James E. Malackowski
`
`3/29/2022
`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 JAMES E.
`MALACKOWSKI, 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 10:30 a.m.
`EDT, Tuesday, March 29, 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 1172.001
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`3/29/2022
`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 JAMES E.
`MALACKOWSKI, 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 10:30 a.m.
`EDT, Tuesday, March 29, 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 1172.001
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`James E. Malackowski
`
`3/29/2022
`Page 2
`
`APPEARANCES:
`
` On behalf of the Petitioner:
`
` ROBERT T. VLASIS, ESQ.
`
` Weil, Gotshal & Manges
`
` 2001 M Street, N.W., Suite 600
`
` Washington, D.C. 20036
`
` (202) 682-7000
`
` robert.vlasis@weil.com
`
` and
`
` CALEB SMALL, ESQ.
`
` Weil, Gotshal & Manges
`
` 767 Fifth Avenue
`
` New York, New York 10153
`
` (212) 310-8000
`
` caleb.small@weil.com
`
` and
`
` JAMES TORI EVANS, ESQ.
`
` Axinn, Veltrop & Harkrider LLP
`
` 114 West 47th Street
`
` New York, New York 10036
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`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1172.002
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`James E. Malackowski
`
`3/29/2022
`Page 3
`
`APPEARANCES (Continued):
`
` On behalf of the Petitioner:
`
` PETRA SCAMBOROVA, ESQ.
`
` Regeneron Pharmaceuticals, Inc.
`
` 777 Old Saw Mill River Road
`
` Tarrytown, New York 10591
`
` On behalf of the Patent Owners:
`
` JOHN T. BENNETT, ESQ.
`
` Allen & Overy
`
` 1 Beacon Street
`
` Boston, Massachusetts 02108
`
` (857) 353-4500
`
` john.bennett@allenovery.com
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`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1172.003
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`James E. Malackowski
`
`3/29/2022
`Page 4
`
` C O N T E N T S
`
`WITNESS EXAMINATION BY COUNSEL FOR
`
`JAMES E. MALACKOWSKI PETITIONER
`
` BY MR. VLASIS 5
`
` E X H I B I T S
`
`EXHIBIT NO. PAGE
`
`2205 - Declaration of James E. Malackowski
`
` In Support of Patent Owner Response 5
`
`2124 -
`
`
`
` - - -
`
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`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1172.004
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`James E. Malackowski
`
`3/29/2022
`Page 5
`
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` P R O C E E D I N G S
`
`Whereupon,
`
` JAMES E. MALACKOWSKI,
`
`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. VLASIS:
`
` Q. Good morning, Mr. Malackowski.
`
` A. Good morning, sir.
`
` Q. You can confirm there's nothing up on your
`
`computer other than the Weil cloudshare and Zoom?
`
` A. Correct.
`
` Q. And you don't have any notes with you?
`
` A. No. I do have a hard copy of my
`
`declaration, but it has no notes or highlighting.
`
` Q. And do you have any other documents with
`
`you?
`
` A. I do not.
`
` Q. Is there anyone in the room with you?
`
` A. There is not.
`
` (Exhibit No. 2205 was identified for
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1172.005
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`James E. Malackowski
`
`3/29/2022
`Page 6
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` the record.)
`
` MR. VLASIS: Caleb, why don't we display
`
`Mr. Malackowski's declaration. It's Exhibit 2205.
`
`BY MR. VLASIS:
`
` Q. And Jim, do you prefer to look at it on
`
`the screen or would you rather just look at your hard
`
`copy?
`
` A. I think the hard copy will be easier for
`
`everyone.
`
` Q. Okay. Why don't we just take it off,
`
`then. So Exhibit 2205 is -- this is your
`
`declaration, Mr. Malackowski?
`
` A. Yes, sir.
`
` Q. And did you author this declaration?
`
` A. Yes, sir, with help from my team at Ocean
`
`Tomo.
`
` Q. Could you refer to page 30 of your
`
`declaration?
`
` A. Yes, sir.
`
` Q. And is that your signature?
`
` A. It is.
`
` Q. Does your declaration, Exhibit 2205,
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1172.006
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`James E. Malackowski
`
`3/29/2022
`Page 7
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`represent your complete opinion in these proceedings
`
`to date?
`
` A. Yes, certainly with respect to the subject
`
`matter identified in the declaration.
`
` Q. And since writing your declaration, have
`
`you identified any corrections that you need to
`
`address?
`
` A. No, sir.
`
` Q. Do you remember about how much time you
`
`spent writing your declaration?
`
` A. Two to three hours. My team spent
`
`additional hours.
`
` Q. About how much time do you think your team
`
`spent?
`
` A. I think in total, given the work that we
`
`had done previously on related subjects, less than 40
`
`hours.
`
` Q. Is there any information you considered in
`
`forming your opinions for this declaration that is
`
`not disclosed in the declaration?
`
` A. I don't believe so, no.
`
` Q. Now, I know that in the ITC case, you
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1172.007
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`James E. Malackowski
`
`3/29/2022
`Page 8
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`spoke with, I believe, some other experts and folks
`
`at Novartis. Since that time, in the course of
`
`preparing this declaration, have you spoken to any
`
`additional experts or Novartis employees?
`
` A. I have not.
`
` Q. Did you meet with anybody to prepare for
`
`your deposition?
`
` A. I met virtually with Mr. Bennett yesterday
`
`for 90 minutes perhaps.
`
` Q. Did you meet with anyone else?
`
` A. Mr. Clemons with my office was on the call
`
`as well. That's all.
`
` Q. Could you refer to paragraph 24 of your
`
`declaration?
`
` A. Yes, sir.
`
` Q. And in this paragraph, is it true that you
`
`are identifying a number of advantages of a prefilled
`
`syringe?
`
` A. It is.
`
` Q. I want to ask you a couple of questions
`
`about the advantages that you've identified here. So
`
`the first one is -- well, I guess in the first
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1172.008
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`James E. Malackowski
`
`3/29/2022
`Page 9
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`sentence, do you consider the single use sealed
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`sterile tray to be an advantage over a vial?
`
` MR. BENNETT: Objection to the form.
`
` THE WITNESS: I don't specifically cite to
`
`the tray as being a unique advantage specific to the
`
`'631.
`
`BY MR. VLASIS:
`
` Q. Let's go to the next sentence. So you say
`
`that the use of prefilled syringes offer certain
`
`advantages over vials, including reduced injection
`
`time.
`
` Do you see that?
`
` A. I do.
`
` Q. Do you know if a reduced injection time is
`
`something that's claimed in the '631 patent?
`
` A. I don't believe that a measure of time is
`
`claimed in the patent. I do believe that there are
`
`advantages to PFS generally that inherently include
`
`reduced injection time. I would defer to the
`
`language of the specification specifically.
`
` Q. What about the possible reduced risk of
`
`endophthalmitis. Do you know if that's an advantage
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1172.009
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`James E. Malackowski
`
`3/29/2022
`Page 10
`
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`that's claimed in the '631 patent?
`
` A. Again, I believe the benefits of reduced
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`contamination are discussed within the specification.
`
`I can't recall if this particular indication is
`
`cited. I would refer to the patent itself.
`
` Q. The same question with respect to the
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`reduction in intraocular air bubble and silicone oil
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`droplets. Do you know if that is a feature that's
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`claimed in the '631 patent?
`
` A. Again, by claimed, I presume you're
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`referring to the claim language specifically, so we
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`should pull that out. There are a number of
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`dependent claims. But I do believe that the patent
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`itself in total describes the benefits cited in your
`
`last question.
`
` Q. How about the last one, improved precision
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`in the volume and dose. Do you know if the claims
`
`enable improved precision over the vial?
`
` A. So that's a slightly different question
`
`because you suggested claims enabling. I defer to
`
`the technical expert. I believe the answer to that
`
`is yes. But I also believe that the specification
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1172.010
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`James E. Malackowski
`
`3/29/2022
`Page 11
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`described generally such benefits.
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` Q. In the course of your engagement, did you
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`confirm with any of the technical experts that the
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`'631 patent enables these advantages?
`
` MR. BENNETT: Objection to form.
`
` THE WITNESS: Confirm in the sense that
`
`I've reviewed their supplemental declarations that
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`describe in detail on a claim and claim element basis
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`the coextensive nature of the products at issue and
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`the claims of the patent.
`
`BY MR. VLASIS:
`
` Q. So you're saying you did confirm these
`
`specific advantages are enabled by the claims of the
`
`'631 patent?
`
` MR. BENNETT: Same objection.
`
` THE WITNESS: I did confirm the benefits
`
`as cited by looking to the technical expert reports,
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`which I believe address all of these benefits.
`
`BY MR. VLASIS:
`
` Q. When you say you did confirm the benefits,
`
`you mean you confirmed that the benefits are provided
`
`by the '631 patent claims?
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1172.011
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`James E. Malackowski
`
`3/29/2022
`Page 12
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` MR. BENNETT: Same objection.
`
` THE WITNESS: Generally, yes.
`
`BY MR. VLASIS:
`
` Q. Do you know which, if any, of these
`
`advantages were available in the prior art before the
`
`'631 patent?
`
` A. There is also discussion within the
`
`various technical expert reports, the composition of
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`the prior art and the attempts to have a PFS solution
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`for these indications. Generally, I understand that
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`it is the combination of elements claimed in the '631
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`that allows for an effective product with these
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`benefits and that the prior art, although it may have
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`had reference to certain of the benefits, was not
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`commercially successful in its implementation.
`
` Q. So you agree that there were prior art
`
`syringes before the '631 patent?
`
` A. Of course.
`
` Q. And do you know if those prior art
`
`syringes had any of these advantages that are in the
`
`second sentence of paragraph 24?
`
` A. Again, I would defer to the technical
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1172.012
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`James E. Malackowski
`
`3/29/2022
`Page 13
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`experts that describe the prior art vis-a-vis the
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`claim elements of the patent. My understanding is
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`that none of the prior product had the collective set
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`of advantages that would result in a commercially
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`acceptable product. But I would defer to the
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`technical experts on each individual element and its
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`inclusion in the prior art and its limitations.
`
` Q. I was asking more about these individual
`
`advantages rather than the collective set. So maybe
`
`we'll just use one as an example. Do you know if,
`
`before the '631 patent, the syringes that were
`
`available reduced injection time as compared to a
`
`vial?
`
` A. That really is a technical question
`
`outside my scope. Better for the technical experts.
`
`My understanding is that in general, a prefilled
`
`syringe has the benefit of reducing injection time,
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`but only if the commercial application of that is
`
`acceptable and effective. So theoretically, it may
`
`be true. Practically, it may be a failure within the
`
`market.
`
` Q. And when you say that's a better question
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1172.013
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`James E. Malackowski
`
`3/29/2022
`Page 14
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`for the technical experts, is that true for each of
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`the individual advantages here in the second
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`sentence?
`
` A. Yes. A comparison of the prior art
`
`adoption of particular features and limitations
`
`therein is addressed in the technical experts. It's
`
`outside the scope of my declaration.
`
` Q. Let's refer to paragraph 27.
`
` A. Yes, sir.
`
` Q. And here you refer to your review of
`
`Mr. Leinsing's declaration, correct?
`
` A. I do.
`
` Q. And you are relying on his declaration to
`
`provide your understanding of the invention of the
`
`'631 patent?
`
` A. In part, certainly as it relates to the
`
`specific sentences stated here. There are other
`
`descriptions of the benefits of the '631 within my
`
`declaration that provide other reference points.
`
` Q. And in the first sentence, you mention
`
`that Mr. Leinsing has opined that the '631 patent is
`
`directed to the invention of a terminally-sterilized
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1172.014
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`James E. Malackowski
`
`3/29/2022
`Page 15
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`small-volume PFS, and then it continues.
`
` Do you see that?
`
` A. I do.
`
` Q. And you mentioned terminally sterilized.
`
`Do you know if terminal sterilization plays a role in
`
`a physician's decision to use a prefilled syringe
`
`over a vial?
`
` A. Ultimately, I believe that would be a
`
`question that's better for Dr. Calman. But my
`
`understanding is that the sterilization has a direct
`
`effect on the commercial viability of the product
`
`given the nature of the active ingredients as well as
`
`the pressures associated with the small syringe.
`
` Q. Okay. But you would defer to Dr. Calman
`
`as to whether physicians actually consider the
`
`sterilization in deciding whether to prescribe a
`
`prefilled syringe or a vial; is that right?
`
` A. To specifically isolate out that element
`
`from a doctor's consideration is outside the scope of
`
`my work. I looked at the collective benefits of the
`
`features, so he is who I would turn to if I wanted to
`
`somehow apportion out physician consideration of that
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1172.015
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`James E. Malackowski
`
`3/29/2022
`Page 16
`
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`one element.
`
` Q. Okay. And you mentioned small volume.
`
`Are you referring to the VEGF antagonist solution?
`
` MR. BENNETT: Objection to form.
`
` THE WITNESS: Yes. More particularly,
`
`though, the structure of the PFS syringe itself.
`
`BY MR. VLASIS:
`
` Q. And similar question. Do you know if
`
`physicians prescribe a prefilled syringe over a vial
`
`because of the structure of the PFS syringe itself?
`
` A. Well, again, I believe that all of these
`
`elements work in combination and are related and that
`
`results in the basis of demand. Whether or not the
`
`particular structure of the syringe as opposed to,
`
`you know, glass versus plastic or the size and shape,
`
`I have not apportioned that out specifically. I
`
`don't frankly recall if any of the technical experts
`
`have addressed that.
`
` Q. The next feature says low levels of
`
`silicone oil. Do you see that?
`
` A. I do.
`
` Q. And similar question. Do you know if the
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1172.016
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`James E. Malackowski
`
`3/29/2022
`Page 17
`
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`level of silicone oil influences a physician's
`
`decision when deciding whether to prescribe a
`
`prefilled syringe or a vial?
`
` A. Again, that is outside the scope of my
`
`declaration. My understanding from the record is
`
`that the friction forces associated with the syringe
`
`affect the doctor's delivery and inappropriate forces
`
`may create additional risk. I would refer to
`
`Dr. Calman on how that influences a physician
`
`uniquely in their selection apart from all of the
`
`other features of the products at issue.
`
` Q. And same with the low level of silicone
`
`oil?
`
` A. Same, yes.
`
` Q. Let's refer to paragraph 38. So this is
`
`a -- just for the record, this is a Novartis --
`
`paragraph 38 has a slide from a Novartis confidential
`
`document about Genentech's Lucentis product.
`
` MR. BENNETT: Could we just mark the
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1172.017
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`Q.
`
`Paragraph 38, Mr. Malackowski,
`
`this
`
`includes a figure that's labeled figure 3.
`
`Do you see that?
`
`A.
`
`I do.
`
`
`
`James E. Malackowski
`3/29/2022
`Page 18
`
`transcript as confidential under the protective
`
`order, please?
`
`BY MR. VLASIS:
`
`
`
`VY Trustpoint.One
`
`www.trustpoint.one
`800.FOR.DEPO
`www.aldersonreporting.com
`(800.367.3376)
`Regeneron Exhibit 1172.018
`Regeneron v. Novartis
`IPR2021-00816
`
`Regeneron Exhibit 1172.018
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`IPR2021-00816
`
`www.trustpoint.one
`800.FOR.DEPO
`www.aldersonreporting.com
`(800.367.3376)
`Regeneron Exhibit 1172.019
`Regeneron v. Novartis
`
`James E. Malackowski
`
`Trustpoint.One Alderson
`
`Regeneron Exhibit 1172.019
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`IPR2021-00816
`
`www.trustpoint.one
`800.FOR.DEPO
`www.aldersonreporting.com
`(800.367.3376)
`Regeneron Exhibit 1172.020
`Regeneron v. Novartis
`
`James E. Malackowski
`
`Trustpoint.One Alderson
`
`Regeneron Exhibit 1172.020
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`IPR2021-00816
`
`www.trustpoint.one
`800.FOR.DEPO
`www.aldersonreporting.com
`(800.367.3376)
`Regeneron Exhibit 1172.021
`Regeneron v. Novartis
`
`James E. Malackowski
`
`Trustpoint.One Alderson
`
`Regeneron Exhibit 1172.021
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`James E. Malackowski
`
`3/29/2022
`
`17
`
`18
`
`19
`
`Q.
`
`Let's go to the top of page 26. And you
`
`say,
`
`"However,
`
`in 2017, Lucentis sales increased by
`
`1 percent
`
`in the U.S. mainly driven by the launch of
`
`
`
`Page 22
`
`20 prefilled syringes and growth in new indications."
`
`21
`
`22
`
`Do you see that?
`
`A.
`
`As reported by Roche, yes.
`
`V7 Trustpoint.One
`
`www.trustpoint.one
`800.FOR.DEPO
`www.aldersonreporting.com
`(800.367.3376)
`Regeneron Exhibit 1172.022
`Regeneron v. Novartis
`IPR2021-00816
`
`Regeneron Exhibit 1172.022
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`James E. Malackowski
`
`3/29/2022
`Page 23
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` Q. Do you know how much of that 1 percent
`
`growth is attributable to the launch of the prefilled
`
`syringe versus the growth in new indications?
`
` A. I don't believe that this data breaks that
`
`out. The records continue by showing that there was
`
`growth across all indications consistent with the
`
`rollout of the prefilled syringes.
`
` Q. And were there new dosage sizes approved
`
`after 2017? Actually, I'll strike that question.
`
` Do you know if there were new dosage
`
`strengths that were approved after 2017?
`
` A. If you refer to paragraph 25 of my report,
`
`I describe what I understand to be approved dosing
`
`since 2012, and there would have been an approval for
`
`Lucentis .3 milligram PFS in March of 2018. And then
`
`obviously also the Eylea 2.0 milligram PFS in August
`
`of 2019.
`
` Q. Do you know how much the growth of
`
`Lucentis prefilled syringe is attributable to the
`
`prefilled syringe presentation versus the approval of
`
`a new dosage strength in March of 2018?
`
` A. I have not seen any quantitative data to
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1172.023
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`James E. Malackowski
`
`3/29/2022
`Page 24
`
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`apportion between those. The qualitative business
`
`data attributes the growth to the introduction of the
`
`PFS as reflected in the various charts and analysis
`
`within my report.
`
` Q. And you understand that after the launch
`
`of Lucentis in the prefilled syringe, sales of Eylea
`
`in the vial were greater than the sales of Lucentis
`
`in the prefilled syringe?
`
` A. At approximately the time of launch,
`
`that's true. You and I discussed that in my ITC
`
`deposition.
`
` Q. At the time of the launch for the next
`
`year, right?
`
` A. I don't recall the precise period
`
`afterwards, but that's approximately my -- correct.
`
` Q. Let's refer to paragraph 48.
`
` A. Yes, sir.
`
` Q. So for the record, I'm going to ask
`
`questions about the Lucentis-Genentech agreements and
`
`Genentech produced some of those, but also Novartis
`
`did. So I'm only going to refer to the ones that
`
`Novartis produced for confidentiality reasons.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1172.024
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`James E. Malackowski
`
`3/29/2022
`
`
`
`So in paragraph 48, you state that after
`
`failure to develop its own Lucentis PFS, Genentech
`
`was able to obtain approval for, and bring to the
`
`United States market, a Lucentis PFS in 2016, but
`
`only after licensing the '631 patent;
`
`is that right?
`
`A.
`
`Q.
`
`Yes, sir.
`
`And the license you're referring to is
`
`Genentech's license with Lucentis? Let me strike
`
`that.
`
`The license you're referring to is
`
`Genentech's license with Novartis?
`
`A.
`
`Yes, sir.
`
`Page 25
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`Q.
`
`And did you attempt to ascribe any value
`
`to the license with the '631 patent?
`
`MR. BENNETT: Objection to form.
`
`20
`
`BY MR. VLASIS:
`
`21
`
`Q.
`
`Monetary value?
`
`22
`A.
`I have not attempted to assess, for
`
`
`V7 Trustpoint.One Alderson
`
`www.trustpoint.one
`800.FOR.DEPO
`www.aldersonreporting.com
`(800.367.3376)
`Regeneron Exhibit 1172.025
`Regeneron v. Novartis
`IPR2021-00816
`
`Regeneron Exhibit 1172.025
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`3/29/2022
`James E. Malackowski
`Page 26
`
`1
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`2
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`example, a reasonable royalty rate in the form of
`
`that valuation.
`
`I did qualitatively consider that.
`
`But for a license to the patent,
`
`the product would
`
`not have been commercially available or viable.
`
`So
`
`to that extent, it bears a substantial portion of
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`6
`
`total value.
`
`
`
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`13
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`MR. BENNETT: Objection to the form.
`
`THE WITNESS: Not quantitatively.
`
`I did,
`
`however, consider qualitatively the imported '631 as
`
`I described for you.
`
`17
`
`BY MR. VLASIS:
`
`V7 Trustpoint.One
`
`www.trustpoint.one
`800.FOR.DEPO
`www.aldersonreporting.com
`(800.367.3376)
`Regeneron Exhibit 1172.026
`Regeneron v. Novartis
`IPR2021-00816
`
`Regeneron Exhibit 1172.026
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`6 Exhibit 2124.
`
`7
`
`8
`
`9
`
`10
`
`11
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`BY MR. VLASIS:
`
`Q.
`
`And Mr. Malackowski,
`
`so this is going to
`
`be Exhibit 2124,
`
`the exhibit that's cited in footnote
`
`62 to your declaration.
`
`Do you see that?
`
`A.
`
`Yes, sir.
`
`James E. Malackowski
`
`3/29/2022
`Page 27
`
`
`
`
`(Exhibit No. 2124 was identified for
`
`the record. )
`
`MR. VLASIS:
`
`So Caleb,
`
`if you can display
`
`1
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`2
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`4
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`5
`
`
`
`
`Trustpoint.One Alderson
`
`www.trustpoint.one
`800.FOR.DEPO
`www.aldersonreporting.com
`(800.367.3376)
`Regeneron Exhibit 1172.027
`Regeneron v. Novartis
`IPR2021-00816
`
`Regeneron Exhibit 1172.027
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`
`
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`Q.
`
`What's the basis for your opinion that the
`
`'631 patent has a sufficient disclosure to allow
`
`someone skilled in the art to reduce the invention to
`
`3/29/2022
`James E. Malackowski
`Page 28
`
`
`18
`
`practice?
`
`Trustpoint.One Alderson
`
`www.trustpoint.one
`800.FOR.DEPO
`www.aldersonreporting.com
`(800.367.3376)
`Regeneron Exhibit 1172.028
`Regeneron v. Novartis
`IPR2021-00816
`
`Regeneron Exhibit 1172.028
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`
`
`1
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`James E. Malackowski
`
`3/29/2022
`Page 29
`
`
`A.
`
`That's my general understanding of the
`
`requirements that are necessary for a patent to be
`
`issued by the USPTO.
`
`Q.
`
`Right. But what qualifies you to come to
`
`that conclusion?
`
`A.
`
`I only draw that conclusion as what is an
`
`understanding as a licensing professional of the
`
`requirements in order for the patent to be issued in
`
`the first place. Obviously,
`
`this patent was reviewed
`
`and issued by the PTO.
`
`So pending some evidence to
`
`the contrary, which is really more of a technical
`
`assessment,
`
`I shared with you my presumption.
`
`V7 Trustpoint.One
`
`www.trustpoint.one
`800.FOR.DEPO
`www.aldersonreporting.com
`(800.367.3376)
`Regeneron Exhibit 1172.029
`Regeneron v. Novartis
`IPR2021-00816
`
`Regeneron Exhibit 1172.029
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`IPR2021-00816
`
`www.trustpoint.one
`800.FOR.DEPO
`www.aldersonreporting.com
`(800.367.3376)
`Regeneron Exhibit 1172.030
`Regeneron v. Novartis
`
`James E. Malackowski
`
`Trustpoint.One Alderson
`
`Regeneron Exhibit 1172.030
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`IPR2021-00816
`
`www.trustpoint.one
`800.FOR.DEPO
`www.aldersonreporting.com
`(800.367.3376)
`Regeneron Exhibit 1172.031
`Regeneron v. Novartis
`
`James E. Malackowski
`
`Trustpoint.One Alderson
`
`Regeneron Exhibit 1172.031
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`James E. Malackowski
`
`3/29/2022
`Page 32
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` Q. Okay. Let's look at paragraph 52 of your
`
`declaration.
`
` A. Yes, sir.
`
` Q. And here you refer to Vetter's agreement
`
`with Bayer; is that right?
`
` A. Novartis agreement with Vetter and then
`
`ultimately Vetter's relationship with Bayer, yes.
`
` Q. And Bayer received a license to the '631
`
`patent from Vetter vis-a-vis Vetter's rights to
`
`sublicense that it obtained from Novartis, right?
`
` A. Yes, I would describe it as a sublicense.
`
` Q. And the sublicense is royalty free, right?
`
` A. There is no running royalty, that is
`
`correct.
`
` Q. And the license that Bayer received also
`
`included other IP in addition to the '631 patent?
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1172.032
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`James E. Malackowski
`
`3/29/2022
`Page 33
`
` A. Yes, sir.
`
` MR. VLASIS: Why don't we take a quick
`
`break. I think I can wrap up in a minute.
`
` (Recess.)
`
` MR. VLASIS: Thanks for your time,
`
`Mr. Malackowski. I don't have any further questions
`
`today.
`
` THE WITNESS: Thank you.
`
` MR. BENNETT: We have no questions.
`
`Thanks for your time, Jim.
`
` THE WITNESS: Thank you, sir. Very
`
`professional.
`
` (Whereupon, at 11:12 a.m., the taking of
`
`the instant deposition ceased.)
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`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1172.033
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`
`
`
`
`
`
`
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`
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`CERTIFICATE OF REPORTER
`
`
`
`
`UNITED STATES OF AMERICA)ss.:
`
`
`
`
`
`
`
`
`
`
`
`
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`STATE OF MARYLAND
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`I, MARY GRACE CASTLEBERRY,RPR,the officer before
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`whom the foregoing deposition was taken, do hereby certify that the
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`witness whosetestimony appears in the foregoing deposition was duly
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`sworn by me;that the testimonyof said witness was taken by meto the
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`best of my ability and thereafter reduced to typewriting under my
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`direction; that I am neither counselfor, related to, nor employed by any
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`of the parties for the action in which this deposition was taken, and
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`further that I am not a relative or employee of any attorney or counsel
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`employed by the parties thereto, nor financially or otherwise interested
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`in the outcomeof the action.
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`otary Public in andfor
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`the State ofMaryland
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`Regeneron Exhibit 1172.034
`Regeneron v. Novartis
`IPR2021-00816
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`James E. Malackowski
`
`3/29/2022
`Page 35
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`Notice Date: 03/31/2022
`Deposition Date: 3/29/2022
`Deponent: James E. Malackowski
`Case Name: Regeneron Pharmaceuticals, Inc.
` v. Novartis Pharma AG
`Page:Line Now Reads Should Read
`______ ________________________ ___________________
`______ ________________________ ___________________
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`______ ________________________ ___________________
`______ ________________________ ___________________
`______ ________________________ ___________________
`______ ________________________ ___________________
`______ ________________________ ___________________
`________ _____________________________ ________________________
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Regeneron Exhibit 1172.035
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`James E. Malackowski
`
`3/29/2022
`Page 36
`
` CERTIFICATE OF DEPONENT
`I hereby certify that I have read and examined the
`foregoing transcript, and the same is a true and
`accurate record of the testimony given by me.
`Any additions or corrections that I feel are
`necessary, I will attach on a separate sheet of
`paper to the original transcript.
`
` _________________________
` Signature of Deponent
`I hereby certify that the individual representing
`himself/herself to be the above-named individual,
`appeared before me this _____ day of ____________,
`20__, and executed the above certificate in my
`presence.
`
` ____________________
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