`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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`
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`PATENT OWNER’S OBJECTIONS TO 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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`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 evidence served by Petitioner Sandoz Inc. on
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`December 22, 2016 in connection with its Petition for Inter Partes Review. The
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`exhibits objected to, and grounds for Lilly’s objections, are listed below. Lilly also
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`objects to Petitioner’s reliance on or citations to any objected evidence in its
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`papers.
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`Many of the exhibits served by Sandoz Inc. on December 22, 2016 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 1063
`Lilly objects to Exhibit 1063 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 1063 contains a web page purportedly
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`available to the public in 2001. Exhibit 1063 therefore bears no relevance to what
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`the person of ordinary skill in the art would have known by the relevant date.
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`Therefore, Exhibit 1063 should be excluded under FRE 402 and 403. Lilly further
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`objects to Exhibit 1063 because it has not been properly authenticated under FRE
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`901, is not self-authenticating under FRE 902, and is not a “duplicate” as defined
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`by FRE 1001(e). Exhibit 1063 is therefore inadmissible under FRE 901, 1002, and
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`1003.
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`Exhibit 1067
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`B.
`Lilly objects to Exhibit 1067 under FRE 802 because it is inadmissible
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`hearsay, specifically a portion of a demonstrative exhibit from 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 1067 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. Lilly further objects to Exhibit 1067 because it has not
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`been properly authenticated under FRE 901, is not self-authenticating under FRE
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`902, and is not a “duplicate” as defined by FRE 1001(e). Exhibit 1067 is therefore
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`inadmissible under FRE 901, 1002, and 1003. Lilly also objects to Exhibit 1067
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`because it is incomplete, and it therefore should be excluded under FRE 106, 401,
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`402, and 403.
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`C. Exhibit 1071
`Lilly objects to Exhibit 1071 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 1071 contains a web page purportedly
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`available to the public in 2016. Exhibit 1071 therefore bears no relevance to what
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`the person of ordinary skill in the art would have known by the relevant date.
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`Therefore, Exhibit 1071 should be excluded under FRE 402 and 403. Lilly further
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`objects to Exhibit 1071 because it has not been properly authenticated under FRE
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`901, is not self-authenticating under FRE 902, and is not a “duplicate” as defined
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`by FRE 1001(e). Exhibit 1071 is therefore inadmissible under FRE 901, 1002, and
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`1003.
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`D. Exhibit 1074
`Lilly objects to Exhibit 1074, the transcript of the deposition of Dr. Bruce
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`Chabner, as incomplete because Petitioner has not filed all exhibits introduced at
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`the deposition, including the exhibits Lilly introduced on redirect. It therefore
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`should be excluded under FRE 106, 401, 402, and 403.
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`Exhibit 1075
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`E.
`Lilly objects to Exhibit 1075, the reply declaration of Dr. Ron D. Schiff,
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`under FRE 402 to the extent it includes or relies on irrelevant or inadmissible
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`information and under FRE 403 to the extent that it includes or relies on
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`information—such as Exhibit 1078—the probative value of which is substantially
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`outweighed by the danger of unfair prejudice, wasting time, or needlessly
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`presenting cumulative evidence. See, e.g., Ex. 1075 at 36.
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`Lilly further objects to Exhibit 1075 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 1089. See, e.g., Ex. 1075 at 18.
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`Exhibit 1076
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`F.
`Lilly objects to Exhibit 1076 under FRE 402 and 403 to the extent Petitioner
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`relies on it as prior art or as reflecting the state of the prior art because it is
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`irrelevant and its probative value is substantially outweighed by the danger of
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`wasting time in this compressed proceeding. Exhibit 1076 was created in 2000 by
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`individuals at Lilly who had knowledge of the invention and was not available to
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`the public; it therefore bears no relevance to what the person of ordinary skill in the
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`art would have known by the relevant date.
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`G. Exhibit 1077
`Lilly objects to Exhibit 1077 under FRE 402 and 403 to the extent Petitioner
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`relies on it as prior art or as reflecting the state of the prior art because it is
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`irrelevant and its probative value is substantially outweighed by the danger of
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`wasting time in this compressed proceeding. Exhibit 1077 was created on
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`December 3, 1999 by individuals at Lilly who had knowledge of the invention and
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`was not available to the public; it therefore bears no relevance to what the person
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`of ordinary skill in the art would have known by the relevant date.
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`H. Exhibit 1078
`Lilly objects to Exhibit 1078 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 1078 was published in 2002 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 1078 should be excluded under FRE 402
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`and 403.
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`Exhibit 1079
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`I.
`Lilly objects to Exhibit 1079 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 1079 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
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`by the relevant date. Therefore, Exhibit 1079 should be excluded under FRE 402
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`and 403.
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`Exhibit 1080
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`J.
`Lilly objects to Exhibit 1080 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 1080 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 1080 should be excluded under FRE 402
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`and 403.
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`K. Exhibit 1081
`Lilly objects to Exhibit 1081 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 1081 was published in 2012 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 1081 should be excluded under FRE 402
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`and 403.
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`Exhibit 1082
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`L.
`Lilly objects to Exhibit 1082 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 1082 contains web pages purportedly
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`available to the public in 2001 and later. Exhibit 1082 therefore bears no relevance
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`to what the person of ordinary skill in the art would have known by the relevant
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`date. Therefore, Exhibit 1082 should be excluded under FRE 402 and 403.
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`M. Exhibit 1083
`Lilly objects to Exhibit 1083 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 1083 was published in 2001 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 1083 should be excluded under FRE 402
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`and 403.
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`N. Exhibit 1084
`Lilly objects to Exhibit 1084 under FRE 402 and 403 to the extent Petitioner
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`relies on it as prior art or as reflecting the state of the prior art because it is
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`irrelevant and its probative value is substantially outweighed by the danger of
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`wasting time in this compressed proceeding. Exhibit 1084 was created in 2000 by
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`individuals at Lilly who had knowledge of the invention and was not available to
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`the public; it therefore bears no relevance to what the person of ordinary skill in the
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`art would have known by the relevant date.
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`O. Exhibit 1085
`Lilly objects to Exhibit 1085 under FRE 402 and 403 to the extent Petitioner
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`relies on it as prior art or as reflecting the state of the prior art because it is
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`irrelevant and its probative value is substantially outweighed by the danger of
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`wasting time in this compressed proceeding. Exhibit 1085 was created in 2000 by
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`individuals at Lilly who had knowledge of the invention and was not available to
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`the public; it therefore bears no relevance to what the person of ordinary skill in the
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`art would have known by the relevant date.
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`Exhibit 1086
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`P.
`Lilly objects to Exhibit 1086 as incomplete because it does not include the
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`relevant errata sheet served on Petitioner on December 28, 2016 and because
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`Petitioner has not filed all exhibits introduced at the deposition. It therefore should
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`be excluded under FRE 106, 401, 402, and 403.
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`Q. Exhibit 1088
`Lilly objects to Exhibit 1088 under FRE 402 and 403 to the extent Petitioner
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`relies on it as prior art or as reflecting the state of the prior art because it is
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`irrelevant and its probative value is substantially outweighed by the danger of
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`wasting time in this compressed proceeding. Exhibit 1088 was created in 2001 by
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`individuals at Lilly who had knowledge of the invention and was not available to
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`the public; it therefore bears no relevance to what the person of ordinary skill in the
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`art would have known by the relevant date.
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`R. Exhibit 1089
`Lilly objects to Exhibit 1089 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 1089 was published in 2002 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 1089 should be excluded under FRE 402
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`and 403.
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`Exhibit 1091
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`S.
`Lilly objects to Exhibit 1091, the reply declaration of Dr. Patrick J. Stover,
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`under FRE 402 to the extent it includes or relies on irrelevant or inadmissible
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`information and under FRE 403 to the extent that it includes or relies on
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`information the probative value of which is substantially outweighed by the danger
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`of unfair prejudice, wasting time, or needlessly presenting cumulative evidence.
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`Lilly further objects to Exhibit 1091 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 1109. See, e.g., Ex. 1091 at 9.
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`Exhibit 1092
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`T.
`Lilly objects to Exhibit 1092 under FRE 402 and 403 to the extent that it is
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`irrelevant and its probative value is substantially outweighed by the danger of
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`wasting time in this compressed proceeding. Although Exhibit 1092 indicates it
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`was published in 1999, Exhibit 1092 does not indicate when in 1999 it was
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`published. To the extent Exhibit 1092 is not prior art, it should be excluded under
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`FRE 402 and 403.
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`U. Exhibit 1093
`Lilly objects to Exhibit 1093, the declaration of Dr. David B. Ross, under
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`FRE 402 to the extent it includes or relies on irrelevant or inadmissible information
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`and under FRE 403 to the extent that it includes or relies on information the
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`probative value of which is substantially outweighed by the danger of unfair
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`prejudice, wasting time, or needlessly presenting cumulative evidence.
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`Lilly further objects to Exhibit 1093 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.
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`Lilly also objects to Exhibit 1093 because it does not comply with FRE 602,
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`FRE 702-703, the requirements for an expert declaration, and 37 C.F.R. § 42.65,
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`including that it improperly includes opinions without having demonstrated the
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`requisite expertise, basis, methodology or foundation. Exhibit 1093 contains
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`content over which the testifier has no personal knowledge, as well as putative
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`expert testimony that is unqualified, unreliable, and based on facts or data that
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`experts in the field would not reasonably rely upon. See Daubert v. Merrell Dow
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`Pharms., Inc., 509 U.S. 579 (1993).
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`V. Exhibit 1096
`Lilly objects to Exhibit 1096 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 1096 was published in 2015 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 1096 should be excluded under FRE 402
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`and 403.
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`W. Exhibit 1097
`Lilly objects to Exhibit 1097 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 1097 was purportedly published in 2010 and,
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`therefore, bears no relevance to what the person of ordinary skill in the art would
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`have known by the relevant date. Therefore, Exhibit 1097 should be excluded
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`under FRE 402 and 403.
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`X. Exhibit 1098
`Lilly objects to Exhibit 1098 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 1098 was published in 2007 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 1098 should be excluded under FRE 402
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`and 403.
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`Y. Exhibit 1099
`Lilly objects to Exhibit 1099 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 1099 was purportedly published in 2002 and
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`is dated 2016 and, therefore, bears no relevance to what the person of ordinary skill
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`in the art would have known by the relevant date. Therefore, Exhibit 1099 should
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`be excluded under FRE 402 and 403. Lilly further objects to Exhibit 1099 because
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`it has not been properly authenticated under FRE 901, is not self-authenticating
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`under FRE 902, and is not a “duplicate” as defined by FRE 1001(e). Exhibit 1099
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`is therefore inadmissible under FRE 901, 1002, and 1003.
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`Z.
`Exhibit 1100
`Exhibit 1100 purports to describe a table with reference ranges for, inter
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`alia, creatinine, but that exhibit is incomplete. Exhibit 1100 includes only a
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`portion of the excerpted table with no description of that table or the data contained
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`therein. Therefore, Exhibit 1100 should be excluded under FRE 106, 401, 402,
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`and 403.
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`AA. Exhibit 1104
`Lilly objects to Exhibit 1104 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 1104 was published in 2000 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 1104 should be excluded under FRE 402
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`and 403.
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`BB. Exhibit 1106
`Lilly objects to Exhibit 1106 under FRE 402 and 403 to the extent that it is
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`irrelevant and its probative value is substantially outweighed by the danger of
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`wasting time in this compressed proceeding. Although Exhibit 1106 indicates it
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`was published in 1999, Exhibit 1106 does not indicate when in 1999 it was
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`published. To the extent Exhibit 1106 is not prior art, it should be excluded under
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`FRE 402 and 403.
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`CC. Exhibit 1109
`Lilly objects to Exhibit 1109 because it has not been properly authenticated
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`under FRE 901, is not self-authenticating under FRE 902, and is not a “duplicate”
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`as defined by FRE 1001(e). Exhibit 1109 is therefore inadmissible under FRE 901,
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`1002, and 1003.
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`DD. Exhibit 1119
`Lilly objects to Exhibit 1119 to the extent Petitioner relies on it as prior art
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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 in this compressed
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`proceeding. Exhibit 1119 was not available to the public in 1999 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.
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`EE. Exhibit 1120
`Lilly objects to Exhibit 1120 to the extent Petitioner relies on it as prior art
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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 in this compressed
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`proceeding. Exhibit 1120 was not available to the public in 1999 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.
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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
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`Date: December 30, 2016
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`Case IPR 2016-00318
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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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`December 30, 2016 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
`
`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.
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`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
`
`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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`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
`
`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
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`/Dov P. Grossman/
`Dov P. Grossman
`Reg. No. 72,525
`Lead Counsel for Patent Owner
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`
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`P: 212-813-8800
`F: 212-355-3333
`
`Attorneys for Teva Pharmaceuticals
`USA, Inc. and Fresenius Kabi USA,
`LLC
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`Date: December 30, 2016