IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`
`ELI LILLY AND COMPANY
`Petitioner,
`
`v.
`
`TEVA PHARMACEUTICALS INTERNATIONAL GMBH
`Patent Owner.
`
`___________________
`
`Case IPR2018-01425
`U.S. Patent No. 9,890,210
`___________________
`
`TEVA PHARMACEUTICALS INTERNATIONAL GMBH'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
`
`
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`
`ELI LILLY AND COMPANY
`Petitioner,
`
`v.
`
`TEVA PHARMACEUTICALS INTERNATIONAL GMBH
`Patent Owner.
`
`___________________
`
`Case IPR2018-01425
`U.S. Patent No. 9,890,210
`___________________
`
`TEVA PHARMACEUTICALS INTERNATIONAL GMBH'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
`
`
`
`Case IPR2018-01425
`Patent No. 9,890,210
`Patent Owner, Teva Pharmaceuticals International GmbH ("Teva"), objects
`
`under the Federal Rules of Evidence (FRE) and 37 C.F.R. § 42.64(b)(1) to the
`
`admissibility of Exhibits 1010, 1011, 1031-1035, 1038-1052, 1055-1057, 1061,
`
`1062, 1064-1077, 1089, 1090, 1095, 1101, 1103-1106, 1136, and 1186-1191 (the
`
`"Challenged Evidence"), filed by Petitioner Eli Lilly and Company ("Lilly") on
`
`August 8, 2018, with Lilly's Petition for Inter Partes Review. Teva's Objections
`
`are filed within ten business days of the date of issuance of the Institution of Inter
`
`Partes Review; therefore, Teva's Objections to Evidence are timely under 37
`
`C.F.R. § 42.64(b)(1). Teva files these Objections to provide notice to Lilly that
`
`Teva may move to exclude the Challenged Evidence under 37 C.F.R. § 42.64(c),
`
`unless cured by Lilly.
`
`I.
`
`IDENTIFICATION OF GROUNDS FOR OBJECTIONS
`A. Exhibit 1010
`Exhibit 1010 purports to be the “Declaration of Dr. Andrew C. Charles,
`
`M.D.” Teva objects to paragraphs 26-27, 34, 60-67, 89, 150, and 168-169 in
`
`Exhibit 1010 under FRE 402 and FRE 403. Lilly does not cite any of these
`
`paragraphs in its Petition, rendering Dr. Charles’ testimony in these paragraphs
`
`irrelevant under FRE 401. Teva therefore objects to these paragraphs under FRE
`
`402. Teva also objects to these paragraphs under FRE 403 because they have no
`
`probative value, create unfair prejudice to Teva, and will only confuse the issues
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`Case IPR2018-01425
`Patent No. 9,890,210
`and waste the Board’s time.
`
`Teva also objects to paragraphs 18-24, 26-28, 34-41, 43-47, 49-51, 62-63,
`
`70, 90, 104, 113-114, 117, 120-121, 130, 134, 136-138, 142, 152-153, and 156-157
`
`of EX1010 because these paragraphs rely on evidence that is inadmissible under
`
`FRE 402, 403, 901, 1001(e), and/or 1003. See infra.
`
`Exhibit 1011
`
`B.
`Exhibit 1011 purports to be the “Declaration of Dr. Alain P. Vasserot,
`
`Ph.D.” Teva objects to paragraphs 62-63 and 125-126 in Exhibit 1011 under FRE
`
`402 and FRE 403. Lilly does not cite any of these paragraphs in its Petition,
`
`rendering Dr. Vasserot’s testimony in these paragraphs irrelevant under FRE 401.
`
`Teva therefore objects to these paragraphs under FRE 402. Teva also objects to
`
`these paragraphs under FRE 403 because they have no probative value, create
`
`unfair prejudice to Teva, and will only confuse the issues and waste the Board’s
`
`time.
`
`Teva also objects to paragraphs 21-23, 26-28, 30-47, 54-58, 60, 77, 85-86,
`
`88, 90, 93-94, 99-103, 106, 110-112, 115-116, 121 of EX1011 because these
`
`paragraphs rely on evidence that is inadmissible under FRE 402, 403, 901,
`
`1001(e), and/or 1003. See infra.
`
`C. Exhibits 1031-1035, 1038-1050, 1052, 1055-1057, 1061, 1062, 1064-
`1077, 1089, 1090, 1095, 1101, and 1103-1106
`
`Teva objects to Exhibits 1031-1035, 1038-1050, 1052, 1055-1057, 1061,
`
`- 2 -
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`Case IPR2018-01425
`Patent No. 9,890,210
`1062, 1064-1077, 1089, 1090, 1095, 1101, and 1103-1106 as lacking
`
`authentication under FRE 901. In particular, Teva objects to Exhibits 1031-1034,
`
`1038-1050, 1052, 1055-1057, 1061, 1062, 1064-1077, 1089, 1090, 1095, 1101,
`
`and 1103-1106 under FRE 901 because Lilly fails to provide sufficient evidence
`
`indicating the origin or publication of these documents, and accordingly fails to
`
`provide sufficient information regarding their authenticity. Teva further objects to
`
`Exhibits 1033, 1035, 1043, 1047, 1050, 1055, and 1074 under FRE 901 because
`
`these Exhibits are stamped with a label or other markings not consistent with being
`
`the claimed document. Teva further objects to Exhibits 1034, 1040, 1041, 1045,
`
`1046, 1065, 1067, 1074, and 1089 because these Exhibits purport to be published
`
`at one date, yet have markings indicating that they were recently downloaded at a
`
`later date. Collectively, these Exhibits are inadmissible under FRE 901 because
`
`Lilly has failed to provide sufficient evidence indicating the origin of the
`
`documents and has not provided sufficient information regarding their authenticity.
`
`Further, these Exhibits are not self-authenticating under FRE 902.
`
`Teva also objects to these Exhibits because they are not a "duplicate" as
`
`defined by FRE 1001(e) insofar as each exhibit is not "a copy . . . which accurately
`
`reproduces the original." Thus, under FRE 1003, these Exhibits are inadmissible
`
`because they are not a "duplicate."
`
`- 3 -
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`Case IPR2018-01425
`Patent No. 9,890,210
`D. Exhibit 1051
`Exhibit 1051 purports to be a copy of "Sigma-Aldrich, Biochemicals &
`
`Reagents for Life Science Research" catalog. Neither the Petition nor Lilly's
`
`experts has established that EX1051 was publicly available before November 14,
`
`2005, the priority date of U.S. Patent No. 9,346,881. Patent Owner therefore
`
`objects to Exhibit 1051 as irrelevant under FRE 402 and unfairly prejudicial under
`
`FRE 403.
`
`Exhibits 1136 and 1186-1191
`
`E.
`Exhibits 1136 and 1186-1191 purport to be excerpts from the File History of
`
`U.S. Patent Nos. 8,597,649 (EX1136) and 9,890,210 (EX1186-1191). Teva objects
`
`to these Exhibits under FRE 403 because they are incomplete documents, with
`
`only select portions of the whole presented as exhibits. These exhibits are therefore
`
`misleading and confusing, and create unfair prejudice to Teva. Teva also objects to
`
`these Exhibits under FRE 1002 because as an “excerpt,” they are not the original
`
`file history document. For the same reason, Teva objects to these Exhibits under
`
`FRE 1003 because they are not duplicates of the original file history documents.
`
`
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`Case IPR2018-01425
`Patent No. 9,890,210
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`
`II. CONCLUSION
`To the extent Lilly fails to correct the defects associated with the Challenged
`
`Evidence in view of Teva's objections herein, Teva may file a motion to exclude
`
`the Challenged Evidence under 37 C.F.R. § 42.64(c).
`
`
`
`Respectfully submitted,
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C
`
`
`Date: March 11, 2019
`1100 New York Avenue, N.W.
`Washington, D.C. 20005-3934
`(202) 371-2600
`
`
`Deborah A. Sterling, Ph.D.
`Registration No. 62,732
`Lead Attorney for Patent Owner
`
`
`
`
`
`
`
`
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`- 5 -
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`
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`Case IPR2018-01425
`Patent No. 9,890,210
`
`
`
`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
`
`I certify that the above-captioned "TEVA PHARMACEUTICALS
`
`INTERNATIONAL GMBH'S OBJECTIONS TO EVIDENCE" was served in its
`
`entirety on March 11, 2019, upon the following parties via email:
`
`William B. Raich
`Erin M. Sommers
`Pier D. DeRoo
`Yieyie Yang
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, LLP
`901 New York Avenue, NW
`Washington, DC 20001
`william.raich@finnegan.com
`erin.sommers@finnegan.com
`pier.deroo@finnegan.com
`yieyie.yang@finnegan.com
`
`
`
`Sanjay M. Jivraj
`Mark J. Stewart
`Eli Lilly and Company
`Lilly Corporate Center Patent Dept.
`Indianapolis, IN 46285
`jivraj_sanjay@lilly.com
`stewart_mark@lilly.com
`
`
`
`STERNE, KESSLER, GOLDSTEIN & FOX L.L.C.
`
`
`
`Deborah A. Sterling, Ph.D.
`Date: March 11, 2019
`1100 New York Avenue, N.W. Registration No. 62,732
`Washington, D.C. 20005-3934
`Lead Attorney for Patent Owner
`(202) 371-2600
`
`12795809
`
`- 6 -
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`
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