Karl R. Leinsing
`
`Portsmouth, NH
`
`6/3/2019
`Page 1 (1)
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`1
`
`2
`
`3
`
`4
`
`5 MYLAN PHARMACEUTICALS INC.
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Petitioner,
`
`V.
`
`SANOFI-AVENTIS DEUTSCHLAND GmbH,
`
`Patent Owner.
`
`Case IPR2018-01675
`
`Case IPR2018-01676
`
`Case IPR2018-01678
`
`Case IPR2018-01680
`
`DEPOSITION OF KARL R. LEINSING
`
`Monday, June 3, 2019
`
`Portsmouth, New Hampshire
`
`Reported by: Deanna J. Dean, RDR, CRR
`
`NH License No. 87
`
`Job No. 86100
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2163.001
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Portsmouth, NH
`Page 2
`
`Karl R. Leinsing
`
`1
`
`2
`
`3
`
`Monday, June 3, 2019
`9:01 a.m.
`
`4
`
`5
`
`6
`
`Deposition of KARL R. LEINSING,
`held at the offices of Hampton Inn and Suites,
`23 Portwalk Place, Portsmouth, New Hampshire,
`before Deanna J. Dean, a Registered
`Professional Reporter, Registered Diplomate
`Reporter, Certified Realtime Reporter, and
`Licensed CourtReporterofthe State of New
`10
`11 Hampshire.
`12
`
`7
`
`8
`
`9
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`3 O,~t1· ffi50DRICH&ROSATI
`
`APPEARANCES
`
`Page 3
`
`0006
`1~gee
`: RIC~
`TORCZON, ESQ.
`B~CWd t~~ \)'5A1PmBERRY, ESQ.
`W erryberry@wsgr.com
`~~~ 2ort~l~~~q~~lj & ROSA n
`~~ ~3~;~IEL R. SCHARN, ESQ.
`
`ns~am~~gr.com
`
`~1JSHAL & MANGES
`) t -1~10153-0119
`.
`.
`D
`,ESQ.
`su 1p. un u well.com
`
`25
`
`1
`
`2
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`6/3/2019
`Page 2 (2 - 5)
`Page 4
`APPEARANCES (cont'd.)
`
`_L
`: J
`goe z
`
`UULL
`. GOETZ, ESQ.
`r.com
`
`\ ) I- \'.euue, 52nd Floor
`3 °J~[~D,~s8~rwc
`
`1
`
`2
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`11 ALSO PRESENT:
`MATT.HEW GRF.INERT, ESQ.
`12
`MYf~t'}i1PRa~i%i~Wti cal Company
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`1
`
`5
`
`INDEX
`
`2
`3 Examination
`4 KARL R. LEINSING
`5
`By Mr. Ansley
`
`Page
`
`7
`
`6
`
`7
`
`8
`
`9
`
`EXHIBITS
`
`10
`Page
`Description
`11 Number
`8
`12 Exhibit 1001 US Patent No. 8,679,069
`8
`13 Exhibit 1002 US Patent No. 8,603,044
`8
`14 Exhibit 1003 US Patent No. 8,922,486
`8
`15 Exhibit 1004 US Patent No. 8,922,486
`8
`16 Exhibit 1005 US Patent No. 9,526,844
`1 7 Exhibit 1011 Declaration of Karl Leinsing, 15
`MSME, PE
`18
`19 Exhibit 1012 Curriculum Vitae of Karl
`Leinsing
`20
`21 Exhibit 1013 US Patent No. 6,221,046
`(Burroughs)
`22
`23 Exhibit 1014 US Patent No. 6,235,004
`(Steenfeldt-Jensen)
`24
`25
`
`26
`
`26
`
`32
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2163.002
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`A. That's correct.
`Q. And you mentioned five patents in a
`2
`3 previous answer.
`2
`Page
`Description
`3 Number
`In your declaration you discuss the
`4
`4 Exhibit 1015 US Patent Application No. US
`5 patentability of these five patents. Is that
`2002/0052578 Al (Moller)
`5
`6 correct?
`6 Exhibit 1016 US Patent No. 6,932,794
`A. Yes.
`7
`(Giambattista)
`Q. All right. I want to go ahead and produce
`7
`8
`8 Exhibit 1017 US Patent No. 6,582,404
`9 exhibits premarked 1001 through 1005.
`(Klitgaard)
`9
`(Premarked Exhibits 1001 - 1005 are handed
`10
`10 Exhibit 1020 US Patent No. 4,865,591 (Sams) 84 11
`to the witness.)
`11 Exhibit 1032 European Patent Specification 87
`12 BY MR. ANSLEY:
`No. EP0608343B 1
`12
`Q. Mr. Leinsing, the court reporter has
`13
`13 Exhibit 2100 Article Titled "Injection
`14 handed you documents that have been premarked in
`Force of SoloSTAR Compared
`14
`15 these IPRs as Exhibits 1001 through 1005.
`with Other Disposable Insulin
`And are these exhibits the Sanofi patents
`16
`Pen Devices at Constant Volume
`1 7 that you analyzed in your declaration?
`Flow Rates" (van der Burg)
`17
`A. Yes.
`18
`18 Exhibit 2101 Article Titled "An Evaluation 122
`Q. Okay. And for purposes of this
`19
`of Prefilled Insulin Pens: A
`19
`2 o deposition, I'm going to refer to the exhibits by
`Focus on the Next Generation
`21 the last three digits of the patent number. So
`FlexPen" (Davis, et al.)
`21
`22 I'll refer to Exhibit 1001 as the '069 patent,
`22 Exhibit 2102 Drawing Created by Attorney
`23 Exhibit 1002 as the '044 patent, Exhibit 1003 as
`Ansley
`23
`24 the '486 patent, Exhibit 1004 as the '844 patent,
`24 Exhibit 2103 Page of Exhibit 1013 with
`25 and Exhibit 1005 as the '008 patent.
`Witness's Red Marks
`25
`
`26
`
`26
`
`26
`
`105
`
`151
`
`189
`
`Karl R. Leinsing
`
`Portsmouth, NH
`
`6/3/2019
`Page 3 (6 - 9)
`Page 8
`
`1
`
`6
`EXHIBITS (cont'd.)
`
`1
`
`15
`
`16
`
`20
`
`Page 7
`
`Page 9
`
`1
`
`8
`9
`
`13
`
`14
`
`15
`
`19
`
`PROCEEDINGS
`KARL R. LEINSING
`2
`3 a witness called for examination, having been first
`4 duly sworn according to law, was examined and
`5 testified as follows:
`EXAMINATION
`6
`7 BY MR ANSLEY:
`Q. Good morning.
`A. Good morning.
`Q. Could you please state your name for the
`10
`11 record.
`A. Carl R. Leinsing.
`12
`Q. And how do you spell the last name?
`A. L-e-i-n-s-i-n-g.
`Q. Thank you.
`Do you have an understanding of why you're
`16
`17 here to testify today?
`A. Yes.
`18
`Q. And what is your understanding?
`A. That there's been some IPRs that were
`20
`21 filed regarding five patents and the declaration I
`22 wrote in support of those IP Rs.
`Q. And to clarify, you signed a single
`23
`24 declaration that was submitted with each of these
`25 IPR petitions. Is that right?
`
`1
`
`2
`
`7
`
`19
`
`Do you understand that?
`A. Yes.
`Q. And I may also refer to the group of these
`3
`4 five patents as either the Sanofi patents, the
`5 SoloSTAR patents, or the challenged patents.
`Do you understand that?
`6
`A. Yes.
`Q. Okay. You've been deposed before.
`8
`9 Correct?
`A. Yes.
`10
`11 Q. And how many times, approximately?
`A. Approximately 30 times or so.
`12
`Q. And of those 30 times, how many of those
`13
`14 depositions were you serving as an expert?
`A. Just about all of them.
`15
`Q. So are there any depositions where you've
`16
`17 testified not as an expert?
`MR. TORCZON: Objection. Scope.
`18
`A. No, not that I can recall.
`Q. All right. Well, I'm going to go over
`20
`21 some rules and guidelines. Sounds like you're
`22 fairly familiar with the process. However, it
`23 can't hurt to go over some things.
`So I'll be asking you a series of
`24
`25 questions, and you must provide an answer to each
`Alderson Court Reporting
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Sanofi Exhibit 2163.003
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Karl R. Leinsing
`
`6/3/2019
`Page 4 (10 - 13)
`Page 12
`
`Portsmouth, NH
`Page 10
`1 of my work with injector pens.
`1 of my questions unless you are instructed not to do
`Q. Okay. What time frame are you thinking of
`2 so on the basis of privilege from counsel.
`2
`3 when you first saw any one of these patents?
`Do you understand?
`A. I can't recall.
`A. Yes.
`Q. Was it before 2000 or after 2000?
`Q. Okay. And if you do not understand a
`5
`MR. TORCZON: Objection. Form.
`6 question that I'm asking, please ask for
`A. I don't know. They look familiar from
`7 clarification. Okay?
`7
`A. Okay.
`8 looking at the embodiment. So whether it was these
`Q. We'll take breaks throughout the
`9 particular patents or then the preceding patents
`10 that they continue from, I don't recall. It's
`10 deposition. If a question is pending, you'll need
`11 probably all during the 2010 and onward time frame.
`11 to answer my question before we go on a break. Is
`Q. And when were you first engaged by counsel
`12 that clear?
`12
`A. That's clear.
`13 in this matter?
`Q. All right. And you're represented by
`A. I don't remember. I think it was sometime
`14
`14
`15 in2018.
`15 counsel today. Is that right?
`Q. And so you believe that you first became
`A. Yes.
`16
`16
`1 7 aware of at least some of the Sanofi patents before
`MR. TORCZON: Objection. Form.
`Q. And who is your counsel today?
`18 2018. Is that right?
`A. Yes.
`A. Those that are here present.
`Q. Okay. And which patents do you recall
`Q. All right. And so your counsel may object
`20
`21 from time to time during the deposition today. You 21 seeing or reviewing before 2018?
`A. I don't recall. They all look the same.
`22 are still obligated to answer any ofmy questions
`Q. Okay. Would you have -- strike that.
`2 3 unless your counsel specifically instructs you not
`Do you recall reading any of these patents
`24 to on the basis of privilege. Do you understand
`24
`25 that?
`25 thoroughly before 2018?
`
`3
`
`4
`
`8
`
`9
`
`13
`
`17
`
`18
`
`19
`
`20
`
`4
`
`5
`
`6
`
`19
`
`22
`
`23
`
`1
`
`4
`
`7
`
`11
`
`15
`
`19
`2 o
`
`21
`
`Page 13
`A. Yes.
`I probably read at least one of them.
`A.
`Q. All right. And do you understand that
`Q. And when was the first time you read any
`2
`3 you're under oath to tell the truth today?
`3 one of these patents in its entirety?
`A. Yes.
`MR. TORCZON: Objection. Form.
`Q. And throughout the course of this
`I don't recall prior to this case how much
`A.
`5
`6 deposition as well. Is that right?
`6 I've looked at it, but I know at least in this case
`A. Yes.
`7 I've read it in its entirety.
`Q. And you understand that this is the same
`Q. Okay. And you've read in this case each
`8
`8
`9 oath that you would take before a judge in a court
`9 of these patents in its entirety, or no?
`10 of law. Is that right?
`A. Yes.
`A. Yes, that's my understanding.
`Q. Okay. So yes, you have?
`Q. And is there any reason that you cannot
`A. Yes, I have.
`12
`13 provide truthful and accurate testimony during this
`Q. All right. And how many times have you
`14 deposition?
`14 read through the '069 patent in its entirety?
`A. No.
`A. At least two or three times.
`Q. All right. So looking at Exhibits 1001
`Q. And when was the last time you reviewed
`16
`16
`1 7 through 1005, have you read each of those documents 1 7
`it?
`18 before?
`A. Yesterday.
`A. Yes.
`Q. How about for the '044? How many times
`19
`Q. And you've read them in their entirety?
`2 o have you read through the '044 patent in this case?
`A. Yes.
`A. At least once or twice.
`Q. And when did you first become aware of any
`Q. And when was the last time you reviewed
`22
`22
`2 3 one of these patents?
`2 3 the '044 patent?
`A.
`I don't know the exact date when I first
`A. Saturday.
`24
`2 5 seen them, but I've seen them in the past in some
`Q. Okay. The '486 patent, how many times
`Alderson Court Reporting
`
`Page 11
`
`1
`
`2
`
`4
`
`5
`
`10
`
`11
`
`12
`
`13
`
`15
`
`18
`
`21
`
`24
`
`25
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Sanofi Exhibit 2163.004
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Karl R. Leinsing
`
`3
`
`4
`
`5
`
`6
`
`9
`
`Portsmouth, NH
`Page 14
`1 have you read through the entirety of the '486
`2 patent?
`A. At least once or twice.
`Q. And when did you last review it?
`A.
`I'm not sure. It was probably Saturday of
`5
`6 last week.
`Q. Okay. And would your answer for the '844
`7
`8 patent be the same?
`A. Yes.
`9
`Q. And for the '008 patent would your answer
`10
`11 be the same or different?
`A. That one's a little bit different. I
`12
`13 reviewed that one yesterday and then also last
`14 week.
`Q. And how many times do you think you
`15
`16 reviewed the '008 patent in its entirety?
`A. At least twice.
`1 7
`Q. So you testified earlier that you were
`18
`19 engaged in this matter sometime in 2018. Is that
`20 right?
`MR. TORCZON: Objection. Asked and
`answered.
`A. Yes, sometime in 2018.
`Q. Okay. When did you begin drafting your
`24
`25 declaration?
`
`6/3/2019
`Page 5 (14- 17)
`Page 16
`If you could look at the first page inside
`1
`2 the cover. It's marked Roman numerette 1. You see
`3 the table of contents, and it continues over the
`4 next four pages.
`Do you see that?
`A. Yes.
`Q. So which of these sections did you write
`7
`8 the first draft for?
`MR. TORCZON: Objection. Relevance.
`A. I know I wrote the level of skill in the
`10
`11 art -- a lot of these. I'm not sure which ones I
`12 started. I think we started off with tossing
`13 around a lot of different prior art back and forth.
`14 I found some prior art.
`And then I drafted a lot of the sections,
`15
`16 especially the qualifications, legal standards I've
`1 7 had from the past. The attorneys then filled in a
`18 lot of that, since that's the legal part.
`Q. How about any of the sections beginning on
`19
`2 o page 91 and continuing through page 469?
`A. I don't recall, you know, who started
`21
`22 what. I think they helped put together the tables
`23 in the very beginning, and then every single
`24 section after that, I went through step by step of
`2 5 each of the prior arts with the attorneys. They
`Page 17
`A. I don't recall.
`1 took notes. They drafted everything together.
`Q. Was it soon after you were engaged?
`2 There wasn't any single statement that was made in
`A. No. I was talking to the law firm,
`3 here that either I didn't create or I didn't
`3
`4 actually, for quite a while, because I was actually
`4 approve.
`Q. You stated that you found some of the
`5 working on a case against Mylan at the time.
`5
`Q. Okay. What case was that?
`6 prior art.
`A. That was on an EpiPen that failed.
`What prior art specifically did you locate
`7
`7
`8 and find?
`8 Liability case.
`Q. Did you write the first draft of your
`A. Well, Klitgaard, for one. Because I was
`9
`9
`10 declaration?
`10 working on some other injector pen-type projects,
`A. I wrote many different sections. It was a
`11 and the Klitgaard was part of that project.
`11
`Q. Any others?
`12 huge declaration, and then we pieced it together as
`12
`13 time went on.
`A.
`I think I also had found Moller, but I
`13
`Q. I'm going to introduce Exhibit 1011 that's
`14 believe they had found Moller as well. And I found
`14
`15 been premarked in this matter. It is premarked.
`15 Steenfeldt-Jensen, and I think they found that one
`16 as well. Then I found many others. I don't recall
`It will make carrying the box much easier.
`16
`1 7 right now.
`(Premarked Exhibit 1011 is handed to the
`Q. You stated just now that you were working
`witness.)
`18
`18
`19 BYMR. ANSLEY:
`19 on some other pen -- I'm sorry. Strike that.
`Q. Mr. Leinsing, you've been handed premarked 20
`You stated just now that you were working
`20
`21 Exhibit lOll.
`21 on other pen injector type products -- projects.
`This document is a declaration you
`22 What were these other projects?
`22
`2 3 prepared for each of the IPR petitions. Correct?
`MR. TORCZON: Objection. Scope.
`23
`A. Correct, minus the exhibits.
`24 Relevance.
`24
`Q. Minus the exhibits. Okay.
`A. One was another patent litigation case.
`Alderson Court Reporting
`
`21
`
`22
`
`23
`
`1
`
`2
`
`6
`
`17
`
`25
`
`Page 15
`
`25
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Sanofi Exhibit 2163.005
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Karl R. Leinsing
`
`9
`
`6/3/2019
`Page 6 (18 - 21)
`Portsmouth, NH
`Page 20
`Page 18
`Q. Are the -- do the parties in that patent
`1 your work in this matter up until the date you
`1
`2 litigation case include any of the parties in these
`2 signed this declaration?
`A. No. I don't do my accounting.
`3 IPRs?
`Q. Okay. And do you bill through ATech
`MR. TORCZON: Objection. Scope.
`4
`4
`5 Designs? Is that right?
`5 Relevance.
`A. No.
`A. That's correct.
`6
`6
`Q. What was another one of the projects you
`Q. Are there any other employees at ATech
`7
`7
`8 were working on on pen injector products?
`8 Designs besides yourself?
`MR. TORCZON: Same objections.
`MR. TORCZON: Objection. Scope.
`9
`A. There was another, I think, pen injector
`10 Relevance.
`10
`A. No technical employees, but I have
`11 litigation. Actually, it wasn't a patent
`11
`12 litigation case. It was a contract dispute case.
`12 full-time contractors that work for me. I have an
`13 And then I was doing some work on injection
`13 engineer full-time on staff. And then someone that
`14 helps with accounting and other assistance work.
`14 profiles of auto-injectors.
`Q. Were all the other pen injector projects
`15 Someone who cleans my office.
`15
`Q. We all need that.
`16 that you've been working on recently, have those
`1 7 been part of litigations -- strike that.
`Did any of these contractors assist in any
`17
`For all the other pen injector products
`18 way with the drafting of this declaration?
`18
`A. No.
`19 you've been working on recently, have you provided 19
`2 o Q. What did you do to prepare for today's
`2 o expert witness services for litigations in those
`21 projects?
`21 deposition?
`A.
`MR. TORCZON: Objection. Form.
`I reviewed my declaration. I reviewed
`22
`22
`23 Relevance. Scope.
`23 the -- I guess we're calling them the group of
`A. Yes, except for the auto-injector
`24 Sanofi patents.
`24
`Q. Okay.
`2 5 consulting project.
`
`3
`
`16
`
`25
`
`Page 21
`Page 19
`Q. Okay. And who are the parties in these
`A. And then I reviewed all of the prior art
`1
`1
`2 that's mentioned in my declaration.
`2 other pen injector litigations that you've been
`Q. When you say "the prior art," are you
`3 working on recently?
`3
`4 referring to the references that you call
`MR. TORCZON: Objection. Scope.
`A. One was the Novo Nordisk versus Teva.
`5 Burroughs, Steenfeldt-Jensen, Moller, Giambattista,
`Q. Okay. And the others?
`6 and Klitgaard?
`A. That's correct.
`MR. TORCZON: Same objection.
`Q. Any other documents that you reviewed?
`A. I don't -- I don't recall, actually, off
`8
`Let me ask a different question.
`9 the top of my head.
`Q. Okay.
`Were there any other documents that you
`10
`A. That's, I think, Voltares. I don't
`11 reviewed in preparation for your deposition?
`11
`A. I reviewed the decisions on the IPRs and
`12 remember the other company.
`12
`Q. All right. How many hours approximately
`13 Sanofi's responses.
`13
`Q. Did you review any other documents?
`14 have you spent since you were engaged in this
`A. I feel like I have, but I can't recall
`15 matter until you signed your declaration?
`15
`A. I don't recall.
`16 right now.
`Q. Sure.
`Q. And then how many hours, approximately,
`17
`When did you start preparing for this
`18 did you spend drafting the declaration that's
`18
`19 deposition?
`19 Exhibit lOll?
`A. A lot of time.
`2 o A. Early in May, because I took a vacation a
`Q. Yeah. If you could estimate the number of
`21 little bit in the middle of May.
`21
`Q. Okay. And did you meet with attorneys in
`22 hours, is it over 400 or under 400?
`22
`A. I wouldn't even want to guess. It was a
`2 3 preparation for this deposition?
`2 3
`A. Yes.
`24 lot of time.
`24
`Q. And when did -- how many meetings did you
`Q. Okay. Do you know how much you billed for 25
`Alderson Court Reporting
`
`4
`
`5
`
`6
`
`7
`
`10
`
`16
`
`20
`
`25
`
`7
`
`8
`
`9
`
`14
`
`17
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Sanofi Exhibit 2163.006
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Karl R. Leinsing
`
`6/3/2019
`Page 7 (22 - 25)
`Page 24
`
`5
`
`6
`
`7
`
`8
`
`9
`
`17
`
`18
`
`Portsmouth, NH
`Page 22
`1 have with attorneys to prepare for this deposition?
`A. We just met twice.
`2
`Q. And when was your first meeting with the
`3
`4 attorneys to prepare for this deposition?
`MR. TORCZON: Objection. Relevance.
`A. Last Thursday.
`Q. And how long did you meet for on Thursday?
`MR. TORCZON: Same objection.
`A. Just during the day, about eight hours.
`Q. Were there any non-attorneys at this
`10
`11 meeting?
`A. Other than the nice lady who brought us
`12
`13 lunch and breakfast, no.
`Q. Okay. Do you recall the names of the
`14
`15 attorneys that were attending this meeting last
`16 Thursday?
`MR. TORCZON: Objection. Relevance.
`A. All the ones on the business cards.
`Q. Okay. So all the attorneys who -- not all
`19
`2 o the attorneys, but the attorneys you met with on
`21 Thursday include some of the attorneys that are in
`22 this room. Is that fair?
`A. Yes.
`23
`Q. Okay. And then the second time you met
`24
`25 with attorneys, when was that?
`
`1 report. Is that right?
`A. That's correct.
`2
`Q. Could you please tum to page 471 at the
`3
`4 back of your declaration, but keep your finger on
`5 page 1.
`All right. On pages 471 to 473, is this a
`6
`7 complete list of the materials you examined to form
`8 the opinions contained in your declaration?
`A. Yes, plus my general knowledge of other, I
`9
`10 think, prior art and patents in the type of art of
`11 pen injectors.
`Q. Okay. But there are no --you didn't
`12
`13 review any documents for purposes of this
`14 declaration that aren't listed here on pages 4 71 to
`15 473. Is that right?
`A. That's correct.
`Q. All right. So, then, to summarize,
`17
`18 looking back at paragraph 1, your opinions in this
`19 report -- let me re-ask that.
`Looking back at paragraph 1, are your
`20
`21 opinions in this report based on anything other
`22 than your skills, knowledge, training, education,
`2 3 experience in matters of this nature, and your
`2 4 examination of the documents listed on pages 4 71
`25 through 473?
`
`16
`
`1
`
`2
`
`3
`
`4
`
`11
`
`16
`
`Page 25
`Page 23
`A. So it would be these documents and some
`MR. TORCZON: Objection. Relevance.
`1
`A. Friday.
`2 documents that these patents reference. I think
`3 there's some other patents in the chain that would
`Q. And how long did you meet for on Friday?
`A. About eight hours.
`4 also be included in that.
`Q. So what documents are you thinking of?
`Q. All right. And the same people were in
`5
`5
`A. Well, the Sanofi patents themselves
`6 attendance at that meeting. Is that correct?
`6
`A. Yes.
`7 reference patents within them, the same with the
`7
`8 prior art that I cite in my analysis.
`Q. All right. Could we tum to paragraph 1
`8
`Q. If you would look at Exhibit 1001 for me,
`9 of your declaration. It's on page 1.
`9
`10 please. Just pull it out. Feel free to take a
`Let me know when you're there.
`10
`A.
`11 look through here, but let me know if you can
`I'm there.
`Q. Okay. Now, you've been retained by
`12 identify or are able to identify what documents
`12
`13 you're thinking of.
`13 Mylan's counsel to provide opinions on the
`A. So on the face of the patents, it talks
`14 patentability of the Sanofi patents. Correct?
`14
`15 about the patents in the chain.
`MR. TORCZON: Objection. Form.
`15
`Q. Under "Related US Application Data"?
`A. Correct.
`16
`Q. All right. And those opinions are
`A. Yes.
`17
`Q. Okay.
`18 described and contained in this declaration. Is
`A.
`In particular with my arguments that talk
`19 that right?
`19
`A. Correct.
`20 about the date of the inside of the thread on the
`20
`Q. And you state further at the end of
`21 piston rod. And so going back through the whole
`21
`22 chain and doing that analysis.
`22 paragraph 1 that your opinions are based on your
`Q. Okay. So other than the documents listed
`23 skills, knowledge, training, education, and
`23
`24 in pages 471 through 473 and the related
`24 experience in matters of this nature, and your
`25 application data for the Sanofi patents, did you
`25 examination of materials utilized in preparing this
`Alderson Court Reporting
`
`17
`
`18
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Sanofi Exhibit 2163.007
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Karl R. Leinsing
`
`6/3/2019
`Page 8 (26 - 29)
`Page 28
`
`Portsmouth, NH
`Page 26
`1 review any other documents to arrive at the
`2 opinions in your declaration?
`A. The patents that are cited in the prior
`3
`4 arts that I use in my arguments, there's some
`5 patents mentioned in there.
`Q. Okay. I guess we can go ahead and
`6
`7 introduce those now.
`(Premarked Exhibits 1013 to 1016 are
`8
`handed to the witness.)
`THE WITNESS: The '008 patent also
`10
`11 mentions a couple patents as well in the
`background.
`12
`13 BY MR. ANSLEY:
`Q. You've been handed premarked Exhibits
`14
`15 1013, 1014, 115, and 1016, and these are
`16 respectively the Burroughs, Steenfeldt-Jensen,
`1 7 Moller, and Giambattista references discussed in
`18 your declaration. Is that right?
`A. That's correct.
`19
`(Premarked Exhibit 101 7 is handed to the
`witness.)
`21
`22 BY MR. ANSLEY:
`Q. All right. I'm also handing you premarked
`2 3
`24 Exhibit 1017, which is the Klitgaard reference
`25 that's discussed in your declaration. Is that
`Page 27
`
`9
`
`20
`
`11
`
`12
`
`13
`
`16
`
`You know what? Strike that, too. You
`1
`2 mentioned some others in the prior art.
`Let's look at Exhibit 1013, and you
`3
`4 mentioned that you had reviewed some documents that
`5 are referenced in some of the prior art references.
`So are there any documents that you
`6
`7 reviewed that aren't listed on pages 4 71 to 4 73
`8 that are referenced in the Burroughs reference?
`A Yes. In the '046 patent, US Patent
`9
`10 No. 5,295,976.
`Q. Okay.
`It's on line 42, column 1.
`A
`Q. Okay.
`A And in column 1, line 60, US Patent
`14
`15 No. 5,308,340.
`Q. Okay.
`A Then in column 2, line 23, US Patent
`17
`18 Application No. 08/399764.
`Q. Any others?
`19
`In this '046 patent, not that I can see,
`2 o A
`21 unless I missed one.
`Q. Okay. And let's look at
`22
`23 Steenfeldt-Jensen, which is Exhibit 1014.
`Did you review any documents that are
`24
`2 5 referenced in here that are not listed on pages 4 71
`Page 29
`1 right?
`1 to 4 73 of your declaration for purposes of arriving
`A That's correct.
`2 at the opinions in your declaration?
`2
`Q. I want to go back to the '008 patent since
`A. Do you realize the patent you gave me is
`3
`3
`4 you mentioned that you reviewed some documents that
`4 highlighted?
`Q. Yeah, that's not our highlighting. We
`5 were referenced in there.
`5
`Can you identify for me what documents you
`6 have the same thing.
`6
`7 reviewed to arrive at the opinions in your
`A.
`In the '004 patent, column 1, there is
`7
`8 declaration from -- yeah.
`8 some references there, but I don't recall whether I
`A Yes.
`9 actually looked at those or not. EP -- on line 46,
`Q. And what are those?
`10 EP427910.
`10
`Q. You mean 327?
`11 A US Patent No. 5,304,152. Another patent,
`12 W09938554A2.
`A. 327. Yeah. Sorry.
`Q. No worries.
`Q. And those are two patents that are
`13
`14 identified in column 1 at line 53 and line 60 of
`A. And then column 1, line 65, EP450905. And
`14
`15 the '008 patent. Is that right?
`15 then column 2, line 7, EP608343.
`Q. Okay. Any other documents from the
`A That's correct.
`16
`Q. Did you review, other than the documents
`17 Steenfeldt-Jensen reference?
`1 7
`18 in pages 471 -- that are listed in pages 471
`A. Not that I can recall. There might be
`18
`19 through 473 of your declaration, and other than the
`19 others listed in the reference.
`Q. Let's take a look at Moller, which is
`2 o two documents from the column 1 of the '008 patent,
`20
`21 and other than the related application data of the
`21 Exhibit 1015.
`22 Sanofi patents, did you review any other documents
`Did you review for purposes of arriving at
`22
`2 3 for purposes of arriving at your petition -- I'm
`23 the opinions in your declaration any of the
`24 sorry -- your declaration -- for purposes of
`24 documents identified herein there are not listed on
`25 arriving at the opinions in your declaration?
`2 5 pages 4 71 to 4 73 of your declaration?
`Alderson Court Reporting
`
`9
`
`16
`
`11
`
`12
`
`13
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Sanofi Exhibit 2163.008
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Karl R. Leinsing
`
`17
`
`2 5
`
`1
`
`4
`
`5
`
`Portsmouth, NH
`Page 30
`A So the same for the Moller patent as the
`1
`2 others. Any patent per application that's
`3 referenced, I reviewed column 1 -- actually,
`4 there's no really columns here. Page one,
`5 paragraph 2. It says EP327990, which I think is
`6 the same as the other patent. Paragraph 7,
`7 EP608343. Paragraph 8, WO99/38554. Then there's
`8 another one in paragraph 9, WO96/26754.
`Q. Paragraph 8, it lists WO99/38554, as you
`9
`10 mentioned.
`Do you have an understanding of the
`11
`12 relation of this patent to the Steenfeldt-Jensen
`13 reference you analyzed in your declaration?
`I believe that's related to it, but I'm
`A
`14
`15 not sure. Yeah, I can't tell from the documents in
`16 front of me.
`Q. Okay. We might come back to that.
`All right. Let's look at Exhibit 1016 --
`18
`19 which is Giambattista.
`Are there any documents that are
`2 o
`21 identified herein that you reviewed for purposes of
`22 arriving at your declaration, other than the
`23 documents that are identified on pages 471 through
`24 473 of your declaration?
`A Yes. All the patents listed in column 1
`Page 31
`
`6/3/2019
`Page 9 (30 - 33)
`Page 32
`(Premarked Exhibit 1012 is handed to the
`witness.)
`2
`3 BY MR ANSLEY:
`Q. So what is this document?
`A. This is my curriculum vitae.
`Q. Is this your -- is it fair if we just call
`6
`7 it a CV?
`A. CV, sure.
`Q. I can't pronounce curriculum vitae.
`A.
`I can't very well, either.
`10
`11 Q. Yeah, it's tough. I'll goof it up.
`Is this your latest CV?
`12
`A. As of today, no.
`Q. Okay. What is the date that this CV is
`14
`15 current until?
`A.
`It's at the bottom of the page. It says
`16
`17 July 27, 2018.
`Q. Okay. And what is different about the CV
`18
`19 that is Exhibit 1012 and your current CV?
`MR. TORCZON: Objection. Scope.
`20
`I know I have two more patents since then.
`A.
`21
`22 I just finished a trachea device alarm. And then
`23 there's probably a little more testifying
`24 experience. That's all I can recall right now.
`Q. And when you say there's two more patents,
`25
`Page 33
`1 do you mean there are two more issued patents?
`A. Correct. Two more granted patents.
`MR. TORCZON: Objection. Scope.
`Q. And do either of those two patents cover
`4
`5 anything that you would characterize as a pen
`6 injector?
`MR. TORCZON: Objection. Scope.
`A. No.
`Q. As of the date of this CV that's Exhibit
`10 1012, is everything in this truthful and accurate?
`A. What date did you say?
`11
`Q. Let me re-ask that.
`As of July 27, 2018, is everything in
`13
`14 Exhibit 1012 truthful and accurate?
`A. Yes.
`15
`Q. Okay. Now, you obtained your Bachelor of
`16
`1 7 Science in mechanical engineering from the
`18 University of New Hampshire in 1988. Is that
`19 right?
`2 o A. That's correct.
`Q. Now let's tum to page 3 of your CV. It
`21
`22 says you held a number of positions at different
`23 employers from 1979 through 1992.
`At any of these positions did you work on
`24
`2 5 the development or design of anything that you
`Alderson Court Reporting
`
`8
`
`9
`
`13
`
`2
`
`3
`
`7
`
`8
`
`9
`
`12
`
`2
`
`3
`
`1 for the background of the invention.
`Q. Any others?
`A Not that I can recall at this time.
`Q. All right. One more. Klitgaard, Exhibit
`4
`5 1017.
`Are there any documents identified herein
`6
`7 that you reviewed for puiposes of arriving at the
`8 opinions in your declaration that are not
`9 identified in pages 4 71 through 4 73 of your
`10 declaration?
`11 A
`In column 1 there is a section of scope of
`12 related art. All of the references there as well.
`Q. Any others?
`13
`14 A Not that I can recall at this time.
`Q. So other than the documents that are
`15
`16 identified in pages 4 71 through 4 73 and the
`1 7 documents that we've identified together from the
`18 Sanofi patents and these five prior art references,
`19 are there any other documents that you reviewed for
`2 o purposes of arriving at the opinions contained in
`21 your declaration?
`22 A No, not that I can recall.
`Q. All right.
`23
`I'm going to hand you a document that's
`24
`2 5 been pre marked 1012.
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Sanofi Exhibit 2163.009
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Karl R. Leinsing
`
`Portsmouth, NH
`Page 34
`
`6/3/2019
`Page 10 (34 - 37)
`Page 36
`
`2
`
`5
`
`6
`
`7
`
`8
`
`9
`
`13
`
`17
`
`21
`
`24
`
`5
`
`6
`
`7
`
`8
`
`9
`
`8
`
`9
`
`12
`
`3
`
`1
`
`2
`
`3
`
`Do you see that?
`A. Yes.
`Q.
`Is the dual-acting pen injector for Eli
`4 Lilly that's discussed in paragraph 6 the same
`5 thing being referenced as the insulin injection
`6 system for Eli Lilly in the first bullet point of
`7 your CV?
`A. Yes.
`Q. The same thing? Okay.
`When did you start working on this insulin
`10
`11 injection system for Eli Lilly?
`MR. TORCZON: Objection. Relevance.
`A.
`It was sometime in the 1990s there. I'm
`13
`14 not sure which -- I don't remember which year it
`15 was.
`Q. And then when did your work on this
`16
`17 insulin injection system cease?
`A.
`It was about a one- or two-year project.
`18
`19 So it was before 2000, that's for sure. I just
`2 0 don't recall the exact year, or years.
`Q. And then this insulin injection system,
`21
`22 why do you characterize it in your CV as a pen
`23 injector?
`I'm sorry. Let me re-ask that.
`24
`This insulin injection system that's
`
`1 would characterize as a pen injector?
`A No.
`Q. Let's tum to page 2 of your CV. It says
`3
`4 you worked at IV AC beginning in 1992. Correct?
`A Correct.
`Q. How do you pronounce that?
`A. "IVAC."
`Q. "IVAC"? Okay. Thanks.
`And what is IV AC?
`A
`IVAC was a leader in IV pumps and
`10
`11 disposables, including syringe pumps and rela