November 20, 2020
`Mylan Institutional LLC v. Novo Nordisk A/S
`Dorthe Kot Engelund
`THIS DOCUMENT CONTAINS HIGHLY CONFIDENTIAL INFORMATION
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Page 1
`
`- - - - - - - - - - - - - - - - - - - - - - - - - -X
`
`MYLAN INSTITUTIONAL, LLC,
`
` Petitioner,
`
`-vs-
`
`NOVO NORDISK A/S,
` Patent Owner.
`
`- - - - - - - - - - - - - - - - - - - - - - - - - -X
` Case No. IPR2020-00324
` U.S. Patent No. 8,114,833
`
` HIGHLY CONFIDENTIAL
` VIDEOTAPED ZOOM REMOTE DEPOSITION OF
` DORTHE KOT ENGELUND
` Friday, November 20, 2020
` 6:00 a.m. EST
`
`Reported by:
`Jeannette McCormick
`
`1
`
`2
`
`3
`
`4
`
`5 6
`
`7
`
`8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Novo Nordisk Ex. 2100, P. 1
`Mylan Institutional v. Novo Nordisk
` IPR2020-00324
`
`
`Mylan Institutional LLC v. Novo Nordisk A/S
`Dorthe Kot Engelund
`THIS DOCUMENT CONTAINS HIGHLY CONFIDENTIAL INFORMATION
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Page 1
`
`- - - - - - - - - - - - - - - - - - - - - - - - - -X
`
`MYLAN INSTITUTIONAL, LLC,
`
` Petitioner,
`
`-vs-
`
`NOVO NORDISK A/S,
` Patent Owner.
`
`- - - - - - - - - - - - - - - - - - - - - - - - - -X
` Case No. IPR2020-00324
` U.S. Patent No. 8,114,833
`
` HIGHLY CONFIDENTIAL
` VIDEOTAPED ZOOM REMOTE DEPOSITION OF
` DORTHE KOT ENGELUND
` Friday, November 20, 2020
` 6:00 a.m. EST
`
`Reported by:
`Jeannette McCormick
`
`1
`
`2
`
`3
`
`4
`
`5 6
`
`7
`
`8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Novo Nordisk Ex. 2100, P. 1
`Mylan Institutional v. Novo Nordisk
` IPR2020-00324
`
`
`
`November 20, 2020
`Mylan Institutional LLC v. Novo Nordisk A/S
`Dorthe Kot Engelund
`THIS DOCUMENT CONTAINS HIGHLY CONFIDENTIAL INFORMATION
`
`Page 2
`
` VIDEOTAPED REMOTE ZOOM DEPOSITION
`of DORTHE KOT ENGELUND, taken pursuant to Notice,
`held remotely on Friday, November 20, 2020, at
`6:00 a.m. EST, before JEANNETTE MCCORMICK, a
`Certified Shorthand Reporter, and a Notary Public.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Novo Nordisk Ex. 2100, P. 2
`Mylan Institutional v. Novo Nordisk
` IPR2020-00324
`
`
`
`November 20, 2020
`Mylan Institutional LLC v. Novo Nordisk A/S
`Dorthe Kot Engelund
`THIS DOCUMENT CONTAINS HIGHLY CONFIDENTIAL INFORMATION
`
`A P P E A R A N C E S: (REMOTELY VIA ZOOM)
`
`Page 3
`
` PERKINS COIE, LLP
` (VIA ZOOM)
` Attorneys for Petitioner Mylan Institutional
` 1888 Century Park East, Suite 1700
` Los Angeles, California 90067
` BY: LARA DUEPPEN, ESQ.
`(310) 788-3349 (Telephone)
`(310) 843-1266 (Fax)
` ldueppen@perkinscoie.com
`
` PERKINS COIE, LLP
` (VIA ZOOM)
` Attorneys for Petitioner Mylan Institutional
` 33 E. Main Street, Suite 201
` Madison, Wisconsin 53703-3095
` BY: EMILY GREB, ESQ.
` BRANDON WHITE, ESQ.
`(608) 663-7494 (Telephone)
`(608) 283-4494 (Fax)
` egreb@perkinscoie.com
`
` PERKINS COIE, LLP
` (VIA ZOOM)
` Attorneys for Petitioner Pfizer, Inc.
` 700 13th Street, NW
` Washington, D.C. 20005-3960
` BY: BRANDON M. WHITE, ESQ.
`(202) 654-6206 (Telephone)
`(202) 654-6211 (Fax)
` bmwhite@perkinscoie.com
`
`1
`
`2 3 4
`
`5
`
`6
`
`7
`
`8
`9
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`16
`17
`
`18
`
`19
`
`20
`
`21
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Novo Nordisk Ex. 2100, P. 3
`Mylan Institutional v. Novo Nordisk
` IPR2020-00324
`
`
`
`November 20, 2020
`Mylan Institutional LLC v. Novo Nordisk A/S
`Dorthe Kot Engelund
`THIS DOCUMENT CONTAINS HIGHLY CONFIDENTIAL INFORMATION
`
`A P P E A R A N C E S: (REMOTELY VIA ZOOM)
`(CONTINUED)
`
`Page 4
`
` WINSTON & STRAWN, LLP
` (VIA ZOOM)
` Attorneys for Petitioner Pfizer, Inc.
` 1901 L Street, NW
` Washington, D.C. 20036-3506
` BY: SHARON LIN, ESQ.
` (202) 282-5756 (Telephone)
` (202) 282-5100 (Fax)
` slin@winston.com
`
` FENWICK & WEST, LLP
` (VIA ZOOM)
` Attorneys for Patent Owner Novo Nordisk A/S
` 902 Broadway, Suite 14
` New York, New York 10010-6035
` BY: JEFFREY OELKE, ESQ.
` (212) 430-2600 (Telephone)
` joelke@fenwick.com
`
`Also Present:
`
` Signe Bondgaard Conkel (Novo Nordisk)
`
`1
`
`2
`
`3 4 5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Novo Nordisk Ex. 2100, P. 4
`Mylan Institutional v. Novo Nordisk
` IPR2020-00324
`
`
`
`November 20, 2020
`Mylan Institutional LLC v. Novo Nordisk A/S
`Dorthe Kot Engelund
`THIS DOCUMENT CONTAINS HIGHLY CONFIDENTIAL INFORMATION
`
`Page 5
`
` George Inmon (Videographer)
`
` I N D E X
`
`WITNESS EXAMINATION BY PAGE
`
`DORTHE KOT ENGELUND
` MS. DUEPPEN 10
` MR. OELKE 234
`
` PREVIOUSLY MARKED
`
` E X H I B I T S
`
`NUMBER DESCRIPTION PAGE
`
`1001 U.S. Patent No. 8,114,833 14
`
`1004 PCT Publication
` No. WO 03/002136 227
`2023 Declaration of
` Dorthe Kot Engelund (31 pages) 15
`2050
`
`
`
`
`1 2
`
`3 4
`
`5 6
`
`7 8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Novo Nordisk Ex. 2100, P. 5
`Mylan Institutional v. Novo Nordisk
` IPR2020-00324
`
`
`
`November 20, 2020
`Mylan Institutional LLC v. Novo Nordisk A/S
`Dorthe Kot Engelund
`THIS DOCUMENT CONTAINS HIGHLY CONFIDENTIAL INFORMATION
`
` I N D E X
` (CONTINUED)
` E X H I B I T S
`
`Page 6
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` 125
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`NUMBER DESCRIPTION PAGE
`2051
`
`
`
`
`
`
`2052
`
`
`2053
`
`
`2055
`
`
`2056
`
`
`2057
`
`
`2058
`
`
`2059
`
`
`
`
`
`
`
`
` 69
`
`
`
` 41
`
`
`
` 95
`
`
`
` 119
`
`
`
`
`
`
`
`) 36
`
`
`
`
`
` 105
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1
`2
`3
`
`4 5
`
`6 7
`
`9
`
`11
`
`13
`
`15
`
`17
`
`19
`
`21
`
`Novo Nordisk Ex. 2100, P. 6
`Mylan Institutional v. Novo Nordisk
` IPR2020-00324
`
`
`
`November 20, 2020
`Mylan Institutional LLC v. Novo Nordisk A/S
`Dorthe Kot Engelund
`THIS DOCUMENT CONTAINS HIGHLY CONFIDENTIAL INFORMATION
`
` I N D E X
` (CONTINUED)
`
` E X H I B I T S
`
`Page 7
`
`NUMBER DESCRIPTION PAGE
`
`2060
`
`
`2062
`
`
`
`
`2064
`
`2066
`
`
`2067
`
`
`2068
`
`2069
`
`
`2070
`
`
`2071
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` 189
`
` 191
`
`
`
`
`
`
`
`
`
`
` 145
`
`
` 198
`
` 201
`
` 158
`
`
`
` 137
`
`
`
` 204
`
`
`
` 195
`
`
`
`
`
`
`
`
`
`1
`2
`3
`
`4 5
`
`6 7
`
`9
`
`11
`
`13
`
`15
`
`16
`
`18
`
`20
`
`21
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Novo Nordisk Ex. 2100, P. 7
`Mylan Institutional v. Novo Nordisk
` IPR2020-00324
`
`
`
`November 20, 2020
`Mylan Institutional LLC v. Novo Nordisk A/S
`Dorthe Kot Engelund
`THIS DOCUMENT CONTAINS HIGHLY CONFIDENTIAL INFORMATION
`
` I N D E X
` (CONTINUED)
`
` E X H I B I T S
`
`Page 8
`
`NUMBER DESCRIPTION PAGE
`
`2072
`
`
`2073
`
`2074
`
`
`2075
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` 185
`
` 220
`
`
` 222
`
`
`) 226
`
`1
`
`2
`
`3
`
`4 5
`
`6 7
`
`8
`
`10
`
`12
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Novo Nordisk Ex. 2100, P. 8
`Mylan Institutional v. Novo Nordisk
` IPR2020-00324
`
`
`
`November 20, 2020
`Mylan Institutional LLC v. Novo Nordisk A/S
`Dorthe Kot Engelund
`THIS DOCUMENT CONTAINS HIGHLY CONFIDENTIAL INFORMATION
`
`Page 9
`
` THE VIDEOGRAPHER: Good morning. My
` name is am George Inmon, and I'm from
` BlueBear Solutions. I will not be in the
` same room as the witness, nor will the court
` reporter Jeannette McCormick. Thus, I'll be
` recording this deposition remotely, and the
` reporter will swear the witness in remotely.
` This is the start of the remote video
` recorded deposition of Dorthe Engelund in the
` case of Mylan Institutional, LLC versus Novo
` Nordisk A/S, Case Number IPR 2020-00324.
` We are now on the record. Today's date
` is November 20, 2020. The time is now 6:06
` a.m., Eastern time.
` Attorneys, please make voice
` introductions.
` MS. DUEPPEN: This is Lara Dueppen from
` Perkins Coie on behalf of Petitioner Mylan
` Institutional, LLC.
` MR. OELKE: And this is Jeff Oelke from
` Fenwick & West on behalf of the Patent Owner,
` Novo Nordisk A/S, and on behalf of the
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Novo Nordisk Ex. 2100, P. 9
`Mylan Institutional v. Novo Nordisk
` IPR2020-00324
`
`
`
`November 20, 2020
`Mylan Institutional LLC v. Novo Nordisk A/S
`Dorthe Kot Engelund
`THIS DOCUMENT CONTAINS HIGHLY CONFIDENTIAL INFORMATION
`
`Page 10
` witness, Ms. Engelund. And joining us also
` are from Novo Nordisk is Signe Bondgaard
` Conkel and Alexandra Maria Olympia Junge.
` MS. LIN: And this is Sharon Lin on
` behalf of Petitioner Pfizer, Incorporated.
` MR. WHITE: And Brandon White and Emily
` Greb, from Perkins Coie, are also on for
` Petitioner.
` THE VIDEOGRAPHER: Are there any
` stipulations or announcements from either
` party?
` MS. DUEPPEN: Not at this time.
` THE VIDEOGRAPHER: Okay. The court
` reporter will now please swear in the
` witness.
`
` DORTHE KOT ENGELUND,
` having been first remotely sworn,
` testified as follows:
`
` EXAMINATION
`BY MS. DUEPPEN:
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Novo Nordisk Ex. 2100, P. 10
`Mylan Institutional v. Novo Nordisk
` IPR2020-00324
`
`
`
`November 20, 2020
`Mylan Institutional LLC v. Novo Nordisk A/S
`Dorthe Kot Engelund
`THIS DOCUMENT CONTAINS HIGHLY CONFIDENTIAL INFORMATION
`
`Page 11
` Q. Good morning, Ms. Engelund. How are you this
`morning?
` A. Fine.
` Q. Would you please state and spell your full
`name for the record.
` A. Yeah. It's Dorthe Kot Engelund. It's
`D-O-R-T-H-E K-O-T E-N-G-E-L-U-N-D.
` Q. Okay. Thank you. My name is Lara Dueppen.
`I'm counsel for Mylan.
` I understand that you've been deposed before.
`Is that correct?
` A. That is correct.
` Q. And how many times have you been deposed?
` A. Three times.
` Q. Once fairly recently, right?
` A. Yes.
` Q. So you probably know the routine, then, but
`I'm going to go over a few of the ground rules just
`so we're on the same page. Is that okay?
` A. That's okay.
` Q. Okay. First, I want to remind you that
`you're under oath.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Novo Nordisk Ex. 2100, P. 11
`Mylan Institutional v. Novo Nordisk
` IPR2020-00324
`
`
`
`November 20, 2020
`Mylan Institutional LLC v. Novo Nordisk A/S
`Dorthe Kot Engelund
`THIS DOCUMENT CONTAINS HIGHLY CONFIDENTIAL INFORMATION
`
`Page 12
`
` Do you understand that?
` A. Yes.
` Q. Your counsel may have some objections to some
`of the questions I'm going to be asking you, but
`unless he instructs you not to answer, you can go
`ahead and answer. Okay?
` A. Okay.
` Q. And I want to make sure that you understand
`the questions that I'm asking. So if there's
`something that you don't understand or need
`clarification for, please let me know, and I'll try
`to rephrase. Fair enough?
` A. It's fair, yes.
` Q. And I also ask that you try to give verbal
`responses to my questions so that the court reporter
`is able to take everything you say down. No nodding
`your head or um-mms or anything like that. Is that
`okay?
` A. That's okay.
` Q. And also for the court reporter's sake, we'll
`try not to talk over each other. I'll try not to
`talk over you, and if you would please do the same,
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Novo Nordisk Ex. 2100, P. 12
`Mylan Institutional v. Novo Nordisk
` IPR2020-00324
`
`
`
`November 20, 2020
`Mylan Institutional LLC v. Novo Nordisk A/S
`Dorthe Kot Engelund
`THIS DOCUMENT CONTAINS HIGHLY CONFIDENTIAL INFORMATION
`
`Page 13
`
`I would appreciate it. Is that fair?
` A. It's fair.
` Q. Okay. And, of course, if you need to take a
`break during the course of this deposition, please
`feel free to let me know. I only ask that we not
`take a break while the question -- while a question
`is pending. Okay?
` A. Okay.
` Q. And during any breaks, do you understand that
`you're not to discuss the substance of your
`testimony with counsel or anyone else, including
`e-mail, texts, instant messaging, anything like
`that?
` A. Yes.
` Q. Great. Okay. Ms. Engelund, how did you or
`did you prepare for your deposition today?
` MR. OELKE: And, Ms. Engelund, I just
` caution you not to disclose any
` communications in answering that question.
` You can go ahead.
` THE WITNESS: I read some documents and
` we had some meetings in the last couple of
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Novo Nordisk Ex. 2100, P. 13
`Mylan Institutional v. Novo Nordisk
` IPR2020-00324
`
`
`
`November 20, 2020
`Mylan Institutional LLC v. Novo Nordisk A/S
`Dorthe Kot Engelund
`THIS DOCUMENT CONTAINS HIGHLY CONFIDENTIAL INFORMATION
`
`Page 14
`
` days.
`BY MS. DUEPPEN:
` Q. Okay. And who did you meet with?
` A. With Jeff.
` Q. With Jeff. Anyone else?
` A. No.
` Q. How long did you guys meet?
` A. A couple of hours.
` Q. Okay. And did you speak with anybody else in
`preparation for your deposition for today?
` A. No.
` MS. DUEPPEN: Okay. So I would like to
` introduce a couple of documents. And I think
` that George will send those over to you via
` Chat.
` The first one is Exhibit 1001, and the
` second is 2022.
` (Whereupon, Petitioner's Deposition
` Exhibit No. 1001 was marked for
` Identification.)
`BY MS. DUEPPEN:
` Q. So let me know, Ms. Engelund, when you've
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Novo Nordisk Ex. 2100, P. 14
`Mylan Institutional v. Novo Nordisk
` IPR2020-00324
`
`
`
`November 20, 2020
`Mylan Institutional LLC v. Novo Nordisk A/S
`Dorthe Kot Engelund
`THIS DOCUMENT CONTAINS HIGHLY CONFIDENTIAL INFORMATION
`
`Page 15
`
`received those documents.
` A. I have the first. I guess the second will
`come.
` THE VIDEOGRAPHER: Counsel, I don't have
` 2022. And if someone at your firm could --
` maybe Emily could send me that, I would much
` appreciate it.
` MS. DUEPPEN: I apologize. I think
` that's 2023. That was my mistake. Sorry
` about that.
` THE WITNESS: Yeah, it's here.
` (Whereupon, Petitioner's Deposition
` Exhibit No. 2023 was marked for
` Identification.)
`BY MS. DUEPPEN:
` Q. So you have both 1001 and 2023 in front of
`you?
` A. Yes.
` MR. OELKE: Hold on one second. I'm in
` Chat. I don't see it, the documents. I
` mean, I'm not too concerned about these two,
` but I need to -- is there another -- okay.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Novo Nordisk Ex. 2100, P. 15
`Mylan Institutional v. Novo Nordisk
` IPR2020-00324
`
`
`
`November 20, 2020
`Mylan Institutional LLC v. Novo Nordisk A/S
`Dorthe Kot Engelund
`THIS DOCUMENT CONTAINS HIGHLY CONFIDENTIAL INFORMATION
`
`Page 16
`
` Thank you.
`BY MS. DUEPPEN:
` Q. Ms. Engelund, do you recognize the document
`marked Exhibit 2023 as your declaration that you
`submitted in connection with this IPR?
` A. Just a minute. I need to open it. Yes.
`Yes, I do.
` Q. Okay. And with respect to Exhibit 1001, do
`you recognize Exhibit 1001 as U.S. Patent Number
`8,114,833 as the patent at issue in this IPR?
` A. Yes.
` Q. And if we call that patent the '833 patent,
`you'll understand that I'm referring to this exhibit
`and this patent?
` A. Yes.
` Q. Great. Ms. Engelund, did you review your
`declaration to prepare for your deposition today?
` A. Yes.
` Q. And your declaration also refers to several
`documents marked as exhibits in this matter,
`including the '833 patent.
` Did you review those documents referenced in
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Novo Nordisk Ex. 2100, P. 16
`Mylan Institutional v. Novo Nordisk
` IPR2020-00324
`
`
`
`November 20, 2020
`Mylan Institutional LLC v. Novo Nordisk A/S
`Dorthe Kot Engelund
`THIS DOCUMENT CONTAINS HIGHLY CONFIDENTIAL INFORMATION
`
`Page 17
`
`your declaration in preparation for today?
` A. Yes.
` Q. All of the documents?
` A. I don't remember whether it was all. It
`was -- there was a lot.
` Q. Okay. And have you reviewed or relied on any
`documents that are not referenced in your
`declaration to prepare for today?
` A. No.
` Q. All right. Do you have any corrections or
`clarifications that you need to make to your
`declaration?
` A. No.
` Q. And do you have any hard -- and do you have a
`hard copy of your declaration or any of the other
`documents in front of you today?
` A. Yes, I do.
` Q. The declaration and all the documents, or
`which documents do you have in front of you?
` A. The declaration and all the documents.
` Q. So all the exhibits that you have referenced
`in the declaration?
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Novo Nordisk Ex. 2100, P. 17
`Mylan Institutional v. Novo Nordisk
` IPR2020-00324
`
`
`
`November 20, 2020
`Mylan Institutional LLC v. Novo Nordisk A/S
`Dorthe Kot Engelund
`THIS DOCUMENT CONTAINS HIGHLY CONFIDENTIAL INFORMATION
`
`Page 18
`
` A. Yes.
` Q. Okay. And are any of those documents marked
`in any way by you or anyone else or are they clean
`copies?
` A. They are clean copies.
` Q. Perfect. So you'll probably want to keep
`your declaration nearby, for the most part, but
`we'll be going through a lot of the other documents
`as well.
` A. Yes.
` Q. So first, if you could turn to paragraph 3 of
`your declaration, Exhibit 2023. Let me know when
`you're there?
` A. Yes, I am there.
` Q. Okay. So there you state that you have a
`master's degree in pharmacy; is that correct?
` A. That's correct.
` Q. And after a degree, you started working at
`Novo Nordisk, and have worked there ever since; is
`that right?
` A. That's right.
` Q. During your time at Novo, is it fair to say
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Novo Nordisk Ex. 2100, P. 18
`Mylan Institutional v. Novo Nordisk
` IPR2020-00324
`
`
`
`November 20, 2020
`Mylan Institutional LLC v. Novo Nordisk A/S
`Dorthe Kot Engelund
`THIS DOCUMENT CONTAINS HIGHLY CONFIDENTIAL INFORMATION
`
`Page 19
`
`that you worked primarily on projects related to
`insulin products and the liraglutide product?
` MR. OELKE: Objection to form.
` THE WITNESS: It's more broad because I
` worked with several different injectables.
` So it was also for hemophilia and so on.
`BY MS. DUEPPEN:
` Q. Okay. So in terms of -- in terms of the
`injectable products you had, can you name all of the
`drugs that you worked with?
` MR. OELKE: Objection to form.
` THE WITNESS: There are a lot of
` different products. Should I name them all?
`BY MS. DUEPPEN:
` Q. Well, let's start with the insulin products
`that you worked on. What are the brand names of the
`insulin products that you worked on?
` A. Oh, I'm not sure I'm able to give you the
`brand names, but I can tell you that it is NovoRapid
`and NovoMix 30, and 50 and 70. I worked with Faster
`Insulin Aspart. Yeah. That is the insulin products
`I remember right now.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Novo Nordisk Ex. 2100, P. 19
`Mylan Institutional v. Novo Nordisk
` IPR2020-00324
`
`
`
`November 20, 2020
`Mylan Institutional LLC v. Novo Nordisk A/S
`Dorthe Kot Engelund
`THIS DOCUMENT CONTAINS HIGHLY CONFIDENTIAL INFORMATION
`
`Page 20
`
` Q. Okay. And the liraglutide product, that's
`the -- that's Novo's Victoza product; is that right?
` A. That's right.
` Q. Are there any other products that include
`liraglutide as the drug substance?
` A. Yes. Not at that time, but now there are a
`product where you have combined an insulin product
`with liraglutide.
` Q. And you -- are you working on -- sorry --
`strike that.
` And you've worked on those as well?
` A. No.
` Q. And you -- so you've only worked on Victoza?
` A. Yes.
` MR. OELKE: Objection to form.
`BY MS. DUEPPEN:
` Q. Okay. So in paragraphs 3 and 4 of your
`declaration, you also -- you mentioned that you
`worked on other ready-to-use liquid formulations.
` Is that what you're talking about with the
`hemophilia products and the other products you
`mentioned there's -- you said that there were
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Novo Nordisk Ex. 2100, P. 20
`Mylan Institutional v. Novo Nordisk
` IPR2020-00324
`
`
`
`November 20, 2020
`Mylan Institutional LLC v. Novo Nordisk A/S
`Dorthe Kot Engelund
`THIS DOCUMENT CONTAINS HIGHLY CONFIDENTIAL INFORMATION
`
`Page 21
`
`several of them?
` A. Yes.
` Q. Okay. Okay. So if you turn paragraph 7 of
`your declaration, in paragraph 7, you state that you
`are making this declaration to establish an
`invention date for the claimed subject matter of the
`'833 patent.
` Do you see that?
` A. Yes.
` Q. What do you mean by "invention date"?
` MR. OELKE: Objection to form.
` THE WITNESS: By invention date, I mean
` the date where we defined that we would use
` propylene glycol as the preferred and optimal
` isotonic agent for liraglutide.
`BY MS. DUEPPEN:
` Q.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`21
`
`22
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` Q. Okay. In paragraph 8, you also state that
`you're making this declaration to show that
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Novo Nordisk Ex. 2100, P. 21
`Mylan Institutional v. Novo Nordisk
` IPR2020-00324
`
`
`
`November 20, 2020
`Mylan Institutional LLC v. Novo Nordisk A/S
`Dorthe Kot Engelund
`THIS DOCUMENT CONTAINS HIGHLY CONFIDENTIAL INFORMATION
`
`Page 22
`
`propylene glycol unexpectedly and surprisingly
`reduced clogging and deposits compared to mannitol.
` Do you see that?
` A. Yes.
` Q. I just want to clarify. Your testimony in
`your report, and during your deposition today, is
`based solely on your personal knowledge as a
`research scientist who is working on liraglutide
`formulation; is that right?
` A. Yes.
` Q. In paragraph 11 of your declaration, you
`state that as Novo "prepared for larger scale
`clinical trials, we encountered problems during
`production of large scale formulations containing
`mannitol, which were related to significant
`production problems in the form of deposits on the
`production equipment as well as clogging of
`injection needles."
` Do you see that?
` A. Yes.
` Q.
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Novo Nordisk Ex. 2100, P. 22
`Mylan Institutional v. Novo Nordisk
` IPR2020-00324
`
`
`
`November 20, 2020
`Mylan Institutional LLC v. Novo Nordisk A/S
`Dorthe Kot Engelund
`THIS DOCUMENT CONTAINS HIGHLY CONFIDENTIAL INFORMATION
`
`1
`
`11
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Page 23
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` M
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Novo Nordisk Ex. 2100, P. 23
`Mylan Institutional v. Novo Nordisk
` IPR2020-00324
`
`
`
`November 20, 2020
`Mylan Institutional LLC v. Novo Nordisk A/S
`Dorthe Kot Engelund
`THIS DOCUMENT CONTAINS HIGHLY CONFIDENTIAL INFORMATION
`
`Page 24
`
` Now, if you could take a look at the '833
`patent, Exhibit 1001. If you could turn on that
`first page -- or sorry about that.
` If you could turn to page 11 of Exhibit 1001,
`column 1, lines 18 to 26, which is the Field of
`Invention, and the Field of Invention states that,
`"The present invention relates to pharmaceutical
`formulations comprising a peptide and propylene
`glycol, to methods of preparing the formulations,
`and to uses of such formulations in the treatment of
`diseases and conditions for which use of the peptide
`contained in such formulations is indicated." And
`"The present invention further relates to methods
`for reducing the clogging of injection devices by a
`peptide formulation and for reducing deposits on
`production equipment during production of a peptide
`formulation."
` Do you see that?
` A. Yes.
` Q. So based on that language in the patent,
`would you agree that the patent describes the
`invention generally as relating to peptide
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Novo Nordisk Ex. 2100, P. 24
`Mylan Institutional v. Novo Nordisk
` IPR2020-00324
`
`
`
`November 20, 2020
`Mylan Institutional LLC v. Novo Nordisk A/S
`Dorthe Kot Engelund
`THIS DOCUMENT CONTAINS HIGHLY CONFIDENTIAL INFORMATION
`
`Page 25
`formulations that include propylene glycol, and in
`certain aspects the use of those formulations to
`reduce clogging of injection devices and reducing
`deposits on production equipment? Is that fair?
` MR. OELKE: Objection to form.
` THE WITNESS: Yes, that's fair.
`BY MS. DUEPPEN:
` Q. And then if you look down column 1 on the
`same page, just a bit to the Background of the
`Invention, starting at line 33, it states that, "The
`present inventors have observed that mannitol causes
`problems during the production of peptide
`formulations as it crystallizes resulting in
`deposits in the production equipment and in the
`final product."
` Further down it says, "Finally, the present
`inventors have observed that in peptide formulations
`to be administered by injection, the presence of
`mannitol results in clogging of injection devices."
` So would you agree, based on that language,
`that the primary purpose of using propylene glycol
`in peptide formulations in place of mannitol is to
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Novo Nordisk Ex. 2100, P. 25
`Mylan Institutional v. Novo Nordisk
` IPR2020-00324
`
`
`
`November 20, 2020
`Mylan Institutional LLC v. Novo Nordisk A/S
`Dorthe Kot Engelund
`THIS DOCUMENT CONTAINS HIGHLY CONFIDENTIAL INFORMATION
`
`Page 26
`
`reduce deposits on production equipment and to
`reduce clogging?
` MR. OELKE: Objection to form.
` THE WITNESS: Yeah. You can say that
` that is -- that that is the purpose, but of
` course, you must also check that the physical
` and chemical stability is maintained, and
` that all other parameters which is important
` for the specific peptide is okay also using
` propylene glycol.
`BY MS. DUEPPEN:
` Q. Understood. But it does -- it -- but the
`primary reason why mannitol was being replaced was
`due to clogs and deposits on the production
`equipment, correct?
` MR. OELKE: Objection to form.
` THE WITNESS: That is correct. But, of
` course, the other things must also be checked
` and be okay.
`BY MS. DUEPPEN:
` Q. And the other things would need to be checked
`because you need to have -- strike that.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Novo Nordisk Ex. 2100, P. 26
`Mylan Institutional v. Novo Nordisk
` IPR2020-00324
`
`
`
`November 20, 2020
`Mylan Institutional LLC v. Novo Nordisk A/S
`Dorthe Kot Engelund
`THIS DOCUMENT CONTAINS HIGHLY CONFIDENTIAL INFORMATION
`
`Page 27
` The other things need to be checked in order
`to -- in order for the FDA to approve your drug,
`correct?
` MR. OELKE: Objection to form.
` THE WITNESS: Yeah, that is correct.
` Change in an excipient in a pharmaceutical
` product, it's not an easy task because you
` have to -- you have to verify a lot of
` different parameters, and among these are
` physical and chemical stability and microbial
` efficacy, that potency is okay, and a lot of
` different things.
`BY MS. DUEPPEN:
` Q. Okay. Understood. Okay. I'd like to jump
`to some of the earlier studies that you cite in your
`report.
` MS. DUEPPEN: So if -- George, if you
` could send over the document that's
` previously marked as 2050.
` (Whereupon, Petitioner's Deposition
` Exhibit No. 2050 was marked for
` Identification.)
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Novo Nordisk Ex. 2100, P. 27
`Mylan Institutional v. Novo Nordisk
` IPR2020-00324
`
`
`
`November 20, 2020
`Mylan Institutional LLC v. Novo Nordisk A/S
`Dorthe Kot Engelund
`THIS DOCUMENT CONTAINS HIGHLY CONFIDENTIAL INFORMATION
`
`BY MS. DUEPPEN:
` Q. And, Ms. Engelund, if you could confirm once
`you've received that document, that would be great.
` A. Yes, I got it.
`
`
`
`Page 28
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1
`
`2
`
`3
`
`4
`
`6
`
`22
`
`
`
`
`
`
`
`
`
`
` Q. Does each report or document get a protocol
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Novo Nordisk Ex. 2100, P. 28
`Mylan Institutional v. Novo Nordisk
` IPR2020-00324
`
`
`
`November 20, 2020
`Mylan Institutional LLC v. Novo Nordisk A/S
`Dorthe Kot Engelund
`THIS DOCUMENT CONTAINS HIGHLY CONFIDENTIAL INFORMATION
`
`Page 29
`
`number?
` A. Yes, it does. Yes.
` Q. And I see that there's a document number up
`in the left-hand corner of this document as well. I
`think that says, if I can read it here, 01433003?
` A. Yes.
` Q. And the document number is different than the
`protocol number.
` What's the difference between the document
`and the protocol number?
` A. The one is the document number for the
`protocol, and the other number is a number for the
`report.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Novo Nordisk Ex. 2100, P. 29
`Mylan Institutional v. Novo Nordisk
` IPR2020-00324
`
`
`
`November 20, 2020
`Mylan Institutional LLC v. Novo Nordisk A/S
`Dorthe Kot Engelund
`THIS DOCUMENT CONTAINS HIGHLY CONFIDENTIAL INFORMATION
`
`1
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Page 30
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Novo Nordisk Ex. 2100, P. 30
`Mylan Institutional v. Novo Nordisk
` IPR2020-00324
`
`
`
`November 20, 2020
`Mylan Institutional LLC v. Novo Nordisk A/S
`Dorthe Kot Engelund
`THIS DOCUMENT CONTAINS HIGH
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
