CONFERENCE CALL
`
`Page 1
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` STEADYMED LTD., STEADYMED THERAPEUTICS, INC.,
` and STEADYMED U.S. HOLDINGS, INC.
` Petitioner,
`
` v.
`
` UNITED THERAPEUTICS CORPORATION,
` Patent Owner.
`
` Conference Call Before the Panel
` NOVEMBER 19, 2015
`
`REPORTED BY: Meredith R. Schramek
` Registered Professional Reporter
` Notary Public
`Job No. 100494
`
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`UT Ex. 2001
`SteadyMed v. United Therapeutics
`IPR2016-00006
`P.1
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`Page 1
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` STEADYMED LTD., STEADYMED THERAPEUTICS, INC.,
` and STEADYMED U.S. HOLDINGS, INC.
` Petitioner,
`
` v.
`
` UNITED THERAPEUTICS CORPORATION,
` Patent Owner.
`
` Conference Call Before the Panel
` NOVEMBER 19, 2015
`
`REPORTED BY: Meredith R. Schramek
` Registered Professional Reporter
` Notary Public
`Job No. 100494
`
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`SteadyMed v. United Therapeutics
`IPR2016-00006
`P.1
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`Page 2
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` CONFERENCE CALL
` A P P E A R A N C E S
`For the Petitioner:
` STUART POLLACK, ESQ. (Via Telephone)
` DLA Piper
` 1251 Avenue of the Americas
` New York, New York 10020
`
` LISA HAILE, ESQ. (Via Telephone)
` DLA Piper
` 4365 Executive Drive
` Suite 1100
` San Diego, California 92121
`
`For the Patent Owner:
` STEPHEN MAEBIUS, ESQ. (Via Telephone)
` GEORGE QUILLIN, ESQ.
` Foley & Lardner
` Washington Harbor
` 3000 K Street NW
` Washington, D.C. 20007
`
` DOUG CARSTEN, ESQ. (Via Telephone)
` Wilson Sonsini Goodrich & Rosati
` 12235 El Camino Real
` San Diego, California 92130
`
`Also Present: Shaun Snader (Via Telephone)
`Administrative Patent Judges:
` Judge Harlow (Via Telephone)
` Judge Chang (Via Telephone)
` Judge Green (Via Telephone)
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`SteadyMed v. United Therapeutics
`IPR2016-00006
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` P R O C E E D I N G S
` JUDGE HARLOW: This is IPR2016-00006
`Steadymed, LTD., et al., versus United Therapeutics
`Corporation concerning Patent Owner United
`Therapeutics' request for authorization to move for
`additional discovery regarding whether Chirogate should
`have been named as a real party in interest to this
`proceeding.
` Will counsel for Petitioners please identify
`themselves.
` MR. POLLACK: Good afternoon, Your Honor.
`This is Stuart Pollack from DLA Piper on behalf of
`Petitioner Steadymed Therapeutics. And I'm joined by
`my partner, Dr. Lisa Haile of the same firm.
` JUDGE HARLOW: Thank you. Will counsel for
`Patent Owner please identify themselves.
` MR. MAEBIUS: Yes, Your Honor. This is Steve
`Maebius from Foley & Lardner, and I have with me Doug
`Carsten from Wilson Sonsini, Shaun Snader from United
`Therapeutic, and I believe that my colleague, George
`Quillin is on the line. George, are you there?
` MR. QUILLIN: Yes, I am. Thank you.
` JUDGE HARLOW: Thank you. Is there a court
`reporter on the line today?
`
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`UT Ex. 2001
`SteadyMed v. United Therapeutics
`IPR2016-00006
`P.3
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` THE COURT REPORTER: Yes, I'm here.
` JUDGE HARLOW: Thank you. And is there
`anybody else on the call who's not yet been identified?
` MR. POLLACK: Not for Petitioner, Your Honor.
` JUDGE HARLOW: Thank you.
` MR. MAEBIUS: Nobody else for Patent Owner.
` JUDGE HARLOW: Thank you very much. As
`counsel is aware, we decide requests for additional
`discovery under an interest of justice standard.
`Before I move on, actually one of my colleagues has
`kindly just reminded me to ask that a transcript of
`this call be filed because we do have a court reporter
`present.
` MR. MAEBIUS: We will do that.
` JUDGE HARLOW: Thank you. I will get back to
`the business at hand. As I was saying, we decide
`requests for additional discovery under an interest of
`justice standard applying the five factors laid out in
`and Garmin versus Cuozzo. Under this framework,
`requests for additional discovery must be narrowly
`tailored and supported by a showing of evidence or
`reasoning that something useful will be uncovered by
`that discovery as well as the other factors.
` With that introduction, will counsel for
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`UT Ex. 2001
`SteadyMed v. United Therapeutics
`IPR2016-00006
`P.4
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`Patent Owner please describe the additional discovery
`you sought and state Patent Owner's position as to why
`such discovery should be allowed.
` MR. MAEBIUS: Yes, we will. We'd like to
`first point out that the board has held in a couple of
`cases that where a party has made a suggestion of which
`patent to be targeted, that's been one factor that the
`board used to determine whether they were a real party
`in interest, and that's what we believe is applicable
`in this case. And one of those is IPR2014-00171,
`Paper 49 at page 7 and also PGR2015-00011, Paper 14 at
`page 6. And in addition to that, the Trial Practice
`Guide indicates that a party at whose behest a petition
`has been filed should also be included in the real
`party in interest.
` In this petition, Your Honors, Steadymed has
`named only itself as an RPI. However, there's a
`publically available agreement from 2013 between
`Steadymed and Chirogate indicating that Steadymed will
`purchase its entire requirements for treprostinil from
`Chirogate. Treprostinil is the drug product that is
`the subject of the patent that's at issue in this
`petition.
` The agreement for this states that Chirogate
`
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`SteadyMed v. United Therapeutics
`IPR2016-00006
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`will warrant that it does not infringe on any
`intellectual property and that, upon request, it will
`provide Steadymed with a noninfringement letter
`evidencing that its process in manufacturing the
`product does not infringe on any third-party patent.
` The other point is that Chirogate submitted a
`drug master file with the FDA in order to manufacture
`treprostinil in September of 2014. A drug master file
`is a procedure that a supplier uses when it doesn't
`want to disclose its manufacturing process to its
`customer or distributor who may file the ANDA.
` Steadymed is not itself a drug manufacturer
`and is not authorized to produce treprostinil by the
`FDA. Steadymed is, according to its Web site, a
`company that has a pump product for delivering various
`drugs. So it's our position that Steadymed would not
`have any knowledge of which of 12 different
`process-related patents to be targeted in an IPR unless
`its contractually bound supplier had informed it of
`which specific process-related patent to be targeted.
` So we are seeking authorization to file this
`motion for additional discovery that would be narrowly
`tailored to the question of whether Chirogate has
`participated in selecting the patent that is the
`
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`UT Ex. 2001
`SteadyMed v. United Therapeutics
`IPR2016-00006
`P.6
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`subject of this IPR petition and we would make sure
`that our discovery requests are not unduly burdensome
`and that they do not seek to produce litigation work
`product. And that's the summary of why we're
`requesting authorization for this motion.
` JUDGE HARLOW: Thank you. Counsel for
`Petitioner, would you like to respond?
` MR. POLLACK: Yes. Thank you, Your Honor.
`This is Stuart Pollack for Steadymed. I really didn't
`hear Mr. Maebius state any evidence to show beyond
`speculation that, in fact, there's a relationship
`between Steadymed and -- I'm not sure if it's Chirogate
`or Chirogate -- that rises to a real party in interest.
`As Your Honors, I'm sure, know, the real party in
`interest standard, which is stated in the Trial
`Practice Guide requires that essentially, the principal
`inquiry is whether the nonparty here, Chirogate,
`exercised or could have exercised control over a
`party's participation in a proceeding that's in the
`Trial Practice Guide at 77 Federal Register at 48759.
`So that's really the standard.
` All I've heard Mr. Maebius say is something
`about they would have the ability to identify patents.
`Actually, here the patents -- Chirogate's played no
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`UT Ex. 2001
`SteadyMed v. United Therapeutics
`IPR2016-00006
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`role in this IPR. I don't represent them or have any
`connection to them. The patents that are relevant here
`are listed in a publication from the FDA called the
`Orange Book. And these are listed voluntarily by
`United Therapeutics as covering trepostinil. So the
`patents at issue were those which were posted by United
`Therapeutics, the Patent Owner itself, in the Orange
`Book as covering and/or leading to its product. That's
`where that information comes from.
` As Your Honors already know, I'm sure, under
`the Garmin Standard Factor 1, which you recited, the
`party requesting discovery should already be in
`possession of evidence tending to show beyond
`speculation that, in fact, something useful will be
`uncovered. Here you know Chirogate -- the only
`relation between us and them is supplier and customer.
`As Mr. Maebius indicated, the agreement between
`Steadymed and Chirogate is publically available. It's
`on the SEC Edgar Web site, and it doesn't indicate
`anything beyond that they would provide a letter
`contending that they don't infringe. There's no
`indemnification, not that that would be enough here
`anyway. And there's nothing that could be discovered
`that would turn Chirogate into a party that's
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`SteadyMed v. United Therapeutics
`IPR2016-00006
`P.8
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`controlling this IPR.
` Now, the board has recently denied a number
`of motions for discovery on conference calls like this
`one where there was nothing offered by the Patent Owner
`to support discovery. For example, recently in Samsung
`Display Company, a case in which Judge Chang was
`involved in, this is IPR2015-01415, Paper 7.
`September 4, 2015, at page 5. There a four-judge panel
`found after a conference call like this one that there
`was no persuasive evidence asserted by the Patent Owner
`that a third party was involved in the filing of the
`present IPRs. And that's the case here as well. And
`for that reason there, the board denied even filing a
`motion.
` Similarly Brinkmann Corporation versus A&J
`Manufacturing, that's IPR2015-00056, Paper 21,
`October 29, 2015, at 4. Thereafter a conference call,
`also the board denied a briefing where Garmin Factor
`Number 1 wasn't satisfied because the only allegation
`was the third party had the same motivation, strategy,
`same expert, and same invalidity defense as a third
`party. We don't even have that here.
` And finally just last week, just a week ago
`in Mangrove Partners Master Fund, Limited, versus
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`UT Ex. 2001
`SteadyMed v. United Therapeutics
`IPR2016-00006
`P.9
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`VirnetX, IPR2015-01046, that's Paper Number 18,
`November 12, 2015, at 2, the board denied briefing
`after a conference call where, quote, "The Patent
`Owner's request amounts to more than a mere allegation
`of some kind of general association between Petitioner
`and the third party, their RPX." So in Mangrove the
`Petitioner alleged that when the Petitioner had an
`equity stake in the third party -- I don't think
`Mr. Maebius or United Therapeutics is suggesting that
`there's any such ownership connection between these two
`companies here, and, in fact, there isn't -- that
`counsel for Petitioner represented the third party in
`the Mangrove case. I don't -- I will represent to you
`I do not represent or have any connections with Chiro
`or Chirogate. And there were similarly publicly
`available documents that showed a much stronger
`connection control than here. And because that's all
`they had, the board denied even filing briefing on
`discovery.
` Here there's simply nothing that could be
`discovered other than that the two companies have a
`supplier, a customer relationship that would ever show
`that what's required, which is that Chirogate has
`control over this IPR.
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`IPR2016-00006
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` And, you know, I think in the interest of
`justice here, which is the standard under 42.5051, as
`Your Honors have pointed out, even the filing of a
`motion should be denied. It's going to increase -- and
`I think that's the purpose of it. It's going to
`increase the cost to my client of this IPR for us to
`respond to their motion, which I think will ultimately
`be denied. But the cost of us having to do the
`briefing will be significant. And I don't think it's
`in the interest of justice to increase the cost of this
`IPR, nor do I want to see throughout this IPR
`proceeding United Therapeutics encouraged to file
`motions just so we can spend money responding to them.
` MR. MAEBIUS: Your Honor, may the Patent
`Owner briefly reply to that?
` JUDGE HARLOW: Yes. Please go ahead.
` MR. MAEBIUS: The agreement itself between
`Chirogate and Steadymed is, in fact, evidence of
`privity between the parties and coordination in
`relation to third-party patents. In addition to that,
`there are multiple patents listed in the Orange Book
`that could have been targeted, and I haven't heard
`Mr. Pollack indicate how Steadymed came upon the
`knowledge that led them to select this particular
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`UT Ex. 2001
`SteadyMed v. United Therapeutics
`IPR2016-00006
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`patent.
` And, in fact, the DMF, the drug master file,
`that Chirogate filed is another piece of evidence that
`Chirogate is not disclosing to Steadymed the particular
`process it uses. So Steadymed would not have known
`which of these numerous Orange Book patents to have
`challenged. So we believe that there's a degree of
`involvement, and we seek a very limited amount of
`discovery to determine that or at least the opportunity
`to request that discovery in a motion.
` JUDGE HARLOW: Thank you. Will the parties
`please hold the line briefly while my colleagues and I
`take a moment to confer?
` MR. MAEBIUS: Sure.
` MR. POLLACK: Thank you, Your Honor.
` (Off the record 2:15 p.m. to 2:18 p.m.)
` JUDGE HARLOW: Thank you both to the parties
`for presenting your arguments today. We've had a
`chance to confer, but we would still like to take this
`matter under advisement and issue a written order at a
`later time. Given that we have a court reporter on the
`call, it would be helpful to have the transcript filed
`as soon as possible, and we will issue a written order
`after receipt of the transcript.
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`IPR2016-00006
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` CONFERENCE CALL
`MR. POLLACK: Okay.
`MR. MAEBIUS: Thank you, Your Honor.
`JUDGE HARLOW: Thank you.
` (Hearing adjourned at 2:18 p.m.)
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` CONFERENCE CALL
` CERTIFICATE OF REPORTER
`
`STATE OF NORTH CAROLINA )
`COUNTY OF MECKLENBURG )
`
` I hereby certify that the foregoing is a true and
`correct transcript from the record of proceedings in
`the above-entitled matter.
` This, the 19th day of November, 2015.
`
` ______________________
` MEREDITH R. SCHRAMEK
` Notary Public in and for
` County of Mecklenburg
` State of North Carolina
` Notary Number 200814200186
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`SteadyMed v. United Therapeutics
`IPR2016-00006
`P.14
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