`
`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
`
`Exhibit 2130
`Page 001 of 429
`
`
`
` 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
`
`1 2 3 4 5 6 7 8 9 1
`
`0
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`Exhibit 2130
`Page 002 of 429
`
`
`
`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
`
`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
`
`Exhibit 2130
`Page 003 of 429
`
`
`
`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
`
`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
`
`Exhibit 2130
`Page 004 of 429
`
`
`
`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
`
` _ _ _ _ _
`
`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
`
`Exhibit 2130
`Page 005 of 429
`
`
`
`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"
`
`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
`
`Exhibit 2130
`Page 006 of 429
`
`
`
`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"
`
`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
`
`Exhibit 2130
`Page 007 of 429
`
`
`
`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
`
` - - - - -
`
`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
`
`Exhibit 2130
`Page 008 of 429
`
`
`
`09:02:34
`09:02:36
`09:02:37
`09:02:40
`09:02:43
`09:02:46
`09:02:50
`09:03:05
`09:03:15
`09:03:20
`09:03:25
`09:03:26
`09:03:29
`09:03:31
`09:03:32
`09:03:33
`09:03:37
`09:03:39
`09:03:41
`09:03:44
`09:03:46
`
`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
`
`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
`
`Exhibit 2130
`Page 009 of 429
`
`
`
`09:03:50
`09:03:54
`09:03:54
`09:03:57
`09:04:00
`09:04:01
`09:04:05
`09:04:08
`09:04:13
`09:04:18
`09:04:23
`09:04:26
`09:04:32
`09:04:33
`09:04:34
`09:04:35
`09:04:37
`09:04:38
`09:04:38
`09:04:38
`09:04:38
`09:04:38
`
`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 VIDEOGRAPHER: The court -- the
` 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
`
`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
`
`Exhibit 2130
`Page 010 of 429
`
`
`
`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
`
`10
`
`09:04:38
`09:04:52
`09:04:53
`09:04:56
`09:04:57
`09:04:59
`09:05:02
`09:05:05
`09:05:06
`09:05:11
`09:05:13
`09:05:15
`09:05:17
`09:05:20
`09:05:23
`09:05:28
`09:05:29
`09:05:31
`09:05:33
`09:05:34
`09:05:38
`09:05:39
`
` 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:
`
`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
`
`Exhibit 2130
`Page 011 of 429
`
`
`
`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
`
`11
`
`09:05:39
`09:05:41
`09:05:42
`09:05:46
`09:05:49
`09:05:50
`09:05:51
`09:05:54
`09:05:54
`09:05:56
`09:05:57
`09:05:59
`09:05:59
`09:06:02
`09:06:05
`09:06:06
`09:06:08
`09:06:10
`09:06:14
`09:06:19
`09:06:26
`09:06:31
`
` 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
`
`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
`
`Exhibit 2130
`Page 012 of 429
`
`
`
`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
`
`12
`
`09:06:34
`09:06:39
`09:06:43
`09:06:45
`09:06:46
`09:06:46
`09:06:49
`09:06:52
`09:06:57
`09:06:58
`09:07:01
`09:07:07
`09:07:11
`09:07:14
`09:07:17
`09:07:18
`09:07:21
`09:07:23
`09:07:24
`09:07:27
`09:07:27
`09:07:36
`
`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?
` A. As far as I recall -- it was a long time
`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?
` A. I -- I believe -- if we're in 2012,
`around 2010. But I don't have the -- the exact
`
`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
`
`Exhibit 2130
`Page 013 of 429
`
`
`
`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
`
`13
`
`09:07:40
`09:07:45
`09:07:47
`09:07:50
`09:07:53
`09:07:54
`09:07:54
`09:07:56
`09:07:57
`09:08:02
`09:08:04
`09:08:07
`09:08:11
`09:08:12
`09:08:13
`09:08:13
`09:08:15
`09:08:17
`09:08:18
`09:08:19
`09:08:24
`09:08:27
`
`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?
`
`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
`
`Exhibit 2130
`Page 014 of 429
`
`
`
`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
`
`14
`
`09:08:27
`09:08:30
`09:08:33
`09:08:36
`09:08:40
`09:08:44
`09:08:46
`09:08:48
`09:08:49
`09:08:49
`09:08:50
`09:08:52
`09:08:54
`09:08:57
`09:08:59
`09:09:01
`09:09:02
`09:09:06
`09:09:09
`09:09:12
`09:09:14
`09:09:16
`
` 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.
`
`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
`
`Exhibit 2130
`Page 015 of 429
`
`
`
`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
`
`15
`
`09:09:20
`09:09:22
`09:09:25
`09:09:33
`09:09:39
`09:09:41
`09:09:45
`09:09:47
`09:09:50
`09:09:50
`09:09:51
`09:09:51
`
`09:09:58
`09:10:01
`09:10:03
`09:10:07
`09:10:08
`09:10:10
`09:10:12
`09:10:15
`
` 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,
`
`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
`
`Exhibit 2130
`Page 016 of 429
`
`
`
`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
`
`16
`
`09:10:20
`09:10:33
`09:10:35
`09:10:37
`09:10:39
`09:10:42
`09:10:43
`09:10:45
`09:10:45
`09:10:48
`09:10:51
`09:10:53
`09:10:55
`09:10:55
`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
`
`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
`
`Exhibit 2130
`Page 017 of 429
`
`
`
`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
`
`also have -- Austin is sharing a copy of each of
`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?
` A. No. I just -- I -- I can't refresh it.
`It still shows 1/20/22 exhibits, and there's
`
`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
`
`Exhibit 2130
`Page 018 of 429
`
`
`
`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
`09:12:55
`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?
`
`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
`
`Exhibit 2130
`Page 019 of 429
`
`
`
`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.
`
`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
`
`Exhibit 2130
`Page 020 of 429
`
`
`
`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
`09:14:42
`09:14:45
`09:14:48
`09:14:50
`09:14:51
`09:14:53
`09:14:55
`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
`
`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
`
`Exhibit 2130
`Page 021 of 429
`
`
`
`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?
` A. Not in detail. I have -- I have looked
`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.
` Q. What percentage of your practice -- what
`percentage of -- what percentage of your practice
`focuses on the treatment of angiogenic eye
`disorders?
` A. I would guess 30 percent.
`
`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
`
`Exhibit 2130
`Page 022 of 429
`
`
`
`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?
`
`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
`
`Exhibit 2130
`Page 023 of 429
`
`
`
`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
`09:17:51
`09:17:56
`09:17:57
`09:17:58
`09:18:00
`09:18:01
`09:18:03
`09:18:04
`09:18:04
`09:18:07
`09:18:11
`09:18:12
`09:18:15
`09:18:17
`09:18:19
`09:18:23
`09:18:28
`
` 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?
`
`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
`
`Exhibit 2130
`Page 024 of 429
`
`
`
`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
`09:19:18
`09:19:19
`09:19:23
`09:19:27
`09:19:30
`09:19:31
`09:19:34
`09:19:36
`
` A. Not -- not -- no other therapeutics that
`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?
` A. That is -- that -- yes.
` 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?
` A. Again, I -- I can't honestly give you an
`answer. I don't remember exactly which month it
`was in. I would assume that it was shortly after
`
`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
`
`Exhibit 2130
`Page 025 of 429
`
`
`
`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
`09:19:50
`09:19:53
`09:19:56
`09:19:57
`09:20:07
`09:20:13
`09:20:17
`09:20:21
`09:20:23
`09:20:25
`09:20:29
`09:20:32
`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
`
`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
`
`Exhibit 2130
`Page 026 of 429
`
`
`
`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
`09:21:49
`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.
` But I think that -- that the training
`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?
`
`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
`
`Exhibit 2130
`Page 027 of 429
`
`
`
`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 larger sets of
`data that were available to -- for ranibizumab
`prior to completion of the Phase 3 studies and
`prior to FDA approval of ranibizumab.
` Q. What did those show?
` A. Those -- those showed that there was an
`average gain of vision among patients with macular
`degeneration treated with monthly ranibizumab
`of -- of 7 to 8 letters. And that kind of
`improvement had not been seen before.
` Q. How --
` A. But --
` Q. Sorry.
` A. Yeah, I just wanted to add that --
`that -- because you were asking me when we
`switched from Macugen to Avastin. And it's
`interesting, historically, that that happened
`
`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
`
`Exhibit 2130
`Page 028 of 429
`
`
`
`CONFIDENTIAL
`Transcript of Thomas Albini M.D.
`Conducted on January 20, 2022
`
`28
`
`09:23:23
`09:23:26
`09:23:31
`09:23:34
`09:23:39
`09:23:43
`09:23:47
`09:23:50
`09:23:52
`09:23:53
`09:23:56
`09:23:59
`09:24:02
`09:24:04
`09:24:09
`09:24:12
`09:24:14
`09:24:15
`09:24:20
`09:24:24
`09:24:29
`09:24:33
`
`before the Phase 3 ranibizumab data was published,
`before the -- before there was any large datasets
`for off-label use of Avastin, but it was
`extrapolated from the success seen in the Phase 2
`studies of ranibizumab and from anecdotal
`experience with bevacizumab.
` Q. How did that success -- you mentioned --
`did you say 9 letters gained?
` A. I -- I don't want to -- I'd have to
`really see the documents so that I could give you
`a fully informed expert opinion on how many exact
`letters, but it was within that range of 7 to 9
`letters, to the best of my recollection.
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
