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
`___________________
`
`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 IPR2018-01710
`U.S. Patent No. 8,586,045
`___________________
`
`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 IPR2018-01710
`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 1014, 1015, 1031-1035, 1038-1052, 1055-1062, 1064-
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`1078, 1082-1090, 1093-1095, 1101, 1107-1126, 1130, 1136, 1142, 1206-1213,
`
`1237-1244, 1246-1257, 1259, and 1260 (the "Challenged Evidence"), filed by
`
`Petitioner Eli Lilly and Company ("Lilly") on September 28, 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
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`Challenged Evidence under 37 C.F.R. § 42.64(c), unless cured by Lilly.
`
`I.
`
`IDENTIFICATION OF GROUNDS FOR OBJECTIONS
`A. Exhibit 1014
`Exhibit 1014 purports to be the "Declaration of Dr. Andrew C. Charles,
`
`M.D." Teva objects to paragraphs 39-49, 63-66, 74, 79, 85, 114, 138, 143, 145,
`
`147, 153, 155, 162, 165, 169, 174, and 179 in Exhibit 1014 under FRE 402 and
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`FRE 403. Lilly does not cite any of these paragraphs in its Petition or Petitioner's
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`Reply, rendering Dr. Charles' testimony in these paragraphs irrelevant under FRE
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`401. Teva therefore objects to these paragraphs under FRE 402. Teva also objects
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`to these paragraphs under FRE 403 because they have no probative value, create
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`Case IPR2018-01710
`Patent No. 8,586,045
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`unfair prejudice to Teva, and will only confuse the issues and waste the Board's
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`time.
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`Teva also objects to paragraphs 16-28, 40-42, 44, 26-53, 62, 65, 66, 86, 105,
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`107-112, 116-118, 124-133, 139, 140, 142, 147, 150, 151, 163-165, 170, 171, 174-
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`176, 179, 182, and 189 of Exhibit 1014 because these paragraphs rely on evidence
`
`that is inadmissible under FRE 402, 403, 901, 1001(e), and/or 1003. See infra.
`
`Exhibit 1015
`
`B.
`Exhibit 1015 purports to be the "Declaration of Dr. Alain P. Vasserot,
`
`Ph.D." Teva objects to paragraphs 15, 17-20, 23-26, 58, 62-64, 110, 112, and 114
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`in Exhibit 1015 under FRE 402 and FRE 403. Lilly does not cite any of these
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`paragraphs in its Petition or Petitioner's Reply, rendering Dr. Vasserot's testimony
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`in these paragraphs irrelevant under FRE 401. Teva therefore objects to these
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`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
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`only confuse the issues and waste the Board's time.
`
`Teva also objects to paragraphs 15-27, 29-46, 53-57, 59-68, 90, 91, 93, 95,
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`98, 99, 104-108, 114, 115, 117-119, 122, 123, 126, 127, and 133 of Exhibit 1015
`
`because these paragraphs rely on evidence that is inadmissible under FRE 402,
`
`403, 901, 1001(e), and/or 1003. See infra.
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`Case IPR2018-01710
`Patent No. 8,586,045
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`C. Exhibits 1031-1035, 1038-1050, 1052, 1055-1057, 1061, 1062, 1064-
`1078, 1082-1090, 1093-1095, 1101, 1107-1126, 1142, 1237-1244,
`1246-1257, 1259, and 1260
`
`Teva objects to Exhibits 1031-1035, 1038-1050, 1052, 1055-1057, 1061,
`
`1062, 1064-1078, 1082-1090, 1093-1095, 1101, 1107-1126, 1142, 1237-1244,
`
`1246-1257, 1259, and 1260 as lacking authentication under FRE 901. In particular,
`
`Teva objects to these Exhibits 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, 1074, 1117,
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`1237, 1238, 1244, 1247, 1250, 1252, 1259, and 1260 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, 1089, 1107, 1109, 1123, 1237, 1238, 1244, 1247, and 1250
`
`because these Exhibits purport to be published at one date, yet have markings
`
`indicating that they were recently downloaded or publicly available 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
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`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."
`
`D. Exhibits 1035, 1040, 1051, 1070, 1085, 1088, 1093, 1113, 1117,
`1124, 1240, and 1253
`
`Lilly offers Exhibits 1035, 1040, 1051, 1070, 1085, 1088, 1093, 1113, 1117,
`
`1124, 1240, and 1253 as prior art. Neither the Petition nor Lilly's experts have
`
`established that these Exhibits were publicly available before November 14, 2005,
`
`the priority date of U.S. Patent No. 8,586,045. Patent Owner therefore objects to
`
`Exhibits 1035, 1040, 1051, 1070, 1085, 1088, 1093, 1113, 1117, 1124, 1240, and
`
`1253 as irrelevant under FRE 402 and unfairly prejudicial under FRE 403.
`
`Exhibits 1136, 1143, and 1206-1213
`
`E.
`Exhibits 1136, 1143, and 1206-1213 purport to be excerpts from the File
`
`History of U.S. Patent Nos. 8,597,649 (Ex. 1136) and 8,586,045 (Ex. 1143, Ex.
`
`1206-1213). 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,
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`Case IPR2018-01710
`Patent No. 8,586,045
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`Teva objects to these Exhibits under FRE 1003 because they are not duplicates of
`
`the original file history documents.
`
`Exhibits 1035, 1058-1060, 1083, 1093, 1130, 1253, 1255, and 1259
`
`F.
`Exhibits 1035, 1058-1060, 1083, 1093, 1130, 1253, 1255, and 1259 purport
`
`to be pages from certain textbooks. Teva objects to these Exhibits under FRE 403
`
`because they are incomplete documents, with only select pages of the whole
`
`presented as an exhibit. Exhibits 1035, 1058-1060, 1083, 1093, 1130, 1253, 1255,
`
`and 1259 are therefore misleading and confusing, and create unfair prejudice to
`
`Teva. Teva also objects to Exhibits 1035, 1058-1060, 1083, 1093, 1130, 1253,
`
`1255, and 1259 under FRE 1002 because Lily only introduces certain pages, while
`
`not including the entire chapter or table of contents for examination. For the same
`
`reason, Teva objects under FRE 1003 because Exhibits 1035, 1058-1060, 1083,
`
`1093, 1130, 1253, 1255, and 1259 are not duplicates of the original documents.
`
`G. Exhibits 1108, 1111, 1112, 1115, 1118, 1250-1252, 1256, 1257, and
`1260
`
`Exhibits 1108, 1111, 1112, 1115, 1118, 1250-1252, 1256, 1257, and 1260
`
`purport to be the prescribing information for various drugs. Each Exhibit does not
`
`facially indicate that it was publicly available. Neither the Petition nor Lilly's
`
`experts have established that these Exhibits were publicly available before
`
`November 14, 2005, the priority date of U.S. Patent No. 8,586,045. For example,
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`Exhibit 1252 indicates that it is a "Revised Draft" of the Remicade Prescribing
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`Information. Exhibit 1256 indicates that it is from a "U.S. BLA Amendment."
`
`Exhibit 1260 clearly indicates that the prescribing information as presented in the
`
`document was not issued. See p. 49. Patent Owner therefore objects to Exhibits
`
`1108, 1111, 1112, 1115, 1118, 1250-1252, 1256, 1257, and 1260 as irrelevant
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`under FRE 402 and unfairly prejudicial under FRE 403.
`
`H. Exhibits 1057, 1059, 1060, 1093, 1094, and 1259
`Exhibits 1057, 1059, 1060, 1093, 1094, and 1259 do not have exhibit labels
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`and are not uniquely numbered in sequence. Teva objects to these Exhibits as not
`
`complying with 37 C.F.R. § 42.63.
`
`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).
`
`
`
`Respectfully submitted,
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C
`
`
`Date: April 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
`
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`Case IPR2018-01710
`Patent No. 8,586,045
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`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
`
`The undersigned hereby certifies that the above-captioned "TEVA
`
`PHARMACEUTICALS INTERNATIONAL GMBH'S OBJECTIONS TO
`
`EVIDENCE" was served in its entirety on April 17, 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: April 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
`
`13005529_4
`
`- 7 -
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