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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 IPR2017-015921
`Patent US 8,410,131 B2
`_______________________
`
`
`WEST-WARD PHARMACEUTICALS INTERNATIONAL LIMITED’S
`RESPONSE TO PATENT OWNER OBSERVATIONS ON CROSS-
`EXAMINATION OF ALLAN J. PANTUCK, M.D.
`
`
`
`
`1 IPR2018-00507 has been joined to this proceeding.
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`
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`
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`TABLE OF CONTENTS
`
`Table of Authorities .................................................................................................. ii
`
`I.
`
`II.
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`Response To Observation I: Wasik And Navarro .......................................... 1
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`Response To Observation II: Zhang And Wasik 1994 ................................... 2
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`III. Response To Observation III: Cottens WO ’010 ............................................ 3
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`IV. Response To Observation IV: Determining The Scope Of “Tumor” ............ 3
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`V.
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`Response To Observation V: Lymphoproliferative Disorders ....................... 3
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`VI. Response To Observation VI: Temsirolimus Dosing And Everolimus ......... 3
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`VII. Response To Observation VII: Tumor Proliferation Despite mTOR
`Inhibition .......................................................................................................... 4
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`VIII. Response To Observations VIII, IX, X, XII, And XIII ................................... 4
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`IX. Response To Observation XI: Petitioner’s Chart Of “Rapamycin-
`Tumor-Related References” ............................................................................ 4
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`i
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`TABLE OF AUTHORITIES
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` Page(s)
`
`Cases
`Actelion Pharm. v. Icos,
`IPR2015-00561, Paper 33 (Mar. 18, 2016) ........................................................... 1
`
`LG Elecs. v. ATI Techs.,
`IPR2015-00325, Paper 52 (Jan. 25, 2016) ............................................................ 1
`
`Medtronic v. Nuvasive,
`IPR2013-00506, Paper 37 (Oct. 15, 2014) ............................................................ 1
`
`
`
`
`
`ii
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`
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`
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`Novartis, in its observations on cross-examination of Dr. Pantuck (Paper 60,
`
`“Obs.”), impermissibly argues its case rather than concisely pointing out relevant
`
`testimony and its relevance. That is, Novartis’s argumentative observations
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`impermissibly characterize the subject testimony rather than quoting it or accurately
`
`summarizing it, address multiple passages in a single observation, characterize
`
`other exhibits, re-argue old arguments, and introduce new arguments. Actelion
`
`Pharm. v. Icos, IPR2015-00561, Paper 33 at 2-3 (Mar. 18, 2016) (examples of
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`offending observations are in Actelion Ex. 1049 at 14-15); LG Elecs. v. ATI Techs.,
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`IPR2015-00325, Paper 52 at 3-4 (Jan. 25, 2016); Medtronic v. Nuvasive, IPR2013-
`
`00506, Paper 37 at 3-4 (Oct. 15, 2014) (dismissing motion that included argument).
`
`Petitioners’ Response identifies Novartis’s improper observations. The
`
`responses use the same organization as Novartis’s observations.
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`I.
`
`Response To Observation I: Wasik And Navarro
`
`Novartis cites and mischaracterizes incomplete testimony at Exhibit 2113 at
`
`164:12-165:6 and 207:18-20. Novartis mischaracterizes Dr. Pantuck’s testimony
`
`relating to Wasik and Navarro. Novartis cites Exhibit 2113 at 164:12-165:6 and
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`207:18-20 to argue that Dr. Pantuck “admitted that solid excretory system tumors
`
`were ‘not specifically enumerated’ in Navarro.” Obs. at 1. Novartis states that this
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`is relevant because “Dr. Pantuck testified that without preclinical data in a specific
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`cancer, a POSA would not have had a reasonable expectation that a rapamycin
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`1
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`
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`analog would inhibit the growth of that cancer.” Id. Novartis’s citation of
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`Dr. Pantuck’s testimony, however, is incomplete and out of context. At 164:19-23,
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`Dr. Pantuck explains: “I would say the same answer that I gave previously for the
`
`incorporation of the term ‘tumor’ from Cottens, similarly in Navarro, that a tumor
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`without any further limitation as an example of a hyperproliferative disorder.” At
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`207:21-208:2, Dr. Pantuck explains, “Wasik lists tumors of the kidney as being
`
`one type that can be inhibited with -- with everolimus.”
`
`II. Response To Observation II: Zhang And Wasik 1994
`Novartis mischaracterizes and misquotes Exhibit 2113 at 118:4-18 and
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`124:8-126:33. Novartis argues that “Dr. Pantuck admitted that ‘a POSA would
`
`understand’ Wasik 1994 used ‘tumor’ ‘to refer to a liquid tumor’ and the Wasik
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`1994 ‘authors used the term “nonlymphoid tumor” to refer to solid tumors’; and
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`that Zhang did ‘not disclose any type of solid tumor.’” Obs. at 2. However,
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`Dr. Pantuck specifically testified that Wasik’s use of the term “tumor” as referring
`
`to a lymphoma in a paragraph in Wasik 1994 was limited to “this context in this
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`paragraph,” not how Wasik 1994 understood the definition of “tumor” generally.
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`Ex. 2113, 124:20-22. This testimony, therefore, is not relevant to how Cottens
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`used the term “tumor” or how that term was incorporated by reference into Wasik.
`
`Dr. Pantuck also did not state that Zhang did “not disclose any type of solid
`
`tumor.” See Obs. At 2. This quote does not appear anywhere in Exhibit 2113.
`
`2
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`
`
`
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`Instead, with regard to Zhang, Dr. Pantuck testified that “there’s nothing tested in
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`this paper specifically on solid tumor cell lines” (118:16-18) and that “Zhang is --
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`is studying a pathway in a particular liquid tumor cell model that may or may not
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`be relevant to a solid tumor as well” (118:11-13).
`
`III. Response To Observation III: Cottens WO ’010
`Novartis mischaracterizes and misquotes Exhibit 2113 at 162:9-16.
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`Dr. Pantuck did not agree, as Novartis alleges, that Cottens WO ’010 did “not
`
`specifically mention kidney tumors.” Instead, Dr. Pantuck testified that “It
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`includes tumors without any further limitation.” 162:15-16.
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`IV. Response To Observation IV: Determining The Scope Of “Tumor”
`No response is necessary because it does not impact Petitioner’s arguments
`
`at Reply at 18.
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`V. Response To Observation V: Lymphoproliferative Disorders
`Novartis does not identify any testimony from Dr. Pantuck that specifically
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`addresses the distinction between “anti-tumor” and “anti-PTLD” activity. Instead,
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`Novartis improperly argues its position regarding this distinction. For this reason,
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`the entirety of Observation V is improper.
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`VI. Response To Observation VI: Temsirolimus Dosing And Everolimus
`Novartis does not identify any testimony from Dr. Pantuck that specifically
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`addresses whether everolimus “had different pharmacokinetic properties than
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`temsirolimus and rapamycin.” Obs. at 5. Instead, Novartis improperly argues its
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`3
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`position regarding everolimus’s pharmacokinetic properties and what was known
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`about the dose of everolimus that would potentially inhibit tumor growth in cancer
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`patients. For this reason, the entirety of Observation VI is improper.
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`VII. Response To Observation VII: Tumor Proliferation Despite mTOR
`Inhibition
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`Novartis does not identify any testimony from Dr. Pantuck that specifically
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`addresses the relevance of Price and Bierer to a POSA in the 2001 or 2002 time
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`frame. Instead, Novartis makes improper attorney argument regarding the
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`relevance of Price and Bierer. For this reason, the entirety of Observation VII is
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`improper.
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`VIII. Response To Observations VIII, IX, X, XII, And XIII
`Each of observations VIII, IX, X, XII and XIII make improper attorney
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`argument rather than limiting the respective observations to cited testimony and
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`explaining the relevance of that testimony. For this reason, each of Observations
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`VIII, IX, X, XII and XIII, in their entirety, are improper.
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`IX. Response To Observation XI: Petitioner’s Chart Of “Rapamycin-
`Tumor-Related References”
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`Novartis inserts improper attorney argument instead of limiting the
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`observation to cited testimony and explaining the relevance of that testimony. For
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`this reason, the entirety of Observation XI is improper. In addition, Novartis
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`mischaracterizes Dr. Pantuck’s testimony regarding Petitioner’s chart. Novartis
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`argues that “Dr. Pantuck admitted that the chart at Reply 9 ‘would not have been
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`4
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`
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`used … in 2001 for a POSA to have made [the] determination’ of whether ‘to
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`choose rapamycin for further development’” and that Dr. Pantuck admitted to
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`“using hindsight today.” Obs. at 10. However, these citations were taken out of
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`context. Instead, Dr. Pantuck explained that the chart would not have been used in
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`2001 because the chart did not exist in 2001, not because a POSA would not have
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`done a similar analysis: “Well, I mean, the graphic was just produced today, so it
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`wouldn’t have affected -- it wouldn’t -- this graphic would not have been used to -
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`- in 2001 for a POSA to have made that determination.” Ex. 2113 at 101:14-18.
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`Respectfully submitted,
`
`
`
`
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`Dated: August 22, 2018
`
`
`By: /Marta E. Delsignore/
`Marta E. Delsignore (Reg. No. 32,689)
`
`Counsel for Petitioner West-Ward
`Pharmaceuticals International Limited
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`5
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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 WEST-WARD
`
`PHARMACEUTICALS INTERNATIONAL LIMITED’S RESPONSE TO
`
`PATENT OWNER OBSERVATIONS ON CROSS-EXAMINATION OF
`
`ALLAN J. PANTUCK, M.D. was served by electronic mail on Patent Owner’s
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`lead and backup counsel at the following email addresses:
`
`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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