`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
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`- - - - - - - - - - - - - - - - - - - - - - - - - -X
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`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
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`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.
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`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
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`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
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` 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)
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`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
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`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
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`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)
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` E X H I B I T S
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`202-347-3700
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`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
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`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
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`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:
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`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.
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`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,
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`
`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
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`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
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`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.
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`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
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` 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
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`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
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`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?
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`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
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` 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
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`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
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`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.
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`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
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` 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
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`
`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
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`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.
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` Q. Okay. In paragraph 8, you also state that
`you're making this declaration to show that
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`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
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`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.
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`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
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`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
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`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
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`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
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`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.
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`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.)
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`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.
`
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`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
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`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.
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`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
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`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