`
`
`Filed on behalf of: Acrux DDS PTY LTD.
`
`
`
`Acrux Limited
`
`
`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
`Emails: efigg@rothwellfigg.com
`
` aharston@rothwellfigg.com
`
`
`
`
`
`
`
`
`
`
`
`
`
`Paper _____
`
`Filed: August 8, 2017
`
`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 RESPONSE
`PURSUANT TO 37 C.F.R. § 42.64(b)(1)
`
`
`
`
`
`
`
`
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Acrux DDS PTY Ltd. and Acrux
`
`Case IPR2017-00190
`
`
`
`
`Limited (collectively, “Petitioners”) hereby object to the admissibility of the
`
`following evidence submitted by Kaken Pharmaceutical Co., Ltd. and Valeant
`
`Pharmaceuticals International, Inc. (collectively, “Patent Owners”) with the Patent
`
`Owners’ Response (Paper No. 27) (“POR”).1
`
`Evidence Submitted by
`Patent Owners
`Exhibits 2001/20032
`(Declaration of Yochiyuki
`Tatsumi, Ph.D.)
`
`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).
`
`
`1 Petitioners have reasserted their Objections to Evidence Submitted with Patent
`
`Owners’ Preliminary Response (“POPR”) to preserve them.
`
`2 Petitioners list both exhibit numbers with respect to objections directed to the
`
`original Japanese language document and the corresponding English translation
`
`offered by Patent Owners.
`
`
`
`2
`
`
`
`
`
`Evidence Submitted by
`Patent Owners
`
`Exhibits 2002/20043
`
`Case IPR2017-00190
`
`Petitioners’ Objection(s)
`
`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.
`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 hearsay (Fed. R. Evid. 802) to the
`extent the document is being used to prove the
`truth of the matters asserted.
`
`Inadmissible as lacking authentication (Fed. R.
`Evid. 901). Patent Owner’s declarant Dr. Tatsumi
`(Exhibit 2001/2003) does not provide sufficient
`
`
`3 Although it appears Patent Owners have provided a “Corrected Research and
`
`Development Report” (Exhibit 2040, with corresponding Japanese language
`
`document at Exhibit 2039) Patent Owners have not specified what was corrected
`
`from the version filed previously as Exhibit 2004. Further, the POR cites to
`
`Exhibit 2004 and Dr. Tatsumi’s Declaration in Support of the POR cites to Exhibit
`
`2039. Compare POR, at 41 to Ex. 2025, at ¶¶ 14-15. To the extent Patent Owners
`
`have filed any exhibit in support of the POR in an attempt to cure the timely
`
`objections asserted in Petitioner’s Objections to Evidence Submitted with the
`
`POPR, filed on May 15, 2017, they are untimely as supplemental evidence was due
`
`by or before May 30, 2017. 37 C.F.R. § 42.64(b)(2).
`
`
`
`3
`
`
`
`
`
`Evidence Submitted by
`Patent Owners
`
`Exhibits 2007, 2008, 2009,
`2010
`
`Exhibit 2011
`
`Exhibits 2012, 2013, 2014,
`2015, 2016, 2017
`
`Case IPR2017-00190
`
`Petitioners’ Objection(s)
`
`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 unsupported expert testimony
`(Fed. R. Evid. 702). See, e.g., POR, at 9-10, 13-16,
`25-30.
`
`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.,
`POR, at 9-10, 13-16, 25-30.
`Inadmissible as unsupported expert testimony
`(Fed. R. Evid. 702). See, e.g., POR, at 15, 25.
`
`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.,
`POR, at 15, 25.
`
`Inadmissible as lacking authentication (Fed. R.
`Evid. 901) as there is no indication of source
`accompanying the document, no witness testimony
`is offered to indicate its source and books are not
`self-authenticating under FRE 902.
`Inadmissible as unsupported expert testimony
`(Fed. R. Evid. 702). See, e.g., POR, at 11-13, 15-
`16, 23.
`
`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.,
`POR, at 11-13, 15-16, 23.
`
`
`
`4
`
`
`
`
`
`Evidence Submitted by
`Patent Owners
`Exhibit 2018
`
`Exhibits 2024/2025
`(Declaration of Yochiyuki
`Tatsumi, Ph.D.)
`
`
`
`Case IPR2017-00190
`
`Petitioners’ Objection(s)
`
`Inadmissible as unsupported expert testimony
`(Fed. R. Evid. 702). See, e.g., POR, at 23-24.
`
`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.,
`POR, at 23-24.
`
`Inadmissible as lacking authentication (Fed. R.
`Evid. 901) as there is no indication of source
`accompanying the document, no witness testimony
`is offered to indicate its source and articles
`retrieved from the internet are not self-
`authenticating under FRE 902.
`Inadmissible as lacking foundation, assuming facts
`not in evidence, conclusory, and containing
`testimony concerning several exhibits for which
`authentication is lacking.
`
`Paragraph 8 is 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).
`
`Paragraphs 9, 10 and 13 are submitted in violation
`of 37 C.F.R. § 1.933. The information set forth in
`these paragraphs, as well as the Patent Owner’s
`exhibits cited therein, should have been submitted
`both during prosecution of the ’506 patent and
`earlier in this proceeding, e.g., in connection with
`Dr. Tatsumi’s Declaration submitted in support of
`the Patent Owner’s Preliminary Response (Exhibit
`2001/2003).
`
`Paragraph 17 is inadmissible as irrelevant (Fed. R.
`Evid. 402) to the extent it is not directed to the
`5
`
`
`
`
`
`Evidence Submitted by
`Patent Owners
`
`Exhibit 2027
`(Declaration of Boni E.
`Elewski, M.D.)
`
`
`
`Case IPR2017-00190
`
`Petitioners’ Objection(s)
`
`claimed subject matter and/or the prior art cited in
`the grounds on which the review was instituted.
`
`Paragraphs 14 through 16 and 18 through 21 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., POR, at 37, 44.
`
`To the extent a portion or portions of the
`Declaration of Yochiyuki Tatsumi, Ph.D. (or the
`exhibits cited and discussed therein) are being
`offered to cure Petitioners’ timely Objections to
`Evidence Submitted with the POPR, filed on May
`15, 2017, they are inadmissible as untimely. In
`order to address those objections, Patent Owners
`were required to submit supplemental evidence by
`or before May 30, 2017 which they failed to do.
`37 C.F.R. § 42.64(b)(2).
`Inadmissible as lacking foundation, assuming facts
`not in evidence, conclusory, unsupported by
`sufficient facts or data (Fed. R. Evid. 702), and
`containing testimony concerning several exhibits
`for which authentication is lacking.
`
`To the extent a portion or portions of the
`Declaration of Boni E. Elewski, M.D. (or the
`exhibits cited and discussed therein) are being
`offered to cure Petitioners’ timely Objections to
`Evidence Submitted with the POPR, filed on May
`15, 2017, they are inadmissible as untimely. In
`order to address those objections, Patent Owners
`were required to submit supplemental evidence by
`6
`
`
`
`
`
`Evidence Submitted by
`Patent Owners
`
`Exhibit 2028
`(Declaration of Vince
`Thomas)
`
`Exhibits 2030/2031
`
`Exhibits 2033/2034
`
`
`
`Case IPR2017-00190
`
`Petitioners’ Objection(s)
`
`or before May 30, 2017 which they failed to do.
`37 C.F.R. § 42.64(b)(2).
`Inadmissible as lacking foundation, assuming facts
`not in evidence, conclusory, unsupported by
`sufficient facts or data (Fed. R. Evid. 702), and
`containing testimony concerning several exhibits
`for which authentication is lacking.
`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 lacking authentication (Fed. R.
`Evid. 901). Patent Owner’s declarant Dr. Tatsumi
`(Exhibit 2024/2025) does not provide sufficient
`evidence to establish that these exhibits are 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 incomplete (Fed. R. Evid. 106) as
`the exhibit sets forth tables of mean data allegedly
`obtained while not presenting its full underlying
`information (e.g., the experimental protocol used
`to obtain the data, laboratory notebook pages, etc.)
`in fairness to allow Petitioners to test its validity.
`
`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 lacking authentication (Fed. R.
`Evid. 901). Patent Owner’s declarant Dr. Tatsumi
`(Exhibit 2024/2025) does not provide sufficient
`evidence to establish that these exhibits are 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).
`7
`
`
`
`
`
`Evidence Submitted by
`Patent Owners
`Exhibits 2036, 2037, 2038
`
`Exhibits 2039/2040,
`2042/2043, 2045/2046
`
`
`
`Case IPR2017-00190
`
`Petitioners’ Objection(s)
`
`Inadmissible as incomplete (Fed. R. Evid. 106) as
`they set forth tables of mean data allegedly
`obtained while not presenting the full underlying
`information in fairness to allow Petitioners to test
`its validity.
`
`Inadmissible as hearsay (Fed. R. Evid. 802) to the
`extent the documents are being used to prove the
`truth of the matters asserted.
`
`Inadmissible as lacking authentication (Fed. R.
`Evid. 901). Patent Owner’s declarant Dr. Tatsumi
`(Exhibit 2024/2025) states that the exhibits were
`located in his “corporate files” (see Exhibit 2025, ¶
`9), however, that testimony is contradicted by the
`stamp on each exhibit’s cover which appears to
`indicate that it was obtained from the University of
`California Los Angeles Biomedical Library.
`
`Submitted in violation of 37 C.F.R. § 1.933.
`These exhibits and the information relating to
`them set forth in Dr. Tatsumi’s Declaration
`submitted in support of the POR (Exhibit
`2024/2025) should have been submitted both
`during prosecution of the ’506 patent and earlier in
`this proceeding, e.g., in connection with Dr.
`Tatsumi’s Declaration submitted in support of the
`Patent Owner’s Preliminary Response (Exhibit
`2001/2003).
`Inadmissible as incomplete (Fed. R. Evid. 106) as
`these exhibits set forth summaries of data
`allegedly obtained while not presenting its full
`underlying information in fairness to allow
`Petitioners to test its validity.
`
`Inadmissible as hearsay (Fed. R. Evid. 802) to the
`extent the documents are being used to prove the
`truth of the matters asserted.
`8
`
`
`
`
`
`Evidence Submitted by
`Patent Owners
`
`Exhibit 2053
`
`Exhibit 2054
`
`Exhibits 2055, 2056, 2069,
`2070, 2072
`
`
`
`Case IPR2017-00190
`
`Petitioners’ Objection(s)
`
`Inadmissible as lacking authentication (Fed. R.
`Evid. 901). Patent Owner’s declarant Dr. Tatsumi
`(Exhibit 2024/2025) does not provide sufficient
`evidence to establish that these exhibits are 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).
`
`To the extent these exhibits are being offered to
`cure Petitioners’ timely Objections to Evidence
`Submitted with the POPR, filed on May 15, 2017,
`they are inadmissible as untimely. In order to
`address those objections, Patent Owners were
`required to submit supplemental evidence by or
`before May 30, 2017 which they failed to do. 37
`C.F.R. § 42.64(b)(2).
`Inadmissible as incomplete (Fed. R. Evid. 106) as
`the exhibit is missing pages 1 and 2.
`
`Inadmissible as lacking authentication (Fed. R.
`Evid. 901) as there is no indication of source
`accompanying the document and no witness
`testimony is offered to indicate its source.
`Inadmissible as unsupported expert testimony
`(Fed. R. Evid. 702). See, e.g., POR, at 23.
`
`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 lacking authentication (Fed. R.
`Evid. 901) as there is no indication of source
`accompanying the document and no witness
`testimony is offered to indicate its source.
`Inadmissible as lacking authentication (Fed. R.
`Evid. 901) as there is no indication of source
`accompanying the documents, no witness
`9
`
`
`
`
`
`Evidence Submitted by
`Patent Owners
`
`Exhibit 2058
`
`Exhibit 2059
`
`Exhibit 2060
`
`Exhibit 2063
`
`
`
`Case IPR2017-00190
`
`Petitioners’ Objection(s)
`
`testimony is offered to indicate their source and
`journals are not self-authenticating under FRE
`902.
`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 lacking authentication (Fed. R.
`Evid. 901) as there is no indication of source
`accompanying the document, no witness testimony
`is offered to indicate its source and journals are not
`self-authenticating under FRE 902.
`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 lacking authentication (Fed. R.
`Evid. 901) as there is no indication of source
`accompanying the document, no witness testimony
`is offered to indicate its source and articles
`retrieved from the internet are not self-
`authenticating under FRE 902.
`Inadmissible as irrelevant (Fed. R. Evid. 402) as
`the exhibit is not cited or referenced in either the
`POR or any supporting declaration. The citation
`to Exhibit 2060 in the Declaration of Vince
`Thomas (Exhibit 2028) is to a different document
`(an internet article which appears to differ in
`content from the Exhibit 2060 submitted by Patent
`Owners). See Exhibit 2028, ¶ 16.
`Inadmissible as incomplete (Fed. R. Evid. 106) as
`the exhibit appears to be missing multiple pages.
`
`Inadmissible as lacking authentication (Fed. R.
`Evid. 901) as there is no indication of source
`accompanying the document, no witness testimony
`is offered to indicate its source and articles
`retrieved from the internet are not self-
`10
`
`
`
`
`
`Evidence Submitted by
`Patent Owners
`
`Exhibits 2071, 2079, 2080,
`2081, 2085, 2090, 2091
`
`Exhibit 2086
`
`Exhibit 2087
`
`Exhibit 2088
`
`
`
`Case IPR2017-00190
`
`Petitioners’ Objection(s)
`
`authenticating under FRE 902.
`Inadmissible as lacking authentication (Fed. R.
`Evid. 901) as there is no indication of source
`accompanying the documents, no witness
`testimony is offered to indicate their source and
`articles retrieved from the internet are not self-
`authenticating under FRE 902.
`Inadmissible as incomplete (Fed. R. Evid. 106) as
`the exhibit is an abstract of a 36 page article and
`Petitioners should be provided with the full article
`for context.
`
`Inadmissible as lacking authentication (Fed. R.
`Evid. 901) as there is no indication of source
`accompanying the document, no witness testimony
`is offered to indicate its source and articles
`retrieved from the internet are not self-
`authenticating under FRE 902.
`Inadmissible as irrelevant (Fed. R. Evid. 402) as
`the exhibit is not cited or referenced in either the
`POR or any supporting declaration.
`
`Inadmissible as lacking authentication (Fed. R.
`Evid. 901) as there is no indication of source
`accompanying the document, no witness testimony
`is offered to indicate its source and articles
`retrieved from the internet are not self-
`authenticating under FRE 902.
`Inadmissible as incomplete (Fed. R. Evid. 106) as
`the text at the bottom of page 1 is cut off by an
`advertisement, it appears that the full website
`content has not been provided, and Petitioners
`should be provided with the full website for
`context.
`
`Inadmissible as lacking authentication (Fed. R.
`Evid. 901) as there is no indication of source
`accompanying the document, no witness testimony
`11
`
`
`
`
`
`Evidence Submitted by
`Patent Owners
`
`Exhibits 2093, 2094, 2095
`
`Exhibit 2097 (and Appendix
`A and B thereto)
`
`Exhibits 2098, 2099
`
`
`
`Case IPR2017-00190
`
`Petitioners’ Objection(s)
`
`is offered to indicate its source and articles
`retrieved from the internet are not self-
`authenticating under FRE 902.
`Inadmissible as incomplete (Fed. R. Evid. 106) as
`the exhibits provide partial information, since,
`inter alia, the referenced spreadsheets and/or
`alleged source data are either not identified or not
`provided and there is no information provided as
`to how the data used to prepare the exhibit was
`collected. This information is necessary such that,
`in fairness, Petitioners may test the sufficiency of
`the summary information provided.
`
`Inadmissible as irrelevant (Fed. R. Evid. 402) as
`the exhibits are not cited or referenced in either the
`POR or any supporting declaration.
`
`Inadmissible as hearsay (Fed. R. Evid. 802) to the
`extent the documents are being used to prove the
`truth of the matters asserted.
`
`Inadmissible as lacking authentication (Fed. R.
`Evid. 901) as there is no indication of source
`accompanying much of the information provided
`in the exhibits and no witness testimony is offered
`to explain the source(s) of the information.
`Inadmissible as untimely. The Declaration of
`Ashley Winkler and the accompanying appendices
`appear to be offered to cure Petitioners’ timely
`Objections to Evidence Submitted with the POPR,
`filed on May 15, 2017. In order to address those
`objections, Patent Owners were required to submit
`supplemental evidence by or before May 30, 2017
`which they failed to do. 37 C.F.R. § 42.64(b)(2).
`Inadmissible as incomplete (Fed. R. Evid. 106) as
`the exhibits provide partial information, since,
`inter alia, the referenced spreadsheets and/or
`alleged source data are either not identified or not
`12
`
`
`
`Evidence Submitted by
`Patent Owners
`
`Case IPR2017-00190
`
`Petitioners’ Objection(s)
`
`provided and there is no information provided as
`to how the data used to prepare the exhibit was
`collected. This information is necessary such that,
`in fairness, Petitioners may test the sufficiency of
`the summary information provided.
`
`Inadmissible as hearsay (Fed. R. Evid. 802) to the
`extent the documents are being used to prove the
`truth of the matters asserted.
`
`Inadmissible as lacking authentication (Fed. R.
`Evid. 901) as there is no indication of source
`accompanying much of the information provided
`in the exhibits and no witness testimony is offered
`to explain the source(s) of the information.
`
`
`The foregoing objections are made within 5 business days of service of the
`
`
`
`
`
`
`
`
`POR in accordance with 37 C.F.R. § 42.64(b)(1).
`
`
`
`
`
`
`
`
`
`Date: August 8, 2017
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`By:
`
`
`
`
`
`/s/ 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
`
`
`
`
`
`
`
`
`
`13
`
`
`
`Case IPR2017-00190
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the foregoing PETITIONERS’
`
`
`
`
`
`OBJECTIONS TO EVIDENCE SUBMITTED WITH PATENT OWNER’S
`
`RESPONSE PURSUANT TO 37 C.F.R. § 42.64(b)(1) were served electronically
`
`via email on August 8, 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
`Anthony Hartman
`anthony.hartmann@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
`
`
`
`/s/ 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
`Counsel for Petitioners
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
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`
`
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`14
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`
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