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
` JOHN P. BANTLE, M.D.
`
` VIA VIDEO/TELECONFERENCE
` THURSDAY, JULY 11, 2024
` 10:05 a.m. EASTERN TIME
`
`Job No.: 534504
`Pages: 1 - 78
`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
` JOHN P. BANTLE, M.D.
`
` VIA VIDEO/TELECONFERENCE
` THURSDAY, JULY 11, 2024
` 10:05 a.m. EASTERN TIME
`
`Job No.: 534504
`Pages: 1 - 78
`Reported by: Lisa V. Feissner, RDR, CRR, CLR
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`Mylan Pharms. Inc. v. Novo Nordisk A/S
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`
`Transcript of John P. Bantle, M.D.
`Conducted on July 11, 2024
`
`2
`
` Oral deposition of JOHN P. BANTLE, M.D.,
`held REMOTELY, via ZOOM, on THURSDAY, JULY 11, 2024,
`BEGINNING at 10:05 a.m., pursuant to NOTICE, before
`Lisa V. Feissner, RDR, CRR, CLR, Notary Public.
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`Novo Nordisk Exhibit 2552
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`
`
`Transcript of John P. Bantle, M.D.
`Conducted on July 11, 2024
`
`3
`
`A P P E A R A N C E S:
`ON BEHALF OF PETITIONER:
` EMILY J. GREB, ESQUIRE
` AARON SCHINDLER, 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
` egreb@perkinscoie.com
` aschindler@perkinscoie.com
` bbeel@perkinscoie.com
`
`ON BEHALF OF PATENT OWNER:
` MEGAN F. RAYMOND, ESQUIRE
` JOSHUA REICH, ESQUIRE (NY office)
` GROOMBRIDGE WU BAUGHMAN & STONE LLP
` 801 17th Street, NW, Suite 1050
` Washington, DC 20006
` 202.505.5878
` megan.raymond@groombridgewu.com
` joshua.reich@groombridgewu.com
`
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`Mylan Pharms. Inc. v. Novo Nordisk A/S
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`Transcript of John P. Bantle, M.D.
`Conducted on July 11, 2024
`
`4
`
` C O N T E N T S
`EXAMINATION OF JOHN P. BANTLE, M.D. PAGE
` By Ms. Raymond 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 1001 15
`MPI Exhibit 1282 25
`MPI Exhibit 1300 11
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`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
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`10:05:27
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`Transcript of John P. Bantle, M.D.
`Conducted on July 11, 2024
`
`5
`
` P R O C E E D I N G S
` JOHN P. BANTLE, M.D.,
`having been first duly sworn, was examined and
`testified as follows:
` EXAMINATION
`BY MS. RAYMOND:
` Q Good morning, Dr. Bantle.
` A Good morning.
` Q Is it your understanding that you're here
`to testify about the '462 patent today?
` A Yes.
` Q And the report you submitted in IPR
`2023-00724, marked as Exhibit 1300, you're prepared
`to testify about that today?
` A Yes.
` Q Okay. And are you aware of an expert
`named Dr. Jusko?
` MS. GREB: Object to form.
` A Yes.
` Q Have you talked to Dr. Jusko in
`connection with your testimony about the '462
`patent?
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`Transcript of John P. Bantle, M.D.
`Conducted on July 11, 2024
`
`6
`
` A No.
` Q Have you read any of Dr. Jusko's reports
`regarding the '462 patent?
` A Yes.
` Q Which reports are those?
` A I cannot tell you specifically which
`report. I think it was his first report from some
`many months ago.
` Q So the first report in this IPR?
` A I think so. If you'd like to know with
`certainty, I could look at my report to see which
`one it was.
` Q If you could take a look at your report
`and tell me which report of Dr. Jusko you reviewed.
`Could you please do that.
` A Yes.
` MS. GREB: So for clarity on the record,
`Dr. Bantle, are you taking out a paper copy of
`Exhibit 1300, your reply declaration?
` THE WITNESS: No. Right now I'm looking
`at the first declaration, the original declaration.
` MS. GREB: And that's Exhibit 1003?
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`Transcript of John P. Bantle, M.D.
`Conducted on July 11, 2024
`
`7
`
` THE WITNESS: Yes.
` Well, I'm not finding it in the original
`declaration. I'm looking now in the reply
`declaration to see if I can find it there.
`BY MS. RAYMOND:
` Q Thank you.
` A I didn't find it there either. May
`counsel direct me to where I would find it?
` Q I was just asking whether you recalled
`which Jusko report you'd reviewed. So you're not
`finding it as listed in the materials considered,
`but you do recall reviewing a report of Dr. Jusko's
`on the '462 patent?
` A Yes.
` Q And do you recall whether that report was
`for an IPR or whether it was for litigation in
`another forum?
` MS. GREB: I'm going to object to form.
`Certainly any questions related to litigations in
`another forum would not be appropriate in this
`deposition.
` MS. RAYMOND: There aren't speaking
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`Transcript of John P. Bantle, M.D.
`Conducted on July 11, 2024
`
`8
`
`objections. If you want to --
` (Cross-talk.)
` MS. GREB: I know.
` You can answer the question yes or no.
` A Could you ask it again?
` Q Yes. Do you recall whether that report
`that you reviewed of Dr. Jusko's was for an IPR or
`whether it was for another -- a litigation in
`another forum?
` MS. GREB: Same objection.
` A I believe it was for the IPR.
` Q Do you recall reviewing any deposition
`transcripts of Dr. Jusko?
` MS. GREB: Object to form.
` A No.
` Q Do you recall, when reviewing Dr. Jusko's
`report, reviewing Dr. Jusko's background?
` MS. GREB: Object to form.
` A I do recall reviewing a little bit about
`his background, yes.
` Q And do you have a view as to whether your
`expertise is different from Dr. Jusko's?
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`Transcript of John P. Bantle, M.D.
`Conducted on July 11, 2024
`
`9
`
` MS. GREB: Object to form.
` A Yes. We are different.
` Q And how are you different?
` A I'm an M.D., and I think he is a
`pharmacist, has a Ph.D. degree in pharmacy, I
`believe.
` Q Do you recall the opinions in his report
`being about different topics than you opined on or
`the same topics?
` MS. GREB: Object to form.
` A I think some were similar or the same,
`and others were quite different.
` Q Do you know why you and Dr. Jusko
`testified about some of the same topics in your
`report?
` MS. GREB: Object to form. Object to
`foundation.
` A Well, I think in some instances, the
`topic was relevant to both of us, and we both have
`knowledge about it. And in other instances --
` MS. GREB: And I'm going to also caution
`the witness not to reveal the contents of any
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`Transcript of John P. Bantle, M.D.
`Conducted on July 11, 2024
`
`10
`
`communications with attorneys.
` To the extent you can answer the question
`based on your personal knowledge and any reading of
`Dr. Jusko's report outside of communications with
`attorneys, that's fine. But if you're veering into
`communications with attorneys, you should not answer
`the question.
` A And would you ask the question again?
` Q Do you know why you and Dr. Jusko
`testified about some of the same topics in your
`reports?
` MS. GREB: Same instruction, and same
`objections.
` A I think it was because in some areas, our
`knowledge and experience overlap.
` Q And do you know why there are multiple
`expert reports on the same areas where the knowledge
`and experience of the experts overlaps?
` MS. GREB: So I'm going to instruct you
`not to answer that question, Dr. Bantle. Any
`communications with attorneys would be not
`discoverable, and the question asks for
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`Transcript of John P. Bantle, M.D.
`Conducted on July 11, 2024
`
`11
`
`communications that would be work product protected
`and not discoverable under the PTAB rules.
` Q Are you going to follow your attorney's
`instruction?
` A Yes.
` (Previously marked Exhibit 1300 presented
`to the witness.)
`BY MS. RAYMOND:
` Q Could you please turn to paragraph 30 of
`your report. And when I'm saying "your report,"
`paragraph 30 of your second report marked
`Exhibit 1300.
` A Got it.
` Q And do you see the phrase "critical to
`the operability of the claimed invention" in
`paragraph 30?
` A Yes.
` Q Is it your understanding that the
`operability of the claimed invention must itself be
`claimed?
` MS. GREB: Object to form, foundation.
` A I don't understand the question. Could
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`Transcript of John P. Bantle, M.D.
`Conducted on July 11, 2024
`
`12
`
`you rephrase it?
` Q What do you mean by "critical to the
`operability of the claimed invention"?
` MS. GREB: Object to form.
` A This paragraph states that it must be
`critical to the operability of the claimed
`intervention [sic].
` Q Yes. And what do you mean by that?
` MS. GREB: Object to form.
` A I think it means that the claimed
`intervention [sic] must in some way be critical.
` Q What do you mean by, it means that the
`claimed intervention must in some way be critical?
` MS. GREB: Object to form.
` A Well, it must be more than what -- let me
`state it in a different way.
` It must create a difference relative to
`the broader prior art.
` Q It must create a difference in what
`relative to the broader prior art?
` MS. GREB: Object to form.
` A Some feature of the intervention [sic].
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`Transcript of John P. Bantle, M.D.
`Conducted on July 11, 2024
`
`13
`
` Q Does that feature need to be claimed in
`the patent at issue?
` MS. GREB: Object to form, foundation.
` A Well, that seems to be more a legal
`question than a medical question. And so I don't
`feel completely confident of how to answer the
`question.
` But yes, I think it must.
` Q In forming your opinions, did you assume
`that the feature needed to be claimed in the patent
`at issue?
` MS. GREB: Object to form.
` A Yes.
` Q Could you please turn to paragraph 56 of
`your report marked Exhibit 1300.
` A Yes, I've got it.
` Q And there you refer to the Board's claim
`construction, and you say, the once-weekly
`1.0 milligram dose of semaglutide achieve a
`particular level of efficacy.
` Do you see that language at the end of
`paragraph 56?
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`Transcript of John P. Bantle, M.D.
`Conducted on July 11, 2024
`
`14
`
` A I see that it states there's no
`requirement that the 1 milligram dose of semaglutide
`achieve a particular level of efficacy.
` Q And is it your position that no efficacy
`at all is required by the '462 claims under this
`construction?
` MS. GREB: Object to form.
` A Well, I'm of the opinion that no
`particular level of efficacy is necessary.
` Q And is it your position that no efficacy
`at all is required by the '462 claims under this
`construction?
` MS. GREB: Object to form.
` A I think, looking at that language
`literally, yes, there would be no level of efficacy
`required.
` Q And do the claims require an expectation
`that type 2 diabetes is treated by giving the
`patient semaglutide at 1 milligram once weekly?
` MS. GREB: Object to form, foundation.
` A Yes.
` Q Would claim 1 of the '462 patent be met,
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`Transcript of John P. Bantle, M.D.
`Conducted on July 11, 2024
`
`15
`
`in your opinion, if the 1 milligram once-weekly
`semaglutide actually made diabetes worse in a
`patient?
` MS. GREB: Object to form, foundation.
` A I need to look at claim 1 before I answer
`that question. So shall I search for it?
` (Previously marked Exhibit 1001 presented
`to the witness.)
` Q Sure. Claim 1 is Exhibit 1001, if you'd
`like to look at it.
` A So I now have the patent, and I now have
`to go back and find the claims, which I believe are
`at the end.
` Here it is. Column 35. A method for
`treating type 2 diabetes, comprising administering
`semaglutide once weekly in the amount of
`1.0 milligram to a subject in need thereof.
` So your question is, again -- can you
`restate it?
` Q Sure. Would claim 1 of the '462 patent
`be met, in your opinion, if the 1 milligram
`once-weekly semaglutide actually made diabetes worse
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`Transcript of John P. Bantle, M.D.
`Conducted on July 11, 2024
`
`16
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`in patients?
` MS. GREB: Object to form.
` A Well, I'm not sure how to answer that
`question. I guess the key word there is "treating."
`And if a treatment makes a condition worse, is it
`still a treatment.
` I would say yes, it is; it's just not a
`good treatment.
` Q So that would -- in your opinion, if the
`semaglutide made the diabetes worse, that would
`still meet claim 1 of the '462 patent?
` MS. GREB: Object to form.
` A Yes. No level of efficacy is required,
`and so a negative effect, I guess, would still meet
`that claim.
` And I guess, as I think about this, I
`might add, I'm aware of treatments for a variety of
`conditions that do make the condition worse, not
`better. So that is in the realm of possibility, I
`would say.
` Q Could you please turn to paragraph 66 of
`your report.
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`Transcript of John P. Bantle, M.D.
`Conducted on July 11, 2024
`
`17
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` A Of the reply report or the opening
`report?
` Q Sorry. Of the reply report,
`Exhibit 1300.
` For the purpose of today, if I just refer
`to one of your reports as your report, can we just
`understand that that's the reply report,
`Exhibit 1300?
` A Yes. And I'm sorry, which paragraph?
` Q Sure. If you could turn to paragraph 66,
`please.
` A Yes, I have it.
` Q And my question is, are you aware of any
`disclosures in the prior art of dosing a GLP-1
`analog in anything other than tenths of a milligram
`doses?
` MS. GREB: Object to form.
` A Yes.
` Q What disclosures are those?
` MS. GREB: Object to form.
` A The only example of which I know is
`dulaglutide, which was dosed in increments as small
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`Transcript of John P. Bantle, M.D.
`Conducted on July 11, 2024
`
`18
`
`as 0.
` Q Would you please turn to paragraph 109 of
`your report.
` (Reporter interruption.)
` A I'm sorry. Which paragraph?
` Q Sorry. And so your last answer was about
`dulaglutide?
` A Dulaglutide, d-u-l.
` Q Thank you.
` If we could turn to paragraph 109 of your
`report, Exhibit 1300.
` A Yes, I have it.
` Q And it's your opinion that when --
`despite seeing that the phase 3 semaglutide studies
`were postponed, that a POSITA nevertheless would
`have thought that the results from that study were
`good?
` MS. GREB: Object to form.
` A Well, before I answer the question, I
`think I must read paragraph 109, which is actually
`quite long. So it will take a moment.
` I've read it now. Would you repeat the
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`10:27:16
`10:27:18
`10:27:19
`10:27:21
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`10:27:32
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`Transcript of John P. Bantle, M.D.
`Conducted on July 11, 2024
`
`19
`
`question since it's been a moment since you
`initially stated it?
` Q Sure. Is it your opinion that despite
`the semaglutide phase 3 studies being on hold, a
`POSA nevertheless would have thought that the
`results from the semaglutide studies were good?
` MS. GREB: Object to form.
` A Yes.
` Q Okay. And --
` A If I may qualify my answer.
` A POSA may have initially been disturbed
`by the word "postponed." But as a POSA looked more
`into the situation, a POSA would have discovered
`three things, all of which would have been
`encouraging.
` First of all, a POSA would have seen the
`2009 Novo Nordisk Securities and Exchange Commission
`filing of a Form 6-K, which indicated that the
`phase 2 trial of semaglutide had been successfully
`completed with a favorable outcome, and semaglutide
`showing efficacy and safety comparable to
`liraglutide.
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`10:28:29
`10:28:34
`10:28:39
`10:28:43
`10:28:49
`10:28:55
`10:28:59
`10:29:01
`10:29:14
`10:29:18
`10:29:23
`10:29:26
`10:29:31
`10:29:34
`10:29:41
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`Transcript of John P. Bantle, M.D.
`Conducted on July 11, 2024
`
`20
`
` Secondly, a POSA would have been aware of
`the 2010 Novo Nordisk annual report, which also
`stated that the phase 2 trial of semaglutide had
`been completed successfully, and that Novo Nordisk
`was awaiting data on long-acting liraglutide to
`decide between to two and which to develop for its
`long-acting portfolio.
` And then thirdly, a 2012 call between
`Novo Nordisk executives and various other people,
`investors, I believe, stated that semaglutide had
`successfully completed the phase 2 trial and was
`ready to enter phase 3 trial, but Novo Nordisk was
`postponing a decision about when to start that trial
`until it saw data about long-acting liraglutide and
`wanted to decide between the two as to which it
`should develop as a long-acting analog.
` And I think the Novo Nordisk executives
`summed up the position as a nice spot for Novo
`Nordisk to be in.
` So a POSA would not have been discouraged
`even though the word "postponed" was used.
` Q So how long was Novo going to wait or to
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`10:30:16
`10:30:19
`10:30:28
`10:30:29
`10:30:31
`10:30:35
`10:30:39
`10:30:41
`10:30:43
`10:30:47
`10:30:52
`10:30:56
`10:30:57
`10:31:02
`10:31:02
`10:31:05
`10:31:08
`10:31:11
`10:31:15
`10:31:16
`10:31:18
`10:31:20
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`Transcript of John P. Bantle, M.D.
`Conducted on July 11, 2024
`
`21
`
`postpone the phase 3 semaglutide studies to see the
`results for the long-acting liraglutide studies?
` MS. GREB: Object to form, foundation.
` A I don't know. But I think the call was
`in early 2012, and maybe in February, I believe, and
`the speaker for Novo Nordisk said they would be
`waiting until summer.
` So it was some months.
` Q Okay. But in 2010, the annual report
`referred to postponing the phase 3 trials pending a
`long-acting portfolio development strategy decision,
`right?
` MS. GREB: Object to form, foundation.
` A Yes.
` Q And that long-acting portfolio
`development strategy decision had to do with the
`long-acting liraglutide results.
` Is that correct?
` MS. GREB: Object to form, foundation.
` A Yes. There was no problem with
`semaglutide. Actually, the data on semaglutide
`looked very favorable. But they waited to make a
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`10:31:24
`10:31:27
`10:31:30
`10:31:31
`10:31:34
`10:31:37
`10:31:40
`10:31:42
`10:31:45
`10:31:51
`10:31:55
`10:31:58
`10:32:00
`10:32:02
`10:32:07
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`Transcript of John P. Bantle, M.D.
`Conducted on July 11, 2024
`
`22
`
`decision as to which of the molecules to develop
`because they wanted to see data on long-acting
`liraglutide.
` And I think a POSA would have realized
`that was fine because they had limited resources and
`wanted to invest in the molecule that was the most
`promising of the two.
` Q So in your opinion, a POSA would have
`assumed that Novo would have waited years to get the
`liraglutide long-acting results, even though the
`semaglutide results would have been assumed to be
`very favorable by a POSA.
` Is that correct?
` MS. GREB: Object to form.
` A Well, I can't speak to Novo Nordisk and
`its intent. But it would appear so.
` Q And what's your basis for the data
`looking very favorable for semaglutide?
` A Well, the first and perhaps most
`important is the SEC 6-K filing from 2009 where they
`reported that the results of the phase 2 trial of
`semaglutide were very favorable.
`
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`Transcript of John P. Bantle, M.D.
`Conducted on July 11, 2024
`
`23
`
` Q Is that the language from that SEC
`report, "very favorable"?
` MS. GREB: Object to form, foundation.
` A I'd need to look at the report if you
`want me to quote the language exactly. Would you
`like me to do so?
` Q Yes, please.
` MR. SCHINDLER: Here's the 6-K.
` THE WITNESS: Thank you.
` MS. GREB: What exhibit number?
` MR. SCHINDLER: Exhibit 1282.
` MS. GREB: Okay. So Dr. Bantle --
` MS. RAYMOND: Excuse me. It's not proper
`for you all to be giving him exhibit numbers. He
`has his report in front of him, and he has the
`exhibits. If you'd like to look at the 6-K report,
`we can have a conversation. But it's not
`appropriate for you all to be having on one end --
` MS. GREB: Oh. I think we thought that's
`what you wanted him to do when you said, "Yes,
`please."
` MS. RAYMOND: I think he asked about if
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`10:33:32
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`Transcript of John P. Bantle, M.D.
`Conducted on July 11, 2024
`
`24
`
`he could look at his 6-K report, and I said, yes, he
`could look at his 6-K report.
` MS. GREB: Yeah, I guess we thought the
`6-K report was the SEC filing. But if you don't
`want him to have it, we can move it away. I think
`that was just a misunderstanding.
` What do you want him to look at it?
` MS. RAYMOND: He can look at it. It just
`sounded like there were conversations going on on
`your end, which aren't appropriate during a
`deposition with your witness.
` MS. GREB: No, we were just looking for
`the 6-K report.
` MS. RAYMOND: Okay.
` MS. GREB: So what exhibit is in front of
`you, Dr. Bantle?
` THE WITNESS: 1282.
` MS. GREB: Okay. And that's the 6-K
`report?
` THE WITNESS: Yes.
` MS. GREB: Do we want to put it up on the
`screen so everybody is looking at the same thing?
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`10:34:17
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`Transcript of John P. Bantle, M.D.
`Conducted on July 11, 2024
`
`25
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` MS. RAYMOND: That's fine. We can do
`that.
` (Previously marked Exhibit 1282 presented
`to the witness.)
` THE WITNESS: So I think the relative
`portion is on page 12, in the middle of that page.
`BY MS. RAYMOND:
` Q Okay.
` A And it says, Novo Nordisk recently
`finalized a phase 2 study investigating safety and
`efficacy of five doses of semaglutide (NN9535), a
`once-weekly human GLP-1 analogue, versus placebo and
`open-label liraglutide add-on therapy in people with
`type 2 diabetes. At study start, patients were
`treated with metformin or controlled with diet and
`exercise.
` The 12-week multi-center, multi-national
`double-blind, placebo-controlled, randomized
`dose-finding trial, which included a little more
`than 400 patients, demonstrated that clinical
`efficacy and safety of semaglutide was broadly in
`line with liraglutide. Semaglutide was well
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`10:35:50
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`10:35:54
`10:35:58
`10:36:01
`10:36:04
`10:36:09
`10:36:11
`10:36:12
`10:36:14
`10:36:18
`10:36:22
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`Transcript of John P. Bantle, M.D.
`Conducted on July 11, 2024
`
`26
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`tolerated and was not associated with an increase in
`injection site reactions, antibody formation or
`calcitonin levels.
` After more detailed analysis of the
`dose-response findings on efficacy and safety, Novo
`Nordisk will discuss the future plans for
`semaglutide development with regulatory authorities
`before initiation of phase 3 development.
` Q And that's --
` A That's the end of the paragraph.
` Q Okay. And that's the basis for your
`stating that the SEC report -- the SEC report
`reported very favorable results for semaglutide,
`correct?
` MS. GREB: Object to form.
` A Yes. That's my interpretation. It says
`efficacy and safety were comparable to liraglutide,
`and liraglutide was a very successful drug.
` Q And does it say what doses of semaglutide
`were comparable -- had comparable results to what
`doses of liraglutide?
` A No, it does not. But a POSA would have
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`10:38:04
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`10:38:17
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