`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` -----------------------------x
` AMNEAL PHARMACEUTICALS, LLC,
` Petitioner
` CASES IPR2013-00368
` vs. IPR2013-00371
` IPR2013-00372
` SUPERNUS PHARMACEUTICALS, INC.
` Patent Owner
` -----------------------------x
`
` TELECONFERENCE BEFORE
` Judges Kamholz, Green, and Braden
` Wednesday, June 4, 2014
` 2:30 p.m.
`
`
`
` Reported by:
` Jennifer Ocampo-Guzman, CRR, CLR
` JOB NO. 34708
`
`
`
` JUDGE KAMHOLZ: Good afternoon.
` This is Judge Kamholz for the board.
` I'm joined by Judges Green and Braden.
` Is there a court reporter on the
` line?
` (Discussion off the record.)
` JUDGE KAMHOLZ: This conference
` call is in cases IPR2013-368, 371 and
` 372, Amneal v. Supernus. We have
` outstanding issues from both parties.
` Could you please start with a roll
` call.
` Petitioner?
` MS. ELLISON: Good afternoon, Your
` Honor. This is Eldora Ellison from
` Sterne, Kessler, Golstein & Fox and I
` have with me H. Keeto Sabharwal.
` MR. SABHARWAL: Good afternoon.
` JUDGE KAMHOLZ: And for patent
` owner?
` MR MAEBIUS: Good afternoon, Your
` Honor. This is Steve Maebius with Foley
` & Lardner on behalf of Supernus and also
` with me is Andy Baluch on behalf of
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` Supernus.
` MR. MORRIS: And good afternoon,
` Your Honor. It's Greg Morris from Paul
` Hastings on behalf of Supernus.
` JUDGE KAMHOLZ: Thank you.
` If there is anyone else who will be
` speaking, please first identify the
` party that you represent.
` As I said, we have e-mail inquiries
` from both sides regarding issues in this
` case.
` Ms. Ellison, why don't we start
` with your e-mail, since that came in
` first. You had proposed to replace an
` exhibit; is that right?
` MS. ELLISON: It's not to replace
` an exhibit. It's just that through an
` unintentional clerical error we had not
` uploaded Exhibit 1025. This is an
` exhibit that has previously been served
` on the patent owner and the patent owner
` has stated that they don't oppose our
` request simply to file this exhibit.
` That's all we would like to do, Your
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` TELEPHONIC APPEARANCES:
`
` On Behalf of Petitioner:
` STERNE, KESSLER, GOLDSTEIN & FOX, PLLC
` 1100 New York Avenue, NW
` Washington, DC 20005
` 202.371.2600
` BY: ELDORA L. ELLISON, PhD, ESQ.
` eellison@skgf.com
` H. KEETO SABHARWAL, ESQ.
` Keetos@skgf.com
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` On Behalf of Patent Owner:
` PAUL HASTINGS, LLP
` 191 N. Wacker Drive
` 30th Floor
` Chicago, Illinois 60606
` 312.499.6000
` BY: GREGORY A. MORRIS, ESQ.
` gregorymorris@paulhastings.com
`
` FOLEY & LARDNER, LLP
` 3000 K Street, N.W.
` Suite 600
` Washington, DC 20007-5109
` 202.672.5300
` BY: STEPHEN B. MAEBIUS, ESQ.
` smaebius@foley.com
` ANDREW S. BALUCH, ESQ.
` abaluch@foley.com
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`DAVID FELDMAN WORLDWIDE, INC.
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
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` in its patent owner's response, and as
` the board certainly understands and has
` stated in other cases, such as in the
` St. Jude versus University of Michigan
` IPR, a petitioner can't be expected to
` anticipate in its petition every
` counterargument that a patent owner
` might make in its response. That's IPR
` number 2013-00041, and as the board has
` noted, or I believe the board recognizes
` there have been a number of instances
` where the board has explained that they
` can deal with this issue as to whether
` there are new arguments raised in the
` reply, they can deal with this in the
` final written decision and we submit
` that that's appropriate here.
` For instance, in the Amkor v.
` Tessera IPR, that's IPR2013-00242, the
` board said we can discern this ourselves
` and figure it out in the final written
` decision.
` Likewise, in the Distinctive
` Developments v. Uniloc IPR, which is
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` IPR2013-00391, and the board also made
` such a determination in its final
` decision in the Corning v. DSM IPR,
` which is IPR2013-00047. And then even
` in CBMs, the board has noted it is
` perfectly capable of figuring this out
` in its final written decision, for
` instance, in the Liberty Mutual versus
` Progressive, CVM2012-00010.
` So we submit that there is no need
` for briefing on this issue at this
` point, Your Honor.
` JUDGE KAMHOLZ: Thank you, Ms.
` Ellison.
` Mr. Maebius, can you give me an
` example of perhaps the most egregious,
` in your view, violation of the rule?
` MR. MAEBIUS: Yes, Your Honor. I
` think I would defer this question to
` Mr. Morris, and it relates to Exhibit
` Number 1068.
` MR. MORRIS: Yes. Your Honor, this
` is Greg Morris for Supernus.
` Exhibit 1068 was an example that
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` Honor.
` JUDGE KAMHOLZ: That's fine with
` us. You may proceed.
` MS. ELLISON: Thank you.
` JUDGE KAMHOLZ: And that was all
` from you, correct?
` MS. ELLISON: That's right, Your
` Honor.
` Okay, Mr. Maebius?
` MR. MAEBIUS: Yes, Your Honor. We
` are requesting guidance on how we should
` go about pointing out certain exhibits
` and arguments that have been presented
` in petitioner's reply that are belated
` and could have been submitted earlier.
` This is among the four expert
` declarations and 80 new exhibits that
` were a part of their reply and we've
` seen that several different proceedings
` have handled this issue in different
` ways. So basically what we're asking
` for is authorization, regardless of what
` the paper may be styled, to file a very
` short, two-column paper that points out
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` which exhibits among the 80 new exhibits
` and arguments are belated and things
` that could have been presented earlier.
` And this is in accordance with the trial
` practice guide, which states that the
` petitioner's reply should not include
` arguments that go to the prima facie
` case of patentability or unpatentability
` or evidence that could have been
` presented in a prior filing.
` JUDGE KAMHOLZ: Understood. And I
` agree that there has been some
` differences among panels in how this
` issue has been handled.
` Ms. Ellison, do you have any
` comments?
` MS. ELLISON: Yes, Your Honor.
` First, with respect to the merits of
` their argument, we of course disagree
` that any of the evidence we submitted
` was necessary to make our prima facie
` case. This is quintessential
` impeachment or rebuttal evidence in
` response to arguments raised by Supernus
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`DAVID FELDMAN WORLDWIDE, INC.
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
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` served almost three months after the
` board instituted trial in this matter,
` and it was in support of their patent
` owner response and it has to do with
` Exhibit 2016, Your Honor, is the
` declaration. This was an allegation
` that Dr. Rudnic made about the
` criticality of the ratio, and not only
` did we -- did we respond accordingly
` based on what he put in his declaration,
` but subsequently at his April 2014
` deposition, I asked him extensively
` about this issue. And this was used
` directly to impeach and undermine both
` the credibility, as well as the
` reliability of his statements, as well
` as the arguments accompanied by
` Supernus.
` So this is the most, quote/unquote,
` egregious example, this is
` quintessential impeachment and so,
` therefore, Your Honor, I would again
` echo Dr. Ellison's sentiments, that, if
` anything at all, the board can address
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` these issues in the final written
` decision. There is no need -- we
` already submitted extensive briefing on
` all of these issues to Your Honors and I
` don't think that we need to burden the
` board with any more paper.
` JUDGE KAMHOLZ: Thank you. The
` board will confer. We are going to go
` on mute and we will come back shortly.
` MS. ELLISON: Thank you.
` (The panel conferred off the
` record.)
` JUDGE KAMHOLZ: This is Judge
` Kamholz back on the line with Judges
` Green and Braden. Do I still have
` petitioner?
` MS. ELLISON: Yes, Your Honor.
` JUDGE KAMHOLZ: And patent owner?
` MR. MORRIS: Yes, Your Honor.
` MR. MAEBIUS: Yes, Your Honor.
` JUDGE KAMHOLZ: Thank you.
` The panel has discussed the issue
` and our view at this time is we do not
` require any submission from the patent
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` was raised for the first time in a Van
` Buskirk declaration that was submitted
` along with a reply. It was, although
` Amneal was aware of that reference
` during the litigation that was run in
` parallel with this action, it wasn't
` cited in Amneal's petition or in the
` initial Van Buskirk declaration, even
` though it could have been.
` JUDGE KAMHOLZ: This is a Williams
` paper?
` MR. MORRIS: This is a Williams
` paper, Your Honor, Exhibit 1068.
` And so the Exhibit 1068 was cited
` by Amneal in early 2013 in the district
` court litigation, as I was mentioning,
` in support of its opening expert report
` for Dr. Osberger (phonetic), in which
` the part of the allegations were the
` invalidity of the Chang '740 patent,
` just as it is here, and now they are
` in -- in Mr. Van Buskirk's reply report,
` in the reply itself, they're belatedly
` citing Exhibit 1068 in support of
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` Amneal's prima facie obviousness
` arguments, and also we object to the
` extent that this exhibit is, to the
` extent this is new alleged prior art
` that is not within ground 2, which is
` the ground that the board initiated on.
` JUDGE KAMHOLZ: Ms. Ellison?
` MS. ELLISON: My colleague, Mr.
` Sabharwal is going to respond.
` MR. SABHARWAL: Good afternoon,
` Your Honor. This is Keeto Sabharwal on
` behalf of petitioner.
` Your Honor, as Dr. Ellison said,
` any arguments that they are claiming are
` new, are quintessential impeachment
` evidence and appropriate rebuttal
` evidence directly in response to
` allegations made by Supernus, both in
` their patent owner response and in its
` declaration. And specifically with
` respect to Exhibit 1068, Your Honor, I
` point the court to paragraph 146 of the
` declaration of Edward Rudnic. This is a
` 200-plus-paragraph declaration that was
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`DAVID FELDMAN WORLDWIDE, INC.
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
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` of record promptly, as well as our order
` which will be following in due course.
` MR. MAEBIUS: Thank you, Your
` Honor. Okay.
` JUDGE KAMHOLZ: Are there any other
` questions from either side? Ms.
` Ellison?
` MS. ELLISON: No, Your Honor.
` JUDGE KAMHOLZ: Mr. Maebius?
` MR. MAEBIUS: No.
` JUDGE KAMHOLZ: Did I hear a
` question?
` MR. MORRIS: I'm not sure, Your
` Honor. Is it only on this issue or we
` moving on to the next issue? I
` apologize, I didn't know if you meant --
` there was another issue on the call,
` Your Honor.
` JUDGE KAMHOLZ: Forgive me. Please
` proceed.
` MR. MORRIS: Your Honor, it's Greg
` Morris for Supernus, and we just wanted
` to raise a matter with you about
` deposition scheduling.
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` Amneal in its reply has submitted
` four declarations, and part of that
` reply, and the parties have not been
` able to agree on the deposition schedule
` for -- for those four experts. And the
` issue, Your Honor, is that we requested
` a specific sequence for those
` depositions to take place as set forth
` in the rules that we may choose the
` order in which those witnesses are to be
` examined; and Amneal has not provided
` dates that are in the order as we had
` requested. And that's even in light of
` the fact that when Amneal was trying to
` schedule the deposition of Supernus'
` witnesses, they asserted that same rule
` against us, and they requested a
` specific order and we then complied.
` But they threatened that if we did not
` provide that order, they would take the
` matter before the board.
` JUDGE KAMHOLZ: Is the issue here
` that there is not enough time or is it
` simply the order?
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` owner outlining his concerns with the
` reply and the evidence. The matter is
` really within the discretion of the
` panel and already goes to the merits of
` the case. So we will really have to
` address this as part of the final
` written decision, and that's how we
` would prefer to handle it at this point.
` We understand patent owner's
` concerns that there is material in the
` reply in their view they have to
` confront for the first time at this
` stage of the proceeding, but I think the
` petitioner has also explained that this
` may very well be impeachment evidence
` and the board, the panel will simply
` have to consider that as it deals with
` the case on the merits.
` We will, however, remind the
` petitioner that the purpose of the reply
` is to respond to arguments raised in the
` patent owner's response. And that's --
` a reply that raises new issues or
` belatedly raises new evidence will not
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` be considered and we will not
` distinguish proper portions of the reply
` from improper portions.
` In other words, the petitioner runs
` the risk of having the entire content of
` the reply and the evidence submitted
` with it not considered if any portion of
` it is not proper, proper reply evidence.
` I would like to make that clear.
` Do you understand that,
` Dr. Ellison?
` MS. ELLISON: Yes, I do, Your
` Honor. Thank you.
` JUDGE KAMHOLZ: Sure.
` And Mr. Maebius, is that clear to
` you as well?
` MR. MAEBIUS: Yes, we understand,
` Your Honor. I think we are just unsure
` of how to avoid some kind of waiver that
` presents us from raising the issue on
` appeal, if that were ever necessary.
` JUDGE KAMHOLZ: You have a
` transcript of this conference call,
` which I'm sure Ms. Ellison will be made
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`DAVID FELDMAN WORLDWIDE, INC.
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
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` But under the current schedule, we
` could only -- we could only provide our
` witnesses, make our witnesses available
` in the order they asked for, for the
` first three, and the fourth witness
` would need to be deposed on the same day
` as the third witness. And it's just
` based on their availability, Your Honor;
` and frankly, since they mentioned their
` efforts to make their witnesses
` available, frankly, we've been much more
` accommodating than they were. Because
` in the seven weeks that they had to make
` their five witnesses available, they
` only offered us 13 days and we've
` offered ten in just a matter of few
` weeks for our witnesses.
` JUDGE KAMHOLZ: Well, I think what
` we would like to do then is allow you to
` stipulate the changes of due dates four
` and five, see if you can work it out,
` and if you are still having trouble,
` then come back to us.
` As I look, as I look at the
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` schedule for this case, we have oral
` argument scheduled for August 12th,
` which out of curiosity, do both parties
` expect to request oral argument?
` MS. ELLISON: Yes, sir, Your Honor.
` MR. MORRIS: Yes, Your Honor.
` JUDGE KAMHOLZ: I would suggest
` then, whatever you do as far as
` rescheduling dates four and five, please
` file your requests for oral argument by
` June 30th. That is due date four that
` is currently set, and there's a reason
` for that, it's simply logistics, so that
` we can plan for that, an hour of hearing
` room schedule.
` But otherwise, you may move due
` dates four and five as you like but no
` later than due date six.
` MR. MORRIS: Thank you, Your Honor.
` JUDGE KAMHOLZ: As I said, if that
` can't resolve the situation, then please
` do come back to us.
` MR. MORRIS: We appreciate that.
` JUDGE KAMHOLZ: There was another
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` MR. MORRIS: I think it's a little
` bit of both, Your Honor. I think we
` were trying to be reasonable with Amneal
` and one suggestion we had was that we
` would extend the period to take
` depositions or certainly raise that
` issue with the board, and we're amenable
` to doing that.
` But the other thing, Your Honor, is
` that we also, for -- strategically, we
` wanted to have a certain order of
` witnesses and that was something that
` Supernus would like to do.
` JUDGE KAMHOLZ: Well, we're coming
` up on due date four, on June 30th; is
` that right?
` MR. MORRIS: That's correct, Your
` Honor.
` JUDGE KAMHOLZ: If we give the
` parties leave to stipulate the changes
` of due dates four and five, will that
` help alleviate the situation?
` MR. MORRIS: From Supernus' point
` of view, I believe it would. But I
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` think, I guess we also have to hear from
` Amneal.
` JUDGE KAMHOLZ: Ms. Ellison?
` MS. ELLISON: It would probably
` help, Your Honor. Let me just state by
` way of background. Supernus, just a few
` days ago, identified the order in which
` they would like to depose our witnesses,
` and as I read it, we've offered in this
` rather short time period, which is just
` about a three-week deposition window, we
` have offered 13 different dates for our
` witnesses. And as I look at the sort of
` the matrix of availability of our
` witnesses, we could accommodate the
` order that they asked for, except that
` two of the witnesses would need to be
` deposed, the last two witnesses would
` need to be deposed on the same day. If
` we're able to adjust the schedule as you
` just authorized, I can go back to Mr.
` Green, the witness they hope to depose
` last, and see if he's available, given a
` new set of deadlines.
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`DAVID FELDMAN WORLDWIDE, INC.
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
`
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` C E R T I F I C A T E
` STATE OF NEW YORK )
` : ss.
` COUNTY OF NEW YORK )
`
` I, Jennifer Ocampo-Guzman, a
` Notary Public within and for the State
` of New York, do hereby certify that the
` within is a true and accurate
` transcript of the proceedings taken on
` June 4, 2014.
` I further certify that I am not
` related to any of the parties to this
` action by blood or marriage and that I
` am in no way interested in the outcome
` of this matter.
` IN WITNESS WHEREOF, I have
` hereunto set my hand this 16th day of
` June 2014.
`
` ________________________________
` JENNIFER OCAMPO-GUZMAN, CRR, CLR
`
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` matter I now see regarding a pending
` district court litigation. Would you
` like to take us through that?
` MR. MAEBIUS: Sure. We just wanted
` to point out that we had filed an
` updated notice concerning the dismissal
` of the litigation. So it's already been
` filed.
` JUDGE KAMHOLZ: Thank you.
` Has there been any progress, or I
` should say discussions regarding
` settlement of the IPR?
` MR. SABHARWAL: Your Honor, this is
` Keeto Sabharwal on behalf of the
` petitioner.
` We have had discussions, but
` unfortunately they were unavailing and
` as it stands right now, the parties are
` proceeding full speed ahead. There has
` been no recent discussion of resolution.
` JUDGE KAMHOLZ: Any comments from
` patent owner?
` MR. MAEBIUS: Nothing further from
` me, Your Honor.
`
`23
`
` JUDGE KAMHOLZ: All right. I think
` then those are all the issues for now.
` Is there anything else? Ms.
` Ellison?
` MS. ELLISON: Not from petitioner,
` Your Honor. Thank you very much.
` JUDGE KAMHOLZ: Mr. Maebius?
` MR. MAEBIUS: No, nothing further.
` Thank you.
` JUDGE KAMHOLZ: Thank you. The
` call is adjourned.
` (Time noted: 2:52 p.m.)
`
`DAVID FELDMAN WORLDWIDE, INC.
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
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`certify 24:9
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`curiosity 21:4
`current 20:2
`currently
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`CVM2012-...
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`date 18:16
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`DC 2:7 3:14
`deadlines
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`deal 8:14,16
`deals 14:18
`decision 8:17
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`declaration
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`declarations
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`depose 19:9
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`
`DAVID FELDMAN WORLDWIDE, INC.DAVID FELDMAN WORLDWIDE, INC.
`
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
`
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`district 10:16
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`handled 6:21
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`Judge 4:2,3,8
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`DAVID FELDMAN WORLDWIDE, INC.
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
`
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`Okay 6:10
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`opening
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`order 16:2
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