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`Paper No. ___
`Filed: May 3, 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
`SUPPLEMENTAL MOTION TO EXCLUDE
`37 C.F.R. §42.64
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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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`
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`INTRODUCTION ........................................................................................ 1
`I.
`ARGUMENT................................................................................................ 1
`II.
`III. CONCLUSION ............................................................................................ 6
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`TABLE OF CONTENTS
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`-i-
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`I.
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`INTRODUCTION
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`Petitioners oppose Novartis’s Supplemental Motion to Exclude of April 30,
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`2018. Novartis fails to establish entitlement to the requested relief. 37 C.F.R. §
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`42.20(c). A motion to exclude evidence must identify where each objection
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`originally was made, and must explain why the evidence is not admissible, “but
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`may not be used to challenge the sufficiency of the evidence to prove a particular
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`fact.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48756, 48767 (Aug. 14,
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`2012). Novartis’s Motion is also a thinly-veiled merits brief in support of its
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`Motion to Amend. It fails on the merits and should be denied.
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`II. ARGUMENT
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`Novartis seeks to exclude Exhibits 1065-1069 “as untimely under the
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`Board’s rules, and for lack of any relevance foundation under Fed. R. Evid. 401-
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`403.” Mot. at 1. Novartis offers three arguments in support of exclusion. Novartis
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`first argues that Exhibits 1065-1069 were submitted for the first time with
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`Petitioners’ Sur-Reply and “without any expert testimony or other evidence to lay
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`any foundation whatsoever,” citing 37 C.F.R. 42.23(b). But Rule 42.23(b) does not
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`require expert testimony to accompany the submission of exhibits. Further,
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`Novartis did not object to any of Exhibits 1065-1069 for lack of foundation or
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`authenticity or cite Rule 42.23(b) in its objections. Paper 87. The exhibits are self-
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`authenticating patents or patent publications, and their foundation as such is
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`-1-
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`established by the documents themselves. F.R.E. 902(1)-(5). Moreover, a motion
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`to exclude is not an appropriate vehicle for raising alleged noncompliance with
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`Rule 42.23(b). Cisco Sys., Inc. v. TQ Delta, LLC, IPR2016-01760, Paper 35 at 42-
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`43 (“A motion to exclude is not a vehicle to argue that a reply contains new
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`arguments.”); F5 Networks, Inc. v. Radware, Ltd., IPR2017-00124, Paper 48 at 68
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`(“[T]he Board has repeatedly stated that a motion to exclude is not the proper
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`vehicle to challenge the scope of a reply.”); Blackberry Corp. v. Zipit Wireless,
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`Inc., IPR2014-01508, Paper No. 49 at 40 (same); Liberty Mutual Ins. Co. v.
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`Progressive Casualty Ins. Co., CBM2012-00002, Paper 66 at 62 (“While a motion
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`to exclude may raise issues related to admissibility of evidence, it is not an
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`opportunity to file a sur-reply, and also is not a mechanism to argue that a reply
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`contains new arguments or relies on evidence necessary to make out a prima facie
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`case.”); Kyocera Corp. et al. v. Softview LLC., IPR2013-00007, Paper 51 at 34 (“A
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`motion to exclude is neither a substantive sur-reply, nor a proper vehicle for
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`arguing whether a reply or supporting evidence is of appropriate scope.”).
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`Petitioners’ Sur-Reply was necessitated when Novartis chose to disregard 37
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`C.F.R. 42.23(b), which requires that “All arguments for the relief requested in a
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`motion must be made in the motion.” Novartis indicated in its Corrected
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`Contingent Motion to Amend (Paper 61 at 2) that it was “instead holding any
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`rebuttal argument until reply.” In its Reply in Support of Contingent Motion to
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`-2-
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`Amend (Paper 64), Novartis made new arguments and cited new testimonial
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`evidence. The Board thus authorized Petitioners to file a sur-reply, including the
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`submission of additional evidence. Paper 66 at 2-3. In Paper 72, the Board limited
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`its authorization “to responding to arguments and citations to expert testimony
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`expressly set forth in Patent Owner’s Reply to Petitioner’s Opposition to Patent
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`Owner’s contingent motion to amend.” Paper 72 at 2. Petitioners’ April 19, 2018
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`Sur-Reply (Paper 85) and related submissions (including Exhibits 1065-1069) were
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`timely filed on April 19, 2018 pursuant to the Board’s Order. Paper 66 at 3.
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`Petitioners’ April 19, 2018 submissions complied with Rule 42.23(b) and the
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`Board’s orders (Papers 66, 72) by responding to arguments raised in Novartis’s
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`Reply (Paper 64). Petitioners’ Sur-Reply cited Exhibits 1065-1069 to respond to
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`Novartis’s reply argument and new expert testimony “that loading dose regimens
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`are species of dosing regimens and that the term dosing regimen means ‘a schedule
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`of doses of a therapeutic agent per unit of time.” Paper 85 at 10 (citing Reply at 5,
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`EX2096, ¶¶18-20). As Petitioners pointed out, Novartis’s argument assumes that
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`“a dosing regimen” in a method for treating must be the only dosing regimen for
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`the same active ingredient, and Novartis argued on that basis that the inclusion of
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`“a dosing regimen” in an open-ended method closes the method off to different
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`dosing regimens for the same active. Paper 85 at 10.
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`Petitioners cited Exhibits 1065-1069 to demonstrate that methods of
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`-3-
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`treatment routinely employ more than one dosing regimen for a given active at
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`different times. Paper 85 at 10-11. Exhibits 1065-1069 are relevant because they
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`demonstrate that the scope of an open-ended method for treating claims is not
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`limited to a single dosing regimen for the same active. In other words, the plain
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`meaning of a “dosing regimen,” much less the broadest reasonable construction of
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`the term, does not close an open-ended method for treating from further
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`comprising a different dosing regimen for the same drug, (e.g., up-titration, dose
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`reduction, loading dose regimen, etc.). These patents and patent publications are
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`relevant because they contradict Novartis’s argument that a “dosing regimen”
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`comprised by a claim categorically excludes another “dosing regimen” for the
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`same drug from also being comprised by the claim. See Cisco Sys., IPR2016-
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`01760, Paper 35 at 43-44 (“Finding that Petitioner’s response to Patent Owner’s
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`claim construction identification is an improper new argument would deprive
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`Petitioner of the ability to address Patent Owner’s claim construction evidence and
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`argument introduced after Institution.”).
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`Novartis’s second argument is that the Exhibits 1065-1069 are irrelevant
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`because two of them (EX1068-EX1069) were published after the earliest claimed
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`priority date of the ’405 patent, one of them as late as September 2017. Mot. at 1-2.
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`Notably, however, the term “dosing regimen” does not appear anywhere in the
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`specification of the ’405 patent and was proposed for entry into the patent in
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`-4-
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`November 2017 with its Motion to Amend. Exhibits 1065-1069 demonstrate that
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`the plain meaning and broadest reasonable construction of “dosing regimen” at the
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`time of the earliest claimed priority date, as well as when Novartis sought to
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`introduce it into the patent in 2017, did not categorically exclude another dosing
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`regimen for the same drug from also being comprised by the claim.
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`Novartis argues that Exhibits 1065-1069 are irrelevant if they do not disclose
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`a method for treating MS. Mot. at 1-2. But Novartis itself cited non-MS- and non-
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`fingolimod-specific literature to attempt to establish a plain meaning of the term
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`“dosing regimen.” Paper 64 at 5 (citing EX2105). Exhibits 1065-1069 establish
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`that “a dosing regimen” being comprised by a method for treating is not
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`“universally-accepted” as closing off the method off to other dosing regimens for
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`the same drug. Petitioners also pointed out that neither fingolimod nor MS
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`treatment somehow categorically prohibits using different dosing regimens at
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`different times in the same method for treating. Paper 85 at 10-12. Indeed,
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`Petitioners cited evidence that a method for treating RRMS with fingolimod can
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`include using different dosing regimens for fingolimod over time. Id.; see also
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`EX1042 at 76:4-79:25; EX1061 at 330:18-332:14; EX1004 at 15; EX2067
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`(“Reduced fingolimod dosage treatment for patients with multiple sclerosis and
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`lymphopenia or neutropenia.”). Exhibits 1065-1069 satisfy the threshold for
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`admission under F.R.E. 401-403.
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`-5-
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`Novartis’s third argument for exclusion is that “the documents prove
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`Novartis’s point.” Mot. at 2-3. However, no rule of evidence (certainly none cited
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`by Novartis) justifies exclusion of evidence because the party moving to exclude
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`suddenly believes the evidence supports their case. Moreover, Novartis is
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`incorrect. The use of modifiers such as “first,” “second,” “induction,”
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`“maintenance,” for dosing regimens in Exhibits 1065-1068 and the lack of such
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`modifiers in the proposed amended claims does not rewrite the proposed amended
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`claims to categorically exclude additional dosing regimens. As a threshold matter,
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`Exhibit 1069 does not use any of these modifiers. Moreover, Novartis’s argument
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`erroneously assumes that because the proposed amended claims are not limited to
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`embodiments comprising an additional dosing regimen that they are limited to
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`categorically precluding such embodiments. Novartis reads the phrase
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`“comprising…a dosing regimen” to mean “comprising…one and only one dosing
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`regimen.” Its attempt to rewrite the proposed amended claims through an
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`erroneous claim construction argument does not justify excluding Exhibits 1065-
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`1069.
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`III. CONCLUSION
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`Petitioners request that Novartis’s Supplemental Motion to Exclude be
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`denied.
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`-6-
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`Dated: May 3, 2018
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`Respectfully submitted,
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`/ Steven W. Parmelee /
` Steven W. Parmelee
` Reg. No. 31,990
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`-7-
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`CERTIFICATE OF SERVICE
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`
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`This is to certify that I caused to be served true and correct copies of the
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`foregoing Petitioners’ Opposition to Novartis’s Supplemental Motion to Exclude
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`on this 3rd day of May, 2018, on the Patent Owner at the correspondence address
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`of the Patent Owner as follows:
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`Jane M. Love, Ph.D.
`Robert W. Trenchard
`GIBSON, DUNN & CRUTCHER LLP
`200 Park Avenue, 47th Floor
`New York, NY 10166
`Email: jlove@gibsondunn.com
`Email: rtrenchard@gibsondunn.com
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`
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`Dated: May 3, 2018
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`/ Steven W. Parmelee /
` Steven W. Parmelee
` Reg. No. 31,990
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`-8-
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