`
`Transcript of Horst Koller, Volume
`2
`
`Date: May 16, 2022
`Case: Regeneron -v- Novartis (PTAB)
`
`Planet Depos
`Phone: 888.433.3767
`Email: transcripts@planetdepos.com
`www.planetdepos.com
`
`WORLDWIDE COURT REPORTING & LITIGATION TECHNOLOGY
`
`Novartis Exhibit 2347.001
`Regeneron v. Novartis, IPR2021-00816
`
`REDACTED VERSION
`
`

`

`Transcript of Horst Koller, Volume 2
`Conducted on May 16, 2022
`
`1 (231 to 234)
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`231
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`233
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`PRESENT: (All appeared via Zoom Conference)
`
` WEIL, GOTSHAL & MANGES
` BY: MR. CHRISTOPHER PEPE
` 2001 M Street NW
` Washington, D.C. 20005
` (202) 682-7153
`
` - and -
`
` WEIL, GOTSHAL& MANGES
` BY: MR. TOM YU
` 767 Fifth Avenue
` New York, New York 10153-0119
` (212) 310-8586
`
` appeared on behalf of the Petitioner;
`
` ALLEN & OVERY
` BY: MR. WILLIAM JAMES
` 1101 New York Avenue, NW
` Washington, D.C. 20005
` (202) 683-3895
`
` - and -
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` ALLEN & OVERY
` BY: MR. MATTHEW MINER
` One Beacon Street
` Boston, Massachusetts 02108
` (857) 353-4509
`
` appeared on behalf of the Patent
` Owners.
`
`ALSO PRESENT:
`
` Ms. Petra Scamborova
` Mr. Andrew Gesior
` Regeneron
`
` Ms. Rachel Carrick, Technician
` Ms. Stephanie A. Battaglia, CSR, RMR, CRR
` Planet Depos
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` UNITED STATES PATENT AND TRADEMARK OFFICE
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`--------------------------------------------------
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` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`--------------------------------------------------
`
` REGENERON PHARMACEUTICALS, INC.
`
` Petitioner,
`
` V.
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` NOVARTIS PHARMA AG,
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` NOVARTIS TECHNOLOGY, LLC,
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` NOVARTIS PHARMACEUTICALS CORPORATION,
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` Patent Owners
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`--------------------------------------------------
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` Patent Number:
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` 9,220,631
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`--------------------------------------------------
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`16
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` CONTINUED DEPOSITION OF HORST KOLLER
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`17
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` Monday, May 16, 2022
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`Reported by:
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`STEPHANIE A. BATTAGLIA, CSR, RMR, CRR
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`Job No.: 448280
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`232
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`234
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` I N D E X
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`WITNESS: PAGE:
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`Horst Koller
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`EXAMINATION BY:
`
`Mr. James 237, 393
`Mr. Pepe 390
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` E X H I B I T S
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`Exhibit 1 Koller IPR Deposition 338
` February 20, 2021
` Koller Exhibit 1
`
`Exhibit 1001 U.S. Patent No. 9,220,631 320
` Regeneron 1001.001 -
` Regeneron 1001.013
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`Exhibit 1003 Declaration of 243
` Horst Koller
` Regeneron 1003.001 -
` Regeneron 1003.198
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`Exhibit 1007 WO 2011/006877 340
` Regeneron 1007.001 -
` Regeneron 1007.035
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`Exhibit 1008 Patent Application 243
` No. WO 2009/030976
` Regeneron 1008.001 -
` Regeneron 1008.32
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`Exhibit 1009
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`Exhibit 1074
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` May 16, 2022
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` 6:03 a.m., Central Time
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` Continued Deposition of HORST KOLLER, held
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`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
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`Novartis Exhibit 2347.002
`Regeneron v. Novartis, IPR2021-00816
`
`REDACTED VERSION
`
`

`

`Transcript of Horst Koller, Volume 2
`Conducted on May 16, 2022
`
`235
`
`2 (235 to 238)
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`237
`
`Overy on the line today.
` KOLLER HORST,
`called as a witness herein, having been first duly
`sworn was examined and testified virtually as
`follows:
` EXAMINATION
` BY MR. JAMES:
` Q Hello, Mr. Koller.
` A Good morning, Mr. James.
` Q Thank you for taking the time to talk to
`us.
` So just, let's see, we took your
`deposition last December, do you recall that?
` A Right, I recall that.
` Q And have you given any other testimony
`since that time?
` A No, I haven't.
` Q Have you picked up any additional
`consulting work on prefilled syringes since that
`time?
` A Yes, I have.
` Q For Regeneron?
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`(Cont'd.):
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`Exhibit 1105 Reply Declaration of 244
` Horst Koller
` Regeneron 1105.001 -
` Regeneron 1105.188
`
`Exhibit 1106 Reply Declaration of 310
` Dr. Szilard Kiss
` Regeneron 1106.001 -
` Regeneron 1106.035
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`Exhibit 1214 Drug Delivery Technology 333
` Delivering Therapeutic
` siRNA
` Regeneron 1214.001 -
` Regeneron 1214.076
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`Exhibit 2030 Cell and Protein 277
` Compatibility of
` Parylene-C Surfaces
` Novartis Exhibit 2030.001 -
` Novartis Exhibit 2030.008
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`Exhibit 2115 Process Review Summary 374
` GENEITC_1207-0002409 -
` GENEITC_1207-0002416
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`Exhibit 2121 License and Collaboration 318
` Agreement
` Novartis 2121.001 -
` Novartis 2121.0023
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`236
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` A No.
` MS. REPORTER: Here begins the
` Q Does the prefilled syringe -- let me
`videoconference deposition of Koller Horst in the
`strike that.
`matter of Regeneron versus Novartis.
` Is it a prefilled syringe for intravitreal
` Today's date is May 16, 2022, and the time
`administration?
`is 6:03 a.m., Central Time.
` A I am not sure yet because I am helping
` My name is Stephanie Battaglia of Planet
`this company to build up an overall syringe
`Depos.
`business, so it is not specific product-related,
` Beginning with the noticing party, will
`it is more from the technical point of view how to
`counsel please introduce themselves, state whom
`make a syringe pump basically.
`they represent, and stipulate to the swearing in
`0
` Q I see.
`of the witness remotely.
`11
` Can you tell me what you did to prepare
` Mr. James?
`12
`for your deposition today?
` MR. JAMES: My name is William James from
`13
` A I was reading of course my reply
`Allen & Overy on behalf of the Patentee Novartis,
`14
`declaration with related exhibits.
`and I can confirm that I agree to that.
`15
` Q Anything else?
` MR. PEPE: Chris Pepe representing
`16
` A I had a couple of talks with my counsel.
`Petitioner Regeneron. With me is Tom Yu, also
`17
` Q Other than counsel did you speak with
`with Weil, Gotshal. And we have on the line Petra
`18
`anybody else about your deposition?
`Scamborova and Andrew Gesior with Regeneron, and
`19
` A No.
`we confirm as well.
`20
` MR. JAMES: If I could -- sorry to
` Q When did you speak with counsel?
`21
` A Last week.
`interrupt, I also have Matthew Miner from Allen &
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`Novartis Exhibit 2347.003
`Regeneron v. Novartis, IPR2021-00816
`
`REDACTED VERSION
`
`

`

`Transcript of Horst Koller, Volume 2
`Conducted on May 16, 2022
`239
`
` Q On how many occasions?
` A It was three occasions.
` Q For approximately how long in total?
` A Between eight and ten hours.
` Q Did you review any documents in
`preparation for your deposition other than the
`documents that are cited in your reply
`declaration?
` MR. PEPE: Objection to the extent it
`calls for privilege.
` Horst, you can answer yes or no if you
`remember.
` THE WITNESS: Yes, I remember.
`BY MR. JAMES:
` Q You recall reviewing documents outside of
`the documents that are cited in your declaration?
` A Yes.
` Q Were those scientific articles?
` A One I was mentioning was an ISO standard.
` Q Which ISO standard is that?
` A It is ISO standard 11135.
` Q And why did you review that ISO standard
`
`3 (239 to 242)
`
`241
`
` Q And can you just tell me generally what
`11135 is about?
` A It shows you this is a guideline on
`process development or cycle development, possible
`related validation of EtO cycling, and it gives
`you a couple of options how to do that and how to
`approach that.
` Q Does it talk about the validation of a
`sterility assurance level?
` A It is mentioning sterility assurance level
`in general terms.
` Q Does it provide for a method of achieving
`any particular sterility assurance level?
` A It is giving you a proposal how to achieve
`the -- for the product specific required sterility
`assurance level.
` Q So the process would be able to achieve a
`sterility assurance level of, for example, 10 to
`the minus 3, is that right?
` A It would give you guideline to do that if
`you pre-specify SAL 10 to the minus 3, yes.
` Q And if you elected to you could select a
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`standard?
` MR. PEPE: Objection, calls for privilege.
` Horst, you can answer to the extent you
`can do so without divulging any of the
`communications we had during our meetings.
` THE WITNESS: This standard talks about
`EtO sterilization and process.
`BY MR. JAMES:
` Q Beyond ethylene oxide sterilization and
`processes do you recall any other -- any of the
`other contents of ISO 11135?
` A No.
` Q Was that ISO standard cited by an expert
`in this matter?
` A I would need to go back to my original
`declaration if -- it was not cited, I am not sure
`if I gave that as an answer to you that you might
`follow certain ISO standards which are related to
`ASTM standards, but I am not too familiar from
`European standards with ASTM standards so my focus
`was usually more on the ISO standard, this is
`where the relation comes from.
`
`different SAL such as 10 to the minus 6, would
`that be right?
` A Yes. Then you need to follow a certain
`principle, which is pretty much the same. The
`principals there are described in general terms,
`and then depending on the required SAL they just
`you know what you would need to do.
` Q Does it indicate in the ISO 11135 that the
`ethylene oxide can damage some drug products?
` MR. PEPE: Object to form.
`0
` THE WITNESS: I would need to pull it up.
`11
`I mean, it is divided into whether it addresses
`12
`two parts, one is the sterility part and one is
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`the functional terms of the device to sterilize.
`14
`BY MR. JAMES:
`15
` Q The actual device that's used?
`16
` A They talk about device in general terms,
`17
`they don't give specifics, give specific -- it
`18
`gives a guidance how to achieve -- what kind of
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`approaches you have to achieve certain SAL levels,
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`and one is focusing on the microbiology, which is
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`the sterility, and then it gives the indication to
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`Novartis Exhibit 2347.004
`Regeneron v. Novartis, IPR2021-00816
`
`REDACTED VERSION
`
`

`

`4 (243 to 246)
`
`Transcript of Horst Koller, Volume 2
`Conducted on May 16, 2022
`243
`say, okay, that functional performance needs to be
`checked as part of the overall approach.
` Q Mr. Koller, do you have a copy of
`Boulange?
` A Yes, if you can send me the exhibit
`number, I have a bunch of files here from the list
`with tab numbers and exhibit numbers.
` Q Okay, one moment.
` A I think this is Boulange, it is 1008.
` Q That's right, yes. So if you can open
`Exhibit 1008, please.
` (Document identified as Exhibit 1008 for
` identification.)
`BY MR. JAMES:
` Q Do you have a copy of your declaration --
`sorry, your reply declaration there in front of
`you?
` A It's listed as Exhibit 1003.
` (Document identified as Exhibit 1003 for
` identification.)
`BY MR. JAMES:
` Q I believe Exhibit 1003 was original
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` Q And how many hours did you spend putting
`this together, Mr. Koller?
` A In total 50, 50, 60 hours.
` Q And would you say you spent more time on
`it or the lawyers?
` A I spent more --
` MR. PEPE: Object to form, calls for
`speculation.
` THE WITNESS: I mean, I don't know how
`much time the lawyers spent, but it is based on my
`original declaration, which is baseline for my
`reply declaration, so, as I said, I spent
`approximately 50 to 60 hours.
`BY MR. JAMES:
` Q And how did the process work, did you
`actually draft this declaration on the computer or
`did you -- or did the lawyers provide you with the
`drafts?
` MR. PEPE: Object to form.
` THE WITNESS: The lawyers provided me with
`a general draft and then I was going through and
`made my expert comments and then they had me to
`246
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`244
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`declaration in the IPR.
` Your reply declaration is Exhibit 1105.
` THE TECHNICIAN: Sir, I have that as
`Tab 67.
` MR. JAMES: I apologize.
` THE WITNESS: I just found it.
` MR. JAMES: I will try to call the tabs
`out. I appreciate the help.
` (Document identified as Exhibit 1105 for
` identification.)
` THE WITNESS: I have now my reply
`declaration and Boulange patent in front of me.
`BY MR. JAMES:
` Q Okay, great.
` It is a patent application, right?
` A It is a WO number, yes.
` Q It's a patent application, correct?
` A Patent application.
` Q And then this declaration, 1105, your rely
`declaration, it was signed by you on the 12th of
`April of this year, is that right?
` A That's right.
`
`put it into the right language. As you might hear
`English is not native language, so they helped me
`also in sort of some of the language issues I had
`here.
`BY MR. JAMES:
` Q So they provided you with a draft and then
`you provided comments and they helped with the
`language, is that right?
` A That's right.
` MR. PEPE: Object to form.
`0
`BY MR. JAMES:
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` Q And if you could look at Paragraph 28 -- I
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`am going to apologize, I am going to be jumping
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`around a little bit today, sorry for that.
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` A 28.
`15
` Q 28, yes.
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` 28 is under a heading where you say that
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`the Parylene-C wouldn't need to come into contact
`18
`with the VEGF-Antagonist, right?
`19
` A Right.
`20
` Q And in the middle of the paragraph you say
`21
`that Boulange describes that the Parylene-C
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`Novartis Exhibit 2347.005
`Regeneron v. Novartis, IPR2021-00816
`
`REDACTED VERSION
`
`

`

`Transcript of Horst Koller, Volume 2
`Conducted on May 16, 2022
`247
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`5 (247 to 250)
`
`249
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`original I am not the chemist, I cannot talk that
`specific. I can talk to the chemistry when the
`Parylene-C is on the coated system, which would be
`the rubber coating here.
`BY MR. JAMES:
` Q So you don't -- you are not here to talk
`about the chemistry of polymer -- sorry -- of
`Parylene-C, but you can speak to it after it's
`applied, is that your testimony?
` MR. PEPE: Object to form.
` THE WITNESS: I mean, the Parylene-C has a
`material safety datasheet so I would first of all
`would look into the material safety datasheet to
`see what information is available.
` This is talking about chemistry, if it is
`monomer very likely, but I am not sure, I need to
`say I am guessing here, and then they would also
`give you some information about biocompatibility,
`toxicology information, all on the material safety
`datasheet, because that needs to be supplied if it
`is sort of shipped to the manufacturer. And then
`they have usually also some information about
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`coating need only be applied to the sides of the
`stopper, right?
` A Right.
` Q And then you cite to a portion of the
`specification, it's on Page 9 of the exhibit, if
`you can turn to that.
` A Page 9 of the --
` Q I am sorry, sorry, of Boulange 1008.09.
` A Yes, I am there.
` Q And you cite to this portion beginning at
`Line 25, I think, but before we get there just the
`process for applying Parylene-C is a vapor
`deposition process, right?
` A It is a plasma deposition process, right.
` Q Do you apply the polymer or the monomers
`when you apply Parylene-C?
` A I would need to read the information
`coming from the supplier. I know that you spray
`it into the system and then you apply a plasma and
`then usually a plasma forms and then the
`polymer --
` Q Okay.
`
`248
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` A -- the deposition.
` Q When you have done it in the past,
`Mr. Koller, did you apply the monomers or the
`polymers to the item you were coating?
` MR. PEPE: Object to form.
` THE WITNESS: I can't remember off the top
`of my head.
`BY MR. JAMES:
` Q But you have actually done it?
` A We ask a company to do it for us.
` Q You haven't actually done it, another
`company did it for you?
` MR. PEPE: Object to form.
` THE WITNESS: Right.
`BY MR. JAMES:
` Q So you don't know whether they applied a
`monomer or a polymer, right?
` A I am not sure what they are using, yes.
` Q Do you know if the polymer forms before
`you apply it or if it polymerizes in situ?
` MR. PEPE: Object to form.
` THE WITNESS: As I explained in my
`
`250
`flammability and what you need to make sure that
`you don't harm your colleagues by using like this
`part of chemistry.
` So I would need to go into more detail on
`the material safety datasheet.
`BY MR. JAMES:
` Q The reason I am asking you these questions
`is that you have offered an opinion that you could
`just coat part of this stopper, and I am just
`trying to explore the basis for that opinion. Do
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`you understand that?
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` A I understand that.
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` Q And the portion of the spec that you cite
`13
`is on Page 1008.009, Line 25 down to Line 29, do
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`you see that?
`15
` A I see that.
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` Q What it says is, "Such a thickness has the
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`advantage of ensuring that, regardless of the
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`profile, shape or surface characteristics of the
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`coated part, at the end of the process of
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`depositing/polymerizing the polymer material, the
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`Novartis Exhibit 2347.006
`Regeneron v. Novartis, IPR2021-00816
`
`REDACTED VERSION
`
`

`

`Transcript of Horst Koller, Volume 2
`Conducted on May 16, 2022
`251
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`6 (251 to 254)
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`253
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`correct?
` MR. PEPE: Object to form.
` THE WITNESS: Correct. It is how you
`would define the setup and the system, and it
`could cover a little bit more than the contact
`region.
`BY MR. JAMES:
` Q A little bit more. Where does it say
`that, Mr. Koller?
` A So it depends how you set up the system,
`you can define a clear cut of and you ask me to
`say, okay, can it cause a little bit more or can
`it cause more than the contact region, then I
`would need to design what is exactly my contact
`region of rubber component inside a syringe,
`otherwise I cannot give --
` Q Did that -- I am sorry, I didn't mean --
` MR. PEPE: Objection.
` THE WITNESS: Otherwise I cannot give an
`exact information of the contact regions. I would
`need to define that by building certain equipment
`in order to only contact the -- only -- excuse
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`desired region, namely at least the region
`corresponding to the contact region, with no
`discontinuity, and does so durably." Do you see
`that?
` A I see that.
` Q And so it says that it covers at least the
`region corresponding to the contact region in that
`sentence, right?
` A Right.
` And Boulange also defines the contact
`region, which is the region between the two moving
`parts, so it would be either the rubber components
`and then on the other side the container as
`described in his drawing.
` Q But in this patent specification -- let me
`strike that.
` In this patent application he doesn't
`actually show you a stopper without the entirety
`of the stopper being coated, correct?
` MR. PEPE: Objection, mischaracterizes the
`document.
` THE WITNESS: He says that it is possible
`
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`namely, at least the region corresponding with the
`contact region, so from a technical point of view
`this is very, very possible because it is also
`stating the art what people doing right now to
`coating specific surfaces on rubber components, so
`there is technology out there in order to perform
`that to do that.
`BY MR. JAMES:
` Q You hadn't actually used that technology
`to do this kind of coating though, correct?
` MR. PEPE: Object to form.
` THE WITNESS: I was using plasma
`deposition on rubber components during development
`of a special syringe composition.
`BY MR. JAMES:
` Q But you hadn't actually used Parylene-C to
`coat an object, you had other people do it for
`you, right?
` A Right.
` Q And when it says at least the region
`corresponding to the contact region, that
`indicates that in fact it could cover more,
`
`254
`me -- only polymerize or deposit the Parylene-C on
`the contact region.
`BY MR. JAMES:
` Q But there is no description of that kind
`of equipment being built in this Boulange
`application, right?
` MR. PEPE: Object to form. I haven't
`found any indication on such equipment in here.
`BY MR. JAMES:
` Q Just going back to my earlier question,
`0
`the stopper that's shown in the figures, it's
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`coated in its entirety with Parylene-C, correct?
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` MR. PEPE: Objection, misstates the
`13
`document.
`14
` THE WITNESS: What figure are you talking
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`to?
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`BY MR. JAMES:
`17
` Q Figure 2.
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` A 10 is the contact region to the side which
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`is the container surface and because it makes the
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`line it is, okay, the stability where it can be,
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`but it clearly states that could only also put
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`Novartis Exhibit 2347.007
`Regeneron v. Novartis, IPR2021-00816
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`REDACTED VERSION
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`7 (255 to 258)
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`257
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`Transcript of Horst Koller, Volume 2
`Conducted on May 16, 2022
`255
`some Parylene-C at least on the contact region,
`which would be up to the edge of the lip which is
`in product contact.
` Q Sorry, maybe my question wasn't clear.
` The figure shows the Parylene-C number 8
`coating the entirety of that stopper, right?
` MR. PEPE: Objection, form,
`mischaracterizes the document.
` THE WITNESS: Line 8 goes along the
`surface of the polymer, of the rubber stopper.
`BY MR. JAMES:
` Q In fact, Line 8 -- let's make sure we are
`on the same page here, Mr. Koller, Line 8 is the
`Parylene-C coating, correct?
` A Correct.
` Q And approximately where the numeral 3 is
`that would be the drug-containing portion of the
`syringe, is that right?
` MR. PEPE: Objection, form,
`mischaracterizes the document.
` THE WITNESS: If I look at Figure 2 in the
`total then the product contact side would be
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`right?
` MR. PEPE: Objection, asked and answered.
` THE WITNESS: I mean, as I say based on
`the picture it covers the back-end surface and the
`side, which is what he described based on the
`system here, I am missing the line which then
`would cover the product contact side.
`BY MR. JAMES:
` Q Okay.
` A I mean, based on that Figure No. 2 I don't
`have to prove that it covers the product contact
`side with Parylene-C.
` Q All you can see is that it covers all of
`the stopper that's shown in that expanded view,
`correct?
` MR. PEPE: Objection, asked and answered.
` THE WITNESS: I mean, this is -- as I say,
`this is what I can see here, it covers the back
`end and the side up to the second lip.
` Excuse me for a second. Excuse me, the
`safe was open in my room and it just gave alarm, I
`am not sure why, maybe open too long, apologies,
`258
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`opposite number 3, where 5 and 6 is.
` So it says intended to receive a medical
`product which is number 6, so 3 is on the back-end
`side where the piston would be, and 6 is then the
`medical product, as he explains, number 4 also
`shows then the force of the direction.
`BY MR. JAMES:
` Q Okay, I see.
` So in this figure as shown in the little
`expanded figure on Figure 2 it shows 8, which is
`Parylene-C coating the entirety of the surface of
`the stopper that's shown there, right?
` A I mean, the close-up here covers the back
`end of the stopper and the first strip and then it
`goes to the second group, but there is no
`mentioning here to say that it covers the product
`contact side, if I follow the figure here in
`number 2.
` Q I understand.
` All that they show us in Figure 2 in that
`little expanded version is that the Parylene-C
`coats the entirety of the stopper that's shown,
`
`sorry about that.
`BY MR. JAMES:
` Q No worries.
` If we look at your declaration again,
`Paragraph 29.
` A Right.
` Q You explain there that it was common in
`the art to coat the tip of a stopper with
`fluoropolymer to prevent negative interactions
`with the drug product, is that right?
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` A It was common in the art, yes, to coat,
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`but to use fluoropolymer coating on the product
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`contact side of rubber plungers.
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` Q And how is the fluoropolymer applied to
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`the stoppers?
`15
` MR. PEPE: Object to form.
`16
` THE WITNESS: First you mount the rubber
`17
`piece on its own, there are two options, option
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`one is due to a molding process where you mold the
`19
`stopper to its shape like a vessel iron basically,
`20
`and then after opening the iron you put very thin
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`fluoropolymer film on top, you close the mold
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`Novartis Exhibit 2347.008
`Regeneron v. Novartis, IPR2021-00816
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`REDACTED VERSION
`
`

`

`Transcript of Horst Koller, Volume 2
`Conducted on May 16, 2022
`259
`again, and then you vulcanize the fluoropolymer
`coating or the fluoropolymer film on to the
`product contact side. After that it gets trimmed,
`this is what in the drawing usually see on the
`trim edge, then it gets -- it gets kept out of the
`so-called fill which is, you know, it is
`containing like multiple pieces and then it was in
`cutting. Then you do washing. And depending on
`what is needed you might do this surface
`siliconization to specific parts of the rubber
`component.
`BY MR. JAMES:
` Q Are there any references that you are
`citing in support of your position that you could
`cover the Parylene-C coated stopper with a
`fluoropolymer?
` MR. PEPE: Object to form.
` THE WITNESS: Can you please repeat your
`question?
`BY MR. JAMES:
` Q Yes.
` Are you citing any references to support
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` MR. PEPE: He was talking while you
`started talking.
` MR. JAMES: Well, I thought he was
`finished.
` MR. PEPE: That's probably the fourth or
`fifth time it's happened.
`BY MR. JAMES:
` Q Can you finish, Mr. Koller?
` A I need to add some more sentence to it.
` The last sentence describes that says you
`can make a certain holder or check where you put
`the fluoropolymer coated system in the check, you
`can hold them and then you can apply in a certain
`chamber area to deposition of the Parylene-C and
`then you would coat anything expected product
`contact side.
` This is possible, and this is also done on
`certain parts on standard products as example by
`the so-called B2 for the coating they have on
`certain rubber components which is known since
`many, many years.
` Q My question is are you citing any
`
`8 (259 to 262)
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`261
`
`260
`
`your position that you could cover a Parylene-C
`coated stopper with a fluoropolymer?
` MR. PEPE: Same objection.
` THE WITNESS: If you -- I don't understand
`your question.
`BY MR. JAMES:
` Q You are saying that in this -- in these
`paragraphs that we have looked at that you could
`coat the Parylene-C coated stopper with a
`fluoropolymer. I am asking you if you have a
`document that shows that.
` A I say here by mounting the stopper, which
`is the form stopper in the holder to cover the
`direct contact region, which would be also then
`the fluoropolymer coated site, and then exposed
`the contact region which would be the ribs to
`Parylene-C. So --
` Q Are you talking about masking --
` MR. PEPE: Objection.
` Counsel, can you let him finish his
`answer?
` MR. JAMES: I thought he was finished.
`
`262
`documents that show fluoropolymer being coated on
`to Parylene-C?
` MR. PEPE: Object to form.
` THE WITNESS: No, I don't cite any
`documents to coat fluoropolymer on Parylene-C
`because this is not where you would do it anyway,
`you would not put Parylene-C first and then do the
`coating, you would always go the other way around,
`because, as I explained, the fluoropolymer is a
`molding process with an additional film so you
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`need to get the rubber in place in shape, then you
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`do the film, then you do the trimming, then you
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`might wash, and then you might put the Parylene-C
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`on the surfaces.
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`BY MR. JAMES:
`15
` Q Are you citing any documents that disclose
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`the fluoropolymer being placed on to a stopper and
`17
`then Parylene-C being applied to the stopper?
`18
` A No, I don't cite any document.
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` Is your reference going back to citation
`20
`of the process itself, because in Example 1 of
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`Boulange he gives information about various
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`Novartis Exhibit 2347.009
`Regeneron v. Novartis, IPR2021-00816
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`REDACTED VERSION
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`

`

`Transcript of Horst Koller, Volume 2
`Conducted on May 16, 2022
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`medical devices or container piston systems
`testing some with non-coated pistons, others with
`coated pistons.
` The coated pistons 3 were coated with the
`coating 8, as previously defined, so Boulange is
`talking about putting his coating 8 Parylene-C on
`already-coated pistons.
` Q Which page are you on?
` A I am on the 1008.015, Example 1 of the
`Boulange document, Line Number 16.
` Q Does he say anything there about that
`there is a fluoropolymer coating on the pistons?
` A No. In this section it is not talking
`about fluoropolymer.
` Q Does this example indicate that there is a
`masking of the drug-facing portion of the stopper?
` A Not necessarily. It depends on the
`systemic what he wants to make, always have a
`system in place, as I explained before, which is
`making sure that Parylene-C or his coating number
`8 is not deposited on the product contact side of
`the surface.
`
`9 (263 to 266)
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`265
`
` Q Does it use a word that means the same
`thing as masking in your field?
` MR. PEPE: Object to form.
` THE WITNESS: No.
`BY MR. JAMES:
` Q Give me one moment.
` In Boulange does it disclose prefilled
`syringes containing a protein drug product?
` A Boulange describes gas-type siliconized
`prefilled syringe system which can be used for
`different type of applications.
` Q Does it disclose prefilled syringes
`containing a protein drug product?
` MR. PEPE: Object to form.
` THE WITNESS: Give me a minute, please.
` I say the container is intended to
`accommodate a medical product in the liquid,
`gaseous, fluid, pasty, or lyophilized phase, which
`may have a variability viscosity, and is therefore
`able to flow, so if you say medical product in the
`liquid phase of course that could be any kind of
`injectable drug for pharmacologic applications.
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` Q I understand that it could say something
`BY MR. JAMES:
`different, Mr. Koller, I am asking you about what
` Q Does it disclose a prefilled syringe
`it does say.
`containing a protein drug product?
` Does it say that there is any masking of
` MR. PEPE: Objection, asked and answered.
`any part of the stopper i