CONFIDENTIAL
`
`Page 1
`
` CONFIDENTIAL - LUCIAN V. DEL PRIORE, M.D., PH.D.
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` MYLAN PHARMACEUTICALS, : CASE IPR2021-00880
` INC., CELLTRION, INC., :
` and APOTEX, INC., : Patent 9,669,069 B2
` Petitioners, :
` :
` vs. :
` :
` REGENERON PHARMACEUTICALS, : CASE IPR2021-00881
` INC., :
` Patent Owner : Patent 9,254,338 B2
` ----------------------- :
`
` VIDEOTAPE DEPOSITION OF:
` LUCIAN V. DEL PRIORE, M.D., PH.D.
` NEW YORK, NEW YORK
` FRIDAY, APRIL 29, 2022
`
` REPORTED BY:
` SILVIA P. WAGE, CCR, CRR, RPR
` JOB NO. 5149547
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
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`Mylan Exhibit 1111
`Mylan v. Regeneron, IPR2021-00880
`Page 1
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`

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`CONFIDENTIAL
`
`1 CONFIDENTIAL - LUCIAN V DEL PRIORE, M D , PH D
`2 I N D E X
`3 WITNESS: LUCIANO V DEL PRIORE, M D , PH D PAGE
`4 EXAMINATION BY MR McLAUGHLIN 10
`5
`
` E X H I B I T S
`
`Page 4
`
`6
`
`7
`
` NO DESCRIPTION PAGE
`
` Del Priore Exhibit 1 Petitioner's Notice 10
`8 of Deposition of
` Lucian V Del Priore,
`9 M D Ph D , in IPR
` 2021-00880,
`10 Del Priore Exhibit 2 Petitioner's Notice 10
` of Deposition of
`11 Lucian V Del Priore,
` M D Ph D , in IPR
`12 2021-00881
` Del Priore Exhibit 3 Expert Declaration of 32
`13 Lucian V Del Priore,
` M D , Ph D
`14 Confidential Subject
` to Protective Order
`15 Del Priore Exhibit 4 copy of Dr Del 33
` Priore's curriculum
`16 vitae
` Del Priore Exhibit 5 US Patent 9,669,069 44
`17 B2 previously marked
` Mylan 1001
`18 Del Priore Exhibit 6 US Patent 9,254,338 44
` B2 previously marked
`19 Mylan 1001
` Del Priore Exhibit 7 article titled, 77
`20 "VEGF-Trap: A VEGF
` Blocker with Potent
`21 Antitumor effects,"
` previously marked
`22 Mylan Exhibit 1004
`23
`24
`25
`
`Page 2
`1 CONFIDENTIAL - LUCIAN V. DEL PRIORE, M.D., PH.D.
`
`2 3
`
` APRIL 29, 2022
`4 9:15 A.M.
`5 Videotape deposition of LUCIAN V. DEL
`6 PRIORE, M.D., PH.D., held at the offices of
`7 ARNOLD & PORTER KAYE SCHOLER, 250 55th Street,
`8 4th Floor, New York, New York, pursuant to
`9 agreement before SILVIA P. WAGE, a Certified
`10 Shorthand Reporter, Certified Realtime Reporter,
`11 Registered Professional Reporter, and Notary
`12 Public for the States of New Jersey, New York and
`13 Pennsylvania.
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
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`Page 3
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`Page 5
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`1 CONFIDENTIAL - LUCIAN V DEL PRIORE, M D , PH D
`2 A P P E A R A N C E S:
`3
`
` RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`4 Attorney For the Petitioner
` Six West Hubbard Street
`5 Chicago, Illinois 60654
` 312 222 7241
`6 Nmclaughlin@rmmslegal com
` Tehrich@rmmslegal com
`7 Hsalmen@rmmslegal com
` BY: NEIL B McLAUGHLIN, PH D , ESQ
`8 BY: THOMAS H EHRICH, ESQ (VIA TELECONFERENCE)
`9
`
` ARNOLD & PORTER KAYE SCHOLER LLP
`10 Attorney for the Patent Owner
` 601 Massachusetts Avenue, NW
`11 Washington, DC 20001-3743
` 202 942 6828
`12 Jeremy cobb@arnoldporter com
` Alice ho@arnoldporter com
`13 BY: JEREMY COBB, ESQ
` BY: ALICE HO, ESQ , PH D
`
`14
`15 A L S O P R E S E N T:
`16
`
` PETRA SCAMBOROVA, ESQ
`17 REGENERON PHARMACEUTICALS, INC
` (VIA TELECONFERENCE)
`
`18
`
` EILEEN WOO, ESQ
`19 REGENERON PHARMACEUTICALS, INC
` (VIA TELECONFERENCE)
`
`20
`
` JAMES EVANS, ESQ
`21 REGENERON PHARMACEUTICALS, INC
` (VIA TELECONFERENCE)
`
`22
`
` MATTHEW CHIN-QUEE
`23 VIDEOGRAPHER
`24
`25
`
`1 CONFIDENTIAL - LUCIAN V DEL PRIORE, M D , PH D
`2 E X H I B I T S
`3 NO DESCRIPTION PAGE
`4 Del Priore Exhibit 8 article titled, 101
` "Duration of Action
`5 of Intravitreal
` Ranibizumab and
`6 Bevacizumab in
` Exudative AMD Eyes
`7 Based on Macular
` Volume Measurements"
`8 Del Priore Exhibit 9 article titled, 112
` "VEGF-Trap-Eye for
`9 the Treatment of
` Neovascular
`10 Age-related Macular
` Degeneration,"
`11 previously marked
` Exhibit 1006
`12 Del Priore Exhibit 10 article titled, 124
` "Angiogenesis An
`13 Integrative Approach
` from Science to
`14 Medicine"
` Del Priore Exhibit 11 Regeneron 136
`15 Pharmaceuticals Inc
` 10-Q previously
`16 marked Mylan Exhibit
` 1021
`17 Del Priore Exhibit 12 Expert Declaration of 158
` Dr Thomas Albini in
`18 Support of Petition
` for Inter Partes
`19 Review of U S Patent
` No 9,254,338 B2
`20 previously marked
` 1002
`21 Del Priore Exhibit 13 Highlights of 166
` Prescribing
`22 Information for Eylea
` previously marked
`23 Exhibit 2185
`24
`25
`
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`
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`
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`
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`Mylan Exhibit 1111
`Mylan v. Regeneron, IPR2021-00880
`Page 2
`
`

`

`CONFIDENTIAL
`
`Page 8
`1 CONFIDENTIAL - LUCIAN V. DEL PRIORE, M.D., PH.D.
`2 THE VIDEOGRAPHER: We're going on the
`3 record at 9:15 a.m. on April 29th, 2022.
`4 This is Media Unit No. 1 of the video
`5 recorded deposition of Dr. Lucian Del Priore in
`6 the matter of Mylan Pharmaceuticals Inc., et al.,
`7 v. Regeneron Pharmaceuticals Inc., et al., in the
`8 United States Patent and Trademark Office, Case
`9 No. IPR 2021-00881.
`10 The deposition is being held at
`11 Arnold & Porter Kaye Scholer LLP at 250 West 55th
`12 Street, New York, New York.
`13 My name is Matthew Chin-Quee from
`14 Veritext and I'm the Legal Videographer.
`15 The Court Reporter is Silvia Wage
`16 from Veritext.
`17 Will anyone attending in person and
`18 remotely please state your appearance and
`19 affiliation for the record.
`20 MR. McLAUGHLIN: My name is Neil
`21 McLaughlin on behalf of Mylan Pharmaceuticals
`22 Inc., from the law firm of Rakoczy Molino
`23 Mazzochi Siwik.
`24 I also just want to note for the
`25 record that these proceedings or this deposition
`
`Page 9
`1 CONFIDENTIAL - LUCIAN V. DEL PRIORE, M.D., PH.D.
`2 also is being taken in Case No. IPR 2021-00880.
`3 MR. COBB: This is Jeremy Cobb with
`4 Arnold & Porter on behalf of Patent Owner
`5 Regeneron.
`6 Also with me in person is Alice Ho
`7 with Arnold & Porter and Petra Scamborova and
`8 Eileen Woo both in-house Counsel at Regeneron and
`9 I believe that James Evans is on the line also
`10 in-house Counsel at Regeneron.
`11 THE STENOGRAPHER: Dr. -- I'm sorry.
`12 Go ahead, Matt.
`13 THE VIDEOGRAPHER: Will the Reporter
`14 please swear in the witness.
`15 MR. McLAUGHLIN: I just wanted to
`16 note --
`17 MR. COBB: There might be more
`18 people.
`19 MR. McLAUGHLIN: I also want to note
`20 that my colleague Thomas Ehrich from RMMS is also
`21 on.
`22 THE VIDEOGRAPHER: Will the Reporter
`23 --
`24 MR. EHRICH: I'm sorry. This is
`25 Thomas Ehrich also from Mylan also from Rakoczy
`
`Page 6
`1 CONFIDENTIAL - LUCIAN V. DEL PRIORE, M.D., PH.D.
`2 E X H I B I T S
`3 NO. DESCRIPTION PAGE
`4 Del Priore Exhibit 14 Table 14.2.3/2a 174
` Summary of Proportion
`5 of Vision Loss from
` Baseline to Week 96
`6 Last Observation
` Carried Forward
`7 previously marked
` Exhibit 2060 marked
`8 Confidential Material
` - Subject to
`9 Protective Order
` Del Priore Exhibit 15 article titled, 190
`10 "Differential
` Response to Anti-VEGF
`11 Regimens in
` Age-related Macular
`12 Degeneration Patients
` with Early Persistent
`13 Retinal Fluid"
`14
`15
`16
`17
`18
`19
`20
`21
`22
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`Page 7
`1 CONFIDENTIAL - LUCIAN V. DEL PRIORE, M.D., PH.D.
`2 - - -
`3 DEPOSITION SUPPORT INDEX
`4 - - -
`
` Direction to Witness Not to Answer
` Page Line
`
` 47 16
`
` Request for Production of Documents
` Page Line
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`56
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`7
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`89
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`10
`11
`12 Stipulations
` Page Line
`
`13
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` 174 21
`
`14
`15 Question Marked
` Page Line
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`16
`17
`18 Reservation
` Page Line
`
`19
`20
`21 Motion to Strike
` Page Line
`
`22
`23
`24
`25
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`Mylan v. Regeneron, IPR2021-00880
`Page 3
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`

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`CONFIDENTIAL
`
`Page 10
`1 CONFIDENTIAL - LUCIAN V. DEL PRIORE, M.D., PH.D.
`2 Molino Mazzochi Siwik. Thank you.
`3 THE WITNESS: And my name is Lucian
`4 Del Priore and I'm serving as an expert witness.
`5 LUCIANO V. DEL PRIORE, M.D., PH.D.,
`6 Yale Eye Center, 40 Temple Street, Suite 1B,
`7 New Haven, Connecticut 06510, after having
`8 been duly sworn, was examined and testified
`9 as follows:
`10 THE STENOGRAPHER: Thank you.
`11 You may proceed.
`12 EXAMINATION BY MR. McLAUGHLIN:
`13 Q. Good morning, Dr. Del Priore.
`14 A. Good morning.
`15 Q. I'm going to hand you what has
`16 previously been marked as Del Priore Dep
`17 Exhibit 1 and Del Priore Dep Exhibit 2.
`18 (Deposition Del Priore Exhibit 1,
`19 Petitioner's Notice of Deposition of Lucian V.
`20 Del Priore, M.D. Ph.D., in IPR 2021-00880, was
`21 marked for identification.)
`22 (Deposition Del Priore Exhibit 2,
`23 Petitioner's Notice of Deposition of Lucian V.
`24 Del Priore, M.D. Ph.D., in IPR 2021-00881, was
`25 marked for identification.)
`
`Page 11
`1 CONFIDENTIAL - LUCIAN V. DEL PRIORE, M.D., PH.D.
`2 Q. So what I've handed you are the
`3 Petitioner's Notice of Deposition of Lucian Del
`4 Priore M.D., Ph.D., in Case Matters IPR
`5 2021-00880 and IPR 2021-00881.
`6 Have you seen these dep notices prior
`7 to today?
`8 A. Yes.
`9 Q. Okay. So it's your understanding
`10 that you're being deposed today pursuant to these
`11 notices and the agreement of the parties in these
`12 IPRs?
`13 A. Yes.
`14 Q. And you do understand that there are
`15 two IPR proceedings, correct?
`16 A. I see two separate case numbers, yes.
`17 Q. And do you understand that your
`18 declaration that you submitted represents your
`19 direct examination in these proceedings?
`20 A. Yes, I do.
`21 Q. And do you understand that the
`22 questions I'll be asking you today represent your
`23 cross-examination testimony?
`24 A. Yes.
`25 Q. Have you ever been cross-examined?
`
`Page 12
`1 CONFIDENTIAL - LUCIAN V. DEL PRIORE, M.D., PH.D.
`2 A. Yes.
`3 Q. Approximately, how many times?
`4 A. Maybe two or three times.
`5 Q. And in what context were those
`6 cross-examinations taken?
`7 A. Serving as an expert witness related
`8 to medical malpractice.
`9 Q. All of them were medical malpractice
`10 related?
`11 A. Yes; not my individual cases, serving
`12 as an expert.
`13 Q. Sure.
`14 And that was at a trial?
`15 A. One was in court, yes.
`16 Q. And, approximately, how many times
`17 have you been deposed?
`18 A. Maybe three or four times.
`19 Q. Were any of those patent cases?
`20 A. Not to my recollection.
`21 Q. Okay. So I'd like to ask you a
`22 little bit about your experience today.
`23 Do you have experience working with
`24 VEGF receptor sequences?
`25 A. I have knowledge of sequences. But
`
`Page 13
`1 CONFIDENTIAL - LUCIAN V. DEL PRIORE, M.D., PH.D.
`2 can you be more specific?
`3 Q. Do you have personal experience -- do
`4 you have personal experience working with VEGF
`5 receptor sequences in terms of cloning --
`6 A. No.
`7 Q. -- modifying --
`8 A. No.
`9 Q. -- manipulating?
`10 THE STENOGRAPHER: You have to wait
`11 for him to finish the question. I'm sorry.
`12 THE WITNESS: Okay.
`13 Q. Were you following the VEGF-Trap-Eye
`14 literature and Regeneron press releases as
`15 VEGF-Trap-Eye was going through clinical trials
`16 between 2007 and 2010?
`17 A. Yes.
`18 Q. And in that time period, did you ever
`19 undertake an investigation into the amino acid
`20 sequence of VEGF-Trap-Eye?
`21 MR. COBB: Objection, scope.
`22 A. That's outside of the scope of my
`23 declaration.
`24 Q. You may still answer.
`25 A. Can you repeat the question?
`
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`Mylan v. Regeneron, IPR2021-00880
`Page 4
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`

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`CONFIDENTIAL
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`Page 14
`1 CONFIDENTIAL - LUCIAN V. DEL PRIORE, M.D., PH.D.
`2 Q. During that time frame of 2007 to
`3 2010, did you ever undertake an investigation
`4 into the amino acid sequence of VEGF-Trap-Eye?
`5 A. No.
`6 Q. Have you ever been involved in a
`7 development of a VEGF receptor fusion protein for
`8 use as a therapeutic?
`9 A. No, I have not.
`10 Q. Have you ever been involved in the
`11 design of a purification process for a commercial
`12 VEGF antagonist?
`13 A. No, I have not.
`14 Q. Have you ever been involved in a
`15 design of a manufacturing process for a
`16 commercial VEGF antagonist?
`17 A. No.
`18 Q. Have you ever been involved in the
`19 formulation of a commercial VEGF antagonist?
`20 A. No.
`21 Q. Do you have training in the field of
`22 biopharmaceutical manufacturing?
`23 A. I have -- not formal training but
`24 some experience with having tried to develop
`25 something on my own.
`
`Page 15
`1 CONFIDENTIAL - LUCIAN V. DEL PRIORE, M.D., PH.D.
`2 Q. And what was that?
`3 A. It was an enzyme called Dispase,
`4 D-I-S-P-A-S-E.
`5 Q. Is that a VEGF receptor fusion
`6 protein?
`7 A. No, it is not.
`8 Q. And what time frame was that in?
`9 A. I don't recall exact dates but,
`10 roughly, around 2000 to 2006, roughly. But I
`11 don't recall the exact date.
`12 THE STENOGRAPHER: I'm sorry. Can
`13 you fix the microphones because they're not
`14 towards you.
`15 (There is a discussion off the
`16 record.)
`17 BY MR. McLAUGHLIN:
`18 Q. So, when you were in the process of
`19 working with Dispase as a potential therapeutic,
`20 where were you at the time?
`21 MR. COBB: Objection, form.
`22 Q. Actually, let me rephrase that.
`23 Where were you employed in that time
`24 frame when you were working with Dispase?
`25 A. Columbia University in New York was
`
`Page 16
`1 CONFIDENTIAL - LUCIAN V. DEL PRIORE, M.D., PH.D.
`2 my employer during most of that period of time.
`3 Q. And did you have a collaborator that
`4 you were working on this with?
`5 A. Yes.
`6 Q. And who was that collaborator?
`7 A. There was more than one collaborator.
`8 Q. Was it a biopharmaceutical company?
`9 A. It was not a biopharmaceutical
`10 company, no.
`11 Q. So, in your work with Dispase, did it
`12 ever get to the point where you were commercially
`13 manufacturing Dispase?
`14 A. We attempted to commercial
`15 manufacture Dispase.
`16 Q. And were you involved in the design
`17 of the commercial manufacture process?
`18 A. Yes.
`19 Q. And is that your only experience in
`20 the field of biopharmaceutical manufacturing?
`21 A. That's the only time we tried to
`22 manufacture a biopharmaceutical product.
`23 Q. So you wouldn't consider yourself an
`24 expert in the field of biopharmaceutical
`25 manufacturing, correct?
`
`Page 17
`1 CONFIDENTIAL - LUCIAN V. DEL PRIORE, M.D., PH.D.
`2 MR. COBB: Objection,
`3 mischaracterizes his testimony.
`4 A. Can you repeat the question?
`5 Q. You would not consider yourself an
`6 expert in the field of biopharmaceutical
`7 manufacturing, correct?
`8 MR. COBB: Same objection.
`9 A. I -- I would not want to say that I
`10 was an expert in that area.
`11 Q. Are you a licensed ophthalmologist?
`12 A. Yes.
`13 Q. As of January 2011, were you a
`14 licensed ophthalmologist?
`15 A. Yes.
`16 Q. Are you currently a practicing
`17 ophthalmologist?
`18 A. Yes.
`19 Q. And, as of January 2011, were you a
`20 practicing ophthalmologist?
`21 A. Yes.
`22 Q. Do you treat angiogenic eye disorders
`23 in your current practice?
`24 A. Yes, I do.
`25 Q. And were you treating angiogenic eye
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`CONFIDENTIAL
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`Page 18
`1 CONFIDENTIAL - LUCIAN V. DEL PRIORE, M.D., PH.D.
`2 disorders as of January 2011?
`3 A. Yes.
`4 Q. Do you treat age-related macular
`5 degeneration in your current practice?
`6 A. Yes.
`7 Q. Is it okay if we refer to that as
`8 "AMD" going forward for the remainder of the
`9 deposition?
`10 A. Yes, that would be fine.
`11 Q. Okay. Were you treating AMD in your
`12 practice as of January 2011?
`13 A. Yes, I was.
`14 Q. Same questions with respect to
`15 diabetic macular edema.
`16 Do you treat diabetic macular edema
`17 in your current practice?
`18 A. Yes, I do.
`19 Q. Is it okay if we call that "DME" --
`20 A. Yes.
`21 Q. -- for the remainder of today's
`22 deposition?
`23 Okay. And were you treating AMD in
`24 your clinical practice as of January 2011?
`25 A. Yes.
`
`Page 19
`1 CONFIDENTIAL - LUCIAN V. DEL PRIORE, M.D., PH.D.
`2 Q. And do you treat diabetic retinopathy
`3 in your current practice?
`4 A. Yes, I do.
`5 Q. And were you treating diabetic
`6 retinopathy in your clinical practice as of
`7 January 2011?
`8 A. Yes.
`9 Q. Do you treat central retinal vein
`10 occlusion in your current clinical practice?
`11 A. Yes.
`12 Q. And were you treating central retinal
`13 vein occlusion in your clinical practice as of
`14 2011?
`15 A. Yes.
`16 Q. Is it okay if we call that "CRVO"?
`17 A. Yes.
`18 Q. And then BRVO that's branch retinal
`19 vein occlusion, correct?
`20 Is it okay --
`21 A. That is, yes.
`22 Q. Is that okay --
`23 A. Yes.
`24 Q. -- if we use that acronym going
`25 forward?
`
`Page 20
`1 CONFIDENTIAL - LUCIAN V. DEL PRIORE, M.D., PH.D.
`2 A. Uh-huh.
`3 Q. And were you treating or do you
`4 currently treat BRVO in your current clinical
`5 practice?
`6 A. Yes, I do.
`7 Q. And were you treating BRVO as of
`8 January 2011?
`9 A. Yes, I was.
`10 Q. Do you currently treat choroidal
`11 neovascularization?
`12 A. Yes, I do.
`13 Q. And were you treating choroidal
`14 neovascularization as of January 2011?
`15 A. Yes.
`16 Q. Were there any other angiogenic eye
`17 disorders that you were treating as of
`18 January 2011 in your clinical practice?
`19 MR. COBB: Objection to form.
`20 A. Yes.
`21 Q. What were those?
`22 MR. COBB: Objection, form.
`23 A. Well, the list is not exhaustive.
`24 But retinopathy of prematurity, sickle cell
`25 disease. I have to think about what else would
`
`Page 21
`1 CONFIDENTIAL - LUCIAN V. DEL PRIORE, M.D., PH.D.
`2 fit inside that category. I mean, there are
`3 numerous; something called macular
`4 telangiectasia, myopic degeneration, ocular
`5 histoplasmosis, android streaks. There are many.
`6 Q. And I'm not sure if this is possible,
`7 but can you give a ballpark estimate as to the
`8 frequency of -- like, for example, what would you
`9 say you treat the most in your clinical practice
`10 in terms of angiogenic eye disorders?
`11 MR. COBB: Objection, calls for
`12 speculation.
`13 A. It would be hard to speculate. The
`14 two most common are macular degeneration and
`15 diabetes.
`16 Q. And what do you mean when you say,
`17 "diabetes," are you talking about diabetic
`18 macular edema?
`19 A. So diabetes affects the eye in a
`20 variety of different fashions and it includes
`21 diabetic macular edema and something called
`22 proliferative diabetic retinopathy where patients
`23 get blood vessel growth and bleeding inside the
`24 eye from diabetes.
`25 Q. Did you ever see patients that are
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`
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`CONFIDENTIAL
`
`Page 22
`1 CONFIDENTIAL - LUCIAN V. DEL PRIORE, M.D., PH.D.
`2 suffering from more than one angiogenic eye
`3 disorder?
`4 A. Yes.
`5 Q. How often do you typically see that?
`6 A. I don't have an exact percentage, but
`7 it's not uncommon. I mean, these can co-exist in
`8 the same individual.
`9 Q. Do you have an example of ones that
`10 -- examples of ones that you commonly see?
`11 MR. COBB: Objection form, calls for
`12 speculation.
`13 A. You're asking about individual
`14 patient examples that I can recall that might
`15 have more than one condition?
`16 Q. If you can recall.
`17 A. I mean, I've seen patients with
`18 diabetes and macular degeneration simultaneously.
`19 Patients with diabetes who have vein occlusions,
`20 either branch retinal vein occlusions or develop
`21 central vein occlusions --
`22 THE STENOGRAPHER: I'm sorry. Can
`23 you just say that a little louder and a little
`24 slower.
`25 THE WITNESS: Of course.
`
`Page 23
`1 CONFIDENTIAL - LUCIAN V. DEL PRIORE, M.D., PH.D.
`2 A. Yeah, I see patients with diabetes
`3 and macular degeneration simultaneously. I,
`4 certainly, have seen patients who have diabetes
`5 who also have vein occlusions, either branch
`6 retinal vein occlusions or central retinal vein
`7 occlusions. And I've seen patients with sickle
`8 cell disease who also have diabetes and have a
`9 combination of sickle cell and diabetic
`10 retinopathy.
`11 Q. You said earlier you consider sickle
`12 cell disease an angiogenic eye disorder.
`13 MR. COBB: Objection.
`14 Q. -- can you?
`15 MR. COBB: Go ahead.
`16 Q. Can you explain how that is an
`17 angiogenic eye disorder?
`18 MR. COBB: Objection, scope.
`19 A. I don't think I've said anything
`20 about it in my declaration.
`21 Q. It's okay. You can still answer.
`22 MR. COBB: Same objection, scope.
`23 A. Can you repeat the question?
`24 Q. Earlier you characterized sickle cell
`25 disease as an angiogenic eye disorder. I'm just
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`Page 24
`1 CONFIDENTIAL - LUCIAN V. DEL PRIORE, M.D., PH.D.
`2 curious how sickle cell disease qualifies as an
`3 angiogenic eye disorder.
`4 MR. COBB: Objection, beyond the
`5 scope of his declaration.
`6 A. I don't think I addressed that in the
`7 declaration.
`8 Q. Well, that's okay.
`9 Just speaking as a practicing
`10 ophthalmologist, can you explain how sickle cell
`11 disease manifests as an angiogenic eye disorder?
`12 MR. COBB: Objection, scope.
`13 A. Again, I think it's outside the scope
`14 of my declaration.
`15 Q. Well, No. 1, I disagree. No. 2, you
`16 still have to answer the question, even though
`17 your attorney --
`18 A. Can you repeat what you said at No.
`19 1?
`20 Q. Speaking as a practicing
`21 ophthalmologist, can you explain how sickle cell
`22 disease manifests as an angiogenic eye disorder?
`23 MR. COBB: Objection, scope.
`24 A. So sickle cell disease has
`25 characteristics that include non-profusion or
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`Page 25
`1 CONFIDENTIAL - LUCIAN V. DEL PRIORE, M.D., PH.D.
`2 poor circulation to the retina and subsequent to
`3 that patients can develop angiogenesis or blood
`4 vessel growth inside the eye.
`5 Q. Do you currently administer anti-VEGF
`6 agents to patients with angiogenic eye disorders
`7 in your clinical practice?
`8 A. Yes.
`9 Q. Which ones do you, typically,
`10 administer?
`11 MR. COBB: Objection, form.
`12 A. I administer -- there are multiple
`13 agents that I administer.
`14 Q. Do you administer Eylea?
`15 A. Yes, I do.
`16 Q. Do you know what the active
`17 ingredient of Eylea is?
`18 MR. COBB: Objection, form.
`19 A. Can you be more specific?
`20 Q. Do you know what the active
`21 pharmaceutical ingredient is in Eylea?
`22 A. Yes.
`23 Q. And what is that?
`24 MR. COBB: Objection, form.
`25 A. The active ingredient in Eylea now is
`
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`CONFIDENTIAL
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`1 CONFIDENTIAL - LUCIAN V. DEL PRIORE, M.D., PH.D.
`2 known -- is aflibercept.
`3 (Stenographer clarification.)
`4 A. Aflibercept.
`5 Q. And do you administer Lucentis?
`6 A. I do.
`7 Q. Do you know what the active
`8 pharmaceutical ingredient of Lucentis is?
`9 A. Yes, I do.
`10 Q. And what is that?
`11 A. Ranibizumab.
`12 Q. And do you administer Avastin?
`13 A. Yes, I do.
`14 Q. Do you know what the active
`15 pharmaceutical ingredient of Avastin is?
`16 A. Yes.
`17 Q. And what is that?
`18 A. Bevacizumab.
`19 Q. Are there any others that you
`20 currently administer to patients with angiogenic
`21 eye disorders?
`22 MR. COBB: Objection, form.
`23 A. Well, sometimes I administer
`24 intraocular steroids for the treatment of
`25 angiogenic eye disorders.
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`Page 27
`1 CONFIDENTIAL - LUCIAN V. DEL PRIORE, M.D., PH.D.
`2 Q. And which steroids do you administer?
`3 A. Triamcinolone.
`4 Q. And which angiogenic eye disorders do
`5 you treat with Triamcinolone?
`6 A. Well, not commonly but diabetic
`7 macular edema is probably the most common.
`8 Q. And prior to the approval of Eylea in
`9 2011, were you administering anti-VEGF agents to
`10 patients with angiogenic eye disorders?
`11 A. Yes, I was.
`12 Q. Which ones were you administering
`13 prior to the approval of Eylea in 2011?
`14 MR. COBB: Objection, scope.
`15 You may answer in your personal
`16 capacity.
`17 THE WITNESS: I didn't hear your
`18 objection. I'm sorry.
`19 MR. COBB: So just make sure you give
`20 me a chance to object.
`21 But the objection was objection to
`22 scope. You may answer the question in your
`23 personal capacity.
`24 THE WITNESS: Okay.
`25 A. So it's not in my declaration, but as
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`Page 28
`1 CONFIDENTIAL - LUCIAN V. DEL PRIORE, M.D., PH.D.
`2 a practicing physician at that time, I was
`3 administering Lucentis and Avastin.
`4 Q. Okay. And when administering
`5 Lucentis, how would you, typically, dose
`6 Lucentis?
`7 MR. COBB: Objection, scope.
`8 You may answer in your personal
`9 capacity.
`10 A. Alright. That's not in my
`11 declaration, but I was administering it as a
`12 practicing physician of an interval of,
`13 approximately, every four weeks.
`14 Q. Did you ever deviate from every
`15 four-week administration of Lucentis?
`16 MR. COBB: Objection, scope.
`17 You may answer in your personal
`18 capacity.
`19 A. Yes.
`20 Q. And can you describe the manner in
`21 which you would deviate from the four-week
`22 administration of Lucentis?
`23 MR. COBB: Objection, form, scope.
`24 You may answer in your personal
`25 capacity.
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`Page 29
`1 CONFIDENTIAL - LUCIAN V. DEL PRIORE, M.D., PH.D.
`2 THE WITNESS: Okay.
`3 A. As a practicing physician, sometimes
`4 I would go out to five weeks for a variety of
`5 reasons. Sometimes it was around insurance
`6 coverage. Some insurance carriers didn't cover
`7 the medication if it was administered more
`8 frequently than every 30 days, scheduling issues,
`9 that sort of thing.
`10 Q. Did you ever administer Lucentis on
`11 an as-needed basis?
`12 MR. COBB: Objection, scope.
`13 You may answer in your personal
`14 capacity.
`15 A. So, in my personal capacity as a
`16 treating physician, there were patients who
`17 received Lucentis less frequently than every four
`18 weeks.
`19 Q. Alright. Are you talking about in
`20 your practice?
`21 A. In my practice, yes.
`22 Q. And how would you assess whether
`23 patients needed additional treatments of
`24 Lucentis?
`25 MR. COBB: Objection, form, scope.
`
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`CONFIDENTIAL
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`1 CONFIDENTIAL - LUCIAN V. DEL PRIORE, M.D., PH.D.
`2 You may answer in your personal
`3 capacity.
`4 A. So it's not within my declaration,
`5 but as a practicing physician, I would employ
`6 retinal imaging, mainly optical coherence
`7 tomography to assess how frequently a patient
`8 needs to be treated.
`9 Q. You said "optical coherence
`10 tomography"?
`11 A. Yes.
`12 Q. Is it okay if we refer to that as
`13 "OCT" for the remainder of the deposition?
`14 A. I think everybody would like that
`15 better.
`16 Q. Did you use anything other than OCT
`17 to assess patients?
`18 MR. COBB: Objection, form.
`19 A. We would occasionally use -- as a
`20 practicing physician, I would occasionally use
`21 fluorescein angiography or fundus photographs,
`22 but that fell by the wayside pretty quickly
`23 because most studies indicated that OCT was just
`24 much more reliable.
`25 Q. And what did OCT measure?
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`Page 31
`1 CONFIDENTIAL - LUCIAN V. DEL PRIORE, M.D., PH.D.
`2 MR. COBB: Objection, scope.
`3 A. So it's outside of my declaration.
`4 Q.