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 IPR2018-01423
`U.S. Patent No. 9,266,951
`___________________
`
`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 IPR2018-01423
`U.S. Patent No. 9,266,951
`___________________
`
`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 IPR2018-01423
`Patent No. 9,266,951
`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 1004, 1005, 1031-1036, 1038-1052, 1055-1057, 1061,
`
`1062, 1064-1077, 1081, 1082, 1089, 1090, 1095, 1098, 1101, 1136, 1143, and
`
`1146-1154 (the "Challenged Evidence"), filed by Petitioner Eli Lilly and Company
`
`("Lilly") on August 8, 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 Challenged Evidence under 37 C.F.R.
`
`§ 42.64(c), unless cured by Lilly.
`
`I.
`
`IDENTIFICATION OF GROUNDS FOR OBJECTIONS
`A. Exhibit 1004
`Exhibit 1004 purports to be the “Declaration of Dr. Andrew C. Charles,
`
`M.D.” Teva objects to paragraphs 31, 32, 65-72, 98, 157, 175-178 in Exhibit 1004
`
`under FRE 402 and FRE 403. Lilly does not cite any of these paragraphs in its
`
`Petition, rendering 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 value,
`
`create unfair prejudice to Teva, and will only confuse the issues and waste the
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`Case IPR2018-01423
`Patent No. 9,266,951
`Board’s time.
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`Teva also objects to paragraphs 18-26, 28, 31-45, 48-52, 54-56, 67-68, 75,
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`85, 99, 113, 122-123, 126, 129-130, 135-136, 142, 144-146, 149-150, 159-160,
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`163, 165, 168-169, 171-173 of EX1004 because these paragraphs rely on evidence
`
`that is inadmissible under FRE 402, 403, 901, 1001(e), and/or 1003. See infra.
`
`Exhibit 1005
`
`B.
`Exhibit 1005 purports to be the “Declaration of Dr. Alain P. Vasserot,
`
`Ph.D.” Teva objects to paragraphs 21, 27, 54, 128-131 in Exhibit 1005 under FRE
`
`402 and FRE 403. Lilly does not cite any of these paragraphs in its Petition,
`
`rendering Dr. Vasserot’s 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 value, create
`
`unfair prejudice to Teva, and will only confuse the issues and waste the Board’s
`
`time.
`
`Teva also objects to paragraphs 16-28, 30-47, 54-58, 77-78, 81, 83, 85, 87,
`
`92-95, 97-98, 101, 106-107, 110, 113, 116-117, 120-121, 124-125 of EX1005
`
`because these paragraphs rely on evidence that is inadmissible under FRE 402,
`
`403, 901, 1001(e), and/or 1003. See infra.
`
`C. Exhibits 1031-1036, 1038-1050, 1052, 1055-1057, 1061, 1062, 1064-
`1077, 1081, 1082, 1089, 1090, 1095, 1098, and 1101
`
`Teva objects to Exhibits 1031-1036, 1038-1050, 1052, 1055-1057, 1061,
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`Case IPR2018-01423
`Patent No. 9,266,951
`1062, 1064-1077, 1081, 1082, 1089, 1090, 1095, 1098, and 1101 as lacking
`
`authentication under FRE 901. In particular, Teva objects to Exhibits 1031-1034,
`
`1036, 1038-1050, 1052, 1055-1057, 1061, 1062, 1064-1077, 1081, 1082, 1089,
`
`1090, 1095, 1098, and 1101 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 objects to Exhibits 1033, 1035, 1043, 1047, 1050, 1055, and 1074 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, 1081, 1089 because these Exhibits
`
`purport to be published at one date, yet have markings indicating that they were
`
`recently downloaded 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
`
`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."
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`Case IPR2018-01423
`Patent No. 9,266,951
`D. Exhibit 1051
`Exhibit 1051 purports to be a copy of "Sigma-Aldrich, Biochemicals &
`
`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,
`
`2005, the priority date of U.S. Patent No. 9,266,951. Patent Owner therefore
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`objects to Exhibit 1051 as irrelevant under FRE 402 and unfairly prejudicial under
`
`FRE 403.
`
`Exhibits 1136, 1143, and 1146-1154
`
`E.
`Exhibits 1136, 1143, and 1146-1154 purport to be excerpts from the File
`
`History of U.S. Patent Nos. 8,597,649 (EX1136), 8,586,045 (EX1143), and
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`9,266,951 (EX1146-EX1154). 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, Teva objects to these Exhibits under FRE 1003 because they are
`
`not duplicates of the original file history documents.
`
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`Case IPR2018-01423
`Patent No. 9,266,951
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`II. 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: March 5, 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 IPR2018-01423
`Patent No. 9,266,951
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`
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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 March 5, 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: March 5, 2019
`1100 New York Avenue, N.W. Registration No. 62,732
`Washington, D.C. 20005-3934
`Lead Attorney for Patent Owner
`(202) 371-2600
`
`12805620
`
`- 6 -
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`
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