`Conference Call
`April 15, 2015
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`----------------------------x
`METRICS, INC. MAYNE PHARMA, :
`and JOHNSON MATTHEY, INC., :
` Petitioner, :
` vs. : Case IPR2014-01041
`SENJU PHARMACEUTICAL CO., : Case IPR2014-01043
`LTD., BAUSCH & LOMB, INC., :
`and BAUSCH & LOMB PHARMA :
`HOLDINGS CORP., :
` Patent Owner. :
`----------------------------x
`INNOPHARMA LICENSING, INC., :
`INNOPHARMA LICENSING LLC, :
`INNOPHARMA INC., INNOPHARMA :
`LLC, MYLAN PHARMACEUTICALS :
`INC., and MYLAN INC., :
` Petitioner, : Case IPR2015-00902
` vs. : Case IPR2015-00903
`SENJU PHARMACEUTICAL CO., :
`LTD., BAUSCH & LOMB, INC., :
`and BAUSCH & LOMB PHARMA :
`HOLDINGS CORP., :
` Patent Owner. :
`----------------------------x
`
` Conference Call
` Tuesday, April 15, 2015
` 11:00 a.m.
`
`Pages: 1 - 51
`Reported by: Cappy Hallock, RPR, CRR, CLR
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`202-220-4158
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`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
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`SENJU EXHIBIT 2001
`INNOPHARMA v. SENJU
`IPR2015-00903
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`IPR2014-01041; IPR2014-01043; IPR2015-00902; IPR2015-00903
`Conference Call
`April 15, 2015
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` A P P E A R A N C E S
` (all appearances telephonically)
`
` PRESIDING:
` GRACE KARAFFA OBERMANN, Administrative
` Patent Judge
` FRANCISCO C. PRATS, Administrative Patent
` Judge
` ERICA A. FRANKLIN, Administrative Patent
` Judge
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` ON BEHALF OF PETITIONER METRICS, INC., MAYNE
` PHARMA, and JOHNSON MATTHEY, INC.:
` PATRICK D. McPHERSON, ESQUIRE
` Duane Morris LLP
` 505 9th Street, N.W., Suite 1000
` Washington, D.C. 20004-2166
` 202-776-7800 (P) 202-776-7801 (F)
` pdmcpherson@duanemorris.com
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`IPR2014-01041; IPR2014-01043; IPR2015-00902; IPR2015-00903
`Conference Call
`April 15, 2015
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`APPEARANCES: (Continued)
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`3
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` ON BEHALF OF PETITIONER INNOPHARMA LICENSING
` INC., INNOPHARMA LICENSING LLC, INNOPHARMA
` INC., INNOPHARMA LLC, MYLAN PHARMACEUTICALS
` INC., and MYLAN INC.:
` JITENDRA MALIK, Ph.D.
` BRYON SKELTON, Ph.D.
` LANCE SODERSTROM, ESQUIRE
` Alston & Bird LLP
` 4721 Emperor Blvd., Suite 400
` Durham, North Carolina 27703-8580
` 919-862-2200 (P) 919-862-2260 (F)
` jitty.malik@alston.com
` bryan.skelton@alston.com
` lance.soderstrom@alston.com
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`IPR2014-01041; IPR2014-01043; IPR2015-00902; IPR2015-00903
`Conference Call
`April 15, 2015
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`APPEARANCES: (Continued)
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`4
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` ON BEHALF OF PATENT OWNER SENJU
` PHARMACEUTICAL CO., LTD., BAUSCH &
` LOMB, INC., and BAUSCH & LOMB PHARMA
` HOLDINGS CORP.,
` BRYAN C. DINER, ESQUIRE
` JUSTIN J. HASFORD, ESQUIRE
` JONATHAN R.K. STROUD, ESQUIRE
` Finnegan, Henderson, Farabow,
` Garett & Dunner, LLP
` 901 New York Avenue, N.W.
` Washington, D.C. 20001-4413
` 202-408-4000 (P) 202-408-4400 (F)
` bryan.diner@finnegan.com
` justin.hasford@finnegan.com
` jonathan.stroud@finnegan.com
`
`Reported by:
` Cappy Hallock, RPR, CRR, CLR
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`Conference Call
`April 15, 2015
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` P R O C E E D I N G S
` - - - - - -
` JUDGE OBERMANN: Good morning. This
`is a consolidated conference call in
`IPR2014-01041, IPR2014-01043, IPR2015-00902,
`IPR2015-00903.
` This is Judge Grace Obermann, and
`before we get started I would like to confirm
`that a Judge Prats is on the line?
` Judge Prats, are you there?
` JUDGE PRATS: Judge Prats is here.
` JUDGE OBERMANN: Judge Franklin, are
`you on the line?
` JUDGE FRANKLIN: I'm here.
` JUDGE OBERMANN: Thank you, Judge
`Franklin.
` I would like to ask, is there a court
`reporter on the phone?
` THE REPORTER: Yes, Your Honor.
` JUDGE OBERMANN: And may I ask, which
`party retained the court reporter?
` MR. DINER: The Patent Owner did, Your
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`Conference Call
`April 15, 2015
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`Honor. This is Brian Diner, speaking on behalf
`of the Patent Owner.
` JUDGE OBERMANN: Thank you, Mr. Diner.
`Would you please file a true copy of the
`transcript in due course as an exhibit in all
`four proceedings?
` MR. DINER: Yes, we will, Your Honor.
` JUDGE OBERMANN: Thank you.
` The Board requested this conference
`call to find out what the status is of the
`parties' progression on maybe a meeting of the
`minds on the joinder motion. So I did send
`around an e-mail asking all counsel to be
`prepared to discuss a number of issues today.
` What I would like to do is start with
`a roll call of counsel, just so that we know who
`is on the line for each party.
` I understand that the Patent Owner is
`the same in both proceedings but I would like to
`ask first, Mr. Diner, are you representing Senju
`in all four actions?
` MR. DINER: Yes, I am, Your Honor, and
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`Conference Call
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`I am also joined by my colleagues, if you would
`like me to name them at this point in time.
` JUDGE OBERMANN: Yes, I would. Thank
`you, Mr. Diner.
` MR. DINER: Justin Hasford and
`Jonathan Stroud.
` JUDGE OBERMANN: Thank you, and may I
`ask who is appearing for Petitioner Metrics in
`IPR2015-01041 and -043?
` MR. McPHERSON: This is Patrick
`McPherson on the line, representing Metrics, the
`Petitioner in those two IPRs, Your Honor.
` JUDGE OBERMANN: Thank you,
`Mr. McPherson.
` And may I please hear which counsel is
`representing Petitioner, is it InnoPharma in
`IPR2015-00902 and -903?
` MR. MALIK: Yes, Your Honor. This is
`Jitendra Malik. With me is my co-counsel Lance
`Sonderstrom. We are representing Petitioner
`InnoPharma and their related parties, including
`Mylan, in the two IPRs.
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` JUDGE OBERMANN: Okay.
` As an initial matter I would like
`counsel to first address whether there is any
`issue of a time bar regarding the petitions that
`were filed in the -902 and -903 actions, absent
`joinder. Would these petitions be time barred?
` Let me hear first from counsel for
`Patent Owner.
` MR. DINER: Your Honor, this is Brian
`Diner for the Patent Owner, and I do not believe
`that they would be time barred.
` JUDGE OBERMANN: And Mr. Malik, do you
`have anything to add to that?
` MR. MALIK: No, I do not. I do not
`believe they would be time barred.
` JUDGE OBERMANN: I'm glad we can get
`that out of the way early on.
` Okay, let's start with whether there
`has been a meet and confer on the issue of
`joinder. And I would like both parties to take
`their turns reporting on the status of that.
` Let's start with counsel for
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`Petitioner. It sounds like Mr. Malik had
`approached counsel for Patent Owner to perhaps
`have a meet and confer, so let's start with
`Mr. Malik on that.
` What is the status of the meet and
`confer?
` MR. MALIK: Your Honor, we have
`actually had three meet and confers. And at the
`conclusion of all three meet and confers, we are
`unable to have a meeting of the mind. So that is
`sort of the 10,000 foot overview of the meet and
`confers that happened today.
` JUDGE OBERMANN: Can you please
`explain for the Board what the nature of the
`disagreement is?
` MR. MALIK: The nature of the
`disagreement, from InnoPharma's point of view,
`are some of the conditions that Senju has asked
`in connection with the joinder petition,
`particularly with respect to depositions of
`experts, who can attend, and the nature of the
`hearing as to who can speak. I can go into more
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`detail if you wish on each one of those points.
` With respect to the schedule,
`InnoPharma doesn't have a strong opinion on it at
`this time. That's something more that Senju and
`Metrics seem to have more stronger opinions on,
`so I will defer on that. Certainly with respect
`to the procedures that are being discussed today,
`I'm happy to discuss what the nature of the
`disagreement is, if Your Honor would like to hear
`about that at this time.
` JUDGE OBERMANN: Yes, I would like you
`to try to frame the dispute, and then I will give
`counsel for Senju and also counsel for Metrics an
`opportunity to respond.
` MR. MALIK: Obviously, in this case,
`there are two different experts, but the
`positions, the invalidity bases are identical, as
`we put in our motion. The fact that there are
`two different experts isn't automatically a bar
`to joinder. In fact, in IPR2015-518 there were
`different experts and the panel still allowed
`joinder.
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` The nature of the disagreement is
`obviously there will be two depositions, one of
`Metrics' expert and also with respect to our
`expert. We are not opposing the deposition of
`our expert. I'm sure Metrics is not, but I will
`let Metrics speak for themselves.
` With respect to the two depositions,
`counsel for Senju has asked that the other
`counsel, so if, for example, Metrics' expert were
`being deposed, that neither counsel for
`InnoPharma nor its expert be present. And
`vice-versa, when Dr. Laskar, InnoPharma's expert
`was being deposed, neither Metrics' counsel or
`their expert be present. And we have not yet
`seen the Board implement such rules and we have
`not yet seen any authority affording those
`conditions, so that's the first nature of the
`disagreement.
` With respect to depositions of their
`expert, counsel for Senju was asked that, in
`essence, one counsel take the deposition, the
`other one essentially remain silent. We are not
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`opposed to consolidating and working together,
`but at this time, you know, we don't think it is
`appropriate to completely, in essence, silence
`one counsel while the other one essentially takes
`one hundred percent lead leaving the other one no
`opportunity to speak whatsoever.
` And finally, with respect to the
`hearing itself, Senju has said only one counsel
`be allowed to speak and we obviously -- we have
`been in IPRs before where two counsel has spoken
`so we don't think that is appropriate either.
` JUDGE OBERMANN: Thank you, Mr. Malik.
`Does that sum up your presentation of the dispute
`as you see it?
` MR. MALIK: Yes, Your Honor.
` JUDGE OBERMANN: Okay, thank you.
` I would like to hear next from counsel
`for Senju. Could you please respond?
` MR. DINER: Yes, Your Honor. This is
`Brian Diner, counsel for Senju.
` We disagree on a number of different
`aspects, Your Honor. First off, I would have to
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`say that it's the Patent Owner's position that we
`do oppose joinder unless the schedule was
`extended out because there are going to be
`substantive differences as between the two
`petitions.
` And with regard to the expert
`depositions, which counsel from InnoPharma has
`acknowledged are different experts and there are
`different substance positions being offered
`there, we usually --
` JUDGE OBERMANN: I'm sorry to
`interrupt, but when you say the schedule needs to
`be extended out, you are talking about the
`schedule in the first two filed IPRs.
` MR. DINER: That is correct, Your
`Honor, pursuant to what the statute permits the
`rules do, as well as the legislative history.
` JUDGE OBERMANN: And how, what is your
`position on timing? When would the final hearing
`on all four proceedings go forward, if you know?
` MR. DINER: I'm glad you asked. We
`have been really mulling that about, Your Honor,
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`and thinking about it some. And we are kind of
`coming out -- and I know Your Honors are very
`interested in what is happening in the parallel
`proceedings in the district court cases. So a
`schedule I think would be, what we would propose
`would be tied to that. Let me explain.
` In the district court proceeding
`which, as you know from the papers that was filed
`yesterday, it is going forward as to Metrics.
`The motion to dismiss that they filed has been
`denied and that is going forward. Presently in
`the district court cases in New Jersey there are
`-- it is going to go forward with at least three
`defendants and five patents, and the judge in the
`district court has set a trial date for March
`6th, 2016.
` And so what we were thinking, Your
`Honor, if you're going to join, that an
`appropriate extension would be one that would put
`the two cases on a similar path and pace. And
`that is because, as you know, from our
`preliminary response, we were looking to have the
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`petition be denied because it was in conflict
`with the Hatch-Waxman, which you denied. But as
`you probably remember from reading our arguments
`that one of the things that we emphasized was
`this race to the federal circuit to try to
`avoid -- and it's our objective to get there at
`the same time -- to try to avoid a situation
`where you have inconsistent decisions based on
`maybe the same grounds of inpatentability and
`what the Petitioners are alleging are the same
`arguments, same evidence.
` So what we would propose is that in
`order to do this fairly, and put everyone on
`equal footing on this race to the federal
`circuit, that if trial is scheduled for March 6th
`of 2016 in which both defendants right now will
`appear to be there, as well as a third defendant,
`then we would propose that we have a hearing
`sometime in April of 2016.
` It would put it all on the same track.
`It would coincide with the decision that the
`defendants in the district court will have before
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`the 30-month stay. And it would nicely, Your
`Honors, put it all up at the federal circuit
`right at the same time for decision to avoid
`inconsistent decisions and the problems, as we
`all know from the Fresenius case and others, that
`that can cause. So I have gotten a little bit
`ahead of myself.
` But since you asked, I thought I would
`put that out there. And I can go back and
`address the other arguments that counsel for
`InnoPharma made.
` JUDGE OBERMANN: Okay. I appreciate
`that very much.
` So I don't have to interrupt you
`again, I just want to make clear that what you
`would propose in the event that we did grant the
`later filed petitions in -902 and -903, and if we
`were to grant the joinder, your position would be
`that the oral hearing in all four should coincide
`on the same date sometime in April of 2016.
` MR. DINER: That's correct.
` JUDGE OBERMANN: Okay. So that
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`does -- I'm looking at -- if we did not join,
`since InnoPharma is not time barred, in the event
`that we granted their petition but did not join,
`I believe that the schedule would go out until
`September of -- our final decisions in those two
`wouldn't be due probably until September of 2016.
`So you are advocating some sort of an abbreviated
`schedule in those later filed petitions
`regardless of whether we join?
` MR. DINER: That's correct, Your
`Honor.
` JUDGE OBERMANN: Okay, that's helpful.
`In that case, please proceed and address the
`other issues.
` MR. DINER: Thank you very much, Your
`Honor.
` So one of the points that my friend
`from InnoPharma made was with regard to the
`petition and the declaration of the expert I
`believe as being identical. Actually, Your
`Honor, they characterize those as being
`consistent and in terms of the petition. And the
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`declarations, they called it congruent which
`implicitly in each of those words means that
`there is some differences. We went into them and
`sort of surfaced a number of different
`substantive differences that, if Your Honor
`likes, I can go into. But there are a number of
`differences, some claim construction to the
`substantive factual arguments being made and the
`legal support for those enhanced and supplemented
`legal arguments.
` They also, Your Honor, adopt the
`position of the Board in an institution decision
`and effectively attempt to get what by analogy is
`the second bite at the apple, which I know Your
`Honor is familiar with in the Unilever case, and
`it's exactly like trying to just use the
`institution decision as a road map to fill gaps
`and file these serial petitions and prejudice
`Patent Owners and tax the Board's already taxed
`resources.
` He mentioned, Mr. Malik mentioned the,
`I believe it was the IPR case 2014-00518. I
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`don't think that that one really applies to this
`case, if I have the right number and the right
`case in mind based on what he said, because in
`that case the Patent Owner did not oppose the
`joinder, did not file a preliminary response in
`the case that was considered for joining, or --
`or in the second filed case I should say. And
`they also agreed to a one-month extension of the
`time deadlines in that case, which is not
`applicable here at all, because while InnoPharma
`may be more sympathetic to extending the
`deadline, I think it is fair to say on behalf of
`Mylan and my friend Pat McPherson from Metrics
`that his client would not be.
` And then the other point I would like
`to make, he talked about experts being present at
`the deposition. They would like, the Petitioners
`would like their experts to be present when the
`first Petitioner's expert is being deposed, and
`we object to that, Your Honor.
` And, as you know, the Board follows
`the Federal Rules of Evidence, and there is a
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`Federal Rule of Evidence 615(c) dealing with
`sequestration of witnesses, and there is case law
`out there as well dealing with sequestration of
`expert witnesses, In re Omeprazole from the
`Southern District of New York in 2002, as well as
`a Fourth Circuit case in 1996, the Opus 3 case,
`all of which point to various factors why experts
`on the same side as the V, Your Honor, in other
`words, the same side as the Petitioner, should
`not be present while the other expert is being
`deposed because it effectively gives them a dry
`run on substantive, essential issues, and it
`ruins their objectivity.
` And, you know, we would be prepared,
`if Your Honor would like, to brief that some
`more. But we do have that, our first scheduled
`deposition coming up, Your Honor, on April 29th
`of Metrics' expert, Dr. Kompella. So to some
`extent that is before the Board for its
`consideration, and I guess to some extent a
`decision on that issue.
` So I think at that point I think I
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`have addressed all the points that Mr. Malik had
`made and I will rest and let Mr. McPherson have a
`go at it.
` JUDGE OBERMANN: Let me just ask what
`is the basis, if any, of your opposition -- your
`position that should we consolidate these that
`only one counsel should be allowed to speak at
`the final hearing?
` MR. DINER: Well, Your Honor, there
`are a number of cases out there which talk about
`in cases where they have joined that the parties
`have made concessions, or the Board has ordered
`that the second party take a silent role so as
`not to exasperate the situation and ratchet up
`the complexity and ask questions over again that
`others have asked, and to keep things
`streamlined. Otherwise, we get into disputes as
`to what can be asked and how long it can take,
`and those sort of things and a lot of that. And
`it just means coming back to the Board for
`guidance and disputes to be resolved. There are
`a number of cases that talk about the silent role
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`or the understudy role, and it seems to be
`consistent with that.
` JUDGE OBERMANN: Okay. Before I move
`to counsel for Metrics, Mr. Diner, I would like
`to ask one last thing.
` MR. DINER: Very well.
` JUDGE OBERMANN: Do you have any
`objections to or do you foresee any impossibility
`or difficulty to putting together a schedule,
`should we decide to grant the later filed
`petitions and should we decide to join them.
`Setting aside these disputes that you have about
`presence of experts and counsel at depositions
`and what the particular format of the final
`hearing would be, would you be able to get
`together with opposing counsel to put together a
`schedule that would work?
` In other words, do you foresee any
`sort of impossibility as far as the scheduling
`goes to be able to put together a schedule that
`would work to consolidate these cases so that we
`could get final decisions out in all four
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`sometime in July of 2016?
` MR. DINER: Well, from our end, Your
`Honor, I don't see it as a problem. We would be
`very happy to work with our colleagues from
`InnoPharma and with Metrics. I suspect that
`Metrics' position is that -- they won't agree to
`an extension, at least that has been their
`position so far, whereas Mr. Malik said on behalf
`of InnoPharma, I think he is a little more
`sympathetic to that. And so we are certainly
`willing to work with them, Your Honor, and we are
`happy to meet and confer and do this for them.
` JUDGE OBERMANN: Okay, thank you, Mr.
`Diner.
` And along those lines, I'm just
`thinking if we were to look for final decisions
`in all four in July of 2016, that would make the
`Decision to Institute in the later filed actions,
`we would want those to be due in July. I'm just
`trying to get a sense of cutting back your time
`on the preliminary response.
` You mentioned that there may be some
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`differences between the factual arguments and
`maybe some differences in the evidentiary
`support, including the identity of the experts.
`Is there any reason why you couldn't file or
`waive your preliminary response in the -902 and
`-903 cases so that the due date for filing would
`fall on April 30th of 2015?
` MR. DINER: Would that be conditioned
`upon extending it out as Your Honor was
`contemplating a moment ago to a final decision
`sometime in July of 2016?
` JUDGE OBERMANN: Well, I don't see how
`we are going to get there unless we cut your
`preliminary response time down. I'm not
`saying -- I'm not going to say that we are
`definitely going to grant the later filed
`petitions at this point. That would be in our
`Decision to Institute or not, but just so that we
`can sort of get ahead of the curve, I would like
`to have your preliminary response due on April
`30th so that I can try to get the decisions to
`institute out early, and that way in the event
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`that we do go forward on the later two and in the
`event we do want to join we are not looking at,
`you know, an impossible situation.
` MR. DINER: The only -- it could
`become impossible for us if we were having to do
`that with no opportunity -- I know that you're
`not making the decision now on the phone at this
`conference about putting a date to July of 2016,
`for example, for a final decision. But if we
`knew that was somewhat likely then we would
`probably concede to that in order to get the two
`cases or to get these IPRs on the same schedule.
` JUDGE OBERMANN: Let me just be clear.
`I don't think I'm asking for a concession because
`I can order you to do it earlier. There is
`nothing in the rule that provides you a right to
`three months.
` MR. DINER: I understand, Your Honor.
` JUDGE OBERMANN: I can shorten your
`time, but I don't want to do that if you can
`demonstrate that there is some kind of prejudice.
`What I'm hearing is that there may be
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`differences, but I don't hear how those
`differences at this point justify giving you
`three months. Even if we didn't join, I mean, it
`would be nice to get these things out earlier
`even if we don't join. So right now I'm actually
`asking you is there any prejudice that you would
`suffer if I were to change the date to April
`30th.
` And before you answer, let me just
`give you a little prelude to what I'm thinking of
`doing. I'm thinking of requiring you to file
`your preliminary response by April 30th, and on
`that same day I would ask all three parties to
`come forward with a proposed joint schedule --
`well, let me back up.
` Your preliminary response, should you
`decide to file one on April 30th, should include
`any opposition to joinder. And at the same time
`in a separate document I would ask all three
`parties to file a joint schedule, a proposed
`schedule to be followed in the four actions, and
`I would give all three of you an opportunity in
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`that joint document to discuss any disagreements
`you have about the dates so that we could
`decide -- I could decide everything in the
`Decision to Institute.
` MR. DINER: I see. Okay.
` Well, then, if I may, I will answer
`your question with regard to the prejudice to the
`Patent Owner with regard to having to file on the
`30th, recognizing what you have just said and
`what you were giving us a prelude into.
` It's primarily, we are in the throes
`of trying to file our Patent Owner's response in
`the Metrics IPRs which is due May 19th, Your
`Honor, and on April 29th, as I mentioned earlier,
`we are scheduled to depose Dr. Kompella. So that
`would be the day before you would like us to file
`our preliminary response in the InnoPharma's
`IPRs.
` And we are also, just so Your Honor
`knows, contemplating putting in four substantive
`declarations and we are also contemplating a
`motion to amend as we discussed at the conference
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`call with Your Honor back in March, March 17th.
`So it is our feeling that if we had to do all
`that and also put in the preliminary response by
`April 30th, that that would be prejudicial to the
`Patent Owner.
` JUDGE OBERMANN: What date could you
`have it in by reasonably?
` MR. DINER: Could we get it in just
`after our Patent Owner's responses due on May
`19th?
` Would that work for the Board?
` JUDGE OBERMANN: Well, I don't want to
`put it in now, but I would like to know, would
`May 19th be an acceptable date to you, Mr. Diner?
` MR. DINER: How