·1· · · · ·UNITED STATES PATENT AND TRADEMARK OFFICE
`
`·2· · · · · BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`·3
`
`·4· MYLAN PHARMACEUTICALS INC.,
`
`·5· · · · · · Petitioner,
`
`·6· v.
`
`·7· ALLERGAN, INC.,
`
`·8· · · · · · Patent Owner.
`
`·9· ___________________________/
`
`10
`
`11· · · · · · · · · · ·Case IPR2016-01127
`
`12· · · · · · · · · · · Patent 8,685,930
`
`13· · · · · · · · · · ·Case IPR2016-01128
`
`14· · · · · · · · · · · Patent 8,629,111
`
`15· · · · · · · · · · ·Case IPR2016-01129
`
`16· · · · · · · · · · · Patent 8,642,556
`
`17· · · · · · · · · · ·Case IPR2016-01130
`
`18· · · · · · · · · · · Patent 8,633,162
`
`19· · · · · · · · · · ·Case IPR2016-01131
`
`20· · · · · · · · · · · Patent 8,648,048
`
`21· · · · · · · · · · ·Case IPR2016-01132
`
`22· · · · · · · · · · · Patent 9,248,191
`
`23
`
`24· · · · DEPOSITION OF ANDREW F. CALMAN, M.D., PH.D.
`
`25· · · · · · · · · WEDNESDAY, JULY 12, 2017
`
`1
`
`ALL 2082 - REPLACEMENT
`MYLAN PHARMACEUTICALS V. ALLERGAN
`IPR2016-01128
`
`

`

`·1· REPORTED BY:· MEGAN F. ALVAREZ, RPR, CSR 12470
`
`Page 2
`
`·1· · · · · · ·EXHIBITS MARKED FOR IDENTIFICATION
`
`Page 4
`
`·2· JOB LA-133836
`
`·3
`
`·4
`
`·5· · · · · · · · · · · · · --o0o--
`
`·6
`
`·7
`
`·8· · · · · · BE IT REMEMBERED that, pursuant to Notice, and
`
`·9· on Wednesday, JULY 12, 2017, commencing at WILSON
`
`10· SONSINI GOODRICH & ROSATI, One Market Street, Spear
`
`11· Tower, Suite 3300, San Francisco, California, before me,
`
`12· Megan F. Alvarez, a Certified Shorthand Reporter,
`
`13· Registered Professional Reporter, personally appeared
`
`14· for their deposition
`
`15· · · · · · · ·ANDREW F. CALMAN, M.D., PH.D.
`
`16· · · · · · · · ____________________________
`
`17· called as a witness by Patent Owner, who, having been
`
`18· first duly sworn, was examined and testified as follows:
`
`19· · · · · · · · · · · · · --o0o--
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`·2· No.· · · · · · · Description· · · · · · · · · · ·Page
`
`·3· Exhibit 2077· ·Local Cyclosporine Therapy ........133
`
`· · · · · · · · · ·for Experimental Autoimmune
`
`·4· · · · · · · · ·Uveitis in Rats, Nussenblatt,
`
`· · · · · · · · · ·et al., Pages 1559 through
`
`·5· · · · · · · · ·1562, Ophthalmology Archives
`
`·6
`
`·7· · · · · · · · · · · · · --o0o--
`
`·8
`
`·9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`·1· · · · · · · · · · · · ·I N D E X
`
`Page 3
`
`Page 5
`·1· · · ·EXHIBITS PREVIOUSLY MARKED FOR IDENTIFICATION
`
`·2· · · · · · · · · ·INDEX OF EXAMINATIONS
`
`·2· · · · · · · ·REFERRED TO IN THIS DEPOSITION
`
`·3· EXAMINATION BY MR. KANE· ...........................7
`
`·3
`
`·4· EXAMINATION BY MR. MILLS· ........................159
`
`· · Exhibit· · · · · · · · · · · ·Initial Reference
`
`·5· EXAMINATION BY MR. KANE· .........................168
`
`·4· · No.· · · · · · · · · · · · · ·Page· · ·Line
`
`·6· EXAMINATION BY MR. MILLS· ........................169
`
`·7
`
`·8· · · · · · · · · · · · · --o0o--
`
`·9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`·5· · 42· ·..........................16· · · 16
`
`·6· · 1007· .........................49· · · 25
`
`·7· · 1011· ........................127· · · 11
`
`·8· · 1039· .........................13· · · 25
`
`·9· · 1058· ........................125· · · 13
`
`10· · 2008· .........................49· · · ·7
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`2
`
`

`

`Page 6
`
`·1· · · · · · · · · ·A P P E A R A N C E S
`·2· APPEARANCES:
`·3
`·4· FOR THE PATENT OWNER:
`·5· · · · · · MICHAEL J. KANE, ESQ.
`· · · · · · · TASHA M. FRANCIS, PH.D., ESQ.
`·6· · · · · · FISH & RICHARDSON P.C.
`· · · · · · · 3200 RBC PLAZA
`·7· · · · · · 60 SOUTH SIXTH STREET
`· · · · · · · MINNEAPOLIS, MINNESOTA 55402
`·8· · · · · · 612.335.5070
`· · · · · · · KANE@FR.COM
`·9· · · · · · TFRANCIS@FR.COM
`10
`· · FOR THE REMAINING PETITIONERS:
`11· (APPEARING TELEPHONICALLY)
`12· · · · · · GARY SPEIER, ESQ.
`· · · · · · · CARLSON, CASPERS, VANDENBURGH, LINDQUIST
`13· · · · · · & SCHUMAN, P.A.
`· · · · · · · 225 SOUTH SIXTH STREET, SUITE 4200
`14· · · · · · MINNEAPOLIS, MN 55402
`· · · · · · · GSPEIER@CARLSONCASPERS.COM
`15
`16· FOR THE RESPONDENT:
`17· · · · · · JAD A. MILLS, ESQ.
`· · · · · · · ANNA PHILLIPS, ESQ.
`18· · · · · · WILSON SONSINI GOODRICH & ROSATI
`· · · · · · · 701 FIFTH AVENUE, SUITE 5100
`19· · · · · · SEATTLE, WASHINGTON 98104
`· · · · · · · 206.883.2554
`20· · · · · · JMILLS@WSGR.COM
`21
`22· · · · · · · · · · · · · --oOo--
`23
`24
`25
`
`Page 8
`·1· that she can get our both of our comments down.· I'm
`·2· a fast talker as well, so we'll both have to try to
`·3· watch that a little bit and not try to step on each
`·4· other.· Okay?
`·5· · · ·A.· ·Yes.
`·6· · · ·Q.· ·If I ask you a question that you don't
`·7· understand, please let me know and I'll to do a
`·8· better job on that.· Okay?
`·9· · · ·A.· ·Okay.
`10· · · ·Q.· ·It's also important that since we are
`11· trying to create a transcript here that you need to
`12· answer verbally.· Yeses, nos, not nods of the head
`13· or shaking of the head or the uh-huhs or huh-uhs,
`14· that kind of thing.· All right?
`15· · · ·A.· ·Yes.
`16· · · ·Q.· ·We'll try to take a break approximately on
`17· an hourly basis or so.· But if you need a break
`18· somewhere in the middle, let us know.· We can do
`19· that.· We just won't -- we'll just ask if there's an
`20· outstanding question, that you answer the question
`21· before we take a break.· All right?
`22· · · ·A.· ·Yes.
`23· · · ·Q.· ·Of the 18 times you've been deposed, how
`24· many of those related to patent issues?
`25· · · ·A.· ·Two, to the best of my recollection.
`
`Page 7
`·1· · · · · · WEDNESDAY, JULY 12, 2017, 9:08 A.M.
`·2
`·3· · · · · · · ·ANDREW F. CALMAN, M.D., PH.D.,
`·4· · · having been first duly sworn, was examined and
`·5· · · · · · · · · ·testified as follows:
`·6
`·7· · · · · · · · · · · · EXAMINATION
`·8· BY MR. KANE:
`·9· · · ·Q.· ·Good morning.· Could you state your name
`10· for the record?
`11· · · ·A.· ·Andrew Frederick Calman.
`12· · · ·Q.· ·And what's your current business address,
`13· Dr. Calman?
`14· · · ·A.· ·2480 Mission Street, San Francisco,
`15· California 94110.
`16· · · ·Q.· ·And I believe you've been deposed before,
`17· right?
`18· · · ·A.· ·Yes.
`19· · · ·Q.· ·How many times?
`20· · · ·A.· ·About 18.
`21· · · ·Q.· ·Okay.· So you know the general ground
`22· rules, then.· But before we get started, I'm going
`23· to ask you a series of questions, you're going to
`24· provide the answers.· It will be important to let me
`25· finish my question before you start your answer so
`
`Page 9
`·1· · · ·Q.· ·And can you describe generally what those
`·2· depositions were?
`·3· · · ·A.· ·Well, there was one in the Markman case,
`·4· and I believe there's just one -- in the Markman
`·5· phase of Allergan v. Teva Mylan, et al., for this
`·6· product.· And there was one or two, but I believe
`·7· it's just one, on the invalidity and noninfringement
`·8· phase of that same case.
`·9· · · ·Q.· ·So both of your depositions that related
`10· to patents were in connection with the district
`11· court litigation over Restasis currently pending in
`12· Texas?
`13· · · ·A.· ·Correct.
`14· · · ·Q.· ·Okay.
`15· · · ·A.· ·There was another matter, but it was an
`16· antitrust matter that had grown out of a patent
`17· matter.· But I was not involved in the patent phase
`18· at all.
`19· · · ·Q.· ·Okay.· And then, in general, in the other
`20· 16 or so depositions that you've given, what did
`21· they generally relate to?
`22· · · ·A.· ·Injuries and medical malpractice.
`23· · · ·Q.· ·Okay.
`24· · · ·A.· ·With a smattering of other things.· There
`25· was an employment discrimination case.
`
`3
`
`

`

`Page 10
`
`·1· · · · · · I think that's it.
`·2· · · ·Q.· ·Okay.
`·3· · · ·A.· ·Off the top of my head.
`·4· · · ·Q.· ·The other --
`·5· · · ·A.· ·Oh, there was a wrongful death case.
`·6· · · ·Q.· ·Okay.· The other matter that related --
`·7· the antitrust matter that you mentioned, did that
`·8· relate to a drug?
`·9· · · ·A.· ·Yes.
`10· · · ·Q.· ·What kind of drug was that?
`11· · · ·A.· ·An antibiotic eye drop.
`12· · · ·Q.· ·Who were the parties?
`13· · · ·A.· ·Apotex and Allergan.
`14· · · ·Q.· ·And who did you represent in that case?
`15· · · ·A.· ·Well, I was engaged by Allergan -- excuse
`16· me -- by Apotex.
`17· · · ·Q.· ·Where was that case located, if you
`18· recall?
`19· · · ·A.· ·I think Delaware.· But it never went to
`20· trial, so I don't know for sure.
`21· · · ·Q.· ·What was the name of the product?
`22· · · ·A.· ·Zymaxid.
`23· · · ·Q.· ·Do you recall the time frame when that
`24· occurred?
`25· · · ·A.· ·It settled earlier this year.
`
`Page 12
`·1· the -- to my knowledge, is part of the U.S. Patent
`·2· and Trademark Office.
`·3· · · ·Q.· ·Okay.· And you understand you're
`·4· testifying under oath today?
`·5· · · ·A.· ·Of course.
`·6· · · ·Q.· ·So the testimony today is just as though
`·7· you were in a courtroom giving it in front of a
`·8· judge or jury.
`·9· · · ·A.· ·Of course.
`10· · · ·Q.· ·Okay.· Any reason you can't give accurate
`11· or truthful, complete testimony today?
`12· · · ·A.· ·No.
`13· · · ·Q.· ·What did you do to prepare for the
`14· deposition today?
`15· · · ·A.· ·I reviewed various documents.· I met with
`16· counsel, reviewed -- you know, obviously reviewed my
`17· declaration and others and prior art.
`18· · · ·Q.· ·When did you meet with counsel?
`19· · · ·A.· ·Yesterday and the day before.
`20· · · ·Q.· ·How long?
`21· · · ·A.· ·About eight hours each day.
`22· · · ·Q.· ·Okay.· And who -- who was present at those
`23· meetings?
`24· · · ·A.· ·Jad Mills.· Anna Phillips.· I think
`25· Wendy Devine may have poked her head in for a brief
`
`Page 11
`
`·1· · · ·Q.· ·Okay.· And generally --
`·2· · · ·A.· ·You know what?· I don't think I was
`·3· deposed for that case, though.· I didn't actually
`·4· testify.
`·5· · · ·Q.· ·Did you provide a report?
`·6· · · ·A.· ·Yeah.
`·7· · · ·Q.· ·And, again, just at a high level, what did
`·8· the report relate to?
`·9· · · ·A.· ·Well, it's subject to a protective order
`10· which I believe is still in effect.· So what I think
`11· I can probably safely share is what I've seen in
`12· public press releases, that it was -- not my term
`13· but press term -- was a product switching case
`14· related to this drug.
`15· · · ·Q.· ·Okay.· You understand that this deposition
`16· relates to several -- what are called IPRs pending
`17· in the patent office?
`18· · · ·A.· ·That's my understanding.
`19· · · ·Q.· ·And what do you understand an IPR to be?
`20· · · ·A.· ·Well, my understanding of inter partes
`21· review is it's a pathway where parties can challenge
`22· the validity of patents through -- rather than going
`23· through the court system, going through what's
`24· called the PTAB, which I believe stands for Patent
`25· and Trademark Appeals Board, which is a part of
`
`Page 13
`
`·1· period.
`·2· · · ·Q.· ·Anyone else?
`·3· · · ·A.· ·Not that I recall.
`·4· · · ·Q.· ·Anybody on the phone?
`·5· · · ·A.· ·Not that I'm aware of.
`·6· · · ·Q.· ·Okay.· Do you recall what documents you
`·7· reviewed?
`·8· · · ·A.· ·Well, I'm sure I can't remember every
`·9· single thing.· But, in general, I reviewed the
`10· various declarations in the case, the various -- not
`11· court, but the various PTAB documents such as
`12· institution, petition, response, order, and then the
`13· various prior art references.
`14· · · ·Q.· ·Okay.· Okay.· Did you talk to anyone other
`15· than counsel in preparation for your deposition?
`16· · · ·A.· ·No.
`17· · · ·Q.· ·Did you talk to anyone at Mylan in
`18· preparation for the deposition?
`19· · · ·A.· ·No.
`20· · · ·Q.· ·Have you ever spoken to anyone at Mylan
`21· about this case?
`22· · · ·A.· ·Not to the best of my recollection.
`23· · · ·Q.· ·Okay.· All right.· We have -- handing you
`24· what's been marked previously as Exhibit 1039.
`25· · · · · · And do you recognize this document,
`
`4
`
`

`

`Page 14
`
`·1· Dr. Calman?
`·2· · · ·A.· ·Yes.
`·3· · · ·Q.· ·What is this?
`·4· · · ·A.· ·This is my declaration for the six IPR
`·5· cases.
`·6· · · ·Q.· ·Okay.· And if you turn to page 55, that's
`·7· your electronic signature?
`·8· · · ·A.· ·Yes.
`·9· · · ·Q.· ·And it's dated June 30th, 2017?
`10· · · ·A.· ·Yes.
`11· · · ·Q.· ·And you understand this same declaration
`12· was filed in all six of the IPR proceedings?
`13· · · ·A.· ·That is my understanding.
`14· · · ·Q.· ·Okay.· When did you begin working on the
`15· declaration for the IPRs?
`16· · · ·A.· ·It would have been late May or early June,
`17· to the best of my recollection.
`18· · · ·Q.· ·Okay.· Do you recall approximately how
`19· much time you spent drafting the declaration?
`20· · · ·A.· ·I don't have a precise idea of that. I
`21· can give you an estimate.· It's probably somewhere
`22· between 20 and 30 hours.
`23· · · ·Q.· ·Okay.· Did you draft the declaration
`24· yourself?
`25· · · ·A.· ·Well, it was a -- it was a collaboration
`
`Page 16
`·1· · · · · · The drafting process generally included
`·2· sending drafts back and forth and changing them.
`·3· BY MR. KANE:
`·4· · · ·Q.· ·And did you -- did you originate the first
`·5· draft that was exchanged back and forth, or did
`·6· counsel do the drafting?
`·7· · · ·A.· ·I think there were parts of both.· Parts
`·8· of it were initially written by me, and parts were
`·9· initially written by counsel, if I recall correctly.
`10· I don't -- there were a lot of drafts.· I don't have
`11· a precise recollection.
`12· · · ·Q.· ·Okay.· Let's take a quick look and hand
`13· you another exhibit here, Dr. Calman.
`14· · · · · · Handing you what's been marked previously
`15· as Exhibit 42.
`16· · · · · · Do you recognize this?
`17· · · ·A.· ·I do.
`18· · · ·Q.· ·What is this?
`19· · · ·A.· ·This is my CV.
`20· · · ·Q.· ·And is this dated June 29, 2017?
`21· · · ·A.· ·Yes.
`22· · · ·Q.· ·Was it accurate as of that date?
`23· · · ·A.· ·Yes.
`24· · · ·Q.· ·Have there been any changes?
`25· · · ·A.· ·Let me look.
`
`Page 15
`
`·1· with counsel.
`·2· · · ·Q.· ·And which counsel collaborated?
`·3· · · ·A.· ·WSGR.
`·4· · · ·Q.· ·Anyone else?
`·5· · · ·A.· ·No, not unless -- not that I'm aware of.
`·6· · · ·Q.· ·And which counsel at Wilson?
`·7· · · ·A.· ·I'm sorry?
`·8· · · ·Q.· ·Which counsel at Wilson Sonsini?
`·9· · · ·A.· ·Let's see.· Jad Mills.· Grace Winschel,
`10· W-I-N-S-C-H-E-L.· Anna Phillips.· Wendy Devine. I
`11· think Jacqueline Altman may have been involved.
`12· · · · · · And there may have been others involved,
`13· but those are the ones that I'm aware of.
`14· · · ·Q.· ·And can you describe the drafting process
`15· generally?
`16· · · · · · MR. MILLS:· And I'm -- at this point, I'm
`17· just going to issue an instruction that, on the
`18· basis of work product and privilege, you should
`19· disclose in answering the questions posed to you
`20· today your opinions as well as the bases for your
`21· opinions, but you should not disclose the contents
`22· of any confidential communications you may have had
`23· with counsel.
`24· · · · · · THE WITNESS:· So let me look at the
`25· question again.
`
`Page 17
`
`·1· · · · · · Not to the best of my knowledge.
`·2· · · ·Q.· ·And --
`·3· · · ·A.· ·Actually, there's one change.· Let me look
`·4· at this.· And I have changed this on my subsequent
`·5· versions.
`·6· · · · · · There are two hospitals here where I no
`·7· longer practice in the list of admitting privileges,
`·8· and those are San Francisco General Hospital and
`·9· St. Mary's Hospital.
`10· · · ·Q.· ·Okay.· Thank you for that update.
`11· · · · · · And when you say "practice," you are a
`12· practicing ophthalmologist, right?
`13· · · ·A.· ·Correct.
`14· · · ·Q.· ·And in preparing your analysis, you relied
`15· on lawyers for the legal principles that you were to
`16· incorporate?
`17· · · ·A.· ·In part.
`18· · · ·Q.· ·And where else did you obtain information
`19· about the legal principles you were to use?
`20· · · ·A.· ·I have done some background reading over
`21· the last couple of years.
`22· · · ·Q.· ·In what -- can you explain what kind of
`23· background reading you've done?
`24· · · ·A.· ·I actually enrolled in a course called
`25· OmniPrep Patent Course, which I didn't complete, but
`
`5
`
`

`

`Page 18
`·1· I did enroll in it and went through some of their
`·2· materials.
`·3· · · · · · I went to two continuing legal education
`·4· courses over the last two years on Hatch-Waxman.
`·5· · · · · · And I read a book called -- it's called
`·6· "The Generic Challenge."
`·7· · · · · · And I've read various articles online
`·8· about various patents' issues.
`·9· · · ·Q.· ·Okay.· In forming your opinions, you
`10· relied on that additional outside reading?
`11· · · ·A.· ·Well, I would say that that was background
`12· information.
`13· · · ·Q.· ·Okay.· In forming your opinions, did you
`14· follow any guidance that the lawyers provided in
`15· terms of the legal principles that you were to
`16· apply?
`17· · · ·A.· ·I would say that's a fair statement.
`18· · · ·Q.· ·I understand that you're not a lawyer; is
`19· that correct?
`20· · · ·A.· ·That is correct.
`21· · · ·Q.· ·What caused you to be interested in the
`22· subject of patents over the last couple of years?
`23· · · ·A.· ·I saw -- I thought it was very
`24· interesting.· I had some exposure to patents.· My
`25· brother holds 55 patents in the technology field and
`
`Page 20
`·1· have the ability to read and understand and apply,
`·2· to some degree, statistical principles.· That does
`·3· not mean that I hold myself out to be an expert in
`·4· statistics per se.
`·5· · · ·Q.· ·Okay.· Are you offering opinions in these
`·6· matters as a expert in statistics?
`·7· · · ·A.· ·Well, again, I think that there's some
`·8· semantics here.· I think my prior answer is
`·9· applicable to your question.· I do have an ability
`10· to read and understand statistical data.· I did not
`11· perform my own statistical analysis.
`12· · · ·Q.· ·And we'll come to that.
`13· · · · · · You talked to Dr. Bloch, I understand?
`14· · · · · · MR. MILLS:· Objection.· Foundation.
`15· · · · · · THE WITNESS:· Not in connection with this
`16· case.
`17· BY MR. KANE:
`18· · · ·Q.· ·Okay.· You reviewed Dr. Bloch's
`19· declaration in connection with this case?
`20· · · ·A.· ·I did.
`21· · · ·Q.· ·Okay.· Do you consider yourself an expert
`22· in pharmacokinetics?
`23· · · ·A.· ·Again, through my knowledge, skills,
`24· training, education in 27-plus years -- more if you
`25· count my lab career working in labs on various
`
`Page 19
`·1· has been an expert witness in high-tech patent
`·2· cases.
`·3· · · · · · I had an invention a few years ago which I
`·4· thought about patenting and elected not to.
`·5· · · · · · So that was my exposure, and my brother
`·6· encouraged me to explore this.· And I started
`·7· reading about Hatch-Waxman.· Some people may think
`·8· it's dry; I actually found it kind of interesting.
`·9· So I saw it as a natural outgrowth of my expert
`10· witness work on smaller cases.
`11· · · ·Q.· ·When you say "smaller cases," what are you
`12· referring to?
`13· · · ·A.· ·Mostly ocular injuries and medical
`14· malpractice.
`15· · · ·Q.· ·I see.
`16· · · · · · You don't consider yourself an expert in
`17· patent law?
`18· · · ·A.· ·I don't consider myself an expert in any
`19· form of law.
`20· · · ·Q.· ·You don't consider yourself an expert in
`21· statistics, do you?
`22· · · ·A.· ·Well, what I would say is that there are
`23· degrees of expertise.· And through my knowledge,
`24· skills, experience, training, and education as a
`25· scientist and as a clinician over many years, I do
`
`Page 21
`
`·1· projects, reviewing scientific and clinical
`·2· publications, working on clinical trials, and
`·3· serving as an expert on various cases, and, you
`·4· know, taking various courses, including, you know,
`·5· courses on evidence-based medicine and epidemiology,
`·6· I have acquired some expertise in understanding and
`·7· interpreting pharmacokinetic studies.
`·8· · · · · · That said, I do not hold myself out an
`·9· expert in pharmacokinetics per se.
`10· · · ·Q.· ·Do you still work at Premier Eyecare in
`11· San Francisco?
`12· · · ·A.· ·I do.
`13· · · ·Q.· ·And you're also an associate clinical
`14· professor?
`15· · · ·A.· ·Yes.
`16· · · ·Q.· ·Have you taken any additional roles
`17· besides those that are not listed in your CV?
`18· · · ·A.· ·Not to my knowledge.
`19· · · ·Q.· ·Okay.
`20· · · ·A.· ·"Roles" is a pretty broad category, but I
`21· think I've listed the relevant professional roles
`22· that I've had.
`23· · · ·Q.· ·Okay.· If we look at the list of
`24· publications that starts on page 8 of
`25· Exhibit 1042...
`
`6
`
`

`

`Page 22
`
`·1· · · ·A.· ·Yeah.
`·2· · · ·Q.· ·To the best of your knowledge, is that a
`·3· complete list of your publications?
`·4· · · ·A.· ·Yes.
`·5· · · ·Q.· ·Do any of these publications relate to
`·6· dry eye?
`·7· · · ·A.· ·No.· Well, not directly anyway.
`·8· · · ·Q.· ·Okay.· Have you published in any papers on
`·9· KCS?
`10· · · ·A.· ·No.
`11· · · ·Q.· ·Have you published any papers on making
`12· ophthalmic formulations?
`13· · · ·A.· ·Not to the best of my recollection, no.
`14· · · ·Q.· ·And I guess on that front, do you consider
`15· yourself to be an expert in making ophthalmic
`16· formulations?
`17· · · ·A.· ·Again, I've had 27 years in labs -- well,
`18· 27 years in clinical work plus 12 years in labs
`19· doing basic research.· And through that knowledge,
`20· education, skills, training, and experience, I have
`21· acquired certain knowledge about pharmaceutical
`22· formulations, including ophthalmic formulations and
`23· their application in clinical practice, in clinical
`24· trials, et cetera.
`25· · · · · · So although I do have -- I have acquired
`
`Page 24
`·1· · · ·A.· ·No, with the caveat that I did -- I was
`·2· working with professors as a resident in
`·3· ophthalmology, and we certainly used ophthalmic
`·4· cyclosporin formulations at that time.· Whether any
`·5· of them published anything on any of the patients
`·6· that I collaborated with them on, I don't know.· So
`·7· not to the best of my knowledge.
`·8· · · ·Q.· ·What were the nature of those formulations
`·9· that you were working on?
`10· · · ·A.· ·To the best of my recollection -- again,
`11· this was a long time ago -- we were using 2 percent
`12· cyclosporin in olive oil.
`13· · · ·Q.· ·And was it a commercial product?
`14· · · ·A.· ·It was a compounded product.
`15· · · ·Q.· ·What do you mean when you say "compounded
`16· product"?
`17· · · ·A.· ·So you go through what's called a
`18· compounding pharmacy -- in this case, it was the
`19· UCSF pharmacy -- and the pharmacist makes up the
`20· drug custom for you.
`21· · · ·Q.· ·Okay.· And this is during the time you
`22· were a resident?
`23· · · ·A.· ·Yes.
`24· · · ·Q.· ·And --
`25· · · ·A.· ·And possibly part of the time I was a
`
`Page 23
`·1· some expertise in that area, I don't hold myself out
`·2· to be an expert in formulation per se.
`·3· · · ·Q.· ·Okay.· You mentioned you thought about
`·4· filing a patent application a couple years ago.
`·5· · · · · · Have you ever filed a patent application?
`·6· · · ·A.· ·No.
`·7· · · ·Q.· ·In connection with that potential
`·8· invention a couple years ago, did you talk to a
`·9· patent lawyer?
`10· · · ·A.· ·I don't remember if I actually talked to a
`11· patent lawyer.· And it was more than a couple; it
`12· was about 12 years ago.
`13· · · ·Q.· ·Okay.· I assume that means there was never
`14· an application drafted?
`15· · · ·A.· ·That's correct.
`16· · · ·Q.· ·And, again, just generally, what was the
`17· nature of the potential invention?
`18· · · ·A.· ·It was a surgical instrument.
`19· · · ·Q.· ·For ophthalmic surgery?
`20· · · ·A.· ·Yes.
`21· · · ·Q.· ·So that -- do I understand correctly,
`22· then, you've never applied for a patent?
`23· · · ·A.· ·That is correct.
`24· · · ·Q.· ·Have you ever been involved in developing
`25· a cyclosporin ophthalmic product?
`
`Page 25
`
`·1· medical student as well.
`·2· · · ·Q.· ·Okay.· And what were you using that
`·3· compounded product on patients for?
`·4· · · ·A.· ·Well, we used it for sure on some patients
`·5· who had had corneal transplants, and we used it on a
`·6· rare condition called ligneous, L-I-G-N-E-O-U-S,
`·7· conjunctivitis.
`·8· · · · · · You know, It's been a long time.· I don't
`·9· remember whether we used it on other conditions as
`10· well.· I just don't remember.
`11· · · ·Q.· ·Okay.· And did you have any involvement in
`12· deciding what the formulation would be made by the
`13· compounding pharmacy?
`14· · · ·A.· ·Well, there may have been some
`15· discussions, but I don't remember specifically.
`16· · · ·Q.· ·Have you ever been involved in any other
`17· development of a cyclosporine ophthalmic
`18· formulation?
`19· · · ·A.· ·Not to the best of my recollection.
`20· · · ·Q.· ·Have you been involved in the development
`21· of any ophthalmic formulation?
`22· · · ·A.· ·I guess it depends what you mean by
`23· "development."· I've been involved certainly in
`24· clinical trials.
`25· · · ·Q.· ·Do you recall which clinical trials?
`
`7
`
`

`

`Page 26
`·1· · · ·A.· ·Well, I believe they're listed in my CV.
`·2· Page 11 --
`·3· · · ·Q.· ·Okay.
`·4· · · ·A.· ·-- and 12.
`·5· · · ·Q.· ·All right.· And that's a complete list?
`·6· · · ·A.· ·Well, to the best of my recollection and
`·7· knowledge, yes.
`·8· · · ·Q.· ·And in these clinical trials, did you have
`·9· any input into the formulations that would be used
`10· in the trials?
`11· · · ·A.· ·Not to the best of my recollection.· But I
`12· should add that there were some additional
`13· discussions with personnel in the research
`14· department at Alcon over some clinical trials of
`15· glaucoma drugs where I would have had input into
`16· which formulations were used.· However, we never got
`17· past the initial discussion.
`18· · · ·Q.· ·In that sort of a discussion, though, are
`19· you talking about the specific, say, excipients and
`20· other ingredients, or are you just talking about
`21· choosing between formulations that have been
`22· developed already?
`23· · · ·A.· ·Definitely the second part.· Potentially
`24· the first part.· We didn't get to that stage --
`25· · · ·Q.· ·Okay.
`
`Page 28
`
`·1· focus of their research.
`·2· · · ·Q.· ·Okay.· In the Brimonidine formulations,
`·3· did you have any input into what could be used in
`·4· place of the BAK?
`·5· · · ·A.· ·No.· I believe that was -- that was at an
`·6· earlier stage than my involvement.
`·7· · · ·Q.· ·Okay.· All right.· And likewise in the
`·8· Travatan, did you have any input into which
`·9· preservative would be used in place of the BAK?
`10· · · ·A.· ·Well, I know I was certainly involved in
`11· discussions.· I don't remember if they were at --
`12· you know, certainly at the stage where they were
`13· disclosing the treatment protocols and rationale and
`14· basic science to the clinical investigators.
`15· Whether I was involved in discussions earlier than
`16· that, I don't have a recollection.
`17· · · ·Q.· ·All right.· Have you ever performed
`18· bioavailability analysis for the delivery of ocular
`19· drugs in animals?
`20· · · ·A.· ·Not that I can recall.
`21· · · ·Q.· ·Okay.· Do you use Restasis in your
`22· practice?
`23· · · ·A.· ·I do.
`24· · · ·Q.· ·And how do you use Restasis in your
`25· practice?
`
`Page 27
`
`·1· · · ·A.· ·-- in the discussions.
`·2· · · ·Q.· ·Were there any other projects you were
`·3· involved in where you were having detailed
`·4· discussions about excipients and other components in
`·5· ophthalmic formulations in development stages?
`·6· · · ·A.· ·Well, again, it depends what stages you're
`·7· talking about.· The Travatan, or travoprost, studies
`·8· were in part an effort to minimize toxicity to the
`·9· ocular surface.· And so the excipients were an
`10· important issue in those clinical trials.· I was
`11· definitely involved in Phase 3 and Phase 4.· I don't
`12· think I was involved in Phase 1 or Phase 2 or
`13· preclinical.
`14· · · ·Q.· ·And in those trials, what was the
`15· excipient of concern?
`16· · · ·A.· ·Well, the goal was to eliminate BAK.· And
`17· so they were using a novel -- a novel preservative
`18· which the name is escaping me at this point.· But
`19· that was the goal.
`20· · · ·Q.· ·Okay.· All right.
`21· · · ·A.· ·And there were similar considerations. I
`22· don't know if they applied to the ones that I was
`23· directly involved with, but some of the Brimonidine
`24· formulations were also formulated -- reformulated in
`25· such a way as to eliminate BAK.· And that was a
`
`Page 29
`·1· · · ·A.· ·Well, as I discussed in my declaration, I
`·2· individualize treatment.· Some individuals with some
`·3· types of dry eye and some clinical pictures, I
`·4· employ it as one treatment modality.
`·5· · · ·Q.· ·Can you explain what you mean by that?
`·6· · · ·A.· ·Well, it's a -- it would be a rather
`·7· lengthy discussion.· But I think to summarize, I
`·8· typically use it in patients with moderate to severe
`·9· aqueous-deficient dry eye where I believe there is
`10· an inflammatory component as one component of their
`11· treatment plan.
`12· · · ·Q.· ·Okay.· And you understand that Restasis
`13· has been indicated to increase tear production in
`14· certain patients?
`15· · · ·A.· ·Well, it's a very specific labeled
`16· indication.· To paraphrase without having the label
`17· in front of me, it's indicated to increase tear
`18· production in patients whose tear production is
`19· presumed to be suppressed by inflammation associated
`20· with KCS.
`21· · · ·Q.· ·And are you using it consistent with that
`22· labeling?
`23· · · ·A.· ·To some extent, yes, but I do
`24· individualize treatment, and I don't necessarily
`25· perform before and after measurement of
`
`8
`
`

`

`Page 30
`
`·1· tear production.
`·2· · · ·Q.· ·Okay.· If we look back at the clinical
`·3· trials you've been involved in, you mentioned
`·4· Brimonidine as an example.· And isn't it -- is it
`·5· true that many of these studies involve
`·6· glaucoma-related drugs?
`·7· · · ·A.· ·That is true.
`·8· · · ·Q.· ·Did any of them involve cyclosporin?
`·9· · · ·A.· ·I don't believe so.
`10· · · ·Q.· ·Did any of them involve treatments for
`11· dry eye patients?
`12· · · ·A.· ·In a sense because the -- again, the
`13· thrust of eliminating the BAK was to facilitate
`14· treatment of patients with ocular surface
`15· conditions, including that broad constellation of
`16· entities collectively known as dry eye, to be able
`17· to treat those patients for their glaucoma without
`18· comprising their ocular surface.
`19· · · · · · And so that was a major focus of the
`20· Brimonidine and travoprost development.· And
`21· probably was -- I mean, this was a long time ago; I
`22· don't remember the exact study protocols.· But it
`23· probably was reflected in the -- in the patients --
`24· in the target patient population and the monitoring
`25· modalities.
`
`Page 32
`·1· list.· These are some of the documents that I relied
`·2· upon, yes.
`·3· · · ·Q.· ·Okay.· What other documents did you rely
`·4· upon?
`·5· · · ·A.· ·Well, just off the top of my head, I'm not
`·6· seeing, for example, the petition, response,
`·7· institution decision.· I'm looking for the various
`·8· declarations.
`·9· · · · · · So I did review petitions, responses,
`10· preliminary responses, institution decisions. I
`11· think there were a couple of orders.· And then the
`12· declarations of Dr. Sheppard; Loftsson,
`13· L-O-F-T-S-S-O-N; Amiji, A-M-I-J-I; and Bloch,
`14· B-L-O-C-H.
`15· · · · · · Again, off the top of my head, that's --
`16· that's what I remember reviewing.· And I believe
`17· that everything that is referenced in here is listed
`18· the appendix.· If not, then the reference would be
`19· in the text.
`20· · · ·Q.· ·Okay.· And so was this listing an attempt
`21· to call out the specific documents referenced in
`22· your opinion?
`23· · · ·A.· ·I think that would be the overall thrust
`24· of it, yes.
`25· · · ·Q.· ·Were there any documents that you
`
`Page 31
`·1· · · ·Q.· ·If I understand correctly, the active
`·2· ingredient in the treatment was being offered for
`·3· glaucoma, but the concern or the issue with BAK was
`·4· not to aggravate patients that were also suffering
`·5· with some sort of a dry eye condition?
`·6· · · ·A.· ·That's close.· I wouldn't say it exactly
`·7· that way.· But, yes, many of the patients who have
`·8· glaucoma are also elderly.· And there is a strong
`·9· overlap in the target population between dry eye and
`10· glaucoma, and so that was underlying this effort.
`11· · · ·Q.· ·But the focus was the treating the
`12· glaucoma?
`13· · · ·A.· ·Well, these are glaucoma drugs, obviously.
`14· But at least in some cases -- and I -- I would have
`15· to go read these study protocols from 15, 20 years
`16· ago -- was towards protecting the ocular surface
`17· while treating the glaucoma.
`18· · · ·Q.· ·Turn back to your declaration, Dr. Calman.
`19· · · · · · And if we turn to appendix at page 56,
`20· please.· This is entitled "List of Exhibits."
`21· · · · · · Do you see that?
`22· · · ·A.· ·I do.
`23· · · ·Q.· ·And is this the documents that you relied
`24· upon in forming your opinions in these matters?
`25· · · ·A.· ·Well, it's not meant to be an exhaustive
`
`Page 33
`
`·1· recall -- well, let me strike that.
`·2· · · · · · If you start, other than Dr. Amiji -- as
`·3· you 1001 of the patents at issue, so those are six
`·4· patents that ar