Conference Call - March 4, 2020
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` UNITED STATES PATENT AND TRADEMARK OFFICE
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` __________________________
`
` MYLAN PHARMACEUTICALS, )
`
` INC., )
`
` Petitioner, )
`
` ) U.S. Patent No.
`
` vs. ) 7,326,708
`
` MERCK SHARP & DOHME )
`
` CORPORATION, )
`
` Patent Owner. )
`
`___________________________)
`
` REPORT OF PROCEEDINGS via teleconference of
`
` the above-entitled cause before the Honorable
`
` Timothy G. Majors, Robert A. Pollock and Sheridan K.
`
` Snedden, Judges of said Panel, on the 4th day of
`
` March 2020 at the hour of 2:00 p.m.
`
` Reporter by: Sandra Rocca
`
` Certification No. 084-003435
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Mylan (IPR2020-00040) Ex. 1017, p. 001
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`
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` UNITED STATES PATENT AND TRADEMARK OFFICE
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` __________________________
`
` MYLAN PHARMACEUTICALS, )
`
` INC., )
`
` Petitioner, )
`
` ) U.S. Patent No.
`
` vs. ) 7,326,708
`
` MERCK SHARP & DOHME )
`
` CORPORATION, )
`
` Patent Owner. )
`
`___________________________)
`
` REPORT OF PROCEEDINGS via teleconference of
`
` the above-entitled cause before the Honorable
`
` Timothy G. Majors, Robert A. Pollock and Sheridan K.
`
` Snedden, Judges of said Panel, on the 4th day of
`
` March 2020 at the hour of 2:00 p.m.
`
` Reporter by: Sandra Rocca
`
` Certification No. 084-003435
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Mylan (IPR2020-00040) Ex. 1017, p. 001
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`Conference Call - March 4, 2020
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`Page 2
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` A P P E A R A N C E S:
`
` KATTEN MUCHIN ROSENMAN, LLP
` By: MR. JITENDRA MALIK
` MS. ALISSA PACCHIOLI
` 550 South Tryon Street, Suite 2900
` Charlotte, North Carolina 28202
`
` appeared on behalf of the
` Petitioner;
`
` WILLIAMS & CONNOLLY, LLP
` By: MR. ANTHONY SHEH
` MR. BRUCE GENDERSON
` 725 12th Street, NW
` Washington, D.C. 20005-5901
`
` appeared on behalf of the
` Patent Owner.
`
` (All parties appeared via teleconference.)
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Mylan (IPR2020-00040) Ex. 1017, p. 002
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`
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`Conference Call - March 4, 2020
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` JUDGE MAJORS: Why don't we kick things off.
`
` Again this is Judge Majors talking. We're here
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` today for a request for a conference in IPR2020 0040
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` based on Petitioner's request for additional
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` pre-institution briefing.
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` We've reviewed the email correspondence.
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` The way we'll quick things off today is we'll open
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` the floor up to Petitioner. Petitioner, you can
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` state the reasons for the request. To the extent
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` they go beyond the email, that's fine. Patent
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` Owner, then we'll open up the floor to you to
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` respond, and we can then table whether or not there
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` will be any opportunity for further reply if
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` necessary. But we may also jump if in if we have
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` questions along the way.
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` Before we get going, just a couple of
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` preliminary things. Is there a court reporter
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` online?
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` CERTIFIED STENOGRAPHER: Yes, there is. I'm
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` here.
`
` JUDGE MAJORS: Thank you. All right. And
`
` why don't we go ahead and take a quick role call,
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` and whoever is going to be doing the talking for the
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` particular party, just let me know that. That would
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` be helpful. Why don't we start with Petitioner.
`
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`
`Mylan (IPR2020-00040) Ex. 1017, p. 003
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`Conference Call - March 4, 2020
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` Counsel, who do we have online?
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` MR. MALIK: Good afternoon, Your Honor.
`
` This is Jitendra Malik, lead counsel for Mylan. And
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` with me is Alissa Pacchioli, backup counsel for
`
` Mylan.
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` JUDGE MAJORS: Okay, thank you. Did you
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` say, Mr. Malik? Is that how it's pronounced?
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` MR. MALIK: Yes, sir.
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` JUDGE MAJORS: Thank you. For Patent Owner?
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` MR. GENDERSON: Good afternoon, this is Tony
`
` Sheh from Williams & Connelly on behalf of Patent
`
` Owner. I'm joined by Bruce Genderson, also Williams
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` Connelly on behalf of Patent Owner.
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` JUDGE MAJORS: Okay. And thank you,
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` Mr. Sheh and Genderson. All right, so with that,
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` why don't we kick things off. Again, we'll open the
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` floor up to Petitioner, Mr. Malik, I assume you'll
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` be doing the talking. And with that, you can go
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` ahead and begin when you're ready.
`
` MR. MALIK: Good afternoon, Your Honor.
`
` Jitendra Malik, counsel for Mylan. I guess the
`
` easiest way is to kind of break this up into smaller
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` pieces. I think the first part is the five-page
`
` reply dealing just with the antedating evidence. I
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` don't think there seems to be much of a dispute
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`GregoryEdwards, LLC | Worldwide Court Reporting
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`
`Mylan (IPR2020-00040) Ex. 1017, p. 004
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`Conference Call - March 4, 2020
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` between the parties as to whether or not that
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` information in the POPR was foreseeable. So unless
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` the panel has specific questions, I can move on to I
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` guess the crux of the dispute which would be the
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` 314, 325(d) related issues and whether that's
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` permitted and then also, I'll address the
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` Petitioner's opposition to the surreply.
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` JUDGE MAJORS: Sure, that's fine. If you
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` wouldn't mind, could just say for us what -- at
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` least from Petitioner's perspective, what the
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` antedation -- is this just a sort of prototypical,
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` we've reduced to practice the invention before such
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` and such prior art.
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` MR. MALIK: Yes. The prior art is WO 0 --
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` forgive me, I don't have the number off the top of
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` my head. But yes, they believe that they reduced --
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` the actual reduction to practice prior to the date
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` of -- one or two a date of the WO reference that we
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` use in several of our grounds.
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` JUDGE MAJORS: Okay. And they have several
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` declarations I think you said in the email in
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` support of that.
`
` MR. MALIK: Yes. Several declarations and I
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` think they attached some lab notes and various other
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` I guess experimental data or production that they
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`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Mylan (IPR2020-00040) Ex. 1017, p. 005
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`Conference Call - March 4, 2020
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` had. So that's the nature of their evidence and
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` that's what we've asked that at least five pages to
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` respond and there doesn't seem to be much of a
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` dispute between the parties on that issue.
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` JUDGE MAJORS: Why don't you then go ahead
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` and move on to the discretionary issues.
`
` MR. MALIK: Sure. So I think the biggest
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` part that we really wanted to focus on is the 314(a)
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` and 325(d). We provided two cases, IPR2019 400, and
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` IRP2019 207 where the those panels granted ten pages
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` to respond where a Patent Owner put up 314 and
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` 325(d) arguments. And then if you go through and
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` continue, you'll see that the panels allowed for a
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` five-page surreply in response to Petitioner's 314
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` and 325(d) issues.
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` So you know, this is something that is not
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` an unusual request. Frankly, you know, from our
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` perspective, the request should have been
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` foreseeable when they put in significant 314 and
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` 325(d) arguments. I think that what they're
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` essentially saying -- and obviously they will
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` correct me if I'm wrong -- that in essence, the 314
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` and 325(d) arguments were foreseeable and everything
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` that we put in our opening petition should have
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` safely addressed it.
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`
`Mylan (IPR2020-00040) Ex. 1017, p. 006
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`Conference Call - March 4, 2020
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` And they cite two cases which I do briefly
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` want to discuss with the Panel. I think the first
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` one is the Instrumentation Lab, which is IPR2018
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` 264. And I've taken a look at that case and what
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` the case -- basically my reading of it essentially
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` says that, look, the PTAB designates certain things
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` precedential and informative. It's on the website.
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` We petitioners, are obligated to address those
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` things, precedential and the informative case.
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` Obviously in the context of the case that they
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` attached, it was just in the general practice
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` factors, you know, which basically we have done.
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` And so what -- how I read that case is if
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` something is designated precedential and you don't
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` talk about it in your opening petition, well, you've
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` kind of lost your opportunity. I'll point out that
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` in our petition, we addressed all of the
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` precedential authority. I mean, Becton Dickinson is
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` there on page 66. Then we talk about the Valve
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` Corporation case, that's on page 67; NHK Spring Co.
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` is addressed.
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` So to the extent that particular order
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` focuses on, yes, we're on notice of precedential
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` authority, we're obligated to deal with it in our
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` petition, well, we've done that. That's a narrow
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`
`Mylan (IPR2020-00040) Ex. 1017, p. 007
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`
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`Conference Call - March 4, 2020
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` proposition, at least as we read it.
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` The other case, the Mylan case -- and just
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` for the record, even though it's the same Mylan
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` entity, I was not counsel of record in the IPR they
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` cite. A couple points. First, that case was pre
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` SAP. SAP was decided April of 2018. The Order that
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` they cite is from 2017. Whether that decision would
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` be the same post SAP -- and as Your Honors are aware
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` SAP removed certain discretions from Panels -- 314
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` and 325 took on a whole new emphasis after SAP. So
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` whether that Mylan case in 2015 would have gone the
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` same way, that's an open question.
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` But I also took a look at that case and what
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` was going on. Basically the Petitioner in that case
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` wanted to essentially elaborate or expand on things
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` that were already addressed in the petition. And so
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` what the Panel said -- I'm reading from the Order --
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` "The Board may authorize a reply to afford a
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` Petitioner an opportunity to address evidence or
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` argument that could not have been foreseeable. A
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` reply, however, is not an opportunity to revisit or
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` elaborate on previously raised arguments."
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` I don't intend to revisit or elaborate the
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` previously discussed arguments. I intend to
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` respond, you know, consistent with what happened in
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`
`Mylan (IPR2020-00040) Ex. 1017, p. 008
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`Conference Call - March 4, 2020
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` the two IPR cases that I cited. Frankly, I'm very
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` tight on space. I have 15 pages. I don't have the
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` luxury of wasting space restating what I've already
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` stated. I mean in some cases, these are exact
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` quotes from the PTAB about the fact that you
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` consistently decline 325(d), that the only thing you
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` can do is cite to the fact that this is previously
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` cited to the examiner.
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` I'm not really going to revisit or
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` elaborate. I'm actually going to respond directly.
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` With 15 pages, I really can't waste space, so I
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` can't really go -- you know, say too many things.
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` The other point to make out there is, look,
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` you're judges. To the extent that I go beyond the
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` scope of any Order, you're well within your right
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` just to ignore it. So the concern of us rehashing
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` isn't quite as I think a concern because you will
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` just simply ignore it.
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` So then I guess with the five-page surreply,
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` what I'm struggling with is that if they're saying
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` that everything on 325 and 314 were foreseeable,
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` then that same argument would apply to their request
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` for a surreply because then everything with respect
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` to any evidence for five pages -- for the five-page
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` surreply would have also been foreseeable.
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`
`Mylan (IPR2020-00040) Ex. 1017, p. 009
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`Conference Call - March 4, 2020
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` I'm struggling to see how they can reconcile
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` opposing our request for a 314, 325(d) briefing
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` while at the same time making the request for the
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` five-page surreply.
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` JUDGE MAJORS: Okay. Mr. Sheh, would you
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` like to respond?
`
` MR. SHEH: Yes, thank you, Your Honor. This
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` is again Tony Sheh on behalf of Patent Owner Merck.
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` As Mr. Malik noted, there's not a lot of dispute
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` between the parties on the issue of a five-page
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` reply to the antedation evidence. But as I heard
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` Mr. Malik go forth, it also doesn't appear that
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` Petitioner's requesting sort of a free-wheeling 15
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` pages on all issues including the merits of
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` patentability. And I don't hear him requesting a
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` reply -- any space in the reply to address, for
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` instance, whether or not Mylan sufficiently
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` addressed a key claim limitation, which is the 1:1
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` stoichiometry of the claim itself.
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` So I'm going to presume that the -- that
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` that is not part of their request, but we can
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` revisit that I suppose in further questioning with
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` the Board. Obviously we would oppose that request.
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` So I think counsel also examined the cases
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` that had been cited in the email to the Board. And
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`
`Mylan (IPR2020-00040) Ex. 1017, p. 010
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`Conference Call - March 4, 2020
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` I just want to note that, you know, the notion that
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` the fact that Mylan has enough space to address the
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` fact of these precedential decisions in its
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` petition, there's been sort of cited as the reason
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` as what Mylan was supposed to do. I mean, those
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` decisions elucidates the factors, and indeed,
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` addressing all those factors is exactly what Merck
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` did and that's exactly what Mylan could have also
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` done. Those factors are not, you know, a secret.
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` And instead, it didn't. It sort of gave sort of a
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` little bit of case law as Mr. Malik alluded to, but
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` at the end of the day it did not address all factors
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` and it has space to do so in its petition.
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` So it's a bit odd to me for Mr. Malik to
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` acknowledge that they had the space but didn't use
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` it to address factors that were known to them.
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` Again, like and I think counsel conceded that all
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` the facts are being raised in Merck's POPR on issue
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` of discretion, they're equally available to both
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` parties. And so I don't understand how it is that
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` Mylan should be given a reply on those issues which
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` could have and should have been addressed in the
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` petition.
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` That and the cases that have been cited, the
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` HemoSonics case and the Mylan versus Sanofi case,
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`
`Mylan (IPR2020-00040) Ex. 1017, p. 011
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`Conference Call - March 4, 2020
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` stand for the proposition that where these arguments
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` can be and should be raised in a petition, they
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` should be raised in a petition in the first
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` instance.
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` And I'll also note that the two cases they
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` have cited, which are the Amneal versus Almirall
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` case and the -- I'm sorry -- the Apotex v UCB case,
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` I mean, in those cases the Board still addressed
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` whether or not there was good cause for reply. And
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` in the Almirall case, basically said that well,
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` these arguments weren't reasonably foreseeable. We
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` accept that and we accept that as good cause.
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` And in the Apotex case, I mean, the Board
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` observed that those discretionary arguments turned
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` on facts arising after the filing of the petition.
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` So good cause is there obviously because the
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` Petitioner could not have sort of much anticipated
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` developments after the fact. So I don't see those
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` cases as justifying sort of, you know, a reply just
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` cause a Petitioner wants to say a bit more about
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` discretion.
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` And the last thing I'll touch on is on the
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` surreply. You know, so the issue with the surreply
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` is again, it's a little bit of a practical issue for
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` the Board because it's taken about two weeks for the
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Mylan (IPR2020-00040) Ex. 1017, p. 012
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`
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`Conference Call - March 4, 2020
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`Page 13
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` parties to join issue now and the parties are
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` basically asking for two weeks and two weeks. So an
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` institution is -- on the usual timetable is in May.
`
` So we're just taking away from sort of this
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` expedited timetable.
`
` But the other issue is he said that you
`
` can't reconcile -- I think counsel said that he
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` can't reconcile why it is that the same logic of
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` good cause doesn't apply to a surreply. First, I'll
`
` just note that the cases that we cited, the --
`
` apologies -- Mylan has cited the Board has granted
`
` five pages and five pages on the issue of
`
` antedation, like five pages of reply, five pages of
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` surreply, found good cause in the same moment in
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` time. And you know, like in terms of why it is that
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` we get a surreply, I think the statute is clear.
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` The decision of institution is based on information
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` in the petition and then any reply -- any response
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` by the Patent Owner, not whatever the parties can
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` spin up in after-the-fact briefing. Those are the
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` two main documents on which the institution is
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` based.
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` And indeed, the Board's own rule, this is
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` 42.108 Subsection C, says it is good cause for this
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` precise reason. If the Board is going to allow
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`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Mylan (IPR2020-00040) Ex. 1017, p. 013
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`
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`Conference Call - March 4, 2020
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`Page 14
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` reply briefing, that's the standard that has to be
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` met, not just because it would be helpful. It would
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` always be helpful to have more briefing, I
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` understand that, but we could go around and around
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` in circles until the parties are both blue in the
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` face. So with that said, I think I'll rest my case
`
` there for now. Thank you, Your Honor.
`
` JUDGE MAJORS: Okay. Thank you, Mr. Sheh.
`
` MR. MALIK: Your Honor, may I respond just
`
` briefly?
`
` JUDGE MAJORS: Sure, briefly.
`
` MR. MALIK: So regarding the anticipation
`
` discussion, obviously with respect to the page
`
` limits that I was explaining where we got the 5 and
`
` the 15, what I would suggest is the same thing that
`
` if the court is so inclined to do what the Apotex
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` Panel did, where at the very end they pointed out --
`
` they said you're free to address the issues again
`
` for 15 pages. There's not that much I can say. But
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` if there's a specific thing that they want to deal
`
` with, obviously that's fine, you can point out, as
`
` that Panel did. They were particularly interested
`
` in 325(d) as opposed to the 314(a) issue. Now --
`
` JUDGE MAJORS: Let me just jump in for a
`
` second on that just to be abundantly clear. What I
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Mylan (IPR2020-00040) Ex. 1017, p. 014
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`
`
`Conference Call - March 4, 2020
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`Page 15
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` understood Mr. Sheh to be saying is that whatever
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` the response, assuming the Board may allow one --
`
` I'm not saying yet whether we will -- but it's not
`
` going to be open-ended from the standpoint of you
`
` get 15 pages and you get to address whatever you
`
` choose that was brought up in the POPR. It would be
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` limited to the antedation issue, the 325(d) issue,
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` as well as the 314 discretionary issue. It's not an
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` opportunity to come in and say, well, here's --
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` here's what we think are the flaws in the POPR's
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` rebuttal as to, you know, the merits of the 102.
`
` MR. MALIK: I guess with respect to that,
`
` that's really up to the Panel as far as their
`
` discretion. We will address any and all issues that
`
` you so authorize.
`
` What our original request was to be able to
`
` use the 15 pages as we saw fit and I was more
`
` explaining in the email how we got to the 15 pages,
`
` but obviously, the scope of any surreply is
`
` completely up to you. And we will of course, you
`
` know, limit our scope to whatever the Panel decides.
`
` So with respect to the Apotex case, I think
`
` counselor Sheh said certain things about things that
`
` occurred after trial. Just in the interest of full
`
` disclosure, I am lead counsel on the Apotex case.
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Mylan (IPR2020-00040) Ex. 1017, p. 015
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`
`
`Conference Call - March 4, 2020
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`Page 16
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` What happened there was they raised 325(d)
`
` issues in connection with whether or not the
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` arguments raised in the petition were duplicative of
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` file history. And the 314(a) issue that he was
`
` referring to was the fact that there were certain --
`
` I believe there was a stay that was occurring after
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` the fact. If you take a look at Orders, the Panel
`
` was not interested in 314(a) issues because the
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` District Court stayed the matter and they wanted a
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` discussion on 325(d). And so if you look at the
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` subsequent reply, 325(d), which had to do with
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` events that occurred in the file history as opposed
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` to -- which was basically how similar the -- what
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` Apotex's petition was to the arguments that were
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` raised. So it didn't have anything to do with
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` subsequent events, though I will acknowledge that
`
` there's half a paragraph at the very end of a
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` ten-page reply on 314(a). The other case we were
`
` not involved with or I was not.
`
` JUDGE MAJORS: I guess -- Mr. Malik, I'm
`
` sorry to interrupt you, but I have a question. I'm
`
` just trying to get a sense of -- it seems like
`
` there's agreement or at least no disagreement on the
`
` antedating piece.
`
` On the 325(d) and 314, now, I hear you. You
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Mylan (IPR2020-00040) Ex. 1017, p. 016
`
`
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`Conference Call - March 4, 2020
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`Page 17
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` say that Petitioner wants an opportunity to respond.
`
` But in just looking through the papers -- and I will
`
` confess, I haven't studied them in great depth just
`
` yet -- but I'm sort of looking at the 325(d) issue
`
` and as I gather it, the issue is the extent to which
`
` the WO '498 reference was already presented to or at
`
` least before the Office previously, and I guess
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` perhaps another patent was as well. And it seemed
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` like that in the petition itself, there's a
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` discussion around this reference having been, you
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` know, before the examiner and I guess it's also
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` cited in the specification, and that's addressed
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` perhaps not in excruciating detail, but it's
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` addressed in the petition where it says the Board
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` routinely does not exercise discretion under 325(d)
`
` when it's just something that was presented to the
`
` examiner but wasn't substantively argued about it.
`
` I'm characterizing the argument.
`
` The Patent Owner says, well, this is a
`
` little bit different because it wasn't just part of
`
` an IDS. It was part of a very short list, if you
`
` will, of references that were cited, and by the way,
`
` to the extent that it wasn't just mentioned in
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` passing in the specification, it was also described
`
` in some detail about I guess what the active agent
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Mylan (IPR2020-00040) Ex. 1017, p. 017
`
`
`
`Conference Call - March 4, 2020
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`Page 18
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` is for these claims and the salt of the active. So
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` kind of they would say whatever, you know, the
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` examiner needed was sort of put right there in front
`
` of them.
`
` So anyway, that's a long-winded way of kind
`
` of circling back to, doesn't that already join the
`
` issue? What more do we need to hear from the
`
` parties on this point?
`
` MR. MALIK: I guess, you know, there is a
`
` CFR provision with respect to -- I notice if you
`
` look at their response -- and obviously I would
`
` confess though I have not written my response, so
`
` I'm just kind of responding to my preliminary
`
` thoughts. There is a -- they spent a fair amount of
`
` time talking about Patent Office procedure, the
`
` examiner's presumed to have reviewed -- or you know,
`
` there is -- obviously everyone on this call is a
`
` lawyer. We're all legal experts. There is a CFR
`
` provision directed to experts which basically says
`
` -- and I grant you it's in the form of experts --
`
` that expert testimony in the form of Patent Office
`
` procedure is not admissible.
`
` So certainly I think, you know, we want to
`
` make some points that to the extent they're saying
`
` the examiners could have considered or did consider
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Mylan (IPR2020-00040) Ex. 1017, p. 018
`
`
`
`Conference Call - March 4, 2020
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`Page 19
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` or do that, that really does go into Patent Office
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` procedure which a large part, according to the CFR
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` provision, is not admissible. Now, I grant you it
`
` is in the terms of experts, but I would argue that
`
` where a lawyer is talking about Patent Office
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` procedures, it kind of reminds me of old inequitable
`
` conduct experts that we saw pre (inaudible) where
`
` they got on the stand and basically said, this is
`
` how the Patent Office does things.
`
` So I guess if that's your concern, Your
`
` Honor, you know, one solution would be simply to
`
` reduce the allocated page length for the -- for
`
` those issues and that -- I mean again, it will force
`
` me to be even more concise. And as I said, to the
`
` extent it is rehashing arguments over, you can
`
` simply ignore it. So that would be some of the
`
` points that I would raise.
`
` In connection with 314, obviously we've
`
` addressed the fact that it's not a follow-on
`
` petition. I'm not going to say that again. We've
`
` addressed the fact that trial -- the District Court
`
` is in the infancy, but they do cite the E1 case.
`
` The E1 case focused on institution if I recall
`
` versus the actual trial date, just point out the
`
` difference.
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Mylan (IPR2020-00040) Ex. 1017, p. 019
`
`
`
`Conference Call - March 4, 2020
`
`Page 20
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` And then I am not aware of any precedential
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` or informative decision besides just being a member
`
` of joint defense group in a litigation and that in
`
` and of itself prevents an IPR from being instituted
`
` under 314, and so certainly given the opportunity to
`
` cite some cases for the Board, assuming they exist
`
` or at least respond with respect to that issue.
`
` And as I said with respect to anticipation,
`
` that is more up to the Board as to whether or not
`
` they want to allow us to discuss it. If the Board
`
` wants us to focus on one issues or a set of issues,
`
` if they don't want to hear anything more on 325(d)
`
` but only 314 antedations, we are willing to respond
`
` however the Board would like us to respond, if the
`
` Board is so inclined to do so.
`
` JUDGE MAJORS: Mr. Sheh, is that you?
`
` MR. SHEH: I apologize for interrupting
`
` counsel. I just wanted to sort of see if the Panel
`
` would be willing to hear our response to that.
`
` JUDGE MAJORS: For maybe a minute and then
`
` what we're going to do is I'll put everyone on hold,
`
` confer with my co-panelists behind the scenes and
`
` then we'll jump back on. With that Mr. Sheh, you
`
` can respond briefly.
`
` MR. SHEH: Understood. I will keep it very
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Mylan (IPR2020-00040) Ex. 1017, p. 020
`
`
`
`Conference Call - March 4, 2020
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`Page 21
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` short, Your Honor. There's a case Xactware versus
`
` Spectrometry [phonetic], the sort of buttressing of
`
` arguments, identification of missing or misstated
`
` law or facts. Those are all within the Board's
`
` purview to assess in the first instance. And you
`
` know, it's not good cause under 42.108(c).
`
` I think Mr. Malik mentioned the notion of
`
` expert testimony on Patent Office procedures. We
`
` didn't file an expert dec on this issue. I don't
`
` know that -- I think counsel may have given away the
`
` house on that, but you know, that's just not in
`
` play. And I think counsel also alluded to the fact
`
` that the Board can ignore or reduce the page
`
` estimates.
`
` I think the other relevant consideration is
`
` that the Patent Owner is going to have to respond to
`
` all the arguments and we will be not ignoring and we
`
` will be not be sort of reducing the amount of work
`
` that is incurred on our end pre-institution. So
`
` I'll leave it there. Thank you, Your Honor.
`
` JUDGE MAJORS: Okay. Thank you. As I said,
`
` I'm going to put everyone on hold. We'll try to be
`
` brief. But just be patient, if you would, and we'll
`
` jump back on as soon as we can.
`
` MR. SHEH: Thank you, Your Honor.
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Mylan (IPR2020-00040) Ex. 1017, p. 021
`
`
`
`Conference Call - March 4, 2020
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`Page 22
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` (Conference call place on hold.)
`
` JUDGE MAJORS: Okay, thank you for your
`
` patience. Your Panel's back. We've discussed
`
` amongst ourselves and our decision is as follows:
`
` Each side will be permitted eight pages. They will
`
` be permitted to -- starting with Petitioner, to
`
` address the three issues, the three is the
`
` antedation issue, 314(a) discretion, and 325(d)
`
` discretion.
`
` You can apportion among those pages as you
`
` see fit. However, I would note that, as you're
`
` probably aware, it's often the case -- I won't say
`
` it's universally so -- but it's often the case that
`
` with antedation evidence, it's very difficult for
`
` the Board to deny on that basis at institution
`
` because at that point, it's usually evidence that
`
` has not been tested and for which Petitioner has not
`
` had an opportunity to test it.
`
` So that being said, you may decide you want
`
` to focus your eight pages somewhat more on the other
`
` issues, if you want. However, as I said earlier,
`
` they're yours to use as you see fit.
`
` A few other provisos. No other issues
`
` beyond those three are going to be permitted. And
`
` in addition, no new evidence is going to be
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Mylan (IPR2020-00040) Ex. 1017, p. 022
`
`
`
`Conference Call - March 4, 2020
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`Page 23
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` submitted in either of the papers. As far as timing
`
` is concerned, as someone pointed out -- and I don't
`
` recall which of you it was -- but if we let this go
`
` a month from now, that that puts us into April and
`
` starts to get close to the institution date.
`
` Therefore, Petitioner's paper is going to be
`
` due next week -- and I'll allow you to respond to
`
` this in a second if there's some reason you can't do
`
` it -- but next week on the 11th of March, and Patent
`
` Owner's response to that would be due on the 18th of
`
` March. With all that being said, any questions from
`
` either Petitioner's counsel or Patent Owner's
`
` counsel?
`
` MR. MALIK: So Your Honor, just a couple
`
` points. On March 11th, I have a hearing in the
`
` District of Vermont in another matter so that -- if
`
` we could -- if I could get to the 13th, I would --
`
` if the Panel is so inclined, I would appreciate a
`
` two-day extension in light of the Vermont hearing on
`
` the 11th.
`
` And then one other request, and
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