UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`- - - - - - - - - - - - - x
`MYLAN PHARMACEUTICALS :
`INC., :
` Petitioner, : Case No. IPR2023-007244
` v. : U.S. Patent No.
`NOVO NORDISK A/S, : 10,335,462
` Patent Owner. :
`- - - - - - - - - - - - - X
`
` Deposition of
` ARTHUR Z. SCHWARTZBARD, M.D., F.A.C.C.
` Conducted Virtually
` Tuesday, July 9, 2024
` 10:01 a.m. EDT
`
`Job No.: 542784
`Pages 1 - 60
`Reported by: Debra A. Whitehead
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` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`- - - - - - - - - - - - - x
`MYLAN PHARMACEUTICALS :
`INC., :
` Petitioner, : Case No. IPR2023-007244
` v. : U.S. Patent No.
`NOVO NORDISK A/S, : 10,335,462
` Patent Owner. :
`- - - - - - - - - - - - - X
`
` Deposition of
` ARTHUR Z. SCHWARTZBARD, M.D., F.A.C.C.
` Conducted Virtually
` Tuesday, July 9, 2024
` 10:01 a.m. EDT
`
`Job No.: 542784
`Pages 1 - 60
`Reported by: Debra A. Whitehead
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`Transcript of Arthur Z. Schwartzbard, M.D., F.A.C.C.
`Conducted on July 9, 2024
`
`2
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` Deposition of ARTHUR Z. SCHWARTZBARD, M.D.,
`F.A.C.C., conducted virtually.
`
` Pursuant to notice, before Debra Ann Whitehead,
`E-Notary Public in and for the State of Maryland.
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`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
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`Transcript of Arthur Z. Schwartzbard, M.D., F.A.C.C.
`Conducted on July 9, 2024
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`3
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` A P P E A R A N C E S
` ON BEHALF OF PETITIONER:
` PHILIP S. MAY, ESQUIRE
` MEGAN F. RAYMOND, ESQUIRE
` GROOMBRIDGE, WU, BAUGHMAN & STONE LLP
` 801 17th Street, NW, Suite 1050
` Washington, DC 20006
` (202) 505-5830
`
`ON BEHALF OF PATENT OWNER:
` BRANDON M. WHITE, ESQUIRE
` PERKINS COIE LLP
` 700 13th Street, NW, Suite 800
` Washington, DC 20005-3960
` (202) 654-6206
` - and -
` RODNEY SWARTZ, ESQUIRE
` PERKINS COIE LLP
` 1120 NW Couch Street, 10th Floor
` Portland, Oregon 97209-4128
` (5030 727-2000
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`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
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`Transcript of Arthur Z. Schwartzbard, M.D., F.A.C.C.
`Conducted on July 9, 2024
`
`4
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` A P P E A R A N C E S C O N T I N U E D
`ALSO PRESENT:
` PRESTON IMPERATORE, ESQ.,
` Mylan Pharmaceuticals
` SEDRICK LAMPKINS, A/V Technician
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`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
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`Transcript of Arthur Z. Schwartzbard, M.D., F.A.C.C.
`Conducted on July 9, 2024
`
`5
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` C O N T E N T S
`EXAMINATION OF ARTHUR Z. SCHWARTZBARD, M.D. PAGE
` By Mr. May 6
`
` EXHIBITS MARKED IN TODAY'S SESSION
` (Attached to the Transcript)
`EXHIBIT PAGE
` Exhibit 2601 Article, "Diabetic Agents, From 38
` Metformin to SGLT2 Inhibitors
` and GLP1 Receptor Agonists,"
` by Wilcox, et al.
` Exhibit 2602 Article, "The Changing Landscape 51
` of Diabetes Therapy for
` Cardiovascular Risk Reduction,"
` by Newman, et al.
`
` EXHIBITS MARKED IN PRIOR SESSIONS
` (Not attached)
`EXHIBIT PAGE
` Exhibit 1304 Declaration of Arthur Z. 17
` Schwartzbard, M.D., F.A.C.C.
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`Transcript of Arthur Z. Schwartzbard, M.D., F.A.C.C.
`Conducted on July 9, 2024
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`6
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` P R O C E E D I N G S
` ARTHUR Z. SCHWARTZBARD, M.D., F.A.C.C.,
` having been duly sworn, testified as follows:
` EXAMINATION BY COUNSEL FOR PETITIONER
`BY MR. MAY:
` Q Good morning, Dr. Schwartzbard.
` Can you please state your name and spell
`it, for the record.
` A Arthur Schwartzbard. A-R-T-H-U-R
`S-C-H-W-A-R-T-Z-B-A-R-D.
` Q Where are you currently employed?
` A I am a cardiologist at NYU Medical Center
`in Manhattan.
` Q And what is your business address?
` A 530 First Avenue, Suite 5, New York, New
`York, 10016.
` Q Dr. Schwartzbard, have you ever sat for a
`deposition like this before?
` A When you say "like this," Philip -- it's
`okay to call you Philip?
` Q That's fine.
` A Not in patent. I don't recall sitting in
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`Mylan Pharms. Inc. v. Novo Nordisk A/S
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`Transcript of Arthur Z. Schwartzbard, M.D., F.A.C.C.
`Conducted on July 9, 2024
`
`7
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`a patent litigation deposition like this before.
` Q Have you had a deposition in another kind
`of case before?
` A Yes.
` Q What kind of case were those depositions
`in before?
` A Pharmaceutical litigation.
` Q When you say "pharmaceutical litigation,"
`what do you mean?
` A Litigation between companies about a
`medication.
` Q And what kind of claim was at issue in
`that litigation?
` A Infringements and things like that. But
`it's a little different from this.
` Q So it was a patent case, though.
` Is that right?
` A I would say patent-related maybe, but not
`patent like this. I mean, different. This is
`different.
` Q Do you remember the name -- our when that
`case occurred that you had that deposition in
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`Transcript of Arthur Z. Schwartzbard, M.D., F.A.C.C.
`Conducted on July 9, 2024
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`8
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`previously in the pharmaceutical litigation
`patent-related case?
` A Within the last few years. I don't
`remember exact date.
` Q Was it within the last four years?
` A Yes.
` Q All right.
` MR. MAY: Counsel, I don't think we've
`received notice of that previous deposition
`testimony in Dr. Schwartzbard's declaration or his
`CV.
` A It may be beyond four years, Phil, I'm
`not sure of dates. Forgive me, I'm not exact on
`dates. I don't know exactly when that case was.
` Q Dr. Schwartzbard, do you know what
`medication that was about?
` A It was a medication called Exforge.
` Q E-X-F-O-R-G-E?
` A Yes.
` Q And what was that medication for?
` A It's a blood pressure medication.
` Q Who were you testifying on behalf of in
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`Transcript of Arthur Z. Schwartzbard, M.D., F.A.C.C.
`Conducted on July 9, 2024
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`9
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`that litigation?
` A Again, I don't remember the exact firms,
`but it was on behalf of pharmacies.
` Q So not the specific law firm, but do you
`know what company retained you to testify in that
`litigation?
` A There were several pharmaceutical
`companies like pharmacy chains like Walgreens, CVS
`type of pharmacies.
` Q So you were testifying --
` A I don't know, I don't recall if it was
`within four years or not.
` Q So you were testifying on behalf of
`different pharmacies.
` Is that right?
` A Correct.
` Q And what kinds of opinions were you
`providing on behalf of those pharmacies?
` A I was really just retained to discuss the
`medication.
` Q When you say "to discuss the medication,"
`what do you mean?
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`Transcript of Arthur Z. Schwartzbard, M.D., F.A.C.C.
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`10
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` A How it worked, what the data showed for
`that medication, what is similar or different
`about that medication, that medical opinion.
` Q Similar or different to that medication
`in what way?
` A What's the degree of blood pressure
`lowering, what's the trial evidence for the drug,
`et cetera.
` Q Did you testify only in deposition, or
`did you ultimately testify in trial as well?
` A Only in deposition.
` Q Do you know if that case ultimately went
`to trial?
` A I do not.
` Q Besides the litigation regarding Exforge,
`have you ever had your deposition taken in any
`other context?
` A Are we again within the four year, or are
`we going way further back or -- I'm not sure what
`you mean.
` Q Yeah, this is at any point. Besides that
`pharmaceutical litigation, at any point have you
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`11
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`had your deposition taken?
` A I have.
` Q And has it ever been for a patent case?
` A Not that I'm aware.
` Q What kinds of cases have you had your
`deposition taken in, besides the Exforge case?
` A So many years ago I -- this is many years
`ago, this is maybe 14 or 15 years ago, I testified
`about a drug called fenofibrate.
` Q And again when you say testified about
`the drug, in what context?
` A I had a deposition taken. I think that
`was your question.
` Q Right. And what kind of litigation was
`that in?
` A Again, I was retained just as a medical
`expert to discuss the medication, to discuss
`cholesterol and the disease state.
` Q And on whose behalf were you retained?
` A This is so many years ago, I don't
`remember the names of the firms.
` Q Do you remember was it a pharmaceutical
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`company, or was it again on behalf of different
`pharmacies?
` A Again, I don't recall. It's many years
`ago.
` Q So you've been doing great so far on
`this, but I just want to go over a few ground
`rules on a deposition before we continue.
` Is that okay?
` A Fine.
` Q So as you see, today we have a court
`reporter who is taking down all the testimony we
`give. So I please just ask that we don't speak
`over each other, and that you give full yes-no
`answers, no nods or shaking of your head.
` Is that okay?
` A Yes.
` Q I'm going to do my best today to ask
`clear questions. You've done great so far seeking
`clarification as needed. But if there is a
`question that you don't understand, please ask for
`clarification. Okay?
` A Okay.
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`Mylan Pharms. Inc. v. Novo Nordisk A/S
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`Transcript of Arthur Z. Schwartzbard, M.D., F.A.C.C.
`Conducted on July 9, 2024
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`13
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` Q And if you don't ask for clarification,
`I'll assume that you have understood the question
`as I've asked it. Okay?
` A Okay.
` Q Is there anything that would prevent you
`from giving full and truthful testimony today?
` A No.
` Q Do you have any applications open on your
`computer besides this Zoom meeting?
` A No.
` Q If for some reason that changes, you
`suddenly get a pop-up from an e-mail, just let me
`know and just close out of whatever else may be
`open. I understand these remote depositions can
`be a little weird in that context.
` A Thank you.
` Q Is there anyone else in the room with
`you?
` A No.
` Q Again, if that changes, please just tell
`us and let us know.
` A Will do.
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`14
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` Q And then do you have anything with you
`for the deposition, paper copies of your
`declaration possibly?
` A With me in the room, besides a cup of
`coffee and some water and snacks, is copies of my
`report and exhibits that were submitted as part of
`that report.
` Q And are there any -- sorry.
` A I'm sorry. I also have a folder that has
`Dr. Blaha's declaration and exhibits as well.
` Q Are there any notes or anything like that
`on any of the papers that you have with you?
` A No notes.
` Q All right. Have you ever prescribed
`Ozempic to a patient?
` A I have.
` Q When did you first start prescribing
`Ozempic?
` A I don't recall an exact year.
` Q Do you have an approximate year?
` A I've been prescribing it for several
`years.
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`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
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`Transcript of Arthur Z. Schwartzbard, M.D., F.A.C.C.
`Conducted on July 9, 2024
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`15
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` Q More than five?
` A Yes.
` Q Have you been prescribing it since it was
`first approved?
` A Yes and no. I would say after a drug is
`first approved, it's often hard to get it
`approved. So, yes, some prescriptions for that;
`but often guided by what the patient's insurance
`will okay.
` Q When you say "hard to get it approved,"
`do you mean by the insurance company?
` A Yes.
` Q Approximately what percentage of your
`patients do you prescribe Ozempic to?
` A I prescribe Ozempic only for diabetics,
`and I prescribe it along with other GLP-1
`agonists. So I couldn't quote you an exact
`percentage. Don't know.
` Q Approximately what percentage of your
`patients have type 2 diabetes?
` A A fair number. In cardiology, as you
`might expect, diabetics get plenty of heart
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`disease. So I would say probably at least a third
`of my practice has type 2 diabetes.
` Q Somewhere between a third and a half?
` Is that a fair estimate?
` A I don't know that it's a half. But I
`would say at least a third have type 2 diabetes.
` Q And then of that third, approximately how
`many of those patients are you prescribing Ozempic
`to?
` A Again, as part of my prescribing GLP-1s I
`do prescribe Ozempic. It's not the only GLP-1
`agonist that I write, so I couldn't give you a
`percentage.
` Q What other GLP-1s do you write
`prescriptions for?
` A I've written for many; including
`Trulicity, Victoza, Mounjaro, multiple GLP-1s.
`Again, in part governed by what the patient's
`insurance will support.
` Q And approximately how many patients do
`you see, so that we can turn these percentages
`into numbers?
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`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
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` A If you're referring to how many patients
`I see in a day?
` Q Sorry, no. Thank you for the
`clarification. We've been talking about a third
`of your patients have type 2 diabetes. So kind of
`what's that number that we're talking about in
`round numbers?
` A So to give context to my week, I probably
`see in an office practice somewhere between 20 and
`25 each day, plus another five to ten on the wards
`every day. So I'm thinking about 30 to 35 people
`a day. So it's a busy clinical practice. So
`applying your numbers, the numbers we're just
`talking about, at least a third, talking about a
`lot of diabetics being seen every week.
` I may just add, Phil, I'm a consultative
`cardiologist, so I see not only patients in my own
`practice but also patients on the wards.
` Q Okay. If you can turn to Exhibit 1304,
`which is your declaration that you provided in
`this case.
` (Exhibit 1304, previously marked, not
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`IPR2023-00724
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`Transcript of Arthur Z. Schwartzbard, M.D., F.A.C.C.
`Conducted on July 9, 2024
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`18
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`attached.)
` A Bear with me. One more time. Exhibit
`1304 you said?
` Q Yeah. And that should be your
`declaration.
` MR. WHITE: And, Dr. Schwartzbard, that's
`your declaration, we pulled that out separately.
` THE WITNESS: Oh, you're referring to my
`report.
` MR. WHITE: Yes.
` Q Yes.
` A Okay. Sorry. I have that out. Thank
`you.
` Q It's technically a declaration, so I'll
`apologize if I refer to it as a declaration. But
`declaration, report, same thing.
` A Okay. Sorry. I have that out. I'm with
`you.
` Q All right. If you can turn to Paragraph
`12 of your declaration, which you can find it on
`Page 18.
` A Yes.
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`19
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` Q In the first sentence you say that "In
`2012, before the priority date of the '462 patent,
`clinicians treating patients with T2D had several
`options," and then you list a few.
` Do you see that?
` A I do.
` Q Were the clinicians who were treating
`patients with type 2 diabetes that you are
`referring to there cardiologists or
`endocrinologists?
` A I'm going to say endocrinologist more
`often on the insulin, but cardiologists, many that
`I work with also prescribe sulfonylureas and
`metformin there as well.
` Q What was your personal prescribing
`practice in 2012 with respect to your patients
`that had diabetes?
` A Drugs like these listed and others,
`including pioglitazone, TZD that's mentioned
`elsewhere in the report. But these were some of
`the most common medicines used at that time.
` Q All right. If you could turn to
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`Novo Nordisk Exhibit 2557
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00019
`
`
`
`Transcript of Arthur Z. Schwartzbard, M.D., F.A.C.C.
`Conducted on July 9, 2024
`
`20
`
`Paragraph 14.
` A Yes, sir.
` Q In the final sentence there you refer to
`comparison to the closest prior art. What do you
`understand the closest prior art to mean?
` A So I'm referring to what was available,
`what was available to physicians prior to the
`patent that we're discussing.
` Q Was semaglutide available to physicians
`prior to July 1st, 2012?
` MR. WHITE: Objection to form.
` A I don't recall the entry date, the exact
`entry date for semaglutide, but GPL-1s were
`available to physicians.
` Q Was semaglutide specifically available
`prior to July 1st, 2012?
` MR. WHITE: Objection to form.
` A Again, Philip, I'm not testifying here
`today the exact clinical date of when semaglutide
`was clinically available to physicians.
` Q Do you know when semaglutide was first
`available to physicians in general?
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`Novo Nordisk Exhibit 2557
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00020
`
`
`
`Transcript of Arthur Z. Schwartzbard, M.D., F.A.C.C.
`Conducted on July 9, 2024
`
`21
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` A I may have cited that elsewhere in the
`report. I don't remember the date.
` Q But it's your opinion that semaglutide
`qualifies as the closest prior art?
` A There were certainly publications about
`semaglutide in other doses other than 1 milligram
`prior to the approval date.
` Q Was there any data available for any
`doses of semaglutide prior to July 1st, 2012?
` MR. WHITE: Objection. Form. Scope.
` A So maybe you could clarify what you mean
`by "data." There certainly was a lot of basic
`science, Phase 1, Phase 2, et cetera. If that
`counts as data, yes, there was data available
`prior to the approval date.
` Q And sorry, I'm speaking not generally
`about the approval date but I'm speaking
`specifically about prior to July 1st, 2012.
` A And I thought I answered you, but I'll
`try again. There was plenty of publications
`referring to semaglutide in other doses before the
`priority date.
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`Novo Nordisk Exhibit 2557
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00021
`
`
`
`Transcript of Arthur Z. Schwartzbard, M.D., F.A.C.C.
`Conducted on July 9, 2024
`
`22
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` Q And did those publications include
`information about any cardio-protective benefits
`of semaglutide?
` A So elsewhere in the report I go over some
`of the basic science of GLP-1s and what was
`already available in the -- in the literature.
`And again, not sure about what you're driving at.
`But maybe I can clarify as I understand your
`question.
` Was there already preliminary data in
`basic science and preclinical data for semaglutide
`beforehand, the answer is yes.
` Q Was there clinical data for semaglutide
`prior to July 1st, 2012, with respect to
`cardio-protective benefits?
` A If you mean was there a cardiovascular
`outcome trial prior to 2012, no.
` Q Was there any other clinical data for
`semaglutide prior to July 1st, 2012, with respect
`to cardio-protective benefits or cardiovascular
`data points?
` A Again, elsewhere in the report I listed
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`
`Novo Nordisk Exhibit 2557
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00022
`
`
`
`Transcript of Arthur Z. Schwartzbard, M.D., F.A.C.C.
`Conducted on July 9, 2024
`
`23
`
`multiple paragraphs of some of the data that was
`already known in the literature about GLP-1
`agonists and cardiovascular protection. In fact,
`I spent about 25 paragraphs on that. So I would
`rather not answer that as a yes or no.
` Q Yeah, and I'm asking specifically about
`semaglutide, not GLP-1s in general.
` A So we say "cardiovascular effect," does
`cardiovascular effect include weight loss? Does
`it include data on reduction of A1C? I would
`argue it does. And there was already data in the
`literature about those benefits.
` Q Prior to July 1st, 2012, was there any
`clinical data regarding a 0.8-milligram
`once-weekly dosage of semaglutide?
` A There was a prior clinical protocol using
`the .8, a national clinical trial I think in the
`database using the .8-milligram dosage. And
`that's actually also referred to in the report.
` Q So there was a protocol. But were there
`any outcomes from that clinical trial protocol
`prior to July 1st, 2012?
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`Novo Nordisk Exhibit 2557
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00023
`
`
`
`Transcript of Arthur Z. Schwartzbard, M.D., F.A.C.C.
`Conducted on July 9, 2024
`
`24
`
` A Again, so if I can just clarify, Philip,
`what you mean by "outcomes."
` In my report I distinguish between
`effects on cardiovascular risk factors, A1C,
`weight, sugar control, lipid effect, and what is a
`cardiovascular outcome trial.
` Q All right. So let's actually talk about
`that for a minute.
` So you spent a lot of time in your report
`talking about different risk factors. I think you
`mentioned a lot of them. A1C, weight, sugar
`control, lipid effects, blood pressure.
` Is that right?
` A Those are some of the many effects that
`GLP-1 agonists have, correct.
` Q And then you're distinguishing those from
`cardiovascular outcome trials. I guess what do
`you consider to be an outcome of a cardiovascular
`outcome trial?
` A Well, there's a lot of ways to look at
`cardiovascular outcomes. You can -- clinicians
`can look at a large database and review a large
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`Novo Nordisk Exhibit 2557
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00024
`
`
`
`Transcript of Arthur Z. Schwartzbard, M.D., F.A.C.C.
`Conducted on July 9, 2024
`
`25
`
`database and see if patients that got a drug had
`better outcomes.
` You can look at an insurance database,
`you can look at a pharmaceutical company's
`database. There's a lot of ways to review
`cardiovascular data. And you can also do what I'm
`referring to as a cardiovascular outcome trial,
`where you randomize, placebo control a patient or
`a group of people to placebo versus drug and
`say -- follow them over a couple of years and say
`does this group of patients have less heart
`attack, less stroke, less death, et cetera.
` That's what in my report I'm referring to
`as a cardiovascular outcome trial.
` Q And so do you consider things like
`reduction in three point MACE, reduction in heart
`failure, reduction in myocardial infarction, those
`are cardiovascular outcomes?
` A Those are cardiovascular outcomes but can
`be found multiple ways. You can -- as I mentioned
`earlier.
` Q Prior to July 1st, 2012, was there any
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`Novo Nordisk Exhibit 2557
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00025
`
`
`
`Transcript of Arthur Z. Schwartzbard, M.D., F.A.C.C.
`Conducted on July 9, 2024
`
`26
`
`cardiovascular outcome data for semaglutide?
` A The cardiovascular outcome trial, as I
`defined it earlier, for semaglutide came out I
`think approximately 2016.
` Q Was there any other cardiovascular
`outcome data for semaglutide prior to July 1st,
`2012, outside of the cardiovascular outcome trial?
` A Again, there was, as I mentioned already,
`there was in the literature a lot of data looking
`at GLP-1 agonists, not just semaglutide but others
`in the class, looking at some of those effects
`that I mentioned already, reductions in A1C,
`effects on weight, effects on sugar, effects on
`lipids, database reviews, tons of this in the
`literature for years prior to the publication of
`SUSTAIN 6.
` Q And just to redirect you back to my
`question, though, was there any other
`cardiovascular outcome data for semaglutide prior
`to July 1st, 2012, outside of the cardiovascular
`outcome trial?
` A Again, there was dosing trials looking at
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`Novo Nordisk Exhibit 2557
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00026
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`
`
`Transcript of Arthur Z. Schwartzbard, M.D., F.A.C.C.
`Conducted on July 9, 2024
`
`27
`
`the effects on sugar and these markers that I've
`referred to earlier, but not the cardiovascular
`outcome trial as we've defined it so far. That
`one came out in 2016.
` Q Can you please turn to Paragraph 15 of
`your declaration. And I'm looking at Page 22,
`about halfway down the paragraph.
` A I have the page open.
` Q All right. The sentence that reads, "The
`1.0 milligram once-weekly dose of semaglutide
`demonstrated no cardiovascular benefits that were
`of a different kind, rather than a different
`degree, than seen with other drugs in the GLP-1
`receptor agonist class that showed cardiovascular
`benefit in other doses of Ozempic."
` Do you see that?
` A I do.
` Q When you talk about "a different kind
`rather than a different degree," what do you
`understand that to mean?
` A So if you ask me were there -- are there
`cardiovascular outcome trials and benefits seen
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`Novo Nordisk Exhibit 2557
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00027
`
`
`
`Transcript of Arthur Z. Schwartzbard, M.D., F.A.C.C.
`Conducted on July 9, 2024
`
`28
`
`with other GLP-1 agonists, the answer is there
`are.
` And so if I'm distinguishing between
`Ozempic and other GLP-1 agonist outcome trials,
`and I say, well, two trials, or three in this
`particular case, three drugs have shown
`cardiovascular outcome trial benefits, semaglutide
`being one of them, Ozempic being one of the three,
`but the other two trials also show reductions in
`MACE, reductions in nonfatal MI, reductions in
`stroke, et cetera.
` And so if I'm comparing multiple drugs in
`the class, what I mean by a difference in kind
`versus a difference in degree is if all three
`trials show things like a reduction in stroke, but
`one trial shows a little more stroke reduction
`than another, that I would call a difference in
`degree rather than a difference in kind.
` Q What do you categorize as a difference in
`kind?
` A Effects that are seen with only one drug
`from the class, and not with others.
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`Novo Nordisk Exhibit 2557
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00028
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`
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`Transcript of Arthur Z. Schwartzbard, M.D., F.A.C.C.
`Conducted on July 9, 2024
`
`29
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` So, for example, if no other GLP-1
`agonist had shown a reduction in stroke, and only
`one drug did, that would imply a difference in
`kind to me.
` When multiple drugs in the class show a
`reduction in stroke, that's a difference in
`degree, not in kind.
` Q Prior to this case, had you ever looked
`at a patent before?
` A I'm not sure what you mean by that. We
`see package inserts that I guess refer to
`patent as clinicians, but no, I've never reviewed
`patent details before, no.
` Q And did you review the patent at issue in
`this case?
` A As need to prepare this report.
` Q What do you mean by "as needed"?
` A Only as discussed in my report. I'm not
`an attorney, so I'm not a patent expert, let me
`testify to that clearly.
` Q No, I appreciate that.
` Prior to 2012 had you ever prescribed any
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`Novo Nordisk Exhibit 2557
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00029
`
`
`
`Transcript of Arthur Z. Schwartzbard, M.D., F.A.C.C.
`Conducted on July 9, 2024
`
`30
`
`GLP-1 receptor agonist?
` A I had. My -- again, I don't remember the
`exact dates, I've testified to that already. But
`the first GLP-1 that I had written was a drug
`called Byetta. It was, I should say, known
`commercially as Byetta, also known as exenatide,
`and it was a multiple-time-a-day drug. It wasn't
`a once-a-week drug.
` Q Did exenatide have -- strike that. Was
`exenatide shown to have improvements in
`cardiovascular outcomes?
` A Again, let's take you back to my earlier
`answer on that, what you consider cardiovascular
`outcomes.
` So exenatide did have published data
`looking at a huge database, and I commented on
`this in the report, on almost 40,000 people,
`showing less cardiovascular events when the
`database was reviewed.
` It also had well-known effects on sugar
`and weight loss and lipids and cardiovascular risk
`factors that were known to play a role in diabetic
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`Novo Nordisk Exhibit 2557
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00030
`
`
`
`Transcript of Arthur Z. Schwartzbard, M.D., F.A.C.C.
`Conducted on July 9, 2024
`
`31
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`and cardiovascu
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