Michael J. Miller, Ph.D.
`
`3/16/2022
`Page 1
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` ____________________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ____________________
`
` REGENERON PHARMACEUTICALS, INC.,
`
` Petitioner
`
` v.
`
`NOVARTIS PHARMA AG, NOVARTIS TECHNOLOGY LLC, NOVARTIS
`
` PHARMACEUTICALS CORPORATION,
`
` Patent Owners.
`
` ____________________
`
` Case IPR2021-00816
`
` Patent Number 9,220,631
`
` ____________________
`
` Deposition via Zoom of MICHAEL J. MILLER,
`Ph.D., a witness herein, called for examination by
`counsel for Petitioner in the above-entitled matter,
`pursuant to notice, the witness being duly sworn by
`MARY GRACE CASTLEBERRY, a Notary Public in and for
`the State of Maryland, taken at 9:31 a.m. EDT,
`Wednesday, March 16, 2022, and the proceedings being
`taken down by Stenotype by MARY GRACE CASTLEBERRY,
`RPR, and transcribed under her direction.
`
`
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1210.001
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`3/16/2022
`Page 1
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` ____________________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ____________________
`
` REGENERON PHARMACEUTICALS, INC.,
`
` Petitioner
`
` v.
`
`NOVARTIS PHARMA AG, NOVARTIS TECHNOLOGY LLC, NOVARTIS
`
` PHARMACEUTICALS CORPORATION,
`
` Patent Owners.
`
` ____________________
`
` Case IPR2021-00816
`
` Patent Number 9,220,631
`
` ____________________
`
` Deposition via Zoom of MICHAEL J. MILLER,
`Ph.D., a witness herein, called for examination by
`counsel for Petitioner in the above-entitled matter,
`pursuant to notice, the witness being duly sworn by
`MARY GRACE CASTLEBERRY, a Notary Public in and for
`the State of Maryland, taken at 9:31 a.m. EDT,
`Wednesday, March 16, 2022, and the proceedings being
`taken down by Stenotype by MARY GRACE CASTLEBERRY,
`RPR, and transcribed under her direction.
`
`
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1210.001
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Michael J. Miller, Ph.D.
`
`3/16/2022
`Page 2
`
`APPEARANCES:
`
` On behalf of the Petitioner:
`
` CHRISTOPHER M. PEPE, ESQ.
`
` Weil, Gotshal & Manges
`
` 2001 M Street, N.W., Suite 600
`
` Washington, D.C. 20036
`
` (202) 682-7000
`
` christopher.pepe@weil.com
`
` and
`
` ELIZABETH S. WEISWASSER, ESQ.
`
` NATALIE C. KENNEDY, ESQ.
`
` Weil, Gotshal & Manges
`
` 767 Fifth Avenue
`
` New York, New York 10153
`
` (212) 310-8000
`
` elizabeth.weiswasser@weil.com
`
` natalie.kennedy@weil.com
`
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`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1210.002
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Michael J. Miller, Ph.D.
`
`3/16/2022
`Page 3
`
`APPEARANCES (Continued):
`
` On behalf of the Petitioner:
`
` JAMES TORI EVANS, ESQ.
`
` Axinn, Veltrop & Harkrider LLP
`
` 114 West 47th Street
`
` New York, New York 10036
`
` and
`
` PETRA SCAMBOROVA, ESQ.
`
` Regeneron Pharmaceuticals, Inc.
`
` 777 Old Saw Mill River Road
`
` Tarrytown, New York 10591
`
` On behalf of the Patent Owner:
`
` ELIZABETH J. HOLLAND, ESQ.
`
` Allen & Overy
`
` 1221 Avenue of the Americas
`
` New York, New York 10020
`
` (212) 610-6365
`
` eholland@allenovery.com
`
` nmitrokostas@goodwinlaw.com
`
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`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1210.003
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Michael J. Miller, Ph.D.
`
`3/16/2022
`Page 4
`
` C O N T E N T S
`
`WITNESS EXAMINATION ON BEHALF OF
`
`MICHAEL MILLER, Ph.D. PETITIONER PATENT OWNER
`
` BY MR. PEPE 6
`
` BY MS. HOLLAND 137
`
` BY MR. PEPE 154
`
` BY MS. HOLLAND 158
`
` BY MR. PEPE 160
`
` Afternoon Session - Page 120
`
` E X H I B I T S
`
`EXHIBIT NO. PAGE
`
`1001 - United States Patent Number 9,220,631 27
`
`1007 - International Publication Number WO
`
` 2011/006877 (Sigg) 67
`
`1029 - International Publication Number WO
`
` 2008/077155 (Lam) 105
`
`2056 - Document entitled Scientific Discussion 122
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`22
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`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1210.004
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Michael J. Miller, Ph.D.
`
`3/16/2022
`Page 5
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` E X H I B I T S (Continued):
`
`EXHIBIT NO. PAGE
`
`
`
`
`
`
`
`
`
`
`
` 135
`
` 134
`
`2138 - PowerPoint entitled Lucentis - Pre-Filled
`
` Syringes, Pharmaceutical Development
`
` Aspects, December 17, 2007 130
`
`
`
` 101
`
`2187 - ANSI/AAMI ST67:2011 61
`
`2188 - ISO 14161 54
`
`2190 - Aseptic Process of Diced Tomatoes by
`
` Bash and Gould 126
`
`2203 - Declaration of Michael J. Miller, Ph.D.
`
` In Support of Novartis's Patent Owner
`
` Response 14
`
`2206 - Declaration of Dr. Sigg 100
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1210.005
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Michael J. Miller, Ph.D.
`
`3/16/2022
`Page 6
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` P R O C E E D I N G S
`
`Whereupon,
`
` MICHAEL J. MILLER, Ph.D.,
`
`was called as a witness by counsel for Petitioner,
`
`and having been duly sworn by the Notary Public, was
`
`examined and testified as follows:
`
` EXAMINATION BY COUNSEL FOR PETITIONER
`
`BY MR. PEPE:
`
` Q. Good morning, Dr. Miller. You understand
`
`that you are here today for a deposition as part of
`
`IPR 2021-00816?
`
` A. Yes.
`
` Q. And this IPR relates to US Patent Number
`
`9,220,631. Do you understand that?
`
` A. Yes.
`
` Q. Have you ever been deposed before?
`
` A. Yes, I have.
`
` Q. How many times have you been deposed
`
`before?
`
` A. Approximately a dozen times.
`
` Q. So I'll just briefly walk through how
`
`things are going to work today just to give you a
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1210.006
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Michael J. Miller, Ph.D.
`
`3/16/2022
`Page 7
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`little refresh.
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` So we have a court reporter here who's
`
`writing everything down for us. So it's really
`
`important that when I'm talking, you wait until I
`
`finish with my questions. And then when you are
`
`answering your questions, I will wait until you're
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`finished before I ask my next question.
`
` Does that sound good?
`
` A. Yes, it does.
`
` Q. Okay. Now, if you don't understand a
`
`question that I ask you, don't hesitate to let me
`
`know that and I'll do my best to rephrase it to ask a
`
`question that you do understand.
`
` Is that okay?
`
` A. Yes, it is.
`
` Q. And in general, we'll probably take breaks
`
`about once an hour. If, however, you need a break
`
`before an hour approaches, just let me know. The
`
`only thing I would ask is that if there's a question
`
`pending, you answer it before we go on break.
`
` Does that sound good?
`
` A. Understood.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1210.007
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Michael J. Miller, Ph.D.
`
`3/16/2022
`Page 8
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` Q. Is there any reason you wouldn't be able
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`to testify truthfully today?
`
` A. No.
`
` Q. Now, you just mentioned you have been
`
`deposed about 12 times before. Were those all with
`
`respect to patent cases?
`
` A. No. I've been deposed on a number of
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`product liability cases as well.
`
` Q. Do you recall, of the depositions you've
`
`had, how many of those have been patent cases?
`
` A. I'd have to go back to my CV to take an
`
`actual count. But from a percentage standpoint, I
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`would say at least 60 percent were associated with
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`patents.
`
` Q. And do you recall generally the subject
`
`matter of what those patents involved?
`
` A. I do generally, yes.
`
` Q. And what were they?
`
` A. A number of patents were related to
`
`ophthalmic products and the manner in which they were
`
`preserved. There were two cases I worked on in which
`
`I opined on an active pharmaceutical ingredient,
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1210.008
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Michael J. Miller, Ph.D.
`
`3/16/2022
`Page 9
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`budesonide, that was used to make a Pulmicort type
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`product and I opined on sterilization processes
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`associated with that material.
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` And I recall another case I was deposed
`
`and testified at trial. This was also a preserved
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`pharmaceutical product as well. I just don't recall
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`the specifics. But generally, those are the topics
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`associated with those cases.
`
` Q. And for the case involving ophthalmic
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`products, do you recall what the product was?
`
` MS. HOLLAND: Let me just interrupt for a
`
`second. If this is not public information, then --
`
`and it's confidential and under a confidentiality
`
`agreement, please don't give that information.
`
` THE WITNESS: Right. The ophthalmics -- I
`
`mean, they were topically applied ophthalmic drops.
`
`I just don't recall specifically what products they
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`were associated with.
`
`BY MR. PEPE:
`
` Q. So it was not an ophthalmic product that
`
`was administered via a syringe?
`
` A. To my knowledge, that is correct.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1210.009
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Michael J. Miller, Ph.D.
`
`3/16/2022
`Page 10
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` Q. Now, with respect to the sterilization
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`case, do you recall, if you're able to tell me, what
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`the sterilization process was that was at issue?
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` A. Yes. That one I probably can't get too
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`specific because that was under court order and I
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`don't know what my obligations are today on that.
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` MR. PEPE: Elizabeth, is there a way for
`
`you to get on the camera? I think you're going to
`
`need to be visible on the camera for these.
`
` MS. HOLLAND: Because -- I mean, I can
`
`try.
`
` MR. PEPE: Okay.
`
` MS. HOLLAND: Do you see me now? I can't
`
`really move the table or anything.
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` MR. PEPE: If you're going to be in the
`
`room with him, I need to be able to see what you're
`
`doing as well so I can see both of you.
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` MS. HOLLAND: Is this good enough?
`
` MR. PEPE: Yeah, that's fine.
`
` MS. HOLLAND: Okay.
`
`BY MR. PEPE:
`
` Q. And in terms of trial testimony, you've
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1210.010
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Michael J. Miller, Ph.D.
`
`3/16/2022
`Page 11
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`testified in patent cases at trial once; is that
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`right?
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` A. I testified for the budesonide case, I
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`testified in the initial trial, I also testified at
`
`the appeal. And there was a third patent case that I
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`testified in the initial trial. This would have
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`been, I believe, the United Therapeutics case that I
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`was involved in.
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` Q. Now, with respect to this particular
`
`matter, when were you retained by Novartis?
`
` A. I may have been retained in 2021. I just
`
`can't remember the exact date.
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` Q. Now, prior to your engagement in this
`
`matter in 2021, have you done any prior consulting
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`work for Novartis?
`
` A. There is a possibility that I did some
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`minor consulting with Novartis on an alternative
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`microbiology method for the microbiology laboratory,
`
`but I don't recall when that actually occurred. But
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`it was very minimal work, if at all.
`
` Q. Now, with respect to this deposition, what
`
`did you do to prepare?
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1210.011
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Michael J. Miller, Ph.D.
`
`3/16/2022
`Page 12
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` A. I reviewed my declaration and reviewed
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`some of the exhibits that I relied on in my
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`declaration.
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` Q. Did you have any meetings with counsel in
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`advance of the deposition?
`
` A. I did.
`
` Q. When did that take place?
`
` A. This took place yesterday with Elizabeth
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`Holland.
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` Q. Any other meetings?
`
` A. No.
`
` Q. Now, with respect to your work on this
`
`matter, are you being compensated by Novartis?
`
` A. I am being compensated. It's not directly
`
`by Novartis. I've been retained through a third
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`party, IMS.
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` Q. And do you know what your billing rate is
`
`for this matter?
`
` A. What IMS is billing, the third party? I
`
`don't recall what that is.
`
` Q. What is the amount that you receive from
`
`IMS on an hourly rate for this matter?
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1210.012
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Michael J. Miller, Ph.D.
`
`3/16/2022
`Page 13
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` A. For this matter, $800 per hour.
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` Q. And to date, do you know how many hours
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`you've billed?
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` A. No, I don't recall what that is.
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` Q. Have you submitted bills so far or
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`invoices?
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` A. I have. I have submitted two invoices to
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`IMS to date.
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` Q. Can you estimate whether it's more or less
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`than 50 hours?
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` A. I believe it's less than 50 hours. But,
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`again, I'd have to go back to the actual invoices to
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`understand that.
`
` Q. Now, with respect to the other litigation
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`matters that you have worked on, have you been
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`retained through IMS before?
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` A. No, I haven't.
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` Q. Okay. So this was the first time you've
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`been retained through IMS for litigation consulting?
`
` A. Yes, that's correct.
`
` Q. And presently, is consulting your
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`full-time profession?
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1210.013
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Michael J. Miller, Ph.D.
`
`3/16/2022
`Page 14
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` A. Yes.
`
` Q. And can you approximate what percentage of
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`that time is spent on litigation consulting?
`
` A. I would have to look at a specific time
`
`frame. If I look at the last 12 months, the amount
`
`toward litigation is relatively small, I would say 10
`
`percent or less.
`
` Q. Now, you should have -- why don't we take
`
`out the first exhibit, which is Exhibit 2203.
`
` MS. HOLLAND: Okay. Do you want me to
`
`hand that to Dr. Miller?
`
` MR. PEPE: Sure.
`
` (Exhibit No. 2203 was identified for
`
` the record.)
`
`BY MR. PEPE:
`
` Q. Dr. Miller, you've just been handed
`
`Exhibit 2203. Do you recognize that to be a copy of
`
`the declaration you submitted in this proceeding?
`
` A. Yes, it is.
`
` Q. Are all the pages there?
`
` A. They appear to be.
`
` Q. So in your declaration, you explain that
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1210.014
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Michael J. Miller, Ph.D.
`
`3/16/2022
`Page 15
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`you worked at Advanced Sterilization Products from
`
`1988 to 1991. And that's in paragraph 6 of your
`
`declaration if you want to get pointed there.
`
` A. Yes, that is correct.
`
` Q. And while at ASP, you did some work
`
`related to sterilization methods; is that right?
`
` A. Yes, that's correct.
`
` Q. Now, in your time at ASP, did you do any
`
`work on sterilization methods with respect to drug
`
`products?
`
` A. No, not on drug products.
`
` Q. And so with respect to your time at ASP,
`
`the sterilization work you were doing was related to
`
`medical devices; is that right?
`
` A. In some cases, medical devices; in other
`
`cases, hospital instrumentation. And the reason for
`
`that was this was ASP's primary focus on developing
`
`the technology and commercializing it.
`
` Q. And in your time at ASP, did you do any
`
`work with respect to sterilization of prefilled
`
`syringes?
`
` A. No. At that time that was out of scope
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1210.015
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Michael J. Miller, Ph.D.
`
`3/16/2022
`Page 16
`
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`for the work in developing the technology.
`
` Q. And then after you left ASP, you went to
`
`work at Bausch & Lomb from 1991 to 2002, correct?
`
` A. Yes.
`
` Q. And you state in your declaration that you
`
`worked on sterilization of ophthalmic products while
`
`at Bausch & Lomb; is that right?
`
` A. Yes, that's correct.
`
` Q. And while you were there, did you work on
`
`the development of sterilization methods for
`
`ophthalmic drug products?
`
` A. Yes.
`
` Q. Can you recall what drug products you
`
`worked on?
`
` A. Not specifically. They were fairly wide
`
`range. They included all sterile topical products
`
`that was manufactured from Bausch & Lomb's
`
`pharmaceutical division as well as all of the sterile
`
`contact lens care products manufactured in the
`
`contact lens care division.
`
` So it was a combination of a variety of
`
`different modalities for the ophthalmic medicines
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1210.016
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Michael J. Miller, Ph.D.
`
`3/16/2022
`Page 17
`
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`that Bausch & Lomb at the time were developing and
`
`manufacturing.
`
` Q. So when you say "topical products," were
`
`you working on the development of sterilization
`
`methods for any drug products that were injected into
`
`the eye?
`
` A. I may have. I just can't remember what
`
`injectable ophthalmics Bausch & Lomb was making at
`
`the time and what products were coming into my
`
`laboratory.
`
` Q. So you can't recall one way or the other
`
`whether you worked on any of the injectable products?
`
` A. That's correct.
`
` Q. And similarly, while at Bausch & Lomb, do
`
`you recall whether you worked on any prefilled
`
`syringe drug products?
`
` A. I can't recall if I worked on prefilled
`
`syringe products at the time.
`
` Q. And while at Bausch & Lomb, did you do any
`
`work with respect to terminal sterilization of drug
`
`products?
`
` A. Yes.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1210.017
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Michael J. Miller, Ph.D.
`
`3/16/2022
`Page 18
`
` 1
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` Q. And those were topical products?
`
` A. These were either topical or injectable or
`
`topical applied with contact lens care products. So
`
`it was both contact lens care and traditional
`
`ophthalmic pharmaceuticals.
`
` Q. And you just said in your answer that it
`
`was injectables, but previously you had said you
`
`weren't sure if you worked on injectables. Can you
`
`clarify what you meant by injectables?
`
` A. Well, yes. I can recall there were both
`
`topical and injectable products being developed at
`
`Bausch & Lomb at the time I was there. I just can't
`
`recall specific injectable products or brand names
`
`that I might have worked on. A lot of the topical
`
`products I can't remember the names either.
`
` So I may have worked on both topicals and
`
`injectables that the company was working on at the
`
`time and that would have included sterilization,
`
`aseptic processing and internal sterilization
`
`processes.
`
` Q. Now, after you left Bausch & Lomb in 2002,
`
`you went to work at Pharmaceutical Systems, Inc.; is
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1210.018
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Michael J. Miller, Ph.D.
`
`3/16/2022
`Page 19
`
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`that right?
`
` A. Yes, that's correct.
`
` Q. And is Pharmaceutical Systems, Inc. a
`
`consulting company?
`
` A. It was a consulting company at the time,
`
`yes.
`
` Q. Was it your consulting company?
`
` A. No, it wasn't. I was hired to work in a
`
`consulting and a management role at that company.
`
` Q. Now, while you worked at Pharmaceutical
`
`Systems, Inc., did you work on any ophthalmic
`
`products?
`
` A. I do not recall working on ophthalmic
`
`products during that time.
`
` Q. Did you do any work regarding terminal
`
`sterilization of drug products while you were there?
`
` A. Yes, I did.
`
` Q. What types of drug products, do you
`
`recall?
`
` A. Well, these were fairly wide range. Most
`
`of the sterile drug products would have been
`
`introduced intravenously or intramuscularly. So
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1210.019
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Michael J. Miller, Ph.D.
`
`3/16/2022
`Page 20
`
` 1
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`there was a wide range of products and applications.
`
`And I did work on aseptic processing as well as
`
`terminal sterilization of components used in the
`
`aseptic processing procedures.
`
` Q. When you say terminal sterilization of
`
`components, do you mean components before they were
`
`filled with a drug product?
`
` A. Yes, that is correct.
`
` Q. So with respect to components, you would
`
`call that terminal sterilization as well?
`
` A. Yeah. These would be using conventional
`
`terminal sterilization type processes, which could
`
`include moist heat, dry heat, ethylene oxide, even
`
`radiation sterilization.
`
` Q. Okay. But you would consider it terminal
`
`sterilization of the components even though there's
`
`no drug product in the components at that point?
`
` A. Well, in those instances, the term
`
`"terminal sterilization" in the industry had -- in
`
`some cases had been applied toward the use of the
`
`same types of sterilization technologies to reach a
`
`10 to the minus 6 sterility level of components as
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1210.020
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Michael J. Miller, Ph.D.
`
`3/16/2022
`Page 21
`
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`well.
`
` So this -- the term "terminal
`
`sterilization" has been used in the industry to
`
`describe both the final sterilization of drug product
`
`in its finished primary container, but that term has
`
`also been used by some in the industry as the
`
`sterilization steps used in the components that could
`
`be used in processes such as aseptic filling.
`
` Q. Now, in your time at Pharmaceutical
`
`Systems, did you do any work with respect to
`
`sterilization processes for terminal sterilization of
`
`a prefilled syringe that already had the drug product
`
`in it?
`
` A. I don't recall working in that area during
`
`my time at PSI.
`
` Q. And because I think you may have been
`
`using slightly different nomenclature, I'm going to
`
`ask that question more generally with respect to your
`
`work at ASP and Bausch & Lomb.
`
` Did you do any work at either of those
`
`companies related to terminal sterilization of drug
`
`products that were already in their primary
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1210.021
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Michael J. Miller, Ph.D.
`
`3/16/2022
`Page 22
`
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`packaging?
`
` A. Yes, I did.
`
` Q. And just to be clear, we're talking about
`
`a drug product having been filled in its primary
`
`packaging and then sterilized, right?
`
` A. That is correct.
`
` Q. And with respect to your work at -- and
`
`that would have occurred at Bausch & Lomb, correct?
`
` A. Yes, correct.
`
` Q. And you didn't do that work at ASP,
`
`correct?
`
` A. No, I did not do the work at ASP.
`
` Q. And so with respect to the work at Bausch
`
`& Lomb, what were the methods of sterilization that
`
`were used to terminally sterilize drug products that
`
`were already in their primary packaging?
`
` A. Yes. Primarily that work would have been
`
`around radiation sterilization of saline products in
`
`their final containers.
`
` Q. Are there any other types of sterilization
`
`methods you used at Bausch & Lomb with respect to
`
`sterilizing a drug product after it had been put in
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1210.022
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Michael J. Miller, Ph.D.
`
`3/16/2022
`Page 23
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`its primary packaging?
`
` A. As I recall, most of the drug products, if
`
`they were not terminally sterilized using radiation,
`
`they were aseptically filled. That being said, I did
`
`work on a number of medical devices that would have
`
`been terminally sterilized in their final containers
`
`using other types of sterilization methods.
`
` Q. And what were those other methods?
`
` A. Those other methods would have included
`
`moist heat sterilization. I recall some work with
`
`ethylene oxide as well.
`
` Q. So with respect to your time at Bausch &
`
`Lomb, did you do any work on terminal sterilization
`
`of drug products after they were put in their primary
`
`packaging using either ethylene oxide or hydrogen
`
`peroxide?
`
` A. The answer is yes. I can't recall the
`
`products with ethylene oxide. I do recall additional
`
`work that we were working on with vaporized hydrogen
`
`peroxide or VHP and hard contact lenses. The
`
`ethylene oxide might have also been used looking at
`
`next generation hard contact lenses as well, but I
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1210.023
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Michael J. Miller, Ph.D.
`
`3/16/2022
`Page 24
`
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`just do not recall specifically what those products
`
`were.
`
` Q. So my question was about using either
`
`ethylene oxide or hydrogen peroxide to terminally
`
`sterilize a drug product in its primary packaging,
`
`right? You only mentioned contact lenses in that
`
`previous answer.
`
` So with respect to drug products that were
`
`already in their primary packaging, did you do any
`
`work with terminal sterilization using either
`
`vaporized hydrogen peroxide or ethylene oxide while
`
`you were at Bausch & Lomb?
`
` A. No, I don't recall that.
`
` Q. Okay. Thank you.
`
` So if we move on, after you left
`
`Pharmaceutical Systems, Inc., you went to work at Eli
`
`Lilly in 2003; is that correct?
`
` A. Yes, that's correct.
`
` Q. And while you were at Eli Lilly, did you
`
`work on sterilization methods for drug products?
`
` A. Yes, I did.
`
` Q. And what types of drug products were
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1210.024
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Michael J. Miller, Ph.D.
`
`3/16/2022
`Page 25
`
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`those?
`
` A. Well, these included large molecule drug
`
`products such as insulin and human growth hormone as
`
`well as small molecule products which would have been
`
`in some cases also presented as a sterile
`
`preparation.
`
` Q. And the sterilization you did on drug
`
`products at Eli Lilly, was that with respect to drug
`
`products that had already been placed in their
`
`primary packaging?
`
` A. Most of the products that I worked with
`
`were aseptically filled. So the aseptic processing
`
`technique would have involved the aseptic addition of
`
`the drug product into previously sterilized
`
`containers, but those containers were not
`
`subsequently terminally sterilized with the drug
`
`product in the containers.
`
` Q. And while you were at Eli Lilly, did you
`
`work on the sterilization of any prefilled syringes
`
`after the drug product had been filled into the
`
`syringe?
`
` A. I did work on sterilization processes of
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1210.025
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Michael J. Miller, Ph.D.
`
`3/16/2022
`Page 26
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`prefilled syringe manufacturing areas, preparing
`
`those barrier isolators for the filling process, but
`
`I don't recall working on any terminal sterilization
`
`of prefilled syringes as a final step.
`
` Q. And you subsequently left Eli Lilly in
`
`2009, correct?
`
` A. That's correct.
`
` Q. And since you left Eli Lilly, you've been
`
`working as president of Microbiology Consultants; is
`
`that right?
`
` A. Yes, that is correct.
`
` Q. And that's your own consulting company?
`
` A. Yes.
`
` Q. In your time at Microbiology Consultants,
`
`have you done any work on sterilization methods for
`
`prefilled syringes that already have the drug
`
`products in place when the sterilization process
`
`takes place?
`
` A. No, I have not.
`
` Q. Have you worked on any terminal
`
`sterilization projects since 2009 in any type of
`
`container where the drug product is already in the
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1210.026
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Michael J. Miller, Ph.D.
`
`3/16/2022
`Page 27
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`container when the sterilization takes place?
`
` A. I may have. I just don't recall any
`
`specific project working in that area.
`
` Q. Now, I'd like you to take a look at your
`
`declaration and if you can go to paragraph 26.
`
` A. I'm there.
`
` Q. And in paragraph 26, you reproduce the
`
`definition of a person of ordinary skill in the art.
`
` Do you see that?
`
` A. I do.
`
` Q. And just to be clear, this is a definition
`
`that was provided to you, correct?
`
` A. Yes, it was.
`
` (Exhibit No. 1001 was identified for
`
` the record.)
`
`BY MR. PEPE:
`
` Q. Now, why don't we take out another
`
`exhibit. Take out Exhibit 1001.
`
` A. I have it.
`
` Q. Dr. Miller, you have Exhibit 1001, which
`
`is U.S. Patent Number 9,220,631?
`
` A. Yes.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1210.027
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`Michael J. Miller, Ph.D.
`
`3/16/2022
`Page 28
`
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` Q. Now, did you review the '631 patent as
`
`part of your analysis?
`
` A. Yes, I did.
`
` Q. When was the first time you reviewed the
`
`'631 patent?
`
` A. I don't recall the date. This would have
`
`been after I was retained by counsel.
`
` Q. Now, if we go back to your declaration,
`
`the definition of a person of ordinary skill, and you
`
`see there is -- the first sentence in the definition
`
`sets forth educational requirements and design
`
`experience with respect to a PFS and/or the
`
`development of ophthalmic drug products or drug
`
`delivery devices.
`
` Do you see that?
`
` A. I do.
`
` Q. And then the next sentence says, "Such a
`
`person would have been a member of a product
`
`development team and would have drawn upon
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