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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` -----------------------------------------------X
` STEADYMED LTD., STEADYMED THERAPEUTICS, INC., and
` STEADYMED U.S. HOLDINGS, INC.
` Petitioner,
` v.
`
` UNITED THERAPEUTICS CORPORATION,
`
` Patent Owner.
` -----------------------------------------------X
`
` DATE: October 6, 2016
`
` TIME: 2:01 p.m.
`
` TELEPHONIC CONFERENCE CALL BEFORE the
` Panel among the respective parties, before
` LA TONIA C. LEWIS, RPR, a Notary Public of the
` State of New York.
`
`JOB NO. 114034
`
`TSG Reporting - Worldwide 877-702-9580
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`SteadyMed v. United Therapeutics
`IPR2016-00006
`
` P.1
`
`UT Ex. 2060
`
`

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`Page 2
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`Page 3
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` A P P E A R A N C E S: (Continued)
`
` WILSON SONSINI GOODRICH & ROSATI
` Attorney for United Therapeutics
` 1700 K Street NW
` Washington, D.C. 20007
` BY: KATHERINE HASPER, ESQ.
` RICHARD TORCZON, ESQ.
`
` Administrative Patent Judges:
` Judge Harlow
` Judge Green
` Judge Chang
`
` * * *
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` A P P E A R A N C E S:
`
` DLA PIPER
` Attorneys for the Petitioner
` 1251 Avenue of the Americas
` New York, New York 10020
` BY: STUART POLLACK, ESQ.
` LISA HAILE, ESQ.
` MYA CHOKSI
`
` FOLEY & LARDNER
` Attorney for the Patent Owner
` Washington Harbor
` 3000 K Street NW
` Washington, D.C. 20007
` BY: STEPHEN MAEBIUS, ESQ.
` GEORGE QUILLIN, ESQ.
`
` United Therapeutics
` 1735 Connecticut Ave NW
` Washington, D.C. 20009
` BY: SHAUN SNADER
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` JUDGE HARLOW: Good afternoon.
` This is Judge Harlow. Is counsel for UTC
` on the line?
` MR. SNADER: This is Shaun Snader,
` counsel for UTC. And I'm expecting at
` least a couple of more people to join.
` JUDGE HARLOW: We'll wait just a few
` minutes for your counsel to get on the
` line.
` MS. HASPER: This is Katherine
` Hasper from Wilson Sonsini on behalf of
` United Therapeutics. I joined while Shaun
` was talking to you.
` JUDGE HARLOW: It sounds like
` everybody's here. Judges Green, Chang,
` and Harlow are also on the line. This is
` a conference call in IPR 2016-00006,
` Steadymed versus United Therapeutics
` concerning United Therapeutics' request
` for authorization to file a motion to
` strike portions of Steadymed's reply and
` currently filed expert declaration as well
` as UTC's request to file a -- certified
` responses to Steadymed's reply.
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` Will counsel for Steadymed, please,
` identify themselves?
` MR. POLLACK: Good afternoon, your
` Honor. This is Stuart Pollack from DLA
` Piper in New York. I represent petitioner
` Steadymed. I am also joined from my
` office by Mya Chocksi, who is just going
` to be listening in for educational
` purposes.
` MS. HAILE: And also Lisa Haile with
` DLA Piper.
` JUDGE HARLOW: Thank you. And will
` UTC please identify themselves.
` MR. MAEBIUS: Good afternoon, your
` Honor. This is Steve Maebius with Foley &
` Lardner on behalf of patent owner, UTC.
` And I'm here with George Quillin as well
` in my office.
` MR. TORCZON: And Richard Torczon
` from Wilson Sonsini is also on the line.
` MS. HASPER: As is Katherine Hasper
` also from Wilson Sonsini.
` JUDGE HARLOW: Thank you. And it
` appears as well that we have a court
`
`TSG Reporting - Worldwide 877-702-9580
`
`2
`
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
` P.2
`
`UT Ex. 2060
`
`

`
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` reporter on the line. Is there anyone
` else who hasn't been identified at this
` time?
` MR. SNADER: I believe, you have my
` name. But this is Shaun Snader, counsel
` for United Therapeutics.
` JUDGE HARLOW: Thank you,
` Mr. Snader. Mr. Maebius, why don't you
` get started. Would you please elaborate
` on UTC's request for authorization to file
` a motion to strike and/or certify.
` MR. MAEBIUS: Yes, thank you, your
` Honor. The first issue we wanted to raise
` is the new arguments that were presented
` in the Rogers' declaration. They go
` beyond the scope of the patent owner's
` response. And, specifically, we're
` concerned about paragraphs 44 to 48 as
` well as paragraphs 60 to 63, which
` presents new arguments related to terminal
` gravimetric analysis, new arguments about
` PXRD pattern, and the new argument that's
` based on only the melting point of point
` A, which wasn't addressed in the patent
`
`Page 8
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` Proceedings
` petitioner's reply that refer to the
` conclusions arising from those paragraphs.
` And given that petitioner's reply was
` right up against the board limit, we
` maintain that this inclusion of so many
` additional arguments in the declaration of
` Rogers is an improper incorporation by
` reference. And I'd like to point out in
` another interparty's review, IPR
` 2014-00454 at paper number 12, page ten,
` that was a similar situation in which the
` board decided that it would not consider
` the arguments that weren't discussed in
` the papers filed by the petitioner when
` there were expenses, additional arguments
` in the petition not discussed that were in
` the declaration but not discussed in the
` petition.
` And then the third issue that patent
` owner wishes to raise on this call, is
` certain mischaracterizations of our
` expert, Dr. Williams' testimony in the
` petitioner's reply. And I won't go
` through every single example of that, but
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` owner's response.
` And I'd like to point out in another
` interparty's review of IPR 2015-01786. In
` that case, the board noted that they have
` discretion to strike or alternatively
` consider patent owner's position regarding
` new argument and certify omission for
` observation or during an oral hearing. So
` I'd like to more broadly raise the point
` that we believe we should be allowed to
` reply in some way to these new arguments
` if they're going to remain in the record
` in the Rogers' declaration. The second
` issue we wanted to raise really to the
` corporation by reference of various
` paragraphs in the Rogers' declaration
` that's not addressed anywhere in the
` petitioner's reply. And, specifically,
` under this issue, we would like to point
` out paragraphs 23 to 48, 53 to 63, 65 to
` 73, and 75 to 83, and 85 to 88. None of
` those paragraphs are discussed in the
` petitioner's reply although certain
` isolated paragraphs are cited in the
`
`Page 9
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` Proceedings
` one example is on page seven of the
` petitioner's reply where there is a
` passage from Dr. Williams' testimony which
` was clarified during redirect. And in
` another stipulation that was similar to
` this IPR 2013-00358, the patent owner had
` requested an opportunity to file
` observations on its own expert in that
` case because petitioner's reply had
` mischaracterized the testimony. And the
` patent owner pointed out that it would be
` prejudicial because there was no other
` opportunity for patent owner to file a
` paper addressing this type of situation.
` And so in this IPR, the board did agree
` that it would receive a list of the
` citations to the transcript where it was
` mischaracterized. And further allowed the
` patent owner at the oral hearing to
` present other parts of the deposition
` testimony that clarified the
` mischaracterized part.
` So we would ask that the board give
` us an opportunity in that IPR 2013-00358
`
`TSG Reporting - Worldwide 877-702-9580
`
`3
`
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
` P.3
`
`UT Ex. 2060
`
`

`
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` to address these mischaracterizations.
` JUDGE HARLOW: Thank you,
` Mr. Maebius. In recognition of your
` comment regarding the board having
` decisions in the past that allow any
` patent owner to file a list identifying --
` and since you discussed portions of
` testimony or in other cases, portions of
` replies that allegedly exceed the scope of
` the patent owner response, I was wondering
` if you could comment on whether UTC would
` be comfortable with, instead of allowing
` various motions and surreplies -- and it
` sounds like now, a request for
` authorization to file observations. If
` UTC would be comfortable with following
` that list approach where the panel would
` allow UTC to submit a list identifying
` instances of the claims -- arguments
` exceeding scope of the patent owner
` response or mischaracterizations of
` testimony that both identify the location
` of the item with which you have issue and
` a short description thereof and then
`
`Page 12
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` Proceedings
` MR. MAEBIUS: I think in the case of
` the Rogers' paragraphs that reflect the
` arguments, we would need to address it
` with a surreply and a declaration from our
` own expert. In the case of the
` mischaracterized testimony, it would
` simply be a matter of pointing out other
` parts of the deposition transcript that
` clarified it.
` JUDGE HARLOW: Understood. Thank
` you. Mr. Pollack, would you like to
` respond?
` MR. POLLACK: Thank you, your Honor.
` This is Stewart Pollack on behalf of the
` petitioner, Steadymed. This is just an
` attempt to either, one, get a -- get the
` last word in on these issues or two, you
` know, make further argument on arguments
` in our reply that were completely
` responsive to the patent owner's response.
` I would first like to point out, I think I
` understood Mr. Maebius correctly. He's
` not saying there are any new arguments in
` the petitioner's reply, he's only saying
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` permitting a response from the petitioner
` explaining why, in fact, the item doesn't
` exceed scope or in the case of the
` testimony why the characterization is not
` accurate. Would UTC be comfortable with
` an approach like that?
` MR. MAEBIUS: If that was going to
` be presented in the context of considering
` whether it would be struck from the
` record, I think we would be comfortable
` with that approach. But if it's not
` struck from the record, then I think the
` patent owner should be allowed to reply in
` some way because these are really new
` arguments relying on different pieces of
` evidence. And so we feel we should be
` able to address it with our own evidence.
` JUDGE HARLOW: Understood. And when
` you say address it with your own evidence,
` are you envisioning, specifically, in a
` surreply or you had mentioned in your
` discussion that the other parties had been
` allowed to address things with oral
` arguments. Would that be sufficient?
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`Page 13
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` Proceedings
` that he feels that the declaration,
` somehow raised new arguments, but not the
` reply itself. So the only complaint about
` the reply that I heard here, I believe, is
` that they didn't like how Dr. Williams'
` testimony is characterized. And he gave
` an example of page seven of our reply, so
` I took a look there. And we don't
` actually characterize Dr. Williams'
` testimony there, we quote it. So it's
` there quoted in full. And he doesn't like
` what's said.
` And he says, well, in our -- in
` their redirect they led him to try to
` answer differently. And I looked at page
` seven, which had to do with whether or not
` Dr. Williams knew what process was used to
` make certain cherry-picked processes --
` whether they were, in fact, the Moriarty
` prirog (phonetic) or otherwise. And they
` are saying he said something different in
` redirect. In fact, he was recrossed on
` that issue. And in response to that his
` testimony which is an exhibit, 2059, his
`
`TSG Reporting - Worldwide 877-702-9580
`
`4
`
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
` P.4
`
`UT Ex. 2060
`
`

`
`Page 14
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` deposition which was submitted in full,
` pages 27023 to 27012. He said, I simply
` just don't know how these ten
` cherry-picked points were made. So
` there's really -- it's not a
` mischaracterization. It is what he said,
` we simply quoted it. We left it there for
` the court to decide what their
` interpretation is and exactly what he said
` it is. So it is not a
` mischaracterization. Numerous board
` decisions, I've looked, they've denied
` these kind of motions to strike including
` denying even the -- as we're doing here,
` the opportunity to file the motion to
` strike.
` As stated in one of those decisions,
` Texas Instruments versus Unified
` Scientific Batteries. That's IPR number
` 2013-00213. It's paper number 27 dated
` April 27, 2014, at 3 in an opinion that
` Judge Chang was involved in. The board
` there said a motion to strike is not
` ordinarily a proper mechanism for raising
`
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` Proceedings
` patent at issue. And that that meant that
` the polymorphs was at least as pure, if
` not purer than the 393 patent that was in
` Dr. Wingler's declaration as well. Much
` to Steadymed's surprise, patent owner
` expert, Dr. Williams came back and said
` you can't compare melting points of
` polymorphs. Now, at his deposition he
` conceded -- Dr. Williams conceded that his
` basis for that was his personal
` experience. He didn't have any articles
` or references. We came back with a
` declaration from Dr. Rogers who is an
` expert on polymorphs stating that the
` melting points of polymorphs can be
` compared for their purity.
` That is the -- the argument that was
` raised in our petition, which they opposed
` and which he is replying with. So it's
` not a new argument. And they should have
` anticipated that we would do that in
` response to their questioning
` Dr. Wingler's opinion on this issue. In
` regards to arguments that were not in the
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` the issue of whether a reply or reply
` evidence is beyond the proper scope
` permitted under the rules. And that's,
` you know, what the board has said
` uniformly in numerous decisions I've seen.
` I don't recognize their other panels.
` That's not necessarily precedential, but
` across the board that's been what the
` panel decisions have said.
` In that decision, the patent owner's
` similarly complained that the petitioner's
` use of deposition testimony
` mischaracterized, but as the board said,
` and this is a quote, "Motion to strike
` regarding this issue is not warranted as
` we are able to evaluate testimony in
` context and determine what weight, if any,
` it should be given". That's at paper
` number 27 in that proceeding at page four.
` That was IPR 2013-00213.
` Let me move to striking Dr. Rogers'
` declaration. We raised in our petition
` that the melting point of the Ferri's was
` higher than the melting point in the 393
`
`Page 17
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` reply, you know, we asked United
` Therapeutics which arguments they were
` referring to. And they referred to nearly
` every paragraph in his declaration
` including his qualifications, the
` materials reviewed, the summary of his
` opinion.
` Now, when I pointed it to him -- we
` pointed out to him that that they're
` including the qualification material as
` considered and the summary of opinions,
` they've withdrawn those objections. So
` they have no problem with the summary of
` opinion or the materials considered. The
` only parts or conclusions he draws -- the
` only parts they're objecting to now are in
` some sections in order to introduce a
` topic. He explains, for example, what is
` a crystal? What is a polymorph? What do
` those words mean? He did say things like
` that we believe it would be helpful for
` the board to understand some of the
` language used in our reply and in his
` conclusions.
`
`TSG Reporting - Worldwide 877-702-9580
`
`5
`
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
` P.5
`
`UT Ex. 2060
`
`

`
`Page 18
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` But that's all just basic scientific
` information. I don't think it's
` controversial or they object to it. I
` also hear they're objecting to paragraphs
` 44 through 48. And now for the first
` time, they're also saying 60 to 63. I've
` looked at these paragraphs, what they are
` is, they described the Ferri's reference
` as if we produced the figures from the
` Ferri's reference. And they say these
` figures are in the Ferri's reference and
` then have some quotations from the Ferri's
` reference. That's it.
` I don't know why they're objecting
` to the Ferri's reference, which is one of
` the key references we've been relying on.
` The same information was referred to by
` Dr. Wingler in his declaration,
` Exhibit 1009. That was submitted with our
` petition. He is just recounting just to
` get his opinions here is what the
` reference shows. That's not a new
` argument. And it's not adding to our
` arguments in the reply.
`
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` supply the board with their observations
` on cross examination. As far as a
` surreply of simply an attempt to get the
` last word, I'm guessing that the reason
` why they want to do this is they want to
` re-characterize Dr. Williams' testimony in
` some way. You know, they don't allege
` that quotes to this testimony were not
` responsive through the patent owner
` response.
` The only cases where the board has
` allowed a surreply is where the patent
` owner had the burden of proof on an issue.
` That's not the case here. That's the only
` time that we've looked that the board has
` granted these kind of surreplies in some
` cases. The board has allowed a list to be
` supplied, a one or two page list of where
` the patent owner thought there were issues
` but it was merely a list. I really don't
` think that's necessary here. Everything
` is completely in response to their patent
` owner's response so the board can look.
` And I think the board will see that
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` In any event, patent owner is going
` to have the opportunity to depose
` Dr. Rogers, we've offered them dates for
` his deposition next week and they can
` submit the usual observations on
` cross-examination. That's the, you
` know -- striking the reply in Dr. Rogers'
` declaration is not the appropriate remedy.
` And in a case of very similar facts HTC
` Corp, the NFC technology, that's IPR
` 2014-01198, paper 45 dated November 19,
` 2015 at 2. The board panel there held
` that petitioner's decision, to cite to
` certain portions for the record and not to
` cite to others may impact the
` persuasiveness of its arguments given to
` the evidence. But that decision alone
` does not justify our authorization of a
` motion to strike uncited evidence.
` Striking a portion of the record may
` be akin to a sanction. And it is not a
` suitable means in achieving patent owner's
` stated purpose. If they have an issue
` with Dr. Rogers they can depose him and
`
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` that's the case. But, you know, just for
` putting in allegedly, new evidence, the
` board is -- does not allow surreply. For
` example, Cannon Incorporated versus
` Intellectual Ventures Two LLC, that's IPR
` number 2014-00631 paper number 39 dated
` April 9, 2015 at 3. The panel there held
` that the extent to the argument in
` petitioner's reply and the testimony and
` Dr. Stevenson's rebuttal declaration
` replied to arguments in evidence in the
` patent owner's response, they are rebuttal
` arguments in evidence and we are not
` persuaded that the presence of such
` rebuttal arguments in evidence warrants
` authorization to file a surreply to
` petitioner's reply.
` That's essentially the same facts
` here that they want to have or respond to
` our reply because they don't like what it
` says. But there isn't a showing that it's
` outside the scope of their patent owner
` response.
` JUDGE HARLOW: Thank you,
`
`TSG Reporting - Worldwide 877-702-9580
`
`6
`
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
` P.6
`
`UT Ex. 2060
`
`

`
`Page 22
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`Page 23
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` Proceedings
` Mr. Pollack. Did you have anything
` further?
` MR. POLLACK: Oh, that's all, your
` Honor.
` JUDGE HARLOW: Mr. Maebius, do you
` have anything to say in reply?
` MR. MAEBIUS: Just briefly, your
` Honor. I wanted to address two points.
` One is that we did confer prior to
` requesting this call with counsel and did
` narrow the scope of what we're objecting
` to in the Rogers' declaration. And it is
` just specific paragraphs I mentioned. And
` also these new arguments that relate to
` thermogravimetric analysis PXRD pattern in
` form A have nothing to do with the melting
` point of form B. They don't have
` thermogravimetric analysis. And PXRD have
` nothing to do with melting point at all.
` And in patent owner's response there is no
` discussion of form A or thermogravimetric
` analysis or PXRD pattern. Nor is there
` any discussion of any of these in
` petitioner's original petition.
`
`Page 24
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` Proceedings
` identifying what Steadymed regards as the
` material contained in UTC's response that
` triggered or caused Steadymed to include
` in its reply the items identified by UTC
` and to list where each item appears in the
` petition. This paper similarly cannot
` exceed five pages, may not contain
` argument, and is going to be due no later
` than three days after UTC's filing.
` In addition, we'd request that the
` parties file a copy of the transcript from
` the court reporter. Are there any further
` questions or concerns?
` MR. MAEBIUS: Your Honor, this is
` Steve Maebius for patent owner. We just
` wanted to clarify with respect to the
` request to address testimony that was
` cited in the petitioner's reply at the
` oral hearing. Will this listing of items
` be intended to elicit a decision from you
` on whether we can also address the
` mischaracterized testimony at the final
` hearing?
` JUDGE HARLOW: I'm sorry,
`
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` JUDGE HARLOW: Thank you,
` Mr. Maebius. If the parties could please
` hold the line, while my colleagues and I
` take a moment to confer.
` (Whereupon, a short recess was
` taken.)
` JUDGE HARLOW: Thank you for
` holding. We will issue a formal written
` order, but our plan is to authorize patent
` owner to submit a paper in the form of a
` list that provides the location or
` identification and concise description of
` any portion of the reply or the Rogers'
` declaration that patent owner wishes to
` draw to our attention regarding
` the -- regarding exceeding the scope or
` improper incorporation of evidence. The
` paper filed by patent owner may not exceed
` five pages, may not contain argument, and
` will be due no later than three days from
` the entry of the written order. We,
` likewise, are going to authorize
` petitioner to submit a response that's
` itemized to correspond to UTC's submittal
`
`Page 25
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` Proceedings
` Mr. Maebius. Could you repeat that one
` more time, it didn't come through quite
` clearly on my end.
` MR. MAEBIUS: Well, this listing of
` the new arguments in petitioner's reply,
` and the Rogers' declaration, and the
` instances of mischaracterized testimony
` from patent owner's expert, will that
` allow us to get a decision on the question
` of whether we can address at the final
` hearing the mischaracterized testimony of
` Dr. Williams by pointing out other parts
` of the Williams' deposition transcript.
` JUDGE HARLOW: Can I ask you to hold
` for a moment while we confer one more
` time?
` MR. MAEBIUS: Sure.
` (Whereupon, a short recess was
` taken.)
` JUDGE HARLOW: Thank you for
` holding. Just to clarify, the parties
` will not be permitted to introduce new
` evidence at the oral hearing. You will be
` permitted to point out any alleged
`
`TSG Reporting - Worldwide 877-702-9580
`
`7
`
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
` P.7
`
`UT Ex. 2060
`
`

`
`Page 26
`
` Proceedings
` mischaracterization and to identify other
` parts of the transcript if they are of
` record that might be responsive, but the
` parties will not be permitted to raise new
` arguments or present new evidence.
` MR. MAEBIUS: Thank you, your
` Honors.
` JUDGE HARLOW: Thank you all very
` much. That concludes our conference call.
` (Whereupon, at 2:33 p.m., the above
` matter concluded.)
`
` I, LA TONIA C. LEWIS, a Notary
` Public for and within the State of New
` York, do hereby certify that the above is
` a correct transcription of my stenographic
` notes.
` DATED: 10-11-2016
`
` ____________________________
` LA TONIA C. LEWIS
`
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`TSG Reporting - Worldwide 877-702-9580
`
`8
`
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
` P.8
`
`UT Ex. 2060
`
`

`
`A
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`able (2)
`11:18 15:17
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`CHOKS