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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`__________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`
`SANDOZ INC.,
`Petitioner,
`
`v.
`
`PHARMACYCLICS LLC,
`Patent Owner.
`
`__________________
`
`Case IPR2019-00865
`U.S. Patent No. 9,795,604
`__________________
`
`PATENT OWNER’S OBJECTIONS TO PETITIONER’S EVIDENCE
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`
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`The Federal Rules of Evidence (“FRE”) generally apply to proceedings before
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`Case IPR2019-00865
`U.S. Patent No. 9,795,604
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`
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`the Board. 37 C.F.R. § 42.62(a). Pursuant to 37 C.F.R. § 42.64(b)(1) and the FRE,
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`Patent Owner Pharmacyclics LLC submits the following objections to certain
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`exhibits submitted by Petitioner Sandoz Inc. These objections apply equally to
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`Petitioner’s reliance on these exhibits in any subsequently filed documents. These
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`objections are timely filed and served within ten business days of the Board’s
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`decision to institute trial in these proceedings.
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`Exhibit 1002
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`Patent Owner objects to Exhibit 1002 under FRE 401–403 as lacking
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`relevance to the instituted grounds. Exhibit 1002 discloses and claims only
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`formulations of ibrutinib, not methods of treatment with no in vitro, preclinical, or
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`clinical data relevant to treating cGVHD or any other disease. Exhibit 1002 thus
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`does not make any fact more or less probable and is unfairly prejudicial, confuses
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`the issues, misleads the factfinder, and/or is a waste of time.
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`Exhibit 1003
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`To the extent Petitioner relies on the content of Exhibit 1003 for the truth of
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`the matter asserted, Patent Owner objects to Exhibit 1003 as inadmissible hearsay
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`(see FRE 801 and 802) that does not fall under any exceptions, including FRE 803,
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`804, 805, and 807.
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`Case IPR2019-00865
`U.S. Patent No. 9,795,604
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`Exhibit 1004
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`To the extent Petitioner relies on the content of Exhibit 1004 for the truth of
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`the matter asserted, Patent Owner objects to Exhibit 1004 as inadmissible hearsay
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`(see FRE 801 and 802) that does not fall under any exceptions, including FRE 803,
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`804, 805, and 807.
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`Exhibit 1005
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`To the extent Petitioner relies on the content of Exhibit 1005 for the truth of
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`the matter asserted, Patent Owner objects to Exhibit 1005 as inadmissible hearsay
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`(see FRE 801 and 802) that does not fall under any exceptions, including FRE 803,
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`804, 805, and 807.
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`Exhibit 1006
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`Patent Owner objects to Exhibit 1006, Declaration of James L. Ferrara, M.D.
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`Patent Owner objects to Exhibit 1006 as not being based on sufficient facts or data,
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`the product of reliable principles and methods, and/or a reliable application of the
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`principles and methods to the facts (FRE 702, 703), and/or lacking a disclosed basis
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`of sufficient facts or data (FRE 705). Patent Owner objects to ¶¶ 55–59 and all
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`paragraphs that rely on those paragraphs under FRE 401–403 as lacking relevance
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`to the instituted grounds. Patent Owner further objects to ¶¶ 75, 84, 86, 88, 89, 92,
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`94, 101, 107–109, 111–113, 115, 118, 123, 131, 132, 134, 135, 137, 139, 140, 144,
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`149, and all paragraphs that rely on those paragraphs as misleading and/or confusing
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`Case IPR2019-00865
`U.S. Patent No. 9,795,604
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`(FRE 403). To the extent Petitioner relies on the content of those paragraphs of
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`Exhibit 1006 for the truth of the matter asserted, Patent Owner objects to such
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`content as inadmissible hearsay (see FRE 801 and 802) that does not fall under any
`
`exception, including FRE 803, 804, 805, and 807.
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`Exhibit 1007
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`To the extent Petitioner relies on the content of Exhibit 1007 for the truth of
`
`the matter asserted, Patent Owner objects to Exhibit 1007 as inadmissible hearsay
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`(see FRE 801 and 802) that does not fall under any exceptions, including FRE 803,
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`804, 805, and 807. Patent Owner further objects to Exhibit 1007 because it lacks
`
`proper foundation and/or authenticity under FRE 901.
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`Exhibit 1009
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`Patent Owner objects to Exhibit 1009 as an incomplete document (FRE
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`106).
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`Exhibit 1010
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`To the extent Petitioner relies on the content of Exhibit 1010 for the truth of
`
`the matter asserted, Patent Owner objects to Exhibit 1010 as inadmissible hearsay
`
`(see FRE 801 and 802) that does not fall under any exceptions, including FRE 803,
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`804, 805, and 807. Patent Owner further objects to Exhibit 1010 because it lacks
`
`proper foundation and/or authenticity under FRE 901.
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`U.S. Patent No. 9,795,604
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`Exhibit 1012
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`To the extent Petitioner relies on the content of Exhibit 1012 for the truth of
`
`the matter asserted, Patent Owner objects to Exhibit 1012 as inadmissible hearsay
`
`(see FRE 801 and 802) that does not fall under any exceptions, including FRE 803,
`
`804, 805, and 807. Patent Owner further objects to Exhibit 1012 because it lacks
`
`proper foundation and/or authenticity under FRE 901.
`
`Exhibit 1013
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`Patent Owner objects to Exhibit 1013 as not relevant, confusing, unfairly
`
`prejudicial, and wasting time because it is not relevant to any issue in these IPR
`
`proceedings (FRE 401–403).
`
`Exhibit 1014
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`Patent Owner objects to Exhibit 1014 as an incomplete document (FRE
`
`106).
`
`Exhibit 1015
`
`To the extent Petitioner relies on the content of Exhibit 1015 for the truth of
`
`the matter asserted, Patent Owner objects to Exhibit 1015 as inadmissible hearsay
`
`(see FRE 801 and 802) that does not fall under any exceptions, including FRE 803,
`
`804, 805, and 807. Patent Owner further objects to Exhibit 1015 because it lacks
`
`proper foundation and/or authenticity under FRE 901.
`
`
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`4
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`Exhibit 1016
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`To the extent Petitioner relies on the content of Exhibit 1016 for the truth of
`
`the matter asserted, Patent Owner objects to Exhibit 1016 as inadmissible hearsay
`
`(see FRE 801 and 802) that does not fall under any exceptions, including FRE 803,
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`804, 805, and 807. Patent Owner further objects to Exhibit 1016 because it lacks
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`proper foundation and/or authenticity under FRE 901.
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`Exhibit 1017
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`To the extent Petitioner relies upon Exhibit 1017 to show the state of the art,
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`Patent Owner objects to Exhibit 1017 as not relevant, confusing, unfairly prejudicial,
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`and wasting time because Exhibit 1017 has not been shown to qualify as prior art
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`(FRE 401–403). To the extent Petitioner relies on the content of Exhibit 1017 for
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`the truth of the matter asserted, Patent Owner objects to Exhibit 1017 as inadmissible
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`hearsay (see FRE 801 and 802) that does not fall under any exceptions, including
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`FRE 803, 804, 805, and 807. Patent Owner further objects to Exhibit 1017 because
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`it lacks proper foundation and/or authenticity under FRE 901.
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`Exhibit 1018
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`Patent Owner objects to Exhibit 1018 as not relevant, confusing, unfairly
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`prejudicial, and wasting time because it is not relevant to any issue in these IPR
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`proceedings (FRE 401–403).
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`U.S. Patent No. 9,795,604
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`Exhibit 1019
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`Patent Owner objects to Exhibit 1019 as not relevant, confusing, unfairly
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`prejudicial, and wasting time because it is not relevant to any issue in these IPR
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`proceedings (FRE 401–403).
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`Exhibit 1020
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`Patent Owner objects to Exhibit 1020 as not relevant, confusing, unfairly
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`prejudicial, and wasting time because it is not relevant to any issue in these IPR
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`proceedings (FRE 401–403). To the extent Petitioner relies on the content of Exhibit
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`1020 for the truth of the matter asserted, Patent Owner objects to Exhibit 1020 as
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`inadmissible hearsay (see FRE 801 and 802) that does not fall under any exceptions,
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`including FRE 803, 804, 805, and 807. Patent Owner further objects to Exhibit 1020
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`because it lacks proper foundation and/or authenticity under FRE 901. Patent Owner
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`also objects to Exhibit 1020 under the Best Evidence Rule (FRE 1001–1003).
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`Exhibit 1021
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`Patent Owner objects to Exhibit 1021 as an incomplete document (FRE
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`106).
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`Exhibit 1022
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`Patent Owner objects to Exhibit 1022 as not relevant, confusing, unfairly
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`prejudicial, and wasting time because it was not cited in the Petition (FRE 401–403).
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`To the extent Petitioner relies on the content of Exhibit 1022 for the truth of the
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`Case IPR2019-00865
`U.S. Patent No. 9,795,604
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`matter asserted, Patent Owner objects to Exhibit 1022 as inadmissible hearsay (see
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`FRE 801 and 802) that does not fall under any exceptions, including FRE 803, 804,
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`805, and 807. Patent Owner further objects to Exhibit 1022 because it lacks proper
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`foundation and/or authenticity under FRE 901.
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`
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`Respectfully submitted,
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`Date: October 10, 2019
`
`
`By: /William B. Raich/
`William B. Raich (Reg. No. 54,386)
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`7
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`Case IPR2019-00865
`U.S. Patent No. 9,795,604
`CERTIFICATE OF SERVICE
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`The undersigned certifies that a copy of the foregoing Patent Owner’s
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`Objections To Petitioner’s Evidence was served electronically via email on
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`October 10, 2019, in its entirety on the following:
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`Kirk T. Bradley
`Alston & Bird LLP
`101 South Tryon Street, Suite 4000
`Charlotte, NC 28280
`kirk.bradley@alston.com
`
`Siraj M. Abhyankar
`Alston & Bird LLP
`1201 W. Peachtree Street NE #4900
`Atlanta, GA 30309
`shri.abhyankar@alston.com
`
`Christopher L. McArdle
`Alston & Bird LLP
`90 Park Avenue, Suite 1200
`New York, NY 10016
`chris.mcardle@alston.com
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`Petitioner has consented to service by email.
`
`Date: October 10, 2019
`
`By: /William Esper/
`William Esper
`Litigation Legal Assistant
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, LLP
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