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