Trials@uspto.gov
`571-272-7822
`
`Paper 34
`Entered: January 11, 2018
`
`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
`Patent US 9,187,405 B2
`_______________
`
`Before LORA M. GREEN, CHRISTOPHER M. KAISER,
`and ROBERT A. POLLOCK, Administrative Patent Judges.
`
`POLLOCK, Administrative Patent Judge.
`
`ORDER
`Conduct of the Proceeding
`Discovery under 37 C.F.R. § 41.51(b)(1)
`Ordering Briefing on Discovery under
`37 C.F.R. § 41.52(b)(2)
`
`1 Cases IPR2017-01550, IPR2017-01946, and IPR2017-01929 have been
`joined with this proceeding.
`
`
`571-272-7822
`
`Paper 34
`Entered: January 11, 2018
`
`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
`Patent US 9,187,405 B2
`_______________
`
`Before LORA M. GREEN, CHRISTOPHER M. KAISER,
`and ROBERT A. POLLOCK, Administrative Patent Judges.
`
`POLLOCK, Administrative Patent Judge.
`
`ORDER
`Conduct of the Proceeding
`Discovery under 37 C.F.R. § 41.51(b)(1)
`Ordering Briefing on Discovery under
`37 C.F.R. § 41.52(b)(2)
`
`1 Cases IPR2017-01550, IPR2017-01946, and IPR2017-01929 have been
`joined with this proceeding.
`
`
`
`IPR2017-00854
`Patent 9,187,405 B2
`
`At the request of lead Petitioner, Apotex, a conference call in the above
`
`proceedings was held on January 10, 2018, among counsel for the respective
`
`Petitioners, Patent Owner, and Judges Pollock, Green, and Kaiser to discuss
`
`Apotex’s request for routine or additional discovery of (1) minutes of a
`
`February 2, 2005 face-to-face meeting between FDA and Novartis (“the FDA
`
`minutes”); (2) Novartis’s briefing book for a March 26, 2007 End-of-Phase II
`
`meeting (“the briefing book”); and (3) an unredacted version of Exhibit 2063.
`
`A. Routine Discovery
`
`Under 37 C.F.R. § 41.51(b)(1)(i), “[u]nless previously served or otherwise
`
`by agreement of the parties, any exhibit cited in a paper or in testimony must be
`
`served with the citing paper or testimony.” A brief excerpt of the FDA minutes is
`
`quoted in Exhibit 2066, which is a letter from Novartis to a Dr. Miller of Mount
`
`Sinai School of Medicine (“the Miller letter). In Exhibit 2025 (Dr. Lublin’s second
`
`declaration), Patent Owner’s expert relies on the excerpt quoted in Exhibit 2066.
`
`Ex. 2025, ¶ 55; see also Paper 26, 26–27 (referencing same). As we understand
`
`the record, Novartis and Dr. Lublin rely on the Miller letter with respect to the
`
`excerpt of the FDA minutes, but not on any other portion of the FDA minutes.
`
`Accordingly, the FDA minutes are not “cited in a paper or in testimony.”
`
`The briefing book is similarly not “cited in a paper or in testimony.” Rather,
`
`an excerpt of that document is quoted in Exhibit 2064, a letter Novartis sent to the
`
`FDA regarding a March 26, 2007 End-of Phase II meeting (“the Katz letter”). As
`
`with the FDA minutes, Dr. Lublin relies on the Katz letter rather than the entirety
`
`of the briefing book. Ex. 2025 ¶ 46; see also Paper 26, 26 (referencing same).
`
`Dr. Lublin relies on Exhibit 2063 as evidence of communications in the
`
`Spring of 2007 between Novartis and Dr. Lublin’s assistant, Colleen Farrell, on
`
` 2
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`
`
`
`
`
`IPR2017-00854
`Patent 9,187,405 B2
`
`behalf of the Mount Sinai IRB. Ex. 2025 ¶¶ 51, 56; see also Paper 26, 26–27
`
`(referencing same). Shortly after the January 10, 2018 conference call in this case,
`
`Patent Owner filed, at our request, a December 5, 2017 Declaration of Peter J.
`
`Waibel, attesting that “the redacted portion of [Exhibit 2063] constitutes internal
`
`conversation at Novartis only and does not include additional communication with
`
`any personnel at Mount Sinai School of Medicine.” Ex. 2078, ¶ 11. Because
`
`Dr. Lublin does not rely on the redacted portion of Exhibit 2036—nor have we any
`
`reason to believe that he even saw the unredacted document—the redacted portion
`
`of the exhibit is also not “cited in a paper or in testimony.”
`
`Also, under 37 C.F.R. § 41.51(b)(1)(iii), and absent a claim of privilege,
`
`“[u]nless previously served, a party must serve relevant information that is
`
`inconsistent with a position advanced by the party during the proceeding
`
`concurrent with the filing of the documents or things that contains the
`
`inconsistency.” As the Board explained in Garmin, “[r]outine discovery under
`
`37 C.F.R. § 41.51(b)(1)(iii) is narrowly directed to specific information known to
`
`the responding party to be inconsistent with a position advanced by that party in
`
`the proceeding, and not broadly directed to any subject area in general within
`
`which the requesting party hopes to discover such inconsistent information.
`
`Garmin Int’l, Inc. v. Cuozzo Speed Techs. LLC, Case No. IPR2012-00001, slip op.
`
`at 4 (PTAB March 5, 2013) (Paper 26) (precedential).
`
`In the present case, Petitioner has not articulated any evidence or reasoning
`
`indicating that the requested documents relevant information that is inconsistent
`
`with a Novartis’s positions. As we have no reason to doubt the integrity of
`
`Novartis or it counsel, we decline to order production of these documents under
`
`37 C.F.R. § 41.51(b)(1). See 37 C.F.R. § 41.11.
`
` 3
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`
`
`IPR2017-00854
`Patent 9,187,405 B2
`
`B. Additional Discovery
`
`In the alternative, Apotex seeks the requested documents as additional
`
`discovery under 37 C.F.R. § 42.51(b)(2). “The test for a party seeking additional
`
`discovery in an inter partes review is a strict one.” Symantec Corp. v. Finjan, Inc.,
`
`Case IPR2015-01545, slip op. at 4 (PTAB Dec. 11, 2015) (Paper 9). “The moving
`
`party must show that such additional discovery is in the interest of justice.”
`
`37 C.F.R. § 42.51(b)(2)(i). Among the factors important to this analysis is whether
`
`Petitioner can show more than “[t]he mere possibility of finding something useful,
`
`and mere allegation that something useful will be found.” See Garmin Int’l, at *6.
`
`After considering the parties’ arguments, we are persuaded that Petitioner
`
`has made a sufficient showing to warrant briefing on the matter. Briefing shall be
`
`conducted as set forth in following Order.
`
`
`
`It is
`
`ORDER
`
`ORDERED that Petitioner Apotex may file a motion seeking additional
`
`discovery and Patent Owner may file an opposition to Petitioner’s motion;
`
`FURTHER ORDERED that both papers are due 10 days from the date of
`
`this Order and shall not exceed 10 pages in length.
`
` 4
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`IPR2017-00854
`Patent 9,187,405 B2
`
`FOR PETITIONER APOTEX:
`
`Steven W. Parmelee
`Michael T. Rosato
`Jad A. Mills
`WILSON SONSINI GOODRICH & ROSATI
`sparmelee@wsgr.com
`mrosato@wsgr.com
`jmills@wsgr.com
`
`FOR PETITIONER ARGENTUM:
`
`Teresa Stanek Rea
`Deborah H. Yellin
`Shannon M. Lentz
`CROWELL & MORING LLP
`trea@crowell.com
`dyellin@crowell.com
`slentz@crowell.com
`
`Tyler C. Liu
`ARGENTUM PHARMACEUTICALS, LLC
`tliu@agpharm.com
`
`FOR PETITIONER TEVA:
`
`Amanda Hollis
`Eugene Goryunov
`KIRKLAND & ELLIS LLP
`Amanda.hollis@kirkland.com
`egoryunov@kirkland.com
`
`FOR PETITIONER SUN PHARMA:
`
`Samuel Park
`WINSTON & STRAWN LLP
`spark@winston.com
`
`
` 5
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`
`
`IPR2017-00854
`Patent 9,187,405 B2
`
`
`
`FOR PATENT OWNER:
`
`Jane M. Love
`GIBSON, DUNN & CRUTCHER LLP
`jlove@gibsondunn.com
`
`
`
`
` 6
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