LESLIE Z. BENET
`
`Page 1
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________________________________
`APOTEX INC., APOTEX CORP., ARGENTUM PHARMACEUTICALS
` LLC, ACTAVIS ELIZABETH LLC, TEVA
` PHARMACEUTICALS USA, INC., SUN PHARMACEUTICALS
` INDUSTRIES LTD., SUN PHARMACEUTICAL INDUSTRIES,
` INC., AND SUN PHARMA GLOBAL FZE,
` Petitioners,
` vs.
` NOVARTIS A.G.,
` Patent Owner.
`____________________________________________________
` IPR2017-00854
` Patent No. 9,187,405
`
` VIDEOTAPED DEPOSITION OF LESLIE Z. BENET, Ph.D.
` San Francisco, California
` Tuesday, March 13, 2018
`
`REPORTED BY:
`REBECCA L. ROMANO, RPR, CSR No. 12546
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`212-279-9424
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`Veritext Legal Solutions
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`Apotex v. Novartis
`IPR2017-00854
`NOVARTIS 2100
`
`

`

`LESLIE Z. BENET
`
`Page 4
`1 APPEARANCES OF COUNSEL (cont'd)
`
`2 3 4
`
`ALSO PRESENT:
`5 Tyler Liu, Argentum Pharmaceuticals, LLC(via
`6 telephone)
`7 Brandon Miller, Videographer
`
`8 9
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`25 /////
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`Page 2
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`1 UNITED STATES PATENT AND TRADEMARK OFFICE
`2 BEFORE THE PATENT TRIAL AND APPEAL BOARD
`3 ____________________________________________________
`4 APOTEX INC., APOTEX CORP., ARGENTUM PHARMACEUTICALS
` LLC, ACTAVIS ELIZABETH LLC, TEVA
`5 PHARMACEUTICALS USA, INC., SUN PHARMACEUTICALS
` INDUSTRIES LTD., SUN PHARMACEUTICAL INDUSTRIES,
`6 INC., AND SUN PHARMA GLOBAL FZE,
`7 Petitioners,
`8 vs.
`9 NOVARTIS A.G.,
`10 Patent Owner.
`11 ____________________________________________________
`12 IPR2017-00854
` Patent No. 9,187,405
`
`13
`14
`15
`16
`17 VIDEOTAPED DEPOSITION OF LESLIE Z. BENET,
`18 Ph.D., taken on behalf of the Patent Owner, at
`19 Wilson Sonsini Goodrich & Rosati, One Market Plaza,
`20 Spear Tower, Suite 3300, San Francisco, California,
`21 commencing at 9:38 a.m., March 13, 2018 before
`22 Rebecca L. Romano, Certified Shorthand Reporter
`23 No. 12546
`24
`25
`
`1 I N D E X
`2 DEPONENT EXAMINATION
`3 LESLIE Z. BENET, PH.D. PAGE
`
`Page 5
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`4 5
`
` BY MR. TRENCHARD 9
`6 BY MR. MILLS 56
`
`7 8 9
`
` PREVIOUSLY MARKED EXHIBITS
`10 NUMBER PAGE
`11 Exhibit 1047 21
`12
`13 Exhibit 1048 47
`14
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`21
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`Page 3
`1 APPEARANCES OF COUNSEL
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`23
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`For the Petitioner - Apotex Inc., Apotex Corp.:
`4 WILSON SONSINI GOODRICH & ROSATI
`5 BY: JAD A. MILLS
`6 Attorney at Law
`7 701 Fifth Avenue
`8 Suite 5100
`9 Seattle, Washington 98104-7036
`10 (206) 883-2554
`11 jmills@wsgr.com
`12
`13 For the Patent Owner - Novartis A.G.:
`14 GIBSON, DUNN & CRUTCHER LLP
`15 BY: ROBERT W. TRENCHARD
`16 BY: JANE M. LOVE(via telephone)
`17 Attorneys at Law
`18 200 Park Avenue
`19 New York, New York 10166-0193
`20 (212) 351-4000
`21 rtrenchard@gibsondunn.com
`22 jlove@gibsondunn.com
`23
`24
`25 /////
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`

`LESLIE Z. BENET
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`Page 6
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`Page 8
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`1 phone?
`2 MR. LIU: Tyler Liu on behalf of
`3 Argentum Pharmaceuticals.
`4 THE VIDEOGRAPHER: Thank you. You may
`5 now swear in the witness.
`6 THE REPORTER: If you could raise your
`7 right hand for me, please.
`8 THE DEPONENT: (Complies.)
`9 THE REPORTER: You do solemnly state,
`10 under penalty of perjury, that the testimony you
`11 are about to give in this deposition, shall be the
`12 truth, the whole truth and nothing but the truth?
`13 THE DEPONENT: I do.
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`1 San Francisco, California; Tuesday, March 13, 2018
`2 9:38 a.m.
`3 ---o0o---
`
`4 5
`
` THE VIDEOGRAPHER: Good morning. We're
`6 going on the record at 9:38 a.m. on
`7 March 13th, 2018.
`8 Please note the microphones are
`9 sensitive, may pick up whispering, private
`10 conversations and cellular interference. Please
`11 silence all cell phones and place them away from
`12 the microphones as they interfere with deposition
`13 audio.
`14 Audio and video recording will continue
`15 to take place unless all parties agree to go off
`16 the record. This is media No. 1 of the
`17 video-recorded deposition of Dr. Leslie Benet --
`18 Benet.
`19 THE DEPONENT: Benet, but I'll go by
`20 either name.
`21 MR. TRENCHARD: That one's a more French
`22 name.
`23 THE VIDEOGRAPHER: In the matter of
`24 Apotex, Incorporated, et al., versus Novartis AG,
`25 filed in United States Patent and Trademark Office
`
`Page 7
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`Page 9
`
`1 LESLIE Z. BENET, Ph.D.,
`2 having been administered an oath, was examined and
`3 testified as follows:
`
`4 5
`
` EXAMINATION
`6 BY MR. TRENCHARD:
`7 Q. Good morning, Dr. Benet.
`8 A. Good morning.
`9 Q. Thank you very much for coming today.
`10 As you just heard, my name is
`11 Bob Trenchard. I'm with Gibson Dunn & Crutcher and
`12 I represent Novartis.
`13 You understand you're under oath today,
`14 of course?
`15 A. I do.
`16 Q. Is there anything that would interfere
`17 with your ability to give complete and truthful
`18 testimony today?
`19 A. No.
`20 Q. Okay. Are you on any medication that
`21 affects your memory or perception?
`22 A. I am not.
`23 Q. Okay. When was the last time you
`24 consumed alcohol?
`25 A. Last Saturday, lunch.
`
`1 before the Patent Trial and Appeal Board.
`2 Case No. IPR2017-00854.
`3 This deposition is being held at
`4 One Market Plaza, Spear Tower, Suite 3300,
`5 San Francisco, California.
`6 My name is Brandon Miller from
`7 Veritext Legal Solutions and I'm the videographer.
`8 The court reporter is Rebecca Romano from the firm
`9 of Veritext Legal Solutions.
`10 I'm not related to any parties in this
`11 action nor am I financially interested in the
`12 outcome.
`13 Counsel and all present in the room, and
`14 everyone attending remotely, will please state
`15 their appearances and affiliations for the record.
`16 MR. MILLS: This is Jad Mills with the
`17 law firm Wilson Sonsini Goodrich & Rosati
`18 representing Apotex, Inc., and Apotex Corp., and
`19 here with Dr. Benet.
`20 MR. TRENCHARD: Robert Trenchard from the
`21 law firm of Gibson Dunn & Crutcher. And with me on
`22 the phone is my partner, Dr. Jane Love, also with
`23 Gibson Dunn & Crutcher. We represent the patent
`24 owner, Novartis.
`25 THE VIDEOGRAPHER: Anyone else on the
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`LESLIE Z. BENET
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`Page 10
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`Page 12
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`1 Q. The effects have clearly worn off by
`2 then?
`3 A. Maybe.
`4 Q. Okay. Fair enough.
`5 So we'll get to your experience in a
`6 second. I gather you've been through this drill
`7 several times before. But just for the sake of the
`8 record, allow me to make a few things clear.
`9 First, of course, your answers today must
`10 be verbal, in the form of words, rather than grunts
`11 or nods.
`12 Do you understand?
`13 A. I understand.
`14 Q. Thank you.
`15 We will try to take breaks probably every
`16 hour or so. If at any point you need a break, just
`17 let me know, and subject to maybe finishing a few
`18 questions, I'm happy to try to accommodate you.
`19 Okay?
`20 A. Thank you.
`21 Q. I'll be asking questions today. If you
`22 don't understand one of my questions, please don't
`23 hesitate to tell me and we'll work it out and try
`24 to figure out a way that you can understand.
`25 Okay?
`
`Page 11
`
`1 A. Thank you. Yes.
`2 Q. And, of course, if you -- if you don't
`3 tell me that there's some ambiguity or problem with
`4 my question, I'm going to assume that you do
`5 understand them. But as I said, we'll work through
`6 any complications with language along the way.
`7 Okay?
`8 A. I understand.
`9 Q. Okay. So I gather you have participated
`10 as an expert in other litigations before; is that
`11 right?
`12 A. That's correct.
`13 Q. And you've provided testimony in those
`14 other cases?
`15 A. I have.
`16 Q. Has that testimony been in the form of
`17 writing, such as a declaration or aff- --
`18 affidavit?
`19 A. Yes, it is.
`20 Q. Has it also been in the form of
`21 deposition testimony, like what we're doing right
`22 now?
`23 A. It has.
`24 Q. Have you testified live at trial before?
`25 A. I have.
`
`1 Q. Okay. So I'd like to just go through
`2 each of those categories a little bit, starting
`3 with the first one. And I'm asking you for an
`4 approximation because I realize that you've had a
`5 long career.
`6 Approximately how many times have you
`7 submitted written testimony in a case?
`8 A. Wow. Probably more than 150 times.
`9 Q. And have all of those always been as an
`10 expert?
`11 A. No. No.
`12 Q. So have you submitted written testimony
`13 as a direct witness on -- on occasion?
`14 A. Yes.
`15 Q. Okay. How many times have you done that?
`16 A. Once.
`17 Q. What sort of case was that?
`18 A. University issue with a professor.
`19 Q. Understood.
`20 Other than that one time, have all of
`21 your other instances of submitting written
`22 testimony been as an expert?
`23 A. Yes.
`24 Q. And that's an expert in pharmacology?
`25 A. Yes.
`
`Page 13
`1 Q. Have you submitted this written testimony
`2 in -- strike that.
`3 Do you have a -- strike that again.
`4 Do you know what courts or bodies the
`5 cases were pending in front of?
`6 A. Every.
`7 Q. Every.
`8 A. Every -- U.S. and Europe.
`9 Q. Fair enough.
`10 So U.S. state court proceedings?
`11 A. Yes.
`12 Q. U.S. federal court proceedings?
`13 A. Yes.
`14 Q. Proceedings in the patent office?
`15 A. Yes.
`16 Q. Proceedings in a European forum?
`17 A. Yes.
`18 Q. What sort of European forum?
`19 A. The -- equivalent to the -- what this --
`20 this patent type of process in Europe.
`21 Q. Does the term European opposition sound
`22 familiar?
`23 A. That's correct.
`24 Q. So it was in European oppositions?
`25 A. Yes.
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`LESLIE Z. BENET
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`Page 14
`1 Q. And how many times have you submitted
`2 written testimony before the U.S. Patent Office?
`3 A. It's -- so let me clarify that. It's
`4 only for these type of procedures that we're doing
`5 today.
`6 Q. Let's just start more broadly and then
`7 we'll -- we'll narrow it down.
`8 So more broadly, how often have you
`9 submitted written testimony to the
`10 U.S. Patent Office?
`11 A. I'm not really sure because that -- I'm
`12 not really sure whether it did. I -- I know for
`13 sure this is the second U.S. case under this
`14 format.
`15 Q. By "this format," you mean an IPR?
`16 A. IPR, yes.
`17 Q. And what was the first one?
`18 A. It was Insys Pharmaceuticals versus
`19 GW Pharmaceuticals.
`20 Q. And when did you submit testimony in that
`21 case?
`22 A. Probably in May of last year.
`23 Q. And without going into any confidential
`24 information, could you just generally describe the
`25 subject matter of your testimony?
`
`Page 16
`1 connection with the acquisition of those patents?
`2 A. In U.S.?
`3 Q. In the U.S.
`4 A. Not that I recall.
`5 Q. Do you recall submitting any declarations
`6 to the patent office in connection with acquiring
`7 those patents?
`8 A. I -- I don't recall. It's a long time
`9 ago.
`10 Q. Fair enough.
`11 So just returning to federal district
`12 court, federal court, how often have you submitted
`13 written testimony in district court?
`14 Again, I'm asking for approximations. I
`15 do appreciate it's a long time.
`16 A. It's really hard for me to -- to -- state
`17 versus federal. I -- I -- I don't know.
`18 Q. Fair enough.
`19 How many patent cases outside of the
`20 patent office, in Europe or the United States, have
`21 you submitted testimony?
`22 A. Several times. Approximately 150, I
`23 would say 140 are patent issues.
`24 Q. And what are the other nine, other than
`25 that one that was a university issue?
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`Page 15
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`Page 17
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`1 A. It was a patent issue.
`2 Q. A patent issue.
`3 And you submitted that testimony as a
`4 pharmacology expert?
`5 A. I did.
`6 Q. Were you deposed in that case?
`7 A. I was.
`8 Q. Do you know if that case is still ongoing
`9 or has it been resolved?
`10 A. It's not settled.
`11 Q. It's not.
`12 Do you know it's been decided by the
`13 board yet?
`14 A. I believe it has not been decided.
`15 Q. How many European patent office
`16 proceedings have you submitted testimony?
`17 A. Three or four.
`18 Q. And, again, that was as an expert in
`19 pharmacology?
`20 A. Initially, it was from my own patents,
`21 but more recently as an expert.
`22 Q. You own a number of U.S. patents as well;
`23 is that right?
`24 A. That's correct.
`25 Q. Did you submit any written testimony in
`
`1 A. Well, there are some -- well, actually,
`2 the number should be a little lower. 130 maybe,
`3 because of -- personal injury type of expert.
`4 Q. Was that -- what -- medical malpractice
`5 type cases?
`6 A. No, this was product.
`7 Q. Product liability?
`8 A. Product liability.
`9 Q. Understood. Thank you.
`10 So focusing on the one other IPR in which
`11 you submitted testimony -- you said you were
`12 deposed in that case; is that right?
`13 A. I was.
`14 Q. How many declarations did you submit in
`15 that?
`16 A. This is the same case as Europe, so it
`17 gets -- it gets complicated.
`18 I think in the U.S. only one.
`19 Q. And so you -- were you deposed only once
`20 in that case?
`21 A. Yes.
`22 Q. And who were you working for in that --
`23 sorry -- who has retained you in that case?
`24 A. Insys Pharmaceuticals.
`25 Q. Who was counsel for Insys?
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`LESLIE Z. BENET
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`Page 18
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`Page 20
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`1 A. Chicago firm. I don't recall.
`2 Q. Fair enough.
`3 And you say that the patent dispute in
`4 that case is related to a European opposition
`5 patent dispute; is that right?
`6 A. Very -- very similar, yes.
`7 Q. How many times have you submitted live
`8 testimony in a courtroom?
`9 A. Ten times.
`10 Q. What sort of cases?
`11 A. Mostly patent -- no, personal injury and
`12 patent.
`13 Q. So -- so product liability type cases?
`14 A. Right, product liability and patent.
`15 One -- product liability once.
`16 Q. And then the rest were patent cases?
`17 A. No, it was false advertising.
`18 Q. Fair enough. Fair enough.
`19 So a false advertising case, a product
`20 liability case and the rest are patent cases?
`21 A. Yes, I believe so.
`22 Q. And in those patent cases, was all of
`23 your testimony as an expert?
`24 A. Yes.
`25 Q. And to your knowledge, were -- was your
`
`1 the law firm of Wilson Sonsini before?
`2 A. I have.
`3 Q. How many times?
`4 A. They were the law firm for my first firm,
`5 so impacts of -- not impacts.
`6 Q. For the first IPR you mean?
`7 A. No, no.
`8 Q. No. Okay.
`9 A. My -- I founded four companies and
`10 Wilson Sonsini were the attorney for my first
`11 company. AvMax was the name. A-V-M-A-X was the
`12 name of that company.
`13 Q. So Wilson Sonsini helped you incorporate
`14 your first company?
`15 A. Incorporate and were also my patent
`16 attorneys.
`17 Q. Are they still?
`18 A. No. That company doesn't exist.
`19 Q. Other than using Wilson Sonsini to
`20 incorporate one of your prior companies, have you
`21 ever worked with Wilson Sonsini before?
`22 A. Probably, but I don't recall exactly.
`23 Q. And when was your company incorporated?
`24 A. '94.
`25 Q. And you said it still -- doesn't exist
`
`Page 19
`1 testimony accepted as expert testimony by the court
`2 in those cases?
`3 A. It was.
`4 Q. To your knowledge, was there any effort
`5 to exclude your testimony as expert testimony in
`6 those cases?
`7 A. I had one Daubert hearing and I was
`8 successful.
`9 Q. Do you remember what case that was in?
`10 A. I think it's a GlaxoSmithKline case, but
`11 I can't -- it's a number of years ago. Yeah.
`12 Q. Who were you -- strike that.
`13 Who had retained you in that case?
`14 A. I think GlaxoSmithKline, but I'm not
`15 sure.
`16 Q. Okay. We won't hold you to it.
`17 Thank you.
`18 Okay. And in those in-court instances,
`19 were you provided live testimony?
`20 Were there juries involved in any of
`21 those proceedings?
`22 A. About half and half.
`23 Q. So half jury, half bench?
`24 A. Yes.
`25 Q. Prior to this case, have you worked with
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`Page 21
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`1 anymore?
`2 A. It was sold to Eastman Chemical.
`3 Q. When was that?
`4 A. Early -- early 2000s.
`5 Q. And did Wilson Sonsini help you with the
`6 sale?
`7 A. No. They were no longer our attorneys.
`8 Q. Do you remember the lawyers you worked
`9 with at Wilson Sonsini in that case?
`10 A. No.
`11 Q. Okay.
`12 A. It was not Jad Mills.
`13 Q. I figured.
`14 (Discussion off the stenographic record.)
`15 Q. (By Mr. Trenchard) Okay. So I'm going
`16 to hand you what has previously been marked by
`17 petitioners as Exhibit 1047 in this case and I'll
`18 ask you to identify it for me.
`19 A. Thank you.
`20 Q. Okay. Do you recognize that?
`21 A. I do. It's my expert report dated
`22 February 15, 2018.
`23 Q. And that was when you signed the report,
`24 on February 15th?
`25 A. I authorized the law firm to sign for me.
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`LESLIE Z. BENET
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`Page 22
`1 Q. So on page 61 that Leslie Z. Benet in the
`2 signature line that's typed, that's what you
`3 authorized the law firm to --
`4 A. I did.
`5 Q. So you didn't actually sign any document
`6 in connection with this --
`7 A. That's correct.
`8 Q. -- with this declaration. Thank you.
`9 When did you first start -- strike that.
`10 Wilson Sonsini has retained you as an
`11 expert in this matter, right?
`12 A. That's correct.
`13 Q. When did they first retain you?
`14 A. Mid-December of 2017.
`15 Q. Had you spoken to anyone from
`16 Wilson Sonsini before mid-December 2017 about this
`17 case?
`18 A. No.
`19 Well, before I was retained -- I spoke
`20 with Mr. Mills before I was retained.
`21 Q. Okay. And how long before you were
`22 retained?
`23 A. Maybe a week.
`24 Q. And Mr. Mills was the first one to
`25 contact you?
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`Page 24
`
`1 Q. Between the first time you spoke to
`2 Mr. Mills and the retention letter, did you speak
`3 to anybody about this case?
`4 A. No.
`5 Q. So you executed the retention letter in
`6 December of 2017?
`7 A. Yes.
`8 Q. And does that retention letter say that
`9 you'll be paid on an hourly basis?
`10 A. It gives my fees. It lists my fees, yes.
`11 Q. And what are your fees?
`12 A. My fees are 800 -- $800 per hour for
`13 preparing an expert report and $1,600 an hour for
`14 anything through a deposition.
`15 Q. Okay. After -- between the -- the first
`16 discussion you had with Mr. Mills and the execution
`17 of your retention letter, did you receive any
`18 documents related to this case?
`19 A. I did.
`20 Q. What did you receive?
`21 A. The patent in issue.
`22 Q. Anything else?
`23 A. I believe that Mr. Mills sent me some
`24 public documents, but I did not read any of those
`25 before. Only the patent before I was retained.
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`Page 23
`
`1 A. He was.
`2 Q. Did you speak to anybody else at
`3 Wilson Sonsini about your work in this case?
`4 A. There were other lawyers on the phone
`5 call, but Mr. Mills was always on the calls at
`6 those times.
`7 Q. So just focusing on the first time you
`8 spoke to anybody about this case, was that in
`9 December of 2017?
`10 A. It was.
`11 Q. And that was with Mr. Mills?
`12 A. Yes.
`13 Q. And I don't want to know the contents of
`14 the discussion. I'm just trying to get the timing
`15 and who was involved.
`16 Was anybody else involved in the
`17 discussion?
`18 A. No.
`19 Q. Nobody on your end?
`20 A. No.
`21 Q. And nobody on Mr. Mills' end?
`22 A. No.
`23 Q. And then about a week after that you
`24 signed a retention letter?
`25 A. Yes.
`
`Page 25
`1 Q. And by "the patent," you mean the '405
`2 patent at issue?
`3 A. I mean the '405 patent, yes.
`4 Q. Okay. Thank you.
`5 Okay. So after the execution of your
`6 retention letter, did you receive any more
`7 documents from counsel for the petitioners?
`8 A. I did.
`9 Q. And are those the documents listed on
`10 Exhibit A of your declaration?
`11 A. They are. Appendix A.
`12 Q. Pardon me?
`13 A. Appendix A.
`14 Q. Appendix A. I apologize. Appendix A.
`15 And that's after page 61 of your
`16 declaration.
`17 A. That's correct.
`18 Q. Just returning briefly to this issue of
`19 the -- of your signature on page 61, how did you
`20 authorize Wilson Sonsini to affix your signature?
`21 Was it in writing? Was it orally?
`22 A. It was -- I sent an email authorizing.
`23 Q. And was that on February 15th?
`24 A. Either February 15th or 14th, yeah.
`25 Q. Might have been Valentine's Day. Okay.
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`LESLIE Z. BENET
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`Page 26
`1 Do you know whether any changes were made
`2 to your declaration between the time you sent your
`3 email authorizing Wilson Sonsini to affix this
`4 signature and the submission of this declaration?
`5 A. There were no changes.
`6 Q. And how do you know that?
`7 A. I had the document that I reviewed.
`8 Q. Okay. Fair enough.
`9 So returning to the question of the
`10 subject of when you received documents, I'd just
`11 like to look at Appendix A for a moment in your
`12 declaration.
`13 Okay. Do you have that in front of you?
`14 A. I do.
`15 Q. Thank you.
`16 So Exhibit No. 1001 on the first page
`17 there, the very first exhibit, do you see that?
`18 A. I do.
`19 Q. And that is the '405 patent you referred
`20 to earlier, right?
`21 A. That's correct.
`22 Q. So that is a document you received before
`23 executing your retention letter, right?
`24 A. It is.
`25 Q. Are there other documents on this list
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`1 that you remember receiving before executing your
`2 retention letter?
`3 A. I -- I don't know that.
`4 Q. But at some point you received all of the
`5 documents on Appendix A?
`6 A. Yes, except the document that I provided.
`7 Q. Okay. And what document was that?
`8 A. Well, I provided my curriculum vitae and
`9 I -- 1049, I believe.
`10 Q. 1049. So that's the FDA guidance
`11 registry?
`12 A. The FDA guidance, right.
`13 Q. That's the one about allometric scaling,
`14 right?
`15 A. Not allometric scaling, but it -- it's --
`16 Q. Fair enough.
`17 A. You're not --
`18 Q. It's about -- it's about scaling from
`19 animals to --
`20 A. Yes.
`21 Q. -- human -- human equivalent dose, right?
`22 A. Yes.
`23 Q. Okay. So 1049.
`24 A. Right.
`25 Q. Fair enough. I certainly don't want to
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`1 misuse terms in your speciality, so please
`2 definitely correct me if I do.
`3 So 1049 was a document you provided to
`4 Wilson Sonsini.
`5 Any other document besides that and your
`6 curriculum vitae that you provided to
`7 Wilson Sonsini?
`8 A. No, I do not believe so.
`9 Q. So other than folks at Wilson Sonsini,
`10 who else have you spoken to before today about your
`11 work in this case?
`12 A. No one.
`13 Q. So do you know -- and you said that there
`14 were other lawyers involved on telephone calls.
`15 You recall saying that earlier?
`16 A. Yes.
`17 Q. Do you know if those other lawyers were
`18 representing other petitioners or were they
`19 Wilson Sonsini lawyers?
`20 A. They were both. Both Wilson Sonsini.
`21 Q. Do you remember their names?
`22 A. Steven Grace. Is that right?
`23 (Discussion off the stenographic record.)
`24 Q. (By Mr. Trenchard) You can remember --
`25 you remember what you remember.
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`1 A. Yeah.
`2 Q. Don't -- we can swear Mr. Mills some
`3 other day, but right now it's just you.
`4 Okay?
`5 A. Okay.
`6 Q. Okay. So there were two Wilson Sonsini
`7 lawyers?
`8 A. Yes.
`9 Q. Okay. So you have not spoken to counsel
`10 for the other petitioners in this case before
`11 today?
`12 A. That's correct.
`13 Q. So before today, have you spoken to --
`14 strike that.
`15 In -- on your Appendix A, you see on the
`16 first page of Appendix A, Exhibit 1002?
`17 A. Yes.
`18 Q. You see the declaration of
`19 Barbara S. Giesser?
`20 Do you see that?
`21 A. Yes.
`22 Q. Do you know Dr. Giesser?
`23 A. No.
`24 Q. Have you ever spoken to her before?
`25 A. No.
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`LESLIE Z. BENET
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`1 Q. Did you read her declaration in
`2 connection with preparing your declaration?
`3 A. No.
`4 Q. So in carrying out your analysis for this
`5 matter, you spoke only with Wilson Sonsini lawyers;
`6 is that right?
`7 A. Right.
`8 Q. So just for the record, you didn't speak
`9 to a librarian?
`10 A. I did not.
`11 Q. You didn't speak to a physician?
`12 A. I did not.
`13 Q. Did you talk to an immunologist?
`14 A. I did not.
`15 Q. A neurologist?
`16 A. I did not.
`17 Q. Someone specializing in
`18 multiple sclerosis research?
`19 A. I did not.
`20 Q. A physician specializing in treating
`21 multiple sclerosis patients?
`22 A. I did not.
`23 Q. I do appreciate this. I just have to,
`24 for the record, make this clear.
`25 Any students?
`
`1 documents did you review related to Tysabri?
`2 A. I read a lot of the papers. I read
`3 the -- the FDA document in terms of the approval.
`4 I was looking for the basis for the approval and
`5 the information that was provided for the approval
`6 of that drug.
`7 Q. And why did you look at that information?
`8 A. Because Dr. Steinman was very much
`9 involved with that, and I wanted to see what the --
`10 his basis for interaction in that was, what some of
`11 his thinking was.
`12 Q. Do you know Dr. Steinman?
`13 A. I do not.
`14 Q. And by Dr. Steinman -- let's just nail
`15 this down for the record.
`16 If you could look at your appendix,
`17 Exhibit 2022 -- on page 4 of your appendix, do you
`18 see there where it says the declaration of
`19 Lawrence Steinman, M.D.?
`20 A. Yes.
`21 Q. And that's the Dr. Steinman we've been
`22 talking about, right?
`23 A. That's correct.
`24 Q. And did you -- you read his declaration
`25 in connection with preparing your declaration?
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`Page 33
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`1 A. I did not.
`2 Q. Did you have any research assistants help
`3 you out with this?
`4 A. I did not.
`5 Q. So other than providing counsel with
`6 Exhibit 1049, the FDA guidance, did you conduct --
`7 let me strike that.
`8 Other than identifying Exhibit 1049, did
`9 you conduct any research or review of any
`10 literature in connection with your work on your
`11 declaration, other than what's on Appendix A?
`12 A. I did.
`13 Q. What did you do?
`14 A. I reviewed most of the documents related
`15 to the -- to Tysabri, approval and development of
`16 that drug.
`17 Q. Sorry. What was the name of the drug?
`18 A. Tysabri. T-Y-S-A --
`19 Q. Oh, Tysabri.
`20 A. Tysabri.
`21 Q. I apologize.
`22 A. No, you -- you don't have to apologize.
`23 Tysabri.
`24 Q. Tysabri.
`25 Okay. So you -- what did you -- what
`
`1 A. I did.
`2 Q. Did you cite any of the Tysabri
`3 documentation you refer to anywhere in your
`4 declaration?
`5 A. I did not.
`6 Q. And why not?
`7 A. Didn't think it was relevant to the
`8 questions that I was asked to address.
`9 Q. So apart from Exhibit 1049, the FDA
`10 guidance, the Tysabri documentation you just
`11 described and the materials listed on Appendix A,
`12 did you review any other materials in connection
`13 with the preparation of your declaration?
`14 A. Yes. I -- I looked at a number of the
`15 Jusko papers that were not in his declaration or
`16 directly cited.
`17 Q. And did you cite any of those in your
`18 declaration?
`19 A. I did not.
`20 Q. And why not?
`21 A. They weren't relevant to the opinions I
`22 was asked to provide.
`23 Q. Sitting here, do you remember which Jusko
`24 papers you looked at?
`25 A. Well, I -- I read all his papers at one
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`LESLIE Z. BENET
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`1 time or another, so I can't tell you exactly.
`2 Q. You are both in the same field, yes?
`3 A. That's correct.
`4 Q. And do you know Dr. Jusko?
`5 A. Very well, yes.
`6 Q. But in connection with your preparation
`7 of this declaration, do you remember which of
`8 Dr. Jusko's papers you looked at?
`9 A. Well, I certainly read the ones that he
`10 quoted in his expert report, but I -- I read some
`11 others that were the background that led to that
`12 paper, where he does his analysis of the -- he --
`13 he takes the fingolimod and does his PKPD
`14 relationship. And so I read some of the background
`15 papers that led up to that paper.
`16 Q. And did those background papers have
`17 anything directly to do with fingolimod?
`18 A. No.
`19 Q. They were more methodological papers?
`20 A. They were.
`21 Q. When was the last time you spoke to
`22 Dr. Jusko?
`23 A. Spoke with him. Probably last -- a year
`24 ago.
`25 Q. You have never spoken about this case
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`1 with him?
`2 A. No.
`3 Q. Have you ever collaborated with Dr. Jusko
`4 on any research?
`5 A. We have written a few papers together,
`6 but it's not science papers. It's telling how
`7 great somebody is and reviewing their career.
`8 Q. It sounds like hagiographies.
`9 A. Yeah.
`10 Q. Okay. Fair enough.
`11 But -- so you've never done any research
`12 with Dr. Jusko?
`13 A. No research with Dr. Jusko.
`14 Q. Have you conducted any research with
`15 anybody at -- at Buffalo, where he works -- the
`16 university where he works?
`17 A. Yeah. Yeah, I have.
`18 Q. And who else. Who?
`19 A. Dr. Gearhart Levy. Dr. Lian Gfung,
`20 L-I-A-N G-F-U-N-G. Lian Gfung. A number of
`21 retired faculty members.
`22 Q. If you can look at your appendix again,
`23 page 3, for me.
`24 You see Exhibit No. 2003?
`