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