`
`MANSOOR AMIJI - 02/22/2017MANSOOR AMIJI - 02/22/2017
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`·
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`·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.,
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`·6· · · · · · · · · ·Petitioner
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`·7· · · · · · · · · · · ·v.
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`·8· · · · · · · · ALLERGAN, INC.,
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`·9· · · · · · · · · Patent Owner
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`10· · · · · · · · · ____________
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`11· · · · · · · ·Case IPR2016-01127
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`12· · · · · · · · Patent 8,685,930
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`13· · · · · · · ·Case IPR2016-01128
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`14· · · · · · · · Patent 8,629,111
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`15· · · · · · · ·Case IPR2016-01129
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`16· · · · · · · · Patent 8,642,556
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`17· · · · · · · ·Case IPR2016-01130
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`18· · · · · · · · Patent 8,633,162
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`19· · · · · · · ·Case IPR2016-01131
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`20· · · · · · · · Patent 8,648,048
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`21· · · · · · · ·Case IPR2016-01132
`
`22· · · · · · · · Patent 9,248,191
`· · · · · · · · · · ____________
`23
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`24· · · ·DEPOSITION OF MANSOOR AMIJI, Ph.D.
`
`25· · ·Wednesday, February 22, 2017 9:10 a.m.
`
`
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`1
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`ALL 2023
`MYLAN PHARMACEUTICALS V. ALLERGAN
`IPR2016-01128
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`

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`·1· · · · · · · · Fish & Richardson P.C.
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`·1· · · · · · · · · · · I N D E X
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`MANSOOR AMIJI - 02/22/2017MANSOOR AMIJI - 02/22/2017
`Page 2
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`Pages 2..5
`Page 4
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`·2· · · ·One Marina Park Drive, Boston, MA 02210
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`·2· ·WITNESS· · · · DIRECT· · CROSS· · REDIRECT
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`·3
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`·4· ·Reported by:
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`·3· ·MANSOOR AMIJI, Ph.D.
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`·4· ·By Ms. Coletti· ·5
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`·5· ·Janet Sambataro, RMR, CRR, CLR
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`·6· ·JOB NO. LA-115711
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`·5
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`·6
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`·7
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`·8
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`·7· · · · · · · PREVIOUSLY MARKED EXHIBITS
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`·8· ·Number· · · · · · · · · · · · · · · · · · Page
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`·9· · · · · · · · · · · ·February 22, 2017
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`·9· ·Exhibit 1001· · · · · · · · · · · · · · · ·44
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`10· · · · · · · · · · · ·9:10 a.m.
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`10· ·Exhibit 1002 in IPR 2016-01129· · · · · · ·16
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`11
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`12
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`11· ·Exhibit 1002 in IPR 2016-01128· · · · · · ·16
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`12· ·Exhibit 1002 in IPR 2016-01129· · · · · · ·16
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`13· · · · Deposition of MANSOOR AMIJI, PH.D., held
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`13· ·Exhibit 1002 in IPR 2016-01130· · · · · · ·17
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`14· ·at the offices of Fish & Richardson P.C., One
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`14· ·Exhibit 1002 in IPR 2016-01131· · · · · · ·17
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`15· ·Marina Park Drive, Boston, Massachusetts,
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`15· ·Exhibit 1002 in IPR 2016-01132· · · · · · ·17
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`16· ·pursuant to Agreement before Janet Sambataro, a
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`16· ·Exhibit 1003· · · · · · · · · · · · · · · ·18
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`17· ·Registered Merit Reporter, Certified Realtime
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`17· ·Exhibit 1004· · · · · · · · · · · · · · · ·44
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`18· ·Reporter, Certified LiveNote Reporter, and a
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`18· ·Exhibit 1006· · · · · · · · · · · · · · · ·46
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`19· ·Notary Public within and for the Commonwealth of
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`19· ·Exhibit 1007· · · · · · · · · · · · · · · ·47
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`20· ·Massachusetts.
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`21
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`22
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`23
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`24
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`25
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`·1· ·APPEARANCES:
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`·2· ·FISH & RICHARDSON P.C.
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`·3· ·(By Susan Morrison Coletti, Esquire)
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`Page 3
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`·4· ·222 Delaware Avenue
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`·5· ·Wilmington, Delaware 19899
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`·6· ·302.652.5070
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`·7· ·coletti@fr.com
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`·8· ·Counsel for the Petitioner
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`·9· ·- and -
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`10· ·FISH & RICHARDSON P.C.
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`11· ·(By Tasha M. Francis, Ph.D., Esquire)
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`12· ·3200 RBC Plaza
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`13· ·60 South Sixth Street
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`14· ·Minneapolis, Minnesota 55402
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`15· ·612.335.5070
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`16· ·Counsel for the Petitioner
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`17
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`18· ·WILSON SONSINI GOODRICH & ROSATI
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`19· ·(By Jad Mills, Esquire)
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`20· ·701 Fifth Avenue, Suite 5100
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`21· ·Seattle, Washington 98104
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`22· ·206.883.2554
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`23· ·jmills@wsgr.com
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`24· ·Counsel for the Respondent
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`25
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`20· ·Exhibit 1008· · · · · · · · · · · · · · · ·47
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`21· ·Exhibit 1009· · · · · · · · · · · · · · · ·162
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`22· ·Exhibit 1015· · · · · · · · · · · · · · · ·106
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`23
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`24
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`25
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`Page 5
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`·1· · · · · · · · P R O C E E D I N G S
`·2· · · · · · · · MANSOOR AMIJI, Ph.D.,
`·3· ·having been duly sworn, after presenting
`·4· ·identification in the form of a driver's license,
`·5· ·deposes and says as follows:
`·6· · · · · · · · · DIRECT EXAMINATION
`·7· ·BY MS. COLETTI:
`·8· · · · Q.· ·Good morning, Dr. Amiji.
`·9· · · · A.· ·Good morning.
`10· · · · Q.· ·Can you please state and spell your
`11· ·name for the record.
`12· · · · A.· ·Mansoor, spelled M-A-N-S-O-O-R, middle
`13· ·initial M., as in Mary, last name A-M-I-J-I.
`14· · · · Q.· ·And can you please state your business
`15· ·address.
`16· · · · A.· ·Northeastern University, 360 Huntington
`17· ·Avenue, Boston, Massachusetts 02115.
`18· · · · Q.· ·Now, before I get started into the
`19· ·substance of today's deposition, I'll go over a
`20· ·few ground rules.
`21· · · · I believe you've been deposed before.· Is
`22· ·that right?
`23· · · · A.· ·Yes.
`24· · · · Q.· ·So you probably know some of these, but
`25· ·I'll go over them anyway.
`
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`Pages 6..9
`Page 8
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`MANSOOR AMIJI - 02/22/2017MANSOOR AMIJI - 02/22/2017
`Page 6
`·1· · · · You understand you're under oath.· The court
`·2· ·reporter just swore you in.· Right?
`·3· · · · A.· ·Yes.
`·4· · · · Q.· ·And you understand that any testimony
`·5· ·that you give today can be used in the IPR
`·6· ·proceeding that we're here today talking about.
`·7· ·You understand that.· Right?
`·8· · · · A.· ·Yes.
`·9· · · · Q.· ·And you understand that the testimony
`10· ·that you give today is the same as if you were
`11· ·giving it in court.
`12· · · · Do you understand that as well?
`13· · · · A.· ·Yes.
`14· · · · Q.· ·And so you understand that it's
`15· ·important to testify completely and truthfully
`16· ·and accurately.· Right?
`17· · · · A.· ·Yes.
`18· · · · Q.· ·Because our court reporter here is
`19· ·recording our conversation, it's important that
`20· ·you verbalize your answers, so "yes" or "no" as
`21· ·opposed to nodding or shaking your head.· Do you
`22· ·understand that?
`23· · · · A.· ·Yes.
`24· · · · Q.· ·And it's important that we don't speak
`25· ·over each other.· So I will try to let you finish
`
`·1· · · · A.· ·Sure.
`·2· · · · Q.· ·Now, I think you said already you have
`·3· ·been deposed before.· Is that correct?
`·4· · · · A.· ·Yes.
`·5· · · · Q.· ·About how many times?
`·6· · · · A.· ·Five or six times.
`·7· · · · Q.· ·And always as an expert witness or in
`·8· ·other capacities as well?
`·9· · · · A.· ·In some of the cases, I've -- in other
`10· ·capacities as well.
`11· · · · Q.· ·And let's talk about the expert witness
`12· ·work first.· What sorts of cases were they?· Were
`13· ·they all patent infringements?· Were there other
`14· ·kinds of cases in which you testified as an
`15· ·expert?
`16· · · · A.· ·Some were patent infringement.· There
`17· ·are also other types of cases.
`18· · · · Q.· ·What were the other types?
`19· · · · A.· ·Contract disputes.
`20· · · · Q.· ·Okay.· What else?
`21· · · · A.· ·There was also one case that involved a
`22· ·university that was -- the plaintiffs were
`23· ·St. John's University, and they were suing and I
`24· ·was asked to serve as an expert to look at the
`25· ·technical aspect of the case.
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`Page 7
`·1· ·an answer before I ask my next question, and I'd
`·2· ·ask that you allow me to finish my question
`·3· ·before you give your answer.· Is that okay?
`·4· · · · A.· ·Yes.
`·5· · · · Q.· ·Your attorney may object from time to
`·6· ·time, but unless for some reason he instructs you
`·7· ·not to answer the question, do you understand
`·8· ·you're obligated to answer my question as best
`·9· ·you can?
`10· · · · A.· ·Yes.
`11· · · · Q.· ·If one of my questions is confusing or
`12· ·if you need some clarification, please let me
`13· ·know and I'll try to rephrase it.· Okay?
`14· · · · A.· ·Yes.
`15· · · · Q.· ·So then is it fair to assume that if
`16· ·you answer my question, that you've understood
`17· ·it?
`18· · · · A.· ·Yes.
`19· · · · Q.· ·Dr. Amiji, is there any reason, medical
`20· ·or otherwise, that you can't give complete,
`21· ·truthful and accurate testimony today?
`22· · · · A.· ·No.
`23· · · · Q.· ·And if that ever changes during the
`24· ·course of the day, if you start to feel ill, just
`25· ·let me know.· Is that okay?
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`Page 9
`·1· · · · Q.· ·What was the dispute about in that
`·2· ·case?· Do you recall?
`·3· · · · A.· ·It involved patents, but not
`·4· ·necessarily from infringement side.· It was just
`·5· ·the patents and who were the owners, the rightful
`·6· ·owners of the patents.
`·7· · · · Q.· ·I see.· And what about cases where you
`·8· ·were not serving as an expert witness?· What
`·9· ·sorts of cases were those?· I think you said you
`10· ·were deposed in cases where you were not an
`11· ·expert witness.· Is that right?
`12· · · · A.· ·No.· I'm not sure I said that.
`13· · · · Q.· ·Maybe I misunderstood you, then.· So in
`14· ·all these five or six depositions that you gave,
`15· ·you were always an expert witness.· Is that
`16· ·right?
`17· · · · A.· ·Yes.· I was asked to serve as an expert
`18· ·looking at the technical matters.
`19· · · · Q.· ·Okay.· When was the last time you were
`20· ·deposed?
`21· · · · A.· ·November of last year.
`22· · · · Q.· ·And what did that relate to, generally?
`23· ·Was that a patent infringement case?
`24· · · · A.· ·Yes.
`25· · · · Q.· ·What was the technology, generally?
`
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`MANSOOR AMIJI - 02/22/2017MANSOOR AMIJI - 02/22/2017
`Page 10
`·1· · · · A.· ·It was a drug formulation patent.
`·2· · · · Q.· ·Was it a Hatch-Waxman case or ANDA
`·3· ·case?
`·4· · · · A.· ·Yes.
`·5· · · · Q.· ·Have you ever been deposed in an IPR
`·6· ·proceeding before?
`·7· · · · A.· ·No, I haven't.
`·8· · · · Q.· ·Have you ever served as an expert
`·9· ·witness in an IPR proceeding, before this one?
`10· · · · A.· ·Yeah.· I don't believe I have served on
`11· ·an IPR proceeding before.
`12· · · · Q.· ·In all of the cases where you were --
`13· ·excuse me, in all of the patent cases where you
`14· ·served as an expert witness, were they all
`15· ·Hatch-Waxman cases?
`16· · · · A.· ·No.· As I said before, I have served on
`17· ·cases like the St. John's case I mentioned, which
`18· ·also involved patents, but it wasn't a
`19· ·Hatch-Waxman case.
`20· · · · Q.· ·But that wasn't a patent infringement
`21· ·case?· Is that right?
`22· · · · A.· ·No.· It wasn't a patent infringement.
`23· · · · Q.· ·So limiting it just to the patent
`24· ·infringement cases that you have served as an
`25· ·expert on, were all of those Hatch-Waxman cases?
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`Pages 10..13
`Page 12
`·1· · · · Q.· ·So a good chunk of the business day.
`·2· ·Is that fair?
`·3· · · · A.· ·Yeah.
`·4· · · · Q.· ·And which lawyers were present?· The
`·5· ·lawyers that are here?
`·6· · · · A.· ·Yes.· All three of them.
`·7· · · · Q.· ·All three of them.· Was anyone else
`·8· ·present?
`·9· · · · A.· ·Mr. Parmelee was on the call yesterday,
`10· ·just for a few -- maybe an hour or so.
`11· · · · Q.· ·Was anyone else present in the room
`12· ·with you and the lawyers yesterday or the day
`13· ·before when you were preparing for the
`14· ·deposition?
`15· · · · A.· ·No.
`16· · · · Q.· ·And did you speak to anyone else, other
`17· ·than lawyers, in preparation for your deposition?
`18· · · · A.· ·No.
`19· · · · Q.· ·You said you read the patents, the
`20· ·prosecution histories.· What other documents did
`21· ·you read besides those?
`22· · · · A.· ·The declarations, my declarations. I
`23· ·also reviewed some of the exhibits that are
`24· ·attached to the declarations.
`25· · · · Q.· ·Was there anything outside the
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`Page 11
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`·1· · · · A.· ·Yes.
`·2· · · · Q.· ·And have you ever been an expert
`·3· ·witness in a case related to ophthalmic drugs
`·4· ·before?
`·5· · · · A.· ·No, I have not.
`·6· · · · Q.· ·Did you do anything to prepare for
`·7· ·today's deposition?
`·8· · · · A.· ·Yes.
`·9· · · · Q.· ·What did you do?
`10· · · · A.· ·I read my declarations.· I read
`11· ·patents.· I read the prosecution history.· I read
`12· ·a lot of documents.
`13· · · · Q.· ·Did you meet with anyone to prepare for
`14· ·today's deposition?
`15· · · · A.· ·Yes.
`16· · · · Q.· ·Who did you meet with?
`17· · · · A.· ·With attorneys.
`18· · · · Q.· ·When did you do that?
`19· · · · A.· ·The day before yesterday and yesterday.
`20· · · · Q.· ·For about how long?
`21· · · · A.· ·Just a few hours both days.
`22· · · · Q.· ·A few hours each day?
`23· · · · A.· ·Yes.
`24· · · · Q.· ·About how many?
`25· · · · A.· ·Maybe five or six hours.
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`Page 13
`·1· ·declarations, the attachments, and the patents
`·2· ·that you reviewed?· So anything that you didn't
`·3· ·cite in your declarations?
`·4· · · · A.· ·No.
`·5· · · · Q.· ·Okay.· And did you review those on your
`·6· ·own or did you review them with the lawyers or
`·7· ·both?
`·8· · · · A.· ·Some of it I reviewed on my own.
`·9· ·Sometimes we would have some discussions, and
`10· ·we'd do it together.
`11· · · · Q.· ·And when did you start preparing for
`12· ·the deposition?
`13· · · · A.· ·Maybe about two weeks ago.
`14· · · · Q.· ·Did you read all of your declarations
`15· ·again or did you focus on any one in particular?
`16· · · · A.· ·No.· I read all, and specifically
`17· ·looking at all.· I also looked at the IPR
`18· ·decision that came from the patent board.
`19· · · · Q.· ·The institution decision?
`20· · · · A.· ·Correct.
`21· · · · Q.· ·Is that what you mean?
`22· · · · A.· ·Yes.
`23· · · · Q.· ·Do you understand, Dr. Amiji, that
`24· ·there is a concurrent litigation going on between
`25· ·Allergan and Mylan or Restasis in District Court?
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`Pages 14..17
`Page 16
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`MANSOOR AMIJI - 02/22/2017MANSOOR AMIJI - 02/22/2017
`Page 14
`·1· · · · A.· ·I was informed of that a long time ago,
`·2· ·but I haven't really had any interactions on
`·3· ·that.
`·4· · · · Q.· ·Do you know anything about that
`·5· ·litigation?
`·6· · · · A.· ·No, I don't.
`·7· · · · Q.· ·Have you reviewed any documents or
`·8· ·court orders from that proceeding?
`·9· · · · A.· ·No.
`10· · · · Q.· ·Has anyone talked to you about any
`11· ·documents or court orders from that proceeding?
`12· · · · · · ·MR. MILLS:· I'm just going to register
`13· ·an objection on the basis of privilege and
`14· ·attorney work product.· And to the extent that
`15· ·the question inquires into any conversations with
`16· ·counsel, then I would instruct you to not answer
`17· ·with regards to conversations with counsel.
`18· · · · · · ·MS. COLETTI:· Dr. Amiji is an expert
`19· ·witness.· There is no privilege between lawyers
`20· ·and an expert witness.· So I think that's an
`21· ·improper instruction.
`22· ·BY MS. COLETTI:
`23· · · · Q.· ·So did anyone tell you anything about
`24· ·the Court orders or the proceedings in the
`25· ·District Court?
`
`·1· ·Mylan's ANDA has been approved or not?
`·2· · · · A.· ·No, I don't.
`·3· · · · Q.· ·And you don't have any knowledge
`·4· ·regarding any problems Mylan may or may not be
`·5· ·having with its ANDA.· Is that right?
`·6· · · · A.· ·That's right.
`·7· · · · Q.· ·And have you been asked to serve as an
`·8· ·expert witness in the District Court litigation?
`·9· · · · A.· ·No, I have not.
`10· · · · Q.· ·Okay.· I'm going to hand you,
`11· ·Dr. Amiji, and I'm going to read them one by one,
`12· ·but these are all your declarations but so our
`13· ·record is clear.
`14· · · · So first I have what has been marked as
`15· ·Exhibit 1002 in IPR 2016-01127, and it's your
`16· ·declaration related to the '930 patent.
`17· · · · Then I'm going to hand you what's been
`18· ·marked as Exhibit 1002 in IPR 2016-01128.· It's
`19· ·your declaration related to the '111 patent.
`20· · · · · · ·MR. MILLS:· Do you have copies of any
`21· ·of these documents?
`22· · · · · · ·MS. COLETTI:· I do.· I'll hand you a
`23· ·whole pile in just a moment.
`24· · · · Q.· ·Next I have what's been marked as
`25· ·Exhibit 1002 in IPR 2016-01129.· It's your
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`Page 15
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`·1· · · · A.· ·No.
`·2· · · · · · ·MR. MILLS:· Same instruction.
`·3· · · · Q.· ·And have you asked for any documents
`·4· ·from that proceeding?· You said you didn't review
`·5· ·anything.
`·6· · · · Have you asked for anything but not gotten
`·7· ·it?
`·8· · · · A.· ·No.
`·9· · · · Q.· ·Do you know anything about Mylan's ANDA
`10· ·or Mylan's generic product?
`11· · · · A.· ·No.
`12· · · · Q.· ·Do you know anything about any of the
`13· ·other -- let me step back a minute.
`14· · · · Do you know anything about whether there are
`15· ·other generic companies attempting to make
`16· ·generic versions of Restasis?
`17· · · · A.· ·No, I don't.
`18· · · · Q.· ·Have you been contacted by lawyers for
`19· ·any of the other generic companies regarding
`20· ·Restasis?
`21· · · · A.· ·No, I have not.
`22· · · · Q.· ·And do you know the status of Mylan's
`23· ·ANDA with FDA?
`24· · · · A.· ·No, I don't.
`25· · · · Q.· ·So fair to say you don't know whether
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`Page 17
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`·1· ·declaration related to the '556 patent.
`·2· · · · Then I've got what has been marked as
`·3· ·Exhibit 1002 in IPR 2016-01130.· It's your
`·4· ·declaration related to the '162 patent.
`·5· · · · Next is Exhibit 1002 in IPR 2016-01131.
`·6· ·It's your declaration related to the '048 patent.
`·7· ·And then finally, Exhibit 1002 in IPR 2016-01132.
`·8· ·It's your declaration related to the '191 patent.
`·9· · · · And, Dr. Amiji, you have your six
`10· ·declarations in front of you?· Are all of those
`11· ·in front of you?
`12· · · · A.· ·Yes.
`13· · · · Q.· ·For purposes of today's questioning,
`14· ·I'm going to focus mostly on the second document
`15· ·we marked.· It's the one for the '111 patent.· So
`16· ·if you'd like to reference any of the others, you
`17· ·have all of them.· But that's the one I'm going
`18· ·to spend most of my time questioning on.
`19· · · · And I see, Dr. Amiji, you have a binder of
`20· ·documents in front of you.· What's in your binder
`21· ·that you brought with you today?
`22· · · · A.· ·So that's the same, the declarations
`23· ·and then the corresponding patents.
`24· · · · Q.· ·Okay.· And is there anything in your
`25· ·binder that's marked up or in any way is
`
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`MANSOOR AMIJI - 02/22/2017MANSOOR AMIJI - 02/22/2017
`Page 18
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`·1· ·highlighted or underlined?
`·2· · · · A.· ·No, it's not.
`·3· · · · Q.· ·It's just clean copies of the same
`·4· ·documents I just handed you?
`·5· · · · A.· ·Yes.
`·6· · · · Q.· ·All right.· So let me also hand you
`·7· ·what was marked as Exhibit 1003 -- and I believe,
`·8· ·Counsel, you already have this one -- to each of
`·9· ·your declarations.· It's your CV.
`10· · · · And I want to start out by discussing your
`11· ·education and experience a little bit.· And you
`12· ·have your CV there in front of you.· So can you
`13· ·start by telling me about your education
`14· ·beginning after high school.
`15· · · · A.· ·So I did my bachelor's degree in
`16· ·pharmacy at Northeastern University, and I
`17· ·graduated in 1988.· And then went on to do my
`18· ·Ph.D. at Purdue University in West Lafayette,
`19· ·Indiana.· And I graduated from there in '92.
`20· · · · And then I worked for a company in Madison,
`21· ·Wisconsin, called Columbia Research Labs until
`22· ·December of '92.
`23· · · · And in January of 1993, I came back to
`24· ·Northeastern University as an assistant
`25· ·professor.· And I've been at Northeastern now for
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`Pages 18..21
`Page 20
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`·1· · · · A.· ·For oral, mucosal delivery and
`·2· ·transdermal delivery.
`·3· · · · Q.· ·Were you working on a particular drug
`·4· ·or were you developing a drug delivery platform
`·5· ·or system?
`·6· · · · A.· ·Both.
`·7· · · · Q.· ·What was the particular drug you were
`·8· ·working on?
`·9· · · · A.· ·There were several products.· One that
`10· ·is still commercially available called Replens.
`11· · · · Q.· ·What is does Replens do?
`12· · · · A.· ·It's a moisturizer for post menopausal
`13· ·women, a vaginal moisturizer.
`14· · · · Q.· ·And other than that product, Replens,
`15· ·what other products were you working on?
`16· · · · A.· ·So oral products using hydrogel
`17· ·technology.· There was also work that we're doing
`18· ·related to use of chewing gum-based delivery
`19· ·systems.
`20· · · · Q.· ·All right.· And when you went back to
`21· ·Northeastern in January of 1993, you set up your
`22· ·own lab?
`23· · · · A.· ·Yes.
`24· · · · Q.· ·Is that fair to say?
`25· · · · A.· ·Yes.
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`Page 19
`·1· ·24 years, and climbed from assistant professor to
`·2· ·my current position, which is university
`·3· ·distinguished professor.
`·4· · · · Q.· ·How long were you at -- I'm going to
`·5· ·work backwards.· How long were you at, I think
`·6· ·you said, Columbia Research Labs in Madison?
`·7· ·Just a few months?· Is that right?
`·8· · · · A.· ·That's correct.· From July '92 to
`·9· ·December '92.
`10· · · · Q.· ·And what was your work there, just
`11· ·generally?
`12· · · · A.· ·I was a senior research --
`13· · · · · · ·(Discussion off the record.)
`14· · · · Q.· ·Sorry about that.· You were saying --
`15· ·you were telling me about your work at Columbia
`16· ·Research Labs.· I think you started to say you
`17· ·were a senior research...
`18· · · · A.· ·Scientist at Columbia.· I started there
`19· ·right after I finished my Ph.D., and I was -- it
`20· ·was a small startup company that was started by a
`21· ·professor at the University of Wisconsin,
`22· ·Madison, a pharmacy professor named Joe Robinson.
`23· · · · Q.· ·And what sorts of work were you doing?
`24· · · · A.· ·I was developing drug formulations.
`25· · · · Q.· ·For what kind of application?
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`Page 21
`·1· · · · Q.· ·Okay.· And you have -- I think you said
`·2· ·your bachelor's was in pharmacy.
`·3· · · · A.· ·Yes.
`·4· · · · Q.· ·And what was your Ph.D. in?
`·5· · · · A.· ·In pharmaceutical sciences.
`·6· · · · Q.· ·And what was your thesis?
`·7· · · · A.· ·So I was interested in looking at how
`·8· ·materials interact with biological fluid,
`·9· ·especially with blood, and the properties of
`10· ·materials and how they interact with blood
`11· ·components.
`12· · · · Q.· ·You did not go to medical school.· Is
`13· ·that fair?
`14· · · · A.· ·No.· I did not go to medical school.
`15· · · · Q.· ·So you're not a physician.· Is that
`16· ·right?
`17· · · · A.· ·Yes.· I'm not a physician.
`18· · · · Q.· ·And you're also not an ophthalmologist.
`19· ·Fair?
`20· · · · A.· ·No.· I'm not an ophthalmologist.
`21· · · · Q.· ·So is it fair to say you've never
`22· ·treated any ocular disease in patients?
`23· · · · · · ·MR. MILLS:· Objection.· Form.
`24· · · · A.· ·I have not treated any patients with
`25· ·ocular diseases.· I've done work, as shown in my
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`Pages 22..25
`Page 24
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`MANSOOR AMIJI - 02/22/2017MANSOOR AMIJI - 02/22/2017
`Page 22
`·1· ·CV, on drug formulations for treating ocular
`·2· ·disorders.
`·3· · · · Q.· ·But you've never treated a patient with
`·4· ·dry eye.· Is that fair?
`·5· · · · A.· ·No.· I have not.
`·6· · · · Q.· ·Is it also fair to say you've never
`·7· ·done a clinical trial on an ocular drug?
`·8· · · · A.· ·No, I have not.
`·9· · · · Q.· ·And have you ever evaluated the results
`10· ·of a clinical trial on an ocular drug?
`11· · · · A.· ·Not specifically on ocular drug, but I
`12· ·have evaluated clinical trial results.
`13· · · · Q.· ·And I looked at your CV.· Is it fair to
`14· ·say you don't have any publications that are
`15· ·specifically on ocular or ophthalmic drugs?
`16· · · · A.· ·I may not have specific publications,
`17· ·but I have worked on ocular formulations and
`18· ·certainly have also consulted with companies on
`19· ·ocular formulations.
`20· · · · Q.· ·Your CV, I think I counted, it's 88
`21· ·pages.· Is that right?
`22· · · · A.· ·Yes.
`23· · · · Q.· ·Would it surprise you to know that the
`24· ·word "eye" does not appear anywhere in your
`25· ·88-page CV?
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`·1· ·there or not.
`·2· · · · Q.· ·I think you said you have worked on
`·3· ·ocular delivery systems.
`·4· · · · A.· ·Yes.
`·5· · · · Q.· ·Can you tell me about that?
`·6· · · · A.· ·Yes.· I worked on materials, polymeric
`·7· ·systems that are administered in the eye.· I'm
`·8· ·especially interested in materials that respond
`·9· ·to different stimuli and how they can create a
`10· ·locally acting therapeutic.
`11· · · · I also worked with lipid-based delivery
`12· ·systems.· I worked with cyclosporin.
`13· · · · Q.· ·Is it fair to say that you've never
`14· ·worked on a cyclosporin formulation for the eye,
`15· ·though.· Is that right?
`16· · · · A.· ·I've worked with emulsion-based
`17· ·delivery system for cyclosporin.
`18· · · · Q.· ·But not for the eye?
`19· · · · A.· ·No.· Not for the eye.
`20· · · · Q.· ·And you said you've worked on polymeric
`21· ·delivery systems.
`22· · · · A.· ·Yes.
`23· · · · Q.· ·How do those relate to an ophthalmic or
`24· ·ocular delivery system?
`25· · · · A.· ·They increase residence time in the
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`Page 23
`·1· · · · A.· ·Well, the fact that, you know, there's
`·2· ·sometimes formulations that are developed that
`·3· ·use the word "mucosal delivery" or "ophthalmic
`·4· ·delivery," it's not necessarily, you know, has to
`·5· ·have the word "eye" on it.
`·6· · · · Q.· ·Okay.· So would it surprise you to know
`·7· ·that the word "eye" is not on your CV?
`·8· · · · A.· ·No, it doesn't surprise me.
`·9· · · · Q.· ·And the word "ocular" is not on your
`10· ·CV.
`11· · · · A.· ·Again, I've worked on ocular delivery
`12· ·systems.· I have also worked on a number of
`13· ·different polymeric delivery systems for the eye.
`14· · · · Q.· ·But none of your publications on your
`15· ·88-page CV have the word "ocular" in them.· Is
`16· ·that fair to say?
`17· · · · A.· ·Again, I haven't looked through it, and
`18· ·I haven't done a word search on my CV to tell you
`19· ·whether there is a word "ocular" or not.
`20· · · · Q.· ·And the same would go for the word
`21· ·"ophthalmic."· None of your publications have the
`22· ·word "ophthalmic" in the title such that that
`23· ·word appears on your CV.
`24· · · · A.· ·Again, I haven't done a word search of
`25· ·my CV to find whether the specific words are
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`·1· ·eye.
`·2· · · · Q.· ·And so have you worked on a specific
`·3· ·formulation, a specific polymeric delivery system
`·4· ·for use in the eye?
`·5· · · · A.· ·Sometimes they're specific.· Sometimes
`·6· ·it's a platform technology that we want to test
`·7· ·to see that it will have a residence time in the
`·8· ·eye as well.
`·9· · · · Q.· ·So have you worked on any specific
`10· ·formulation that's been administered to the eye
`11· ·of a person?
`12· · · · A.· ·You mean human person?
`13· · · · Q.· ·Yes.
`14· · · · A.· ·No.
`15· · · · Q.· ·Have you worked on any specific
`16· ·delivery system that's been administered to the
`17· ·eye of some other mammal?
`18· · · · A.· ·Yes.
`19· · · · Q.· ·What?
`20· · · · A.· ·Usually we do our studies for eye, we
`21· ·use rabbit models.
`22· · · · Q.· ·And are those systems with drugs in
`23· ·them, or are you just testing the delivery
`24· ·system?
`25· · · · A.· ·In some cases, they'll have drugs.· In
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`MANSOOR AMIJI - 02/22/2017MANSOOR AMIJI - 02/22/2017
`Page 26
`·1· ·some cases, they are delivery system.· In some
`·2· ·cases, we also use for imaging applications.
`·3· · · · Q.· ·But none of those deliveries -- ocular
`·4· ·delivery systems have ever been used in a human
`·5· ·being, as far as you're aware?
`·6· · · · A.· ·Are you asking the ones that are
`·7· ·developed in my lab?
`·8· · · · Q.· ·Yes.
`·9· · · · A.· ·Have they been used in humans or in
`10· ·some of my consulting work, whether they have
`11· ·been used in humans?
`12· · · · Q.· ·Yeah.· Let me ask a cleaner question.
`13· · · · Have any of the delivery systems that you
`14· ·have worked on in your lab been used in the eye
`15· ·of a human being?
`16· · · · A.· ·No.
`17· · · · Q.· ·And you list in your CV a number of
`18· ·awards.· Is that right?
`19· · · · A.· ·Yes.
`20· · · · Q.· ·Is it fair to say that none of those
`21· ·relate to ocular drugs?
`22· · · · A.· ·I'm not sure what you mean by awards
`23· ·related to ocular drugs.
`24· · · · Q.· ·Well, have any of the awards you've
`25· ·received been related to your work on an ocular
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`Pages 26..29
`Page 28
`·1· · · · Q.· ·Is it fair to say you are not an expert
`·2· ·on dry eye disease?
`·3· · · · · · ·MR. MILLS:· Objection.· Form.
`·4· · · · A.· ·I'm not sure I understand that
`·5· ·question.· What do you mean by expert in dry eye
`·6· ·disease?· A medical expert?
`·7· · · · Q.· ·Yes.· You're not a medical expert on
`·8· ·dry eye disease.
`·9· · · · A.· ·No. I don't treat patients.
`10· · · · Q.· ·Have you ever studied the underlying
`11· ·causes of dry eye disease in your lab or
`12· ·elsewhere in your research?
`13· · · · A.· ·I study inflammatory diseases.· I have
`14· ·certainly a number of publications and grants in
`15· ·inflammatory diseases.
`16· · · · Q.· ·But never dry eye disease,
`17· ·specifically?
`18· · · · A.· ·No. I haven't specifically looked at
`19· ·dry eye disease.
`20· · · · Q.· ·Have you ever formally studied the
`21· ·treatments for dry eye outside the context of
`22· ·this case?
`23· · · · A.· ·Again, I've had a lot of experience in
`24· ·looking at inflammatory diseases, the general
`25· ·categories of inflammatory diseases.
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`Page 27
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`·1· ·or ophthalmic drug?
`·2· · · · A.· ·My awards are related to my
`·3· ·contributions in pharmaceutical science, my
`·4· ·contributions in advancing controlled drug
`·5· ·delivery systems.· I'm a fellow of both the
`·6· ·American Association of Pharmaceutical Scientists
`·7· ·as well as the Controlled Release Society.· And
`·8· ·all the awards that I received are based on my
`·9· ·contributions in the pharmaceutical sciences.
`10· · · · Q.· ·Right.· So I see about halfway down on
`11· ·Page 87 of your CV, there's a list.· There's a
`12· ·list of your awards on Page 87.· Is that right?
`13· · · · A.· ·Yes.
`14· · · · Q.· ·And there are specific awards, for
`15· ·example, for outstanding research in oral drug
`16· ·delivery.· Do you see that?
`17· · · · A.· ·Yes.
`18· · · · Q.· ·There are no awards specific to
`19· ·research in ophthalmic or ocular drug delivery
`20· ·listed on your CV.· Is that right?
`21· · · · A.· ·Well, they're not, you know, specific
`22· ·ones for ophthalmic.· The fact that I have awards
`23· ·on pharmaceutical sciences, I received a number
`24· ·of awards in the field of pharmaceutical science
`25· ·in drug formulation and drug delivery.
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`Page 29
`·1· · · · Q.· ·Do you understand that dry eye disease
`·2· ·is an inflammatory disease?
`·3· · · · A.· ·In cases, a dry eye disease, as
`·4· ·defined, is a broad class, and there the subset
`·5· ·is KCS, which is an inflammatory disease.
`·6· · · · Q.· ·So have you ever studied the treatments
`·7· ·specifically for dry eye disease outside the
`·8· ·context of this case?
`·9· · · · A.· ·Studied in a manner like read articles
`10· ·about it or did research on it?
`11· · · · Q.· ·Done research on the treatments for dry
`12· ·eye disease, outside the context of this case.
`13· · · · A.· ·No.· I have not done research, but I
`14· ·certainly have read articles.
`15· · · · Q.· ·Outside the context of this case?
`16· · · · A.· ·Yes.
`17· · · · Q.· ·What treatments were available to treat
`18· ·dry eye patients in 2002, early 2003, to the best
`19· ·of your knowledge?
`20· · · · A.· ·There were a number of different types
`21· ·of therapeutics that are available, as well as
`22· ·artificial tears were available.
`23· · · · Q.· ·What were the therapeutics that were
`24· ·available?
`25· · · · A.· ·Again, I don't know exactly.· I haven't
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`Pages 30..33
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`MANSOOR AMIJI - 02/22/2017MANSOOR AMIJI - 02/22/2017
`Page 30
`·1· ·looked into the specific kinds of compounds that
`·2· ·are available.· But I know that there are
`·3· ·prescription drugs that were prescribed, maybe
`·4· ·off-label use, in treatment of dry eye.· But I
`·5· ·know artificial tears were available.
`·6· · · · Q.· ·So you know artificial tears were
`·7· ·available.· Do you know any of the specific
`·8· ·prescription drugs that were available before
`·9· ·Restasis came on the market in 2003?
`10· · · · A.· ·Again, if you have something you want
`11· ·to show me, I can look through that.· Sitting
`12· ·here, I don't know exact drugs and drug names.
`13· · · · Q.· ·Do you know which tests are used to
`14· ·measure dry eye disease in patients?
`15· · · · A.· ·Yes.· I have -- the Schirmer test is
`16· ·one of them that looks at the amount of tear
`17· ·production and then staining, corneal staining is
`18·