UNITED STATES PATENT AND TRADEMARK OFFICE
` __________________________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` __________________________
` MYLAN PHARMACEUTICALS, INC.,
` Petitioners,
` v.
` NOVO NORDISK A/S,
` Patent Owner.
` __________________________
` Case IPR2023-00724
` U.S. Patent No. 10,335,462
` __________________________
` Deposition of STEVEN COCA, D.O., M.D.
` Conducted Virtually
` Tuesday, July,16, 2024
` 10:03 a.m. EDT
`Job No.: 543599
`Pages: 1 - 159
`Stenographically reported by: Judith E. Bellinger,
`RPR, CRR, CSR-TX CCR-WA, CCR-NM
`Reported by: Judith E. Bellinger, RPR, CRR
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`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
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` __________________________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` __________________________
` MYLAN PHARMACEUTICALS, INC.,
` Petitioners,
` v.
` NOVO NORDISK A/S,
` Patent Owner.
` __________________________
` Case IPR2023-00724
` U.S. Patent No. 10,335,462
` __________________________
` Deposition of STEVEN COCA, D.O., M.D.
` Conducted Virtually
` Tuesday, July,16, 2024
` 10:03 a.m. EDT
`Job No.: 543599
`Pages: 1 - 159
`Stenographically reported by: Judith E. Bellinger,
`RPR, CRR, CSR-TX CCR-WA, CCR-NM
`Reported by: Judith E. Bellinger, RPR, CRR
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`Transcript of Steven Coca, D.O., M.D.
`Conducted on July 16, 2024
`
`2
`
` Deposition of STEVEN COCA, D.O., M.D.,
`conducted virtually.
`
` Pursuant to notice, before Judith E.
`Bellinger, Registered Professional Reporter,
`Certified Realtime Reporter, and Notary Public in
`and for the State of Maryland.
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`Novo Nordisk Exhibit 2554
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
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`Transcript of Steven Coca, D.O., M.D.
`Conducted on July 16, 2024
`
`3
`
` A P P E A R A N C E S
`ON BEHALF OF THE PETITIONERS:
` DAVID ANSTAETT, ESQUIRE
` CHRISTOPHER JONES, ESQUIRE
` PERKINS COI LLP
` 33 East Main Street
` Suite 201
` Madison, WI 53703
` 608.663.7460
`
`ON BEHALF OF THE PATENT OWNER:
` JOSHUA D. REICH, ESQUIRE
` GROOMBRIDGE, WU, BAUGHMAN & STONE LLP
` 565 Fifth Avenue
` New York, NY 10017
` 332.269.0030
`
` J. STEVEN BAUGHMAN, ESQUIRE
` GROOMBRIDGE, WU, BAUGHMAN & STONE LLP
` 801 17th
` Washington, DC 20006
` 202.505.5830
`
`PLANET DEPOS
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`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
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`Transcript of Steven Coca, D.O., M.D.
`Conducted on July 16, 2024
`
`4
`
` A P P E A R A N C E S C O N T I N U E D
`
`ALSO PRESENT:
` Sean, Planet Depos Technician
` Preston Imperatore - In-house counsel, Mylan
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`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
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`Transcript of Steven Coca, D.O., M.D.
`Conducted on July 16, 2024
`
`5
`
` C O N T E N T S
`EXAMINATION OF STEVEN COCA, PH.D. PAGE
` By Mr. Reich 7
` By Mr. Anstaett 148
` E X H I B I T S
` (Attached to the transcript)
`Coca Exhibits: PAGE
`Exhibit 1 United States Patent Number 21
` 10,335,462 B2
`Exhibit 2 Declaration of Steven G. Coca, D.O., 27
` M.D.
`Exhibit 3 Antihypertensive effect of 44
` glucagon-like peptide 1 in Dahl
` salt-sensitive rats
`Exhibit 4 Anti-hypertensive and natriuretic 50
` effect of a glucagon-like peptide 1
` in Dahl S rats: a novel function for
` a pleotrophic hormone?
`Exhibit 5 Glucagon-Like Peptide 1 Induces 57
` Natriuresis in Healthy Subjects and
` in Insulin-Resistant Obese Men
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`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
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`
`Transcript of Steven Coca, D.O., M.D.
`Conducted on July 16, 2024
`
`6
`
` E X H I B I T S C O N T I N U E D
`Exhibit 6 Glucagon-Like Peptide-1 Is Involved 77
` in Sodium and Water Homeostasis in
` Humans
`Exhibit 7 Effect of renal impairment on the 85
` pharmacokinetics of the GLP-1
` analogue liraglutide
`Exhibit 8 Mild Renal Impairment and the 90
` Efficacy and Safety of Liraglutide
`Exhibit 9 Role of Intensive Glucose Control in 109
` Development of Renal End Points in
` Type 2 Diabetes Mellitus
`Exhibit 10 Highlights of Prescribing 115
` Information
`Exhibit 11 Effects of Semaglutide on Chronic 128
` Kidney Disease in Patients with Type
` 2 Diabetes
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`Novo Nordisk Exhibit 2554
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00006
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`
`Transcript of Steven Coca, D.O., M.D.
`Conducted on July 16, 2024
`
`7
`
` P R O C E E D I N G S
` STEVEN COCA, D.O., M.D.,
` Being first duly sworn, was examined
`and testified as follows:
` EXAMINATION BY COUNSEL FOR THE PATENT OWNER
`BY MR. REICH:
` Q Good morning, Dr. Coca.
` A Good morning, Josh.
` Q How are you today?
` A Doing well. How are you?
` Q Not bad.
` Have you ever been deposed before?
` A Yes, I have.
` Q And when was that deposition?
` A Late 2023.
` Q And what was the subject matter of that
`deposition?
` A Subject matter was related to proton
`pump inhibitors and their association with chronic
`kidney disease.
` Q And was it a patent case or was it a
`different proceeding?
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`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00007
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`Transcript of Steven Coca, D.O., M.D.
`Conducted on July 16, 2024
`
`8
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` A It was not a patent case.
` Q And do you remember who the parties
`were?
` A I was testifying on behalf of Takeda
`Pharmaceuticals.
` Q And the subject matter of your
`testimony, what did it relate to, specifically?
` A It was related to the question of
`whether proton pump inhibitors were causative for
`the development of chronic kidney disease, and
`there was a generic report that I did, and there
`were case-specific reports in related depositions.
` Q Have you been deposed in any other
`matters?
` A No.
` Q So I'm sure you're aware of some of the
`basics from your prior deposition, but just want
`to cover a few items.
` First, it's important that we don't
`talk over each other, we have a court reporter
`and, for a clear record, it's important that I ask
`a question, I pause, I give you a chance to
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`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00008
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`Transcript of Steven Coca, D.O., M.D.
`Conducted on July 16, 2024
`
`9
`
`answer, and then rinse and repeat.
` Do you understand that?
` A I understand.
` Q Second, please provide verbal answers,
`you know, nods and shakes won't be picked up.
`It's very natural to do. So to the best of your
`ability, please, try and remember to say yes or
`no, and if not, I'll try and remind you.
` Fair?
` A Will do.
` Q And I'll try my best to ask clear
`questions. If at any point you don't understand a
`question I've asked, please, ask me to rephrase
`it. But if you don't, I'm going to assume you
`understood the question that I've asked.
` Is that fair?
` A That is fair.
` Q And what did you do to prepare for
`today's deposition?
` MR. ANSTAETT: Dr. Coca, I'll just
`caution you that in answering this question, you
`shouldn't reveal the content of any communications
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`Mylan Pharms. Inc. v. Novo Nordisk A/S
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`Transcript of Steven Coca, D.O., M.D.
`Conducted on July 16, 2024
`
`10
`
`you've had with lawyers.
` But, otherwise, you can answer.
` A Josh, in preparation in regards to this
`deposition today, throughout the whole history of
`my work on this or just immediately recent
`activities?
` Q Let's just be clear. What you did to
`prepare for today's deposition.
` A Early on, of course, there was review
`of the patent, the relevant literature, the
`drafting and editing of the declaration. And most
`recently, I met with counsel to discuss -- and
`reviewed my declaration again since it was a
`little bit of time since it was first drafted and
`we reviewed some of the pertinent literature and
`exhibits associated with my declaration.
` Q Is everything you reviewed cited in
`your declaration or did you review anything
`outside, that was not identified as considered in
`your declaration?
` A I would -- I guess one additional
`review I did was of the recently published FLOW
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`Transcript of Steven Coca, D.O., M.D.
`Conducted on July 16, 2024
`
`11
`
`trial in the New England Journal that was
`potentially pertinent to this case, also, just
`pertinent to my clinical practice and clinical
`research that I do, since it was a groundbreaking
`clinical trial published in the New England
`Journal, presented at the European conference a
`few months ago. And also, I reviewed some of the
`references that were embedded in that FLOW trial
`publication.
` So that all came out after the
`declaration.
` Q Is the New England Journal a
`prestigious medical journal?
` A Yes, it is.
` Q Fair to say one of the most prestigious
`medical journal in the world?
` MR. ANSTAETT: Objection. Form.
` A It was one of the -- it has one of the
`highest impact factors.
` Q And I heard you say it was a
`groundbreaking clinical trial; is that right?
` MR. ANSTAETT: Objection. Form.
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`Transcript of Steven Coca, D.O., M.D.
`Conducted on July 16, 2024
`
`12
`
` A Yeah. Some qualify it that way.
` Q Could you, please, explain why some
`qualify the FLOW trial as a groundbreaking
`clinical trial?
` A It was an anticipated trial because it
`was one of the first GLP trials to study a
`diabetic kidney disease cohort at the outset, with
`a primary endpoint that was related to all kidney
`events, hard kidney clinical end points.
` Q When you say hard clinical kidney end
`points, could you, please, explain what you mean
`by that?
` A Yeah, generally, and this has been
`somewhat of a moving target in nephrology and
`communities, but, generally, the endpoint consist
`of a need for dialysis or end-stage -- or a
`termination -- or a classification of end-stage
`kidney disease with a significant -- and/or a
`significant reduction in eGFR from baseline.
`Typically, these trials use a predefined threshold
`of 40 percent, 50 percent, or 57 percent decrease
`in eGFR as part of the composite kidney endpoint.
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`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
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`Transcript of Steven Coca, D.O., M.D.
`Conducted on July 16, 2024
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`13
`
` Q What would not be a hard clinical
`kidney endpoint? What are some examples?
` A Generally, the more intermediate-type
`end points are continuous changes in serum
`creatinine or eGFR, or eGFR slope, changes in
`urine albumin or urine protein, typically
`classified as a urine-albumin-to-creatinine ratio,
`or urine-protein-to-creatinine ratio.
` So those are more intermediate and not
`considered some of the hard, definitive clinical
`end points that we use in nephrology trials.
` Q Would change in blood pressure be
`considered a soft endpoint?
` A Change in blood pressure is not a hard
`clinical endpoint, correct.
` Q Would change in blood glucose also not
`be a hard clinical endpoint?
` A Correct.
` Q And so, I think you had testified that
`this was one of the first trials to look at a --
`strike that.
` So you said it was one of the first GLP
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`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
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`Transcript of Steven Coca, D.O., M.D.
`Conducted on July 16, 2024
`
`14
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`trials to study a diabetes disease cohort at the
`outset, with the primary endpoint that was related
`to all kidney end points.
` Do you remember that?
` A Yes.
` Q What were the previous ones? Did you
`discuss those in your declaration?
` MR. ANSTAETT: Objection. Form.
` A Yes, there have been -- yes, I
`discussed many of the previous studies in my
`declaration.
` Q And those studies relate to hard
`clinical -- hard kidney clinical end points?
` A Some do, some don't. Some of the end
`points, the kidney end points were secondary
`outcomes and were -- and some were softer clinical
`end points, and some were hard clinical outcomes
`assessed, but not of the primary endpoint.
` Q I think we'll circle back.
` But just to cover some other basic
`points.
` Who else is in the room with you right
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`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00014
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`Transcript of Steven Coca, D.O., M.D.
`Conducted on July 16, 2024
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`15
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`now?
` A David and Chris.
` Q And do you have any materials in the
`room with you right now?
` A Yes. I have a copy -- a paper copy of
`my declaration and a paper copy of my CV.
` Q Do you have any other paper copies with
`you?
` A No, I don't.
` Q And are those clean copies, no notes,
`no anything else?
` A Correct. Clean copies.
` Q Okay. And on the screen right now, do
`you have anything up besides this Zoom meeting?
` A No. Nothing besides the Zoom meeting.
` Q Okay. Will you let me know if that
`changes?
` A Yes, I will.
` Q So, you understand that you are here
`today because you provided a declaration in IPR
`2023-00724?
` A Yes.
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`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
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`Transcript of Steven Coca, D.O., M.D.
`Conducted on July 16, 2024
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`16
`
` Q And your declaration is Exhibit 1306?
` A Correct.
` Q And your declaration is Exhibit 1306?
` A Correct.
` Q And if today I refer to that
`Exhibit 1306 as your declaration, or your report,
`do you understand that they're all the same thing,
`right?
` Exhibit 1306 is your declaration and
`your report?
` A Yes, I understand.
` Q Okay. And you understand that you
`provided opinions on behalf of Petitioner Mylan in
`this proceeding?
` A Yes, I do.
` Q Okay. Did you write your declaration?
` MR. ANSTAETT: Objection.
` I'm going to instruct the witness not
`the answer. That calls for privileged
`information.
` MR. REICH: I think I'm entitled to
`know if he wrote any part of his declaration,
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`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
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`Transcript of Steven Coca, D.O., M.D.
`Conducted on July 16, 2024
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`17
`
`Dave.
` MR. ANSTAETT: I think that gets into
`the work product protection, Josh.
` Q Does your declaration reflect your
`opinions?
` A Yes, it does.
` Q When you were reviewing your
`declaration, was there anything inaccurate that
`you wanted to call to my attention today?
` A No.
` Q In your declaration, you describe a
`fair amount of references, correct?
` A Correct.
` Q Do you think your description of those
`references are fair?
` A Yes.
` Q And you have no changes that you want
`to make today to your declaration; is that right?
` A Correct.
` Q You're a treating physician; is that
`correct?
` A Yes.
`
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`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00017
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`Transcript of Steven Coca, D.O., M.D.
`Conducted on July 16, 2024
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`18
`
` Q In your opinion, what does it mean to
`treat type 2 diabetes?
` A It's a broad question.
` Anything specific about treatment of
`type 2 diabetes? There's a lot of aspects to
`that.
` Q Is treating type 2 diabetes limited to,
`for example, reducing HbA1c in a patient?
` MR. ANSTAETT: Objection. Form.
` A No. It's complicated.
` Q In what way is it complicated?
` A First, glycemic control is one of the
`primary objectives in treating someone with
`diabetes, but, first of all, there is a -- it's
`not a complete continuum. You can't control
`glucose excessively or you can induce the risk of
`hypoglycemia. So it's finding the right range of
`glucose for a given patient that's well-tolerated.
` Generally, patients with diabetes can
`also have hypertension and we use agents to treat
`hypertension. There's also, obviously, dietary
`considerations. An assessment of organs, the
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`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
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`Transcript of Steven Coca, D.O., M.D.
`Conducted on July 16, 2024
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`19
`
`eyes, the heart, the kidneys, the nervous system.
`The list goes on and on.
` So, I mean, it's a complex
`multifactorial assessment and intervention.
` Q So in your opinion, would treating type
`2 diabetes encompass treating the symptoms and
`complications that come from type 2 diabetes?
` MR. ANSTAETT: Objection. Form.
` A Well, it depends where the patient is
`on their continuum of disease and whether it's
`new-onset or long-standing diabetes, and whether
`they have manifested any complications heretofore
`from their diabetes. So, there's a lot to
`consider there, on an individual basis.
` Q So if I say "chronic kidney disease" or
`"CKD," do you understand those to be the same
`thing?
` A Yes.
` Q Would you agree that chronic kidney
`disease can be caused by type 2 diabetes?
` MR. ANSTAETT: Objection to form.
` A Yes.
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`888.433.3767 | WWW.PLANETDEPOS.COM
`
`Novo Nordisk Exhibit 2554
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00019
`
`
`
`Transcript of Steven Coca, D.O., M.D.
`Conducted on July 16, 2024
`
`20
`
` Q Would you consider chronic kidney
`disease to be a symptom of type 2 diabetes?
` A I would not classify it as a symptom.
` Q What would you classify chronic kidney
`disease as?
` A I would classify it as a potential
`complication of diabetes, and I'd classify it as a
`syndrome.
` Q So you agree that chronic kidney
`disease is a complication of type 2 diabetes?
` A It can be.
` Q In your opinion, if you treat a
`patient's -- strike that.
` In your opinion, if a patient with type
`2 diabetes also has chronic kidney disease, would
`you consider treating that patient's chronic
`kidney disease to be treating their type 2
`diabetes?
` MR. ANSTAETT: Objection to form.
` A No.
` Q You said you reviewed the patent in
`this case, correct?
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`Novo Nordisk Exhibit 2554
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00020
`
`
`
`Transcript of Steven Coca, D.O., M.D.
`Conducted on July 16, 2024
`
`21
`
` A Correct.
` MR. REICH: So, Sean, if you could,
`please, pull up Exhibit 1001.
` (Coca Exhibit 1 marked for
`identification and attached to the transcript.)
` MR. ANSTAETT: Stand by, Counsel.
` Q And, Dr. Coca, if you have a paper copy
`of Exhibit 1001 in front of you. I understand you
`said you didn't, but if you do and you want to
`look at it, just let me know, that's fine with me.
`Otherwise, I'll direct you.
` PLANET DEPOS TECHNICIAN: Exhibit 1001
`is up.
` Q Can you, please, turn to column 5,
`line 16?
` MR. ANSTAETT: When we, or when Josh
`brings up exhibits, can we throw those in the
`chat, please?
` PLANET DEPOS TECHNICIAN: Sure,
`Counsel.
` MR. REICH: Do you have it, Dave?
` MR. ANSTAETT: I do not. I just happen
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`
`Novo Nordisk Exhibit 2554
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00021
`
`
`
`Transcript of Steven Coca, D.O., M.D.
`Conducted on July 16, 2024
`
`22
`
`to have a paper copy of the patent, you know, with
`me. So, you can go ahead and ask questions about
`this, but, you know, for future exhibits, I am
`going to want to get them in the chat. And this
`one hasn't shown up yet.
` PLANET DEPOS TECHNICIAN: Stand by,
`Counsel. I'm uploading it to the chat.
` MR. ANSTAETT: I didn't know if I had
`to refresh the chat.
` PLANET DEPOS TECHNICIAN: I'm just
`going to create a OneDrive link and I'll put all
`the exhibits in there.
` MR. ANSTAETT: Okay.
` PLANET DEPOS TECHNICIAN: The link is
`up.
` MR. ANSTAETT: I see it. I'm just
`opening it up and, yeah, I got it. Thank you.
` Steve, are you able to see on your
`screen?
` THE WITNESS: Yeah. I see the current
`page, yeah.
` MR. REICH: So, Sean, if we could turn
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`
`Novo Nordisk Exhibit 2554
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00022
`
`
`
`Transcript of Steven Coca, D.O., M.D.
`Conducted on July 16, 2024
`
`23
`
`to column 5, I believe it's around page 9 or 10,
`but it'll be in the top left.
` Q Dr. Coca, do you see, starting on
`line 16, the definition of treatment or treating
`in the spec?
` A Line 16? Is that with the prevention
`and/or treatment of eating disorders?
` Q Sorry, on the left-hand side is column
`5. "In one embodiment the term 'treatment' or
`'treating' as used herein means the management and
`care of a patient for the purpose of combating a
`condition such as disease or disorder." And then
`it continues and it says -- sorry. "The term
`'treatment' or 'treating' is intended to include
`the full treatment or treatments for a given
`condition from which the patient is suffering,
`such as administration of the active compound to
`alleviate the symptoms or complications."
` Do you see that?
` A I see that.
` Q So with that definition in mind, would
`you agree that treating a patient that has chronic
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`Novo Nordisk Exhibit 2554
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00023
`
`
`
`Transcript of Steven Coca, D.O., M.D.
`Conducted on July 16, 2024
`
`24
`
`kidney disease and type 2 diabetes, that treating
`the patient's chronic kidney disease is part of
`treating the patent's type 2 diabetes?
` MR. ANSTAETT: Objection to form.
`Calls for a legal conclusion.
` A Treating the kidney disease is not
`considered treating the diabetes.
` Q So you had previously agreed that
`chronic kidney disease is a complication of type 2
`diabetes.
` Do you recall that?
` A Yes. It can be.
` Q And you agree that treating chronic
`kidney disease is at least treating a complication
`of the patent's type 2 diabetes?
` MR. ANSTAETT: Objection to form.
` A It depends on the individual patient.
`There are patients that have chronic kidney
`disease, in the setting of type 2 diabetes, that
`is not necessarily due to diabetic kidney disease.
`We've learned this from biopsy studies in patients
`with type 2 diabetes and CKD. And depending on
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`Novo Nordisk Exhibit 2554
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00024
`
`
`
`Transcript of Steven Coca, D.O., M.D.
`Conducted on July 16, 2024
`
`25
`
`the study, up to a quarter of patients with type 2
`diabetes and chronic kidney disease may have a
`different etiology of their chronic kidney
`disease, so, it depends.
` Q But when it's a complication of type 2
`diabetes, you would agree treating CKD is treating
`that complication?
` MR. ANSTAETT: Objection to form.
` A Well, when we say "treating CKD,"
`heretofore, we don't have agents that necessarily
`directly treat the kidney disease. We have agents
`that slow -- potentially slow the progression of
`that kidney disease. There is no -- there's not
`necessarily a cure for this chronic kidney
`disease.
` Q What do you mean by "heretofore"?
` A All treatments, so-called treatments
`for -- well, for certain types of chronic kidney
`disease, do not completely stop the progression,
`as opposed to there are certain classes of
`immune-mediated kidney disease, some of the
`glomerulonephritis, where there are treatment
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`
`Novo Nordisk Exhibit 2554
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00025
`
`
`
`Transcript of Steven Coca, D.O., M.D.
`Conducted on July 16, 2024
`
`26
`
`protocols that are instituted specifically to
`target the kidneys and resolve the underlying
`issue in the kidneys and return kidney function to
`normal and alleviate that kidney damage so that
`the patient doesn't regress.
` So that's where I'm drawing the
`distinction.
` Q In 2010, was it known why chronic
`kidney disease was caused by type 2 diabetes?
` A Well, there were -- by 2010, there
`were -- there were complex paradigms that were
`known and published. Of course, science keeps
`advancing through the years and, as a scientific
`field, some of that has advanced. But we did know
`that type 2 -- chronic kidney disease, in the
`setting of diabetes, is a complex syndrome that
`involves multiple pathways of injury to the -- to
`various compartments in the kidney, including the
`glomerular structures, the vasculature, the
`tubular interstitium, and part of it involved
`inflammation, part of it involved activation of
`pro-fibrotic pathways, et cetera.
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`Novo Nordisk Exhibit 2554
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00026
`
`
`
`Transcript of Steven Coca, D.O., M.D.
`Conducted on July 16, 2024
`
`27
`
` So, it has been known, for some time,
`that it is a complex syndromic condition.
` MR. REICH: So if we could pull up your
`declaration, Exhibit 1306, and go to page 32,
`paragraph 66.
` (Coca Exhibit 2 marked for
`identification and attached to the transcript.)
` PLANET DEPOS TECHNICIAN: Stand by.
` A I have that.
` Q And in the bottom half you wrote, "The
`exact mechanism by which hyperglycemia causes
`chronic kidney disease is remarkably complex and
`still poorly understood today."
` Do you see that?
` A I see that.
` MR. ANSTAETT: Objection. Form.
` Q I should have read the whole part of
`the sentence, but in the first it says "while the
`empirical connection between diabetes (i.e.,
`hyperglycemia) and CKD have long been known and
`accepted, the exact mechanism by which
`hyperglycemia causes CKD is remarkably complex and
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`Novo Nordisk Exhibit 2554
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00027
`
`
`
`Transcript of Steven Coca, D.O., M.D.
`Conducted on July 16, 2024
`
`28
`
`still poorly understood today."
` Do you see that?
` A I see that.
` Q Do you agree with that?
` A Yes. Because it is -- I mean, there
`are various paradigms, as shown in this schematic
`by Pyram, that is in the exhibit on page 33. But,
`again, paradigms like this continue to expand,
`continue to be modified, and the -- you know, the
`whole answer is not completely known, again,
`because it's complex and it also varies by
`individual. But the point here was that it is
`multifactorial and complex, involving multiple
`molecular and cellular pathways that result in
`injury to various kidney compartments and kidney
`tissue.
` Q Okay. But to be clear, do you agree
`that the exact mechanism by which type 2 diabetes
`causes chronic kidney disease is remarkably
`complex and still poorly understood today?
` A I agree that it's remarkably complex
`and I agree it's not completely understood today.
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`Novo Nordisk Exhibit 2554
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00028
`
`
`
`Transcript of Steven Coca, D.O., M.D.
`Conducted on July 16, 2024
`
`29
`
` Q Have you ever prescribed Ozempic?
` A I, myself, have not triggered a
`prescription for it in my practice.
` Q What do you mean you "have not
`triggered a prescription for it" in your practice?
` A First of all, I'm at an academic
`medical center where I -- we have trainees always
`with us, both in the inpatient/outpatient
`settings. Most of my clinical time is actually on
`the inpatient nephrology consultative services,
`both on the general wards and in the intensive
`care units at the Mount Sinai Hospital.
` My outpatient responsibilities include
`precepting of the nephrology fellows in the CKD
`clinic. And thus, in that supervisory role, the
`attending, such as myself, do not -- we do not
`enter the prescriptions, the fellows are the ones
`entering the orders for various prescriptions of
`any type. And those are the patients we have
`primary or more management of. There's some
`patients, depending on who they were referred
`from, where we give suggestions back to the
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`Novo Nordisk Exhibit 2554
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00029
`
`
`
`Transcript of Steven Coca, D.O., M.D.
`Conducted on July 16, 2024
`
`30
`
`primary care provider or the endocrinologist that
`refer the patient to our clinic.
` So that's why it was a complex answer.
` Q So as part of this triggering or
`precepting, do you suggest what therapy should be
`prescribed to a particular patient?
` A Yes.
` Q When was the first time you suggested,
`in this role, to prescribe Ozempic to a patient?
` A Two things. One, we -- in general, we
`view the recently -- we call it the
`guideline-directed medical therapies, including
`Ozempic, which fits in the GLP-1 receptor agonist
`class, the SGL-2 [sic] inhibitor class, which is
`for transcription, it's the sodium-glucose
`cotransporter 2 inhibitor class of medications.
`And, also, the nonsteroidal mineralocorticoid
`receptor antagonist, specifically, in that case,
`finerenone.
` But for the latter two, for the GLP-1
`and the SGLT2, we generally do not have a
`preference in the agent when we suggest these
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`Novo Nordisk Exhibit 2554
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00030
`
`
`
`Transcript of Steven Coca, D.O.,
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