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`Paper No. _
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`Filed: January 22, 2018
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`APOTEX INC., APOTEX CORP.,
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`ARGENTUM PHARMACEUTICALS LLC,
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`ACTAVIS ELIZABETH LLC, TEVA PHARMACEUTICALS USA, INC.,
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`SUN PHARMACEUTICAL INDUSTIRES, LTD.,
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`SUN PHARMACEUTICAL INDUSTRIES, INC., and
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`SUN PHARMA GLOBAL FZE,
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`Petitioners,
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`NOVARTIS A.G.,
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`Patent Owner.
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`IPR2017-008541
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` /012
`Patent No. 9,187,405
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`4
`PETITIONER’S MOTION FOR DISCOVERY
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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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`I.
`RELIEF REQUESTED
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`Pursuant to 37 C.F.R. §§42.51(b), 42.52(a)(2) and Paper 34, Petitioner
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`requests an order requiring Novartis to produce (i) minutes of its February 2, 2005
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`meeting with FDA (“FDA Minutes”), (ii) Novartis’s briefing book for the March
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`26, 2007 End-of-Phase 11 meeting (“Briefing Book”), (iii) the phase III protocol
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`referenced in Exhibit 2065 (“Protocol”), and (iv) an unredacted copy of EX2063.
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`Novartis relies in its Patent Owner’s Response (“POR”) upon excerpts fi'om
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`Novartis relies in its Patent Owner’s Response (“POR”) upon excerpts fi'om
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`the FDA Minutes and Briefing Book to argue that the 0.5 mg daily dose of
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`the FDA Minutes and Briefing Book to argue that the 0.5 mg daily dose of
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`fingolimod was administered to RRMS patients in the phase III trials because it
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`fingolimod was administered to RRMS patients in the phase III trials because it
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`was expected to lack “any efficacy.” POR at 25-27, 40. Petitioner is entitled to see
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`was expected to lack “any efficacy.” POR at 25-27, 40. Petitioner is entitled to see
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`the entire documents, not just the excerpts Novartis selected for inclusion.
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`the entire documents, not just the excerpts Novartis selected for inclusion.
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`Otherwise, Patent Owner will deny Petitioner its right to submit other portions of
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`Otherwise, Patent Owner will deny Petitioner its right to submit other portions of
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`the documents “that in fairness ought to be considered.” F.R.E. 106.
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`Petitioner initially objected to Novartis’s reliance in its POR and
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`the documents “that in fairness ought to be considered.” F.R.E. 106.
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`Petitioner initially objected to Novartis’s reliance in its POR and
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`declarations on excerpts of the documents quoted in Exhibits 2063-2066. Paper 31
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`declarations on excerpts of the documents quoted in Exhibits 2063-2066. Paper 31
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`at 10. The same day that Novartis served its supplemental evidence, Petitioner
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`at 10. The same day that Novartis served its supplemental evidence, Petitioner
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`again asked Novartis to produce complete copies of the FDA minutes and Briefing
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`again asked Novartis to produce complete copies of the FDA minutes and Briefing
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`Book. EX1044. After an unfruitful meet and confer, Petitioner promptly requested
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`Book. EX1044. After an unfruitful meet and confer, Petitioner promptly requested
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`Board assistance. EX1045 at 2. Petitioner then began depositions of Novartis’s
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`witnesses. During one of those depositions, Dr. Lublin testified that the clinical
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`Board assistance. EX1045 at 2. Petitioner then began depositions of Novartis’s
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`witnesses. During one of those depositions, Dr. Lublin testified that the clinical
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`trial protocol referenced in EX2065 describes Novartis’s justification for including
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`the 0.5 mg dose. EX1042 at 15 8:15 -l66:24. Petitioner requested production of the
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`Protocol, but Novartis never complied. EX1042 at 245223-24623.
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`the 0.5 mg dose. EX1042 at 15 8:15 -l66:24. Petitioner requested production of the
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`Protocol, but Novartis never complied. EX1042 at 245223-24623.
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`Petitioner followed up with another email to Trials regarding its
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`Petitioner followed up with another email to Trials regarding its
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`teleconference request and noted that it was also requesting the Protocol. EX1045
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`teleconference request and noted that it was also requesting the Protocol. EX1045
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`at 1. After the teleconference, the Board issued an order stating “Petitioner Apotex
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`at 1. After the teleconference, the Board issued an order stating “Petitioner Apotex
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`may file a motion seeking additional discovery.” Paper 34 at 4.
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`may file a motion seeking additional discovery.” Paper 34 at 4.
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`As explained in detail below, all four documents are relevant because they
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`As explained in detail below, all four documents are relevant because they
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`contain or refer to communications between Patent Owner and the FDA addressing
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`the justification for administering the 0.5 mg dose. The only way to prove or
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`contain or refer to communications between Patent Owner and the FDA addressing
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`the justification for administering the 0.5 mg dose. The only way to prove or
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`disprove Novartis’s argument is to see the actual documents. Requiring production
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`disprove Novartis’s argument is to see the actual documents. Requiring production
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`of the documents is thus in the interests ofjustice and is necessary to afford
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`Petitioner a fair cross-examination of Novartis’s witnesses. 37 C.F.R. §§
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`42.51(b)(1)(i), (iii), (2)(i)-(ii). Petitioner’s Reply is due February 2, 2018.
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`of the documents is thus in the interests ofjustice and is necessary to afford
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`Petitioner a fair cross-examination of Novartis’s witnesses. 37 C.F.R. §§
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`42.51(b)(1)(i), (iii), (2)(i)-(ii). Petitioner’s Reply is due February 2, 2018.
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`Petitioner thus requests Novartis produce the documents promptly.
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`Petitioner thus requests Novartis produce the documents promptly.
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`II.
`DETAILS ABOUT REQUESTED DOCUMENTS
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`A.
`“FDA Minutes” Document
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`Dr. Lublin relies on—
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`EX2025 at 1155. Dr. Lublin repeatedly testified that the—
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`EX1042 at 165216-24; EX2025 at 11114-5 (“FDA accordingly pressed to understand
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`EX1042 at 165216-24; EX2025 at 11114-5 (“FDA accordingly pressed to understand
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`fingolimod’s minimum effective dose.”), 1139 (“FDA was dissatisfied with the
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`fingolimod’s minimum effective dose.”), 1139 (“FDA was dissatisfied with the
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`Phase II trial’s failure to identify a minimum effective dose. FDA accordingly
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`Phase II trial’s failure to identify a minimum effective dose. FDA accordingly
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`pushed Novartis to include a lower dose in the Phase III trial”), 1144 (“We debated
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`whether and how to include the lower dose FDA wanted”), 111157-5 8 (“-
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`whether and how to include the lower dose FDA wanted”), 111157-5 8 (“-
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`Novartis relied upon Dr. Lublin’s testimony to establish—
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`Novartis relied upon Dr. Lublin’s testimony to establish—
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`—” POR 40 (discussing
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`EX2064); POR at 25—27 (citing EX2025, 11115, 7, 39-42, 50-58). Novartis has
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`EX2064); POR at 25—27 (citing EX2025, 11115, 7, 39-42, 50-58). Novartis has
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`directly put at issue—
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`—.”). Regarding the Protocol, Dr. Lublin confirmed that “we
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`would have to review that document” if we wanted to understand the document
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`would have to review that document” if we wanted to understand the document
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`and “what they saw.” EX1042 at 185225-186225, 189213-19024.
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`D.
`Unredacted Copy of EX2063
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`Novartis refuses to produce an unredacted copy of EX2063 because it argues
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`the redactions cover “internal” Novartis communications regarding its attempts to
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`and “what they saw.” EX1042 at 185225-186225, 189213-19024.
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`D.
`Unredacted Copy of EX2063
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`Novartis refuses to produce an unredacted copy of EX2063 because it argues
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`the redactions cover “internal” Novartis communications regarding its attempts to
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`get the Mt. Sinai IRB to participate in the TRANSFORMS trial. Novartis never
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`get the Mt. Sinai IRB to participate in the TRANSFORMS trial. Novartis never
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`asserted any privilege. These internal conversations are facially relevant because
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`asserted any privilege. These internal conversations are facially relevant because
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`they relate to the information Novartis chose to give and withhold from the IRB.
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`III. ARGUMENT
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`Complete copies of the FDA Minutes, Briefing Book, and Clinical Trial
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`Protocol, and EX2063 should be produced pursuant to 37 C.F.R. §§ 42.51(b)(2)(i)-
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`(ii) and F.R.E. 106. In evaluating additional discovery, the Board considers
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`(ii) and F.R.E. 106. In evaluating additional discovery, the Board considers
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`whether: (1) there is more than a “mere allegation” something useful will be
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`whether: (1) there is more than a “mere allegation” something useful will be
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`uncovered; (2) the request does not improperly attempt to alter the Board’s trial
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`uncovered; (2) the request does not improperly attempt to alter the Board’s trial
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`procedures by seeking litigation positions; (3) equivalent information is not easily
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`obtainable by other means; (4) instructions are easy to understand; and (5) requests
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`are not overly burdensome. Garmin Int’l Inc. et. al. v. Cuozzo Speed Techs. LLC,
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`are not overly burdensome. Garmin Int’l Inc. et. al. v. Cuozzo Speed Techs. LLC,
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`IPR2012-00001, Paper 26, 6-16 (precedential). Additional discovery is
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`IPR2012-00001, Paper 26, 6-16 (precedential). Additional discovery is
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`appropriate here, where evidence on an issue raised by Novartis (justification for
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`appropriate here, where evidence on an issue raised by Novartis (justification for
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`including the 0.5 mg dose in the phase III studies) is “uniquely in the possession of
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`the party that raised it.” 77 Fed. Reg. 48756, 48761 (Aug. 14, 2012).
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`The Board has previously found it in the interests ofj ustice to order the
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`the party that raised it.” 77 Fed. Reg. 48756, 48761 (Aug. 14, 2012).
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`The Board has previously found it in the interests ofj ustice to order the
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`production of complete copies of excerpted documents relied upon by a party to
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`production of complete copies of excerpted documents relied upon by a party to
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`provide the context for the relied upon excerpts. See, e. g., Baby Trend, Inc. et al.
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`provide the context for the relied upon excerpts. See, e. g., Baby Trend, Inc. et al.
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`v. Wonderland Nurserygoods Co., Ltd, IPR2015-0084l, Paper 24 at 3-5 (ordering
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`production of complete copies of deposition transcripts where Patent Owner
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`v. Wonderland Nurserygoods Co., Ltd, IPR2015-0084l, Paper 24 at 3-5 (ordering
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`production of complete copies of deposition transcripts where Patent Owner
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`submitted excerpts to counter Petitioner’s obviousness arguments and establish
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`submitted excerpts to counter Petitioner’s obviousness arguments and establish
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`secondary indicia). Here, the interests ofj ustice similarly require production of the
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`secondary indicia). Here, the interests ofj ustice similarly require production of the
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`identified documents and the Garmin factors favor production.
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`A. More Than a Possibility and Mere Allegation
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`The existence of the requested documents cannot reasonably be disputed.
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`identified documents and the Garmin factors favor production.
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`A. More Than a Possibility and Mere Allegation
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`The existence of the requested documents cannot reasonably be disputed.
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`Novartis’s papers identify the requested documents as communications between
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`FDA and Novartis that discussed the inclusion of the 0.5 mg dose and the futility
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`analysis in the Phase III trial. At best, Novartis has provided only excerpts of these
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`documents (and refuses to provide the protocol entirely).
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`that the 0.5 mg dose was administered in the phase III trial “—
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`that the 0.5 mg dose was administered in the phase III trial “—
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`the 0.5 mg dose to be effective. POR at 27 (“As Dr. Lublin shows, if 0.5 mg daily
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`had been obvious in June 2006, then- Novartis would have bypassed that
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`dose to include an even lower dose in the Phase III Trials. (Lublin Dec., Ex. 2025
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`the 0.5 mg dose was administered because it was expected to lack efficacy. In
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`the 0.5 mg dose was administered because it was expected to lack efficacy. In
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`reasonably expected to be efficacious. EX2064 at 25 ((Appendix D: Section 12.1)
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`POR G’aper 27) two previously-undisclosed prior art references describing the use
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`of the 0.5 mg dose in phase III clinical trials. POR at 25 (citing EX2031 and
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`of the 0.5 mg dose in phase III clinical trials. POR at 25 (citing EX2031 and
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`exhibits were each published in April 2006 and were each prior art to the ’405
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`exhibits were each published in April 2006 and were each prior art to the ’405
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`patent. EX1042 at 221 :6-222214 (EX2031), 243213-244221. His testimony
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`establishes that each of these references discloses each and every element in the
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`establishes that each of these references discloses each and every element in the
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`claims at issue in this IPR. EX1042 at 238223-24025, 24123-242216, 244222-245 :6;
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`The anticipatory references newly cited by Novartis (EX2031, EX2072) thus
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`contradict Novartis’s argumensts that Webb (EX2014) would have discouraged a
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`contradict Novartis’s argumensts that Webb (EX2014) would have discouraged a
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`POSA from administering the 0.5 mg dose to RRMS patients and that no one
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`reasonably expected the 0.5 mg dose to have therapeutic efficacy. As Dr. Lublin
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`reasonably expected the 0.5 mg dose to have therapeutic efficacy. As Dr. Lublin
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`agreed, “a person of ordinary skill in the art in June 2006, would agree with [him]
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`justification for the 0.5 mg dose are thus relevant and useful.
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`justification for the 0.5 mg dose are thus relevant and useful.
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`and Protocol discuss the “justification” for including the 0.5 mg dose in the study.
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`See Section II, supra. Production of the Protocol also will enable Petitioners and
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`See Section II, supra. Production of the Protocol also will enable Petitioners and
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`characterization of portions of these documents, the interests ofj ustice require that
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`Petitioner be permitted to review the complete documents and submit to the Board
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`characterization of portions of these documents, the interests ofj ustice require that
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`Petitioner be permitted to review the complete documents and submit to the Board
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`any portions “that in fairness ought to be considered at the same time.” F.R.E. 106;
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`Mobile Tech, Inc. v. Invue Security Prods. Inc., IPR2016-00898, Paper 34 at 76
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`(noting that F.R.E. 106 “provides a basis for including” evidence and denying
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`(noting that F.R.E. 106 “provides a basis for including” evidence and denying
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`by name, date, and locations where they are described in Novartis’s exhibits and
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`witness testimony. They are easily-identifiable documents within Novartis’s
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`witness testimony. They are easily-identifiable documents within Novartis’s
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`possession. The request is easy to understand and narrowly targeted.
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`possession. The request is easy to understand and narrowly targeted.
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`Not Overly Burdensome
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`Novartis has claimed that it could not identify the final Briefing Book (as opposed
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`Novartis has not identified any burden in producing the FDA Minutes.
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`Novartis has claimed that it could not identify the final Briefing Book (as opposed
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`to drafts) and claimed that the Briefing Book was too large to produce. But it has
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`to drafts) and claimed that the Briefing Book was too large to produce. But it has
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`not described making a good faith search to identify the final Briefing Book or
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`not described making a good faith search to identify the final Briefing Book or
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`explained why it is unable to locate the underlying document it provided to FDA.
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`explained why it is unable to locate the underlying document it provided to FDA.
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`table of contents for the briefing book to identify relevant subsections or discussing
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`table of contents for the briefing book to identify relevant subsections or discussing
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`cost shifting to narrow the amount of material. Petitioner raised production
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`cost shifting to narrow the amount of material. Petitioner raised production
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`promptly and Novartis has had almost two months, but simply refuses to provide
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`promptly and Novartis has had almost two months, but simply refuses to provide
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`the information because it does not want the Board to see it. The parties have
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`already stipulated to a protective order that adequate to address any confidentiality
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`the information because it does not want the Board to see it. The parties have
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`already stipulated to a protective order that adequate to address any confidentiality
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`concerns that Novartis might raise. This factor too favors production.
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`As discussed above, each of the Garmin factors supports production of the
`
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`
`requested documents in the interests ofj ustice.
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`IV. CONCLUSION
`8BJK A9:ALN=89:4
`Petitioner requests the relief detailed above.
` + + S,+, +E
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`concerns that Novartis might raise. This factor too favors production.
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`As discussed above, each of the Garmin factors supports production of the
`
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`requested documents in the interests ofj ustice.
`S,+ HT+, +E +,+, U G,+ H
`
`IV. CONCLUSION
`8BJK A9:ALN=89:4
`Petitioner requests the relief detailed above.
` + + S,+, +E
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`
`-10-
`00
`
`
`
`-10-
`00
`
`
`
`
`
`Dated: January 22, 2018
`
` +
`
`
`
`
`Respectfully submitted,
`
` , H+U
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`
`/ Steven W. Parmelee /
`» +- j T
`
`/ Steven W. Parmelee /
`» +- j T
»
`Steven W. Parmelee
` +- j T
`Steven W. Parmelee
` +- j T
`Reg. No. 31,990
` I O33
`
`
`
`
`
`
`
`-11-
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`
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`
`
`
`List of Exhibits
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`
`Description
`Exhibit No.
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`
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`
`
`
`
`1001
`US. Patent No. 9,187,405, “SIP Receptor Modulators for Treating
` ++ 3/21 V H +
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`Relapsing-Remitting Multiple Sclerosis” (filed April 21, 2014)
`
`Relapsing-Remitting Multiple Sclerosis” (filed April 21, 2014)
`
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`(issued November 17, 2015)
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`Declaration of Dr. Barbara S. Giesser
`
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`(issued November 17, 2015)
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`Declaration of Dr. Barbara S. Giesser
`
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`Curriculum Vitae of Dr. Barbara S. Giesser
`
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`John Kovarik and Silke Appel-Dingemanse: International
`2 E !- Y
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`Curriculum Vitae of Dr. Barbara S. Giesser
`
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`1004
`John Kovarik and Silke Appel-Dingemanse: International
`2 E !- Y
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`Publication No. WO 2006/058316 (published June 1, 2006)
`
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`1005
`Thomson, FTY720 in Multiple Sclerosis: The Emerging Evidence of
`1 ET, ¶¾¿ÀÁ³~ÂÃ~ÃÄ
`its Therapeutic Value, CORE EVIDENCE, 1(3):157-167 (2006)
`
`~}½} #" ) # QOR1/0D/ QDR
`1006
`U. S. Patent No. 6,004,565 (Chiba) “Compositions and Methods of
`D ++ D21D1 Q#E FR V#T , + , +E , U
`Using Compositions with Accelerated Lymphocyte Homing
`, I #T , + , . +E HH
`1005
`Thomson, FTY720 in Multiple Sclerosis: The Emerging Evidence of
`1 ET, ¶¾¿ÀÁ³~ÂÃ~ÃÄ
`its Therapeutic Value, CORE EVIDENCE, 1(3):157-167 (2006)
`
`~}½} #" ) # QOR1/0D/ QDR
`1006
`U. S. Patent No. 6,004,565 (Chiba) “Compositions and Methods of
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`Using Compositions with Accelerated Lymphocyte Homing
`, I #T , + , . +E HH
+
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`Immunosuppressive Properties” (filed September 23, 1997) (issued
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`Immunosuppressive Properties” (filed September 23, 1997) (issued
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+TF O 33/R Q ,,
`December 21, 1999)
`
`
` HTF 333R
`1007
`Kappos, L., et al. , FTY720 in Relapsing MS: Results ofa Double-
`/ ! , & } ¶¾¿ÀÁÅ}³ÂÅÄ}ÆÇ
`Blind Placebo-Controlled Trial with a Novel Oral
`´}Ç~~}È}É~}
`Immunomodulator, JOURNAL OF NEUROLOGY 252(Suppl 2):1 1/41,
`}~ " & "
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`December 21, 1999)
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`Kappos, L., et al. , FTY720 in Relapsing MS: Results ofa Double-
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