`
`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`
`Date: January 20, 2022
`Case: Mylan Pharmaceuticals Inc. -v- Regeneron Pharmaceuticals, Inc. (PTAB)
`
`Planet Depos
`Phone: 888.433.3767
`Email: transcripts@planetdepos.com
`www.planetdepos.com
`
`WORLDWIDE COURT REPORTING & LITIGATION TECHNOLOGY
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2023 PAGE 001
`
`
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` MYLAN PHARMACEUTICALS, INC.
` Petitoner,
` v.
` REGENERON PHARMACEUTICALS, INC.
` Patent Owner.
`
` IPR2021 00880, Patent No. 9,699,069 B2
` IPR2021 00881, Patent No. 9,254,338 B2
`
` * CONFIDENTIAL *
` VIDEOTAPED DEPOSITION
` THOMAS ALBINI, M.D.
` Thursday, January 20, 2022
` 9:02 a.m. EST
`
`Job No.: 421116
`Pages 1 355
`Reported by: APRIL REID
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`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
`
`2
`
` Videotaped Deposition of THOMAS ALBINI, M.D.
`held virtually. All appeared remotely.
`
` A P P E A R A N C E S
`
` ON BEHALF OF THE PETITIONER MYLAN
`PHARMACEUTICALS, INC.:
` HEINZ J. SALMEN, ESQ.
` NEIL B. McLAUGHLIN, ESQ.
` ERIC R. HUNT, ESQ.
` RAKOCZY MOLINO MAZZOCHI SIWIK, LLP
` 6 W Hubbard Street, Suite 500
` Chicago, IL 60654
` (312) 527 2157
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2023 PAGE 003
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`
`
`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
`
`3
`
` A P P E A R A N C E S cont'd
`
` ON BEHALF OF PATENT OWNER REGENERON
`PHARMACEUTICALS, INC.:
` DEBORAH FISHMAN, ESQ.
` ARNOLD & PORTER KAYE SCHOLER, LLP
` 3000 El Camino Real
` Five Palo Alto Square, Suite 500
` Palo Alto, CA 94306 3807
` (650) 319 4773
` and
` JEREMY COBB, ESQ.
` ALICE SIN YU HO, ESQ.
` ARNOLD & PORTER KAYE SCHOLER, LLP
` 601 Massachusetts Avenue, NW
` Washington, DC 20001
` (202) 942 5000
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`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
`
`4
`
` A P P E A R A N C E S cont'd
`
`ALSO PRESENT:
`
`VINNY LEE, in house counsel Viatris Mylan
`PETRA SCAMBOROVA, in house counsel Regeneron
`EILEEN WOO, in house counsel Regeneron
`AUSTIN COSTELLO, Planet Depos Technician
`ROBERT LEONARD, Video Specialist
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`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
`
`5
`
` I N D E X
`
`THOMAS ALBINI, M.D. PAGE
`
`Examination by Ms. Fishman 11
`
`Examination by Mr. Salmen 347
`
`Examination by Ms. Fishman 353
`
` E X H I B I T S
`Albini DESCRIPTION PAGE
`Exhibit 1 Expert Declaration of Dr. 16
` Thomas A. Albini re the '069
` patent
`Exhibit 2 Expert Declaration of Dr. 16
` Thomas A. Albini re the '338
` patent
` Exhibit 3 HCP chart 59
`Exhibit 4 IQVIA Claims chart 60
`Exhibit 5 Article titled 98
` "Brolucizumab related retinal
` vasculitis with exacerbation
` following ranibizumab
` retreatment: A
` clinicopathologic case study"
`
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`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
`
`6
`
` E X H I B I T S
`Albini DESCRIPTION PAGE
`Exhibit 6 Article entitled "A Peek Down 118
` the Pipeline: Emerging Drug
` Delivery Options for Retinal
` Disease"
`Exhibit 7 Article entitled 118
` "Pharmacokinetics of
` Intravitreal Antibiotics in
` Endophthalmitis"
`Exhibit 8 United States Patent No. 161
` 9,254,338 B2.
`Exhibit 9 Retina Society Meeting 204
` Presentation
`Exhibit 10 Mitchell article. 217
`Exhibit 11 Article titled "A 252
` Variable dosing Regimen with
` Intravitreal Ranibizumab for
` Neovascular Age related
` Macular Degeneration: Year 2
` of the PrONTO Study"
`
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`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
`
`7
`
` E X H I B I T S
`Albini DESCRIPTION PAGE
`Exhibit 12 Adis publication. 293
`Exhibit 14 graphic of what Adis 299
` discloses as the dosing
` regimen for VIEW1.
`Exhibit 15 Article titled "intravitreal 303
` Aflibercept (VEGF Trap Eye)
` in Wet Age related Macular
` Degeneration"
`Exhibit 16 Press release titled 308
` "Regeneron and Bayer
` HealthCare Initiate Phase 3
` Global Development Program
` For VEGF Trap Eye In Wet
` Age Related Macular
` Degeneration (AMD)"
`Exhibit 17 U.S. Patent No. 7,374,758 328
`Exhibit 18 Dixon 337
`
`
`
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`APOTEX V. REGENERON IPR2022-01524
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`
`
`09:02:34
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`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
`
`8
`
` P R O C E E D I N G S
` THE VIDEOGRAPHER: Here begins video
`file number one in the video deposition of
`Thomas Albini, M.D., in the matter of Mylan
`Pharmaceuticals, Inc. versus Regeneron
`Pharmaceuticals, Inc. in the United States
`Patent and Trademark Office, Case No.
`IPR2021 00880, also IPR2021 00881, Patent
`No. 9,669,069 B2 and 9,254,338 B2.
` Today's date is January 20th, 2022. The
`time on my video monitor is 9:03 a.m. Eastern
`Time.
` My name is Robert Leonard. I'm the
`video specialist. I represent Planet Depos.
` This deposition is being taken via Zoom
`online.
` Will counsel please identify themselves
`verbally and state who they represent.
` MS. FISHMAN: Good morning. This is
`Deborah Fishman of Arnold & Porter on behalf
`of patent owner Regeneron. With me today are
`my colleagues, Jeremy Cobb and Alice Ho, also
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`Exhibit 2130
`Page 009 of 429
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2023 PAGE 009
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`
`
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`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
`
`9
`
` of Arnold & Porter, also on behalf of
` Regeneron.
` And also attending are Petra Scamborova
` and Eileen Woo, our in house counsel at
` Regeneron.
` MR. SALMEN: This is Heinz Salmen of
` Rakoczy Molino Mazzochi Siwik in Chicago on
` behalf of petitioner Mylan. With me on the
` Zoom is my colleague, Neil McLaughlin, also
` of RMMS and also on behalf of Mylan.
` Also with us is Vinny Lee, in house
` counsel at Viatris Mylan.
` the
` THE VIDEOGRAPHER: The court
` court reporter today is April Reid. She also
` is with Planet Depos.
` Will the court reporter please swear in
` the witness.
`THEREUPON:
` THOMAS ALBINI, M.D.
` being first duly sworn or affirmed to
` testify to the truth, the whole truth, and
` nothing but the truth, was examined and
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`APOTEX V. REGENERON IPR2022-01524
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`
`
`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
`
`10
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` testified as follows:
` THE COURT REPORTER: Thank you, sir.
` We may begin.
` MS. FISHMAN: Thank you.
` Good morning, Dr. Albini.
` Before we get going, Robert, can you
` highlight the witness so that everyone else
` becomes smaller and the witness is
` basically takes up most of the screen.
` And then the second request of others on
` the line is if everyone who doesn't have a
` speaking role today
` so that would be
` Dr.
` other than Dr. Albini, me, and Heinz,
` if you could put yourselves off video; I'd
` appreciate it.
` THE VIDEOGRAPHER: Counsel, in terms of
` the
` the witness being highlighted, that
` would be explained by the technician.
` MS. FISHMAN: It's happening now. Thank
` you. Perfect. Okay. Okay.
` EXAMINATION
`BY MS. FISHMAN:
`
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`APOTEX V. REGENERON IPR2022-01524
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`
`
`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
`
`11
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` Q. Good morning, Dr. Albini.
` You understand that our court reporter,
`April, has sworn you in under oath. Is there any
`reason you cannot give complete and accurate
`testimony today?
` A. There is not.
` Q. Okay. Have you ever been deposed
`before?
` A. I have.
` Q. You have.
` And how many times have you been
`deposed?
` A. Unfortunately, I don't keep very
`accurate records, but I believe about half a dozen
`times in 15 years.
` Q. Okay. And what were the nature of those
`proceedings in which you were deposed?
` A. The vast majority were medical
`malpractice issues, where I served as an expert
`witness. Once or twice may have been for a
`disability hearing for a patient of mine. And I
`was deposed once where I served as an expert
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2023 PAGE 012
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`
`
`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
`
`12
`
`09:06:34
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`witness on macular degeneration and the
`possibility that smoking led to some negligence
`for
` in a lawsuit involving a tobacco company a
`couple years ago.
` Q. What
` A. But those were the only cases I recall.
` Q. Okay. And so the
` the case involving
`macular degeneration, what was the
` what was the
`nature of that lawsuit?
` it was a long time
` A. As far as I recall
`ago, but as far as I recall, I was asked to
` by
`a tobacco company to discuss the relative
`importance of genetics versus the environmental
`factor of smoking as a risk factor for macular
`degeneration.
` Q. Okay. Have you ever served as an expert
`in a patent related matter before?
` A. I have not.
` Q. Okay. When did you begin working for
`Mylan?
` if we're in 2012,
` I believe
` A. I
`around 2010. But I don't have the
` the exact
`
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2023 PAGE 013
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`
`
`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
`
`13
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`date at the tip of my fingertips.
` Q. So I
` I
` I believe you misspoke.
`We're in now, believe it or not, 2022.
` A. Oh, '22. Yeah, that's right. Sorry
`about that.
` Q. That's okay.
` A. 2020 or 2019.
` Q. Okay. Got it.
` Now, you've mentioned you've been
`deposed before, but just to review the rules of
`the road, if there's any question that I ask that
`you do not understand, please let me know.
` A. (Nods head.)
` Q. Is that all right?
` A. Yes.
` Q. Okay. If you answer my question, I will
`assume that you understood it. Is that fair?
` A. That's fair.
` Q. Okay. And as you know, the court
`reporter's taking down a verbal transcript, so any
`responses to my question need to be audible. Is
`that okay?
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`
`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
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`14
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` A. That's fair.
` Q. Okay. And as we discussed earlier, I
`understand that you're on call of some fashion
`today and you may be called away. My only request
`is that if you are called away, that you answer a
`pending question and then we can accommodate a
`break. Is that
` A. Fair.
` Q. Is that okay? Okay.
` A. Fair enough.
` Q. Okay. If you need a break for any
`reason during the deposition, please just ask me
`for it and I'll do my best to accommodate it once
`the line of questioning or question pending is
`resolved. Does that make sense?
` A. It does. Thank you.
` Q. And then your counsel may interpose
`objections today, but unless your counsel
`instructs you not to answer for reasons related to
`privilege, do you understand that you're obligated
`to provide me a response to each of my questions?
` A. I understand.
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`APOTEX V. REGENERON IPR2022-01524
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`
`
`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
`
`15
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` Q. Okay. Now, you've submitted expert
`declarations in support of Mylan's petitions in
`IPR2021 00880 involving, for shorthand, the '069
`patent and in IPR2021 00881 involving the '338
`patent.
` MS. FISHMAN: Austin, can you please
` introduce tabs 1 and 2 as Exhibits 1 and 2 to
` the deposition of Dr. Albini.
` REMOTE TECHNICIAN: Yes, ma'am. Stand
` by.
` (Exhibit 1 was marked for identification
` and is attached to the transcript.)
` (Exhibit 2 was marked for identification
` and is attached to the transcript.)
` Q. And, Dr. Albini, Austin will make those
`available for download. You can also work off of
`your hard copy documents, if that's easier for
`you.
` Once they're available, I'll just ask
`you to confirm that the documents I've marked are
`true and correct copies of the declarations you've
`submitted in the '069 and '338 patent proceedings,
`
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`APOTEX V. REGENERON IPR2022-01524
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`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
`
`16
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`09:10:56
`09:10:58
`09:11:00
`09:11:02
`09:11:03
`09:11:05
`09:11:17
`09:11:17
`
`respectively.
` A. Just to clarify, are you asking me to
`make a comment about the copies of the
`declarations that I have in front of me here as
`hard copies or the copies that are going to be
`posted somewhere online?
` Q. The ones that are going to be posted
`online.
` I'd just like you to take a look to make
`sure that they are
` well, to confirm for
`yourself that they're consistent with what you
`submitted in the proceeding and what you have in
`front of you.
` A. Sure.
` MS. FISHMAN: Austin, can you let us
` know when they're available. I don't see
` them in my download link.
` REMOTE TECHNICIAN: Yes.
` If you refresh the page now, they should
` both be available.
`BY MS. FISHMAN:
` Q. So, Dr. Albini, if it's easier, we could
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2023 PAGE 017
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`
`
`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
`
`17
`
`09:11:20
`09:11:23
`09:11:26
`09:11:29
`09:11:29
`09:11:31
`09:11:36
`09:11:39
`09:11:42
`09:11:45
`09:11:45
`09:11:49
`09:11:52
`09:11:53
`09:11:57
`09:12:00
`09:12:08
`09:12:12
`09:12:14
`09:12:15
`09:12:16
`09:12:18
`
` Austin is sharing a copy of each of
`also have
`them. But if you're able to refresh the link, you
`can actually go in and
` and scroll through the
`document.
` A. I see it.
` Scrolling's not working. It looks like
`I have a screen view. Oh, I see what you're
`saying. So if I go in here
` the problem I'm
`having is it's not clear to me where I refresh
`this thing.
` Q. Up on your browser to the left of the
`I can't believe I'm giving advice on this, but...
` A. I'm so sorry.
` Q. Up on your browser to the left of where
`the URL is, there's a little, like, three quarters
`of a circle arrow. That one will refresh it.
` A. I do not
` I'm in some sort of full
`screen view. Let me see.
` Q. You're in a
` are you in a full screen
`view of Exhibit 1?
` I can't refresh it.
` I
` A. No. I just
`It still shows 1/20/22 exhibits, and there's
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2023 PAGE 018
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`
`
`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
`
`18
`
`09:12:25
`09:12:25
`09:12:29
`09:12:32
`09:12:32
`09:12:36
`09:12:40
`09:12:43
`09:12:46
`09:12:48
`09:12:49
`09:12:51
`09:1 :55
`09:12:59
`09:13:04
`09:13:07
`09:13:09
`09:13:12
`09:13:13
`09:13:16
`09:13:18
`09:13:25
`
`nothing there.
` Refresh. I found it. Down on the menu.
`Now we got it.
` Q. Okay.
` A. Yes, and I can indeed scroll through it.
`And on cursory look through
` I don't think you
`want me to read through the whole thing, but on
`cursory look through, it certainly looks the same
`as the material that I provided and have reviewed.
` Q. Okay. Very good.
` And so for purposes of your deposition,
`I'm going to refer to your declaration in the '069
`proceeding as Exhibit 1 and in the '338 patent
`proceeding as Exhibit 2.
` And you're also welcome to just
`reference your hard copy declarations because I
`know it can be hard to manage multiple documents
`in a deposition.
` What did you do, Dr. Albini, to prepare
`for your deposition here today?
` A. You're saying subsequent to preparing
`the actual declaration?
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2023 PAGE 019
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`
`
`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
`
`19
`
`09:13:27
`09:13:27
`09:13:31
`09:13:36
`09:13:38
`09:13:44
`09:13:49
`09:13:51
`09:13:57
`09:13:59
`09:13:59
`09:14:04
`09:14:05
`09:14:08
`09:14:09
`09:14:09
`09:14:11
`09:14:12
`09:14:16
`09:14:17
`09:14:18
`09:14:19
`
` Q. That's right.
` A. So
` I met with the attorneys a few
`times on phone calls, I think two Zoom sessions
`over the last week, and then some in person
`meetings on Tuesday and Wednesday of this week
`with Mr. Salmen and Mr. McLaughlin.
` Q. Approximately how long did you meet with
`counsel for Mylan in person to prepare
` in the
`meetings this week to prepare for your deposition
`here today?
` A. So excluding the RMMS counsel, so
`just
` Q. No. I'm sorry.
` A. Everybody?
` Q. Everybody.
` Whoever you met with, yeah.
` A. I would
` I would assume somewhere on
`the order of ten hours, something like that. Ten
`to 12 hours.
` Q. Total or per day?
` A. Total.
` Q. Okay.
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2023 PAGE 020
`
`
`
`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
`
`20
`
`09:14:21
`09:14:23
`09:14:23
`09:14:25
`09:14:27
`09:14:29
`09:14:31
`09:14:32
`09:14:35
`09:14:38
`09:14:40
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`09:14:48
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`09:14:58
`09:15:02
`09:15:06
`09:15:08
`
` MS. FISHMAN: Austin, you can take down
` the exhibit.
`BY MS. FISHMAN:
` Q. Did you review your declarations as part
`of your preparation for the deposition today?
` A. Yes.
` Q. Did you review other materials in
`preparation for the deposition here today?
` A. Only the exhibits that are included in
`these binders.
` Q. So have you reviewed patent owner
`Regeneron's preliminary response that was filed in
`each of these proceedings after you submitted your
`declaration?
` A. That would be the prosecution history?
` Q. No. I'm sorry.
` After you submitted your declarations
`and after Mylan submitted its petitions, Regeneron
`had an opportunity to put in its own briefs called
`a patent owner preliminary response. So my
`question is: Have you reviewed either of
`Regeneron's preliminary responses in these
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2023 PAGE 021
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`
`
`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
`
`21
`
`09:15:12
`09:15:12
`09:15:19
`09:15:22
`09:15:26
`09:15:29
`09:15:32
`09:15:33
`09:15:39
`09:15:42
`09:15:43
`09:15:44
`09:15:48
`09:15:48
`09:15:52
`09:15:54
`09:15:58
`09:16:00
`09:16:02
`09:16:04
`09:16:07
`09:16:08
`
`proceedings?
` I have looked
` A. Not in detail. I have
`through them, certainly. They were
` they
`were
` some of that material was mentioned to me
`during preparation, but I
` I have not read those
`in great detail.
` Q. Regeneron also submitted a declaration
`from Dr. Diana Do in support of one of its
`preliminary responses. Did you review the
`declaration of Diana Do?
` A. I did not.
` Q. Okay. Turning now to your clinical
`practice.
` Dr. Albini, what percentage of your
`practice would you say is uveitis, or the
`treatment of uveitis?
` A. Probably 40 to 50 percent.
` what
` Q. What percentage of your practice
`percentage of
` what percentage of your practice
`focuses on the treatment of angiogenic eye
`disorders?
` A. I would guess 30 percent.
`
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2023 PAGE 022
`
`
`
`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
`
`22
`
`09:16:11
`09:16:13
`09:16:14
`09:16:17
`09:16:21
`09:16:23
`09:16:26
`09:16:30
`09:16:31
`09:16:39
`09:16:42
`09:16:46
`09:16:53
`09:16:53
`09:16:57
`09:17:03
`09:17:10
`09:17:11
`09:17:13
`09:17:19
`09:17:23
`09:17:25
`
` Q. And what is the rest of your time spent
`doing in your practice?
` A. The other types of cases are surgical
`retina cases, mostly retinal detachments, macular
`epiretinal membranes.
` Q. And has that, in a practice division,
`the 40/30/30, been generally true since you
`finished fellowship?
` A. To be totally honest, I don't run the
`numbers, so I don't know. But anecdotally, yes.
` Q. Okay. When did you first administer an
`anti VEGF agent by intravitreal injection?
` MR. SALMEN: Objection, form.
` A. I
` to the best of my recollection, I
`believe as a fellow in 2004, 2005.
` Q. And what anti VEGF agent did you first
`administer?
` A. Again, it was a long time ago. To the
`best of my recollection, it was Macugen.
` Q. Okay. What anti VEGF agents have you
`injected intravitreally for the treatment of
`angiogenic eye disorders?
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2023 PAGE 023
`
`
`
`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
`
`23
`
`09:17:26
`09:17:30
`09:17:38
`09:17:45
`09:17:46
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`09:18:00
`09:18:01
`09:18:03
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`09:18:12
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`09:18:17
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`09:18:23
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`
` MR. SALMEN: Objection, form.
` A. Macugen, bevacizumab, ranibizumab,
`aflibercept, brolucizumab. Those are the ones I
`can think of right now.
` Q. Okay. And when you say bevacizumab,
`that's Avastin used off label for audiogenic eye
`disorders; is that correct?
` A. That is correct.
` Q. And when you say ranibizumab, that's
`Lucentis, which is indicated for ophthalmic
`disorders; correct?
` MR. SALMEN: Objection, form.
` A. That's correct.
` Q. And when you say aflibercept, are you
`referring to the product that's marketed as Eylea?
` A. That is correct.
` Q. And when you say brolucizumab, are you
`referring to the brand name Beovu?
` A. That is correct.
` Q. Okay. Any
` have you injected any
`other anti VEGF agents for the treatment of
`angiogenic eye disorder?
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2023 PAGE 024
`
`
`
`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
`
`24
`
`09:18:30
`09:18:43
`09:18:46
`09:18:49
`09:18:53
`09:18:53
`09:18:56
`09:19:00
`09:19:04
`09:19:05
`09:19:07
`09:19:10
`09:19:14
`09:19:17
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`09:19:23
`09:19:27
`09:19:30
`09:19:31
`09:19:34
`09:19:36
`
` no other therapeutics that
` not
` A. Not
`I can think of that would commonly be put in that
`category, although I inject a fair amount of
`steroids, which do have an anti angiogenic
`property.
` Q. And when you use steroids, do you use
`those as an alternative to VEGF therapy or
`anti VEGF therapy or as an adjunct to anti VEGF
`therapy, typically?
` MR. SALMEN: Objection, form.
` A. Both scenarios can apply.
` Q. Okay. Now, Macugen was the first
`approved anti VEGF therapy in the United States;
`correct?
` yes.
` that
` A. That is
` Q. And it was approved in December of 2004?
` A. To the best of my recollection, yes.
` Q. When was the first time you injected
`Macugen?
` I can't honestly give you an
` A. Again, I
`answer. I don't remember exactly which month it
`was in. I would assume that it was shortly after
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`Page 025 of 429
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2023 PAGE 025
`
`
`
`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
`
`25
`
`09:19:39
`09:19:41
`09:19:45
`09:19:47
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`09:19:53
`09:19:56
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`09:20:07
`09:20:13
`09:20:17
`09:20:21
`09:20:23
`09:20:25
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`09:20:32
`09:20:33
`09:20:41
`09:20:43
`09:20:47
`09:20:53
`
`December of 2004.
` Q. Okay. When was the last time you used
`Macugen to treat a patient?
` A. A long, long time ago. I can't
`again, I don't have those dates marked down on my
`wall or anything. I don't remember.
` But I
` you know, my recollection is
`that very shortly after bevacizumab was shown to
`be effective, and I think that was in the fall of
`2000
` somewhere fall of 2005, probably a month
`or so after that we were using predominantly
`bevacizumab.
` I was a fellow at that point, and this
`was at the Eye Institute where I was training.
` Q. And when you're saying "we," is this at
`Bascom Palmer?
` A. No. This was at the Baylor College of
`Medicine, Cullen Eye Institute. I was a fellow on
`the retina service at that point.
` Q. Okay. And so after bevacizumab was
`shown to be effective off label in the treatment
`of angiogenic eye disorders, you pretty much
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2023 PAGE 026
`
`
`
`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
`
`26
`
`09:20:57
`09:21:03
`09:21:04
`09:21:07
`09:21:08
`09:21:11
`09:21:13
`09:21:15
`09:21:18
`09:21:18
`09:21:24
`09:21:33
`09:21:36
`09:21:42
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`09:21:54
`09:22:00
`09:22:03
`09:22:07
`09:22:09
`09:22:10
`09:22:11
`
`stopped using Macugen; is that fair?
` A. That's fair.
` Q. Why did you stop injecting Macugen?
` MR. SALMEN: Objection, form.
` A. Honestly, I can tell you that the most
`honest answer is that I was told to by my
`supervisor at that point, since I was in a
`training role. So the decision wasn't really mine
`to make.
` that the training
` But I think that
`physician made that decision because of efficacy
`data that was available for both bevacizumab and
`ranibizumab at the time, showing greater efficacy
`than
` than what was shown with
` with Macugen
`and also anecdotal experience that my training
`physicians and other physicians had had with
`bevacizumab.
` Q. And what was the efficacy data for
`bevacizumab that you're referring to?
` A. For
` MR. SALMEN: Objection, form.
` A. For bevacizumab?
`
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`Page 027 of 429
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2023 PAGE 027
`
`
`
`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
`
`27
`
`09:22:12
`09:22:12
`09:22:17
`09:22:19
`09:22:22
`09:22:28
`09:22:34
`09:22:40
`09:22:43
`09:22:47
`09:22:48
`09:22:52
`09:22:57
`09:23:02
`09:23:06
`09:23:09
`09:23:09
`09:23:10
`09:23:12
`09:23:14
`09:23:16
`09:23:21
`
` Q. Correct.
` A. There was very little efficacy data for
`bevacizumab. There were two case reports that
`showed that there was some effect.
` The
` the popularity of bevacizumab was
`at least, in part, dependent on