DeForest McDuff
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`San Diego, CA
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`10/9/2019
`Page 1
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` UNITED STATES PATENT AND TRADEMARK OFFICE
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` MYLAN PHARMACEUTICALS INC., and PFIZER INC.
`
` Petitioners,
`
` v.
`
` SANOFI-AVENTIS DEUTSCHLAND GMBH,
`
` Patent Owner.
`
` Videotaped Deposition of DeFOREST McDUFF, Ph.D.
`
` San Diego, California
`
` Wednesday, October 9, 2019
`
` 9:24 A.M.
`
`Job No. 88612
`
`Pages 1 - 92
`
`Reported by: Leslie A. Todd, CSR No. 5129 and RPR
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2318.001
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`San Diego, CA
`
`10/9/2019
`Page 1
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` UNITED STATES PATENT AND TRADEMARK OFFICE
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` MYLAN PHARMACEUTICALS INC., and PFIZER INC.
`
` Petitioners,
`
` v.
`
` SANOFI-AVENTIS DEUTSCHLAND GMBH,
`
` Patent Owner.
`
` Videotaped Deposition of DeFOREST McDUFF, Ph.D.
`
` San Diego, California
`
` Wednesday, October 9, 2019
`
` 9:24 A.M.
`
`Job No. 88612
`
`Pages 1 - 92
`
`Reported by: Leslie A. Todd, CSR No. 5129 and RPR
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2318.001
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`DeForest McDuff
`
`San Diego, CA
`
`10/9/2019
`Page 2
`
` A P P E A R A N C E S
`
`ON BEHALF OF THE PATENT OWNER:
`
` ROBERT T. VLASIS, III, ESQUIRE
`
` WEIL, GOTSHAL & MANGES LLP
`
` 2001 M Street NW, Suite 600
`
` Washington, D.C. 20036
`
` (202) 682-7024
`
`ON BEHALF OF THE PETITIONERS:
`
` ELHAM FIROUZI STEINER, ESQUIRE
`
` TAYLOR DIMLER, ESQUIRE
`
` JAMES P. H. STEPHENS, ESQUIRE
`
` WILSON SONSINI GOODRICH & ROSATI, P.C.
`
` 12235 El Camino Real, Suite 200
`
` San Diego, California 92130-3002
`
` (858) 350-2246
`
`ALSO PRESENT:
`
` NOAH BENNAN, MA (Director - Insight Economics)
`
` ISAAC ORIHUELA, VIDEOGRAPHER
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`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2318.002
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`DeForest McDuff
`
`San Diego, CA
`
`10/9/2019
`Page 3
`
` Videotaped deposition of DeFOREST McDUFF,
`
`Ph.D. was held at:
`
` U.S. GRANT HOTEL
`
` 326 Broadway Avenue
`
` San Diego, California 92101
`
` Pursuant to Notice, before Leslie A. Todd,
`
`Certified Shorthand Reporter for the State of
`
`California.
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`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2318.003
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`DeForest McDuff
`
`San Diego, CA
`
`10/9/2019
`Page 4
`
` C O N T E N T S
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`EXAMINATION OF DeFOREST McDUFF, Ph.D. PAGE
`
` By Mr. Vlasis 7, 88
`
` By Ms. Steiner 81
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` E X H I B I T S
`
`NUMBER PAGE
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`No. 2223 Document entitled "SoloSTAR wins
`
` the 2008 Good Design award" 89
`
`No. 2224 Expert Opinion on Drug Delivery,
`
` Taylor Francis Online 89
`
`No. 2225 Excerpt to 5/29/18 trial transcript 89
`
`PREVIOUSLY MARKED EXHIBITS (attached)
`
`No. 1060 Declaration of Forest McDuff,
`
` Ph.D. 8
`
`No. 2116 Expert Opinion on Drug Delivery,
`
` Andreas Bode article 74
`
`No. 2145 US Lantus SoloSTAR Launch Book,
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` 2007 58
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`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2318.004
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`DeForest McDuff
`
`San Diego, CA
`
`10/9/2019
`Page 5
`
` E X H I B I T S (Continued)
`
`NUMBER PAGE
`
`PREVIOUSLY MARKED EXHIBITS (not attached)
`
`No. 2146 Document Bates SANOFI3_90330807 57
`
`No. 1081 Document from Lantus website 70
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`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2318.005
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`DeForest McDuff
`
`San Diego, CA
`
`10/9/2019
`Page 6
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` P R O C E E D I N G S
`
` -------------------
`
` THE VIDEOGRAPHER: We are now on the
`
`record in the matter of Mylan Pharmaceuticals,
`
`Inc., and Pfizer, Inc., versus Sanofi-Aventis
`
`Deutschland GmbH. Today's date is October 9th,
`
`2019. The time on the record is 9:24 a.m.
`
` This video recorded deposition of
`
`DeForest McDuff is being taken at the U.S. Grant
`
`in San Diego, California.
`
` I'm the camera operator. My name is
`
`Isaac Orihuela in association with Alderson
`
`Reporting. The court reporter is Leslie Todd,
`
`also in association with Alderson Reporting.
`
` Will all attorneys please identify
`
`themselves and the parties they represent,
`
`beginning with the party noticing this proceeding.
`
` MR. VLASIS: Robert Vlasis with Weil
`
`Gotshal & Manges on behalf of Sanofi.
`
` MS. STEINER: Ellie Steiner from Wilson
`
`Sonsini Goodrich & Rosati on behalf of Mylan
`
`Pharmaceuticals, Inc., and the witness. With me
`
`today is Taylor Dimler and James Stephens, both of
`
`Wilson Sonsini. Also present today is Noah
`
`Brennan.
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2318.006
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`DeForest McDuff
`
`San Diego, CA
`
`10/9/2019
`Page 7
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` THE VIDEOGRAPHER: Thank you. The
`
`reporter can swear in the witness.
`
` ROBERT DeFOREST McDUFF, Ph.D.,
`
` and having been first duly sworn,
`
` was examined and testified as follows:
`
` EXAMINATION
`
`BY MR. VLASIS:
`
` Q Good morning, Dr. McDuff.
`
` A Good morning.
`
` Q Could you please state your name and
`
`address for the record.
`
` A Yes. Robert DeForest McDuff. Would you
`
`like work address? Home address?
`
` Q Work address would be fine.
`
` A 177 Huntington Avenue, 17th Floor,
`
`Boston, Mass 02115.
`
` Q How many times have you testified in
`
`deposition as an expert?
`
` A Around 50 times.
`
` Q If you have any trouble understanding my
`
`question, please let me know. Otherwise, if you
`
`provide an answer, I'm going to assume you heard
`
`it, you understood it, and you answered it to the
`
`best of your ability.
`
` Is that fair?
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2318.007
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`DeForest McDuff
`
`San Diego, CA
`
`10/9/2019
`Page 8
`
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` A I'll do my best, yes.
`
` Q And if you need a break at any time, let
`
`me know. I just ask that you answer the question
`
`before we take a break, if there's a question
`
`pending.
`
` Is there any reason why you could not
`
`give truthful testimony today?
`
` A No.
`
` Q Is it correct that you have been
`
`retained by Mylan and Pfizer with respect to six
`
`IPR proceedings involving certain of Sanofi's
`
`device patents?
`
` A Yes, that's right.
`
` (Exhibit No. 1060 was previously
`
` marked for identification.)
`
`BY MR. VLASIS:
`
` Q And in front of you is Exhibit 1060. Do
`
`you recognize the exhibit?
`
` A Yes, this is my declaration in those IPR
`
`proceedings.
`
` Q And is it your understanding that the
`
`six proceedings listed on the cover of
`
`Exhibit 1060 are the only IPR proceedings in which
`
`the opinions set forth in the exhibit are being
`
`provided?
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2318.008
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`DeForest McDuff
`
`San Diego, CA
`
`10/9/2019
`Page 9
`
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` A Sitting here, I don't have certainty on
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`that. I -- I would ask counsel to confirm that
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`one way or the other, but that's my understanding
`
`sitting here.
`
` Q And the declarations that you submitted
`
`across all six of the IPR proceedings that are
`
`listed on the front of Exhibit 1060 are
`
`substantively identical; is that correct?
`
` A Yes.
`
` Q Did you write this declaration?
`
` A Yes.
`
` Q And who wrote the first draft?
`
` A I did, along with members of my staff
`
`working at my direction.
`
` Q Who were the members of your staff that
`
`assisted you?
`
` A Primarily, Mr. Noah Brennan and
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`Ms. Sophia Luo. L-U-O.
`
` Q Other than Mr. Brennan and Ms. Luo, did
`
`anyone else assist you in drafting your
`
`declaration?
`
` A We had other staff members check certain
`
`aspects of the declaration, but to a much smaller
`
`degree.
`
` Q Other than counsel and Mr. Brennan,
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2318.009
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`DeForest McDuff
`
`San Diego, CA
`
`10/9/2019
`Page 10
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`Ms. Luo, and certain other of your staff, did you
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`speak with anyone else to help prepare your
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`declaration?
`
` A I don't believe so. Not outside those
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`individuals.
`
` Q You didn't speak with Dr. Biggs?
`
` A I did not, no. I did review his
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`declaration.
`
` Q Did you speak with any of Mylan's other
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`experts?
`
` A I did not. Yet I did review some of
`
`those declarations which were cited in my report.
`
` Q Did you speak with any employee of
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`Mylan, Pfizer or Biocon?
`
` A No.
`
` Q When did you first have access to
`
`Dr. Biggs' declaration?
`
` A I believe it was around the time I
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`submitted my report.
`
` Q Was the Biggs declaration executed at
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`the time that you reviewed it?
`
` A I believe so, yes.
`
` Q How much time did you have to review
`
`Dr. Biggs' declaration before you finalized your
`
`declaration?
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2318.010
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`DeForest McDuff
`
`San Diego, CA
`
`10/9/2019
`Page 11
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` A I don't recall the exact timing, yet I
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`had sufficient time to review it and incorporate
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`it into my report.
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` Q Was it on the same day that you executed
`
`your declaration?
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` A It would have been within a day or two.
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`Could have been the same day. I don't have an
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`exact recollection of the timeline.
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` Q And how many hours did you personally
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`spend preparing your declaration?
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` A I don't have the exact number for you,
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`but if I were ballparking, I personally spent
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`between 20 and 50 hours, and my staff spent more
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`time assisting in research and analysis and
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`drafting of my declaration at my direction.
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` Q And about how many hours would you
`
`estimate your staff spent helping you prepare your
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`declaration?
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` A In total, maybe a few hundred.
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` Q Did you personally review all of the
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`materials that are cited in your declaration?
`
` A I reviewed them to the extent I felt it
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`was necessary to do so. I can't say I reviewed
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`personally every single one, but I did to the
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`degree necessary.
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2318.011
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`DeForest McDuff
`
`San Diego, CA
`
`10/9/2019
`Page 12
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` Q Okay. And did someone on your staff or
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`a combination of people on your staff personally
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`review all the materials cited in your
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`declaration?
`
` A Yes.
`
` Q And would that have been done prior to
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`you executing your declaration?
`
` A Yes.
`
` Q And how much time did you spend
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`preparing for your deposition?
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` A Ballpark, maybe 10 or 15 hours.
`
` Q Other than counsel, did you speak with
`
`anyone to help you prepare for your deposition?
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` A I did. I spoke with Mr. Brennan and
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`Ms. Luo on my staff.
`
` Q Anyone else?
`
` A No.
`
` Q And how much have you billed to date
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`for your work in these proceedings, the IPR
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`proceedings?
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` A I believe it's between 50,000 and
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`100,000. I don't have an exact figure for you.
`
` Q Are you offering any opinions in this
`
`case that are specific to any particular device
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`patent or any device patent claim?
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2318.012
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`DeForest McDuff
`
`San Diego, CA
`
`10/9/2019
`Page 13
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` MS. STEINER: Objection. Form.
`
` THE WITNESS: Maybe you could clarify
`
`what you mean by that. I do believe my
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`declaration is specific to the device claims.
`
`BY MR. VLASIS:
`
` Q Do you have any opinions that differ for
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`any particular patent versus other another patent,
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`for example?
`
` A I have provided one opinion that
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`Dr. Grabowski has not differentiated between any
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`of the patents or the patent claims, and so I do
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`provide critique of his work on that basis.
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`That's the most on-point section of my declaration
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`that comes to mind sitting here.
`
` Q Otherwise, the opinions that you're
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`providing in your declaration apply collectively
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`for all of the patents that are at issue; is that
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`right?
`
` A We -- we would have to look at any
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`specific opinion to be sure, but generally, most
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`of my opinions apply to all of the patents and
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`claims.
`
` Q In paragraph 7 of your declaration, you
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`refer to the alleged commercial success of Lantus
`
`SoloSTAR.
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2318.013
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`DeForest McDuff
`
`San Diego, CA
`
`10/9/2019
`Page 14
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` Are you offering an opinion that Lantus
`
`SoloSTAR has not been commercially successful?
`
` MS. STEINER: Objection. Form, scope.
`
` THE WITNESS: I'm offering opinions with
`
`respect to commercial success as a secondary
`
`consideration, and I have provided an opinion that
`
`there are -- is no nexus to the patents at issue,
`
`and blocking patents reduce the relevance of any
`
`product performance. So I am providing opinions
`
`with respect to the commercial success of Lantus
`
`SoloSTAR.
`
`BY MR. VLASIS:
`
` Q Do you have an opinion as to whether or
`
`not the Lantus SoloSTAR product has been
`
`commercially successful?
`
` A Is that the same question as the prior
`
`one?
`
` Q The prior question was the inverse. My
`
`prior question was, are you offering an opinion
`
`that SoloSTAR has not been commercially
`
`successful? And the current question is, do you
`
`have an opinion as to whether or not SoloSTAR has
`
`been commercially successful?
`
` A In terms of the secondary consideration,
`
`I do not believe that there is commercial success
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2318.014
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`DeForest McDuff
`
`San Diego, CA
`
`10/9/2019
`Page 15
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`with respect to the patents-in-suit.
`
` Q Do you know how many revenues Sanofi has
`
`earned from sales of the SoloSTAR patent?
`
` A Give me just a minute to look in my
`
`declaration. (Peruses document.)
`
` I don't believe I have the exact total
`
`readily available. It may be in my declaration,
`
`but I can't find it at the moment. It would be in
`
`the multiple billions.
`
` Q So you -- you acknowledge that the
`
`SoloSTAR pen has sold billions of dollars in
`
`sales?
`
` A Over the years, yes.
`
` Q Do you have an opinion as to whether the
`
`SoloSTAR device has been profitable for Sanofi?
`
` MS. STEINER: Objection. Scope.
`
` THE WITNESS: No, I've not seen the
`
`information necessary to perform that analysis,
`
`nor has Dr. Grabowski performed that analysis.
`
`And I describe that in my declaration.
`
`BY MR. VLASIS:
`
` Q What would be your expectation as to
`
`whether or not Sanofi has earned a profit on the
`
`SoloSTAR device?
`
` MS. STEINER: Objection. Scope.
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2318.015
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`DeForest McDuff
`
`San Diego, CA
`
`10/9/2019
`Page 16
`
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` THE WITNESS: I simply haven't seen the
`
`information. They may have earned a profit, but
`
`that certainly has not been demonstrated or shown
`
`by Dr. Grabowski or otherwise.
`
`BY MR. VLASIS:
`
` Q Do you know which -- well, let's look at
`
`paragraph 14 of your declaration.
`
` A I'm there.
`
` Q On page 12, you state: "There is a
`
`general lack of generic competition for insulin
`
`treatments."
`
` Do you see that?
`
` A Yes.
`
` Q And what are the devices that compete
`
`with SoloSTAR?
`
` A Is that question directed at this
`
`sentence? I'm not sure I understand the scope of
`
`your question.
`
` Q Yes. You're stating that there is a
`
`general lack of generic competition for insulin
`
`treatments, and I'm asking for more information
`
`for that statement.
`
` In particular, I'm asking you to
`
`identify who are the generic or biosimilar
`
`competitors for the products at issue in this
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2318.016
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`DeForest McDuff
`
`San Diego, CA
`
`10/9/2019
`Page 17
`
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`proceeding.
`
` A Those would be the products that are
`
`included in the insulin market that is described
`
`in paragraphs 25 through 27 of my declaration.
`
` They're also listed in Attachment B-10.
`
` Q So the products -- excuse me -- the
`
`products that are listed in Attachment B-10 to
`
`your declaration are competitors to Lantus
`
`SoloSTAR?
`
` A Generally speaking, yes.
`
` Q And are the products listed in
`
`Attachment B-10 sufficient to meet the demand for
`
`insulin products in the United States?
`
` MS. STEINER: Objection. Form.
`
` THE WITNESS: It ds what you mean by
`
`that. It's not a question I specifically sought
`
`to answer for that declaration.
`
`BY MR. VLASIS:
`
` Q What was the basis for your statement
`
`that there's a general lack of generic competition
`
`for insulin treatments?
`
` A That's based on my understanding of the
`
`market and certain articles that have commented on
`
`the increasing prices for insulin in recent years,
`
`and that results in part from a lack of generic
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2318.017
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`DeForest McDuff
`
`San Diego, CA
`
`10/9/2019
`Page 18
`
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`competition.
`
` Q I just counted there are 40 products
`
`listed in Attachment B-10. Does that sound about
`
`right to you?
`
` A More or less.
`
` Q In paragraph 20 of your declaration, you
`
`state that SoloSTAR and OptiClik had similar
`
`growth rates in their first four years of being on
`
`the market.
`
` Does that sound like a fair summary?
`
` A The paragraph contains more detail, but,
`
`yes, that's fair.
`
` Q And you conclude from that that the
`
`growth rates for SoloSTAR provide little
`
`indication of commercial success?
`
` MS. STEINER: Objection. Form.
`
` THE WITNESS: I would say more
`
`specifically Dr. Grabowski's reporting of the
`
`growth rates of over 8,000 percent show very
`
`little about commercial success one way or the
`
`other.
`
`BY MR. VLASIS:
`
` Q How many prescriptions were written for
`
`OptiClik in its first four years of launch?
`
` A Looking at Attachment B-10, it appears
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2318.018
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`DeForest McDuff
`
`San Diego, CA
`
`10/9/2019
`Page 19
`
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`to be several million.
`
` Q Just over 2.5 million, does that look
`
`about right?
`
` A It looks about right, yes.
`
` Q And how many prescriptions were written
`
`for Lantus SoloSTAR in its first years -- four
`
`years of launch?
`
` A It looks to be around 19 million,
`
`according to Attachment B-11 -- I'm sorry, B-10.
`
` Excuse me, I'm looking at the wrong
`
`product. Give me just a moment. (Peruses
`
`document.)
`
` Around 11 million.
`
` Q So you would agree that Lantus SoloSTAR
`
`achieved more than four times more prescriptions
`
`in its first four years of launch than OptiClik
`
`did in its first four years of launch; is that
`
`correct?
`
` A Based on the figures we looked at, that
`
`sounds about right.
`
` Q Your opinion is that Sanofi migrated
`
`Lantus patients from the OptiClik to SoloSTAR; is
`
`that right?
`
` A From Lantus Vial and OptiClik to
`
`SoloSTAR.
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2318.019
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`DeForest McDuff
`
`San Diego, CA
`
`10/9/2019
`Page 20
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` Q And if you look at Attachment B-10, how
`
`many prescriptions were written for OptiClik in
`
`2008?
`
` A I'm seeing 1.1 million.
`
` Q And the following year in 2009, how many
`
`prescriptions were written for SoloSTAR?
`
` A Here I'm seeing 2.2 million.
`
` Q And from 2008 to 2009, Lantus Vial was
`
`relatively flat; is that right?
`
` A That looks about right, yes.
`
` Q So is it fair to say then that at least
`
`half of SoloSTAR's prescriptions in 2009 could not
`
`have been from migrating patients from Lantus Vial
`
`or OptiClik?
`
` A I don't think that's necessarily true,
`
`no.
`
` Q Well, there's more prescriptions for
`
`SoloSTAR in 2009 than there were for OptiClik in
`
`2008, correct?
`
` A I agree with that, yes.
`
` Q So where did those extra million
`
`prescriptions come from in 2009 if they didn't
`
`come from the OptiClik or the vial?
`
` A You can see part of this with Lantus
`
`Vial in the line below, which is growing every
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2318.020
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`DeForest McDuff
`
`San Diego, CA
`
`10/9/2019
`Page 21
`
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`single year through 2008. And then 2008 to 2009,
`
`that's the first year Lantus Vial is no longer
`
`growing. So I think you have to think about the
`
`trajectory of Lantus Vial and where those
`
`prescriptions would have been had Sanofi not
`
`converted patients to SoloSTAR.
`
` Q Is it fair to say that roughly a million
`
`of the prescriptions written in 2009 could not
`
`have been from migrating patients from the vial
`
`and OptiClik?
`
` MS. STEINER: Objection. Form, asked
`
`and answered.
`
` THE WITNESS: I wouldn't conclude that
`
`looking at these figures.
`
`BY MR. VLASIS:
`
` Q But there were more prescriptions
`
`written overall in the market for 2009 versus
`
`2008, correct?
`
` A Across all products?
`
` Q Correct.
`
` A That's true.
`
` Q And if you sum OptiClik, SoloSTAR and
`
`Vial in 2008 and compare it to the sum of
`
`OptiClik, SoloSTAR and Vial in 2009, there are
`
`roughly a million more prescriptions in 2009; is
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2318.021
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`DeForest McDuff
`
`San Diego, CA
`
`10/9/2019
`Page 22
`
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`that correct?
`
` A That seems about right, eyeballing the
`
`figures here.
`
` Q And since there were a million new
`
`prescriptions in 2009 for those three products,
`
`those would be new patients who had not had any
`
`prescriptions prior to 2009; is that right?
`
` A Maybe. I don't have figures on the
`
`number of patients here.
`
` Q So it could be that or a million
`
`prescriptions that were written in 2009 that were
`
`not written in 2008; is that correct?
`
` A I'm not sure what you're getting at. I
`
`do agree that the number of prescriptions went up.
`
`That could be either because there were more
`
`patients or because there were more prescriptions
`
`per patient.
`
` Q Understood.
`
` Would you agree that SoloSTAR grew the
`
`size of the insulin injectable pen market?
`
` MS. STEINER: Objection. Form.
`
` THE WITNESS: Well, Dr. Grabowski and I
`
`have disagreement over whether to call that an
`
`economic market. He has called it a market. I
`
`don't think that it is. I think it's more of a
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2318.022
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`DeForest McDuff
`
`San Diego, CA
`
`10/9/2019
`Page 23
`
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`segment or a category within the broader insulin
`
`market. So I have disagreement with that term.
`
` With respect to whether Lantus SoloSTAR
`
`grew that category, I would have to go back and
`
`look. If you've got somewhere in my declaration
`
`that shows that, I'm happy to look at it with you.
`
`BY MR. VLASIS:
`
` Q I don't believe you have a separate
`
`analysis of the sub-pen market, unless I missed it
`
`in your -- in your declaration.
`
` So let's try it this way. Would you
`
`agree that SoloSTAR helped to grow the size of the
`
`total market as presented in Attachment B-10?
`
` MS. STEINER: Objection. Form.
`
` THE WITNESS: It's one product of many.
`
`So I would say while there may be some small
`
`contribution from that one product, it's not a
`
`significant contribution, particularly given
`
`Sanofi's conversion from Vial and OptiClik to
`
`SoloSTAR. I would view it more as a replacement
`
`than a growth.
`
`BY MR. VLASIS:
`
` Q And you would agree with me that the
`
`total number of prescriptions in the market is
`
`growing each year, correct?
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2318.023
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`DeForest McDuff
`
`San Diego, CA
`
`10/9/2019
`Page 24
`
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` A We would have to look to make sure what
`
`years you have in mind.
`
` Q Feel free to look at Attachment B-10.
`
` And the total number of prescriptions
`
`increases each year from 1999 through 2017; is
`
`that correct?
`
` A Across those years, that appears to be
`
`right.
`
` Q And it's growing in the magnitude of
`
`essentially doubling from 1999 to 2017; is that
`
`right?
`
` A More or less, yes.
`
` Q So the insulin market has grown from
`
`1999 through 2017, correct?
`
` A I agree, yes.
`
` Q And SoloSTAR was launched in that --
`
`within that time window, correct?
`
` A It was.
`
` Q And did SoloSTAR help to contribute to
`
`the growth in that market?
`
` MS. STEINER: Objection. Form.
`
` THE WITNESS: I would give the same
`
`answer that I provided previously. I'm happy to
`
`try to give it again, but it's the same answer.
`
`BY MR. VLASIS:
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2318.024
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`DeForest McDuff
`
`San Diego, CA
`
`10/9/2019
`Page 25
`
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` Q I believe you said that there was a
`
`small contribution from that one product. And
`
`that it's not significant.
`
` A There was more to my answer, but I
`
`did -- that was included, yes.
`
` Q So sitting here today, your opinion is
`
`that the SoloSTAR pen made only a small,
`
`insignificant contribution to the insulin and
`
`insulin analog product market.
`
` MS. STEINER: Objection.
`
`Mischaracterizes the witness's testimony.
`
` THE WITNESS: I would summarize it like
`
`this: Lantus SoloSTAR is one of many products in
`
`the market, so there may be some small
`
`contribution from that product. But because of
`
`Sanofi's conversion from Lantus Vial and Lantus
`
`OptiClik to SoloSTAR, I view the SoloSTAR product
`
`as primarily replacing the vial and the OptiClik
`
`as opposed to providing independent growth.
`
`BY MR. VLASIS:
`
` Q What else do you attribute the growth in
`
`the market to if it was not due to SoloSTAR?
`
` A There are a number of factors changing
`
`over time. There are a number of other products
`
`that are being used. The just increasing use of
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2318.025
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`DeForest McDuff
`
`San Diego, CA
`
`10/9/2019
`Page 26
`
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`insulin as a diabetes treatment over time would be
`
`a primary factor.
`
` Q Was the SoloSTAR device an improvement
`
`over the OptiClik device?
`
` MS. STEINER: Objection. Scope, form.
`
` THE WITNESS: I don't know that I've
`
`characterized it one way or the other or drawn a
`
`conclusion on that specifically. It might depend
`
`what you mean by that.
`
`BY MR. VLASIS:
`
` Q Does SoloSTAR have any features that are
`
`better than the OptiClik's features?
`
` MS. STEINER: Objection. Form.
`
` THE WITNESS: I've not done a feature-
`
`by-feature analysis, so I don't know that I could
`
`answer that directly in the way you've put it.
`
`Yet I have described some of the problems
`
`associated with the OptiClik pen and some of the
`
`reasons why that product was not accepted by
`
`physicians and patients. So to some degree, the
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`SoloSTAR is just different than the OptiClik and
`
`does not have those same problems, to my
`
`understanding.
`
`BY MR. VLASIS:
`
` Q Would you agree with the general
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2318.026
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`DeForest McDuff
`
`San Diego, CA
`
`10/9/2019
`Page 27
`
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`sentiment that the OptiClik was a bad pen?
`
` MS. STEINER: Objection. Form.
`
` THE WITNESS: I -- I would defer that
`
`question to the medical doctors in terms of
`
`whether it was a bad pen. It certainly did have
`
`weak economic performance.
`
`BY MR. VLASIS:
`
` Q And the SoloSTAR pen has had better
`
`economic performance than the OptiClik pen; is
`
`that right?
`
` A That's true, yes.
`
` MR. VLASIS: Why don't we take a quick
`
`break.
`
` THE VIDEOGRAPHER: Going off the record
`
`at 9:54 a.m.
`
` (Pause.)
`
` THE VIDEOGRAPHER: We are back on the
`
`record at 9:56 a.m.
`
`BY MR. VLASIS:
`
` Q Do you know if the SoloSTAR pen has a
`
`lower injection force than the OptiClik pen?
`
` MS. STEINER: Objection. Scope.
`
` THE WITNESS: I don't have an opinion on
`
`that one way or the other.
`
`BY MR. VLASIS:
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2318.027
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`DeForest McDuff
`
`San Diego, CA
`
`10/9/2019
`Page 28
`
` 1
`
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` Q Have you seen any opinions in that
`
`regard in this case in any of the materials that
`
`you reviewed?
`
` A I do understand some of the technical
`
`experts to be evaluating that issue. It's just
`
`not one that I've drawn an independent opinion on.
`
` Q We touched on this a little earlier, but
`
`you -- one of your criticisms of Dr. Grabowski is
`
`that he did not include a comparison of sales and
`
`profits to costs; is that fair?
`
` A Yes.
`
` Q Is it your opinion that without an
`
`analysis of sal
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