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` PROCEEDINGS
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` - - - - - - - - - - - - - - - - -
` MYLAN PHARMACEUTICALS, INC.,
` Petitioner,
` V.
` SANOFI-AVENTIS DEUTSCHLAND GMBH,
` Patent Owner.
` - - - - - - - - - - - - - - - - -
` Case No. IPR2018-01675
` Case No. IPR2018-0122
` - - - - - - - - - - - - - - - - -
` TELECONFERENCE
` February 13, 2019
` HELD BEFORE ADMINISTRATIVE PATENT JUDGES
` BART A. GERSTENBLITH, JAMES MAYBERRY and
` HYUN J. JUNG
`
` ** REVISED **
`
` REPORTED BY: Ronda J. Thomas, RPR, CRR
` JOB NO.: 155589
`
`TSG Reporting - Worldwide 877-702-9580
`
`Mylan Exhibit - 1039
`Mylan v. Sanofi - IPR2018-01675
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` PROCEEDINGS
` February 13, 2019
` 2:02 p.m.
` A telephone conference was held before
` the Honorable Bart A. Gerstenblith, JAMES Mayberry
` and Hyun J. Jung. Held also before Ronda J.
` Thomas, Registered Professional Reporter,
` Certified Realtime Reporter and Notary Public for
` the District of Columbia and the State of
` Maryland.
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` PROCEEDINGS
` APPEARANCES:
` ON BEHALF OF PETITIONER:
` RICHARD TORCZON, ESQUIRE
` WESLEY DERRYBERRY, ESQUIRE
` ELHAM STEINER, ESQUIRE
` Wilson Sonsini Goodrich & Rosati
` 1700 K Street, NW
` Washington, DC 20006
`
` ON BEHALF OF PATENT OWNER:
` BRIAN CHANG, ESQUIRE
` ANISH DESAI, ESQUIRE
` ADRIAN PERCER, ESQUIRE
` Weil, Gotshal & Manges
` 201 Redwood Shores Parkway
` Redwood Shores, CA 94065
`
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` JUDGE GERSTENBLITH: Good afternoon,
` everyone. This is Judge Gerstenblith. With
` me on the line are Judges Jung and Mayberry.
` This is a conference call in several
` related cases with Mylan v. Sanofi. I'm not
` going to list out all the numbers because I
` think it's fairly flexible, but we'll --
` we'll try to list them at the end depending
` on how many different cases we discuss from
` the family. It covers at least those related
` to IPR2018-01675.
` With that, let's do a roll call. Who do
` we have on the line for petitioner, please?
` MR. TORCZON: Your Honor, you have
` Richard Torczon from Mylan. I believe also
` on the line are Wes Derryberry and Ellie
` Steiner.
` JUDGE GERSTENBLITH: Will you be
` speaking on behalf of petitioner?
` MR. TORCZON: I will, Your Honor.
` JUDGE GERSTENBLITH: Okay. Thank you.
` And who do we have on the line for
` patent owner?
` MR. CHANG: Good afternoon, Your Honor.
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` You have Brian Chang on the line for patent
` owner, and also on with me are Anish Desai
` and Adrian Percer.
` JUDGE GERSTENBLITH: Will you be
` speaking on behalf of patent owner,
` Mr. Chang?
` MR. CHANG: Yes, Your Honor.
` JUDGE GERSTENBLITH: I believe -- but
` please correct me -- was it petitioner who
` arranged for a court reporter?
` MR. TORCZON: We did, Your Honor. She
` is on the line, and we will submit a
` transcript as soon as it's prepared and we've
` had a chance to check with Sanofi on its
` correctness.
` JUDGE GERSTENBLITH: Perfect. Thank you
` very much.
` I have a list of three things to discuss
` amongst the cases, and I have written them
` out with each case number; but please tell
` me, as we go through, if you identify that
` I've only mentioned one case and it has
` applications in more than one, please don't
` be afraid to interrupt me. I will certainly
`
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` not hold it against you. I want to make sure
` that the transcript is as clear as possible
` now that we have multiple things happening in
` at least five cases.
` To start, I want to start with
` petitioner's motion to correct the petition.
` And my understanding is that petitioner was
` authorized to file two motions, one in
` IPR2018-01675 and a second in IPR2019-00122.
` Am I right about that so far,
` Mr. Torczon?
` MR. TORCZON: You are, Your Honor.
` JUDGE GERSTENBLITH: And there was no
` other case that that happened in, right?
` MR. TORCZON: We checked, Your Honor.
` Those were the only two.
` JUDGE GERSTENBLITH: Okay. Let me ask a
` question with the second case, 00122,
` because -- I'm sorry. I'm looking at my
` emails as we discuss this. I apologize.
` Hang on for one second. I apologize.
` Okay. That's what I wanted to check.
` So, Mr. Chang, patent owner has not yet
` filed a response to Mylan's motion to correct
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` in the 00122 case; is that right?
` MR. CHANG: That's correct, Your Honor.
` And we -- I believe it was actually indicated
` to the board in the initial email from
` petitioner that patent owner did not oppose
` the correction in that case. So we don't
` intend on filing a response unless the board
` would like us to file a paper simply stating
` that we don't oppose.
` JUDGE GERSTENBLITH: Okay. I did not
` examine that case in full to compare it to
` 1675 case. Sorry. That's 1675. But I don't
` need to delve into the reason or not that
` patent owner either does or does not oppose
` the correction. But it does, I guess,
` understanding what patent owner's position
` is, either allows me to talk about the motion
` or I would wait.
` So do we have -- do I understand
` correctly, Mr. Chang, that you're
` representing right now that patent owner does
` not oppose the motion in 00122?
` MR. CHANG: That's correct, Your Honor.
` And to the extent that it is helpful, the
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` reason that we don't oppose in 00122 but did
` in 1675 is that in 00122 we were given notice
` of the intended correction before we filed
` our patent owner preliminary response, and we
` felt that we were sufficiently able to
` address it in that response.
` JUDGE GERSTENBLITH: Okay. Thank you
` very much. That actually explains a lot and,
` I think, sort of confirms the panel's finding
` with respect to the motion to correct the
` petition in both cases but also in 1675.
` So the panel is going to grant the
` motion to correct. And the question -- and
` just to explain a little bit of the thought
` process -- which all this will be detailed in
` the order, but the order may not contain
` additional detail. It may, but I make no
` promises.
` It appeared to the panel uncontested
` that this error was a typo. And our rule
` contemplates specifically this type of
` situation, unlike some of the other cases
` that may or may not have been cited in
` different papers with respect to the motions
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` to correct, that it is acknowledged by both
` parties that this appears to be a typo.
` So the question for us is what is the
` broader implication on both the case,
` schedule, and on patent owner? At least
` those two. I don't mean to suggest there may
` not be others, but for us those were the two
` primary things.
` For the case, we're still early enough
` in the case that we did not feel there would
` be a potential prejudice to anybody just
` based on the timing of the case. That being
` said, there was an obvious issue with respect
` to the timing of patent owner's response in
` the 01675 case, and that's exactly the point
` that Mr. Chang just made with respect to the
` 00122 case, which is that there is no problem
` with timing because patent owner filed its
` preliminary response after having noticed
` that Mylan had a typo and sought correction.
` So we are going to grant the motion.
` Motion is granted.
` Second issue is how do we now
` accommodate patent owner filing a new
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` preliminary response in the 1675 case?
` So, Mr. Chang, what did you have in mind
` there?
` MR. CHANG: So our proposal there was
` simply that we would file an amended
` preliminary response with the amendments
` limited to addressing the impact of the new
` citation. Effectively, we would strip out
` the language that was in the already filed
` response where we had asserted that the
` citation didn't stand for what it was
` purported to stand for and insert our
` response to the new citation.
` The rest of the preliminary response
` would not be changed; and, if it would be,
` you know, helpful, we could submit as an
` exhibit with it a redline showing exactly
` what is changed. I imagine we can do that in
` fairly short order, potentially by the end of
` the week.
` JUDGE GERSTENBLITH: That was going to
` be my second question, which was the timing,
` understanding that Monday is a holiday. So
` I'm not looking to put added pressure on
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` anybody.
` So what do you think is reasonable for
` when you would have this filed?
` MR. CHANG: I think if we could get
` until Tuesday, so essentially three business
` days, I think we could definitely get it done
` in that time.
` JUDGE GERSTENBLITH: Does that mean that
` everybody's gonna be working on the holiday?
` MR. CHANG: No, I would --
` JUDGE GERSTENBLITH: Or should we make
` it the 20th?
` MR. CHANG: If the board is willing to
` accommodate the 20th, we'll take it. I think
` that should be plenty of time.
` JUDGE GERSTENBLITH: Okay. With the
` caveat then we're not looking to have
` everybody work on the holiday, right?
` MR. CHANG: Correct.
` JUDGE GERSTENBLITH: All right.
` Mr. Torczon, is there anything that
` petitioner would like to share with or
` questions about what we discussed with the
` motion to correct or any objection to patent
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` owner's proposal to file an amended
` preliminary response by February 20?
` MR. TORCZON: No, Your Honor. All
` along, our concern has mostly been about
` scope and clarity of the changes. I think
` the changes that they made in the 122 IPR,
` you know, satisfy our concerns about scope.
` So we're happy to proceed as you propose.
` JUDGE GERSTENBLITH: Okay. So let me
` make sure that there's no questions.
` Patent owner will file an amended
` preliminary response in the 01675 case by
` Wednesday, February 20.
` Any questions anymore about the motion
` to correct from petitioner?
` MR. TORCZON: No, Your Honor.
` JUDGE GERSTENBLITH: From patent owner?
` MR. CHANG: Just to clarify, does the
` board also want filed with the amended
` preliminary response the redline, or would
` the amended document itself be sufficient?
` JUDGE GERSTENBLITH: The amended
` document is sufficient.
` MR. CHANG: Thank you, Your Honor.
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` JUDGE GERSTENBLITH: Essentially --
` well, I can speak for myself, but my
` colleagues may be curious. When I review it
` all in detail, I won't even be looking at the
` one that was already filed.
` MR. CHANG: Yes, Your Honor. That's
` what we intended by proposing that we just
` file an amended document as well.
` JUDGE GERSTENBLITH: And I look at it --
` and maybe I'm incorrect, but I had to learn
` this kind of the hard way that, when there's
` something amended, it should supersede what
` was filed before; but, when there's a
` supplemental, it essentially adds rather than
` supersedes. But it's always good to clarify.
` I think I heard somebody ask a question.
` MR. TORCZON: This is Richard Torczon,
` Your Honor, from Mylan. I was going to
` propose -- it's fine that they put in the
` substitute response. I was wondering if it
` would be appropriate just to have them mark
` the changes, just so it's clear where the
` changes are, just because it will help us be
` sure we understand the scope of the change.
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` So underlining or highlighting or
` something like that.
` JUDGE GERSTENBLITH: Okay. Then so be
` it. So let's do this. You know, if we're
` gonna do that, I guess we need -- I guess we
` need an exhibit, you know, with the redline
` changes.
` Does that sound legitimate, Mr. Chang?
` MR. CHANG: Yes, we can do that.
` JUDGE GERSTENBLITH: Okay. But not as a
` paper. Just the paper -- just, you know, the
` amended document.
` MR. CHANG: Understood.
` JUDGE GERSTENBLITH: Okay. Any other
` questions about the motion to correct?
` MR. TORCZON: I have a question, Your
` Honor. This is Richard Torczon again.
` We simply filed an exhibit. Based on
` what you just said, I'm wondering if you
` wanted us to file a substitute petition. I
` don't think it's necessary, but to the extent
` the panel wants one, we're happy to do it.
` JUDGE GERSTENBLITH: So I think that the
` scope of the change is such that it's no
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` problem to leave it as is. My recollection
` was that, when we talked about the motion, we
` thought it was sufficient because it was just
` a line-cite change that it be sort of filed
` the way that you did, which I think -- I
` think it was just an exhibit to the motion.
` MR. TORCZON: Yes.
` JUDGE GERSTENBLITH: Is that right?
` MR. TORCZON: Yes, Your Honor.
` JUDGE GERSTENBLITH: I guess the panel
` would say that it's, you know, sort of
` petitioner's choice. I think we're fine the
` way it is. It will clearly be stated
` otherwise, and we've talked about it so much
` that I don't think somebody reviewing this
` would be confused based on the record we've
` set.
` But, if you want to discuss with your
` client and you decide that you would like to
` file a corrected petition, I think the panel
` would be okay with that.
` MR. TORCZON: Your Honor, Mylan is
` trying to keep these proceedings from getting
` overcomplicated. That's been our goal all
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` along. So if you were happy with the
` exhibit, we are happy to rest with the
` exhibit.
` JUDGE GERSTENBLITH: Okay. Sounds good.
` So let me -- I'm always hesitant to say it,
` but any other questions on the motion to
` correct?
` MR. CHANG: No, Your Honor.
` JUDGE GERSTENBLITH: Okay. Sounds good.
` So the second item that I have on my
` list is just following up on the housekeeping
` of the record. And I apologize. It sounded
` like there was some confusion just in the
` email, and that's completely my fault. I am
` talking about now two cases, IPR2018-01675
` and IPR2018-01680.
` On our last call we talked about 1675
` and specifically that there were -- or I
` should say are three different papers
` identified as the petition, and we asked that
` the petitioner let us know which one should
` be kept and which ones we don't need. We
` received your email which indicated in 1675
` that papers 3 and 4 are duplicates of paper 2
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` and that we could expunge papers 3 and 4.
` The question back was that, you know,
` whenever we're talking about something
` happening with the record in general or
` taking a certain action, we want both sides
` to speak on the issue.
` So we didn't mean to come across in an
` unusual way, but in any communication to us
` the ideal situation, unless there is some
` all-out emergency, is that one side sends an
` email to the other side, "Hey, we're gonna
` write to the board, and we're gonna say this.
` Do you want to add something?" And, if so,
` take what they're adding, and you guys agree.
` And then one person sends it, and you can
` have both sides' views, you know, direct
` copy-and-paste in the same email.
` So we don't have to have a
` back-and-forth between us and you, back and
` forth, who's ready at this time? And we
` don't have to receive multiple emails from
` everybody on the same point. That is all in
` one email. That satisfies the meet and
` confer requirement and also makes it easier
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` just from a keeping-things-together
` perspective.
` So I'm just going to ask patent owner,
` Mr. Chang or otherwise, does patent owner
` object to expunging papers 3 and 4 from Case
` 01675?
` MR. CHANG: We have no objection to
` that, Your Honor.
` JUDGE GERSTENBLITH: Okay. And does
` patent owner object -- so in the -- I
` apologize. I'm going to restart that second
` part, but the transcript keeps going. So I'm
` stuck.
` In 01680, we were told by petitioner
` that paper 3 is a duplicate of paper 2. And
` I'm just clicking over to that case, 1680.
` In that case we have two documents identified
` as the petition. So we said that we could
` expunge paper 3, the duplicate of paper 2.
` Mr. Chang, does patent owner object to
` that?
` MR. CHANG: Also no objection.
` JUDGE GERSTENBLITH: Okay. Mr. Torczon,
` is there anything else we should talk about
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` about expunging the papers, or are we good to
` proceed?
` MR. TORCZON: I think you're good to
` proceed, Your Honor.
` JUDGE GERSTENBLITH: Okay. Perfect.
` Now I have the third issue on the list
` for our discussion is -- and we got a
` second -- I believe two emails on this, the
` second one came in this morning. This is
` about Case IPR2019-00122. And specific to
` this case is the request by petitioner to
` file a reply to patent owner's preliminary
` response to respond to arguments made with
` respect to discretionary basis for denying
` institution under 314, which is similar to
` the issue that we already addressed in the
` four related cases where we authorized
` petitioner to file a 12-page reply and for
` patent owner to file a sur-reply, and it
` looks like we limited each sur-reply to five
` pages.
` Anything I said inaccurate about that,
` Mr. Torczon, so far?
` MR. TORCZON: So far, so good, Your
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` Honor.
` JUDGE GERSTENBLITH: Okay. Mr. Chang,
` anything I said that's inaccurate so far?
` MR. CHANG: Not so far, Your Honor.
` JUDGE GERSTENBLITH: Okay. I'm assuming
` that both sides got to discuss this. And I'm
` assuming there was a disagreement based on
` the emails. The disagreement was about the
` number of pages.
` So I looked at the situation. And what
` it looks like -- and I'm not here to make the
` arguments for you, but I hope we can narrow
` this a little. It looks like petitioner
` would like to have more pages, specifically,
` I guess, in discussions, asked about 24
` pages -- that's two, four -- because patent
` owner, in its preliminary response in the
` 00122 case, responded to arguments that
` petitioner made in its replies from, say, at
` least the 01675 case, which then resulted in
` patent owner's 314 arguments being
` substantially longer than those that were
` made in the other preliminary responses. And
` so petitioner would like to have more pages
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` because the argument spans more pages.
` And I understand from the emails today
` that patent owner would like to keep
` petitioner's reply to the same contours as
` what we had in the other four cases, which
` would be 12 pages.
` Mr. Torczon, what am I missing, if
` anything?
` MR. TORCZON: I think that's
` substantially right. I mean, I think we can
` get a little color to it. As you indicated,
` there seems to be sort of progressive
` briefing going on here, sort of an
` unfortunate consequence of the way the cases
` got docketed. These cases have been all
` spread out. And so, as Your Honor pointed
` out, Sanofi essentially has put in its
` sur-reply in its preliminary response.
` The problem from our perspective is not
` only did they essentially double the number
` of pages, there are new arguments, there are
` eight new exhibits. That seems to us to be a
` significant increase and expansion of what
` was previously presented.
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` So it's going to be hard to address all
` of that in the 12 pages. It seems to us
` that, given the doubling and the significant
` increase overall, a doubling of our pages
` would be appropriate. If not, if we're going
` to be kept to 12 or something approaching 12,
` I think there would be two consequences.
` One is, despite our efforts to try to
` maintain unity across the cases, we're going
` to have to slice and dice and compact stuff
` from the earlier replies in order to fit in
` the new argument.
` I also think it raises a question of
` whether a sur-reply is even appropriate at
` that point given that Sanofi will have
` already had a chance to put in a sur-reply.
` So I think that, because of the way the
` briefing has developed, it complicates the
` issues. But I think the -- because of that
` change, the original solution's no longer
` appropriate. We'd be happy to go with 24.
` If the panel wants a sur-reply, that's fine
` too.
` But if it's less than that, I really
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` think, one, the quality of the briefing will
` suffer; but, two, it raises a serious
` question about whether a sur-reply is
` appropriate.
` JUDGE GERSTENBLITH: Okay. Let me turn
` the floor to Mr. Chang if there's anything to
` add from patent owner's perspective.
` MR. CHANG: Yes, Your Honor. Thank you.
` I think, from our perspective, what was
` really happening here is that the petitioner
` is requesting the 12-page reply that they've
` gotten in the other proceedings and what is
` effectively a 12-page sur-reply, as Your
` Honor pointed out, to respond to our
` responses to the arguments that we were on
` notice of at the time that we filed this
` preliminary response.
` And that's really why we put in the
` increased -- the additional arguments that
` increased pages, because we understand that
` the normal practice before the board is that
` the parties should use their principal paper
` to address, you know, any potential
` counterarguments of which they had notice.
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` So, in this particular instance, because
` of the circumstances, granting the petitioner
` twice as many pages for reply would
` essentially be giving them a response to the
` sur-reply arguments as opposed to just
` providing them the reply that they had in the
` other proceeding.
` And I think it's also worth pointing out
` that there are still four additional
` proceedings between these parties in which
` patent owner preliminary responses have not
` been filed yet. So if petitioner gets the
` 24-page reply that they're seeking now, then
` that's going to put us on notice of
` additional arguments that we'll have to
` address in our next preliminary response
` which -- you know, that would just increase
` the pages more and potentially result in us
` winding up back here a couple weeks down the
` road talking about whether the petitioner
` should get a 30-page reply.
` So I think our proposal is that we
` should keep the replies and sur-replies
` within the same contours as has already been
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` granted since we need to keep the -- to
` prevent the briefing schedule in these
` proceedings from spiraling out of control.
` MR. TORCZON: Your Honor, if I may?
` Your Honor, may Mylan reply?
` JUDGE MAYBERRY: This is Judge Mayberry.
` We're having a slight technical problem. If
` you'll bear with us for a moment, we'll be
` right back on.
` MR. TORCZON: Will do, Your Honor.
` JUDGE GERSTENBLITH: Hi, everyone.
` Apologies. Can anybody hear me?
` MR. TORCZON: Yes, Your Honor. This is
` Richard Torczon from Mylan. We can hear you.
` JUDGE GERSTENBLITH: Sorry about that.
` This is Judge Gerstenblith. My phone
` literally died, Mr. Chang, in the middle of
` what you were saying about 35 seconds ago.
` Let me just tell you the last thing I heard,
` and I apologize for asking you to repeat
` yourself.
` MR. CHANG: No problem.
` JUDGE GERSTENBLITH: What I heard was
` that there were four -- and maybe this is
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` just for elaboration also -- that there are
` four other cases that we haven't even been
` talking about so far today, to my
` understanding, that are in a similar
` situation as 00122; meaning, patent owner has
` not yet filed a preliminary response,
` although, in 00122, patent owner has just
` literally -- I believe it was two days ago,
` if I'm right.
` MR. CHANG: Yes.
` JUDGE GERSTENBLITH: Can you continue
` from that point -- I apologize -- with the
` general idea of what you were saying.
` MR. CHANG: Yes, Your Honor.
` The idea there is that, you know, I
` think we have preliminary responses due in
` those other four proceedings, you know,
` several weeks to a month from now. And if
` we're in a situation here where the
` petitioner is now going to get a 24-page
` reply brief to introduce arguments that are
` responsive to what was in the 00122
` preliminary response, you know, that is, in
` turn, going to put us on notice of additional
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` arguments that we will need to address in
` those subsequent preliminary responses, which
` will further increase the number of pages
` that we devote to this issue.
` And our concern is just that, if that
` happens, that we're just going to end up back
` here on the phone with the board down the
` road discussing whether authorization is
` appropriate for a 30-page reply or a 36-page
` reply. And, you know, to head that off, we
` think that the 12-page reply and 5-page
` sur-reply that were authorized in the other
` proceedings is the appropriate scope of the
` briefing and that sticking to those contours
` will prevent the briefing in the subsequent
` matters from getting out of hand.
` JUDGE GERSTENBLITH: So let me just tell
` you that this is a very interesting issue
` from a scheduling perspective as well as a
` legal perspective of sorts, the obvious
` scheduling problem being that these cases are
` very staggered. The legal perspective
` being -- you know, I'm not going to sit here
` and pick, you know, which came first, so to
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` speak, the chicken or the egg.
` In other words, you have additional
` information. Should you or should you not
` include it in a paper or not? I'm certainly
` not going to say one way or the other right
` now.
` I will point out an obvious -- excuse
` the pun in patent law -- but an obvious --
` the obvious reason that we are in this spot
` right now -- and, again, I'm not looking to
` say -- to point fingers as to whether it's
` right or wrong -- just a point of fact is
` that, in the 00122 case, patent owner has
` made different arguments than what was on
` that issue in the other cases.
` So what patent owner is asking us is to
` tell petitioner, hey, I know patent owner
` made a bunch more arguments, but you know
` what? You're not allowed to talk about them
` until, you know, I don't know when -- when,
` if ever. And you can't talk about them,
` petitioner, because we didn't talk about them
` in the other cases.
` They didn't have a brief, right?
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` So we're in this spot because there's
` something different. So the question is, do
` we allow and accommodate for that difference
` and what ramifications it has? Or do we try
` to go back to a point where there isn't a
` difference and go from there?
` So we want to be very mindful of
` fairness to everybody, right? But also
` understand that th