`___________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
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`ELI LILLY AND COMPANY,
`Petitioner,
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`v.
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`TEVA PHARMACEUTICALS INTERNATIONAL GMBH,
`Patent Owner.
`
`___________________
`
`Case IPR2018-01710
`U.S. Patent No. 8,586,045
`___________________
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`
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`Mail Stop "PATENT BOARD"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`TEVA PHARMACEUTICALS INTERNATIONAL GMBH'S
`OBJECTIONS TO EVIDENCE
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`
`
`Case IPR2018-01710
`Patent No. 8,586,045
`
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`Patent Owner, Teva Pharmaceuticals International GmbH ("Teva"), objects
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`under the Federal Rules of Evidence (FRE) and 37 C.F.R. § 42.64(b)(1) to the
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`admissibility of Exhibits 1098, 1261-1279, 1281-1288, 1290-1297, 1300-1304,
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`1308-1311, 1313-1318, 1331-1338, and 1343-1349 (the "Challenged Evidence"),
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`filed by Petitioner Eli Lilly and Company ("Lilly") on October 4, 2019, with Lilly's
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`Reply. Teva's Objections are filed within five business days of the Reply;
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`therefore, Teva's Objections to Evidence are timely under 37 C.F.R. § 42.64(b)(1).
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`Teva files these Objections to provide notice to Lilly that Teva may move to
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`exclude the Challenged Evidence under 37 C.F.R. § 42.64(c), unless cured by
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`Lilly.
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`IDENTIFICATION OF GROUNDS FOR OBJECTIONS
`A. Exhibits 1337 and 1338
`Exhibit 1337 purports to be the “Declaration of Dr. Joseph P. Balthasar,
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`Ph.D.” Teva objects to paragraphs 1-14, 88, and 89 in Exhibit 1337 under FRE 402
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`and FRE 403. Similarly, Exhibit 1338 purports to be the “Declaration of Dr.
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`Andrew Charles, M.D.” Teva objects to paragraphs 1-4, 145, and 146 of Exhibit
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`1338 under FRE 402 and 403. Lilly does not cite any of these paragraphs in its
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`Reply, rendering Dr. Balthasar’s and Dr. Charles’ testimony in these paragraphs
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`irrelevant under FRE 401. Teva therefore objects to these paragraphs under FRE
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`402. Teva also objects to these paragraphs under FRE 403 because they have no
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`Case IPR2018-01710
`Patent No. 8,586,045
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`probative value, create unfair prejudice to Teva, and will only confuse the issues
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`and waste the Board’s time. Teva also objects to Exhibits 1337 and 1338 to the
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`extent that they rely on evidence that is inadmissible under FRE 106, 402, 403,
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`901, 1001(e), and/or 1003, as described below.
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`B.
`Exhibits 1098, 1263-1271, 1281-1288, 1290-1297, 1308-1311, 1313-
`1318, 1331-1336, and 1347-1349
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`Teva objects to exhibits 1098, 1263-1271, 1281, 1283-1288, 1290-1297,
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`1308-1311, 1313-1318, 1331-1336, and 1347-1349 as lacking authentication under
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`FRE 901. Collectively, these Exhibits are inadmissible under FRE 901 because
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`Lilly has failed to provide sufficient evidence indicating the origin of the
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`documents and has not provided sufficient information regarding their authenticity.
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`Further, these Exhibits are not self-authenticating under FRE 902.
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`Teva also objects to exhibits 1098, 1263-1271, 1281-1288, 1290-1297,
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`1308-1311, 1313-1318, 1331-1336, and 1347-1349 as incomplete. Each of these
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`exhibits appears to be part of a larger work, rendering each exhibit inadmissible
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`under FRE 106 and FRE 403.
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`Teva also objects to exhibits 1098, 1264-1265, 1267-1271, 1286, 1291-
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`1293, 1296, 1311, 1313, 1314, 1316, 1317, 1331, 1335-1336, 1344, and 1347-1349
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`as irrelevant under FRE 401 through FRE 403. These exhibits are not cited in
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`Lilly’s reply, and several are published well after the filing date of the ’045 patent.
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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
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`exhibits under FRE 402. Teva also objects to these exhibits under FRE 403
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`because they have no probative value, create unfair prejudice to Teva, and will
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`only confuse the issues and waste the Board’s time.
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`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
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`401 through FRE 403. These exhibits are not cited in Lilly’s reply, and several are
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`published well after the filing date of the ’045 patent. There are, therefore,
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`irrelevant under FRE 401. Teva therefore objects to these exhibits under FRE 402.
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`Teva also objects to these exhibits under FRE 403 because they have no probative
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`value, create unfair prejudice to Teva, and will only confuse the issues and waste
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`the Board’s time.
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`Teva also objects to exhibits 1270, 1271, 1278, 1284, 1287, 1308, 1311, and
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`1349 under FRE 1001 through FRE 1003. For example, these documents have
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`stray markings and other indicia that they are not original, or even clean copies of
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`the original document. Accordingly, Teva objects to these exhibits for failure to
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`comply with the best evidence rule.
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`Patent No. 8,586,045
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`CONCLUSION
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`To the extent Lilly fails to correct the defects associated with the Challenged
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`Evidence in view of Teva's objections herein, Teva may file a motion to exclude
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`the Challenged Evidence under 37 C.F.R. § 42.64(c).
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`
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`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
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`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
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`I certify that the above-captioned "TEVA PHARMACEUTICALS
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`INTERNATIONAL GMBH'S OBJECTIONS TO EVIDENCE" was served in its
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`entirety on October 11, 2019, upon the following parties via email:
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`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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