UNITED STATES PATENT AND TRADEMARK OFFICE
` ----------------------------------
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ----------------------------------
` MYLAN PHARMACEUTICALS INC.,
` Petitioner,
` v.
` NOVO NORDISK A/S,
` Patent Owner.
` --------------------------
` Case No. IPR2023-00724
` Patent No. 10,335,462
`
` DEPOSITION OF ROBIN S. GOLAND, M.D.
` TUESDAY, APRIL 9, 2024
` 9:00 A.M.
`
`Job No.: 532164
`Pages 1 - 104
`Reported by: Adrienne Mignano, RPR
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`
` ----------------------------------
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ----------------------------------
` MYLAN PHARMACEUTICALS INC.,
` Petitioner,
` v.
` NOVO NORDISK A/S,
` Patent Owner.
` --------------------------
` Case No. IPR2023-00724
` Patent No. 10,335,462
`
` DEPOSITION OF ROBIN S. GOLAND, M.D.
` TUESDAY, APRIL 9, 2024
` 9:00 A.M.
`
`Job No.: 532164
`Pages 1 - 104
`Reported by: Adrienne Mignano, RPR
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`Transcript of Robin S. Goland, M.D.
`Conducted on April 9, 2024
`
`2
`
` Deposition of ROBIN S. GOLAND, M.D., held at
`the law firm of:
`
` PERKINS COIE, LLP
` 1155 Avenue of the Americas
` New York, New York 10036
`
` Pursuant to Notice, before Adrienne M.
`Mignano, a Notary Public and Registered Professional
`Reporter in and for the State of New York.
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`Transcript of Robin S. Goland, M.D.
`Conducted on April 9, 2024
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`3
`
` A P P E A R A N C E S
`
`ON BEHALF OF PETITIONER:
` DAVID L. ANSTAETT, ESQUIRE
` PERKINS COIE, LLP
` 33 East Main Street
` Suite 201
` Madison, Wisconsin 53703
` 608.663.7460
`
`ON BEHALF OF PATENT OWNER:
` JENNY WU, ESQUIRE
` GROOMBRIDGE, WU, BAUGHMAN, STONE LLP
` 565 Fifth Avenue
` Suite 2900
` New York, New York 10017
` 332.269.0030
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`Transcript of Robin S. Goland, M.D.
`Conducted on April 9, 2024
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`4
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` C O N T E N T S
`EXAMINATION OF ROBIN S. GOLAND PAGE
` By Mr. Anstaett 6
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`Transcript of Robin S. Goland, M.D.
`Conducted on April 9, 2024
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`5
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` E X H I B I T S
` (Attached to the transcript)
`GOLAND DEPOSITION EXHIBITS PAGE
`Exhibit 1001 U.S. Patent Number 10,335,462 10
`Exhibit 1095 Petitioner's Notice of 8
` Deposition of
` Dr. Robin S. Goland
`Exhibit 2054 Expert Declaration of 10
` Robin S. Goland, M.D.
`Exhibit 2072 Highlights of Prescribing 32
` Information for Ozempic,
` Revised December 2017
`Exhibit 2076 Highlights of Prescribing 30
` Information for Ozempic,
` Revised March 2022
`Exhibit 2080 The New Yorker article 85
` entitled "The Year of Ozempic,"
` dated 12-14-23
`Exhibit 2081 The New York Times article 93
` titled "What's Next for Ozempic"
` dated 12-20-23
`Exhibit 2082 Journal article regarding the 46
` SUSTAIN 10 clinical trial by
` Capehorn, et al.
`Exhibit 2083 Journal article regarding the 55
` SUSTAIN 4 clinical trial
`Exhibit 2084 Journal article regarding the 66
` SUSTAIN 7 clinical trial
`Exhibit 2085 Journal article regarding the 70
` SUSTAIN 3 clinical trial
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`Transcript of Robin S. Goland, M.D.
`Conducted on April 9, 2024
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`6
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`Whereupon,
` ROBIN S. GOLAND, M.D.,
`being first duly sworn or affirmed to testify to
`the truth, the whole truth, and nothing but the
`truth, was examined and testified as follows:
` EXAMINATION BY COUNSEL FOR THE PETITIONER
`BY MR. ANSTAETT:
` Q Good morning, Doctor. Could you
`state your name for the record, please.
` A Robin Goland.
` Q Have you had your deposition taken
`before?
` A Yes.
` Q How many times?
` A Three.
` Q And have you been a witness -- an
`expert witness in a patent litigation before?
` A Yes, I have.
` Q And how many times?
` A Three.
` Q Were those the three depositions you
`gave previously?
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`Conducted on April 9, 2024
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`7
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` A Yes.
` Q Well, you probably know the rules of
`the road, then, but I'll go over them just
`briefly. I'll do my best today to ask clear
`questions, but at times I'm sure I'll fail to do
`that. So if you don't understand a question
`that I have asked, please let me know and I'll
`try to rephrase it, okay?
` A Okay.
` Q All right. You're very good, I can
`see already, at giving verbal answers. You just
`need to continue to do that rather than nodding
`your head or shaking your head because we are
`creating a transcript, okay?
` A I understand.
` Q We'll try not to talk over each other
`today. That will make the court reporter's life
`much easier. Your counsel may object from time
`to time, and unless she specifically instructs
`you not to answer the question, you can go ahead
`and answer the question, all right?
` A Yes.
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`Transcript of Robin S. Goland, M.D.
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`8
`
` Q And you let me know if you want to
`take a break at any point today and we will do
`that, all right?
` A I will.
` Q Okay. We're going to mark this as
`Exhibit 1095.
` (Goland Exhibit 1095 marked for
`identification and attached to the transcript.)
` Q So Exhibit 1095 is simply the
`Deposition Notice for your deposition today.
` Do you understand you're here today
`to provide sworn testimony in a proceeding
`that's taking place before the United States
`Patent Trial and Appeal Board?
` A I'm sorry, I missed the last part.
` Q That's okay.
` Do you understand you're here today
`to provide sworn testimony in a proceeding
`before the United States Patent Trial and Appeal
`Board?
` A Yes.
` Q Okay. And what did you do to prepare
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`Transcript of Robin S. Goland, M.D.
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`9
`
`for your deposition today?
` MS. WU: I'll caution the witness not
`to share any privileged information or
`communication.
` A I reviewed some literature. I wrote
`a declaration in collaboration with my lawyers.
` Q Did you meet with anyone to prepare
`for your deposition today?
` A The lawyers.
` Q Okay. When did you meet with them?
` A Well, we -- I don't have the exact
`dates. I could look it up, I believe. But we
`met by Zoom and we met yesterday.
` Q Okay. How long in total do you think
`you spent preparing your declaration?
` A Seven or eight hours would be my
`estimate.
` Q Okay. Have you reviewed the
`transcripts of any depositions that have been
`taken in this case?
` A No, I have not.
` Q Okay. Let me give you a copy of your
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`Transcript of Robin S. Goland, M.D.
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`10
`
`declaration. And this has been previously
`marked as Exhibit 2054.
` (Goland Exhibit 2054 marked for
`identification and attached to the transcript.)
` Q Do you recognize, Dr. Goland, what's
`been marked as Exhibit 2054 as the declaration
`that you submitted in these proceedings?
` A Yes.
` Q And I'm going to mark one other
`exhibit so you have it handy today. This has
`been previously marked as Exhibit 1001.
` (Goland Exhibit 1001 marked for
`identification and attached to the transcript.)
` Q You are familiar, I take it, with
`Novo Nordisk's U.S. Patent Number 10,335,462; is
`that fair?
` A Yes.
` Q And that's what's been handed to you
`and marked as Exhibit 1001, correct?
` A Yes.
` Q And if I refer to that today as the
`'462 patent, you'll understand what I'm talking
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`11
`
`about?
` A Yes.
` Q Aside from the '462 patent, did you
`review any other patents in preparing your
`expert declaration?
` A No, I did not.
` Q All right. In paragraph 3 of your
`declaration, Exhibit 2054, you say that you're
`offering opinions "regarding certain objective
`indicia of nonobviousness, specifically,
`unexpected results, long-felt need, skepticism
`and praise related to the '462 patent."
` Do you see that?
` A I do.
` Q So you're not offering an opinion as
`to the broader question of whether the claims of
`the '462 patent would have been obvious to a
`person of skill in the art at the priority date,
`correct?
` A I am offering opinions about
`unexpected results, long-felt need, skepticism
`and praise.
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`12
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` Q Okay. So not the overall question of
`obviousness, fair?
` A I believe so, yes.
` Q Okay. Did you review the
`declarations submitted by any of Mylan's expert
`witnesses in this proceeding?
` A No.
` Q If you turn to Section IV of your
`declaration, which I believe starts on page 7
`and goes through page 9, you have a Legal
`Standards section there.
` Do you see that?
` A I do.
` Q All right. And in that section you
`describe certain legal principles that were
`described to you and that may be relevant to
`your opinions; is that right?
` A Yes, that's correct.
` Q Does Section IV in your declaration
`identify all of the legal standards that you
`were instructed on for purposes of offering
`opinions in this proceeding?
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`13
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` A Yes.
` Q Okay. In considering whether the
`objective indicia of nonobviousness that you
`discuss in your report have a nexus to the '462
`patent claims, did you consider whether Ozempic
`embodies claims from patents other than the '462
`patent?
` MS. WU: Objection. Form.
` A I'll need that question restated. I
`would like to point out that I'm here in my
`capacity as a practicing endocrinologist, so
`conducting clinical trials. As you know, I'm
`not a patent attorney, so the legal terms are
`those that I have learned from the lawyers that
`I was asked to apply in my capacity as a doctor,
`not a lawyer.
` So those were a lot of legal terms.
`So maybe you could break it down for me and I
`will try my best to answer your question.
` Q Of course.
` My question was, you offer opinions
`concerning certain objective indicia of
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`14
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`nonobviousness, correct?
` A Well, I offered opinions on the
`criteria that we just agreed upon, which I
`believe you, in a legal framework, consider that
`to be -- I'm not even sure I could say it
`properly -- indicia of nonobviousness.
` Q Correct. You offered opinions on
`things like unexpected results --
` A Yes.
` Q -- long-felt unmet need, skepticism
`and praise, correct?
` A Correct.
` Q Okay. And your opinions in that
`regard relate to Ozempic, correct?
` A They relate to what I'm familiar
`with, which is using the medication Ozempic
`given at 1 milligram subcutaneously to patients
`at one dose per week. So that's what I'm
`talking about here.
` Q Okay. And, for example, in
`paragraph 26 of your report, where you're
`describing the legal standards that you applied
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`15
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`in reaching your opinions, you talk about the
`nexus between a patented invention and the
`objective indicia of nonobviousness that you
`discuss.
` Do you see that?
` A I do.
` Q And, as I understand it, in
`determining whether there was a nexus between
`things like unexpected results and other
`objective indicia in the '462 patent claims, you
`didn't look at any other patents that may or may
`not cover Ozempic; is that fair to say?
` A That is true.
` Q Now, in paragraph 26 of your report,
`you say that you were "instructed that there is
`no requirement that evidence of objective
`indicia be tied exclusively to claim elements
`that are not disclosed in a particular prior art
`reference."
` Do you see that?
` A I do.
` Q Okay. In reaching the opinions that
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`16
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`you offer in your declaration, did you
`understand that where objective indicia result
`from something other than what is both claimed
`and novel in the claim, there is no nexus to the
`merits of the claimed invention?
` MS. WU: Objection. Form.
` Q Were you instructed on that legal
`principle, to the best of your recollection?
` A I'll need you to restate that.
` Q Of course.
` In reaching your opinions on
`objective indicia, did you understand that where
`objective indicia result from something other
`than what is both claimed and novel in the
`claim, there is no nexus to the merits of the
`claimed invention?
` A I refer you to paragraph 26. This is
`what I was instructed on by my lawyers. And not
`being a lawyer, being a doctor, this is what I
`understand.
` Q Okay. Generally speaking, do you
`know what the term "prior art" means in the
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`17
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`patent context?
` MS. WU: Objection. Scope.
` A I'm not sure I could give you a
`proper legal definition.
` Q Okay. I take it, then, in reaching
`your opinions that you offer in the case, you
`didn't review any prior art to the '462 patent;
`is that fair to say?
` MS. WU: Objection. Form and scope.
` A Well, once again, I'm not a patent
`lawyer. So I reviewed the aspects that a doctor
`would reasonably be able to talk about, which
`are those parameters that we talked about.
` Q Let me just -- I'll try to break it
`down so it's not -- so we're not using as many
`legal terms.
` A That would be helpful.
` Q In your declaration in paragraph 14,
`you -- that's in a section of your report titled
`"Priority Date and One of Ordinary Skill."
` Do you see that?
` A Uh-huh.
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`18
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` Q Okay. And one of the things you say
`in there or you address in there is the time of
`the invention, which you say you "understand is
`March 17, 2010, or at least May 28, 2010 ... but
`in any event no later than July 1, 2012."
` Do you see that?
` A I do.
` Q And in reaching the opinions that you
`offer in your declaration, you didn't, as I
`understand it, review any literature or patents
`or material from before July of 2012; is that
`fair?
` MS. WU: Objection. Form.
` A Well, I'm -- as a practicing doctor,
`I'm certainly familiar with the diabetes
`literature prior to 2010.
` Q But you didn't review any of that
`literature in forming the opinions that were
`offered in your declaration; is that fair to
`say?
` MS. WU: Objection. Form.
` A Well, in discussing the impact that
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`19
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`this medication had in the prior field, one
`needs to be aware of the prior effect and the
`studies of the prior medicine. So that's not
`entirely fair.
` Q I guess -- you have an appendix in
`your declaration that lists the materials you --
` A Ah, those references.
` Q -- reviewed in coming your opinions;
`is that correct?
` A I'm sorry to interrupt you.
` Q That's okay.
` A The references are not in the
`appendix, that is correct.
` Q Okay. The only references that you
`list in your appendix are from after what we
`call the priority date, so after July of 2012;
`is that fair?
` A That is correct.
` Q Okay. In paragraph 21 of your expert
`report -- and I'll just give you a moment to
`look at that, but there you describe your
`understanding concerning what qualifies as
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`20
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`evidence of unexpected results.
` A I am there.
` Q Okay. In forming your opinions in
`this matter, did you determine what the closest
`prior art is to the '462 patent claims?
` A I formed my opinion on the results
`that Ozempic brought to the treatment of people
`with diabetes and the prior results that earlier
`treatment brought.
` Q There were many earlier treatments
`for diabetes before Ozempic, correct?
` A There were.
` Q Okay. Did you determine what the
`closest prior art is to the '462 patent claims
`in reaching your opinions?
` A A big problem in the field of
`treating people with diabetes -- and as you know
`from looking at my CV, I take care of 15,000 of
`them as the head of a big diabetes center -- a
`huge problem in taking care of people with
`type 2 diabetes is virtually everything that we
`could offer prior to Ozempic sub-Q weekly was
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`21
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`that it would cause low blood sugar and weight
`gain. So it was pretty easy to compare this new
`drug to the previous drugs and to find that the
`results that we were seeing with this new drug
`were pretty surprising and unexpected.
` Q Well, not all previous drugs for
`diabetes caused low blood sugar and weight gain,
`correct?
` A At best, they were weight neutral or
`they caused a little bit of weight gain. So if
`you have a 300-pound person in the office and
`you provided a 5 percent weight loss, which is
`what -- even a 10 percent weight loss, which was
`very hard to achieve, I was the only happy
`person in the office. That person -- and it was
`often the wife -- would say, do you weigh 270
`pounds? There is no reason to have a happy
`dance here.
` We were sorely lacking, short of
`bariatric surgery, a medical treatment that
`could provide large-scale weight loss. I didn't
`believe it was possible, frankly. And I would
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`Transcript of Robin S. Goland, M.D.
`Conducted on April 9, 2024
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`22
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`spend a lot of time educating people that a 5-
`to 10-pound weight loss was as good as we were
`going to do, and we should be happy with that
`because the blood sugar sometimes got a little
`better. And so that was the state of the art in
`my medical parlance prior to 2017.
` Q When you were reaching your opinions
`in this case, did you understand that the
`starting reference point for evaluating
`unexpectedness is the closest prior art?
` MS. WU: Objection. Scope and form.
` A "Closest prior art." I understood it
`to be what was available before the availability
`of the medication.
` Q And as we've said, there are many
`things for treating type 2 diabetes that were
`available before Ozempic, correct?
` A Well, there weren't -- there were
`several things available.
` Q All right. Did you determine which
`of those several things was the closest prior
`art to the '462 patent claims in reaching your
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`Transcript of Robin S. Goland, M.D.
`Conducted on April 9, 2024
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`23
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`opinions in this case?
` A Yes, I did.
` Q And what was the closest prior art,
`in your opinion?
` A There were other GLP-1 analogs, and
`there were other drugs, such as metformin, that
`caused a little bit of weight loss without
`hypoglycemia.
` Q And which one of those was the
`closest prior art, in your opinion?
` MS. WU: Objection. Scope.
` A The other GLP-1 drugs.
` Q Which ones were those?
` MS. WU: Objection. Scope.
` A Exenatide, Victoza and Bydureon.
` Q Now, exenatide is -- that was a GLP-1
`analog that was dosed twice daily; is that
`right?
` A That is correct.
` Q All right. Bydureon is a GLP-1
`analog that was dosed once weekly, correct?
` A Yes.
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`Transcript of Robin S. Goland, M.D.
`Conducted on April 9, 2024
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`24
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` Q Victoza was a GLP analog that was
`dosed once daily, correct?
` A That is correct.
` Q What about dulaglutide?
` A And Trulicity was later.
` Q And you said Trulicity. That's
`dulaglutide, correct?
` A Yes. I forgot that one.
` Q What about albiglutide?
` A That was another one that came out
`later.
` Q When you say "later," what do you
`mean?
` A Well, later than -- chronologically,
`exenatide was available very early.
` Q Dulaglutide was available on the
`market before Ozempic; is that right?
` A I would have to look up the dates.
` Q How about albiglutide? Was that
`available on the market before Ozempic?
` A I think that was about the same time
`later, but I would have to look up the timeline.
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` Q Okay. Of all those GLP-1 receptor
`agonists, which one do you view as the closest
`prior art to the claims of the '462 patent?
` MS. WU: Objection. Form and scope.
` A I would need those terms described.
` Q Which terms?
` A So which has the same -- so in
`medical language, which of those has the same
`effect? Which of them is in the same class?
`Please explain the question.
` Q I take it that is not something you
`addressed in your declaration; is that fair?
` A Well, possibly the words need to be
`explained. I think that would help me.
` Q You -- I take it it wasn't explained
`to you that you needed to identify the closest
`prior art in preparing your declaration; is that
`fair? Because it seems like something you're
`not familiar with.
` A Well, the things that I talked about
`were the unexpected results, the skepticism, the
`long-felt need and the praise.
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`26
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` Q And I didn't see anything in your
`declaration where you identified what you view
`as the closest prior art to the '462 patent. If
`there is someplace in your declaration where you
`think you did that, could you point it out to
`me?
` A I do not think those words are
`exactly in there.
` Q Okay.
` In reaching your opinions in this
`case, did you consider whether the prior art to
`the '462 patent disclosed the use of semaglutide
`to treat type 2 diabetes?
` MS. WU: Objection. Form.
` A So you're asking were there earlier
`patents for semaglutide, I would say, prior to
`this patent?
` Q Sure.
` A I'm not aware that there were.
` Q Were you aware, in reaching your
`opinions, that the prior art to the '462 patent
`disclosed the chemical structure of semaglutide?
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`27
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` A So again, this is out of the scope of
`my expertise. I'm here as a clinical doctor who
`uses these medications. I'm not a chemist so I
`really can't speak to the chemical structure of
`these medications with great expertise.
` Q Okay. Have you ever prescribed
`Ozempic to a person without type 2 diabetes?
` A No. I run a very big diabetes
`center. I don't know very many people without
`type 2 diabetes.
` Q So you've never prescribed Ozempic to
`somebody who was not diagnosed with type 2
`diabetes but might be considered prediabetic; is
`that fair?
` A No.
` Q I'm sorry, I should have asked a
`better question. I shouldn't have ended it "is
`that fair" because it makes the answer
`ambiguous. You have never prescribed Ozempic to
`someone who doesn't have diabetes but might be
`described as prediabetic?
` A So the diabetes center at Columbia is
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`28
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`hugely oversubscribed with people with real,
`actual diagnosed diabetes so we don't have the
`bandwidth to take care of people with
`prediabetes except antibody-positive type 1
`prediabetes, so I wouldn't really have the
`opportunity to manage pre-type 2 diabetes.
` Q Okay.
` If you would look at paragraph 43 in
`your declaration.
` A Okay.
` Q And you say there -- this is at the
`end of paragraph 43. You say, "Thus, in my
`opinion, treating patients with Ozempic
`according to the FDA-approved label for Ozempic
`practices (that is, meets all the limitations
`of) at least claim 1 of the '462 patent because
`Ozempic (the active ingredient of which is
`semaglutide) is administered once weekly in an
`amount of 1 milligram to treat type 2 diabetes,
`as required by claim 1."
` Do you see that?
` A I do.
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`29
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` Q All right.
` Now, you understand that there are
`FDA-approved maintenance doses for Ozempic other
`than 1 milligram, correct?
` A The labeling suggests that you
`titrate from .25 to .5 and to 1, as tolerated.
`The vast majority of my patients are on
`1 milligram. A few years ago a 2 milligram dose
`was approved, but for many years 1 milligram was
`the FDA-recommended dose.
` Q Well, the FDA-recommended dose is a
`half milligram. A half milligram is also a
`maintenance dose for Ozempic in the label,
`correct?
` A My read of the label is .25, then .5,
`to 1, as tolerated. So I would argue that 1 is
`the most common -- it's certainly the most
`commonly prescribed dose.
` Q My question wasn't what is the most
`commonly prescribed dose. My question was a
`half milligram is an FDA-approved maintenance
`dose of semaglutide for treating type 2
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`diabetes, correct?
` A Are you getting out the label?
` Q Do you agree with that?
` A Well, .25, .5 and 1 are all approved
`doses but they are part of the titration
`schedule.
` Q Well, my question for you is about
`the maintenance dose, not the titration doses.
`You can titrate up to 1 milligram, correct, but
`the label also says you can stay with a
`maintenance dose of a half milligram but you
`titrate to 1 milligram if additional glycemic
`control is necessary; is that right?
` A My read of it is that you should aim
`to get to 1 milligram.
` MR. ANSTAETT: Okay. Let's go ahead
`and mark 2076.
` A And in a handful of patients who
`can't tolerate the 1 milligram, I go back down
`to the .5.
` Q Okay.
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`31
`
` (Goland Exhibit 2076 marked for
`identification and attached to the transcript.)
` Q Okay. So the court reporter has
`handed you what's marked as Exhibit 2076.
` Do you recognize this as the
`prescribing information for Ozempic as of March
`2022?
` A Right. Do you have the 2017 label?
` Q Sure. Let me ask you -- let me
`just -- we can mark that next, but let me just
`ask you, with respect to Exhibit 2076, you
`agree -- I think you said yes, but you agree
`this is the Ozempic prescribing information as
`of March 2022; is that right?
` A Yes.
` Q And there is a section on the first
`page of the exhibit that says "Dosage and
`Administration," correct?
` A I see that.
` Q And the instructions are to start at
`.25 milligrams once weekly and, after 4 weeks,
`increase the dose to a half milligrams once
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`32
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`weekly, correct?
` A I see that.
` Q And then the label instructs, "If
`additional glycemic control is needed, increase
`the dose to 1 milligram once weekly after at
`least 4 weeks on the half milligram dose,"
`correct?
` A That is correct.
` Q And so the half milligram dose is a
`maintenance dose for Ozempic, according to these
`instructions, correct?
` A Yes.
` Q Okay. Did you think that there --
`I'm happy to show you the 2017 prescribing
`information if you would like to see that.
` A Yes, I would, because this also has
`the 2 milligram dose, which wasn't available
`early on.
` Q Correct.
` MR. ANSTAETT: Let's go ahead and
`mark this as Exhibit 2072.
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`33
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` (Goland Exhibit 2072 marked for
`identification and attached to the transcript.)
` Q So the court reporter has handed you
`what's been previously marked as Exhibit 2072.
` Do you recognize that exhibit as the
`Ozempic prescribing information as of December
`2017?
` A Yes, I do.
` Q And then it has a Dosage and
`Administration section, correct?
` A Yes.
` Q And the instructions there are to
`"Start at .25 milligrams once weekly. After
`4 weeks, increase the dose to a half milligram
`once weekly. If after at least 4 weeks
`additional glycemic control is needed, increase
`to 1 milligram once weekly," correct?
` A That is correct.
` Q So this label also instructed that
`the half milligram dose of Ozempic was a
`maintenance dose, correct?
` A Well, it cou
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