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CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
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`Page 1
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` UNITED STATES PATENT AND TRADEMARK OFFICE
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` __________________
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` BEFORE THE PATENT TRIAL AND APPEAL BOARD
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` __________________
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` AMNEAL PHARMACEUTICALS, LLC
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` Petitioner
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` vs.
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` SUPERNUS PHARMACEUTICALS, LLC
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` Patent Owner
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` U.S. Patent Nos. 8,394,405,
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` 8,394,406 and 8.206,740
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` __________________________
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` Cases IPR2013-00368, IPR2013-00371,
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` and IPR2013-00372
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` __________________________
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` CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
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`VIDEOTAPED DEPOSITION OF HENRY GEORGE GRABOWSKI, Ph.D.
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` Tuesday, May 13, 2014
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` New York, New York
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`Reported by:
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`Robin LaFemina
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`Ref. No.: 11689
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`212.400.8845 - Depo@TransPerfect.com
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` May 13, 2014
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` 9:06 a.m.
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` Videotaped Deposition of HENRY GEORGE
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`GRABOWSKI, Ph.D., held at the offices of
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`Paul Hastings, 75 East 55th Street, New
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`York, New York, pursuant to Notice, before
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`Robin LaFemina, a Registered Professional
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`Reporter, Certified LiveNote Reporter and
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`Notary Public within and for the State of
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`New York.
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`A P P E A R A N C E S:
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` STERNE KESSLER GOLDSTEIN FOX
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` Attorneys for Petitioner
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` 1100 New York Avenue, NW
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` Washington, DC 20005
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` BY: DENNIES VARUGHESE, PHARM.D., ESQ.
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` dvarughe@skgf.com
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` 202.772.8805
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` -and-
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` DAVID HOLMAN, PH.D., ESQ.
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` dholman@skgf.com
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` PAUL HASTINGS LLP
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` Attorneys for Patent Owner and Witness
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` 191 North Wacker Drive
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` Thirteenth Floor
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` Chicago, Illinois 60606
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` BY: GREGORY A. MORRIS, PH.D., ESQUIRE
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` gregorymorris@paulhastings.com
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` 312.499.6064
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`APPEARANCES (Continued):
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` PAUL HASTINGS LLP
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` Attorneys for Patent Ownerand Witness
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` 75 East 55th Street
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` New York, New York 10022
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` BY: VANESSA Y. YEN, ESQUIRE
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` vanessayen@paulhastings.com
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` -and-
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` EVAN DIAMOND, ESQ. (11:48-2:24)
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` evandiamond@paulhastings.com
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` 212.318.6000
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` FOLEY & LARDNER LLP
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` Attorneys for Patent Ownerand Witness
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` Washington Harbour
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` 3000 K Street, N.W.
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` Suite 600
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` Washington, DC 20007-5109
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` BY: ANDREW S. BALUCH, ESQUIRE
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` abaluch@foley.com
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` 202.672.5520
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` ALSO PRESENT:
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` RODOLFO DURAN, Videographer
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` Confidential
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` THE VIDEOGRAPHER: This is tape
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` number 1 of the videotaped deposition
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` of Dr. Henry Grabowski in the matter
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` Amneal Pharmaceuticals, LLC and
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` Supernus Pharmaceuticals, LLC. This
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` deposition is being held at the offices
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` of Paul Hastings, 75 East 55th Street,
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` New York, New York on May 13, 2014 at
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` approximately 9:06 a.m.
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` My name is Rodolfo Duran, I am
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` the legal video specialist. The court
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` reporter today is Ms. Robin LaFemina.
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` We are both in association with
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` TransPerfect Legal Solutions.
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` Will counsel please introduce
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` themselves.
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` MR. VARUGHESE: Dennies
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` Varughese from the Law Firm of Sterne
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` Kessler Goldstein & Fox on behalf of
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` petitioner Amneal Pharmaceuticals, LLC.
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` With me today is Mr. David Holman, also
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` on behalf of Sterne Kessler Goldstein &
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` Fox and also on behalf of Amneal.
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` MS. YEN: Vanessa Yen from Paul
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` Hastings on behalf of Supernus and the
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` witness.
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` MR. MORRIS: Greg Morris from
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` Paul Hastings on behalf of Supernus and
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` the witness.
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` MS. BALUCH: Andrew Baluch from
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` the Law Firm of Foley & Lardner, LLP on
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` behalf of Supernus and the witness.
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` MR. VARUGHESE: Good morning,
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` Dr. Grabowski.
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` THE VIDEOGRAPHER: Will the
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` court reporter please swear in the
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` witness.
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`H E N R Y G E O R G E G R A B O W S K I,
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` called as a Witness, having been duly
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` sworn by Robin LaFemina, a Notary
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` Public within and for the State of New
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` York, was examined and testified as
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` follows:
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`EXAMINATION BY
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`MR. VARUGHESE:
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` Q. Good morning, Dr. Grabowski.
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` A. Good morning.
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` Q. How are you doing?
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` A. Okay.
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` Q. Can you state your full name for
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`the record, please?
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` A. Henry George Grabowski.
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` Q. And your professional address?
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` A. Department of Economics, Duke
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`University, Durham, North Carolina 20078.
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` Q. You understand that you're here
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`testifying as part of an inter partes review?
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` A. Yes.
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` Q. Do you know what that is?
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` A. I have some idea.
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` Q. What's your idea?
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` A. That one can petition the Patent
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`Office, the US Patent Office to have a
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`review of issued patents.
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` Q. Have you been part of any other
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`inter partes reviews?
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` A. Yes.
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` Q. Which one?
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` A. There was one in a case that I
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`was recently in, I would have to give some
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`thought to be sure that I give you the right
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`case.
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` Q. Did you testify in that case?
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` A. No. The case was settled.
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` Q. Okay.
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` How long ago was that?
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` A. Toward the end of last year, I
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`think.
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` Q. Was that a pharmaceutical case?
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` A. Yes.
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` Q. Is that the only other inter
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`partes review that you've been involved in?
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` A. Yes.
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` Q. Who retained you for this
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`particular matter?
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` A. I was retained by Paul Hastings
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`on behalf of the client.
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` Q. Okay.
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` And are you being compensated
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`for your time on this matter?
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` A. Yes.
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` Q. And who is compensating you?
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` A. I assume that Galderma
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`ultimately compensates me, but I get my
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`checks through Paul Hastings.
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` Q. Do you have an engagement with
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`Galderma?
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` A. No. Not directly.
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` Q. And do you have an engagement
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`with Supernus?
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` A. No.
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` Q. You testified in a related
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`litigation last year, do you recall?
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` A. Yes.
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` Q. I think -- I believe it was you
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`and I in the deposition room at that time,
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`too.
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` A. Yes.
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` Q. And you were appearing at that
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`deposition on behalf of Galderma; right?
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` A. Yes.
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` Q. Is that engagement still ongoing?
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` A. To the best of my knowledge, it
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`is.
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` Q. And just so we're clear, today's
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`proceeding you may hear referred to as a
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`deposition both by me, possibly by others in
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`this room, but you understand it is actually
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`a cross-examination of your inter partes
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`review.
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` Do you understand that?
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` A. I don't understand that, but
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`I'll take your representation.
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` Q. Okay.
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` Can you tell me, sir, I know
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`obviously you're very experienced in this
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`arena, how many times have you been deposed
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`before?
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` A. At least maybe 25 times.
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` Q. Were those all patent cases?
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` A. No.
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` Q. Approximately how many of those
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`were patent cases?
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` A. Maybe three quarters.
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` Q. Three quarters, did you say?
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` A. Yes.
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` Q. So given that you've testified
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`in nearly 25 depositions, and I'll go
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`through the ground rules pretty briefly just
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`so that we're all on the same page, do you
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`understand that you're under oath?
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` A. Yes.
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` Q. Do you understand that you are
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`to testify truthfully and accurately to the
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`best of your ability?
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` A. Yes.
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` Q. I'm going to ask you questions.
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` Are you aware of any ailments or
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`any medications that you're taking today
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`that would preclude you from testifying
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`truthfully and accurately to my questions?
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` A. No.
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` Q. Dr. Grabowski, I'm not here to
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`play any word games with you. I'm going to
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`try to ask my questions in plain English,
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`I'm going to assume that you understand the
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`plain and ordinary meaning of those words.
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`Obviously if you don't understand them, will
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`you let me know?
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` A. Yes.
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` Q. And if you need a break, please
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`let me know, you can have a break whenever
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`you need one, but if there is a question
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`pending, I'm going to ask that you try to
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`answer that question before we take a break
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`unless there's some sort of emergency.
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` Is that okay with you?
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` A. Yes. That's fine.
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` Q. Dr. Grabowski, I'm about to hand
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`you what's been marked as Supernus Exhibit
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`2017 in Amneal Pharms. versus Supernus
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`Pharms. IPR2013-00368. I'm also going to
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`hand you what's been marked as Supernus
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`Exhibit 2017 in Amneal Pharms. versus
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`Supernus Pharms. IPR 27-00372. And finally
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`I'm going to hand you what's been marked as
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`Supernus Pharms. Exhibit 2017 in Amneal
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`Pharms. versus Supernus Pharms. IPR27-00371.
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` Please take a moment to orient
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`yourselves to those documents, please.
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` (Witness reviewing document.)
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` A. Yes.
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` Q. Okay?
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` Dr. Grabowski, have you seen
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`these documents before?
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` A. Yes, I have.
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` Q. Can you identify them, please?
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` A. Yes. These are my declarations
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`in this matter involving the patent, the
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`'740 patent, the '405 patent and the '406
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`patent.
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` Q. And those are three
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`declarations, one for each of the three
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`different inter partes reviews, for the '740
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`patent, the '405 patent and the '406 patent;
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`is that correct?
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` A. Yes.
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` Q. And just so the record is clear,
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`by the '740 patent, we are referring to US
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`Patent No. 8,206,740.
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` Do you understand that?
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` A. Yes.
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` Q. And then when we see '405
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`patent, we are referring to US Patent
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`8,394,405?
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` A. Yes.
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` Q. And when we say the '406 patent,
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`we are talking about US Patent No. 8,394,406?
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` A. Yes.
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` Q. Okay.
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` How are these declarations
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`different from one another?
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` A. They refer to different patents.
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` Q. Okay.
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` Any other differences?
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` A. The patents don't all expire on
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`the same date, so that affected one of my
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`calculations on projecting operating profits
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`under a particular scenario. That's one
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`difference.
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` Q. Okay.
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` So if you could turn to page 3
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`of your declaration for the '740 patent, and
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`specifically paragraph 9, can you read the
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`last sentence of paragraph 9 for the record,
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`sir?
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` A. My report focuses on the
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`commercial success of Oracea, which is a
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`commercial embodiment of the '740 patent.
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` Q. Okay.
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` And you've put forth your
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`opinion with respect to that issue in these
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`declarations; is that correct?
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` A. Yes.
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` Q. And what is your conclusion?
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` A. I don't understand the question.
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`The conclusion of what are all my opinions?
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` Q. No. On the question of
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`commercial success.
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` A. Oh. That Oracea is a commercial
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`success.
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` Q. And that renders the '740 patent
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`nonobvious; is that your opinion?
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` A. Well, there's a two step
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`procedure that there is my analysis of
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`commercial success, which covers sales,
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`prescriptions, comparisons with other
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`products used for rosacea, the profitability
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`of the product are all metrics that I use in
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`determining commercial success and then the
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`second step is to see whether that
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`commercial success has a nexus or link to
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`the patented invention, and that analysis is
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`described in Section 4 beginning on page 23,
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`the section entitled The Commercial Success
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`of Oracea Is Due to the Unique Benefits and
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`Advantages.
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` Q. Okay. Thanks.
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` So that analysis that you
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`conducted, is there any difference in that
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`analysis between the three patents, or I
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`should say -- strike that. Is there a
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`difference in the analysis that you put
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`forth in those three separate declarations?
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` A. There's a comparable analysis in
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`each case. One difference is in the
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`operating profits section, as I mentioned.
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`Other than that, I would have to go through
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`the report to see if there's any other
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`differences, but basically the analysis is
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`similar.
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` Q. Okay.
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` And just so we're clear, today
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`I'm going to have you refer to the
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`declaration of the '740 patent. Okay? Is
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`that all right?
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` A. Yes.
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` Q. So the record is clear, when I
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`refer you to a paragraph, we'll be referring
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`to the declaration of the '740 patent.
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` A. That's fine.
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` Q. Dr. Grabowski, I'm going to hand
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`you what's been marked as Amneal Exhibit
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`1001 in Amneal Pharms. versus Supernus
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`Pharms. IPR 2013-00368. I'm also going to
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`hand you what's been marked as Amneal
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`Exhibit 1007 in IPR 2013-00371. And finally
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`I'm going to hand you what's been marked as
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`Amneal Exhibit 1009 in IPR 2013-00372.
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` Please take a moment to orient
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`yourselves to those documents, sir.
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` (Witness reviewing documents.)
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` A. Okay.
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` Q. Okay?
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` Do you recognize those documents,
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`sir?
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` A. Yes.
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` Q. Can you identify them?
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` A. These are the patents that were
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`issued by the Patent Office to inventors
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`Chang, et al., the assignee is Supernus and
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`the patents are the ones at issue here.
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` Q. Okay. And just to be clear,
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`Amneal 1001 is the '740 patent; correct?
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` A. Yes.
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` Q. And Amneal Exhibit 1007 is the
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`'405 patent?
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` A. Yes.
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` Q. And Amneal Exhibit 1009 is the
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`'406 patent?
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` A. Right.
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` Q. Okay.
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` Have you seen these patents
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`before?
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` A. Yes.
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` Q. Have you reviewed them?
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` A. I have reviewed them; yes.
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` Q. In their entirety?
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` A. I believe at some point I looked
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`at them in their entirety. It may have been
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`several months ago.
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` Q. Did you review them in
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`connection with preparing your declarations
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`in these IPRs?
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` A. Yes.
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` Q. Did you review the claims?
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` A. Yes.
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` Q. Can you tell me how these
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`patents are different from one another?
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` A. What I reviewed is just to
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`refresh my memory about the -- that each of
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`the patents -- well, basically let me say,
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`first of all, that I rely on Dr. Rudnic for
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`that the product Oracea is covered by the
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`claims of the patent and that Oracea is a
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`commercial embodiment of the claims and I
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`just went back and reviewed that that was
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`the case based on my layman's understanding
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`of that.
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` Q. So in your declarations, you've
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`opined on whether or not Oracea is a
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`commercial success and whether that success
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`renders the claims of the '740, '405 and
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`'406 patents nonobvious; is that correct?
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` A. Well, that it's a commercial
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`success and there's a nexus to the patent
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`and I understand that that's a secondary
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`condition of nonobviousness. I think it's
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`for the Patent Office to determine how my
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`analysis is to be utilized.
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` Q. Fair enough.
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` You just said you undertook to
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`determine whether there's a nexus between
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`the commercial success and the patent; is
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`that correct?
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` A. Yes.
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` Q. When you say the patent, what
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`are you talking about? Are you talking
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`about the claims, are you talking about the
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`specification of the patent? A nexus to
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`what?
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` MS. YEN: Objection to form.
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` A. Well, it's stated in here that
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`I'm talking about that the claimed
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`inventions, there's a nexus to the claimed
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`invention and I rely on Dr. Rudnic who is a
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`scientist who has examined the issue and
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`indicates there is a -- the Oracea, the
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`product that I'm analyzing the commercial
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`success of, is covered by the claims and
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`it's an embodiment of the claims, of each of
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`these patents.
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` Q. So did you try to analyze
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`whether there's a nexus to the claims of the
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`patents?
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` A. Not beyond assuring myself that
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`what is in Dr. Rudnic's report corresponds
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`to his analysis of the patent, but that's
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`the extent that I, you know, I rely on his
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`opinions.
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` Q. Okay.
`
` Let's say if I were to ask you
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`are there any features of the claims of the
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`'405 patent that for purposes of your
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`opinion are different from the features of
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`the '740 patent, you know, is there any
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`special nexus with respect to the '405
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`patent that wouldn't exist with respect to
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`the '740 patent?
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` MS. YEN: Objection. Form.
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` A. I'm not sure what you're asking
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`me. You know, all I -- as I said, I'm --
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`this is -- Dr. Rudnic has these opinions and
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`I haven't tried to look at what's different
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`about these patents. I've just tried to use
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`my layman's understanding to say that yes,
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`each of the -- each patent's claims cover
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`the product Oracea.
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` Q. All the claims of each patent?
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` MS. YEN: Objection. Form.
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` A. I haven't looked at all the
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`claims of the patent. Some of them involve
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`technical chemical issues. I've read
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`through them, but I haven't attempted to
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`pars out whether all the claims that Dr. --
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`that's an area for Dr. Rudnic.
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` Q. But Dr. Rudnic didn't opine on
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`nexus, so you don't know if there's a nexus
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`to all the claims of each of the patents?
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` A. It's a question for Dr. Rudnic.
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`Dr. Rudnic, his opinion is that the
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`commercially approved product Oracea is
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`covered by the claims and is an embodiment
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`of the claims and that is sufficient for me
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`to do my analysis along with other input of
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`nexus. It's one of the components of my
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`nexus analysis.
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` Q. Okay.
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` So as part of your nexus
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`analysis, do you know which claims there's a
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`nexus to?
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` A. If we look at the '740 patent
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`that we started with, claim number 1 is an
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`oral pharmaceutical composition of
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`doxycycline, which at a once-daily dosage
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`will give steady state blood levels of
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`doxycycline at a minimum of 1.0 micrograms
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`per milliliter and a maximum of 1.0
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`micrograms per milliliter, the composition
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`consisting of an immediate release (IR)
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`portion comprising 30 mg. doxycycline, a
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`delayed release portion comprising 10 mg.
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`doxycycline and optionally one or more
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`pharmaceutically acceptable excipients, so
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`my understanding from Dr. Rudnic is that
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`this product Oracea is covered by claim 1
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`and then and then claim 19, a method for
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`treating rosacea in a mammal in need there
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`of comprising, administering an oral
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`pharmaceutical composition of doxycycline
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`comprising -- which at a once-daily dosage
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`will give steady state blood levels of
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`doxycycline of a minimum, and then there's a
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`range -- same range. The composition
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`consisting of an immediate release IR
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`portion comprising 30 mg. doxycycline, a
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`delayed release portion comprising 10 mg.
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`doxycycline and optionally one or more
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`pharmaceutically acceptable expedients.
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` Q. Okay. So I see that you just
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`read into the record claim 1 and claim 19.
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`Let's look at some of the other claims.
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`Let's look at claim 7.
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` Do you see that, sir?
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` A. Yes.
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` Q. Okay. Can you read that into
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`the record?
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` A. The composition of claim 1 which
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`is in a dosage form of a combination of
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`pellets.
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` Q. Did you analyze or as part of
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`your analysis, did you determine whether
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`there was any nexus between the sales of
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`Oracea and to this feature of being a dosage
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`form of a combination of pellets?
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` MS. YEN: Objection to form.
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` A. I did not do that analysis.
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` Q. Okay. Let's look at claim 8.
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`Can you read that, sir?
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` A. The composition according to
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`claim 1 where the DR portion comprises at
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`least one enteric polymer.
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` Q. And as part of your analysis,
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`did you understand to determine whether
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`there was a nexus between the sales of
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`Oracea and to the feature wherein the DR
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`comprises at least one enteric polymer?
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` A. No, I did not. Dr. Rudnic did
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`an analysis of patent claims and construction
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`and I rely on him.
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` Q. Okay, but do you know if he
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`undertook to determine whether there was a
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`nexus?
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` MS. YEN: Objection.
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` A. I'm not sure what you're asking
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`me. He looked at the claims of the patent
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`and he analyzed whether Oracea was a
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`commercial embodiment of the claims and
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`whether it was covered by the claims.
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` Q. Okay. So my question was, and
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`I'll read it back to you, as part of your
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`analysis, did you undertake to determine
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`whether there was a nexus between the sales
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`of Oracea and to the feature where in the DR
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`portion comprises at least one enteric
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`polymer?
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` MS. YEN: Objection to form.
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` MR. VARUGHESE: My question was
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` about nexus.
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` A. Where the --
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` MS. YEN: Objection.
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` A. I think I may have misunderstood
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`your question. You're asking me whether I
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`did that analysis.
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` Q. Yes.
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` A. I think that's within the scope
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`of Dr. Rudnic.
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` Q. So you are relying on Dr. Rudnic
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`to determine whether there was a nexus?
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` MS. YEN: Objection to form.
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` A. I rely on his opinions as part
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`of my nexus opinion.
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` Q. Okay. So getting back to claim
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`8, there's a feature recited there. It
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`says: Wherein the DR portion comprises at
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`least one enteric polymer, and my question
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`to you was: Did you evaluate whether a
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`nexus exists between the sales of Oracea to
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`that feature?
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` MS. YEN: Objection to form.
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` A. No, I did not.
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` Q. Do you see claim 9, sir?
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` A. Yes.
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` Q. It's a rather lengthy claim and
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`I'll do us all a favor and not read that
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`into the record, but you will see in claim 9
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`there is a number of excipients mentioned
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`there.
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` Do you see that?
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` A. Yes.
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` Q. Did you undertake to determine
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`whether sales of Oracea, whether there was a
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`nexus between those sales to these features
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`recited in claim 9?
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` MS. YEN: Objection to form.
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` A. No. That wasn't the scope of my
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`assignment.
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` Q. Please look at claim 10. Can
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`you read that into the record, sir?
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` A. The composition according to
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`claim 1, wherein the DR formulation is in
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`the form of granules, pellets or tablet.
`
` Q. Okay.
`
` Did you do any analysis to
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`determine whether there was a nexus between
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`the sales of Oracea to the features recited
`
`in claim 10?
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` MS. YEN: Objection to form.
`
` A. No, I did not do an analysis of
`
`whether -- of that issue. That's in Dr.
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`Rudnic's area.
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` Q. I'd like to draw your attention
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`to claim 12.
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` Can you please read that, sir?
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` A. The composition of claim 11,
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`wherein the one or more pharmaceutically
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`acceptable excipients is a binder, a
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`disintegration agent, a filling agent, a
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`surfactant, a solubilizer, a stabilizer, and
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`combinations thereof.
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` Q. Did you undertake to determine
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`whether there was a nexus between the sales
`
`of Oracea to the features recited there in
`
`claim 12?
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` A. No --
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` MS. YEN: Objection to form.
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` A. No, that's in Dr. Rudnic's area.
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` Q. So, Dr. Grabowski, I guess my
`
`question to you is if in your nexus analysis
`
`in determining whether a nexus existed
`
`between the sales of Oracea to the claims of
`
`these three patents, did you evaluate nexus
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`on a claim by claim basis?
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` MS. YEN: Objection to form.
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` A. No. As I indicated in my report
`
`in footnote 10, as explained in the expert
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`declaration of Dr. Rudnic, Oracea is covered
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`at least claims 1, 2, 5 to 13 and 19 to 22
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`of the Chang '740 patent.
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` Q. I guess my question to you is:
`
`The features recited in those claims, did
`
`you undertake to evaluate whether there was
`
`a nexus to the specific features recited in
`
`those claims?
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` MS. YEN: Objection to form.
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` A. I've relied on Dr. Rudnic that
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`Oracea is covered by those specific claims
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`and is a commercial embodiment of the patent
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`mentioned and that was in part of my
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`analysis of nexus.
`
` Q. But I am asking a little
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`different question. I'm asking whether you
`
`considered those specific features in
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`determining whether there was a nexus. I
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`understand that you relied on Dr. Rudnic for
`
`the notion that commercial -- that Oracea is
`
`a commercial embodiment of the claims. I'm
`
`asking you: Did you look at those specific
`
`features in your nexus analysis?
`
` MS. YEN: Objection to form.
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`29
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`

`

`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
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`Page 30
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` Grabowski - Confidential
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` A. I looked at them, but then I
`
`rely on Dr. Rudnic that it's covered and
`
`then I do my analysis -- my economic analysis.
`
` Q. So you didn't look at the
`
`specific features of the claims?
`
` MS. YEN: Objection to form.
`
` A. I think I just said I looked at
`
`them, but I'm not a patent expert. I rely
`
`on a scientist, an expert who is in this
`
`area and has done an analysis for the Patent
`
`Office in this matter, and I rely on his
`
`opinions, and then I do my economic analysis.
`
` Q. So you rely on Dr. Rudnic on
`
`whether or not there's a nexus between the
`
`sales of Oracea and these specific features?
`
` MS. YEN: Objection to form.
`
` A. It's one input that I rely on,
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`that this is a commercial embodiment, and
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`then I do other economic analysis and I also
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`rely on Dr. Webster who is a medical expert
`
`in terms of what the important features ar

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