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`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`Transcript of Ivan Hofmann
`
`Date: June 23, 2022
`Case: Mylan Pharmaceuticals Inc. -v- Regeneron Pharmaceuticals, Inc. (PTAB)
`
`Planet Depos
`Phone: 888.433.3767
`Email: transcripts@planetdepos.com
`www.planetdepos.com
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`WORLDWIDE COURT REPORTING & LITIGATION TECHNOLOGY
`
`Exhibit 2289
`Page 001 of 159
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`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`Transcript of Ivan Hofmann
`Conducted on June 23, 2022
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`1
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`1 (1 to 4)
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` A P P E A R A N C E S
`ON BEHALF OF THE PETITIONER:
` JEFFREY A. MARX, ESQUIRE
` DEANNE M. MAZZOCHI, ESQUIRE (VIA PHONE)
` RAKOCZY MOLINO MAZZOCHI SIWIK, LLP
` 6 West Hubbard Street, Suite 500
` Chicago, Illinois 60654
` 312-527-2157
`ON BEHALF OF THE PATENT OWNER:
` DAVID A CAINE, ESQUIRE
` ARNOLD & PORTER KAYE SCHOLER, LLP
` 3000 El Camino Real
` Five Palo Alto Square, Suite 500
` Palo Alto, California 94306-3807
` 650-319-4710
` and
` MATTHEW M. WILK, ESQUIRE
` ARNOLD & PORTER KAYE SCHOLER, LLP
` 250 West 55th Street
` New York, NY 10019-9710
` 212-836-7152
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` UNITED STATES PATENT AND TRADEMARK O
`
`ICE
`
` ________________________
`
` BE ORE THE PATENT TRIAL AND APPEAL BOARD
`
` ________________________
`
` MYLAN PHARMACEUTICALS, INC.
`
` Petitioner,
`
` v.
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` REGENERON PHARMACEUTICALS, INC.
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` Patent Owner.
`
`2 3 4 5 6 7 8 9
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` ______________________________________
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` IPR202
`
`00880, Patent No. 9,699,069
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` IPR202
`
`0088 , Patent No. 9,254,338 B2
`
`______________________________________
`
` CON IDENTIAL PROTECTIVE ORDER MATERIAL
`
` Videotaped Deposition of IVAN HO MANN
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` Chicago, Illinois
`
` Thursday, June 23, 2022
`
` 9:06 a.m. CST
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`Job No.: 452029
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`2 3 4 5 6 7 8 9
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`20
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`Pages: 350
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`Reported by: THERESA A. VORKAPIC,
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`2
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` CSR, RMR, CRR, RPR
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` A P P E A R A N C E S (Continued)
`ALSO PRESENT:
` Eileen Woo, Director at Regeneron
` Pharmaceuticals, Inc. (Via
` teleconference)
` Vinny Lee, In-house Counsel, Mylan
` Pharmaceuticals (Via teleconference)
` Rachel O Sullivan, Summer Associate RKMS
` Austin Olijar, Videographer, Planet Depos,
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`PLANET DEPOS
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`2
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` Videotaped deposition of Ivan Hofmann,
`held at the location of:
`
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` RAKOCZY MOLINO MAZZOCHI SIWIK, LLP
` 6 West Hubbard Street
` Suite 500
` Chicago, Illinois 60654
` 312-527-2157
`
`
` Pursuant to notice before Theresa A. Vorkapic,
`a Certified Shorthand Reporter, Registered Merit
`Reporter, Certified Realtime Reporter, Registered
`Professional Reporter and a Notary Public in and
`for the State of Illinois.
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`Exhibit 2289
`Page 002 of 159
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`

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`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`Transcript of Ivan Hofmann
`Conducted on June 23, 2022
`5
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`2 (5 to 8)
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`7
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` P R O C E E D I N G S
` THE VIDEOGRAPHER: Here begins Disk No. 1
`in the videotaped deposition of Ivan Hofmann in
`the matter of Mylan Pharmaceuticals, Inc. versus
`Regeneron Pharmaceuticals, Inc. in the
`United States Patent and Trademark Office before
`the Patent Trial and Appeal Board, Cause Nos.
`IPR 2021-00880 and IPR 2021-00881.
` Today's dated is June 23, 2022. The time
`on the video monitor is 9:07 a.m. Central Standard
`Time. The videographer today is Austin Olijar
`representing Planet Depos. This videotaped
`deposition is taking place at RMMS, LLP, Chicago,
`Illinois 60604.
` Would counsel please voice-identify
`themselves and state whom they represent.
` MR. CAINE: Sure. David Caine with Arnold
`& Porter. We represent Regeneron. With me today
`is Matthew Wilk, and on the phone is Eileen Woo
`from Regeneron.
` MR. MARX: Jeffrey Marx on behalf of
`Petitioner, Mylan. With me today is our summer
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` C O N T E N T S
`EXAMINATION OF IVAN HOFMANN PAGE
` Examination By Mr. Caine 8
` Examination By Mr. Marx 338
` Further Examination By Mr. Caine 348
`
` E X H I B I T S
` (Attached to transcript.)
`HOFMANN DEPOSITION EXHIBITS PAGE
`
` Exhibit 1 Janssen V Teva New Jersey 54
` Transcript
` Exhibit 2 Memorandum Opinion, 76
` Concordia V Method
` Exhibit 3 Charlottesville Concordia v 80
` Method trial transcript
` 4-21-16
` Exhibit 4 "FDA Approves Genentech's 107
` Vabysmo, the First
` Bispecific Antibody For the
` Eye to Treat Two Leading
` Causes of Vision Loss"
`
`8
`
`associate, Rachel O'Sullivan. On the line as well
`is Deanne Mazzochi from RMMS and Vinny Lee,
`in-house counsel for Mylan.
` The court reporter today is Theresa
`Vorkapic representing Planet Depos. Would the
`reporter please swear in the witness.
` THE REPORTER: Would you raise your right
`hand, please.
` (The witness was duly sworn.)
` IVAN HOFMANN,
`called as a witness herein, having been first duly
`sworn, was examined and testified as follows:
` EXAMINATION
`BY MR. CAINE:
` Q Good morning, Mr. Hofmann.
` A Good morning.
` Q Eylea is a commercial success, right?
` A That is not my opinion, and that is
`inconsistent with the facts and information as I
`explain in detail in my declaration.
` Q You're aware that Eylea has generated
` in gross sales?
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` I N D E X (Continued)
`PREVIOUSLY MARKED EXHIBITS PAGE
`1018 Scientific publication 187
`1023 '959 Patent 113
`1136 CV 40
`1137 Hoffman Declaration 41
`1154 (not identified on the 309
` record)
`2086 (not identified on the 179
` record)
`2136 Eylea Marketing Materials 268
`2137 Marketing Materials 276
`2138 Physician Atu-Wave 2 252
`2140 Physician Atu Wave 5 259
`2176 Q4 2020 Performance Update 222
`2197 Physician Atu Benchmark 163
` Wave Full Report 9/15/11
`2210 (not identified on the 305
` record)
`2226 (not identified on the 304
` record)
`2259 ASRS PAT Surveys 210
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`Exhibit 2289
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`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`Transcript of Ivan Hofmann
`Conducted on June 23, 2022
`9
`
` A Well, I mean, there was very limited
`information produced by Regeneron. You know, I
`didn't find mathematical errors in how these
`numbers were compiled from the information that
`was cited, but there was not a ton of information
`produced by Regeneron to support the information.
`BY MR. CAINE:
` Q You had access to the exhibits that are
`cited on Page 172 of the Manning declaration,
`Exhibits 2285 and 2170?
` MR. MARX: Objection. Form.
`BY THE WITNESS:
` A I did.
`BY MR. CAINE:
` Q You didn't perform a calculation on your
`own to determine whether the figures that were
`reported by Dr. Manning were correct; is that
`right?
` A I think that's kind of a negative
`characterization. I did look at the information,
`and like I said, mathematically the numbers added
`up from what was cited from the limited
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` MR. MARX: Objection. Foundation.
`BY THE WITNESS:
` A That number sounds a little bit unfamiliar
`to me. I recognize that it's had a marketplace
`performance that is relatively significant, but
`the question that is the subject of this inquiry
`is whether there is -- commercial success is a
`term of art in an obviousness inquiry in a patent
`case. And based on my analysis, as I explain in
`detail in my declaration, that is not so.
` Q Let's look at Exhibit 2052 which is
`Dr. Manning's report. Let me give you a copy of
`Exhibit 2052.
` You've seen Exhibit 2052 before?
` A It's lengthy. I haven't flipped through
`every page, but yes, I've certainly reviewed the
`Manning declaration.
` Q If we turn to Attachment D-1 which is
`going to be on Page 171.
` Are you there?
` A I'm there.
` Q Do you see on the total line for gross
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`sales, the number is just under
` MR. MARX: Objection. Foundation.
`BY THE WITNESS:
` A I can agree that the number reads on that
`of. Of course, that's gross sales before
`deducting all the things that need to be deducted
`to get to net sales and all the things that need
`to be deducted to get to gross profit and all the
`things that need to get deducted to get to
`operating profit and beyond.
`BY MR. CAINE:
` Q You also see a net sales figure of
`33,169,380,000?
` MR. MARX: Objection. Foundation.
`BY THE WITNESS:
` A That's what appears in this schedule
`before deducting other expenses.
`BY MR. CAINE:
` Q You have no disagreement with those
`calculations, correct?
` MR. MARX: Same objection.
`BY THE WITNESS:
`
`information that was produced by Regeneron.
` Q Now, your position, to be clear, is that a
`product that over the course of a nine-to-ten-year
`period has sold more than
` worth of
`gross sales and more than $33 billion worth of net
`sales is not a commercial success; is that right?
` MR. MARX: Objection. Mischaracterizes
`witness testimony.
`BY THE WITNESS:
` A I think that I would defer to the complete
`0
`entirety of my declaration where I explain in
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`detail why one has to be careful that even if a
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`product has, you know, some level of sales in the
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`market, you're just kind of flippantly using
`14
`"commercial success" as a colloquial term.
`15
` I mean, commercial success is a term of
`16
`art, and an obviousness inquiry requires that one
`17
`look at certainly sales figures, as well as cost
`18
`to deduct from those figures and then determine
`19
`whether there is a nexus and a demonstrable nexus
`20
`that wasn't done by Manning, as I explain in
`21
`detail in my report, that fails to provide
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`Exhibit 2289
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`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`Transcript of Ivan Hofmann
`Conducted on June 23, 2022
`3
`evidence of commercial success as a term of art in
`an obviousness inquiry.
`BY MR. CAINE:
` Q Now, you mention operating profit. The
`operating profit, as you can see from
`Attachment D-1 to Dr. Manning's declarations, is
`on Page 171, is
`; is that right?
` MR. MARX: Objection. Lack of foundation.
`BY THE WITNESS:
` A According to Attachment D-1, that is the
`number that appears there.
`BY MR. CAINE:
` Q And you didn't perform your own
`calculation to test that number, did you?
` A Well, I don't think that's -- sorry.
` MR. MARX: Sure. Objection. Lack of
`foundation.
`BY THE WITNESS:
` A I don't think that's fair. I certainly
`looked at what was -- everything that was in the
`Manning declaration and I -- you know, like I
`said, I didn't find mathematical errors. I found
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` What I'm saying is that there has been
`no -- no reliable, complete assessment or opinion
`provided by Dr. Manning and, in fact, tremendous
`defects in what Dr. Manning put forth to establish
`commercial success as a term of art in an
`obviousness inquiry, and that's a very important
`thing.
` You can't just fixate on the numbers of
`sales or numbers of profits without fully
`assessing and properly considering all the things
`that Manning failed to do in his declaration with
`respect to the marketplace performance of Eylea.
`BY MR. CAINE:
` Q What level of sales are needed for a
`pharmaceutical treatment to obtain commercial
`success?
` MR. MARX: Objection. Hypothetical.
`BY THE WITNESS:
` A There is no hard and fast rule, and I
`don't think you can even think about it in the way
`your question presupposes. You have to look at
`the facts and circumstances, the market dynamics,
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`a lot of mischaracterization errors and a lot of
`problems in the conclusions that he reached
`relative to the lack of nexus and lack of a basis
`to find commercial success as a term of art in an
`obviousness inquiry for the reasons that I explain
`in great detail in my declaration.
`BY MR. CAINE:
` Q Your position is that a pharmaceutical
`treatment that's achieved a profit of
` over the course of a nine- to
`ten-year period is not a commercial success; is
`that right?
` MR. MARX: Objection. Lack of foundation,
`form, mischaracterizes the witness testimony.
`BY THE WITNESS:
` A What it seems like you're missing or
`you're trying to impose on me or the presumption
`in the question is lacking is that there's, I
`don't know, the ability to discuss marketplace
`performance and how a product is sold. I'm not --
`I'm not saying
` in operating profit is
`an insignificant volume of profits.
`
`and all the different things that exist with
`respect to the particular product and the market
`within which it competes.
`BY MR. CAINE:
` Q One of the things you look at in
`evaluating whether a product is commercially
`successful is sales share; is that right?
` MR. MARX: Objection. Form, lack of
`foundation.
`BY THE WITNESS:
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` A I think that sometimes is a metric that is
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`looked at, and that kind of falls in what I said
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`in my last answer, relative performance.
`13
`BY MR. CAINE:
`14
` Q Right. And so gain of sales share is one
`15
`of the things that you can look at to evaluate
`16
`whether a product is commercially successful,
`17
`right?
`18
` MR. MARX: Objection. Form,
`19
`mischaracterizes the witness testimony.
`20
`BY THE WITNESS:
`21
` A I think it can be.
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`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`Transcript of Ivan Hofmann
`Conducted on June 23, 2022
`7
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`5 (17 to 20)
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` Q In that same period, 2012, Avastin's sales
`share went from 63 percent in 2011 to
`48.48 percent in 2012, right?
` MR. MARX: Objection. Lack of foundation.
`BY THE WITNESS:
` A Pulling information from ATUs, which like
`I said, I don't know how reliable they are or
`accurate or that we should be treating them as
`perfection the way your question presupposes. I
`can read the numbers here, and yes, that's the
`number that appear in this chart for 2012.
`BY MR. CAINE:
` Q From 2011 to 2012, Lucentis's sales share
`went from 37 percent to 30.30 percent, right?
` MR. MARX: Objection. Lack of foundation.
`BY THE WITNESS:
` A With all the caveats I gave in my last
`answer as to the danger in putting too much weight
`on these ATUs which are subject to limited
`questions to a limited number of physicians that
`result in quantitative numbers, those are the
`numbers that appear.
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`BY MR. CAINE:
` Q Let's look at Attachment C-1 to
`Dr. Manning's report which is on Page 158.
` Do you have Attachment C-1?
` A I do.
` Q Okay. Let's look at the ATU survey data
`which is in the middle of the table.
` Do you have that?
` A I do.
` Q In 2011, Eylea's sales share was
`0 percent, right?
` MR. MARX: Objection. Lack of foundation.
`BY THE WITNESS:
` A Well, I mean, there's a host of issues. I
`mean, I will agree with you, that is the number
`that appears in this chart, but, I mean, there's a
`host of questions and problems with ATUs and how
`complete and reliable they are in getting to
`what -- wherever you're going with this, but, yes,
`0 is what appears as of 2011.
`BY MR. CAINE:
` Q And for 2011, Avastin had a 63 percent
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`sales share, and Lucentis had a 37 percent sales
`share, correct?
` MR. MARX: Objection. Lack of foundation.
`BY THE WITNESS:
` A Like I said, I mean, I can read numbers as
`well as you can as to what appears there, but,
`again, these ATUs are helpful in some ways but
`incomplete in many ways as to properly reflecting
`what is going on in the market.
`BY MR. CAINE:
` Q In 2012, Eylea went from a 0 percent sales
`share to a 21.21 percent sales share, right?
` MR. MARX: Objection. Lack of foundation.
`BY THE WITNESS:
` A For all the reasons I explained in my last
`couple of answers, you know, I don't know how much
`we can look at ATUs as the most reliable thing.
`They are relatively incomplete and sometimes
`biased surveys. You know, I can read the numbers
`off of what appears here for 2012, and, yes, that
`is the number that appears in the Attachment C-1.
`BY MR. CAINE:
`
`BY MR. CAINE:
` Q Between 2011 and 2012, Eylea gained sales
`share from both Avastin and Lucentis, right?
` MR. MARX: Objection. Lack of foundation.
`BY THE WITNESS:
` A I think -- I don't know where to begin.
`There's -- mathematically I don't disagree that
`that's how the percentages fall according to the
`ATUs which are subject to all of the
`incompleteness and defects that exist with respect
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`BY MR. CAINE:
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` Q If we look at 2021, that period of time,
`13
`Eylea's sales share was 41.89 percent; Avastin's
`14
`was 39.05 percent; and Lucentis's was
`15
`14.88 percent.
`16
` Do you see that?
`17
` MR. MARX: Objection. Lack of foundation.
`18
` MR. CAINE: I'm sorry. Let me correct it.
`19
`BY MR. CAINE:
`20
` Q 15.4 percent.
`21
` MR. MARX: Objection. Lack of foundation.
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`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`Transcript of Ivan Hofmann
`Conducted on June 23, 2022
`2
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`23
`must have marketplace performance tied to the
`patent at issue in order to establish commercial
`success as a term of art in an obviousness
`inquiry.
`BY MR. CAINE:
` Q Eylea has achieved substantial marketplace
`performance relative to Avastin and Lucentis,
`right?
` MR. MARX: Objection. Form, vague, lack
`of foundation.
`BY THE WITNESS:
` A I think I'm not going to disagree that the
`dollar sales and relative sales have some level of
`significance, you know, given the volumes that we
`see, but there is a tremendous hazard in landing
`just there because the lack of establishment of
`nexus and all the different things that I explain
`in detail in my report, in my declaration show
`that they aren't tied to the patent at issue.
`BY MR. CAINE:
` Q I'm trying to use your term, and I think
`you used the term "marketplace performance."
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`BY THE WITNESS:
` A I mean, like I said, I can read the
`numbers off of this chart the same as you. The
`problems I have, have to do with, one, the
`reliability and usefulness of the ATUs; and, two,
`probably most importantly, this doesn't really
`demonstrate that the '338 patent influenced or
`makes the percentages have further weight.
`BY MR. CAINE:
` Q I'm not talking about nexus now. So I
`want to differentiate between whether a product is
`commercially successful and the nexus for that
`commercial success. So here is the question:
` Between 2011 and 2021, both Avastin and
`Lucentis lost sales share to Eylea, correct?
` MR. MARX: Objection. Form, lack of
`foundation.
`BY THE WITNESS:
` A I think an important semantics thing that
`you and I should try and establish is "commercial
`success" is a term of art in an obviousness
`inquiry, and so there is a distinction that we
`
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` A Yes.
`have to be very careful about with respect to
` Q And -- because you aren't comfortable with
`marketplace performance, whether it's dollars,
`the term "commercial success"; I understand that.
`whether that's percentages versus commercial
` So from a marketplace performance
`success, because commercial success as a term of
`perspective, Eylea has been successful in taking
`art in an obviousness inquiry does require nexus
`market share from competitors and in its overall
`and does require that the patent at issue is the
`revenue, gross, net and operating profit
`driver of sales.
`performance?
` So I think it would be helpful if, because
` MR. MARX: Objection. Form,
`you keep saying commercial success, we should
`mischaracterizes the witness testimony.
`0
`understand that I don't disagree that the
`BY THE WITNESS:
`11
`underlying ATU which has its own defects and
` A The numbers are what they are. There is a
`12
`everything else, as I've said in my many prior
`certain subjectivity in what your question asks,
`13
`answers reflects some of the percentages that are
`but I'm not -- I'm not suggesting that
`14
`here. But we have to be careful because, one,
`multibillion dollars in sales or profits is
`15
`these ATUs are imperfect and only have so much in
`insignificant. The problem I have is that that
`16
`terms of people that were interviewed and how the
`does not equal commercial success.
`17
`questions were framed and all the different things
` Commercial success must be tied to the
`18
`that are within those.
`claimed invention to the patents at issue, and
`19
` And, in any event, you sounded like in
`that has not been established, as I explained in
`20
`your question you didn't want me to address the
`detail in my report.
`21
`question of nexus to the '366 patent and that
`BY MR. CAINE:
`22
`seems like a hazardous place to go because you
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`

`

`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`Transcript of Ivan Hofmann
`Conducted on June 23, 2022
`25
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`7 (25 to 28)
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`27
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`relative to Avastin and Lucentis, right?
` MR. MARX: Objection. Lack of foundation,
`form.
`BY THE WITNESS:
` A From one data source, and all the data
`sources are helpful but also incomplete, but
`that's what's reflected in this schedule.
`BY MR. CAINE:
` Q Are you aware of any data source that
`shows that Eylea hasn't obtained the largest sales
`share for a treatment of the diseases that we're
`talking about today, wet AMD, DME, et cetera?
` MR. MARX: Objection. Form.
`BY THE WITNESS:
` A In terms of what's publicly available, you
`also have to be careful because these data sets
`don't reflect discounts, rebates, kickback
`schemes. There are things are being done to
`influence sales, but these are the data sets that
`I think are available. One just has to look at
`them with a cautious eye.
`BY MR. CAINE:
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` Q With respect to treatments for eye
`disorders that we're talking about here today, wet
`AMD, DME, et cetera, is there a better performing
`treatment on the market?
` MR. MARX: Objection. Form, vague, lack
`of foundation.
`BY MR. CAINE:
` Q From an economic standpoint.
` MR. MARX: Same objections.
`BY THE WITNESS:
` A Well, I mean, that's a little bit
`confusing. I mean, it is certainly -- looking at
`the Schedule C-1 that you have in front of me, it
`has achieved over time a greater percentage,
`again, but that's based on ATUs. The dollar sales
`are what they are. There's a lot of -- this is a
`huge market, and many have profited greatly from
`it in this huge market, but the thing that one has
`to be particularly careful about is whether that's
`tied to the claims of the patent at issue or not,
`and that has clearly not been established by
`Manning.
`
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`BY MR. CAINE:
` Q You don't report any different percentages
` Q We don't have on exhibit -- excuse me --
`in your declaration, right?
` A I did not.
`Attachment C-1 only the data from the ATU survey.
` Q Now, why don't we turn to Attachment D-8,
`You also see Medicare Part B data and Vestrum
`please, which is on Page 180 of Dr. Manning's
`data; right?
`report, Exhibit 2052.
` MR. MARX: Objection. Lack of foundation.
` Attachment D-8 sets out the payment limits
`BY THE WITNESS:
` A That's what appears here, yes.
`for, among others, Eylea, Lucentis and Avastin
`BY MR. CAINE:
`over time. These are Medicare payment limits, I
` Q The Vestrum data for 2021 shows that
`believe; is that right?
`0
`Eylea's sales share is actually higher than ATU;
` MR. MARX: Objection. Lack of foundation.
`11
`it's just under
`, right?
`BY THE WITNESS:
`12
` A Yes. So -- I'm sorry for the -- the way
` MR. MARX: Objection. Lack of foundation.
`13
`these exhibits or attachments are set up. They
`BY THE WITNESS:
`14
` A I don't have the underlying data in front
`build on one another, and so I just wanted to make
`15
`of me, but that's what appears on C-1, but, again,
`sure.
`16
`you have to be very careful because if that's not
` I think building off of -- I guess, it's
`17
`tied to the claims of the patents at issue, then
`D-4 to D-6 to D-8, they are the Medicare limits.
`18
`that doesn't get you nexus, doesn't get you
`BY MR. CAINE:
`19
`commercial success.
` Q The payment limits for Eylea and Lucentis
`20
`BY MR. CAINE:
`for wet AMD and RVO are fairly comparable over
`21
` Q It does establish marketplace performance
`time, right?
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`Exhibit 2289
`Page 008 of 159
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`

`

`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`Transcript of Ivan Hofmann
`Conducted on June 23, 2022
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` MR. MARX: Objection. Form, lack of
`foundation, vague.
`BY THE WITNESS:
` A I mean, there is a subjectivity in that,
`but generally, Eylea and Lucentis for wet AMD and
`RVO are closer certainly than DME and DR, and we
`don't -- that doesn't address the other available
`treatments.
`BY MR. CAINE:
` Q For the period from 2012 to 2016, Eylea
`and Lucentis for wet AMD and RVO both have payment
`limits of over $1,900 per injection, correct?
` MR. MARX: Objection. Lack of foundation,
`form and mischaracterizes the document as well.
`BY THE WITNESS:
` A What was the time frame you were asking
`about?
`BY MR. CAINE:
` Q 2012 to 2016.
` MR. MARX: Same objection.
`BY THE WITNESS:
` A According to this bar chart, I'm not a
`
`8 (29 to 32)
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`payment limit for Lucentis has been under $1,200
`per injection, right?
` MR. MARX: Objection. Mischaracterizes
`the document, lack of foundation.
`BY THE WITNESS:
` A Can you repeat that.
`BY MR. CAINE:
` Q Sure. The payment limit for Lucentis for
`DME and DR has been under $1,200 since 2012,
`correct?
` MR. MARX: Objection. Lack of foundation.
`BY THE WITNESS:
` A I mean, obviously you're reading off the
`numbers that appear in this bar chart. Whether or
`not they reflect all the discounts, I don't know
`as I sit here right now, but they are lower than
`1,200.
`BY MR. CAINE:
` Q Avastin's payment limit has been eight to
`$10 from the entire period from 2012 to 2021,
`right?
` MR. MARX: Objection. Mischaracterizes
`
`30
`hundred percent sure as I sit here whether those
`the document, lack of foundation.
`reflect discounts, but according to what's in the
`BY THE WITNESS:
` A I mean, I think -- and this is probably
`bar chart, the numbers are above 1,900, but, like
`some combination of discussions with technical
`I said, I'm just not a hundred percent sure if
`experts, but Avastin, I don't believe, is on label
`those reflect discounts.
`for this --
`BY MR. CAINE:
`BY MR. CAINE:
` Q From 2017 to 2021, both Eylea and Lucentis
` Q That's not my question. My question was
`for wet AMD and RVO are in the range of $1,600 to
`simply if the payment limit for Avastin has been
`over $1,900 per injection in terms of a payment
`in the range of eight to $10 during the entire
`limit, correct?
`0
`period from 2012 to 2021.
` MR. MARX: Objection. Lack of foundation,
`11
` MR. MARX: Objection. Mischaracterizes
`mischaracterizes the document.
`12
`the document, lack of foundation, asked and
`BY THE WITNESS:
`13
` A Again, not sure if this data set reflects
`answered.
`14
`the discounts that are provided, but, I mean, the
`BY THE WITNESS:
`15
` A My only point, as I explain in my report,
`numbers on the bar chart show the numbers -- I
`16
`I don't disagree that Avastin has long been
`mean, it's just shy of 1,600 in 2021. Like I
`17
`generic and, therefore, is at a lower
`said, I'm just not -- I'm not able to see whether
`18
`reimbursement level than products that are still
`he's explained whether discounts are fully
`19
`on label and are indicated for the treatment and
`reflected here.
`20
`aren't subject to generic competition. So the
`BY MR. CAINE:
`21
`numbers, I think, are reflected as they show
` Q For the period from 2012 through 2021, the
`22
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`Exhibit 2289
`Page 009 of 159
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`

`

`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`Transcript of Ivan Hofmann
`Conducted on June 23, 2022
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`subject to, I guess, all those caveats.
`BY MR. CAINE:
` Q From at least 2016 through 2021, Eylea's
`price limit per injection has been higher than
`that of Lucentis and Avastin, correct?
` MR. MARX: Objection. Lack of foundation,
`form.
`BY THE WITNESS:
` A I'm sorry. Say that again.
`BY MR. CAINE:
` Q Sure.
` From 2016 through 2021, Eylea's payment
`limit has been higher than that of Lucentis and
`Avastin?
` MR. MARX: Objection. Lack of foundation,
`form.
`BY THE WITNESS:
` A I think, you know, just looking at the bar
`graph, directionally that's so. Again, without
`doing anything to establish that that has anything
`to do with the '338 patent, I think that's what
`the numbers in the bar chart show.
`
`9 (33 to 36)
`
`35
`
`chart, but it does seem like at least
`directionally what you're saying is consistent
`with the data sets that are here, but these data
`sets are also, you know, from varying sources and
`with varying limited information that is of
`varying probably completeness and reliability.
`BY MR. CAINE:
` Q Eylea's increasing sales share over time
`at the expense of Avastin and Lucentis,
`particularly considering the data that we looked
`at on payment limits, demonstrates that Eylea
`has -- Eylea's marketplace performance has
`exceeded that of Lucentis and Aventis, correct?
` MR. MARX: Objection. Form, lack of
`foundation and mischaracterizes the witness
`testimony.
`BY THE WITNESS:
` A Though I think I've said it in numerous
`answers, we don't -- we don't have underlying, you
`know, confidence in what the levels of discounts,
`what the levels of other aspects are in getting to
`these data sets, and we don't have any
`
`36
`BY MR. CAINE:
`demonstration from the Manning declaration that
`any of this is really attributable to the patent
` Q During that same period, 2016 to 2021,
`at issue that we're talking about.
`Eylea has gained sales share relative to both
` So I guess there's so many embedded
`Lucentis and Avastin, correct?
`hazards in your question that I think -- you know,
` MR. MARX: Objection. Lack of foundation,
`I can read off percentages or numbers if you want
`form.
`me to, but I'm not sure that we should be putting
`BY THE WITNESS:
` A I don't -- I don't think that is shown in
`great weight on what is being characterized here,
`D-8.
`because as I explain in detail in my report, I
`BY MR. CAINE:
`think it's being mischaracterized and improperly
`0
`attributed to the patent at issue.
` Q It's shown in the attachment we looked at
`11
`BY MR. CAINE:
`just a moment ago, which is C-1.
`12
` During that period, 2016 to 2021, Eylea's
` Q I think you are mixing two things that you
`13
`sales share has grown relative to Lucentis and
`yourself separated. You asked that we not use the
`14
`Avastin?
`term "commercial success." I used the term
`15
` MR. MARX: Objection. Lack of foundation,
`"marketplace performance."
`16
`mischaracterizes document.
` That's the term that you used in your
`17
`BY THE WITNESS:
`testimony, right?
`18
` A I mean, th