`
`PUBLIC VERSION
`Mylan Pharmaceuticals Inc. v. Novo Nordisk A/S Christine Bjørn Jensen
`Confidential - Under the Protective Order
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`Page 1
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________________
`
`)
`MYLAN PHARMACEUTICALS INC., )
`)
`Petitioner, )
`) Case No. IPR2023-00724
`vs. )
`) Patent No. 10,335,462
`NOVO NORDISK A/S, )
`)
`Patent Owner. )
`_______________________________)
`
`***CONFIDENTIAL UNDER THE PROTECTIVE ORDER***
`
`DEPOSITION OF: CHRISTINE BJØRN JENSEN
`London, United Kingdom
`Friday, March 22, 2024
`(cid:28)(cid:29)(cid:20)(cid:24)(cid:3)(cid:68)(cid:17)(cid:80)(cid:17)
`
`Reported by:
`Matthew J. Martinez, Registered Professional Reporter
`Certified Shorthand Reporter No. 13208 (CA)
`______________________________________________________
`DIGITAL EVIDENCE GROUP
`1730 M Street, NW, Suite 812
`Washington, D.C. 20036
`(202) 232-0646
`
`www.DigitalEvidenceGroup,comDigital Evidence Gorup C'rt 2024
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`202-232-0646
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`PROTECTIVE ORDER MATERIAL
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`Mylan Pharmaceuticals Inc. v. Novo Nordisk A/S Christine Bjørn Jensen
`Confidential - Under the Protective Order
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`Page 2
` Deposition of CHRISTINE BJØRN JENSEN, taken on
`behalf of the Petitioner, at 3 New Street Square,
`London, EC4A 3BF, United Kingdom, beginning at 9:15 a.m.
`and ending at 1:19 p.m., on Friday, March 22, 2024,
`before Matthew J. Martinez, Registered Professional
`Reporter, Certified Shorthand Reporter No. 13208.
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`Mylan Pharmaceuticals Inc. v. Novo Nordisk A/S Christine Bjørn Jensen
`Confidential - Under the Protective Order
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`A P P E A R A N C E S:
`For the Petitioner:
` Perkins Coie LLP
` BY: DAVID L. ANSTAETT, ESQ.
` --AND--
` BY: AARON SCHINDLER, ESQ.
` --AND--
` BY: BRANDON M. WHITE
` 33 East Main Street
` Suite 201
` Madison, Wisconsin 53703-3095
` Tel: 608.663.7460
` DAnstaett@perkinscoie.com
` ASchindler@perkinscoie.com
` BMWhite@perkinscoie.com
`
`For the Patent Owner:
` Groombridge Wu Baughman & Stone ALPC
` BY: J. STEVEN BAUGHMAN, ESQ.
` 801 17th Steet Northwest
` Suite 1050
` Washington DC 20006
` Tel: 202.505.5832
` steve.baughman@groombridgewu.com
` -- AND--
` BY: JENNIFER H. WU, ESQ.
` --AND--
` BY: JOSHUA REICH, ESQ.
` 565 Fifth Avenue
` Suite 2900
` New York, NY 10017
` jennifer.wu@groombridgewu.com
` joshua.reich@groombridgewu.com
`
`Also Present:
`Chloe Jiang, Novo Nordisk
`
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`Mylan Pharmaceuticals Inc. v. Novo Nordisk A/S Christine Bjørn Jensen
`Confidential - Under the Protective Order
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` WITNESS INDEX
`
`Page 4
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`Witness Page
`CHRISTINE BJØRN JENSEN
`Examination By Mr. Anstaett .....................8
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`Mylan Pharmaceuticals Inc. v. Novo Nordisk A/S Christine Bjørn Jensen
`Confidential - Under the Protective Order
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`Page 5
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` EXHIBIT INDEX
`Exhibit Description Page
`1 Petitioner's Notice of Deposition 9
` of Christine Jensen
`2 Deposition Transcript of Christine 10
` Jensen - November 8, 2023
`3 Declaration of Christine B. Jensen, 14
` M.D., Ph.d
`4 U.S. Patent Number 10,355,462 19
`5 Novo Nordisk
`
`6 Bates No. NN-OZEM-004346366 and 29
` Bates No. NNI-WGVY0023242, E-mail
` from Milan Zdravkovic to various
` individuals; Subject: Project
` Review Presentation - semaglutide
`7 Bates No. NN-OZEM-004346367 and 29
` Bates No. NNI-WGVY0023243,
` semaglutide Project Review -
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`Mylan Pharmaceuticals Inc. v. Novo Nordisk A/S Christine Bjørn Jensen
`Confidential - Under the Protective Order
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` EXHIBIT INDEX, CON'T
`Exhibit Description Page
`8 Novo Nordisk
`
`Page 6
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`9 Bates No. NN-OZEM-004442611 to 41
` NN-OZEM-004442613,
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`10 Novo Nordisk
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`11 Novo Nordisk
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`12 Novo Nordisk
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`Mylan Pharmaceuticals Inc. v. Novo Nordisk A/S Christine Bjørn Jensen
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` EXHIBIT INDEX, CON'T
`Exhibit Description Page
`14 Novo Nordisk
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`Page 7
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`Mylan Pharmaceuticals Inc. v. Novo Nordisk A/S Christine Bjørn Jensen
`Confidential - Under the Protective Order
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`Page 8
` London, United Kingdom; Friday, March 22, 2024
` 9:15 a.m.
` ---0---
`
` THE COURT REPORTER: Raise your right hand,
`please.
` You do solemnly swear or affirm that the evidence
`you shall give in this matter shall be the truth, the
`whole truth, and nothing but the truth?
` THE WITNESS: I do.
`
` CHRISTINE BJØRN JENSEN,
` herein produced as a witness, having been first duly
` sworn, testified as follows:
`
` EXAMINATION
`BY MR. ANSTAETT:
` Q Good Morning, Dr. Jensen. It's nice to you
`see you again.
` Can you state your name for the record?
` A Christine Bjørn Jensen.
` Q And I know we've been over these rules many
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`Mylan Pharmaceuticals Inc. v. Novo Nordisk A/S Christine Bjørn Jensen
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`Page 9
`
`times, but I'll do it again just briefly.
` I'm going to do my best to ask clear questions
`today, but if at some point I ask a question that you
`don't understand, please let me know and I'll try to
`rephrase it.
` Okay?
` A Okay.
` Q And we have to give -- you have to give verbal
`answers. We'll try not to talk over each other.
` Your counsel may object from time to time, but
`unless he instructs you not to answer a question, you
`should go ahead and answer the question notwithstanding
`the objection.
` And if at any point today you want to take a break,
`just let me know and we can do that.
` Okay?
` A Okay.
` Q All right. Terrific.
` MR. ANSTAETT: Can I get the video deposition
`notice. That's Exhibit 1.
` (Deposition Exhibit 1 was marked
` for identification.)
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`Mylan Pharmaceuticals Inc. v. Novo Nordisk A/S Christine Bjørn Jensen
`Confidential - Under the Protective Order
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`Page 10
`
`BY MR. ANSTAETT:
` Q So the court reporter has handed you what
`we've marked as Exhibit 1, which is a deposition notice.
` Do you understand that you're here today to provide
`sworn testimony in a proceeding taking place before the
`United States Patent Trial and Appeal Board?
` A Yes.
` Q All right. And you submitted a declaration in
`these proceedings concerning certain of your activities
`related to the development of semaglutide; is that
`right?
` A Correct.
` MR. ANSTAETT: Okay. And then we'll mark this
`as Exhibit 2.
` (Deposition Exhibit 2 was marked
` for identification.)
`BY MR. ANSTAETT:
` Q Do you recall I took your deposition in
`November 2023 in related district court litigation?
` A Yes.
` Q Okay. We've marked as Exhibit 2 the
`transcript of that deposition, and I'm just giving it to
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`Mylan Pharmaceuticals Inc. v. Novo Nordisk A/S Christine Bjørn Jensen
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`Page 11
`you now just in case we need to look at it at some point
`today, but you don't need to look at it now.
` Okay?
` A Yes.
` Q All right. Now, do you recall at the
`beginning of that deposition in November 2023 you swore
`an oath to provide truthful testimony?
` A I do.
` Q Okay. And did you review that deposition
`transcript in preparing for today's deposition?
` A Yes.
` Q Okay. Who's your current employer?
` A Novo Nordisk.
` Q And your current position?
` A I'm a senior alliance director.
` Q All right. And I understand you joined
`Novo Nordisk in September 2007?
` A That's correct.
` Q Okay. And when you joined Novo Nordisk, you
`were not very familiar with GLP-1 receptor agonists.
` Is that fair to say?
` MR. BAUGHMAN: Object to the form.
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` THE WITNESS: That's correct.
`BY MR. ANSTAETT:
` Q Okay. And you had not heard of semaglutide
`before you joined Novo Nordisk in September 2007; is
`that correct?
` A That's correct.
` Q And by the time you joined Novo Nordisk, a
`Phase 1 study of semaglutide was already underway and
`nearing completion; is that right?
` A That's correct.
` Q And you were not -- you were not involved in
`the invention of the semaglutide compound itself; is
`that right?
` A That's correct.
` Q And you can't identify semaglutide by looking
`at its chemical structure, correct?
` A That's correct.
` Q Okay. And before you joined Novo Nordisk in
`September 2007, you had never designed a clinical trial
`for a pharmaceutical product; is that right?
` A That's correct.
` Q Okay. Do you know Anne Flint?
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` A I do.
` Q How do you know Anne Flint?
` A She used to be my colleague.
` Q At Novo Nordisk?
` A At Novo Nordisk.
` Q Okay. Are you aware that Dr. Flint submitted
`a declaration in these proceedings?
` A Yes.
` Q Okay. Have you seen Dr. Flint's declaration?
` A No.
` Q Okay. Have you spoken with Dr. Flint about
`her declaration?
` A No.
` Q Did you review Dr. Flint's deposition
`transcript in these proceedings?
` A No.
` Q Okay. And aside from your lawyers -- and I
`don't want to hear about any conversations you had with
`your lawyers -- did you speak with anyone else about
`your declaration?
` A No.
` Q All right. So what we've marked as Exhibit 3
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`Page 14
`is -- excuse me -- the declaration that you submitted in
`these proceedings. And I'll just give you a moment to
`look it over, if you'd like, but I'll just ask you to
`confirm that.
` Can you confirm that Exhibit 3, which was marked as
`Exhibit 2050 in the IPR, is your declaration?
` A Yes.
` (Deposition Exhibit 3 was marked
` for identification.)
`BY MR. ANSTAETT:
` Q All right. And you signed your declaration on
`January 17, 2024; is that right?
` A Yes, I can see that.
` Q Okay. And when were you first contacted about
`submitting a declaration in this proceeding?
` A I don't remember.
` Q Okay. Do you remember who contacted you?
` A One of the lawyers.
` Q Okay. How did you prepare the declaration?
` A So this was -- I mean, since this is a legal
`document, I would not know the format of it. So I
`essentially provided the story and then I reviewed how
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`it came out and made sure that it was correct to the
`best of my knowledge and...
` Q Okay. The events you described in your
`declaration took place about 12 to 15 years ago; is that
`right?
` A Yes.
` Q Did you have difficulty recalling events that
`took place that long ago?
` A Yes.
` Q Okay. Did you review documents to refresh
`your recollection about the events that took place
`during that time frame?
` A So this declaration came after preparing for
`the first deposition, so during that first deposition we
`reviewed many documents, including those that went --
`naturally went into this.
` Q Okay. Did you review -- did you review
`additional documents in preparing your declaration
`beyond the ones that you had reviewed in preparation for
`your November 2023 deposition?
` A I don't think so.
` Q Okay. And you've attached certain documents
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`to your declaration as exhibits; is that right?
` A Yes.
` Q Okay. And in preparing your declaration, did
`you review any documents that are not cited as exhibits
`in your declaration?
` A Probably.
` Q Okay. Do you recall what documents those
`were?
` A No.
` Q Okay. How did you select the documents that
`you cited as exhibits in your declaration?
` A Those are the ones that are the most essential
`documents pertaining to the invention.
` Q All right. Were the documents provided to you
`by Novo's lawyers?
` A No.
` Q Okay. How did you -- how did you obtain them?
` A They were obtained from -- most of them from
`my own laptop in the course of collecting evidence for
`this trial.
` Q Okay. But -- I guess what I want -- I
`understand that's the original source, but when you were
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`putting together your declaration, how did you go about
`obtaining the documents that are cited as exhibits?
` A I'm not sure I understand the question.
` Q When you were preparing your declaration, did
`you go back through your computer and find these
`documents, or were they given to you by the lawyers when
`you were preparing your declaration?
` A Yeah, by that time, they probably had a better
`overview of what the documents were than I did.
` Q Okay. By "they," you're referring to Novo's
`lawyers?
` A Yes.
` Q Okay. Do you recall if the lawyers provided
`you documents that are not cited in your declaration?
` A I don't remember.
` Q Okay. In preparing for your deposition today,
`did you review any documents that are not cited as
`exhibits in your declaration?
` A Yes.
` Q What did you review that is -- that's not
`cited as an exhibit to your declaration?
` MR. BAUGHMAN: I'm going to object on the
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`Page 18
`basis of privilege. If you want to ask about individual
`documents, I think that's appropriate, but the
`collection of documents, I would assert privilege.
` So I instruct you not to answer that question.
` THE WITNESS: Okay.
`BY MR. ANSTAETT:
` Q Okay. So after arriving at Novo Nordisk in
`September of 2007, you helped design a Phase 2
`dose-finding study of semaglutide in Type 2 diabetes,
`known as Trial NN9535-1821, or the 1821 trial; is that
`right?
` MR. BAUGHMAN: Object to the form.
` THE WITNESS: Correct.
`BY MR. ANSTAETT:
` Q Okay. And that trial tested several
`once-weekly doses of semaglutide, including once-weekly
`doses of 0.4 and 0.8 milligrams; is that right?
` A That's correct.
` Q Okay. And the trial also included
`dose-escalated regimens with titrated treatment doses of
`0.8 and 1.6 milligrams; is that right?
` A That's correct.
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` Q Okay. But the 1821 trial did not include
`0.25, 0.1, and 1.0 milligram doses of semaglutide;
`right?
` A That's correct.
` Q Okay. And you and your colleagues at
`Novo Nordisk received the results of the 1821 trial by
` is that right?
` MR. BAUGHMAN: Object to the form.
` THE WITNESS: I'll have to check the exact
`date, but I'm --
`BY MR. ANSTAETT:
` Q Sure.
` I think it's in Paragraph 12 of your declaration,
`but feel free to look at whatever you need to.
` A Could you say the date again?
` Q Yes.
` A That's correct.
` Q Okay.
` MR. ANSTAETT: This is Exhibit 4.
` (Deposition Exhibit 4 was marked
` for identification.)
`BY MR. ANSTAETT:
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`MPI EXHIBIT 1312 PAGE 19
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`3/22/2024
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`Mylan Pharmaceuticals Inc. v. Novo Nordisk A/S Christine Bjørn Jensen
`Confidential - Under the Protective Order
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`Page 20
` Q So we've marked as Exhibit 4 U.S. Patent
`Number 10,355,462, which I'll refer to today as the '462
`patent.
` Okay?
` A Yes.
` Q And you're the sole-named inventor on the '462
`patent, correct?
` A That's correct.
` Q All right. And if you look the Claim 1, which
`is at the very back of the patent, Claim 1 recites, "A
`method for treating Type 2 diabetes comprising of
`administering semaglutide once weekly in an amount of
`1.0 milligram to a subject in need thereof."
` Do you see that?
` A I do.
` Q All right. Now, Claim 1 does not mention any
`particular balance of tolerability and efficacy in
`treating Type 2 diabetes.
` Do you agree with that?
` A That's correct.
` Q All right. And then if you -- I'm sorry, I'm
`going to have you hop around between documents today,
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`Mylan Pharmaceuticals Inc. v. Novo Nordisk A/S Christine Bjørn Jensen
`Confidential - Under the Protective Order
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`Page 21
`but if you'll look at Paragraph 6 in your declaration.
` In Paragraph 6 of your declaration, Exhibit 3, also
`Exhibit 2050, you say in the last sentence of that
`paragraph that you proposed the
`
` A That's what it says.
` Q All right. And in Paragraph 7 of your
`declaration,
`
` Do you see that?
` A Yes.
` Q All right. In fact, you were not the first
`person at Novo Nordisk
`
` correct?
` MR. BAUGHMAN: Object to the form.
` THE WITNESS: I think
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`MPI EXHIBIT 1312 PAGE 21
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`Mylan Pharmaceuticals Inc. v. Novo Nordisk A/S Christine Bjørn Jensen
`Confidential - Under the Protective Order
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`Page 22
` Q And among those suggestions was a suggestion
`to potentially
` correct?
` A I think it was suggested at
`
`.
`
` Q Okay. And suggested by
` is that right?
` A Yes.
` Q Okay. And after receiving the results of the
`1821 trial in
` it was
`
` is that right?
` MR. BAUGHMAN: Object to the form.
` THE WITNESS: Can you state that again?
`BY MR. ANSTAETT:
` Q Sure.
` After receiving the results of the 1821 trial in
`, it was one of your
`
`?
` MR. BAUGHMAN: Object to the form.
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`Mylan Pharmaceuticals Inc. v. Novo Nordisk A/S Christine Bjørn Jensen
`Confidential - Under the Protective Order
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`Page 23
`
` THE WITNESS: I don't remember.
` (Deposition Exhibit 5 was marked
` for identification.)
`BY MR. ANSTAETT:
` Q Okay. So what we've marked as Exhibit 5 is
`.
`
` Do you see that?
` A Yes.
` Q All right. And you -- you describe, and,
`again, I apologize for asking you to hop back and forth.
`I don't know that you actually need to do it, but
`
` Do you see that?
` A Was that a question?
` Q Yes.
` A What was the question?
` Q Oh, I'm sorry.
` In --
`
`; is that right?
` A Correct.
` Q Okay. And
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`Mylan Pharmaceuticals Inc. v. Novo Nordisk A/S Christine Bjørn Jensen
`Confidential - Under the Protective Order
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`Page 24
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` A Yes.
` Q
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` A Yes.
` Q All right.
`
` A Yes.
` Q
` A That's correct.
` Q
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`Mylan Pharmaceuticals Inc. v. Novo Nordisk A/S Christine Bjørn Jensen
`Confidential - Under the Protective Order
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`
`
`
` Q Okay.
`
`me. Let me ask that again.
`
`
`Page 25
`
` -- excuse
`
`, correct?
`
` A I don't think so.
` Q Okay. And you don't know who the members of
`that committee were in
`; is that right?
` A I knew back then, but I don't remember that
`anymore.
` Q Okay.
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`Mylan Pharmaceuticals Inc. v. Novo Nordisk A/S Christine Bjørn Jensen
`Confidential - Under the Protective Order
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`Page 26
`
` Do you see that?
` A Yes.
` Q
`
`
`
`
`
`
`
` Do you see that?
` A Yes.
` Q And you're CBJJ, correct?
` A That's correct.
` Q So in this e-mail Dr.
`
`es, correct?
` MR. BAUGHMAN: Object to the form.
` THE WITNESS: Yes, he's -- well, I don't know
`if he's doing that, but he's asking me to look into the
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`Mylan Pharmaceuticals Inc. v. Novo Nordisk A/S Christine Bjørn Jensen
`Confidential - Under the Protective Order
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`Page 27
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`BY MR. ANSTAETT:
` Q
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` A I didn't have when I saw it the first time.
` Q Okay.
` A Back in November.
` Q Okay. And you don't remember whether or not
`you looked into the
`
` correct?
` MR. BAUGHMAN: Object to the form.
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`MPI EXHIBIT 1312 PAGE 27
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`Mylan Pharmaceuticals Inc. v. Novo Nordisk A/S Christine Bjørn Jensen
`Confidential - Under the Protective Order
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`Page 28
` THE WITNESS: No, but I'm pretty certain that
`I also told you that I -- I mean, I would have looked
`into it because that's -- I mean, there's no reason why
`I should not look into it.
`BY MR. ANSTAETT:
` Q But you don't remember doing that, right?
` A No.
` Q And you haven't attached anything to your
`declaration showing that you did that, correct?
` A No.
` Q Okay. And you don't remember responding to
` correct?
` MR. BAUGHMAN: Object to the form.
` THE WITNESS: I don't remember what I did.
`BY MR. ANSTAETT:
` Q Okay. And you don't remember if you had ever
`considered using
`
` MR. BAUGHMAN: Object to the form.
` THE WITNESS: No, there are many things I
`don't remember, that including.
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`Mylan Pharmaceuticals Inc. v. Novo Nordisk A/S Christine Bjørn Jensen
`Confidential - Under the Protective Order
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`Page 29
`
`BY MR. ANSTAETT:
` Q That including?
` A Yes, I don't remember.
` Q Okay.
` A It could have happened. I don't know.
` Q Okay. Are you aware of any other discussions
`within Novo Nordisk
`
`?
` MR. BAUGHMAN: Object to the form.
` THE WITNESS: I'm not aware.
`BY MR. ANSTAETT:
` Q Okay.
` MR. ANSTAETT: Can we go off the record for a
`second?
` (Discussion off the record.)
` MR. ANSTAETT: We can go back on.
` (Deposition Exhibit 6 was marked
` for identification.)
` (Deposition Exhibit 7 was marked
` for identification.)
`BY MR. ANSTAETT:
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`Mylan Pharmaceuticals Inc. v. Novo Nordisk A/S Christine Bjørn Jensen
`Confidential - Under the Protective Order
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` Q So the court reporter has handed you what
`we've marked as Exhibits 6 and 7, and they've been
`produced in the district court litigations.
` Counsel and I have had a discussion about using
`them in -- in the IPR. They're marked as confidential
`under the protective order, and that should be
`understood to apply to the IPR protective order as well.
` Okay. Exhibit 6 is an e-mail to a number of
`people, including you, from Dr. Zdravkovic dated
`June 17th, 2009.
` Do you see that?
` A Yes.
` Q Okay.
`
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`Mylan Pharmaceuticals Inc. v. Novo Nordisk A/S Christine Bjørn Jensen
`Confidential - Under the Protective Order
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`Mylan Pharmaceuticals Inc. v. Novo Nordisk A/S Christine Bjørn Jensen
`Confidential - Under the Protective Order
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`Page 32
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` A I don't remember it. But I've since reviewed
`the documents, so I can see that that's what we did.
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`Mylan Pharmaceuticals Inc. v. Novo Nordisk A/S Christine Bjørn Jensen
`Confidential - Under the Protective Order
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`Mylan Pharmaceuticals Inc. v. Novo Nordisk A/S Christine Bjørn Jensen
`Confidential - Under the Protective Order
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` MR. BAUGHMAN: Object to the form.
` THE WITNESS: I can see that, yes.
`BY MR. ANSTAETT:
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`Mylan Pharmaceuticals Inc. v. Novo Nordisk A/S Christine Bjørn Jensen
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`Page 35
` Q Okay. And then if you'll turn to Slide 17.
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` MR. BAUGHMAN: Object to the form.
` THE WITNESS: I mean, that would be intuitive.
`BY MR. ANSTAETT:
` Q
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`Mylan Pharmaceuticals Inc. v. Novo Nordisk A/S Christine Bjørn Jensen
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`Mylan Pharmaceuticals Inc. v. Novo Nordisk A/S Christine Bjørn Jensen
`Confidential - Under the Protective Order
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` MR. BAUGHMAN: Object to the form.
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`.
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`BY MR. ANSTAETT:
` Q Okay. And then if I can turn you back to your
`declaration.
` If you'll look at Paragraph 17 of your declaration,
`and
` in that paragraph.
` Do you see that?
` A Yes.
` Q All right. We've marked as Exhibit 8
` And then
`
`22
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`in Paragraph 17,
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`www.DigitalEvidenceGroup,comDigital Evidence Gorup C'rt 2024
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`MPI EXHIBIT 1312 PAGE 37
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`Mylan Pharmaceuticals Inc. v. Novo Nordisk A/S Christine Bjørn Jensen
`Confidential - Under the Protective Order
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`Page 38
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`; is that right?
` A Yes.
` (Deposition Exhibit 8 was marked
` for identification.)
`BY MR. ANSTAETT:
` Q All right. And do you believe that you
`authored this document?
` A Yes, at least -- I mean, most of the slides.
` Q Okay. Did you review it in preparation for
`your deposition today?
` A Yes.
` Q Okay. And then if you look at Page 9 -- and
`here I'm referring to the page numbers that are kind of
`in the bottom kind of the l