Case 1:22-cv-00061-TSK-JPM Document 618 Filed 09/01/23 Page 1 of 59 PageID #: 47914
`Casasbt: 22eveOODRISTSIGBRIMDdeocnentG14324léGBROs Pike 4dt Po3PatpaD #:0fB14
`PagelD #: 27043
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`Exhibit 2
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`

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`Case 1:22-cv-00061-TSK-JPM Document 618 Filed 09/01/23 Page 2 of 59 PageID #: 47915
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`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`
`Page 1
`
`25 PagelD #: 27044
`
`REGENERON PHARMACEUTICALS,
`INC.,
`
`Plaintiff,
`
`-Vs-
`
`Case No. 1:22-cv-00061
`
`MYLAN PHARMACEUTICALS,
`Defendant.
`
`INC.,
`
`*** OUTSIDE COUNSEL EYES ONLY ***
`
`VIDEOTAPED DEPOSITION OF FRANKLIN SWARTZWELDER
`
`TAKEN ON BEHALF OF THE DEFENDANT
`
`ON APRIL 12, 2023, BEGINNING AT 9:18 A.M.
`
`IN BARTLESVILLE, OKLAHOMA
`
`APPEARANCES:
`
`on behalf of the PLAINTIFF, REGENERON PHARMACEUTICALS,
`INC.
`
`wornuo&
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`Mr. Thomas Fletcher
`
`13
`
`Mr. Adam Pan
`
`20
`
`21
`
`22
`
`23
`
`24
`
`Ms. Haylee Bernal Anderson
`WILLIAMS & CONNOLLY
`
`680 Maine Avenue SW
`
`Washington, DC 20024
`(202) 434-5000
`tfletcher@wc.com
`apan@wc.com
`handerson@wc.com
`(Appearances continued on next page.}
`REPORTED BY:
`Shannon S. Harwood, CSR, RPR, CRR
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 618 Filed 09/01/23 Page 3 of 59 PageID #: 47916
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`Page 2
`
`1
`2
`
`INDEX
`
`PAGE
`
`Page 4
`
`3 Direct Examination by Mr. Ehrich
`
`7
`
`EXHIBITS
`
`4 5
`
`Description
`6 Exhibit
`7 Defendant's Exhibit 2012 Opening expert report of
`& Dr. Swartzwelder
`8g
`
`9 Defendant's Exhibit 2013 Joumal article by
`Dr. Swartzwelder
`10 Defendant's Exhibit 2014 Birch 2006
`11 Defendant's Exhibit 2015 715 Patent
`
`22
`
`45
`67
`
`12 Defendant's Exhibit 2016 Responsive expert report of
`13 Dr. Swartzwelder
`87
`
`14 Defendant's Exhibit 2017 Reply expert report of
`15 Dr. Swartzwelder
`92
`16 Defendant's Exhibit 2018 Excerpts from prosecution 136
`history
`17 Defendant's Exhibit 2019 Johnson 342
`18 Defendant's Exhibit 2020 Johnson 249
`
`145
`146
`
`19 Defendant's Exhibit 2021 Rodrigues 2013
`20 Defendant's Exhibit 2022 Kenerson 728
`21 Defendant's Exhibit 2023 531 Patent
`
`172
`181
`203
`
`22 Defendant's Exhibit 2024 Vijayasankaran 2018
`23
`24
`25
`
`207
`
`1
`
`STIPULATIONS
`
`2 3
`
`It is hereby stipulated and agreed by and
`4 between the parties hereto, through their respective
`5 attomeys, that the deposition of FRANKLIN SWARTZWELDER,
`6 PhD, may be taken pursuant to agreement and notice and.
`4 im accordance with the West Virginia Rules of Civil
`
`8 Procedure on April 12, 2023, at the Hilton Garden, Inn,
`9 205 SW Frank Phillips Boulevard, Bartlesville, Oklahoma,
`10 before Shannon 8. Harwood, CSR, RPR, CRR.
`
`6 ALSO APPEARING: Gabriel Pack, Videographer
`
`1
`
`3
`
`(Appearances continued.)
`-and -
`
`Mr. Garrett Spiker (Via Zoom)
`4 Mr. John Pizzo (Via Zoom)
`STEPTOR & JOHNSON
`5 400 White Oaks Boulevard
`Bridgepomt, West Virgmia 26330
`& (30-4) 933-9600
`pauret Spiker@steptoc-johnson.com
`T
`- and -
`
`&
`
`Mr. Bay Franks (Via Zoom)
`9 CAREY DOUGLAS KESSLER & RUBY
`707 Virginia Street East
`10 901 Chase Tower
`Charleston, West Virginia 25323
`1) (04) 345-2234
`edicelaw.com
`12
`
`- and -
`
`13
`
`Ms. Petra Scambeorova, Ph.D., ID.
`14 REGENERON PHARMACEUTICALS,INC.
`777 Old Saw Mill Road
`15 Tarrytown, New York 10591-6707
`(914) 847-7611
`16 petrascamborova@regenerep.com
`17
`on behalf ofthe DEFENDANT, MYLAN PHARMACEUTICALS, INC.
`
`MR. Thomas H. Ehrich, Ph.D.
`19 RAKOCZY MOLINO MAZZOCHI SIWIK
`Six West Hubbard Street
`W® Chicage, Dlinois 6064
`(312) 222-5117
`21 tehrich@nnmslegal con:
`22
`
`(Appearances continued on next page.}
`
`“4
`25
`
`1 (Appearances continued.)
`2 Mr, Neil McLaughlin
`RAKOCZY MOLINO MAZZOCHI SIWIK
`3 Six West Hubbard Street
`Chicago,Illinois 60654
`4 (312) 222-7241
`nroclaughlin@rmmslegal.com
`
`www.veritext.com
`
`Veritext Legal Solutions
`
`2 (Pages 2 - 5)
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`Case 1:22-cv-00061-TSK-JPM Document 618 Filed 09/01/23 Page 4 of 59 PageID #: 47917
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`Page 8
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`Page 6
`1 questions. In order to preserve the record, it's just
`THE VIDEOGRAPHER: This is the videotaped
`1
`2 part of the process, but you still need to answer all of
`2 deposition of Franklin Swartzwelder in the matter of
`3 the questions unless your attorney specifically asks you
`3 Regeneron Pharmaceuticals versus Mylan Pharmaceuticals.|
`4 notto.
`4 This deposition is being held et 205 Southwest Frank
`5
`And,finally, this is not an endurancetest.
`5 Phillips Boulevard in Bartlesville, Oklahoma, on April
`6 If you need a break or need to leave at any time, please
`6 12,2023. Weare on the record at 9:18 a.m.
`7 just let me know. The only thing [ would ask is that
`7
`Wil counselplease state your appearances for
`8 you please -- if there's a question pending, please just
`8 the record?
`9 answer the question before we break.
`9
`MR. EHRICH: Tom Ebrich of RMMSfor the Mylan)
`10
`=A. Thank you.
`10 defendant and my cocounsel will introduce himself.
`[11
`Q. Okay. I'd like to hand you what's been marked
`11
`MR. McLAUGHLIN: Neil McLaughlin also from
`12 as Exhibit DX 2012.
`12 RMMSon behalfof Mylan.
`13
`(Defendant's Exhibit No. 2012 was marked for
`13
`MR. FLETCHER: Tom Fletcher, Williams &
`14 Connolly, LLP for Regeneron Pharmaceuticals, Inc. With|14 identification and made part of the record.)
`15 me are my colleagues, Adam Pan and Haylee Bernal
`1S
`Q.
`(By Mr. Ehrich) Do you recognize this as your
`16 Anderson from Williams & Connolly, and also present from 16 opening report in this case?
`17 Regeneron Pharmaceuticals is Petra Scamborova.
`17.
`A. Yes, [do recognize this as my -- as my
`18
`THE VIDEOGRAPHER: On the computer?
`18 opening expert report.
`
`19 Q. Okay. AndIbelieve your backgroundMR. FRANKS: Raymond $8. Franks, IE, Carey, 19
`
`
`20 Douglas, Kessler & Ruby in Charleston, West Virginia,
`20 qualifications starts with Paragraph 11 on Page 2,
`21 local counsel for Regeneron.
`21 correct?
`22
`THE VIDEOGRAPHER: The court reporter willnow 22
`<A. That's correct.
`23 swear in the witness.
`23°
`«Q. ~Okay. Andisit fair to very briefly
`24
`(Witness sworn.}
`24 summarize as mostof your career was spent in industry
`25 WHEREUPON,
`25 in the area of cell culture media development?
`
`25 Advanced --
`
`Page 7
`
`A. Yes,it's fair to -- to say that.
`1
`FRANKLIN SWARTZWELDER,PhD,
`1
`Q. Okay. Could you please -- I'd like to ask a
`2
`2 after having been first duly sworn, deposes and says in
`3 couple of questions about a couple of the specific
`3 reply to questions propounded as follows, to-wit;
`4 points in this section. Could you please go to the
`4
`DIRECT EXAMINATION
`5 bottom of Page 3 and on to page 4, paragraph 17. It
`5 BY MR. EHRICH:
`6 says that you focused on the design, development and
`6
`Q. Good moming, Dr. Swartzwelder.
`7 manufacture of catalog cell culture products.
`7
`A. Good moming.
`8
`Do you see that at the top of Page 4?
`8
`QQ. Could you please state your full namefor the
`9
`<A. Yes, I see where it states that I focused on
`9 record?
`10 design, development, and manufactured catalog cell
`10
`A. Yeah, my nameis Franklin Swartzwelder.
`
`11=Q. Okay. And have you ever been deposed before? 11 culture products and new custom CHO media.
`12
`A. No, [havenot.
`12.
`Q. Okay. And,sir, just an additional question.
`13.
`Q. Okay. So just a couple of ground mules, As
`13 What is catalog cell culture product?
`14 you can, see the deposition is being transcribed, and so
`14
`A Acatalog cell culture product in -- in my job
`15 please rememberthat the transcriptionists do not
`15 involve the production of cell culture media that were
`16 understand a nod or shake of the head, so please make
`16 basically manufactured and placed on the shelf for sale
`17 all of your answers verbal. And if any of my questions
`17 and distribution te researchers --
`18 are nnclear, please just let me know and Pll be happy
`18
`Q. Okay.
`19 to repeat or rephrase them.
`19
`A -in both academia and industry.
`20
`And as we are going along today,if you later
`20
`Q. Okay. Are yon -- are you able sitting here
`21 happen to think of something you want to add to an
`21 today to think of any examples ofcatalogcell culture
`22 earlier question, please just let me know and we'll be
`22 products that you would have been involved in the design
`23 happy to revisit that.
`23 or development of?
`240
`OA.
`oT will.
`24
`A One example that I can give you is EX-CELL
`25
`Q. Your attomey will be objecting to some of my
`
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`Case 1:22-cv-00061-TSK-JPM Document 618 Filed 09/01/23 Page 5 of 59 PageID #: 47918
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`Page 10
`
`I
`2
`
`Q. Okay.
`A.
`--CHO Medium.
`
`@. Okay. Anddid the -- did the EX-CELL Advanced
`3.
`4 CHO Medium contain -- sorry. Apologize. Let me back up
`5 asecond.
`
`Page 12
`1 that I worked with during my time at Sigma-Aldrich.
`2
`Q. Okay. And does -- does this mean that the
`3 formulations were designed for use with CHO cells
`4 specifically?
`5
`A. The formulations are originally designed for
`6 use with CHO cells specifically.
`7
`Q. Okay. And do you happen to recall if the
`8 EX-CELL Advanced includes nickel in the formulation?
`
`A.
`9
`10 fT did.
`
`[don't recall that and J couldn't share that
`
`Are you familiar with the term hydrolysate?
`6
`<A. Yes, I'm familiar with the term hydrolysate.
`7
`QQ. Okay. And are you familiar with the term
`8
`9 serum as it's used in the cell culture mdustry?
`A. Very familiar.
`Q. Okay.
`11
`Q. Okay. So you understand if I say -- use the
`A. Because it's proprietary formulation.
`12.
`word serum,I'm probably talking about -- or I'm
`13 talking about, for example, fetal calf serum or --
`13.
`Q. Okay. Then-- then in that case,I'd like to
`
`14. A.-Fetal bovine serum.
`14 go just one paragraph ahead to Paragraph 18 --
`15
`A. Sure.
`
`15
`16
`
`Q. Fetal bovine serum, exactly.
`«=A. Yes.
`
`-- of your opening report. It says that you
`=Q._
`16
`17 - the second sentence says, "As part of that work, you
`Q. Okay. Okay. Did -- does -- when you were at
`17
`18 routinely assessed existing cell culture processes." Do
`18 Sigma, did the EX-CELL Media, did -- was it a -- did -
`19 was ita media that was meant for use with serum or was
`19 you see that?
`20 it meant as serum-free formulation?
`20
`~=6A. And what is your question?
`
`21~~A. It was meant as a serum-free formulation.
`21
`Q. Well, just make sure you're -- we're at the
`22 sameplace.
`23.
`«OAL Yes.
`
`24
`25
`
`«=. Okay.
`A. Yeah, I apologize.
`
`Page 13
`QQ. Okay. No problem. And then so just to follow
`1
`2 up on thisa little bit, can you give an example or two
`3 of what kind -- sort of things you would look at in
`4 assessing existing cell culture processes? Can you
`5 just, I guess, walk me through what that entails a
`6 little bit?
`
`A. Assessing cell culture processes in --
`7
`8 involves -- if we start from ground zero,it involves
`9 taking a cell, in this case, a CHO cell.
`10 Q Okay.
`11
`A. And identifying what base medium it would grow
`12 im best.
`
`15 Advanced Medium is in the use of culturing CHO cells to
`16 produce proteins.
`17)
`Q. Okay.
`18
`<A, That's one example.
`19
`@. Okay. And turning back to the text of your
`20 report, I see that it -- you say -- you nse the tenm
`
`21 "new custom Chinese Hamster Ovary" or CHO subculture 21==Q. So -and then does it mean that-- just soI
`22 media products, and I'm curious. Why do you specify
`22 -- just so I understand what you're saying, were all --
`23 that they're CHO subculture media products?
`23 did all -- sitting here this morning, is it your memory
`24 that all of these projects would involve CHOcells
`24
`A.
`I specify in the excerpt from my resume -- my
`25 specifically?
`
`Q. Okay.
`130
`=A. And we would assess growth, viability, and if
`14
`15 it was a clone that was engineered to produce a product,
`16 we would assess the level of the expression ofthat
`17 product. We may look at other attributes andcritical
`18 quality attributes -.
`19
`Q. Okay.
`20
`=A.
`se of the clone.
`
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`Q. Okay. And do you -- do yourecall, did the
`22
`23 formulation include hydrolysate?
`24
`=A.
`Itdoes not include hydrolysate.
`25
`@ Okay. And was it meant to be used with
`
`Page 11
`hydrolysate or was it meant to be used just on ifs own?
`MR. FLETCHER: Objection.
`A. EX-CELL Advanced is meant to be used onits
`
`own initially, but for batch culture.
`.
`(By Mr. Ehrich} Okay.
`. And fed batchculture.
`. For fed batch culture?
`
`. Yeah.
`
`CSaAtinewhoe
`
`QQ. Okay. So by the term "fed batch culture," I
`9
`10 think you're kind of anticipating my next question. Is
`11 it fair to say that EX-CELL Advancedis designed to be
`12 used to culture cells that are producing recombinant
`13 protems?
`14.
`A. EX-CELL Advanced -— what one use of EX-~-CELL
`
`25 CV, [specify CHO because that was the predominant cell
`
`

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`Page 14
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`Page 16
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`culture.
`
`Okay.
`Temperature.
`Okay.
`Assessing optimal pH.
`Uh-huh.
`
`1 2 3 4 5 6
`
`>OPrePre
`
`Those would be -- and -- and obviously
`7
`8 assessing growth and -- growth and viability in the
`9 culture.
`
`=Q. Okay. And would the processes have -- were
`10
`11 these always fed batch processes or were you also
`12 looking at other general process -- processes?
`13.
`A They were always either batch or fed batch.
`14
`Q. Okay. And you mentioned customers. Would
`14 customers have included, like, universities as well as
`16 companies or...
`17.
`=A. Our customers included academicinstitutions
`
`18 and also biotherapeutic manufacturers.
`19
`Q. Okay. And in terms of recommending
`20 improvements to media compensation, just sitting today
`21 and talking in general terms so you're not violating any
`22 confidentiality agreements, can you provide any examples
`23 of improvements that you would have recommended or that
`24 would have been made during the course ofthis process?
`25
`A Frequently, most often a request from
`
`1 customers were to improve growth, titer.
`2
`Q. Uh-huh.
`3A. ~Product quality. Could you repeat your
`4 question for me?
`§
` Q. Sure. Can you think of any-- to the extent
`6 you can talk aboutit, and -- and you know,just from
`7 memory this morming, provide any examplesofspecific
`8 improvements to -- to media compositions that -- that
`9 you would have made at some point here?
`10—=«A.
`_-Yeah,as -- as I said earlier, the requests
`11 were usually for improvements in growth and specific --
`12 and more -- more specifically in productivity. So we
`13 would set a target based on the original performance of
`14 the clone and how far we felt we could push it with
`15 media and other culture conditions.
`
`Q. Okay.
`16
`=A. To increase productivity.
`17
`Q. Okay.
`18
`19
`A. And -—and we had many examples ofthat. That
`20 was something we did routinely in the laboratory.
`203Q. Okay. Thank you. And you also mentioned cell
`21=Q. Okay. Kind ofa quick aside question, you
`21 culture processes in addition to the media composition.
`22 Can you provide just some general examples of optimizing
`22 mentioned product quality. What were the examples of
`23 acell culture process?
`23 product quality that you -- that you -- that you would
`24 be addressing or optimizing?
`24
`A. Some examples of improving a cell culture
`25
`<A. The most frequent issue with regard to
`
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`A. Yes,all these projects would invelve CHO
`1
`2 cells specifically during my time at Sigma.
`3
` Q. Ob, Tunderstand. Just focusing on the
`4 tumeline reflected --
`5
`A. Yeah.
`
`6
`7
`
`. --in Paragraph 18?
`AL Yes.
`
`Q. Okay. And so it was your experience during
`&
`9 that time that different CHO cell lines would have
`10 different media requirements?
`11
`MR. FLETCHER: Objection.
`A,
`12.
`‘W's my experience that different CHO cell
`13 lines would have different media requirements.
`14
`Q.
`(By MrEhrich) Okay. And I understand that
`15 you -- your -- it says that you're recommending
`16 improvements in media composition or other aspects of
`17 the cell culture process, right?
`i8
`<AYes, that's correct.
`19
`Q. Okay. So does this mean that the -- is it
`20 fair to characterize what you're doing is optimization,
`21 then, or is there another word that you prefer?
`22
`=A. The use of optimization is a fair
`23 characterization of optimization of media and of
`24 process.
`25
`Q. Andofprocess. Okay. Andso when you were
`
`Page 15
`1 assessing existing cell culture processes, would it be
`2 the case that the cells were not growing atall or they
`3 were dying in the media or they weren't growing as well?
`4 I guess I -- I guess what I'm trying -- what I'm trying
`5 to ask is what general level of problem were you -- were
`6 you coming in fo -- fo solve or to optimize?
`7
`MR. FLETCHER: Objection.
`8
`A. Frequently customers would cometo us with a
`9 request to improve growth and productivity --
`10
`Q.
`(By Mr. Ebrich} Okay.
`11
`A.
`--ofa particular clone from a particular
`12 cell line.
`13
`
`Q. Okay. So oftentimes, ifnot usually, a clone
`14 that was engineered to produce some sort of recombinant
`15 polypeptide?
`16
`=A. Yes, it would be frequently 2 clone that was
`17 engineered to produce a glycoprotein frequently.
`18
`Q. Aglycoprotein frequently.
`19
`A. Yeah.
`
`25 process would include density inoculation of the
`
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`Page 20
`
`1 CHO-K1. Is that fair to say?
`2
`A. Based on experienceof the scientists in -- on
`3 the team --
`
`Q, Uh-huh.
`4
`<A. —we would select a group of media. It could
`5
`6 be anywhere from four te 10. I recall one project where
`7 Lactually screened 30.
`8
`Q. Okay.
`9
`A. And, ofcourse, J didn't use high throughput.
`10 There were limitations to the high throughput
`11 methodology with 30 media.
`12. . Oh, understood. Okay. Butto clarify,
`13 though, this was again an optimization process?
`14
`A. At that point, it was an interrogative — an
`14 interrogation process to understand whatthe cells
`16 needed.
`
`1 productivity of a clone was -- I’m sorry?
`2
`Q. No, lapologize. Product-- product quality,
`3 what were some examples of--
`4.
`A, Thank you.
`5
`@Q. No problem. Product quality that you -- that
`6 you were addressing --
`7
`<A. The —the most frequent examples ofproduct
`8 quality that we were asked to improve were directed
`9 toward stability of the clone, long-term stability and
`10 glycan expression, like a protein -- glycan expression
`11 on thecell on the -- on that product.
`12)
`QQ. Ub-buh. Okay. Glycosylationprofilesis --
`13.
`A. Absolutely, yes.
`14.
`Q. Okay.
`15
`A. Right on.
`16
`Q. Thank you. And then in terms of examples of
`17=Q..- Okay. So if I was -- I just want to — and
`17 improvements in media compensation, can youget-- like,
`18 I guess, what -- what specifically about the composition
`18 this was -- just to reset our timeframe,this is all
`19 around between 2003 and 2015?
`19 would you -- would you change, again, just from -- kind
`20
`A Yes.
`20 of from memory? For example, would you change the
`
`21 carbohydrate source or change the amount of glucose or 21.9=Q. More or less. Okay.
`22 change the composition of the metals or the lipids? Any
`22.
`~=A.
`In the lab, yes.
`
`23 -- any examples that you can think of? 23=Q. Okay. So at the time, if [had a CHO cell
`24
`A. The way our approach wentat Sigma-Aldrich --
`24 line that was producing a glycoprotein, would -- would
`25 this is public information--
`25 the expectation be that one of your CHO-K1 formulations
`
`Page 19
`
`Q Okay.
`1
`A. —is we interrogated the clones to determine
`2
`3 what they desired to improve growth,titer, product
`4 quality. Excuse me. Wedid that through a library of
`3 media many chemically defined, but many not chemically
`6 defined and we would screen — we had an understanding
`7 depending on the lineage of the CHO cell which media
`8 would work better for that lmeage, and bylineage, 1
`9 mean, like DG-44, DUX-B11, CHO-K1. Excuse me. And we
`
`Page 21
`1 would generally be sufficient to produce someofit --
`2 some glycoprotein?
`3.
`A.
`[would just qualify that they aren't CHO-K1
`4 formulations. They're CHO.
`§
` Q. CHO. General CHO formulations. Okay. All
`6 right. Thank you.
`7
`A. Yeah, and maybeto take a brief step back,the
`8 first thing we would do when we get -- when we gota
`9 clone from a client would be to either use their medium
`
`10 would screen them in high throughput screens.
`li
`We new the formulationsfor all these media,
`
`Q. So thinking back on your experience, again, as
`
`10 that they were already growing it in --
`11
`Q. Okay.
`12
`A.
`--and assess the performance at that level.
`12 but we would usually use 10, 10 to 12 media, and we
`13.
`Q. Okay.
`would do high throughput screening using Design of
`14.~~A. And thenlook to adaptit to our -- some of
`Experiment in deep-well micro titer plates and then we
`15 our base media.
`would apply nultivariant data analysis to the results to
`determine which — which components of the media had a
`favorable -» showed a favorable outcomefor a particular
`attribute of the cell, whether it be growth, again,
`growth, productivity, glycosylation profile, acylation,
`20 so but we would usually just start out early on with
`21 just growth and productivity and viability.
`22
`
`Q. Okay.
`16
`=A. Did] answer your question?
`17
`Q. You did, but then to follow up, can I assume
`18
`19 there would be some cases where the client would be
`
`20 using one of your catalog media and then they would ask
`21 you to optimize from there?
`22
`«AL Yes.
`
`23 summarized in Paragraph 18, it sounds like there were —
`24 there was a basal — base media or a set of base media
`
`23 that you would recommend for, for example, CHO/db-Fr or
`
`«Q. Okay. And was it your general experience that
`2300
`24 the catalog media would success -- be -- successfully
`25 produce some glycoprotein and then you would improve
`
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`Page 22
`
`1 productivity after that point?
`2
`A. There would be some expectation that the clone
`3 would already been producing some glycoprotein --
`4 glycoprotein or they wouldn't have sentit to us to
`5 optimize.
`6 . Gotit. Understood. Thank you. Okay. I'd
`7 like te follow up with what's been marked as DX 2013.
`& Flip to the second page.
`9
`THE REPORTER:It's 2013?
`
`MR. EHRICH: Yes, DX 2013.
`10
`(Defendant's Exhibit No. 2013 was marked for
`11
`12 identification and made part of the record.)
`13°)
`Q.
`(By Mr. Ehrich) I believe this is a journal
`14 article that you are one of the authors of: is that
`13 correct?
`16
`=A. That's correct.
`
`=6Q.:s« Andis it okay if] refer to this general
`17
`18 article as Deeds 2004?
`19
`A Yes.
`
`Q. Okay. Andit looks as though -- is it fair to
`20
`21 say thatthis is work that you performed while you were
`22 at Sigma-Aldnch?
`23.
`=A.
`It's fair to say that this is a project m
`24 which [ put into a very small amount of work on.
`25
`Q. Okay.
`
`OProPre
`OPOPo>
`
`enwnontk|he
`
`‘
`WW
`
`Okay. The first page.
`Yes.
`. The left-hand column.
`
`Page 24
`
`Yes,
`Andthe last paragraphofthe left-hand
`column.
`
`Yes,
`Second sentence.
`
`"Many animal component-free formulations"?
`That one.
`
`. Got it. Thank you.
`11
`. Yep. No problem. And then those two
`12
`13 sentences, and then the second sentence says, "However,
`14 the options for insect cell culture are limited," and so
`15 Twas just irying -- [ was just curious. Is if -- does
`16 this mean that there's a set of cell culture products
`17 for CHO and a different set of cel] culture products for
`18 insectcells?
`
`MR. FLETCHER: Objection -- I don’t know what
`19
`20 the computer was saying, but I was saying objection.
`21
`THE REPORTER: Frank, was that an objection?
`22
`=A. There are different media formulations that
`
`23 exist for CHO as compared to insect cells.
`24
`@.
`(By Mr. Ebrich) Okay.
`25
`MR. COPLAND:Hi, folks. This is Gordon
`
`Page 23
`
`Page 25
`
`In the project, I was hired as a principal
`A.
`1
`2 scientist into the R&D group andI actually -- part of
`3 my training was to follow some other scientists that
`4 were already doing work in the lab, and so I supported
`5 this effort.
`6
`Q. Okay. Okay. So just out of curiosity, is
`7 it -- this article, you would agree,is discussing
`8 culture media for insect cell lines as opposed to
`{A recess was taken from 9:46 a.m.to
`9
`9 mammalian cell lines, correct?
`10
`A. That is correct.
`10 9:48 am.)
`li
`THE VIDEOGRAPHER: Backon the record at
`11=@Q. So the formulations for insect cell lines are
`12 &48 am.
`12 generally different than the formulations for mammalian
`13 cell lines?
`
`1 Copland. I'm just duckingin for John Pizzo, We're
`2 trying to find the Swartzwelder depasitton. Is this it?
`3
`MR. McLAUGHLIN: This is it. Are we muted?
`
`MR. COPLAND: Mr. Harwood, I see -- or I see
`4
`5 Shannon Harwood. Mr. Harwood, are you the deponent?
`6
`THE REPORTER: Can we gooff the record?
`7
`MR. EHRICH: Yeah,let's go off the record.
`8
`THE VIDEOGRAPHER:Off the record at 9:46 a.m.
`
`(By Mr. Ehrich) Okay, Welcome back,
`Q.
`13.
`14 Dr. Swartzwelder.
`
`15
`
`A. Thanks.
`
`MR. FLETCHER: Objection.
`14
`A, Could you sort of clarify that for me?
`15
`
`
`16 16=Q._s« So we're still on the Deeds 2004 paper.Q. (By Mr. Ehrich} Yeah, and maybeit would be
`
`17.
`A. Yes.
`17 helpful to just hone in on a passage. [f you could --
`18 look -- if you could look at the first page, please,
`19 toward the bottom of the first page on the left-hand
`20 <olumn,seeit says -- the second sentence says, "Many
`21 animal component-free formulations have been developed
`22 for other cell culture platforms, such as CHO and NSO."
`23)
`A.
`[msorry, Tom. Pm not -
`24
`Q. Sure.
`25
`A.
`
`--[ can't find the location.
`
`Q. Could you please go to the second page, the
`18
`19 one that has a lot of figures and graphs?
`20
`A. Yes.
`
`=Q. And you see Discussion beginning on the bottom
`21
`22 of the right-hand column?
`23)
`A, Yes, Ido.
`24
`Q. Okay. Do you see the second sentence begins,
`25 “Primarily, the methyl ester fatty acids"?
`
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`characterize cod liver oil?
`
`It's rather complex. [ would expect not.
`A.
`Q. Okay. Thank you. Could we -- let's go to the
`next page, please?
`A. Uh-huh.
`
`Q. And the reason I want to talk about this paper
`in the first place was the top of the left-hand columm
`talks about factorial matrix -- matrix experiment. Do
`you see that?
`A. Yes.
`
`Q. Okay. Is that related to the Design of
`Experiment process that you were talking aboutearlier?
`A. Yes, it’s actually -- we use this design
`expert software, which is a DOE,design -- a Design of
`Experiment software that we routinely apply in our
`studies.
`
`1 2 3 4 5 6 7 8 9
`
`11
`
`Q. Okay. And just continuing a couple of
`sentences down that left-hand column toward the top,
`looks as though the results are shown in Figure 1,
`agree?
`A. Excuse me. The cell growth -- yeah, the cell
`growth aspect ofthe insect cells was analyzed --
`Q. Uh-huh.
`A. - in Figure 1,
`Q. And just a quick question in the same area, do
`
`]
`
`A, Yes.
`
`Q. And thenit says they need to be exchanged
`2
`3 with a defined lipid mixture. Canyoutell me what a -
`4 what the term "defined lipid mixture" means?
`5
`A.
`In this context for this paper --
`6
`Q. Yes.
`7
`A, --itisa mixture of defined lipid raw
`8 materials that are mixed within the solution -- in a
`
`9 solution and supplemented into the culture.
`10
`Q. Okay. And you see the next sentence says --
`11 begins, “Since codliver oil is an undefined material"?
`12)
`AL Yes,
`
`Q. Okay. And so apparently the methyl ester
`13.
`14 fatty acids were previously coming from cod liveroil;
`15 is that right?
`16
`=A. Thatis correct.
`
`«Okay. And can youtell me, then, what an
`«Q.
`17)
`18 undefined material would be?
`19
`A. Anundefined raw material that's used in cell
`
`20 culture would be a material where all the components
`21 were not known chemically.
`22
`Q, Okay. And that would melude cad liver oil?
`23.
`=A. Cod liveroil is an example, yes.
`24
`Q. Okay. And you said raw material. Does that
`25 mean, then, at this point you were just -- sorry. Sigma
`
`25
`
`Page 27
`1 of other companies at this time -- point were just using
`2 cod -- untreated, unprocessed cod liver oil as a
`3 supplement?
`4
`MR. FLETCHER: Objection.
`5
`A. Cod liver oil was a supplement that was
`6 processed and -- and clean with respect to -- it was
`7 purified as a component and stored under controlled GMP
`8 conditions, Good Manufacturing Practice conditions.
`9
`@Q.
`(By Mr. Ehrich) Okay. Thank you.
`10
`=A. Tilleaveit at that for now.
`11
`QQ. Okay. And by the appearanceofthe words "cod
`12 liver" in the phrase "cod liveroil,”is it fair to say
`13 that cod liver oil is extracted from codliver?
`
`+A. Tm oot sufficiently familiar with that to --
`14.
`15 to answer that question.
`16
`Q. Okay. I believe you said that cod liver oil
`17 includes un -- uncharacterized molecules?
`
`=A. Yes, it would include uncharacterized
`18
`19 molecules. Notall of the components would be known in
`20 it.
`
`. All of the components would be known?
`. Not.
`
`. Would not be known?
`
`. Yeah, not known.
`. Okay, Would it have been possible to fully
`
`—eFPowwerADwwWwWbe
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`—_
`13
`14
`15
`16
`17
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`18
`19
`70
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`24
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`you see the senfence that begins, "This allowsthe
`researcher"-- and, again, this is on Page 3, top ofthe
`left-hand column.
`A. Yes.
`
`Q. Okay. And it says, "This allows the
`researcher to run only 1/4 of the possible conditions
`and at the same time keeps the loss of significant data
`to a minum." Do you see that sentence?
`A. Yes.
`
`Q. Tust -- it sounds like you engaged in
`something -- maybenotfor this paper specifically, but
`it sounds like you engaged in a similar processfairly
`regularly while you were at Sigma. Js that fair to say?
`A. That's fair to say.
`Q. Okay. And does the one-fourth fraction sound
`about -- does that correspond to your memory of about
`how many -- how much effort, how many experiments
`this -- this would save?
`
`MR. FLETCHER: Objection.
`A. Could you repeat that?
`Q.
`(By Mr. Ehrich) Sure.
`A. Sorry.
`Q. Sure. Sure. It says that, This allows the
`researcherto run only one-fourth or one quarter of the
`possible conditions, right?
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