`___________________
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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.
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`___________________
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`Case IPR2018-01426
`U.S. Patent No. 9,890,211
`___________________
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`TEVA PHARMACEUTICALS INTERNATIONAL GMBH'S
`OBJECTIONS TO EVIDENCE
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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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`Case IPR2018-01426
`Patent No. 9,890,211
`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 1012, 1013, 1031-1035, 1038-1052, 1055-1057, 1061,
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`1062, 1064-1078, 1084-1090, 1095, 1101, 1103-1126, 1136, 1142, and 1196-1202
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`(the "Challenged Evidence"), filed by Petitioner Eli Lilly and Company ("Lilly")
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`on August 8, 2018, with Lilly's Petition for Inter Partes Review. Teva's Objections
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`are filed within ten business days of the date of issuance of the Institution of Inter
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`Partes Review; therefore, Teva's Objections to Evidence are timely under 37
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`C.F.R. § 42.64(b)(1). Teva files these Objections to provide notice to Lilly that
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`Teva may move to exclude the Challenged Evidence under 37 C.F.R. § 42.64(c),
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`unless cured by Lilly.
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`I.
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`IDENTIFICATION OF GROUNDS FOR OBJECTIONS
`A. Exhibit 1012
`Exhibit 1012 purports to be the “Declaration of Dr. Andrew C. Charles,
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`M.D.” Teva objects to paragraphs 26-27, 60-67, 90, 160, and 183-184 in Exhibit
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`1012 under FRE 402 and FRE 403. Lilly does not cite any of these paragraphs in
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`its Petition, rendering Dr. Charles’ testimony in these paragraphs irrelevant under
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`FRE 401. Teva therefore objects to these paragraphs under FRE 402. Teva also
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`objects to these paragraphs under FRE 403 because they have no probative value,
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`create unfair prejudice to Teva, and will only confuse the issues and waste the
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`Patent No. 9,890,211
`Board’s time.
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`Teva also objects to paragraphs 18-24, 26-28, 34-40, 43-47, 49-51, 62-63,
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`70, 91, 105, 114-115, 118, 121-122, 128, 136, 140, 142-144, 148-152, 162-163,
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`167-168, and 171-172 of EX1012 because these paragraphs rely on evidence that is
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`inadmissible under FRE 402, 403, 901, 1001(e), and/or 1003. See infra.
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`Exhibit 1013
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`B.
`Exhibit 1013 purports to be the “Declaration of Dr. Alain P. Vasserot,
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`Ph.D.” Teva objects to paragraphs 74-75, 132, 135, and 153-154 in Exhibit 1013
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`under FRE 402 and FRE 403. Lilly does not cite any of these paragraphs in its
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`Petition, rendering Dr. Vasserot’s testimony in these paragraphs irrelevant under
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`FRE 401. Teva therefore objects to these paragraphs under FRE 402. Teva also
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`objects to these paragraphs under FRE 403 because they have no probative value,
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`create unfair prejudice to Teva, and will only confuse the issues and waste the
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`Board’s time.
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`Teva also objects to paragraphs 22-24, 27-29, 31-48, 56-59, 67-69, 70, 72,
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`90, 98-99, 103-104, 106, 108, 110-111, 116-119, 122-123, 126, 128, 130, 134,
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`138-140, 143-144, and 149 of EX1013 because these paragraphs rely on evidence
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`that is inadmissible under FRE 402, 403, 901, 1001(e), and/or 1003. See infra.
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`C. Exhibits 1031-1035, 1038-1050, 1052, 1055-1057, 1061, 1062, 1064-
`1078, 1084-1090, 1095, 1101, 1103-1126, and 1142
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`Teva objects to Exhibits 1031-1035, 1038-1050, 1052, 1055-1057, 1061,
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`1062, 1064-1077, 1083-1090, 1095, 1101, 1103-1126, and 1142 as lacking
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`authentication under FRE 901. In particular, Teva objects to Exhibits 1031-1034,
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`1038-1050, 1052, 1055-1057, 1061, 1062, 1064-1078, 1084-1090, 1095, 1101,
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`1103-1126, and 1142 under FRE 901 because Lilly fails to provide sufficient
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`evidence indicating the origin or publication of these documents, and accordingly
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`fails to provide sufficient information regarding their authenticity. Teva further
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`objects to Exhibits 1033, 1035, 1043, 1047, 1050, 1055, 1074, and 1117 under
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`FRE 901 because these Exhibits are stamped with a label or other markings not
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`consistent with being the claimed document. Teva further objects to Exhibits 1034,
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`1040, 1041, 1045, 1046, 1065, 1067, 1074, 1078, 1089, 1107, 1109, and 1123
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`because these Exhibits purport to be published at one date, yet have markings
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`indicating that they were recently downloaded at a later date. Collectively, these
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`Exhibits are inadmissible under FRE 901 because Lilly has failed to provide
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`sufficient evidence indicating the origin of the documents and has not provided
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`sufficient information regarding their authenticity. Further, these Exhibits are not
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`self-authenticating under FRE 902.
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`Teva also objects to these Exhibits because they are not a "duplicate" as
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`defined by FRE 1001(e) insofar as each exhibit is not "a copy . . . which accurately
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`reproduces the original." Thus, under FRE 1003, these Exhibits are inadmissible
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`because they are not a "duplicate."
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`D. Exhibit 1051
`Exhibit 1051 purports to be a copy of "Sigma-Aldrich, Biochemicals &
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`Reagents for Life Science Research" catalog. Neither the Petition nor Lilly's
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`experts has established that EX1051 was publicly available before November 14,
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`2005, the priority date of U.S. Patent No. 9,346,881. Patent Owner therefore
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`objects to Exhibit 1051 as irrelevant under FRE 402 and unfairly prejudicial under
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`FRE 403.
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`Exhibits 1136 and 1196-1202
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`E.
`Exhibits 1136 and 1196-1202 purport to be excerpts from the File History of
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`U.S. Patent Nos. 8,597,649 (EX1136) and 9,890,211 (EX1196-1202). Teva objects
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`to these Exhibits under FRE 403 because they are incomplete documents, with
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`only select portions of the whole presented as exhibits. These exhibits are therefore
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`misleading and confusing, and create unfair prejudice to Teva. Teva also objects to
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`these Exhibits under FRE 1002 because as an “excerpt,” they are not the original
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`file history document. For the same reason, Teva objects to these Exhibits under
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`FRE 1003 because they are not duplicates of the original file history documents.
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`II. CONCLUSION
`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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`Respectfully submitted,
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C
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`Date: March 11, 2019
`1100 New York Avenue, N.W.
`Washington, D.C. 20005-3934
`(202) 371-2600
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`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 March 11, 2019, upon the following parties via email:
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`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
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`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
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`STERNE, KESSLER, GOLDSTEIN & FOX L.L.C.
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`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
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`12795809
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