Case IPR 2016-00318
`Patent 7,772,209
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`SANDOZ INC.,
`Petitioner,
`
`v.
`
`ELI LILLY & COMPANY,
`Patent Owner.
`__________________
`
`Case No: IPR2016-00318
`Patent No. 7,772,209
`__________________
`
`PATENT OWNER’S OBJECTIONS TO EVIDENCE
`
`
`Patent 7,772,209
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`SANDOZ INC.,
`Petitioner,
`
`v.
`
`ELI LILLY & COMPANY,
`Patent Owner.
`__________________
`
`Case No: IPR2016-00318
`Patent No. 7,772,209
`__________________
`
`PATENT OWNER’S OBJECTIONS TO EVIDENCE
`
`
`
`Case IPR 2016-00318
`Patent 7,772,209
`Patent Owner Eli Lilly & Company (“Lilly”) hereby objects pursuant to 37
`
`C.F.R. § 42.64(b)(1) and the Federal Rules of Evidence (“FRE”) to the
`
`admissibility of certain purported evidence served by Sandoz Inc. 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.
`
`I.
`
`IDENTIFICATION OF CHALLENGED EVIDENCE AND GROUNDS
`FOR OBJECTIONS
`
`A.
`
`Exhibit 1002
`
`Lilly objects to Exhibit 1002 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 1002 is therefore inadmissible under FRE 901,
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`1002, and 1003.
`
`B.
`
`Exhibit 1004
`
`Lilly objects to Exhibit 1004, the declaration of Dr. Ron D. Schiff, 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 1031—the probative value of which is substantially outweighed by the
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`danger of unfair prejudice, wasting time, or needlessly presenting cumulative
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`evidence. See, e.g., Ex. 1004 at 50, 52.
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`Case IPR 2016-00318
`Patent 7,772,209
`Lilly further objects to Exhibit 1004 under FRE 901, 1002, and 1003 on the
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`basis that it cites or relies on exhibits that have not been properly authenticated or
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`lack foundation, such as Exhibit 1002. See, e.g., Ex. 1004 at 12. Lilly further
`
`objects to Exhibit 1004 for failing to comply with 37 C.F.R. § 42.53.
`
`Lilly further objects to Appendix D of Exhibit 1004 under FRE 401 and 402
`
`as irrelevant, as unfairly prejudicial, needlessly cumulative, and wasting time under
`
`FRE 403, because it has not been properly authenticated under FRE 901 and is not
`
`self-authenticating under FRE 902, and as inadmissible hearsay under FRE 801
`
`and 802. Appendix D of Exhibit 1004 is a claim chart summarizing Petitioner’s
`
`positions regarding other exhibits and, therefore, is not admissible evidence in this
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`proceeding, including because it does not tend to make a fact more or less probable
`
`so as to be relevant evidence and is thus irrelevant and inadmissible under FRE
`
`401. Under the rules, claim charts such as Appendix D of Exhibit 1004 may be
`
`included in a Petition, but are counted toward the page (now word) limits; the
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`submission of a claim chart as an appendix to an exhibit is an improper attempt to
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`evade those limits, and Appendix D of Exhibit 1004 should not be considered.
`
`Lilly further objects to Appendix D of Exhibit 1004 under FRE 402 as irrelevant
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`and as unfairly prejudicial, needlessly cumulative, and wasting time under FRE
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`403 to the extent that this exhibit is not expressly relied on in Petitioner’s Petition
`
`for Inter Partes Review. Lilly further objects to Appendix D of Exhibit 1004
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`Case IPR 2016-00318
`Patent 7,772,209
`because it is a claim chart whose author and source have not been identified, and
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`thus it has not been properly authenticated under FRE 901 and is not self-
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`authenticating under FRE 902. Lilly further objects to Appendix D of Exhibit
`
`1004 as inadmissible hearsay under FRE 801 and FRE 802 because it is an out-of-
`
`court statement being offered to prove the truth of the matter asserted by a
`
`declarant who has not been identified and is not available for cross examination.
`
`C.
`
`Exhibit 1008
`
`Lilly objects to Exhibit 1008 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 1008 is date stamped September 8, 1999,
`
`and, therefore, bears no relevance to what the person of ordinary skill in the art
`
`would have known by the relevant date. Therefore, Exhibit 1008 should be
`
`excluded under FRE 402 and 403.
`
`D.
`
`Exhibit 1022
`
`Lilly objects to Exhibit 1022 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 Petition for Inter Partes
`
`Review or Dr. Schiff’s declaration.
`
`E.
`
`Exhibit 1024
`
`Lilly objects to Exhibit 1024 because it has not been properly authenticated
`
`under FRE 901, is not self-authenticating under FRE 902, and is not a “duplicate”
`4
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`Case IPR 2016-00318
`Patent 7,772,209
`as defined by FRE 1001(e). Exhibit 1024 is therefore inadmissible under FRE 901,
`
`1002, and 1003.
`
`F.
`
`Exhibit 1026
`
`Lilly objects to Exhibit 1026 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 1026 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 1026 should be excluded under FRE 402
`
`and 403. Lilly further objects to Exhibit 1026 for failing to comply with 37 C.F.R.
`
`§ 42.53. Lilly further objects to Exhibit 1026 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 1026 is therefore inadmissible
`
`under FRE 901, 1002, and 1003.
`
`G.
`
`Exhibit 1027
`
`Lilly objects to Exhibit 1027 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 1027 does not have a 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
`
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`Case IPR 2016-00318
`Patent 7,772,209
`relevant date. Therefore, Exhibit 1027 should be excluded under FRE 402 and
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`403.
`
`H.
`
`Exhibit 1031
`
`Lilly objects to Exhibit 1031 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 1031 indicates it was accepted for
`
`publication on January 7, 1999, Exhibit 1031 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 1031 should be excluded under FRE 402
`
`and 403.
`
`I.
`
`Exhibit 1032
`
`Lilly objects to Exhibit 1032 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 1032 was published in August 1999 and,
`
`therefore, bears no relevance to what the person of ordinary skill in the art would
`
`have known by the relevant date. Therefore, Exhibit 1032 should be excluded
`
`under FRE 402 and 403.
`
`J.
`
`Exhibit 1037
`
`Lilly objects to Exhibit 1037 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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`Case IPR 2016-00318
`Patent 7,772,209
`this compressed proceeding. Exhibit 1037 was published in 2003 and, therefore,
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`bears no relevance to what the person of ordinary skill in the art would have known
`
`by the relevant date. Therefore, Exhibit 1037 should be excluded under FRE 402
`
`and 403.
`
`K.
`
`Exhibit 1042
`
`Lilly objects to Exhibit 1042 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 1042 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 1042 should be excluded under FRE 402
`
`and 403.
`
`L.
`
`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
`
`this compressed proceeding. Exhibit 1046 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 1046 should be excluded under FRE 402
`
`and 403.
`
`7
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`
`
`Date: June 30, 2016
`
`Case IPR 2016-00318
`Patent 7,772,209
`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
`
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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))
`
`The undersigned hereby certifies that the foregoing Patent Owner’s
`
`Objections to Evidence was served on June 30, 2016 by delivering a copy via
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`electronic mail on the following attorneys of record for the Petitioner:
`
`Ralph J. Gabric
`Reg. No. 34,167
`rgabric@brinksgilson.com
`
`Laura Lydigsen
`Pro hac vice
`llydigsen@brinksgilson.com
`
`Brinks Gilson & Lione
`455 Cityfront Plaza Drive
`Suite 3600 NBC Tower
`Chicago, IL 60611-5599
`T: 312-321-4200; F: 312-321-4299
`
`Bryan T. Richardson, Ph.D.
`Reg. No. 70,572
`brichardson@brinksgilson.com
`
`Brinks Gilson & Lione
`4721 Emperor Blvd.
`Suite 220
`Durham, NC 27703-8580
`T: 919-998-5700; F: 919-998-5701
`
`Date: June 30, 2016
`
`/Dov P. Grossman/
`Dov P. Grossman
`Reg. No. 72,525
`Lead Counsel for Patent Owner
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