UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`PHIGENIX, INC.
`Petitioner
`
`IMIVTUNOGEN, INC.
`Patent Owner
`
`Case IPR2014-00676
`
`Patent 8,337,856 B2
`
`PHIGENIX, INC.’S MOTION TO EXCLUDE
`
`UNDER 37 C.F.R. § 42.64(c)
`
`Mail Stop "PATENT BOARD"
`Patent Trial and Appeal Board -
`U .8. Patent and Trademark Office
`
`P.O.'Box 1450
`
`Alexandria, VA 22313-1450
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`PHIGENIX, INC.
`Petitioner
`
`IMIVTUNOGEN, INC.
`Patent Owner
`
`Case IPR2014-00676
`
`Patent 8,337,856 B2
`
`PHIGENIX, INC.’S MOTION TO EXCLUDE
`
`UNDER 37 C.F.R. § 42.64(c)
`
`Mail Stop "PATENT BOARD"
`Patent Trial and Appeal Board -
`U .8. Patent and Trademark Office
`
`P.O.'Box 1450
`
`Alexandria, VA 22313-1450
`
`
`
`PHIGENIX, INC.’S MOTION TO EXCLUDE UNDER 37 C.F.R. § 42.64(c)
`CASE IPR2014—00676
`
`Pursuant to 37 C.F.R. 42.64(c) and 37 C.F.R. § 42.62(a) (applying the
`
`Federal Rules of Evidence to Inter Partes Review proceedings), Petitioner
`
`Phigenix, Inc. (“Phigenix”) moves to exclude the new evidence designated PO
`
`Materials (“Belated Materials”)1, served by Patent Owner ImmunoGen, Inc.
`
`(“ImmunoGen”) on February 12, 2015, as improperly produced under 37 C.F.R. §
`
`42.63; as lacking foundation under F..R.E 901; and as inadmissible hearsay under
`
`F.R.E. 802.
`
`Accordingly, Phigenix further moves to exclude Exhibits 2240, 2241, 2242,
`
`2243, 2244, 2256, 2319 and 2320, which rely on the Belated Materials, as
`
`improper hearsay under F.R.E. 802. Phigenix also moves to exclude those portions
`
`ofExhibit 2131 (“Jarosz Declaration”) (paragraphs 12, 14, 44, 45, 46, 55, 56, 57,
`
`58, 107 of the Jarosz Declaration) that rely on Exhibits 2240, 2241, 2242, 2243,
`
`2244, 2256, 2319 and 2320 as improper hearsay under F.R.E. 802 and not qualified
`
`to be the basis for an expert opinion under F.R.E. 703.
`
`Phigenix additionally moves to exclude all those elements of ImmunoGen’s
`
`Expert Reports improperly incorporated by reference under 37 C.F.R § 42.6(a).
`
`l The Belated Materials pertain to alleged sales information of KADCYLATM.
`Thus, these are only relevant should the Board rely on such sales as evidence of
`commercial success.
`
`
`
`PHIGENIX, INC.’S MOTION TO EXCLUDE UNDER 37 C.F.R. § 42.64(c)
`CASE IPR2014-00676
`
`1.
`
`Statement of Facts
`
`ImmunoGen submitted its Patent Owner’s Response to the Petition with
`
`accompanying Exhibits 2240, 2241, 2242, 2243, 2244, 2256, 2319 and 2320 and
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`the Jarosz Declaration on January 22, 2015. Pursuant to 37 C.F.R. § 42.64(c), on
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`January 29, 2015, Phigenix timely served its Objections to Evidence
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`(“Objections”), including specific objections to Exhibits 2240, 2241, 2242, 2243,
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`2244, 2256, 2319 and 2320 and the Vahdat, O’Shaughnessy and Jarosz
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`Declarations. See Exhibit A. Pursuant to 37 C.F.R. § 42.64(b)(2), on February 12,
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`2015, ImmunoGen responded to the Objections by serving its Supplemental
`
`Evidence. See Exhibit B. ImmunoGen’s Supplemental Evidence included a
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`Supplemental Declaration of John C. Jarosz, dated February 10, 2015. See Exhibit
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`C. ImmunoGen’s Supplemental Evidence also included “[s]ervice of confidential
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`supplemental evidence (“PO Materials [designated herein as “Belated
`
`Materials”]”) related to Exhibits 2240-2244, 2256, 2319, and 2320 [] made subject
`
`to the Patent Trial and Appeal Board’s Default Protective Order provided in
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`Appendix B of the Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,771
`
`(Aug. 14, 2012).” See Exhibit C.
`
`The Belated ‘Materials served by ImmunoGen consist of two pdf files: one
`
`file entitled “PROTECTIVE ORDER MATERIAL - Supp. Evidence - IMS pt. 1”
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`is a chart of data that is 72 pages long; another file entitled “PROTECTIVE
`
`3
`
`
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`PHIGENIX, INC.’S MOTION TO EXCLUDE UNDER 37 C.F.R. § 42.64(c)
`CASE IPR2014-00676
`
`ORDER MATERIAL - Supp. Evidence - IMS pt. 2” is a chart of data that is 18
`
`pages long. ImmunoGen did not previously produce or file either chart of data in
`
`any format.
`
`Pursuant to 37 C.F.R. § 42.64(c), on February 20, 2015, Phigenix timely
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`served its Objections to New Evidence Produced by ImmunoGen, Inc. on February
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`12, 2015, in which Phigenix objected to the Belated Materials. See Exhibit D.
`
`ImmunoGen did not produce any further supplemental evidence in response to
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`Phigenix’s objections to the Belated Materials. The Belated Materials have not yet
`
`been filed as evidentiary Exhibits by ImmunoGen.
`
`II. Argument
`
`i.
`
`The Belated Materials Are Im r0 er Under 37 C.F.R.
`
`42.63
`
`37 C.F.R. § 42.63(a) states the following:
`
`Exhibits required. Evidence consists of affidavits, transcripts of
`depositions, documents, and things. All evidence must be filed in the
`form of an exhibit.
`
`37 C.F.R. § 42.63(a) (bold added).
`
`Neither of the charts produced as supplemental evidence in thevBelated
`
`Materials by ImmunoGen has been filed as an exhibit. Indeed,
`
`the Belated
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`Materials have never been filed in any format and, as such, constituted new
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`documents produced to Phigenix on February 12, 2015.
`
`
`
`PHIGENIX, INC.’S MOTION TO EXCLUDE UNDER 37 C.F.R. § 42.64(c)
`CASE IPR2014-00676
`
`Under 37 C.F.R. § 42.64(b)(1), “[o]nce a trial has been instituted, any
`
`objection must be served within five business days of service of evidence to which
`
`‘
`
`the objection is directed.” This rule does not exclude objections to evidence when
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`that evidence is first produced as supplemental evidence. Accordingly, on
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`February 20, 2015, Phigenix objected to the Belated Materials within five business
`
`days of service of the newly produced documents, including raising an objection
`
`under 37 C.F.R. § 42.63. ImmunoGen took no action to address this objection.
`
`Accordingly, Phigenix requests that the Board exclude the Belated Materials
`
`as evidence that may be relied upon by ImmunoGen because the Belated Materials
`
`are improper as evidence under 37 C.F.R. § 42.63.
`
`ii.
`
`The Belated Materials Lack Foundation Under F.R.E. 901
`
`As discussed above, the Belated Materials cannot be relied upon as evidence
`
`under 37 C.F.R. § 42.63. Even if, arguendo, the Belated Materials may be
`
`considered proper under 37 C.F.R. § 42.63, the Belated Materials lack foundation
`
`and have not been authenticated under F.R.E. 901. ImmunoGen produced a
`
`Supplemental Declaration of John C. Jarosz on February 10, 2015, which states as
`
`follows: “Exhibits 2240—224, 2256, 2319, and 2320 are compilations of data
`
`provided by IMS Institute for Healthcare Informatics (“IMS”).” See para. 6 of
`
`Exhibit C. The Supplemental Declaration does not make any reference to the
`
`actual Belated Materials themselves nor does it explain their provenance. As such,
`
`5
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`
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`PHIGENIX, INC.’S MOTION TO EXCLUDE UNDER 37 C.F.R. § 42.64(e)
`CASE IPR2014-00676
`
`.
`
`the Supplemental Declaration fails to provide any foundation for reliance on the
`
`Belated Materials as evidence. Indeed, the Belated Materials themselves do not
`
`contain any reference to “IMS” within the charts themselves. On February 20,
`
`2015, Phigenix timely objected to the Belated Materials for lack of foundation.
`
`ImmunoGen did not serve any supplemental evidence to address this objection.
`
`Accordingly, Phigenix requests that the Board exclude the Belated Materials
`
`as evidence that may be relied upon by ImmunoGen because the Belated Materials
`
`are unauthenticated documents that lack foundation under F.R.E. 901.
`
`iii.
`
`The Belated MaterialsAre I‘nadmissible Hearsay Under F.R.E.
`Sfl
`
`The Belated Materials are charts of data allegedly originated by a third non-
`
`testifying party (allegedly IMS) that are offered to prove the truth of the matter
`
`asserted (pharmaceutical sales data used by Exhibits 2240, 2241, 2242, 2243,
`
`2244, 2256, 2319 and 2320 and relied on by the Jarosz Declaration). As such, the
`
`Belated Materials are out-of—court statements by another that are relied upon for
`
`the truth of the matters asserted therein, and thus hearsay. See F.R.E. 801, 802.
`
`No exceptions to the rule against hearsay apply to the Belated Materials nor did
`
`ImmunoGen point to any such exceptions when initially proffering the Belated
`
`Materials in response to Phigenix’s Objections to Exhibits 2240, 2241, 2242,
`
`2243, 2244, 2256, 2319 and 2320. Accordingly, Phigenix requests that the Board
`
`
`
`PHIGENIX, INC.’S MOTION TO EXCLUDE UNDER 37 C.F.R. § 42.64(c)
`CASE IPR2014-00676
`
`exclude the Belated Materials as evidence that may be relied upon by ImmunoGen
`
`because the Belated Materials are inadmissible hearsay under F.R.E. 802.
`
`iv.
`
`Exhibits 2240-44,‘ 2256, 2319 and 2320 Are Inadmissible Hearsay
`Under F.R.E. 802
`
`Exhibits 2240, 2241, 2242, 2243, 2244, 2256, 2319 and 2320 are
`
`representations of data that is allegedly derived from IMS in the form of the
`
`Belated Materials. As discussed above, the Belated Materials may not be relied
`
`upon as evidence since they are improperly produced under 37 C.F.R. § 42.63, lack
`
`foundation under F.R.E. 901, and are improper hearsay under F.R.E. 802. The
`
`Supplemental Declaration of John C. Jarosz did not cure any of these defects since
`
`it does not 'even reference the Belated Materials. As such, each of Exhibits 2240,
`
`2241, 2242, 2243, 2244, 2256, 2319 and 23 20 constitute out—of—court statements by
`
`another that are relied upon for the truth of the matters asserted therein, and thus
`
`hearsay. See F.R.E. 801, 802. No exceptions to the rule against hearsay apply nor
`
`did ImmunoGen point to any such exceptions when proffering the Supplemental
`
`Declaration of John C. Jarosz in response to Phigenix’s Objections to Exhibits
`
`2240, 2241, 2242, 2243, 2244, 2256, 2319 and 2320.
`
`Accordingly, Phigenix requests that the Board exclude Exhibits 2240, 2241,
`
`2242, 2243, 2244, 2256, 2319 and 2320 as evidence that may be relied upon by
`
`
`
`PHIGENIX, INC.’S MOTION TO EXCLUDE UNDER 37 C.F.R. § 42.64(c)
`CASE IPR2014-00676
`
`lmmunoGen because the Belated Materials are inadmissible hearsay under
`
`Exhibits 2240, 2241, 2242, 2243, 2244, 2256, 2319 and 2320.
`
`V.
`
`Paragraphs 12, 14, 44, 45, 46, 55, 56, 57, 58, 107 of‘the Jarosz
`Declaration that Rely on Exhibits 2240-2244, 2256, 2319 and 2320
`Are Not Qualified To Be The BasisFor An Expert Opinion Under
`F.R.E. 703
`
`Paragraphs 12, 14, 44, 45, 46, 55, 56, 57, 58, 107 ofthe Jarosz Declaration
`
`(Exhibit 2131) rely on Exhibits 2240, 2241, 2242, 2243, 2244, 2256, 2319 and
`
`2320 to support the statements of Mr. Jarosz. As discussed above, these Exhibits
`
`are all representations of data that is allegedly derived from IMS in the form of the
`
`Belated Materials. As such, these paragraphs are relying on data that has not been
`
`properly entered as evidence under 37 C.F.R. § 42.63, is lacking foundation under
`
`F.R.E. 901 ; and is inadmissible hearsay under F.R.E. 802. There is a substantial
`
`prejudicial effect to permitting a declarant to rely on evidence that has not been
`
`properly authenticated and is an out—of—court statement by another which is relied
`
`upon for the truth of the matter asserted. Therefore, Exhibits 2240, 2241, 2242,
`
`2243, 2244, 2256, 2319 and 2320 are not qualified to be the basis for an expert
`
`opinion under F.R.E. 703.
`
`Accordingly, Phigenix requests Paragraphs 12, 14, 44, 45, 46, 55, 56, 57, 58,
`
`107 of the Jarosz Declaration (Exhibit 2131) be excluded as evidence because
`
`those paragraphs rely on Exhibits 2240, 2241, 2242, 2243, 2244, 2256, 2319 and
`
`8
`
`
`
`PHIGENIX, INC.’S MOTION TO EXCLUDE UNDER 37 C.F.R. § 42.64(c)
`CASE IPR2014—00676
`
`2320, which are not qualified to be the basis for an expert opinion under F.R.E.
`
`703.
`
`vi.
`
`‘
`
`Evidence Incorporated Only by Reference Should be Excluded As
`Improper
`
`It is improper to incorporate by reference arguments from one document into
`
`another document. 37 C.F.R. § 42.6(a)(3). One purpose of the prohibition against
`
`incorporation by reference is to eliminate abusesithat arise from incorporation.
`
`Rules of Practice for Trials Before The Patent Trial and Appeal Board and Judicial
`
`Review of Patent Trial and Appeal Board Decisions; Final Rule, 77 Fed. Reg.
`
`48,612, 48,617 (Aug. 14, 2012); see also DeSilva-v. DiLeonardi, 181 F.3d 865,
`
`866—67 (7th Cir. 1999) (Incorporation “by reference amounts to a self-help increase
`
`in the length of the [] brief[,]” and “is a pointless imposition on the court’s time. A
`
`brief must make all arguments accessible to the judges, rather than ask them to
`
`play archeologist with the record”). As explained in Cisco Systems, Inc. v. C-
`
`Cation Techs., LLC, Case IPR2014-00454 (PTAB Aug. 29, 2014) (Paper 12),
`
`citations to “large portions of another document, Without sufficient explanation of
`
`those portions, amounts to incorporation by reference.” Cisco, Case IPR2014-
`
`00454, slip op. at 8. Accordingly, Phigenix requests that the Board exclude all
`
`evidence not properly incorporated into PO’s Response by sufficient explanation.
`
`
`
`PHIGENIX, INC.’S MOTION TO EXCLUDE UNDER 37 C.F.R. § 42.64(c)
`CASE IPR2014—00676
`
`III. Conclusion
`
`For the above reasons, Phigenix respectfully requests that the Board exclude
`
`the Belated Materials, Exhibits 2240, 2241, 2242, 2243, 2244, 2256, 2319 and
`
`2320, and paragraphs 12, 14, 44, 45, 46, 55, 56, 57, 58, 107 ofthe Jarosz
`
`Declaration (Exhibit 2131) from evidence.
`
`ANDREWS KURTH, LLP
`
` Date: June 11,2015
`
`,
`
`Ml.Dig.
`.
`Lead Attorney for ' etitioner
`Phigenix, Inc.
`Registration No. 48,328
`
`1350 I Street, NW, Suite 1100
`Washington, DC 20005
`(202—662-3 042)
`
`10
`
`
`
`PHIGENIX, INC.’S MOTION TO EXCLUDE UNDER 37 C.F.R. § 42.64(c)
`CASE IPR2014-00676
`
`CERTIFICATE OF SERVICE 137 C.F.R. § 42.61”)
`
`The undersigned hereby certifies that the above-captioned “Phigenix Inc’s
`
`Motion to Exclude Evidence” was served via electronic mail upon the following
`
`parties:
`
`Eldora L. Ellison, PhD.
`Sterne, Kessler, Goldstein & Fox P.L.L.C.
`
`1100 New York Ave., NW.
`Washington, DC. 20005-3934 .
`Tel: (202) 772-8508
`’
`Fax: (202) 371-2540
`eellison@skgf.com
`
`Eric K. Steffe
`
`Sterne, Kessler, Goldstein & Fox P.L.L.C.
`
`1100 New York Ave., NW.
`Washington, DC. 20005-3934
`Tel: (202) 772-8625
`‘Fax: (202) 371-2540
`esteffengkgfcom
`
`Date: June 11, 2015 Phignix, Inc.
`
`1350 I Street, NW, Suite 1100
`Washington, DC 20005
`(202-662-3042)
`
`11
`
`
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