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`Page 1
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` UNITED STATES DISTRICT COURT
`
` FOR THE DISTRICT OF DELAWARE
`
` ---oOo---
`
` ASTRAZENECA AB, Case Number
`
` Plaintiff, 14-664-GMS
`
` vs (Consolidated)
`
` AUROBINDO PHARMA LTD. and
`
` AUROBINDO PHARMA USA, INS.,
`
` Defendants.
`
` ______________________________________________________
`
` VIDEOTAPED DEPOSITION OF DAVID P. ROTELLA, Ph.D.
`
` Palo Alto, California
`
` Thursday, May 26, 2016
`
` Volume I
`
` Reported by:
`
` THOMAS J. FRASIK
`
` RPR, CSR No. 6961
`
` Job No: 2314618
`
` Pages: 1 - 201
`
`800-567-8658
`
`973-410-4040
`
`Veritext Legal Solutions
`
`AstraZeneca Exhibit 2174
`Mylan v. AstraZeneca
`IPR2015-01340
`
`Page 1 of 92
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`

`

`Page 2
`
`1 Appearances, Continued:
`
`Page 4
`
`2 3 4
`
` (Wilson Sonsini appearance, continued):
`5 12235 El Camino Real, Suite 200
`6 San Diego, California 92130
`7 858-350-2246
`8 esteiner@wsgr.com
`9
`10
`11
`12 For Defendants Sun Pharma Global FZE,
`13 Sun Pharmaceutical Industries, Ltd.,
`14 and Amneal Pharmaceuticals, LLC:
`15 WINSTON & STRAWN LLP
`16 BY: CHRISTOPHER P. WILSON (Telephonically)
`17 Attorney At Law
`18 35 West Wacker Drive
`19 Chicago, Illinois 60601
`20 312-558-3274
`21 cpwilson@winston.com
`22
`23
`24
`25
`
`Page 3
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`1 Appearances, Continued:
`
`Page 5
`
`1 UNITED STATES DISTRICT COURT
`
`2 FOR THE DISTRICT OF DELAWARE
`
`3 ---oOo---
`
`4 ASTRAZENECA AB, Case Number
`
`5 Plaintiff, 14-664-GMS
`
`6 vs (Consolidated)
`
`7 AUROBINDO PHARMA LTD. and
`
`8 AUROBINDO PHARMA USA, INS.,
`
`9 Defendants.
`
`10 ______________________________________________________
`
`11
`
`12 Videotaped Deposition of DAVID P. ROTELLA,
`
`13 Ph.D., VOLUME I, at 601 California Avenue, Palo Alto,
`
`14 California, beginning at 9:18 a.m., and ending at
`
`15 4:51 p.m., on Thursday, May 26, 2016, before
`
`16 Thomas J. Frasik, Registered Professional
`
`17 Reporter, Certified Shorthand Reporter
`
`18 Number 6961.
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25 Job No. CS2314618
`
`1 Appearances of Counsel:
`
`234
`
` For Defendant Wockhardt:
`5 DUANE MORRIS LLP
`6 BY: JIAZHONG LUO (Telephonically)
`7 Attorney At Law
`8 30 South 17th Street
`9 Philadelphia, Pennsylvania 19103
`10 215-979-1809
`11 jluo@duanemorris.com
`12
`13
`14
`15
`16 Also Present:
`17
`18 Cyril Suskevitch, Videographer
`19
`20
`21
`22
`23
`24
`25
`
`2 3 4
`
` For Plaintiff AstraZeneca AB:
`5 FINNEGAN HENDERSON FARABOW
`6 GARRETT & DUNNER LLP
`7 BY: CHARLES E. LIPSEY
`8 M. DAVID WEINGARTEN, Ph.D.
`9 MICHAEL SU
`10 Attorneys At Law
`11 11955 Freedom Drive, Two Freedom Square
`12 Reston, Virginia 20190
`13 571-203-2700
`14 charles.lipsey@finnegan.com
`15
`16
`17
`18 For Defendant Mylan Pharmaceuticals, Inc.,
`19 and David P. Rotella, Ph.D.:
`20 WILSON SONSINI GOODRICH & ROSATI LLP
`21 BY: ELHAM (ELLIE) FIROUZI STEINER
`22 KATHERINE D. HASPER
`23 JAD MILLS
`24 GRACE WINSCHEL
`25 Attorneys At Law
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`Page 6
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`Page 8
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`1 E X H I B I T S
`2 DAVID P. ROTELLA, Ph.D. DEPOSITION
`3 NUMBER DESCRIPTION MARKED
`
`4 5
`
` Exhibit 64 Prediction of Human Clearance of 110
`6 Twenty-Nine Drugs (10 pgs)
`7 Exhibit 65 Synthesis of Novel Potent 135
`8 Dipeptidyl Peptidase IV
`9 Inhibitors (12 pgs)
`10 Exhibit 66 DPP4 Update documents (20 pgs) 147
`11 Exhibit 67 Specific and Irreversible 149
`12 Cyclopeptide Inhibitors of
`13 Dipeptidyl Peptidase (11 pgs)
`14 Exhibit 68 Crystal Structures of Cytochrome 164
`15 P-450CAM (11 pgs)
`16 Exhibit 69 Regioselectivity in the 166
`17 Cytochromes P-450 (10 pgs)
`18 Exhibit 70 Pharmacokinetics and Metabolism 167
`19 of Rimantadine Hydrochloride in
`20 Mice and Dogs (6 pgs)
`21 Exhibit 71 Declaration of David P. Rotella, 173
`22 Ph.D. in the United States Patent
`23 And Trademark Office (4 pgs)
`24
`25
`
`1 I N D E X
`
`2 DAVID P. ROTELLA, Ph.D., VOLUME I EXAMINATION
`
` BY MR. LIPSEY 13
`
`3 4
`
`5 6 7 8 9
`
`10 INSTRUCTIONS NOT TO ANSWER/REFUSALS TO ANSWER:
`
`11
`
`12 Page Line
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`13 (None)
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`14
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`15
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`16
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`18
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`19
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`20
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`21
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`22
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`23
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`24
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`25
`
`1 E X H I B I T S
`2 DAVID P. ROTELLA, Ph.D. DEPOSITION
`3 NUMBER DESCRIPTION MARKED
`
`1 E X H I B I T S
`2 DAVID P. ROTELLA, Ph.D. DEPOSITION
`3 NUMBER DESCRIPTION MARKED
`
`Page 7
`
`Page 9
`
`4 5
`
` Exhibit 72 Experimental and computational 185
`6 approaches to estimate solubility
`7 and permeability in drug discovery
`8 and development settings (22 pgs)
`9 Exhibit 73 Strategy In Drug Research 190
`10 (16 pgs)
`11 Exhibit 74 Cluster Analysis and the Design 194
`12 of Cogener Sets (16 pgs)
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
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`25
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`4 5
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` Exhibit 57 Expert Report of 18
`6 David P. Rotella, Ph.D.,
`7 On The Validity of U.S.
`8 Patent No. RE 44,186 (67 pgs)
`9 Exhibit 58 Reply Expert Report of 18
`10 David P. Rotella, Ph.D. (9 pgs)
`11 Exhibit 57-A Expert Report of 23
`12 David P. Rotella, Ph.D., On The
`13 Invalidity of U.S. Patent
`14 No. RE 44,186 (81 pgs)
`15 Exhibit 59 Curriculum Vitae of Dr. Rotella 26
`16 (10 pgs)
`17 Exhibit 60 Miniperspectives: Advances in 41
`18 Type 2 Diabetes Therapy (2 pgs)
`19 Exhibit 61 Rebuttal Expert Report of 62
`20 Ann E. Weber, Ph.D. (133 pgs)
`21 Exhibit 62 Analogue-based Drug 68
`22 Discovery III (20 pgs)
`23 Exhibit 63 Analogue-based Drug 77
`24 Discovery II (28 pgs)
`25
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`Page 10
`1 PREVIOUSLY MARKED EXHIBITS
`2 DAVID P. ROTELLA, Ph.D. DEPOSITION
`3 NUMBER PAGE CITED
`
`1 Palo Alto, California
`2 Thursday, May 26, 2016
`3 9:18 a.m.
`
`Page 12
`
`4 5
`
` THE VIDEOGRAPHER: Good morning.
`6 We are on video record on May 26th, 2016,
`7 and the time is 9:18 a.m. This is the video-recorded
`8 deposition of David Rotella.
`9 My name is Cyril Suskevitch. I'm here with
`10 the court reporter, Tom Frasik. We're both here
`11 representing Veritext Legal Solutions.
`12 This deposition is being held today at Wilson
`13 Sonsini in Palo Alto, California, and the caption of the
`14 case is AstraZeneca versus Aurobindo Pharma, and the
`15 case number is C.A. 14-664-GMS.
`16 Please note that audio and video recording will
`17 take place unless everyone agrees to go off the record.
`18 The microphones are very sensitive and they will pick up
`19 private whispers and conversations.
`20 Would everyone please identify themselves for
`21 the record.
`22 MR. LIPSEY: Charles Lipsey with Morgan
`23 Finnegan Henderson representing the plaintiff
`24 AstraZeneca. I'm joined by my colleagues from
`25 Morgan Finnegan Henderson, Mr. David Weingarten
`
`Page 13
`
`1 and Mr. Michael Su.
`2 MS. STEINER: Ellie Steiner with Wilson Sonsini
`3 Goodrich & Rosati for Mylan Pharmaceuticals, Inc., and
`4 the witness, Dr. Rotella. With me today are my
`5 colleagues, Katherine Hasper, Jad Mills and
`6 Grace Winschel.
`7 THE VIDEOGRAPHER: And on the phone once more?
`8 MR. WILSON (Telephonically):
`9 Christopher Wilson of Winston Strawn LLP
`10 on behalf of the Sun and Amneal defendants.
`11 MR. LUO (Telephonically): Jiazhong Luo
`12 from Duane Morris, Philadelphia office,
`13 representing Wockhardt.
`14
`15 DAVID P. ROTELLA, Ph.D.,
`16 having been administered an oath, was examined
`17 and testified as follows:
`18 ---o0o---
`19 EXAMINATION
`20 BY MR. LIPSEY:
`21 Q. Good morning, Dr. Rotella.
`22 A. Good morning.
`23 Q. Would you state your full name and residential
`24 address for the record, please?
`25 A. David Paul Rotella. I reside at 78 Iroquois
`
`4 5
`
` Defendants 18 19
`6 Plaintiffs 8 44
`7 Plaintiffs 28 51
`8 Plaintiffs 34 59
`9 Plaintiffs 31 61
`10 Plaintiffs 29 64
`11 Plaintiffs 23 66
`12 Plaintiffs 18 96
`13 Plaintiffs 40 102
`14 Plaintiffs 35 106
`15 Plaintiffs 33 120
`16 Plaintiffs 37 123
`17 Plaintiffs 39 127
`18 Defendants 20 129
`19 Plaintiffs 47 142
`20 Plaintiffs 24 155
`21 Plaintiffs 26 159
`22 Plaintiffs 25 162
`23 Plaintiffs 42 169
`24 Plaintiffs 43 169
`25 Plaintiffs 44 177
`
`Page 11
`1 PREVIOUSLY MARKED EXHIBITS
`2 DAVID P. ROTELLA, Ph.D. DEPOSITION
`3 NUMBER PAGE CITED
`
`4 5
`
` Plaintiffs 46 182
`6 Plaintiffs 41 183
`7 Plaintiffs 22 192
`
`8 9
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`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
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`Page 14
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`Page 16
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`1 Avenue in Lake Hiawatha, New Jersey.
`2 Q. And are you currently employed?
`3 A. I am currently employed.
`4 Q. And by whom are you currently employed?
`5 A. Montclair State University.
`6 Q. And where is that?
`7 A. That's in Montclair, New Jersey.
`8 Q. And in what capacity?
`9 A. I am a professor of chemistry.
`10 Q. Okay. Do you have any other employment at this
`11 time in addition to your employment as a professor at
`12 Montclair?
`13 A. I am employed by -- as a drug discovery
`14 consultant on an ad hoc basis by law firms and
`15 pharmaceutical companies, and that's a part-time
`16 ad hoc.
`17 Q. Have you ever had your deposition taken before?
`18 A. Yes, I have.
`19 Q. On how many occasions?
`20 A. Two occasions.
`21 Q. And what were those?
`22 A. The most recent was in February of this year
`23 for a case involving a pharmaceutical, it was ...
`24 Am I allowed to --
`25 MS. STEINER: I would cushion you not to
`
`1 it.
`2 Q. I'm not looking for all the gory details. I'm
`3 just trying to determine whether there's anything
`4 potentially pertinent to what we're doing here.
`5 Can you at a high level describe --
`6 THE WITNESS: It has to do --
`7 THE REPORTER: I'm sorry. One at a time.
`8 THE WITNESS: I'm sorry.
`9 It has to do with when information was
`10 presented regarding the molecule in question and the
`11 format and venue for that presentation.
`12 BY MR. LIPSEY:
`13 Q. Did that have to do with your role in
`14 connection with the Gordon Conferences?
`15 A. Yes, it did.
`16 Q. Okay. And what was the other occasion on which
`17 you've been deposed?
`18 A. The other occasion was in 2010. It was a case
`19 involving -- it was an obviousness case involving the
`20 drug vardenafil. And in that case, I was representing
`21 or working with Bayer Pharmaceuticals, the originator.
`22 I don't remember who the other party was.
`23 Q. Was it a generic drug company?
`24 A. It probably was. I can't remember.
`25 Q. Do you recall in general what the nature of
`
`Page 15
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`Page 17
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`1 disclose any confidential information.
`2 BY MR. LIPSEY:
`3 Q. Just a --
`4 A. Can I --
`5 Q. Well, let's sneak up on it. I assume if it's
`6 a pending case, the fact that there's a pending case and
`7 who the parties are is a matter of public record.
`8 A. Okay. Well, that's why I wanted to ask.
`9 It is Gilead versus ABBVIE.
`10 Q. What in general is the subject matter there?
`11 A. It has to do with a pharmaceutical product
`12 marketed by Gilead.
`13 Q. And if we all say hepatitis C therapeutic,
`14 we'll be talking about the same product?
`15 A. Yes.
`16 Q. And which party are you -- I assume you're an
`17 expert witness?
`18 A. For ABBVIE.
`19 Q. And they are challenging the patent; is
`20 that right?
`21 A. My role in the case is a very tiny piece of it.
`22 And I assume that they're challenging something, I don't
`23 know the details of what's being -- what's being
`24 contested. I'm just simply aware of what my role in the
`25 case is and it's just, as I said, just a small piece of
`
`1 those obviousness issues was?
`2 A. I do not.
`3 Q. Have you ever testified at trial?
`4 A. I have not.
`5 Q. Did the 2010 case that you mentioned for Bayer
`6 go to trial, if you know?
`7 A. It did not.
`8 Q. Well, since you've done this before, I will
`9 spare you the long lecture. But just to remind both of
`10 us, as we were just reminded by the reporter, we need to
`11 speak one at a time. I need an audible answer from you.
`12 If you don't understand any of my questions, please
`13 speak up, I'll try to solve the problem. If you need to
`14 take a break, speak up, we'll take a break.
`15 Is that okay?
`16 A. That's fine with me.
`17 Q. Okay. Is there any reason that you might not
`18 be able to give full and complete and truthful testimony
`19 today, such as a medical condition or some drugs that
`20 you're taking or anything like that?
`21 A. It is possible -- I have Type 1 diabetes,
`22 and that's what these are for (indicating). So it is
`23 possible that if my blood sugar drops too low, I will
`24 be -- it will be difficult for me to speak, and so if
`25 that happens, I will ask for a short recess.
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`Page 18
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`1 Q. Absolutely.
`2 A. And that's the only reason. And I take
`3 insulin, so ...
`4 Q. Okay.
`5 MS. STEINER: Counsel, based on Dr. Rotella's
`6 medical condition, if we could request that we try to
`7 take breaks, even short breaks, every hour or hour and
`8 a half or so, that would be great.
`9 MR. LIPSEY: That's fine with me. I tend to
`10 have so much fun doing this that I lose track of time.
`11 MS. STEINER: Yes, I recall.
`12 BY MR. LIPSEY:
`13 Q. Okay. Let's take a moment to get some of the
`14 paper that we're going to be chatting about in front of
`15 us.
`16 I'd like the reporter to mark for
`17 identification as Plaintiff' Deposition Exhibit 57 a
`18 copy of the expert report of David P. Rotella, Ph.D.,
`19 on the invalidity of US Patent Number RE 44186, and as
`20 Plaintiff's Deposition Exhibit 58 a copy of the reply
`21 expert report of David P. Rotella, Ph.D., both in this
`22 case.
`23 (Deposition Exhibits 57 and 58
`24 were marked for identification.)
`25 MR. LIPSEY: And just in case we need it,
`
`Page 19
`1 I would like to show you a document that's previously
`2 been marked for identification as Defendant's Deposition
`3 Exhibit 18, which is a copy of US Reissue Patent
`4 RE 44186.
`5 (Previously marked Exhibit 18
`6 was shown to the witness
`7 and is annexed hereto.)
`8 BY MR. LIPSEY:
`9 Q. And just to get our bearings straight, the
`10 44186 patent, Defendants' Deposition Exhibit 18, is
`11 the patent which is the subject of your opinions in
`12 this case?
`13 A. Yes.
`14 Q. Okay. And the -- and what we have as
`15 Plaintiff's Deposition Exhibit 57 is a copy of your
`16 opening report in this case; is that right?
`17 A. That's right.
`18 (Inaudible exchange among counsel.)
`19 MR. LIPSEY: That's not my copy anymore.
`20 He marked it. Sorry about that.
`21 And when did you execute your opening report,
`22 Plaintiff's Deposition Exhibit 57?
`23 THE WITNESS: It was filed January 29th of
`24 this year.
`25 BY MR. LIPSEY:
`
`Page 20
`1 Q. Okay. And when were you first contacted in
`2 connection with the possibility of providing expert
`3 testimony in this case?
`4 A. At some point in 2015. I don't recall the
`5 exact date.
`6 Q. Early, mid, late?
`7 A. I don't recall.
`8 Q. Okay. And who contacted you?
`9 A. Katherine Hasper.
`10 Q. And what, if anything, were you told about the
`11 case at that time?
`12 MS. STEINER: I caution the witness not to
`13 disclose privileged information and communications with
`14 your counsel.
`15 THE WITNESS: I was told that this was a case
`16 related to, I believe it's called Hatch-Waxman issues,
`17 with the compound saxagliptin.
`18 BY MR. LIPSEY:
`19 Q. Okay. Were you provided with any written
`20 materials at that time?
`21 A. I can't recall.
`22 Q. Did there come a time when you were provided
`23 with written materials to assist in the formulation of
`24 your opinions?
`25 A. I would request references, and I don't recall
`
`Page 21
`1 which ones, and I requested those through Katherine.
`2 Q. Were you provided with copies of any references
`3 in connection with the formulation of your opinions in
`4 connection with this case?
`5 That's a terrible question. I object to
`6 the form. Sustained.
`7 Okay. You said you asked for references.
`8 Were they references that had been the subject of
`9 discussion with your counsel prior to your request
`10 for copies?
`11 MS. STEINER: Objection.
`12 I'm going to caution the witness not to
`13 disclose confidential information.
`14 I think you're bordering pretty close to
`15 privileged information there, counsel.
`16 BY MR. LIPSEY:
`17 Q. What I'm trying to get at is how you came
`18 to know of the existence of the materials that you
`19 principally rely upon in your report. And the first
`20 part of that is were you either told about or shown
`21 copies of any of those documents before you knew they
`22 existed and depend on?
`23 MS. STEINER: Again, I'm going to caution the
`24 witness not to disclose any confidential, privileged
`25 information based on communications with counsel.
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`1 THE WITNESS: I was asked by counsel to provide
`2 opinions based on -- or provide opinions on obviousness
`3 related to the discovery synthesis identification and
`4 discovery of saxagliptin. And I carried out a
`5 literature search for documents that might be
`6 rel -- that might be relevant. In some cases,
`7 I could -- I could get those references easily;
`8 in other cases, I could not.
`9 BY MR. LIPSEY:
`10 Q. And how did you go about doing the literature
`11 search?
`12 A. I used SciFinder to investigate what was known
`13 in the field, based on priority dates provided to me by
`14 counsel.
`15 Q. Did you have preexisting knowledge of any of
`16 the literature that you were looking for?
`17 MS. STEINER: Objection to form.
`18 THE WITNESS: I did, and that's because
`19 I worked in this field in the past.
`20 BY MR. LIPSEY:
`21 Q. And that was at Bristol Myers Squibb; is that
`22 right?
`23 A. That's correct.
`24 Q. And which references were those that you had
`25 preexisting knowledge of?
`
`Page 24
`
`1 Chemistry Letters from 1996.
`2 Q. And that's the one that starts at page 1163?
`3 A. Yes.
`4 Q. Okay.
`5 A. Cheng and Prusoff, Biochemical Pharmacology,
`6 starting on page 3099.
`7 Q. Okay.
`8 A. Chiou, the next paper in the list, starting
`9 on page 243.
`10 Hanessian, from 1997, starting on page 1881.
`11 Q. Okay.
`12 A. Korfmacher, Koshland, Lin, Lipinski. And
`13 that's all.
`14 Q. How about the patent literature at the top; did
`15 you -- what of those were you familiar with prior to the
`16 commencement of the formation of your opinions?
`17 A. Oh, yeah. I believe the patent application,
`18 19998, I believe that is the Villhauer patent, I was
`19 aware of that one. I don't remember what the other
`20 patent refers to, the other WO application there.
`21 Q. Okay. Any others?
`22 A. No.
`23 Q. Had you seen either the reissue patent,
`24 RE 44,186, which is Defendant's Deposition Exhibit 18,
`25 or the original patent, 6,395,767, prior to the
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`Page 23
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`Page 25
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`1 A. Are my references listed in this? I don't
`2 remember if they're listed in here or not.
`3 Q. I believe there is an exhibit which is your
`4 materials considered. It is Exhibit B to Plaintiff's
`5 Deposition Exhibit 57.
`6 A. I'm not certain I have a list of those in this
`7 copy. If you can -- if someone has one, I can review
`8 it. This copy doesn't have the exhibits attached.
`9 MS. STEINER: It might be easier to mark
`10 another exhibit.
`11 MR. LIPSEY: Let's go ahead and mark as
`12 Plaintiff's Deposition Exhibit 57-A a complete copy
`13 of Dr. Rotella's opening report.
`14 (Deposition Exhibit 57-A was marked
`15 for identification.)
`16 BY MR. LIPSEY:
`17 Q. Let me just get a question on the record
`18 so we all know what we're answering.
`19 My reference to Exhibit B in Plaintiff's
`20 Deposition Exhibit 57-A, which is a list of the
`21 materials considered in connection with your opening
`22 report in this case, can you identify the publications
`23 of which you had preexisting knowledge prior to the
`24 commencement of the formulation of your opinions?
`25 A. Ashworth, et al., BioOrganic and Medicinal
`
`1 commencement of your work on this case?
`2 MS. STEINER: Objection to form.
`3 THE WITNESS: No, I did not.
`4 BY MR. LIPSEY:
`5 Q. If you recall, how did you come to be aware
`6 of the Ashworth publication appearing in the 1996
`7 publication, starting at page 1163, which with your
`8 permission we'll call Ashworth One; is that all right?
`9 A. That's fine.
`10 Q. All right. How did you become familiar with
`11 Ashworth One, if you recall?
`12 A. That was part of the information that I was
`13 provided with by Bristol Myers when I began to work on
`14 this program as a medicinal chemist.
`15 Q. Okay. And how about the Hanessian publication
`16 that you've identified, the 1997 one?
`17 A. The same.
`18 MS. STEINER: Objection to form.
`19 BY MR. LIPSEY:
`20 Q. Were there other materials you were provided
`21 when you began working on this program at BMS beyond
`22 those two, if you recall?
`23 A. Well, I'm reasonably certain that all of the
`24 ones I identified were part of the literature that we
`25 were provided with as a part of working on that program.
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`1 Q. Okay.
`2 A. Now --
`3 Q. Go ahead.
`4 A. I apologize. The Chiou paper and the Cheng and
`5 Prusoff paper, I was aware of from my days in graduate
`6 school.
`7 Q. Okay. Just to give us a frame of reference, to
`8 get some dates straight, I'd like the reporter to mark
`9 for identification as Plaintiff's Deposition Exhibit 59
`10 a copy of what appears to be the CV of Dr. Rotella.
`11 (Deposition Exhibit 59 was marked
`12 for identification.)
`13 BY MR. LIPSEY:
`14 Q. Can you identify Plaintiff's Deposition
`15 Exhibit 59, please?
`16 A. This is the CV that I provided to Wilson
`17 Sonsini.
`18 Q. And was it complete and accurate to the best of
`19 your knowledge as of the time your expert report was
`20 submitted in January of 2016?
`21 A. Yes.
`22 Q. Are there any additions, corrections or
`23 modifications to it to make it current today?
`24 A. There has been some change in my current
`25 research funding, but other than that, no.
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`1 A. Prior to the DPP4 program, I worked on the
`2 discovery of PDE5 inhibitors.
`3 Q. Like Viagra?
`4 A. Yes.
`5 Q. Okay.
`6 A. On a calcium-sensing receptor project.
`7 Q. And what kind of condition was that for?
`8 A. Osteoporosis. I worked on a CCR2 antagonist
`9 program for cardiovascular applications.
`10 Q. What type of cardiovascular applications?
`11 A. Atherosclerosis.
`12 Q. Okay.
`13 A. And there were a couple of anticoagulant
`14 programs that were -- we called exploratory.
`15 Q. Anything else?
`16 A. No.
`17 Q. Okay. When you started work on the DPP4
`18 program, what was your position and to whom did
`19 you report?
`20 A. My position title was principal research
`21 scientist, and I reported to Larry Hamann.
`22 Q. Did you continue to report to Dr. Hamman until
`23 your departure from the DPP4 project?
`24 A. Yes.
`25 Q. And what -- did you then move to other projects
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`1 Q. And what is there new in your current
`2 research funding?
`3 A. Unfortunately, nothing. Some of those things
`4 have -- some of those have ended.
`5 Q. Okay. I guess working chronologically forward
`6 in your experience, which actually ends on the second
`7 page of Plaintiff's Deposition Exhibit 59, was there any
`8 experience you had in any of your prior employment
`9 relating to DPP4 or its inhibition prior to the time you
`10 joined Bristol Myers Squibb?
`11 MS. STEINER: Objection to form.
`12 THE WITNESS: No.
`13 BY MR. LIPSEY:
`14 Q. Okay. Now, it indicates here that you joined
`15 Bristol Myers Squibb in 1997; is that right?
`16 A. That's correct.
`17 Q. And that you left in 2003; is that right?
`18 A. That's correct.
`19 Q. Okay. During what part of that time did you
`20 work on matters relating to DPP4?
`21 A. I worked on the DPP4 program for approximately
`22 one year. I can't remember more precisely than that.
`23 So approximately 2002 to 2003.
`24 Q. And what projects had you been working on at
`25 BMS prior to joining the DPP4 program?
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`1 in BMS?
`2 A. No. I left the company.
`3 Q. Oh, okay. I should have figured that out, I'm
`4 sorry.
`5 And what were your responsibilities as a
`6 principal research scientist on the DPP4 project?
`7 A. My primary responsibilities were to conceive
`8 of and synthesize new DPP4 inhibitors. I worked with
`9 other members of the team and supervised two research
`10 assistants who worked with me on that project.
`11 Q. And who were they?
`12 A. Yeheng Zhu, Y-e-h-e-n-g Z-h-u, and Zhong Sun,
`13 Z-h-o-n-g S-u-n.
`14 Q. And were they your assistants throughout your
`15 tenure on the DPP4 project?
`16 A. Yes.
`17 Q. I gather that at the time you joined the
`18 project, saxagliptin had already been discovered; is
`19 that right?
`20 MS. STEINER: Objection to form.
`21 BY MR. LIPSEY:
`22 Q. Well, let me ask an open-ended question to make
`23 your lawyer happy.
`24 What was the status of saxagliptin development,
`25 if any, at the time you joined the project?
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`1 A. Saxagliptin had been discovered and synthesized
`2 at that point. Beyond that, I can't remember what its
`3 official status in the company was at that time. My
`4 role was to serve on the -- or the objective of the
`5 project at that time was to discover a backup molecule
`6 to saxagliptin.
`7 Q. And was such a molecule ultimately discovered?
`8 A. Yes.
`9 Q. And what was that?
`10 A. I don't remember. It's Bristol Myers'
`11 designation.
`12 Q. Do you remember its structure?
`13 A. Yes.
`14 Q. And what was that?
`15 A. It is effectively descyanosaxagliptin.
`16 Q. And for whatever reader we may ultimately have
`17 of the transcript, that means saxagliptin without the
`18 CN group?
`19 A. Yes.
`20 Q. Okay. And who discovered that?
`21 A. I can't recall.
`22 Q. Did you keep a laboratory notebook while you
`23 were at BMS?
`24 A. Yes.
`25 Q. And to the extent you did experiments, did you
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`1 record those experiments at or around the time you did
`2 them along with the results at or around the time you
`3 got them?
`4 A. Yes.
`5 Q. And you endeavored to do so accurately to the
`6 best of your ability?
`7 A. Yes.
`8 Q. And did your laboratory associates working with
`9 you also keep laboratory notebooks in the same way?
`10 A. Yes, they did.
`11 Q. Okay. Were there any of the records that you
`12 kept of the work you were doing or planning to do while
`13 you were on the DPP4 project?
`14 A. I don't have any records from my work on that
`15 project.
`16 Q. Oh, I'm sorry. By "kept," I meant that you had
`17 or made at the time that you were doing the work. I
`18 didn't mean to imply you still had them. Let me ask a
`19 better question.
`20 Did you either prepare or receive periodic
`21 reports of the work that was being done on the DPP4
`22 project while you were there?
`23 MS. STEINER: Objection to form.
`24 THE WITNESS: I did, in conjunction with
`25 chemistry group meetings that we held on a periodic
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`1 basis.
`2 BY MR. LIPSEY:
`3 Q. Okay. And were those reports you received?
`4 A. I contributed my own reports and would see
`5 the reports submitted by my colleagues on the
`6 project team.
`7 Q. We've seen some of the other Bristol Myers
`8 Squibb employees' things that, for lack of a better
`9 word, looked like target sheets and seemed to be made
`10 periodically with descriptions of compounds that either
`11 were being made or were going to be made. Did you have
`12 such target sheets?
`13 A. Probably. We -- I may have called it work in
`14 progress. I can't remember the specifics.
`15 Q. Okay. Do you recall the circumstances under
`16 which you received the Hanessian publication that you
`17 have referred to, specifically the 1997 Hanessian
`18 publication?
`19 MS. STEINER: Objection to form.
`20 THE WITNESS: It was a part of the synthetic
`21 chemical literature that was relevant for the program.
`22 BY MR. LIPSEY:
`23 Q. And what was your understanding of why?
`24 A. Why what?
`25 Q. Why it was relevant to the program.
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`1 A. Because it illustrated methods for the
`2 synthesis of cyclopropanated pyrrolidines or proline
`3 derivatives.
`4 Q. Did you have occasion to use the chemical
`5 reactions which Hanessian described in your own work?
`6 A. I can't recall specifically.
`7 Q. What, if anything, were you told during your
`8 time with the DPP4 project at BMS about the origins of
`9 the saxagliptin molecule?
`10 A. I can't remember.
`11 Q. Okay. Since your departure from BMS in 2003,
`12 looking back at your CV, Plaintiff's Deposition
`13 Exhibit 59, is any of the work that you have done
`14 subsequently related to DPP4 or its inhibition?
`15 A. No.
`16 Q. On the second page of your CV, Plaintiff's
`17 Deposition Exhibit 59, there's a list of your education.
`18 You got a bachelor of science in pharmacy from
`19 University of Pittsburgh; is that right?
`20 A. That's correct.
`21 Q. And a Ph.D. in medicinal chemistry from the
`22 Ohio