UNITED STATES FATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC,
`
`Petitioner
`
`QUALICAPS CO., LTD,
`
`Patent Owner
`
`Case IPR2017-00203
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`Patent 6,649,180
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`PATENT OWNER’S OBJECTIONS TO EVIDENCE
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`UNDER 37 C.F.R. § 42.64(b)(1)
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`DC: 64325514
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC,
`
`Petitioner
`
`QUALICAPS CO., LTD,
`
`Patent Owner
`
`Case IPR2017-00203
`
`Patent 6,649,180
`
`PATENT OWNER’S OBJECTIONS TO EVIDENCE
`
`UNDER 37 C.F.R. § 42.64(b)(1)
`
`DC: 64325514
`
`
`
`IPR2017-00203
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`Pursuant to 37 C.F.R. § 42.64(b)(1) and the Federal Rules of Evidence
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`(“FRE”), as applied by the Patent Trial and Appeal Board (“Board”), Patent Owner,
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`Qualicaps Co., Ltd., submits the following objections to evidence filed by Petitioner
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`with its Petition for Inter Par-res Review (Paper No. 1) (“Petition”). These objections
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`are timely filed within ten (10) business days of the May 16, 2017 institution decision
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`(Paper No. 10).
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`Patent Owner reserves the right
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`to present further objections to these or
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`additional Exhibits submitted by Petitioner, as aliowed by the applicable rules or
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`other authority, including without limitation upon conclusion of cross-examination
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`of Dr. Arthur Kibbe.
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`Exhibits 1004, 1005, 1007, and 1008
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`Exhibits 1004 (Yamamoto), 1005 (Japanese Pharmacopeia), 1007 (21 C.F.R.
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`§ 172.874), and 1008 (National Formulary) are inadmissible for at
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`least
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`the
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`following reasons, including under the FRE:
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`These exhibits are inadmissible under FRE 1002 and 1003 (“Best Evidence
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`Rule”). Copies of an original printed publication are sufficient evidence, “unless a
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`genuine question is raised about the original’s authenticity or the circumstances
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`make it unfair to admit the duplicate.” FRE 1003. Here, the copies produced by
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`Petitioner have been altered, thus a “genuine question” has been raised. See, e.g.,
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`S.E.C. v. Hughes Capital Corp, 124 F.3d 449, 456 (3d Cir. 1997) (alterations to
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`.. 1 ..
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`
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`IPR2017~00203
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`original check stubs made before generating copies raised a genuine question of
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`authenticity). At a minimum, each has foreign characters bearing the genera} format
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`“TEVA__MS_OO45XXX” inserted at the lower right corner of each page (see, e.g., Ex.
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`1004 at p. 1), and numerous c0pying defects throughout (see, e.g., id. at p. 7, Table
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`1). Further, there is no burden on Petitioner to produce unaltered copies because the
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`originals are publically available. These exhibits are therefore inadmissible under
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`the Best Evidence Rule.
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`Exhibit 1006
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`Exhibit 1006 (Greminger) is inadmissible for at least the following reasons,
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`including under the FRE:
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`Exhibit 1006 is inadmissible because it is not relevant under FRE 401 and
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`402. Petitioner relied on this exhibit for Ground 2. See Petition at page 41. The Board
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`denied institution with respect to Ground 2. See Paper No. 10 at page 17. Therefore,
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`Exhibit 1006 is not relevant to the instituted ground.
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`Exhibit 1009
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`Exhibit 1009 (Handbook of Pharmaceutical Excipients) is inadmissible for at
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`least the following reasons, including under the FRE:
`
`Exhibit 1009 is inadmissible under FRE 401 and 402 because it
`
`tacks
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`relevance to the instituted ground. Exhibit 1009 contains no publication date.
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`-2-
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`
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`IPR2017-00203
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`Without a publication date, Petitioner cannot demonstrate a reasonable Iiketihood
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`that Exhibit 1009 is a prior-art, printed publication. Therefore, Exhibit 1009 is
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`inadmissible as not relevant under FRE 401 and 402.
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`Further, while Exhibit 1009 states there is a copyright date (see Exhibit 1009
`
`at page 2), Petitioner cannot rely on this statement for the truth of the matter it asserts
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`because it is not evidence that the reference was a printed publication as of a
`
`particular date. A copyright date is inadmissible hearsay under FRE 802. See
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`Standard Innovation Corp. v. Lela, Ina, iPR2014—00148, Paper 41 at 13—16 (April
`
`23, 2015) (copyright dates held to be inadmissible hearsay evidence of publication);
`
`ServiceNow, Inc. 12. Hewlett~Packard Ca, IPR2015-00716, Paper 13 at 15m17 (Aug.
`
`26, 2015) (holding the same). Therefore, the copyright date in Exhibit 1009 is
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`inadmissible hearsay under FRE 802.
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`Exhibit 1011
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`Exhibit 101} (Dr. Kibbe’s deciaration) is
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`inadmissible for at
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`least
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`the
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`following reasons, including under the FRE:
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`Dr. Kibbe’s declaration should be excluded because it is hearsay under FRE
`
`802, and does not meet the standard for an expert to rely on hearsay under FRE 702
`
`and 703. Dr. Kibbe’s opinionsuincluding those that ailege invalidity of the ’180
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`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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`-3-
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`
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`IPR2017-00203
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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 Yamarnoto in Combination
`
`with Japanese Pharmacopeia.” Yet instead, Dr. Kibbe repeats the Petition essentially
`
`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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`pages); see also id. at pages 39-41 (copying the Petition’s claim construction
`
`positions on “gelling agent” and “gelling aid”); id. at 95—402 (copying Petition’s
`
`alleged rebuttal of Patent Owner’s unexpected results evidence). In fact, Exhibit
`
`2021 shows that the entirety of Dr. Kibbe’s purported opinion is a virtual word-for-
`
`word c0py of the Petition.
`
`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
`
`assistance to the trier of fact through the application of specialized knowledge, and
`
`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
`
`technoiogy, where the expett did not
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`investigate those facts himself but only
`
`“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
`
`expert’s testimony under FRE 702 and 703 where expert’s methodology was
`
`-4-
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`
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`IPR2017-00203
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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);
`
`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
`
`reliable methodology to the inadmissible materials. Otherwise, the expert is simply
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`repeating hearsay evidence without applying any expertise whatsoever.”) (internal
`
`quotation marks and citations omitted). Therefore, Dr. Kibbe’s declaration should
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`be excluded as inadmissible hearsay.
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`Exhibit 1012
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`Exhibit 1012 (Shin~Etsu website) is inadmissible for at ieast the following
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`reasons, including under the FRE:
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`ribis exhibit lacks authentication, and thus is inadmissible under FRE 901.
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`Exhibit 1012 appears to be two separate printouts of two separate websites
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`describing materiai associated with “Shin-Etsu Chemicai Co., Ltd.” However,
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`Petitioner may not rely on the content of alieged website printouts without preper
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`authentication. Petitioner has offered no evidence establishing that Exhibit 1012
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`contains true and correct printouts from websites. Petitioner has not provided the
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`testimony of any witness with persona}. knowledge of the websites. See Neste Oil
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`OYJ 12. Reg Synthetic Fuels, LLC, IPR2013-000578, Paper 53 at 34 (P.T.A.B. Mar.
`
`
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`IPR2017—00203
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`12, 2015). Consequentiy, Petitioner has not provided evidence sufficient to support
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`a finding that Exhibit 1012 “is what [Petitioner] claims it is.” FRE 901(3).
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`Exhibit 1012 is also inadmissihie under FRE 401 and 402 because it iacks
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`relevance to the instituted ground. Exhibit 1012 gives no indication as to when the
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`material} was allegedly published. Notably, the face of the document provides that
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`the earliest copyright date is 2001, which is two years after the priority date of the
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`’ 180 Patent. See Exhibit 1012 at p 1. (“Copyright (c) 2001—2013 ShinmEtsu Chemicai
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`Co., LtdAli [sic] Rights Reserved”). It therefore has no relevance to the instituted
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`ground and is not admissible under FRE 401 and 402.
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`Additionally, while Exhibit 1012 states there are ranges of copyright dates
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`(see Exhibit 1012 at pages 1—2), Petitioner cannot rely on this statement for the truth
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`of the matter it asserts because it is not evidence that the reference was a printed
`
`publication as of a particular date. Copyright dates are inadmissible hearsay under
`
`FRE 802. See Standard Innovation Corp. v. Lela, Ina, lPR2014w00148, Paper 41 at
`
`13—16 (April 23, 2015) (copyright dates held to be inadmissible hearsay evidence of
`
`publication); ServiceNow, Inc. v. Hewlett-Packard Co, iPR2015-00716, Paper 13 at
`
`15—17 (Aug. 26, 2015) (holding the same). Therefore, the copyright date ranges in
`
`Exhibit 1012 are inadmissible hearsay under FRE 802.
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`
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`IPR2017-00203
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`Exhibit 1013
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`Exhibit 1013 (Advances in Food Research) is inadmissible for at least the
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`following reasons, including under FRE:
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`Exhibit 1013 is inadmissible under FRE 401 and 402 because it
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`tacks
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`relevance to this proceeding. Neither the Petition nor Dr. Kibbe’s declaration cites
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`Exhibit 1013. It therefore has no reievance t0 the instituted ground.
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`
`
`Date: May 31, 2017
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`ReSpectfutly submitted,
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`IPR2017~00203
`
`
`
`
`Jesswa L. P ext;
`Registraton No.: 50,286
`Andrea G. Reister
`
`Registration No.: 36,253
`
`Scott E. Kamhotz
`
`Registration No.: 48,543
`
`COVINGTON & BURLING LLP
`
`One CityCenter, 850 Tenth Street, NW
`Washington, DC 20001
`(202) 662-6000
`
`MaryAnne Armstrong
`
`Registration No.: 40,069
`
`Lynde F. Herzbach
`
`Registration No.: 74,886
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`BIRCH, STEWART, KOLASCH & BIRCH, LLP
`8110 Gatehouse Road, Suite 100 East
`Fans Church, VA 22402
`(703) 205 -8000
`
`Attorneys for Patent Owner
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`
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`CERTIFICATE OF SERVICE
`
`IPR2017—00203
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`Pursuant to 37 C.F.R. § 42.6, I hereby certify that on this 31st day of May
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`2017,
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`the foregoing Patent Owner’s Objections to Evidence Under 37 C.F.R.
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`§42.64(b)(1) 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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`Mitchel! G. Stockwell
`
`David C. Holloway
`Jonathan D. Olinger
`Miranda C. Rogers
`Mylan-WC-IPR@kilpatricktownsend.com
`Kilpatrick Townsend & Stockton LLP
`1100 Peachtree Street, Suite 2800
`
`Atlanta, GA 30309
`
`Date: May 31, 2017
`
`
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