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`Paper No. ___
`Filed: April 24, 2018
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
`
`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,
`
`v.
`
`NOVARTIS A.G.,
`Patent Owner.
`_____________________________
`
`IPR2017-008541
`Patent No. 9,187,405
`_____________________________
`
`PETITIONERS’ OPPOSITION TO NOVARTIS’S
`MOTION TO EXCLUDE
`37 C.F.R. §42.64
`
`
`1 Cases IPR2017-01550, IPR2017-01946, and IPR2017-01929 have been joined
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`with this proceeding.
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`
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`I.
`II.
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`TABLE OF CONTENTS
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`INTRODUCTION ........................................................................................ 1
`ARGUMENT................................................................................................ 1
`A.
`Exhibits 1002 and 1003....................................................................... 1
`B.
`Exhibits 1032, 1035, 1037. ................................................................. 7
`C.
`Exhibit 1051. ...................................................................................... 7
`D. Deposition Transcripts and Evidence .................................................. 8
`III. CONCLUSION .......................................................................................... 15
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`-i-
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`I.
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`INTRODUCTION
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`Petitioners oppose Novartis’s Motion to Exclude (Paper 80). Novartis fails
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`to establish entitlement to the requested relief. 37 C.F.R. § 42.20(c). “A party
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`wishing to challenge the admissibility of evidence must object timely to the
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`evidence at the point it is offered[.]” Office Patent Trial Practice Guide, 77 Fed.
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`Reg. 48756, 48767 (Aug. 14, 2012). A motion to exclude evidence must identify
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`where each objection originally was made, and must explain why the evidence is
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`not admissible, “but may not be used to challenge the sufficiency of the evidence
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`to prove a particular fact.” Id. Novartis chose to disregard the Board’s rules
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`regarding the timing and identification of objections. This failure alone justifies
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`denial of the Motion. Novartis’s Motion is also a thinly-veiled challenge to the
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`sufficiency of the evidence, and fails on the merits. It should be denied.
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`II. ARGUMENT
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`A. Exhibits 1002 and 1003.
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`Novartis moves to exclude “all, or at least the pharmacology opinions in, the
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`declaration of Dr. Barbara Giesser and related CV” under F.R.E. 702. Mot., 1. Yet,
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`Novartis never identifies portions of EX1002 or EX1003 with particularity that it
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`believes should be excluded or where it objected to such portions.
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`Novartis’s Motion should also be denied because it a thinly-veneered
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`challenge to the sufficiency of the evidence. Novartis repeats its baseless and
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`-1-
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`spurious allegation against Dr. Giesser’s review of the prior art. Mot., 2-4.
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`Novartis’s assertions are simply untrue. Dr. Giesser is a Professor of Clinical
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`Neurology at UCLA who has spent the past 30 years treating RRMS patients.
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`EX1002, ¶¶ 1-4; EX1003. She provided credible, reliable, independent, and
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`relevant testimony based on her many years of experience in the field.
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`Novartis argues that Dr. Giesser admitted during her deposition that counsel
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`allegedly limited her analysis to a selection of references they permitted her to see.
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`Mot., 3-4. This is not correct. Although Dr. Giesser testified that her “work” with
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`fingolimod related to treating patients and that she had not done “any laboratory
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`testing” for this case (EX2039 at 11:14-12:14), Novartis falsely argues that Dr.
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`Giesser failed to search the prior art. Novartis began by asking whether Dr.
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`Giesser’s literature search identified references “other than” those she identified in
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`her declaration, which she answered affirmatively by identifying a reference she
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`did not cite in her declaration. EX2039 at 49:12-50:6. Novartis then asked, aside
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`from what Dr. Giesser already mentioned, whether she performed other searches.
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`Novartis reads limitations into Dr. Giesser’s analysis that are not present.
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`Novartis also erroneously argues that Dr. Giesser failed to review the
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`references she discusses in her declaration. Mot., 3-4.. Dr. Giesser testified
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`unequivocally that she “read the exhibits mentioned in the declaration on which
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`I’ve rendered an opinion.” EX2039 at 95:23-96:1; id. at 97:8-13 (“if it’s mentioned
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`-2-
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`in the declaration, I would have read it. I just don’t remember it off the top of my
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`head.”), 97:22-98:2 (“I would have read enough of the paper to be able to form an
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`opinion.”), 105:17-106:3 (“I do not believe that I would have quoted a reference or
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`formed an opinion about something that I haven’t read.”).
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`Novartis insinuates that, because Dr. Giesser testified that she received
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`copies of the exhibits from counsel, these references must have been previously
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`unknown to her. Mot., 3-5. But Dr. Giesser never testified that she was previously
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`unaware of the references she relied upon or that her analysis was restricted to
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`documents counsel approved. Indeed, at least some of the documents she received
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`from counsel are documents she uses regularly in her medical practice. EX2039 at
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`102:24-105:16. Dr. Steinman, Novartis’s witness, also confirmed that he received
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`the vast majority of the documents he relied upon from counsel. EX1061 at 76:4-
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`78:15. He also testified that he did not read all of them and that it would have been
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`impossible to do so. Id. at 92:19-93:5, 94:8-23 (“I don’t think there’s a single
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`document that I read every word”). Novartis’s accusations are a red herring.
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`Novartis faults Dr. Giesser for not discussing the Webb reference in a reply
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`declaration because Novartis considers Webb a “key” reference “on the Patent’s
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`face.” Mot., 3-5. Novartis’s emphasis on Webb greatly exaggerates its relevance.
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`Dr. Giesser discussed the subsequent and more informative Kataoka reference
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`(EX1029) in her declaration. EX1002, ¶¶52, 64, 136, 140. Dr. Steinman testified
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`-3-
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`that the Kataoka reference published after Webb and that it cited Webb as teaching
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`that lymphocyte sequestration was not the sole mechanism of action for
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`fingolimod’s efficacy against EAE. EX1061 at 314:17-316:8. Dr. Chun testified
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`that neither Kataoka nor any other reference he knew of even cited Webb for an
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`alleged 70% lymphopenia threshold for clinical efficacy. EX1063 at 272:14-273:6.
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`As discussed below, Dr. Chun, a Webb co-author, confirmed that Webb does not
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`establish a 70% lymphocyte depletion threshold for any efficacy and that its results
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`cannot even be extrapolated to different types of rodents. EX1063 at 185:2-186:23,
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`188:7-191:5, 191:15-24, 272:14-273:6, 274:18-276:21.
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`Novartis’s assertion that Dr. Giesser should have used the issued patent to
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`work backwards to outdated animal studies (Mot. at 3-4) is puzzling at best. The
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`very case Novartis relies upon to try to exclude Dr. Giesser’s testimony concluded
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`that an expert’s focus on in vitro and animal data instead of references addressing
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`human use coincided with hindsight. AstraZeneca AB v. AuroBindo Pharma, LTD.,
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`232 F. Supp. 3d 636, 646-47 (D. Del. 2017) (lead compound structural obviousness
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`case). In short, the court in AstraZeneca condemned the expert for doing what
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`Novartis’s experts did in this case: focusing on outdated animal studies.
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`Moreover, Novartis’s complaints about Webb are moot because Novartis
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`examined Dr. Giesser about Webb during her deposition. Dr. Giesser clarified why
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`Webb does not say what Novartis claims it says, explaining that the data presented
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`-4-
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`in Webb does not establish an absence of “any” clinical efficacy for doses
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`achieving less than 70% depletion, that Figure 5A of Webb indicates that all doses
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`of fingolimod produced a very visible reduction in the clinical score, that the
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`efficacy of the three doses “clustered” together, and that the lower clinical scores
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`for the fingolimod-treated mice demonstrated that all doses produced efficacy .
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`EX2039 at 76:18-78:13, 84:6- 85:1; see also EX1061 at 242:6-245:19. Dr. Giesser
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`also pointed out that a comparison of Figures 5A and 6B indicates that only the
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`highest dose in Figure 5A appears to clear the 70% lymphocyte reduction threshold
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`asserted by Novartis, even though the lower doses demonstrated clinical efficacy.
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`EX2039 at 85:15-86:8. Novartis’s argument that Dr. Giesser lacked expertise to
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`provide an appropriate scientific interpretation of the data in Webb is incorrect.
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`Supporting Dr. Giesser’s testimony, Dr. Chun also confirmed that Webb
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`does not teach that 70% lymphopenia is required to see any efficacy, and that it
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`was an “error” to assert such an argument. EX1063 at 185:2-186:23, 188:7-189:25,
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`191:15-24, 272:14-273:6, 274:18-276:21. He confirmed that Webb’s statement
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`about 70% lymphopenia does not apply even to different EAE rodents (EX1063 at
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`190:2-191:5), much less humans. He agreed that Novartis’s interpretation of Webb
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`was not how a scientist would read Webb. EX1063 at 185:2-186:23, 188:7-190:2.
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`Drs. Steinman and Chun also confirmed that Webb Figure 5A shows each of the
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`tested doses of fingolimod alleviated the EAE attack. EX1061 at 236:18-239:19,
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`-5-
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`245:20-246:18; EX1063 at 160:23-161:9, 162:7-25.
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`Novartis argues that Dr. Giesser had never been an expert witness before and
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`is not a lawyer. Mot., 4 (citing EX2039 at 9:12-10:1). But Dr. Giesser testified in
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`her declaration as to what framework she employed. EX1002, ¶¶31-33. Dr. Giesser
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`simply did not apply the constrained, hindsight-driven approach Novartis accuses
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`her of undertaking. Novartis’s cases (Mot., 5-6) addressing hindsight analyses are
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`simply inapplicable. Exclusion of Dr. Giesser’s testimony would be especially
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`inappropriate here where the Board will make any factual findings, not a lay jury.
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`Novartis argues the Board should deter “manufactured expert opinion” as a
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`matter of policy. Mot., 3-4. Petitioners respectfully submit that the only
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`manufactured expert testimony submitted in this case has been that concocted by
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`Novartis’s attorneys, often through declarations containing conspicuously similar
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`phrasing. See, e.g., EX2098, ¶¶7-8 (“the product of our collective judgment”);
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`EX2096, ¶40 (“product of the nine authors’ collective judgment”); EX2022, ¶22
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`(“I have spoken with counsel and reviewed and commented upon drafts they
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`prepared….”); EX2024, ¶4 (same); EX2025, ¶10 (same). Indeed, it was Drs.
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`Steinman and Jusko who had to admit they were stuck with the testimony Novartis
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`assigned to them. EX1061 at 83:20-23 (“[E]very word is something I would have
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`to stand by because I signed it. That’s essentially what the process is.”); EX1064 at
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`42:16- 43:2(“I think you recognize the nature of what these declarations are like”).
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`-6-
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`Finally, Novartis argues Petitioners did not dispute that Dr. Giesser’s
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`“pharmacologic testimony was beset with error.” Mot., 6. Again, Novartis fails to
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`specify what testimony it seeks to exclude. However, Dr. Benet’s testimony
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`independently confirmed, from the perspective of a pharmacologist, that none of
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`Novartis’s “pharmacology” theories undermine any of Dr. Giesser’s conclusions.
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`B.
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`Exhibits 1032, 1035, 1037.
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`Novartis attempts to exclude Exhibits 1032 (Board decision), 1035
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`(Gilenya® Orange Book listing), and 1037 (Gilenya® Orange Book-listed patent) as
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`irrelevant. Mot., 7-8. Once again, Novartis’s Motion fails to identify where
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`Novartis objected to these exhibits or where they are relied upon. Novartis admits
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`Exhibit 1032 constitutes legal authority. Mot., 7. Among other things, Exhibit 1032
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`demonstrates that Novartis has previously litigated the meaning of the Chiba and
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`Budde references and establishes the result of that litigation. At a minimum,
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`Exhibits 1032, 1035, and 1037 are relevant for preclusion and estoppel purposes.
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`They are also relevant to Petitioners’ mandatory notices, the disclosures of the
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`references, and secondary indicia arguments. E.g., Pet., 13-14, 16, 20, 49, 52-53,
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`62-63. Novartis fails to explain how the exhibits unduly prejudice Novartis.
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`C. Exhibit 1051.
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`Novartis attempts to exclude as irrelevant a confidential clinical trial
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`protocol document obtained in discovery in this case, Exhibit 1051. Mot., 9-10. Its
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`-7-
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`relevance was set forth at length in Petitioners’ Motion for Discovery and in the
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`Board’s Order granting discovery. Paper 35 at 1-2, 4-9; Paper 47 at 2, 4-7. Once
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`again, Novartis fails to identify where in the record it to Exhibit 1051.
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`Novartis also wrongly argues EX1051 is irrelevant because it is confidential.
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`Mot., 7. Novartis put at issue the rationale for including the 0.5 mg dose in the
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`Phase III trial. Paper 27 at 25-27, 40; Paper 45 at 3. Exhibit 1051 demonstrates that
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`Novartis’s claim is false. Petitioners’ cited Exhibit 1051 in the Reply to
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`demonstrate the falsity of Novartis’s argument. Paper 56 at 21-23.
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`Novartis argues that Mt. Sinai hospital refused to participate in the Phase III
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`study despite Novartis’s justification in the protocol for including the 0.5 mg dose.
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`Mot., 9-10. Regardless, Dr. Lublin confirmed that thousands of centers did
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`participate in administering the 0.5 mg dose. EX1062 at 46:6-16, 49:10-55:19.
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`D. Deposition Transcripts and Evidence
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`Novartis is unable to indicate where it objected to each exhibit, and fails to
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`identify where it objected to each question it now seeks to exclude. “An objection
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`to the admissibility of deposition evidence must be made during the deposition.”
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`37 C.F.R. §42.64(a). “All objections made at the time of the deposition” to the
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`manner of taking it or to “the evidence presented” shall be noted on the record, and
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`“[a]ny objection to the content, form, or manner of taking the deposition…is
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`waived unless made on the record during the deposition[.]”37 C.F.R. §42.53(f)(4),
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`-8-
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`(8). Novartis failed to make any objections to the exhibits themselves during either
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`of the Chun or Jusko depositions. EX1063 at 277:9-280:10, 283:2-284:2, 284:11-
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`285:10, 285:20-23, 295:6-16; EX1064 at 113:16-114:6, 131:23-132:7, 135:11-25,
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`143:23-144:8, 158:8-159:11. Novartis also did not object to many of the questions
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`posed regarding these exhibits. It thus waived any such objections. Novartis’s
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`failure to identify where the underlying objections were timely lodged with
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`particularity justifies denial of Novartis’s motion.
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`1.
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`EX1054-EX1056 and EX1063
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`Although Novartis did not once object on the basis of foundation, timeliness,
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`or argumentative during the Chun Deposition, Novartis argues for exclusion of
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`deposition evidence on these bases. Mot., 12-13. This is impermissible.
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`Novartis also fails to substantively justify exclusion. Dr. Chun testified that
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`each of Exhibits 1054-1056 was published in its respective periodical, and that
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`each of Exhibits 1055-1056 was published before June 2006. EX1063 at 277:9-
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`280:10, 283:2-284:2, 284:11-285:10, 285:20-23, 295:6-16. Periodicals are self-
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`authenticating publications. F.R.E. 902(6). Exhibits 1055-1056 are thus
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`indisputably prior art references. Novartis fails to explain why any additional
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`“foundation” is required to make these prior art references admissible; nor has it
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`identified any evidentiary basis for excluding them.
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`Novartis attempts to exclude Exhibits 1054-1056 and Dr. Chun’s testimony
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`-9-
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`regarding them by retroactively attempting to characterize Dr. Chun as exclusively
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`a fact witness. This argument is unsupportable. Novartis submitted a 36-page CV
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`(EX2099) in support of Dr. Chun’s 20-page declaration (EX2098). Dr. Chun spent
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`6 of 44 substantive paragraphs of his declaration discussing his “Experience and
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`Qualifications.” EX2098, ¶¶10-15. He defined the scope of his declaration as
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`“address[ing] the declaration of pharmacologist Dr. Leslie Z. Benet in this matter
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`(Ex. 1047)” and as providing both “technical and historical perspective on what
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`was known at the time about FTY720 (fingolimod), its effects, and MOAs
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`[mechanisms of action].” Id., ¶¶1, 16. Among other things, Dr. Chun repeatedly
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`testified regarding “the ability of a dose to produce sustained clinical
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`improvement” and provided his opinion that he “would expect that sustained
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`suppression would be needed for efficacy in humans.” Id., ¶¶7, 29, 36, 38, 40, 43-
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`44. Novartis’s arguments that Dr. Chun is merely a fact witness or that the
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`testimony regarding Exhibits 1054-1056 is outside the scope of cross-examination
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`are contortions designed to obscure the truth.
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`Novartis apparently regrets submitting Dr. Chun as an expert witness
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`because Dr. Chun testified during his deposition that Novartis’s 70% lymphopenia
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`teaching away argument based on Webb is based on an erroneous reading of
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`Webb. EX1063 at 185:2-186:23, 188:7-189:25, 190:2-191:5, 191:15-24, 272:14-
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`273:6, 274:18-276:21. Novartis has now decided to recast Dr. Chun because he
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`-10-
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`dared to disagree with Novartis’s unscientific reading of the prior art.
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`Novartis argues that lines 278:3-318:23 of Exhibit 1063 should be excluded
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`because Dr. Chun allegedly “is not an expert in evaluating human data,” not an MS
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`specialist, and not a pharmacologist. Mot., 11-12 (citing EX1063 at 287:23-292:5,
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`296:4-318:19). As a threshold matter, the Board noted in its Institution Decision
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`that the level of skill was “generally that of an M.D. or Ph.D. with expertise in the
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`area of neurology.” Paper 11 at 8-9. Dr. Chun is an M.D., Ph.D. (Neuroscience)
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`and an Adjunct Professor at UCSD School of Medicine. EX2099 at 1. He has been
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`an Adjunct Professor of Pharmacology at UCSD since 2002 and an Adjunct
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`Professor Neuroscience at USCD since 2003. Id. at 4. Dr. Chun’s testimony
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`confirmed that Exhibits 1055-1056 are relevant to his testimony that MS efficacy
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`required sustained lymphopenia in humans. EX1063 at 285:20-286:25, 294:6-14,
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`312:3-25.
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`Novartis’s argument that Exhibit 1055 and 1056 are outside the scope of Dr.
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`Chun’s declaration because his declaration “never mentions” them (Mot., 11) lacks
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`merit. The scope of cross examination is tied to “the subject matter of the direct
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`examination and matters affecting the witness’s credibility,” not just the pieces of
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`prior art the expert relies upon during direct. F.R.E. 611(b). Moreover, a court may
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`allow inquiry into additional matters during cross-examination as if on direct
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`examination. Id. The interests of justice are not served here by allowing Novartis to
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`-11-
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`bury publications Novartis funded. F.R.E. 611(a)(1) (“for determining the truth”).
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`Novartis speculates that Petitioners never questioned Dr. Steinman about
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`Exhibits 1054-1056 because they were allegedly afraid of his views of the
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`references. To the contrary, Petitioners crossed Dr. Chun about his testimony about
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`sustained lymphopenia using Exhibits 1054-1056 because they were within the
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`appropriate scope of cross-examination and because Petitioners came across them
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`while reviewing Dr. Chun’s publications in preparation for his deposition, after Dr.
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`Steinman’s deposition concluded. Exhibit 1054 appears in Dr. Chun’s CV
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`(EX2099) that was submitted with his declaration (EX2098), and Exhibit 1054
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`cites Exhibit 1055 regarding fingolimod’s properties, including lymphopenia.
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`EX1063 at 278:3-279:4, 284:11-285:19, 316:16-317:12, 318:12-20; EX2099 at 14
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`(entry 81). Dr. Chun requested additional data to aid in the interpretation of
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`Tedesco-Silva, and Skerjanec (EX1057) provides the requested data. EX1063 at
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`294:23-299:20. Both Tedesco-Silva (EX1056) and Skerjanec (EX1057) address the
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`issue of whether doses of fingolimod produced sustained suppression of
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`lymphocytes, exactly the issue Dr. Chun addresses in his declaration. EX2098, ¶¶7,
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`37-38, 40, 43. The questioning was properly within the scope of cross-
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`examination.
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`Even though Novartis failed to object to the exhibits during the deposition,
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`Novartis now argues that the exhibits are untimely. Mot., 12-13. But there is no
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`-12-
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`rule that cross-examination is limited to prior art references submitted with the
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`petition or with the reply. Indeed, the Board’s rules expressly contemplate the
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`presentation of evidence to witnesses during deposition. 37 C.F.R. §§ 42.53(f)(4),
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`(8), 42.65(a). Novartis’s reliance on Toshiba Corp. v. Optical Devices, LLC, IPR
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`2014-01447, Paper 34 at 44-46 is inapposite. That case dealt with the untimely
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`service of supplemental evidence that should have been served in response to
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`Patent Owner’s evidentiary objections. In this case, Novartis only served Dr.
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`Chun’s declaration on March 23, 2018, even though Dr. Chun testified that
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`Novartis retained Dr. Chun for fingolimod litigation work as early as 2016 and
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`spent hours consulting for Novartis in the month before service of Novartis’s POR
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`in November 2017. EX1063 at 48:1-50:3, 51:7-52:9, 53:11-25, 54:2-57:3, 246:2-
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`248:20. In other words, Novartis decided to hold back Dr. Chun’s declaration from
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`its POR. Novartis’s gamesmanship means that only Novartis’s witnesses had an
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`opportunity to address Exhibits 2055-2056. Novartis had the opportunity to
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`conduct re-direct examination on these references and opted not to do so.
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`2.
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`EX1057-EX1060 and EX1064
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`Novartis once again fails to identify with particularity where it lodged
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`evidentiary objections during the deposition to Exhibits 1057-1060. Novartis never
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`once objected to the admissibility of any of these exhibits, nor did it utter the
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`words foundation, impeachment, Rule 608, or timeliness.
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`-13-
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`Novartis again seeks to insulate its witnesses from publications that
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`contradict or undermine their testimony. Mot., 13-15. Dr. Jusko’s theory that a
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`POSA would have had to limit human equivalent doses to a 75 kg patient was first
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`presented in his March 2018 sur-reply. Indeed, Dr. Jusko’s November 2017
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`declaration discussed conversions for subjects with lower weights. EX2024, ¶50
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`(70 kg subject). Dr. Jusko continued to use lower weights for part of his Fourth
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`Declaration but criticized Dr. Benet for providing a range of weights that Dr. Jusko
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`alleged “artificially skews the dose lower” than 75 kg. (EX2095 (4th Jusko Decl.),
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`¶¶20 (70 kg), 31(75 kg). Dr. Jusko testified, however, that he could not recall doing
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`any research to determine if there were studies that reported average weights for
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`MS patients. EX1064 at 130:17-24. Petitioners’ counsel thus appropriately
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`questioned Dr. Jusko regarding various studies reporting an average weight for MS
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`and RRMS patients that was 60-65 kg, lower than the 75 kg minimum threshold
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`arbitrarily selected by Dr. Jusko. EX1064 at 130:25-132:21, 134:24-135:9
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`(EX1057); EX1064 at 135:11-137:11, 139:3-141:22 (EX1058); EX1064 at 143:23-
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`144:24, 146:11-23, 148:4-150:11 (EX1059); EX1064 at 158:8-160:7 (EX1060).
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`Novartis baldly asserts that “[n]one of these studies…undermined Dr.
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`Jusko’s testimony,” and improperly uses its motion to provide attorney argument
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`about the references. Mot., 13-15. Novartis fails to mention that Dr. Jusko himself
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`testified that the MS patients in the US and abroad had similar weights. EX1064 at
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`-14-
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`161:16-163:7. Moreover, Novartis’s attorney argument that the MS patients were
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`underweight due to their MS treatment merely confirms that Dr. Jusko inflated the
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`weight measure by using non-MS patients in order to obtain a predetermined
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`result. As Dr. Steinman testified, the “standard of care” “often” used for treating
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`relapses in RRMS patients is using corticosteroids to blunt the relapse and
`
`“alleviate the variety of different manifestations of a relapse.” EX1061 at 37:2-
`
`39:7. He also testified that “if they did have a relapse, I would be giving steroid as
`
`well” as fingolimod. Id. at 41:4-6. The exhibits are clearly relevant.
`
`Novartis argues that Exhibits 2057-2060 were “improper impeachment”
`
`under F.R.E. 608(b). Not only did Novartis fail to register this objection during the
`
`deposition, the rule Novartis cites is about proving specific instances of a witness’s
`
`conduct. Petitioners did not introduce Exhibits 1057-1060 to prove an instance of
`
`Dr. Jusko’s conduct, but to show how Dr. Jusko’s restriction of MS patients’
`
`weights had skewed his analysis. The testimony and exhibits confirm that Dr.
`
`Jusko’s blinkered focus on persons weighing 75 kg unnaturally excluded MS
`
`patients who very commonly weigh much less, in part due to treatment with
`
`prednisone and other glucocorticoids. The questioning was appropriate and timely.
`
`III. CONCLUSION
`
`Petitioners request that Novartis’s Motion to Exclude be denied.
`
`-15-
`
`
`
`
`
`Dated: April 24, 2018
`
`
`
`
`
`Respectfully submitted,
`
`/ Steven W. Parmelee /
` Steven W. Parmelee
` Reg. No. 31,990
`
`
`
`
`
`
`
`
`
`
`-16-
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`
`
`This is to certify that I caused to be served true and correct copies of the
`
`foregoing Petitioners’ Opposition to Novartis’s Motion to Exclude on this 24th day
`
`of April, 2018, on the Patent Owner at the correspondence address of the Patent
`
`Owner as follows:
`
`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
`
`
`
`
`Dated: 24 April 2018
`
`
`
`
`
`
`/ Steven W. Parmelee /
` Steven W. Parmelee
` Reg. No. 31,990
`
`
`
`-17-
`
`
`
`
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