 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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`A. Lack of Authenticity6
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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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`5 Patent Owner timely objected to these exhibits as well in its Patent Owner’s
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`Objections to Evidence, Paper No. 67 at 4-5.
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`6 Patent Owner timely objected to these exhibits in its Patent Owner’s Objections to
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`Evidence, Paper No. 17 at 4-5 and Patent Owner’s Objection to Evidence, Paper
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`No. 67 at 3-4.
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`9
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`IPR2016-00286
`U.S. Patent No. 8,822,438
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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
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`information from the website . . . .” Neste Oil OYJ v. REG Synthetic Fuels, LLC,
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`IPR2013-00578, slip op. 4 (PTAB Mar. 12, 2015) (Paper 53). For this reason, the
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`Board has required that “[t]o authenticate printouts from a website, the party
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`proffering the evidence must produce some statement or affidavit from someone
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`with knowledge of the website . . . .” EMC Corp. v. Personalweb Techs., LLC,
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`Case IPR2013-00084, 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 1040, 1041, 1048, 1049, 1051-1053, 1055-1057, 1088, 1128, 1130, 1140,
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`and 1166. However, Petitioners have not provided a sufficient basis to conclude
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`that these exhibits are what Petitioners claim, or that any of these exhibits is self-
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`authenticating under Federal Rule of Evidence 902. Accordingly, Patent Owner
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`maintains its objection and moves to exclude each of these exhibits under Federal
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`Rule of Evidence 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 and B-2], 1032, 1042-1044, 1058-1063, 1067, and 1140 on this
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`basis. None of these has been properly authenticated as required by Federal Rule
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`10
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`IPR2016-00286
`U.S. Patent No. 8,822,438
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`of Evidence 901. Petitioners have failed to provide evidence regarding the origin
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`of these documents and to establish whether the documents are true and correct
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`copies. Exhibit 1017, Attachment B1, which appears to be a summary table of the
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`‘438 file history, and Exhibits 1017, Attachment B2 and 1067, which appear to be
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`summary tables of sales for selected oncology drugs between 2013 and 2015, lack
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`proper authentication and foundation. Nowhere do Petitioners describe the
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`circumstances surrounding the preparation of each of the attachments and exhibits.
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`Nor have Petitioners provided anyone to vouch for the accuracy of the information
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`found in the documents. Exhibit 1032 purports to be the “Taxotere® Prescribing
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`Information”, but this exhibit lacks proper authentication and foundation at least
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`because the circumstances surrounding the source and the accuracy of the
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`“Taxotere® Prescribing Information” have not been established. See Ex. 1002 at ¶
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`81. Exhibits 1042-1044 and 1058-1063, which appear to be financial analyst
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`reports, similarly suffer from a lack proper authentication and foundation. Here
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`too, Petitioners have not set forth the circumstances surrounding the preparation of
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`each of the documents. Nor have Petitioners provided a basis for establishing the
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`accuracy of the information found in each of the documents. Exhibit 1140 appears
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`to be a manuscript of an article titled “Therapeutic management of bone metastasis
`
`
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`11
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`IPR2016-00286
`U.S. Patent No. 8,822,438
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`in prostate cancer: an update.” However, this document provides no indication that
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`this represents the final, as published, copy of the article.
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`For both the website and non-website documents discussed above,
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`Petitioners have failed to meet the minimum standards for authenticity required
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`under Fed. R. Evid. 901(a). Patent Owner moves to exclude the exhibits on that
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`basis.
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`B. Hearsay7
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`Patent Owner maintains its objection and moves to exclude Exhibits 1042-
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`1044, 1055, 1056, 1058-1063, and 1067 under Federal Rules of Evidence 801 and
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`802. These exhibits contain out-of-court statements by non-parties that the
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`petitioner obviously seeks to use to prove the truth of the matter asserted.
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`Petitioners and their expert, Dr. McDuff, 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 1042-1044,
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`1056, and 1058-1063 appear to be investment analyst reports. The contents of
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`these exhibits constitute hearsay because they meet both of the requirements of
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`Fed. R. Evid. 801: they are written statements not made while testifying in the
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`7 Patent Owner timely objected to these exhibits in its Patent Owner’s Objections to
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`Evidence, Paper No. 17 at 7.
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`
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`12
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`IPR2016-00286
`U.S. Patent No. 8,822,438
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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 Exhibit 1017
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`at 25 (citing Exhibits 1059 and 1060 regarding the relative market shares of Zytiga
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`and Xtandi) and 27-31 (citing Exhibits 1042-1044, 1056, 1058, and 1060-1063
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`regarding the relative positioning of Zytiga and Xtandi in the marketplace); see
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`also Petition, Paper No. 1 at 50 (citing McDuff, Exhibit 1017, ¶¶27-29) and 51
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`(citing McDuff, Exhibit 1017, ¶¶23-30). In addition, Exhibits 1055 and 1067
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`purport to be compilations of revenue and sales figures for pharmaceutical
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`products from 2012-2013 and 2012-2015, respectively. These exhibits also
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`constitute impermissible hearsay as they are written statements not made while
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`testifying in the current proceeding (Fed. R. Evid. 801(c)(1)), and they are being
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`offered to prove the truth of the matter asserted therein (Fed. R. Evid. 801(c)(2)).
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`See Exhibit 1017 at B-2 (citing Exhibit 1055 regarding the worldwide sales for
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`“top selling oncology drugs”) and B-3 (citing Exhibit 1067 regarding the gross
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`sales, units sold, and average sales prices for three oncology drugs); see also
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`Exhibit 1017 at 24 (citing Exhibit 1017, B-2) and 26 (citing Exhibit 1017, B-3).
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`Petitioners do not provide any basis for the Board to conclude that these exhibits
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`fall within any hearsay objection. With no applicable exception, this evidence
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`should be excluded under Rule 802.
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`13
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`IPR2016-00286
`U.S. Patent No. 8,822,438
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`VI. 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 1017, 1017 [B-1 and B-2], 1032, 1040-1067, 1088, 1091 paragraphs 23-
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`29, 32-34, 42, 44-46 and 72-74, 1092, 1093 paragraph 13, 1094, 1097-1156, 1160-
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`1163, 1165-1173, and 1175-1190.
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`
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`Date: January 30, 2017
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`
`Respectfully submitted,
`
`
`/Dianne B. Elderkin/
`Dianne B. Elderkin (Lead Counsel)
`Reg. No. 28,598
`Barbara L. Mullin (Back-up Counsel)
`Reg. No. 38,250
`Ruben H. Munoz (Back-up Counsel)
`Reg. No. 66,998
`AKIN GUMP STRAUSS HAUER
`& FELD LLP
`Two Commerce Square
`2001 Market Street, Suite 4100
`Philadelphia, PA 19103
`Tel.: (215) 965-1340
`Fax: (215) 965-1210
`
`David T. Pritikin (pro hac vice)
`dpritikin@sidley.com
`Bindu Donovan (pro hac vice)
`bdonovan@sidley.com
`Paul J. Zegger (Reg. No. 33,821)
`
`
`
`14
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`
`
`pzegger@sidley.com
`Todd Krause (Reg. No. 48,860)
`tkrause@sidley.com
`Isaac Olson (pro hac vice)
`iolson@sidley.com
`Alyssa B. Monsen (pro hac vice)
`amonsen@sidley.com
`SIDLEY AUSTIN LLP
`787 Seventh Avenue
`New York, NY 10019
`Tel.: (212) 839-5300
`Fax: (212) 839-5599
`
`Counsel for Patent Owner
`
`15
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`IPR2016-00286
`U.S. Patent No. 8,822,438
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`IPR2016-00286
`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 January 30, 2017 by filing this document through the End-
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`to-End System, as well as delivering a copy via electronic mail to counsel of record
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`for the Petitioners and Patent Co-Owner at the following addresses:
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`
`
`
`
`William Hare - bill@miplaw.com
`Gabriela Materassi - materassi@miplaw.com
`
`Teresa Stanek Rea - TRea@Crowell.com
`Shannon M. Lentz - SLentz@Crowell.com
`
`Anthony C. Tridico - anthony.tridico@finnegan.com
`Jennifer H. Roscetti - jennifer.roscetti@finnegan.com
`
`
`Date: January 30, 2017
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`Respectfully submitted,
`
`
`/Dianne B. Elderkin/
`Dianne B. Elderkin
`Registration No. 28,598
`Counsel for Patent Owner
`
`
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`16
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