UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Page 1
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` STEADYMED LTD., STEADYMED THERAPEUTICS,
` INC., and STEADYMED U.S. HOLDINGS, INC.
` Petitioner,
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` v.
`
` UNITED THERAPEUTICS CORPORATION,
` Patent Owner.
`
` Conference Call Before the Panel
`
` May 10, 2016
`
`Reported by:
`JENNIFER DE LEON
`JOB NO. 107543
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`UT Ex. 2019
`SteadyMed v. United Therapeutics
`IPR2016-00006
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` BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`Page 1
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` STEADYMED LTD., STEADYMED THERAPEUTICS,
` INC., and STEADYMED U.S. HOLDINGS, INC.
` Petitioner,
`
` v.
`
` UNITED THERAPEUTICS CORPORATION,
` Patent Owner.
`
` Conference Call Before the Panel
`
` May 10, 2016
`
`Reported by:
`JENNIFER DE LEON
`JOB NO. 107543
`
`TSG Reporting - Worldwide 800-702-9580
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`SteadyMed v. United Therapeutics
`IPR2016-00006
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` Tuesday, May 10, 2016
` 12:33 p.m.
`
` Conference Call Before The Panel,
`held telephonically, pursuant to
`Agreement, before Jennifer De Leon,
`a Notary Public of the State of New York.
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`IPR2016-00006
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`APPEARANCES:
`
` For the Petitioner:
` Stuart Pollack, Esq. (Via Telephone)
` DLA Piper
` 1251 Avenue of The Americas
` New York, New York 10020
`
` For the Patent Owner:
` STEPHEN MAEBIUS, ESQ. (Via Telephone)
` GEORGE QUILLIN, ESQ.
` Foley & Lardner
` Washington Harbor
` 3000 K Street NW
` Washington, D.C. 20007
`
` For United Therapeutics
` SHAUN SNADER (Via Telephone)
` 1735 Connecticut Avenue NW
` Washington, D.C. 20009
`
`Administrative Patent Judges:
`Judge Harlow (Via Telephone)
`Judge Green (Via Telephone)
`Judge Chang (Via Telephone)
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` CONFERENCE CALL
` P R O C E E D I N G S
` JUDGE HARLOW: You have Judges Harlow,
`Green, and Chang on the line. This is a
`conference call in IPR2016-0006, Steadymed
`versus United Therapeutics. As I understand
`it from the correspondence from the parties,
`we have three matters to address on today's
`call: Petitioner's request for
`authorization to file a motion to submit
`supplemental information, Patent Owner's
`request to confer with the board regarding
`an intended motion to amend the claim, and a
`proposed stipulation by the parties to
`extend Due Dates 1 through 4.
` Will counsel for Petitioner -- and I'm
`sorry, we're going to repeat this
`exercise -- please identify yourselves.
` MR. POLLACK: Good afternoon, Your Honor.
`This is Stuart Pollack on behalf of
`Petitioner Steadymed.
` JUDGE HARLOW: And Patent Owner?
` MR. MAEBIUS: Steven Maebius is here along
`with George Quillin.
` And Shaun Snader, are you on the line?
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` MR. SNADER: Yes. This is Shaun Snader
`with United Therapeutics also for Patent
`Owner.
` JUDGE HARLOW: Do we have a court reporter
`on the line?
` THE REPORTER: Yes, I'm here.
` JUDGE HARLOW: And -- thank you very much.
`Is there anyone else on the call who's not
`been identified?
` MR. POLLACK: Not for Petitioner, Your
`Honor.
` JUDGE HARLOW: All right.
` MR. MAEBIUS: Nor --
` JUDGE HARLOW: I'm sorry. Go ahead, Mr.
`Maebius.
` MR. MAEBIUS: Nor from Patent Owner, Your
`Honor.
` JUDGE HARLOW: Thank you. Let's begin
`with Petitioner's request for authorization
`to file a motion to submit supplemental
`information. As I understand it, Petitioner
`seeks authorization to file a motion to
`submit two additional declarations regarding
`the English translation of Qualcomm IEEE:
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`one from Mr. Boris Levine, who executed the
`original translation certification submitted
`as Exhibit 1011, and another by Mr. James
`Saddle (phonetic), the translator identified
`by Mr. Levine in his original declaration as
`having made the translation contained in
`Exhibit 1007.
` As counsel's aware, 37 CFR, 42.123
`permits a filing of a motion to submit
`supplemental information when the request
`for authorization to file such a motion is
`made within a month of institution and the
`supplemental information is relevant to a
`claim for which trial has been instituted.
`With that process, could counsel for
`Petitioner please address his request.
` MR. POLLACK: Yes, Your Honor. You have
`the nature of the motion exactly in your
`summary; Patent Owner doesn't oppose this
`motion. It is identical to the facts,
`nearly identical to the facts in a prior
`proceeding Taiwan Semiconductor versus DSS
`Technology. That's IPR No. 2014-1030. It's
`Paper No. 11 of February 3rd, 2015. And
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`they're similarly -- Petitioner wish to file
`supplemental information that consisted of a
`declaration attesting to the accuracy of a
`translation of a Japanese patent application
`from Japanese to English. Similarly, the
`Patent Owner did not object. And the board
`granted authorization of filing of the
`motion and also granted the motion since the
`supplemental information, Petitioner sought,
`and I quote, "To submit does not change the
`grounds of unpatentability authorized in
`this proceeding, nor does it change the
`evidence initially presented in the petition
`to support those grounds of patentability.
`Instead such information merely constitutes
`additional evidence that allegedly confirms
`the accuracy of the English translation."
`And that's a quote from that Paper No. 11 in
`IPR2014-1030 at 3. Petitioner also meets
`the requirements of 42.123(a) which require
`that the request for authorization be made
`within one month of the April 8th
`institution.
` Another request was made on May 6th and
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`that the supplemental information may be
`relevant since the board instituted trial
`based on the Qualcomm IEEE Japanese patent's
`translation just as in that Taiwan
`Semiconductor case where the supplemental
`declaration was deemed relevant since
`there's evidence that confirmed the accuracy
`of the translation, so here confirms that
`Exhibit 100 --1007 which the board relied
`upon on its ground. So substitution is an
`accurate translation of Exhibit 1006, the
`original Japanese reference, and, therefore,
`it serves as a basis of grounds of
`unpatentability authorized in the
`proceeding, and that's the same as in the
`prior Taiwan Semiconductor matter.
` JUDGE HARLOW: Thank you, Mr. Pollack.
`Counsel for Patent Owner, would you like to
`respond?
` MR. MAEBIUS: We don't have any response
`other than to confirm that we don't oppose.
` JUDGE HARLOW: And am I correct in
`understanding that you don't oppose the
`request for authorization to file the
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`motion, or do you also not oppose the motion
`itself?
` MR. MAEBIUS: We don't oppose the motion
`itself.
` JUDGE HARLOW: Understood. Thank you very
`much. Let's turn to Patent Owner's request,
`then, to confer with the board regarding its
`intent to file a motion to amend the claim
`that 37 CFR, 42121 governs amendment of the
`patent and IPR proceeding and sets forth the
`requirements for the scope and content of
`any such motion to amend. Section 42121
`permits the Patent Owner to file one motion
`to amend the claims that require that the
`Patent Owner confer with the board prior to
`filing such a motion. Furthermore, as the
`parties are aware, the board's decision in
`ID 3, as well as the decision in MasterImage
`3D, both set forth and clarify requirements
`for a motion to amend.
` With that background in mind, Counsel for
`Patent Owner, would you like to address your
`request regarding a motion to amend?
` MR. MAEBIUS: Yes, Your Honor. We would
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`like to seek authorization to file a motion
`to amend that would substitute a smaller
`number of new claims for the existing
`claims, 1 through 22, which would be
`considered contingently only if no original
`claim is found patentable. And I can
`provide more detail if needed about the
`proposed sum and substitute claims. But we
`would intend to fully comply with the
`requirement of ID 3 in MasterImage in filing
`our motion if authorization is granted.
` JUDGE HARLOW: Okay. Thank you. What
`additional details would you be able to
`provide at this time regarding the proposed
`amended claims?
` MR. MAEBIUS: The proposed claims would be
`product by process claims that do not
`enlarge the scope of any original claim.
`The preamble would be amended, and they
`would be narrow in scope and any existing
`claim in the patent. If it's helpful, I
`could read through the actual proposed claim
`that we're contemplating.
` JUDGE HARLOW: That's all right. I don't
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`want to peg you in now prior to any filing
`of your motion or submission of the amended
`claims. Counsel for Petitioner, would you
`like to respond?
` MR. POLLACK: Well, Petitioner will, of
`course, oppose the motion to amend, but as I
`stated to counsel for Patent Owner, we don't
`oppose the request for authorization. We'll
`file our response on Due Date 2.
` JUDGE HARLOW: Understood. And I believe
`that brings us to our last topic which is
`the proposed stipulated extension of due
`dates 1 through 4.
` MR. QUILLIN: Your Honor?
` JUDGE HARLOW: I'm sorry. Go ahead.
`Proceed.
` MR. QUILLIN: This is George Quillin for
`the Patent Owner. Before we move off with a
`motion to amend, I do have just a clarifying
`question about MasterImage and the federal
`circuit's decision about how the Patent
`Owner needs to address the known art. There
`are something like a hundred references on
`the -- on the face of the patent. I imagine
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`you're not looking for us to spend a
`paragraph on each one of those. You don't
`want to read that; we don't want to write
`that. If there are, say, a couple of
`references that -- that the Patent Owners
`regards as the closest, does it suffice for
`the Patent Owner to address those closest
`references and then say something broadly
`about not being aware that anything else is
`closer? Is that sort of approach
`acceptable?
` JUDGE HARLOW: Obviously, it's difficult
`to say in the abstract what will or will not
`perfectly suffice. But yes, that sounds
`like a proper interpretation of the federal
`circuit's most recent guidance as well as
`our guidance, in addressing those
`references, which are closest and most on
`point and specific and that addressed the
`newly claimed features, would be most
`helpful and then including a more
`generalized statement that you don't -- you
`don't think there are other secondary
`references that are on point would be
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`helpful.
` MR. QUILLIN: Thank you, Your Honor.
` JUDGE HARLOW: Shall we move to the
`proposed stipulated extension of due dates 1
`through 4?
` Counsel for Petitioners, would you like to
`address these since you sent the original
`correspondence on this issue?
` MR. POLLACK: Sure, Your Honor. This is
`Stuart Pollack again for Petitioner. This
`is actually something that Patent Owner
`seeks, but we did discuss it with them. And
`my understanding is that one of Patent
`Owner's attorneys is on trial for the month
`of June and that's going to be a problem for
`them.
` They've advised us in getting their
`papers done by the June 27th date. We've
`agreed if it can be done -- if it will work
`on the board's schedule -- to give them some
`extra time until July 6th, 2016, to move --
`so due date 1 would move currently from
`June 27th, 2016, to July 6th, due date 2
`would be moved from September 12th to
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`September 27th, 2016, and we would move due
`date 3 from October 11th, 2016, to
`October 14th, 2016. All other due dates
`would be kept the same, I believe, but
`Patent Owner can correct me if I'm wrong
`about that. So we believe this would not
`necessitate changing any of the other due
`dates that would concern the board such as
`oral argument or anything else, final
`decision, in the proceeding and it's only a
`few days. So we are willing to accommodate
`them if that would work.
` JUDGE HARLOW: Understood. Thank you.
`Patent Owner, do you have anything to add?
` MR. MAEBIUS: No, Your Honor. That's a
`correct summary of what we've agreed to with
`Petitioner. We would work with Petitioner
`to ensure that windows of cross-examination
`are available given the compressed schedule
`between certain days.
` JUDGE HARLOW: Okay. Thank you very much.
`Would the parties please hold briefly while
`we take a moment to confer.
` (PAUSE IN PROCEEDINGS.)
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` JUDGE HARLOW: We've had the opportunity
`to confer. And we'll grant Petitioner's
`request for authorization to file a motion
`to submit supplemental information. We
`understand that the Patent Owner does not
`oppose this motion. We will also -- we
`acknowledge that the Patent Owner has met
`its obligation to meet and confer with us
`regarding its desire to submit amended
`claims and file a motion to amend the claims
`at issue in this case. And lastly, we agree
`with and will enter the extension of the due
`dates proposed by the parties. We'll issue
`a written order to -- a brief written order
`to confirm this.
` Is there anything else?
` MR. QUILLIN: Your Honor, this is George
`Quillin for the Patent Owner again. Just
`two things. First on the -- on the
`supplemental evidence, not the information.
` JUDGE HARLOW: Supplemental information.
`I apologize if I misspoke.
` MR. QUILLIN: No, no. I -- it's a
`different question. So the -- you know, the
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`Petitioner has objected to our evidence and
`we're getting ready to respond with
`supplemental evidence. So the question is,
`does our supplemental evidence get filed or
`merely served? As I understand the rules,
`there was -- and some early case law, it's
`my understanding that that supplemental
`evidence is merely filed at this stage
`and -- I'm sorry, merely served at this
`stage and isn't filed until if needed later
`on there's some motion to exclude.
` JUDGE HARLOW: My understanding is that
`your summary is correct as to how to handle
`supplemental evidence going forward.
` MR. QUILLIN: Okay. And then last of all,
`not peculiar to this, the new rules have
`come out and all that, is there any
`information you can provide us about when
`the trial practice guide might be updated?
` JUDGE HARLOW: I do not have any such
`information, I'm sorry.
` MR. QUILLIN: All right. Thank you, Your
`Honor.
` JUDGE HARLOW: All right. I believe that
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`concludes our teleconference unless there is
`anything else.
` MR. POLLACK: Stuart Pollack for
`Petitioner. Just one quick question. Do we
`need to wait for you to issue a written
`opinion summarizing this call before filing
`our supplemental information, or can we just
`go ahead and file it this afternoon?
` JUDGE HARLOW: You may go ahead and file
`it on the -- given the conversation that
`we've had today and the oral order.
` MR. POLLACK: Thanks, Your Honor. Nothing
`further.
` JUDGE HARLOW: All right. Thank you all
`very much.
` (Hearing adjourned at 12:49 p.m.)
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` C E R T I F I C A T E
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`STATE OF NEW YORK )
` ) ss.:
`COUNTY OF NASSAU )
`
` I hereby certify that the foregoing is
`true and correct transcript from the record of
`proceedings in the above-entitled matter.
` This, the 20th day of May, 2016.
`
` _________________________
` JENNIFER DE LEON
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`UT Ex. 2019
`SteadyMed v. United Therapeutics
`IPR2016-00006
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