Case IPR 2016-00318
`Patent 7,772,209
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`SANDOZ INC.,
`APOTEX INC., and APOTEX CORP.,
`EMCURE PHARMACEUTICALS LTD.,
`HERITAGE PHARMA LABS INC.,
`HERITAGE PHARMACEUTICALS INC.,
`GLENMARK PHARMACEUTICALS, INC., USA,
`GLENMARK HOLDING SA,
`GLENMARK PHARMACEUTICALS, LTD., MYLAN LABORATORIES
`LIMITED, TEVA PHARMACEUTICALS,
`FRESENIUS KABI USA, LLC and WOCKHARDT BIO AG
`Petitioners,
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`v.
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`ELI LILLY & COMPANY,
`Patent Owner.
`__________________
`
`Case No: IPR2016-003181
`Patent No. 7,772,209
`__________________
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`PATENT OWNER’S OBJECTIONS TO SUPPLEMENTAL EVIDENCE
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`1 Cases IPR2016-01429, IPR2016-01393, and IPR2016-01340 have been joined
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`with the instant proceeding.
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`Patent 7,772,209
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`SANDOZ INC.,
`APOTEX INC., and APOTEX CORP.,
`EMCURE PHARMACEUTICALS LTD.,
`HERITAGE PHARMA LABS INC.,
`HERITAGE PHARMACEUTICALS INC.,
`GLENMARK PHARMACEUTICALS, INC., USA,
`GLENMARK HOLDING SA,
`GLENMARK PHARMACEUTICALS, LTD., MYLAN LABORATORIES
`LIMITED, TEVA PHARMACEUTICALS,
`FRESENIUS KABI USA, LLC and WOCKHARDT BIO AG
`Petitioners,
`
`v.
`
`ELI LILLY & COMPANY,
`Patent Owner.
`__________________
`
`Case No: IPR2016-003181
`Patent No. 7,772,209
`__________________
`
`
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`PATENT OWNER’S OBJECTIONS TO SUPPLEMENTAL EVIDENCE
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`
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`
`
`1 Cases IPR2016-01429, IPR2016-01393, and IPR2016-01340 have been joined
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`with the instant proceeding.
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`
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`Case IPR 2016-00318
`Patent 7,772,209
`Patent Owner Eli Lilly & Company (“Lilly”) hereby objects pursuant to 37
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`C.F.R. § 42.64(b)(1) and the Federal Rules of Evidence (“FRE”) to the
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`admissibility of certain purported supplemental evidence served by Petitioner
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`Sandoz Inc. on January 17, 2017 in connection with its Petition for Inter Partes
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`Review. The exhibits objected to, and grounds for Lilly’s objections, are listed
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`below. Lilly also objects to Petitioner’s reliance on or citations to any objected
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`evidence in its papers.
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`Some of the exhibits served by Sandoz Inc. on January 17, 2017 were
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`introduced at depositions in this proceeding, and Lilly objected to certain of those
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`exhibits at the depositions as required by 37 C.F.R. § 42.64(a). Nothing contained
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`herein shall be deemed to withdraw any of Lilly’s objections to deposition
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`evidence or the requirement that evidence to cure those objections must have been
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`provided during the deposition, see id.
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`I.
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`IDENTIFICATION OF CHALLENGED EVIDENCE AND GROUNDS
`FOR OBJECTIONS
`A. Exhibit 1064
`Lilly objects to Exhibit 1064 under FRE 802 because it is inadmissible
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`hearsay, specifically trial testimony from Dr. Bruce Chabner in a different
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`proceeding, Eli Lilly v. Teva Parenteral Meds., Inc. et al., 1:10-cv-01376-TWP-
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`DKL (S.D. Ind.). Lilly further objects to Exhibit 1064 as incomplete as it does not
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`include Dr. Chabner’s direct or re-direct testimony. It therefore should be
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`Case IPR 2016-00318
`Patent 7,772,209
`excluded under FRE 106, 401, 402, and 403. Lilly also objects to Exhibit 1064
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`under FRE 402 and 403 because it is irrelevant and its probative value is
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`substantially outweighed by the danger of wasting time and needlessly presenting
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`cumulative evidence in this compressed proceeding.
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`Exhibit 1065
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`B.
`Lilly objects to Exhibit 1065 under FRE 402 and 403 because it is irrelevant
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`and its probative value is substantially outweighed by the danger of wasting time in
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`this compressed proceeding. Exhibit 1065 was published in 2004 and, therefore,
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`bears no relevance to what the person of ordinary skill in the art would have known
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`by the relevant date. Therefore, Exhibit 1065 should be excluded under FRE 402
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`and 403.
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`C. Exhibit 1073
`Lilly objects to Exhibit 1073 under FRE 802 because it is inadmissible
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`hearsay, specifically deposition testimony from Dr. Bruce Chabner in a different
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`proceeding, Eli Lilly v. Teva Parenteral Meds., Inc. et al., 1:10-cv-01376-TWP-
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`DKL (S.D. Ind.). Lilly also objects to Exhibit 1073 under FRE 402 and 403
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`because it is irrelevant and its probative value is substantially outweighed by the
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`danger of wasting time and needlessly presenting cumulative evidence in this
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`compressed proceeding.
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`Case IPR 2016-00318
`Patent 7,772,209
`Lilly also objects to Exhibit 1073 because it contains hundreds of pages of
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`extraneous materials that appear to be other exhibits in this proceeding, are not
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`related to Exhibit 1073, and should not be included in the same exhibit with Dr.
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`Chabner’s deposition testimony from Eli Lilly v. Teva Parenteral Meds., Inc. et al.,
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`1:10-cv-01376-TWP-DKL (S.D. Ind.), even were that deposition testimony
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`otherwise admissible. Lilly incorporates by reference herein any objections it has
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`made to those other materials and reserves the right to interpose objections based
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`on the use, if any, to which the extraneous materials in Exhibit 1073 may be put.
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`D. Exhibit 1130
`Lilly objects to Exhibit 1130 under FRE 802 because it is inadmissible
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`hearsay, specifically deposition testimony from Dr. Steven Zeisel in a different
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`proceeding, Eli Lilly v. Teva Parenteral Meds., Inc. et al., 1:10-cv-01376-TWP-
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`DKL (S.D. Ind.). Lilly also objects to Exhibit 1130 under FRE 402 and 403
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`because it is irrelevant and its probative value is substantially outweighed by the
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`danger of wasting time and needlessly presenting cumulative evidence in this
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`compressed proceeding.
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`Exhibit 1131
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`E.
`Lilly objects to Exhibit 1131 under FRE 802 because it is inadmissible
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`hearsay, specifically trial testimony from Dr. Steven Zeisel in a different
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`proceeding, Eli Lilly v. Teva Parenteral Meds., Inc. et al., 1:10-cv-01376-TWP-
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`Case IPR 2016-00318
`Patent 7,772,209
`DKL (S.D. Ind.). Lilly also objects to Exhibit 1131 under FRE 402 and 403
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`because it is irrelevant and its probative value is substantially outweighed by the
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`danger of wasting time and needlessly presenting cumulative evidence in this
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`compressed proceeding.
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`Respectfully submitted,
`
`/David M. Krinsky/
`David M. Krinsky
`Reg. No. 72,339
`Back-up Counsel for
`Patent Owner
`
`Williams & Connolly LLP
`725 Twelfth Street, N.W.
`Washington, D.C. 20005
`202-434-5338 (Telephone)
`202-434-5029 (Facsimile)
`dkrinsky@wc.com
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`5
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`Date: January 24, 2017
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`Case IPR 2016-00318
`Patent 7,772,209
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`CERTIFICATE OF SERVICE
`(37 C.F.R. § 42.6(e))
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`The undersigned hereby certifies that the foregoing document was served on
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`
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`January 24, 2017 by delivering a copy via electronic mail on the following
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`attorneys of record for the Petitioner:
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`Ralph J. Gabric
`Reg. No. 34,167
`rgabric@brinksgilson.com
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`Joshua H. James
`Reg. No. 72,568
`jjames@brinksgilson.com
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`Brinks Gilson & Lione
`455 Cityfront Plaza Drive
`Suite 3600 NBC Tower
`Chicago, IL 60611-5599
`T: 312-321-4200; F: 312-321-4299
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`Bryan T. Richardson, Ph.D.
`Reg. No. 70,572
`brichardson@brinksgilson.com
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`Brinks Gilson & Lione
`4721 Emperor Blvd.
`Suite 220
`Durham, NC 27703-8580
`T: 919-998-5700; F: 919-998-5701
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`Counsel for Sandoz Inc.
`
`John D. Polivick
`Reg. No. 57,926
`jpolivick@rmmslegal.com
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`William A. Rakoczy
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`Laura Lydigsen
`Pro hac vice
`llydigsen@brinksgilson.com
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`Deanne M. Mazzochi
`Reg. No. 50,158
`dmazzochi@rmmslegal.com
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`Patrick C. Kilgore
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`Pro hac vice to be filed
`wrakoczy@rmmslegal.com
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`Rakoczy Molino Mazzochi Siwik LLP
`6 West Hubbard Street, Suite 500
`Chicago, IL
`P: 312-527-2157/F: 312-527-4205
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`Attorneys for Apotex Inc. and Apotex
`Corp.
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`Thomas J. Parker
`Reg. No. 42,062
`thomas.parker@alston.com
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`Alston & Bird LLP
`90 Park Avenue, 15th Floor
`New York, NY 10016
`P: 212-210-9529/F: 212-210-9444
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`Counsel for Mylan Laboratories Limited
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`Gerard A. Haddad
`Reg. No. 41,811
`GHaddad@BlankRome.com
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`Blank Rome LLP
`The Chrysler Building
`405 Lexington Ave.
`New York, NY 10174
`P: 212-885-5135/F: 917-591-6921
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`Counsel for Glenmark Pharmaceuticals
`Inc., USA, Glenmark Holding SA, and
`Glenmark Pharmaceuticals Ltd.
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`Paul M. Zagar
`Reg. No. 52,392
`PZagar@BlankRome.com
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`Case IPR 2016-00318
`Patent 7,772,209
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`Reg. No. 69,131
`pkilgore@rmmslegal.com
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`Blank Rome LLP
`The Chrysler Building
`405 Lexington Ave.
`New York, NY 10174
`P: 212-885-5290/F: 917-332-3063
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`Counsel for Emcure Pharmaceuticals
`Ltd., Heritage Pharma Labs Inc., and
`Heritage Pharmaceuticals Inc.
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`Patrick A. Doody
`Reg. No. 35,022
`patrick.doody@pillsburylaw.com
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`Pillsbury Winthrop Shaw Pittman LLP
`1650 Tysons Boulevard
`McLean, VA 22102
`P: 703-770-7755/F: 703-770-7901
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`Counsel for Wockhardt Bio AG
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`Gary J. Speier
`Reg. No. 45,458
`gspeier@carlsoncaspers.com
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`Carlson, Caspers, Vandenburgh,
`Lindquist & Schuman
`225 South Sixth Street, Suite 4200
`Minneapolis, MN 55402
`P: 612-436-9600
`F: 612-436-9605
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`Cynthia Lambert Hardman
`Reg. No. 53,179
`chardman@goodwinprocter.com
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`Goodwin Procter LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
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`Case IPR 2016-00318
`Patent 7,772,209
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`Bryan P. Collins
`Reg. No. 43,560
`bryan.collins@pillsburylaw.com
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`Mark D. Schuman
`Reg. No. 31,197
`mschuman@carlsoncaspers.com
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`Case IPR 2016-00318
`Patent 7,772,209
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`/David M. Krinsky/
`David M. Krinsky
`Reg. No. 72,339
`Back-up Counsel
`for Patent Owner
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`
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`P: 212-813-8800
`F: 212-355-3333
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`Attorneys for Teva Pharmaceuticals
`USA, Inc. and Fresenius Kabi USA,
`LLC
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`Date: January 24, 2017
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