Case 1:22-cv-00061-TSK-JPM Document 619 Filed 09/01/23 Page 1 of 65 PageID #: 47973
`CaSasbt: 22eveOODRISTSIGBRIMDdeocnentG1432FiéGBSlOks Pike G4dtB23PatpD 2:01BS73
`PagelD #: 27743
`
`Exhibit 5
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 619 Filed 09/01/23 Page 2 of 65 PageID #: 47974
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`
`UNITED STATES DISTRICT COURT
`
`NORTHERN DISTRICT OF WEST VIRGINIA
`
`REGENERON PHARMACEUTIALS,
`
`INC.,
`
`Plaintiff,
`
`vs.
`
`}1:22-cv-00061
`
`MYLAN PHARMACEUTICALS,
`
`INC.,
`
`Defendants.
`
`REPORTED BY: Tina Alfaro, RPR, CRR, RMR
`
`DEPOSITION OF KARL CSAKY, M.D., Ph.D.
`
`WASHINGTON, D.C.
`
`APRIL 14, 2023
`
`www.veritext.com
`
`888-39]-3376
`
`Veritext Legal Solutions
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 619 Filed 09/01/23 Page 3 of 65 PageID #: 47975
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`PagelD #: 27745
`
`1 APPEARANCES: (cont'd)
`Videotaped deposition of
`1
`
`2 KARL CSAKY, M._D., Ph.D., held at the offices of|2 ON BEHALF OF THE DEFENDANT:
`3
`3
`STEPTOE & JOHNSON
`
`Page 2
`
`Page 4
`
`4
`5
`6
`7
`
`Williams & Connolly, LLP
`680 Maine Avenue, SW
`Washington, D.C.
`
`BY: GORDON COPLAND,ESQ.(remote)
`400 White Oaks Boulevard
`Bridgeport, WV 26330
`
`4
`5
`6
`7
`
`Taken pursuant to notice before Tina M.
`8
`9 Alfaro, a Notary Public within and for the District
`10 of Columbia.
`
`8 ALSO PRESENT; Petra Scamborova (Regeneron)
`9
`Gene Aronov (videographer)
`10
`
`ll
`
`
`
`
`
`
`
`
`
`
`ll
`
`i2
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`
`
`APPEARANCES:
`ON BEHALF OF THE PLAINTIFF:
`WILLIAMS & CONNOLLY, LLP
`BY: ELLEN OBERWETTER, ESQ.
`KAT KAYALT, ESQ.
`680 Maine Avenue, SW
`Washington, D.C. 20024
`
`,
`3 WITNESS
`4 KARL CSARY, M.D., Ph.D.
`;
`Py Me. eeOXTIBITS
`7 DEFENDANT EXHIBITS
`. ent3teDepositon
`9
`Exhibit 2026
`d
`an
`10 Opening Expert Report
`CAREY DOUGLAS KESSLER & RUBY|11 Exhibit 2027
`BY: DAVID POGUE,ESQ.(remote)
`ig
`sPonsive Expert Report
`707 Virginia Street East
`Exhibit 2028
`13
`901
`Chase
`Tower
`Reply Expert Repart
`Chase Towe
`14 Exhibit 2029
`Charleston, wy 25323
`“History of Changes for Study,
`15 NCT-00509795," MYL-AFL-000 7642
`16 Exhibit 2030
`173
`“Annex 1, Summary ofProduct
`ON BEHALF OF THE DEFENDANT:
`
`
`16 RAKOCZY MOLINO MAZZOCHI SIWIK|17 Characteristics,"
`
`17 BY: NEIL McLAUGHLIN,ESQ. iRANTAN90529080.
`LAUREN LESKO,ESQ.
`Exhibit 2031
`178
`June 2009 Optometry Pharma publication
`19
`JAKE RITTHAMEL,ESQ,
`3p Exhibit 2032
`9
`ERIC HUNT, ESQ.(remote)
`"Methodology of Superiority Versus
`6 West Hubbard, Suite 500
`Baulvalence Teale and Wounferionity
`Trials," MYL-AFL-0089608
`Chicago, IL 60610
`
`IND aaTION
`
`150
`
`22
`
`21
`22
`
`www.veritext.com
`
`Veritext Legal Solutions
`
`2 (Pages 2 - 5)
`
`888-391-3376
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 619 Filed 09/01/23 Page 4 of 65 PageID #: 47976
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`Page 6
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`Page 8
`
`THE VIDEOGRAPHER: Good morming. We're
`1
`2 going on the record at 9:17 a.m. on April 14th,
`3 2023. Please note that the microphones are
`4 sensitive and may pick up whispering and private
`
`5 conversations. Please mute your phonesat this
`6 time. Audio and video recording will continue to
`7 take place unless all parties agree to go off the
`8 record,
`
`9
`
`This is media unit 1 of the video-recorded
`
`16 deposition of Karl Csaky taken by counsel for
`11 Defendant in the matter of Regeneron
`12 Pharmaceuticals, lnc. versus Mylan Pharmaceuticals,
`13 Inc., filed in the United States District Court for
`
`14 the Norther District of West Virginia, Clarksburg
`15 Division, Case No. 1:22-CV-61-TSK. The location of
`
`16 this deposition is Williams & Connolly, 680 Maine
`17 Avenue, Southwest, Washington, D.C.
`18
`My name is Gene Aronov representing
`
`19 Veritext, and I'm the videographer. The court
`20 reporter is Tina Alfaro from the firm Veritext. I
`
`21 am not authorized to administer an oath, I'm not
`
`22 related to any party in this action, nor am I
`
`Page 7
`
`Page 9
`
`I financially interested in the outcome.
`2
`If there are any objections to proceeding,
`3 please state them at the time of your appearances.
`4
`Counsel and all present, including
`5 remotely, will now state their appearances and
`6 affiliations for the record beginning with the
`7 noticing attorney.
`8
`MR. McLAUGHLIN: Neil McLaughlin from
`9 Rakoczy Molino Mazzochi Siwik on behalf of the
`10 Mylan Defendant.
`1]
`MR. RITTHAMEL: Jake Ritthamel on behalf
`
`12 of Mylan, also from RMMS.
`13
`MS. LESKO: Lauren Lesko from RMMS,also
`14 on behalf of Mylan.
`15
`MS. OBERWETTER: Ellen Oberwetter -- go
`16 ahead, Gordon.
`17
`MR. COPLAND: Yeah,sorry.
`18
`Gordon Copland with Steptoe & Johnson,
`19 local counsel for Mylan.
`20
`MS. OBERWETTER: Ellen Oberwetier from
`
`21 Williams & Connolly on behalf of Regeneron, and
`22 with me today is Kat Kayali, also from Williams &
`
`22
`
`PREVIOUSLY MARKED EXHIBITS
`l
`2 DEFENDANT EXHIBITS
`3 Exhibit 4
`Patent No. 10,888,601
`
`38
`
`4
`
`38
`
`Exhibit 5
`Patent No. 11,253,572
`5
`123
`6 Exhibit Niesner 10
`Prescribing information for Yesafili,
`7 MYL-AFL-BLA-1079688
`107
`8 Exhibit 204
`“VEGFTrap-Evefor the treatrnent of
`9 meovascular age-related macular
`degeneration,” MYL-AFL-0005010
`
`PAGE
`
`183
`
`EXHIBITS
`I
`2 DEFENDANT BXHBBITS
`3 Exhibit 2033
`5/10/11 e-mail,
`4 RGN-Eyles-Mylan-00506648,efficacy
`sonipt, RGN-EYLEA-MYLAN-005 06649
`Exhibit 2034
`186
`6 New England Joumal of Medicine article,
`MYL-AFL-0008138
`
`T
`
`194
`Exhibit 2035
`"Ongoing Treatment for Patients with
`Neovascular AMD," MYL-AFL-0090400
`
`197
`Exhibit 2036
`9/14/09 Regeneron press release,
`MYL-AFL-0003751
`
`204
`Exhibit 2037
`“DMETargetProduct Profile,"
`RGN-EYLEA-MYLAN-O0 631453
`
`212
`
`3
`9
`
`10
`
`il
`
`12
`
`13
`
`14
`
`Exhibit 2038
`223/08 e-mail,
`RGN-EYLEA-MYLAN-0053 1609; EMBA letter,
`RGN-EYLEA-MYLAN-00531612
`15)
`16 Exhibit 2039
`217
`"VEGF Trap-Eye in Wet AMD Clear-IT 2
`Summary of One-Year Key Results,”
`MYL-AFL-0008075
`
`17
`18
`
`19
`
`238
`Exhibit 2041
`"New Approach ofAnti-VEGF Agents for
`Age-Related Macular Degeneration,”
`20) RGN-EYLEA-MYLAN-0074 1809
`21 Exhibit 2042
`241
`2017 PAT survey, RGN-EYLBA-MYLAN-00
`«699747
`
`PAGE
`
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`
`Veritext Legal Solutions
`
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`
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`Case 1:22-cv-00061-TSK-JPM Document 619 Filed 09/01/23 Page 5 of 65 PageID #: 47977
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`Page 10
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`Page 12
`
`1
`
`A. J understand that this is in the case of
`
`2 Regeneron versus Mylan Pharmaceuticals, Case
`3 No. 1-22-CV-00061-TSK.
`
`(DX Exhibit 2026 was marked
`4
`for identification.}
`5
`6 BY MR. McLAUGHLIN:
`
`MR. HUNT: Eric Hunt. I'm From Rakoczy
`10
`11 Molino Mazzochi Siwik on behalf of the Defendants.
`
`12
`
`13
`
`THE VIDEOGRAPHER: Thank you.
`
`Will the court reporter please swear in
`
`14 the witness and then counsel may proceed.
`15
`(Witness sworn.)
`16 WHEREUPON:
`
`1 Connolly on behalf of Regeneron. Also present
`2 today is Petra Scamborova from Regeneron.
`3
`MR. DOUGLAS: David Pogue, Carey Douglas
`4 Kessler & Ruby, local counsel for Regeneron.
`5
`MR. McLAUGHLIN: Good morning, Dr. Csaky.
`6
`THE WITNESS: Good morning.
`7=Q. Next I'm going to hand you what has been
`7
`THE VIDEOGRAPHER: I'm sorry, sir. Not
`8 marked as DX-2026. This is a copy of your opening
`8 quite there yet, We have one more person involved
`9 | think who hasn't introduced themselves.
`9 expert report filed in this case. If you could
`10 please flip through that, including taking a look
`11 at the back and the signature page, and confirm
`12 that this is indeed a copy of your opening expert
`13 report?
`14.
`A. This is a copy of my opening expert report
`15 regarding the infringement of U.S. Patent No.
`16 11,253,572 and 10,088,601.
`17
`(DX Exhibit 2027 was marked
`18
`for identification.)
`19 BY MR. McLAUGHLIN:
`
`7
`KARL CSAKY,M_D., Ph.D.,
`18 called as a witness herein, having been first duly
`19 sworn, was examined and testified as follows:
`20
`EXAMINATION
`
`21 BY MR. McLAUGHLIN:
`
`22
`
`Q. Good moming, Dr. Csaky.
`
`Q,- And nextI'll be handing you what's been
`202
`21 marked as DX-2027. This is a copy of the
`22 responsive expert report of Dr. Karl Csaky. Could
`
`Page 13
`
`22 Inc., Case No. 22-CV-000617
`
`|
`2
`
`A, Good moming,
`(DX Exhibit 2025 was marked
`
`I you also flip through that one, including the
`2 signature page, and confirm that this is a copy of
`3 your responsive report filed in this case.
`for identification.)
`3
`4
`A, This is my responsive expert report in
`4=Q. I'm goingto be handing what we've
`5 Case No, 1-22-C'V-00061-TSK.
`$ previously marked as DX-2025. This is a document
`6 entitled "Defendant Mylan Pharmaceutical, Inc.'s
`7 notice of deposition of Karl Csaky"; do you see
`& that?
`
`(DX Exhibit 2028 was marked
`6
`for identification.}
`7
`8 BY MR. McLAUGHLIN:
`
`A. I seethat.
`
`Q, Have you seen this document before?
`A. [have not seen this dacumentbefore.
`
`Q. Okay. Do you understand that you're
`13 appearing here today to provide testimony in the
`14 case described in the caption ofthis document,
`15 Regeneron Pharmaceuticals v. Mylan Pharmaceuticals,
`16 Inc.?
`
`A. Tunderstand that I'm here to provide
`17
`18 deposition.
`19
`Q. And you understand that that deposition is
`20 occurring in the case with Regeneron
`
`21 Pharmaceuticals, Inc. versus Mylan Pharmaceuticals,
`
`Q, And next I'm going to hand you what has
`9
`10 been marked as DX-2028. This is the reply expert
`11 report of Dr. Karl Csaky. Can you please flip
`12 through that, including the signature page, and
`13 confirm that that is indeed your reply report.
`14.
`A. This is my reply expert report on Case
`15 No. 1-22-CV-00061-TSK.
`
`Q. Dr. Csaky, do you know who Dr. Yancopoulos
`
`A, Ido know who Dr, Yancopoulosis.
`Q. Are you familiar with the background of
`20 Dr. George Yancopoulos?
`21
`~=A. Tar not familiar with the background of
`22 Dr, George Yancopoulos.
`
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`Case 1:22-cv-00061-TSK-JPM Document 619 Filed 09/01/23 Page 6 of 65 PageID #: 47978
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`Page 16
`A. I would have used my definition and my
`opinion of POSA andused that to determine what a
`POSA was, in this case, an ophthalmologist with
`experience in treating angiogenic eye disorders.
`
`56Q. Right. Q. Do you know if George Yancopoulos is an
`6
`<A. Page 25.
`ophthalmologist with experience in treating
`angiogenic eye disorders?
`7
`OQ. Yes.
`8
`A. lam here.
`A. Ido not know if Dr. Yancopoulos is or was
`an ophthalmologist with experience in treating
`angiogenic eye disorders.
`Q. Could you tum to the previous page,
`page 24, of your opening expert report.
`A. Lam on page 24 of Exhibit 2026.
`Q. This is a section setting forth
`information about claim construction, correct?
`A, Section A states "Claim consiniction."
`
`Page 14
`Q. Can you open your opening expert report,
`|
`2 that's DX-2026, to paragraph 60, please. It
`3 appears on page 25 of the document. Are you there?
`4.
`A, This is 2026,
`
`Q. Allright. Paragraph 60 is where you
`9
`10 provide a -- your definition of the POSA;is that
`1i correct? Actually, let me stop -- back up a
`12 second.
`
`Going forward in this deposition is it
`13
`14 okay if I use the acronym "POSA"to describe a
`15 person of ordinary skill in the art?
`16
`A, Thatis fine to use the word "POSA."
`
`OmDAwr&WwNe
`
`10
`
`11
`
`13
`
`14
`
`16
`
`1?
`17.=Q. When I say “POSA," you'll understand what Q. Did you review any of the claim
`
`18 I'm referring to?
`construction materials drafted by Regeneron in this
`case?
`19
`=A. Ifyou use the word "POSA,"I will
`20 understand what that means.
`
`A, Ireviewed claim constructions as stated
`
`21=@. Okay. So paragraph 60 is where you in the patents that had been formulated by
`
`22 provide your definition of the POSA, correct?
`Regeneron.
`
`
`
`lA.Itstates "In my opinion, the POSA
`2 relevant to the Yancopoulos patents is an
`3 ophthalmologist with experience in treating
`4 angiogenic eye disorders including through the use
`5 of VEGFantagonists and would have access to
`6 individuals with experience with intravitreal
`7 injection formulations."
`8
`. When formulating your opinion set forth in
`9 paragraph 60, did you consider whetheror not
`10 George Yancopoulos falls within the definition ofa
`11 POSAas you've set forth here?
`12
`MS. OBERWETTER: Object to the form. You
`13 can answer.
`
`14
`
`A. In my opinion, I used my definition of
`15 POSA asstated here, which is an "Ophthalmologist
`16 with experience in treating angiogenic eye
`17 disorders including through the use of VEGF
`18 antagonists and would have access to individuals
`19 with experience with intravitreal injection
`20 formulations."
`
`@. And did you consider whether or not George
`21
`22 Yancopoulosfalls within this definition of a POSA?
`
`Q. Did you review Regeneron's claim
`construction brief that was submitted to the Court
`
`in this case?
`
`Page 17
`
`A. Can you refer meto that document?
`Q. [believe it's set forth in -- at least it
`may be set forth in your Exhibit B. I will find
`this for you here ina second. Sorry. You know
`8 what? It actually may be -- ifyou pick up
`9 DX-2027.
`
`10
`
`3=A. [have DX-27.
`
`Q. And if you tum to Exhibit B there.
`A. Tam on
`--
`
`Q. Actually, I'll circle back to that.
`14 Strikethat last question.
`15
`So next question, I want to draw you to
`16 these claim constructions that you have set forth
`17 here on -- in paragraph 56 of your opening expert
`18 report. So now we're back at DX-2026. And you
`i9 understand that Regeneron and Mylan have both
`20 offered competing claim constructions in this case
`21 for the terms that are set forth on page 24?
`22
`A. Tunderstand in reading my report that
`
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`Page 18
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`there is a heading "Regeneron’s proposed
`1
`2 construction in intrinsic evidence," and I see that
`3 Mylan has a “proposed construction in intrinsic
`4 evidence" column.
`
`Page 20
`I as to how the POSA would useor interpret the term
`2 “tertiary”.
`3
`Q. Okay. Can you point me to where thatis
`4 set forth in your opening expert report? Actually,
`5 strike that question.
` Q. Soare any of your opinions dependent on
`5
`6
`Back to page 24. “Tertiary dose"is not
`6 whether or not -- or whether Regeneron's
`7 construction or Mylan’s construction is adopted?
`7 set forth anywhere in the claim construction
`8g
`MS. OBERWETTER: Object to the form.
`8 portion ofyour opening expert report, correct?
`9
`A. Repeat the question.
`9
`A. Can you explain that question?
`Q. Do you understand that at some point the
`10
`=. The term "tertiary dose”is net set forth
`11 anywhere in the claim construction portion ofyour
`Court in this case will either pick Regeneron’s
`construction or pick Mylan's construction of the
`12 opening expert report, correct?
`13
`MS. OBERWETTER: Object to the form.
`terms that are set forth on page 24?
`
`A. I'm not a lawyer. I don't know how the A.:I would haveto review myreport to see if14
`
`proceedings go, and I den't know who makes the
`15 lL used the term "tertiary" in any of my opinions as
`16 final decisions on claim construction acceptance.
`16 it regards to the claims,
`
`17 17.=Q.~Okay. Right now I'm just asking aboutthe=. So is it fair to say, then, that you have
`
`—
`18 section entitled "Claim Construction" in your
`8 not provided opinions -- strike that.
`19
`Have you considered Mylan's construction
`19 opening expert report on page 24. You do not
`20 provide a construction of the term "tertiary dose"
`20 in the process of developing the opinions that are
`21 set forth in your reports in this case?
`21 anywhere in this section, correct?
`22
`MS. OBERWETTER: Object to the form and
`22
`MS. OBERWETTER: Object to the form,
`
`A. On page 56 -- I mean,in section 56,
`2
`3 page 24 alone the word "tertiary dose" is not used
`4 on this page 24, paragraph 56.
`5
`Q, Earlier when you said that you've been
`6 asked to apply an opinion as to how the POSA would
`7 use or interpret the term “tertiary,” what
`8 interpretation were you using of the term
`9 “tertiary” in formulating your opinions in this
`10 case?
`
`claims in my experience as a POSA.
`Q. And when reading the claims did you apply
`Regeneron's proposed construction ofthe terms or
`6 Mylan's proposed construction of the terms?
`7
`A, Increating my report I used Regeneron’s
`& proposed construction to review -- in my opinions
`9 asa POSA in reviewing those claims.
`10
`Q, You have not offered a construction or an
`11 opinion regarding the term "tertiary dose" in this
`12 case, correct?
`13.
`=A. Can you elaborate on an opinion regarding
`14 "tertiary dose"?
`15
`Q. Do you understand that the term "tertiary
`16 dose" appears in one or more claims of the patents
`THE WITNESS: I have provided evidence --
`17
`17 you've been asked to provide an opinion on?
`18
`A. Ido know thattertiary -- the word
`18 strike that. I have provided opinion as to how a
`19 "tertiary" has been used in the claims.
`19 POSA would interpret in day-to-day practice the
`20 term “tertiary”.
`20
`=©Q. Have you been asked to provide an opinion
`
`21 on what the term "tertiary dose” means? 21=Q. And whatis your understanding ofhow a
`22 POSA would apply “tertiary” in day-to-day practice?
`22
`
`=A. Are you asking in my opinion what a POSA
`11
`12 would interpret a "tertiary dose" to mean?
`13.
`Q. Yeah, let's start with that.
`14—A.. [have--
`
`MS. OBERWETTER: Object to the form. Yo
`15
`16 can answer.
`
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`compound, You can answer.
`A. Ihave read the claims and used those
`
`Page 19
`
`I
`
`foundation.
`
`A. Yes. I've been asked to apply an opinion
`
`

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`Page 22
`A. APOSA would interpret the word "tertiary"
`|
`2 in the context ofnumbers of injections that we
`3 give in patients, and "tertiary" would -- ina
`4 POSA's perspective would indicate an injection
`5 given at a certain time in a certain sequence of
`6 events of that injection regimen.
`7
`Q. Okay.
`8
`On page 24 you have not offered an opinion
`9 about what the term "method oftreating" means,
`10 correct?
`
`MS. OBERWETTER;:Object to the form and
`li
`12 foundation in your interpretation on page 24. You
`13 can answer.
`
`=A. Onpage 24, paragraph 56 the term --
`14
`15 repeat the term that I'm stating on this page.
`16
`=Q. I'masking you aboutthe term “method of
`17 treating."
`18
`A. The term “method of treatment” does not
`19 appear on page 24 of paragraph 56.
`20
`8=6.Q.._ In this case you've not been asked to
`21 offer an opinion about the term "aflibercept,"
`22 correct?
`
`Page 24
`
`1 word "aflibercept" means? My opinionis that a
`2 POSA would understand what the word “aflibercept"
`3 means.
`
`4
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`Q. Okay.
`
`In this case you've not been offered to
`5
`6 provide an opinion regarding whether or not a POSA
`7 would have understood VEGF Trap-Eyeto be
`8 aflibercept prior to 2010, correct?
`9
`A. [would haveto go through my documentto
`
`0 see if 1 specifically called out whether the POSA
`11 would have understood the word "VEGF Trap."
`12
`Q. Okay. The question was actually about the
`13 term "VEGF Trap-Eye."
`
`A. "VEGF Trap-Eye." I would have to go
`14.
`15 through and see if I rendered an opinion as to
`16 whether the POSA would have understood the word
`
`17 "VEGF Trap-Eye.”
`18
`Q. So you don't recall sitting here today
`19 whether or not you were asked to provide an opinion
`20 about whether a POSA would have understood “VEGF
`21 Trap-Eye" to be aflibercept prior to 2010?
`22
`~=—A. [don't recall specifically if1 opined on
`
`20
`
`=A. [don't recall the exact date when I was
`
`www.veritext.com
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`Veritext Legal Solutions
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`7 (Pages 22 - 25)
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`888-391-3376
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`A. Are you askingif the -- if] have given Page 25
`
`it's "Best corrected visual acuity”; do you see
`that?
`
`THE REPORTER: Sorry. One more time.
`MR. McLAUGHLIN: "Best corrected visual
`
`Page 23
`A. That's a very broad question. Can you be
`1
`whether a POSA prior to 2010 would have understood.
`2 more specific?
`the word "WEGF Trap-Eye."
`3=Q. Have you been asked to provide your
`Q. Okay. On page 24 of your opening expert
`4 interp- -- a POSA's interpretation of the term
`report you see there's a term in that first row,
`5 "aflibercept" in this case?
`6
`<A. The word "aflibercept"? The context of
`7 aflibercept? Can you be more specific about the
`8 opinions that I've rendered around the term
`9 “aflibercept"?
`acuity.*
`10=Q._- I'm just talking about the word
`A. [see "Best corrected visual acuity.”
`11 “aflibercept."
`Q. Is it okay if we call that BCVA for this
`12
`A.
`‘I've used the word "aflibercept" in my
`deposition?
`A. We can call that BCVA.
`13 Eylea mostly, but I have -- I used the word
`14 "aflibercept" somewhere in my reports.
`Q. Were you asked to provide your opinions
`15=@. You've not offered a proposed construction
`regarding construction ofthe term "BCVA"?
`16 of the term “aflibercept,” correct?
`A. Iwasasked to provide opinions on how the
`17.
`_—sA..:« I'm not sure I understand what you mean by
`POSA interprets and utilizes the term "BCVA."
`18 the word “construction”of the word aflibercept.
`Q. Do you recall when you were first asked to
`19 do that?
`19
`@. Have you been asked to interpret the word
`20 “aflibercept" as a POSA would understand it?
`21
`21 asked to render an opinion on what the POSA -- how
`22 an opinion that the POSA would understand whatthe|22 the POSA would interpret and utilize BCVA.
`
`

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`Case 1:22-cv-00061-TSK-JPM Document 619 Filed 09/01/23 Page 9 of 65 PageID #: 47981
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`Page 26
`Page 28
`1=Q. Doyourecall if it was in the November
`1
`A. As opposedto best corrected visual acuity
`2 2022 time frame?
`2 which indicates that that's a visual acuity in
`3
`A. I don't recall.
`3 which, from the POSA's opinion and perspective,
`4=Q. You don't recall if it was before orafter
`4 would indicate that that visual acuity now is
`5 Novemberof 2022?
`5 with -- when somebody is wearing their glasses,
`6 their contact lenses. So that has now a feature to
`
`<A. Idon'recall.
`6
`Q. Do you knowif it would have been in
`7
`8 December of 20227
`
`7 it in addition to what the visual acuity would
`8 be.
`
`19
`
`9
`A. I don't recall.
`9
`QQ. And how is visual acuity typically
`10)=Q.-_ Do you recall when you werefirst
`10 measured and reported?
`11 contacted aboutthis case to provide opinions on
`11
`MS. OBERWETTER: Object to the form,
`12 behalf of Regeneron?
`incomplete. You can answer.
`13.
`A. J was contacted sometime in 2021, as I
`13
`_—sA..:_It depends on the context.
`14 recall.
`14
`Q. Howso?
`15=Q. And do yourecall doing any work on this
`15
`A. ~Visual acuity can be measured in --
`16 case in late 20227
`16 depending on the specialty. So there are lots of
`
`17.~—sA._[recall working on the case on and off
`17
`ways depending on the office setting that visual
`18 during periods of time. I don't recall exactly the
`18
`acuity can be measured.
`19 time frames in 2022 that I was asked to work on
`Q. What are some of those ways?
`A. It can be done without correction, for
`example. It can be done with somebody wearing
`their glasses. It can be done in a -- the driver's
`
`20 this case.
`21
`Q. If you could turn to paragraph 216 of yo
`22 opening expert report.
`
`20
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`21
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`22
`
`Q. What do you mean when you say "without any) 21
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`Page 27
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`A. I'm on page -- paragraph --
`|
` Q. Paragraph 216 on page --
`2
`A. Paragraph 216, page 100, I am there.
`3
`QQ.This is a section entitled "BCVA"; do you
`4
`5 see that?
`
`6
`
`A. Isee the section entitled "BCVA."
`
`Page 29
`office, for example, where you look into a machine.
`So those are some of the ways that we measure
`acuity in general. Then for best corrected visual
`acuity we always ensure that a person is wearing
`their corrective lenses, glasses, or comtacts as I
`state here.
`
`7~~Q. And do you recall when you werefirst
`Q. So the term -- strike that.
`8 asked to provide the opinions set forth in this
`So the aspect “best corrected" of the term
`9 section of your opening expert report?
`"BCVA," that implies that a person's wearing
`
`10=A. I don't recall when I was asked to provide corrective lenses, glasses, or contacts?
`11 opinions in regards to this section.
`A. In general, best corrected, again,
`12.
`Q. Do you recall when you first reviewed a
`depending on the setting, is when a patient is
`13 draft of this section ofyour opening expert
`wearing their own lenses, contact lenses, so that
`14 report?
`we are assessing other contributions to their
`15.
`A. I don't recall exactly when I reviewed the
`vision, for example, how the retina is affecting
`their vision.
`16 draft of this page.
`17.
`=. Whatis the difference between visual
`18 acuity and best corrected visual acuity?
`19
`A. Visual acuity is a term that denotes the
`20 vision that somebody has without any qualifiers.
`21
`
`Q. And in conducting this assessment do you
`18 analyze the patient's lenses -- contact lenses or
`19 glasses to determine that those are the best lenses
`20 that that patient should be wearing?
`A. Not routinely.
`Q. Okay. In the section of your opening
`
`22
`
`22 qualifiers"?
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`
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