Page 1
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` __________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` __________
`MYLAN PHARMACEUTICALS INC., CELLTRION, INC., and
` APOTEX, INC.,
`
` Petitioners,
`
` - vs. -
`
` REGENERON PHARMACEUTICALS, INC.,
`
` Patent Owner.
` __________
` Case IPR2021-00881
` Patent No. 9,254,338 B2
`
` __________
`
` Wednesday, May 4, 2022
`
` The videotaped Deposition of RICHARD
`
`MANNING, PH.D., taken at the Law Offices of
`
`Arnold & Porter Kaye Scholer LLP, 601
`
`Massachusetts Avenue NW, Washington, DC,
`
`beginning at 9:46 a.m., Eastern Standard Time,
`
`before Ryan K. Black, a Registered Professional
`
`Reporter, Certified Livenote Reporter and Notary
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`Public in and for the District of Columbia.
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` PORTIONS OF TRANSCRIPT DESIGNATED CONFIDENTIAL
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`www.veritext.com
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`888-391-3376
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`Veritext Legal Solutions
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`Mylan Exhibit 1151
`Mylan v. Regeneron, IPR2021-00881
`Page 1
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`Page 2
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`Page 4
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`1 I N D E X (Cont'd)
`2 EXHIBIT DESCRIPTION PAGE
`3 Manning 4 a document titled "Aetna Insurance
`4 Clinical Policy Bulletin date last
`5 review February 18th, 2022, titled
`6 "Vascular Endothelial Growth Factor
`7 Inhibitors for Ocular
`8 Indications".....................197
`9 Manning 5 complaint in Merck v. Teva 395 F3rd
`10 1364 Fed Circuit 2005............209
`11 Manning 6 the current Eylea labeling.......219
`12 Manning 7 hyperlink in the Eylea labeling..219
`13 Manning 8 Article dated 9/20 Which Anti-VEGF
`14 Do I Choose as First-Line
`15 Therapy..........................262
`16 Manning 9 a document American Society of
`17 Retina Specialists Preferences and
`18 Trends, AKA PAT Survey, of 2013..270
`19 Manning 10 the 2017 ASRS PAT Survey.........277
`20 PREVIOUSLY MARKED EXHIBITS
`21 EXHIBIT PAGE
`22 2052............................................8
`23 2051...........................................17
`24 1001...........................................30
`25 2136...........................................37
`
`Page 3
`
`Page 5
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`1 A P P E A R A N C E S:
`2
`
` RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`3 BY: DEANNE M MAZZOCHI, ESQ - Via Zoom
` JEFF MARX, ESQUIRE
`4 6 West Hubbard Street
` Suite 500
`5 Chicago, Illinois 60654
` 312 527 2157
`6 Dmazzochi@rmmslegal com
` jmarx@rmmslegal com
`
` Representing - Petitioners
`
`7
`
`89
`
` ARNOLD & PORTER KAYE SCHOLER, LLP
`10 BY: DAVID CAINE, ESQUIRE
` 3000 El Camino Real
`11 Five Palo Alto Square
` suite 500
`12 Palo Alto, California 94306
` 650 319 4500
`13 david caine@arnoldporter com
`14 - and -
`15 ARNOLD & PORTER KAYE SCHOLER, LLP
` BY: MATTHEW M WILK, ESQUIRE
`16 250 West 55th Street
` New York, New York 10019
`17 212 836 8000
` matthew wilk@arnoldporter com
`
`18
`
` Representing - Patent Owner
`
`19
`20
`21 ALSO PRESENT:
`22 James Evans - Regeneron
`23 Eileen Wu - Regeneron - Via Zoom
`24 Vinny Lee - Mylan
`25 Solomon Francis - Legal Videographer
`
`1 I N D E X (Cont'd)
`2 EXHIBIT PAGE
`3 2150...........................................43
`4 2149...........................................54
`5 2138...........................................66
`6 2197...........................................89
`7 2278..........................................109
`8 Do 4..........................................124
`9 2186..........................................215
`10 2189..........................................218
`11 1024..........................................222
`12 2019..........................................234
`13 2196..........................................249
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`1 I N D E X
`2 TESTIMONY OF: RICHARD MANNING, PH.D PAGE
`3 By Ms. Mazzochi............................8, 290
`4 By Mr. Caine..................................287
`
`5 6
`
` E X H I B I T S
`7 EXHIBIT DESCRIPTION PAGE
`8 Manning 1 a document titled L36962 Medicare
`9 Part A/B local coverage
`10 determination (LCD) comments
`11 summary, for First Coast
`12 Service Options, Inc.............130
`13 Manning 2 United States versus Regeneron
`14 Complaint, Civil Action No.
`15 20-11217, filed June 24, 2020....145
`16 Manning 3 a document titled Horizon Healthcare
`17 Services, Inc., et al., versus
`18 Regeneron Pharmaceuticals, Inc.,
`19 Defendant, filed April 4th,
`20 2020.............................185
`21
`22
`23
`24
`25
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`Mylan Exhibit 1151
`Mylan v. Regeneron, IPR2021-00881
`Page 2
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`Page 6
`1 THE VIDEOGRAPHER: Good morning. We're
`2 going on the record at 9:46 a m. on May 4th,
`3 2022.
`4 Please note that the microphones are
`5 sensitive and may pick up whispering, private
`6 conversations and cellular interference. Please
`7 mute all phones at this time. Audio and video
`8 recording will continue to take place unless all
`9 parties agree to go off the record. This is
`10 Media Unit Number 1 of the video-recorded
`11 deposition of Dr. Richard Manning, taken in
`12 the matter of Mylan Pharmaceuticals, Inc.,
`13 petitioners, and Regeneron Pharmaceuticals, Inc.,
`14 patent owner, filed in the United States Patent
`15 and Trademark Office before the Patent and Trial
`16 Appeal Board. Case Number IPR2021-00880 and
`17 IPR2021-00881.
`18 This deposition is being held at Arnold
`19 & Porter Kaye Scholer, as well as remotely. My
`20 name is Solomon Francis, with Veritext Legal
`21 Solutions, and I'm the videographer. Our court
`22 reporter today is Ryan Black, with Veritext Legal
`23 Solutions.
`24 At this time will counsel please state
`25 their appearances and affiliations for the
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`Page 8
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`1 or affirmed, was examined and testified
`2 as follows:
`3 * * *
`4 THE REPORTER: Thank you.
`5 THE VIDEOGRAPHER: Please proceed,
`6 Counsel.
`7 EXAMINATION
`8 BY MS. MAZZOCHI:
`9 Q. Thank you, Dr. Manning. Could you
`10 please state your full name and address for the
`11 record?
`12 A. Richard L. Manning, 1007 Cottage Street
`13 Southwest, in Vienna, Virginia 22180.
`14 Q. And, Dr. Manning, you've been deposed
`15 several times before. Yes?
`16 A. Yes.
`17 Q. Dr. Manning, let's get straight to it,
`18 and I'd like you to take a look at a document
`19 that's been marked in this case as Exhibit 2052.
`20 And I'd like you to confirm that this is your
`21 declaration submitted in this case.
`22 (Previously marked Exhibit No. 2052 was
`23 introduced.)
`24 MS. MAZZOCHI: And so while Mr. Manning
`25 -- or Dr. Manning is reviewing, I'll just note
`
`Page 7
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`Page 9
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`1 record.
`2 MS. MAZZOCHI: Good morning. My name is
`3 Deanne Mazzochi, from the law firm Rakoczy Molino
`4 Mazzochi Siwik LLP. Also with me is Jeff Marx.
`5 And I will be questioning the witness today on
`6 behalf of the petitioners.
`7 MR. CAINE: Good morning. David Caine,
`8 with Arnold & Porter, on behalf of the patent
`9 owner. With me today are Matthew Wilk, with
`10 Arnold & Porter, and James Evans and Eileen Wu,
`11 who's on the video conference from Regeneron.
`12 Let me just note for the record I
`13 believe that Dr. Manning has submitted a
`14 declaration only in the '881 IPR proceeding.
`15 MR. MARX: Oh, Ms. Mazzochi already
`16 introduced myself. I'm Jeff Marx, on behalf of
`17 the petitioners, from Rakoczy Molino Mazzochi
`18 Siwik.
`19 THE VIDEOGRAPHER: At this time will the
`20 court reporter please swear in the witness and we
`21 can proceed.
`22 * * *
`23 Whereupon --
`24 RICHARD L. MANNING, PH.D.,
`25 called to testify, having been first duly sworn
`
`1 for the record we plan on marking any new
`2 exhibits to the deposition as Manning Exhibit
`3 with the exhibit number. Any previously marked
`4 exhibits that have already been submitted in this
`5 proceeding will use their existing exhibit
`6 numbers.
`7 Thank you.
`8 BY MS. MAZZOCHI:
`9 Q. All right. So, Dr. Manning, can you
`10 confirm that Exhibit 2052 is your expert
`11 declaration for this proceeding?
`12 A. It does appear to be, yes.
`13 Q. All right. If we could take a little
`14 look at some of your background information. If
`15 you could turn to Page 1 of your report, which is
`16 at Page 007 of 289, and I believe it's Paragraph
`17 3. Let me know when you're there.
`18 THE REPORTER: Can we turn the volume up
`19 on this?
`20 THE WITNESS: I'm sorry. Paragraph 3?
`21 MS. MAZZOCHI: Yep.
`22 THE WITNESS: Okay. I'm there.
`23 BY MS. MAZZOCHI:
`24 Q. All right. It states that your career
`25 included serving as -- at multinational
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`Mylan Exhibit 1151
`Mylan v. Regeneron, IPR2021-00881
`Page 3
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`Page 10
`1 pharmaceutical companies including Merck and
`2 Pfizer. Yes?
`3 A. That's correct.
`4 Q. All right. Did either of those years of
`5 your career involve ophthalmic drugs or devices?
`6 A. Not specifically, no. I mean --
`7 Q. Okay. When you were at --
`8 A. -- I didn't work --
`9 Q. When you were --
`10 A. Sorry.
`11 Q. Sorry.
`12 When you were at Merck or Pfizer, did
`13 you work on any drugs targeting the retina?
`14 A. Not that I recall, no.
`15 Q. And let's talk about your time at Pfizer
`16 that concluded in 2009. Where did you start at
`17 Pfizer? Was it within Pfizer proper or a company
`18 that was acquired into Pfizer?
`19 A. I was hired into Pfizer from academics,
`20 so I came into Pfizer directly from the outside.
`21 Q. And when you were at Pfizer, what drug
`22 compounds did you do work on?
`23 A. Well, my role at Pfizer was not
`24 typically product-specific. I mean, I would get
`25 involved in questions that touched on specific
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`Page 12
`1 have been contemplated; questions about payment
`2 policies; questions about financing for
`3 healthcare.
`4 I could go on. I think I've summarized
`5 those in my report, though, and I guess I
`6 would --
`7 Q. So was your role -- yeah. So just so I
`8 have a sense, was your role more of a public
`9 policy-type role where you were trying to drive
`10 and influence policy or were -- well, I'll just
`11 stop with that.
`12 A. My -- I was in the corporate strategic
`13 planning and policy department or division.
`14 That was a small division at the corporate center
`15 where we would not directly affect policy, but
`16 analyze the environment, which included the
`17 policy environment, but also included the payor
`18 environment or the business environment as it was
`19 evolving. So I was not a lobbyist. Although I
`20 would work on occasion with the Washington
`21 office, that was not my primary responsibility.
`22 Q. Okay. Were -- did you ever do any con
`23 -- any analyses in connection with off-label use
`24 promotions of any Pfizer drugs, or off-label
`25 promotions, in general?
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`Page 11
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`Page 13
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`1 drugs from time to time, but I was not on a
`2 product team. I was a -- an economist at the
`3 corporate -- in the corporate center, so my
`4 responsibilities weren't very often or weren't
`5 typically tied to a specific product issue.
`6 Q. Then what exactly were you doing at
`7 Pfizer?
`8 A. I was, as I said, an economist in the
`9 corporate center. I worked on a variety of
`10 issues where, as it describes in my report, I led
`11 economic analysis to shape the practices relating
`12 to emerging business concerns. I would provide
`13 input to senior executives on a variety of
`14 business or -- or other external challenges that
`15 were facing the company. I would interface with
`16 outside academic economists and others who were
`17 evaluating the economic situation that the
`18 company and the industry faced; things associated
`19 with intellectual property challenges, for
`20 example, threats to intellectual property, in --
`21 in the U.S. and abroad; questions about price
`22 controls or questions about, both internationally
`23 and domestically, the prospect of them; questions
`24 about how marketing might be affected by either
`25 regulatory or legislative actions that might
`
`1 A. Well, I guess I'm hanging up on the
`2 question of "analysis." I mean, certainly,
`3 off-label utilization was something that we
`4 talked about or I -- I had work about. But I
`5 wouldn't -- unless you were more specific about
`6 the question, I don't know that I could really
`7 give you an answer.
`8 Q. Okay. Well, during your time at Pfizer,
`9 was that at around the time when there was a huge
`10 criminal complaint filed with Pfizer, as well as
`11 a large civil settlement, in connection with
`12 off-label promotions?
`13 A. There was a -- I don't remember the
`14 exact timing of it, and I was not directly
`15 involved in it -- that, but I do remember there
`16 being a large settlement in a case like that,
`17 yes. I don't remember the exact timing of it.
`18 Q. Did you do any economic analyses
`19 in connection with what was ultimately the
`20 settlement that Pfizer did with the federal
`21 government?
`22 A. No.
`23 Q. Were you involved in any efforts to try
`24 to improve Pfizer's corporate compliance plans in
`25 connection with that criminal and civil charge?
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`Mylan Exhibit 1151
`Mylan v. Regeneron, IPR2021-00881
`Page 4
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`Page 14
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`1 A. No.
`2 THE WITNESS: Sorry. But I -- I'd like
`3 to tell the videographer that there's something
`4 on the screen that --
`5 MR. CAINE: Yeah. Maybe we could just
`6 dismiss that.
`7 BY MS. MAZZOCHI:
`8 Q. Let's go ahead and go to Page 3 of your
`9 Expert Declaration, Exhibit 2052. Paragraph 8.
`10 THE REPORTER: You're cutting out.
`11 MS. MAZZOCHI: Sorry. Let me try that
`12 again.
`13 BY MS. MAZZOCHI:
`14 Q. Turn to Page 3 of Exhibit 2052, your
`15 expert declaration, Page 009 of 289, specifically
`16 Paragraph 8.
`17 A. Okay.
`18 Q. It states you're being compensated at
`19 your standard hourly rate. What is that rate?
`20 A. $950 per hour.
`21 Q. Okay.
`22 A. To be --
`23 Q. And how many --
`24 A. To be clear, Intensity, the firm, is
`25 being compensated at that rate.
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`Page 16
`1 about what the key questions were and to bring
`2 the analyses into a form so the -- I don't know
`3 exactly who did this, but, as you see, the attach
`4 -- the attachments to the declaration had to be
`5 processed and put into that, things like that, to
`6 generate the -- the information that is included
`7 in those attachments.
`8 Q. Okay. And what did Ryan Marsh do in
`9 connection with the preparation of your
`10 declaration?
`11 A. Ryan was the project manager. As I
`12 mentioned, he's also a Ph.D economist, so he and
`13 I -- he and I talked very frequently about my
`14 view of what the questions -- key questions were,
`15 what I wanted him to evaluate, what I wanted the
`16 team to explore, and then we talked about what
`17 the findings implied and what -- what -- what --
`18 how they fit into what I can -- ultimately came
`19 to as my opinion on the matter.
`20 Q. In connection with preparing what -- you
`21 know, some of these documents that are cited in
`22 your expert report, did you prepare any Excel
`23 spreadsheets?
`24 A. Yes. I'm sure there -- in fact, I think
`25 all of the attachments that were here are in some
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`Page 15
`1 Q. Right. And how many others worked on
`2 this -- at the firm worked on this project with
`3 you?
`4 A. Two staff members, primarily. There are
`5 two others that I know worked a fair amount, and
`6 then probably a couple of others in some of the,
`7 you know, document preparation.
`8 Q. Okay. And who are the two staff members
`9 you primarily worked with?
`10 A. Ryan Marsh, who's a Ph.D from
`11 Northwestern University, was the man -- project
`12 manager. Max Urman, and I'm actually not sure
`13 how to spell his last name, but he was one of the
`14 lead consultants. The two others I have in mind
`15 at this moment -- and I may not remember
`16 everybody, I'm sorry -- were Elizabeth Parker and
`17 Arvin Mohapatra.
`18 Q. And what -- what did you ask Mr. Urman
`19 to do in connection with the preparation of this
`20 declaration?
`21 A. Well, there were a variety of things
`22 that were done to prepare for and execute the
`23 declaration. We looked at data, we looked at
`24 large number of data sets or -- or presentations
`25 that were provided to organize the work, to think
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`Page 17
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`1 form in an Excel spreadsheet.
`2 Q. Okay. Did you produce the native
`3 forms of those or just paper copies with your
`4 declaration?
`5 A. To tell you the truth, I'm not sure.
`6 Q. Do you still have the original Excel
`7 spreadsheets in native form?
`8 A. Not on me today, no. I -- but if -- but
`9 if we did, they would be on my firm's network.
`10 Q. Okay. Well, we'll ask that those be
`11 looked for and produced.
`12 Do you know approximately how much your
`13 firm has billed Regeneron to date?
`14 A. Approximately?
`15 Q. Yeah.
`16 A. $500,000, more or less. I'm not sure.
`17 (Previously marked Exhibit No. 2051 was
`18 introduced.)
`19 BY MS. MAZZOCHI:
`20 Q. If you take a look at Page 4 of your
`21 declaration, Paragraph 11, which is Exhibit 2051
`22 [sic] Page 10 of 289, it states that interviews
`23 were conducted with some Regeneron people. Why
`24 did -- did you ask to conduct these interviews or
`25 were they simply offered to you?
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`Mylan Exhibit 1151
`Mylan v. Regeneron, IPR2021-00881
`Page 5
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`Page 18
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`Page 20
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`1 A. We asked to -- I asked for them.
`2 Q. Okay. And you didn't identify their
`3 names. Is there a reason why you didn't identify
`4 their names?
`5 A. It was much more important to me
`6 What their role was. Their names didn't really
`7 matter. And so I wanted to talk to people in,
`8 you know, customer insights, field force
`9 effectiveness, commercial finance, market access
`10 strategy. Those were some of the questions that
`11 I had -- I had questions that were relevant for
`12 people in those roles, and, you know, --
`13 Q. Okay. Is --
`14 A. -- names didn't matter.
`15 Q. Is there a reason why whatever facts
`16 they gave you that you felt were important, why
`17 certain [audio dropped] facts weren't just put
`18 into a declaration that you, in turn, could rely
`19 on and cite to support your -- your -- your
`20 opinions in this declaration?
`21 A. I'm sorry. You broke -- you broke up
`22 there and I didn't hear the whole question.
`23 Q. Sure. Sure. Do you know why,
`24 to the extent you needed any facts from these
`25 individuals, those facts were not recorded in a
`
`1 to confirm that these were documents and
`2 information used in the ordinary course of
`3 business and not otherwise created. What we
`4 received looked to me to be legitimate and
`5 appropriate, and I had no reason to believe that
`6 they were being untruthful.
`7 Q. All right. But you didn't have any
`8 -- you didn't have any ability to validate the
`9 accuracy one way or the other. You didn't go and
`10 audit the Regeneron files, for example, to make
`11 sure that that's act --
`12 MR. CAINE: Obj --
`13 BY MS. MAZZOCHI:
`14 Q. -- in the normal documents.
`15 MR. CAINE: Objection; form.
`16 THE WITNESS: I did not audit Regeneron
`17 files, no.
`18 BY MS. MAZZOCHI:
`19 Q. All right. So the Regeneron director
`20 of customer insights it says, "Interviewed on
`21 November 30th, 2021." Did you personally do that
`22 interview, or one of the individuals on your
`23 staff?
`24 A. I was there. I think Ryan Marsh was
`25 also there, or we did it through a Zoom meeting
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`Page 19
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`Page 21
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`1 declaration to submit in this case?
`2 A. I'm sorry. Do I know why those people
`3 didn't file their own declarations?
`4 Q. Right. If you needed that information
`5 to offer your opinions.
`6 A. Well, the information was more
`7 confirmatory and background in nature. So,
`8 for example, I wanted to know the nature of the
`9 sampling effort that had gone forward and that --
`10 that I discussed in my re -- my declaration. And
`11 so we had a call, I believe that was the call
`12 with the market access strategy individual, just
`13 to talk about what kind of data availability
`14 there was, what the sampling had been like. And
`15 so the -- the result was that we got the data set
`16 that has the sampling information in it, and so
`17 we cited to that data, not to the conversation
`18 about it.
`19 Q. Well, how do you know that the data set
`20 that you got was actually the correct and only
`21 database and not one specifically created for
`22 purposes of this proceeding?
`23 A. I asked that person during those
`24 conversations whether or not the information and
`25 -- during all of the conversations I asked them
`
`1 or some other similar manner, so --
`2 Q. Okay.
`3 A. -- but I was there.
`4 Q. Do you -- did you have any -- do you
`5 have any notes from that, or -- or did Ryan or
`6 anyone on your end take any notes from that
`7 interview?
`8 A. I believe Ryan took notes. I do not
`9 have them. I'm -- Ryan may or may not have them.
`10 I don't know.
`11 MS. MAZZOCHI: All right. Well, we'll
`12 ask that any notes from that conversation be
`13 produced.
`14 BY MS. MAZZOCHI:
`15 Q. What's the name of the person who was
`16 the Regeneron director?
`17 A. As I told you, I didn't record their
`18 names. I don't know.
`19 Q. You don't know who it was?
`20 A. I know his title -- I do not -- or her
`21 title. I do not know his or her name.
`22 Q. Well, wasn't it -- you didn't -- you
`23 didn't want to know their name or you just don't
`24 remember their name?
`25 A. I -- I -- I'm sure I was introduced
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`Mylan v. Regeneron, IPR2021-00881
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`Page 22
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`1 to them by name and we talked in a normal
`2 professional manner, so I would have seen their
`3 name, but I didn't -- it wasn't important to me
`4 in the -- in -- in getting the information I
`5 needed, their name was much less important than
`6 their role. So I talked to them. I don't --
`7 don't remember their name is probably the best
`8 answer.
`9 Q. All right. This individual listed here
`10 is Regeneron Associate Director Field Force
`11 Effectiveness and Ophthalmology. So -- so who
`12 was -- again, you don't remember the name of that
`13 person?
`14 A. I do not.
`15 Q. All right. Who was with you in the
`16 context of that interview?
`17 A. Ryan Marsh would have been there, as
`18 well.
`19 Q. Again, do you know if any notes or
`20 recordings were taken of that interview?
`21 A. I know it was not recorded. He may have
`22 notes. I do not know. I don't have any notes.
`23 MS. MAZZOCHI: All right. We'll ask
`24 that those notes be provided as well.
`25 BY MS. MAZZOCHI:
`
`Page 24
`1 pharmaceutical company like that, they seemed to
`2 be -- they talked about things in the way that my
`3 former colleagues would have talked about them.
`4 They -- there was nothing about them that seemed
`5 to suggest a lack of credibility.
`6 Q. Well, but that's you offering your
`7 opinion, right? We don't have the ability to
`8 gauge what you did because, of course, they're
`9 not available and you didn't identify their
`10 names.
`11 The next person you identified here is
`12 Regeneron Executive Director, Commercial Finance
`13 and Business Planning, and then also Regeneron
`14 Senior Director, SP and A. Again, were these two
`15 individuals interviewed together or separately?
`16 A. My recollection is that they were
`17 together, as well, but I -- I -- that's my
`18 recollection. They did have --
`19 Q. All right. Was -- all right. And was
`20 Ryan Marsh also with you on this call?
`21 A. Yes.
`22 Q. And, again, this was not at Re -- not at
`23 Regeneron, but over a -- was it over a Zoom call
`24 or a phone call?
`25 A. It was, again, a Zoom call. It may have
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`Page 23
`1 Q. And, again, you don't remember the name
`2 of this person?
`3 A. I do not.
`4 Q. The next person identified is Regeneron
`5 Associate Director Sample Operations and
`6 Accountability. Was that person the same
`7 interview or a different interview on that same
`8 day?
`9 A. You know, I'm not remembering exactly,
`10 but it looks like there were two people in that
`11 interview as it -- as it -- as it is there.
`12 Q. Okay. And, again, you don't recall
`13 who the Regeneron Associate Director Sample
`14 Operations and Accountability was?
`15 A. That's correct. I don't.
`16 Q. All right. And you've never met any of
`17 these individuals before?
`18 A. No -- well, other than on the Zoom call.
`19 Q. Sure.
`20 And you had no firsthand knowledge as to
`21 what their operations actually looked like or
`22 whether these individuals are actually credible
`23 and truthful and trustworthy?
`24 A. Other than that they were presented to
`25 be as such, and given that I had worked in a
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`Page 25
`1 been Zoom or some other software. I -- I don't
`2 know for certain.
`3 Q. Okay. And, again, you don't remember
`4 the names of either of these individuals?
`5 A. That's correct.
`6 Q. And you'd never met them before; didn't
`7 know them professionally?
`8 A. That's correct.
`9 Q. And then same for the -- oh, wait. I'm
`10 sorry [audio dropped] call as well.
`11 A. I'm sorry. I didn't hear you.
`12 Q. Did Mr. Marsh take notes as well in
`13 connection with this interview?
`14 A. I do not know. Mr. Marsh and I don't
`15 work in the same physical location, so I don't
`16 know what he was doing during the call. But --
`17 Q. Okay.
`18 A. -- to the extent that anyone would have
`19 notes, I do not. He may.
`20 MS. MAZZOCHI: Okay. Well, to be -- so,
`21 Counsel, to the extent there's any recordings of
`22 these calls, notes of these calls, we would ask
`23 that those be produced, as well as that the
`24 individuals corresponding to these interviews be
`25 identified.
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`Veritext Legal Solutions
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`7 (Pages 22 - 25)
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`Mylan Exhibit 1151
`Mylan v. Regeneron, IPR2021-00881
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`1 All right.
`2 BY MS. MAZZOCHI:
`3 Q. So just so I'm clear, Dr. Manning, it
`4 sounds like there -- there may be some instances
`5 where these people either gave you information or
`6 confirmed information for you, but you did not
`7 necessarily cite that they were the source of
`8 information in your declaration. Is that fair?
`9 A. I did not cite to any of these
`10 individuals as sources of information. That's
`11 correct.
`12 Q. But, nevertheless, you used information
`13 from them as the basis for your opinions in this
`14 declaration. True?
`15 A. Well, they provided background about
`16 some of the data sources and were the contact
`17 through which I requested information. I'm not
`18 sure I would call them the source -- I wouldn't
`19 call them the source of the information.
`20 Regeneron provided the information, is my -- the
`21 way I would describe it.
`22 Q. Okay. But -- but to understand -- but
`23 to understand the proper context for some of this
`24 information, you needed infor -- you needed input
`25 from these individuals that you interviewed?
`
`1 Q. All right. Is there any -- is there any
`2 fact or information that you can specifically
`3 recall they gave you in connection with these
`4 interviews?
`5 MR. CAINE: Objection; form.
`6 THE WITNESS: Other than the data that
`7 have been provided in -- in the appendices, no.
`8 BY MS. MAZZOCHI:
`9 Q. Now, did they actually share that
`10 data with you on these interviews, or did you
`11 interview them and then they provided data to you
`12 in response to that interview?
`13 MR. CAINE: Objection; form.
`14 THE WITNESS: The latter.
`15 BY MS. MAZZOCHI:
`16 Q. Okay. And, again, you have not
`17 confirmed whether any of the data that they gave
`18 you was preexisting in the company records or
`19 whether this was assembled and curated for you in
`20 connection with this proceeding?
`21 MR. CAINE: Objection; form.
`22 THE WITNESS: Other than that I did ask
`23 on every call whether that was the case, whether
`24 these were ordinary course documents that were
`25 used by the business, and they said they were.
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`1 A. Well, for example, as I said, the
`2 sampling data, I wanted to know what was
`3 available, I wanted to know what form it would be
`4 in, I wanted to know if they could arrange to
`5 have the company provide it. And so those things
`6 -- that was the discussion that -- that was had
`7 with regard to that specific topic, and those
`8 data were provided.
`9 Q. When you spoke with the Regeneron Senior
`10 Director for Market Access Strategy in February
`11 9, 2022, that -- that was shortly before you
`12 issued your report. Do you recall, specifically,
`13 what infor -- any additional information you were
`14 looking for from that person besides the sampling
`15 information?
`16 A. I don't remember that specific
`17 conversation. I'm sorry. I don't.
`18 Q. Are there any specifics of these
`19 conversations that you recall?
`20 A. As I said, they're per -- they're not --
`21 they were not acquiring information as much as
`22 they were confirming or requesting information
`23 to be provided by the company, and I don't -- I
`24 wouldn't -- I wouldn't say that I have a clear
`25 memory of any of the details of those calls.
`
`1 That was -- that was what I did.
`2 BY MS. MAZZOCHI:
`3 Q. And that was a specific phrasing you
`4 recall using, "ordinary course"?
`5 A. I -- I may have -- it is a phrase
`6 I've used before. It is a phrase that wouldn't
`7 surprise me if I've used. I know it's a common
`8 term. I may have used something other that meant
`9 the same thing to me, but I don't remember my
`10 exact wording on every call.
`11 Q. All right. Well, do you know if the
`12 individuals you were speaking to understood the
`13 -- you know, the legal implications of documents
`14 created as part of the ordinary course of
`15 business?
`16 A. I don't know. I don't know what they
`17 -- what was in their minds. I did explain to
`18 them that I wanted to confirm or understand
`19 whether these fi -- files had been produced for
`20 the litigation or were they business files that
`21 were used in the ordinary operations of their
`22 business, and every one of them said that they
`23 did understand that.
`24 Q. And what did you do to verify that the
`25 business files they gave you were actually
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`www.veritext.com
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`Veritext Legal Solutions
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`Mylan Exhibit 1151
`Mylan v. Regeneron, IPR2021-00881
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`1 complete?
`2 A. As I've said, I relied upon their
`3 characterization. I relied upon Regeneron's
`4 provision. I've not seen anything that would
`5 make me think that those files were incomplete or
`6 otherwise not represent -- not legitimate.
`7 Q. Okay. Well, we'll get to that later.
`8 All right. Let's take a look at
`9 Paragraph 17 to 20 of your declaration, which are
`10 on Pages 10 to 12 of Exhibit 2052, exhibit Pages
`11 016 to 018 of 219 [sic], and I believe this is
`12 where you -- this is the basis for your belief
`13 that the claims cover the use of Eylea. Let me
`14 know when you get there.
`15 A. I'm there.
`16 (Previously marked Exhibit No. 1001 was
`17 introduced.)
`18 BY MS. MAZZOCHI:
`19 Q. All right. And I'm also going to give
`20 you Exhibit 1001, which is the '338 patent.
`21 And let me know when you have that.
`22 A. I have it.
`23 Q. All right. Can you confirm that the
`24 '338 patent has a January 13th, 2011, priority
`25 date?
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`1