`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`APOTEX, INC.
`Petitioner,
`
`v.
`
`UCB BIOPHARMA SPRL,
`Patent Owner.
`
`U.S. Patent No. 8,333,194 to Fanara et al.
`Issue Date: January 21, 2014
`Title: Pharmaceutical Composition of Piperazine Derivatives
`
`Inter Partes Review No.: IPR2019-00400
`
`PETITIONER’S OBJECTIONS TO EVIDENCE
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`IPR2019-00400
`U.S. Patent No. 8,333,194
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Apotex, Inc. (“Apotex” or “Petitioner”)
`
`timely objects under the Federal Rules of Evidence (“FRE”) to the admissibility of
`
`Exhibits 2024, 2030, and 2031. In addition, Petitioner objects to the admissibility
`
`of paragraphs 6, 71-73, 191-193, and 196-197 of the Declaration of Dr. Sarfaraz K.
`
`Niazi, i.e., Exhibit 2034, under FRE 401 and 403. Collectively, these exhibits
`
`(“Challenged Evidence”) were served by UCB Biopharma Sprl (“UCB” or “Patent
`
`Owner”) with its Patent Owner Complete Response filed on October 15, 2019.
`
`Petitioner’s objections are timely under 37 C.F.R. § 42.64(b)(1) because
`
`they are being filed and served within five business days. Petitioner files these
`
`objections to provide notice to Patent Owner that Petitioner may move to exclude
`
`the Challenged Evidence under 37 C.F.R. § 42.64(c), unless timely cured by Patent
`
`Owner.
`
`IDENTIFICATION OF CHALLENGED EVIDENCE AND GROUNDS FOR
`
`OBJECTIONS
`
`A. Multiple Exhibits Are Inadmissible as Being Irrelevant, and/or
`Containing Hearsay, and Are Therefore More Prejudicial Than
`Probative as to Any Fact of Consequence.
`
`1. Exhibit 2024:
`
`Exhibit 2024 is inadmissible under FRE 401 and 403. Exhibit 2024 purports
`
`to be a Pharmaceutical Manufacturing Handbook dated “2008.” Exhibit 2024 is not
`
`relevant to any issue in the IPR proceeding because the purported date of the
`
`2
`
`
`
`IPR2019-00400
`U.S. Patent No. 8,333,194
`
`document is after the filing date of the ’194 patent. Therefore, Exhibit 2024 is
`
`inadmissible as being irrelevant.
`
`2. Exhibit 2030:
`
`Exhibit 2030 is inadmissible under FRE 401 and 403. Exhibit 2030 purports
`
`to be an article by El-Nakeeb et al. dated “March 14, 2011.” Exhibit 2030 is not
`
`relevant to any issue in the IPR proceeding because the purported date of the
`
`document is after the filing date of the ’194 patent. Therefore, Exhibit 2030 is
`
`inadmissible as being irrelevant.
`
`Exhibit 2030 is also inadmissible under FRE 801 and 802. Patent Owner
`
`relies on the March “2011” date in Exhibit 2030, as well as its description on the
`
`correlation between antihistaminic and antibacterial properties, for the truth of the
`
`matter asserted. Patent Owner cannot rely on the “2011” date shown in
`
`Exhibit 2030 or its description on the correlation between antihistaminic and
`
`antibacterial properties because there is no evidence that the reference was a
`
`printed publication as of a particular date. No hearsay exception applies.
`
`3. Exhibit 2031
`
`Exhibit 2031 is inadmissible under FRE 401 and 403. Exhibit 2031 purports
`
`to be an article by Nemes dated “23 July 2018.” Exhibit 2031 is not relevant to any
`
`issue in the IPR proceeding because the purported date of the document is after the
`
`3
`
`
`
`IPR2019-00400
`U.S. Patent No. 8,333,194
`
`filing date of the ’194 patent. Therefore, Exhibit 2031 is inadmissible as being
`
`irrelevant.
`
`Patent Owner relies on the “23 July 2018” date in Exhibit 2031, as well as its
`
`description on “the [high] risk of contamination,” for the truth of the matter
`
`asserted. Patent Owner cannot rely on the “23 July 2018” date shown in
`
`Exhibit 2031 because there is no evidence that the reference was a printed
`
`publication as of a particular date. No hearsay exception applies.
`
`C. Any Paragraphs in Declaration of Dr. Sarfaraz K. Niazi (i.e.,
`Exhibit 2034) That Rely on the Exhibits Identified above Should Be
`Excluded.
`
`Any paragraph of the Declaration of Dr. Sarfaraz K. Niazi (i.e., paragraphs
`
`56, 71-73, 191-193, and 196-197 of Exhibit 2034) that relies on any of the exhibits
`
`identified above is objected to for the same reason as Petitioner’s objection to the
`
`underlying exhibit.
`
`4
`
`
`
`DATE: 10/21/19
`
`IPR2019-00400
`U.S. Patent No. 8,333,194
`
`Respectfully submitted,
`
`Katten Muchin Rosenman LLP
`
`By: /Jitendra Malik/
`Jitendra Malik, Ph.D.
`Reg. No. 55,823
`
`5
`
`
`
`CERTIFICATION OF SERVICE ON PATENT OWNER
`Pursuant to 37 C.F.R. §§ 42.6(e), 42.8(b)(4), and 42.105, the undersigned
`
`certifies that on October 21, 2019, a complete copy of the foregoing Objections to
`
`Evidence, was served via email to Patent Owner’s counsel at:
`
`James Trainor: jtrainor@fenwick.com
`
`Robert Counihan: rcounihan@fenwick.com
`
`Erica Sutter: esutter@fenwick.com
`
`Respectfully submitted,
`
`Katten Muchin Rosenman LLP
`
`By: /Jitendra Malik/
`Jitendra Malik, Ph.D.
`Reg. No. 55,823
`
`
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