Planet Depos0
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`Transcript of Szilard Kiss, M.D.
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`Date: January 7, 2022
`Case: Regeneron -v- Novartis (PTAB)
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`Planet Depos
`Phone: 888.433.3767
`Email: transcripts@planetdepos.com
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`WORLDWIDE COURT REPORTING & LITIGATION TECHNOLOGY
`
`Novartis Exhibit 2257.001
`Regeneron v. Novartis, IPR2021-00816
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`Transcript of Szilard Kiss, M.D.
`Conducted on January 7, 2022
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`A P P E A R A N C E S
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`Via Zoom Videoconferencing :
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`ON BEHALF OF PETITIONER REGENERON PHARMACEUTICALS,
`INC.:
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` Anish R. Desai, Esquire
` Weil, Gotshal & Manges LLP
` 767 Fifth Avenue
` New York, New York 10153 0119
` PHONE: +1 212 310 8730
` E MAIL: Anish.desai@weil.com
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` and
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` Elizabeth S. Weiswasser, Esquire
` Weil, Gotshal & Manges LLP
` 767 Fifth Avenue
` New York, New York 10153 0119
` PHONE: +1 212 310 8022
` E MAIL: Elizabeth.weiswasser@weil.com
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` and
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` Andrew Peter Gesior, Esquire
` Weil, Gotshal & Manges LLP
` 767 Fifth Avenue
` New York, New York 10153 0119
` PHONE: +1 212 310 8244
` E MAIL:andrew.gesior@weil.com
`
` and
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` Christopher Pepe, Esquire
` Weil, Gotshal & Manges LLP
` 2001 M Street, NW
` Washington, D.C. 20036
` PHONE: +1 202 682 7153
` E MAIL: Christopher.pepe@weil.com
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` CONT'D
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` UNITED STATES PATENT AND TRADEMARK O
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`ICE
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` __________
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` BE ORE THE PATENT TRIAL AND APPEAL BOARD
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` __________
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` REGENERON PHARMACEUTICALS, INC.,
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` Petitioner
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` 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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` Case IPR202
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`008 6
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` Patent No. 9,220,63
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` __________
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` REMOTE DEPOSITION O
` SZILÁRD KISS M.D. UNDER C. .R. § 42.53
` Zoom Recorded Videoconference
` 0 /07/2022
` 9:34 a.m. (EST)
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`REPORTED BY: AMANDA GORRONO, CLR
`CLR NO. 052005 0
`JOB NO. 4 7 55
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` P P E A R A N C E S CONT'D
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`Via Zoom Videoconferencing :
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`ON BEHALF OF PETITIONER REGENERON PHARMACEUTICALS,
`INC.:
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` Robert T. Vlasis, Esquire
` Weil, Gotshal & Manges LLP
` 2001 M Street, NW
` Washington, D.C. 20036
` PHONE: +1 202 682 7024
` E MAIL: Robert.vlasis@weil.com
`
` and
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` Petra Scamborova, PhD, JD
` Regeneron Pharmaceuticals, Inc.
` 777 Old Saw Mill River Road
` Tarrytown, New York 10591
` PHONE: +1 914 847 7611
` E MAIL: Petra.scamborova@regeneron.com
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`ON BEHALF OF THE PATENT OWNERS:
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` Elizabeth J. Holland, Esquire
` Goodwin Procter LLP
` The New York Times Building
` 620 Eighth Avenue
` New York, New York 10018
` PHONE: +1 212 459 7230
` E MAIL: Eholland@goodwinlaw.com
` and
` Molly R. Grammel, Esquire
` Goodwin Procter LLP
` 100 Northern Avenue
` Boston, Massachusetts 02210
` PHONE: +1 617 570 8112
` E MAIL: Mgrammel@goodwinlaw.com
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` REMOTE DEPOSITION O SZILÁRD KISS, M.D. held
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`virtually via Zoom Videoconferencing, before
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`Amanda Gorrono, Certified Live Note Reporter, and
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`Notary Public of the State of New York.
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`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
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`Novartis Exhibit 2257.002
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`Transcript of Szilard Kiss, M.D.
`Conducted on January 7, 2022
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` THE TECH: Please stand by for the
`technician read on and backup recording. Zoom will
`now prompt you for your consent to video-record this
`meeting for backup purposes.
` AUTOMATED MESSAGE: Recording in
`progress.
` MR. DESAI: I'm sorry, we're not,
`we're not video recording this deposition.
` THE TECH: Okay. This is a backup
`video recording. It doesn't mean to be -- it's not
`like, you know, a videotaped deposition.
` MR. DESAI: Got it. Okay.
` THE TECH: Is that okay with you?
` MR. DESAI: That's fine with me as
`long as we're not going to order the video or
`anything like that. That's fine.
` THE TECH: No, no, no. There's no
`videographer. It's not, you know --
` MS. HOLLAND: I assume it's just to
`make sure the transcript is accurate eventually.
` MR. DESAI: That's fine with me.
` THE TECH: Okay. Thank you to
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`A P P E A R A N C E S CONT'D
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`Via Zoom Videoconferencing :
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`ON BEHALF OF THE PATENT OWNERS:
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` Shweta Kumar, Esquire
` Goodwin Procter LLP
` 1900 N Street, NW
` Washington, D.C. 20036
` PHONE: +1 202 346 4254
` E MAIL: Skumar@goodwinlaw.com
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`ALSO PRESENT:
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`Leah Shenfeld, Technician PlanetDepos
`Jenevieve Nutovits Goodwin Procter LLP
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`everyone for attending this proceeding remotely which
`we anticipate will run smoothly.
` Please remember to speak slowly and
`do your best to not talk over one another. Please be
`aware there will be a recording of this proceeding
`for backup purposes. Any off-the-record discussions
`should be had away from the computer. Please
`remember to mute your mic for those conversations.
` Please have your video enabled to
`help the reporter identify who is speaking. If
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`time before speaking.
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` We will provide a complimentary
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`unedited recording of this deposition with the
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`purchase of a transcript. I apologize in advance for
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`any technical-related interruptions.
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` Thank you.
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`SZILÁRD KISS M.D. called as a witness, having been
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`first duly sworn by a Notary Public of the State of
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`New York, was examined and testified as follows:
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`EXAMINATION
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` I N D E X
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`WITNESS EXAMINATION BY PAGE
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`SZILÁRD KISS, M.D. MS. HOLLAND 8
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` EXHIBITS IDENTI IED
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`EXHIBIT DESCRIPTION PAGE
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`Exhibit 03 Declaration of Dr. Szilárd Kiss.. 0
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`/006877 A ................ 58
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`/077 55 A ................ 64
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`Exhibit 007 WO 20
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`Exhibit 029 WO 20
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`Novartis Exhibit 2257.003
`Regeneron v. Novartis, IPR2021-00816
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`

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`Transcript of Szilard Kiss, M.D.
`Conducted on January 7, 2022
`9
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`3 (9 to 12)
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`open to the first page of the Declaration. It's
`actually No. 1031.003.
` A. Yes, I'm open to that page.
` Q. Okay. And I'm going to direct your
`attention to Paragraph 3.
` A. Yes. Just give me one moment to read
`that paragraph.
` Q. Go ahead.
` A. Yes.
` Q. Okay. And you say that there that
`you've assumed that Claim 1 of the '631 patent was
`separately shown to be obvious based on prior art and
`the Declaration of Horst Koller.
` Do you see that?
` A. Yes, I do.
` Q. Did you actually review Mr. Koller's
`Declaration?
` A. I reviewed a portion of Mr. Koller's
`Declaration that related to the POSITA but not the
`whole Declaration.
` Q. Okay. Did you read the parts of the
`Declaration where he talked about the prior art?
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`BY MS. HOLLAND:
` Q. Good morning, Dr. Kiss.
` A. Good morning.
` Q. I'd like to start if I could by
`asking you to open up whatever box or envelope you
`got with the exhibits.
` A. (Indicating.)
` Q. Thank you, yeah.
` A. Give me one second. I'm just opening
`it up here.
` Q. Yeah, sure, no problem.
` A. It looks like I received, one, two,
`three, four, five, six, seven, eight, nine manila
`envelopes or these envelopes.
` Q. That sounds right. Thank you.
` Okay. So why don't you take out the
`one that's your Declaration in this IPR which is
`Exhibit 1031. And we're going to be using the IPR
`exhibit numbers as the deposition exhibit numbers as
`well.
` A. Just give me one moment. At 1031,
`did you say, the one dated --
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` A. I did not read any other part of the
` (Whereupon, Exhibit 1031, Declaration
`Declaration.
`of Dr. Szilárd Kiss, was identified.)
` Q. Okay. So when you say you have
`BY MS. HOLLAND:
`assumed, what was that based on?
` Q. I did.
` A. Okay.
` MR. DESAI: Objection to form.
` A. That is based on an assumption, as I
` THE TECH: Ms. Holland, this is the
`stated, that I assumed that the Claim 1 has
`tech. Would you like me to pull up that exhibit on
`separately been shown to be obvious.
`my screen as well?
` Q. Okay. I just want to be -- I'm
` MS. HOLLAND: I'll ask Mr. Desai and
`sorry. Go ahead.
`company if they want everything up on the screen.
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` A. It's an assumption.
` THE WITNESS: As long as I have a
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` Q. Okay. And you were asked to make
`copy of it, I don't need it up on the screen. I have
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`that assumption by counsel, correct?
`a copy of the Declaration, so...
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` A. I made the assumption in order to
` Q. Okay. Just let us know if you need
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`form my Declaration, correct.
`anything up on the screen and we'll do that.
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` A. Yeah.
` Q. Okay. And counsel asked you to make
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`that assumption; is that right?
` THE TECH: Thank you.
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` A. I have it.
` MR. DESAI: Objection; form, asked
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`and answered. And if you're asking for the
` Q. You have that out, Dr. Kiss? Thank
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`communications between counsel and Dr. Kiss, you
`you.
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` A. I do.
`know, I don't think he has to answer that question.
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`He's otherwise answered it.
` Q. Okay. And what I'd like you to do is
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`Novartis Exhibit 2257.004
`Regeneron v. Novartis, IPR2021-00816
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`

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`4 (13 to 16)
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`Transcript of Szilard Kiss, M.D.
`Conducted on January 7, 2022
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` MS. HOLLAND: I'm asking for the
`basis of the assumption.
` MR. DESAI: An assumption is an
`assumption. You don't have to have a basis for an
`assumption. So let's move on.
` Q. What was your basis for providing in
`your Declaration that you would assume that Claim 1
`has been shown to be obvious?
` MR. DESAI: Objection; form.
` A. It was my assumption that Claim 1 was
`shown to be obvious and my Declaration is based on
`that assumption.
` Q. Okay. You don't have an opinion one
`way or the other about whether Claim 1 is obvious,
`correct?
` A. Claim 1 is beyond the scope of my
`Declaration.
` Q. Okay. So just if you can answer my
`question. Do you have an opinion one way or the
`other on whether Claim 1 is obvious?
` A. Claim 1 is beyond the scope of my
`Declaration.
`
` A. No.
` Q. Okay. Is it fair to say you do not
`have expertise in syringe design?
` A. I do not have expertise in syringe
`design.
` Q. Okay. And is it, is it also fair to
`say that you don't have expertise in techniques for
`sterilizing medical devices?
` A. That's correct. I do not have
`expertise in sterilization for medical devices.
` Q. Okay. Let's go to Page 11 and
`Paragraph 26.
` A. Just give me one moment to turn
`there.
` Q. Sure.
` A. I'm just going to read that paragraph
`if you don't mind giving me a moment to do so.
` Q. Of course.
` A. Yes.
` Q. Okay. The second sentence there you
`say: "It was known that numerous medical
`complications could occur from incorrect intravitreal
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` Q. Okay. So does that mean you don't
`have an opinion?
` A. I have not formed an opinion, as I
`have not had, and not analyzed Claim 1.
` Q. All right. And is it correct to say
`you don't have the appropriate expertise to offer an
`opinion about whether Claim 1 is obvious?
` MR. DESAI: Objection; form, outside
`the scope.
` A. So as I have stated, I have not
`evaluated Claim 1 and I have not evaluated whether I
`would have expertise or not.
` Q. Okay. So are you telling me that --
`well, let me step back for a second.
` Have you looked at Claim 1?
` A. I have not looked at Claim 1.
` Q. Okay. So you don't know what Claim 1
`says?
` A. I have not looked at Claim 1.
` Q. All right. I asked a different
`question.
` Do you know what Claim 1 says?
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`administration."
` Do you see that?
` A. I do, yes.
` Q. Okay. What did you mean "incorrect
`intravitreal administration"?
` A. If the techniques used to administer
`medications into the eye were not properly followed,
`then there could be complications.
` Q. What techniques are you referring to?
` A. So, those techniques include the
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`volume of fluid that's injected, using aseptic
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` A. Yes, I did.
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` A. Yes.
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` Q. And by that you mean you need to make
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`sure that the procedure is done under sterile
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` A. No. I mean it has to be done under
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`Novartis Exhibit 2257.005
`Regeneron v. Novartis, IPR2021-00816
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`

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`Transcript of Szilard Kiss, M.D.
`Conducted on January 7, 2022
`7
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` Q. What do you mean by that?
` A. Appropriate use of antibiotics,
`appropriate use of Betadine®, making sure the lashes
`are out of the way.
` Q. Okay. Would incorrect intravitreal
`administration also include using inappropriate
`forces to actually administer the injection into the
`eye?
` A. I don't have an opinion on the forces
`used to administer injections. In my personal
`experience, the forces for intravitreal injections
`that I use I can't differentiate between, but that's
`just my personal opinion.
` Q. Okay. Do you have an opinion as to
`whether if you used too much force in giving the
`injection or it would, it could result in medical
`complications?
` A. If done incorrectly, there can be
`complications. So too much volume, you know, I could
`imagine too much force, you know, banging on the eye
`of course would lead to complications, yes.
` Q. Okay. Do you know what a shelf life
`
` MR. DESAI: Objection; scope.
` A. So personally, you know, what I do
`personally is look at the expiration and if a drug is
`expired, I don't use it.
` Q. Okay. In the course of your
`practice, do you use medications that are not FDA
`approved?
` MR. DESAI: Objection; form.
` A. So, if you can just be more specific,
`you know, I think, yeah, more specific.
` Q. Sure. Well, let's, I guess let's
`talk about VEGF-antagonists for a moment.
` In your practice, are all the
`VEGF-antagonists that you use FDA approved?
` MR. DESAI: Objection; form.
` A. Once again, I think that I would need
`more clarification as to what you mean by FDA
`approved.
` Q. If you let me know what you need in
`terms of clarification, I'll try to do that.
` A. So, I'm not sure what you're trying
`to ask. You know, do I use what's on the label? Do
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`of a drug product means?
` A. No, I do not.
` Q. You've never heard that term?
` A. I think those are two different
`questions. So I have heard the term. I don't know
`what that means, though, in an expert way.
` Q. Okay. So as a doctor, just, in the
`course of your practice, do you have an understanding
`that drugs can remain on the shelf for a specific
`period of time before they need to stop being used?
` MR. DESAI: Objection; scope,
`relevance.
` A. So as a doctor and my personal, you
`know, use of medications, I look at the expiration
`date, and if it's before the expiration date, I use
`it. If it's on or after, I don't. But I don't do a
`mental calculus personally to think about what the
`shelf life would be.
` Q. All right. But it's your
`understanding, though, that you can use the drug
`product up until its expiration date and then you
`can't use it after that; is that correct?
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`I only use what the FDA says I should use? Do I use
`it for the, you know, the purpose that's on the
`label?
` You know, I can give you an example.
`This week I have a lady who has lymphoma, intraocular
`lymphoma. Intraocular methotrexate, intraocular use
`is not specifically on the label of methotrexate, but
`I did give it to her in order to save her sight.
` Q. Thank you for that, Dr. Kiss. Now I
`understand what the problem was with my question.
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` So I think based on your last answer,
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`is it correct to say that the drug products you use
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`are FDA approved for some purpose but that you as a
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` MR. DESAI: Objection; scope.
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` A. So, this is beyond sort of the scope
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`of my Declaration. So personally, there are things
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`that I do in my practice that do not specifically
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`follow a label of a medication.
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` Q. Understood. So my question now is:
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`Of the medications you use, have they been FDA
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`approved for some purpose?
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`Novartis Exhibit 2257.006
`Regeneron v. Novartis, IPR2021-00816
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`

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`Transcript of Szilard Kiss, M.D.
`Conducted on January 7, 2022
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` MR. DESAI: Objection; form, scope.
` A. So, you know, I have not done an
`analysis of that. I'm trying to be, you know,
`truthful and honest as possible, and so I'm trying to
`think.
` And my answer is I don't know. You
`know. I would have to really, you know, look at my
`practice to see which drugs I've used and what the
`FDA approval is and if it's FDA approved or not.
` Q. All right. You don't know whether as
`a physician, you can use drugs that have not been FDA
`approved?
` MR. DESAI: Objection; argumentative.
` You don't have to answer that
`question.
` MS. HOLLAND: I didn't think there
`was anything argumentative about it. I'm sorry if it
`came off that way so I'll try again.
`BY MS. HOLLAND:
` Q. Do you know one way or the other
`whether you are permitted as a physician to use
`drugs, products that do not have FDA approval for any
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`indication?
` MR. DESAI: Objection; scope.
` A. So this is beyond my level of
`expertise. That's why I said I would have to do more
`research.
` I will give you an example of which I
`don't know the answer to which is AREDS vitamins,
`right. I don't know what the definition of a drug is
`and I don't know whether AREDS vitamins for macular
`degeneration have been FDA approved. I know they are
`available, but I would be remiss in commenting
`whether I'm using AREDS vitamins for macular
`degeneration as per the FDA or if it has not gone
`under evaluation by the FDA.
` Q. All right. Let me ask you some
`different questions then. Do you agree that the
`FDA's approval of a treatment as being safe and
`efficacious is an important factor in deciding which
`treatment to use for a patient?
` MR. DESAI: Objection to form, scope.
` A. I think it's more complex than that.
` Q. Can you answer whether FDA's approval
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`of a treatment as being safe and efficacious is an
`important factor in deciding which treatment to use
`for a patient?
` MR. DESAI: Objection; form and
`scope.
` A. So, this is beyond my Declaration,
`but personally I do offer AREDS vitamins to patients
`and I'm not quite sure if the FDA has evaluated that.
`So if -- and I don't know, I would have to do more
`research. If the AREDS vitamins are not FDA
`approved, then I am recommending a non-FDA-approved
`vitamin for patients based on the AREDS 1 and AREDS 2
`studies.
` Q. That wasn't exactly my question, but
`maybe we can do it this way. Can you look in your
`box for your ITC deposition transcript?
` A. Would you mind letting me know what
`the --
` Q. It should just say ITC deposition
`transcript.
` MS. HOLLAND: Do you need that put up
`on the screen, Anish?
`
`24
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` THE WITNESS: Do you know which
`exhibit it is? Okay. There we go. It's not an
`exhibit. It's the ITC redacted, yeah.
` MR. DESAI: Give me a second to pull
`it up. I have it.
` Is this the redacted version,
`Elizabeth?
` MS. HOLLAND: Yeah, it should be.
`What I'm asking about is not, is not in the redacted
`part.
`0
` MR. DESAI: I know. I just want to
`11
`make sure I have the right copy up. That's all. So
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`give me a second and I'll --
`13
` MS. HOLLAND: Yeah, yeah, of course.
`14
` MR. DESAI: I got it. Let's see
`15
`here. There we go. I got it.
`16
`BY MS. HOLLAND:
`17
` Q. Dr. Kiss, can you turn to Page 287 of
`18
`the transcript?
`19
` A. Yes, just give me one moment. I
`20
`don't think -- there we go. I had the wrong one.
`21
`There we go.
`22
`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`Novartis Exhibit 2257.007
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`Transcript of Szilard Kiss, M.D.
`Conducted on January 7, 2022
`25
`
` Q. Okay. So if you're at Page 287, you
`can look at the question and answer on Lines 5 to 13.
`You can read that to yourself for a second, and then
`I have a question for you.
` A. I am just having trouble. 287 is
`like these little boxes is what the 287 is going to
`be under or?
` Q. Yeah. At the top it should say
`Page 72, and then it should say like 285 to 288.
` A. Okay. Yes. Sorry. Yes. Could you
`remind me which one you wanted me to review here at
`287?
` Q. Yeah, on Page 287 and then there's a
`question and answer on Lines 5 to 13.
` A. Yes.
` Q. All right. So, you were asked there:
`"On balance when you're determining what treatment to
`use with one of your patients, is the FDA's approval
`of a treatment as being safe and efficacious, is that
`an important factor for you in coming up with a
`course of treatment?"
` And you answered: "Yes, it is. It
`
`7 (25 to 28)
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`27
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`context of this IPR, you don't agree with that
`answer?
` MR. DESAI: Objection; form.
` A. So you asked if I agreed with this
`statement as stated here, and I do. The question you
`had asked me previously was in a different context,
`so...
` Q. I just want to make sure I understand
`your last answer. Are you trying to qualify that
`answer in some way, or are you saying that you just
`thought I was asking a different question previously?
` MR. DESAI: Objection; form.
` I don't know how you could possible
`answer that the way it was stated but go ahead and
`try.
` A. So you had asked me if FDA approval
`is important in general and I mentioned that I'm not
`sure if the AREDS vitamins are approved, but I still,
`you know, ask patients to take it or recommend it.
`In the context of a deposition, we were talking about
`not in general FDA but very specific to that case.
` Q. What do you mean by that?
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`is. It's an important factor. Not the only factor,
`but an important factor, yes."
` And I just want to make sure you
`still agree with the testimony you gave there?
` A. So I think that there are two
`different questions here. I do agree with that
`testimony, yes.
` Q. Thank you.
` A. But I think just to put it into
`context, this was in a different context in a
`different deposition, and the context we were talking
`about here was very different than the question that
`you asked me.
` Q. That's fine. I just wanted to make
`sure you still agreed with your answer. And you said
`you did, right?
` A. Yes.
` Q. Okay.
` A. In the context -- wait, but in the
`context of this deposition, in the context of this
`particular case that where the deposition was taken.
` Q. Are you saying that you, in the
`
` A. You took a quote that I agree with
`from the transcript and tried to apply it to what I'm
`saying today. And what I am -- what I mean by that
`is I fully stand by my transcript, and I fully stand
`by what I'm saying today, because they are different
`situations based on --
` Q. Well, how did -- how do you
`understand the situations to be different?
` A. The question that I was asked by you
`was whether FDA approval is important and the example
`0
`I gave where I'm not sure if it is FDA approved or
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`not is AREDS vitamins and AREDS supplements are used
`12
`to decrease the risk of macular degeneration. And so
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`there, you know, if it is not FDA approved, it would
`14
`not be important.
`15
` Q. So I'm sorry I have to go back to
`16
`this, but I do because of your qualification. So is
`17
`it true, as you testified, that when you're
`18
`determining a treatment to use with your patients,
`19
`FDA approval is an important factor but not the only
`20
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`21
` A. Personally FDA approval is part of
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`PLANET DEPOS
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`Novartis Exhibit 2257.008
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`Transcript of Szilard Kiss, M.D.
`Conducted on January 7, 2022
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`the calculus, yes, if necessary.
` Q. Do you have a problem answering that
`it's an important factor?
` MR. DESAI: Objection; argumentative.
` A. When it comes to AREDS vitamins, no.
` Q. Okay. When you were thinking about a
`course of treatment for your patient, as asked in
`your transcript from February 22, 2021, is it an
`important factor that the FDA has approved the
`treatment as safe and efficacious?
` A. If you could be more specific about
`the course of treatment.
` Q. Do you not -- what don't you
`understand by course -- about course of treatment?
` A. So I give a course of treatment of
`AREDS vitamins to patients, and like I said, I'm not
`sure if they are FDA approved, but there, it is not
`important. So that is a course of treatment, where
`FDA approval does not come into my personal calculus
`of giving or recommending patients medication.
` Q. That still didn't answer my question.
`Let me try this again.
`
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`already. If you'd like to read it in, that's fine.
`I don't -- if all you want is to have that testimony
`that he said in the record, then fine. Read it in.
` MS. HOLLAND: I believe I did read it
`in already.
` MR. DESAI: Then why don't we move
`on?
` MS. HOLLAND: Because the issue is
`that Dr. Kiss seems to think that there is some
`qualification to that testimony which doesn't appear
`in the transcript, so...
`BY MS. HOLLAND:
` Q. Dr. Kiss, why don't you -- well, let
`me withdraw that.
` All right. Well, I'm going to ask a
`different question. Do you use a drug called
`Avastin® on your -- with your patients who have --
`who regular VEGF-antagonist?
` MR. DESAI: Objection; form.
` A. In what context would I use that?
` Q. Do you use Avastin® to give
`injections to patients who require a VEGF-antagonist
`32
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`30
` MR. DESAI: Elizabeth, it did answer
`for macular degeneration, for example?
` A. During what time course? Ever?
`your question, but if you want to try for the tenth
`time to ask the same thing, we can keep going.
` Q. Currently?
` A. Currently, no.
` MS. HOLLAND: I wouldn t have to try
`for the tenth time if there wasn t a qualification to
` Q. Okay. And is it correct that some of
`a very simple Q and A from a deposition. So I m
`your patients would be unwilling to use Avastin®
`going to try again.
`because it's not been approved by the FDA for the
` MR. DESAI: It s not as simple as it
`treatment of macular degeneration, for example?
`seems to you, but it is -- Dr. Kiss obviously has --
` MR. DESAI: Objection; scope.
`doesn t view it as simple as you do.
` Can I ask, Elizabeth, what the
`0
` MS. HOLLAND: Can we mark -- I m
`relevance to Avastin® is to his IPR Declaration?
`11
`sorry, can we mark this deposition transcript?
` MS. HOLLAND: The relevance is I'm
`12
` MR. DESAI: No. I don t think we ve
`trying to understand his previous answers to my
`13
`agreed to use this, but if you want to have an
`questions.
`14
`agreement to use depositions from ITC case, we can
` MR. DESAI: That is not relevance to
`15
`discuss that. I m not going to do it on an
`his IPR Declaration. Can you articulate why you
`16
`individual basis.
`think Avastin® is relevant to his IPR Declaration?
`17
` MS. HOLLAND: All right. Well, I m
` MS. HOLLAND: Dr. Kiss has testified
`18
`assuming if we re not doing it here, we re not doing
`about the obviousness of a method of treatment claim,
`19
`it at all. So that s fine.
`so his methods of treating patients is relevant.
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` MR. DESAI: That s not a fair
` MR. DESAI: I think you can answer.
`21
`assumption either, but you ve read the testimony in
`Avastin®.
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`Novartis Exhibit 2257.009
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`Transcript of Szilard Kiss, M.D.
`Conducted on January 7, 2022
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` A. So personally, and, you know, beyond
`the scope of 24, 25 and 26 of the '631 patent, the
`biggest reason I don't recommend using Avastin® is it
`doesn't work as well.
` Q. Okay. Can you please answer my
`question, Doctor? It's going to go a lot more
`quickly if you can.
` Is one of the reasons you don't use
`it that it is not FDA approved?
` MR. DESAI: Objection.
` You've answered the question. You
`should answer the question how you see fit, okay? So
`go ahead and answer again.
` A. The main reason that I don't use
`Avastin® is the efficacy for intraocular treatments
`of diseases related to ocular neovascularization.
` Q. Can you answer one way or the other
`whether the fact that it is not FDA approved for
`those indications is a factor?
` A. For use of intraocular Avastin®?
` Q. Yes.
` A. It can be a factor.
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