`Patent Owner’s Objections to Evidence
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`FRESENIUS KABI USA, LLC
`Petitioner
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`v.
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`CEPHALON, INC.
`Patent Owner
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`_____________
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`Case IPR2016-00098
`Patent No. 8,791,270
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`_____________________
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`PATENT OWNER’S
`OBJECTIONS TO EVIDENCE
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`IPR2016-00098
`Patent Owner’s Objections to Evidence
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`Pursuant to 37 C.F.R. § 42.64(b)(1), Patent Owner, Cephalon, Inc.
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`(“Cephalon”), asserts the following objections to evidence submitted by
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`Petitioner Fresenius Kabi USA, LLC in support of its Petition for Inter Partes
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`Review of U.S. Patent No. 8,791,270. Cephalon reserves the right to file a motion
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`to exclude the evidence to which these objections are directed.
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`For the following reasons, Patent Owner objects to Exhibit 1004, described
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`by Petitioner as “Birgit Maas et al., Stability of Bendamustine Hydrochloride in
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`Infusions, 49 PHARMAZIE 775 (1994) (German language original and certified
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`English translation)” (“Maas”).
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`Exhibit 1004 is objected to under FRE 901 because Petitioner has not
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`demonstrated the authenticity of Exhibit 1004. Petitioner relies heavily on the
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`chromatogram depicted on page 1004-0002 of Maas. Petitioner provided the
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`Board with a different copy of the Maas reference in IPR2016-00111 (attached
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`here as Ex. 2025). Ex. 2025 depicts the same chromatogram with substantially less
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`detail than Ex. 1004. In fact, these two copies of the Maas reference differ
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`substantially from a copy of Maas produced by other Petitioners in IPR2015-00503
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`(attached here as Ex. 2026). The variations in image quality among multiple
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`copies of the same reference highlight that the Petitioner’s estimates of the
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`degradants depicted in the chromatogram in Maas are suspect in that they are
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`IPR2016-00098
`Patent Owner’s Objections to Evidence
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`dependent on the quality of the underlying image. These drastic variations in
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`image quality among multiple copies of the Maas reference underscore Petitioner’s
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`failure to establish that the copy of Maas submitted as Ex. 1004 is a true and
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`correct copy of the original Maas publication. Petitioner does not disclose the
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`source of the copy that it submitted as Ex. 1004, the relationship between that copy
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`and the original publication, or the steps taken to preserve the fidelity of the copy
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`to the original publication.
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`Exhibit 1004 is also objected to under FRE 403. Where the authenticity of
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`Exhibit 1004 has not been established and where multiple copies of the Maas
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`reference differ substantially from one another, Ex. 1004 should be excluded.
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`Unauthenticated, Ex. 1004’s probative value (if any) is substantially outweighed
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`by the danger of unfair prejudice and the high risk of misleading the Board through
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`reliance on a reference which is not what it purports to be.
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`Exhibit 1004 is also objected to under 37 C.F.R. § 42.51(b)(1)(iii), which
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`requires Petitioner to “serve relevant information that is inconsistent with a
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`position advanced by the party during the proceeding concurrent with the filing of
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`the documents or things that contain the inconsistency.” Where multiple copies of
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`the Maas reference differ substantially from one another, Petitioner must disclose
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`the source of the copy submitted as Ex. 1004, the relationship between that copy
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`IPR2016-00098
`Patent Owner’s Objections to Evidence
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`and the original publication, or the steps, if any, taken to preserve the fidelity of
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`Ex. 1004 to the original publication.
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`For the same reasons, Patent Owner objects to the portions of the Petition (2-
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`3, 10-12, 24, 26, 28-53), supporting Declaration of Michael J. Akers, Ph.D. (¶¶ 30-
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`32, 38-52, and 58), and supporting Declaration of Bernard Olsen (¶¶ 6, 40-43, 48-
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`193) to the extent each incorporates or otherwise relies on Exhibit 1004, which has
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`not been authenticated.
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`Dated: May 18, 2016
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`Respectfully Submitted,
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`KAYE SCHOLER LLP
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`/s/ Soumitra Deka
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`Soumitra (Sam) Deka
`(Reg. No. 70,252)
`Two Palo Alto Square
`3000 El Camino Real, Suite 400
`Palo Alto, CA 94306
`Tel: (212) 836-8000
`Fax: (212) 836-8689
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`Attorneys for Patent Owner
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`IPR2016-00098
`Patent Owner’s Objections to Evidence
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing document,
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`PATENT OWNER’S OBJECTIONS TO EVIDENCE, was served via
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`electronic mail on May 18, 2016 to the following counsel of record for the
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`Petitioner:
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`Lawrence Sung
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`Neal Seth
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`WILEY REIN LLP
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`nseth@wileyrein.com
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`lsung@wileyrein.com
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`Dated: May 18, 2016
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`/s/ Soumitra Deka
`Soumitra (Sam) Deka
`(Reg. No. 70,252)
`KAYE SCHOLER LLP
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`4
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