Case IPR 2016-00237
`Patent 7,772,209
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`NEPTUNE GENERICS, LLC,
`APOTEX INC., APOTEX CORP., TEVA PHARMACEUTICALS,
`FRESENIUS KABI USA, LLC, and
`WOCKHARDT BIO AG
`Petitioners,
`
`v.
`
`ELI LILLY & COMPANY,
`Patent Owner.
`__________________
`
`Case No: IPR2016-002371
`Patent No. 7,772,209
`__________________
`
`
`
`PATENT OWNER’S OBJECTIONS TO EVIDENCE
`
`
`
`
`
`
`1 Cases IPR2016-01190, IPR2016-01335, and IPR2016-01341 have been joined
`
`with the instant proceeding.
`
`
`
`
`Patent 7,772,209
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`NEPTUNE GENERICS, LLC,
`APOTEX INC., APOTEX CORP., TEVA PHARMACEUTICALS,
`FRESENIUS KABI USA, LLC, and
`WOCKHARDT BIO AG
`Petitioners,
`
`v.
`
`ELI LILLY & COMPANY,
`Patent Owner.
`__________________
`
`Case No: IPR2016-002371
`Patent No. 7,772,209
`__________________
`
`
`
`PATENT OWNER’S OBJECTIONS TO EVIDENCE
`
`
`
`
`
`
`1 Cases IPR2016-01190, IPR2016-01335, and IPR2016-01341 have been joined
`
`with the instant proceeding.
`
`
`
`
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`Case IPR 2016-00237
`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
`
`admissibility of certain purported evidence served by Petitioner Neptune Generics,
`
`LLC, on December 22, 2016 in connection with its Petition for Inter Partes
`
`Review. The exhibits objected to, and grounds for Lilly’s objections, are listed
`
`below. Lilly also objects to Petitioner’s reliance on or citations to any objected
`
`evidence in its papers.
`
`Many of the exhibits served by Petitioner Neptune Generics, LLC, on
`
`December 22, 2016 were introduced at depositions in this proceeding, and Lilly
`
`objected to certain of those exhibits at the depositions as required by 37 C.F.R.
`
`§ 42.64(a). Nothing contained herein shall be deemed to withdraw any of Lilly’s
`
`objections to deposition evidence or the requirement that evidence to cure those
`
`objections must have been provided during the deposition, see id.
`
`I.
`
`IDENTIFICATION OF CHALLENGED EVIDENCE AND GROUNDS
`FOR OBJECTIONS
`A. Exhibit 1043
`Lilly objects to Exhibit 1043 under FRE 402 and 403 because it is irrelevant
`
`and its probative value is substantially outweighed by the danger of wasting time in
`
`this compressed proceeding. Exhibit 1043 was published in 2002 and, therefore,
`
`bears no relevance to what the person of ordinary skill in the art would have known
`
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`Case IPR 2016-00237
`Patent 7,772,209
`by the relevant date. Therefore, Exhibit 1043 should be excluded under FRE 402
`
`and 403.
`
`Exhibit 1044
`
`B.
`Lilly objects to Exhibit 1044 under FRE 402 and 403 because it is irrelevant
`
`and its probative value is substantially outweighed by the danger of wasting time in
`
`this compressed proceeding. Exhibit 1044 was published in 2015 and, therefore,
`
`bears no relevance to what the person of ordinary skill in the art would have known
`
`by the relevant date. Therefore, Exhibit 1044 should be excluded under FRE 402
`
`and 403.
`
`C. Exhibit 1045
`Lilly objects to Exhibit 1045 under FRE 402 and 403 because it is irrelevant
`
`and its probative value is substantially outweighed by the danger of wasting time in
`
`this compressed proceeding. Exhibit 1045 was published in 2015 and, therefore,
`
`bears no relevance to what the person of ordinary skill in the art would have known
`
`by the relevant date. Therefore, Exhibit 1045 should be excluded under FRE 402
`
`and 403. Lilly further objects to Exhibit 1045 as incomplete as it is missing pages,
`
`and it therefore should be excluded under FRE 106, 401, 402, and 403.
`
`D. Exhibit 1046
`Lilly objects to Exhibit 1046 under FRE 402 and 403 because it is irrelevant
`
`and its probative value is substantially outweighed by the danger of wasting time in
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`this compressed proceeding. Exhibit 1046 does not have a discernable publication
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`Case IPR 2016-00237
`Patent 7,772,209
`date and indicates that it was obtained on 11/15/2016, and Petitioner has not
`
`established that it is prior art. Absent such a showing, it bears no relevance to what
`
`the person of ordinary skill in the art would have known by the relevant date.
`
`Therefore, Exhibit 1046 should be excluded under FRE 402 and 403. Lilly further
`
`objects to Exhibit 1046 as incomplete as it is missing pages, and it therefore should
`
`be excluded under FRE 106, 401, 402, and 403. Lilly also objects to Exhibit 1046
`
`because it has not been properly authenticated under FRE 901, is not self-
`
`authenticating under FRE 902, and is not a “duplicate” as defined by FRE 1001(e).
`
`Exhibit 1046 is therefore inadmissible under FRE 901, 1002, and 1003.
`
`Exhibit 1047
`
`E.
`Lilly objects to Exhibit 1047 under FRE 402 and 403 because it is irrelevant
`
`and its probative value is substantially outweighed by the danger of wasting time in
`
`this compressed proceeding. Exhibit 1047 was published in 2001 and, therefore,
`
`bears no relevance to what the person of ordinary skill in the art would have known
`
`by the relevant date. Therefore, Exhibit 1047 should be excluded under FRE 402
`
`and 403.
`
`Exhibit 1050
`
`F.
`Lilly objects to Exhibit 1050 under FRE 802 because it is inadmissible
`
`hearsay, specifically deposition testimony from Dr. Bruce Chabner in a different
`
`proceeding, Sandoz Inc. et al. v. Eli Lilly, IPR2016-00318. Lilly further objects to
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`Case IPR 2016-00237
`Patent 7,772,209
`Exhibit 1050 under FRE 402 and 403 because it is irrelevant and its probative
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`value is substantially outweighed by the danger of wasting time and needlessly
`
`presenting cumulative evidence in this compressed proceeding. Lilly also objects
`
`to Exhibit 1050 as incomplete because it does not include the relevant errata sheet
`
`served on the parties to IPR2016-00318 on December 12, 2016, and it therefore
`
`should be excluded under FRE 106, 401, 402, and 403.
`
`G. Exhibit 1051
`Lilly objects to Exhibit 1051 under FRE 802 because it is inadmissible
`
`hearsay, specifically trial testimony from Dr. Bruce Chabner in a different
`
`proceeding, Eli Lilly v. Teva Parenteral Meds., Inc. et al., 1:10-cv-01376-TWP-
`
`DKL (S.D. Ind.). Lilly further objects to Exhibit 1051 under FRE 402 and 403
`
`because it is irrelevant and its probative value is substantially outweighed by the
`
`danger of wasting time and needlessly presenting cumulative evidence in this
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`compressed proceeding.
`
`H. Exhibit 1052
`Lilly objects to Exhibit 1052 under FRE 802 because it is inadmissible
`
`hearsay, specifically deposition testimony from Dr. Bruce Chabner in a different
`
`proceeding, Eli Lilly v. Teva Parenteral Meds., Inc. et al., 1:10-cv-01376-TWP-
`
`DKL (S.D. Ind.). Lilly further objects to Exhibit 1052 under FRE 402 and 403
`
`because it is irrelevant and its probative value is substantially outweighed by the
`
`
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`Case IPR 2016-00237
`Patent 7,772,209
`danger of wasting time and needlessly presenting cumulative evidence in this
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`compressed proceeding.
`
`Exhibit 1053
`
`I.
`Lilly objects to Exhibit 1053 under FRE 402 and 403 to the extent that it is
`
`irrelevant and its probative value is substantially outweighed by the danger of
`
`wasting time in this compressed proceeding. Although Exhibit 1053 indicates it
`
`was published in 1999, Exhibit 1053 does not indicate when in 1999 it was
`
`published. To the extent Exhibit 1053 is not prior art, it should be excluded under
`
`FRE 402 and 403.
`
`Exhibit 1055
`
`J.
`Lilly objects to Exhibit 1055 under FRE 802 because it is inadmissible
`
`hearsay, specifically deposition testimony from Dr. Steven Zeisel in a different
`
`proceeding, Eli Lilly v. Teva Parenteral Meds., Inc. et al., 1:10-cv-01376-TWP-
`
`DKL (S.D. Ind.). Lilly further objects to Exhibit 1055 under FRE 402 and 403
`
`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.
`
`K. Exhibit 1056
`Lilly objects to Exhibit 1056 under FRE 802 because it is inadmissible
`
`hearsay, specifically trial testimony from Dr. Steven Zeisel in a different
`
`proceeding, Eli Lilly v. Teva Parenteral Meds., Inc. et al., 1:10-cv-01376-TWP-
`6
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`Case IPR 2016-00237
`Patent 7,772,209
`DKL (S.D. Ind.). Lilly further objects to Exhibit 1056 under FRE 402 and 403
`
`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.
`
`Exhibit 1057
`
`L.
`Lilly objects to Exhibit 1057 under FRE 402 and 403 because it is irrelevant
`
`and its probative value is substantially outweighed by the danger of wasting time in
`
`this compressed proceeding. Exhibit 1057 purportedly contains minutes from a
`
`meeting occurring in 2001 and, therefore, bears no relevance to what the person of
`
`ordinary skill in the art would have known by the relevant date. Therefore, Exhibit
`
`1057 should be excluded under FRE 402 and 403. Lilly further objects to Exhibit
`
`1057 under FRE 802 because it is inadmissible hearsay.
`
`M. Exhibit 1058
`Lilly objects to Exhibit 1058 under FRE 402 and 403 because it is irrelevant
`
`and its probative value is substantially outweighed by the danger of wasting time in
`
`this compressed proceeding. Although Exhibit 1058 indicates it was accepted for
`
`publication on April 12, 1999, Exhibit 1058 does not have a final publication date
`
`and Petitioner has not established that it is prior art. Absent such a showing, it
`
`bears no relevance to what the person of ordinary skill in the art would have known
`
`
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`7
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`Case IPR 2016-00237
`Patent 7,772,209
`by the relevant date. Therefore, Exhibit 1058 should be excluded under FRE 402
`
`and 403.
`
`N. Exhibit 1076
`Lilly objects to Exhibit 1076 as incomplete because it does not include the
`
`relevant errata sheet served on Petitioner on December 28, 2016. It therefore
`
`should be excluded under FRE 106, 401, 402, and 403.
`
`O. Exhibit 1077
`Lilly objects to Exhibit 1077, the supplemental declaration of Dr. W. Archie
`
`Bleyer, under FRE 402 to the extent it includes or relies on irrelevant or
`
`inadmissible information and under FRE 403 to the extent that it includes or relies
`
`on information—such as Exhibit 1058—the probative value of which is
`
`substantially outweighed by the danger of unfair prejudice, wasting time, or
`
`needlessly presenting cumulative evidence. See, e.g., Ex. 1077 at 66.
`
`Lilly further objects to Exhibit 1077 under FRE 901, 1002, and 1003 on the
`
`basis that it cites or relies on exhibits that have not been properly authenticated or
`
`lack foundation.
`
`Exhibit 1078
`
`P.
`Lilly objects to Exhibit 1078, the declaration of Dr. Joel B. Mason, under
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`FRE 402 to the extent it includes or relies on irrelevant or inadmissible information
`
`and under FRE 403 to the extent that it includes or relies on information—such as
`
`Exhibit 1086—the probative value of which is substantially outweighed by the
`8
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`Case IPR 2016-00237
`Patent 7,772,209
`danger of unfair prejudice, wasting time, or needlessly presenting cumulative
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`evidence. See, e.g., Ex. 1078 at 16.
`
`Lilly further objects to Exhibit 1078 under FRE 901, 1002, and 1003 on the
`
`basis that it cites or relies on exhibits that have not been properly authenticated or
`
`lack foundation, such as Exhibit 1089. See, e.g., Ex. 1078 at 22, 23.
`
`Q. Exhibit 1080
`Lilly objects to Exhibit 1080, the declaration of Dr. David W. Feigal, Jr.,
`
`under FRE 402 to the extent it includes or relies on irrelevant or inadmissible
`
`information and under FRE 403 to the extent that it includes or relies on
`
`information the probative value of which is substantially outweighed by the danger
`
`of unfair prejudice, wasting time, or needlessly presenting cumulative evidence.
`
`Lilly further objects to Exhibit 1080 under FRE 901, 1002, and 1003 on the
`
`basis that it cites or relies on exhibits that have not been properly authenticated or
`
`lack foundation.
`
`Lilly also objects to Exhibit 1080 because it does not comply with FRE 602,
`
`FRE 702-703, the requirements for an expert declaration, and 37 C.F.R. § 42.65,
`
`including that it improperly includes opinions without having demonstrated the
`
`requisite expertise, basis, methodology or foundation. Exhibit 1080 contains
`
`content over which the testifier has no personal knowledge, as well as putative
`
`expert testimony that is unqualified, unreliable, and based on facts or data that
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`Case IPR 2016-00237
`Patent 7,772,209
`experts in the field would not reasonably rely upon. See Daubert v. Merrell Dow
`
`Pharms., Inc., 509 U.S. 579 (1993).
`
`R. Exhibit 1083
`Lilly objects to Exhibit 1083 under FRE 402 as irrelevant and as unfairly
`
`prejudicial, needlessly cumulative, and wasting time under FRE 403 to the extent
`
`that this exhibit is not expressly relied on in Petitioner’s Reply or the declarations
`
`of Drs. Bleyer, Mason, and Feigal.
`
`Exhibit 1086
`
`S.
`Lilly objects to Exhibit 1086 under FRE 402 and 403 because it is irrelevant
`
`and its probative value is substantially outweighed by the danger of wasting time in
`
`this compressed proceeding. Exhibit 1086 was published in 2007 and, therefore,
`
`bears no relevance to what the person of ordinary skill in the art would have known
`
`by the relevant date. Therefore, Exhibit 1086 should be excluded under FRE 402
`
`and 403.
`
`Exhibit 1089
`
`T.
`Lilly objects to Exhibit 1089 because it has not been properly authenticated
`
`under FRE 901, is not self-authenticating under FRE 902, and is not a “duplicate”
`
`as defined by FRE 1001(e). Exhibit 1089 also contains handwritten notes imposed
`
`on top of the document in the exhibit. The super-imposed handwriting has not
`
`been properly authenticated under FRE 901, is not self-authenticating under FRE
`
`
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`10
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`Case IPR 2016-00237
`Patent 7,772,209
`902, and is not a “duplicate” as defined by FRE 1001(e). Exhibit 1089 is therefore
`
`inadmissible under FRE 901, 1002, and 1003.
`
`Lilly further objects to Exhibit 1089 under FRE 402 and 403 because it is
`
`irrelevant and its probative value is substantially outweighed by the danger of
`
`wasting time in this compressed proceeding. Exhibit 1089 was published in 2016
`
`and, therefore, bears no relevance to what the person of ordinary skill in the art
`
`would have known by the relevant date. Therefore, Exhibit 1089 should be
`
`excluded under FRE 402 and 403
`
`U. Exhibit 1091
`Lilly objects to Exhibit 1091 under FRE 402 and 403 because it is irrelevant
`
`and its probative value is substantially outweighed by the danger of wasting time in
`
`this compressed proceeding. Although Exhibit 1091 indicates it was accepted for
`
`publication on June 22, 1999, Exhibit 1091 does not have a final publication date
`
`and Petitioner has not established that it is prior art. Absent such a showing, it
`
`bears no relevance to what the person of ordinary skill in the art would have known
`
`by the relevant date. Therefore, Exhibit 1091 should be excluded under FRE 402
`
`and 403.
`
`V. Exhibit 1097
`Exhibit 1097 contains handwritten notes imposed on top of the document in
`
`the exhibit. The super-imposed handwriting has not been properly authenticated
`
`
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`11
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`Case IPR 2016-00237
`Patent 7,772,209
`under FRE 901, is not self-authenticating under FRE 902, and is not a “duplicate”
`
`as defined by FRE 1001(e). Exhibit 1097 is therefore inadmissible under FRE 901,
`
`1002, and 1003. Lilly further objects to Exhibit 1097 as incomplete because it
`
`contains only one page of Section 6. It therefore should be excluded under FRE
`
`106, 401, 402, and 403.
`
`W. Exhibit 1098
`Lilly objects to Exhibit 1098 under FRE 402 and 403 because it is irrelevant
`
`and its probative value is substantially outweighed by the danger of wasting time in
`
`this compressed proceeding. Exhibit 1098 was published in 2000 and, therefore,
`
`bears no relevance to what the person of ordinary skill in the art would have known
`
`by the relevant date. Therefore, Exhibit 1098 should be excluded under FRE 402
`
`and 403.
`
`X. Exhibit 1099
`Lilly objects to Exhibit 1099 under FRE 402 and 403 because it is irrelevant
`
`and its probative value is substantially outweighed by the danger of wasting time in
`
`this compressed proceeding. Although Exhibit 1099 indicates it was accepted for
`
`publication on March 16, 1999, Exhibit 1099 does not have a final publication date
`
`and Petitioner has not established that it is prior art. Absent such a showing, it
`
`bears no relevance to what the person of ordinary skill in the art would have known
`
`
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`12
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`Case IPR 2016-00237
`Patent 7,772,209
`by the relevant date. Therefore, Exhibit 1099 should be excluded under FRE 402
`
`and 403.
`
`Y. Exhibit 1100
`Lilly objects to Exhibit 1100 under FRE 402 and 403 because it is irrelevant
`
`and its probative value is substantially outweighed by the danger of wasting time in
`
`this compressed proceeding. Exhibit 1100 does not have a discernable publication
`
`date and Petitioner has not established that it is prior art. Absent such a showing, it
`
`bears no relevance to what the person of ordinary skill in the art would have known
`
`by the relevant date. Therefore, Exhibit 1100 should be excluded under FRE 402
`
`and 403.
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`Respectfully submitted,
`
`/Dov P. Grossman/
`Dov P. Grossman
`Reg. No. 72,525
`Lead Counsel for
`Patent Owner
`
`Williams & Connolly LLP
`725 Twelfth Street, N.W.
`Washington, D.C. 20005
`202-434-5812 (Telephone)
`202-434-5029 (Facsimile)
`dgrossman@wc.com
`
`
`
`13
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`Date: December 30, 2016
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`Case IPR 2016-00237
`Patent 7,772,209
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`CERTIFICATE OF SERVICE
`(37 C.F.R. § 42.6(e))
`
`The undersigned hereby certifies that the foregoing document was served on
`
`
`
`December 30, 2016 by delivering a copy via electronic mail on the following
`
`attorneys of record for the Petitioners:
`
`Sarah E. Spires
`Reg. No. 61,501
`237Neptune@skiermontderby.com
`
`Skiermont Derby LLP
`2200 Ross Ave., Ste. 4800W
`Dallas, Texas 75201
`P: 214-978-6600/F: 214-978-6601
`
`Attorneys for Neptune Generics, LLC
`
`John D. Polivick
`Reg. No. 57,926
`jpolivick@rmmslegal.com
`
`William A. Rakoczy
`Pro hac vice to be filed
`wrakoczy@rmmslegal.com
`
`Rakoczy Molino Mazzochi Siwik LLP
`6 West Hubbard Street, Suite 500
`Chicago, IL
`P: 312-527-2157/F: 312-527-4205
`
`Attorneys for Apotex Inc. and Apotex
`Corp.
`
`Gary J. Speier
`Reg. No. 45,458
`gspeier@carlsoncaspers.com
`
`
`
`
`Dr. Parvathi Kota
`Reg. No. 65,122
`237Neptune@skiermontderby.com
`
`
`
`
`Deanne M. Mazzochi
`Reg. No. 50,158
`dmazzochi@rmmslegal.com
`
`Patrick C. Kilgore
`Reg. No. 69,131
`pkilgore@rmmslegal.com
`
`
`
`Mark D. Schuman
`Reg. No. 31,197
`mschuman@carlsoncaspers.com
`
`
`
`
`
`
`Case IPR 2016-00237
`Patent 7,772,209
`
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`
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`
`
`Bryan P. Collins
`Reg. No. 43,560
`bryan.collins@pillsburylaw.com
`
`
`/Dov P. Grossman/
`Dov P. Grossman
`Reg. No. 72,525
`Lead Counsel for Patent Owner
`
`
`
`Date: December 30, 2016
`
`
`
`
`
`Carlson, Caspers, Vandenburgh,
`Lindquist & Schuman
`225 South Sixth Street, Suite 4200
`Minneapolis, MN 55402
`P: 612-436-9600
`F: 612-436-9605
`
`Cynthia Lambert Hardman
`Reg. No. 53,179
`chardman@goodwinprocter.com
`
`Goodwin Procter LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`P: 212-813-8800
`F: 212-355-3333
`
`Attorneys for Teva Pharmaceuticals
`USA, Inc. and Kabi Fresenius USA,
`LLC
`
`Patrick A. Doody
`Reg. No. 35,022
`patrick.doody@pillsburylaw.com
`
`Pillsbury Winthrop Shaw Pittman LLP
`1650 Tysons Boulevard
`McLean, VA 22102
`P: 703-770-7755/F: 703-770-7901
`
`Counsel for Wockhardt Bio AG
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