`
`
`
`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 No. 6,649,180
`
`
`
`PETITIONER MYLAN PHARMACEUTICALS INC.’S RESPONSE TO
`PATENT OWNER’S OBJECTIONS AND SUPPLEMENTAL EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64(b)(2)
`
`
`
`

`

`
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. (“Mylan”) submits the following in
`
`Response to Patent Owner Qualicaps Co., Ltd.’s (“Qualicaps”) Objections to
`
`Evidence Under 37 C.F.R. § 42.61(b)(1) served on May 31, 2017. Mylan reserves
`
`all rights to respond to Qualicaps’ objections to Exhibits that are not specifically
`
`referenced below and to respond further to Qualicaps’ objections to Exhibits that
`
`are referenced below.
`
`Objection(s)
`
`Response
`
`
`
`Exhibits 1004, 1005, 1007 and 1008
`
`Exhibits 1004 (Yamamoto), 1005 (Japanese
`Pharmacopeia), 1007 (21 C.F.R. § 172.874), and 1008
`(National Formulary) are inadmissible for at least the
`following reasons, including under the FRE:
`These exhibits are inadmissible under FRE 1002
`and 1003 (“Best Evidence Rule”). Copies of an original
`printed publication are sufficient evidence, “unless a
`genuine question is raised about the original's authenticity
`or the circumstances make it unfair to admit the duplicate.”
`FRE 1003. Here, the copies produced by Petitioner have
`been altered, thus a “genuine question” has been raised.
`See, e.g., S.E.C. v. Hughes Capital Corp., 124 F.3d 449,
`456 (3d Cir. 1997) (alterations to original check stubs
`made before generating copies raised a genuine question of
`authenticity). At a minimum, each has foreign characters
`bearing the general format “TEVA - MS - 0045xxx”
`inserted at the lower right corner of each page (see, e.g.,
`Ex. 1004 at p. 1), and numerous copying defects
`throughout (see, e.g., id. at p. 7, Table 1). Further, there is
`no burden on Petitioner to produce unaltered copies
`because the originals are publically available. These
`exhibits are therefore inadmissible under the Best
`Evidence Rule.
`Federal Rule of Evidence 1003 provides that “[a]
`duplicate is admissible to the same extent as the original
`
`- 1 -
`
`

`

`
`
`
`
`unless a genuine question is raised about the original’s
`authenticity or the circumstances make it unfair to admit
`the duplicate.” The Advisory Committee Notes provide
`that “[w]hen the only concern is with getting the words or
`other contents before the court with accuracy and
`precision, then a counterpart serves equally as well as the
`original, if the counterpart is the product of a method
`which insures accuracy and genuineness. By definition in
`Rule 1001(4), supra, a ‘duplicate’ possesses this
`character.” Exhibits 1004, 1005, 1007, and 1008 are
`duplicates and are therefore admissible under FRE 1003.
`Although Patent Owner asserts that a “genuine question”
`has been raised about the original’s authenticity, Patent
`Owner only points to the presence of Bates labels on the
`document. Patent Owner points to nothing about the
`content of the document itself that raises a “genuine
`question” as to the original document’s authenticity.
`Further, Patent Owner points to nothing about the content
`of the document itself that raises a question as to the
`accuracy or precision of the words or other contents of the
`document relied upon by petitioner.
`Petitioner is providing a non-Bates-labeled versions
`of these exhibits as supplemental evidence.
`Exhibit 1006
`
`Exhibit 1006 (Greminger) is inadmissible for at
`least the following reasons, including under the FRE:
`Exhibit 1006 is inadmissible because it is not
`relevant under FRE 401 and 402. Petitioner relied on this
`exhibit for Ground 2. See Petition at page 41. The Board
`denied institution with respect to Ground 2. See Paper No.
`10 at page 17. Therefore, Exhibit 1006 is not relevant to
`the instituted ground.
`Exhibit 1006 is relevant at least as evidence to rebut
`Patent Owner’s purported evidence of non-obviousness of
`unexpected results. Exhibit 1006 is also a document that
`may be used by an expert witness to ascertain and provide
`testimony about what a person of ordinary skill in the art
`would have understood prior to the priority date of the
`patent at issue in the proceedings. See, e.g., Petition at pp.
`- 2 -
`
`Objection(s)
`
`Response
`
`
`
`

`

`
`
`
`
`52-56.
`
`Exhibit 1009
`
`Objection(s)
`
`Response
`
`
`
`Exhibit 1009 (Handbook of Pharmaceutical
`Excipients) is inadmissible for at least the following
`reasons, including under the FRE:
`Exhibit 1009 is inadmissible under FRE 401 and
`402 because it lacks relevance to the instituted ground.
`Exhibit 1009 contains no publication date. -Without a
`publication date, Petitioner cannot demonstrate a
`reasonable likelihood that Exhibit 1009 is a prior-art,
`printed publication. Therefore, Exhibit 1009 is
`inadmissible as not relevant under FRE 401 and 402.
`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 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 Standard
`Innovation Corp. v. Lela, Inc., IPR2014-00148, 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 in Exhibit 1009 is
`inadmissible hearsay under FRE 802.
`Exhibit 1009 is relevant at least as a document that
`may be used by an expert to ascertain and provide
`testimony about what a person of ordinary skill in the art
`would have understood prior to the priority date of the
`patent at issue in the proceedings.
`Exhibit 1009 is a publication as at least
`demonstrated by information in Exhibit 1009 including the
`identification of publishers, publication production staff,
`presence of ISBN numbers, and information regarding the
`location of printing.
`Patent Owner does not challenge the authenticity of
`Exhibit 1006. Subsequent editions of Exhibit 1006 show a
`publication date of 1986 for Exhibit 1006. See, e.g.,
`Exhibit 1020 submitted herewith.
`- 3 -
`
`

`

`
`
`Objection(s)
`
`
`
`
`
`Exhibit 1011
`
`Exhibit 1011 (Dr. Kibbe's declaration) is
`inadmissible for at least the following reasons, including
`under the FRE:
`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 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).For example, Dr. Kibbe's declaration purports
`to give his opinion on “Ground 1: 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 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 pages); see also id. at pages
`39-41 (copying the Petition's claim construction positions
`on “gelling agent” and “gelling aid”); id. at 95-102
`(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 copy 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 technology,
`where the expert did not investigate those facts himself but
`only “scanned” some notes provided to him by defendant);
`Robinson v. Sanctuary Record 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
`- 4 -
`
`

`

`
`
`
`
`methodology was founded on hearsay supplied by the
`party itself, rather than “a source of first-hand, 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 expert must form his own
`opinions by applying his extensive experience and a
`reliable methodology to the inadmissible materials.
`Otherwise, the expert is simply repeating hearsay evidence
`without applying any expertise whatsoever.”) (internal
`quotation marks and citations omitted). Therefore, Dr.
`Kibbe's declaration should be excluded as inadmissible
`hearsay.
`Exhibit 1011 is the Declaration of Arthur H. Kibbe,
`Ph.D., Petitioner’s expert here. Dr. Kibbe’s declaration
`contains his uncompelled direct testimony and is submitted
`in the form consistent with the requirements of 3 C.F.R.
`§ 42.53(a). Dr. Kibbe declared the testimony in the
`declaration contains his opinions and conclusions and that
`if called upon to testify, he would provide those opinions
`and conclusions. The factual testimony that Dr. Kibbe
`provides in Exhibit 1011 is the basis upon which the
`petition was created and submitted. That the factual case
`set forth in Dr. Kibbe’s declaration so plainly sets forward
`the obviousness of the claims explains the little need for
`additional attorney argument to be included in the petition
`to advance Petitioner’s case.
`Exhibit 1012
`
`Exhibit 1012 (Shin-Etsu website) is inadmissible
`for at least the following reasons, including under the FRE:
`This exhibit lacks authentication, and thus is
`inadmissible under FRE 901. Exhibit 1012 appears to be
`two separate printouts of two separate websites describing
`material associated with “Shin-Etsu Chemical Co., Ltd.”
`However, Petitioner may not rely on the content of alleged
`website printouts without proper authentication. Petitioner
`has offered no evidence establishing that Exhibit 1012
`contains true and correct printouts from websites.
`Petitioner has not provided the testimony of any witness
`with personal knowledge of the websites. See Neste Oil
`- 5 -
`
`Response
`
`Objection(s)
`
`
`
`

`

`
`
`
`
`OYJ v. Reg Synthetic Fuels, LLC, IPR2013-000578, Paper
`53 at 3-4 (P.T.A.B. Mar.12, 2015). Consequently,
`Petitioner has not provided evidence sufficient to support a
`finding that Exhibit 1012 “is what [Petitioner] claims it is.”
`FRE 901(a)
`Exhibit 1012 is also inadmissible under FRE 401
`and 402 because it lacks relevance to the instituted ground.
`Exhibit 1012 gives no indication as to when the material
`was allegedly published. Notably, the face of the document
`provides that the earliest copyright date is 2001, which is
`two years after the priority date of the '180 Patent. See
`Exhibit 1012 at p 1. (“Copyright (c) 2001-2013 Shin-Etsu
`Chemical Co., Ltd. All [sic] Rights Reserved”). It
`therefore has no relevance to the instituted ground and is
`not admissible under FRE 401 and 402.
`Additionally, while Exhibit 1012 states there are
`ranges of copyright dates (see Exhibit 1012 at pages 1-2),
`Petitioner cannot rely on this statement for the truth 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, Inc., IPR2014-
`00148, 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.
`Exhibit 1012 is a compilation of websites describing
`materials sold by Shin-Etsu Chemical Co., Ltd. Petitioner
`does not offer Exhibit 1012 as prior art. Exhibit 1012 is
`relevant at least as a document that may be used by an
`expert to ascertain and provide testimony about what a
`person of ordinary skill in the art would have understood
`prior to the priority date of the patent at issue in the
`proceedings.
`Exhibit 1012 is self-authenticating under FRE
`902(7) as an inscription, sign, tag, or label purporting to
`have been affixed in the course of business and indicating
`origin, ownership, or control. Namely, Exhibit 1012
`- 6 -
`
`Response
`
`
`
`

`

`
`
`
`
`
`
`
`
`provides information regarding the trade names
`Pharmacoat and TC-5 and their relation to technical names
`found in other prior art, such as the Japanese
`Pharmacopeia and the Handbook of Pharmaceutical
`Excipients.
`
`Further, Mylan hereby submits the following additional supplemental
`
`evidence. Petitioner submits that this supplemental evidence provides additional
`
`foundation and authenticity support, and should resolve Patent Owner’s objections
`
`to Exhibits 1004-1009, 1011, and 1012.
`
`Exhibit No. Description
`
`United States Patent No. 5,756,123 (“Yamamoto”)
`
`The Japanese Pharmacopeia (The Society of Japanese
`Pharmacopeia, 13th ed. 1996) (“Japanese Pharmacopeia”)
`
`21 C.F.R. § 172.874 (1998)
`
`National Formulary (American Pharmaceutical Association,
`12th ed. 1965)
`
`Handbook of Pharmaceutical Excipients Sixth Edition (2009)
`
`
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`
`
`
`
`- 7 -
`
`

`

`
`
`Date: June 14, 2017
`
`By: s/Mitchell G. Stockwell
`Mitchell G. Stockwell
`Registration No. 39,389
`Lead Counsel for Petitioner
`
`
`
`
`
`Back-Up Counsel
`D. Clay Holloway
`Reg. No. 58,011
`cholloway@kilpatricktownsend.com
`Kilpatrick Townsend & Stockton LLP
`1100 Peachtree Street, NE
`Suite 2800
`Atlanta, Georgia 30309
`(404) 815 6500
`
`Jonathan D. Olinger (pro hac vice)
`jolinger@killpatricktownsend.com
`Kilpatrick Townsend & Stockton LLP
`1100 Peachtree Street, NE
`Suite 2800
`Atlanta, Georgia 30309
`(404) 815 6500
`
`Lead Counsel
`Mitchell G. Stockwell
`Reg. No. 39,389
`mstockwell@kilpatricktownsend.com
`Kilpatrick Townsend & Stockton
`LLP
`1100 Peachtree Street, NE
`Suite 2800
`Atlanta, Georgia 30309
`(404) 815 6500
`
`
`
`
`
`
`
`- 8 -
`
`

`

`
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that on June 14, 2017 a copy of the
`
`foregoing Petitioner Mylan Pharmaceuticals Inc.’s Response to Patent Owner’s
`
`Objections and Supplemental Evidence Pursuant to 37 C.F.R. § 42.64(B)(2) was
`
`served by electronic mail by agreement of the parties on the following counsel of
`
`record for Patent Owner.
`
`Jessica L. Parezo (jparezo@cov.com)
`Andrea G. Reister( areister@cov.com)
`Scott E. Kamholz (skamholz@cov.com)
`Michael N. Kennedy (mkennedy@cov.com)
`Megan P. Keane (mkeane@cov.com)
`Covington & Burling LLP
`One CityCenter, 850 Tenth Street, NW
`Washington, DC 20001
`
`MaryAnne Armstrong (maa@bskb.com)
`Lynde F. Herzbach (lynde.herzbach@bskb.com)
`Birch, Stewart, Kolasch & Birch, LLP
`8110 Gatehouse Road, Suite 100 East
`Falls Church, VA 22042
`
`
`
`By: s/Mitchell G. Stockwell
`Mitchell G. Stockwell
`Registration No. 39,389
`Lead Counsel for Petitioner
`
`
`- 9 -
`
`
`
`
`
`
`
`
`
`
`
`Dated: June 14, 2017
`
`