·1· · · · ·UNITED STATES PATENT AND TRADEMARK OFFICE
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`·2· · · · · BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`·3· ·______________________________________________________
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`·4· ·MYLAN PHARMACEUTICALS, INC.,· · · ·)
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`·5· · · · · · Petitioner,· · · · · · · ·)
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`·6· · ·vs.· · · · · · · · · · · · · · · )
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`·7· ·ALLERGAN, INC.,· · · · · · · · · · )
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`·8· · · · · · PATENT OWNER.· · · · · · ·)
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`·9· ·______________________________________________________
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`10· · · · · · · DEPOSITION OF DANIEL BLOCH, Ph.D.
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`11· ·______________________________________________________
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`12· · · · · · · · · · · · · 8:45 a.m.
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`13· · · · · · · · · · · · July 14, 2017
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`14· · · · · · · · 701 Fifth Avenue, Suite 5100
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`15· · · · · · · · · · ·Seattle, Washington
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`16
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`17· · · · · · CASE IPR2016-01127, PATENT 8,685,930
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`18· · · · · · CASE IPR2016-01128, PATENT 8,629,111
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`19· · · · · · CASE IPR2016-01129, PATENT 8,642,566
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`20· · · · · · CASE IPR2016-01130, PATENT 8,633,162
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`21· · · · · · CASE IPR2016-01131, PATENT 8,648,048
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`22· · · · · · CASE IPR2016-01132, PATENT· 9,248,191
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`23
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`24
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`25· ·REPORTED BY:· Pat Lessard, CCR #2104
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`1
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`ALL 2083
`MYLAN PHARMACEUTICALS V. ALLERGAN
`IPR2016-01128
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`·1· · · · · · · · · · A P P E A R A N C E S
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`Page 2
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`·2
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`·3· ·FOR THE PETITIONER:
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`·4· · · · · ·MR. MICHAEL J. KANE
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`·5· · · · · ·Fish & Richardson
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`·6· · · · · ·3200 RBC Plaza
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`·7· · · · · ·60 South Sixth Street
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`·8· · · · · ·Minneapolis, MN 55402
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`·9· · · · · ·612.335.5070
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`10· · · · · ·kane@fr.com
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`11
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`12· ·FOR THE RESPONDENT:
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`13· · · · · ·MR. STEVEN W. PARMELEE
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`14· · · · · ·MS. GRACE A. WINSCHEL
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`15· · · · · ·Wilson Sonsini Goodrich & Rosati
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`16· · · · · ·701 Fifth Avenue, Suite 5100
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`17· · · · · ·Seattle, WA 98104-7036
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`18· · · · · ·206.471.2083
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`19· · · · · ·sparmelee@wsgr.com
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`20· · · · · ·MS. JACQUELINE ALTMAN
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`21· · · · · ·Wilson Sonsini Goodrich & Rosati
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`22· · · · · ·12235 El Camino Real, Suite 200
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`23· · · · · ·San Diego, CA 92130-3002
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`24· · · · · ·858.350.2300
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`25· · · · · ·jacqueline.altman@wsgr.com
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`·1· · · · · · · · · · E X A M I N A T I O N
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`Page 3
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`·2· ·ATTORNEY· · · · · · · · · · · · · · · · · · · · PAGE
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`·3· ·BY MR. KANE:· · · · · · · · · · · · · · · · · · · ·4
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`·4
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`·5· · · · · · · · · E X H I B I T· I N D E X
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`·6· ·No.· · · · · · · · · DESCRIPTION· · · · · · · · PAGE
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`·7· ·Exhibit 2078· ·Center for Drug Evaluation and· · ·95
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`·8· ·Research Medical Review(s).
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`·9· ·Exhibit 2079· ·Document titled "Ophthalmology· · ·77
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`10· ·Volume 107, Number 7, July 2000."
`
`11· ·Exhibit 2080· ·QuickCalcs Unpaired test· · · · · ·85
`
`12· ·results.
`
`13· ·Exhibit 2081· ·QuickCalcs Unpaired test· · · · · ·86
`
`14· ·results.
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`15
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`16· · · · · · · · · ·REFERRED EXHIBIT INDEX
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`17· ·Exhibit 1040· ·Declaration.· · · · · · · · · · · · 7
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`18· ·Exhibit 1043· ·Curriculum Vitae of Daniel A.· · · ·8
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`19· ·Bloch, Ph.D.
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`20· ·Exhibit 2027· ·Report marked 074.· · · · · · · · ·44
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`21· ·Exhibit 1004· ·Excerpt.· · · · · · · · · · · · · ·48
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`22· ·Exhibit 1007· ·Sall publication.· · · · · · · · · 77
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`23· ·Exhibit 2008· ·Portion of the Restasis label.· · ·92
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`24
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`25
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`Page 4
`·1· ·DANIEL BLOCH,· · · · · · being duly sworn, testified
`·2· · · · · · · · · · · · · · upon oath, as follows:
`·3· · · · · · · · · · E X A M I N A T I O N
`·4· ·BY MR. KANE:
`·5· · · · Q.· ·Good morning, Dr. Bloch.
`·6· · · · A.· ·Good morning.
`·7· · · · Q.· ·Could you state your full name for the
`·8· ·record.
`·9· · · · A.· ·Daniel, middle initial A, last name Bloch
`10· ·spelled with an H.
`11· · · · Q.· ·What's your current business address?
`12· · · · A.· ·My current business address?
`13· · · · Q.· ·Yes.
`14· · · · A.· ·8987 East Tanque, spelled T A N Q U E.· And
`15· ·then another word Verde, V E R D E.· And then a pound
`16· ·sign 309-387.· Tucson, Arizona 85749.
`17· · · · · · ·I've given you that.· That's my mailing
`18· ·address.· I have an office at Stanford but I live in
`19· ·Tucson and my letterhead has that address on it, my
`20· ·Tucson address.
`21· · · · Q.· ·Thank you.· Have you been deposed before?
`22· · · · A.· ·Yes.
`23· · · · Q.· ·How many times, approximately?
`24· · · · A.· ·A dozen.
`25· · · · Q.· ·So you've been through the drill before but
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`Page 5
`·1· ·I'll just kind of give you the ground rules again.
`·2· · · · A.· ·Okay.
`·3· · · · Q.· ·So I'm going to be asking questions.· You're
`·4· ·going to be providing the answers.· Your counsel may
`·5· ·have some objections at some points along the way.
`·6· · · · · · ·Our court reporter here is going to be
`·7· ·taking down everything that we say, so it's important
`·8· ·that -- a couple things.· One, it seems like you may
`·9· ·be a fast talker and I'm definitely a fast talker, so
`10· ·we both should try to maybe slow down to help her out.
`11· · · · · · ·Another thing is I'll do my best to let you
`12· ·finish your answer before I start speaking again and,
`13· ·likewise, you should let me finish my questions before
`14· ·you start speaking so that she can get that down.
`15· ·Okay?
`16· · · · A.· ·Sure.
`17· · · · Q.· ·If I don't ask a question that you
`18· ·understand or is confusing to you please let me know
`19· ·and I'll try to clarify for you.· Okay?
`20· · · · A.· ·Okay.
`21· · · · Q.· ·And if you answer the question I'm going to
`22· ·assume that you understood the question.· All right?
`23· · · · A.· ·Yes.
`24· · · · Q.· ·That's another thing, you have to answer
`25· ·verbally "Yes" and "No," not uh-huhs or huh-uhs or
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`Page 6
`·1· ·nods of the head or shakes of the head.· She can't get
`·2· ·that down, so that's a good point to remember.
`·3· · · · · · ·Finally, we'll take periodic breaks roughly,
`·4· ·usually about an hour or so of questions and then let
`·5· ·everybody stretch their legs and what have you.
`·6· · · · · · ·If you need a break --
`·7· · · · A.· ·I'll let you know.
`·8· · · · Q.· ·-- let me know.
`·9· · · · A.· ·Okay.
`10· · · · Q.· ·Very good.· Is there any reason that you
`11· ·can't give accurate and truthful testimony today?
`12· · · · A.· ·No.
`13· · · · Q.· ·You understand that you're under oath and
`14· ·the testimony you are giving is under oath and is
`15· ·admissible in court?
`16· · · · A.· ·I do understand, yes.
`17· · · · Q.· ·You were talking over me there.· You've got
`18· ·to slow down and let me finish my question.· Okay?
`19· · · · A.· ·Yes.
`20· · · · Q.· ·What did you do to prepare for your
`21· ·deposition today?
`22· · · · A.· ·I read over materials that are pertinent to
`23· ·or included in my declaration and I met with counsel.
`24· · · · Q.· ·When did you meet with counsel?
`25· · · · A.· ·Yesterday for several hours as well as the
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`Page 8
`·1· · · · · · ·Is that right?· No?· I'm not really quite
`·2· ·sure.· Sorry.
`·3· · · · Q.· ·The signature is June 30th.
`·4· · · · A.· ·All right.· So it had to be early in June.
`·5· · · · Q.· ·Okay.· How much time did you spend working
`·6· ·on the declaration?
`·7· · · · A.· ·Many hours.· I don't really have an estimate
`·8· ·with me.· Certainly more than 50.
`·9· · · · Q.· ·And did you draft the declaration yourself
`10· ·or how did that process work?
`11· · · · A.· ·Yes, I did.
`12· · · · Q.· ·So you typed the words yourself?
`13· · · · A.· ·No.· Counsel -- counsel prepared the
`14· ·formatting of the declaration and they aided me in
`15· ·figures, formatting and things of that nature, but I
`16· ·wrote the text.
`17· · · · Q.· ·How did you write the text?· Did you type it
`18· ·in some sort of document and send it to counsel?
`19· · · · A.· ·Yeah.· Yeah, we went back and forth.
`20· · · · Q.· ·Okay.· I'll hand you what's previously been
`21· ·marked as Exhibit 1034.
`22· · · · · · ·Do you recognize that document?
`23· · · · A.· ·It appears to be a version of my CV.· Yes.
`24· · · · Q.· ·I see it's dated November 1, 2016.
`25· · · · A.· ·Yes, I see that, too.
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`Page 7
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`·1· ·day before.
`·2· · · · Q.· ·Did you speak to anyone other than counsel
`·3· ·about the deposition?
`·4· · · · A.· ·No.
`·5· · · · Q.· ·I'm going to hand you, Dr. Bloch, what's
`·6· ·been marked as Exhibit 1040.
`·7· · · · A.· ·Okay.
`·8· · · · Q.· ·Do you recognize that document?
`·9· · · · A.· ·Yes, this is my declaration, a copy of my
`10· ·declaration.
`11· · · · Q.· ·And on page 35, that's your electronic
`12· ·signature?
`13· · · · A.· ·Yes, it is.
`14· · · · Q.· ·And if you look at the front cover you'll
`15· ·see that there are a total of six IPRs listed.
`16· · · · · · ·Do you see that?
`17· · · · A.· ·Right.
`18· · · · Q.· ·And you provided the same declaration or one
`19· ·deposition for all six IPRs?
`20· · · · A.· ·That's my understanding why they're listed
`21· ·here.
`22· · · · Q.· ·When did you begin working on this
`23· ·declaration?
`24· · · · A.· ·Sometime early in June -- no, sometime early
`25· ·in July, I think.
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`Page 9
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`·1· · · · Q.· ·Was it accurate as of that date?
`·2· · · · A.· ·Yes.
`·3· · · · Q.· ·Have there been any changes to your CV in
`·4· ·the meantime?
`·5· · · · A.· ·There are some minor ones, I believe.· There
`·6· ·has been at least one manuscript that was submitted
`·7· ·that has been accepted, so that would be a change.
`·8· · · · · · ·Otherwise, I don't think I changed -- I
`·9· ·would have changed anything.· I think that's probably
`10· ·the only change of substance, maybe.
`11· · · · Q.· ·What was the nature of that manuscript?
`12· · · · A.· ·Oh, it had to do with an intervention of a
`13· ·pharmaceutical company having to do with artificial
`14· ·protection of too much scarring as a result of back
`15· ·surgery on the spine.
`16· · · · Q.· ·When you say "intervention," what do you
`17· ·mean?
`18· · · · A.· ·They have to cut you open and put this tube
`19· ·in here where they are surgically trying to help you
`20· ·with your debilitation.
`21· · · · Q.· ·Thank you.· And looking at the front of your
`22· ·CV -- I may have said 1034 before but it's actually
`23· ·Exhibit 1043, if I misspoke -- I saw you got a BS from
`24· ·Stanford in statistics and a Ph.D. from Johns Hopkins
`25· ·in statistics?
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`Page 10
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`·1· · · · A.· ·That's correct.
`·2· · · · Q.· ·Has your employment history been focused on
`·3· ·statistics?
`·4· · · · A.· ·Yes.· Well, in terms of the academic part of
`·5· ·my career.
`·6· · · · · · ·I've been self-employed as a contractor as
`·7· ·well.· That's a completely different profession.
`·8· · · · Q.· ·What kind of activities did you undertake as
`·9· ·a contractor?
`10· · · · A.· ·I was a general contractor in California. I
`11· ·built homes.
`12· · · · Q.· ·Really.
`13· · · · A.· ·Custom homes, things of that nature.· That's
`14· ·why there's a gap between 1972 and 1984 on that front
`15· ·page.
`16· · · · Q.· ·Prior to -- well, let me step back.· You're
`17· ·obviously aware this IPR, or these are IPRs and they
`18· ·relate to a proceeding going on in the Patent Office,
`19· ·correct?
`20· · · · A.· ·Yes, I've been told that.
`21· · · · Q.· ·You also understand that there's a District
`22· ·Court litigation going on in Marshall, Texas?
`23· · · · A.· ·Yes.
`24· · · · Q.· ·And you've been engaged to work on the
`25· ·litigation as well?
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`Page 11
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`·1· · · · A.· ·Yes, I have.
`·2· · · · Q.· ·Prior to being engaged with respect to the
`·3· ·dispute regarding Restasis, had you done any work
`·4· ·related to ophthalmology?
`·5· · · · A.· ·Well, that's a very broad question.· As a
`·6· ·biostatistician, I've interacted with people at
`·7· ·Stanford that have done studies with eye tissues.
`·8· · · · · · ·I have consulted for startup companies
`·9· ·having to do with devices that they've had for the
`10· ·eye.
`11· · · · · · ·Most recently with the startup company,
`12· ·actually in Tucson, Arizona, where they have a device
`13· ·where they can snake something in the back of the eye
`14· ·to help ocular, macular degeneration.
`15· · · · · · ·So, you know, broadly, yes, I have been
`16· ·involved with ocular-type things.· And with
`17· ·specifically with this compound, you know.
`18· · · · Q.· ·And by the compound, you're talking about
`19· ·cyclosporin?
`20· · · · A.· ·Well, what is it called.· Restasis?
`21· · · · Q.· ·Yes.
`22· · · · A.· ·R E S T A S I S.
`23· · · · Q.· ·Yes.· That's the brand name.· Cyclosporin is
`24· ·the active ingredient.
`25· · · · · · ·So have you done any work related to
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`Page 12
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`·1· ·treatment of dry eye or KCS?
`·2· · · · A.· ·When you say have I done any work, I've
`·3· ·advised people.· I had a colleague at Stanford who has
`·4· ·dry eye and she asked me to -- at the time that she
`·5· ·got that diagnosis to peruse the literature to help
`·6· ·her understand, you know, what the evidence is of one
`·7· ·thing perhaps working better than another.
`·8· · · · · · ·So that was a case that was -- it wasn't
`·9· ·through a pharmaceutical company, it was just a
`10· ·private kind of thing.
`11· · · · · · ·But otherwise, I think with dry eye, I don't
`12· ·recall that being a subject matter that I've been
`13· ·involved with.
`14· · · · Q.· ·Okay.
`15· · · · A.· ·Excuse me.
`16· · · · Q.· ·As part of your professional career as a
`17· ·biostatistician, have you been involved with the
`18· ·approval of drugs by FDA?
`19· · · · A.· ·Yes.
`20· · · · Q.· ·Have you assisted in review of the
`21· ·submissions to FDA?
`22· · · · · · ·MR. PARMELEE:· Objection; form.
`23· · · · Q.· ·(By Mr. Kane)· Have you assisted?
`24· · · · A.· ·What was the question you asked me?· I lost
`25· ·my train of thought when the objection came in.
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`Page 13
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`·1· · · · Q.· ·My question was have you assisted in
`·2· ·submissions to the FDA?
`·3· · · · A.· ·Yes.
`·4· · · · Q.· ·Have you assisted in review of submissions
`·5· ·made to the FDA?
`·6· · · · A.· ·Yes.· But not as an employee of the FDA.
`·7· · · · Q.· ·What was your role in review of submissions
`·8· ·made to the FDA?
`·9· · · · A.· ·Well, it varied depending upon what the
`10· ·submission was.· A Phase I submission would be a very
`11· ·different submission than a Phase III preliminary
`12· ·trial that was done to get approval.
`13· · · · Q.· ·I guess my question was directed at, if you
`14· ·weren't an employee of the FDA, why were you reviewing
`15· ·submissions made to the FDA?
`16· · · · A.· ·Because of my expertise in biostatistics the
`17· ·company asks me to do this sometimes.
`18· · · · Q.· ·Have you ever been involved or engaged by
`19· ·FDA to review any submissions?
`20· · · · A.· ·No.
`21· · · · Q.· ·You've never been on an FDA advisory panel?
`22· · · · A.· ·I have been, yes.
`23· · · · Q.· ·What does that consist of?
`24· · · · A.· ·Again, that's a very varied topic.
`25· · · · · · ·For example, one meeting was a group of
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`Page 14
`·1· ·somewhere around 30 of us met with higher-ups in the
`·2· ·statistical personnel of the FDA, biologics, devices
`·3· ·and drugs, where the discussion had to do with missing
`·4· ·data in submissions.
`·5· · · · · · ·And the FDA wanted advice in terms of how
`·6· ·they should handle that broadly but also more
`·7· ·specifically how much missing data it would be okay to
`·8· ·have and that was a very lively discussion.
`·9· · · · · · ·So that's just a specific example of the
`10· ·kind of functions that the FDA uses advisory boards
`11· ·for if it's biostatistical in nature.
`12· · · · Q.· ·How long have you been involved with FDA
`13· ·statistical advisory boards?
`14· · · · A.· ·I'm not currently on the advisory board.
`15· ·You'd have to go to my CV.· I think I might have the
`16· ·dates there.· I don't actually know.
`17· · · · Q.· ·Okay.· Why don't we do that.
`18· · · · A.· ·I don't know if it's here.· Is it here?· I'm
`19· ·just looking for it.
`20· · · · · · ·Well, 1995 to 2006, it's number eleven.
`21· · · · Q.· ·Right.· Okay.
`22· · · · A.· ·It was in that time frame.
`23· · · · Q.· ·Okay.· And that's a special government
`24· ·employee, they pay you to be on the advisory board or
`25· ·advisory panel?
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`Page 15
`·1· · · · A.· ·I said including FDA statistical advisory
`·2· ·panel.· And I was a special government employee also
`·3· ·working with the Veterans Administration hospital in
`·4· ·Palo Alto.
`·5· · · · · · ·The way the Veterans Administration performs
`·6· ·many very high level clinical trials.
`·7· · · · · · ·Excuse me, I'm going to get some water.
`·8· · · · · · ·In fact, some of the best clinical trials
`·9· ·that are done in this country are through the VA
`10· ·system, where their subjects in the VA are veterans.
`11· · · · · · ·And these protocols are actually headed by
`12· ·statisticians, unlike many other grants which are
`13· ·headed by PIs which are specialists in the particular
`14· ·field.
`15· · · · · · ·And I was the adviser to the VA on the
`16· ·planning and execution of those trials.· And there are
`17· ·VA centers throughout the country, five or six, that
`18· ·are involved in these clinical trials that are funded
`19· ·through the government.
`20· · · · · · ·So I was a special government employee for
`21· ·that.· I don't believe I got paid but they had to
`22· ·designate me somehow to be involved.
`23· · · · Q.· ·I see.· And is that -- looking at your
`24· ·professional activities, it's number nine there, is
`25· ·that what you were referring to?
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`Page 16
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`·1· · · · A.· ·Yes, probably.· That's right.
`·2· · · · Q.· ·Okay.· So you understand that FDA has
`·3· ·statisticians who review clinical data in connection
`·4· ·with a drug approval process?
`·5· · · · A.· ·Yes, more than an understanding.· Yes, I
`·6· ·know that's true.· Yes.
`·7· · · · Q.· ·And have you interacted with those
`·8· ·statisticians?
`·9· · · · A.· ·Yes.
`10· · · · Q.· ·In what capacities?
`11· · · · A.· ·Well, again, that's fairly varied.· I've
`12· ·been on conference calls with companies discussing
`13· ·what the FDA statisticians had concerns with respect
`14· ·to the -- with the investigational plan that had been
`15· ·submitted to the FDA.· So there was a discussion about
`16· ·the content that way, long distance.
`17· · · · · · ·I have given lectures at the FDA to
`18· ·statisticians and interacted with them directly in
`19· ·that way.· Those lectures have been mostly having to
`20· ·do with introducing to them some of the newer things
`21· ·that were going on in statistics that I had expertise
`22· ·with in terms of how they could apply it to their
`23· ·needs.
`24· · · · · · ·So it's a variety of ways I've interacted
`25· ·with statisticians at the FDA.
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`Page 17
`·1· · · · Q.· ·Okay.· And do they use those statistical
`·2· ·panels, statistical advisory panels, for instance, to
`·3· ·stay abreast of current statistical methods?
`·4· · · · · · ·MR. PARMELEE:· Objection; form.
`·5· · · · A.· ·I think -- well, I don't know if they use it
`·6· ·specifically for that purpose, but those features are
`·7· ·how statistics, you know, continues to evolve and will
`·8· ·come out when you're at an advisory panel because
`·9· ·people will bring up newer methods that perhaps could
`10· ·be used.
`11· · · · Q.· ·(By Mr. Kane)· When you've given lectures to
`12· ·the FDA regarding statistics, what format or context
`13· ·did that come up in?
`14· · · · A.· ·I can recall one lecture which had to do
`15· ·with presenting to them -- it's a mouthful -- it's
`16· ·called non-parametric regression, non-parametric
`17· ·regression methods, which they wanted to use -- I'm
`18· ·sorry.
`19· · · · · · ·I haven't had this frog in my throat all
`20· ·week and now I have to have it.
`21· · · · Q.· ·That's the way it goes.
`22· · · · A.· ·And they were hoping to be able to use that
`23· ·methodology in their post-marketing surveillance
`24· ·program, and that's a fairly critical part of what
`25· ·they do.· But that's, you know, it speaks for itself.
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`·1· ·It's post the approval process.
`·2· · · · Q.· ·Understood.· I was trying to understand how
`·3· ·you were asked to provide that lecture or a lecture
`·4· ·like that, those types of lectures to FDA.
`·5· · · · A.· ·I think whoever was the head of statistics
`·6· ·in -- I think this was -- this was in the drug side.
`·7· ·It wasn't in the biologics.· He called me up and asked
`·8· ·if I would do that and I said "Yes."
`·9· · · · Q.· ·Okay.· And so you know the people, the
`10· ·statisticians and some of the senior people on FDA?
`11· · · · A.· ·That changes.· There's a revolving door.· So
`12· ·I wouldn't say right now I know anybody that's there,
`13· ·but I can't be sure if I know them now.
`14· · · · Q.· ·Do you know how many statisticians FDA
`15· ·employs?
`16· · · · A.· ·I don't know.
`17· · · · Q.· ·Is it a sizeable number?
`18· · · · A.· ·I guess size is in eyes of the beholder.
`19· ·Probably quite few.
`20· · · · · · ·We have three different divisions and every
`21· ·specialty has people that specialize in things so it's
`22· ·probably quite a few.
`23· · · · Q.· ·Okay.· Do you think they're good at their
`24· ·job?
`25· · · · · · ·MR. PARMELEE:· Objection; form.
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`Page 19
`·1· · · · A.· ·Again, that's a quality judgment.· Some are
`·2· ·good and some are not.
`·3· · · · Q.· ·(By Mr. Kane)· Do you think the FDA as an
`·4· ·agency does a good job of analyzing data and approving
`·5· ·safe efficacious drugs?
`·6· · · · · · ·MR. PARMELEE:· Objection; form.
`·7· · · · A.· ·You know, given the constraints they have, I
`·8· ·think they do as good a job as they can.
`·9· · · · Q.· ·(By Mr. Kane)· In your role as a
`10· ·biostatistician, have you interacted with clinicians?
`11· · · · A.· ·Yes.
`12· · · · Q.· ·And what are the clinicians' role in
`13· ·designing and studying and getting a drug approved?
`14· · · · A.· ·Again, that's -- it's such a broad question.
`15· ·Usually a medical device or drug or biologic is
`16· ·available or is going to be invented or it's going to
`17· ·be developed because that possibility exists, perhaps
`18· ·through discovery in some lab at Stanford or an
`19· ·entrepreneur has an idea and they design a better
`20· ·design, a better hearing device.
`21· · · · · · ·And then that -- it's called a clinician.
`22· ·His role, if he wants to develop it commercially, it
`23· ·involves getting a whole team of people together to
`24· ·help him develop that.
`25· · · · · · ·And so his role then will be very varied
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`Page 20
`·1· ·because he might then also be responsible for getting
`·2· ·money so that he can develop his ideas or interacting
`·3· ·in a technical way with people like myself or even
`·4· ·with the FDA, and their functions are limitless.
`·5· · · · Q.· ·Okay.· And do they oftentimes have expertise
`·6· ·in a disease or a condition that the product is
`·7· ·directed at?
`·8· · · · A.· ·Well, "often" is if they themselves are a
`·9· ·specialist and, for example, a cancer researcher, and
`10· ·they're the ones who have the idea.· They might
`11· ·actually be the ones that start the process of making
`12· ·it commercially available.
`13· · · · · · ·It doesn't have to be -- it could be an
`14· ·entrepreneur who solicits an idea from somebody and
`15· ·asks them to help them understand because they're not
`16· ·technically able themselves.
`17· · · · · · ·Does that answer your question?
`18· · · · Q.· ·It does.· You used the word a couple of
`19· ·times and I'm not sure what it is.· Interpreter?
`20· · · · A.· ·En -- E N -- entrepreneur.
`21· · · · Q.· ·Okay.
`22· · · · A.· ·I probably misspoke the word myself.
`23· · · · Q.· ·All right.· I just wanted to make sure I
`24· ·understood what you were saying there.· Very good.
`25· · · · · · · ·Would you look at your CV.· On page 20 you
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`Page 21
`·1· ·have a list of prior litigations you've been involved
`·2· ·in in the last four years.
`·3· · · · · · ·Do you see that?
`·4· · · · A.· ·Yes.
`·5· · · · Q.· ·And it looks like you listed five matters
`·6· ·there, correct?
`·7· · · · A.· ·Yeah.· When I prepared this, it would have
`·8· ·been the past four years. Right?
`·9· · · · Q.· ·Right.· And obviously now you're engaged in
`10· ·the litigation between Allergan and Mylan and other
`11· ·generic companies with regard to Restasis, correct?
`12· · · · A.· ·Yes, that's correct.
`13· · · · Q.· ·Are there any other litigations you've been
`14· ·involved in besides the five here and the Allergan
`15· ·matter?
`16· · · · A.· ·I'm currently involved with another
`17· ·litigation.
`18· · · · Q.· ·What is that?
`19· · · · A.· ·I think that's proprietary.
`20· · · · Q.· ·Has there been a lawsuit filed?
`21· · · · A.· ·Yes.
`22· · · · Q.· ·Could you just give me the names of the
`23· ·parties?
`24· · · · A.· ·You know, I don't feel comfortable with
`25· ·that.· I'm not sure I can.
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`Page 22
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`·1· · · · Q.· ·What is --
`·2· · · · A.· ·I signed a protective order.· I don't have
`·3· ·it here.
`·4· · · · Q.· ·Okay.· What's the nature of the dispute?
`·5· · · · A.· ·It has to do with a dispute having to do
`·6· ·with the stabilization of a drug.
`·7· · · · Q.· ·How long have you been involved in that
`·8· ·matter?
`·9· · · · A.· ·Within the last six months.
`10· · · · Q.· ·Have you provided an expert report at this
`11· ·point?
`12· · · · A.· ·For that particular matter?
`13· · · · Q.· ·Yes.
`14· · · · A.· ·Yes.
`15· · · · Q.· ·You have?
`16· · · · A.· ·Yes.
`17· · · · Q.· ·Have you been deposed in that matter?
`18· · · · A.· ·Yes.
`19· · · · Q.· ·I think you've -- well, I think you can tell
`20· ·me the name.· It's a publicly filed lawsuit and I
`21· ·think you can at least tell us the names of the
`22· ·parties.
`23· · · · A.· ·I don't actually recall that right now.
`24· · · · Q.· ·Okay.· Do you know where the lawsuit is
`25· ·pending?
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`Page 24
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`·1· · · · A.· ·Yes.
`·2· · · · Q.· ·So is it fair to say that any document not
`·3· ·listed here was not used to form your opinions?
`·4· · · · · · ·MR. PARMELEE:· Objection; form.
`·5· · · · A.· ·Let me come back.· You used the word were
`·6· ·they sufficient for me to form.
`·7· · · · · · ·Sometimes I wish I could have had better but
`·8· ·it was not available for me.
`·9· · · · Q.· ·(By Mr. Kane)· Okay.
`10· · · · A.· ·So sufficient sometimes has the implication
`11· ·that it was good enough.· Well, I like the best, if I
`12· ·can get it.· So that's just a clarification.
`13· · · · · · ·But otherwise, in terms of -- I think you
`14· ·used -- the double negative that you brought in, I
`15· ·would just say, again, for what I wrote I understand
`16· ·this is the best I could have in terms of information
`17· ·and it covered the aspects that I did address in my
`18· ·declaration.
`19· · · · Q.· ·And it was -- let me put it this way.· It
`20· ·was adequate for you to offer the opinions that you
`21· ·provided in the declaration?
`22· · · · A.· ·The opinions that I set forth in my
`23· ·declaration are based on this information.· Adequate
`24· ·or not, it was based on this information.
`25· · · · Q.· ·Okay.· And it was based only on the
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`Page 23
`·1· · · · A.· ·Does that mean where it's going to actually
`·2· ·be heard?
`·3· · · · Q.· ·Yes, where the trial would be.
`·4· · · · A.· ·I think in Delaware.
`·5· · · · Q.· ·Look back to the declaration now,
`·6· ·Exhibit 1040.
`·7· · · · A.· ·Should I put this aside?
`·8· · · · Q.· ·Yes, just put it aside for now.
`·9· · · · · · ·If you turn to the back page, page 36,
`10· ·there's an appendix.· Do you see that?
`11· · · · A.· ·Yes.· The list of exhibits?
`12· · · · Q.· ·Yes.· And what is included on this list of
`13· ·exhibits?
`14· · · · A.· ·These exhibits contain the information that
`15· ·I -- the information I used in preparation of this
`16· ·declaration.
`17· · · · Q.· ·Okay.· Did you rely on any other documents
`18· ·in preparing the declaration?
`19· · · · A.· ·No.
`20· · · · Q.· ·And how did you come to have the documents
`21· ·on that list?
`22· · · · A.· ·They were provided to me by counsel.
`23· · · · Q.· ·You felt that this list, this set of
`24· ·documents was sufficient for you to form your
`25· ·opinions?
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`Page 25
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`·1· ·information listed in this exhibit?
`·2· · · · A.· ·Yes.· I think I told you that already.
`·3· · · · Q.· ·Okay.· Did you look at any publicly
`·4· ·available FDA files relating to the Restasis approval?
`·5· · · · A.· ·For this declaration, no, I did not.
`·6· · · · Q.· ·So you didn't rely on any publicly available
`·7· ·FDA files for this declaration?
`·8· · · · A.· ·As I just said, for this declaration I did
`·9· ·not.
`10· · · · Q.· ·Who did you talk to in connection with the
`11· ·Restasis dispute with the exclusion of counsel?· So
`12· ·have you talked to anyone else other counsel with
`13· ·respect to this dispute?
`14· · · · A.· ·No.
`15· · · · Q.· ·Have you ever talked to a Dr. Amiji?
`16· · · · A.· ·Who?
`17· · · · Q.· ·Dr. Amiji.
`18· · · · A.· ·I don't know who he is.
`19· · · · Q.· ·Have you ever talked to Dr. Calman?
`20· · · · A.· ·Yes.· But not having to do with the
`21· ·declaration.· I did talk to him when I was preparing
`22· ·my report having to do with the -- I don't know what
`23· ·you call it.
`24· · · · Q.· ·The litigation?
`25· · · · A.· ·The litigation.
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`Page 26
`·1· · · · Q.· ·And what topics did you talk to Dr. Calman
`·2· ·about in regard to the litigation?
`·3· · · · A.· ·I would have to get that report.· That's not
`·4· ·part of this proceeding.
`·5· · · · Q.· ·Okay.· So nothing that Dr. Calman told you
`·6· ·was used in forming the declaration of the IPRs?
`·7· · · · A.· ·No.
`·8· · · · Q.· ·Have you ever talked to a Mr. Hoffman?
`·9· · · · A.· ·No.· Well, I mean there are Hoffmans in my
`10· ·past that I've talked to.· But not -- I think you're
`11· ·talking about an economist involved in this matter.
`12· ·I've never met him nor talked to him.
`13· · · · Q.· ·Okay.· But you know he's involved?
`14· · · · A.· ·I've been told he's involved.
`15· · · · Q.· ·Have you ever talked to anybody at Mylan --
`16· · · · A.· ·No.
`17· · · · Q.· ·-- about this matter?
`18· · · · A.· ·I'm sorry, no.
`19· · · · Q.· ·Did you review the declaration of Dr. Amiji
`20· ·in connection with your work on this matter?
`21· · · · A.· ·No.
`22· · · · Q.· ·Did you review the declaration of Dr. Calman
`23· ·in connection with your work on this matter?
`24· · · · A.· ·No.
`25· · · · Q.· ·Did you review the declaration of
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`·1· ·Dr. Hoffman in connection with your work on this
`·2· ·matter?
`·3· · · · A.· ·No.
`·4· · · · Q.· ·Did you review the IPR petitions filed in
`·5· ·this matter by Mylan?
`·6· · · · A.· ·I don't know.· I don't think so.· I don't
`·7· ·think it's part of what this is.
`·8· · · · Q.· ·Have you reviewed any of the papers filed in
`·9· ·the Patent Office in connection with this matter
`10· ·except for your declaration?
`11· · · · · · ·MR. PARMELEE:· Objection; form.
`12· · · · A.· ·The only materials I reviewed for this
`13· ·declaration are set forth here in the appendix here
`14· ·listing the list of exhibits.· That's it.
`15· · · · Q.· ·(By Mr. Kane)· Okay.· And the opinions
`16· ·you're offering in connection with the IPR are totally
`17· ·contained within the declaration?
`18· · · · A.· ·Yes.
`19· · · · Q.· ·So if you have other opinions, for instance,
`20· ·in the litigation matter, you're not offering that to
`21· ·the Patent Office, correct?
`22· · · · A.· ·My opinions are related to the scope of work
`23· ·that I had for this declaration only.
`24· · · · Q.· ·Okay.
`25· · · · A.· ·Right.
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`Page 28
`·1· · · · Q.· ·If you turn to then paragraph ten of the
`·2· ·declaration, the Scope of Work.· It's on page four.
`·3· · · · A.· ·Yes.
`·4· · · · Q.· ·And you say there that "I have been retained
`·5· ·by the Petitioner to provide statistical analyses for
`·6· ·certain data reported in Stevenson, Sall Figures 1-2
`·7· ·and to provide statistical analyses for Allergan's PK
`·8· ·studies testing cyclosporine ophthalmic emulsions as
`·9· ·used by Dr. Attar in her Exhibit B to her Declaration
`10· ·presented to the USPTA."
`11· · · · · · ·Do you see that?
`12· · · · A.· ·I do.
`13· · · · Q.· ·Is that the full scope of what you were
`14· ·asked to work on in connection with the IPRs?
`15· · · · A.· ·Yes.· This is the scope of work that I
`16· ·addressed.· It's spelled A T T A R.· Attar.
`17· · · · Q.· ·And you're offering your opinions as an
`18· ·expert in biostatistics?
`19· · · · A.· ·Yes.
`20· · · · Q.· ·Are you offering an opinion as an expert in
`21· ·treatment of dry eye?
`22· · · · A.· ·No.
`23· · · · Q.· ·Are you offering an opinion as a medical
`24· ·physician?
`25· · · · A.· ·No.
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`Page 29
`·1· · · · Q.· ·Are you offering any opinions as an expert
`·2· ·in formulation of opthalmic products?
`·3· · · · A.· ·No.
`·4· · · · Q.· ·Are you offering any opinions with respect
`·5· ·to thermodynamics?
`·6· · · · A.· ·No.
`·7· · · · Q.· ·Are you offering opinions as an expert in
`·8· ·pharmacokinetics?
`·9· · · · · · ·MR. PARMELEE:· Objection; form.
`10· · · · A.· ·Pharmokinetics also can be referring to the
`11· ·biostatistics having to do with pharmacokinetics, so I
`12· ·know a lot about that but not in terms of the medical
`13· ·science of pharmacokinetics.
`14· · · · · · ·I think that's what you're asking, and so
`15· ·no, I'm not.
`16· · · · Q.· ·(By Mr. Kane)· That is what I was asking so
`17· ·thank you for clarifying that.
`18· · · · · · ·You are not offering an opinion as an expert
`19· ·in patent law, correct?
`20· · · · A.· ·Correct.
`21· · · · Q.· ·You're not offering any opinions with
`22· ·respect to the validity of any of the patents in
`23· ·dispute in the IPRs?
`24· · · · A.· ·No.· No, I'm not.
`25· · · · Q.· ·Did you review the patents in the IPRs?
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