Transcript of William R. Roush
`
`October 21, 2016
`
`Argentum Pharmaceuticals LLC v. Research Corporation Technologies, Inc.
`
`Alderson Reporting
`1-800-367-3376
`info@aldersonreporting.com
` http://www.aldersonreporting.com
`
`Alderson Reference Number: 66921
`
` ARGENTUM Exhibit 1050
` Argentum Pharmaceuticals LLC v. Research Corporation Technologies, Inc.
`IPR2016-00204
`
`Page 00001
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`
`
`October 21, 2016
`
`Argentum Pharmaceuticals LLC v. Research Corporation Technologies, Inc.
`
`Alderson Reporting
`1-800-367-3376
`info@aldersonreporting.com
` http://www.aldersonreporting.com
`
`Alderson Reference Number: 66921
`
` ARGENTUM Exhibit 1050
` Argentum Pharmaceuticals LLC v. Research Corporation Technologies, Inc.
`IPR2016-00204
`
`Page 00001
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`
`
`William R. Roush
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`October 21, 2016
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`Washington, D.C.
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`UNITED STATES PATENT AND TRIAL APPEAL BOARD
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`Page 1
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`- - - - - - - - - - - - - - X
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` ARGENTUM PHARMACEUTICALS LLC, :
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`Petitioner,
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`: Case No.
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`v.
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`: IPR2016-00204
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` RESEARCH CORPORATION
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`: Patent No.
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` TECHNOLOGIES, INC.,
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`: RE 38,551
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`Respondent.
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`:
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`- - - - - - - - - - - - - - - X
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`Washington, D.C.
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`Friday, October 21, 2016
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`Deposition of WILLIAM R. ROUSH, a witness
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`herein, called for examination by counsel for
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`Petitioner in the above-entitled matter, pursuant to
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`notice, the witness being duly sworn by MARY GRACE
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`CASTLEBERRY, a Notary Public in and for the District
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`of Columbia, taken at the offices of Covington &
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`Burling, 850 Tenth Street, N.W., Washington, D.C., at
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`8:30 a.m., Friday, October 21, 2016, and the
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`proceedings being taken down by Stenotype by MARY
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`GRACE CASTLEBERRY, RPR, and transcribed under her
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`direction.
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`William R. Roush
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`October 21, 2016
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`Washington, D.C.
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`APPEARANCES:
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`Page 2
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`On behalf of the Petitioner:
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`MATTHEW J. DOWD, ESQ.
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`Dowd PLLC
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`1717 Pennsylvania Avenue, N.W.
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`Washington, D.C. 20006
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`(202) 573-3853
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`On behalf of Respondent:
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`ANDREA G. REISTER, ESQ.
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`EVAN KRYGOWSKI, ESQ.
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`Covington & Burling
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`850 Tenth Street, N.W.
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`Washington, D.C. 20001
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`(202) 662-6000
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`ALSO PRESENT:
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`TYLER LIU, ESQ.
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`Argentum
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`William R. Roush
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`October 21, 2016
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`Washington, D.C.
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` C O N T E N T S
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`WITNESS EXAMINATION BY COUNSEL FOR
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`WILLIAM R. ROUSH PETITIONER
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` BY MR. DOWD 5
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`Page 3
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` AFTERNOON SESSION - 177
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` E X H I B I T S
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`ROUSH EXHIBIT PAGE
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`No. 1: Drawing 38
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`No. 2: Drawing (Blank) 41
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`No. 3: Drawing 45
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`PREVIOUSLY MARKED EXHIBITS REFERENCED
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` No. 1001: 159
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` No. 1009: 71
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` No. 1010: 170
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` No. 1012: 108
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` No. 1013: 85
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` No. 1014: 82
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`William R. Roush
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`October 21, 2016
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`Washington, D.C.
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`PREVIOUSLY MARKED EXHIBITS
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`REFERENCED
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`October 21, 2016
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`Whereupon,
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`P R O C E E D I N G S
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`WILLIAM R. ROUSH,
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`called as a witness by counsel for Petitioner, and
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`having been duly sworn by the Notary Public, was
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`examined and testified as follows:
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`EXAMINATION BY COUNSEL FOR PETITIONER
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`BY MR. DOWD:
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`Q.
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`A.
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`Q.
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`Good morning, Dr. Roush.
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`Good morning.
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`My name is Matthew Dowd. I'm an attorney
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`for the petitioner in this case and the petitioner is
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`Argentum, as I'm sure you know. And we are here for
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`your cross-examination or deposition with respect to
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`the testimony that you have offered in the present
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`IPR.
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`And I know you've had your deposition
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`taken several times before, is that right?
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`A.
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`Q.
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`A.
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`Q.
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`Yes.
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`Approximately how many times?
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`I don't know. 20? A number.
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`So you understand the basic approach.
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`William R. Roush
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`October 21, 2016
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`Washington, D.C.
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`A.
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`Q.
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`I think so.
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`I'll ask questions. I'll try to ask them
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`as clearly as I can, and you'll answer them with a
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`verbal response, right?
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`A.
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`Q.
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`I will.
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`And if there is a question that you don't
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`understand, you could ask for clarification and
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`generally you have to answer a question. Your
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`attorney may object to them but unless your attorney
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`instructs you not to answer, then we'll give your
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`attorney a chance to enter the objection and then
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`we'll get your response. Is that okay?
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`A.
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`Q.
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`I'll do my best. Thank you.
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`And if you ever need a break at any time,
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`let me know and we're happy to do that. We'll take a
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`break periodically to accommodate everyone.
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`Can you tell me when you first became
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`aware of the drug Vimpat?
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`A.
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`Q.
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`A.
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`When I first became aware --
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`Yes.
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`-- of Vimpat? At least three years ago
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`but precisely, I couldn't say.
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`William R. Roush
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`October 21, 2016
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`Washington, D.C.
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` Q. And how did you become aware of the drug
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`Page 7
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`Vimpat?
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` A. How did I become aware? Of the name
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`Vimpat, I guess I became aware in connection with
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`when I was approached by attorneys to ask if I would
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`be available to work on a previous case in federal
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`court in trial about a year ago.
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` Q. And when you say attorneys, you're
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`referring to other attorneys at Covington, is that
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`right?
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` A. Correct.
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` Q. And these are attorneys for UCB, is that
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`right?
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` A. I don't recall precisely. It would have
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`been UCB perhaps. Yeah, it would have been the
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`external counsel for UCB, correct.
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` Q. And so I just want to make sure that we
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`have the same terminology and understanding. So when
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`you refer to the case in federal court, you're
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`referring to the trial in Delaware before Judge Stark
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`that concerned the '551 patent, is that right?
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` A. Among others, yes.
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`William R. Roush
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`October 21, 2016
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`Washington, D.C.
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` Q. There are other issues that were presented
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`Page 8
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`in that trial, as you understand, right?
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` A. That's my recollection, yes.
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` Q. Now, can you tell me what you did to
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`prepare for your deposition today?
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` A. For my deposition today, I reviewed my
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`declaration. I reviewed Dr. Wang's declaration. I
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`reviewed a number of the references that I cited in
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`my declaration. I met with counsel.
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` Q. Did you talk to anyone other than counsel
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`about your deposition?
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` A. No, I did not.
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` Q. And what is the hourly rate that you are
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`charging for your work associated with the present
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`case?
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` A. I'm not sure if it's 625 or 650 but it's
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`one of those two.
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` Q. And can you tell me approximately how much
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`money you've earned in connection with the present
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`IPR?
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` A. Oh, I don't know. I haven't looked. I
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`haven't submitted any invoices. I don't know. How
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`October 21, 2016
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`Washington, D.C.
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`many hours have I spent? Probably at this point --
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`prior to coming to Washington this week, I probably
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`spent on the order of 25 to 30 hours, but that's just
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`a guess. I'm not -- I don't actually know.
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`Q.
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`And so the 25 to 30 hours, that includes
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`all the time you spent drafting your declaration?
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`A.
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`Q.
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`Correct.
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`And can you tell me approximately how much
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`money you've earned in connection with your work for
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`the trial in district court?
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`A.
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`I don't recall. I probably -- I'm sure I
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`spent more than 100 hours but that's a year ago. I
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`don't recall.
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`Q.
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`And did you submit a bill to UCB or
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`Covington with respect to your work in the trial?
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`A.
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`Q.
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`A.
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`Q.
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`A.
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`I billed for my time, correct.
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`But you don't remember?
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`At this point, no.
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`So it could be over $100,000?
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`It's possible. It depends on the number
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`of hours I spent. I think I just said it is probably
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`at least 100 but above that, I don't recall.
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`October 21, 2016
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` Q. Okay. I'm just --
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` A. 100 hours in terms of -- right. But
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`probably more than 100 but I don't know for sure.
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` Q. Sure. Sure. Okay. And so remind me,
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`when were you first engaged by UCB to work on the
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`trial, the district court trial?
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` A. Good question. Working backwards, the
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`trial was last November, if I recall correctly. It
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`was probably at least a year and a half prior to
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`that, maybe two years prior to that but I've not
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`reviewed that exact date. I don't recall.
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` Q. So you don't remember, sitting here today,
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`when you were first engaged by UCB counsel?
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` A. Well, I recall I was engaged by Covington
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`and the external counsel for UCB and I'm estimating
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`that it was probably a year and a half, possibly two
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`years prior to the trial that was in Delaware last
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`November.
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` Q. How many days of the trial did you attend?
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` A. My recollection is that I attended
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`everything in the trial up through the point of my
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`testimony and cross-examination. I don't have
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`William R. Roush
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`October 21, 2016
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`recollection of remaining at trial after I completed
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`my cross-examination.
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` Q. And so how many days were you in
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`Wilmington prior to the trial?
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` A. At this point, I don't even remember how
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`many days the trial was, and I probably arrived a few
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`days before the trial but at this point, I don't have
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`a distinct recollection.
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` Q. So you can't remember even though this was
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`only November of last year?
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` A. I have a very busy life. I do a lot of
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`things and that work was completed and it's a year
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`ago. It's not something that I have in my mind
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`precisely what I did on what day when at that point
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`in time.
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` Q. I wasn't asking specifically about
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`particular days. I was just asking generally in
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`terms of if you remembered how many days you got
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`there before trial started.
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` A. And I believe I said I don't recall
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`precisely but undoubtedly I was there a few days
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`before the trial began.
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` Q. Okay. And for your consulting work, do
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`you generally bill for the time when you're there a
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`few days before a trial begins?
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` A. I only bill for the time that I spent
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`working on the case so if I was doing work on those
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`days before trial that had to do with the trial, yes,
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`that would have been billed. But no, I don't bill
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`for every hour on location for one of these events.
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` Q. Can you tell me approximately how many
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`trials at which you've testified?
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` A. Trials. I think it's around eight.
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` Q. Eight, okay.
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` A. Maybe nine, but I would put it at that
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`number.
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` Q. And the eight to nine, do you know if
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`those were all patent cases?
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` A. In the trials, those would have all been
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`patent cases.
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` Q. And were you engaged as an expert during
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`those trials?
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` A. I was.
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` Q. And can you tell me which cases those
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`were?
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` A. I'll do my best. The first I recall was
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`at the end of 2004. I was an expert in the Lipitor
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`trial in New Jersey. I think the next case I was
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`involved with was Crestor, also a trial in New
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`Jersey.
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` But others that I have done, all, you
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`know, in the U.S., would be -- I did Lyrica, which I
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`forget the location where all of these were but I did
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`Lyrica, I did ezetimibe. There was a second Crestor
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`case having to do with a different counterion, a
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`different salt form that was the rosuvastatin zinc
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`trial. I did Vimpat. This past year, I did
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`tapentadol. Just a few months ago, I did everolimus
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`in the U.S.
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` Are there others? Sitting here right now,
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`those are the ones that I remember.
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` Q. Now, considering your experience as an
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`expert, is it fair to say that you've either
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`testified through trial or deposition in about 15 or
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`20 instances?
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` A. Yeah, there have been other instances
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`where I've been deposed in circumstances where there
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`was not a trial or did not lead to a trial, yes.
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` Q. And the 15 to 20 numbers, does that sound
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`Page 14
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`about right to you?
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` A. Yes.
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` Q. And you understand that this is a case
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`that deals with a brand name company versus a generic
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`company, right?
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` A. That's my understanding, yes.
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` Q. And in those 15 to 20 cases in which
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`you've testified, it's fair to say that you've always
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`testified on the side of the brand company, isn't
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`that right?
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` A. Well, among these depositions I've
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`mentioned, there are several where there weren't --
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`well, there is at least one where there was not a
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`brand involved. And the others, in one instance, a
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`gave a tutorial to the Court in a Markman hearing.
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`So those two I think are a bit different. The others
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`would have been the ANDA-type case that the previous
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`trial was about.
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` Q. Getting back to my question, though, it's
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`fair to say that in these 15 to 20 cases, you've
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`testified on the side of the brand company?
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` A. I have. And I mentioned that there is at
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`least one, possibly two where I don't think that the
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`brand -- my testimony I don't think really qualified
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`as being for either a brand or not for a brand so --
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` Q. And it's also correct to say that in these
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`15 to 20 cases, you've never testified on behalf of a
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`generic company, right?
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` A. That is correct.
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` Q. Let me switch gears and ask you a few
`
`questions about your experience and background
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`generally in chemistry. I understand you got your
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`Ph.D. in 1977, is that right?
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` A. That is correct.
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` Q. And you were a post-doc at Harvard for
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`about a year after that, is that right?
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` A. Correct.
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` Q. And can you just describe your
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`professional experience as a professor after your
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`post-doc year?
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` A. My first faculty appointment was at MIT in
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`Cambridge and that was 1978 through I think 1986. I
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`was assistant and then associate professor of
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`chemistry in the department of chemistry at MIT.
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` Very early 1987, I moved to Indiana
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`University in Bloomington, Indiana where I was -- I
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`guess I began as an associate professor but
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`ultimately was promoted to the rank of distinguished
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`professor of chemistry.
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` Then if I recall correctly, if I have the
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`dates right, I think it was 1996, I moved to the
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`University of Michigan in Ann Arbor where I was
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`recruited as the Warner-Lambert/Parke-Davis professor
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`of chemistry and the department chair. During my
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`period there, I was chairman of the department of
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`chemistry. I was at the University of Michigan until
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`the end of 2004, and then very early in 2005, I
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`assumed my current positions at the Scripps Research
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`Institute at the new campus in Jupiter, Florida.
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` Q. In looking at your publications, it seems
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`like a large part of your early and even most of your
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`career has been focused on synthetic chemistry, that
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`is right?
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` A. By training, I am a synthetic organic
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`chemist and my research has always utilized the tools
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`of a synthetic organic chemistry. Increasingly, in
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`fact, my program, after relocating to the Scripps
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`Research Institute, has been always exclusively
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`focused on drug discovery of medicinal chemistry or
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`at least the emphasis in my group has moved to the
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`point where today it's 100 percent focused on -- in
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`that area.
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` Q. And you moved to Scripps in 2005,
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`approximately?
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` A. I moved into my house on Christmas day
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`2004 and began January 4th, 2005, yes.
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` Q. That's a date that's easy to remember,
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`right?
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` A. That's my wife's birthday, January 4th,
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`2000- -- well, yes.
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` Q. But many of the early years of your
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`research were focused, I mean, purely as synthetic
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`chemistry research, right?
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` A. Well, I wouldn't say purely. Even as
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`early as, oh, gee, I'm trying to remember the dates,
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`whether it was 1984 or 1985 but in the early 1980s, I
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`had a research program focusing on the metabolism of
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`a group of mycotoxins which were alleged by our State
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`Department to be involved in chemical warfare, the
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`so-called yellow rain problem. And so I had papers
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`in the early 19 -- somewhere in the 1980 time frame
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`where we were working on metabolite ID, on really
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`understanding aspects of the pharmacology of this
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`class of mycotoxins.
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` After moving to Indiana University, and I
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`don't recall the time point, 1990-'91 perhaps, I
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`began a program focusing on development of inhibitors
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`of cysteine proteases to target treatment of certain
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`parasitic diseases. And so over the years, my
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`interests have -- I mean, I've always had an interest
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`in the medicinal pharmacologic side of chemistry, but
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`over the years, my program has increasingly expanded
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`more and more and more into these nontraditional
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`synthetic areas.
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` Q. And is part of that driven based on the
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`source of funding, for example?
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` A. No. It's driven by my interests.
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` Q. And you mentioned a research program in
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`'91 for protease inhibitors, is that right?
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` A. Cysteine protease inhibitors, correct.
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`The date of the first publication of mine on that is
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`1994 but the research was started prior to that. But
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`sitting here today, I don't remember exactly the line
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`of demarcation.
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` Q. So 1994 is your first publication that you
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`would -- you know, that you would consider as one
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`where it's an example of your research directed to
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`medicinally-related compounds?
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` A. No.
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` Q. Then what year would that be?
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` A. As I said, papers in the early/mid-1980s
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`focusing on the metabolism of a group of mycotoxins.
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`That's certainly a medicinal chemistry problem. And
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`there are other papers I published from my MIT days
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`where we made analogs, isomers, stereoisomers of a
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`natural product for biological evaluation, so there
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`certainly are medicinally-related efforts,
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`publications from my group that predate the 1990
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`period.
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` Q. And in any of those papers, did you
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`publish results of any structure-activity
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`relationships with respect to your compounds that you
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`were working on?
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` A. I think I did. I've not pre-reviewed any
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`of those papers in preparation for this but I think I
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`did, yes.
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` Q. And can you be more specific?
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` A. There is a paper -- Tim Blizzard was the
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`coauthor and I think it was published in the Journal
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`of Organic Chemistry but what year it was, I can't
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`remember. And I don't recall whether it was isomers
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`of verrucarin J or verrucarin B but these are two
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`natural products that we made and we synthesized a
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`number of isomers of the natural product to explore
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`the structure-activity relationship question and
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`certainly the synthesis of the isomers are in those
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`papers.
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` We did get SRA data on them. I think, to
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`my recollection sitting here today, I included that
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`information in those papers.
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` And then there is other work that we did
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`also in the epoxy tricothecene micotoxin area where
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`we made analogs of the natural product where we
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`changed, again, the stereochemistry and changed the
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`nature of a group, a reactive group that was alleged
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`to play a role in the biologic response of the
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`molecules.
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` So those are two additional cases where we
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`made -- using the skills of a synthetic chemist to
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`make structures to probe biological questions, and
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`that's part of an SRA effort.
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` Q. You understand the term QSAR, right?
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` A. I do, yes.
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` Q. And have you ever published a paper
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`describing the results of a QSAR study?
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` A. So far, no, I have not.
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` Q. Let me ask a different question. Over the
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`years, I take it you've probably taught a number of
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`courses to students, right?
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` A. I have, yes.
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` Q. And have you ever taught a course directed
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`to medicinal chemistry?
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` A. Actually, no, I haven't, other than within
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`the -- so not a formal lecture course. Within my
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`research group meetings, you know, that's an
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`all-the-time, weekly discussion.
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` Q. I'm just asking about courses.
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` A. Well, in the university construct, faculty
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`members do get credit for teaching for having
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`research group meetings, so a research group meeting
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`is part of the teaching duties of a faculty member.
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`And in that environment, yes, I do teach medicinal
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`chemistry, but I've not given a course that's been
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`listed in the, you know, the university syllabus as a
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`medicinal chemistry course.
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` Q. Okay. This will go a lot faster if we
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`just answer the question, Doctor, and I understand
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`you might want to add more information, but that was
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`a pretty straightforward question.
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` A. And I gave a straightforward answer.
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` Q. And to the extent that you want to add
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`additional information to my questions, your attorney
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`will have an opportunity to redirect you. But I
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`would ask you just to answer the question. You
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`answered the question and then you added information
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`so I'm going to move to strike that information.
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` MS. REISTER: The answer was responsive to
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`your question.
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` MR. DOWD: In your opinion, that's fine.
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`Understood.
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`BY MR. DOWD:
`
` Q. Have you ever taught a course to any
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`students directed to pharmacology?
`
` A. No, I have not.
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` Q. And so it's fair to say that you haven't
`
`taught any courses directed to the study of CNS
`
`disorders, right?
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` A. I've not taught a formal lecture course on
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`CNS disorders, no.
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` Q. And what is your understanding of the term
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`"CNS disorders"?
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` A. Are you asking with respect to the way
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`it's defined in the '551 or are you asking just my
`
`understanding divorced from this case? So what is --
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` Q. Is there a difference?
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` A. I think there could be.
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` Q. Okay. If you could explain that to me.
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` A. Well, which do you want me to discuss? I
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`asked for clarification as to what you really are
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`getting at.
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` Q. No, I understood. I asked you a question
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`whether you ever taught a course directed to CNS
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`disorders. You answered that question.
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` A. Correct.
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` Q. Right? And so I'm asking about your
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`understanding of the term CNS disorders.
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` A. Well, in a very broad sense -- and I
`
`qualify this answer as being unrelated to anything
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`involved with this course but CNS disorders are
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`disorders having to do with the central nervous
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`system.
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` Q. And what are some examples of CNS
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`disorders?
`
` A. Some examples? Parkinson's disease,
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`epilepsy, Alzheimer's. There is a wide, wide range.
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`Migraine headache. I mean, there is a wide, wide
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`range of disorders that would be associated with the
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`central nervous system.
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` Q. Okay.
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` A. Glioblastoma, which is a brain -- many
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`different disorders that would be CNS.
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` Q. And are you familiar with types of CNS
`
`disorders that exhibit convulsions as a symptom?
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` A. I'm not an expert in that area but I'm
`
`aware of epilepsy. There is a number of
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`convulsive -- disorders that do have convulsions
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`associated with them but that's beyond my area of
`
`expertise.
`
` Q. Do you know of any other CNS disorders
`
`that have convulsions as a symptom other than
`
`epilepsy?
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` MS. REISTER: Objection, scope.
`
` THE WITNESS: That's not something that
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`I've looked into. My understanding is that there are
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`but beyond a very low-level, general statement that
`
`I've just given, I'm unprepared to answer.
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`BY MR. DOWD:
`
` Q. And earlier in response to one of my
`
`questions, you referenced the use of the term CNS
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`disorders with respect to the '551 patent. Do you
`
`remember that?
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` A. I do.
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` Q. And your answer suggested that you may
`
`think there is a difference between what the term CNS
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`disorders means generally to you and what CNS
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`disorders means with respect to the '551 patent. Do
`
`you remember that?
`
` A. I do.
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` Q. And what is your understanding with
`
`respect to the term CNS disorders concerning the '551
`
`patent?
`
` A. In order to answer the question, I would
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`like to look to specific places within the '551 so
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`can I have a copy, please?
`
` Q. You don't remember the '551 patent?
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` A. I do but I don't have an entirely
`
`photographic memory and --
`
` Q. No, I understand.
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` A. -- I would like to be in a position to
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`correctly properly point to the places that I would
`
`like to refer to within the patent.
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` Q. Can you tell me how many hours that you
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`spent preparing for your deposition today?
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` A. 10.
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` Q. Only 10?
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` A. Probably.
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` Q. When did you arrive in D.C.?
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` MS. REISTER: Objection, relevance.
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` THE WITNESS: When did I arrive? I
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`arrived -- what day is today? Friday. Wednesday
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`night.
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`BY MR. DOWD:
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` Q. And you met with counsel all day
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`yesterday?
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` A. No, Tuesday night.
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` Q. Tuesday night. So you met with counsel
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`Wednesday?
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` A. Part of the day.
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` Q. How many hours?
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` A. So I misspoke earlier. I forgot the two
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`days. So maybe I've spent 15 hours in preparation.
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`I forgot about that earlier today. Part of the day
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`then, part of the day yesterday, but I still would
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`like to see a copy of the '551 patent so that I can
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`properly answer the question which is on the table.
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` Q. I'm asking a different question now,
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`Doctor.
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` MS. REISTER: Are you withdrawing the
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`earlier question, Mr. Dowd?
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` MR. DOWD: No, he answered that. I'm not
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`withdrawing it. He gave an answer that was
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`nonresponsive so I moved on to other questions for
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`the time being.
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`BY MR. DOWD:
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` Q. Because you understand, Doctor, part of
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`your role here is as an expert in a particular
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`subject matter. Do you understand that?
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` A. I pride very much my role as an expert.
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`I'm under oath. I want to make sure that I give a
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`correct answer that's fair to both you and to counsel
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`on this other side of the table. I want to make sure
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`that I speak correctly, properly and I feel I'm
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`entitled, if I've asked for it, to see a copy of the
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`'551 patent.
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` Q. Do you have any understanding of what the
`
`term CNS disorders means with respect to the '551
`
`patent?
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`1-800-FOR-DEPO
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`www.aldersonreporting.com
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`Alderson Court Reporting
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`Page 00029
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`
`
`William R. Roush
`
`October 21, 2016
`
`Washington, D.C.
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` MS. REISTER: Objection, calls for a legal
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`Page 29
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`conclusion.
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` THE WITNESS: I have my interpretation --
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` (Interruption.)
`
`BY MR. DOWD:
`
` Q. I understand that you've looked at the
`
`'551 patent and you're asking for it, but I have the
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`right to ask you what your understanding of that is,
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`and so you either have one or you don't.
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` A. I have, I believe, a good understanding of
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`the '551 patent. But at the same time, I would like
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`to not misspeak and not provide an answer with words
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`that are not the words that I -- I have the concept
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`in my mind but I would like to make sure that I use
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`language that is consistent with the document.
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` Q. Okay. Can you tell me what your
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`understanding is of the meaning of the term CNS
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`disorders as it's used in the '551 patent?
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` A. Once again, may I please --
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` MS. REISTER: Objection, calls for a legal
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`conclusion, asked and answered.
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`BY MR. DOWD:
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`www.aldersonreporting.com
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`Alderson Court Reporting
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