`
`
`
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_________________________
`
`ARGENTUM PHARMACEUTICALS LLC,
`
`Petitioner,
`
`v.
`
`CIPLA LIMITED,
`
`Patent Owner.
`_________________________
`
`Case No.: IPR2017-00807
`Patent No.: 8,168,620 B2
`_________________________
`
`
`PATENT OWNER’S OBJECTIONS TO EVIDENCE
`AS OF MARCH 13, 2018
`
`
`
`
`
`Cipla Limited's Objections to Evidence
` Case IPR2017-00807
`Pursuant to 37 C.F.R. § 42.64(b)(1), Patent Owner Cipla Limited (“Cipla”)
`
`timely objects under the Federal Rules of Evidence (FRE) to the admissibility of
`
`Exhibits 1055-1082, 1084-1085, 1087, 1089-1092, 1094-1125, 1127-1129, 1131-
`
`1139, ¶¶1-20, 26, 32, 38, 41, 50, 56-66, 75-85, 87-111, 113-114, 119-120, 123-
`
`124, 126, 130-131, 133, 137-139, 142, 146, 149, and 151-153 and Exhibits 1, 2a, 5,
`
`and 7 of Exhibit 1140; Exhibit 1141 at 44:13-45:8, 47:15-48:6, 62:17-64:7; Exhibit
`
`1142 at 6:8-11:15, 196:22-198:14, 92:3-94:21, 109:7-115:4, 114:16-121:20; ¶¶1-
`
`6, 10, 43-44, 46-48, 53-54, 72-74, 78, 80, and 94-95 of Exhibit 1144; and ¶¶1-6,
`
`22, 23, 53, 54, 59, 66, 72-73, 78, and 80-81 of Exhibit 1145/1165 1148-1150,
`
`1152-1153, 1159-1165, and 1166-1168 (the “Challenged Evidence"”), served by
`
`Petitioner Argentum Pharmaceuticals LLC (“Argentum”) on March 6, 2018, with
`
`its Reply to the Patent Owner Response. Cipla files these objections to provide
`
`notice to Argentum that Cipla may move to exclude the Challenged Evidence
`
`under 37 C.F.R. § 42.64(c), unless timely cured by Argentum.
`
`2
`
`
`
`I.
`
`
`Cipla Limited's Objections to Evidence
` Case IPR2017-00807
`IDENTIFICATION OF CHALLENGED EVIDENCE AND GROUNDS
`FOR OBJECTIONS
`1. Exhibits 1055-1139, 1148-1150, 1152-1153, 1159-1165, and 1168; ¶¶1-
`20, 26, 32, 38, 41, 50, 56-66, 75-85, 87-111, 113-114, 119-120, 123-124,
`126, 130-131, 133, 137-139, 142, 146, 149, and 151-153 and Exhibits 1,
`2a, 5, and 7 of Exhibit 1140; ¶¶1-6, 10, 43-44, 46-48, 53-54, 72-74, 78, 80,
`and 94-95 of Exhibit 1144; and ¶¶1-6, 22, 23, 53, 54, 59, 66, 72-73, 78,
`and 80-81 of Exhibit 1145/1165.
`
`Cipla objects to the use of Exhibits 1055-1139, 1148-1150, 1152-1153,
`
`1159-1165, and 1168 under FRE 401 and 403. The aforementioned exhibits are not
`
`substantively relied on, or even cited, in Argentum’s Reply. Consequently, these
`
`Exhibits do not appear to make any fact of consequence more or less probable than
`
`it would be without them.
`
`Cipla also objects to paragraphs 1-20, 26, 32, 38, 41, 50, 56-66, 75-85, 87-
`
`111, 113, 114, 119, 120, 123, 124, 126, 130, 131, 133, 137-139, 142, 146, 149, and
`
`151-153 and Exhibits 1, 2a, 5, and 7 of Exhibit 1140; paragraphs 1-6, 10, 43-44,
`
`46-48, 53-54, 72-74, 78, 80, and 94-95 of Exhibit 1144, and paragraphs 1-6, 22,
`
`23, 53, 54, 59, 66, 72-73, 78, and 80-81 of Exhibit 1145/1165 because those
`
`paragraphs are not substantively relied on, or even cited, in Argentum’s Reply, or
`
`they rely on the exhibits listed above, and are therefore not relevant under FRE 401
`
`and 403. Alternatively, if Argentum asserts that the aforementioned paragraphs are
`
`relevant, then Argentum must incorporate them by reference into its Reply. Doing
`
`3
`
`
`
`Cipla Limited's Objections to Evidence
` Case IPR2017-00807
`so, however, makes Argentum’s Reply over length, violating the word count limit
`
`set forth in 37 C.F.R. § 42.24(c).
`
`2. Exhibits 1055, 1057, 1059, 1060, 1061, 1066, 1067, 1068, 1076, 1079,
`1085, 1094, 1099, 1102, 1103, 1104, 1105, 1106, 1107, 1117, 1118, 1121,
`1124, 1128, 1131, 1132, 1136, and 1146.
`
`Cipla objects to Exhibits 1055, 1057, 1059, 1060, 1061, 1066, 1067, 1068,
`
`1076, 1079, 1085, 1094, 1099, 1102, 1103, 1104, 1105, 1106, 1107, 1117, 1118,
`
`1121, 1124, 1128, 1131, 1132, 1136, and 1146 under FRE 401 and 403. The
`
`aforementioned exhibits do not appear to make any fact of consequence more or
`
`less probable than it would be without them.
`
`In addition, Argentum has submitted no evidence to authenticate the
`
`aforementioned exhibits, making them inadmissible under FRE 901.
`
`Argentum also relies upon the contents of the aforementioned exhibits for
`
`the truth of the matters asserted therein. Therefore, the aforementioned exhibits are
`
`inadmissible hearsay under FRE 801 and 802. No exception applies.
`
`Cipla also objects to Exhibits 1094 and 1146 under FRE 106. Exhibits 1094
`
`and 1146 appear to be an excerpts of larger documents, and thus, are incomplete.
`
`4
`
`
`
`Cipla Limited's Objections to Evidence
` Case IPR2017-00807
`3. Exhibits 1056, 1058, 1062, 1063, 1064, 1065, 1069, 1070, 1071, 1072,
`1073, 1074, 1075, 1077, 1078, 1080, 1081, 1082, 1084, 1087, 1089, 1090,
`1091, 1092, 1095, 1096, 1097, 1098, 1100, 1101, 1108, 1109, 1110, 1111,
`1112, 1113, 1114, 1115, 1116, 1119, 1120, 1122, 1123, 1125, 1127, 1129,
`1133, 1134, 1135, 1137, 1138, 1147, 1148, 1149, 1150, 1151, 1152, 1153,
`1154, 1155, 1156, 1159, 1160, 1161, 1162, 1164, 1166, 1167, and 1168.
`
`Cipla objects to Exhibits 1056, 1058, 1062, 1063, 1064, 1065, 1069, 1070,
`
`1071, 1072, 1073, 1074, 1075, 1077, 1078, 1080, 1081, 1082, 1084, 1087, 1089,
`
`1090, 1091, 1092, 1095, 1096, 1097, 1098, 1100, 1101, 1108, 1109, 1110, 1111,
`
`1112, 1113, 1114, 1115, 1116, 1119, 1120, 1122, 1123, 1125, 1127, 1129, 1133,
`
`1134, 1135, 1137, 1138, 1147, 1148, 1149, 1150, 1151, 1152, 1153, 1154, 1155,
`
`1156, 1159, 1160, 1161, 1162, 1164, 1166, 1167, and 1168 under FRE 401 and
`
`403. The aforementioned exhibits do not appear to make any fact of consequence
`
`more or less probable than it would be without them. In addition, Cipla also objects
`
`to Exhibits 1166 and 1167 as being more prejudicial than probative because those
`
`Exhibits are not prior art, making it not relevant to this proceeding.
`
`Argentum also relies upon the contents of the aforementioned exhibits for
`
`the truth of the matters asserted therein. Therefore, the aforementioned exhibits are
`
`inadmissible hearsay under FRE 801 and 802. No exception applies.
`
`Cipla objects to Exhibits 1092, and 1149 under FRE 106. Exhibits 1024,
`
`1033, 1092, and 1149 appear to be an excerpts of a larger document or book, and
`
`thus, are incomplete.
`
`5
`
`
`
`Cipla Limited's Objections to Evidence
` Case IPR2017-00807
`In addition, Cipla objects to Exhibit 1147 under FRE 901 because it appears
`
`to be a compilation of more than one document. In addition, Argentum has
`
`submitted no evidence to authenticate the Exhibit 1147, making it inadmissible
`
`under FRE 901.
`
`4. Exhibit 1148
`Cipla objects to Exhibit 1148 under FRE 401. Under 35 U.S.C. § 331(b), a
`
`petitioner may request cancellation of a patent claim “only on the basis of prior art
`
`consisting of patents or printed publications.” But Exhibit 1148 is not prior art,
`
`making it not relevant to this proceeding.
`
`Cipla also objects to Exhibit 1148 under 403 because it is more prejudicial
`
`than probative: they contain prejudicial statements about what was known in the
`
`art after the invention of the challenged ’620 patent.
`
`5. Exhibit 1055 and ¶¶ 53 and 54 of Exhibit 1144.
`Exhibit 1055 purports to be patient record from Dr. Accetta. See Petitioner’s
`
`Exhibit List As Of March 6, 2018. Cipla objects to Exhibit 1055 under 401 and
`
`403. The aforementioned exhibit does not appear to make any fact of consequence
`
`more or less probable than it would be without it. Moreover, the probative value of
`
`Exhibit 1055 is substantially outweighed by one or more of the following:
`
`incompleteness, unfair prejudice, confusing the issues, misleading, needlessly
`
`6
`
`
`
`Cipla Limited's Objections to Evidence
` Case IPR2017-00807
`presenting cumulative evidence. Also under FRE 401 and 403, Cipla also objects
`
`to Exhibit 1055 as illegible and incomplete.
`
`In addition, under 35 U.S.C. § 331(b), a petitioner may request cancellation
`
`of a patent claim “only on the basis of prior art consisting of patents or printed
`
`publications.” Exhibit 1055 is not prior art, making it not relevant to this
`
`proceeding. Nor is Exhibit 1055 “prior art consisting of patents or printed
`
`publications.” For these additional reasons, Exhibit 1055 is inadmissible under
`
`FRE 403 as being more prejudicial than probative.
`
`Cipla also objects to Exhibit 1055 under FRE 901. Argentum has submitted
`
`no evidence to authenticate the document.
`
`Argentum also relies upon the contents of Exhibit 1055 for the truth of the
`
`matters asserted therein. Therefore, it is inadmissible hearsay under FRE 801 and
`
`802. No exception applies. Indeed, even if an exception existed, Exhibit 1055 is
`
`hearsay within hearsay and is therefore inadmissible.
`
`Moreover, Cipla objects to Exhibit 1055 under FRE 1002. Exhibit 1055 is
`
`not the original document, or even a reproduction of the original, and therefore
`
`Argentum is required to use the original Exhibit 1055 to prove its content.
`
`Cipla further objects to paragraphs 53 and 54 of Exhibit 1144. Because these
`
`paragraphs rely on Exhibit 1055, paragraphs 53 and 54 are inadmissible for the
`
`same reasons. In addition, these paragraphs are inadmissible under FRE 702 and
`
`7
`
`
`
`Cipla Limited's Objections to Evidence
` Case IPR2017-00807
`703. Dr. Schleimer does not have any “scientific, technical, or specialized
`
`knowledge” in examining and treating patients, nor is Dr. Schleimer’s testimony
`
`based on sufficient facts or data nor the product of “reliable principles and
`
`methods.” Furthermore, an expert in Dr. Schleimer’s field would not reasonably
`
`rely on Exhibit 1055, and given that the exhibit is more prejudicial than probative,
`
`it is inadmissible under FRE 703.
`
`6. Paragraphs 18, 50, 87, 89, 90, 92, 108, 149, and Ex. 1 of Exhibit 1140.
`Cipla objects to paragraphs 18, 50, 87, 89, 90, 92, 108, 149, and Ex. 1 of
`
`Exhibit 1140 under FRE 702 and 703. In those paragraphs, Mr. Staines relies on
`
`Exhibits 1007, 1009, 1065, 1071, 1072, 1105, 1125, 1126, and 1127, but Mr.
`
`Staines does not have any “scientific, technical, or specialized knowledge”
`
`pertaining to these types of documents, neither is Mr. Staines’s testimony based on
`
`sufficient facts or data nor the product of “reliable principles and methods.”
`
`Furthermore, an expert in Mr. Staines’s field would not reasonably rely on the
`
`aforementioned exhibits, and given that the exhibits are more prejudicial than
`
`probative, they is inadmissible under FRE 703.
`
`7. Exhibit 1142 at 6:8-11:15, 196:22-198:14, 92:3-94:21, 109:7-115:4,
`114:16-121:20; Exhibit 1141 at 44:13-45:8, 47:15-48:6, 62:17-64:7;
`Exhibit 1144 ¶¶41, 75, 83, 89, 93; and Exhibit 1145/1165 ¶¶81-82.
`
`Cipla objects to Exhibit 1142 at 6:8-11:15, 196:22-198:14, 92:3-94:21,
`
`109:7-115:4, 114:16-121:20; and Exhibit 1141 at 44:13-45:8, 47:15-48:6, 62:17-
`
`8
`
`
`
`Cipla Limited's Objections to Evidence
` Case IPR2017-00807
`64:7 under FRE 401 and 403. 37 C.F.R. § 42.53(d)(5)(ii) states that “the scope of
`
`the [cross]-examination is limited to the scope of the direct testimony.” The
`
`aforementioned cross-examination testimony, however, was objected to during the
`
`deposition as outside the scope of the direct testimony, and therefore, outside the
`
`proper scope of cross-examination. Accordingly, under FRE 401 and 403 this
`
`testimony does not appear to make any fact of consequence more or less probable
`
`than it would be without them. Moreover, probative value of such aforementioned
`
`testimony is outweighed by one or more of the following: prejudice, confusing the
`
`issues, and misleading.
`
`Cipla also objects to paragraphs 41, 75, 83, 89, and 93 of Exhibit 1144 and
`
`paragraphs 81-82 of Exhibit 1145/1165 under FRE 702 and 703. In those
`
`paragraphs, Drs. Schleimer and Donovan rely on the aforementioned deposition
`
`testimony.
`
`Argentum’s Reply and Exhibits 1140, 1144, and 1145/1165.
`
`8.
`Cipla objects to Argentum’s Reply and Exhibits 1140, 1144, and 1145/1165
`
`under 35 U.S.C. § 312(a)(3), 37 C.F.R. § 42.23, 37 C.F.R. § 42.104, and Office
`
`Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,767 (Aug. 14, 2012).
`
`Argentum was required to present all of its arguments and evidence in support of
`
`its invalidity grounds in its case-in-chief in its Petition. Argentum impermissibly
`
`adds new arguments and evidence in its reply and declarations in support thereof.
`
`9
`
`
`
`Cipla Limited's Objections to Evidence
` Case IPR2017-00807
`In addition, Cipla has previously explained that Argentum knew, or should have
`
`known, all the prima facie and objective indicia evidence that Cipla relied upon in
`
`both its POPR and POR. Nevertheless, Argentum waited until its reply to present
`
`additional arguments and evidence that allegedly support its positions. For
`
`example, Exhibits 1055, 1056, 1146, 1149, 1151-1156, 1159-1162, and 1166-1168
`
`all support arguments that Argentum made, or knew it should have made, in its
`
`Petition and are therefore objectionable. Accordingly, every citation to these
`
`exhibits in Argentum’s Reply or declarations in support thereof should be
`
`excluded. As the Trial Guide explains, “[t]he Board will not attempt to sort proper
`
`from improper portions of the reply.” Accordingly, Argentum’s Reply and
`
`supporting declarations should be excluded. Exhibits 1055, 1056, 1148, 1150,
`
`1157, 1159-1162, and CIP2165.
`
`Cipla objects to Exhibits 1055, 1056, 1148, 1150, 1157, 1159-1162, and
`
`CIP2165 under FRE 401 and 403. In its Reply, Argentum improperly relies on
`
`these exhibits as if they were prior art. See, e.g., Paper 30, 5, 17, 19. Each of these
`
`documents was published after the priority date of the ’620 patent, and thus does
`
`not constitute prior art. Accordingly, the probative value of Exhibit 1045 is
`
`substantially outweighed by one or more of the following: unfair prejudice,
`
`confusing the issues, misleading.
`
`10
`
`
`
`Cipla Limited's Objections to Evidence
` Case IPR2017-00807
`
`Exhibit 1146.
`
`9.
`Cipla objects to Exhibit 1146 under FRE 901. Argentum appears to suggest
`
`that Exhibit 1146 is derived from the same source material as Cipla’s exhibit
`
`CIP2113, but Argentum has failed to provide any evidence authenticating Exhibit
`
`1146 or confirming that the two exhibits are related.
`
` CONCLUSION
`II.
`To the extent Argentum fails to correct the defects associated with the
`
`Challenged Evidence in view of Cipla's objections herein, Cipla may file a motion
`
`to exclude the Challenged Evidence under 37 C.F.R. § 42.64(c).
`
`Respectfully submitted,
`
`STERNE, KESSLER, GOLDSTEIN & FOX, PLLC
`
`
`___________________________
`
` Dennies Varughese (Reg. No. 61,868)
`Date: March 13, 2018
`Lead Counsel for Patent Owner
`
`
`
`
`
`1100 New York Avenue, N.W.
`Washington, D.C. 20005-3934
`(202) 371-2600
`
`9122560.1
`
`
`
`
`
`
`
`11
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that the foregoing Patent Owner’s
`
`Objections of Evidence was served electronically via e-mail on March 13, 2018, in
`
`its entirety on the following counsel of record for Petitioners:
`
`Michael R. Houston: mhouston@foley.com
`Joseph P. Meara: jmeara@foley.com
`James P. McParland: jmcparland@foley.com
`Andrew R. Cheslock: acheslock@foley.com
`Tyler C. Liu: TLiu@agpharm.com
`ARG-dymista@foley.com
`
`FOLEY & LARDNER LLP
`321 North Clark Street
`Suite 2800
`Chicago, IL 60654
`
`STERNE, KESSLER, GOLDSTEIN & FOX, PLLC
`
`
`
`
`
`
`
`
`
`
`
`______________________
` Dennies Varughese (Reg. No. 61,868)
`Date: March 13, 2018
`Lead Counsel for Patent Owner
`
`
`
`
`
`1100 New York Avenue, N.W.
`Washington, D.C. 20005-3934
`(202) 371-2600
`
`
`
`
`
`
`
`
`
`
`
`
`