·1· · · · UNITED STATES PATENT AND TRADEMARK OFFICE
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`·2· · · · · · · · · · · · · - - -
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`·3· · · · ·BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`·4· · · · · · · · · · · · · - - -
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`·5· · · · · · · ·MYLAN PHARMACEUTICALS INC.,
`· · · · · · · · · · · · · Petitioner,
`·6
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`·7· · · · · · · · · · · · · · v.
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`·8
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`·9· · · · ·POZEN INC. AND HORIZON PHARMA USA, INC.,
`· · · · · · · · · · · · Patent Owners.
`10
`
`11· · · · · · · · · · · · · - - -
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`12· · · · · · · · · Case No. IPR2017-01995
`· · · · · · · · · · · ·Patent 9,220,698
`13
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`14· · · · · · · · · · · · · - - -
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`15
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`16
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`17· · · · · ·Videotaped Deposition of DAVID C. METZ,
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`18· ·M.D., taken at the Hilton Philadelphia City Avenue,
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`19· ·4200 City Avenue, Philadelphia, Pennsylvania 19131,
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`20· ·on Friday, May 25, 2018, commencing at 8:58 a.m.,
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`21· ·before Jennifer Mann, a Shorthand Reporter and
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`22· ·Notary Public.
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`23
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`24
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`25
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`·2· · · · · · · · · · · · · - - -
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`·3· · · · ·BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`·4· · · · · · · · · · · · · - - -
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`·5· · · · · · · ·MYLAN PHARMACEUTICALS INC.,
`· · · · · · · · · · · · · Petitioner,
`·6
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`·7· · · · · · · · · · · · · · v.
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`·8
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`·9· · · · ·POZEN INC. AND HORIZON PHARMA USA, INC.,
`· · · · · · · · · · · · Patent Owners.
`10
`
`11· · · · · · · · · · · · · - - -
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`12· · · · · · · · · Case No. IPR2017-01995
`· · · · · · · · · · · ·Patent 9,220,698
`13
`
`14· · · · · · · · · · · · · - - -
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`15
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`16
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`17· · · · · ·Videotaped Deposition of DAVID C. METZ,
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`18· ·M.D., taken at the Hilton Philadelphia City Avenue,
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`19· ·4200 City Avenue, Philadelphia, Pennsylvania 19131,
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`20· ·on Friday, May 25, 2018, commencing at 8:58 a.m.,
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`21· ·before Jennifer Mann, a Shorthand Reporter and
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`22· ·Notary Public.
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`23
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`24
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`25
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`·1· ·APPEARANCES:
`
`·2
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`·3· · · · · PERKINS COIE LLP
`· · · · · · BY:· ROBERT D. SWANSON, ESQUIRE
`·4· · · · · 700 13th Street, NW
`· · · · · · Suite 600
`·5· · · · · Washington, D.C. 20005
`· · · · · · Attorney for Mylan Pharmaceuticals Inc. and
`·6· · · · · Dr. Metz
`· · · · · · RSwanson@perkinscoie.com
`·7· · · · · (202) 654-1729
`
`·8
`· · · · · · COOLEY LLP
`·9· · · · · BY:· ELLEN A. SCORDINO, ESQUIRE
`· · · · · · 500 Boylston Street
`10· · · · · 14th Floor
`· · · · · · Boston, Massachusetts 02116
`11· · · · · Attorney for Patent Owner Horizon Pharma USA,
`· · · · · · Inc.
`12· · · · · escordino@cooley.com
`· · · · · · (617) 937-2492
`13
`
`14· ·VIA TELEPHONE:
`
`15· · · · · BAKER BOTTS LLP
`· · · · · · BY:· STEPHEN M. HASH, ESQUIRE
`16· · · · · 98 San Jacinto Boulevard
`· · · · · · Suite 1500
`17· · · · · Austin, Texas 78701
`· · · · · · Attorney for Patent Owner Pozen, Inc.
`18· · · · · stephen.hash@bakerbotts.com
`· · · · · · (512) 322-2587
`19
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`20
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`21· ·ALSO PRESENT:
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`22· · · · · Sean Dougherty, Videographer
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`23
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`24
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`25
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`·1· · · · · · · · · · · · ·I N D E X
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`·2· ·WITNESS· · · · · · · INTERROGATION BY· · · · · PAGE
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`·3· ·David C. Metz, M.D.
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`·4· · · · · · · · · · · ·Ms. Scordino· · · · · · · · 6
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`·5
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`·6
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`·7
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`·8· · · · · · · · · · ·E X H I B I T S
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`·9· ·EXHIBIT NUMBER· · · · · DESCRIPTION· · · · · · ·PAGE
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`10· ·2109· · Confidential - PZ00034117 to PZ00034197· 44
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`11· ·2110· · Expert Report of David C. Metz, M.D.· · ·68
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`12· ·2111· · Second Declaration of Dr. Metz· · · · · ·71
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`13· · · · · · · · · · · ·(Previously marked exhibits,
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`14· · · · 1001, 1002, 1005, 1006, 1009, and 1010, were
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`15· · · · referenced and attached.)
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`16
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`17
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`18
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`19
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`20
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`21
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`22
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`23
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`24
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`·1· · · · · · · · ·LITIGATION SUPPORT INDEX
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`·2· · · · · · Direction to Witness Not to Answer
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`·3· ·Page· ·Line· · · · · ·Page· ·Line· · · · · Page Line
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`·4· · 12· · ·10
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`·5
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`·6
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`·7
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`·8
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`·9
`· · · · · · ·Request for Production of Documents
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`12· · · · · · · · · · · · · (NONE)
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`13
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`14
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`15
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`16
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`17
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`18
`· · · · · · · · · · · · ·Stipulations
`19
`· · ·Page· ·Line· · · · · ·Page· ·Line· · · · · Page Line
`20
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`21· · · · · · · · · · · · · (NONE)
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`·1· · · · · · · · · · ·- - -
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`·2· · · · · · · · · THE VIDEOGRAPHER:· This is a
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`·3· ·recorded deposition of Dr. David Metz in the
`
`·4· ·matter of Mylan Pharmaceutical versus Pon- --
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`·5· ·Pozen, Inc. -- my apologies -- being heard
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`·6· ·before the US Patent Trial and Appeal Board,
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`·7· ·Case No. IPR2017-01995.· This deposition is
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`·8· ·being held at 4200 City Ave., Philadelphia, on
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`·9· ·May 25th, 2018, scheduled to start at 9:00 a.m.
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`10· · · · · · · · · My name is Sean Dougherty, and I
`
`11· ·am the videographer.· The court reporter is
`
`12· ·Jennifer -- Jennifer Mann -- my apologies.
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`13· · · · · · · · · Counsel, will you please
`
`14· ·introduce yourselves for the record, at which
`
`15· ·then the court reporter will swear in the
`
`16· ·witness.
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`17· · · · · · · · · MS. SCORDINO:· Ellen Scordino
`
`18· ·with Cooley LLP, on behalf of Patent Owner
`
`19· ·Horizon.
`
`20· · · · · · · · · MR. HASH:· Steve Hash from Baker
`
`21· ·Botts on behalf of Patent Owner Pozen.
`
`22· · · · · · · · · MR. SWANSON:· Robert Swanson
`
`23· ·from Perkins Coie on behalf of Mylan.
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`24· · · · · · · · · · ·- - -
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`25· · · · · · · · · DAVID C. METZ, M.D., after
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`·1· · · · having been first duly sworn, was examined and
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`·2· · · · testified as follows:
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`·3· · · · · · · · · · · · · - - -
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`·4· · · · · · · · · · · ·THE VIDEOGRAPHER:· The time is
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`·5· · · · 8:58 a.m.· You may began your questioning.
`
`·6· · · · · · · · · · · · · - - -
`
`·7· · · · · · · · · · DIRECT EXAMINATION
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`·8· · · · · · · · · · · · · - - -
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`·9· ·BY MS. SCORDINO:
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`10· · · · Q.· ·Good morning --
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`11· · · · A.· ·Starting early.
`
`12· · · · Q.· ·-- Dr. Metz.
`
`13· · · · A.· ·Good morning.
`
`14· · · · Q.· ·Can you please state your full name and
`
`15· ·address for the record?
`
`16· · · · A.· ·David C. Metz, 26 Penarth Road, Bala
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`17· ·Cynwyd, PA.
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`18· · · · Q.· ·Now, you've been deposed before, right?
`
`19· · · · A.· ·Correct.
`
`20· · · · Q.· ·How many times?
`
`21· · · · A.· ·Probably about six or seven, I guess.· One
`
`22· ·of which was with yourself.
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`23· · · · Q.· ·How many times since January of 2017 have
`
`24· ·you been deposed?
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`25· · · · A.· ·Zero.
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`·1· · · · Q.· ·And was your last deposition in the
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`·2· ·Horizon v. Dr. Reddy's, Mylan litigation that you
`
`·3· ·testified at trial?
`
`·4· · · · A.· ·Yes.· I think so.
`
`·5· · · · Q.· ·Okay.· That was -- that was some time ago.
`
`·6· ·I'll just go through the ground rules again, and let
`
`·7· ·me know if you don't -- if you've got any questions.
`
`·8· ·You'll let me know if you don't understand the
`
`·9· ·question.· Otherwise, I will assume that you've
`
`10· ·understood when you answer.
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`11· · · · A.· ·Sure.
`
`12· · · · Q.· ·You'll answer with verbal responses?
`
`13· · · · A.· ·Sure.
`
`14· · · · Q.· ·And we'll try not to talk over each other,
`
`15· ·so the court reporter can get down what we're both
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`16· ·saying.· Okay?
`
`17· · · · A.· ·Okay.
`
`18· · · · Q.· ·Your attorney may object, but unless he
`
`19· ·instructs you not to answer, you'll still answer the
`
`20· ·question.
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`21· · · · A.· ·That's fine.
`
`22· · · · Q.· ·We'll take breaks about every hour, but if
`
`23· ·you would like a break before then or if you need to
`
`24· ·take a call, just let me know and we'll take a
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`25· ·break.· I just ask that if there's a pending
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`·1· ·question, you try to answer the question before we
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`·2· ·go on break.
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`·3· · · · A.· ·Sure.
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`·4· · · · Q.· ·Is there any reason why you cannot testify
`
`·5· ·truthfully today?
`
`·6· · · · A.· ·No.
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`·7· · · · Q.· ·How did you prepare for this deposition?
`
`·8· · · · A.· ·I spent yesterday afternoon with
`
`·9· ·Mr. Swanson in this very room going over my report
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`10· ·and the references attached thereto.
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`11· · · · Q.· ·When you say "the references attached
`
`12· ·thereto," do you mean the exhibits that you cited in
`
`13· ·the report?
`
`14· · · · A.· ·That is correct.
`
`15· · · · Q.· ·Outside of the meeting with Dr. --
`
`16· ·Mr. Swanson yesterday, did you do anything else to
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`17· ·prepare for today's deposition?
`
`18· · · · A.· ·I reread my report last night before I
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`19· ·went to sleep.
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`20· · · · Q.· ·Prior to yesterday, did you do anything to
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`21· ·prepare for your deposition?
`
`22· · · · A.· ·Well, we set up a time and we arranged to
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`23· ·have this meeting.· This is part of a much bigger
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`24· ·effort, but I didn't -- I'm not counting all that
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`25· ·stuff as part of this particular deposition today,
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`·1· ·so no.
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`·2· · · · Q.· ·And when you say "part of a much bigger
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`·3· ·effort," are you referring to the district court
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`·4· ·litigation relating to the '698 patent?
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`·5· · · · A.· ·Correct.
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`·6· · · · Q.· ·So, now just talking about for this IPR,
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`·7· ·did you meet with any attorneys from Dr. Reddy's?
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`·8· · · · A.· ·Well, some people from Dr. Reddy's had
`
`·9· ·contacted me in the hopes of joining this
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`10· ·litigation.· And so, I did speak with them about it,
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`11· ·but I was told afterwards that behind the scenes
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`12· ·there had been some discussions and Dr. Reddy's was
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`13· ·not going to be involved today.
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`14· · · · Q.· ·Okay.· And when were you contacted by
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`15· ·Dr. Reddy's?
`
`16· · · · A.· ·That was the last week in March, first
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`17· ·week in April, I think, because I was out of the
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`18· ·country, so I know it was during that period, but I
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`19· ·can't remember exactly which day.
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`20· · · · Q.· ·And during that contact, they were
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`21· ·specifically talking to you about an IPR related to
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`22· ·the '698?
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`23· · · · A.· ·Correct --
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`24· · · · · · · · · · · ·MR. SWANSON:· Dr. Metz, just
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`25· · · · to -- be careful not to, you know, divulge any
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`·1· · · · of the substantive conversations that you had,
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`·2· · · · but you can answer the basic outline of the
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`·3· · · · question.
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`·4· · · · · · · · · · · ·THE WITNESS:· Can you repeat
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`·5· · · · that question, please?
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`·6· · · · · · · · · · · ·MS. SCORDINO:· Can you read back
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`·7· · · · the question?
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`·8· · · · · · · · · · · · · - - -
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`·9· · · · · · · · · · · ·(Whereupon, the court reporter
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`10· · · · read back the record as requested.)
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`11· · · · · · · · · · · · · - - -
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`12· ·BY MS. SCORDINO:
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`13· · · · Q.· ·So, I'll -- so, I'll ask it --
`
`14· · · · A.· ·I think that's correct, yes.
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`15· · · · Q.· ·And were you engaged with them to
`
`16· ·participate in the IPR related to the '698 patent?
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`17· · · · A.· ·I'm not sure how to exactly answer that
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`18· ·question.· I spoke to them and said yes, I would be
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`19· ·potentially interested in -- in doing that.· We even
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`20· ·started working a little bit on a report, but then I
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`21· ·was told afterwards that this was not going to
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`22· ·happen, so I wasn't engaged as such.· I'm already
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`23· ·engaged with Dr. Reddy's representatives for the
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`24· ·district court litigation, so I wouldn't have had to
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`25· ·be formally engaged for this, I assume.
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`·1· · · · Q.· ·So, with respect to the IPR and the
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`·2· ·petition, you drafted a declaration or you began
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`·3· ·drafting a declaration for Dr. Reddy's?
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`·4· · · · A.· ·I didn't actually produce a document as
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`·5· ·such, but we started talking about how it would
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`·6· ·compare with the document that you have for today's
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`·7· ·discussion.
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`·8· · · · Q.· ·Okay.· And what did you talk about?
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`·9· · · · · · · · · · · ·MR. SWANSON:· Dr. Metz, I would
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`10· · · · caution you not to answer, you know, any
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`11· · · · specifics.· You can talk about the fact that
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`12· · · · you spoke with Dr. Reddy's, but, you know, do
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`13· · · · not answer any questions about the substance of
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`14· · · · those conversations.
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`15· ·BY MS. SCORDINO:
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`16· · · · Q.· ·So, can you answer that question without
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`17· ·your counsel's instruction to not answer?
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`18· · · · A.· ·I don't understand.
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`19· · · · Q.· ·Do you remember the content of that
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`20· ·conversation?
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`21· · · · A.· ·The content of that discussion was --
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`22· · · · · · · · · · · ·MR. SWANSON:· Well, hold on,
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`23· · · · Dr. Metz.
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`24· ·BY MS. SCORDINO:
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`25· · · · Q.· ·So, I'm just asking if you remember the
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`·1· ·content.· He's instructed you not tell me the
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`·2· ·content.· I just want to know if you remember the
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`·3· ·content.
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`·4· · · · A.· ·I -- I remember being contacted. I
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`·5· ·remember saying fine, I will do it.· I remember
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`·6· ·discussing that we would have a similar type report,
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`·7· ·but it never went any further than -- than that.
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`·8· · · · Q.· ·Okay.· When you -- what -- what do you
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`·9· ·mean by "similar type report"?
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`10· · · · · · · · · · · ·MR. SWANSON:· Dr. Metz, I will
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`11· · · · instruct you not to answer that question.
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`12· · · · Counsel --
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`13· · · · · · · · · · · ·MS. SCORDINO:· Okay.· So, Rob is
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`14· · · · it your position that he has been engaged by
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`15· · · · DRL for an IPR petition related to the '698
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`16· · · · patent?
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`17· · · · · · · · · · · ·MR. SWANSON:· No.
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`18· · · · · · · · · · · ·THE WITNESS:· And it's not mine
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`19· · · · either.
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`20· ·BY MS. SCORDINO:
`
`21· · · · Q.· ·Okay.· Then those conversations are not
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`22· ·privileged.· They are not your attorney for purposes
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`23· ·of an IPR if you've not been engaged by them, and
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`24· ·so, you can answer the question.· It's an improper
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`25· ·instruction to not answer.
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`·1· · · · · · · · · · · ·Are you going to -- so, are you
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`·2· ·going to listen to your counsel's instruction, or
`
`·3· ·are you going to answer the question?
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`·4· · · · · · · · · · · ·MR. SWANSON:· Dr. Metz, you can,
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`·5· · · · you know, give -- give some sort of basic
`
`·6· · · · answer as to the question, but, you know,
`
`·7· · · · please move on from this.
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`·8· · · · · · · · · · · ·THE WITNESS:· Okay.
`
`·9· ·BY MS. SCORDINO:
`
`10· · · · Q.· ·So -- so as you're not confused, the
`
`11· ·question is, can you tell me what you meant by, they
`
`12· ·said that you would have a similar report to the one
`
`13· ·that you had already done for the IPR with Mylan.
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`14· · · · A.· ·That the report that would come out of
`
`15· ·that engagement with -- with the -- the IPR would be
`
`16· ·joining this current litigation.· So, I would have
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`17· ·assumed that it would have been a Pozen versus Mylan
`
`18· ·and Dr. Reddy versus Pozen just versus Mylan.· But I
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`19· ·understand that today I am here representing Mylan
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`20· ·and only Mylan.
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`21· · · · Q.· ·Okay.· So, with respect to DRL, what did
`
`22· ·the DRL attorneys tell you about the IPR?
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`23· · · · A.· ·He told me that he was interested in his
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`24· ·company joining the current litigation and I would
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`25· ·-- would I be willing to -- to provide a declaration
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`·1· ·for that as well, along similar lines.· And we then
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`·2· ·went back to my original -- he asked me if I had a
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`·3· ·contract that was exclusive to Mylan or not, and I
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`·4· ·said I didn't think so.
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`·5· · · · · · · · · · · ·And then he sent me the copy of
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`·6· ·my contract and we both looked at it.· I was in
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`·7· ·another continent, so this was all -- it wasn't done
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`·8· ·by face-to-face or by phone.· It was actually done
`
`·9· ·by e-mail.· And I looked at his declaration that
`
`10· ·he -- he sent me, which was the same -- the -- the
`
`11· ·contract that he sent me, which is the same contract
`
`12· ·that I had.· And I said, sure, that seems to me that
`
`13· ·it's okay.· I'm happy to do it.· And then I was
`
`14· ·contacted afterwards and was told that it isn't
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`15· ·happening.· What went on amongst the various
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`16· ·lawyers, I -- I have no idea.
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`17· · · · Q.· ·So, you did not review your declaration
`
`18· ·that you provided to Mylan with DRL's counsel and
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`19· ·start to make edits to it?
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`20· · · · · · · · · · · ·MR. SWANSON:· Objec- -- hold on.
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`21· · · · Objection.· Asked and answered.
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`22· · · · · · · · · · · ·THE WITNESS:· I definitively did
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`23· · · · not do that.· I was told I was actually not
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`24· · · · allowed to share what I had done with Mylan
`
`25· · · · until they had sorted out what they were going
`
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`·1· · · · to do.
`
`·2· ·BY MS. SCORDINO:
`
`·3· · · · Q.· ·Okay.
`
`·4· · · · A.· ·There was a lot of legalese behind the
`
`·5· ·scenes that I think is beyond my understanding of
`
`·6· ·this case.
`
`·7· · · · Q.· ·Did you have any substantive discussions
`
`·8· ·with DRL with respect to the '698 petition and a
`
`·9· ·declaration by yourself?
`
`10· · · · · · · · · · · ·MR. SWANSON:· Objection.· Asked
`
`11· · · · and answered.· Counsel, please move on.
`
`12· · · · · · · · · · · ·THE WITNESS:· No.
`
`13· ·BY MS. SCORDINO:
`
`14· · · · Q.· ·Did you speak with any employees of Mylan
`
`15· ·regarding your IPR declaration?
`
`16· · · · A.· ·No.
`
`17· · · · Q.· ·Did you speak with any authors of the
`
`18· ·prior art regarding your declaration?
`
`19· · · · A.· ·No.· I know many of them, but I have not
`
`20· ·spoken with any of them about this.
`
`21· · · · Q.· ·Did you speak with Dr. Mayersohn about
`
`22· ·your declaration?
`
`23· · · · A.· ·No.
`
`24· · · · Q.· ·Did you speak with Dr. Mayersohn about his
`
`25· ·declaration?
`
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`·1· · · · A.· ·No.
`
`·2· · · · Q.· ·Did you review the deposition transcript
`
`·3· ·of Dr. Mayersohn that was taken earlier this week?
`
`·4· · · · A.· ·No.
`
`·5· · · · Q.· ·Did you discuss the substance of
`
`·6· ·Dr. Mayersohn's deposition in preparation for your
`
`·7· ·deposition today?
`
`·8· · · · · · · · · · · ·MR. SWANSON:· I object.· And,
`
`·9· · · · Dr. Metz, you can give this a yes-or-no answer,
`
`10· · · · but do not discuss any substance of discussions
`
`11· · · · that were had, if any.
`
`12· · · · · · · · · · · ·THE WITNESS:· Yes.
`
`13· ·BY MS. SCORDINO:
`
`14· · · · Q.· ·Did anything in that discussion about
`
`15· ·Dr. Mayersohn's deposition change any of the
`
`16· ·opinions you intend to give today?
`
`17· · · · A.· ·No.
`
`18· · · · Q.· ·Did anything in that discussion about
`
`19· ·Dr. Mayersohn's deposition change any of the
`
`20· ·testimony that you're going to give today?
`
`21· · · · A.· ·No.
`
`22· · · · Q.· ·Are there any statements in your
`
`23· ·declaration -- declaration that you believe are
`
`24· ·wrong or incorrect?
`
`25· · · · A.· ·No.
`
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`·1· · · · Q.· ·How did you come to be an expert retained
`
`·2· ·by just Mylan for this IPR?
`
`·3· · · · A.· ·I -- as you know from prior -- my prior
`
`·4· ·testimony with you, I was contacted by a company I
`
`·5· ·do consulting work for, GLG, as to whether I would
`
`·6· ·be interested in doing a patent law case. I
`
`·7· ·answered yes.· They contacted Perkins Coie, namely
`
`·8· ·Melody Glazer, who had originally made the inquiry,
`
`·9· ·put the two of us in contact with one another.· And
`
`10· ·I was originally actually employed by as a -- by GLG
`
`11· ·in providing service to Mylan.
`
`12· · · · · · · · · · · ·Mylan subsequently expanded that
`
`13· ·to include in addition Dr. Reddy's and Lupin. I
`
`14· ·think there was another company involved, but I
`
`15· ·wasn't involved with them.· It was those three.
`
`16· ·That's the way it's structured at the moment, is if
`
`17· ·I do work for only one of the parties, then I'm only
`
`18· ·billing that party.· If I do work that is in
`
`19· ·combination, then I bill all of the parties.· This
`
`20· ·particular issue is only relating to Mylan, and I
`
`21· ·was told such when we drew it up.
`
`22· · · · Q.· ·So -- so, when did you draw it up, and by
`
`23· ·"it," are you referring to a contract related to
`
`24· ·this IPR?
`
`25· · · · A.· ·I'm -- I'm talking to the -- I'm talking
`
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`·1· ·about the declaration.
`
`·2· · · · Q.· ·Okay.
`
`·3· · · · A.· ·That -- my report that's to be discussed
`
`·4· ·today.· And that was -- I'm going to time it again
`
`·5· ·to my trip.· So, it was towards the middle, end of
`
`·6· ·March.
`
`·7· · · · Q.· ·So, towards the middle, end of March, you
`
`·8· ·were contacted by Mylan attorneys and asked to
`
`·9· ·provide a declaration for this IPR?
`
`10· · · · A.· ·That is correct.
`
`11· · · · · · · · · · · ·Now, maybe it was late February,
`
`12· ·early -- I can't be precise, but it was somewhere
`
`13· ·around the spring.
`
`14· · · · Q.· ·And prior to that contact, had you
`
`15· ·reviewed the '698 patent?
`
`16· · · · A.· ·I honestly don't remember.
`
`17· · · · Q.· ·You are currently an expert on behalf of
`
`18· ·Mylan, DRL, and Lupin in the district court case
`
`19· ·involving the '698 patent, correct?
`
`20· · · · A.· ·I believe so.
`
`21· · · · Q.· ·And do you have a separate engagement
`
`22· ·governing that litigation?
`
`23· · · · A.· ·No.
`
`24· · · · Q.· ·Now, you recently submitted an expert
`
`25· ·report in that litigation, correct?
`
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`·1· · · · A.· ·I don't know what you mean by "recent,"
`
`·2· ·but I have submitted, yes.
`
`·3· · · · Q.· ·And for that expert report, did you work
`
`·4· ·with attorneys from each of the defendants?
`
`·5· · · · · · · · · · · ·MR. SWANSON:· Objection.· What
`
`·6· · · · is the relevance of this questioning to the
`
`·7· · · · IPR?
`
`·8· ·BY MS. SCORDINO:
`
`·9· · · · Q.· ·You can still answer.
`
`10· · · · A.· ·I still can answer?
`
`11· · · · · · · · · · · ·MR. SWANSON:· You can answer.
`
`12· · · · · · · · · · · ·MS. SCORDINO:· Um-hmm.
`
`13· · · · · · · · · · · ·THE WITNESS:· Can you tell me
`
`14· · · · that again?· I'm sorry.
`
`15· · · · · · · · · · · ·MR. SWANSON:· Can you repeat the
`
`16· · · · question?
`
`17· · · · · · · · · · · · · - - -
`
`18· · · · · · · · · · · ·(Whereupon, the court reporter
`
`19· · · · read back the record as requested.)
`
`20· · · · · · · · · · · · · - - -
`
`21· · · · · · · · · · · ·THE WITNESS:· Yes.· Usually --
`
`22· · · · or not usually.· Always with multiple parties
`
`23· · · · represented on a -- on the same meeting by
`
`24· · · · phone usually.· So, I may have been meeting
`
`25· · · · with one person, but there were people from the
`
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`·1· · · · other companies participating.· I -- the only
`
`·2· · · · time I actually had individual contact with one
`
`·3· · · · company only was the discussion about if
`
`·4· · · · Dr. Reddy's was going to join this, as we've
`
`·5· · · · already discussed, and at times with just the
`
`·6· · · · Mylan representatives for this particular
`
`·7· · · · declaration.
`
`·8· · · · · · · · · · · ·MS. SCORDINO:· And, Counsel, on
`
`·9· · · · the record, I'd like to clarify that objections
`
`10· · · · in IPRs are limited to objection to form.· If
`
`11· · · · you believe it's outside the scope, the proper
`
`12· · · · procedure is to make a motion to strike.· Its
`
`13· · · · is -- it is not to insert speaking objections.
`
`14· · · · · · · · · · · ·MR. SWANSON:· And for the
`
`15· · · · record, a relevance objection is not a form
`
`16· · · · objection.
`
`17· · · · · · · · · · · ·You can proceed.
`
`18· · · · · · · · · · · ·MS. SCORDINO:· Again, the way to
`
`19· · · · handle that is with the motion to strike the
`
`20· · · · testimony.
`
`21· ·BY MS. SCORDINO:
`
`22· · · · Q.· ·What is your current occupation, Dr. Metz?
`
`23· · · · A.· ·I'm a gastroenterologist.
`
`24· · · · Q.· ·And do you still treat patients?
`
`25· · · · A.· ·Yes.
`
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`·1· · · · Q.· ·And are you still involved in research?
`
`·2· · · · A.· ·Yes.
`
`·3· · · · Q.· ·What types of research are you involved in
`
`·4· ·currently?
`
`·5· · · · A.· ·My major area of activity at the moment is
`
`·6· ·neuroendocrine tumors and upper GI disease states,
`
`·7· ·with a specific interest in proton pump inhibitors
`
`·8· ·and other antisecretory drugs.· But I have
`
`·9· ·researched protocols in a variety of -- of areas in
`
`10· ·gastroenterology and neuroendocrinology.
`
`11· · · · Q.· ·And what -- how many patients do you
`
`12· ·treat, approximately?
`
`13· · · · A.· ·I have a very big practice.· I do four
`
`14· ·days of clinical work a week, two of which are
`
`15· ·endoscopic, two of which are seeing patients.· I run
`
`16· ·a tumor board once a month that has about 25, 30
`
`17· ·patients on it each time.· My daily patient ex- --
`
`18· ·exposure is probably 15 or 20 patients per day.· And
`
`19· ·I've been doing this for 30 years, so you can
`
`20· ·multiply that up, it's probably thousands and
`
`21· ·thousands.
`
`22· · · · Q.· ·Do you currently write prescriptions?
`
`23· · · · A.· ·Yes.
`
`24· · · · Q.· ·And do you write prescriptions for PPIs?
`
`25· · · · A.· ·All the time.
`
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`·1· · · · Q.· ·And have you ever written a prescription
`
`·2· ·for Vimovo?
`
`·3· · · · A.· ·No.
`
`·4· · · · Q.· ·Do you treat your patients with NSAIDs?
`
`·5· · · · A.· ·I have many, many patients that are on
`
`·6· ·NSAIDs.· I generally do not prescribe NSAIDs.
`
`·7· ·Although, on occasions, rare occasions for specific
`
`·8· ·indications, I will consider NSAIDs and have
`
`·9· ·prescribed NSAIDs.· I do not tend to prescribe
`
`10· ·chronic NSAIDs for arthritic conditions.
`
`11· · · · Q.· ·Do you know what an IPR is?
`
`12· · · · A.· ·I think I do.
`
`13· · · · Q.· ·What's your understanding?
`
`14· · · · A.· ·My understanding is that this is a review
`
`15· ·that is performed by the patent office between a
`
`16· ·party that has a patent and a party that is
`
`17· ·contesting that patent to determine if it is truly a
`
`18· ·valid patent.
`
`19· · · · Q.· ·And do you understand that here, US Patent
`
`20· ·No. 9220698 is being challenged by IPR?
`
`21· · · · A.· ·That is correct.
`
`22· · · · Q.· ·And will you understand -- I think we have
`
`23· ·been -- but if I continue to refer to this as the
`
`24· ·'698 patent?
`
`25· · · · A.· ·Correct.
`
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`·1· · · · Q.· ·In connection with preparing your
`
`·2· ·declaration, did you review the '698 patent?
`
`·3· · · · A.· ·Yes.
`
`·4· · · · Q.· ·When was the last time you reviewed the
`
`·5· ·claims of that patent?
`
`·6· · · · A.· ·Yesterday.
`
`·7· · · · Q.· ·And did you review all seven claims of the
`
`·8· ·patent?
`
`·9· · · · A.· ·I believe so.
`
`10· · · · Q.· ·And did you review all seven claims of the
`
`11· ·patent in connection with preparing your
`
`12· ·declaration?
`
`13· · · · A.· ·Sure.
`
`14· · · · Q.· ·Have you reviewed Mylan's petition for
`
`15· ·IPR?
`
`16· · · · A.· ·Can I see my declaration, so I can see if
`
`17· ·that's attached?
`
`18· · · · Q.· ·Sure.· Sure.· I'll represent to you that
`
`19· ·it's -- that it's not attached.· It's the petition
`
`20· ·that your declaration supports that was filed with
`
`21· ·the PTAB.
`
`22· · · · A.· ·That it's not in Appendix B?
`
`23· · · · Q.· ·No.
`
`24· · · · A.· ·Then I did not.
`
`25· · · · Q.· ·Okay.· But I will give you your
`
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`·1· ·declaration, so I'm handing you what's already been
`
`·2· ·marked as Exhibit 1002.
`
`·3· · · · A.· ·It looks -- oh, it's got my CV.· I was
`
`·4· ·trying to work out why it's so thick.· Okay.
`
`·5· · · · Q.· ·Did you review the Patent Office
`
`·6· ·institution of the IPR for the '698?
`
`·7· · · · A.· ·The Patent Office institution, is that a
`
`·8· ·document or a building or...
`
`·9· · · · Q.· ·It's a decision.· It's a -- it's a
`
`10· ·document.· So, the Patent Office instituted the IPR
`
`11· ·in this case, and so, they provided a decision as to
`
`12· ·why they --
`
`13· · · · A.· ·As to whether this can go forward, no.
`
`14· · · · Q.· ·So, I -- I believe you said that you were
`
`15· ·contacted by Mylan about this IPR at the middle or
`
`16· ·end of March.· When did you begin working on the
`
`17· ·declaration for the IPR?
`
`18· · · · A.· ·Immediately, because I was -- I knew I was
`
`19· ·going away, and we have a -- a brief period, a few
`
`20· ·weeks really to get that together before I left.
`
`21· · · · Q.· ·Are you aware that the district court
`
`22· ·issued an opinion in the first round of litigation,
`
`23· ·the litigation where you testified at trial?
`
`24· · · · A.· ·I -- I do.· I am.
`
`25· · · · Q.· ·And did you review that opinion?
`
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`·1· · · · A.· ·No.
`
`·2· · · · Q.· ·And what's your understanding of that
`
`·3· ·opinion?
`
`·4· · · · A.· ·That it is being appealed by our side.
`
`·5· · · · Q.· ·Do you know specifically what's being
`
`·6· ·appealed?
`
`·7· · · · A.· ·No.
`
`·8· · · · Q.· ·Are you aware that the opinion involves
`
`·9· ·patents that are listed in the Orange Book
`
`10· ·concerning Vimovo?
`
`11· · · · A.· ·I don't know what the Orange Book is.
`
`12· · · · Q.· ·So, you're not familiar with the FDA's
`
`13· ·Orange Book?
`
`14· · · · A.· ·I -- I know who the FDA are, but I'm not
`
`15· ·sure what you're referring to when you say the
`
`16· ·Orange Book.
`
`17· · · · Q.· ·Okay.· Would you agree with me that the
`
`18· ·two patents in the earlier litigation are related to
`
`19· ·Vimovo?
`
`20· · · · · · · · · · · ·MR. SWANSON:· Object to form.
`
`21· · · · · · · · · · · ·THE WITNESS:· I don't think
`
`22· · · · either of the two patents you're referring to
`
`23· · · · use the word "Vimovo" anywhere, but I think
`
`24· · · · they refer to the materials that are used to
`
`25· · · · make up Vimovo.· So, from one step removed, I'd
`
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`·1· · · · say yes.
`
`·2· ·BY MS. SCORDINO:
`
`·3· · · · Q.· ·And would you agree with me that the '698
`
`·4· ·patent that we're here to talk about today is also
`
`·5· ·related to Vimovo?
`
`·6· · · · · · · · · · · ·MR. SWANSON:· Object to form.
`
`·7· · · · · · · · · · · ·THE WITNESS:· I would agree.
`
`·8· ·BY MS. SCORDINO:
`
`·9· · · · Q.· ·And are you being compensated at $700 an
`
`10· ·hour for your work in this matter?
`
`11· · · · A.· ·That is correct.
`
`12· · · · Q.· ·And as -- about how many hours have you
`
`13· ·billed to the IPR declaration and preparing for this
`
`14· ·deposition?
`
`15· · · · A.· ·How many I've billed would be so far, I
`
`16· ·would say, two or three hours.
`
`17· · · · Q.· ·And is that about the amount of time you
`
`18· ·spent working on your declaration for this IPR?
`
`19· · · · A.· ·Well, it would be almost entirely working
`
`20· ·on the declaration.· But I haven't billed all my
`
`21· ·time yet.
`
`22· · · · Q.· ·So, approximately, how much time have you
`
`23· ·spent working on this matter?
`
`24· · · · A.· ·Well, I've billed up through the end of
`
`25· ·March, I believe.· I have an outstanding bill for
`
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`·1· ·some monies in April, although I can't say how much
`
`·2· ·of that was for this and how much of that was for
`
`·3· ·everything else without guessing.· And then I
`
`·4· ·haven't billed anything for May, which would really
`
`·5· ·primarily include yesterday's preparation, so that
`
`·6· ·hasn't really been included yet, which was about
`
`·7· ·five hours, I think.
`
`·8· · · · Q.· ·Did you talk to anyone on the phone
`
`·9· ·yesterday during your preparation with Mr. Swanson?
`
`10· · · · A.· ·Yes.· My sister called me in the midst of
`
`11· ·it.
`
`12· · · · Q.· ·Did you talk to anyone on the phone about
`
`13· ·the substance of your declaration or the substance
`
`14· ·of your testimony today?
`
`15· · · · A.· ·No.
`
`16· · · · Q.· ·Can you describe for me the process by
`
`17· ·which your declaration was created?
`
`18· · · · A.· ·Well, it was a collaboration really, since
`
`19· ·I'm unaware of all the legalese and -- as I keep on
`
`20· ·getting reminded during these -- these discussions.
`
`21· ·And I find that doing this kind of work for patent
`
`22· ·law specifically very, very confusing.
`
`23· · · · · · · · · · · ·So, I have my medical knowledge
`
`24· ·and proposals, and the lawyers have the legalese
`
`25· ·side of it, and essentially a document arises from
`
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`·1· ·back and forth discussions and e-mails and phone
`
`·2· ·calls, et cetera.· So, it was a true collaboration.
`
`·3· ·I would say that the original -- the order of who I
`
`·4· ·am and what I do and what the legal requirements are
`
`·5· ·and what I've been told is sort of all stated up
`
`·6· ·front by the lawyers.· And my involvement is
`
`·7· ·primarily to accept that and understand that and
`
`·8· ·provide medical, clinical input as necessary to
`
`·9· ·support my comments to which I assign.
`
`10· · · · Q.· ·Which attorneys did you work with?
`
`11· · · · A.· ·With Autumn Nero, Melody Glazer, and Rob
`
`12· ·Swanson.
`
`13· · · · Q.· ·Any other attorneys?
`
`14· · · · A.· ·Not that -- for this IPR, no one else
`
`15· ·jumps to my mind.· I don't think there are any
`
`16· ·others.· There may have been, but I'm not -- I'm not
`
`17· ·sure.· I don't think so.
`
`18· · · · Q.· ·Can we turn to Attachment B in your
`
`19· ·declaration?
`
`20· · · · A.· ·Got it.
`
`21· · · · Q.· ·These are the materials you reviewed for
`
`22· ·your declaration, correct?
`
`23· · · · A.· ·That is correct.
`
`24· · · · Q.· ·And these are the materials you rely on
`
`25· ·for your opinions, correct?
`
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`·1· · · · A.· ·Correct.
`
`·2· · · · Q.· ·How did you select these materials?
`
`·3· · · · A.· ·Well, I know of the
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