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 IPR2018-01427
`U.S. Patent No. 8,597,649
`___________________
`
`
`
`
`
`Mail Stop "PATENT BOARD"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`TEVA PHARMACEUTICALS INTERNATIONAL GMBH'S
`OBJECTIONS TO EVIDENCE
`
`
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`
`ELI LILLY AND COMPANY,
`Petitioner,
`
`v.
`
`TEVA PHARMACEUTICALS INTERNATIONAL GMBH,
`Patent Owner.
`
`___________________
`
`Case IPR2018-01427
`U.S. Patent No. 8,597,649
`___________________
`
`
`
`
`
`Mail Stop "PATENT BOARD"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`TEVA PHARMACEUTICALS INTERNATIONAL GMBH'S
`OBJECTIONS TO EVIDENCE
`
`
`
`Case IPR2018-01427
`Patent No. 8,597,649
`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 1082, 1098, 1240, 1247, 1261-1279, 1281-1288, 1290-
`
`1297, 1308, 1309, 1311, 1313-1318, 1329, and 1330 (the "Challenged Evidence"),
`
`filed by Petitioner Eli Lilly and Company ("Lilly") on September 10, 2019, with
`
`Lilly's Reply. Teva's Objections are filed within five business days of the Reply;
`
`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.
`
`IDENTIFICATION OF GROUNDS FOR OBJECTIONS
`A. Exhibits 1329 and 1330
`Exhibit 1329 purports to be the “Declaration of Dr. Joseph P. Balthasar,
`
`Ph.D.” Teva objects to paragraphs 1-14, 79, and 80 in Exhibit 1329 under FRE 402
`
`and FRE 403. Similarly, Exhibit 1330 purports to be the “Declaration of Dr.
`
`Andrew Charles, M.D.” Teva objects to paragraphs 1-4, 95, and 96 of Exhibit 1330
`
`under FRE 402 and 403. Lilly does not cite any of these paragraphs in its Reply,
`
`rendering Dr. Balthasar’s and 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
`
`- 1 -
`
`
`
`Case IPR2018-01427
`Patent No. 8,597,649
`value, create unfair prejudice to Teva, and will only confuse the issues and waste
`
`the Board’s time. Teva also objects to Exhibits 1325 and 1326 to the extent that
`
`they rely on evidence that is inadmissible under FRE 106, 402, 403, 901, 1001(e),
`
`and/or 1003, as described below.
`
`B.
`Exhibits 1082, 1098, 1240, 1247, 1263-1271, 1281-1288, 1290-1297,
`1308, 1309, 1311, and 1313-1318
`
`Teva objects to exhibits 1082, 1098, 1240, 1247, 1263-1271, 1281, 1283-
`
`1288, 1290-1297, 1308, 1309, 1311, and 1313-1318 as lacking authentication
`
`under FRE 901. 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 exhibits 1082, 1098, 1240, 1247, 1263-1271, 1281-
`
`1288, 1290-1297, 1308, 1309, 1311, and 1313-1318 as incomplete. Each of these
`
`exhibits appears to be part of a larger work, rendering each exhibit inadmissible
`
`under FRE 106 and FRE 403.
`
`Teva also objects to exhibits 1247, 1264, 1265, 1267-1271, 1281, 1286,
`
`1293, 1296, 1311, 1313, 1314, 1316, and 1317 as irrelevant under FRE 401
`
`through FRE 403. These exhibits are not cited in Lilly’s reply, and several are
`
`published well after the filing date of the ’649 patent. They are, therefore,
`
`irrelevant under FRE 401. Teva therefore objects to these exhibits under FRE 402.
`
`- 2 -
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`
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`Case IPR2018-01427
`Patent No. 8,597,649
`Teva also objects to these exhibits 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.
`
`C. Exhibits 1261, 1262, 1270-1279, 1284, 1287, 1308, and 1311
`Teva objects to exhibits 1261, 1262, and 1272-1279 as irrelevant under FRE
`
`401 through FRE 403. These exhibits are not cited in Lilly’s reply, and several are
`
`published well after the filing date of the ’649 patent. There are, therefore,
`
`irrelevant under FRE 401. Teva therefore objects to these exhibits under FRE 402.
`
`Teva also objects to these exhibits 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 exhibits 1270, 1271, 1278, 1284, 1287, 1308 and 1311
`
`under FRE 1001 through FRE 1003. For example, these documents have stray
`
`markings and other indicia that they are not original, or even clean copies of the
`
`original document. Accordingly, Teva objects to these exhibits for failure to
`
`comply with the best evidence rule.
`
`
`
`
`
`- 3 -
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`
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`Case IPR2018-01427
`Patent No. 8,597,649
`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: September 17, 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
`
`- 4 -
`
`
`
`
`
`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 September 17, 2019, upon the following parties via email:
`
`William B. Raich
`Erin M. Sommers
`Pier D. DeRoo
`Yieyie Yang
`John Williamson
`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
`john.williamson@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: September 17, 2019
`1100 New York Avenue, N.W. Registration No. 62,732
`Washington, D.C. 20005-3934
`Lead Attorney for Patent Owner
`(202) 371-2600
`
`13832834.1
`
`
`- 1 -
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`
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