UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`QUALICAPS CO., LTD,
`Patent Owner
`
`_____________
`
`Case IPR2017-00203
`Patent 6,649,180
`_____________
`
`
`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`QUALICAPS CO., LTD,
`Patent Owner
`
`_____________
`
`Case IPR2017-00203
`Patent 6,649,180
`_____________
`
`
`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64
`
`
`
`
`
`IPR2017-00203
`Patent 6,649,810 B1
`
`I.
`
`Introduction
`Patent Owner moves to exclude Petitioner Exhibits 1011, 1012, selected
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`
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`Patent Owner’s Motion to Exclude
`
`passages of Exhibit 1028, and selected paragraphs of Exhibit 1029. Patent Owner
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`also moves to exclude Exhibits 2064 and 2067–2072 for the manner in which
`
`Petitioner relies on them in its Reply (Paper 38). The bases for the motion were
`
`timely filed and served in Patent Owner’s objections to evidence (Paper 17 and Paper
`
`40).
`
`II. Argument
`A. Exhibit 1011 – Dr. Kibbe’s Declaration – Should Be Excluded.
`Patent Owner moves the exclusion of Exhibit 1011 under (i) FRE 802 as
`
`inadmissible hearsay, and (ii) FRE 702 and FRE 703 due to not meeting the standard
`
`for an expert to rely on hearsay. Paper 17, 3–5 (stating objections).
`
` Dr. Kibbe’s opinions—including those that allege invalidity of the ’180
`
`Patent—simply mirror the Petition, nearly verbatim. See Ex. 2021 (Workshare
`
`Compare software comparison between Dr. Kibbe’s declaration and the Petition).
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`For example, Dr. Kibbe’s declaration purports to give his opinion on “Ground 1:
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`Claims 1 and 4 are Unpatentable as Obvious in View of Yamamoto in Combination
`
`with Japanese Pharmacopeia.” Yet instead, Dr. Kibbe repeats the Petition essentially
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`word-for-word. See Ex. 2021 at pages 47–77 (Dr. Kibbe’s purported opinion
`
`regarding Ground 1 simply copies the Petition for about eighteen consecutive
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`1
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`
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`IPR2017-00203
`Patent 6,649,810 B1
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`pages); see also id. at pages 39–41, 95–102 (copying verbatim other sections of the
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`Patent Owner’s Motion to Exclude
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`
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`Petition). In fact, Exhibit 2021 shows that the entirety of Dr. Kibbe’s purported
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`opinion is a virtual word-for-word copy of the Petition.
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`Although an expert may rely on hearsay under certain circumstance (see, e.g.,
`
`FRE 702 and 703) simply repeating what a party has told them provides no
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`assistance to the trier of fact through the application of specialized knowledge, and
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`therefore does not qualify for the exception. See, e.g., Arista Records LLC v.
`
`Usenet.com, Inc., 608 F. Supp. 2d 409, 424–25 (S.D.N.Y. 2009) (excluding portions
`
`of an expert’s testimony under FRE 702 regarding facts related to defendant’s
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`technology, where the expert did not investigate those facts himself but only
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`“scanned” some notes provided to him by defendant); Robinson v. Sanctuary Record
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`Groups, Ltd., 542 F. Supp. 2d 284, 292 (S.D.N.Y. 2008) (excluding portions of an
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`expert’s testimony under FRE 702 and 703 where expert’s methodology was
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`founded on hearsay supplied by the party itself, rather than “a source of first-hand,
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`independent expert knowledge” and as such, it did not provide reliable evidence);
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`see also United States v. Mejia, 545 F.3d 179, 197–98 (2nd Cir. 2008) (“. . . the
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`expert must form his own opinions by applying his extensive experience and a
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`reliable methodology to the inadmissible materials. Otherwise, the expert is simply
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`repeating hearsay evidence without applying any expertise whatsoever.”) (internal
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`2
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`IPR2017-00203
`Patent 6,649,810 B1
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`quotation marks and citations omitted). Therefore, Dr. Kibbe’s declaration should
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`Patent Owner’s Motion to Exclude
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`
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`be excluded as inadmissible hearsay.
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`Exhibit 1012 – Shin-Etsu Website – Should Be Excluded.
`B.
`Patent Owner moves the exclusion of Exhibit 1012 under (i) FRE 901 due to
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`a lack of authentication, (ii) FRE 801 and 802 as inadmissible hearsay, and (iii) FRE
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`401 and FRE 402 as lacking relevance. Paper 17, 5–6 (stating objections).
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`Exhibit 1012 purports to be two separate printouts of two separate websites
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`describing products from Shin-Etsu Chemical Co., Ltd. including TC-5®. Petitioner
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`cites Ex. 1012 in support of its assertions that “[i]n the United States, TC-5E has
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`been sold under the name PHARMACOAT® since October 2002. See generally
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`Ex. 1012” (Petition, p. 32) and “the technical information describing the commercial
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`embodiment of TC-5E, PHARMACOAT®, includes ‘Substitution Type 2910.’
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`Ex. 1012” (Petition, p. 40). Petitioner’s expert, Dr. Kibbe, relies exclusively on
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`Exhibit 1012 in support of his assertions that “I understand that in the United States,
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`TC-5E has been sold under the name PHARMACOAT® since October 2002. Ex.
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`1012. I further understand that prior to October 2002, TC-5E was sold under its
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`generic name ‘Hypromellose.’ Id. The technical information for PHARMACOAT®
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`(formerly known as ‘Hypromellose’) describes four different grades, each of which
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`includes ‘Substitution Type 2910.’ Id.” Ex. 1011, ¶¶ 84, 110 (cited at Petition, pp.
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`32, 40).
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`3
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`IPR2017-00203
`Patent 6,649,810 B1
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`
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`Patent Owner’s Motion to Exclude
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`Exhibit 1012, however, has not been authenticated and is unreliable. The
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`exhibit is nothing more than a printout of webpages of uncertain dates. See Ex. 1012,
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`pp. 1–2 (providing a different web address at the bottom of each page). Further, the
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`web address at page 2 is not even complete. Ex. 1012, p. 2 (providing web address
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`ending in “http...”). Petitioner submitted no evidence to authenticate the web pages
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`reproduced in this exhibit, nor to establish that the websites actually contained what
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`they are purported to have contained as of the date submitted, nor to establish their
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`online publication date, nor to establish that they were published before the priority
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`date of the ’180 patent.
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`As a general matter, the proponent of evidence from a website must
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`authenticate the information from the website itself, and not just from the
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`downloaded pages. See Victaulic Co. v. Tieman, 499 F.3d 227, 236 (3d Cir. 2007),
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`as amended (Nov. 20, 2007) (citing United States v. Jackson, 208 F.3d 633, 638 (7th
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`Cir. 2000)). The Board has required that, for authentication purposes, the party
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`“proffering the evidence must produce some statement or affidavit from
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`someone with knowledge of the website . . . for example a web master or someone
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`else with personal knowledge would be sufficient.” EMC Corp. v. PersonalWeb
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`Techs., LLC, IPR2013-00084, Paper No. 64, p. 45-46 (quoting St. Luke’s Cataract
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`& Laser Inst. v. Sanderson, 2006 WL 1320242, at *2 (M.D. Fla. May 12, 2006)).
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`4
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`IPR2017-00203
`Patent 6,649,810 B1
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`
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`Patent Owner’s Motion to Exclude
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`Petitioner has provided no such authentication for Exhibit 1012. In particular,
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`Petitioner provided no supplemental evidence for Exhibit 1012 in response to Patent
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`Owner’s timely objection in Paper No. 17. Petitioner has not provided the testimony
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`of any witness with knowledge of the website listed in Exhibit 1012, and has not
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`provided any other basis for concluding that the webpage is authentic or to establish
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`the date of publication. Thus, Exhibit 1012 lacks authentication and is inadmissible
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`under FRE 901.
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`
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`In addition, Exhibit 1012 is inadmissible hearsay under FRE 802 and 802
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`because it is offered as evidence of what it describes. Exhibit 1012 states there are
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`ranges of copyright dates. Exhibit 1012, pp. 1–2. Petitioner cannot rely on this
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`statement for the truth of the matter it asserts because it is not evidence that the
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`reference was a printed publication as of a particular date. Copyright dates are
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`inadmissible hearsay under FRE 802. See Standard Innovation Corp. v. Lelo, Inc.,
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`IPR2014-00148, Paper 41 at 13–16 (April 23, 2015) (copyright dates held to be
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`inadmissible hearsay evidence of publication); ServiceNow, Inc. v. Hewlett-Packard
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`Co., IPR2015-00716, Paper 13 at 15–17 (Aug. 26, 2015) (holding the same).
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`Petitioner cites no hearsay exceptions in proffering its evidence, and none applies.
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`See FRE 801 and 802. Accordingly, Exhibit 1012 should also be excluded as
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`inadmissible hearsay.
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`5
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`IPR2017-00203
`Patent 6,649,810 B1
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`
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`Finally, Exhibit 1012 lacks relevance. As stated above, Petitioner cites Exhibit
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`
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`Patent Owner’s Motion to Exclude
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`1012 for its assertion concerning a TC-5® product prior to 2002. Yet Exhibit 1012
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`gives no indication as to when the material was allegedly published, much less any
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`indication of publication prior to 2002. The face of the document provides a
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`copyright date range of 2001-2013, and even the earliest copyright date in this range
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`is two years after the 1999 priority date of the ’180 Patent. Exhibit 1012, p. 1.
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`(“Copyright (c) 2001-2013 Shin-Etsu Chemical Co., Ltd. All [sic] Rights
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`Reserved”). Consequently, Exhibit 1012 could not have contributed to the
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`knowledge of a person of ordinary skill in the art, and the Exhibit should be excluded
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`on relevance grounds.
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`C. Exhibit 1028 – Certain Passages of the Deposition Transcript of
`Jason McConville – Should Be Excluded.
`Patent Owner moves the exclusion of passages 51:15–53:11, 82:15–88:9,
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`90:19–92:5; 94:18–96:18, and 97:14–98:17 of Ex. 1028 (Dr. McConville’s
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`deposition) under (i) FRE 401/402 for lack of relevance, and (ii) 37 C.F.R. § 42.23(b)
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`for exceeding the permissible scope of a Reply, in accordance with the objections
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`lodged by Patent Owner’s counsel during the deposition.
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`Petitioner cites Ex. 1028 for three Reply arguments not in the Petition: that
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`(a) the inventors insufficiently inferred gelling aids caused cloud spotting (Reply, p.
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`18, l. 3–p. 19, l. 13 (citing Ex. 1028, 91:4–91:17; 94:18–96:18); (b) the claimed
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`6
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`IPR2017-00203
`Patent 6,649,810 B1
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`invention does not prevent cloud spotting defects (Reply, p. 19, l. 14–p. 21, l. 14
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`Patent Owner’s Motion to Exclude
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`
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`(citing Ex. 1028, 90:19–91:17; 97:14–98:17); and (c) the inventors’ unexpected
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`results are based on a subjective distinction (Reply, p. 19, l. 14–p. 21, l. 14 (citing
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`Ex. 1028, 51:15–51–21, 82:15–83:15, 85:6–85:16)). These issues are separate and
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`new relative to the instituted ground raised in the Petition. Additionally, the above-
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`cited testimony from Ex. 1028 includes testimony provided in response to questions
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`mischaracterizing the evidence and calling for a legal conclusion. See Reply, p. 19,
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`l. 14–p. 21, l. 14 (citing Ex. 1029, 51:15–53:11 82:15–83:15, 82:15–88:9). Thus,
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`the testimony of Ex. 1028 at 51:15–53:11, 82:15–88:9, 90:19–92:5; 94:18–96:18,
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`97:14–98:17 should be excluded on relevance grounds and for exceeding the
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`permissible scope of a Reply.
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`D. Exhibit 1029 – Reply Declaration of Arthur Kibbe, Paragraphs 5–
`12, 17, and 20 – Should Be Excluded.
`Patent Owner moves the exclusion of paragraphs 5–12, 17, 19, and 20 of
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`Exhibit 1029 under (i) FRE 401/402 as lacking relevance; (ii) 37 C.F.R. § 42.23(b)
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`for exceeding permissible scope of a Reply; (iii) FRE 701, 702, and 703 for not
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`meeting the standards required of an expert witness; and (iv) 37 C.F.R. § 42.65(a)
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`for expressing opinions without disclosing the underlying facts or data on which the
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`opinions are based. Paper 40, pp. 1–2 (stating objections).
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`Petitioner cites Ex. 1029 for three Reply arguments not in the Petition: that
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`7
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`IPR2017-00203
`Patent 6,649,810 B1
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`(a) the inventors insufficiently inferred gelling aids caused cloud spotting (Reply, p.
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`Patent Owner’s Motion to Exclude
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`
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`18, l. 3–p. 19, l. 13 (citing Ex. 1029 ¶¶ 5–7); see also Ex. 1029 ¶ 8); (b) the claimed
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`invention does not prevent cloud spotting defects (Reply, p. 19, l. 14–p. 21, l. 14
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`(citing Ex. 1029 ¶¶ 9–12)); and (c) the inventors’ unexpected results are based on a
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`subjective distinction (Reply, p. 19, l. 14–p. 21, l. 14 (citing Ex. 1029 ¶¶ 9–12)).
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`These issues are separate and new relative to the instituted ground raised in the
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`Petition. Consequently, paragraphs 5-12 of Exhibit 1029 should be excluded on
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`relevance grounds and for exceeding the permissible scope of a Reply.
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`Paragraph 8 should be excluded additionally because Petitioner does not cite
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`it anywhere in the Reply.
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`Further, Ex. 1029 purports to be the scientific opinions of Petitioner’s expert
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`Dr. Kibbe. Yet paragraphs 6–12 of Ex. 1029 fail to cite any evidence at all. There is
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`also no evidence cited for certain statements made in paragraphs 17 and 20 on which
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`the Reply relies. For example, the Reply cites Ex. 1029 at paragraph 17 in asserting
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`that “viscosity was important and the art contained numerous suggestions on how to
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`address that, including by blending HPMCs.” Reply, p. 9 (citing Ex. 1029 ¶ 17). But
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`paragraph 17 provides no evidence citation for its statements that “the Methocel
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`Catalog expressly describes predictably blending HPMC to obtain desire [sic]
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`viscosity” and “viscosity is simply a matter of the molecular weight of the HPMC
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`chain.” Ex. 1029 ¶ 17. Petitioner cites paragraph 20 on page 15 of the Reply, but
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`8
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`IPR2017-00203
`Patent 6,649,810 B1
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`there is no evidence citation for the statement that “No further explanation is needed
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`Patent Owner’s Motion to Exclude
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`
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`because the ability to mix HPMC types is a matter of routine benchwork clearly
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`within the capabilities of the ordinary skilled artisan.” Ex. 1029 ¶ 20. Petitioner has
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`provided no supplemental evidence in response to Patent Owner’s timely objections
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`in Paper No. 20. FRE 702(b) provides that an expert witness may testify in the form
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`of an opinion if “the testimony is based on sufficient facts or data.” Dr. Kibbe’s
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`opinion testimony in paragraphs 6–12, 17, 19, and 20 is not supported by any
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`identified facts or data. Therefore, paragraphs 6–12, 17, and 20 should be excluded
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`for not meeting the requisite expert witness standards required.
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`E.
`
`Exhibits 2064 and 2067–2072 (Tanjoh Deposition Transcript and
`Deposition Exhibits 13–18) – Should Be Excluded.
`Patent Owner moves the exclusion of Exhibits 2064 and 2067–2072 under (i)
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`FRE 401/402 as lacking relevance, and (ii) 37 C.F.R. § 42.65(b) for exceeding the
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`permissible scope of a Reply. Paper 40, 2 (stating objections).
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`Patent Owner submitted these exhibits in response to an order of the Board
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`granting-in-part Petitioner’s motion for additional discovery, Paper 35, p. 8, but did
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`not concede the admissibility of these exhibits. Paper 36, 5. Petitioner cites these
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`exhibits in passing in its Reply (Paper 38, p. 19, l. 3) but does not cite any material
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`from these exhibits. Petitioner’s witness, Dr. Kibbe, cites these exhibits in passing
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`as well (Ex. 1011, ¶ 5) but also does not cite any material from them. Instead,
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`9
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`IPR2017-00203
`Patent 6,649,810 B1
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`Dr. Kibbe himself admits that there is nothing relevant in the exhibits. Ex. 1011 ¶ 6
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`Patent Owner’s Motion to Exclude
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`
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`(“None of these exhibits show any analysis of the chemical make up of the
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`undesirable precipitates of Table 1.”). Petitioner’s failure to cite any material at all
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`from these exhibits make them irrelevant to the proceeding. Moreover, Petitioner
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`cites the exhibits in furtherance of an argument that exceeds the permissible scope
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`of reply, namely, that the inventors insufficiently inferred gelling aids caused cloud
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`spotting (Reply, p. 18, l. 3–p. 19, l. 13). Therefore these exhibits should be excluded
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`for the manner in which Petitioner uses them.
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`Date: October 20, 2017
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`Respectfully submitted,
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`
`By /Scott E. Kamholz/
`Jessica L. Parezo, Reg. No. 50,286
`Andrea G. Reister , Reg. No. 36,253
`Scott E. Kamholz, Reg. No. 48,543
`Michael N. Kennedy, pro hac vice
`Megan P. Keane, pro hac vice
`Covington & Burling LLP
`One CityCenter, 850 Tenth Street, NW
`Washington, DC 20001
`(202) 662-6000
`
`MaryAnne Armstrong, Reg. No. 40,069
`Lynde F. Herzbach , Reg. No. 74,886
`Birch, Stewart, Kolasch & Birch, LLP
`8110 Gatehouse Road, Suite 100 East
`Falls Church, VA 22402
`(703) 205-8000
`
`Counsel for Patent Owner
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`10
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`IPR2017-00203
`Patent 6,649,810 B1
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`Patent Owner’s Motion to Exclude
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`CERTIFICATE OF SERVICE
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`
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`Pursuant to 37 C.F.R. § 42.6, I hereby certify that on this 20th day of October
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`2017, the foregoing Patent Owner’s Motion to Exclude Evidence Pursuant to 37
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`C.F.R. § 42.64 was served by electronic mail, by agreement of the parties, on the
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`following counsel of record for Petitioner.
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`
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`Mitchell G. Stockwell
`D. Clay Holloway
`Miranda C. Rogers
`Mylan-WC-IPR@kilpatricktownsend.com
`Kilpatrick Townsend & Stockton LLP
`1100 Peachtree Street, Suite 2800
`Atlanta, GA 30309
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`Date: October 20, 2017
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` /Scott E. Kamholz/
`Scott E. Kamholz
` Reg. No.: 48,543
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`11
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