UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` -----------------------------------
`
` MYLAN PHARMACEUTICALS INC.,
` Petitioner
` vs
` NOVO NORDISK A/S,
` Patent Owner
`
` -----------------------------------
`
` Case IPR2023-00724
`
` U.S. Patent No. 10,335,462
`
` Oral deposition of
` ALLEN SPIEGEL, M.D.
`
` VIA VIDEO/TELECONFERENCE
` FRIDAY, JULY 26, 2024
` 10:03 a.m. EASTERN TIME
`
`Job No.: 534601
`Pages: 1 - 154
`Reported by: Lisa V. Feissner, RDR, CRR, CLR
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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.,
` Petitioner
` vs
` NOVO NORDISK A/S,
` Patent Owner
`
` -----------------------------------
`
` Case IPR2023-00724
`
` U.S. Patent No. 10,335,462
`
` Oral deposition of
` ALLEN SPIEGEL, M.D.
`
` VIA VIDEO/TELECONFERENCE
` FRIDAY, JULY 26, 2024
` 10:03 a.m. EASTERN TIME
`
`Job No.: 534601
`Pages: 1 - 154
`Reported by: Lisa V. Feissner, RDR, CRR, CLR
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`Transcript of Allen Spiegel, M.D.
`Conducted on July 26, 2024
`
`2
`
` Oral deposition of ALLEN SPIEGEL, M.D.,
`held REMOTELY, via ZOOM, on FRIDAY, JULY 26, 2024,
`BEGINNING at 10:03 a.m., pursuant to NOTICE, before
`Lisa V. Feissner, RDR, CRR, CLR, Notary Public.
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`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
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`Transcript of Allen Spiegel, M.D.
`Conducted on July 26, 2024
`
`3
`
`A P P E A R A N C E S:
`ON BEHALF OF PETITIONER:
` DAVID L. ANSTAETT, ESQUIRE
` BRYAN D. BEEL, Ph.D., ESQUIRE (Portland ofc)
` PERKINS COIE LLP
` 33 East Main Street, Suite 201
` Madison, WI 53703-3095
` 608.663.7494
` danstaett@perkinscoie.com
`
`ON BEHALF OF PATENT OWNER:
` JOSHUA REICH, ESQUIRE
` MEGAN F. RAYMOND, ESQUIRE (DC office)
` GROOMBRIDGE WU BAUGHMAN & STONE LLP
` 565 Fifth Avenue, Suite 2900
` New York, NY 10017
` 332.269.0024
` joshua.reich@groombridgewu.com
`
`A L S O P R E S E N T:
` KOLLIN CASAREZ, A/V Technician
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`Transcript of Allen Spiegel, M.D.
`Conducted on July 26, 2024
`
`4
`
` C O N T E N T S
`EXAMINATION OF ALLEN SPIEGEL, M.D. PAGE
` By Mr. Reich 5
`
` P R E V I O U S L Y
` M A R K E D E X H I B I T S
` (identified but not attached)
`EXHIBITS PAGE
`MPI Exhibit 1117 112
`MPI Exhibit 1302 12
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`Transcript of Allen Spiegel, M.D.
`Conducted on July 26, 2024
`
`5
`
` P R O C E E D I N G S
` ALLEN SPIEGEL, M.D.,
`having been first duly sworn, was examined and
`testified as follows:
` EXAMINATION
`BY MR. REICH:
` Q Good morning, Dr. Spiegel.
` A Good morning, Mr. Reich.
` Q Have you ever been deposed before?
` A No.
` Q Okay. So I'm sure counsel went over some
`of the basics, but just to cover a few ground rules
`so we have a smooth recording and transcript.
` First, everything is being transcribed,
`so it's very important that we don't talk over each
`other. I'll do my best to ask a question, let you
`respond. And I'm sure if your counsel has any
`objections, it would be good to pause so we just
`have a clean transcript. I think Lisa would
`appreciate that.
` Is that fair?
` A It is fair.
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`Transcript of Allen Spiegel, M.D.
`Conducted on July 26, 2024
`
`6
`
` And I want to just quickly qualify my
`"no" answer. I answered "no" with regard to any
`patent issues. I was deposed as the dean of the
`Albert Einstein College of Medicine in a suit
`brought by a student who had been expelled before my
`time. So that's the only time I've been deposed,
`not pertinent to this type of proceeding.
` Q And when was that deposition?
` A 2006.
` Q Okay. So it's been a bit. So I'll still
`cover the ground rules. But I appreciate you
`clarifying.
` Second, please provide verbal answers.
`Head shakes won't be caught on the transcript. So,
`you know, it's very natural to want to shake your
`head, but please do your best to give a verbal
`answer.
` Fair?
` A Yes.
` Q And then I'm going to do my best to ask
`clear questions that hopefully you understand. But
`if you do not understand the question, please let me
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`Transcript of Allen Spiegel, M.D.
`Conducted on July 26, 2024
`
`7
`
`know. I'll try to restate it. But if you don't ask
`for a restatement, I'm going to assume you
`understood what I asked.
` Is that fair?
` A That is fair.
` Q I'll also try to take regular breaks.
`But if you need to take a break, let us know, we'll
`try to accommodate it. But if a question is
`pending, I'll just ask that we finish the question
`and then we break.
` Fair?
` A Thank you.
` Q What did you do to prepare for today's
`deposition?
` MR. ANSTAETT: And Doctor, I'll just
`caution you that you can tell Mr. Reich who you met
`with, when you met with, what you reviewed, but
`don't reveal the content of any conversations you
`had with lawyers.
` THE WITNESS: Understood.
` A What I did to prepare is to read and
`re-read the copy of my reply to Dr. Goland's
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`Transcript of Allen Spiegel, M.D.
`Conducted on July 26, 2024
`
`8
`
`declaration, read her declaration, read the
`deposition that she gave with Mr. Anstaett. And
`then I had communication with the attorneys and some
`prep for just the format of a deposition. That was
`my preparation.
` Q Okay. Other than the attorneys, did you
`meet with anyone else to prepare for today's
`deposition?
` A No.
` Q Did you discuss today's deposition with
`anyone other than the attorneys?
` A I may have mentioned something to my
`wife. She's aware of the fact that my absence is
`due to being here.
` Other than that, no.
` Q That's fair. Probably good to notify her
`where you are today.
` How long did you meet with the attorneys
`from Perkins?
` A I would say the average total would be
`about six hours.
` Q To be clear, did you meet with any
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`Transcript of Allen Spiegel, M.D.
`Conducted on July 26, 2024
`
`9
`
`attorneys other than attorneys from Perkins?
` A No, not to my knowledge.
` Q And what do you have with you in the room
`today?
` A What I have in the room, there's a large
`cardboard box with printouts of all the items listed
`in the appendix as well as the list of abbreviations
`and just a pad to jot some notes on.
` Q There's no notes on that pad right now?
` A I have some notes on the pad. I have a
`quick summary of my understanding of some of the
`relevant patents, some of the relevant doses, just a
`mnemonic device. But it's very limited material.
` MR. ANSTAETT: And I'll say, Josh, I
`didn't realize that he had that with him. We can
`certainly take that away.
` THE WITNESS: No problem. I'll tear it
`up right now.
` It's gone.
` Q Do you have notes on any of the paper
`copies that you have other than the notepad?
` A I have notes on previous copies that I
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`Transcript of Allen Spiegel, M.D.
`Conducted on July 26, 2024
`
`10
`
`used to review. But these are all clean copies.
` Q And do you have anything up on the screen
`right now other than this Zoom?
` A Four quadrants with the folks that are
`relevant in it. That's it.
` Q Okay. And if anything comes up on the
`screen, will you let me know?
` A Of course.
` Q I'm otherwise going to assume that the
`only thing you have in front of you are the clean
`paper copies and the Zoom window.
` Is that fair?
` A Zoom window, yes. The clean copies are a
`little bit distant, but I may call to see those in
`response to your questions, just to let you know.
` And I have a blank pad where I may just
`scribble notes on your question.
` Q Okay. And did you look at anything other
`than Dr. Goland's deposition transcript that is not
`identified in your list of materials considered to
`prepare for today's deposition?
` A Could you restate that? I'm not sure
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`Transcript of Allen Spiegel, M.D.
`Conducted on July 26, 2024
`
`11
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`what you mean by other than her deposition.
` Q Did you look at anything to prepare for
`today's deposition that is not identified in your
`list of materials considered in the back of your
`declaration?
` A Ah, list of materials considered.
` No, I did not.
` Q And did you look at Dr. Goland's
`declaration before or after you wrote your
`declaration?
` A Before.
` Q All right. So you understand you're here
`today because you've provided a declaration in
`IPR 2023-00724?
` A I can't attest to the fact that I know
`that particular number, but I do recognize the term
`IPR. So presumptively, yes, assuming that number is
`the one relevant to this IPR.
` MR. REICH: And if we could pull up
`Exhibit 1302. And Dave, if you want to hand him his
`paper copy, that's fine with me, too.
` MR. ANSTAETT: Okay. We'll get it for
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`Transcript of Allen Spiegel, M.D.
`Conducted on July 26, 2024
`
`12
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`him.
` (Previously marked Exhibit 1302 presented
`to the witness.)
` MR. ANSTAETT: He's got it now.
` THE WITNESS: Yes, I now have it, and I
`do see 2023-00724 with a footnote also to
`IPR 2024-0009.
`BY MR. REICH:
` Q And do you see in the bottom right
`corner, it's marked as Exhibit 1302?
` A I do.
` Q So today if I refer to this as your
`declaration or Exhibit 1302, do you understand that
`what I am referring to is your reply declaration?
` A I do.
` Q Does this declaration reflect the
`complete opinions that you've offered in this
`proceeding?
` A Yes, they do.
` Q And when you reviewed your declaration,
`did you have any corrections you wanted to make?
` A No.
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`Transcript of Allen Spiegel, M.D.
`Conducted on July 26, 2024
`
`13
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` Q Are you familiar with Dr. Goland?
` A Yes, I am.
` Q Can you explain how you're familiar with
`Dr. Goland?
` A Of course. As listed in my reply
`declaration, and I can point to the specifics pages
`if you wish, where it lists my qualifications and
`experience, you may see that I was the director of
`the National Institute of Diabetes and Digestive and
`Kidney Disease at the National Institutes of Health,
`NIH henceforth, and that was from late 1999 until
`the spring of 2006.
` During that period of time, perhaps 2004,
`and I cannot attest to the accuracy of that specific
`year, as part of my responsibilities as the director
`of NIDDK, the diabetes institute, I would visit
`various of our funded diabetes centers, one of which
`was at Columbia medical school.
` Dr. Goland was one of the co-directors of
`the Berrie Diabetes Center at Columbia. I gave a
`grand rounds at Columbia on that visit, and I
`visited with her in the physical facility of the
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`Conducted on July 26, 2024
`
`14
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`Berrie Center.
` That's the one time that I encountered
`her. And I believe that the group at Columbia also
`took me out to dinner at a New York restaurant, for
`which I did not allow them to pay because, as a
`government employee, I was a stickler for following
`those rules.
` So I did meet Dr. Goland in that context,
`but that was the only direct contact I had with her.
` Q Is the Berrie Diabetes Center a
`well-known diabetes center, in your opinion?
` A Can you define what you mean by
`"well-known"?
` Q Is it a prestigious diabetes center?
` A Its prestige is largely local. What I
`mean by that is that it's known in the New York City
`metropolitan area as a good diabetes center.
` But I have to dichotomize here. I said
`that Goland was the co-director, and that's because
`there are two other individuals whom I know
`substantially better than Dr. Goland, and that's
`Dr. Rudolph Leibel, L-E-I-B-E-L, and Dr. Domenico
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`Transcript of Allen Spiegel, M.D.
`Conducted on July 26, 2024
`
`15
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`Achilli. I won't try to spell that name.
` They are co-directors of the Berrie
`Center. They are noted physician scientists, and
`their important research accomplishments in diabetes
`research lends prestige to the Berrie Diabetes
`Center.
` Q Are you aware of who founded the Berrie
`Diabetes Center?
` A I believe, in reading her declaration,
`she takes credit for -- that -- she, that being
`Dr. Goland, takes credit for founding it. So I am
`aware of that.
` I don't have any verification of that or
`independent knowledge that that is true. But she
`made that statement, and I have no reason to doubt
`her.
` Q So you referenced your role at the NIH.
` Is that correct?
` A That is in my reply, yes.
` Q And you said that you were the scientific
`director of the division of -- I'm sorry. Strike
`that.
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`Transcript of Allen Spiegel, M.D.
`Conducted on July 26, 2024
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`16
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` Could you tell me what NIDDK stands for
`again.
` A Absolutely. And I should preface that by
`saying that the names of the various institutes and
`centers at the NIH, of which there are approximately
`26, are a function of various lobbying groups,
`disease advocacy groups.
` So the name of institute which I headed
`has changed over the years. But the name when I was
`the director was the National Institute of Diabetes
`and Digestive and Kidney Diseases, NIDDK.
` Q And you wrote in your reply declaration
`that you were responsible for the oversight of major
`national clinical trials in diabetes.
` Does that ring a bell?
` A Yes, it does.
` Q What were those major national clinical
`trials that you oversaw?
` A They were under the auspices of each of
`the divisions that I've described, so there are
`separate divisions within the institute I headed for
`diabetes, for digestive disease, for kidney disease.
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`Transcript of Allen Spiegel, M.D.
`Conducted on July 26, 2024
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`17
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` I assume, unless you are interested, I
`won't go into the digestive disease national
`clinical trials. I won't go into the kidney disease
`clinical trials. But I'll confine myself to the
`diabetes trials.
` Is that appropriate?
` Q Yeah. We can start with the diabetes
`trials.
` A And then I'll dichotomize those, because
`within the diabetes trials, there are some focused
`on type 1 diabetes and others focused on type 2
`diabetes.
` Shall I confine myself to the type 2
`diabetes?
` Q Yeah, that sounds fair.
` A Good.
` So one of the major trials current during
`my time as director spanned -- and I want to just
`clarify, this is as the institute director. The
`terminology which you started into can be a little
`confusing.
` From '90 to '99, I was the scientific
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`Transcript of Allen Spiegel, M.D.
`Conducted on July 26, 2024
`
`18
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`director, is the terminology, the director of the
`division of intramural research. From late 99 until
`spring of 2006, I was the director, the institute
`director of NIDDK.
` During that period of time, major trials
`that we had, one was called DPP, the Diabetes
`Prevention Program. And strictly speaking, that
`trial addressed approximately 3400 individuals, not
`with diabetes, but with what later became to be
`termed as a result of this trial outcome
`prediabetes.
` And in these individual, the question
`was, can you prevent the subsequent development of
`overt diabetes in these individuals.
` And the answer turned out to be, yes.
`That trial was ended early because the Data Safety
`and Monitoring Board -- and I should stress that I
`attended religiously the national investigator
`clinical trial meetings as well got reports from
`Data Safety and Monitoring Board.
` There were three arms while I was the
`director, and one arm was a control, which was
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`Transcript of Allen Spiegel, M.D.
`Conducted on July 26, 2024
`
`19
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`conventional lifestyle information.
` The second arm was an intensive lifestyle
`intervention to achieve some degree of weight loss
`and more healthy diet and exercise.
` And the third arm was metformin.
` And the results were reported in New
`England Journal, and it turned out that you had a
`58 percent reduction in subsequent years of
`follow-up with the intensive lifestyle intervention;
`a somewhat lower degree of prevention, in the
`35 percent range, for metformin, all by comparison
`to placebo.
` So that was a major trial conducted
`during that period of time in the type 2 diabetes
`relevant space.
` Shall I go on?
` Q We can pause on this one.
` So you said that that trial ended early.
` Is that correct?
` A It ended -- and I'm mindful, as I sit
`here looking out the window in New York City, it
`ended just pre-9/11.
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`Transcript of Allen Spiegel, M.D.
`Conducted on July 26, 2024
`
`20
`
` In August of 2001, I and a man named
`David Nathan, the overall head, from an academic
`center point of view, of the trial, the lead
`investigator, as it's called, both came to New York
`as part of press conferences and interviews that we
`had to report the results of that trial.
` So August 2001.
` Q And when you had testified it ended
`early, that was because it had a predetermined end
`point? Or sorry. Can you explain that a little bit
`more?
` A Of course. As you may know, when
`clinical trials, multicenter trials of this
`magnitude are conducted, it's standard procedure to
`have an independent Data Safety and Monitoring
`Board.
` And they meet periodically, and they
`don't have the authority themselves to stop the
`trial, but they report to me, as the institute
`director, and to colleagues who work under me at the
`institute to recommend a course of action.
` And there can be two reasons for early
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`Transcript of Allen Spiegel, M.D.
`Conducted on July 26, 2024
`
`21
`
`cessation of the trial.
` One, the very fortunate one, positive one
`in this case, that the results are so clearly
`beneficial that one can question what's called
`equipoise, the ethics of continuing to give a
`placebo and not the active, in this case, intensive
`lifestyle intervention.
` Of course, the other reason can be
`futility, and that's a term of art in the clinical
`investigation space which means it's very clear that
`you're never going to achieve the prespecified
`objectives, and so it's unfair and possibly
`inappropriate to continue subjecting the patients
`enrolled in the trial.
` So does that answer your question?
` Q Yeah. How common is it that a trial ends
`early because it's unethical to proceed with giving
`patients a placebo?
` MR. ANSTAETT: Objection to form.
` A I cannot specify in the universe of
`clinical trials that percentage. It's relatively
`rare, but it does occur.
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`Transcript of Allen Spiegel, M.D.
`Conducted on July 26, 2024
`
`22
`
` Q And is it a notable outcome when it
`occurs?
` MR. ANSTAETT: Objection to form.
` A I'm not sure what you mean by "notable."
` Q You said you flew up to give a press
`release.
` Is that correct?
` A I want to explain that type 2 diabetes
`and prediabetes -- by the way, that terminology was
`adapted by the American Diabetes Association
`subsequent to this trial because it became clear
`that there is value to identifying such individuals
`because you have means of preventing their
`development of diabetes.
` In the aggregate, this affects some
`98 million people in the United States. That's of
`great interest from a socioeconomic point of view,
`from a health point of view.
` So yes, there was press interest, and
`that is the reason for the interviews by media.
` Q And for the, you said, aggressive
`lifestyle intervention arm -- is that the proper
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`Transcript of Allen Spiegel, M.D.
`Conducted on July 26, 2024
`
`23
`
`term?
` A Intensive lifestyle intervention.
`"Aggressive" has a little bit of a negative
`connotation.
` Q What did the intensive lifestyle
`intervention arm entail for treatment?
` A What it entailed -- and I'm stressing,
`there was no pharmacologic treatment of these
`individuals. It involved sessions with appropriate
`counselors, dieticians that focused on healthy diet,
`the macronutrient composition of the diet, that is,
`how much fat, how much carbohydrate, how much
`protein, the frequency of eating the meals, and then
`very importantly, also the exercise.
` And what I want to stress -- and this is
`very much part -- I want to just perhaps anticipate
`part of what you're saying -- the successful outcome
`of the trial led to a major educational program
`around the country to inform the public,
`particularly those individuals at great risk of
`developing diabetes -- and the risk factors are
`family history, age, unfortunately, the older we
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`Transcript of Allen Spiegel, M.D.
`Conducted on July 26, 2024
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`24
`
`get, the more likely it is to develop type 2
`diabetes -- and of course, the idea was to let
`individuals know that this can be implemented.
` And what we stressed -- and this is a
`very important point. The issue here was not
`massive weight loss. In the final analysis, after
`about four years of the intervention -- and I'm just
`estimating what the average intervention length was
`for the individuals in the trial -- there was
`perhaps a 5 percent weight loss, which is not a
`massive amount. But that turned out to be
`fundamental in terms of giving this beneficial
`58 percent decrease over subsequent years.
` And I'll just point out also -- and this
`is a practice that the institute would often do --
`after going through all the expense and effort of
`these multiple academic centers, clinical centers
`around the country recruiting these patients for the
`trial, by definition, the trial lasts a finite
`period of time.
` But we then extended, not the trial but
`something called DPPOS, the Diabetes Prevention
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`Transcript of Allen Spiegel, M.D.
`Conducted on July 26, 2024
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`25
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`Program outcome study, with the goal of following
`these patients longer term, how durable would this
`period of prevention of type 2 diabetes be. What
`other outcomes, if any, in terms of cardiovascular
`disease, kidney disease, might be discerned.
` And there have been a series of
`publications over the years; actually, most of them
`subsequent to my leaving the NIH in 2006.
` Q When was the last time you treated a
`patient with type 2 diabetes?
` A I should stress that in coming to the
`Albert Einstein College of Medicine as dean in 2006,
`I ceased two of my former activities. I ceased any
`direct responsibility for patient care, and I ceased
`conducting research in my own laboratory while I was
`dean.
` So the answer to that question is,
`certainly not since 2006, although I obtained and
`continue to have a medical license in New York
`state.
` Q Prior to 2006, when was the last time you
`were responsible for direct responsibility for
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`Transcript of Allen Spiegel, M.D.
`Conducted on July 26, 2024
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`26
`
`patient care?
` A Let me then answer that question by
`spelling out what my role was during different
`stages of my career.
` Of course, as a medical student,
`graduating Harvard Medical School in 1971, I had
`intensive responsibility for patient care.
` As a intern and resident at the Mass
`General Hospital, '71 to '73, intensive
`responsibility for patient care.
` As an endocrine fellow trainee at the
`National Institu
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