Case 1:18-cv-01363-CFC Document 82-15 Filed 03/22/19 Page 1 of 54 PageID #:
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`Case 1:18-cv-01363-CFC Document 82-15 Filed 03/22/19 Page 2 of 54 PageID #:
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`•1• • • • • •IN THE UNITED STATES DISTRICT COURT•2• • • • • • • FOR THE DISTRICT OF DELAWARE•3• •Genentech, Inc. and City of Hope,•4• • • •Plaintiffs and•5• • • •Counterclaim Defendants,•6• • • • v.• • • • • • • • • • • • •C.A. NO. 18-924-CFC•7• •Amgen, Inc.,•8• • • •Defendant and•9• • • •Counterclaim Plaintiff.10• •- - - - - - - - - - - - - - - - - - - - - - - - x11• •Genentech, Inc. and City of Hope,12• • • •Plaintiffs and13• • • •Counterclaim Defendants,14• • • • v.• • • • • • • • • • • • C.A. NO. 18-1363-CFC15• •Samsung Bioepis Co., Ltd.,16• • • •Defendant and17• • • •Counterclaim Plaintiff.18• •- - - - - - - - - - - - - - - - - - - - - - - - x19• • • • • • • • VIDEOTAPED DEPOSITION OF20• • • • • • • • • HOLLY PRENTICE, Ph.D.21• • • • • Friday, February 1, 2019 at 9:21 a.m.22• • • WILMER, CUTLER, PICKERING, HALE AND DORR LLP23• • • • • • • • • • •60 State Street24• • • • • • • •Boston, Massachusetts 0210925• •Reporter:• Lori-Ann London, RPR
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`Case 1:18-cv-01363-CFC Document 82-15 Filed 03/22/19 Page 3 of 54 PageID #:
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`Page 2•1• • • • • • • • •APPEARANCES OF COUNSEL•2•3• •On Behalf of Genentech, Inc.:•4• • • • • • By:• Nancy Lynn Schroeder, Esquire•5• • • • • • WILMER HALE LLP•6• • • • • • 350 South Grand Avenue, Suite 2100•7• • • • • • Los Angeles, California 90071•8• • • • • • 213.443.5393•9• • • • • • nancy.schroeder@wilmerhale.com10• •-and-11• • • • • • Luke McCloud, Esquire12• • • • • • WILLIAMS & CONNOLLY LLP13• • • • • • 725 Twelfth Street14• • • • • • Washington, DC 2000515• • • • • • 202.434.558616• • • • • • lmccloud@wc.com1718• •On Behalf of Amgen Inc.:19• • • • • • By:• Susan Krumplitsch, Esquire20• • • • • • COOLEY21• • • • • • 3175 Hanover Street22• • • • • • Palo Alto, California 94304-113023• • • • • • 650.843.599424• • • • • • skrumplitsch@cooley.com25Page 3•1• • • • • •APPEARANCES OF COUNSEL (Continued)•2•3• •On Behalf of Samsung Bioepis Co., Ltd.:•4• • • • • • By:• Amit Thakore, Esquire•5• • • • • • WHITE & CASE•6• • • • • • 1221 Avenue of the Americas•7• • • • • • New York, New York 10020-1095•8• • • • • • 212.819.2692•9• • • • • • athakore@whitecase.com1011• •ALSO PRESENT:1213• • • • • • Bob Giannini, Videographer141516171819202122232425Page 4•1• • • • • • • • • • • • I N D E X•2•3• •DEPOSITION OF:• • • • • • • • • • • • • • • •PAGE•4• •HOLLY PRENTICE, Ph.D.•5•6• •EXAMINATION BY MR. THAKORE• • • • • • • • • • •6•7• •EXAMINATION BY MS. KRUMPLITSCH• • • • • • • •121•8• •_________________________________________________X•9• • • • • • • • • • •E X H I B I T S10• •NO.• • • • • • • • • • • • • • • • • • • • • PAGE11• •Exhibit 1• •Curriculum Vitae of Holly• • • • • 812• • • • • • • •Prentice, Ph.D.13• •Exhibit 2• •Declaration of Holly Prentice• • •3414• •Exhibit 3• •Patent Application, 10/376,392• • 3915• •Exhibit 4• •International Patent• • • • • • • 4116• • • • • • • •Application, WO 93/0042317• •Exhibit 5• •Behrendt Patent, 7,390,660• • • • 6118• •Exhibit 6• •9/10/07 Office Action• • • • • • •8419• •Exhibit 7• •Treating Citrate-Chelated Metals• 9320• •Exhibit 8• •Gawlitzek Patent ’983• • • • • • 11621• •Exhibit 9• •Gawlitzek Patent ’293• • • • • • 11622232425• •*Original exhibits attached to original transcriptPage 5•1• • • • • • • • • P R O C E E D I N G S•2•3• • • • • • • • •THE VIDEOGRAPHER:• Okay.• Good•4• •morning.• We are on the record.• This is the•5• •videographer speaking, Bob Giannini, with court•6• •reporter, Lori London, with Epiq Court Reporting.•7• •Today’s date is February 1, 2019, and the time is•8• •9:21 a.m.•9• • • • • • • • •We are here at the offices of10• •WilmerHale, located at 60 State Street, Boston,11• •Massachusetts, to take the videotaped deposition of12• •Holly Prentice, in the matter of Genentech, Inc.13• •and City of Hope versus Amgen, Inc.; it’s Case14• •No. 1:18-CV-00924-CFC.15• • • • • • • • •Will counsel please introduce16• •themselves for the record.17• • • • • • • • •MR. THAKORE:• Amit Thakore, from18• •White & Case, for the defendant, Samsung Bioepis.19• • • • • • • • •Just for the record, this deposition20• •is also in Case No. 18-1363.21• • • • • • • • •MS. KRUMPLITSCH:• Susan Krumplitsch,22• •of Cooley LLP, on behalf of Amgen.23• • • • • • • • •MS. SCHROEDER:• Nancy Schroeder, on24• •-- from WilmerHale LLP, on behalf of Genentech.25• • • • • • • • •MR. McCLOUD:• Luke McCloud, from
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`Case 1:18-cv-01363-CFC Document 82-15 Filed 03/22/19 Page 4 of 54 PageID #:
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`Page 6•1• •Williams & Connolly, attending the deposition.•2• • • • • • • • •THE VIDEOGRAPHER:• Will the court•3• •reporter please swear in the witness.•4• • • • • • • • •HOLLY PRENTICE, Ph.D.,•5• •a witness called for examination by the Defendants,•6• •having been satisfactorily identified by the•7• •production of her Massachusetts driver’s license,•8• •and duly sworn by the Notary Public, was examined•9• •and testified as follows:10• • • • • • • • • • • •EXAMINATION11• •BY MR. THAKORE:12• • • • Q• • Good morning.13• • • • A• • Good morning.14• • • • Q• • Will you please state your full name for15• •the record?16• • • • A• • Holly Lynn Prentice.17• • • • Q• • Okay.• And are you currently employed,18• •Dr. Prentice?19• • • • A• • I am self-employed.20• • • • Q• • And is that as a consultant?21• • • • A• • Yes, it is.22• • • • Q• • Okay.• And how long have you been23• •self-employed as a consultant?24• • • • A• • I’m thinking I’m coming up on five years.25• •It’s -- it’s in my CV if you’d like to check.Page 7•1• • • • Q• • And what type of consulting work have you•2• •been doing in the last five years, just generally?•3• • • • A• • I work with biotech companies, primarily•4• •in the areas of development of therapeutics, tech•5• •transfer, manufacturing support, outsourcing•6• •support, regulatory.• I play a variety of roles on•7• •behalf of biotech companies.•8• • • • Q• • And approximately how many biotech•9• •companies would you say you’ve been consulting with10• •over the last five years?11• • • • A• • More than 10.• To get an accurate number,12• •I’d have to really consider that carefully.13• • • • Q• • Okay.• Do you do any consulting work for14• •Genentech, outside of these proceedings?15• • • • A• • I have not.16• • • • Q• • Now, you understand you’re here to17• •testify in connection with the declaration that you18• •submitted in a case involving the plaintiffs,19• •Genentech and the City of Hope, and defendants,20• •Amgen and Samsung Bioepis, correct?21• • • • A• • That is my understanding.22• • • • Q• • Okay.• And your understanding is that23• •that case involves an antibody called trastuzumab,24• •correct?25• • • • A• • That I understand.Page 8•1• • • • • • • • •Could I ask that you speak a•2• •little --•3• • • • Q• • Sure.•4• • • • A• • -- louder, please?•5• • • • Q• • Sorry.•6• • • • • • • • •Yeah, we should just maybe go over a•7• •few ground rules.• If there’s anything I ask and•8• •you don’t quite understand or follow the question,•9• •just let me know; I’ll try to rephrase it.10• • • • • • • • •Now, have you done any work, prior11• •work, involving Trastuzumab?12• • • • A• • I have not done any work on Trastuzumab.13• • • • Q• • So no science, no research, or anything14• •like that, involving trastuzumab; is that correct?15• • • • A• • That is correct.16• • • • Q• • Now, you have a Ph.D. in molecular17• •biology; is that right?18• • • • A• • That is correct.19• • • • • • • • •MR. THAKORE:• Okay.• Why don’t we20• •just mark as Prentice Exhibit 1 a copy of the CV21• •that was provided for this case.22• • • • • • • • •(Exhibit 1 marked for23• • • • • • • • •identification.)24• • • • Q• • Dr. Prentice, do you have Exhibit 1 in25• •front of you?Page 9•1• • • • A• • Yes, I do.•2• • • • Q• • Okay.• And what is Exhibit 1?•3• • • • A• • It’s my CV.•4• • • • Q• • Okay.• Now, on your CV, it mentions that•5• •you received a Ph.D. in molecular biology, correct?•6• • • • A• • Yes, it does.•7• • • • Q• • And -- and when was that, if you recall?•8• • • • A• • Approximately 1994.•9• • • • Q• • Okay.• And did you have to prepare a10• •thesis or a dissertation in connection with the --11• •with that?12• • • • A• • I did.13• • • • Q• • Okay.• And do you recall generally what14• •the subject matter of that was?15• • • • A• • Transcriptional regulation of heat shock16• •promoters.17• • • • Q• • And could you just describe that a little18• •bit more for us?19• • • • A• • When I joined the lab, I was working with20• •a human heat shock promoter and characterizing the21• •transcriptional elements that drive -- that drive22• •expression.• And as I progressed through my work, I23• •also did some research on a fission yeast by the24• •name of "schizosaccharomyces pombe," and the heat25• •shock regulation and genetics of that, of that
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`Case 1:18-cv-01363-CFC Document 82-15 Filed 03/22/19 Page 5 of 54 PageID #:
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`Page 10•1• •yeast.•2• • • • Q• • Okay.• So that work, you would say, did•3• •not involve cell culturing processes, correct?•4• • • • • • • • •THE STENOGRAPHER:• Cell what?•5• • • • • • • • •MR. THAKORE:• Cell culture processes.•6• • • • A• • It did.• As I mentioned, in the earlier•7• •phase, I was characterizing human heat shock•8• •promoter in cell lines.• So that involved the cell•9• •culture.10• • • • Q• • And what cell lines were you using?11• • • • A• • At that time, I was using Hela.12• • • • Q• • H-E-L-A?13• • • • A• • That’s correct.14• • • • Q• • Now, in 1994, you joined Serono15• •Laboratories, correct?16• • • • A• • Yes.17• • • • Q• • Okay.• And could you just describe,18• •generally, what your work at Serono included?19• • • • A• • My work primarily involved the culture of20• •CHO cell lines and the expression of recombinant21• •proteins; however, I also did some work with22• •baculovirus cells and evaluating expression of23• •recombinant proteins in baculovirus as well.24• • • • Q• • Did you work primarily in a lab during25• •that time?Page 11•1• • • • A• • Yes, I did.•2• • • • Q• • And you worked exclusively with CHO•3• •cells?•4• • • • A• • As I mentioned, I used CHO cells and a•5• •variety of insect cell lines for the baculovirus•6• •program.•7• • • • Q• • And what were you specifically•8• •evaluating, as far as the expression of proteins•9• •using those cell lines?10• • • • A• • I was expressing a variety of recombinant11• •proteins.• In some of the work that I did, the12• •objective was to identify approaches that could13• •improve expression levels.• I would say that was,14• •you know, a primary focus of the work that I did15• •there.• I also did some genetic characterization of16• •the resulting cell lines.17• • • • • • • • •It was a very long time ago, so I’d18• •have to go back and refresh my memory if I could19• •give you more detail.20• • • • Q• • On your CV, it says that you joined21• •Biogen Idec in 1996; is that correct?22• • • • A• • That is correct.23• • • • Q• • Okay.• And you were at Biogen until24• •approximately October of 2006; is that correct?25• • • • A• • That is correct.Page 12•1• • • • Q• • So were you working continuously at•2• •Biogen during that time?•3• • • • A• • I was.•4• • • • Q• • And was that full-time employment at•5• •Biogen?•6• • • • A• • It was.•7• • • • Q• • Did you work mostly in the lab at Biogen•8• •as well?•9• • • • A• • I did.10• • • • Q• • Okay.• And what type of projects were you11• •involved in at Biogen during that time period?12• • • • A• • The group that I was in was in --13• •responsible for transitioning programs from14• •research into development.• And in that capacity, I15• •worked on a variety of programs for recombinant16• •proteins that were intended to move forward into17• •manu -- manufacturing.18• • • • Q• • And when you refer to "manufacturing,"19• •are you referring to manufacturing for commercial20• •purposes?21• • • • A• • Most of the programs I worked on were22• •early-stage programs.• So the objective would have23• •been manufacturing for clinical use, but that did24• •not preclude that someday they would be important25• •for commercial program.Page 13•1• • • • Q• • Okay.• Now, on your CV, it says that you•2• •co-led the development of a commercial cell culture•3• •process; do you see that?•4• • • • A• • I do.•5• • • • Q• • And what is -- specifically are you -- do•6• •you mean when you refer to a "commercial cell•7• •culture process"?•8• • • • A• • That particular program was in a late•9• •stage, and the -- the objective of the work was to10• •develop a process, a cell culture process, that met11• •the objectives for commercialization.12• • • • Q• • And were you studying a particular cell13• •culture media, or was it something else?14• • • • A• • In order to develop a cell culture15• •process, the media is a key component.• And so16• •aspects of media, media development supplements,17• •would be very important for such a program.18• • • • Q• • And was there a particular protein of19• •interest that you were studying, or was -- or was20• •this for a process generally speaking?21• • • • A• • Which -- so can you be more specific as22• •to what --23• • • • Q• • Sure.24• • • • A• • -- you’re referring to?25• • • • Q• • So when you refer to "commercial cell
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`Page 14•1• •culture process," were you studying a particular•2• •protein in connection with that work?•3• • • • A• • Now I understand.•4• • • • • • • • •That was a particular product.•5• • • • Q• • And do you recall what that product was?•6• • • • A• • That product, unfortunately, failed in•7• •phase three, so you wouldn’t recognize it as a•8• •commercial product, but I can give you an internal•9• •name, but it would have no meaning to you.10• • • • Q• • Okay.• So just so we’re clear, it’s not a11• •-- when you say "commercial cell culture process,"12• •the product involved in that research was not13• •ultimately commercialized?14• • • • A• • That is correct.15• • • • Q• • Have you worked on any cell culture16• •processes where -- that resulted in a commercial17• •product at Biogen?18• • • • A• • Yeah, I’m -- I’m thinking back.19• • • • • • • • •Some of the programs that I worked on20• •continued after my departure.• I didn’t necessarily21• •keep track of them, but I am recalling a few that I22• •know moved forward, but to be honest, I haven’t23• •kept track of their status.24• • • • Q• • Now, those programs, were those -- are25• •you referring to specific proteins, or are youPage 15•1• •referring to other aspects of the cell culture•2• •process?•3• • • • A• • Can you rephrase?•4• • • • Q• • Yeah.• I’m just trying to understand,•5• •when you say that you worked on cell culture•6• •processes and some of those programs continued•7• •after your departure, are you referring to -- what•8• •specifically are you -- are you referring to that•9• •continued after your departure?10• • • • A• • I’m referring to the -- the individual11• •therapeutics.12• • • • Q• • Okay.• And by "therapeutics," you mean,13• •for example, an antibody or recombinant protein; is14• •that correct?15• • • • A• • That is correct.16• • • • Q• • So as far as you recall, during your time17• •at Biogen, the pro -- the projects that you work on18• •did not result in a commercial product during that19• •time period; is that correct?20• • • • A• • There was one that I worked on in my21• •early days that became a commercial product.22• • • • Q• • Do you recall what that was?23• • • • A• • Product’s known as "Amevive."24• • • • Q• • Okay.• What type of a product is that?25• • • • A• • You mean what type of protein?• It is aPage 16•1• •fusion --•2• • • • Q• • Yeah, I can rephrase.•3• • • • • • • • •Is that a protein?•4• • • • A• • It is a protein.•5• • • • Q• • Is that an antibody?•6• • • • A• • No.•7• • • • Q• • Now, you left Biogen in 2006, correct?•8• • • • A• • Correct.•9• • • • Q• • And why did you leave Biogen at that10• •time?11• • • • A• • I had started at Biogen when it was12• •around 400 people, saw it grow to 4,000 and change,13• •and I decided I would like to go back to a smaller14• •company.15• • • • Q• • Were there any other reasons?16• • • • A• • What’s that?17• • • • Q• • Were there any other reasons?18• • • • A• • I don’t know.• It just wasn’t fun19• •anymore, what I was doing, so I decided I’d like to20• •do something different.21• • • • Q• • Okay.• Are you currently involved in22• •-- strike that.23• • • • • • • • •Are you -- are you in contact with24• •anyone in Biogen today, that you know of?25• • • • A• • I -- I have friends that I interact withPage 17•1• •on occasion.•2• • • • Q• • Do any of your -- does any of your•3• •interaction with people at Biogen -- strike that.•4• • • • • • • • •Do you do any consulting work for•5• •Biogen?•6• • • • A• • I do not.•7• • • • Q• • Have you advised anyone at Biogen•8• •regarding any projects that are ongoing since you•9• •left?10• • • • A• • I have not.11• • • • Q• • Are you familiar with any cell culture12• •media used currently by Biogen?13• • • • A• • I’ve been away from Biogen so long that I14• •really have no insight into the technologies that15• •they’re using.16• • • • Q• • Are you aware of gen -- are you generally17• •aware of cell culture media that Biogen is18• •manufacturing?19• • • • A• • While I was an employee, I was aware, but20• •after leaving, I -- I -- you know, it’s not the21• •kind of information that I would have known.22• • • • Q• • So since you’ve -- since leaving Biogen,23• •you don’t have information about culture media that24• •Biogen manufactures; is that fair?25• • • • A• • After leaving Biogen, I no longer got any
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`Page 18•1• •information related to cell culture media from•2• •Biogen.•3• • • • Q• • Okay.• So what would you consider your•4• •area of expertise to be today?•5• • • • A• • I have expertise in molecular and•6• •cellular biology, specifically in the expression of•7• •recombinant proteins, and the development of•8• •processes appropriate for clinical and commercial•9• •production, as well as outsourcing, tech transfer,10• •and general troubleshooting.11• • • • Q• • Would you say that you have expertise in12• •large-scale commercial processes?13• • • • A• • I have worked with a number of processes14• •that have been scaled and transferred into15• •manufacturing, into large scale, and I have16• •provided expert support for those types of17• •activities.18• • • • Q• • Were you personally involved in those19• •large-scale manufacturing processes?20• • • • A• • Can you be specific as to what you mean?21• • • • Q• • I can rephrase.22• • • • • • • • •Have you personally conducted any23• •manufacturing process at a large scale?24• • • • A• • Hands on, is that what you’re referring25• •to?Page 19•1• • • • Q• • Yes.•2• • • • A• • No.•3• • • • Q• • So you’ve worked -- you’ve worked•4• •primarily on small-scale models; is that correct?•5• • • • A• • The hands-on work that I have performed•6• •has been small scale.• And as I mentioned, I have•7• •also provided technical support for processes that•8• •have moved to large scale.•9• • • • Q• • And what do you mean by "technical10• •support"?11• • • • A• • When you transition a program from small12• •scale to large scale, you need to make a number of13• •adjustments to the process.• You need to -- if you14• •were intending to manufacture, then you need to15• •develop appropriate documentation so that the16• •manufacturing operators know what to do.17• • • • Q• • Um-hm.18• • • • A• • And you also need to provide support when19• •things don’t go as expected.• And my role has been20• •to provide support for those types of activities.21• • • • Q• • And was that -- is that work you’ve been22• •doing as a consultant?23• • • • A• • I have been doing that role as a24• •consultant, yes.25• • • • Q• • Prior to that, were you also involved inPage 20•1• •that type of work?•2• • • • A• • Yes, some.•3• • • • Q• • Are you currently involved in any•4• •scientif -- scientific research at all?•5• • • • A• • (No response.)•6• • • • Q• • Are you currently involved in any•7• •scientific research?•8• • • • A• • How would you define "scientific•9• •research" as opposed to other development10• •activities?• It seems to me like it’s a blurred11• •line.12• • • • Q• • So you would consider some of the13• •consulting work that you’ve been doing for the last14• •five or so years to include scientific research?15• • • • A• • As a consultant, I provide a supporting16• •role to a lot of process development work with --17• •and those -- those -- the development activities18• •are -- have the ultimate objective of clinical or19• •commercial manufacturing.20• • • • • • • • •In addition to that, I have been --21• •also been involved, in past five years, as a mentor22• •for graduate students.23• • • • Q• • Okay.• And those grad students are24• •involved in research, I assume?25• • • • A• • That is correct.Page 21•1• • • • Q• • Now, when you describe your area of•2• •expertise, would you say that that includes all•3• •aspects of cell culture processes?•4• • • • A• • I would say it involves all aspects of•5• •cell culture processes that relate to the•6• •production of recombinant proteins for clinical or•7• •commercial use.•8• • • • Q• • And what -- what do those -- what does•9• •that include?10• • • • A• • Can you rephrase?11• • • • Q• • What are the various aspects of the cell12• •culture process that relates to production of13• •recombinant proteins?14• • • • A• • You need to understand the metabolism of15• •the cell, you need to understand how that relates16• •to the cell culture media that’s being used, and17• •you need to understand the physiochemical18• •parameters and constraints that lie within your19• •system.20• • • • Q• • And the cell culture media that you just21• •mentioned -- strike that.22• • • • • • • • •Does your consulting work currently23• •focus on any one of those aspects more -- more so24• •than others?25• • • • A• • To be successful, the whole system has to
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`Page 22•1• •be considered.• So it would -- I would not expect•2• •to focus on one over the other, but rather to look•3• •at the whole -- the whole package.•4• • • • Q• • Now, you’ve been deposed prior to today,•5• •correct?•6• • • • A• • Could you speak up, please?•7• • • • Q• • You’ve been deposed prior to today,•8• •right?• You’ve had your deposition taken prior to•9• •today?10• • • • A• • That is correct.11• • • • Q• • Okay.• Now, one of those depositions12• •involved the product called "bevacizumab"; is that13• •correct?14• • • • A• • Yes, that is correct.15• • • • Q• • Prior to that deposition, how many times16• •have you been deposed?17• • • • A• • In the past five years?18• • • • Q• • Just in general, if you can recall.19• • • • A• • Two other times.20• • • • Q• • Okay.• One of those depositions, I21• •believe you mention in your declaration, involved22• •an IPR proceeding?23• • • • A• • That is correct.24• • • • Q• • Okay.• Now, what was the subject matter25• •of that IPR proceeding, generally, if you recall?Page 23•1• • • • A• • I’d like to go back and look.• I -- I•2• •don’t want to misspeak.•3• • • • Q• • When was that deposition, roughly?•4• • • • A• • In the fall.•5• • • • Q• • Of -- of last year?•6• • • • A• • Um-hm.•7• • • • Q• • And you have no recollection as to the --•8• •the testimony that you provided in that case?•9• • • • A• • I do have recollection.• I just -- you10• •know, I’m very focused on this deposition for11• •today, and so if I were to comment on that one, I12• •would like to go back and refresh my memory.13• • • • Q• • So do you recall if you were providing14• •opinions on cell culture processes in that case?15• • • • A• • I believe that was part of that one.16• • • • Q• • And do you recall what the subject matter17• •of the patents at issue were?18• • • • A• • Like I said, I focused on what I need to19• •provide for today, so I’d have to go back and20• •refresh my memory on that one.21• • • • Q• • Did you submit a declaration in22• •connection with that deposition proceeding?23• • • • A• • Yes, I did.24• • • • Q• • Do you have any recollection as to what25• •types of opinions you provided in that declaration?Page 24•1• • • • A• • If I were to comment on them, I would•2• •want to go back and look at it again.•3• • • • Q• • Did the -- did that IPR involve -- strike•4• •that.•5• • • • • • • • •Did your opinions involve subject•6• •matter other than cell culture processes?•7• • • • • • • • •MS. SCHROEDER:• Objection, vague.•8• • • • A• • If I were to answer that question, I•9• •would like to go back and -- and review that10• •previous declaration.11• • • • Q• • Do you recall if you provided testimony12• •regarding purification of proteins in connection13• •with that deposition or the declaration in that14• •case?15• • • • A• • Again, if I were to comment specifically,16• •if you could provide me with the declaration, then17• •I would -- I could go through that with you.18• • • • Q• • So you don’t recall if your testimony19• •involved protein purification in that case?20• • • • A• • Again, I would want to review to make21• •sure I did not misspeak.22• • • • Q• • Do you consider yourself an expert in23• •areas such as protein purification?24• • • • A• • I have a fair amount of knowledge as it25• •relates to protein purification.Page 25•1• • • • Q• • And what is that based on?• Is that based•2• •on your work at Biogen and other companies?•3• • • • A• • It is.•4• • • • Q• • And, specifically, when you refer to•5• •"protein purification," what types of methods are•6• •you referring to?• What types of processes are you•7• •referring to?•8• • • • A• • I’m not sure I understand the question.•9• •Can you -- can you rephrase?10• • • • Q• • So what do you mean by "protein11• •purification"?• How do you understand that?12• • • • A• • Protein therapeutics are commonly13• •produced, initially, by cell culture and then14• •subjected to a purification scheme to remove15• •impurities and to concentrate the protein.• So when16• •I think of purification in that context, I think of17• •the events that follow the production of the18• •material in the bioreactor.19• • • • Q• • And you said that you have knowledge of20• •those events that follow production of material in21• •the bioreactor; is that fair?22• • • • A• • Yes, I do.23• • • • Q• • But you wouldn’t consider yourself an24• •expert in those areas; is that correct?25• • • • A• • As I said, I have a fair amount of
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`Page 26•1• •expertise in that area.• I would also characterize•2• •myself as being -- having deeper expertise in cell•3• •culture than in purification, but I also have a•4• •fair amount of expertise in purification.•5• • • • Q• • Have you worked on purification processes•6• •in the lab while you were at Biogen, for example?•7• • • • A• • I did not.•8• • • • Q• • Did you work on purification processes•9• •-- strike that.10• • • • • • • • •Did you do any protein purification11• •analysis at any other employment in your career?12• • • • A• • Can you rephrase the question?13• • • • Q• • Did you personally perform any14• •purification methods during your career?15• • • • A• • Yes, I have purified proteins.16• • • • Q• • And when was that?17• • • • A• • At various companies, various times.18• • • • Q• • But you did not do any of that at --19• •during the time you were at Biogen; is that20• •correct?21• • • • A• • I did not work on the development of22• •purification of proteins at Biogen; however, at23• •various times, I may have purified proteins.24• • • • Q• • Does that include protein A25• •chromatography?Page 27•1• • • • A• • I have used protein A, yes.•2• • • • Q• • Any other types of purification methods•3• •that you have personally conducted?•4• • • • A• • As a graduate student, I used other types•5• •of purification, but it was a very long time ago,•6• •so I don’t have a recollection of details.•7• • • • Q• • Now, you said you were deposed twice•8• •previously; is that correct -- actually, strike•9• •that.10• • • • • • • • •You said you were deposed twice prior11• •to your deposition in the Avastin case, correct?12• • • • A• • Correct.13• • • • Q• • So what was the -- when was the first14• •deposition?15• • • • A• • Approximately 2007.16• • • • Q• • And do you recall what the subject matter17• •of that deposition was?18• • • • A• • That deposition -- again, it was a very19• •long time ago, so I -- I -- I recall that it20• •related to a plasmid or an expression plasmid.21• • • • Q• • And were you testifying on behalf of a22• •company?23• • • • A• • I was a fact witness for my former24• •employer.25• • • • Q• • And who was the former employer that youPage 28•1• •were a fact witness for?•2• • • • A• • Biogen.•3• • • • Q• • Did that proceeding involve a patent?•4• • • • A• • I may have -- no.• I -- I may have•5• •misspoke about the -- the date of that.• I think it•6• •may have been closer to 2012.•7• • • • Q• • Okay.• So you were deposed in•8• •approximately 2012 as a fact witness, based on your•9• •employment at Biogen; is that correct?10• • • • A• • That is correct.11• • • • Q• • And do you recall if those -- if the12• •deposition involved a patent proceeding?13• • • • A• • There was a patent involved, yes.14• • • • Q• • And were you providing opinions about the15• •patent?16• • • • A• • No.17• • • • Q• • And -- strike that.18• • • • • • • • •Did that case result -- did that19• •deposition -- strike that.20• • • • • • • • •Did that proceeding result in a trial21• •of any -- of any type?22• • • • A• • Not that I’m aware.23• • • • Q• • Did you testify in court in connection24• •with that case?25• • • • A• • I did not.Page 29•1• • • • Q• • Did you provide any other opinions in•2• •that case, aside from your declaration --•3• •deposition?•4• • • • • • • • •MS. SCHROEDER:• Objection,•5• •mischaracterizes prior testimony.•6• • • • Q• • You can answer if you understand the•7• •question.•8• • • • A• • Can you --•9• • • • Q• • If you don’t, then I can rephrase it.10• • • • A• • Yeah, can you -- can you re-ask the11• •question, please?12• • • • Q• • I can try to rephrase it.13• • • • • • • • •Did you -- you did not provide any14• •written declarations in that case; is that correct?15• • • • A• • I did not.16• • • • Q• • And just going back to the -- the subject17• •matter, what specifically were you testifying18• •about?19• • • • A• • I don’t recall.20• • • • Q• • You mentioned that it involved an21• •expression plasmid; is that correct?22• • • • A• • That’s that is my vague recollection --23• • • • Q• • Do you recall if there was any particular24• •product or recombinant protein at issue in that25• •case?
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`Page 30•1• • • • A• • Since I’m not sure, I won’t answer.•2• • • • Q• • Do you have a guess as to what product•3• •was involved in the case?•4• • • • A• • I don’t want to misspeak, so...•5• • • • Q• • So you were working with Biogen in some•6• •capacity in connection with that case, correct?•7• • • • • • • • •MS. SCHROEDER:• Objection, vague.•8• • • • A• • I’m not really sure what you mean by•9• •that.10• • • • Q• • Did you speak with anyone at Biogen prior11• •to that deposition?12• • • • A• • I did.13• • • • Q• • And do you recall what -- what you14• •discussed with Biogen?15• • • • A• • I guess I should characterize it as I16• •spoke with the counsel representing Biogen in this17• •case, so it was indirect.18• • • • Q• • Okay.• Was it outside counsel?19• • • • A• • Yes.20• • • • Q• • So did you -- did you speak with anyone21• •at Biogen, for example, scientists at Biogen, in22• •connection with that case?23• • • • A• • No.• I believe the only Biogen24• •representative that I saw was from the legal group.25• • • • Q• • Okay.• Now, when did you begin working onPage 31•1• •your declaration for this case?•2• • • • A• • Because the declaration was founded on a•3• •number of conversations, are you referring to the•4• •conversations or the pen to paper?•5• • • • Q• • Well, when did you first start having•6• •conversations with attorneys regarding this case?•7• • • • A• • I have had interactions with WilmerHale•8• •for quite some time, but specifically as it•9• •pertains to this case, it was more recent.10• • • • Q• • Do you have a -- do you kno