` 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
` WILLIAM J. JUSKO, Ph.D.
`
` VIA VIDEO/TELECONFERENCE
` FRIDAY, JULY 12, 2024
` 10:02 a.m. EASTERN TIME
`
`Job No.: 534506
`Pages: 1 - 59
`Reported by: Lisa V. Feissner, RDR, CRR, CLR
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`
`
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`Novo Nordisk Exhibit 2553
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Transcript of William J. Jusko, Ph.D.
`Conducted on July 12, 2024
`
`2
`
` Oral deposition of WILLIAM J. JUSKO,
`Ph.D., held REMOTELY, via ZOOM, on FRIDAY, JULY 12,
`2024, BEGINNING at 10:02 a.m., pursuant to NOTICE,
`before Lisa V. Feissner, RDR, CRR, CLR, Notary
`Public.
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`Novo Nordisk Exhibit 2553
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`
`
`Transcript of William J. Jusko, Ph.D.
`Conducted on July 12, 2024
`
`3
`
`A P P E A R A N C E S:
`ON BEHALF OF PETITIONER:
` COURTNEY M. PROCHNOW, Ph.D., ESQUIRE
` SHANNON M. BLOODWORTH, ESQUIRE (D.C. ofc)
` BRYAN D. BEEL, Ph.D., ESQUIRE (Portland ofc)
` PERKINS COIE LLP
` 1888 Century Park East
` Suite 1700
` Los Angeles, CA 90067-1721
` 310.788.3284
` cprochnow@perkinscoie.com
` sbloodworth@perkinscoie.com
` bbeel@perkinscoie.com
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`Novo Nordisk Exhibit 2553
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`
`
`Transcript of William J. Jusko, Ph.D.
`Conducted on July 12, 2024
`
`4
`
`A P P E A R A N C E S:
`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
`
`A L S O P R E S E N T:
` KELLI WELCH, A/V Technician
` PRESTON IMPERATORE, ESQ., Mylan
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`Novo Nordisk Exhibit 2553
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`
`
`Transcript of William J. Jusko, Ph.D.
`Conducted on July 12, 2024
`
`5
`
` C O N T E N T S
`EXAMINATION OF WILLIAM J. JUSKO, Ph.D. PAGE
` By Ms. Raymond 6
`
` 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 16
`MPI Exhibit 1301 6
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`Novo Nordisk Exhibit 2553
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
`
`
`
`10:02:02
`10:02:03
`10:02:03
`10:02:06
`10:02:09
`10:02:11
`10:02:12
`10:02:18
`10:02:20
`10:02:24
`10:02:30
`10:02:34
`10:02:36
`10:02:36
`10:02:40
`10:02:42
`10:02:43
`10:02:47
`10:02:47
`
`Transcript of William J. Jusko, Ph.D.
`Conducted on July 12, 2024
`
`6
`
` P R O C E E D I N G S
` WILLIAM J. JUSKO, Ph.D.,
`having been first duly sworn, was examined and
`testified as follows:
` EXAMINATION
`BY MS. RAYMOND:
` Q Good morning, Dr. Jusko.
` A Good morning.
` Q Is it your understanding that you're here
`to testify this morning about the '462 patent?
` A That is correct.
` Q And the report you submitted in IPR
`2023-00724, which is marked as Exhibit 1301, that's
`your report, correct?
` A I don't remember all those numbers you
`recited, but this is an IPR hearing --
` Q Okay.
` A -- that I'm giving testimony.
` Q Sorry for interrupting.
` Can you put in front of you your report
`for this case, your reply report.
` (Previously marked Exhibit 1301 presented
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`Novo Nordisk Exhibit 2553
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00006
`
`
`
`10:02:50
`10:02:50
`10:02:58
`10:02:59
`10:02:59
`10:03:02
`10:03:04
`10:03:06
`10:03:07
`10:03:12
`10:03:14
`10:03:14
`10:03:20
`10:03:22
`10:03:23
`10:03:32
`10:03:34
`10:03:35
`10:03:39
`10:03:40
`10:03:43
`10:03:45
`
`Transcript of William J. Jusko, Ph.D.
`Conducted on July 12, 2024
`
`7
`
`to the witness.)
` THE WITNESS: Okay. So I have -- very
`good.
`BY MS. RAYMOND:
` Q And the report you have in front of you,
`that's one of the reports at least you're here to
`testify about today?
` A Yes, it is.
` Q And that says Exhibit 1301 at the bottom.
` Is that correct?
` A Correct.
` Q And it references IPR 2023-00724.
` Is that correct?
` A That's correct.
` Q Great. Are you aware of a Dr. Bantle?
`Does that name ring a bell?
` A Sometimes your voice is not coming
`through clearly. But I believe you asked something
`about Dr. Bantle.
` Q Yes. Are you aware of a Dr. Bantle?
` A I am aware of him, yes.
` Q Have you read any of his reports in this
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`Novo Nordisk Exhibit 2553
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00007
`
`
`
`10:03:49
`10:03:50
`10:03:52
`10:03:54
`10:03:58
`10:03:58
`10:04:01
`10:04:04
`10:04:08
`10:04:10
`10:04:33
`10:04:36
`10:04:41
`10:04:44
`10:04:45
`10:04:46
`10:04:55
`10:04:57
`10:05:01
`10:05:05
`10:05:06
`10:05:08
`
`Transcript of William J. Jusko, Ph.D.
`Conducted on July 12, 2024
`
`8
`
`IPR?
` A No.
` Q Have you read any of his deposition
`transcripts in this IPR?
` A No.
` Q Have you read any other materials
`prepared by Dr. Bantle in connection with the
`invalidity of the '462 patent?
` MS. PROCHNOW: Objection, form.
` A Not that I know of.
` Q Could you turn to paragraph 17 of your
`report.
` And just as a note, are you hearing me
`okay now?
` A Yes.
` Q Okay.
` A Okay. I'm on paragraph 17.
` Q Okay. And paragraph 17 includes the
`phrase "critical to the operability of the claimed
`invention."
` Do you see that?
` A Yes.
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`Novo Nordisk Exhibit 2553
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00008
`
`
`
`10:05:10
`10:05:13
`10:05:18
`10:05:24
`10:05:30
`10:05:32
`10:05:37
`10:05:41
`10:05:45
`10:05:50
`10:06:00
`10:06:02
`10:06:07
`10:06:10
`10:06:10
`10:06:18
`10:06:21
`10:06:27
`10:06:31
`10:06:34
`10:06:35
`10:06:38
`
`Transcript of William J. Jusko, Ph.D.
`Conducted on July 12, 2024
`
`9
`
` Q And what do you mean by that phrase?
` MS. PROCHNOW: Objection, form.
` A Well, as I state in 17, it's such that it
`is not anticipated by a prior art disclosure. The
`question is whether the difference is critical to
`the operability of the claimed invention.
` Q Okay. So in the context of the '462
`claims, what must be critical?
` MS. PROCHNOW: Objection, form.
` A It's sort of a vague question. Please
`rephrase.
` Q What do you mean by "critical to the
`operability of the claimed invention" in paragraph
`17?
` MS. PROCHNOW: Objection, form.
` A That there are specifics regarding how
`the claimed invention will work.
` Q Could you elaborate on what you mean by
`"there are specifics regarding how the claimed
`invention will work."
` MS. PROCHNOW: Objection, form.
` A Well, it might mean specific quantitative
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`Novo Nordisk Exhibit 2553
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00009
`
`
`
`10:06:43
`10:07:27
`10:07:32
`10:07:35
`10:07:36
`10:07:43
`10:07:45
`10:07:45
`10:07:53
`10:07:54
`10:07:56
`10:08:00
`10:08:06
`10:08:10
`10:08:15
`10:08:21
`10:08:27
`10:08:41
`10:08:43
`10:08:46
`10:08:50
`10:08:56
`
`Transcript of William J. Jusko, Ph.D.
`Conducted on July 12, 2024
`
`10
`
`factors that might have been recited.
` Q Are you saying that the -- I'm still
`having trouble understanding what your understanding
`is.
` When you say "critical to the operability
`of the claimed invention," is it your understanding
`that that operability itself must be claimed in
`the -- sorry.
` Is it your understanding that that
`operability itself must be claimed?
` MS. PROCHNOW: Objection, form.
` A Those words in quotation are legal
`languages. It's my understanding that the first
`claim of the patent does not require any level of
`therapeutic activity. So it's not critical.
` Q So can one prove criticality of claim 1
`by showing a particularly high therapeutic activity
`in practicing the claim?
` MS. PROCHNOW: Objection, form.
` A Maybe you could say that again.
` Q Sure. To prove criticality of claim 1,
`can one do that by showing a particularly high
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`Novo Nordisk Exhibit 2553
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00010
`
`
`
`10:08:59
`10:09:04
`10:09:09
`10:09:10
`10:09:16
`10:09:20
`10:09:24
`10:09:28
`10:09:36
`10:09:39
`10:09:41
`10:09:44
`10:09:49
`10:09:53
`10:10:03
`10:10:06
`10:10:08
`10:10:11
`10:10:12
`10:10:12
`10:10:16
`10:10:37
`
`Transcript of William J. Jusko, Ph.D.
`Conducted on July 12, 2024
`
`11
`
`therapeutic activity in practicing the
`administration of 1 milligram of semaglutide once
`weekly?
` MS. PROCHNOW: Objection, form.
` A Again, you're asking me what would need
`to reflect criticality for that claim?
` Q Right. I'll just ask you in this way.
` You opined that the dose in claim 1 is
`not critical, correct?
` A Correct.
` Q And how did you determine that the dose
`in claim 1 was not critical?
` A Because the patent claim does not require
`any specific degree of efficacy or tolerability.
` Q So for the dose in claim 1 to be
`critical, the patent would need to require a
`specific degree of efficacy or tolerability, based
`on your understanding.
` Is that correct?
` MS. PROCHNOW: Objection, form.
` A That's correct.
` Q Would you please turn to paragraph 33 of
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`Novo Nordisk Exhibit 2553
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00011
`
`
`
`10:10:40
`10:11:00
`10:11:03
`10:11:06
`10:11:11
`10:11:14
`10:11:16
`10:11:17
`10:11:19
`10:11:22
`10:11:28
`10:11:29
`10:11:35
`10:11:41
`10:11:49
`10:11:53
`10:11:57
`10:12:03
`10:12:07
`10:12:07
`10:12:10
`10:12:13
`
`Transcript of William J. Jusko, Ph.D.
`Conducted on July 12, 2024
`
`12
`
`your report.
` A Okay.
` Q And there, you say that you understand
`the Board agreed with Novo Nordisk and Mylan that
`the preamble does not require any particular level
`of efficacy.
` Do you see that?
` A Yes. That's what's stated here.
` Q Okay. And is it your understanding that
`no efficacy at all is required by the '462 claims
`under this construction?
` MS. PROCHNOW: Objection, form.
` A You're asking me if there was no
`efficacy? Doesn't make sense.
` Q I'm trying to understand what your
`understanding is of the meaning of the Board's
`construction when you say, the Board found that the
`preamble does not require any particular level of
`efficacy.
` So in the Board finding, the preamble
`does not require any particular level of efficacy,
`is it your understanding that the preamble doesn't
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`Novo Nordisk Exhibit 2553
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00012
`
`
`
`10:12:15
`10:12:19
`10:12:22
`10:12:26
`10:12:35
`10:12:35
`10:12:43
`10:12:44
`10:12:55
`10:13:04
`10:13:10
`10:13:14
`10:13:25
`10:13:25
`10:13:33
`10:14:24
`10:14:26
`10:14:30
`10:14:33
`10:14:36
`10:14:44
`10:14:51
`
`Transcript of William J. Jusko, Ph.D.
`Conducted on July 12, 2024
`
`13
`
`require any efficacy at all?
` A A level of efficacy means something is
`happening. It can't mean nothing is going on.
` Q Okay. And is it your understanding that
`the preamble requires an expectation that type 2
`diabetes is treated by administering semaglutide
`once weekly at 1 milligram?
` MS. PROCHNOW: Objection, form.
` A The preamble calls for treatment of --
`some level of efficacy for treatment of diabetes.
` Q And so does that require an expectation
`that the type 2 diabetes is treated under this claim
`language?
` MS. PROCHNOW: Objection, form.
` A Yes, it would.
` Q Would administering semaglutide once
`weekly at a 1 milligram dose have to be somewhat
`tolerable in order to be a treatment under your
`understanding of claim 1?
` MS. PROCHNOW: Objection, form.
` A It calls for treatment of diabetes. It
`doesn't specify tolerability.
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`Novo Nordisk Exhibit 2553
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00013
`
`
`
`10:14:53
`10:14:56
`10:14:59
`10:14:59
`10:15:01
`10:15:01
`10:15:02
`10:15:04
`10:15:08
`10:15:09
`10:15:17
`10:15:19
`10:15:32
`10:15:36
`10:15:40
`10:15:43
`10:15:46
`10:15:50
`10:15:55
`10:16:03
`10:16:06
`10:16:07
`
`Transcript of William J. Jusko, Ph.D.
`Conducted on July 12, 2024
`
`14
`
` Q Can you treat diabetes with a drug that's
`entirely intolerable --
` MS. PROCHNOW: Objection, form.
` Q -- at a dose --
` MS. PROCHNOW: Sorry.
` MS. RAYMOND: I'll ask that again.
` Q Can you treat diabetes with a drug that's
`entirely intolerable on a dosing schedule that's
`entirely intolerable?
` MS. PROCHNOW: Objection, form.
` A It would be a very rare patient that
`would accept such treatment.
` Q Is it your understanding of claim 1 that
`a drug that's entirely intolerable on a dosing
`schedule that's entirely intolerable could meet the
`treatment requirement of the preamble?
` MS. PROCHNOW: Objection, form.
` A Well, the preamble calls for treating
`diabetes; it doesn't specify the tolerance issue.
` Q So can you treat diabetes with an
`intolerable drug?
` MS. PROCHNOW: Objection, form.
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`Novo Nordisk Exhibit 2553
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00014
`
`
`
`10:16:13
`10:16:16
`10:16:20
`10:16:24
`10:16:37
`10:16:40
`10:17:10
`10:17:13
`10:17:18
`10:17:21
`10:17:23
`10:17:29
`10:17:32
`10:17:34
`10:17:39
`10:17:58
`10:18:02
`10:18:09
`10:18:11
`10:18:13
`10:18:14
`10:18:16
`
`Transcript of William J. Jusko, Ph.D.
`Conducted on July 12, 2024
`
`15
`
` A Well, you're getting into the realm where
`a clinician would be needed to help answer that
`question. But in my view, if the patient won't
`accept treatment, then it's not a treatment.
` Q Could you turn to paragraph 215 of your
`report, please.
` A All right. I'm at 216.
` Q Okay. Sorry, 215.
` A Paragraph 216.
` Q Paragraph -- could you look at paragraph
`215, please.
` A I'm looking at my paragraph 216.
` Q Okay. Could you please look at your
`paragraph 215.
` A Oh. All right.
` Q Okay. And in preparing your report, you
`reviewed the '462, correct?
` A I reviewed the patent, yes.
` Q And you reviewed the specification of the
`patent.
` Is that correct?
` A Yes.
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`Novo Nordisk Exhibit 2553
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00015
`
`
`
`10:18:19
`10:18:23
`10:18:30
`10:18:34
`10:18:38
`10:18:42
`10:18:45
`10:18:47
`10:18:51
`10:18:51
`10:19:49
`10:19:49
`10:19:51
`10:19:51
`10:19:54
`10:19:58
`10:20:01
`10:20:04
`10:20:11
`10:20:15
`10:20:23
`10:20:28
`
`Transcript of William J. Jusko, Ph.D.
`Conducted on July 12, 2024
`
`16
`
` Q Okay. And do you recall seeing anything
`in the specification about tolerability?
` A I'd have to look back at the patent to
`remember, you know, specific wording like that.
` Q Okay. Do you have access to
`Exhibit 1001?
` MS. PROCHNOW: Do you want me to give him
`the hard copy, Megan?
` MS. RAYMOND: Sure.
` (Previously marked Exhibit 1001 presented
`to the witness.)
` THE WITNESS: I have the patent.
`BY MS. RAYMOND:
` Q You're welcome to look at whatever
`portions of the patent you want. I might point you
`to column 23, lines 1 through 5.
` And my question is going to be whether
`the '462 discusses or discloses that the proportion
`of subjects with GI side effects increases with the
`dose of semaglutide?
` A I'm on page 19 looking at column 23. I
`don't see that.
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`Novo Nordisk Exhibit 2553
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00016
`
`
`
`10:20:30
`10:20:34
`10:20:38
`10:20:41
`10:20:44
`10:20:46
`10:20:53
`10:20:57
`10:21:04
`10:21:06
`10:21:07
`10:21:10
`10:21:16
`10:21:19
`10:21:22
`10:21:27
`10:22:03
`10:22:05
`10:22:22
`10:22:26
`10:22:29
`10:22:32
`
`Transcript of William J. Jusko, Ph.D.
`Conducted on July 12, 2024
`
`17
`
` Q Okay. At the top of column 23, do you
`see where it says, the Proportion of subjects with
`nausea and vomiting increased with dose, but were
`generally mild or moderate and ameliorated by
`titration?
` Do you see that?
` A Okay. I see what you have on the screen
`as well. Oh, there it is. Mild or moderated,
`ameliorated by titration.
` Okay, I see that.
` Q So is it your understanding that side
`effects increased with dose with respect to GI
`issues, nausea and vomiting?
` MS. PROCHNOW: Objection, form.
` A It's a common phenomenon with GL-1
`agonists -- GLP-1 agonists.
` Q Could you please look at paragraph 222 of
`your report. So we're going back to Exhibit 1301.
` A Okay. 222. All right.
` Q And the last sentence of that says,
`Moreover, there is nothing to suggest that the
`1 milligram dose is critical as opposed to other
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`Novo Nordisk Exhibit 2553
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00017
`
`
`
`10:22:36
`10:22:41
`10:22:43
`10:22:44
`10:22:48
`10:22:50
`10:22:54
`10:22:58
`10:22:59
`10:23:00
`10:23:05
`10:23:08
`10:23:11
`10:23:14
`10:23:18
`10:23:21
`10:23:25
`10:23:28
`10:23:31
`10:23:37
`10:23:40
`10:23:44
`
`Transcript of William J. Jusko, Ph.D.
`Conducted on July 12, 2024
`
`18
`
`doses greater than 0.8 milligrams semaglutide.
` Do you see that?
` A Yes.
` Q And it's your understanding that the
`prior art disclosed -- or it's your position that
`the prior art disclosed a range of 0.1 milligram to
`either 1.2 or 1.6 milligrams of semaglutide.
` Is that correct?
` MS. PROCHNOW: Objection, form,
`foundation.
` A Yes, the prior art disclosed that dosing
`range of 0.1 to 1.6 milligrams.
` Q And with respect to criticality, is it
`your understanding that the 1 milligram dose had to
`be different than every other dose in the range
`disclosed in the prior art to be critical?
` MS. PROCHNOW: Objection, form.
` A Please state that again.
` Q Sure. With respect to criticality, is it
`your understanding that the 1 milligram dose had to
`be different than every other dose in the range
`disclosed in the prior art to be critical?
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`Novo Nordisk Exhibit 2553
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00018
`
`
`
`10:23:47
`10:23:55
`10:24:34
`10:24:36
`10:24:37
`10:24:41
`10:24:44
`10:24:56
`10:24:57
`10:25:00
`10:25:03
`10:25:06
`10:25:08
`10:25:21
`10:25:26
`10:25:36
`10:25:41
`10:26:14
`10:26:16
`10:26:20
`10:26:21
`10:26:25
`
`Transcript of William J. Jusko, Ph.D.
`Conducted on July 12, 2024
`
`19
`
` MS. PROCHNOW: Objection, form.
` A Yes, I would...
` Q And is it your understanding that because
`the claims don't require a particular level of
`efficacy, that efficacy and tolerability can't be
`used to show criticality of the '462 claims?
` MS. PROCHNOW: Objection, form.
` A Please say that again.
` Q Is it your understanding that because the
`claims don't require a particular level of efficacy,
`that efficacy and tolerability can't be used to show
`criticality of the '462 claims?
` MS. PROCHNOW: Objection, form.
` A The spectrum of what happens during
`patient treatment would include those elements of
`responsiveness. I'm not sure how to answer your
`question, though.
` Q Are those elements of responsiveness
`relevant to the criticality analysis, as you
`understood it?
` MS. PROCHNOW: Objection, form.
` A Well, semaglutide produces various levels
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`Novo Nordisk Exhibit 2553
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00019
`
`
`
`10:26:30
`10:26:37
`10:26:51
`10:26:54
`10:26:57
`10:27:00
`10:27:07
`10:27:12
`10:27:16
`10:27:21
`10:27:23
`10:27:27
`10:27:29
`10:27:33
`10:27:35
`10:27:40
`10:27:43
`10:27:45
`10:27:48
`10:27:50
`10:27:55
`10:28:02
`
`Transcript of William J. Jusko, Ph.D.
`Conducted on July 12, 2024
`
`20
`
`of efficacy and tolerability. And again, what those
`are are not part of the claim 1.
` Q And so is it your understanding, then,
`that efficacy and tolerability can't be used to
`establish criticality of claim 1?
` MS. PROCHNOW: Objection, form.
` A Not at all. One has to have specifics
`for patient responsiveness in order to establish
`criticality.
` Q One has to have specifics for patient
`responsiveness in the claims themselves in order to
`establish criticality?
` MS. PROCHNOW: Objection, form.
` A It's my understanding that there would
`have to be specific quantitative criteria to
`establish criticality.
` Q And is it your understanding that those
`specific quantitative criteria would need to be in
`the claims themselves?
` MS. PROCHNOW: Objection, form.
` A Probably. It makes sense, although I'm
`not sure about the legal depiction of that.
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`Novo Nordisk Exhibit 2553
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00020
`
`
`
`10:28:15
`10:28:20
`10:28:38
`10:28:39
`10:28:44
`10:28:52
`10:28:54
`10:28:56
`10:28:59
`10:29:01
`10:29:08
`10:29:10
`10:29:15
`10:29:15
`10:29:17
`10:29:18
`10:29:25
`10:29:28
`10:29:30
`10:29:34
`10:29:38
`10:29:42
`
`Transcript of William J. Jusko, Ph.D.
`Conducted on July 12, 2024
`
`21
`
` Q Could you please turn to paragraph 274 of
`your report.
` A Okay.
` Q And towards the end, you have a quote
`from Exhibit 1282 that says -- that refers to --
`well, I'll just read the whole sentence.
` At the end of that paragraph you say,
`Additionally, before the priority date, skilled
`artisans would have been aware that Novo Nordisk
`reported that the NCT657 phase 2 study, quote,
`demonstrated that clinical efficacy and safety of
`semaglutide was broadly in line with liraglutide,
`end quote.
` Do you see that?
` A Yes, I do.
` Q Do you know which dose of liraglutide had
`clinical safety and efficacy broadly in line with
`which dose of semaglutide?
` MS. PROCHNOW: Objection, form.
` A My interpretation of that phrase is that
`a range of doses of both drugs have been studied,
`and there were distinct similarities between the two
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`Novo Nordisk Exhibit 2553
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00021
`
`
`
`10:29:46
`10:29:50
`10:29:52
`10:29:55
`10:29:59
`10:30:03
`10:30:07
`10:30:15
`10:30:22
`10:30:32
`10:30:35
`10:30:43
`10:30:45
`10:30:52
`10:30:54
`10:30:58
`10:31:00
`10:31:04
`10:31:10
`10:31:13
`10:31:16
`10:31:17
`
`Transcript of William J. Jusko, Ph.D.
`Conducted on July 12, 2024
`
`22
`
`types of compounds, especially so that they have the
`same mechanism of action.
` Q Which range of doses of liraglutide had
`similarity with which range of doses of semaglutide?
` MS. PROCHNOW: Objection, form.
` A There was an established dose-response
`range for liraglutide, and the study range of 0.1 to
`1.6 of semaglutide had broad similarities to -- in
`the dose-response for liraglutide.
` Q So is it your understanding that a dose
`of 0.1 milligrams semaglutide had similarities to
`some dose of liraglutide?
` MS. PROCHNOW: Objection, form.
` A It's more general than that. It means
`that low doses of both compounds would produce
`modest effects and higher doses would produce
`greater effects in a classical sigmoidal
`dose-response relationship.
` Q But it doesn't give any information about
`the specific doses that were being compared in this
`quote, correct?
` MS. PROCHNOW: Objection, form.
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`Novo Nordisk Exhibit 2553
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00022
`
`
`
`10:31:21
`10:31:23
`10:31:29
`10:32:04
`10:32:07
`10:32:10
`10:32:14
`10:32:17
`10:32:22
`10:32:26
`10:32:28
`10:32:31
`10:32:32
`10:32:35
`10:32:37
`10:32:41
`10:32:45
`10:32:48
`10:32:49
`10:32:55
`10:32:58
`10:33:03
`
`Transcript of William J. Jusko, Ph.D.
`Conducted on July 12, 2024
`
`23
`
` A Well, there was general knowledge that
`the dosing range of semaglutide was 0.1 to 1.6. So
`it was those doses that were being compared.
` Q And with apologies, skipping back to a
`question that I asked you earlier. While we were
`talking about criticality, I asked you, Is it your
`understanding that those specific quantitative
`criteria would need to be in the claims themselves?
` And you responded, after an objection,
`Probably. It makes sense, although I'm not sure
`about the legal depiction of that.
` Do you recall that testimony?
` MS. PROCHNOW: Objection, form.
` A Yes.
` Q In performing your analysis, did you
`assume that those specific quantitative criteria
`would need to be in the claims themselves to find
`criticality?
` MS. PROCHNOW: Objection, form.
` A As I stated, criticality would have
`specific quantitative criteria that would have to be
`listed.
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`Novo Nordisk Exhibit 2553
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00023
`
`
`
`10:33:05
`10:33:08
`10:33:10
`10:33:10
`10:33:12
`10:33:15
`10:33:16
`10:34:37
`10:34:41
`10:34:44
`10:34:46
`10:34:48
`10:34:51
`10:34:55
`10:34:58
`10:35:02
`10:35:07
`10:35:10
`10:35:14
`10:35:35
`10:35:37
`10:36:00
`
`Transcript of William J. Jusko, Ph.D.
`Conducted on July 12, 2024
`
`24
`
` Q So you assumed that those quantitative
`criteria would need to be listed in the claim,
`correct?
` MS. PROCHNOW: Objection, form.
` A That is my belief.
` Q Okay. Thank you.
` Returning to paragraph 274, and we were
`discussing the quote about clinical efficacy and
`safety of semaglutide being broadly in line with
`liraglutide.
` Do you recall that?
` A Yes.
` Q Was it possible that the announcement was
`referring to a smaller portion of the range of
`semaglutide being broadly in line with liraglutide?
` MS. PROCHNOW: Objection, form.
` A I interpret this -- the word "broadly" as
`meaning the whole array of dose-response
`relationship and types of responses obtained.
` Q Could you turn to paragraph 267 of your
`report, please.
` A Okay.
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`Novo Nordisk Exhibit 2553
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00024
`
`
`
`10:36:01
`10:36:03
`10:36:06
`10:36:09
`10:36:14
`10:36:15
`10:36:18
`10:36:21
`10:36:27
`10:36:32
`10:36:39
`10:36:46
`10:36:51
`10:36:54
`10:37:04
`10:37:08
`10:37:15
`10:37:23
`10:37:26
`10:37:32
`10:37:41
`10:37:44
`
`Transcript of William J. Jusko, Ph.D.
`Conducted on July 12, 2024
`
`25
`
` Q And in about the middle of that
`paragraph, do you see your statement, a skilled
`artisan would have been motivated to optimize the
`dose in that range to 1 milligram?
` A I see that.
` Q What do you mean by, motivate to optimize
`the dose in that range to 1 milligram?
` MS. PROCHNOW: Objection, form.
` A Well, the 0.1 to 1.6 milligram range of
`doses was enacted in the phase 2 study in order to
`assess basically what happens over that range and
`what might be a later preferred dose.
` And certainly, the doses towards the
`higher end are likely to have the best efficacy, but
`that has to be balanced with tolerability.
` So the doses studied went from 0.8 to
`1.6 milligrams. So one would be inclined to pick a
`dose somewhere in that range, but probably between
`0.8 and 1.2. 1 milligram is a nice round number, it
`would be one obvious to try.
` Q And in your report, do you provide the
`opinion that 1 milligram is the optimal dose?
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`Novo Nordisk Exhibit 2553
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00025
`
`
`
`10:37:47
`10:37:51
`10:37:56
`10:38:06
`10:38:11
`10:38:14
`10:38:16
`10:38:18
`10:38:22
`10:38:29
`10:38:32
`10:38:35
`10:38:40
`10:38:45
`10:38:52
`10:38:58
`10:39:02
`10:39:28
`10:39:32
`10:39:43
`10:39:45
`10:39:48
`
`Transcript of William J. Jusko, Ph.D.
`Conducted on July 12, 2024
`
`26
`
` MS. PROCHNOW: Objection, form.
` A I do not claim it as the optimum dose.
`It is a possible optimum dose. But 0.8, 0.9, 1.1
`are also feasible.
` Q And they're also feasible as optimal
`doses based on what metric?
` MS. PROCHNOW: Objection, form.
` A Well, the general expectation that when a
`successful dose-response study has been
`accomplished, somewhere near the higher doses,
`somewhere near a plateau would be a preferred dose
`to use. And it then becomes a decision between
`efficacy and tolerability.
` The fact that -- to get to 1.6, titration
`was involved, means that they were reaching an upper
`level of tolerability at the upper range of the
`dose-response curve.
` Q Did you look at any efficacy and
`tolerability data to determine whether 1 milligram
`is an optimal dose?
` MS. PROCHNOW: Objection, form.
` A Are you asking, did I look at specific
`
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`Novo Nordisk Exhibit 2553
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00026
`
`
`
`10:39:50
`10:39:52
`10:39:53
`10:39:58
`10:40:02
`10:40:04
`10:40:06
`10:40:10
`10:40:12
`10:40:15
`10:40:40
`10:40:46
`10:41:10
`10:41:10
`10:41:12
`10:41:15
`10:41:19
`10:41:27
`10:41:36
`10:41:38
`10:41:41
`10:41:46
`
`Transcript of William J. Jusko, Ph.D.
`Conducted on July 12, 2024
`
`27
`
`data of that nature?
` Q That's correct.
` MS. PROCHNOW: Objection, form.
` A I'm sorry. I heard you say okay?
` Q I said, that's correct.
` Did you look at any efficacy and
`tolerability data to determine whether 1 milligram
`is an optimal dose?
` MS. PROCHNOW: Objection, form.
` A No, I did not.
` Q Could you please turn to paragraph 281 of
`your report.
` A Okay.
` Q And you see where it says, skilled
`artisans would have been motivated with a r