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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 OPPOSITION TO PETITIONERS’
`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 joined
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`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
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`ARGUMENT ................................................................................................... 1
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`A.
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`B.
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`C.
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`The Novartis Inventors’ Report and
`Related Testimony Is Admissible ......................................................... 1
`1.
`The Report Itself Is Admissible .................................................. 1
`2.
`The Experts’ Testimony Is Independently Admissible .............. 5
`Dr. Lublin’s Evidence of Expectations
`and Skepticism is Admissible ............................................................... 6
`1.
`Exhibits 2063-2066 Are Admissible ........................................... 7
`2.
`Dr. Lublin’s Testimony Is Independently Admissible ............. 10
`Novartis’s Testimony About Webb Is Admissible ............................. 11
`1.
`Petitioners Invited This Testimony ........................................... 12
`2.
`Petitioners’ Attempt to Raise a Discovery Deficiency Fails .... 13
`3.
`Rule 702 Does Not Preclude the Testimony ............................. 13
`CONCLUSION .............................................................................................. 15
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`I
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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
`Lankford v. Reladyne,
`LLC, 2016 WL 1444307 (S.D. Ohio Apr. 8, 2016) ............................................. 2
`Monsanto Co. v. David,
`516 F.3d 1009 (Fed. Cir. 2008) ............................................................................ 5
`U.S. E.E.O.C. v. Olsten Staffing Servs. Corp.,
`657 F. Supp. 2d 1029 (W.D. Wis. 2009) .............................................................. 2
`United States v. Caballero,
`277 F.3d 1235 (10th Cir. 2002) .......................................................................... 13
`United States v. Logsdon,
`2013 WL 5755614 (W.D. Okla. Oct. 23, 2013) ................................................. 13
`Weatherford Int’l, LLC,
`IPR2016-01509, 2018 WL 1637993 (P.T.A.B. Apr. 3, 2018) ............................. 8
`Rules
`Fed. R. Evid. 106 ....................................................................................................... 9
`Fed. R. Evid. 602 ............................................................................................... 1, 4, 9
`Fed. R. Evid. 702 ............................................................................................... 13, 14
`Fed. R. Evid. 703 ................................................................................................. 5, 10
`Fed. R. Evid. 801 ................................................................................................... 1, 3
`Fed. R. Evid. 803 ........................................................................................... 1, 7, 8, 9
`Fed. R. Evid. 805 ....................................................................................................... 1
`Fed. R. Evid. 807 ....................................................................................................... 9
`Fed. R. Evid. 901 ................................................................................................... 1, 2
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`I
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`PRELIMINARY STATEMENT
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`IPR2017-00854
`U.S. Patent No. 9,187,405
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`In their motion, Petitioners nowhere dispute that Novartis’s evidence satisfies
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`every relevance criteria. Petitioners instead attack selected Exhibits with a mélange
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`of authentication, hearsay, and personal knowledge objections, sprinkled with some
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`complaints about discovery. None of these objections has any merit, and the Board
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`should consider all of Novartis’s concededly relevant evidence.
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`II
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`ARGUMENT
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`A. The Novartis Inventors’ Report and
`Related Testimony Is Admissible
`Novartis submitted a report prepared by the inventors that describes the
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`animal studies underlying the invention claimed in the ’405 patent. (Ex. 2057.)
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`Novartis experts Drs. Steinman and Jusko in turn discuss this document, which is
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`also addressed in Novartis’s Patent Owners Response. (Paper 26 at 22-25.)
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`Petitioners say the report and all parts of Novartis’s experts’ testimony about
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`it “should be excluded under Fed. R. Evid. 602, 801-803, 805, and 901.” (Paper 82
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`at 1–2.) None of these rules achieves what Petitioners hope for.
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`1.
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`The Report Itself Is Admissible
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`The Novartis report is authentic. Under Fed. R. Evid. 901, a document may
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`be authenticated by “testimony of a witness with knowledge” that the item “is what
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`it is claimed to be.” Fed. R. Evid. 901(b)(1). Novartis authenticated the report with
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`1
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`testimony from a co-author of the document, inventor Christian Schnell. His
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`U.S. Patent No. 9,187,405
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`declaration shows the report is exactly what Novartis says it is—a report that he, co-
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`inventor Peter Hiestand, and others prepared to describe the work that led to the ’405
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`patent. (Ex. 2026 at ¶ 1–2, 4.) That should end the inquiry.
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`Petitioners’ contrary arguments have no merit. Petitioners first assert that Mr.
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`Schnell lacks substantive knowledge of parts of the document that Mr. Hiestand
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`handled. (Paper 82 at 3–4.) That is irrelevant. Rule 901 requires only personal
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`knowledge that the document “is what it is claimed to be.” Mr. Schnell was a co-
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`author. He thus provided that testimony from his own recollection. Testimony from
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`an author indeed is more than is needed under the Rule. See, e.g., U.S. E.E.O.C. v.
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`Olsten Staffing Servs. Corp., 657 F. Supp. 2d 1029, 1033–34 (W.D. Wis. 2009)
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`(rejecting argument that author or witness with personal knowledge of contents of
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`document is required); Lankford v. Reladyne, LLC, 2016 WL 1444307, at *1 (S.D.
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`Ohio Apr. 8, 2016) (affidavit of treatment center’s custodian of records sufficient to
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`authenticate medical records under Rule 901).
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`Petitioners next complain that Mr. Schnell did not see Mr. Hiestand sign the
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`final document. (Paper 82 at 3.) That’s a straw man. Rule 901 does not require that
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`Mr. Schnell serve as notary.
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`Petitioners note also that Mr. Schnell did not “personally” deposit the
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`document into Novartis’s electronic filing system. (Id.) That is another red herring.
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`However the document was stored, Mr. Schnell testified, based on his own memory,
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`that the copy of the document Novartis submitted is what he and his colleagues
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`authored. Even if testimony about how the document was stored were required (it
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`isn’t), Novartis provided that testimony through the Declaration of Peter Waibel (a
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`submission that Petitioners completely ignore). (Ex. 2078 at ¶ 7, 10.) Petitioners’
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`authenticity objection is baseless.
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`The report is non-hearsay. Under Fed. R. Evid. 801, a document is hearsay
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`only if offered for the truth of the matter asserted therein. Novartis does not offer
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`the report for that purpose. The report shows that the inventors had insights to see
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`past the prior art’s teaching that higher doses were needed for efficacy, regardless of
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`whether those insights were actually correct. The inventors’ insights included a
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`novel use of the EAE model to focus on later disease stages than normal, and the
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`identification of a previously unknown mechanism of action (the inhibition of neo-
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`angiogenesis). Both led the inventors to believe that doses below those predicted by
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`the prior art would be effective as an RRMS therapy. (Paper 26 at 22–25.)
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`Nothing about this background information depends on the “truth” of the
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`matter asserted, i.e., that the experimental results are actually reproducible or
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`accurate. Petitioners, however, pretend otherwise—that that Novartis affirmatively
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`uses the document as “support for the claims.” (Paper 82 at 2.) That is wrong.
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`Novartis has no burden to prove the Patent’s claims are “supported” in an IPR.
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`While Petitioners challenge written description in Ground III, the basis of their
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`challenge has nothing to do with the experimental support for the Patent’s claims.
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`Novartis simply never took on a non-existent burden to provide that support
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`anywhere in its submissions—which would be unnecessary in any event, since these
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`experimental results are summarized in the Patent itself (Ex. 1001 at 10:33–11:2).
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`The report reflects the personal knowledge of its authors. The documents’
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`authors plainly had personal knowledge of what they wrote. Nothing more is needed
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`under Fed. R. Evid. 602.
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`Petitioners nonetheless argue the report should be excluded because Mr.
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`Hiestand, rather than Mr. Schnell, had primary knowledge of the report’s EAE
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`dosing data. Petitioners write “Peter Hiestand, not Christian Schnell, is the
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`purported, unsworn and unauthenticated declarant of the hearsay assertions in Ex.
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`2057.” (Paper 82 at 3.) This muddled non-sequitur actually proves the objection is
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`baseless—it concedes that the report reflects Mr. Hiestand’s personal knowledge.
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`Mr. Schnell need not have complete knowledge of every portion of a jointly authored
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`document—once authenticated and proffered for a non-hearsay purpose, the
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`document speaks for itself in relaying Mr. Hiestand’s personal knowledge. Lastly,
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`the assertion that Dr. Hiestand is “unauthenticated” is just bizarre.2
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`2 It is not a normal practice to “authenticate” human beings in PTAB proceedings.
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`2.
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`The Experts’ Testimony Is Independently Admissible
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`Petitioners rely solely on their objections to the Novartis report itself to assert
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`that all of Drs. Steinman’s and Dr. Jusko’s testimony about the report should also be
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`excluded. (Paper 82 at 5.) Even if the objections to the report were founded (they
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`aren’t), that would not justify the expert testimony’s exclusion.
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`Under Fed. R. Evid. 703, experts may rely on evidence that would otherwise
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`“not be admissible” provided the expert “would reasonably rely on those kinds of
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`facts or data in forming an opinion on the subject.” Here, that is the case—
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`researchers routinely rely on experimental reports like this, as is often seen in patent
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`cases. See, e.g., Monsanto Co. v. David, 516 F.3d 1009, 1015–16 (Fed. Cir. 2008)
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`(upholding admission of expert opinion based on experiments conducted by the
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`expert’s client rather than by the expert personally).
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`When an expert properly considers otherwise inadmissible facts, those facts
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`can be presented to the fact finder so long as the risk of prejudice does not outweigh
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`the probative value. Fed. R. Evid. 703. Petitioners make no argument that the
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`admission of this document would be prejudicial in any way, nor could they.
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`Accordingly, the testimony should be allowed irrespective of the ruling on the
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`Novartis report, and the PTAB should consider the exhibit along with that testimony.
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`B. Dr. Lublin’s Evidence of Expectations
`and Skepticism is Admissible
`Petitioners’ obviousness case is based on the hindsight assertion that even
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`though a 0.5 mg daily dose of fingolimod had never even been tested in RRMS
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`patients before, a person of ordinary skill in the art would have expected the dose to
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`be effective anyway in June 2006. Dr. Lublin presents compelling contemporaneous
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`evidence that the opposite was true.
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`FDA had pushed to include the dose in Phase III trials, but scientists and
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`doctors aware of and/or involved in the fingolimod clinical trials doubted the dose
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`would work at all. (Ex. 2025 ¶¶ 4–7, 39, 44–47, 50–58.) Dr. Lublin describes not
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`just his own doubts, but also the doubts of others, including as reflected in various
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`contemporaneous documents such as (1) emails from his own hospital Mount Sinai
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`declining to participate in one of the trials for fear the 0.5 mg dose would not work
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`(Exs. 2063, 2065–66); and (2) a futility protocol for the trials to short-circuit testing
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`for the 0.5 mg dose if data showed no efficacy after six months (Ex. 2064). Those
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`documents were of course written long before anyone had any idea these issues
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`would ever be litigated, and thus do not suffer from the hindsight bias that infects
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`Petitioners’ submissions. Small wonder Petitioners strain so hard to exclude these
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`materials. Their effort has no merit.
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`U.S. Patent No. 9,187,405
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`1.
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`Exhibits 2063-2066 Are Admissible
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`The exhibits are authentic. Each of these Exhibits came from Novartis’s
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`electronic files, and are authenticated through the declarations of Mr. Peter J.
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`Waibel, Esq. (Novartis’s head of U.S. patent litigation) and Dr. Lublin.
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`Mr. Waibel testifies that all four of these exhibits are correspondence in which
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`Novartis was directly involved. Novartis electronically stored the emails, and Mr.
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`Waibel collected the documents from those repositories. Mr. Waibel reviewed and
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`confirmed the emails’ authenticity. (Ex. 2078 at ¶¶ 11–14.) If that were not enough
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`(it is), Dr. Lublin reviewed and personally recalled much this correspondence, which
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`his assistant, Ms. Colleen Farrell, handled. (Ex. 2025 at ¶¶ 52–58.)
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`Petitioners have no basis for challenging authenticity. They start with a series
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`of inapt observations about Novartis document retention policies, including that not
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`all emails and correspondence are always kept. (Paper 82 at 6–7.) But Petitioners
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`do not even try to tie these meaningless allegations to any explicit evidentiary rule
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`or principle. That not all Novartis employees retain all emails does not, of course,
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`call into question the authenticity of these documents. There is no reason to doubt
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`their authenticity.
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`The exhibits are non-hearsay. These documents are all also classic non-
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`hearsay. Novartis does not offer the documents to prove the truth of the matters
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`asserted. They rather are evidence under Fed. R. Evid. 803(3) relevant to a person
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`of skill’s “state of mind”—they illustrate the belief that persons of skill doubted that
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`0.5 mg daily dose would work. (Paper 26 at 25–27, 40–41.) These documents are
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`not proffered to show that these doubts were correct; indeed, those doubts were not
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`correct. The assumption that only higher doses would work turned out to be wrong,
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`although no one besides the inventors knew it until later. (Id. at 20–24.) That is the
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`polar opposite of relying on these documents for their truth. See, e.g., Weatherford
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`Int'l, LLC, IPR2016-01509, 2018 WL 1637993, at *6 (P.T.A.B. Apr. 3, 2018)
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`(denying motion to exclude exhibit as hearsay offered to show skepticism; whether
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`or not the statement was true, it was offered to show that it was espoused, thus
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`reflecting the “state of mind”).
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`To try to force a hearsay objection that does not fit, Petitioners wrongly
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`suggest that any reliance on the content of these documents beyond the “existence
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`of the document in Novartis’s files” should be equated to reliance on them “for the
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`truth” of the matters asserted. (Paper 82 at 8.) For example, Petitioners suggest that
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`by offering these documents to show that the declarants actually held the doubts they
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`expressed, Novartis is relying on the documents for their truth. (Id. at 9 (asserting
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`that Novartis relies on the “truth” of the assertion that “the IRB’s opinion that the
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`inclusion of 0.5 mg dose the Phase III trial was questionable”).) That argument
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`misunderstands and would render meaningless Rule 803(3), which expressly allows
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`the use of an out-of-court statement of a declarant to prove that the declarant held a
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`particular belief, whether right or wrong.
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`Finally, Petitioners assert, without any showing, that all of the documents at
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`issue contain hearsay within hearsay. (Paper 82 at 10.) But Petitioners only discuss
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`Ex. 2065, albeit without identifying any specific statement from the email chain that
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`supposedly should be excluded. None should be. The entire chain is admissible to
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`show state of mind, and further under the recorded recollection and residual
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`exceptions of Fed. R. Evid. 803(5) and 807. The email chain shows real-time
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`communications between Ms. Farrell at Mount Sinai and the Mount Sinai
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`Institutional Review Board (IRB). There is no reason to doubt the veracity of their
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`statements, especially given the corroborating statements in the other documents,
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`and Dr. Lublin’s testimony. (Ex. 2025 ¶ 51–52; Ex. 2053; Ex. 2066.)
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`The exhibits reflect the personal knowledge of their authors. Petitioners
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`assert a Fed. R. Evid. 602 objection against these exhibits (Paper 82 at 6, 11), but
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`nowhere explain it. There is no basis for that objection. The documents’ authors
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`plainly had knowledge of the facts that the documents set out.
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`There is no basis for exclusion under Fed. R. Evid. 106. Petitioners assert
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`that portions of Exhibits 2064 and 2066 that quote portions of certain FDA meeting
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`minutes should be excluded because Novartis purportedly “violated” Rule 106 by
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`relying on these Exhibits without producing the underlying meeting minutes in their
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`entirety. (Paper 82 at 9–10.) That argument is not supported by Rule 106 or any
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`other authority. The exhibits at issue are not in any way incomplete, redacted, or
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`excerpted. Rather they are complete and accurate copies of the documents as they
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`were created in the ordinary course of business. Novartis did not excerpt anything.
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`The fact that these complete, un-redacted, ordinary-course documents quote other
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`material in part does not make them incomplete or even unusual. There is no
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`requirement that Novartis produce the FDA minutes in their entirety merely because
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`these other exhibits happen to refer to them.
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`In any event, Petitioners point to nothing “in fairness” that requires access to
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`information the Board already determined need not be produced. Novartis briefed
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`this discovery issue before the Board, and successfully resisted the production of
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`these exact additional documents. (Papers 35, 47.) The mere fact that Petitioners
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`do not like the Board’s ruling provides no reason to revisit the issue on a motion to
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`exclude.
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`2.
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`Dr. Lublin’s Testimony Is Independently Admissible
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`Petitioners seek to exclude all of Dr. Lublin’s testimony about the skepticism
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`and doubt surrounding the 0.5 mg daily dose—including his own personal
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`recollections of his own personal doubts—based solely on the argument that the four
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`exhibits above are inadmissible. (Paper 82 at 11.) That request is unsupportable.
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`To start, Dr. Lublin’s testimony about the contemporaneous documents is
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`admissible under Rule 703 even if the underlying documents were not admissible
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`(they are), for all the reasons already explained in section II.A.2 above. Dr. Lublin
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`can reasonably rely on the out-of-court doubts expressed by the Mount Sinai IRB,
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`just as any other expert in a patent case can rely on out-of-court statements in
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`forming opinions. His testimony should come in, and the PTAB should consider the
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`documents along with it.
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`Moreover, this testimony should also be allowed because it is a matter of Dr.
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`Lublin’s personal recollection, wholly independent of the documents, and thus
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`survives irrespective of Petitioners’ authenticity, hearsay, and discovery complaints.
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`Petitioners make no independent objection to Dr. Lublin’s independent personal
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`recollections of events, and thus concede the admissibility of those recollections.
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`C. Novartis’s Testimony About Webb Is Admissible
`Petitioners move to exclude testimony from Dr. Jerold Chun, a co-author of
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`the Webb prior art reference (Ex. 2014). (Paper 82 at 11–15.) Dr. Chun refutes
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`Petitioners’ effort to rewrite his article to mean something other than what it actually
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`says. Petitioners also move to exclude Dr. Steinman’s support of the same
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`interpretation of Dr. Chun’s article. (Id.) Petitioners arguments have no merit.
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`1.
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`Petitioners Invited This Testimony
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`Petitioners invited this concededly relevant testimony when they attempted to
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`distort Webb. That paper follows from prior research showing that fingolimod likely
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`worked by suppressing lymphocyte levels in circulating blood. But Webb found in
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`an RRMS animal model that “a threshold of about 70% depletion of peripheral
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`lymphocytes was required to see any efficacy.” (Paper 26 at 5 (quoting Ex. 2014 at
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`118).) Other papers that petitioners concede are relevant show that a 0.5 mg daily
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`dose of fingolimod in humans did not reach this threshold. (Id. at 5–7.) The art thus
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`taught away from the invention.
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`To avoid that conclusion, Petitioners have tried to rewrite Webb to suggest
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`that when the authors said 70%, they really meant something less. (Paper 49 at 11–
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`14.) Dr. Chun responded with a sworn fact declaration. He shows that he and his
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`co-authors did, in fact, mean 70% when they said 70%. (E.g., Ex. 2098 ¶¶ 1, 9.) He
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`explains why: The authors had access to copious data, only some of which was
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`described in detail in the article itself, but all of which informed their collective
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`judgment. (E.g., id. ¶¶ 7, 25–26, 33–34.) Dr. Steinman confirmed that a person of
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`skill would understand that both published and unpublished data supported the 70%
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`threshold, and would thus take the reference at face value. (Ex. 2096 ¶¶ 28, 31–40.)
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`Petitioners now try to exclude this testimony they invited by pretending that
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`Drs. Chun and Steinman are trying to rewrite Webb—when in fact it is Petitioners
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`themselves who have tried to do just that. (Paper 82 at 11–12.) To sustain this,
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`Petitioners must misrepresent the testimony from Drs. Chun and Steinman. But
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`neither man contradicts Webb with undisclosed data. Each merely shows that the
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`authors’ expressly stated conclusions should be taken at face value, in light of the
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`nature of the EAE animal model.
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`2.
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`Petitioners’ Attempt to Raise a Discovery Deficiency Fails
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`To start, Petitioners assert that this testimony should be excluded because
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`neither Dr. Chun nor Novartis produced the data underlying Webb. (Paper 82 at 12.)
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`But as Petitioners concede, there was nothing to produce: neither Novartis nor Dr.
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`Chun have this data in their possession. (Id.) The data belong to Merck, where Dr.
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`Chun was employed while preparing the Webb paper. (See Ex. 2098 ¶ 2.)
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`Petitioners never sought permission to seek third-party discovery from Merck of this
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`data. There is simply no basis for the severe exclusion remedy that Petitioners seek.
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`3.
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`Rule 702 Does Not Preclude the Testimony
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`Petitioners next argue that the testimony should be excluded under Rule 702,
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`arguing that Drs. Chun’s and Steinman’s opinions are not supported by sufficient
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`facts or data. (Paper 82 at 12–13.) But Rule 702 does not apply with respect to Dr.
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`Chun’s testimony, and Dr. Steinman’s testimony easily satisfies the rule.
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`Rule 702 applies only to expert opinion. United States v. Logsdon, 2013 WL
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`5755614, at *2 (W.D. Okla. Oct. 23, 2013) (“Where the witness does not purport to
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`express an expert opinion, but will testify only to facts of which he has personal
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`knowledge, the requirements of Rule 702 and Daubert do not apply.”); United States
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`v. Caballero, 277 F.3d 1235, 1247 (10th Cir. 2002) (“[W]itnesses need not testify as
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`experts simply because they are experts—the nature and object of their testimony
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`determines whether the procedural protections of Rule 702 apply.”). Dr. Chun’s
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`testimony on this issue is not expert opinion. It is fact testimony. Dr. Chun does not
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`purport to opine on how a person of skill would read Webb. He just states what he
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`meant as a matter of fact; explains why; and then describes the data sources the Webb
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`authors used to reach their conclusions. (Ex. 2098 ¶¶ 7–8, 17, 33–35, 38–41.) Dr.
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`Chun’s rejection of Petitioners’ attempt to put words in his mouth is not expert
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`testimony, making Rule 702 irrelevant.
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`Rule 702 does apply to Dr. Steinman, who shows how a person of skill would
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`have understood Webb to be based on both disclosed and undisclosed data, plus the
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`collective judgment of its authors. As nothing in Webb is internally inconsistent, a
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`person of skill would accept Webb’s conclusions at face value. (Ex. 2096 ¶¶ 28, 31–
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`40.) Dr. Steinman did not need to see the undisclosed data to render that opinion.
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`In fact, Dr. Steinman’s entire point is that one of skill would recognize, from
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`review of the reference alone, that there was unpublished granular data behind this
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`EAE study, as is usually the case. (Id. ¶ 31.) A person of skill would further accept
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`the authors’ conclusions without having to see all of the data, especially because the
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`14
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`paper was peer-reviewed and published in a respected journal. (Id. ¶ 33.) That
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`IPR2017-00854
`U.S. Patent No. 9,187,405
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`expert opinion is entirely consistent with Dr. Chun’s factual testimony, and amply
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`grounded in the facts based on his review of the reference itself.
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`III CONCLUSION
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`For the foregoing reasons, the Board should deny the motion to exclude, and
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`consider this important and concededly relevant evidence.
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`Respectfully submitted,
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`Dated: April 24, 2018
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`/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
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`IPR2017-00854
`U.S. Patent No. 9,187,405
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6, I hereby certify that on April 24, 2018, true and
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`accurate copies of the foregoing PATENT OWNER NOVARTIS’S OPPOSITION
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`TO PETITIONERS’ MOTION TO EXCLUDE for IPR2017-00854 were served via
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`electronic mail, on the following counsel of record for Petitioners:
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`For Apotex:
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`For Argentum:
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`For Sun:
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`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
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`Samuel Park: SPark@winston.com
`Charles B. Klein: CKlein@winston.com
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`For Teva:
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`IPR2017-00854
`U.S. Patent No. 9,187,405
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`Winston & Strawn LLP
`35 W. Wacker Drive
`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
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`Respectfully submitted,
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`
`
`/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 24, 2018
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`17
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