UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC.,
`Petitioner
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`v.
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`QUALICAPS CO., LTD,
`Patent Owner
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`_____________
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`Case IPR2017-00203
`Patent 6,649,180
`_____________
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`PATENT OWNER’S REPLY TO PETITIONER’S RESPONSE TO
`MOTION TO EXCLUDE EVIDENCE PURSUANT TO 37 C.F.R. § 42.64
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC.,
`Petitioner
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`v.
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`QUALICAPS CO., LTD,
`Patent Owner
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`_____________
`
`Case IPR2017-00203
`Patent 6,649,180
`_____________
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`PATENT OWNER’S REPLY TO PETITIONER’S RESPONSE TO
`MOTION TO EXCLUDE EVIDENCE PURSUANT TO 37 C.F.R. § 42.64
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`I.
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`IPR2017-00203
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`Introduction
`Patent Owner submits this reply to Petitioner’s Response to Patent Owner’s
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`Motion to Exclude Evidence (Paper No. 51), filed on November 10, 2017.
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`II. Argument
`A. Exhibit 1011 – Dr. Kibbe’s Declaration – Should Be Excluded.
`Petitioner has not provided rationale or evidence showing that Exhibit 1011
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`is anything more than a copy of the Petition, and thus Exhibit 1011 should be
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`excluded as inadmissible hearsay.
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`Not only is Exhibit 1011 a virtual word-for-word rendition of the Petition, Dr.
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`Kibbe testified he reviewed the Petition at the time he drafted his first declaration in
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`the form of Exhibit 1011. Exhibit 1011 indicates Dr. Kibbe reviewed and applied
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`the Petition’s legal framework in his evaluation of the prior art. Ex. 1011 at ¶ 48; see
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`also Ex. 2029 at 23:18 to 25:8 (Dr. Kibbe testified that he reviewed multiple drafts
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`of the Petition before it was submitted). Later in the proceeding, Dr. Kibbe provided
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`contradictory testimony, stating he did not remember having any part of the Petition
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`when drafting Exhibit 1011. Ex. 2076 at 12:9-19.
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`Yet Petitioner provides no evidence or rationale explaining the word-for-word
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`repeat throughout Ex. 1011 of almost every argument in the Petition. Petitioner
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`merely points to avoiding “excess information in declarations that is not addressed
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`in the petition.” Paper No. 51 at 5 (citation omitted). But Petitioner’s apparent
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`attempt to avoid “excess information” in Exhibit 1011 does not explain how Dr.
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`1
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`IPR2017-00203
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`Kibbe’s opinions in Exhibit 1011 ended up nearly identical to the Petition.
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`Consequently, as a copy of the Petition, Exhibit 1011 is being offered as evidence
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`of what it asserts and is inadmissible hearsay.
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`Exhibit 1012 – Shin-Etsu Website – Should Be Excluded.
`B.
`Petitioner has not provided the testimony of any witness with personal
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`knowledge of the two websites listed in Exhibits 1012, and has not provided any
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`other basis for concluding that the webpages are authentic or to establish their dates
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`of publication. See EMC Corp. v. PersonalWeb Techs., LLC, IPR2013-00084, Paper
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`No. 64, p. 45-46 (citations omitted). Petitioner asserts that Exhibit 1012 is “self-
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`authenticating as bearing a trade inscription for a consumer product,” yet does not
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`even identify the relevant trade inscription. Paper No. 51 at 6. Also, Petitioner cites
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`a case addressing an identifier on hard copy letters rather than webpages. Petitioner
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`additionally fails to address webpages with uncertain dates and an incomplete
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`address as presented in Exhibit 1012. See Paper No. 51 at 7. Petitioner has submitted
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`no authentication from the websites themselves and has not attempted to establish
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`any online publication date. As a result, Exhibit 1012 lacks authentication and is
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`inadmissible under FRE 901.
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`Exhibit 1012 is also inadmissible hearsay under FRE 801 and FRE 802
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`because it is offered as evidence of what it asserts. Petitioner contends that it is “not
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`being offered as a truth, but rather as foundation for the argument presented in the
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`IPR2017-00203
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`Petition at pages 30-31.” Paper No. 51 at 8. But the Petition does not even cite
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`Exhibit 1012 at pages 30–31. Further, Petitioner and Dr. Kibbe rely on the truth of
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`the content of Exhibit 1012 for their identical statements that the name of TC-5E
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`sold “[p]rior to October 2002” and the identity of the “Substitution Type” “described
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`in Japanese Pharmacopoeia.” Petition at 32 (citing Ex. 1012 and Ex. 1011 (in turn
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`citing Ex. 1012)); Ex. 1011 at ¶ 84 (citing Ex. 1012). Petitioner, however, fails to
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`provide any rationale or evidence verifying the truth of the content of Exhibit 1012.
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`Petitioner does not even attempt to address a hearsay exception, and none applies.
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`Accordingly, Exhibit 1012 should also be excluded as inadmissible hearsay.
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`Petitioner’s statement that “Patent Owner does not dispute the link that the
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`Petition draws at pages 30-31” (Paper No. 51 at 8) does nothing to establish the
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`relevance of Exhibit 1012 for at least the reason that pages 30-31 never cite to
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`Exhibit 1012. Critically, as Patent Owner explained in its Motion to Exclude
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`Evidence (Paper No. 50 at 6), Exhibit 1012 could not have contributed to the
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`knowledge of a person of ordinary skill in the art, on which Petitioner relies for the
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`argument on page 32 of the Petition regarding the substitution percentages in the
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`HPMC identified in Yamamoto. Given that Petitioner does not challenge that Exhibit
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`1012 did not contribute to the state of the art, it should also be excluded as not
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`relevant and inadmissible under FRE 401/402.
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`3
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`IPR2017-00203
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`C. Exhibit 1028 – Certain Passages of the Deposition Transcript of
`Jason McConville – Should Be Excluded.
` Petitioner’s mere reference to the “supplemental papers [sic] the Board
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`requested,” Paper No. 51 at 8–9, does not address the cited evidentiary deficiencies
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`of Exhibit 1028 based on lack of relevance under FRE 401/402 and exceeding the
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`permissible Reply scope under 37 C.F.R. § 42.23(b). A reference to “supplemental
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`paper[s]” (citing Paper No. 46 (sic)) is an impermissible incorporation by reference
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`compounded by Petitioner’s unauthorized arguments in that paper. Consequently,
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`Petitioner does not remedy the deficient passages of Exhibit 1028, and they should
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`accordingly be excluded.
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`D. Exhibit 1029 – Reply Declaration of Arthur Kibbe, Paragraphs 5–
`12, 17, and 20 – Should Be Excluded.
`Petitioner’s reference to “Paper No. 46” (sic) does not remedy the evidentiary
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`deficiencies of Exhibit 1029. Petitioner fails to address any of the cited evidentiary
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`deficiencies of Exhibit 1029 based on lack of relevance under FRE 401/402 and
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`exceeding the permissible Reply scope under 37 C.F.R. § 42.23(b). And with regard
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`to paragraph 8 of Exhibit 1029, Petitioner does not provide a rationale for the
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`relevance of an opinion not relied upon for any argument in the Reply.
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`With regard to Dr. Kibbe’s failure to cite evidence in the specified paragraphs
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`of Exhibit 1029, Petitioner provides no response at all with regard to paragraphs 6–
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`12. Thus, paragraphs 6–12 should be excluded for at least the reason that the basis
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`IPR2017-00203
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`for doing so is unchallenged.
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`For paragraph 17, Petitioner mentions citations from Exhibit 2017 allegedly
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`directed to “blending HPMC,” yet these are not cited with specificity anywhere in
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`Exhibit 1029. In fact, Exhibit 1029 provides no evidence citation at all for Dr.
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`Kibbe’s opinions about “blending” and “viscosity” being “simply a matter of the
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`molecular weight.” Ex. 1029 ¶ 17. Also, Petitioner attempts to use Exhibit 1004
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`(Yamamoto) to support the statement that “the ability to mix different HPMC types
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`is a matter of routine benchwork.” Id. at ¶ 20. Yet Dr. Kibbe provided no citation for
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`this conclusory assertion either. Accordingly, the testimony in the referenced
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`paragraphs of Exhibit 1029 is not based on any identified facts or data, and should
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`thus be excluded for not meeting the requisite expert witness standards.
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`E.
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`Exhibits 2064 and 2067–2072 (Tanjoh Deposition Transcript and
`Deposition Exhibits 13–18) – Should Be Excluded.
`Petitioner does not provide a rationale establishing the relevance of Exhibits
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`that: i) do not contain any specific material cited by Petitioner; and ii) are cited in
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`passing for an argument exceeding the permissible scope of reply. Petitioner
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`contends these Exhibits “are the alleged basis for the claimed invention,” but,
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`tellingly, provides no support for this statement based on the Exhibits themselves,
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`or any other evidence. Paper No. 51 at 11. As a result, Exhibits 2064 and 2067–2072
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`should be excluded as lacking relevance and exceeding the permissible Reply scope.
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`5
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`Date: November 22, 2017
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`Respectfully submitted,
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`IPR2017-00203
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`r620 Reg. No. 50,286
`eister , Reg. No. 36,253
`Andrea G.
`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
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`MaryAnne Armstrong, Reg. No. 40,069
`Lynde F. Herzbach , Reg. No. 74,886
`Birch, Stewart, Koiasch & Birch, LLP
`8110 Gatehouse Road, Suite 100 East
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`Falls Church, VA 22402
`(703) 205-8000
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`Counsel for Patent Owner
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`
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6,
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`I hereby certify that on this 22nd day of
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`November 2017, the foregoing l’atent Owner’s Reply to Petitioner’s Response to
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`Patent Owner’s Motion to Exclude Evidence Pursuant to 37 C.F.R. §42.64 was
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`served by electronic mail, by agreement of the parties, on the following counsel of
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`record for Petitioner.
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`Mitchell G. Stockwell
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`David C. Holloway
`Miranda C. Rogers
`MyIan-WC-IPR@kilpatrickt0wusend.com
`Kiipatrick Townsend & Stockton LLP
`1100 Peachtree Street, Suite 2800
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`Atlanta, GA 30309
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`Date: November 22, 2017
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