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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS, INC.
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`Petitioner
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`v.
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`YEDA RESEARCH AND DEVELOPMENT CO. LTD.
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`Patent Owner
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`Case No. IPR2015-00644
`Patent No. 8,399,413
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`PATENT OWNER’S OBJECTIONS TO EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64
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`Case No. IPR2015-00644
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`Pursuant to 37 C.F.R. § 42.64, Patent Owner Yeda Research and Development
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`Co., Ltd. (“Yeda”) objects to the admissibility of the documents identified below that
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`were submitted by Petitioner during the preliminary proceedings, for the following
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`reasons:
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`1.
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`Petitioner’s Exhibit 10071 is objected to because it has not been properly
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`authenticated as required by Federal Rule of Evidence (FRE) 901 and there is no
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`admissible evidence establishing that this exhibit was in fact sufficiently publicly
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`accessible such that this document qualifies as a prior art printed publication. Exhibit
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`1007 is also objected to as being hearsay.
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`2.
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`Patent Owner Yeda also objects to the statements regarding Exhibit 1007
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`in the Petition (Paper 2) and Exhibits 1003 (Declaration of Stephen Peroutka) and 1004
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`(Declaration of Ari Green). For example, neither Dr. Peroutka nor Dr. Green provide
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`testimony from personal knowledge regarding whether Exhibit 1007 is authentic or
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`qualifies as a printed publication. Thus, all statements in the Petition and testimony by
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`Drs. Peroutka and Green concerning this exhibit lack foundation and assume facts not
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`in evidence.
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`3.
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`Exhibit 1003 (Declaration of Stephen Peroutka) is objected to as
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`unreliable under Federal Rule of Evidence 702 and Daubert v. Merrell Dow
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`Pharmaceuticals, Inc., 509 U.S. 579 (1993). Dr. Peroutka does not possess the
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`1 “Summary Basis of Approval for the New Drug Application for 20 mg daily
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`Copaxone® (NDA #20-622)” (Ex. 1007).
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`Case No. IPR2015-00644
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`requisite credentials or expertise to render opinions in this case.
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`3.
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`Exhibits 1017 (FDA Guidelines for Industry), 1021 (Goodman &
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`Gilman), 1023 (Haines), 1027 (Boissel 2002), 1034 (Beringer 2005), 1035 (Franklin),
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`1040 (Kragt 2006), 1041 (Manso), 1048 (Betaseron label), 1049 (Rebif label), 1050
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`(Avonex label), 1051 (Tysabri prescribing information), 1053 (Extavia monograph),
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`1054 (Jacobs), 1055 (dictionary), 1057 (Concepts in Clinical Science), 1059 (FDA
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`Guidance) and 1060 (Rebif label) are objected to under Federal Rules of Evidence
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`401/403.
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`These objections have been timely made within ten business days from the
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`Respectfully Submitted,
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`/Elizabeth J. Holland/
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`Elizabeth J. Holland
`Registration No. 47,657
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`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10019-1405
`Tel: 212-813-8800
`Fax: 212-355-3333
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`Attorneys for Patent Owner
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` institution of trial.
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`Date: September 9, 2015
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`Case No. IPR2015-00644
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`CERTIFICATE OF SERVICE
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`I hereby certify that on September 9, 2015, I caused a true and correct copy of
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`the foregoing PATENT OWNER’S OBJECTIONS TO EVIDENCE PURSUANT
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`TO 37 C.F.R. § 42.64 to be served via email on the following attorneys of record for
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`Petitioner:
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`Jeffrey W. Guise
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`jguise@wsgr.com
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`Brandon M. White
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`BMWhite@perkinscoie.com
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`/Eleanor Yost/
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`Dated:
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`September 9, 2015
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