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`IPR2017-00854
`U.S. Patent No. 9,187,405
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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 AG,
`Patent Owner.
`______________________
`Case IPR2017-008541
`U.S. Patent No. 9,187,405
`______________________
`PATENT OWNER NOVARTIS’S MOTION TO EXCLUDE
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`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`1
`Cases IPR2017-01550, IPR2017-01946, and IPR2017-01929 have been
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`joined with this proceeding.
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`IPR2017-00854
`U.S. Patent No. 9,187,405
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`TABLE OF CONTENTS
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`Page
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`PRELIMINARY STATEMENT ........................................................... 1
`ARGUMENT ........................................................................................ 1
`A. Dr. Giesser’s Opinions Are Inadmissible as Unreliable
` under Rule 702 ..................................................................................... 1
`Exhibits Relating to the ’283 Formulation Patent IPR And the
`Confidential Clinical Trial Protocol Are Irrelevant .............................. 7
`Petitioner Marked Inadmissible Exhibits and Elicited
` Inadmissible Testimony at Recent Depositions ................................. 10
`CONCLUSION ................................................................................... 15
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`C.
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`B.
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`II
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`III
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`TABLE OF AUTHORITIES
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`Page(s)
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`Cases
`3d Matrix, Ltd. v. Menicon Co., Ltd.,
`IPR2014-00398, 2014 WL 3851279 (P.T.A.B. Aug. 1, 2014) ............................. 1
`Am. Med. Sys., Inc. v. Laser Peripherals, LLC,
`712 F. Supp. 2d 885 (D. Minn. 2010) ................................................................... 5
`AstraZeneca AB v. Aurobindo Pharma LTD, et al.,
`232 F. Supp. 3d 636 (D. Del. 2017) ...................................................................... 4
`Daubert v. Merrell Dow Pharm., Inc.,
`509 U.S. 579 (1993) .......................................................................................... 1, 2
`Huang v. Marklyn Grp., Inc.,
`Civil Case No. 11-cv-01765-REB-BNB, 2014 WL 3559367 (D.
`Colo. July 18, 2014) .............................................................................................. 5
`Mendenhall v. Cedarapids, Inc.,
`5 F.3d 1557 (Fed. Cir. 1993) ................................................................................ 7
`N.V. v. Abbott Labs.,
`512 F.3d 1363 (Fed. Cir. 2008) ............................................................................ 5
`Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc.,
`520 F.3d 1358 (Fed. Cir. 2008) ............................................................................ 5
`Seaboard Lumber Co. v. United States,
`308 F.3d 1283 (Fed. Cir. 2002) ............................................................................ 2
`Toshiba Corp. v. Optical Devices, LLC,
`IPR2014-01447, Paper 34 (Mar. 9, 2016) .......................................................... 13
`United States v. Williams,
`506 F. 3d 151 (2d. Cir. 2007) ............................................................................... 2
`Warner Chilcott Labs. Ireland Ltd. v. Impax Labs., Inc.,
`No. 2:08-CV-06304 WJM, 2012 WL 1551709 (D.N.J. Apr. 30,
`2012), aff’d, 478 F. App’x 672 (Fed. Cir. 2012) .................................................. 4
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`Statutes
`35 U.S.C. § 103(a) ..................................................................................................... 5
`Rules
`Fed. R. Evid. 401 ..................................................................................... 8, 12, 13, 15
`Fed. R. Evid. 403 ........................................................................................... 8, 12, 15
`Fed. R. Evid. 602 ..................................................................................................... 13
`Fed. R. Evid. 608 ..................................................................................................... 14
`Fed. R. Evid. 611 ............................................................................................... 12, 13
`Fed. R. Evid. 702 ........................................................................................... 1, 2, 3, 5
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`I
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`PRELIMINARY STATEMENT
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`Novartis respectfully moves to exclude (A) all, or at least the pharmacology
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`opinions in, the declaration of Dr. Barbara Giesser and related CV (Ex. 1002, Ex.
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`1003); (B) exhibits relating to an IPR involving an unrelated Novartis formulation
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`patent (Ex. 1032, Ex. 1035, Ex. 1037, Ex. 1041), and a confidential clinical trial
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`document (Ex. 1051); and (C) exhibits and certain testimony from recent depositions
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`(Exs. 1054-59, and parts of 1063 and 1064).
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`II
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`ARGUMENT
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`A. Dr. Giesser’s Opinions Are Inadmissible as Unreliable under Rule
`702
`Novartis appreciates that the Board does not often exclude expert testimony
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`under Fed. R. Evid. 702, preferring instead to weigh the testimony in the overall
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`process of deciding the case. But Dr. Giesser’s testimony and how it was used by
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`Petitioners here are beyond the pale.
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`The Board applies Federal Rule of Evidence 702 to putative expert testimony.
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`3d Matrix, Ltd. v. Menicon Co., Ltd., IPR2014-00398, 2014 WL 3851279, at *5
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`(P.T.A.B. Aug. 1, 2014) (applying Rule 702). Rule 702 requires the Board to act as
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`a “gatekeeper” to “ensure that any and all scientific testimony or evidence admitted
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`is not only relevant, but reliable.” Daubert v. Merrell Dow Pharm., Inc., 509 U.S.
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`579, 589, 597 (1993). The proponents of expert testimony—here, Petitioners—have
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`“the burden of establishing by a preponderance of the evidence that the admissibility
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`requirements of Rule 702 are satisfied . . . .” United States v. Williams, 506 F. 3d
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`151, 160 (2d. Cir. 2007) (citing Daubert, 509 U.S. at 593 n. 10). To be admissible
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`under Rule 702, expert testimony must “help the trier of fact to understand the
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`evidence or to determine a fact in issue”; be “based on sufficient facts or data”; and
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`be “the product of reliable principles and methods” that are “reliably applied . . . to
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`the facts of the case.” These requirements apply equally to jury and non-jury trials.
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`Seaboard Lumber Co. v. United States, 308 F.3d 1283, 1302 (Fed. Cir. 2002) (“[T]he
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`Daubert standards of relevance and reliability for scientific evidence must
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`nevertheless be met [in a bench trial].”).
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`The Board relied on Dr. Giesser’s testimony to institute this IPR, giving
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`Petitioners the benefit of the doubt that Dr. Giesser (i) had performed a lawful
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`analysis of the prior art in arguing that the ’405 Patent is obvious, and (ii) was
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`qualified to provide the perspective of a full person of skill. (Paper 11 at 9–10.)
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`Discovery revealed that this benefit of the doubt was not deserved. It turned out that
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`Petitioners had artificially limited Dr. Giesser’s review of the prior art solely to
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`references handpicked by counsel. That fact was not disclosed in Dr. Giesser’s
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`declaration, and thus unknown to the Board when deciding to institute the case.
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`Petitioners had also prodded Dr. Giesser to provide pharmacologic testimony far
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`beyond her area of expertise. (Paper 26 at 41–46.) Petitioners disputed neither that
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`Dr. Giesser’s analysis was limited to references counsel gave her, or that she is not
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`a qualified pharmacologist. (Paper 49 at 9–11.)
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`This Board depends on the good-faith reliability of expert testimony
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`submitted with Petitions when making institution decisions. As a matter of policy,
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`the Board should deter Petitions supported only with manufactured expert opinion,
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`which can lead to the institution of IPRs in circumstances where the facts do not
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`warrant it. For that reason, Novartis respectfully submits that Dr. Giesser’s
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`testimony should be struck under Fed. R. Evid. 702 in whole or in part, for two
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`reasons.
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`First, Petitioners had Dr. Giesser perform an improper, hindsight-driven
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`analysis. Dr. Giesser purported to testify that a person of skill would have
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`considered a 0.5 mg daily dose of fingolimod an obvious therapy for RRMS in light
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`of the prior art as of June 2006. (Ex. 1002 ¶¶ 101–143.) But in her deposition, Dr.
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`Giesser admitted that she did not actually review the full prior art. (See Paper 26 at
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`28–31; Ex. 2039 at 12:13–14; id. at 95:18–22; id. at 96:7–99:1.) She looked only at
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`a selection of references counsel gave her, and did not conduct her own search and
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`review of the literature. (Ex. 2039 at 49:12–50:9.) Dr. Giesser did not even review
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`key references on the Patent’s face. Nor did Petitioner have her submit a reply
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`declaration to try to remedy the situation by addressing the scope of the prior art that
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`she ignored in her initial declaration. As a result, her only testimony is unlawfully
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`curtailed, lawyer-driven, and fatally incomplete.
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`Novartis’s Patent Owner Response shows that district courts have found such
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`a lawyer-driven review of the prior art per se unlawful hindsight. (Paper 26 at 42–
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`43 (citing AstraZeneca AB v. Aurobindo Pharma LTD, et al., 232 F. Supp. 3d 636
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`(D. Del. 2017); Warner Chilcott Labs. Ireland Ltd. v. Impax Labs., Inc., No. 2:08-
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`CV-06304 WJM, 2012 WL 1551709, at *57 (D.N.J. Apr. 30, 2012), aff’d, 478 F.
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`App’x 672 (Fed. Cir. 2012).) Petitioners never addressed those cases in their Reply,
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`nor disputed that Dr. Giesser’s review was so limited.
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`Petitioners have instead pretended that Novartis is somehow attacking Dr.
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`Giesser’s character. (Paper 49 at 10.) Not true. Dr. Giesser may have been the
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`vehicle for the unlawful testimony, but she was guided by Petitioners themselves, as
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`she testified under oath. Dr. Giesser had never been an expert witness before, and
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`she certainly is not a lawyer with knowledge of what the law requires. (Ex. 2039 at
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`9:12–10:1.) She knew no better.
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`Petitioners have also suggested that Novartis’s objection to Dr. Giesser is
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`merely that Petitioners’ counsel worked closely with her to prepare her declaration.
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`(Paper 49 at 10.) That, too, is a straw man. Counsel and experts always work
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`together, often intensively so. The problem here is how that process yielded
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`manipulated, unlawful testimony. Petitioners have the burden of establishing prima
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`facie obviousness. Their witness accordingly was required to perform a true analysis
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`of the full prior art in forming her opinions, or at the very least address what she
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`missed in a reply declaration. It is undisputed that she did not do so.
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`Fed. R. Evid. 702 prohibits such unreliable testimony. Obviousness must be
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`analyzed from the perspective of a person of ordinary skill in the art “at the time the
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`invention was made.” 35 U.S.C. § 103(a). Hindsight reasoning thus “is always
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`inappropriate for an obviousness test based on the language of Title 35.” Ortho-
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`McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d 1358, 1364 (Fed. Cir. 2008).
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`Given these rules, hindsight-driven expert analyses are regularly excluded under
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`Rule 702. See, e.g., Huang v. Marklyn Grp., Inc., Civil Case No. 11-cv-01765-REB-
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`BNB, 2014 WL 3559367, at *5–*6 (D. Colo. July 18, 2014) (exclusion where “the
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`court cannot ensure that the opinion is not clouded, improperly, by hindsight”); Am.
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`Med. Sys., Inc. v. Laser Peripherals, LLC, 712 F. Supp. 2d 885, 901 (D. Minn. 2010)
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`(obviousness testimony excluded because it would not be helpful “in avoiding the
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`pitfalls of hindsight” (citation and internal quotation marks omitted)); see also
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`lnnogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1373–74 (Fed. Cir. 2008) (district
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`court properly excluded “vague and conclusory obviousness testimony” based on
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`“pitfalls of hindsight that belie a determination of obviousness”). Dr. Giesser’s
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`analysis was entirely hindsight-driven, limited only to the references counsel
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`provided. Dr. Giesser’s declaration should be excluded.
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`Second, and further evidence of the result-oriented nature of her declaration,
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`Dr. Giesser’s testimony strayed far outside her area of expertise. Novartis showed
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`in its preliminary response that petitioners’ initial attempt to qualify Dr. Giesser
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`failed because she had no background in pharmacology. (Paper 8 at 44–45.)
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`Although the Board accepted her opinion for purposes of institution, it did so on the
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`assumption that Petitioners would be able to show that Dr. Giesser had “at least some
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`familiarity with pharmacological principles.” (Paper 11 at 10.) Her deposition
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`showed that this was untrue. (Ex. 2039 at 11:11–12; id. at 13:6–8; id. at 76:23–
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`79:11; Ex. 2024 ¶¶ 76–77.) In their reply, Petitioners did not dispute that Dr. Giesser
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`lacks pharmacological expertise, or that Dr. Giesser’s pharmacologic testimony was
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`beset with error. Petitioners instead tried to back-fill this gap in their case with a
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`declaration from a pharmacologist, Dr. Leslie Benet (Ex. 1047). But that effort
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`cannot fix the flaws in Dr. Giesser’s declaration, which should be excluded to the
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`extent that it purported to give the perspective of a pharmacologist.
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`Without Dr. Giesser’s testimony, the Petition must fail. Petitioners made no
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`effort to submit new, proper testimony from a multiple sclerosis (MS) physician to
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`try to correct for Dr. Giesser’s deficiencies. As a result, once Dr. Giesser’s opinions
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`are stripped away, the Petition lacks the perspective of a full person of skill.
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`B.
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`Exhibits Relating to the ’283 Formulation Patent IPR And the
`Confidential Clinical Trial Protocol Are Irrelevant
`Petitioners submitted four exhibits from an IPR of U.S. Patent No. 8,324,283
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`(the ’283 patent), a Novartis formulation patent not at issue here: (i) the Final
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`Written Decision in the ’283 patent IPR (Ex. 1032); (ii) the Orange Book listing for
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`Gilenya that includes the ’283 Patent (Ex. 1035); (iii) the ’283 patent itself (Ex.
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`1037); and (iv) the Federal Circuit Opinion on Appeal (Ex. 10412). None of these
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`documents is relevant. They appear to have been submitted solely as a cheap shot
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`at Novartis for having been unsuccessful in an unrelated IPR. They should be struck.
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`In addition, Petitioners submitted a confidential protocol from a clinical trial. (Ex.
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`1051.) As a confidential document, this Exhibit is not in the prior art, and is
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`otherwise irrelevant.
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`The Final Written Decision (Ex. 1032). This document is not evidence. It
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`is a prior decision of the Board. Even if it had a bearing on this case (it doesn’t), it
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`would be at most legal authority. Mendenhall v. Cedarapids, Inc., 5 F.3d 1557,
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`2
`This refers to Exhibit 1041 as filed by Argentum Pharmaceuticals LLC in
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`IPR2017-01550, which was joined with this case. Despite Patent Owner’s
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`suggestion to reconcile numbers, Petitioners filed an unrelated exhibit under the
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`same number in IPR2017-00854.
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`1569-70 (Fed. Cir. 1993) (prior decisions are at most entitled to “[d]eferential weight
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`on a legal conclusion, not evidentiary weight on facts in dispute”). Petitioners cite
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`and quote several of the Board’s observations in this document about references at
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`issue here, such as Chiba and Budde. (Paper 2 at 14, 16.) But those observations
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`were made in a different context (a formulation invention) about a different patent
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`(for a formulation) from the perspective of a different person of skill (a formulator).
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`Ex. 1032 is thus irrelevant; the Board’s observations in that opinion are unduly
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`prejudicial; and the opinion should be excluded under Fed. R. Evid. 401 and 403.
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`The Orange Book Listing (Ex. 1035). Petitioners cite the Orange Book
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`listing for fingolimod without any effort to lay a foundation for its relevance. (Paper
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`2 at 62.) Ex. 1035 is not relevant, and should be excluded under Fed. R. Evid. 401.
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`The ’283 Patent (Ex. 1037). The ’283 patent is irrelevant here too. As
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`Petitioners concede, the ’283 patent is not part of the same family as the ’405 patent.
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`(Paper 2 at 20.) The ’283 Patent has different inventors and different owners than
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`the ’405 Patent. (Compare Ex. 1037 at 1 with Ex. 1001 at 1.) Nor is the ’283 patent
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`offered as prior art, as evidence of knowledge in the art, or for any other proper
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`purpose here. Ex. 1037 should be excluded as irrelevant under Fed. R. Evid. 401.
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`The Federal Circuit Opinion on Appeal (Ex. 1041). Petitioner Argentum
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`added this Exhibit to its follow-on petition. (IPR2017-01550 Paper 1 at 21.) Again,
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`even if the Federal Circuit’s decision were pertinent to this case (it isn’t), the opinion
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`is at most authority. Ex. 1041 is not evidence, and has no business being admitted.
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`The Confidential Clinical Trial Protocol (Ex. 1051). In their reply papers
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`(Paper 49 at 21), Petitioners cite a confidential clinical trial protocol document
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`obtained in discovery in this case (Ex. 1051). The document is not relevant to any
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`issue here and should be excluded. This document is undisputedly not prior art. It
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`was confidential, not public. It states on its face that it is “confidential” and that it
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`“may not be used, divulged, published, or otherwise disclosed without the consent
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`of Novartis.” Ex. 1051 at 1. As such, the document could not inform the views of
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`a person of skill. Petitioners’ experts accordingly do not rely on Ex. 1051 in any
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`way; explain how it reflects on how one of ordinary skill would read any of the prior
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`art at issue; or otherwise build a foundation for its admissibility.
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`Petitioners point to the document only in their brief to argue that the expert
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`skepticism Novartis demonstrated, with compelling contemporaneous evidence (Ex.
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`2063), should be discounted because it was purportedly not “persuasive or
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`unanimous.” (Paper 49 at 21.) No expert provides a foundation for that reading,
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`and the document by itself is not probative of that issue. It merely shows an internal
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`hypothesis for why the clinical trial for 0.5 mg might work. That trial was conducted
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`with a futility analysis to protect against the risk it would not work. Despite that
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`hypothesis and futility analysis—both of which had been disclosed to Mount Sinai—
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`that hospital refused to participate for fear the 0.5 mg dose would not work. (See,
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`e.g., Ex. 2063, 2065.) Ex. 1051 is thus not relevant and should be excluded.
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`C.
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`Petitioner Marked Inadmissible Exhibits and Elicited
`Inadmissible Testimony at Recent Depositions
`Petitioners have improperly attempted to inject a series of untimely new
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`references into the record in the guise of cross-examining two of Novartis’s sur-reply
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`witnesses. Specifically, in the depositions of Dr. Chun and Dr. Jusko, Petitioners
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`introduced five new publications that had never before been presented or discussed
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`by anyone in this proceeding. Not surprisingly, the testimony Petitioners obtained
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`about these exhibits was worthless. Because the witnesses had not even seen the
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`documents before, they did not adopt Petitioners’ reading of them while sitting for
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`their deposition. Petitioners ignore these facts, and attempt to force the documents
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`into the record anyway. Petitioners failed to timely submit them via their own
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`experts, denying any opportunity for Novartis’s experts to fairly address them. The
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`Board should reject this stratagem and strike these exhibits and the related testimony.
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`1.
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`Dr. Chun’s Deposition and Exhibits 1054–56
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`Dr. Chun submitted a fact declaration—not expert opinion—about the
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`contents of the Webb reference (Ex. 2014), on which he is a co-author. (Ex. 2098.)
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`He explained the Webb animal experiments and the authors’ intended descriptions
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`of them. The majority of Dr. Chun’s deposition focused on those animal
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`experiments.
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`However, toward the end of the deposition Petitioners examined Dr. Chun on
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`new references outside the scope of his declaration and area of expertise in basic
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`science and animal models, Exs. 1055 and 1056 (in addition to set-up questions
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`about a predicate Exhibit 1054). These exhibits purport to describe human clinical
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`trial data from Phase II trials of fingolimod in transplant patients. Dr. Chun
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`repeatedly explained that he is not an expert in evaluating human data, and was
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`uncomfortable being asked to interpret papers he had never seen before. (Ex. 1063
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`at 287:23–292:5; id. at 296:4–318:19.) Nonetheless, Petitioners purport to cite the
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`testimony and the related document in their observations. (Paper 78 at 7–8.)3
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`The Board should exclude these papers and the related testimony from Dr.
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`Chun (specifically, Ex. 1063 from 278:3–318:23), for several reasons.
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`First, scope: Dr. Chun’s declaration was limited to reciting facts about his
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`Webb paper. His declaration never mentions Exhibits 1055 and 1056. Dr. Chun’s
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`3
`Petitioners’ observations on Dr. Chun’s and other witnesses’ testimony are
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`replete with improper argument, overstatement, or misstatement. Rather than
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`burden the Board with a motion to strike at this late stage of the proceedings,
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`however, Novartis will address these issues in its responsive observation documents.
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`testimony about these exhibits accordingly is entirely out of scope under Fed. R.
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`Evid. 611, and his testimony accordingly can provide no foundation for admitting
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`the exhibits themselves, either.
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`At the deposition, Petitioners argued their examination on these exhibits was
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`in-scope because Dr. Chun’s declaration said he believed that sustained lymphocyte
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`suppression was likely needed to treat RRMS. (Ex. 1063 at 303:20–304:16.) But in
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`the very next sentence, Dr. Chun said he understood that a different expert for
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`Novartis—Dr. Lawrence Steinman—would address the issue. (Ex. 2098 ¶ 44.)
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`Petitioners never asked Dr. Steinman about Exhibits 1054, 1055 and 1056, perhaps
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`because they wanted to avoid the views of a true expert on the Exhibits’ relevance.
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`Whatever their thinking, the Exhibits and related testimony are plainly outside the
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`scope of Dr. Chun’s direct testimony, and should be excluded for that reason alone.
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`Second, relevance: no person of skill in this matter has ever laid a foundation
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`for these exhibits. Dr. Chun is not a person of skill as defined by the Board, as he
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`testified in his deposition: Dr. Chun is neither an MS specialist nor a
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`pharmacologist. (Ex. 1063 at 191:6–14; id. at 214:25–215:20; id. 287:23–292:5.)
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`His testimony on the meaning of these documents accordingly is irrelevant and
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`prejudicial under FRE 401 and 403.
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`Third, timeliness: To the extent that Petitioners seek to introduce new
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`substantive exhibits via the testimony of Dr. Chun, such exhibits are untimely. (See
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`Paper 66 at 2.) Petitioners had the opportunity to submit these exhibits earlier, and
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`they should not be allowed to extend the record by attempting to pin them to Dr.
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`Chun’s non-expert testimony. See Toshiba Corp. v. Optical Devices, LLC, IPR2014-
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`01447, Paper 34 at 44–45 (Mar. 9, 2016) (excluding evidence improperly first
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`submitted in reply as untimely).
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`Fourth, form: Dr. Chun stated repeatedly in his deposition that he lacked the
`
`expertise to interpret these papers. (Ex. 1063 at 191:6–14; id. at 214:25–215:20; id.
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`287:23–292:5.) Dr. Chun’s expertise lies in basic science and animal research, not
`
`human clinical trials. Petitioners’ questioning was thus argumentative and lacked
`
`foundation. See Fed. R. Evid. 611(a), 611(b), 602, and 701.
`
`If Petitioners had wanted to use Exhibits 1055 and 1056 in this proceeding,
`
`the exhibits had to be introduced in a timely manner with proper evidentiary
`
`foundation from a competent expert. The exhibits and resulting testimony from Dr.
`
`Chun should be struck.
`
`2.
`
`Dr. Jusko’s Deposition and Exhibits 1057–60
`
`Petitioners tried a similar gambit with Dr. Jusko in questioning him about
`
`different papers from outside the record, Exhibits 1057–1060. Dr. Jusko had
`
`testified that scaling to human doses from animals should be done using the
`
`assumption from the CDC that the average U.S. female weight in 2006 was about
`
`
`
`13
`
`
`
`
`
`
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`75 kg. (Ex. 2095 ¶ 31.) As Dr. Jusko’s Fifth Declaration indicates, he conferred
`
`
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`IPR2017-00854
`U.S. Patent No. 9,187,405
`
`with Dr. Steinman on his assumptions. (Ex. 2108 ¶ 3.)
`
`During his deposition, Petitioners presented Dr. Jusko with several articles
`
`about MS studies from outside the U.S., and/or from the 1990s, and/or involving
`
`specific populations with lower bone density and thus weight. None of these studies
`
`accordingly undermined Dr. Jusko’s testimony about the proper weight to use when
`
`scaling animal to human doses for a disease modifying therapy in the U.S. in 2006
`
`for RRMS patient populations. As Dr. Jusko testified, weights outside the U.S. tend
`
`to be lower than in the U.S. (Ex. 1064 at 132:20–133:5; id. at 161:8–15.) In addition,
`
`Dr. Jusko explained that the studies used patient populations that likely had weights
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`skewed too low due to the medicines they were on at the time. (Id. at 137:18–142:22;
`
`id. at 161:8–162:18.)
`
`For these reasons, these papers and related testimony are inadmissible as
`
`improper impeachment and irrelevant. (Specifically, the testimony that should be
`
`excluded is at Exhibit 1064 at 113:16-114:6; 130:25-163:9.) Under the FRE, the
`
`Board should exclude attempted impeachment through extrinsic evidence on a
`
`“collateral” issue, such as those in the papers Petitioners used in Dr. Jusko’s
`
`deposition. Fed. R. Evid. 608(b). Moreover, the wide gap between what the papers
`
`showed and Dr. Jusko’s testimony make any such “impeachment” irrelevant anyway
`
`under FRE 401 and 403. For the same reasons, these papers are not admissible as
`
`
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`14
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`substantive evidence either, in addition to having been provided to Novartis on an
`
`
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`IPR2017-00854
`U.S. Patent No. 9,187,405
`
`untimely basis—an independent basis for exclusion, as shown above (at 12–13).
`
`III CONCLUSION
`
`For the foregoing reasons, the Board should exclude or limit the use of the the
`
`foregoing Exhibits, to the extent shown above.
`
`Dated: April 17, 2018
`
`Respectfully submitted,
`
`
`
`/Jane M. Love, Ph.D./
`Jane M. Love, Ph.D.
`Reg. No. 42,812
`Lead Counsel for Patent Owner
`Gibson, Dunn & Crutcher LLP
`200 Park Avenue
`New York, New York 10166-0193
`jlove@gibsondunn.com
`Tel: 212-351-3922
`
`
`
`15
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`
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`
`
`IPR2017-00854
`U.S. Patent No. 9,187,405
`
`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. § 42.6, I hereby certify that on April 17, 2018, true and
`
`accurate copies of the foregoing MOTION TO EXCLUDE for IPR2017-00854 were
`
`served via electronic mail, on the following counsel of record for Petitioners:
`
`For Apotex:
`
`For Argentum:
`
`For Sun:
`
`Steven W. Parmelee: sparmelee@wsgr.com
`Michael T. Rosato: mrosato@wsgr.com
`Jad A. Mills: jmills@wsgr.com
`Wilson Sonsini Goodrich & Rosati
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104
`Telephone: 206-883-2542
`
`Teresa Stanek Rea: trea@crowell.com
`Deborah H. Yellin: dyellin@crowell.com
`Shannon M. Lentz: slentz@crowell.com
`Tyler C. Liu: TLiu@agpharm.com
`Crowell & Moring LLP
`Intellectual Property Group
`1001 Pennsylvania Ave, NW
`Washington, DC 20004-2595
`(202) 624-2620
`
`Samuel Park: SPark@winston.com
`Charles B. Klein: CKlein@winston.com
`Sharick Naqi: SNaqi@winston.com
`Winston & Strawn LLP
`35 W. Wacker Drive
`
`16
`
`
`
`
`
`
`For Teva:
`
`
`
`IPR2017-00854
`U.S. Patent No. 9,187,405
`
`Chicago, IL 60601
`Telephone: (312) 558-7931
`
`Amanda Hollis: amanda.hollis@kirkland.com
`Eugene Goryunov: egoryunov@kirkland.com
`Gregory Springsted: greg.springsted@kirkland.com
`Kirkland & Ellis LLP
`300 North LaSalle
`Chicago, IL 60654
`Telephone: (312) 862-2000
`(202) 624-2620
`
`Respectfully submitted,
`
`
`
`/Jane M. Love, Ph.D./
`Jane M. Love, Ph.D.
`Reg. No. 42,812
`Lead Counsel for Patent Owner
`Gibson, Dunn & Crutcher LLP
`200 Park Avenue
`New York, New York 10166-0193
`jlove@gibsondunn.com
`Tel: 212-351-3922
`
`Dated: April 17, 2018
`
`
`
`17
`
`
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