throbber
Case 1:20-cv-00393-LMB-TCB Document 1387-9 Filed 07/13/22 Page 1 of 7 PageID# 34626
`Case 1:20-cv-00393-LMB-TCB Document 1387-9 Filed 07/13/22 Page 1 of 7 PagelD# 34626
`
`EXHIBIT 9
`EXHIBIT 9
`
`

`

`Case 1:20-cv-00393-LMB-TCB Document 1387-9 Filed 07/13/22 Page 2 of 7 PageID# 34627
`
`431
`
`UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF VIRGINIA
`
`429
`
`APPEARANCES: (Cont.)
`
`For the Defendants:
`
`Civil Action
`No. 1:20-cv-00393-LMB/TCB
`
`June 9, 2022
`2:05 p.m.
`
`)))))))))))))
`
`PHILIP MORRIS PRODCUTS S.A.,
`
`
` Counterclaim Plaintiff,
`
` v.
`
`R.J. REYNOLDS VAPOR COMPANY,
`
` Counterclaim Defendant.
`
` VOLUME 2 - AFTERNOON SESSION
`TRANSCRIPT OF JURY TRIAL PROCEEDINGS
`BEFORE THE HONORABLE LEONIE M. BRINKEMA,
`UNITED STATES DISTRICT COURT JUDGE
`
`Michael Shamus Quinlan, Esq.
`Jones Day (OH-NA)
`901 Lakeside Avenue
`Cleveland, OH 44114-1190
`216-586-3939
`Fax: 216-579-0212
`Email: Msquinlan@jonesday.com
`
`Jason Todd Burnette, Esq.
`Jones Day (GA)
`1420 Peachtree Street, NE
`Suite 800
`Atlanta, GA 30309
`404-521-3939
`Email: Jburnette@jonesday.com
`
`David Michael Maiorana, Esq.
`Jones Day (OH)
`901 Lakeside Ave
`Cleveland, OH 44114
`216-586-3939
`Email: Dmaiorana@jonesday.com
`
`William Edward Devitt, Esq.
`Jones Day (IL)
`77 West Wacker
`Suite 3500
`Chicago, IL 60601
`312-269-4240
`Email: Wdevitt@jonesday.com
`
`Scott L. Wallace, RDR, RMR, CRR
`Official Court Reporter
`United States District Court
`401 Courthouse Square
`Alexandria, VA 2231-5798
`202-277-3739
`scottwallace.edva@gmail.com
`
`APPEARANCES:
`
`For the Plaintiffs:
`
`Maximilian Antony Grant, Esq.
`Latham & Watkins LLP (DC)
`555 11th Street, NW
`Suite 1000
`Washington, DC 20004-1304
`202-637-2200
`Email: Max.grant@lw.com
`
`Clement Joseph Naples, Esq.
`Latham & Watkins, LLP
`885 Third Avenue 25th Floor
`New York, NY 10022
`212-906-1200
`Email: Dement.naples@lw.com
`
`Gregory K. Sobolski, Esq.
`Latham & Watkins, LLP
`505 Montgomery Street
`Suite 2000
`San Francisco, CA 94111-6538
`202-637-2267
`Email: Max.grant@lw.com
`
`Scott L. Wallace, RDR, CRR
`Official Court Reporter
`
`APPEARANCES: (Cont.)
`
`For the Plaintiffs:
`
`Thomas W. Yeh, Esq.
`Latham & Watkins LLP (CA)
`355 South Grand Avenue
`Suite 100
`Los Angeles, CA 90071-1560
`213-891-8050
`Email: Thomas.yeh@lw.com
`
`Matthew John Moore, Esq.
`Latham & Watkins LLP (DC)
`555 11th Street, NW
`Suite 1000
`Washington, DC 20004-1304
`202-637-2200
`Email: Matthew.moore@lw.com
`
`Dale Chang, Esq.
`Latham & Watkins LLP (CA)
`355 South Grand Avenue
`Suite 100
`Los Angeles, CA 90071-1560
`213-891-8050
`Email: Dale.chang@lw.com
`
`Lawrence Jay Gotts, Esq.
`Latham & Watkins LLP (DC)
`555 11th St NW
`Suite 1000
`Washington, DC 20004-1304
`202-637-2200
`Email: Lawrence.gotts@lw.com
`
`Court Reporter:
`
`Proceedings reported by machine shorthand, transcript produced
`by computer-aided transcription.
`
`430
`
`Scott L. Wallace, RDR, CRR, Official Court Reporter
`
`432
`
` C O N T E N T S
`
`
`
`EXAMINATIONS Page
`
`CONTINUED DIRECT EXAMINATION OF PAUL MEYER
`BY MR. SANDFORD
`CROSS-EXAMINATION OF PAUL MEYER
`BY MR. McCRUM
`REDIRECT EXAMINATION OF PAUL MEYER
`BY MR. SANDFORD
`
`DIRECT EXAMINATION OF JAMES FIGLAR
`BY MS. PARKER
`CROSS-EXAMINATION OF JAMES FIGLAR
`BY MR. NAPLES
`REDIRECT EXAMINATION OF JAMES FIGLAR
`BY MS. PARKER
`RECROSS-EXAMINATION OF JAMES FIGLAR
`BY MR. NAPLES
`
` EXHIBITS
`
`DESCRIPTION Page
`
`433
`
`470
`
`497
`
`529
`
`567
`
`578
`
`581
`
`For the Defendants:
`
`Charles Bennett Molster, III, Esq.
`The Law Offices of Charles B.
`Molster III, PLLC
`2141 Wisconsin Avenue NW, Suite M
`Washington, DC 20007
`703-346-1505
`Email: Cmolster@molsterlaw.com
`
`Stephanie Ethel Parker, Esq.
`Jones Day (GA)
`1420 Peachtree Street, NE
`Suite 800
`Atlanta, GA 30309
`404-521-3939
`Email: Sparker@jonesday.com
`Scott L. Wallace, RDR, CRR, Official Court Reporter
`Page 429 to 432 of 584
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`1 of 39 sheets
`
`06/21/2022 08:44:31 AM
`
`

`

`Case 1:20-cv-00393-LMB-TCB Document 1387-9 Filed 07/13/22 Page 3 of 7 PageID# 34628
`469
`
`471
`
`were using '911 and '265. So I took the Solo and the Alto
`
`product information that Reynolds provided and basically went
`
`back and added all those sales up, and took not the gross sales,
`
`the net sales, but summarized all those amounts. And then I did
`
`a calculation applying my reasonable royalty rates to those net
`
`sales to come up with what I'll call the royalty damages. But
`
`it's basically what, through December 31, 2021, Reynolds would
`
`02:58PM 1
`02:58PM 2
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`02:58PM 4
`02:58PM 5
`02:58PM 6
`02:58PM 7
`02:58PM 8
`pay to use these two patents.
`02:58PM 9 Q.
`02:58PM 10
`02:58PM 11
`on the top, the '265 compact heater patent.
`02:58PM 12 A.
`02:58PM 13
`02:59PM 14
`02:59PM 15
`02:59PM 16
`02:59PM 17
`02:59PM 18
`02:59PM 19
`02:59PM 20
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`02:59PM 22
`02:59PM 23
`$29.2 million for that period of time.
`02:59PM 24 Q.
`02:59PM 25
`
`And what conclusion did you reach -- going to Slide 39 --
`
`as to the appropriate royalty damages? Let's start with the one
`
`So for '265, the accused product was the Alto cartridges,
`
`and the accused net sales were 1,333,918,837 that came from
`
`Reynolds' records. I don't think there's any dispute about
`
`that. I think it's just the accounting.
`
`The reasonable royalty rate's 0.6 percent and then you do
`
`the calculation. That's the $8 million I mentioned earlier
`
`today. That's the total damages through December 31st, 2021.
`
`And then on '911, we have two products. We have the Alto
`
`cartridges again and we have the Solo G2 cartridges. And I
`
`added all those amounts up from the Reynolds' records, that's
`
`1,461,111,169. And at 2 percent, that comes out to
`
`And if you add up the total royalty damages for the '265
`
`and the '911 Patent, what's the total amount of damages through
`
`I assume they're infringed, yes, sir.
`
`And you made that clear multiple times in your expert
`
`Yes.
`
`And you haven't been qualified, in fact, are not
`
`03:01PM 1
`right?
`03:01PM 2 A.
`03:01PM 3 Q.
`03:02PM 4
`reports, right?
`03:02PM 5 A.
`03:02PM 6 Q.
`03:02PM 7
`qualified to offer an opinion on infringement, right?
`03:02PM 8 A.
`03:02PM 9
`03:02PM 10
`to the jury to decide infringement.
`03:02PM 11 Q.
`03:02PM 12
`opinion on infringement, right?
`03:02PM 13 A.
`03:02PM 14
`it's just not something I even looked at. I'm assuming it.
`03:02PM 15 Q.
`03:02PM 16
`the asserted patents are valid?
`03:02PM 17 A.
`03:02PM 18 Q.
`03:02PM 19
`of the patents, right?
`03:02PM 20 A.
`03:02PM 21 Q.
`03:02PM 22
`03:02PM 23
`03:02PM 24
`valid and infringed like you did, right?
`03:03PM 25 A.
`
`That's something I just assume from the Court. I'm not
`
`an engineer, so I'm not opining on infringement. So that's up
`
`So you agree with me, you're not qualified to offer an
`
`Well, I'm just not -- I wasn't engaged to do that. So
`
`And you also assumed for purposes of your opinions that
`
`Yes, and I documented that. That's correct.
`
`And again, you're not offering an opinion on the validity
`
`That's correct.
`
`And you understand that the ladies and gentlemen of the
`
`jury will be asked to decide the issues of infringement and
`
`validity, and they're not just going to assume that they are
`
`That's right. I understand that. That's up to them,
`
`Scott L. Wallace, RDR, CRR, Official Court Reporter
`
`Scott L. Wallace, RDR, CRR, Official Court Reporter
`
`470
`
`472
`
`Based on my analysis, my opinion, it's $37.2 million.
`
`And just for reference, these figures can be found at
`
`Yes, PX 133. That's correct, sir.
`
`MR. SANDFORD: I pass the witness, Your Honor. Thank you
`
`very much, Mr. Meyer.
`
`THE COURT: All right. Cross-examination.
`
`MR. McCRUM: Thank you, Your Honor, if I may pass out some
`
`binders.
`
`THE COURT: All right.
`
`MR. McCRUM: With the help of Marshal Hendrick, I'd
`
`appreciate it.
`
`MR. McCRUM: May I proceed, Your Honor?
`
`THE COURT: Yes.
`
`MR. McCRUM: Thank you.
`
` CROSS-EXAMINATION OF PAUL MEYER
`
`02:59PM 1
`December 2021 that you believe is appropriate in this case?
`02:59PM 2 A.
`02:59PM 3 Q.
`03:00PM 4
`PX 133; is that right?
`03:00PM 5 A.
`03:00PM 6
`03:00PM 7
`03:00PM 8
`03:00PM 9
`03:00PM 10
`03:00PM 11
`03:00PM 12
`03:00PM 13
`03:01PM 14
`03:01PM 15
`03:01PM 16
`03:00PM 17
`03:00PM 18
`BY MR. McCRUM:
`03:01PM 19 Q.
`03:01PM 20
`03:01PM 21
`questions for you today.
`03:01PM 22 A.
`03:01PM 23 Q.
`03:01PM 24
`03:01PM 25
`
`Good afternoon, Mr. Meyer. I don't think we have met.
`
`My name is Ryan McCrum. I represent Reynolds and I have some
`
`Thank you.
`
`And to start, I just want to make sure we're all on the
`
`same page about something. With respect to the opinions that
`
`you just gave, you assumed that the patents are infringed,
`
`Okay. And if there's no infringement, there's no
`
`I agree with that. If they find no infringement, there's
`
`And similarly if the patents are valid, there's no
`
`03:03PM 1
`that's right. That's their decision.
`03:03PM 2 Q.
`03:03PM 3
`damages?
`03:03PM 4 A.
`03:03PM 5
`no damages.
`03:03PM 6 Q.
`03:03PM 7
`damages, right?
`03:03PM 8 A.
`03:03PM 9 Q.
`03:03PM 10
`03:03PM 11
`claims are found to be both valid and infringed?
`03:03PM 12 A.
`03:03PM 13 Q.
`03:03PM 14
`courtroom when Mr. Grant gave his opening statement?
`03:03PM 15 A.
`03:03PM 16 Q.
`03:03PM 17 A.
`03:03PM 18 Q.
`03:03PM 19
`03:03PM 20
`you hear him say that?
`03:03PM 21 A.
`03:04PM 22
`it, but that wouldn't surprise me.
`03:04PM 23 Q.
`03:04PM 24
`as foundational?
`03:04PM 25 A.
`
`That's my understanding.
`
`Okay. So in that sense, just to wrap this up, your
`
`opinion on damages only becomes relevant if one or more of the
`
`I agree with that.
`
`Now, let's talk about your opinions. You were in the
`
`Yes, I heard that.
`
`And that's Philip Morris's lawyer, right?
`
`Yes, sir.
`
`And you heard him when he referred to the '911 and '265
`
`patents as, quote, essential to any commercial e-cigarette. Did
`
`I mean, I listened to it. We'd have to go back and see
`
`Because you, yourself, have characterized these patents
`
`I believe based on what I've been told by the science
`
`11 of 39 sheets
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`Scott L. Wallace, RDR, CRR, Official Court Reporter
`Page 469 to 472 of 584
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`Scott L. Wallace, RDR, CRR, Official Court Reporter
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`

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`Case 1:20-cv-00393-LMB-TCB Document 1387-9 Filed 07/13/22 Page 4 of 7 PageID# 34629
`553
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`555
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`All right. And if you'll tell the jury, what is it
`
`All right. This is Vuse Alto, so this is the last
`
`product that we brought up into the marketplace under the Vuse
`
`umbrella, and, again, it was a product that we licensed from one
`
`of our suppliers that we found to be pretty compelling, and it
`
`met the requirements that I talked about earlier in terms of the
`
`regulatory requirements and then we started developing the
`
`science around it and all that stuff. So this is the last of
`
`the line for now until we continue to innovate and -- we have to
`
`go through -- I think as the judge pointed out the other day,
`
`straight through the PMTA process, so from here on in, any new
`
`innovations have to either be off of this design or any new
`
`design has to go straight to the FDA before you can go into
`
`So what is Reynolds's most popular Vuse product today?
`
`Today it is Vuse Alto.
`
`All right. And how is Vuse Alto doing in the United
`
`05:14PM 1
`BY MS. PARKER:
`05:14PM 2 Q.
`05:14PM 3
`you're holding and tell us how that came about.
`05:14PM 4 A.
`05:14PM 5
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`market.
`05:15PM 17 Q.
`05:15PM 18 A.
`05:15PM 19 Q.
`05:15PM 20
`States generally?
`05:15PM 21 A.
`05:15PM 22
`05:16PM 23
`the marketplace today.
`05:16PM 24 Q.
`05:16PM 25
`
`It's doing quite well right now. So I think it's neck
`
`and neck with the other major competitor and probably leading in
`
`All right. Now, I want to go back and ask you some
`
`specifics about some of the parts of the product that the jury
`
`we thought that was, you know, basically the Coca-Cola formula
`
`for us and these products. And they have specific formulations,
`
`right, and they offer specific consumer benefits when applied
`
`05:17PM 1
`05:17PM 2
`05:17PM 3
`05:18PM 4
`especially in the Solo format.
`05:18PM 5 Q.
`05:18PM 6
`05:18PM 7
`about that process?
`05:18PM 8 A.
`05:18PM 9
`05:18PM 10
`05:18PM 11
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`the factory just outside of Winston-Salem for Vuse Solo.
`05:18PM 14 Q.
`05:18PM 15
`05:18PM 16
`05:19PM 17
`So can you tell the jury about that?
`05:19PM 18 A.
`05:19PM 19
`05:19PM 20
`05:19PM 21
`05:19PM 22
`05:19PM 23
`05:19PM 24
`05:19PM 25
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`And can you tell the jury, again just very top line, how
`
`is the e-liquid manufactured and where and just a little bit
`
`Sure. It's basically a food-grade operation, mixing
`
`operation, where you mix the individual components to the
`
`specification that's necessary, and for Solo for many years we
`
`made it -- we started making it first in the R&D facilities and
`
`in Winston-Salem, and now we make it kind of up the street at
`
`Now, I know you've been sitting here with us during the
`
`trial, so you probably heard this yourself, but there's been
`
`some talk in front of the jury about leakage of e-liquids, okay?
`
`Well, all these products have liquid in them. By -- the
`
`only way that they can work is -- everything that's holding the
`
`liquid in, there's still holes, two holes, minimally, on every
`
`product that is in existence today, so they kind of have a
`
`propensity to leak. I mean, you've got liquid trying to be held
`
`into a matrix and it's got two holes in it.
`
`Now, you can try to minimize leakage by the design of the
`
`cartridge that it sits in through gaskets, but also design of
`
`Scott L. Wallace, RDR, CRR, Official Court Reporter
`
`Scott L. Wallace, RDR, CRR, Official Court Reporter
`
`554
`
`556
`
`has heard about earlier.
`
`The jury's heard about e-liquid. What is e-liquid?
`
`Yes. So e-liquid is what's in all of these products that
`
`is the base that generates the aerosol. So I think I described
`
`it earlier. It's mostly comprised of vegetable glycerine,
`
`propylene glycol, a little bit of water, and then flavorings and
`
`pharmaceutical-grade nicotine, and that's all the liquid is.
`
`And so depending on how these products are configured,
`
`once the heater is activated, it is in contact, the liquid is in
`
`contact with that heater and it forms an aerosol that the
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`consumer can then draw into their mouth and hold in their mouth,
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`inhale, to basically smoke the product. So that's the basics on
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`05:16PM 1
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`05:16PM 3 A.
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`how it works.
`05:17PM 14 Q.
`05:17PM 15 A.
`05:17PM 16 Q.
`05:17PM 17
`for the product?
`05:17PM 18 A.
`05:17PM 19 Q.
`05:17PM 20
`05:17PM 21
`you'll tell the jury what "proprietary" means also?
`05:17PM 22 A.
`05:17PM 23
`05:17PM 24
`05:17PM 25
`
`Is the e-liquid important to the product?
`
`It's very important to the product, yes.
`
`And does Reynolds have its own formulations of e-liquid
`
`We do, yes.
`
`Okay. And could you describe those very generally for
`
`the jury? And I understand that they're proprietary, so if
`
`Sure. So, I mean, proprietary means there are kind of
`
`secret formulas, right, so, you know, it's like the Coke recipe,
`
`and Reynolds, when they developed Solo, we developed all of our
`
`own e-liquids, and we wanted to keep those proprietary because
`
`the liquids itself and the density of the liquid can also help
`
`keep things in place and minimize leakage.
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`It's my experience that all these products at some point
`
`in time leak, and it's -- I think it's -- I mean, I just think
`
`they're always going to leak at some point in time. It's got
`
`What about Vuse products? Did the Vuse products still
`
`Yes.
`
`Okay. Now, switching gears, you've again been here in
`
`the courtroom so you understand that Philip Morris is alleging
`
`in this lawsuit that Reynolds willfully infringed its patents.
`
`I'm aware, yes.
`
`Okay. Does Reynolds have any corporate policies that are
`
`We do, yes.
`
`And if you can tell the jury who developed the policies,
`
`05:19PM 1
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`two holes in it, and there's a liquid inside.
`05:20PM 7 Q.
`05:20PM 8
`leak?
`05:20PM 9 A.
`05:20PM 10 Q.
`05:20PM 11
`05:20PM 12
`05:20PM 13
`You know that, right?
`05:20PM 14 A.
`05:20PM 15 Q.
`05:20PM 16
`related to respecting patent rights of other companies?
`05:20PM 17 A.
`05:20PM 18 Q.
`05:20PM 19
`what are they, and how they work?
`05:20PM 20 A.
`05:20PM 21
`05:20PM 22
`the leadership team.
`05:20PM 23 Q.
`05:21PM 24 A.
`05:21PM 25
`
`Yeah. So they -- the policies would have been derived
`
`through both the legal department as well as consultation with
`
`Did you have any role in them?
`
`I did not in writing these specific policies because
`
`we've had these policies in place for many, many years, probably
`
`06/21/2022 08:44:31 AM
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`Case 1:20-cv-00393-LMB-TCB Document 1387-9 Filed 07/13/22 Page 5 of 7 PageID# 34630
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`property, et cetera.
`05:21PM 9 Q.
`05:21PM 10
`05:21PM 11
`infringe other patents?
`05:21PM 12 A.
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`well before I ever got close to being on a leadership team, but
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`the basic essence of the policy is, you know, you respect
`
`intellectual property and then explains, you know, how you
`
`respect that. You don't, you know, infringe if you -- you don't
`
`do any of that stuff, and at the same time, it also speaks to
`
`what will happen with intellectual property developed by the
`
`people who work for the company and how it's the company's
`
`And if you could tell the jury, what are the efforts that
`
`Reynolds takes to ensure that the Reynolds products do not
`
`Well, you have to -- you have to be cognizant of what is
`
`happening in the patent literature landscape, right. So patent
`
`applications are public domain things, right, so they get
`
`published and they're public knowledge. They're supposed to be.
`
`And so when an application is filed and that literature becomes
`
`available, everyone and anyone can read that and understand
`
`what's in those applications and in the granted patents, and so
`
`it's contingent upon a company to stay abreast of that
`
`information because, as an innovation developer, you know that
`
`there's more than one person working on ideas all around the
`
`world, right, and so in some instances it's like a race of, you
`
`know, who's developing technology first and who's going to file
`
`first, et cetera, things like that. So you have to keep abreast
`
`of what's happening in the patent landscape.
`
`Sure, so we -- we've done surveys of the market
`
`landscape, and worked with our suppliers in China and other
`
`places and, of course, were introduced to this product, which I
`
`it was -- and it had a market presence in the U.S., though
`
`small, at the time when we saw it with a supplier, and we found
`
`it highly interesting, and we thought, this is the -- this is
`
`where consumers are going, is they -- they're moving away from
`
`these cigalike products, like Vuse Solo, and moving more to
`
`these what we call pod mods in the marketplace, and so we wanted
`
`a decent pod mod, but if we were to develop it all by ourselves
`
`on our own, which we do have developments of doing that, but we
`
`know that that's a long road because you have to get through
`
`FDA, and that's going to be several years. This was already on
`
`the market.
`
`And so that's why we negotiated with our supplier to get
`
`think was originally called TF16 -- or at least one version of
`
`05:24PM 1 A.
`05:24PM 2
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`a license to use that product because it's really quite good.
`05:25PM 18 Q.
`05:25PM 19
`05:25PM 20
`05:25PM 21
`that process?
`05:25PM 22 A.
`05:25PM 23 Q.
`05:26PM 24
`05:26PM 25
`
`So in your role as head of R&D at Reynolds, at the time
`
`that these e-cigarettes were being developed, can you tell the
`
`jury whether Reynolds copied any other e-cigarettes as part of
`
`I would say no.
`
`Now, I want to switch gears one more time, and this is
`
`the last area I'm going to ask you about this afternoon, and
`
`that's about the FDA, and you told the jury a little bit about
`
`Scott L. Wallace, RDR, CRR, Official Court Reporter
`
`Scott L. Wallace, RDR, CRR, Official Court Reporter
`
`558
`
`560
`
`Would it be responsible for a company just to ignore the
`
`In my opinion it would not be responsible because then
`
`Does Reynolds monitor other companies' patents in order
`
`No, not -- we monitor the whole tobacco landscape patent
`
`literature so that we know what's happening from a competitive
`
`landscape perspective and understand if we're developing things,
`
`are we -- you know, are we kind of being -- are we on top of
`
`somebody else's development or are we way ahead of somebody else
`
`in some other area. I mean those are the things you try to get
`
`05:23PM 1 Q.
`05:23PM 2
`research and patents that are out there from competitors?
`05:23PM 3 A.
`05:23PM 4
`you wouldn't know what has come -- what has happened before.
`05:23PM 5 Q.
`05:23PM 6
`to copy and infringe them?
`05:23PM 7 A.
`05:23PM 8
`05:23PM 9
`05:23PM 10
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`an assessment of.
`05:23PM 14 Q.
`05:24PM 15
`developing the Vuse Solo?
`05:24PM 16 A.
`05:24PM 17 Q.
`05:24PM 18
`05:24PM 19
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`BY MS. PARKER:
`05:24PM 22 Q.
`05:24PM 23
`05:24PM 24
`05:24PM 25
`
`Did Reynolds copy any other e-cigarette product when
`
`No.
`
`Did Reynolds copy any other company's patents when
`
`developing the Vuse Solo?
`
`MR. NAPLES: Objection, Your Honor.
`
`THE COURT: Yes, I'm going to sustain that objection.
`
`Now, you mentioned earlier that Reynolds had purchased
`
`the Vuse Alto from another company or companies. Can you tell
`
`us a little bit more about that? Can you tell the jury a little
`
`bit more about that?
`
`the FDA already, but I would like to follow up and ask you a few
`
`more questions if I may.
`
`Okay. So you told us that when you had this -- at the
`
`time you retired, you had these dual roles and you were head of
`
`R&D and you were head of the FDA regulatory work. As head of
`
`05:26PM 1
`05:26PM 2
`05:26PM 3
`05:26PM 4
`05:26PM 5
`05:26PM 6
`the FDA regulatory work, did you yourself deal with the FDA?
`05:26PM 7 A.
`05:26PM 8 Q.
`05:26PM 9 A.
`05:26PM 10
`05:26PM 11
`05:26PM 12
`05:26PM 13
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`05:27PM 16
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`
`Yes.
`
`And if you can tell the jury about that, please.
`
`Well, sure. I participated in direct meetings with the
`
`director of the Center for Tobacco Products. I had direct
`
`meetings with the -- with FDA Commissioner Scott Gottlieb at the
`
`time when I had those meetings, so I -- and, you know, to talk
`
`about the company, to talk about developments, to talk about
`
`e-cigarettes, to talk about a variety of things in the
`
`marketplace that were happening and concerns.
`
`In addition to that, I've met with a variety of
`
`individual FDA reviewers because we've had to talk about a
`
`number of applications that we've had, both on the traditional
`
`front as well as e-cigarettes. I've sat in those meetings as
`
`well.
`
`And then, you know, helped -- helped develop some of
`
`these PMTAs. I certainly read them all. I didn't write them
`
`all, but I certainly read the narratives. I read large parts of
`
`these applications, commented on them for my scientists, because
`
`it really does take an army to build a 150,000-page document
`
`33 of 39 sheets
`
`Scott L. Wallace, RDR, CRR, Official Court Reporter
`Page 557 to 560 of 584
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`Scott L. Wallace, RDR, CRR, Official Court Reporter
`06/21/2022 08:44:31 AM
`
`

`

`Case 1:20-cv-00393-LMB-TCB Document 1387-9 Filed 07/13/22 Page 6 of 7 PageID# 34631
`577
`
`579
`
`to do and get a successful PMTA. We did that for those
`
`Just to confirm, Dr. Figlar, Reynolds acquired or
`
`purchased the designs for the Ciro, the Vibe and the Alto from a
`
`That is correct.
`
`Thank you. In the short time Ms. Parker had during
`
`Um-hmm.
`
`And the Alto is not cleared by the PMTA, correct?
`
`It is still under review with FDA.
`
`And that is the best-selling Reynolds Vapor product
`
`05:48PM 1
`05:49PM 2
`products.
`05:49PM 3 Q.
`05:49PM 4
`05:49PM 5
`supplier, correct?
`05:49PM 6 A.
`05:49PM 7 Q.
`05:49PM 8
`direct she also talked about this PMTA clearance; is that right?
`05:49PM 9 A.
`05:49PM 10 Q.
`05:49PM 11 A.
`05:49PM 12 Q.
`05:49PM 13
`today, correct?
`05:49PM 14 A.
`05:49PM 15
`of last, last in, last out.
`05:49PM 16 Q.
`05:49PM 17
`05:49PM 18
`market, correct?
`05:49PM 19 A.
`05:49PM 20
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`That is true, but that was our last submission, so kind
`
`Sure, sure. And if the FDA decides not to clear the Alto
`
`for sale in the U.S., then Reynolds has to take it off the
`
`Well, there are a number of provisions that would happen
`
`first. There's administrative review that you can go through,
`
`an appeal, basically, through the FDA, as well as potential
`
`judicial review before it would come off the market, but if,
`
`ultimately, after Reynolds runs through the complete gamut of
`
`options to keep Alto on the market, if the FDA doesn't change
`
`its mind and they say -- then, yeah, it's --
`
`Just a couple of questions, all right? So counsel asked
`
`you about some of the Vuse products that Reynolds acquired, and
`
`Okay.
`
`Do you remember the slide that we put up with the four
`
`Sure.
`
`Okay. If you'll just kind of go through and just
`
`summarize for the jury, for the ones where Reynolds acquired
`
`technology, what did Reynolds do, Reynolds itself, you, your
`
`05:51PM 1 Q.
`05:51PM 2
`05:51PM 3
`I want to follow up about that, okay?
`05:51PM 4 A.
`05:51PM 5 Q.
`05:51PM 6
`products? You know, the slide --
`05:51PM 7 A.
`05:51PM 8 Q.
`05:51PM 9
`05:51PM 10
`05:52PM 11
`team, Reynolds, to get -- to get through the FDA PMTA process?
`05:52PM 12 A.
`05:52PM 13
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`05:52PM 16
`05:52PM 17
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`
`What we did for -- well, all the products but for the
`
`ones we acquired specifics -- specifically, is -- so for Ciro,
`
`Vibe, and Alto in particular, make sure that the quality
`
`manufacture is there, the specifications are absolutely locked,
`
`anything that could -- that you can do to improve the quality
`
`you do in the manufacturing setting so that you then make
`
`products that go to the market and then you start collecting the
`
`data that's required to generate the information for the PMTA,
`
`all the tox data, all the chemistry, all that stuff, and it --
`
`believe me, it's extensive. You have to interrupt actual market
`
`manufacture to make enough samples so that you can get those
`
`products to do the testing.
`
`So we did all the testing, spent all the money on that,
`
`wrote all the applications ourselves to file with the FDA, and
`
`Scott L. Wallace, RDR, CRR, Official Court Reporter
`
`Scott L. Wallace, RDR, CRR, Official Court Reporter
`
`578
`
`580
`
`It's got to come off, right?
`
`It has to come off the market, that's correct.
`
`Right. Dr. Figlar, you also testified about a patent
`
`policy, right, where Reynolds reviews competitor patents, but
`
`it's got this policy where it will say, well, we don't want to
`
`I said we did have -- we do have an intellectual property
`
`Right. The lawyers are involved in that, corrected?
`
`I mean, I think so, yeah. I didn't write the policy, but
`
`Right. You just read the policy; is that right?
`
`I did not write the policy, that's correct. I've read
`
`05:50PM 1 Q.
`05:50PM 2 A.
`05:50PM 3 Q.
`05:50PM 4
`05:50PM 5
`05:50PM 6
`infringe patents. You testified about that, right?
`05:50PM 7 A.
`05:50PM 8
`policy at Reynolds, and we do.
`05:50PM 9 Q.
`05:50PM 10 A.
`05:50PM 11
`I presume that legal had some input, yeah.
`05:50PM 12 Q.
`05:50PM 13 A.
`05:50PM 14
`the policy, yes.
`05:50PM 15 Q.
`05:51PM 16
`05:51PM 17
`05:51PM 18
`05:51PM 19
`05:51PM 20
`BY MR. NAPLES:
`05:51PM 21 Q.
`05:51PM 22
`05:51PM 23
`05:51PM 24
`05:51PM 25
`
`Sure, sure, I understand. Now, Dr. Figlar, you didn't
`
`show the jury any opinions from Reynolds that it doesn't
`
`infringe the asserted patents in this case, did you, Dr. Figlar?
`
`MS. PARKER: Objection.
`
`THE COURT: That one I sustain.
`
`Okay.
`
`MR. NAPLES: No further questions, Your Honor.
`
`THE COURT: All right.
`
`REDIRECT EXAMINATION OF JAMES FIGLAR
`
`BY MS. PARKER:
`
`then support those applications through the FDA, because the FDA
`
`05:53PM 1
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`05:53PM 7
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`05:53PM 11
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`05:54PM 14
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`05:54PM 16
`05:54PM 17
`05:54PM 18
`05:54PM 19
`05:54PM 20
`BY MS. PARKER:
`05:54PM 21 Q.
`05:54PM 22
`05:54PM 23
`05:54PM 24
`05:54PM 25
`
`has questions after you do an application. There's a lot of
`
`back-and-forth that goes on. So -- yeah, it's a heavy lift.
`
`THE COURT: You mentioned earlier that the liquid
`
`component of these e-cigarettes is an important aspect. When you
`
`purchased these three cigarettes from other manufacturers, were
`
`you also purchasing the liquid or were you supplying the liquid?
`
`THE WITNESS: We purchased the liquids that were on the
`
`market at that time because we couldn't -- as much as we may want
`
`to put our own liquids in there, because the FDA had locked the
`
`marketplace, we would have to use the liquids that already were
`
`in those products on the marketplace as of August 8, 2016.
`
`Now, we have plans, of course, to change that, but you
`
`have to go through this PMTA process first before you can then
`
`make alterations to say the liquids that you want to have in your
`
`products. We have plans to do that, but you had to -- we had to
`
`wait for the FDA to clear them first before we could make
`
`addendums to those PMTAs. Does that make sense?
`
`THE COURT: Yes, thank you.
`
`So for the products that Reynolds purchased, we acquired
`
`the technology compared to the one that Reynolds developed --
`
`I'm going to say from scratch, is there any difference in terms
`
`of the PMTA requirements and the amount of time, money, effort
`
`that Reynolds spent on something through the PMTA process for
`
`06/21/2022 08:44:31 AM
`
`Scott L. Wallace, RDR, CRR, Official Court Reporter
`Page 577 to 580 of 584
`
`Scott L. Wallace, RDR, CRR, Official Court Reporter
`38 of 39 sheets
`
`

`

`Case 1:20-cv-00393-LMB-TCB Document 1387-9 Filed 07/13/22 Page 7 of 7 PageID# 34632
`581
`
`583
`
`Requirements, no. But Solo benefited -- well, I don't
`
`know if it's a benefit or not, but Solo was the longest product
`
`on the marketplace, and we had been collecting data on that all
`
`along, and so it had the biggest suite of scientific information
`
`associated with it.
`
`Now, what's allowed through FDA guidance is an ability to
`
`bridge back two other products on the market, so we're able to
`
`benefit with some bridging of Solo data to say Ciro, Vibe, or
`
`Alto, so the burden wasn't quite as heavy for those, but it was
`
`still tens of millions of dollars to get those applications
`
`complete.
`
`MS. PARKER: Thank you, Dr. Figlar. Your Honor, I have no
`
`further questions.
`
`THE COURT: All right. Is there any recross?
`
`MR. NAPLES: Very briefly, Your Honor.
`
`RECROSS-EXAMINATION OF JAMES FIGLAR
`
`05:54PM 1
`those different products?
`05:54PM 2 A.
`05:54PM 3
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`05:55PM 17
`05:55PM 18
`BY MR. NAPLES:
`05:55PM 19 Q.
`05:55PM 20
`05:55PM 21
`05:55PM 22
`down, correct?
`05:55PM 23 A.
`05:55PM 24 Q.
`05:55PM 25
`
`So, Dr. Figlar, you talked about the acquisition and
`
`testing of these products, and you said that one reason why you
`
`went to acquire these was you knew the deeming rule was coming
`
`Sure.
`
`You're not claiming that buying a product from a supplier
`
`is innovation, are you?
`
`05:57PM 1
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`THE COURT: It's beyond the scope. I agree. Sustained.
`
`MR. NAPLES: Well, no further questions, Your Honor.
`
`THE COURT: Good timing, Your Honor, because it's about 3
`
`minutes before 6.
`
`MR. NAPLES: I saw the timing, Your Ho

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