IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ARGENTUM PHARMACEUTICALS LLC, MYLAN PHARMACEUTICALS
`INC., BRECKENRIDGE PHARMACEUTICAL, INC., AND ALEMBIC
`PHARMACEUTICALS, LTD.,
`Petitioners,
`
`v.
`
`RESEARCH CORPORATION TECHNOLOGIES, INC.,
`Patent Owner.
`
`Case No. IPR2016-002041
`Patent No. RE 38,551
`
`PATENT OWNER’S MOTION TO EXCLUDE
`EVIDENCE PURSUANT TO 37 C.F.R. § 42.64
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`1 Case IPR2016-01101, Case IPR2016-01242, and Case IPR2016-01245 have been
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`joined with this proceeding.
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`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ARGENTUM PHARMACEUTICALS LLC, MYLAN PHARMACEUTICALS
`INC., BRECKENRIDGE PHARMACEUTICAL, INC., AND ALEMBIC
`PHARMACEUTICALS, LTD.,
`Petitioners,
`
`v.
`
`RESEARCH CORPORATION TECHNOLOGIES, INC.,
`Patent Owner.
`
`Case No. IPR2016-002041
`Patent No. RE 38,551
`
`PATENT OWNER’S MOTION TO EXCLUDE
`EVIDENCE PURSUANT TO 37 C.F.R. § 42.64
`
`
`
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`1 Case IPR2016-01101, Case IPR2016-01242, and Case IPR2016-01245 have been
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`joined with this proceeding.
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`I.
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`Introduction
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`IPR2016-00204
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`In accordance with 37 C.F.R. § 42.64(c) and the Scheduling Order (Paper
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`No. 20) as modified by the Joint Notice of Stipulation Concerning Schedule (Paper
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`No. 50), Patent Owner Research Corporation Technologies, Inc. moves to exclude
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`Petitioners’ Exhibit 1003, which was cited by Petitioners in support of their
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`Petition for Inter Partes Review under 35 U.S.C. §§ 311-319 and 37 C.F.R. §
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`42.100 et seq. (“Petition,” Paper No. 2), filed on November 23, 2015, and
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`Petitioners’ Exhibits 1048-1213, and deposition testimony from Exhibit 1050 at
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`243:3-271:21 and Exhibit 2035 at 246:22-254:1, which were cited by Petitioners in
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`support of their Petitioner Reply in Support of Petition for Inter Partes Review
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`(“Reply,” Paper No. 52), filed on November 14, 2016. This motion to exclude is
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`based on grounds listed in Patent Owner’s Objections to Evidence Under 37 C.F.R.
`
`§ 42.64(b)(1) (“Patent Owner’s First Objections,” Paper No. 22) and Patent
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`Owner’s Objections to Evidence Under 37 C.F.R. § 42.64(b)(1) (“Patent Owner’s
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`Second Objections,” Paper No. 53), which were timely filed and served on
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`Petitioners on June 7, 2016 and November 21, 2016, respectively. This motion to
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`exclude is also based on grounds identified during the depositions of Dr. William
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`Roush and Dr. Binghe Wang. See, e.g., Ex. 1050 at 243:18-19; Ex. 2035 at
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`248:11-18. Patent Owner’s motion is based on the Federal Rules of Evidence
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`1
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`IPR2016-00204
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`(“FRE”), relevant case law, and the PTAB’s rules as codified in the Code of
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`Federal Regulations, Title 37, at Part 42.
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`II. Argument
`A. Exhibit 1003 – Declaration of Dr. Clayton Heathcock – Should Be
`Excluded
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`Petitioners submitted Exhibit 1003 as evidence in their November 23, 2015
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`Petition. As identified in Patent Owner’s First Objections, Exhibit 1003 should be
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`excluded as inadmissible hearsay under FRE 801(c) and FRE 802.
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`Exhibit 1003 purports to be the declaration of Dr. Clayton Heathcock from
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`IPR2014-01126—a different IPR proceeding with different petitioners. See Ex.
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`1003, p. 1. Petitioners in this proceeding supported their Petition in part with
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`Exhibit 1003. See Petition, p. 5.
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` Exhibit 1003 is inadmissible hearsay under FRE 801 and FRE 802 because
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`it is offered as evidence of what it asserts. See Petition, p. 5. Exhibit 1003 is an
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`entire expert declaration submitted by an expert who is not participating in this
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`proceeding. Consequently, Patent Owner did not have an opportunity to depose
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`Dr. Heathcock or adequately challenge his opinions.
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`The hearsay exception for former testimony does not apply to Exhibit 1003.
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`See FRE 804(b)(1). As this Board has already explained, “the petition in the
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`earlier case [(i.e., IPR2014-01126)] raises different arguments.” See Institution
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`Decision (Paper No. 19), p. 9 n.7. Consequently, it cannot be shown that Patent
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`2
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`IPR2016-00204
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`Owner had “an opportunity and similar motive” to develop Dr. Heathcock’s
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`testimony by cross-examination. See FRE 801(b)(1)(B) (emphasis added). Thus,
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`Exhibit 1003 should be excluded as inadmissible hearsay.
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`B.
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`Exhibits 1048-1213 – Exhibits Filed With Petitioners’ Reply –
`Should Be Excluded
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`Exhibits 1048-1213 filed with Petitioners’ Reply should be excluded
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`because they were not served on Patent Owner with the Reply as required by 37
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`C.F.R. § 42.51(b)(1)(i). None of Exhibits 1048-1213 was timely served with the
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`Reply on the November 14, 2016 due date as set forth in the Joint Notice of
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`Stipulation Concerning Schedule (Paper 50). See Ex. 2189 (email communication
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`from Matthew Dowd at 11:50 PM on November 14, 2016 indicating that the
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`exhibits would be served the following day); see also Ex. 2190 (letter dated
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`November 15, 2016 for hand delivery of USB drive with “documents as filed
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`yesterday”).2 The Certificate of Service included with the Exhibit List filed and
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`2 The November 14, 2016 email communication (Ex. 2189) included attachments
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`identified as “Final Draft Davis Declaration_signed.pdf,” “McDuff Declaration -
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`20161114.pdf,” and “Wang Declaration Final Declaration-11-14-16[2].pdf,”
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`However, none of the documents attached to Ex. 2189 included any exhibit labels
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`or markings, and it is not Patent Owner’s burden or responsibility to determine
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`(continued…)
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`3
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`IPR2016-00204
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`served on November 14, 2016 made reference only to the Exhibit List itself, and
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`did not identify any of Exhibits 1048-1213, for which a Certificate of Service has
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`not ever been filed or served.
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`Under Board rules, a request for an extension of time, or an excuse for late
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`action, must be supported by a showing of good cause. 37 C.F.R. § 42.5(c). Any
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`alleged lack of prejudice to Patent Owner is not a substitute for a showing of good
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`cause why Petitioner did not even attempt to serve the voluminous exhibits—165
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`in total—timely with the Reply. The fact that Petitioners did not complete the
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`filing of their Reply and associated exhibits until after 11:00 PM on November 14,
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`2016 does not provide “good cause” for late service of the exhibits, particularly
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`when Patent Owner agreed to extend the Due Date 2 deadline as a demonstration
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`of reasonableness and professional courtesy to accommodate the change in law
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`firms of lead counsel for Petitioners. Paper 50, p. 1.
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`Moreover, Petitioners’ untimely service method was prejudicial to Patent
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`Owner. Not surprisingly, Petitioners’ 11:50 PM email communication (Ex. 2189)
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`was not read by Patent Owner until the next business day, November 15, 2016, but
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`the email communication did not specify when or how “the volume of the
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`whether these documents are the same as those marked as exhibits and served the
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`following day.
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`4
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`IPR2016-00204
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`associated exhibits” would be served. The sheer volume of the exhibits is
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`precisely why the untimely service was prejudicial, given the need to timely serve
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`evidence objections and prepare for cross-examination. Petitioners’ offer to extend
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`dates rings hollow because Petitioners cannot extend the evidence objection
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`deadline set forth in 37 C.F.R. § 42.64(b)(1), and the parties may not stipulate to an
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`extension of Due Dates 6 and 7. Paper 20, p. 2.
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`For the foregoing reasons, the Board should exclude Exhibits 1048-1213, or,
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`at a minimum, not rely on them for failure to effect timely service.
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`C. Exhibit 1050 at 243:3-271:21 – Dr. Roush Cross-Examination
`Testimony Concerning the ’301 Patent – Should Be Excluded
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`Petitioners submitted Exhibit 1050 as new evidence in their November 14,
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`2016 Reply. As identified during the deposition of Patent Owner’s expert Dr.
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`William Roush, cross-examination testimony regarding the ’301 patent should be
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`excluded as outside the proper scope of cross-examination under 37 C.F.R. §
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`42.53(d)(5)(ii). See, e.g., Ex. 1050 at 243:18-19, 253:5, 256:21-257:4.
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`Exhibit 1050 at 243:3-271:21 purports to be a series of questions and
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`answers from the deposition of Patent Owner’s expert Dr. Roush related to the
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`content and disclosure of the ’301 patent. Dr. Wang subsequently relied on this
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`cross-examination testimony in his second declaration. See Ex. 1084 ¶¶ 25-29.
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`All parties agree that Dr. Roush did not consider the ’301 patent in his direct
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`testimony. See, e.g., Reply, p. 13; Ex. 1084 (Second Wang Decl.) ¶ 25; Ex. 1050
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`5
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`IPR2016-00204
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`(Roush Dep. Tr.) at 243:7-9. Dr. Roush did not address the ’301 patent in his
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`declaration because Dr. Wang did not consider the reference in the instituted
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`grounds. See Ex. 1050 at 244:14-18 (“I was responding to issues that he raised.”);
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`see also Ex. 2194 at 151:22-152:16 (Dr. Wang acknowledging that he only
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`mentioned the ’301 patent in Exhibit 1002 at paragraphs 44 to 49 and 123).
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`“For cross-examination testimony, the scope of the examination is limited to
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`the scope of the direct testimony.” 37 C.F.R. § 42.53(d)(5)(ii). In Exhibit 1050 at
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`243:3-271:21, Petitioner went beyond Dr. Roush’s direct testimony and questioned
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`Patent Owner’s expert about a reference he had not considered. See Ex. 1050 at
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`243:7-9. Thus, the Board should exclude Exhibit 1050 at 243:3-271:21 as outside
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`the proper scope of cross-examination testimony under 37 C.F.R. § 42.53(d)(5)(ii).
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`D. Exhibit 1104 – Summary of PI Values – Should Be Excluded
`Petitioners submitted Exhibit 1104 as new evidence in Dr. Wang’s
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`November 14, 2016 Reply Declaration (Ex. 1084). As identified in Patent
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`Owner’s Second Objections, Exhibit 1104 should be excluded (i) under FRE 901
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`due to a lack of authentication, and (ii) under FRE 1001(e) and FRE 1003 as an
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`inappropriate “duplicate.”
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`Exhibit 1104 purports to be a “Summary of the Protective Indices of all FAA
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`Compounds in Dr. Kohn’s References.” See Ex. 1104, p. 1. In his Reply
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`6
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`IPR2016-00204
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`Declaration, Dr. Wang cites Exhibit 1104 to support his assertion that “Compound
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`3l had a very attractive protective index.” See Ex. 1084 ¶ 96.
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`Exhibit 1104, however, has not been authenticated and is unreliable. The
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`exhibit is nothing more than a spreadsheet of PI values calculated by Petitioners’
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`counsel. See Ex. 2194 at 167:4-17. Petitioner has submitted no evidence to
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`authenticate this document, to establish the date of its creation or to establish the
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`accuracy of the data contained therein. Exhibit 1104 does not even provide
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`citations for its purported PI values beyond a vague listing of the alleged source
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`document. Consequently, Petitioners have not provided evidence sufficient to
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`support a finding that Exhibit 1104 is an accurate compilation of PI values for all
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`FAAs in Dr. Kohn’s publications. See FRE 901(a). Thus, Exhibit 1104 lacks
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`authentication and is inadmissible under FRE 901.
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`Exhibit 1104 is also inadmissible under FRE 1001(e) and FRE 1003 as an
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`inappropriate “duplicate.” First, Exhibit 1104 does not include all PI values
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`reported in the alleged source documents, despite stating otherwise. See Ex. 1104,
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`p. 1 (“Summary of the Protective Indices of all FAA Compounds in Dr. Kohn’s
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`References”). As one example, Conley 1987 (Ex. 2004) contains a PI value for N-
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`acetyl-DL-alanine N-m-fluorobenzylamide (compound 1m), but this information is
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`omitted from Ex. 1104. See Conley 1987 (Ex. 2004) at 571. Second, certain PI
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`values reported in Exhibit 1104 are incorrect. As one example, Exhibit 1104
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`7
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`IPR2016-00204
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`reports a PI value for Compound 3t of 1.81, but Kohn 1991 (Ex. 1012) shows that
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`the correct PI value for that compound is > 1.81. See Kohn 1991 (Ex. 1012) at
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`2445 (reporting an ED50 of 62.0 and a TD50 of > 112). As a result of its omissions
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`and inaccuracies, the Board should exclude Exhibit 1104 as an inappropriate
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`“duplicate” under FRE 1001(a) and FRE 1003.
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`E.
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`Exhibit 1156 – Transcript, Deposition of John Lehner – Should Be
`Excluded
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`Petitioners submitted Exhibit 1156 (Transcript, Deposition of John Lehner)
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`as new evidence in their November 14, 2016 Reply. As identified in Patent
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`Owner’s Second Objections and during the deposition of Dr. Wang, see Ex. 2035
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`248:11-18, Exhibit 1156 should be excluded (1) under FRE 402 as lacking
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`relevance, and (2) under 37 C.F.R. § 42.123(c) as unauthorized evidence outside
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`the scope of an instituted ground.
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`Exhibit 1156 purports to be the transcript of a 2014 deposition of John
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`Lehner. Petitioners’ Reply cites 17 pages of Exhibit 1156 to argue that the LeGall
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`thesis (Ex. 1008) was publicly available as of the priority date of the ’551 Patent.
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`See Reply, pp. 28-29.
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`However, the Board has already determined that Petitioners failed to provide
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`“‘threshold evidence’ that justifies going forward with a trial on any ground that
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`relies on the LeGall thesis as ‘printed publication’ prior art.” Institution Decision
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`(Paper No. 19), p. 12. Since Petitioners failed to prove that the LeGall thesis is
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`8
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`IPR2016-00204
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`prior art, Exhibit 1156 can have no relevance to either of the instituted grounds.
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`Moreover, Petitioners should not be allowed to re-litigate the issue shortly before
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`oral argument, and after Patent Owner has filed it last substantive paper. Thus, the
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`Board should exclude Exhibit 1156 under FRE 402.
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`In addition, the rules make clear:
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`A party seeking to submit supplemental information not
`relevant to a claim for which the trial has been instituted
`must request authorization to file a motion to submit the
`information. The motion must
`show why
`the
`supplemental information reasonably could not have
`been obtained earlier, and that consideration of the
`supplemental information would be in the interests-of-
`justice.
`
`37 C.F.R. § 42.123(c). Petitioners did not file a motion seeking authorization to
`
`submit supplemental information supporting their failed argument that the LeGall
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`thesis is prior art. Rather, Petitioners first introduced Exhibit 1156 during the
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`redirect examination of their own expert. See Ex. 2035 at 246:22-247:7.
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`Petitioners did not even explain why they reasonably could not have obtained
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`Exhibit 1156 earlier. Consequently, the Board should also exclude Exhibit 1156 as
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`unauthorized “supplemental information” under 37 C.F.R. § 42.123(c).
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`9
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`IPR2016-00204
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`F.
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`Exhibit 2035 at 246:22-254:1 – Dr. Wang Cross-Examination
`Testimony Concerning Exhibit 1156 – Should Be Excluded
`
`Petitioners also rely on the redirect testimony of Dr. Wang regarding the
`
`deposition of John Lehner in their November 14, 2016 Reply. See Reply, p. 29.
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`As identified during the deposition of Dr. Wang, this redirect testimony (i.e.,
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`Exhibit 2035 at 246:22-254:1) should be excluded (1) under FRE 402 as lacking
`
`relevance, and (2) under 37 C.F.R. § 42.53(d)(5)(ii) as outside the proper scope of
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`cross-examination. See, e.g., Ex. 2035 at 248:11-18, 253:3-5.
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`Exhibit 2035 at 246:22-254:1 is Petitioners’ redirect testimony of their own
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`expert Dr. Wang regarding the deposition of John Lehner. It was during this
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`redirect testimony that Petitioners first introduced Exhibit 1156 as Wang Exhibit 2.
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`See Ex. 2035 at 246:22-247:7. Petitioners cite this redirect testimony to argue that
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`the LeGall thesis is prior art. See Reply, p. 29.
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`As described above for Exhibit 1156, the Board has already determined that
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`Petitioners failed to provide “‘threshold evidence’ that justifies going forward with
`
`a trial on any ground that relies on the LeGall thesis as ‘printed publication’ prior
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`art.” Institution Decision (Paper 19), p. 12. Thus, Exhibit 2035 at 246:22-254:1
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`can have no relevance to either of the instituted grounds and should be excluded
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`under FRE 402.
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`Moreover, “[f]or cross-examination testimony, the scope of the examination
`
`is limited to the scope of the direct testimony.” 37 C.F.R. § 42.53(d)(5)(ii). In
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`10
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`IPR2016-00204
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`Exhibit 2035 at 246:22-254:1, Petitioners went beyond Dr. Wang’s direct
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`testimony and questioned their expert about a new reference, which he had not
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`included in his first declaration. Thus, the Board should exclude Exhibit 2035 at
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`246:22-254:1 as outside the proper scope of cross-examination testimony under 37
`
`C.F.R. § 42.53(d)(5)(ii).
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`G. Exhibit 1158 – McDuff Declaration Attachments – Should Be
`Excluded
`
`Petitioners submitted Exhibit 1158 as new evidence in Dr. McDuff’s
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`November 14, 2016 Reply Declaration (Ex. 1086). As identified in Patent
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`Owner’s Second Objections, Exhibit 1158 should be excluded under FRE 901 due
`
`to a lack of authentication.
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`Exhibit 1158 purports to be a series of tables containing anti-epileptic drug
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`information, including sales data. In his Reply Declaration, Dr. McDuff cites
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`Exhibit 1158 to support his generalizations about the AED market. See, e.g., Ex.
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`1086 ¶¶ 10, 17, 20, 26, 43, 56.
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`Exhibit 1158, however, has not been authenticated and is unreliable. For
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`example, Exhibit 1158 cites numerous drug labels from unauthenticated websites.
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`See Exhibit 1158 at 2 (citing Exs. 1194-1203 & 1206-1213). Petitioners’ Updated
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`Exhibit List indicates that these drug labels were obtained from various websites
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`nearly 1 and 1/2 years ago. See Paper No. 51, pp. [20–23].
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`11
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`IPR2016-00204
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`As a general matter, the proponent of evidence from a website must
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`authenticate the information from the website itself, and not just from the
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`downloaded pages. See Victaulic Co. v. Tieman, 499 F.3d 227, 236 (3d Cir. 2007),
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`as amended (Nov. 20, 2007) (citing United States v. Jackson, 208 F.3d 633, 638
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`(7th Cir. 2000)). The Board has required that, for authentication purposes, the
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`party “proffering the evidence must produce some statement or affidavit from
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`someone with knowledge of the website … for example a web master or someone
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`else with personal knowledge would be sufficient.” EMC Corp. v. PersonalWeb
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`Techs., LLC, IPR2013-00084, Paper No. 64, pp. 45-46 (quoting St. Luke’s
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`Cataract & Laser Inst. v. Sanderson, 2006 WL 1320242, at *2 (M.D. Fla. May 12,
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`2006)).
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` Petitioners have provided no such authentication for the websites used to
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`create Exhibit 1158. Petitioner also has not provided the testimony of any witness
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`with personal knowledge of the websites listed in Exhibit 1158, and has not
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`provided any other basis for concluding that the webpages are authentic or to
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`establish the date of creation of Exhibit 1158. Thus, Exhibit 1158 lacks
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`authentication and is inadmissible under FRE 901.
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`12
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` Date: December 22 2016
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`Respectfully submitted,
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`IPR2O 16-00204
`
`By
`
`ndrea G. Reister
`
`Registration No.: 36,253
`
`Jennifer L. Robbins
`
`Registration No.2 61,163
`
`Enrique D. Longton
`
`Registration No.2 47,304
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`COVINGTON & BURLING LLP
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`One CityCenter, 850 Tenth Street, NW
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`Washington, DC 20001
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`(202) 662-6000
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`Attorneys for Patent Owner
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`13
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`
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`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6,
`
`I hereby certify that on this 22nd day of
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`December 2016, the foregoing Patent Owner’s Motion to Exclude Evidence
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`Pursuant to 37 C.F.R. § 42.64 was served by electronic mail, by agreement of the
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`parties, on the following counsel of record for Petitioners.
`
`PETITIONER (lPR20 1 6-00204)
`Matthew J. Dowd (mjdowd@dowdpllc.com)
`DOWD PLLC
`
`William G. Jenks (wjenks@jenksiplaw.com)
`JENKS IP LAW
`
`PETITIONER (lPR2016-01101)
`Steven W. Parmelee (sparmelee@wsgr.com)
`Michael T. Rosato (mrosato@wsgr.com)
`Jad A. Mills (jmills@wsgr.com)
`WILSON SONSINI GOODRICH & ROSATI
`
`PETITIONER (IPR2016-01242)
`Matthew L. F edowitz (mfedowitz@merchantgould.corn)
`Daniel R. Evans (devans@merchantgould.com)
`MERCHANT & GOULD P.C.
`
`PETITIONER (lPR20l6—01245)
`Gary J. Speier (gspeier@carlsoncaspers.com)
`Jeffer Ali (jali@carlsoncaspers.com)
`CARLSON, CASPERS, VANDENBURGH, LINDQUIST & SCHUMAN, P.A.
`
`Date: December 22, 2016
`
`
`
`Jeni ifer L. Robbins, Esq.
`Reg. No.: 61,163
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