UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_____________________________
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`ARGENTUM PHARMACEUTICALS LLC, MYLAN PHARMACEUTICALS
`INC., BRECKENRIDGE PHARMACEUTICAL, INC., AND ALEMBIC
`PHARMACEUTICALS, LTD.,
`Petitioners,
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`v.
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`RESEARCH CORPORATION TECHNOLOGIES, INC.,
`Patent Owner.
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`_____________________________
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`IPR2016-002041
`Patent RE 38,551
`_____________________________
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`PETITIONERS’ OPPOSITION TO PATENT OWNER’S
`MOTION TO EXCLUDE EVIDENCE
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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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`_____________________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_____________________________
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`ARGENTUM PHARMACEUTICALS LLC, MYLAN PHARMACEUTICALS
`INC., BRECKENRIDGE PHARMACEUTICAL, INC., AND ALEMBIC
`PHARMACEUTICALS, LTD.,
`Petitioners,
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`v.
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`RESEARCH CORPORATION TECHNOLOGIES, INC.,
`Patent Owner.
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`_____________________________
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`IPR2016-002041
`Patent RE 38,551
`_____________________________
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`PETITIONERS’ OPPOSITION TO PATENT OWNER’S
`MOTION TO EXCLUDE EVIDENCE
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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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`IPR2016-00204
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`INTRODUCTION
`Petitioners file this Opposition to Patent Owner’s Motion to Exclude
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`Evidence (Paper 71) in accordance with Due Date 5 (Papers 20, 50). Patent Owner
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`bears the burden of proof to establish that it is entitled to the requested relief. 37
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`C.F.R. § 42.20(c). A motion to exclude “may not be used to challenge the
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`sufficiency of the evidence to prove a particular fact.” Office Patent Trial Practice
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`Guide, 77 Fed. Reg. 48756, 48767 (Aug. 14, 2012).
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`II. ARGUMENT
`A.
`EXHIBIT 1003 (HEATHCOCK DECLARATION)
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`Patent Owner objects to Exhibit 1003 based on FRE 801(c) and 802. Neither
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`rule requires the exclusion of Exhibit 1003. The Board should deny the motion.
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`First, the hearsay exception of FRE 804(b)(1) applies. Dr. Heathcock’s
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`testimony was offered as sworn testimony, subject to penalty of perjury, in
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`IPR2014-01126. Thus, Dr. Heathcock’s testimony “was given as a witness at a
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`trial, hearing, or lawful deposition, whether given during the current proceeding or
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`a different one.” FRE 804(b)(1)(A). Further, petitioner in that proceeding was
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`“challenging the same claims of the same patent at issue here.” Paper 19 at 2. As
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`a result, Dr. Heathcock’s testimony “is now offered against a party who had—or,
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`in a civil case, whose predecessor in interest had—an opportunity and similar
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`motive to develop it by direct, cross-, or redirect examination.” FRE 804(b)(1)(B).
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`In addition, and contrary to Patent Owner’s assertion, Patent Owner could
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`have deposed Dr. Heathcock in this proceeding, see 37 C.F.R. § 42.52(a), but
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`never sought to take the cross-examination testimony.
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`Second, Patent Owner itself cited Exhibit 1003 and relied on Dr.
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`Heathcock’s testimony from the district court. See Paper 9 at 2; id. at 2 n.2
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`(arguing Dr. Heathcock’s trial testimony, Exhibit 2012, should be considered);
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`Paper 35 at 18, 38, 39, and 43. Patent Owner specifically asserted that, “[b]ecause
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`Dr. Heathcock testified before the filing of the present petition, and his testimony
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`was not taken specifically for the purpose of the present proceeding, it is not “new
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`testimony evidence,’ and the Board can, and should, consider it.” Paper 9 at 2 n.2
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`(citing Flir Sys., Inc. v. Canvs Corp., IPR2014-00773, Paper 7 at 2 (P.T.A.B. Sept.
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`4, 2014)); see also Paper 35 at 18 n.6. Thus, there can be little concern about the
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`reliability of the Dr. Heathcock’s testimony.
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`Third, the institution decision considered Dr. Heathcock’s testimony, Paper
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`No. 19 at 16, 18, and Patent Owner never objected to Dr. Heathcock’s affidavit
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`prior to institution. Instead, Patent Owner offered into evidence Dr. Heathcock’s
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`testimony from the trial in district court.
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`B.
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`EXHIBITS 1048-1213 (TIMELINESS OF REPLY EXHIBITS)
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`Patent Owner’s motion to exclude Exhibits 1048-1213 based on the
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`purported untimeliness of service must be denied because it has no basis in law or
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`fact. Patent Owner complains that while Petitioners’ Reply was timely filed on
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`November 14, 2016, it did not receive the exhibits until hand delivery one day
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`later, November 15, 2016. But next-day delivery of filed documents is specifically
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`allowed for by the rules.
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`Service of documents is governed by Rule 42.6(e)(1). Under Rule
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`42.6(e)(1), “[s]ervice may be made electronically upon agreement of the parties.
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`Otherwise, service may be by Priority Mail Express® or by means at least as fast
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`and reliable as Priority Mail Express®.” 37 C.F.R. § 42.6(e)(1) (emphasis added).
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`Parties to a proceeding before the Board can therefore serve documents (a) by
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`electronic service, if the parties agree, (b) by Priority Mail Express®, or (c) “by
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`means at least as fast and reliable as Priority Mail Express.”
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`Here, lead counsel personally timely delivered the documents at issue by
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`hand the day after filing during business hours. Ex.2190. This is service “by
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`means at least as fast and reliable as Priority Mail Express®.” Indeed, Petitioner’s
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`hand delivery of the exhibits may well have been faster and more reliable than
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`Priority Mail Express®.
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`Importantly, Patent Owner does not argue that such service is not within the
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`scope of Rule 42.6(e)(1). Thus, Patent Owner does not dispute that Petitioner’s
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`service complied with Rule 42.6(e)(1). Because Patent Owner does not even
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`contend Petitioner’s service did not comply with the applicable rule, Patent
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`Owner’s motion must be denied.
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`Oddly, Patent Owner’s motion to exclude relies not on the primary rule
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`governing service of documents but on 37 C.F.R. § 42.51(b)(1)(i), which relates to
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`routine discovery. Rule 42.51(b)(1)(i) states: “(1) Routine discovery…. (i) Unless
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`previously served or otherwise by agreement of the parties, any exhibit cited in a
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`paper or in testimony must be served with the citing paper or testimony.” Even if
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`applicable, service satisfying Rule 42.6 should also satisfy service “with” the citing
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`paper under Rule 42.5. This is particularly so where the rules must be construed
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`together “to secure the just, speedy, and inexpensive resolution of every
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`proceeding.” 37 C.F.R. § 42.1(b). Ultimately, Patent Owner’s complaint is that
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`the e-mail did not include the voluminous exhibits with the Reply. But delivery of
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`the Reply does not invalidate timely service of all the documents together.
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`Even assuming arguendo that service here did not comply with Rule
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`42.6(e)(1), or that service violated Rule 42.5 despite complying with Rule 42.6,
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`Patent Owner cites no rule or legal authority stating that exclusion of otherwise
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`admissible evidence is a permissible remedy. Thus, the Motion fails to offer a
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`legal basis for its requested remedy.
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`Further, the evidence establishes that Patent Owner experienced absolutely
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`no prejudice due to Petitioner’s timely service of documents. During a meet and
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`confer concerning Patent Owner’s objections, counsel for Patent Owner confirmed
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`that all documents were received the day after filing. Ex.1214 (12/2/2016
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`(1:44pm) Email from Dowd to Reister).
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`Furthermore, even if there had been prejudice, Patent Owner had Petitioners’
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`consent to move for an extension of time. See 37 C.F.R. § 42.5(c). Petitioner
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`offered to extend the time necessary to respond to the exhibits. See Exs. 1214-
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`1216 (12/2/2016 (1:44pm) Email from Dowd to Reister; 11/23/2016 (10:21 am)
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`email from Dowd to Reister 10:21 am). The repeated offers obviously included
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`consent to a request by Patent Owner if it had wanted an extension of time. Thus,
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`Petitioners’ offer did not “ring hollow,” as Patent Owner claims. Rather,
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`Petitioners made a bona fide effort to ameliorate any prejudice Patent Owner
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`believes it may have suffered—despite there being none.
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`Finally, even if service had been untimely, and even if Patent Owner
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`identified a basis to exclude admissible evidence due to the next-day service, and
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`even if Patent Owner had demonstrated prejudice, there would still be no basis to
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`exclude Exhibits 1048-1213. The Board’s rules expressly state that “[a] late action
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`will be excused on a showing of good cause or upon a Board decision that
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`consideration on the merits would be in the interests of justice.” 37 C.F.R. §
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`42.5(c)(3). Deciding whether patent claims are valid or invalid is in the public
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`interest. See Lear, Inc. v. Adkins, 395 U.S. 653, 670 (1969). Given the Board’s
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`time and effort in instituting the present proceeding and additional efforts through
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`the oral hearing, it is in the interest of justice for the Board to decide this case on
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`its merits.
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`C.
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`EXHIBIT 1050 AT 243:3-271:21 (ROUSH TESTIMONY)
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`Patent Owner moves to exclude some of Dr. Roush’s testimony under Rule
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`42.53(d)(5)(ii) as purportedly being outside the scope of proper cross-examination.
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`Patent Owner’s motion should be denied for multiple reasons.
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`First, the motion should be rejected because Dr. Roush’s testimony relating
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`to the ’301 patent is directly relevant to the issues of obviousness, the witness’s
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`credibility, and whether the witness considered all of the relevant prior art, as a
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`person of ordinary skill in the art would do. These issues were timely presented.
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`“The person of ordinary skill is a hypothetical person who is presumed to be
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`aware of all the pertinent prior art.” Custom Accessories, Inc. v. Jeffrey-Allan
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`Indust., Inc., 807 F.2d 955, 963 (Fed. Cir. 1986). An obviousness analysis must be
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`performed from the perspective of a person of ordinary skill in the art. See KSR
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`International Co. v. Teleflex Inc., 550 U.S. 398 (2007).
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`Here, Dr. Roush did not consider all of the relevant prior art when he
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`expressly refused to consider the ‘301 patent in the present proceeding. See
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`Ex.1050 at 243:3-9. He testified: “I don’t recall anything to do with the ‘301
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`coming out of any of Dr. Wang’s testimony,” Ex.1050 at 245:14-18. Of course,
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`his recollection is wrong, as Dr. Wang did relied on and discussed in detail the
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`‘301 patent, including reasonable expectation of success. Ex. 1084 ¶¶97-98.
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`Beyond Dr. Wang’s testimony, Dr. Roush’s testimony is relevant to his
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`opinions concerning secondary considerations. He expressed opinions about the
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`state and content of the prior art, unexpected results, skepticism, and failure of
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`others. See Ex. 2036 ¶¶130-194, 274-300, 304-317. While Dr. Roush considered
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`numerous prior art references by Dr. Kohn in assessing these factors, he
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`affirmatively excluded from consideration Dr. Kohn’s ‘301 patent, without any
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`reasoned basis. See, e.g., Exhibit 1050 at 246:2-14 (“it didn’t cross my mind”); id.
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`at 244:6-7 (“Sitting here today, I thought it’s not prior art”).
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` Thus, Dr. Roush’s testimony demonstrates that his obviousness analysis is
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`fundamentally flawed. It is not the analysis of a person of ordinary skill in the art
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`who is aware of all of the relevant prior art. Further, the testimony includes Dr.
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`Roush’s purported reason for not considering the ’301 patent despite Dr. Wang’s
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`discussion of it in his testimony.
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`Second, Patent Owner’s reargument of the issue of the ’301 patent vis-à-vis
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`the scope of the cross-examination is an attempt to nullify the two-page limit the
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`Board established for addressing this issue. See Paper No. 57; Paper No. 63.
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`Third, Patent Owner’s objection concerning “new evidence,” Motion at 5, is
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`not the proper basis for a motion to exclude. “LinkedIn Corp. v. AvMarkets Inc.,
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`No. CBM2013-00025, Paper 30, at 5 (P.T.A.B. Nov. 10. 2014) (motion to exclude
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`“is not a mechanism to argue that a Reply contains new arguments”).
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`D.
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`EXHIBIT 1104 (SUMMARY OF PI VALUES)
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`Patent Owner moves to exclude Exhibit 1104 on two bases: (a) under FRE
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`901 as lacking authentication, and (b) under FRE 1001(e) and FRE 1003 as an
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`“inappropriate ‘duplicate.’” Neither is a sufficient reason to exclude Exhibit 1104.
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`First, Exhibit 1104 does not lack authentication. Exhibit 1104 is an exhibit
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`Dr. Wang relied on in his testimony. Ex.1084 ¶¶96, 234. His testimony
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`establishes that the document is “in a condition that creates no suspicion about its
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`authenticity,” and Patent Owner “does not present sufficient or credible evidence
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`to the contrary.” EMC Corp., IPR2013-00084, Paper No. 64, p. 48. Quite simply,
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`Patent Owner’s motion offers no legal precedent to exclude an expert witness’s
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`compilation of data extracted from various admissible exhibits which have been
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`offered into evidence by both Patent Owner and Petitioner.
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`Second, Patent Owner’s theory about an “inappropriate ‘duplicate’” is
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`equally meritless, as Patent Owner’s argument finds no support in FRE 1001(e) or
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`FRE 1003. Patent Owner’s theory is entirely misplaced.
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`FRE 1001(e) and 1003 concern the admissibility of “duplicates” of original
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`documents. FRE 1001(e) defines “duplicate” as “a counterpart produced by a
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`mechanical, photographic, chemical, electronic, or other equivalent process or
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`technique that accurately reproduces the original.” Exhibit 1104 is not a duplicate;
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`it is a compilation of information extracted from data provided in exhibits that are
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`already in evidence. Tellingly, Patent Owner cites no precedent supporting its
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`theory that, under FRE 1003, an expert’s exhibit which summarizes data from
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`other documents in evidence can be excluded.
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`More to the poin, Exhibit 1104 is admissible under FRE 1006 because it is
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`simply a compilation of data presented in admissible exhibits. Patent Owner
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`makes no objection under FRE 1006. Indeed, Patent Owner’s own witness used a
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`similar compilation of data, to which Petitioner did not object because such
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`compilations are permissible. See Ex.2172.
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`Finally, even if Exhibit 1104 were a “duplicate,” that is no basis to exclude
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`it. Under FRE 1003, “[a] duplicate is admissible to the same extent as the original
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`unless a genuine question is raised about the original’s authenticity or the
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`circumstances make it unfair to admit the duplicate.” Patent Owner has not
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`identified “a genuine question” “about the original’s authenticity.” Further, it
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`would not be “unfair to admit the duplicate.” All Patent Owner has identified are
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`purported minor typographical errors in Exhibit 1104, such as using “>”instead of
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`“=” for one value. See Paper No. 71 at 8. But minor typographical errors of which
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`the Board has been apprised do not undermine the original’s authenticity.
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`Furthermore, Petitioners offered Exhibit 1218 to correct the minor
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`typographical errors. See Exs.1217 & 1218. Patent Owner has had an opportunity
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`to cross-examine Dr. Wang about Exhibit 1104, as well as Exhibit 1218. In short,
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`there is no basis under FRE 1001(e) and 1003 to exclude Exhibit 1104.
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`E.
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`EXHIBIT 1156 LEHNER TRANSCRIPT
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`Patent Owner moves to exclude Exhibit 1156 (Lehner Transcript) on two
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`bases: (a) under FRE 402 as purportedly lacking relevance; and (b) under Rule
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`42.123(c) as outside the scope of an instituted ground. Both bases lack merit.
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`Exhibit 1156 is relevant because it supports the admissibility of evidence
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`that is responsive to Patent Owner’s arguments concerning secondary indicia of
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`nonobviousness. Specifically, Exhibit 1156 is relevant to the admissibility of
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`LeGall (Ex. 1008), which responds to Patent Owner’s arguments about unexpected
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`success, long-felt need, failure of others, and skepticism.
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`Petitioner agrees that the Board made an initial determination about the
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`public accessibility of LeGall, but the Board expressly kept this issue alive, (see
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`Ex.1156, 143:4-12; Ex.2031, 23:4-5); as it should have. See Genzyme Therapeutic
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`Prods. Ltd. P’ship v. Biomarin Pharm. Inc., 825 F.3d 1360, 1367 (Fed. Cir. 2016)
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`(“The purpose of the trial in an inter partes review proceeding is to give the parties
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`an opportunity to build a record by introducing evidence—not simply to weigh
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`evidence of which the Board is already aware.”). Given that the Lehner Transcript
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`is now available, it is admissible evidence from which the Board may conclude
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`that LeGall is prior art and that LeGall can be considered with respect to Patent
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`Owner’s arguments and evidence with respect to the Graham factors.
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`F.
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`EXHIBIT 2035 AT 246:22-254:1 (WANG TESTIMONY)
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`Patent Owner moves to exclude part of Dr. Wang’s redirect testimony
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`(Exhibit 2035) based on FRE 402 (relevance) and Rule 42.53(d)(5)(ii) (scope of
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`cross-examination). Patent Owner’s motion should be denied.
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`First, the cited testimony is relevant to the issue of whether a person of
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`ordinary skill in the art would consider LeGall to be publicly accessible. As noted
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`above, Petitioners respectfully submit that this evidence developed during trial—
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`evidence that was not available to Petitioner prior to institution, is relevant for
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`assessing whether LeGall was available to a person of ordinary skill in the art. See
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`Ex.2035 at 253:6-20.
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`Second, Patent Owner’s argument concerning the scope of cross-
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`examination is that Dr. Wang was asked “about a new reference, which he had not
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`included in his first declaration.” But as discussed above, there is no rule that
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`admissible evidence is limited to exhibits cited in an opening declaration. See
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`Genzyme, 825 F.3d at 1367. Given that the Lehner Transcript is now available, Dr.
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`Wang’s testimony is admissible evidence to prove that LeGall is prior art and that
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`LeGall can be considered with respect to Patent Owner’s arguments and evidence.
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`G.
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`EX. 1158 (MCDUFF DECLARATION ATTACHMENTS)
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`Dr. McDuff has testified that Ex. 1158 “is a true and correct copy of the
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`attachments prepared by me and under my direction and supervision for my
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`Original Declaration.” Ex.1220 (Evidentiary Declaration of Dr. McDuff, served
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`December 6, 2016), ¶3; see also Ex.1086, ¶8. Patent Owner seeks to exclude Ex.
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`1158 in its entirety because it purportedly “has not been authenticated and is
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`unreliable.” Paper 71 at 11. But Patent Owner’s sole basis for exclusion is that it
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`“cites numerous drug labels from unauthenticated websites” that were obtained
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`nearly 1.5 years ago and are cited in Attachment B-1 on page 2 of Ex. 1158. Id.
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`(citing Exs. 1194-1203 & 1206-1213). In contrast, pages 3-12 of Ex. 1158
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`(Attachments B-2 through D-2) cite Exs. 2174, 2136, 1170, 1171, and 2177, which
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`are not among the “drug labels” cited in Attachment B-1. In other words, Patent
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`Owner’s motion fails to support its request to exclude all of Ex. 1158.
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`Patent Owner’s motion also fails to justify the exclusion of Attachment B-1.
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`First, the motion seeks to exclude only Ex. 1158 (also Ex. 1104; see Section D,
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`below) under FRE 901; it does not seek to exclude the cited drug labels (Exs.
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`1194-1203 & 1206-1213) under FRE 901. Paper 71 at 11-12 (“Petitioners have
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`provided no authentication for the websites used to create Exhibit 1158….Thus,
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`Exhibit 1158 lacks authentication and is inadmissible under FRE901.”). Because
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`the motion does not seek to exclude Exs. 1194-1203 and 1206-1213 under FRE
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`901, it is improper for Patent Owner to attempt to exclude Ex. 1158 under FRE 901
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`because of the purported lack of authenticity of those underlying exhibits.
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`Patent Owner’s motion should also be denied because an expert may rely on
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`information that is not admissible if “experts in the particular field would
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`reasonably rely on those kinds of” information. FRE 703. Dr. McDuff testified
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`that Exs. 1194-1213 “are true and correct copies of drug labels for various anti-
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`epileptic drugs (AEDs) that were obtained by me and under my direction and
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`supervision from the FDA or NIH or from the manufacturers’ websites,” and
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`explained where he had identified the source web sites in Attachment B-1. Ex.
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`1220, ¶¶4-5. Dr. McDuff testified that “it is accepted practice in my field to rely
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`on drug labels provided on the FDA web site[,]…provided on the manufacturer’s
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`website[, or]…provided on the U.S. National Library of Medicine (NIH)
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`website…as an accurate public[ or business] record of what the drug labels state
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`with regard to a particular drug.” Ex.1220, ¶6.
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`Patent Owner incorrectly argues that Ex. 1158 should be excluded unless
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`Petitioner produces a webmaster from the FDA and NIH. Paper 71 at 12.
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`However, any “publication purporting to be issued by public authority” is a self-
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`authenticating document under FRE 902(5), and the provenance of the document
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`can be confirmed simply by returning to the public authority.2 The FDA and NIH
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`websites identified by Dr. McDuff as the source for the drug labels in Exs. 1194-
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`1213 (and the labels themselves) purport to be publications of a public authority,
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`and are therefore self-authenticating.
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`Neither case cited by Patent Owner establishes that a public record from a
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`government website requires the testimony of the government’s webmaster in
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`order to establish admissibility. See Victaulic Co. v. Tieman, 499 F.3d 227, 236
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`(3d Cir. 2007) (court erred in taking judicial notice of facts from the Victaulic.com
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`website where ownership of the web address had been subjected to reasonable
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`dispute and without the benefit of discovery); EMC Corp. v. PersonalWeb Techs.,
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`LLC, IPR2013-00084, Paper 64, pp. 45-48 (holding the Petitioner had not
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`established public accessibility of reference prior to the critical date based on its
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`publication on a non-governmental website); see also In re Amgen Inc. Securities
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`2 Dr. McDuff confirmed the availability of the drug labels from the indicated
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`web sites and authenticated Exs. 1221-1224 as drug labels he obtained from either
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`the FDA Website or the NIH Website that were substantively identical to the drug
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`labels provided respectively in Ex. 1194, 1208, 1202, and 1203. Ex. 1220, ¶¶7-11.
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`Litig., 544 F. Supp. 2d 1009, 1023 (C.D. Cal. 2008) (taking judicial notice of drug
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`labels “taken from the FDA website, as documents ‘capable of accurate and ready
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`determination’ and ‘not subject to reasonable dispute’” (quoting FRE 201(b))); In
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`re Wellbutrin SR/Zyban Antitrust Litig., 281 F. Supp. 2d 751, 754 n.2 (E.D. Pa.
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`2003).
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`Furthermore, FRE 901 requires only “evidence sufficient to support a
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`finding that the item is what the proponent claims it is, such as “[t]estimony that an
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`item is what it is claimed to be,” FRE 901(b)(1), a “comparison with an
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`authenticated specimen by an expert witness” FRE 901(b)(3), or evidence that “a
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`purported public record or statement is from the office where items of this kind are
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`kept,” FRE 901(b)(7). Here, Dr. McDuff has testified that these drug labels are
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`public records that he obtained from the FDA website (fda.gov) or the NIH website
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`(nih.gov), or that he had compared them to labels obtained from one of these
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`government web sites. Ex.1220, ¶¶4-11. He also provided information sufficient
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`to confirm his sources. Ex.1220, ¶¶6-11. Dr. McDuff’s testimony establishes that
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`each drug label is “in a condition that creates no suspicion about its authenticity,”
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`and Patent Owner “does not present sufficient or credible evidence to the
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`contrary.” EMC Corp., IPR2013-00084, Paper No. 64, p. 48.
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`For each of the independent reasons discussed above, Patent Owner’s
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`motion to exclude Exhibit 1158 should be denied.
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`-15-
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`IPR2016-00204
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`Respectfully,
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`/ Matthew J. Dowd/
`Matthew J. Dowd
`Reg. No. 47,534
`Dowd PLLC
`1717 Pennsylvania Avenue, NW
`Suite 1025
`Washington, D.C. 20006
`mjdowd@dowdpllc.com
`
`William G. Jenks
`Reg. No. 48,818
`Jenks IP Law
`1050 17th ST NW
`Suite 800
`Washington, D.C. 20036
`Phone: (202) 412-7964
`wjenks@jenksiplaw.com
`
`Counsel for Argentum
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`-16-
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`Date: January 6, 2017
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`IPR2016-00204
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`CERTIFICATE OF SERVICE
`37 CFR §42.6(e)
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`I certify that, on January 6, 2016, this PETITIONERS’ OPPOSITION TO
`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE was served on
`Research Corporation Technologies at the following service electronic addresses:
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`
`
`Andrea G. Reister
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` areister@cov.com
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`Jennifer L. Robbins
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` jrobbins@cov.com
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`Enrique D. Longton
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`elongton@cov.com
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`Dated: 6 January 2017
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`/ Matthew J. Dowd/
`Matthew J. Dowd, Reg. No. 47,534
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`-17-
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