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` UNITED STATES PATENT AND TRADEMARK OFFICE
`
` ________________________
`
`
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
` TRANSCRIPT OF PROCEEDINGS
`
` Before the Honorable Christopher L.
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`Crumbley, the Honorable Lora M. Green, and the
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`Honorable Robert A. Pollock, Administrative Patent
`
`Judges, via conference call, on the 1st day of
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`June, 2016; commencing at 4:00 p.m., the following
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`cases were called:
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` PAR PHARMACEUTICAL, INC.
`
` Petitioner
`
` v.
`
` NOVARTIS AG
`
` Patent Owner
`
` _________________________
`
`
`
` Case IRP2016-00084
`
` U.S. Patent No. 5,665,772
`
` _________________________
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`
`
`Job No.: 113636
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`Pages 1 - 38
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`Reported by: Kimberly Anne Votta, RPR
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`Ex. 1031-0001
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` PAR PHARMACEUTICAL, INC.
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` Petitioner
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` v.
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` NOVARTIS AG
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` Patent Owner
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` _________________________
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`
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` CASE IRP2016-01059
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` U.S. Patent No. 5,665,772
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` _________________________
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`
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` BRECKENRIDGE PHARMACEUTICAL, INC.
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` Petitioner,
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` v.
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` NOVARTIS AG.
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` Patent Owner
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` _________________________
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`14
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` CASE IRP2016-01023
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` U.S. Patent No. 5,665,772
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`Ex. 1031-0002
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`Conference Call
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` BRECKENRIDGE PHARMACEUTICAL, INC.
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` Petitioner,
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` v.
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` NOVARTIS AG
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` Patent Owner
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` _________________________
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`
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` CASE NO. TO BE ASSIGNED
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` U.S. Patent No. 5,665,772
`
` _________________________
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`
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` ROXANE LABORATORIES, INC.
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` Petitioner
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` v.
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` NOVARTIS AG
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` Patent Owner
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` _________________________
`
`
`
` CASE NO. TO BE ASSIGNED
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` U.S. Patent No. 5,665,772
`
` _________________________
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`Ex. 1031-0003
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`Conference Call
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`4
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` A P P E A R A N C E S
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` (Via Telephone)
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` For the Petitioner Par Pharmaceutical, Inc.:
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` JONATHAN M. STRANG, ESQUIRE
`
` MARC ZUBICK, ESQUIRE
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` Latham & Watkins, LLP
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` 555 Eleventh Street, NW
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` Suite 1000
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` Washington, DC 20004-1304
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` (202) 637-2200
`
` For the Petitioner Breckenridge
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` Pharmaceutical, Inc.:
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` MATTHEW L. FEDOWITZ, ESQUIRE
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` MARY BRAM, ESQUIRE
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` ALIREZA BEHROOZ, ESQUIRE
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` Merchant & Gould, P.C.
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` 1900 Duke Street, Suite 600
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` Alexandria, VA 22314
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` (703) 684-2500
`
` For the Petitioner Roxane Laboratories, Inc.:
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` KEITH A. ZULLOW, ESQUIRE
`
` Goodwin Procter, LLP
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` The New York Times Building
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` 620 Eighth Avenue
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` New York, NY 10018
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` (212) 813-8800
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`Ex. 1031-0004
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`Conference Call
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` A P P E A R A N C E S cont.
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` (Via Telephone)
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`5
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` For the Patent Owner Novartis:
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` NICHOLAS N. KALLAS, ESQUIRE
`
` RAYMOND R. MANDRA, ESQUIRE
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` Fitzpatrick, Cella, Harper & Scinto
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` 1290 Avenue of the Americas
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` New York, NY 10104
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` (212) 218-2100
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`Ex. 1031-0005
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`Conference Call
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` P R O C E E D I N G S
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` JUDGE CRUMBLEY: So as I said, this is Judge
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`6
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` Crumbley. I have with me Judges Green and
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` Pollock. We have a phone call today in five
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` related IPRs, and I'll read the numbers. It's
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` IPR2016-00084, 01023, 01059, 01102, and 01103.
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` Go ahead and get the appearances from the
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` parties, Counsel. So let's start with the
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` Petitioner Par Pharmaceutical.
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` MR. STRANG: Yes. This is Jonathan Strang
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` from Latham & Watkins, and with me I have Marc
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` Zubick, also with Latham & Watkins. And that's
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` for Petitioner Par.
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` JUDGE CRUMBLEY: All right. Good afternoon,
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` Mr. Strang.
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` Okay. And do we have someone from
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` Breckenridge on the phone?
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` MR. FEDOWITZ: Yes. This is Matthew
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` Fedowitz on behalf of Breckenridge.
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` JUDGE CRUMBLEY: Hi, Mr. Fedowitz. Do you
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` have anyone else with you representing
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` Breckenridge?
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`Ex. 1031-0006
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` MR. FEDOWITZ: I have Mary Bram and
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` Alireza --
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` THE COURT REPORTER: I'm sorry. I did not
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` hear you.
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` JUDGE CRUMBLEY: Why don't we get names --
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` why don't we get their name spellings after --
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` after the call, if that's all right.
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` MR. STRANG: We'll take care of that, Your
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` Honor.
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` JUDGE CRUMBLEY: All right. Thank you.
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` MR. ZULLOW: This is Keith Zullow, Your
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` Honor, on behalf of Roxane.
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` JUDGE CRUMBLEY: Hi, Mr. Zullow. And who do
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` we have from Novartis on the phone?
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` MR. KALLAS: For the patent owner, Judge
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` Crumbley, we have Nick Kallas, and with me is
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` Ray Mandra.
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` JUDGE CRUMBLEY: All right, Mr. Kallas.
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` So I have an e-mail here -- actually, before
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` we get underway, which party retained the court
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` reporter?
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` MR. STRANG: That's was Petitioner Par, Your
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`Ex. 1031-0007
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` Honor.
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` JUDGE CRUMBLEY: All right, Mr. Strang. So
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` do me a favor and when you receive the
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` transcript provide a copy to the -- to the other
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` parties, and file a copy in PRPS for us. And,
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` actually, the other petitioners need to do the
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` same in their cases as well.
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` MR. STRANG: Yes, Your Honor. Would you
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` like the parties to use a 3,000 series number or
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` our own series of numbers?
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` JUDGE CRUMBLEY: No. I think it's okay for
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` you to just use your own series of numbers.
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` MR. STRANG: Yes, Your Honor.
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` JUDGE CRUMBLEY: All right. Okay. So I
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` have an e-mail here from the parties in the --
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` so between Par and Novartis, but we decided to
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` include Breckenridge and Roxane as well since I
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` think the issues are relevant to their cases as
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` well.
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` The first issue in the e-mail is that the
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` Patent Owner Novartis wants to extend due date
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` one, currently set for July 29th, until late
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`Ex. 1031-0008
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` September. So -- and, Mr. Kallas, why don't you
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` speak to that briefly, and then we can hear from
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` the petitioner on that.
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` MR. KALLAS: Yes, Your Honor. The
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` scheduling issue here arises because there is a
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` district court trial starting on August 29th of
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` this year. That district court trial will occur
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` after due date one, July 29th, which is Patent
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` Owner's response, but before due date two,
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` October 31st, which is Petitioner Par's reply.
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` And just so you have it correctly, hopefully
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` it's clear, due date one on July 29th is Patent
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` Owner's response. There's a district court
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` trial on August 29th. Due date two,
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` October 31st; Petitioner Par's reply.
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` JUDGE CRUMBLEY: And what are you seeking
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` for the --
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` MR. KALLAS: Well, we're seeking here,
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` because there is going to be a trial on the same
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` patent involving several of the same issues, and
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` we -- we think it's only fair that both parties
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` either get to use the trial testimony, or
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`PLANET DEPOS
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`Ex. 1031-0009
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` neither one of them gets to use the trial
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` testimony. However, under the current schedule,
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` Par will be allowed to use the trial testimony
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` in its reply, or it will decline to use it if
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` it's adverse to them, and -- and under the
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` present schedule, the patent owner won't get the
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` opportunity to use any part of that trial
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` testimony. We'll be denied that opportunity.
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` And all we're looking for is a reasonable
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` resolution to this issue, because we believe
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` there should be a level playing field. Either
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` both sides get to use it, or neither gets to use
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` it.
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` And because of that, and we think it's
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` unfair if Patent Owner doesn't get that
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` opportunity, we made several proposals to Par.
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` The first one was to extend the current
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` schedule. And our proposal would be on the
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` lines of, rather than having our paper due --
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` due date one July 29th, we would move that back
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` to shortly after the trial. We believe we could
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` have our papers in on September 16th. And then
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` we would give the Petitioner Par an extension of
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` due date two from October 31st to, say,
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` November 29th, and then no other dates really
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` have to be moved. We think that would
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` accommodate us in -- for us allowing having
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` access and use of this relevant trial testimony.
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` JUDGE CRUMBLEY: Well, let me interrupt you
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` for just a moment. So from what you just said,
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` I'm reading between the lines, I take it that
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` you're not intending to file a motion to amend
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` in this case?
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` MR. KALLAS: Yes. Yes.
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` JUDGE CRUMBLEY: Okay. Because --
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` MR. KALLAS: We -- we would do that. We're
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` hoping that we could work this out, but we've
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` had -- we had several proposals on the table.
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` We think the most fair one would be to move the
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` schedule or change the schedule in the
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` beginning, which doesn't appear to prejudice
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` anybody, and it allows the patent owner the same
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` opportunity that the Petitioner Par would have.
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` JUDGE CRUMBLEY: Right. Now, I take your
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` point. I guess what -- the reason I asked that
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` was, you said that you would -- you were going
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` to propose moving due date two to where due date
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` three, which is the reply to the motion to amend
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` currently as set, which, to me, it says that
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` you're not intending to file a motion to amend;
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` therefore, we actually don't need due date three
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` in the first place.
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` MR. KALLAS: That is correct, Your Honor.
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` JUDGE CRUMBLEY: Okay. So the one thing
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` that I think I'll point out here is that the
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` parties do have the ability to move these dates
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` by stipulation. And if there is this -- you
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` know, if there's no need for due date three in
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` the schedule as it stands right now, that --
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` that might give you enough leeway to accommodate
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` whatever -- whatever moves you're looking to
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` make without the involvement of the Board.
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` So let me -- I know you have a couple
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` alternative proposals as well that are in the
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` e-mail, but let me -- I want to turn to counsel
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` for Par.
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` Mr. Strang, do you -- do you have a response
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` to that? Do you -- are you amenable to
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` discussing, you know, these kinds of moving due
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` dates between the parties, and if we're not
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` needing the Board's involvement if they're not
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` filing a motion to amend?
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` MR. STRANG: Yes, we are, Your Honor. And
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` had we heard these proposals before, we might
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` not even be here today taking up your time. The
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` previous proposal we had was, in total, what was
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` in the e-mail to the Board, which was move due
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` date two -- or, pardon me, move due date one,
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` the patent owner response, back by two months.
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` There was no discussion of what to do with the
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` rest of the due dates.
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` JUDGE CRUMBLEY: Okay.
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` MR. STRANG: As a matter of fact, we -- when
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` we looked at it, we weren't sure how we were
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` going to manage this, because due date six and
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` seven, we can't move. Due date six is right
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` after the holidays. Due date five is 1/3,
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` January 3, so we couldn't move that. So we
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` didn't quite see how to do -- do that. But we
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` think in light of the new proposal presented for
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` the first time today that we could be able to
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` come to an agreement, and that would help us
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` synchronize the schedules for the other
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` proceeding also.
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` JUDGE CRUMBLEY: And that was going to be my
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` next -- next -- once we dealt with this topic,
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` that was going to be my next point, which was
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` that I think it might make our -- the issues
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` with that -- with our second issue maybe a
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` little easier to deal with if we do have this
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` flexibility in the schedule in the first case.
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` So what I would like the parties to do, I'd
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` like Par and Novartis to do, in the 00084 case
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` is just, once we finish today, either sit down
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` together and discuss, you know, whether you can
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` come to some sort of agreement now that we know
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` due date three is not going to be in play, and
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` then come up with a stipulated schedule that you
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` could -- that you could file with the Court.
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` And then, therefore, we wouldn't have to get
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` into modifying the scheduling order in any way
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` at this -- at this point.
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` Does that sound okay to you, Mr. Kallas?
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` MR. KALLAS: Yes, it does, Your Honor.
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` JUDGE CRUMBLEY: All right. Well, I'll put
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` that to you and Mr. Strang to do after we get
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` off the call today.
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` If there's nothing else on that issue, I
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` want to turn to the second issue in the e-mail,
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` which has to do with accelerating the due date
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` for -- in the preliminary response in the 1059
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` proceeding, which seeks joinder to the -- to
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` the 84 proceeding.
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` So I guess I'll turn it again -- this is
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` your request, Mr. Strang. I'll turn it to you
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` first to -- what are you -- what are you seeking
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` from the Board on this -- on this issue?
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` MR. STRANG: Your Honor, as we originally
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` proposed in our motion for joinder, we sought an
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` accelerated schedule for the POPR so that we
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` would more easily synchronize the two
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` proceedings' schedules together. And, in fact,
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`Ex. 1031-0015
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` since there's absolutely -- there's no
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` difference, in our view, as we laid out in our
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` petition, and I don't want to get into the
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` merits here, but there's really no substantive
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` difference between claims 7 and claims 1, 8,
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` and 9, that it would be appropriate and
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` reasonable for Petitioners to have a month for
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` their POPR to the Board with them. We didn't
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` seek to have to the Board's three months and
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` then a month for the POPR. And then that would
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` give us two weeks to address the additional
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` issues that are just in that delta between
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` what -- you know, what you possibly argue
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` between claims 7 and claim 1 and 9.
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` So we gave the parties -- you know, we gave
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` them about a month for each of their responses,
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` ourselves for two weeks, and we seen that was
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` reasonable. We didn't get any sort of
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` counter-proposal or how to integrate that with
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` the existing schedule, and had we known that we
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` were able to -- that the -- that Novartis was
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` willing to move due date two and forego their
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`PLANET DEPOS
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`Ex. 1031-0016
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` motion to amend so we'd have plenty of time,
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` I -- I don't really see why the parties can't
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` come to agreement on that either, Your Honor.
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` JUDGE CRUMBLEY: Well, before we -- before
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` we go down that road, and I have a couple of
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` sort of preliminary questions. The first thing
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` is for Mr. Fedowitz and Mr. Zullow. Are -- are
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` Breckenridge and Roxane also seeking shortened
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` dates in -- in those cases that are also seeking
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` joinder?
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` MR. FEDOWITZ: This is Matt Fedowitz for
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` Breckenridge. We're interested in fully
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` coordinating with Par on that, so whatever works
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` out in that regard, we're -- we're fully on
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` board with that.
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` MR. ZULLOW: And, Your Honor, this is Keith
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` Zullow on behalf of Roxane, and we -- we feel
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` the same way. We want to coordinate fully, and
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` think that all of these should be on the same
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` schedule. So we believe we'll be fine, but
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` whatever Par is able to work out with -- with
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` the patent owner.
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`Ex. 1031-0017
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` JUDGE CRUMBLEY: Right. But -- okay. Okay.
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` I think the issue is that -- that your
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` petitions, or at least some of them, have come
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` later, even later than -- than Par's second
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` petition. So I -- I'm just trying to -- there's
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` a lot of certain moving parts here, so I'm
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` trying to figure out what all the parties want
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` to do moving the schedule.
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` Just another preliminary question, because I
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` just -- I haven't looked that much into the
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` merits, is, are you all past the one year 315(b)
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` date for these joined cases? I'll ask you
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` first, Mr. Strang.
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` MR. STRANG: Yes. Yes, Your Honor. We're
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` past our one year date.
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` JUDGE CRUMBLEY: In the -- in the 1059 case?
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` MR. STRANG: Yes, Your Honor.
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` JUDGE CRUMBLEY: Okay. And then,
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` Mr. Fedowitz, just for your 1102 case, are you
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` past your date as well?
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` MR. FEDOWITZ: Yes, sir.
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` JUDGE CRUMBLEY: Okay. And Mr. Zullow?
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`Ex. 1031-0018
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` MR. ZULLOW: Yes, sir. Same thing.
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` JUDGE CRUMBLEY: Okay. So -- so in the
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` absence of joinder, those -- those cases are --
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` are barred. Okay.
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` I guess the only other question I had for
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` you, Mr. Strang, before I turn to Mr. Kallas --
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` oh, I have -- I have a couple questions. One --
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` one is, do you have a reason why you didn't
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` raise claim 7 in the -- in the original petition
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` in the 84 case?
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` MR. STRANG: Your Honor, there was nothing
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` strategic in -- in the decision. I wasn't at
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` the team -- I wasn't on the team at the time,
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` but it was an inadvertent omission. But I think
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` the real point here is that joinder's
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` appropriate because there's no discernable
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` prejudice to the patent owner. We have exactly
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` the same declaration as in the original
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` petition. We have exactly -- we have the same
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` arguments. All we basically argue is, claim 7
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` essentially rises and falls for the same reasons
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` as claim 1, 8, and 9.
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`Ex. 1031-0019
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` JUDGE CRUMBLEY: No. I take your point on
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` that. I just -- it wasn't in your -- I didn't
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` see it in your motion that it was, for example,
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` a newly asserted claim in the district court
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` litigation in our -- in the complaint, for
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` example. That's not the case, is it?
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` MR. STRANG: No, Your Honor, it is not.
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` JUDGE CRUMBLEY: Okay. All right. And the
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` only other issue I have is -- is, you know -- so
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` you haven't had a discussion with Mr. Kallas
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` about this. So my question to you is, you know,
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` does -- does short -- shortening the time period
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` to a month not in some way harm Novartis's
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` ability to respond to your petition? I mean, I
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` know that you say that claim 7 stands or falls,
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` but, I mean, don't they have the ability to
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` introduce evidence? They're not bound to
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` evidence in the -- in the first case. They --
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` they're actually -- under our new rules, they're
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` actually able to submit new testimonial evidence
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` in response -- to form their response now.
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` How -- how are they able to have a full
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` opportunity to do that in a month?
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` MR. STRANG: Well, Your Honor, I have two
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` answers to your question. The first one is that
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` they don't -- we can give them much more than a
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` month now that due date two is going to move
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` from October 31. Our previous schedule --
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` schedule's goal, a proposed schedule as laid out
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` in the motion for joinder, was to synchronize
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` the petitioner's reply on October 31. Now that
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` we've moved that back to November 29, or at
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` least in that neighborhood, that gives it plenty
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` more time for them to address the issues.
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` And that leads to my second point. The only
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` issue here, the only issue presented by the
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` petition and the second petition, is that
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` claim 7, in effect, rises and falls with
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` claims 1, 8, and 9. So we don't feel that
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` there's going to be an additional -- a
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` significant amount of testimony or evidence that
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` goes to that issue. Claim 7 is the compound of
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` claim 1, with, your claims 8 and 9 are
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` administering the compound, presumably with a
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` carrier, to a patient.
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` JUDGE CRUMBLEY: And I understand your point
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` on that. I just am trying to -- and maybe --
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` maybe this resolves itself if we have a little
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` more time in the first case.
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` But I want -- I want to give Mr. Kallas an
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` opportunity to respond. I guess the first thing
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` to ask you, Mr. Kallas, is, do you oppose
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` shortening somewhat your time period for
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` response to the petition in view of their --
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` their apparent willingness to work with you on
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` extending the first case?
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` MR. KALLAS: Well, I don't know how much
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` that somewhat is, Your Honor, but we do oppose
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` not -- not getting our full time for this.
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` First of all, let me just mention that we're
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` allowed 30 days to oppose the joinder motion.
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` And my understanding is that opposition is due
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` on the 17th of June, and we are going to file an
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` opposition motion. I won't get into the -- the
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` merits of that. I'll save everybody on that.
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` JUDGE CRUMBLEY: No. And I'm not asking you
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` to -- to give us your position now, and we'll
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` take that when we receive it. Are you going to
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` oppose the joinder; for example, Breckenridge,
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` on the claim -- you know, basically a copied
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` petition from the first case?
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` MR. KALLAS: Well, Breckenridge filed -- I'm
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` not certain which Breckenridge petition you're
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` talking about.
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` JUDGE CRUMBLEY: Well, the 1023 case, which,
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` again, maybe I'm -- I haven't seen something
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` different in there, but appears to have the same
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` grounds that we instituted on in the 84 case.
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` Are you intending to oppose the joinder of
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` Breckenridge to the 84 case?
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` MR. KALLAS: Your Honor, Patent Owner will
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` oppose that as well.
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` JUDGE CRUMBLEY: All right. And I'm not
`
` saying you can't. I'm just trying to understand
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` what -- you know, what you're planning on doing.
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` MR. KALLAS: Yeah. And -- and that's -- my
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` reading of the papers is that what -- their
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` grounds are not exactly the same.
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` JUDGE CRUMBLEY: All right.
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` MR. KALLAS: There's additional grounds in
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` their paper. But we will --
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` MR. FEDOWITZ: And just to clarify on the
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` record --
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` THE COURT REPORTER: I'm sorry. You just
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` cut out there.
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` JUDGE CRUMBLEY: Yeah. And do me a favor.
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` That was garbled for me as well, so was that
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` Mr. Fedowitz?
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` MR. FEDOWITZ: Yes, sir. To clarify for the
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` record, the grounds are identical --
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` THE COURT REPORTER: I can't hear.
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` JUDGE CRUMBLEY: The ground are identical --
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` for the reporter, I think he said the grounds
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` are identical to Par's.
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` Mr. Fedowitz, you're getting somewhat
`
` garbled on your line, so you may just want
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` to --
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` MR. KALLAS: Yeah. Your Honor, this is Nick
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` Kallas again. I hope I didn't misspeak. I
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` meant to say the evidence isn't exactly the
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` same, and if I said the grounds were different,
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` then I -- I misspoke.
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` JUDGE CRUMBLEY: Okay. That's fine. So the
`
` other question I had for you is -- and, again,
`
` you know, without getting too far into the
`
` merits, I mean, is it your position that there's
`
` something about claim 7 that makes it separately
`
` patentable from claim 1?
`
` MR. KALLAS: Your Honor, I do believe it is
`
` separately patentable. We're looking at that.
`
` It may require a new type of expert that we have
`
` and need here, a formulation expert. Also,
`
` we're considering whether we need to or should
`
` amend claim 7 in the case. And all of this will
`
` take time to consider.
`
` I think you came up with the point that we
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` were going to raise. Since we were able to
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` respond on our first petition, or when we did
`
` respond, the rules have changed. Now we're able
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` to go and vet this with an expert and put in an
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` expert declaration, and -- and that will take
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` time to prepare.
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` But I'm not -- I believe you; the patent
`
` owner views the world much differently than the
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` other petitioners. As I -- as we look at
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` section 103 and obviousness, we compare that
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` claim with the prior art that cited against it.
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` We don't compare the validity of that claim with
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` other claims that aren't prior art in the same
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` patent. And we should be able to get the full
`
` opportunity to attack that prior art. I believe
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` they're relying on five references. We should
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` get the full opportunity to show to the Court
`
` why those five references don't make sense in
`
` invalidating claim 7. And that's why it's --
`
` it, obviously, cannot be done by June 20th,
`
` which is less than three weeks from today, which
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` is the date that Par had proposed. And we
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` realize by pushing back the schedule, there may
`
` be room in the schedule to line these up. We
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` had not considered that before, and maybe it's
`
` premature to discuss that, and maybe the parties
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` ought to take a step back and see if they could
`
` figure out some other schedule other than the
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`PLANET DEPOS
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`Ex. 1031-0026
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` one Par's proposed, and if they can't, then we
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` come back to the Board and have the Board
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` resolve that.
`
` But, again, I don't think we can say yes or
`
` no whether it will fit in the present schedule
`
` or not, because it wasn't an issue that was ripe
`
` for discussion today. Today it was, Par wanted
`
` a very fast schedule, which -- and our -- our
`
` thought was, it's not very reasonable, and
`
` certainly not fair to the patent owner. And,
`
` Judge Crumbley, you brought up yourself, we're
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` allowed to bring in expert evidence now, and we
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` didn't get that opportunity, unfortunately, with
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` our preliminary response to the first petition.
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` JUDGE CRUMBLEY: No. And I understand that.
`
` But, I mean, let's look at this in the big
`
` picture here, which is that there's something
`
` that you want, which is delaying due date one in
`
` the 84 case, and there's something that the
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`