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`Filed on behalf of: Acrux DDS PTY LTD.
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`Acrux Limited
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`By: E. Anthony Figg, Reg. No. 27,195
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`Aydin H. Harston, Reg. No. 65,249
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`ROTHWELL, FIGG, ERNST & MANBECK, P.C.
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`607 14th St., N.W., Suite 800
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`Washington, DC 20005
`Phone: 202-783-6040;
`Fax: 202-783-6031
`Emails: efigg@rothwellfigg.com
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` aharston@rothwellfigg.com
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`Paper _____
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`Filed: May 15, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`ACRUX DDS PTY LTD. & ACRUX LIMITED,
`Petitioners,
`
`v.
`
`KAKEN PHARMACEUTICAL CO., LTD. and
`VALEANT PHARMACEUTICALS INTERNATIONAL, INC.,
`Patent Owner and Licensee.
`_______________
`
`Case IPR2017-00190
`Patent No. 7,214,506
`_______________
`
`PETITIONERS’ OBJECTIONS TO EVIDENCE SUBMITTED WITH
`PATENT OWNER’S PRELIMINARY RESPONSE
`PURSUANT TO 37 C.F.R. § 42.64(b)(1)
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`Pursuant to 37 C.F.R. § 42.64(b)(1), Acrux DDS PTY Ltd. and Acrux
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`Case IPR2017-00190
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`
`
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`Limited (collectively, “Petitioners”) hereby object to the admissibility of the
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`following evidence submitted by Kaken Pharmaceutical Co., Ltd. and Valeant
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`Pharmaceuticals International, Inc. (collectively, “Patent Owners”) with the Patent
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`Owner’s Preliminary Response (Paper No. 8) (“POPR”).
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`Evidence Submitted by
`Patent Owners
`Exhibits 2001/20031
`(Declaration of Yochiyuki
`Tatsumi, Ph.D.)
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`Petitioners’ Objection(s)
`
`Inadmissible as lacking foundation, assuming facts
`not in evidence, conclusory, and containing
`testimony concerning Exhibit 2004 for which
`authentication is lacking.
`
`Paragraph 8 is inadmissible as irrelevant (Fed. R.
`Evid. 402) to the extent it is not directed to the
`claimed subject matter and/or the prior art cited in
`the grounds on which the review was instituted.
`
`Paragraphs 9 through 12 are inadmissible as there
`is no indication that the declarant has personal
`knowledge of the alleged experiments described
`therein (Fed. R. Evid. 602) and as hearsay to the
`extent the testimony is being used to prove the
`truth of the matters asserted (Fed. R. Evid. 802).
`To the extent Patent Owners are introducing Dr.
`Tatsumi’s testimony as expert opinion, it is
`unsupported by sufficient facts or data (Fed. R.
`Evid. 702). See, e.g., POPR, at 19.
`
`
`1 Petitioners list both the original Japanese language document and the
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`corresponding English translation with respect to their objections to Exhibits 2001
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`through 2004.
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`2
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`
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`Evidence Submitted by
`Patent Owners
`Exhibits 2002/2004
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`Exhibits 2007, 2008, 2009,
`2010
`
`Exhibit 2011
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`
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`Case IPR2017-00190
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`Petitioners’ Objection(s)
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`Inadmissible as lacking authentication (Fed. R.
`Evid. 901). Patent Owner’s declarant Dr. Tatsumi
`(Exhibit 2001/2003) does not provide sufficient
`evidence to establish that Exhibit 2004 is self-
`authenticating under Fed. R. Evid. 902 because
`there is no evidence presented to support his
`conclusory assertions tracking the requirements of
`FRE 803(6)(A)-(C).
`
`Inadmissible as hearsay (Fed. R. Evid. 802) to the
`extent the document is being used to prove the
`truth of the matters asserted.
`
`Inadmissible as incomplete (Fed. R. Evid. 106) as
`it sets forth summaries of data allegedly obtained
`while not presenting all of the data obtained and its
`full underlying information in fairness to allow
`Petitioners to test its validity.
`Inadmissible as unsupported expert testimony
`(Fed. R. Evid. 702). See, e.g., POPR, at 10-12.
`
`Inadmissible as hearsay (Fed. R. Evid. 802) to the
`extent the documents are being used to prove the
`truth of the matters asserted therein. See, e.g.,
`POPR, at 10-12.
`Inadmissible as unsupported expert testimony
`(Fed. R. Evid. 702). See, e.g., POPR, at 10-12.
`
`Inadmissible as hearsay (Fed. R. Evid. 802) to the
`extent the document is being used to prove the
`truth of the matters asserted therein. See, e.g.,
`POPR, at 10-12.
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`Inadmissible as lacking authentication (Fed. R.
`Evid. 901) as there is no indication of source
`accompanying the document, there is no
`supporting witness testimony and books are not
`self-authenticating under FRE 902.
`3
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`Evidence Submitted by
`Patent Owners
`Exhibits 2012, 2013, 2014,
`2015, 2016, 2017
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`Exhibit 2018
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`Case IPR2017-00190
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`Petitioners’ Objection(s)
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`Inadmissible as unsupported expert testimony
`(Fed. R. Evid. 702). See, e.g., POPR, at 8, 10-12.
`
`Inadmissible as hearsay (Fed. R. Evid. 802) to the
`extent the documents are being used to prove the
`truth of the matters asserted therein. See, e.g.,
`POPR, at 8, 10-12.
`Inadmissible as unsupported expert testimony
`(Fed. R. Evid. 702). See, e.g., POPR, at 12.
`
`Inadmissible as hearsay (Fed. R. Evid. 802) to the
`extent the document is being used to prove the
`truth of the matters asserted therein. See, e.g.,
`POPR, at 12.
`
`Inadmissible as lacking authentication (Fed. R.
`Evid. 901) as there is no indication of source
`accompanying the document, there is no
`supporting witness testimony and articles retrieved
`from the internet are not self-authenticating under
`FRE 902.
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`The foregoing objections are made within 10 business days of the institution
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`of the trial in accordance with 37 C.F.R. § 42.64(b)(1).
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`Date: May 15, 2017
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`Respectfully submitted,
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`By:
`
`
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`/ E. Anthony Figg /
`E. Anthony Figg, Reg. No. 27,195
`Aydin H. Harston, Reg. No. 65,249
`ROTHWELL, FIGG, ERNST & MANBECK, P.C.
`607 14th St., N.W., Suite 800
`Washington, DC 20005
`Phone: 202-783-6040; Fax: 202-783-6031
`Counsel for Petitioners
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`4
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`Case IPR2017-00190
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`CERTIFICATE OF SERVICE
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`The undersigned certifies that a copy of the foregoing PETITIONERS’
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`OBJECTIONS TO EVIDENCE SUBMITTED WITH PATENT OWNER’S
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`PRELIMINARY RESPONSE PURSUANT TO 37 C.F.R. § 42.64(b)(1) were
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`served electronically via email on May 15, 2017, in its entirety on the following:
`
`John D. Livingstone
`john.livingstone@finnegan.com
`KakenIPR@finnegan.com
`Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P.
`271 17th Street, NW, Suite 1400
`Atlanta, GA 30363-6209
`
`Naoki Yoshida
`naoki.yoshida@finnegan.com
`Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P.
`901 New York Ave., NW
`Washington, DC 20001-4413
`
`Toan P. Vo
`toan.vo@bausch.com
`Valeant Pharmaceuticals North America LLC
`1400 N. Goodman Street
`Rochester, New York 14609
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`/E. Anthony Figg/
`By:
`E. Anthony Figg, Reg. No. 27,195
`Aydin H. Harston, Reg. No. 65,249
`ROTHWELL, FIGG, ERNST & MANBECK, P.C.
`607 14th St., N.W., Suite 800
`Washington, DC 20005
`Phone: 202-783-6040; Fax: 202-783-6031
`
`
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`Counsel for Petitioners
`5
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