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 IPR2018-01710
`U.S. Patent No. 8,586,045
`___________________
`
`
`
`
`
`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 IPR2018-01710
`U.S. Patent No. 8,586,045
`___________________
`
`
`
`
`
`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 IPR2018-01710
`Patent No. 8,586,045
`
`
`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 1098, 1261-1279, 1281-1288, 1290-1297, 1300-1304,
`
`1308-1311, 1313-1318, 1331-1338, and 1343-1349 (the "Challenged Evidence"),
`
`filed by Petitioner Eli Lilly and Company ("Lilly") on October 4, 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 1337 and 1338
`Exhibit 1337 purports to be the “Declaration of Dr. Joseph P. Balthasar,
`
`Ph.D.” Teva objects to paragraphs 1-14, 88, and 89 in Exhibit 1337 under FRE 402
`
`and FRE 403. Similarly, Exhibit 1338 purports to be the “Declaration of Dr.
`
`Andrew Charles, M.D.” Teva objects to paragraphs 1-4, 145, and 146 of Exhibit
`
`1338 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
`
`- 1 -
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`
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`Case IPR2018-01710
`Patent No. 8,586,045
`
`probative value, create unfair prejudice to Teva, and will only confuse the issues
`
`and waste the Board’s time. Teva also objects to Exhibits 1337 and 1338 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 1098, 1263-1271, 1281-1288, 1290-1297, 1308-1311, 1313-
`1318, 1331-1336, and 1347-1349
`
`Teva objects to exhibits 1098, 1263-1271, 1281, 1283-1288, 1290-1297,
`
`1308-1311, 1313-1318, 1331-1336, and 1347-1349 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 1098, 1263-1271, 1281-1288, 1290-1297,
`
`1308-1311, 1313-1318, 1331-1336, and 1347-1349 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 1098, 1264-1265, 1267-1271, 1286, 1291-
`
`1293, 1296, 1311, 1313, 1314, 1316, 1317, 1331, 1335-1336, 1344, and 1347-1349
`
`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 ’045 patent.
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`- 2 -
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`Case IPR2018-01710
`Patent No. 8,586,045
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`They 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.
`
`C. Exhibits 1261, 1262, 1270-1279, 1284, 1287, 1308, 1311, and 1349
`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 ’045 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, 1311, and
`
`1349 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.
`
`
`
`
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`Case IPR2018-01710
`Patent No. 8,586,045
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`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: October 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
`
`- 4 -
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`
`
`
`
`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 October 11, 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: October 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
`
`13970227.1
`
`
`
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