IPR2019-00400
`Patent 8,633,194
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
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`APOTEX INC.
`Petitioner,
`
`v.
`
`UCB BIOPHARMA SPRL,
`Patent Owner.
`______________
`
`Case IPR2019-00400
`Patent 8,633,194
`______________
`
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`PATENT OWNER’S NOTICE OF OBJECTIONS UNDER 37 C.F.R. § 42.64
`TO EVIDENCE SUBMITTED IN SUPPORT OF PETITIONER’S REPLY
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`Patent 8,633,194
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`APOTEX INC.
`Petitioner,
`
`v.
`
`UCB BIOPHARMA SPRL,
`Patent Owner.
`______________
`
`Case IPR2019-00400
`Patent 8,633,194
`______________
`
`
`PATENT OWNER’S NOTICE OF OBJECTIONS UNDER 37 C.F.R. § 42.64
`TO EVIDENCE SUBMITTED IN SUPPORT OF PETITIONER’S REPLY
`
`
`
`
`
`
`IPR2019-00400
`Patent 8,633,194
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`Pursuant to 37 C.F.R. § 42.64, Patent Owner UCB Biopharma Sprl (“Patent
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`Owner”) objects to the admissibility of the documents identified below that were
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`submitted by Petitioner Apotex Inc. (“Petitioner”) in support of Petitioner’s Reply
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`to Patent Owner’s Complete Response (Paper 33), dated and served on January 16,
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`2020. Patent Owner’s objections are based on the Federal Rules of Evidence
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`(“FRE”), relevant case law, and the Rules of the Patent Trial and Appeal Board
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`(“PTAB”). Patent Owner’s objections are stated with particularity below.
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`A. Exhibit 1031
`Patent Owner objects to the admissibility of Exhibit 1031, described as the
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`Compilation from Niazi, Handbook of Pharmaceutical Manufacturing Formulations,
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`1st Ed., Vols. 1-6, for at least the following reasons:
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`Patent Owner objects to Petitioner’s Exhibit 1031 under FRE 801-802, and no
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`exception applies.
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`B.
`Exhibit 1032
`Patent Owner objects to the admissibility of Exhibit 1032, described as Niazi,
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`Handbook of Pharmaceutical Manufacturing Formulations, Compressed Solid
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`Products, Volume 1, for at least the following reasons:
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`Patent Owner objects to Petitioner’s Exhibit 1032 under FRE 801-802, and no
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`exception applies. Patent Owner objects to Exhibit 1032 under FRE 1002 for being
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`incomplete.
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`1
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`C. Exhibit 1033
`Patent Owner objects to the admissibility of Exhibit 1033, described as Niazi,
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`IPR2019-00400
`Patent 8,633,194
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`Handbook of Pharmaceutical Manufacturing Formulations, Compressed Solid
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`Products, Volume 2, for at least the following reasons:
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`Patent Owner objects to Petitioner’s Exhibit 1033 under FRE 801-802, and no
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`exception applies. Patent Owner objects to Exhibit 1033 under FRE 1002 for being
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`incomplete.
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`D. Exhibit 1034
`Patent Owner objects to the admissibility of Exhibit 1034, described as Niazi,
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`Handbook of Pharmaceutical Manufacturing Formulations, Liquid Products,
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`Volume 3 for at least the following reasons:
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`Patent Owner objects to Petitioner’s Exhibit 1034 under FRE 801-802, and no
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`exception applies. Patent Owner objects to Exhibit 1034 under FRE 1002 for being
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`incomplete.
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`E.
`Exhibit 1035
`Patent Owner objects to the admissibility of Exhibit 1035, described as Niazi,
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`Handbook of Pharmaceutical Manufacturing Formulations, Semisolid Products,
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`Volume 4, for at least the following reasons:
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`Patent Owner objects to Petitioner’s Exhibit 1035 under FRE 801-802, and no
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`exception applies. Patent Owner objects to Exhibit 1035 under FRE 1002 for being
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`2
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`incomplete.
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`IPR2019-00400
`Patent 8,633,194
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`F.
`Exhibit 1036
`Patent Owner objects to the admissibility of Exhibit 1036, described as Niazi,
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`Handbook of Pharmaceutical Manufacturing Formulations, Over-the-Counter
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`Products, Volume 5 for at least the following reasons:
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`Patent Owner objects to Petitioner’s Exhibit 1036 under FRE 801-802, and no
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`exception applies. Patent Owner objects to Exhibit 1036 under FRE 1002 for being
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`incomplete.
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`G. Exhibit 1037
`Patent Owner objects to the admissibility of Exhibit 1037, described as Niazi,
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`Handbook of Pharmaceutical Manufacturing Formulations, Sterile Products,
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`Volume 6, for at least the following reasons:
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`Patent Owner objects to Petitioner’s Exhibit 1037 under FRE 801-802, and no
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`exception applies. Patent Owner objects to Exhibit 1037 under FRE 1002 for being
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`incomplete.
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`H. Exhibit 1038
`Patent Owner objects to the admissibility of Exhibit 1038, described as
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`Copyright Materials for Naizi [sic] Series, for at least the following reasons:
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`Patent Owner objects to Exhibit 1038 under FRE 401-403 as lacking
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`relevance and causing prejudice at least because Exhibit 1038 is presented solely for
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`3
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`IPR2019-00400
`Patent 8,633,194
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`the purposes of establishing the copyright date of Exhibits 1032-37, which are
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`inadmissible as described herein.
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`I.
`Exhibit 1040
`Patent Owner objects to the admissibility of Exhibit 1040, described as
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`Amazon: Handbook of Pharmaceutical Manufacturing Formulations, Third Edition,
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`for at least the following reasons:
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`Patent Owner objects to Petitioner’s Exhibit 1040 under FRE 801-802, and no
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`exception applies. Patent Owner objects to Exhibit 1038 under FRE 401-403 as
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`lacking relevance and causing prejudice at least because Exhibit 1038 is presented
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`solely for the purposes of establishing certain information pertaining to Exhibits
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`1032-37 and Exhibit 1041, which are inadmissible as described herein.
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`J.
`Exhibit 1041
`Patent Owner objects to the admissibility of Exhibit 1041, described as Niazi,
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`Handbook of Pharmaceutical Manufacturing Formulations, Liquid Products,
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`Volume 3, Second Edition, for at least the following reasons:
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`Patent Owner objects to Petitioner’s Exhibit 1041 under FRE 801-802, and no
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`exception applies.
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`K. Exhibit 1044
`Patent Owner objects to the admissibility of Exhibit 1044, described as
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`Official Copyright Certificates of Naizi [sic] Series, for at least the following
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`4
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`reasons:
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`IPR2019-00400
`Patent 8,633,194
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`Patent Owner objects to Exhibit 1044 under FRE 401-403 as lacking
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`relevance and causing prejudice at least because Exhibit 1044 is presented solely for
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`the purposes of establishing the copyright date of Exhibits 1032-37, which are
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`inadmissible for the reasons described herein.
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`L.
`Exhibit 1046
`Patent Owner objects to the admissibility of Exhibit 1046, described as Final
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`Written Decision (IPR2017-00163) incorrectly designated as Exhibit 1025 during
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`the deposition of Dr. Laskar, for at least the following reasons:
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`Patent Owner objects to Exhibit 1046 under FRE 401-402 as lacking
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`relevance at least because (a) Exhibit 1046 is a Final Written Decision in an Inter
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`Partes Review proceeding before this Board and neither parties’ experts are qualified
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`to opine on Exhibit 1046 and (b) neither Petitioner nor Dr. Laskar appear to reference
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`Exhibit 1046 in their Reply or declaration.
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`M. Exhibit 1047
`Patent Owner objects to the admissibility of Exhibit 1047, described as Rowe
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`et al., “Handbook of Pharmaceutical Excipients,” 6th ed. 2009 incorrectly
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`designated as Exhibit 1026 during the deposition of Dr. Niazi, for at least the
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`following reasons:
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`Patent Owner objects to Exhibit 1047 under FRE 1002 for being incomplete.
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`IPR2019-00400
`Patent 8,633,194
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`There is no admissible evidence establishing that Petitioner’s Exhibit 1047 was
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`published prior to July 14, 2004, and therefore, the document does not constitute
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`prior art. Petitioner has failed to establish that Exhibit 1047 qualifies as a publication
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`dated prior to July 14, 2004. Accordingly, Patent Owner objects to Exhibit 1047
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`under FRE 401-403 as lacking relevance.
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`Dated: January 24, 2020
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`Respectfully submitted,
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`FENWICK & WEST LLP
`/s/ Robert E. Counihan (electronically
`signed)
`James S. Trainor, Reg. No. 52,297
`Lead Counsel
`
`Robert E. Counihan, Reg. No. 61,382
`Back-Up Counsel
`
`FENWICK & WEST LLP
`902 Broadway, Suite 14
`New York, NY 10010
`(212) 430-2600
`jtrainor@fenwick.com
`rcounihan@fenwick.com
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`Erica R. Sutter, Reg. No. 77,450
`Back-Up Counsel
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`FENWICK & WEST LLP
`801 California Street
`Mountain View, CA 94041
`(650) 988-8500
`esutter@fenwick.com
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`IPR2019-00400
`Patent 8,633,194
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`Counsel for Patent Owner UCB Biopharma
`Sprl
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`7
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`CERTIFICATE OF SERVICE
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`IPR2019-00400
`Patent 8,633,194
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`Pursuant to 37 C.F.R. § 42.6(e), I hereby certify that on January 24, 2020, the
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`foregoing document is being served by filing this document through the Patent Trial
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`and Appeal Board End to End System, as well as by delivering a copy via electronic
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`mail upon the following counsel of record for the Petitioner:
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`jitty.malik@kattenlaw.com
`alissa.pacchioli@kattenlaw.com
`joe.janusz@kattenlaw.com
`lance.soderstrom@kattenlaw.com
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`Date: January 24, 2020
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`Respectfully submitted,
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`/s/ Robert E. Counihan (electronically
`signed)
`Robert E. Counihan
`Reg. No. 61,382
`Phone: (212) 430-2600
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