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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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`PHIGENIX, INC.
`Petitioner
`
`v.
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`IMMNUNOGEN, INC.
`Patent Owner
`
`_____________________
`
`Case IPR2014-00676
`Patent 8,337,856 B2
`_____________________
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`IMMUNOGEN, INC.'S OPPOSITION TO PHIGENIX'S
`MOTION TO EXCLUDE
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`
`
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`ImmunoGen's Opposition to Phigenix's Motion to Exclude
`IPR2014-00676
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`The Board should deny entirely Petitioner Phigenix's motion to exclude
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`
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`evidence (Paper 28).
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`I.
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`Overview
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`Phigenix has moved to exclude four categories of evidence submitted by
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`Patent Owner ImmunoGen. ImmunoGen will show why none of these categories
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`warrant exclusion and why the Board should deny Phigenix's motion to exclude:
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`Category 1: Supplemental IMS Data. Phigenix advances three faulty reasons why
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`the IMS data should be excluded:
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` Phigenix argues that the IMS Data was not "filed as an exhibit" under Rule
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`42.63, but Rule 42.63 does not require all evidence to be filed as an exhibit.
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`(For example, Rule 42.63(e) addresses the circumstance when evidence is not
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`filed.)
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` Phigenix argues that the IMS Data lack foundation, but ImmunoGen served
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`Phigenix with a declaration attesting to the foundation of the IMS Data at the
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`same time the IMS Data were served.
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` Phigenix argues that the IMS Data are inadmissible hearsay, but the IMS Data
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`are excepted from the preclusion of hearsay as a market report under FRE
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`803(17).
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`Category 2: Summaries of the IMS Data (Exhibits 2240-44, 2256, 2319, and
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`2320). Phigenix argues that summaries of IMS Data should be excluded as
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`- 1 -
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`ImmunoGen's Opposition to Phigenix's Motion to Exclude
`IPR2014-00676
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`hearsay, but the summaries are admissible under FRE 1006, which makes
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`summaries of voluminous documents admissible.
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`Category 3: Portions of the Jarosz Declaration relying on the summaries of the
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`IMS Data. Phigenix argues that portions of the Jarosz Declaration should be
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`excluded under FRE 703 because Jarosz relied on the allegedly inadmissible IMS
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`Data and summaries of that data. But Phigenix is wrong about the inadmissibility
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`of the IMS Data and the data summaries. What is more, FRE 703 explicitly states
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`that experts may rely on inadmissible evidence if experts would reasonably rely on
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`such evidence for their opinion, a predicate established by Jarosz's own testimony.
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`Category 4: Evidence incorporated by reference. Phigenix asks the Board to
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`exclude all evidence improperly incorporated by reference, but Phigenix waived
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`such an argument by failing to serve an objection to this effect, and the motion
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`fails to identify any evidence that Phigenix contends was improperly incorporated.
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`II. Background
`Phigenix's motion to exclude centers on evidence relevant to ImmunoGen's
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`showing of commercial success in its Patent Owner Response.1 Through its expert
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`1 The evidence at issue not related to commercial success falls into a catch-
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`all category of evidence that Phigenix contends was improperly incorporated by
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`reference.
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`- 2 -
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`ImmunoGen's Opposition to Phigenix's Motion to Exclude
`IPR2014-00676
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`Jarosz, ImmunoGen presented charts summarizing revenue and prescription data
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`for Kadcyla®. See Exhibits 2240-44, 2256, 2319 &2320. Jarosz's declaration
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`explained: "Exhibits 2240-2244, 2256, 2319-2320 provide a summary of
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`voluminous IMS revenue and prescription data, as well as marketing and
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`promotional efforts relating to Kadcyla. I and others working under my direction
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`prepared these exhibits." See Exhibit 2131, ¶12.
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`On January 29, 2015, Phigenix served evidentiary objections to the summary
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`charts, and the Jarosz declaration for relying on these summary charts, stating that
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`the summaries lacked foundation, had no "indication of the origin or creator" of the
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`charts, and because the underlying data for the charts was not provided. See Paper
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`28, Exhibit A (Phigenix’s Objections to Evidence), p. 11.
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`In response to Phigenix's objections, ImmunoGen served the underlying IMS
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`Data for the summary charts (Exhibits 2347 and 2348) and a supplemental
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`declaration from Jarosz that explained what the summary charts were and how they
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`were compiled. See Paper 28, Exhibit C (Jarosz’s Supplemental Declaration), ¶6.
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`- 3 -
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`ImmunoGen's Opposition to Phigenix's Motion to Exclude
`IPR2014-00676
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`Unsatisfied by ImmunoGen's supplemental evidence, Phigenix lodged
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`another set of evidentiary objections, this time directed to the supplemental
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`evidence, and has filed its motion to exclude.2
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`III. Argument
`On a motion to exclude evidence, the moving party, here Phigenix, "bears
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`the burden of proof to establish that it is entitled to the relief requested … ." Athena
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`Automation Ltd. v. Huskey Injection Molding Systems Ltd., Case IPR2013-00290,
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`Paper 45, at 52 (Oct. 23, 1014). Phigenix's motion to exclude evidence fails to
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`meet its burden as to any of ImmunoGen's evidence.
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`A.
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`Patent Owner's IMS Data should not be excluded.
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`Phigenix raises three arguments for excluding the IMS Data: (1) they were
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`not filed as exhibits under Rule 42.63, (2) they lack foundation, and (3) they are
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`inadmissible hearsay. None of these arguments has merit.
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`2 There is no procedure for objecting to supplemental evidence, nor a
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`procedure permitting or requiring a party to serve supplemental evidence in
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`response to such an objection. The proper course is for a party to file a motion to
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`exclude, rather than to serve additional objections. See IPR2013-00020, Paper 17,
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`p. 3.
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`- 4 -
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`1.
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`ImmunoGen's Opposition to Phigenix's Motion to Exclude
`IPR2014-00676
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`There is no requirement to file the IMS Data as an exhibit.
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`Phigenix simply misreads the Board's rules when it argues that Rule 42.63
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`required the IMS Data to be filed as an exhibit. First, the rules only authorize a
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`party receiving an objection to respond "by serving supplemental evidence…."
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`Rule 42.64(b)(2). Second, Rule 42.63 does not require all evidence to be filed with
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`the Board. Indeed, that rule addresses the circumstance in which evidence is not
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`filed with the Board.3 See 37 CFR 42.63(e) ("If the exhibit is not filed…")
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`The Board should reject this argument as a basis to exclude the IMS Data.
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`2.
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`The IMS Data do not lack foundation.
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`Phigenix contends that the IMS Data are not authenticated as required by
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`FRE 901. But there is no issue of authentication with the IMS Data.
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`ImmunoGen served the IMS Data on Phigenix, and Jarosz's supplemental
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`declaration authenticates that information. There, he states what the data are and
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`where the data came from: "Exhibits 2240-2244, 2256, 2319, and 2320 are
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`compilations of data provided by IMS Institute for Healthcare Informatics ('IMS')."
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`3 To the extent Phigenix's issue is that no exhibit number has been assigned
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`to the IMS Data, that issue has been resolved by the filing of this motion: the IMS
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`Data are filed as Exhibits 2347 and 2348.
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`- 5 -
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`ImmunoGen's Opposition to Phigenix's Motion to Exclude
`IPR2014-00676
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`This easily satisfies Rule 901's authentication requirement, which can be satisfied
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`by a person testifying from personal knowledge. Rule 901(b)(1).
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`"The burden of proof for authentication is slight." Link v. Mercedes-Benz of
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`N. Am., 788 F.2d 918, 927 (3d Cir. 1986). FRE 901 "may be satisfied by evidence
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`sufficient to support a finding that the matter in question is what its proponent
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`claims." U.S. v. Carroll, No. Crim. A. 99-88, 2000 WL 45870, at *3 (E.D. La. Jan.
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`20, 2000). The list of authentication methods provided by FRE 901(b) is "offered
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`for illustrative purposes only and do[es] not represent the exclusive methods of
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`authenticating evidence." Id. at *3.
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`3.
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`The IMS Data are excepted from hearsay as a market report under FRE
`803(17).
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`Phigenix's final argument for exclusion of the IMS is hearsay, but the IMS
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`Data are excepted from hearsay under FRE 803(17). That rule provides that market
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`reports, compilations, and the like are not excluded by the rule against hearsay if
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`the documents in question "are generally used and relied on by the public or by
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`persons in particular occupations." JIPC Management, Inc. v. Incredible Pizza Co.,
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`2009 WL 8591607, at 17 (C.D.Cal. 2009); see also United Sates v. Masferrer, 514
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`F.3d 1158, 1162 (11th Cir. 2008) (Bloomberg market price quotes for various
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`markets admissible); United States v. Cassiere, 4.F.3d 1006, 1018-19 (1st Cir.
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`1993) (real estate listing of properties sold, sale prices, and dates sales closed
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`- 6 -
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`ImmunoGen's Opposition to Phigenix's Motion to Exclude
`IPR2014-00676
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`admissible). The requirement for reliance by professionals in the field is met here;
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`Mr. Jarosz testified, and there is no evidence to the contrary, that IMS Health data
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`are "routinely relied on by experts in the field to determine drug sales,
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`prescriptions, and promotional expenditures for a given product." See Paper 28,
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`Exhibit C (Mr. Jarosz’s Supplemental Declaration), ¶6; see also Exhibit 2131, ¶11.
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`Finally, IMS is the gold standard for pharmaceutical data: "[m]any courts
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`have relied on IMS data in litigation involving the pharmaceutical markets." See
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`New England Carpenters v. First Bank, 248 F.R.D. 363, 370-371 (D.Mass. 2008);
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`see also In re Cardizem CD Antitrust Litigation, 218 F.R.D. 508, 526
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`(E.D.Michigan, Southern Division, 2003) (calling IMS "the recognized industry
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`leader in data collection for the pharmaceutical industry") (emphasis added); The
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`University of Colorado Foundation, Inc. v. American Cyanamid Co., 216
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`F.Supp.2d 1188, 1196 (D. Colorado 2002) (IMS data used to calculate revenues);
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`New England Carpenters v. First Bank, 248 F.R.D. 363, 370-371 (D.Mass 2008)
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`(IMS data used as a reasonable proxy for what a party paid in retail); In re
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`Neurontin litigation, 244 F.R.D. 89, 111 (D.Mass. 2007) (IMS data used to
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`determine aggregate class-wide liability); In re Terazosin HCl Antitrust Litigation,
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`220 F.R.D. 672, 685 (S.D.Florida 2004) (IMS data used to predict the impact that
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`generic entry would have on the market).
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`- 7 -
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`B.
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`ImmunoGen's Opposition to Phigenix's Motion to Exclude
`IPR2014-00676
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`The summaries of the IMS Data (Exhibits 2240-2244, 2256 2319, 2320)
`are admissible under FRE 1006.
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`Phigenix moves to exclude the summaries of the IMS data, Exhibits 2240-
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`2244, 2256, 2319, and 2320, based on hearsay. But the summaries of the IMS Data
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`are not inadmissible hearsay. FRE 1006 expressly allows into evidence summaries
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`like those of Exhibits 2240-2244, 2256, 2319, and 2320: "The proponent may use a
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`summary, chart, or calculation to prove the content of voluminous writings,
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`recordings, or photographs that cannot be conveniently examined in court."
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`FRE1006. In exchange for this allowance, the Rule requires the proponent to make
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`the originals or duplicates available for examination or copying. Id. That
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`requirement is satisfied here: ImmunoGen delivered copies of the underlying IMS
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`Data to Phigenix's counsel on February 15, 2015, before Phigenix's reply was due,
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`and before the window to depose Jarosz closed.4
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`C. None of Jarosz's declaration should be excluded for relying on the IMS
`Data or the summaries of IMS Data.
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`Phigenix seeks to the exclude the parts of Jarosz's declaration that rely on
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`the summaries of the IMS Data. Phigenix's argument essentially is that because the
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`IMS data and the summaries of the IMS Data are not admissible, Jarosz's
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`testimony relying on those documents should be excluded. As ImmunoGen has
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`shown here, the premise of this argument is incorrect; the IMS Data and the
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`4 Phigenix chose not to depose Jarosz.
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`- 8 -
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`ImmunoGen's Opposition to Phigenix's Motion to Exclude
`IPR2014-00676
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`summaries are admissible. What is more, FRE 703 allows Jarosz to rely on
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`inadmissible evidence for his opinion: "[i]f experts in the particular field would
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`reasonably rely on those kinds of facts or data in forming an opinion on the
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`subject." FRE 703. That condition is met here because Jarosz testified: "Exhibits
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`2240-2244, 2256, 2319, and 2320 are compilations of data provided by IMS
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`Institute for Healthcare Informatics ('IMS'). Data from IMS are routinely relied on
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`by experts in the field to determine drug sales, prescriptions, and promotional
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`expenditures for a given product, such as in the opinions set forth in my initial
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`declaration." See Paper 28, Exhibit C (Mr. Jarosz’s Supplemental Declaration), ¶6.
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`The Board should not exclude any of Jarosz's testimony.
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`D.
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`Phigenix's incorporation-by-reference argument is waived and
`procedurally flawed.
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`Phigenix's motion to exclude "all evidence not properly incorporated into
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`PO’s Response" under 37 C.F.R. § 42.6(a) should be denied. First, Phigenix never
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`objected to any of ImmunoGen's evidence on this basis, and thereby failing to
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`preserve this argument for its motion to exclude. Second, Phigenix's motion failed
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`to identify a single instance of evidence that it contends was improperly
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`incorporated by reference, even though the Board's Trial Practice Guide requires
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`motions to exclude to "identify where in the record the evidence sought to be
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`- 9 -
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`ImmunoGen's Opposition to Phigenix's Motion to Exclude
`IPR2014-00676
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`excluded was relied upon by an opponent." See Office Patent Trial Practice Guide,
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`77 Fed. Reg. 48765, 48767 (Aug. 14, 2012).
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`Phigenix's argument ultimately is of no moment because ImmunoGen did
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`not incorporate by reference any evidence into Patent Owner’s Response. See
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`Paper 18.
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`The Board should deny Phigenix's motion to exclude evidence.
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`IV. Conclusion
`For the reasons set forth above, the Board should deny Phigenix's Motion to
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`Exclude Evidence.
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`Date: June 18, 2015
`1100 New York Avenue, N.W.
`Washington, D.C. 20005-3934
`(202) 371-2600
`
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`
`/Eldora L. Ellison/
`Eldora L. Ellison (Reg. No. 39,967)
`Lead Counsel for Patent Owner
`ImmunoGen, Inc.
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`- 10 -
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`CERTIFICATION OF SERVICE (37.C.F.R. §§ 42.6(e), 42.105(a))
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`
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`The undersigned hereby certifies that the above-captioned IMMUNOGEN,
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`INC.’S OPPOSITION TO PHIGENIX'S MOTION TO EXCLUDE was served in
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`its entirety on June 18, 2015, upon the following parties via electronic mail:
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`
`
`Ping Wang
`ANDREWS KURTH, LLP
`
`
`1350 I Street NW, Suite 1100
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`Washington, DC 20005
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`Tel: (202) 662-3042
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`Fax: (202) 662-3729
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`PingWang@andrewskurth.com
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`
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`
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`Gregory Porter
`ANDREWS KURTH, LLP
`600 Travis, Suite 4200
`Houston, TX 77002
`Tel: (713) 220-4621
`Fax: (713) 220-4257
`GregPorter@andrewskurth.com
`
`
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`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`/Eldora L. Ellison/
`Eldora L. Ellison (Reg. No. 39,967)
`Lead Attorney for Patent Owner ImmunoGen, Inc.
`
`Date: June 18, 2015
`1100 New York Avenue, N.W.
`Washington, D.C. 20005 - 3934
`(202) 371-2600
`2015819_2.DOCX
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