OmAANIDAMNWN
`
`attributes that are key drivers of marketplace
`1
`2 performance,that clinical data showed that Eylea
`3 was noninferior and clinically equivalent but not
`4 superior to ranibizumab?
`5
`MR. MARX: Objection. Outside the scope
`6 of Mr. Hofmann's expertise, lack of foundation.
`7 BY THE WITNESS:
`8
`A I don't know if you're reading from
`9 Paragraph 58, but I can't find or I certainly
`10 didn't follow what you were saying relative to any
`11 particular language in Paragraph 58.
`12 BY MR. CAINE:
`13. Q Well, you offered an opinion in 58 that
`13. A I don't remember.
`14. Q Did you ask to see Exhibit 1018 after
`14 was a critique of Dr. Manning, that Dr. Manning
`15 reviewing Dr. Do's declaration?
`15 didn't consider attributes such as safety and
`16 efficacy that explained, I think, in your view
`16 A I don't remember one wayorthe other.
`17. Q Do you understand there to be a difference
`17 Eylea's marketplace performance;is that right?
`18 between efficacy of treatment and the duration at
`18
`MR. MARX: Objection. Mischaracterizes
`19 whichthat efficacy is maintained?
`19 the document.
`20
`MR. MARX: Objection. Outside the scope.
`20 BY THE WITNESS:
`21 Andfurther, this is completely improper. It's
`21. A I think you're paraphrasing but I think
`22 seekingalegal conclusion with respect to the
`22 paraphrasing in a waythat I canlive with.
`200
`pending claim construction argument that Regeneron
`1 BY MR.CAINE:
`is trying to make.
`2
` Q In this exhibit that we're looking at -
`BY THE WITNESS:
`3.
`A Among otherthings.
`4=Q In this exhibit that we're looking at,
`A I just —I don't havethe scientific
`5 Exhibit 1018, the results that are being reported
`expertise to answer that question.
`6 are that aflibercept was noninferior and
`BY MR. CAINE:
`7 clinically equivalent to monthly ranibizumab, not
`Q Youdidn't have thatscientific expertise
`8 that it was superior, right?
`when you formed the opinions that are set forth in
`9
`MR. MARX: Objection. Outside the scope.
`your declaration, right?
`MR. MARX: Objection. Mischaracterizes
`10
`10 BY THE WITNESS:
`11 the witness testimony.
`11. A I don't feel comfortable commenting on
`12 BY THE WITNESS:
`12 Exhibit 1018.
`I haven't reviewedit. I'm not a
`13. A No. What I'm saying is I had sufficient
`14 basis to form all the opinions in my report, and
`15 asis normally done by economists who are dealing
`16 with complex technicalissuesis I relied on
`17 technical experts.
`18
`I reviewed other documents to make sure
`19 that there wasn't anything that kind of stood out
`20 or didn't seem to makesense in my ability to
`21 interpret as an economist, not as a scientist, not
`22 as a POSA, and based on what I reviewed and
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`99
`
`know howto interpretit, and I don't know — you
`know,I think these are far better questions for
`Drs. Gerritsen and Albini if these are things they
`reviewed. I don't recall seeing references to
`5 them one wayorthe otherin their declarations,
`6 but I don't know that I can respond to your
`7 question as asked.
`8 BY MR. CAINE:
`9
` Q Did you review Dr. Do's declaration?
`10 A Idid.
`11
`Q Did youreview her discussion of
`12 Exhibit 1018?
`
`1 2 3 4
`
`13 scientist. I'm not a POSA. I've relied in
`14 developing my opinions in Paragraph 58 as well as
`15 the entirety of my report and the relevant
`16 sections contained therein.
`17
`I've referenced the technical experts and
`18 their opinions that helped shape and form my
`19 opinions on technical issues as well as making
`20 sure that they were consistent with whatI saw in
`21 the documents that I saw.
`
`22
`
`I haven't seen this document.
`
`I don't
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`203
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`51 (201 to 204)
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`20
`to differentiate between efficacy and duration for
`1
`1 explain and cite to in my report was supported.
`2 the purposeofoffering opinions on marketplace
`2 BY MR.CAINE:
`3 performance.
`3.
`Q What did you do from an economic
`4
`Did you consider those twoto be different
`4 perspective to differentiate between the impact of
`5 attributes?
`5 efficacy and the impactof duration?
`6
`MR. MARX: Objection. Asked and answered,
`6
`MR. MARX: Objectionto the extentit
`7 outside the scope of Mr. Hofmann's expertise.
`7 seeks a legal conclusion and form.
`8 BY THE WITNESS:
`8 BY THE WITNESS:
`I
`9
`A I'mnota scientist and I'm not a POSA.
`9
`A I think I have to go on the attack here a
`10 was afforded the luxury of having Dr. Manning's
`10 bit with Manning. He didn't do anything.
`11 deposition transcript and Dr. Manning's
`11 BY MR. CAINE:
`12 declaration before I issued my declaration. He
`12 Q I'masking, sir, what you did for the
`13 didn't do anything with this. I was rebutting
`13 purposes ofyour declaration to differentiate
`14him. So what I did wasI explained whatI
`14 between efficacy and duration for the purposes of
`15 observedin his failures. Whether or not he's
`15 offering opinions on Eylea's marketplace
`16 here to defend himself, I think the record is
`16 performance?
`17 pretty clear from his deposition he didn't do
`17
`MR. MARX: Objection to the extent it
`18 anything with respect to this. And so we have
`18 seeks a legal conclusion, form and
`19 that in sworn testimony becauseI think he was
`19 mischaracterizes the witness testimony.
`20 asked aboutthat.
`20 BY THE WITNESS:
`21
`I think that what we havehere is the
`21. A That's inherent in — my role here is to
`22 situation where I — so absent him doing anything
`22 respond and rebut the opinions expressed in the
`204
`202
`to address how much we would lookatthe efficacy
`1
`Manning declaration, and so for you to say you're
`2 and safety as flowing from the aflibercept
`not asking whathe did, that's the role I played
`3 molecule, I looked to what I saw from technical
`here.
`I looked at what he did. He did nothing.
`4 experts. I'm nota scientist or a POSA, so that's
`So then I looked at what Drs. Gerritsen
`and Dr. Albini did and expressed and explained my |5_
`the placeI gotofirst.
`understanding from what they did. I reviewed and |6
`And then I reviewedthe rest of the
`considered other documents and information, and1|7 record, and everything I saw wasconsistent with
`explain that, I think, in pretty good detail in my
`8 what I was looking at in the documents and
`declaration.
`9 information that were producedthat suggest that
`So it is — it is a defect and a flaw that
`10 it's not the '338 patent. It's, in fact, things
`11 Manning didn't address anyof this, and I'm
`11 that were associated with prior blocking patents,
`12 highlighting so he didn't address any of it. And
`12 things that were knownin the prior art, among
`13 from whatI've seen in the record, there's
`13 them being efficacy and safety associated with the
`14 evidence that these are attributes that are
`14 aflibercept molecule, as I explain in detail in my
`15 attributable to the aflibercept molecule, as I
`15 report.
`16 explained, and have references to their
`16 BY MR.CAINE:
`17 declarations. And I'm just — I'm not sure what
`17. Q Informing your critiques, did you do
`18 more to say aboutthat.
`18 anything to differentiate between efficacy on the
`19 BY MR. CAINE:
`19 one hand and duration on the other as a basis for
`20 Q Dr. Manningis nothere to defend himself.
`20 Eylea's marketplace performance?
`21 I'm sure he would have a response. ButI'm really
`21
`MR. MARX: Objection. Asked and answered,
`22 asking about what youdid as part of your critique
`22 outside the expert's expertise. And furthermore,
`
`
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`22 I'm relying on their expertise for their lane that
`
`to the extentthis relates to the pending claim
`constructionissue, it seeks a legal conclusion.
`It's an improper line of questioning.
`BY THE WITNESS:
`A It is — you know, my opinions are laid
`outin, I think, copious detail in my declaration,
`andI explain the things that I considered, relied
`upon, reviewed. Among them were the opinions of
`9 technical experts where those finer points, if
`10 their issues were part of what I considered
`11 because I considered the entirety of their
`12 opinions and declarations. But I'm not a
`13 scientist. I'm not a POSA. I'm not weighing in
`14 on anyof that affirmatively one way or the other.
`15 BY MR. CAINE:
`16 Q Let meask the question one more time
`17 because I don't believe you've yet answered it.
`18
`In forming your critiques, did you do
`19 anything to differentiate between efficacy on the
`20 one hand and duration onthe other as a basis for
`21 Eylea's marketplace performance?
`22
`MR. MARX: Objection. Asked and answered.
`206
`
`1 2 3 4 5 6 7 8
`
`Objection. It seeks a legal conclusionas it
`relates to the pending claim construction issue
`and further outside the scope of Mr. Hofmann's
`expertise.
`BY THE WITNESS:
`
`A I'mnota scientist. I'm not a POSA. I'm
`not a patent lawyer. I'm taking what was, I
`think, failure by Dr. Manning in addressing the
`things that were knownin the prior art and the
`10 importantrole that efficacy and safety played
`11 with respect to the aflibercept molecule.
`12
`And thenI relied on technical experts
`13 with confirmatory review through my review of
`14 documents andinformation that were provided by
`15 Regeneronin forming my opinions.
`16
`It's all laid out in my report, and I
`17 don't really have anything to add beyondthat.
`18 BY MR. CAINE:
`19 Q As part of your analysis and your review
`20 of the declarations of Dr. Albini and
`21 Dr. Gerritsen, you did not -- you did not go into
`22 detail on Exhibit 1018, which we've looked at, or
`
`1 2 3 4 5 6 7 8 9
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`1 Exhibit -- just so I haveit right -- 2086,
`2 correct?
`3
`MR. MARX: Objection. Form.
`4 BY THE WITNESS:
`5
`A Nor would it be anywhere near normalfor
`6 an economist to do so. I'm not getting into the
`7 weeds of the technical issues and arguments
`8 because I'm not a POSA. I'm nota scientist. I'm
`9 relying on their opinions, as I've referenced and
`10 explained, having reviewed their declarations.
`11 They've consideredall this stuff, and that stuff,
`12 you know,is something they considered in forming
`13 the opinions on which I ultimately rely.
`14
`I'm not going to reasonably replicate what
`15a scientist whois a skilled clinician, who is a
`16 skilled microbiologist does in their review of
`17 scientific articles. We just have differing
`18 expertise. I rely on their expertise, and then I
`19 do a check by looking at other documents and
`20 information that are provided in this case by
`21 Regeneron, and I didn't see anything that
`22 suggested otherwise to the conclusions that they
`208
`
`
`
`COCOmAANIDUNFWN=
`
`reached, andso, I think, reasonably relied on
`that information collectively, as I explain in
`detail in my declaration.
`Q Youtalked aboutrelying on the technical
`experts with confirmatory review through your
`review of documents and information that were
`
`provided by Regeneron. And I'm askingdid that
`confirmatory review and your review of documents
`include Exhibits 1018 or 2086?
`
`A I don't rememberwhetherI specifically
`10
`11 looked at those documents. I mean, I looked at
`12 the Do report. I looked at the technical experts.
`13 I don't have these documentslisted in my table as
`14 something that I separately reviewed, so I don't
`15 knowif I've seen these before. I don't believe I
`
`16 have.
`
`Buteither way,like, I think what you're,
`17
`18 I guess, suggesting is that I needed to check or
`19 double-check what the POSAsandscientists viewed
`
`20 with respect to information like these articles.
`21
`That isn't what an economist would do.
`
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`appears to be a document I haven't seen before
`from 2009. It's a hundred-page documentthat I'm
`unfamiliar with. So are you going to — yes, I
`have something labeled 2259 in front of me, but I
`have not reviewed any of the hundred pages.
`Q You understand that Exhibit 2259 was
`submitted in this proceeding by Regeneron? I'll
`represent to you thatit was.
`A Lassume so based onthefactthatit's
`9
`10 got an IPR Bates or whateverthe exhibit
`11 referencing scheme is.
`12 Q You'd recognize Exhibit 2259 as one that
`12 Q Youdidn't answer my question.
`13 Dr. Manningcited in his declaration?
`13
`Did you ask Dr. Albini or Dr. Gerritsen to
`14. A I don't rememberif he did one way orthe
`14 explain to you the difference between efficacy and
`15 other.
`15 duration?
`16 Q You would agree with me that you've had an
`16
`MR. MARX: Objection. And I ask counsel
`17 opportunity to review Exhibit 2259 prior to the
`17 not to interrupt Mr. Hofmann while he's answering
`18 preparation of your declaration?
`18 questions.
`19 A I mean, I guess show me where he
`19 BY THE WITNESS:
`20 referencesit in his report.
`20
`A I'marebuttal witness to Dr. Manning. He
`21
`Q I'llrepresent to you that it's referenced
`21 did nothing. So if anything, I did more by doing
`22 in his report.
`22 whatI did and explaining what I found by looking
`20
`
`22 under heading "Eylea's Patented Dosing Regimen
`
`they're in, and I'm providing my perspective
`1
`2 through an economiclens on the lane that I'm in.
`3
`Q Youdidn't ask Dr. Albini or Dr. Gerritsen
`4 to explain to you the difference between efficacy
`5 and duration;is that right?
`6
`MR. MARX: Objection. Asked and answered.
`7 BY THE WITNESS:
`
`8
`A I feel like we've talked aboutthis -- I
`9 don't know how manydozensof times, but Manning
`10 did nothing. I'm rebutting --
`11 BY MR.CAINE:
`
`1 at their declarations and looking at the documents
`2 and information that wasavailable to me in the
`
`3 record.
`4
`You already know the answerthat I have
`5 had no live discussions with Dr. Albini or
`Dr. Gerritsen, so no, I didn't have discussions
`with them, but I had more than adequate
`information and above and beyond addressing of
`9 this issue compared to Dr. Manning, who did
`10 nothing.
`11
`MR. CAINE: Can we see Exhibit 2259,
`12 please.
`13 BY MR. CAINE:
`14. Q I'm going to hand you what's been marked
`15 as Exhibit 2259.
`16
`MR. MARX: No comment. Thelabels
`17 are consistent with Exhibit 2259.
`
`6 7 8
`
`A Okay. But maybe show me because I
`1
`2 don't — you know,a 2009 study for American
`3 Society of Retina Specialists — I don't know —
`4 that was long before the launch of Eylea, and I
`5 just —I don't recall this document. Maybe I
`6 looked at it; maybe I didn't. But I'm unfamiliar
`7 with it as I sit here right now giventhatit's a
`8 hundred pages and there's a whole bunch ofstuff
`9 here.
`10 Q I'llrepresent to you that it was
`11 referenced in Paragraph 89 of Dr. Manning's
`12 report.
`13
`Do you agree?
`14. A Yeah. I mean, I see the reference. I
`15 just I don't — I don't recall —
`16 Q Youare familiar --
`17. A —this as I sit here right now.
`18 Q You are familiar with ASRS PAT surveys?
`19
`MR. MARX: Excuse me one second,
`20 Mr. Hofmann. I'm just going to note for the
`21 record that this section of the Manning report is
`
`18 BY MR. CAINE:
`19 Q Mr. Hofmann, do you have Exhibit 2259 in
`20 front of you? Is that a yes, no? Do you haveit
`21 in front ofyou?
`22 A Solcan answerthat question, but this
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`54 (213 to 216)
`
`1 Addressed an Unmet Need For Longer Dose
`2 Intervals," and Mr. Hofmann has offered no
`3 opinions in this case concerning unmet need. So
`4 outside the scope, this whole line of questioning
`5 and the use of this document.
`6
`MR. CAINE:I disagree.
`7 BY MR.CAINE:
`8
` Q Have you seen ASRS PATsurveys previously?
`9
`A I don't recall as I sit here right now one
`10 way orthe other.
`11
`Q Would you turn for me to Page 93 of
`12 Exhibit 2259.
`13. A So do you meanPage 93 or Slide 93?
`14 Becausethey seem to be oneoff.
`15 Q Page 93, which is Slide 92.
`16 A Okay.
`17. Q Do youunderstand this is a survey from
`18 2009?
`19
`MR. MARX: Objection. Lack of foundation,
`20 outside the scope of Mr. Hofmann's opinions in
`
`COmAAIDUNAWN
`
`MR. MARX: Objection. Still to the use of
`this document, with respect to unmet need.
`Mr. Hofmann has offered no opinions in this case
`on unmet need. Further, I don't recall this page
`being cited by Dr. Manning.
`Tothe extent you're tryingto elicit
`technical expert testimony from Mr. Manning {sic},
`he is not a technical expert, as he has stated
`10 numerous times today.
`11 BY THE WITNESS:
`
`12. A I'mtoo unfamiliar with this document to
`13 even know howto respond. How the study was
`14 conducted, whatthe control questions were aren't
`15 even listed, which usually is part of a survey.
`16 Like, I don't know whatto say. You can read
`17 words from what's there.
`18
`I don't remember Dr. Manning citing to
`19 this slide. I don't rememberthis being something
`20 that was an area offocus for the purposes of my
`21 opinions on commercialsuccess.
`22 BY MR. CAINE:
`
`22 Mr. Hofmann s opinions in this case.
`
`24
`
`26
`
`A I mean, the footer says 2009. So that's
`Q Yousee aboveit, it says -- you see the
`1
`2 words "improves visual outcomes"?
`all I can say,is that's whatit says in the
`3
`MR. MARX: Same objection. Outside the
`footer.
`4 scope of Mr. Hofmannsopinions in this matter and
`BY MR. CAINE:
`Q Do yousee that onthis slide, there is a
`5 seeking testimony -- scientific technical
`question about "the current unmetneed in the
`6 testimony from Mr. Hofmann whichis nothis
`7 expertise.
`treatment ofwet AMD today"?
`MR. MARX: Same objection. Outside the
`8
`And Ill further note for the record that
`scope of Mr. Hofmann's opinions in this matter.
`9 this study, PAT study, lack of foundation. I do
`10 not know who the respondents to this surveyare.
`10 BY THE WITNESS:
`11 My understanding of these PAT surveys is actually
`11. A I mean, you can read the words that are on
`12 anybody can go online and submit responsesto
`12 here. I don't rememberseeing this, and I don't
`13 these surveys, not just a retina specialist. So
`13 recall anywhere in my declaration I address unmet
`14 with those objections --
`14need. That's usually something that's addressed
`15
`MR. CAINE: Mr. Marx, I ve only asked him
`15 byclinicians, if there is an unmet need,
`16 the question, first of all, whether he sees the
`16 long-felt unmet need, but I don't — if you read
`17 words on the page. AndIthink that objection is
`17 words, I can tell you whether you've read them as
`18 improper.
`I think you are engaging in improper
`18 they appear.
`19 speaking objections. So I would ask you again to
`19 BY MR. CAINE:
`20 Q Do yousee that for the responseto that
`20 stop.
`21 question, 33.56 of respondents said "reduces
`21
`MR. MARX:
`22 frequency ofinjections, maintains VA," meaning
`
`I would ask youto stick to
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`CererantauntwWN
`
`questioning. Mr. Hofmann cannot confirm or deny
`these numbers, what they mean, what their import
`is. Outside the scope ofhis expertise, outside
`the scope of his opinions in this case.
`BY THE WITNESS:
`
`A I'm kindof at a loss here because I don't
`
`recall Dr. Manning referencing this in his report.
`I don't see in this survey document or purported
`survey something that explains what the parameters
`10 were for the survey itself and how it was
`11 conducted, what the questions were, what the
`12 control questions were, whichis all stuff I said
`13 before you guys started objecting to each other.
`14
`I don't know whatyou expect me to do with
`15 this. It seems like we could read the letters on
`
`16 the page, but I don't know what to say beyond
`17 that.
`
`18 BY MR. CAINE:
`
`19 Q Do youagree that in 2009, both Lucentis
`20 and Avastin were treatments that were being used
`21 to treat eye disorders,right?
`22
`MR. MARX:Objection to the extentit's
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`29
`
`MR.CAINE: I'm happily doing so.
`MR. MARX:I disagree. This is clearly
`unmet need from Mr. Manning's declaration.
`Mr. Hofmann has offered no opinions on unmetneed.
`MR.CAINE: I disagree with you.
`MR. MARX: You're free to disagree.
`You're free to ask questions you want. I'm free
`to object as outside the scope of Mr. Hofmann's
`opinions. I'm doing so.
`MR. CAINE: Absolutely. That's fine. If
`10
`11 you limit your objection to objection outside the
`12 scope and don't include the speaking objection
`13 about whocan go online andfill out the surveys,
`14 I'm fine with that. So that's what I would ask
`15 you to do.
`16
`MR. MARX:I'll take that under
`17 advisement, but I'll object how I see fit. Thank
`18 you.
`MR.CAINE: I understand you're going to
`19
`20 object how yousee fit. It's just going to make
`21 the objection go more smoothly ifyou make your
`22 objections and don'tlitter the record with
`
`1 2 3 4 5
`
`6 7 8 9
`
`28
`
`220
`
`speaking objections about what people can and
`1
`2 cant respond -- which people can and cant
`3 respond.
`4
`MR. MARX:I would askthat youstick to
`5 Mr. Hofmann s opinions in this matter, and I wont
`6 haveto objectso often.
`7
`MR.CAINE: I will happily do so.
`8
`MR. MARX: Okay. Well, focus on unmet
`9 need. Outside his expertise, outside his opinions
`10 in this case.
`11
`But go ahead and ask your questions.
`12
`MR. CAINE: Thank you.
`13 BY MR. CAINE:
`14 Q Mr. Hofmann, do you see the words
`15 "improves visual outcomes"?
`16 A Isee the words as they appear on that
`17slide. Again, I don't --
`18 Q Do youseethat the response to both A
`19 and B below reduces frequency ofinjections,
`20 maintains VA, which is below improvesvisual
`21 outcomes, is 62.73 percent?
`22
`MR. MARX: Objectionto this line of
`
`outside the scope of Mr. Hofmann's expertise.
`BY MR.CAINE:
`Q I'masking you about the marketplace as it
`existed in 2009.
`
`A I'mnota clinician, but from what I've
`reviewed, I think Avastin was off label to the
`extent it was being used in this space and
`Lucentis did have, and you're just making a very
`9 vague kind of eye disorders. There are specific
`10 labeled indications from my review ofthe labels.
`11
`Q Well, at least in 2009, both Avastin and
`12 Lucentis were being used in the treatment of
`13 wet AMD,correct?
`14
`MR. MARX: Objection to the extentit's
`15 outside Mr. Hofmann's expertise.
`16 BY THE WITNESS:
`17. A I'mnota clinician. I believe — I don't
`18 have the labelin front of me from 2009 for
`19 Lucentis, but I believe it was on label for
`20 Lucentis. I believe it was off label for Avastin
`21 at that point.
`22
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`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`Transcript of Ivan Hofmann
`Conducted on June 23, 2022
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`22
`223
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`56 (221 to 224)
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`reviewed every page, but that's whatit's titled.
`1
`1 BY MR. CAINE:
` Q Are you saying you didn't review every
`2
`2
` Q Both were being used to treat wet AMD at
`3 page prior to preparing and submitting your
`3 that point in time?
`4 declaration?
`4
`MR. MARX: Objection. Outside the scope
`5
`A No. I'msaying asI sit here right now,I
`5 of Mr. Hofmann's expertise.
`6 didn't do so.
`6 BY THE WITNESS:
`7
` Q Did youreview every page before
`7
`A I'mnota clinician, but from what I've —
`8 submitting your declaration?
`8 and that's a better question for a clinician. I
`9
`MR. MARX:Asked and answered.
`9 don't know whyyou're asking me this, but I
`10 believe that there are some documents that suggest 10 BY THE WITNESS:
`11 that Avastin was being usedoff label for wet AMD, 11 A Yeah. So to the extent that I haveit
`12 labeled in my table on pages — in the "Documents
`12 and I believe Lucentis was on label. But I don't
`13 Reviewed" section of my report, I would have
`14 reviewed, yeah, every page prior to the issuance
`15 of my declaration.
`16 BY MR. CAINE:
`17. Q Would you turn to Page 92. Do you have
`18 it?
`19 A Yeah. Just give me a second to take a
`20 look and I think I'm there.
`21
`Okay. Yeah, I'm there.
`22 Q You see tt's titled "Wet AMD Dosing
`
`224
`
`1 Update"?
`2
`A Idosee that.
`3.
`Q Do you see thatthere is a line graph or a
`4 series ofline graphs for different treatments for
`5 wet AMD?
`
`13 have the Lucentis label in front of me.
`14 BY MR.CAINE:
`15
` Q You have -- you said earlier that you
`16 don't know whether you are familiar with ASRS
`17 surveys;is that right?
`18
`MR. MARX: Objection. Mischaracterizes
`19 the witness testimony.
`20 BY THE WITNESS:
`21. A You asked me specifically whether I'm
`22 familiar with ASRS PATsurveys. I look atthis
`222
`and I don't know that I've seen one before. Maybe
`Ihave. I've done other ocular products, but as I
`sit here right now, I'm not — I'm not remembering
`them one wayorthe other.
`MR. CAINE: Well, why don't we dothis.
`We've been going fora little bit more than an
`hour. Why don't we take a break and we'll come
`back and keep going after.
`THE VIDEOGRAPHER:Please stand by. We
`10 are going off the record. Thetime is 2:46 p.m.
`11
`(A recess was had.)
`12
`THE VIDEOGRAPHER: Weare back on the
`13 record. Thetime is 3:01 p.m.
`14 BY MR. CAINE:
`15
` Q Mr. Hofmann, welcome back. Did you review
`16 Exhibit 2176 for the purposes of preparing your
`17 declaration?
`
`1 2 3 4 5 6 7 8 9
`
`<A Idosee that.
`6
`Q Andtheyellow lineis the line graph for
`7
`8 Eylea?
`9
`A With the triangles as the points, yes.
`10 Q Do yousee that for eight-week dosing, the
`11 percentage ofphysicians that use eight-week
`12 maintenance dosing to treat wet AMD with Eylea is
`yy
`14
`MR. MARX: Objection. Mischaracterizes
`15 the document, lack of foundation.
`16 BY THE WITNESS:
`17. A I mean, there's a lot of caveats and
`18 footnotes and everything else in this. If you
`18 A I did.
`19 Q I'm going to hand you Exhibit 2176.
`19 lookatit a little closer about what is what and
`20
`Do you recognize Exhibit 2176 as a Q4 2020
`20 what can be precisely ascertained from this, but I
`21 performance update?
`21 do see atleast directionally Eylea being slightly
`22 behind — how do you pronounceit, brolucizumab?
`22 A Yeah. I mean, it's 137 pages. I haven't
`PLANET DEPOS
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`Exhibit 2289
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`Exhibit 2289
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`COmAAIDUNHBwWN=
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`F at six weeks, but, yeah, is
`the highest for Eylea in week 8.
`Q And if we were to add the percentages for
`weeks 8, 9 through 11, 12 and 13, we would see
`that overi ofphysicians use maintenance
`dosing regimen of eight weeks or longer to treat
`wet AMD with Eylea, right?
`MR. MARX: Objection. Lack of foundation,
`mischaracterizes the document.
`
`10 BY THE WITNESS:
`11. A There is a few things there that probably
`12 need to be unpacked. One, I just don't think
`13 mathematically it goes over
`. Two, I
`14 think that the footnotes are important that say
`15 these are directional, and they're based on sample
`16 sizes of a few dozen ophthalmologists anda little
`17 over 150 retina specialists, which I don't know
`18 how representative that sample is.
`I don't know
`19 what the questions were, whatthe control
`20 questions were. So there's a lot of unknowns.
`21 BY MR. CAINE:
`22 Q Let's deal with the math.
`
`228
`
`Do youagree that for 9 to 11 weeks, the
`percentage reported for Eylea isa:
`MR. MARX: Objection. Lack of foundation.
`BY THE WITNESS:
`
`
`
`CeAIADAMPWN
`
`A Based onthe caveats that I explained in
`my last question that pretty muchare outlined in
`the footnotes that say these are directional, they
`are notstatistically significant, the
`is the point that they put there for 9 to 11.
`10 Q For12, the percentage for Eylea is
`11 RR,right?
`12
`MR. MARX: Objection. Lack of foundation,
`13 mischaracterizes the document.
`
`1 BY MR. CAINE:
`2
`Q Brolucizumab.
`3.
`A There we go.
`4
`Q The percentage for Eylea in terms of
`5 dosing schedule, according to the asterisk, it
`6 says "ongoing followinginitiation of therapy"is
`7 PEE. en
`8
`MR. MARX: Objection. Lack of foundation.
`9 BY THE WITNESS:
`10 A With manyother caveats and probably other
`11 information within this document that explain the
`12 limited sampling that was done to sourcethis.
`13 Q Andjust because my question may have been
`14 imprecise, the
`refers to the eight-week
`15 dosing schedule using Eylea?
`16
`MR. MARX: Objection. Lack of foundation
`17 and mischaracterizes the document.
`
`18 BY THE WITNESS:
`or the percent
`19 A The number
`20
`does appearthere, but there are many
`21 footnotes that explain that there is a very
`22 limited sample size here. There is very little
`
`confidence, I think, in that numberas expressly
`stated below and that these are more so
`
`226
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`COCmAANIDUNWN=
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`directional percentages.
`BY MR. CAINE:
`Q Thef that you see for eight-week
`dosing with Eylea is higher than any of the other
`percentages associated with other weeks,right?
`MR. MARX: Objection. Lack of foundation.
`BY THE WITNESS:
`10. A That's not what I'm seeing. I'm seeing
`11 brolucizumabis higher, not that much but —
`12 BY MR. CAINE:
`13. Q I'm talking about justlimited to the
`14 Eylea line.
`15
`MR. MARX: Same objection.
`16 BY MR. CAINE:
`17. Q Let me reask the question.
`18 A You're saying for the yellow Line,
`19
`is the highest of the — that's the
`20 apex with respect to the Eylea line.
`21
`Q That's right. Do you agree?
`22 A Yes. It's a little bit above the
`
`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`Transcript of Ivan Hofmann
`Conducted on June 23, 2022
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`227
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`57 (225 to 228)
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`14 BY THE WITNESS:
`15. A Yeah.
`I guess —I guess, again, just
`16 optically observing numbers that clearly on the
`17 face of this document say they're not actually
`18 precise and that they're just kind of giving you a
`19 directional flavor, to my last point to where I
`20 said it probablyisn't over
`, | was
`21 looking at
`for that period. But now
`22 whenI take off my glasses andlooka little
`PLANET DEPOS
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`
`Exhibit 2289
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`Page 058 of 159
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`Exhibit 2289
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`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`Transcript of Ivan Hofmann
`Conducted on June 23, 2022
`
`229
` 23
`
`1 closer, I can see that the is probably
`
`1 physicians, without the benefit of seeing what the
`2 attributable to the yellow triangle there.
`2 control questions are, what the actual questions
`3 BY MR.CAINE:
`3 are, those are the numbers that appear on this
`4
` Q Soyou agree with meatleast that if we
`4 page.
`5 combinethe periods 8, 9 to 11 weeks, 12 and
`5 BY MR. CAINE:
`6 13-plus weeks, the percentage of physicians using
`6
`Q Andthe percentage for Eylea dosing at
`7 maintenance dosing of8 orgreater is over
`7 eight weeks for DME is
`, Tight?
`8
`MR. MARX: Objection. Lack of foundation.
`8
`?
`9
`MR. MARX: Objection. Mischaracterizes
`9 BY THE WITNESS:
`10 the document.
`10 A With all the caveats from mylast answer,
`11 that's the numberthat appears here.
`12 BY MR. CAINE:
`13. Q Ifwedo the same as wedid for wet AMD
`14 for DME andlookat the percentages for Eylea
`15 dosing schedule for eight weeks and beyond and add
`16 those up, overi ofphysicians use
`17 maintenance dosing regimen of eight weeks or more
`18 to treat DME with Eylea, correct?
`19
`MR. MARX: Objection. Lack of foundation.
`20 BY THE WITNESS:
`21. A Again, subjectto all the caveats andall
`22 the footnotes as to whatlimited significance one
`232
`
`11 BY MR. CAINE:
`12} Q With Eylea for wet AMD.
`13. A I mean,that's the math of the percentages
`14 that appearhere with all the caveats that appear
`15 here that these are notreally statistically
`16 significant. They are more so directional, as
`17 explainedin the footnotes.
`18 Q And the -- for both Lucentis and Avastin,
`19 the percent of physicians reporting usage of a
`20 dosing schedule of eight weeks orgreater to treat
`21 wet AMD is less thanJ. right?
`22
`MR. MARX: Objection. Lack of foundation.
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`58 (229 to 232)
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`OmAANIDMNWN=
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`can ascertain with respect to the very limited
`sample here and without the benefit of the control
`questions and the questions themselves, that so,
`falling far behind brolucizumab.
`BY MR. CAINE:
`Q The percentage of physicians reporting the
`usage of Avastin to treat DME with a dosing
`schedule of eight weeks or more is less than
`BE. cx
`MR. MARX: Objection. Lack of foundation.
`10
`11 BY THE WITNESS:
`12 A Are you talking about eight weeks and
`13 above?
`
`14 BY MR.CAINE:
`15 Q Yes.
`16
`MR. MARX: Same objection.
`17 BY THE WITNESS:
`
`
`
`
`
`1 BY THE WITNESS:
`2
`A Again, subjectto all the caveats that
`3 these are not statistically significant, they're
`4 based ona very limited sample, the numbers as
`they appearin the line graph do kind of run below
`if you add those up, whereas
`brolucizumab — I'm butchering it, I know — is at
`8 least as high, if not higher, than Eylea.
`9 BY MR.CAINE:
`10 Q Would you turn for me to Page 94. This is
`11 the DME dosing update.
`12
`Do you see that?
`13 A Ido.
`14. Q Do you see that the dosing schedu