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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
`
`WEST-WARD PHARMACEUTICALS INTERNATIONAL LIMITED,
`Petitioner
`
`v.
`
`NOVARTIS AG
`Patent Owner
`_______________________
`
`Case IPR2017-01592
`U.S. Patent No. 8,410,131
`_______________________
`
`
`PETITIONER’S OPPOSITION TO
`PATENT OWNER’S MOTION TO EXCLUDE
`
`
`
`
`
`TABLE OF CONTENTS
`
`Table of Authorities .................................................................................................. ii
`
`I.
`
`II.
`
`The Board Should Deny Novartis’s Motion To Exclude Paragraphs Of
`The Pantuck Declarations And Exhibits Not Cited In The Petition Or
`Reply ................................................................................................................ 2
`
`The Board Should Deny Novartis’s Motion To Exclude Paragraphs Of
`Dr. Pantuck’s Declarations That Provide Background And Context .............. 4
`
`III. The Board Should Deny Novartis’s Motion To Exclude References
`That Novartis Alleges Are Not Prior Art ........................................................ 5
`
`IV. The Board Should Deny Novartis’s Motion To Exclude Exhibits First
`Cited In Petitioner’s Reply Or In Dr. Pantuck’s Reply Declaration ............... 6
`
`V. Dr. Pantuck’s Reply Declaration Is Not Misleading With Respect To
`The Cited Testimony Of Dr. Burris ................................................................. 7
`
`VI. The Board Should Deny Novartis’s Motion To Exclude Dr. Pantuck’s
`Opinions Concerning A SciFinder Search ...................................................... 8
`
`VII. The Board Should Deny Novartis’s Motion To Exclude Exhibits For
`Lack Of Authentication And/Or Lack Of Public Availability ........................ 9
`
`VIII. Novartis’s Catch-All Fails To Identify Any Objections Or Evidence
`Or Otherwise Demonstrate Anything Should Be Excluded ..........................11
`
`IX. Conclusion .....................................................................................................12
`
`
`
`
`
`
`
`
`i
`
`
`
`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Liberty Mutual Ins. v. Progressive Cas. Ins.,
`CBM2012-00002, Paper 66 (Jan. 23, 2014) ......................................................... 7
`
`Mobile Tech, Inc. v. Invue Security Prods. Inc.,
`IPR2016-00892, Paper 33 (Sept. 28, 2017) .......................................................... 8
`
`Other Authorities
`
`37 C.F.R. § 42.20 ..................................................................................................... 11
`
`37 C.F.R. § 42.22 ..................................................................................................... 11
`
`37 C.F.R. § 42.62(a) ................................................................................................... 7
`
`37 C.F.R. § 42.64(b)(1) ............................................................................................ 11
`
`37 C.F.R. § 42.64(c) ............................................................................................. 7, 11
`
`F.R.E. 901(a) .............................................................................................................. 9
`
`F.R.E. 901(b)(4) ......................................................................................................... 9
`
`FRE 106 ..................................................................................................................... 8
`
`
`
`
`
`ii
`
`
`
`
`
`West-Ward Pharmaceuticals International Limited (“West-Ward” opposes
`
`Patent Owner Novartis AG’s (“Novartis”) Motion To Exclude (Paper No. 61).
`
`Novartis moves to exclude or strike the following seven categories of
`
`evidence:
`
`(1) Exhibits and paragraphs of Dr. Pantuck’s declarations not cited in the
`Petition or Reply (Mot. ¶ a. at 1 and 4);
`
`
`(2)
`
`Paragraphs of Dr. Pantuck’s declarations not specifically identified or
`discussed in detail in the Petition or Reply (Mot. ¶ b. at 1 and 4-6);
`
`
`(3) Exhibits (both cited in the Petition or Reply and not cited in the
`Petition or Reply) that Novartis alleges Petitioner has failed to prove
`are prior art, and paragraphs of Dr. Pantuck’s declarations that rely on
`these exhibits (Mot. ¶ c. at 1-2 and 6-8);
`
`
`(4) Exhibits that were first cited in Petitioner’s Reply or in Dr. Pantuck’s
`Reply Declaration (Mot. ¶ d. at 2-3 and 8-10);
`
`
`(5)
`
`
`(6)
`
`Paragraphs in Dr. Pantuck’s Reply Declaration citing to Dr. Burris’s
`testimony as “incomplete and misleading” or considering portions of
`Exhibits 1126 and 1130 (Mot. ¶ e. at 3 and 10-12);
`
`Paragraphs in Dr. Pantuck’s Reply Declaration concerning the results
`of a “SciFinder” search because Dr. Pantuck did not personally carry
`out the search (Mot. ¶ f. at 3 and 12); and
`
`
`(7) Exhibits 1011, 1060, and 1147 on the basis that Ex. 1101 is
`unauthenticated and that none of these exhibits includes information
`sufficient to establish that these exhibits were publicly available as of
`the stated dates (Mot. ¶ g. at 3-4 and 13-14).
`
`
`Finally, Novartis includes a vague and generic request to exclude evidence that
`
`does not appear in instituted grounds other than evidence used for the limited
`
`1
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`
`
`
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`purposes of describing the state of the art or reinforcing the meaning of a prior art
`
`reference included in the instituted grounds. Mot. at 14.
`
`For the reasons discussed below, Novartis fails to establish that any evidence
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`should be excluded and Novartis’s motion should be denied.
`
`I.
`
`The Board Should Deny Novartis’s Motion To Exclude Paragraphs Of
`The Pantuck Declarations And Exhibits Not Cited In The Petition Or
`Reply
`
`Novartis seeks to exclude portions of exhibits and expert testimony that are
`
`not directly cited in Petitioners’ Petition or Reply. There is no requirement that
`
`Petitioner directly cite every exhibit that an expert witness used to form his/her
`
`considered opinions or cite each paragraph of an expert declaration.
`
`Moreover, the exhibits cited by Novartis are cited or referred to in
`
`Dr. Pantuck’s Declaration (Ex. 1010) or Reply Declaration (Ex. 1159). See, e.g.,
`
`exhibits cited in the Pantuck Declaration (Ex. 1010) (Exs. 1028 at ¶ 8, 1029, n.2 at
`
`p. 9, 1030 at ¶ 25, 1031 at ¶ 29, 1032 at 39, 1033-1034 at ¶ 53, 1035 at ¶ 57, 1036-
`
`38 at ¶ 61, 1040 at ¶ 63, 1041-1042 at ¶ 72, 1043-1044 at ¶ 123, 1045-108 at ¶ 95,
`
`1049-1052 at ¶ 96, 1053-54 at ¶ 97, 1056-1057 at ¶ 98, 1058 at ¶ 99, 1060-106 at
`
`¶ 100, 1062-1067 at ¶ 102, 1068 n.4, p. 47, 1070-1071 at ¶ 107, 1072 at ¶ 108,
`
`1073 at ¶ 109, 1074-1076 at ¶ 110, 1077 at ¶ 111, 1078 at ¶ 113, 1079-1083 at
`
`¶ 114, 1084 at ¶ 115, 1086-1087 at ¶ 117, 1088-1089 at ¶ 118, 1090-1091 at ¶ 120,
`
`1092 at ¶ 121, 1093-1099 at ¶ 122, 1100-1101 at ¶ 123, 1102-1103 at ¶ 140, 1104-
`
`2
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`
`
`
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`1106 at ¶ 141, 1107-1111 at ¶ 142); and exhibits cited in the Pantuck Reply
`
`Declaration (Ex. 1159) (1121 at ¶ 141, 1122 at ¶ 4, 1123-1125 Burris deposition
`
`exhibits, 1126 Burris deposition transcript at ¶ 4, 1128-1129 at ¶ 4, 1131 at ¶ 87,
`
`1132 at ¶ 113, 1135 at ¶ 117, 1136 at ¶ 352, 1137 at ¶ 149, 1138 at ¶ 151, 1139 at
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`¶ 86, 1140 n.37 at pp. 125-126, 1041 at ¶ 86, 1143 at ¶ 4, 1144 at37, 1145 at ¶ 87
`
`1146 at ¶ 130, 1148 at ¶ 87, 1149 at ¶ 88, 1150 n.4 at p. 33, 1151 at ¶ 113, 1152
`
`n.20 at p. 83, 1153 at ¶ 139, 1154 n.7 at p. 39, 1155 at ¶ 81, 1156 specification
`
`sheet for HTB-44 which relates to n.8 and ¶ 86, 1158 n.9 at p. 43).
`
`Further, there is no requirement to directly cite each paragraph of an expert
`
`declaration, such as those included for context and information used to form
`
`conclusions, like the following paragraphs of the Pantuck Declaration (Ex. 1010)
`
`(¶¶ 1-18 (personal experience and understanding of applicable law); 21-23, 25, and
`
`27-30 (compound structures and descriptions), 66-67 (understanding of claim
`
`terms), 139 (background on kidney tumors), 148 (understanding of applicable law),
`
`236-239 (understanding of applicable law and conclusions)); or the following
`
`paragraphs of the Pantuck Reply Declaration (Ex. 1159) (¶¶ 1-71 (background as
`
`to materials considered, understanding of claim terms, understanding of state of the
`
`art), 74 (understanding of Dr. Burris’s definition of a POSA), 76-82 and 104-109
`
`(understanding of Dr. Burris’s testimony), 84-100 (understanding of the art), 111-
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`130 (summary of Dr. Burris citation errors), 147-225 (description of known
`
`3
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`
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`activity of mTOR inhibitors), 250-258 (description of prior art), 263-269
`
`(description of prior art), 279-281 (understanding of applicable law and
`
`conclusions), 288 (agrees with Board’s conclusions in Institution Decision), 300-
`
`325 (understanding of Dr. Burris and Dr. Komanduri arguments and backgrounds)
`
`and 383 (unaware of any secondary considerations)).
`
`II. The Board Should Deny Novartis’s Motion To Exclude Paragraphs Of
`Dr. Pantuck’s Declarations That Provide Background And Context
`
`Novartis seeks to exclude portions of Dr. Pantuck’s declarations because
`
`“numerous paragraphs are not specifically identified or discussed in any detail in
`
`the Petition or Reply.” (Mot. 4-6.)
`
`There is no requirement that Petitioner directly cite or discuss in detail each
`
`paragraph of an expert declaration, even those included for context such as
`
`background summaries of Dr. Burris’s Declaration and prosecution of the ’149
`
`patent, art summaries, and conclusion (e.g., Ex. 1159 ¶¶ 134-146, 226-249, 326-
`
`340, 341-382), as well as description of terms used in the declaration such as a
`
`POSA, rapamycin, everolimus, understanding of claim terms, background state of
`
`the art, background summaries of the art, description of the ’131 patent (e.g.,
`
`Ex. 1010 ¶¶ 20, 24, 26, 31-65, 68-69; 71-73, 76-77, 79, 81-84, 87-88, 91-92, 94-
`
`132, 134, 136-138, 140-147, 151-157, 159-161, 164-166, 168-172, 174-176, 179-
`
`188, 190-192, 195-216, 219-222, 225-226, 228-233, 235, 244, 246-247, 280, 284,
`
`290, 294-296, 306 and 308), and so forth.
`
`4
`
`
`
`
`
`III. The Board Should Deny Novartis’s Motion To Exclude References That
`Novartis Alleges Are Not Prior Art
`
`Novartis asserts that Petitioner has failed to demonstrate that Exhibits 1023,
`
`1024 and 1147 are prior art as of February 2001 and/or February 2002 and that
`
`accordingly the Board should exclude those exhibits, the paragraphs of
`
`Dr. Pantuck’s declarations that rely on those exhibits (Ex. 1010, ¶ 63 and Ex. 1159,
`
`¶¶ 275, 299, 317) and the portions of the Petition (at pp. 20 and 59) and Reply (at
`
`p. 18) that rely on those exhibits. In addition, Novartis asserts that Petitioner has
`
`failed to demonstrate that Exhibits 1031, 1036, 1040, 1059-1061, 1076, 1092-
`
`1096, 1140 and 1137, which are not cited in the Petition or Reply, are prior art as
`
`of February 2001 and/or February 2002, and the Board should exclude these
`
`exhibits and the paragraphs of Dr. Pantuck’s declarations that rely on these
`
`exhibits, i.e., Ex. 1010 ¶¶ 29 (Ex. 1031), 61-62 (Ex. 1036), 63 (Ex. 1040), 100
`
`(Exs. 1059-1061), 110-111, (Ex. 1076), 113 (Ex. 1040), 114 (Ex. 1031), 116
`
`(Ex. 1040), 117 (Exs. 1040, 1076), 119 (Ex. 1031), 120 (Ex. 1076), 121
`
`(Ex. 1092), 122 (Exs. 1093-1096), 186 (Exs. 1093-1096), and Ex. 1159 ¶¶ 67
`
`(Ex. 1031), 73 (Ex. 1140), 79 (Ex. 1031), 81 (Exs. 1040, 1092), 83 (Ex. 1040), 84-
`
`85 (Ex. 1092), 87-88, 92, 94-99, 101, and 113 (Ex. 1040), 149 (Ex. 1137), 152
`
`(Ex. 1092), 215 (Exs. 1093-1096), 215 n.37 (Ex. 1140), 220 n.39 and 224 n.40
`
`(Ex. 1059). Novartis’s motion presents substantive arguments about the
`
`5
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`
`
`
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`admissibility of these exhibits.1 A motion to exclude, however, is not an
`
`opportunity to present substantive arguments. As set forth in the Trial Practice
`
`Guide Update (August 2018): “A motion to exclude … may not be used to
`
`challenge the sufficiency of the evidence to prove a particular fact.” Trial Practice
`
`Guide Update (August 2018), II.K. Challenging Admissibility: Motions to
`
`Exclude; Motions to Strike, at 16. For at least this reason, the Board should deny
`
`this portion of Novartis’s motion to exclude.
`
`IV. The Board Should Deny Novartis’s Motion To Exclude Exhibits First
`Cited In Petitioner’s Reply Or In Dr. Pantuck’s Reply Declaration
`
`Novartis argues that several exhibits were not cited in the June 12, 2017
`
`Petition but instead were first cited in the Reply and that this constitutes “a
`
`prolonged and unexplained delay.” These exhibits were cited in Petitioner’s Reply
`
`and in the Declaration of Dr. Pantuck as timely rebuttal to the First Burris
`
`Declaration (Ex. 2001), corrected second declaration of Dr. Burris (Ex. 2092)
`
`dated April 4, 2018, and deposition testimony of Dr. Burris which took place on
`
`May 24, 2018 (Ex. 1126). Petitioner’s timely citation of these exhibits in rebuttal
`
`to Patent Owner’s arguments does not constitute a prolonged and unexplained
`
`
`1 West-Ward contends that the ‘131 patent is only entitled to a priority date of
`
`February 18, 2002.
`
`6
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`
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`
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`delay, and Patent Owner’s assertion that Petitioner should have made these
`
`arguments in the Petition is without merit.
`
`V. Dr. Pantuck’s Reply Declaration Is Not Misleading With Respect To
`The Cited Testimony Of Dr. Burris
`
`Novartis contends that the Board should exclude portions of the Pantuck
`
`Reply Declaration that rely on allegedly “incomplete and misleading citations” to
`
`the testimony of Dr. Burris. In making this argument, Novartis improperly
`
`attempts to engage in self-help and garner additional briefing on the merits by
`
`making arguments regarding its own expert’s testimony. Novartis’s arguments
`
`regarding its own expert’s testimony seek to bolster its as-filed Response,
`
`impermissibly taking another shot at the merits of the petition. Liberty Mutual Ins.
`
`v. Progressive Cas. Ins., CBM2012-00002, Paper 66 at 62 (Jan. 23, 2014). The
`
`Board should deny Novartis’s motion rather than reward Novartis’s self-help
`
`efforts, a reward that would encourage future parties to do the same.
`
`A motion to exclude is not a motion for observations on the testimony of a
`
`party’s own expert or an opportunity to present additional substantive arguments.
`
`See 37 C.F.R. §§ 42.62(a), 42.64(c). To present such substantive argument,
`
`Novartis required permission from the Board—permission that Novartis lacks. See
`
`e.g. email denying request to substitute sur-reply for observations on cross
`
`examination dated August 17, 2018.
`
`7
`
`
`
`
`
`Moreover, Novartis’s invocation of FRE 106 does not substitute for the
`
`leave that would be required from the Board to make the substantive arguments
`
`that Novartis attempts to make through its motion. FRE 106 provides that “[i]f a
`
`party introduces all or part of a writing or recorded statement, an adverse party
`
`may require the introduction, at that time, of any other part—or any other writing
`
`or recorded statement—that in fairness out to be considered at the same time.”
`
`(Emphasis added.) The full transcript of Dr. Burris’s testimony is already in the
`
`record (Ex. 1126), and no “other part” of the transcript needs to be “introduced.”
`
`Further, FRE 106 “provides a basis for including, rather than excluding, evidence.”
`
`Mobile Tech, Inc. v. Invue Security Prods. Inc., IPR2016-00892, Paper 33 at 68-69
`
`(Sept. 28, 2017). As such, Novartis’s substantive arguments presented under the
`
`guise of FRE 106 should be disregarded.
`
`VI. The Board Should Deny Novartis’s Motion To Exclude Dr. Pantuck’s
`Opinions Concerning A SciFinder Search
`
`Novartis asserts that that several paragraphs of Dr. Pantuck’s Reply
`
`Declaration concerning a SciFinder search (Ex. 1150) should be excluded because
`
`Dr. Pantuck did not himself conduct the “SciFinder” search. As support, Novartis
`
`cites Power Integrations in which “the expert could not clearly identify the source
`
`of the data on which he relied.” Mot. at 12. As can be clearly seen, Exhibit 1150
`
`includes the legend “SciFinder® Search Results for Rapamycin References
`
`limited to Tumor or Cancer (1980-2002)” and the footer “Copyright © 2018
`
`8
`
`
`
`
`
`American Chemical Society (ACS). All Rights Reserved.” The source of the
`
`SciFinder Search results, a search for rapamycin references limited to tumor or
`
`cancer date limited to 1980-2002, is apparent on the face of Exhibit 1150.
`
`Moreover, as noted above in Section III, a motion to exclude is not an
`
`opportunity to present substantive arguments.
`
`VII. The Board Should Deny Novartis’s Motion To Exclude Exhibits For
`Lack Of Authentication And/Or Lack Of Public Availability
`
`Novartis asserts that Exhibit 1011 should be excluded because there is no
`
`evidence that this document is authentic or was publicly available as of February
`
`2001 or February 2002, that Exhibit 1060 fails on its face to demonstrate that the
`
`information was published in the American Journal of Transplantation and was
`
`publicly available as of February 2001 or February 2002, and that Exhibit 1147
`
`fails on its face to demonstrate that the information relied upon therein was
`
`publicly available as of February 2001 or February 2002.
`
`“To satisfy the requirement of authenticating, or identifying an item of
`
`evidence, the proponent must produce evidence sufficient to support a finding that
`
`the item is what the proponent claims it is.” F.R.E. 901(a). This authentication
`
`requirement may be satisfied by the “appearance, contents, substance, internal
`
`patterns, or other distinctive characteristics of the item, taken together with all the
`
`circumstances.” F.R.E. 901(b)(4).
`
`9
`
`
`
`
`
`The “distinctive characteristics” of Exhibit 1011 “taken together with all the
`
`circumstances” provide sufficient authentication here. Exhibit 1011 includes a
`
`cover letter and prescribing information or package insert for Rapamune®
`
`(sirolimus) Oral Solution. The cover letter in Exhibit 1011 is electronically signed
`
`by an FDA (a United States government agency) official, Dr. Sandra L. Kweder,
`
`Acting Director, Office of Drug Evaluation IV, Center for Drug Evaluation and
`
`Research, and refers to submissions for a new drug application for Rapamune®
`
`(sirolimus) Oral Solution. Further, Novartis has itself cited exhibit 2025, the
`
`prescribing information or package insert for Rapamune® (sirolimus) Oral Solution
`
`which is essentially identical to the package insert in Exhibit 1011. See e.g. (Ex.
`
`2025 and pp. 39 and 69 of Corrected Patent Owner Response, Paper No. 33 ).
`
`With respect to Novartis’s assertions that Exhibits 1011, 1060 and 1147
`
`were not publicly available as of February 2001 or February 2002, as noted above
`
`a motion to exclude is not an opportunity to present substantive arguments, such as
`
`whether the evidence proves that an Exhibit was publicly available.2
`
`
`2 West-Ward contends that the ‘131 patent is only entitled to a priority date of
`
`February 18, 2002.
`
`10
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`
`
`
`
`VIII. Novartis’s Catch-All Fails To Identify Any Objections Or Evidence Or
`Otherwise Demonstrate Anything Should Be Excluded
`
`Without pointing to any specific exhibits, Novartis seeks to exclude “any
`
`evidence that does not appear in the instituted grounds, other than evidence used
`
`for the limited purposes of describing the state of the art or reinforcing the meaning
`
`of a prior art reference included in the instituted grounds.” Novartis’s motion is
`
`deficient and should be denied because Novartis failed to meet any requirements
`
`for a motion to exclude. For example, Novartis failed to point to and explain any
`
`timely raised objections “identify[ing] the grounds for the objection with sufficient
`
`particularity to allow correction in the form of supplemental evidence” because
`
`there are none. 37 C.F.R. § 42.64(b)(1), (c). Novartis also failed to include any
`
`explanation, much less the required detailed explanation, of any particular
`
`evidence and material facts at issue or the relief requested. 37 C.F.R. §§ 42.20,
`
`42.22). Finally, Novartis failed to demonstrate that any of the unidentified
`
`evidence was not properly submitted in reply to Novartis’s own arguments. For at
`
`least these reasons, Novartis’s deficient motion should be denied.
`
`
`
`
`
`11
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`
`
`
`
`IX. Conclusion
`For the above reasons, the Board should deny Novartis’s motion to exclude.
`
`
`Date: August 22, 2018
`
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`Respectfully submitted,
`
`
`
`
`
`
`
`
`By: /Marta E. Delsignore/
`Marta E. Delsignore (Reg. No. 32,689)
`GOODWIN PROCTER LLP
`620 Eighth Avenue
`New York, NY 10018
`212-813-8822
`mdelsignore@goodwinprocter.com
`
`Counsel for Petitioner West-Ward
`Pharmaceuticals International Limited
`
`
`
`12
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`
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`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), I certify that on this 22nd day of August,
`
`2018, a true and correct copy of the foregoing PETITIONERS’ OPPOSITION
`
`TO PATENT OWNER’S MOTION TO EXCLUDE was served by electronic
`
`mail on Patent Owner’s lead and backup counsel at the following email address:
`
`
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`
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`
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`
`
`
`
`
`
`
`
`Nicholas N. Kallas
`Laura K. Fishwick
`Fitzpatrick, Cella, Harper & Scinto
`nkallas@fchs.com
`lfishwick@fchs.com
`ZortressAfinitorIPR@fchs.com
`
`
`
`
`
`
`
`
`
`
`
`By: /Marta E. Delsignore/
`
`Marta E. Delsignore (Reg. No. 32,689)
`GOODWIN PROCTER LLP
`620 Eighth Avenue
`New York, NY 10018
`212-813-8822
`mdelsignore@goodwinprocter.com
`
`Counsel for Petitioner West-Ward
`Pharmaceuticals International Limited
`
`
`
`
`
`
`
`
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