Trials@uspto.gov
`571-272-7822
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` Paper 6
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`
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` Entered: November 23, 2015
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`STEADYMED LTD.,
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`Patent Owner.
`____________
`
`Case IPR2016-00006
`Patent 8,497,393
`____________
`
`
`
`Before LORA M. GREEN, JONI Y. CHANG, and
`JACQUELINE T. HARLOW, Administrative Patent Judges.
`
`HARLOW, Administrative Patent Judge.
`
`
`DECISION
`Denying Authorization to File a Motion for Additional Discovery
`37 C.F.R. § 42.51(b)(2)
`
`
`
`
`
`
`
`
`571-272-7822
`
`
`
`
`
`
`
`
`
`
`
` Paper 6
`
`
`
` Entered: November 23, 2015
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`STEADYMED LTD.,
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`Patent Owner.
`____________
`
`Case IPR2016-00006
`Patent 8,497,393
`____________
`
`
`
`Before LORA M. GREEN, JONI Y. CHANG, and
`JACQUELINE T. HARLOW, Administrative Patent Judges.
`
`HARLOW, Administrative Patent Judge.
`
`
`DECISION
`Denying Authorization to File a Motion for Additional Discovery
`37 C.F.R. § 42.51(b)(2)
`
`
`
`
`
`
`
`
`
`IPR2016-00006
`Patent 8,497,393
`
`
`
`I.
`
`INTRODUCTION
`
`On November 19, 2015, we held a teleconference regarding Patent
`
`Owner, United Therapeutics Corporation’s (“UTC’s”) request for
`
`authorization to file a Motion for Additional Discovery regarding whether
`
`Chirogate International Inc. (“Chirogate”) should have been named as a real
`
`party-in-interest to this inter partes review proceeding. Petitioner,
`
`SteadyMed LTD (“SteadyMed”) opposes this request. On the call were
`
`Judges Green, Chang, and Harlow, as well as counsel for the parties.1 For
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`the reasons set forth below, we do not authorize UTC to file a Motion for
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`Additional Discovery.
`
`II. ANALYSIS
`
`During the teleconference, the parties made the following
`
`representations regarding the relationship between SteadyMed and
`
`Chirogate. SteadyMed purchases treprostinil from Chirogate. Ex. 2001,
`
`8:16–17. SteadyMed and Chirogate are party to a publicly available Supply
`
`Agreement in which Chirogate warrants that it does not infringe third-party
`
`intellectual property rights in connection with its manufacture and sale of
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`treprostinil to SteadyMed. Id. at 5:25–6:3. The Supply Agreement further
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`provides that at SteadyMed’s request, Chirogate will furnish a letter to
`
`SteadyMed contending that Chirogate’s treprostinil manufacturing process
`
`does not infringe any third-party patent. Id. at 5:25–6:6, 8:19–22. The
`
`Supply Agreement does not include an indemnification clause. Id. at 8:22–
`
`
`
`1 A court reporter also was present on the call, and UTC filed a copy of the
`transcript as Exhibit 2001.
`
`2
`
`
`
`IPR2016-00006
`Patent 8,497,393
`
`
`24. Counsel for SteadyMed in this proceeding does not represent Chirogate.
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`Id. at 10:14–16.
`
`UTC has identified US Patent No. 8,497,393 (“the ’393 patent”), the
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`patent-at-issue in this proceeding, as well as several additional patents, as
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`covering treprostinil in the Food and Drug Administration’s (“FDA’s”)
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`Approved Drug Products with Therapeutic Equivalence Evaluations
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`(“Orange Book”). Chirogate submitted a Drug Master File (“DMF”) to the
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`FDA related to its manufacture of treprostinil. Id. at 6:7–9.
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`UTC contends that additional discovery is warranted because
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`SteadyMed would not have known which process-related treprostinil patent
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`to target via inter partes review, absent instruction from its supplier,
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`Chirogate. Id. at 6:17–21. UTC points to the DMF filed by Chirogate, and
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`the fact that SteadyMed is not itself a drug manufacturer, as supporting the
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`conclusion that SteadyMed would not have identified the ’393 patent as an
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`appropriate target for inter partes review without information from
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`Chirogate. Id. at 11:21–12:11. UTC further argues that the Supply
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`Agreement is “evidence of privity between the parties and coordination in
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`relation to third-party patents.” Id. at 11:18–21.
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`SteadyMed asserts that UTC’s discovery request is premised on mere
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`speculation that Chirogate is controlling this inter partes review. Id. at
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`7:10–14. SteadyMed states that the ’393 patent was voluntarily identified by
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`UTC as covering treprostinil in the Orange Book, and identifies the Orange
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`Book as the source of SteadyMed’s information regarding which patent to
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`target in this proceeding. Id. at 8:2–10. SteadyMed contends that its
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`3
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`IPR2016-00006
`Patent 8,497,393
`
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`relationship with Chirogate is limited to that of customer and supplier, and
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`notes that the Supply Agreement at the core of UTC’s request does not
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`include an indemnification obligation, or “indicate anything beyond that
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`[Chirogate] would provide a letter contending that they don’t infringe.” Id.
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`at 8:22–24.
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`We note that the determination of whether a party is a real party in
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`interest is a “highly fact-dependent question” (Office Patent Trial Practice
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`Guide, 77 Fed. Reg. 48,756, 48,759 (Aug. 14, 2012)) in which the focus is
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`on the party’s relationship to the inter partes review pending before the
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`Board and the degree of control the party can exert over that proceeding.
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`See Aruze Gaming Macau, Ltd. v. MGT Gaming, Inc., Case IPR2014-01288,
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`slip op. at 11 (PTAB Feb. 20, 2015) (Paper 13). We give due consideration
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`to the analysis described in Garmin Int’l, Inc. et al. v. Cuozzo Speed Techs.,
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`LLC, Case IPR2012-00001, slip op. at 6–7 (PTAB Mar. 5, 2013) (Paper 26)
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`(informative), to guide our determination whether a request for additional
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`discovery meets the applicable “interests of justice” standard.
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`The Garmin panel found that the party requesting discovery “should
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`already be in possession of a threshold amount of evidence or reasoning
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`tending to show beyond speculation that in fact something useful will be
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`uncovered.” Garmin, Case IPR2012-00001, slip op. at 7 (Paper 26). We
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`find that UTC has not presented a threshold amount of evidence or reasoning
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`tending to show beyond mere speculation that Chirogate was involved in any
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`way with the filing of the present Petition. UTC has shown at best that
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`Chirogate may have had some incentive to have a petition filed in this inter
`
`4
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`
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`IPR2016-00006
`Patent 8,497,393
`
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`partes review. UTC presents no persuasive evidence or reasoning, however,
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`that Chirogate directed SteadyMed to target the ’393 patent, was otherwise
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`involved in the filing of this inter partes review, or that Chirogate has, or
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`had, the opportunity to direct or control the filing or conduct of this
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`proceeding. Thus, UTC has not established more than the mere possibility
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`of finding something useful, and the mere possibility that something useful
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`will be found is an insufficient basis for granting UTC’s request.
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`III. ORDER
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`It is
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`ORDERED that UTC’s request for authorization to file a Motion for
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`Additional Discovery is DENIED.
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`
`
`
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`5
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`
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`IPR2016-00006
`Patent 8,497,393
`
`
`For PETITIONER:
`
`Stuart E. Pollack
`Lisa A. Haile
`DLA Piper LLP
`stuart.pollack@dlapiper.com
`lisa.haile@dlapiper.com
`steadymed-ipr@dlapiper.com
`
`For PATENT OWNER:
`
`Stephen B. Maebius
`George Quillin
`FOLEY & LARDNER LLP
`smaebius@foley.com
`gquillin@foley.com
`
`Shaun R. Snader
`UNITED THERAPEUTICS CORP.
`ssnader@unither.com
`
`Douglas Carsten
`Richard Torczon
`Robert Delafield
`WILSON, SONSINI, GOODRICH & ROSATI
`dcarsten@wsgr.com
`rtorczon@wsgr.com
`bdelafield@wsgr.com
`
`
`
`6
`
`
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