IPR2016-00204
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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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`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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`Case IPR2016-002041
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`Patent RE38,551 E
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`PETITIONER’S MOTION TO EXCLUDE
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`1 Case IPR2016-01101, Case IPR2016-01242, and Case IPR2016-01245
`have been joined with this proceeding.
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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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`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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`Case IPR2016-002041
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`Patent RE38,551 E
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`PETITIONER’S MOTION TO EXCLUDE
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`1 Case IPR2016-01101, Case IPR2016-01242, and Case IPR2016-01245
`have been joined with this proceeding.
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`IPR2016-00204
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`Pursuant to 37 C.F.R. §§ 42.62, 42.64(c) and the Board’s Scheduling Order
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`(Paper 9), Petitioner Argentum Pharmaceuticals LLC hereby respectfully moves
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`to exclude Exhibits 2125, 2141-2170, and 2174-2182.2 The Federal Rules of
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`Evidence apply to inter partes proceedings. 37 C.F.R. § 42.62; LKQ Corp. v.
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`Clearlamp, LLC, IPR2013-00020, Paper 17, at 3 (PTAB Mar. 5, 2013).
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`Exhibits 2125 and 2141-2170
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`The Board should exclude Exhibits 2125 and 2141-2170. Petitioner timely
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`objected to these exhibits. (Paper No. 41.) Patent Owner relies on these exhibits
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`in its Patent Owner Response. See, e.g., Patent Owner Response, Paper No. 35, at
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`8, 54.
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`First, each of the exhibits lacks any authentication, and therefore the exhibits
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`are inadmissible under Federal Rule of Evidence 901. “To satisfy the requirement
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`of authenticating or identifying an item of evidence, the proponent must produce
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`evidence sufficient to support a finding that the item is what the proponent claims
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`it is.” FRE 901(a). Although the standard for admissibility under Rule 901(a) has
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`been described as “slight,” see United States v. Turner, 718 F.3d 226, 232 (3d Cir.
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`2013), Patent Owner has offered no evidence from any witness having personal
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`2 Petitioner timely objected to Exhibits 2125, 2141-2170, and 2174-2182. See Pet’r
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`Objections, Paper No. 23, filed June 7, 2016; Pet’r Objections, Paper No. 41, filed
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`Aug. 8, 2016.
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`IPR2016-00204
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`knowledge concerning Exhibits 2125 and 2141-2170.
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`Patent Owner offers no evidence regarding the identity of the purported
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`authors of the letters, whether those purported authors did in fact write the letters,
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`or whether those purported authors did in fact work for the companies or entities
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`identified on the letters (for those letters that in fact identify companies).
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`Nor does Patent Owner provide testimony from a witness with knowledge of
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`what the exhibits are. See Fed. R. Evid. 901(b)(1). In fact, Patent Owner’s
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`witness, Dr. Vellturo, demonstrated very little understanding of the letters during
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`his cross-examination. See Ex. 1049, at 90-197.
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`Patent Owner also does not offer “[a] nonexpert’s opinion that handwriting
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`is genuine, based on a familiarity with it that was not acquired for the current
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`litigation.” Fed. R. Evid. 901(b)(2). Nor does Patent Owner offer evidence about
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`“[t]he appearance, contents, substance, internal patterns, or other distinctive
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`characteristics of the item, taken together with all the circumstances.” Fed. R.
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`Evid. 901(b)(4).
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`Patent Owner also fails to authenticate the letters under the “reply doctrine.”
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`See United States, v. Reilly, 33 F.3d 1396, 1407-08 (3d Cir. 1994) (citing 5 Jack B.
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`Weinstein & Margaret A. Berger, Weinstein’s Evidence ¶ 901(b)(4)[05] at 901-76
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`(1993) (“A letter can be authenticated by testimony or other proof that it was sent
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`in reply to a duly authenticated writing. A reply letter often needs no further
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`IPR2016-00204
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`authentication because it would be unlikely for anyone other than the purported
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`writer to know and respond to the contents of an earlier letter addressed to him.”)).
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`In short, Patent Owner offers no evidence to authenticate the letters
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`purportedly written by various individuals who have not testified in the present
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`proceeding. Accordingly, Exhibits 2125 and 2141-2170 should be excluded under
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`Rule 901.
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`Second, each of the exhibits constitutes hearsay under Rule 801 and are
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`inadmissible under Rule 802. If an exception does not apply, the rule against
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`hearsay operates to prohibit out-of-court statements from being offered to prove
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`the truth of the matter asserted. Neste Oil OYJ v. Reg Synthetic Fuels, LLC,
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`IPR2013-00578, at 5-6 (Mar. 12, 2015) (citing Fed. R. Evid. 801–803).
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`Exhibits 2125 and 2141-2170 are all plainly hearsay and should be
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`excluded. They are out-of-court statements sought to be admitted for the truth of
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`the matters asserted therein. This is hearsay. Fed. R. Evid. 801(c). No exception
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`applies.
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`For example, the documents are letters written by various individuals, none
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`of whom have testified in the present proceeding. In certain instances, the
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`documents appear to be facsimiles of the underlying letters, without any clear
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`indication of the source of the facsimile.
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`These exhibits do not fall under the any applicable hearsay exception. For
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`IPR2016-00204
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`example, Exhibits 2125 and 2141-2170 do not qualify as business records for
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`numerous reasons. Under the business records exception, a hearsay record may
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`be admitted if: “1) it was made at or near the time by, or from information
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`transmitted by, someone with knowledge; 2) it was kept in the course of a
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`regularly conducted activity of a business; 3) making the record was a regular
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`practice of that activity; 4) all these conditions are shown by the testimony of the
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`custodian or another qualified witness; and 5) the method or circumstances of
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`preparation do not indicate a lack of trustworthiness.” Neste Oil OYJ v. Reg
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`Synthetic Fuels, LLC, IPR2013-00578, at 5-6 (Mar. 12, 2015) (citing Fed. R.
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`Evid. 803(6)).
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`Here, there is no indication that the record was a regular practice of a
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`regularly conducted activity of a business. Nor does Patent Owner proffer the
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`required testimony from a business custodian or other qualified witness. Indeed,
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`Patent Owner offers no reliable information about the genesis of these exhibits.
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`In addition to the above objections, Exhibits 2125 and 2141-2170 should be
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`excluded under Federal Rule of Evidence 106 as being incomplete and only part
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`of the relevant correspondence. See Fed. R. Evid. 106 (“If a party introduces all
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`or part of a writing or recorded statement, an adverse party may require the
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`introduction, at that time, of any other part—or any other writing or recorded
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`statement—that in fairness ought to be considered at the same time.”).
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`IPR2016-00204
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`Discovery subsequent to the filing of the Patent Owner Response confirms
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`the existence of additional documents and writings related to Exhibits 2125 and
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`2141-2170. Ex.2193, at 176-186 (McDuff Deposition Transcript); Ex1086, at 26-
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`27 n.40 (McDuff Declaration); Ex. 1049, at 90-197 (Vellturo Deposition).
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`“Under the doctrine of completeness, codified at Federal Rule of Evidence 106, ‘a
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`complete statement is required to be read or heard when it is necessary to (1)
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`explain the admitted portion, (2) place the admitted portion in context, (3) avoid
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`misleading the trier of fact, or (4) insure a fair and impartial understanding.’”
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`United States v. Vargas, 689 F.3d 867, 876 (7th Cir. 2012) (quoting United States
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`v. Lewis, 641 F.3d 773, 785 (7th Cir. 2011)). It is unfair under Rule 106 to
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`consider Patent Owner’s selected sliver of the larger correspondence that Patent
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`Owner has withheld. Patent Owner should not be permitted to rely on incomplete
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`correspondence concerning an issue which Patent Owner contends is critical to
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`the patentability of the claims at issue.
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`Furthermore,
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`the evidence adduced during
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`the
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`trial proceeding
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`demonstrates that Patent Owner failed to comply with the discovery rules and
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`failed to serve mandatory discovery. 37 C.F.R. § 42.51(b)(1)(iii). During the
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`deposition of Dr. McDuff, his testimony revealed that Patent Owner has not
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`produced evidence that is inconsistent with arguments and evidence Patent Owner
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`advanced in the current proceeding. See Exhibit 2193, McDuff Deposition Tr. at
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`IPR2016-00204
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`170-185. Patent Owner’s failure to serve such information violates the Board’s
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`discovery rules. See 37 C.F.R. § 42.51(b)(1)(iii) (“(iii) Unless previously served,
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`a party must serve relevant information that is inconsistent with a position
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`advanced by the party during the proceeding concurrent with the filing of the
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`documents or things that contains the inconsistency.”). Accordingly, the Board
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`should exclude Exhibits 2125 and 2141-2170.
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`Exhibits 2174-2180
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`The Board should exclude Exhibits 2174-2180. Petitioner timely objected to
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`these exhibits. Paper No. 41, at 39-41. Patent Owner relies on these exhibits.
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`See Patent Owner Response, Paper No. 35, at 54, 55, 58, 60 (citing Vellturo
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`Declaration, Ex. 2132).
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`Exhibits 2174-2180 should be excluded under Federal Rule of Evidence
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`106 as being incomplete and only part of the relevant correspondence. See Fed.
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`R. Evid. 106 (“If a party introduces all or part of a writing or recorded statement,
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`an adverse party may require the introduction, at that time, of any other part—or
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`any other writing or recorded statement—that in fairness ought to be considered
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`at the same time.”).
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`Here, discovery subsequent to the filing of the Patent Owner Response
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`confirms the existence of additional documents and writings that related to
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`Exhibits 2125 and 2141-2170. For example, Petitioner’s expert witness Dr.
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`IPR2016-00204
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`DeForest McDuff explained
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`Q. And do you have any recollection of specific differences
`in the scope of evidence that may have been presented at trial
`regarding commercial success and the scope of evidence that
`was presented by a patent owner and Dr. Vellturo in the current
`IPR proceeding?
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`MS. REISTER: Objection. Form. Scope. Leading.
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`THE WITNESS: Yes. For example, there was information
`presented at trial about a significant disparity between the
`marketing spend actually reported by UCB and the marketing
`spend as reported in IMS Health and, thus, called into question
`the accuracy of the IMS Health marketing spend and
`comparison across drugs used by Dr. Vellturo.
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`As another example, there are the license agreements that -- or
`I should say license rejections that we discussed earlier today
`and are identified in footnote 43 of my declaration. In addition,
`there was information on Vimpat's off-label use that was
`discussed at trial but was not provided here by UCB. There was
`information relating to non-epilepsy use of other AEDs that
`was discussed at trial that was not provided here. There was
`information relating to UCB's expectations and predictions of
`Vimpat sales that were not provided here in this proceeding.
`Those are some of the items that come to mind.
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`IPR2016-00204
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`Ex.2193 at 177-178; see also Ex.1086 at 26-27, n.40 (noting “several licensing
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`letters that Patent Owner chose not to produce in this proceeding, even though
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`these letters are inconsistent with the positions Patent Owner is taking in this
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`proceeding.”).
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`As set forth above with regard to the “doctrine of completeness,” it is
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`unfair under Rule 106 to consider Patent Owner’s selected sliver of the larger
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`correspondence that Patent Owner has withheld. Patent Owner should not be
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`permitted to rely on incomplete correspondence concerning an issue which Patent
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`Owner contends is critical to the patentability of the claims at issue.
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`Furthermore,
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`the evidence adduced during
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`the
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`trial proceeding
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`demonstrates that Patent Owner failed to comply with the discovery rules and has
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`failed to serve mandatory discovery. During the deposition of Dr. McDuff, his
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`testimony revealed that Patent Owner has not produced evidence that is
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`inconsistent with arguments and evidence Patent Owner advanced in the current
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`proceeding. See Exhibit 2193, McDuff Deposition Transcript, at 170-188; id. at
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`180 (“Dr. Vellturo makes certain claims about commercial success of Vimpat,
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`and there were counter-arguments that I had made in my testimony at trial and
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`information supporting those counter-arguments was not provided in this
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`proceeding.”). Patent Owner’s failure to serve such information violates the
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`Board’s discovery rules. See 37 C.F.R. § 42.51(b)(1)(iii) (“(iii) Unless previously
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`IPR2016-00204
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`served, a party must serve relevant information that is inconsistent with a position
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`advanced by the party during the proceeding concurrent with the filing of the
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`documents or things that contains the inconsistency.”). Accordingly, the Board
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`should exclude Exhibits 2174-2180.
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`Exhibits 2181 and 2182
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`The Board should exclude Exhibits 2181 and 2182. Petitioner timely
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`objected to these exhibits. Paper No. 41, at 41. Patent Owner relies on these
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`exhibits. See Exhibit 2193, at 51.
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`Exhibits 2181 and 2182 are the district court’s Order and Memorandum
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`Opinion in UCB, Inc. et al. v. Accord Healthcare Inc. et al., 1:13- cv- 01206-LPS
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`(D. Del. August 12, 2016). These exhibits lack relevance, as the court’s decision
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`and reasoning are based, in part, on evidence that Patent Owner chose not to
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`produce in the present proceeding. See supra. The district court’s decision was
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`also based on certain stipulated facts that are disputed here. Furthermore, the
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`Court’s decision was based, in part, on the premise that the ‘301 patent was not
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`prior art for purposes of the obviousness analysis. In contrast, the ‘301 patent is
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`prior art for the present proceeding. Accordingly, Exhibits 2181 and 2182 have
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`no relevance to the issues presented to the Board and should not be admitted into
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`evidence.
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`Respectfully submitted,
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`IPR2016-00204
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`Date: December 23, 2016
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`By: /s/ Matthew J. Dowd
`Matthew J. Dowd
`Registration No. 47,534
`Dowd PLLC
`1717 Pennsylvania Avenue, NW
`Suite 1025
`Washington, D.C. 20006
`mjdowd@dowdpllc.com
`(202) 573-3853
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`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
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`Counsel for Petitioner
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`IPR2016-00204
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that the above-captioned PETITIONER’S
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`MOTION TO EXCLUDE was served via electronic mail upon the following:
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`areister@cov.com
`jrobbins@cov.com
`rlongton@cov.com
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`Covington & Burling LLP
`One City Center, 850 Tenth Street, NW
`Washington, DC 20001
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`Date: December 23, 2016
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`/s/ Matthew J. Dowd
`Matthew J. Dowd
`Registration No. 47,534
`Dowd PLLC
`1717 Pennsylvania Avenue, NW
`Suite 1025
`Washington, D.C. 20006
`mjdowd@dowdpllc.com
`(202) 573-3853
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