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`Paper No. ___
`Filed: April 30, 2018
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
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`APOTEX INC., APOTEX CORP., ARGENTUM PHARMACEUTICALS
`LLC, ACTAVIS ELIZABETH LLC, TEVA PHARMACEUTICALS USA,
`INC., SUN PHARMACEUTICAL INDUSTRIES, LTD., SUN
`PHARMACEUTICAL INDUSTRIES, INC., AND SUN PHARMA GLOBAL
`FZE,
`Petitioners,
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`v.
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`NOVARTIS A.G.,
`Patent Owner.
`_____________________________
`
`IPR2017-008541
`Patent No. 9,187,405
`_____________________________
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`PETITIONERS’ REPLY IN SUPPORT OF
`MOTION TO EXCLUDE
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`1 Cases IPR2017-01550, IPR2017-01946, and IPR2017-01929 have been joined
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`with this proceeding.
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`PROTECTIVE ORDER MATERIAL
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`EXHIBITS 2057& 2070. .................................................................................. 1
`I.
`EXHIBITS 2063-2066...................................................................................... 2
`II.
`III. TESTIMONY BASED ON GRANULAR MOUSE DATA. ............................................. 5
`IV. CONCLUSION ................................................................................................. 5
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`TABLE OF CONTENTS
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`-i-
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`PROTECTIVE ORDER MATERIAL
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`Petitioners file this Reply in response to Paper 89 filed on April 24, 2018.
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`I.
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`EXHIBITS 2057& 2070.
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`Novartis contends Mr. Schnell authenticated EX2057 as “a report” he
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`“prepared.” Opp., 2. But he testified that he only prepared “part of the document”
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`and never saw the EAE portion and had no role in finalizing it. EX1050 at 32:9-
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`34:7, 42:11-15, 56:8-57:17. He testified he never saw the final until preparing his
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`declaration (id., 32:12-36:6, 42:11-15), and he still had never read most of it (id.,
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`57:18-60:4), so his testimony that he “remembers” EX2057 “going with” EX2070
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`is pure guesswork. Novartis failed to authenticate EX2057 prior to 2017 when its
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`employees retrieved it. Novartis curiously argues Mr. Schnell’s lack of personal
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`knowledge proves Peter Hiestand had personal knowledge. Opp., 4. But he offered
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`no declaration and Novartis’s argument is mere speculation.
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`Novartis concedes no exception justifies admission by arguing the report is
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`offered not for the truth, but merely as a record of beliefs about RRMS efficacy
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`expressed in June 2009. Opp., 3-4. But no such belief is expressed. In fact, RRMS
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`is not mentioned, nor is any dosing RRMS recommendation, as opposed to
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`confirming FTY720 can “ameliorate EAE in the Lewis rat” and that it may be
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`“effective even if a dose of the drug is missed.” EX2057 at 21-22.
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`Novartis’s assertion that it relies on EX2057 for only non-hearsay purposes
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`is also plainly incorrect. Novartis repeatedly relies on EX2057 as establishing the
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`PROTECTIVE ORDER MATERIAL
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`truth of actual test results to support the efficacy of once-weekly administration of
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`0.3 mg/kg fingolimod. POR, 22-24; EX2024, ¶¶101-107; EX2022, ¶¶101-108.
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`Novartis’s argument (Opp., 5) that expert testimony based on inadmissible
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`evidence theoretically may be admitted proves nothing. See Monsanto Co. v.
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`David, 516 F.3d 1009, 1015-16 (Fed. Cir. 2008) (expert testimony admissible
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`where its sponsor established expert could reasonably rely on a scientific report
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`“prepared by his team” and that the report was “of a type reasonably relied upon by
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`experts in the particular field in forming opinions.”). None of Novartis’s experts
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`testified that experts in their fields routinely rely upon the type of report in
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`EX2057, even though they provided such testimony for other exhibits. EX2076,
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`¶¶3, 5, 7; EX2077, ¶¶3, 5. Neither Dr. Jusko nor Dr. Steinman cite either the
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`Waibel or Schnell declarations or explain why one should rely on EX2057.
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`Counsel’s representations are insufficient. EX1042 at 170:11-25, 178:6-179:6.
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`Novartis also failed to establish that either Dr. Jusko or Dr. Steinman’s discussion
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`of EX2057 is admissible under F.R.E. 703. Dr. Benet identified fatal flaws in
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`Novartis’s reliance on EX2057 to establish efficacy of the 0.5 mg. EX1047, ¶¶102-
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`105. Novartis has now abandoned that analysis, arguing EX2057 should not be
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`relied upon for the truth. Opp., 3. Its experts’ reliance on the hearsay assertions in
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`EX2057 are not entitled to admission under F.R.E. 702-703.
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`II. EXHIBITS 2063-2066.
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`-2-
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`PROTECTIVE ORDER MATERIAL
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`Novartis argues (Opp., 6) that Petitioners “strain” to exclude Exhibits 2063-
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`2066 because they allegedly demonstrate that one IRB panel out of thousands was
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`skeptical. Petitioners seek exclusion because Novartis’s reliance on it is unlawful.
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`Novartis submits for the truth of the matter hearsay statements purporting to
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`summarize further hearsay statements, the latter attributed to unidentified persons
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`sitting on an IRB panel or at the FDA. EX2063 at 2-3 (“They had the following
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`comment:”); EX2065 at 5 (“The comment reads:”), 4 (“comments still involving”;
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`“as per FDA’s request”), 3 (“it wasn’t enough.”), 1 (“IRB has said”); 2 (“FDA’s
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`request”); EX2066 (“FDA’s request”; description and purported quote from FDA
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`minutes). The Waibel declaration authenticates only the time stamp for the final
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`email in the chain, not the statements attributed to IRB or FDA therein.
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`Novartis argues the hearsay statements are “state of mind” evidence. Opp.,
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`8-9. But it fails to establish Ms. Farrell or the IRB panel members were persons of
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`ordinary skill. Further, the truth of her assertions that these statements came from
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`an IRB panel are required to prove Novartis’s argument that the panel espoused
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`these views. This is not a case where an industry publication established that the
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`statements were made. Weatherford, IPR2016-01509, Paper 65 at 15-16.
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`Novartis argues EX2065 is admissible under F.R.E. 803(3), (5) and 807.
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`Opp., 7-9. The “state of mind” of Ms. Farrell, Mr. Watson, or Mr. Prodafikas is not
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`at issue. Novartis may not rely on a record of the “memory or belief” of its non-
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`PROTECTIVE ORDER MATERIAL
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`testifying Novartis personnel “to prove the fact remembered or believed” under
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`F.R.E. 803(3). F.R.E. 803(5) does not apply because no “witness” made or adopted
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`the record “when the matter was fresh” and because is not offered by an adverse
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`party. Moreover, the residual hearsay exception is for “exceptional cases” and does
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`not apply when the proponent made no showing that “reasonable efforts could not
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`have produced more probative evidence.” US Endodontics, LLC v. Gold Standard
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`Instr., LLC., PGR2015-00019, Paper 54 at 40-42.
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`Novartis argues F.R.E. 602 is satisfied because “[t]he documents’ authors
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`plainly had knowledge of the facts that the documents set out.” Opp., 9. This belies
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`Novartis’s argument that it is not relying on the hearsay statements for their truth.
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`Second, it is not “plain” that the “authors” had knowledge of the facts asserted
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`because none of them testified. The argument (Opp., 10) that F.R.E. 106 permits
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`Novartis to rely on incomplete excerpts of hearsay documents because it created
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`the excerpts prior to this proceeding is incorrect. Because Novartis chose not to
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`produce the full document, it may not rely upon the excerpts.
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`Novartis argues Dr. Lublin’s testimony based on Exhibits 2063-2066 is
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`admissible. Opp., 10-11. But F.R.E. 703 does not save Dr. Lublin’s testimony
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`because he was not copied on EX2065-2066 and admitted that he has no personal
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`knowledge of EX2064-2066, never spoke with Ms. Farrell for his testimony, and
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`was relying on Novartis’s counsel’s representations. Mot., Paper 82, 8-9, 11.
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`PROTECTIVE ORDER MATERIAL
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`III. TESTIMONY BASED ON GRANULAR MOUSE DATA.
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`Novartis argues that Petitioners invited Novartis’s speculation based on
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`unproduced granular mouse data by attempting “to distort Webb.” Opp., 12-13.
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`But Dr. Chun’s deposition testimony establishes that Novartis’s strained
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`interpretation of Webb was the distortion. EX1063 at 185:2-186:23, 188:7-191:24,
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`274:18-276:21. Novartis identifies no prior art citing Webb as establishing an “at
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`least 70% lymphopenia” threshold for “any efficacy.”
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`Novartis’s argument that Dr. Chun provided no expert testimony (Opp., 13-
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`15) is unsupported. EX2098, ¶¶1, 10-16; EX2099 at 1-36. Dr. Chun confirmed he
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`lacked personal knowledge of how the experiments were conducted and how Webb
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`was written and submitted. EX1063 at 77:23-84:22, 87:10-88:7, 90:5-91:10, 92:3-
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`93:6, 94:4-16, 126:2-127:8, 150:14-151:16, 153:12-16, 8, 181:7-13-183:15,
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`203:13-25, 271:23-272:13. Novartis argues Dr. Steinman’s testimony is admissible
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`because allegedly “nothing in Webb is internally inconsistent.” Opp., 14-15. But
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`Dr. Steinman’s deposition testimony repeatedly undermined the speculation in his
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`Third Declaration. EX1061 at 228:8-236:11, 240:15-241:3 (“they only really did
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`have four per group”), 240:25-241:3, 262:25-264:16 (“very small” variation).
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`236:18-239:19, 245:20-246:18 (the 0.03 mg/kg reduced severity).
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`IV. CONCLUSION
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`Petitioners request that their Motion to Exclude be granted.
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`-5-
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`PROTECTIVE ORDER MATERIAL
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`Dated: April 30, 2018
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`Respectfully submitted,
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`/ Steven W. Parmelee /
` Steven W. Parmelee
` Reg. No. 31,990
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`-6-
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`PROTECTIVE ORDER MATERIAL
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`CERTIFICATE OF SERVICE
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`This is to certify that I caused to be served true and correct copies of the
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`foregoing Petitioners’ Reply ISO Motion to Exclude on this 30th day of April,
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`2018, on the Patent Owner at the correspondence address of the Patent Owner as
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`follows:
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`Jane M. Love, Ph.D.
`Robert W. Trenchard
`GIBSON, DUNN & CRUTCHER LLP
`200 Park Avenue, 47th Floor
`New York, NY 10166
`Email: jlove@gibsondunn.com
`Email: rtrenchard@gibsondunn.com
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`Dated: April 30, 2018
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`/ Steven W. Parmelee /
` Steven W. Parmelee
` Reg. No. 31,990
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`-7-
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`PROTECTIVE ORDER MATERIAL
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