PAUL A. LASKAR, PH.D.
`
`Page 164
` IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`--------------------------
`APOTEX, INC.,
` Petitioner,
` Inter Partes Review
`No.:
`v. IPR2019-00400
`
`UCB BIOPHARMA SPRL,
`
` Patent Owner.
`-----------------------------------
`
` VOLUME 2
` DEPOSITION OF
` PAUL A. LASKAR, Ph.D.
` JANUARY 28, 2020
` 10:00 a.m.
`
`Reported by: Audra M. Smith, RPR, FCRR
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`212-279-9424
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2037 Page 1
`
`
`
`Page 164
` IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`--------------------------
`APOTEX, INC.,
` Petitioner,
` Inter Partes Review
`No.:
`v. IPR2019-00400
`
`UCB BIOPHARMA SPRL,
`
` Patent Owner.
`-----------------------------------
`
` VOLUME 2
` DEPOSITION OF
` PAUL A. LASKAR, Ph.D.
` JANUARY 28, 2020
` 10:00 a.m.
`
`Reported by: Audra M. Smith, RPR, FCRR
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2037 Page 1
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 165
` APPEARANCES OF COUNSEL
`
`ON BEHALF OF THE PETITIONER:
`KATTEN MUCHIN ROSENMAN, LLP
`BY: JITENDRA MALIK, ESQUIRE
`BY: ALISSA M. PACCHIOLI, ESQUIRE
`550 S. Tryon Street, Suite 2900
`Charlotte, NC 28202
`Phone: 704.444.2000
`jitty.malik@kattenlaw.com
`alissa.pacchioli@kattenlaw.com
`
`ON BEHALF OF THE PATENT OWNER:
`FENWICK & WEST LLP
`BY: ERICA R. SUTTER, ESQUIRE
`650 California Street 26th Floor
`San Francisco, CA 94108-2615
`esutter@fenwick.com
`
`212-279-9424
`
`Veritext Legal Solutions
`www.veritext.com
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`212-490-3430
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`Exhibit 2037 Page 2
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`
`
`PAUL A. LASKAR, PH.D.
`
`Page 166
`
` I N D E X
` *****
`PAUL A. LASKAR, Ph.D. PAGE
` Examination by Ms. Sutter 167
` Examination by Ms. Pacchioli 228
` E X H I B I T S
`LASKAR NUMBER DESCRIPTION PAGE
`Exhibit 1050 Reply Declaration of Dr.
` Paul Laskar, Ph.D. 1/27/20 171
`
` PREVIOUSLY MARKED EXHIBITS
`EXHIBIT NUMBER PAGE
`Exhibit 1001 179
`Exhibit 1002 190
`Exhibit 1003 169
`Exhibit 1004 226
`Exhibit 1006 227
`Exhibit 1024 220
`Exhibit 1027 197
`Exhibit 1045 199
`
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`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2037 Page 3
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 167
`
` P R O C E E D I N G S
` * * * * *
` PAUL LASKAR, Ph.D.,
`having been first duly sworn, was examined and testified
`before me as follows:
` EXAMINATION
`BY MS. SUTTER:
` Q. Good morning, Dr. Laskar. Could you
` please state and spell your full name for the
` record.
` A. Paul Laskar, P-A-U-L L-A-S-K-A-R.
` Q. Could you please provide your business
` address?
` A. 603 Montecito, M-O-N-T-E-C-I-T-O,
` Boulevard, Napa, California 94559.
` Q. And you understand you're here today for
` a deposition?
` A. I do.
` Q. Do you recall that you were deposed on
` October 2, 2019 in connection with this
` proceeding?
` A. Yes, I recall.
` Q. Have you been deposed since that
` deposition?
` A. No.
`
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`212-490-3430
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`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2037 Page 4
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 168
` Q. So I'll just refresh your memory really
` quickly. We can't talk over each other. Give
` audible responses because Ms. Smith can't take
` down your head nods and shakes. I'm going to ask
` you a question. You're going to answer them for
` the best of your abilities. Counsel may object,
` but unless you're specifically instructed not to
` answer, you need to answer my questions. Do you
` understand that?
` A. I do.
` Q. Just like last time, I'll try to take a
` couple breaks. If you need one, feel free to let
` me know. Just answer the last question that was
` pending. Is that agreeable to you?
` A. It is.
` Q. Is there any reason you cannot testify
` truthfully today?
` A. No, there's no reason.
` Q. And you understand that you're under
` oath?
` A. I do.
` Q. Have you provided any written testimony
` in any other proceeding since the last time you
` were deposed in this matter?
` A. No.
`
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`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2037 Page 5
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 169
` Q. And have you provided any oral testimony
` in any proceedings other than this current one
` since the last time you were deposed?
` A. No, I have not.
` Q. Do you recall that you submitted a copy
` of your CV with your original declaration in this
` matter?
` A. Yes, I recall.
` Q. Have there been any changes to your CV
` since you submitted it? I can provide you with a
` copy if that would help.
` A. That would help.
` Q. Handing you what's been marked Exhibit
` 1003. I'll just repeat the question again. If
` there have been any changes, if you could please
` let me know.
` A. Actually, there is -- there's another
` patent application that occurred since this CV. I
` don't have the details of that.
` Q. When you say another patent application
` that has occurred, you mean that you submitted a
` patent application where you're an inventor?
` A. Where I was one of the inventors, yes.
` Q. Do you recall when that was submitted?
` A. I believe November, but I'd have to refer
`
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`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2037 Page 6
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 170
`
` to --
` Q. And what's the subject matter of that
` patent application?
` MS. PACCHIOLI: Just caution
` confidentiality. Don't share anything that's
` confidential on the patent application.
` A. I believe the patent application is
` public. It has to do with a compound for
` pharmaceutical use in neurology.
`BY MS. SUTTER:
` Q. Are you the assignee of that patent
` application?
` A. Praxis Precision Medicines.
` Q. What have you done in preparation for
` today's meeting? I'm not trying to get any
` privileged information.
` A. I reviewed my reply declaration and I met
` with counsel yesterday.
` Q. And by counsel, do you mean just
` Ms. Pacchioli and Mr. Malik?
` A. That's correct.
` Q. Was there anybody else in the room at the
` time?
` A. No.
` Q. How many hours would you say you met with
`
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`
`212-490-3430
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`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2037 Page 7
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 171
`
` them in preparation for this deposition?
` A. Two and a half approximately.
` Q. Did you bring any materials with you
` today?
` A. No.
` Q. And when you said your reply declaration,
` you were referring to the supplemental declaration
` that was submitted in these proceedings; is that
` correct?
` A. Yes, that's correct.
` Q. Dr. Laskar, I've handed you what has been
` marked Exhibit 1050 in this matter. Is this your
` supplemental declaration?
` (Exhibit Number 1050 was marked.)
` A. Yes, it is.
` Q. And your supplemental declaration refers
` to U.S. Patent Number 8,633,194; is that correct?
` A. Yes, that's correct.
` Q. And you'll understand me if I refer to
` that as the '194 patent?
` A. I will.
` Q. Do you have any corrections to make to
` your supplemental declaration?
` A. I think there may be a typo or a
` strike-through that was not removed on page 7,
`
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`
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`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2037 Page 8
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 172
`
` paragraph 22.
` Q. I think there was a stray comma somewhere
` if I recall.
` A. Exactly. I don't remember where that one
` is.
` Q. Is that your edit?
` A. Yes.
` Q. And you also submitted an earlier
` declaration in this matter regarding the '194
` patent, correct?
` A. That's correct.
` Q. Sitting here today, are you changing or
` retracting any of your statements made in that
` declaration?
` A. No, I'm not. And by "that declaration,"
` I presume you mean the original?
` Q. Correct. Unless there is something you
` wanted to change in your reply as well.
` A. No.
` Q. Okay. Is your declaration complete?
` A. To the best of my ability.
` Q. Okay. So you're not adding anything to
` it?
` A. No, I'm not.
` Q. Are you aware of any intention to submit
`
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`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2037 Page 9
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 173
`
` additional opinions in this matter?
` A. No, I'm not.
` Q. And did you talk to anyone else in
` forming your opinions contained in your reply
` declaration?
` A. Any person other than --
` Q. Other than --
` A. -- counsel here, no.
` Q. I'd like you to turn to paragraph 9 of
` your supplemental declaration. And you state that
` all of the challenged claims, i.e. 1 through 11,
` read under the plain and ordinary meaning as
` understood by a POSA would include syrups.
` Did I read that correctly?
` A. Yes.
` Q. In your opinion, would the challenged
` claims include all syrups?
` MS. PACCHIOLI: Object to form.
` A. I don't understand that phrasing "all
` syrups."
`BY MS. SUTTER:
` Q. Well, you said that the challenged claims
` would include syrups. So are you adding a
` limitation on what syrups would be included?
` MS. PACCHIOLI: Same objection.
`
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`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2037 Page 10
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 174
` A. Under my definition, under the plain and
` ordinary meaning as understood by a POSA of what a
` syrup is, that would include all syrups.
`BY MS. SUTTER:
` Q. So what's the plain and ordinary meaning
` of a syrup to a POSA?
` A. I think there are two -- one that a
` layperson would understand, you know, as perhaps
` coming from unabridged in the dictionary that says
` that it's a sweetened viscous liquid. And to a
` POSA, that would mean that it is sweetened, it's
` viscous, and may or may not contain some flavor.
` And actually, there could be a solution,
` or in some restrictive cases, a suspension as
` well.
` Q. In your opinion -- strike that.
` Is it your opinion that the challenged
` claims do not limit the amount of sugar that can
` be present in the formulation?
` MS. PACCHIOLI: Object to form.
` A. As I recall, there is no restriction in
` the claims about the amount of sugar or other
` sweetener that might be present.
`BY MS. SUTTER:
` Q. And you'll agree with me if I said that
`
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`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2037 Page 11
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 175
` sugars can have a preservative effect, correct?
` MS. PACCHIOLI: Object to form.
` A. They can under suitable circumstances
` have a preservative effect.
`BY MS. SUTTER:
` Q. Can you elaborate on what you mean by
` "suitable circumstances"?
` A. If the concentration of sugar in the
` syrup is high enough, then it can have a
` preservative effect.
` Q. How does sugar have a preservative
` effect?
` MS. PACCHIOLI: Object to form.
` A. I'm not a microbiologist, and so my
` answer would be in the context of a formulator and
` not a microbiologist. And sugars can and do, as
` the concentration increases, if you will, restrict
` the amount of free water that would enable a
` microorganism to proliferate.
`BY MS. SUTTER:
` Q. Why would a formulator include sugar in a
` formulation?
` MS. PACCHIOLI: Object to form.
` A. There could be several reasons why a
` formulator would include sugar in a formulation.
`
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2037 Page 12
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 176
` One, it is a sweetener, and therefore renders a
` formulation more palatable. Another is, again,
` depending on the concentration, sugar could have a
` cosolvent effect of increasing the solubility of
` some medicinal agents. And as I just mentioned,
` that at a high enough concentration, it can have a
` preservative effect. Those are the things that
` come immediately to mind. There may be others.
`BY MS. SUTTER:
` Q. So would there be times when a formulator
` would add sugar simply for its preservative
` effect?
` MS. PACCHIOLI: Same objection.
` A. It's a possibility, but in my experience
` as a formulator, my use of sugar in formulations
` would be for their sweetening and enhanced
` palatable effects to a greater degree than others,
` than others such as a preservative.
`BY MS. SUTTER:
` Q. So when sugar is added for its sweetening
` effects, would it be fair to say that any
` preservative effects are secondary to that
` purpose?
` MS. PACCHIOLI: Same objection.
` A. I didn't quite -- I didn't say it quite
`
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2037 Page 13
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 177
` that way; I said my first focus would be.
` But as a formulator in understanding the
` ability of sugar to have a preservative effect, I
` would acknowledge that and that would be -- that
` would be a consideration in its use. I was just
` prioritizing and not trying to be exclusive.
`BY MS. SUTTER:
` Q. I guess my question is: Hypothetically,
` if you were adding sugar to a formulation,
` specifically as a sweetener, that would be the
` primary focus; and then the secondary focus would
` be that it would have preservative effects. Is
` that a correct summary?
` MS. PACCHIOLI: Same objection.
` A. If the concentrations were high enough,
` then the sugar's inherent attribute of having a
` preservative effect is just unavoidable.
`BY MS. SUTTER:
` Q. In paragraph 11 of your report, you state
` in that last sentence: It is my understanding
` that the transitional phrase "consisting
` essentially of" limits the scope of a claim to the
` specified materials or steps and those that do not
` materially affect the basic and novel
` characteristics of the claimed invention.
`
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2037 Page 14
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 178
`
` Did I read that correctly?
` A. Yes, you did.
` Q. What do you mean by "does not materially
` affect the basic and novel characteristics"?
` MS. PACCHIOLI: Object to form.
` A. The basic and novel characteristics would
` refer, I believe, to whatever is considered in the
` invention that is purported to be patentable.
`BY MS. SUTTER:
` Q. Is there a distinction, in your opinion,
` between an excipient that has preservative effects
` versus an excipient that is a preservative?
` MS. PACCHIOLI: Object to form.
` A. Would you repeat that, please?
`BY MS. SUTTER:
` Q. Sure. Is there a distinction, in your
` opinion, between an excipient that has
` preservative effects versus an excipient that is a
` preservative?
` MS. PACCHIOLI: Same objection.
` A. I'm struggling a little bit. A compound
` that has a preservative effect is a preservative,
` and it may be -- it may have another piece -- or
` another function.
` And an excipient that is labeled as a
`
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2037 Page 15
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 179
` preservative does have a preservative effect and
` may or may not have another function in the
` formulation.
`BY MS. SUTTER:
` Q. So in your view, does the claim treat
` excipients differently depending on whether
` they're labeled as a preservative or not?
` MS. PACCHIOLI: Object to form.
` A. I'm sorry. Would you repeat that,
` please?
` THE COURT REPORTER: "So in your view,
` does the claim treat excipients differently
` depending on whether they're labeled as a
` preservative or not?"
` A. What claim -- to what claim are you
` referring?
`BY MS. SUTTER:
` Q. Claim 1 of the '194 patent. I can --
` A. Paragraph 1 has the -- or paragraph 10
` has the Claim 1.
` Q. Just to make it easier for you.
` A. I appreciate that.
` Q. I'm handing you what has been marked as
` Exhibit 1001.
` THE WITNESS: Could you read the question
`
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2037 Page 16
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 180
`
` again, please?
` THE COURT REPORTER: Sure.
` "So in your view, does the claim treat
` excipients differently depending on whether
` they're labeled as a preservative or not?"
` MS. PACCHIOLI: Same objection.
` A. I guess I would use the term ingredient.
` And in this case, referring to Claim 1, there are
` other ingredients that have preservative effects.
`BY MS. SUTTER:
` Q. Are you saying that in Claim 1 there are
` other ingredients that have preservative effects
` or were you saying that in general, ingredients
` may have other preservative effects?
` MS. PACCHIOLI: Object to form.
` A. I'm only considering Claim 1 of the '194
` patent.
`BY MS. SUTTER:
` Q. So what in Claim 1 do you consider as
` having preservative effects?
` A. Well, the methyl and propylparabens have
` preservative effects, and levocetirizine has a
` preservative effect.
` Q. Earlier you were referring to what
` excipients or ingredients are labeled as. Do you
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`Veritext Legal Solutions
`www.veritext.com
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`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2037 Page 17
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 181
`
` recall that?
` A. Correct.
` Q. What were you referring to when you said
` "labeled"?
` MS. PACCHIOLI: Object to form.
` A. "Labeled" as having a preservative effect
` or as being a preservative.
`BY MS. SUTTER:
` Q. Labeled where though?
` MS. PACCHIOLI: Same objection.
` A. Ah. "Labeled" means that the function or
` primary function of the ingredient in the
` formulation is as a preservative. And in Claim 1,
` methyl and propylparaben have, as their labeled
` function, the purpose of being a preservative.
`BY MS. SUTTER:
` Q. And are you referring to, for example, a
` dossier with a pharmaceutical formulation?
` MS. PACCHIOLI: Object to form.
` A. Could you --
`BY MS. SUTTER:
` Q. Are you referring to a dossier for a
` pharmaceutical formulation?
` A. "Dossier."
` Q. Strike that. Are you referring to
`
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2037 Page 18
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 182
` something, for example, like a regulatory
` submission where the function of an ingredient is
` listed?
` MS. PACCHIOLI: Same objection.
` A. That -- when I said "labeled as," then,
` yes. The tabular has a name and a claim purpose
` or function.
`BY MS. SUTTER:
` Q. Got it. So in your view, does the stated
` primary function for the excipient matter for
` purposes of the claim?
` MS. PACCHIOLI: Object to form.
` A. Can you repeat that, please?
` THE COURT REPORTER: "So in your view,
` does the stated primary function for the
` excipient matter for purposes of the claim?"
` MS. PACCHIOLI: Same objection.
` A. No.
`BY MS. SUTTER:
` Q. Claim 1 says after the two I's: A
` preservative mixture consisting essentially of a
` mixture of methyl parahydroxybenzoate and propyl
` parahydroxybenzoate in a ratio 9/1 expressed in
` weight.
` Do you see that?
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`Veritext Legal Solutions
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`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2037 Page 19
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 183
`
` A. I do.
` Q. Is it your opinion that the preservative
` mixture can include sugar?
` A. In this case it is the Claim 1 of '194.
` The fact that levocetirizine also has a
` preservative effect indicates to me that if there
` was sugar (sucrose) present in a sufficient
` amount, that that sucrose could also have a
` preservative effect.
` Q. Just to make sure I understand correctly,
` so you're saying that Claim 1's preservative
` mixture could include sugar if the sugar is
` present at a high enough concentration?
` MS. PACCHIOLI: Object to form.
` A. What -- I'm saying is that in Claim 1 of
` '194, the -- there could be other ingredients
` present in the formulation that have preservative
` effect, such as levocetirizine; and if sucrose
` were present in a sufficient concentration in that
` composition, that sucrose could have a
` preservative effect.
` I'm not saying -- and the converse is if
` it's in a low concentration, that it could be
` devoid of any measurable preservative effect.
`BY MS. SUTTER:
`
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2037 Page 20
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 184
` Q. So I guess I just want to make sure I'm
` understanding this right: Would sugar -- assuming
` it is present at a high enough concentration to
` inhibit bacterial growth -- would it be considered
` part of the preservative mixture in Claim 1 --
` MS. PACCHIOLI: Same objection.
`BY MS. SUTTER:
` Q. -- or a part of the formulation as a
` whole?
` A. In the view of a POSA, I believe, the
` POSA would believe -- would take sugar present at
` a high enough concentration where it had some
` preservative effect as being -- as having a
` preservative effect despite probably not being
` labeled in a regulatory dossier, as you mentioned,
` as being a preservative. It would still -- the
` sucrose would still be labeled as a sweetener and
` flavoring agent in the formulation.
` Q. So that sugar would compose the
` preservative mixture of the formulation?
` MS. PACCHIOLI: Same objection.
` A. Say that --
`BY MS. SUTTER:
` Q. So that sugar would compose the
` preservative mixture of the formulation?
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2037 Page 21
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 185
`
` MS. PACCHIOLI: Same objection.
` A. It would contribute to the preservative
` effect despite not being labeled as -- labeled
` explicitly as a preservative.
`BY MS. SUTTER:
` Q. So I understand it would have
` preservative effects. I'm asking for the purposes
` of the claim where it says "a preservative mixture
` consisting essentially of," would that portion of
` the claim also include sugar?
` MS. PACCHIOLI: Object to form.
` A. It seems to me that, for example,
` levocetirizine has preservative effect and it does
` not appear following the lower case Roman ii.
` So -- and I would treat sucrose in the same
` fashion.
`BY MS. SUTTER:
` Q. Does the amount of sugar, methylparaben,
` and propylparaben need to be present in a ratio of
` 9-to-1?
` MS. PACCHIOLI: Object to form.
` A. I don't understand the question.
`BY MS. SUTTER:
` Q. Well, going back to the claim, you see
` that it says "preservative mixture in a ratio of
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`
`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2037 Page 22
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 186
`
` 9-to-1 expressed in weight."
` Do you see that?
` A. I see that.
` Q. So would sugar, methylparaben, and
` propylparaben need to be present in a ratio of
` 9-to-1 expressed in weight?
` MS. PACCHIOLI: Same objection.
` A. No.
`BY MS. SUTTER:
` Q. Why not?
` MS. PACCHIOLI: Same objection.
` A. There is -- you know, in like manner,
` levocetirizine is not the concentration, is not
` stipulated. And I would -- as I indicated, I
` would regard sucrose in an analogous light, in
` that if there was sugar present, it would need to
` be present at a high enough concentration to have
` a preservative effect. And that concentration of
` sucrose would be unrelated to the ratio of methyl
` and propylparaben.
`BY MS. SUTTER:
` Q. So it's your opinion that the ratio of
` 9-to-1 solely relates to methylparaben and
` propylparaben?
` MS. PACCHIOLI: Object to form.
`
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`
`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2037 Page 23
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 187
` A. As stated in that claim, and as I recall,
` somewhere in the specification it's also.
` Rather than misstate, let me --
` Refers -- Column 1 [sic], line 49, that
` paragraph discusses the ratio of the parabens as
` 9-to-1. It does not mention anything else.
`BY MS. SUTTER:
` Q. Sorry. You said Column 1?
` A. Column 3, sorry. Column 3, line -- the
` paragraph beginning with line 49.
` Q. Claim 1 also says: Said mixture being
` present in an amount of more than zero and up to
` 0.75 milligrams per milliliter of the composition.
` Do you see that?
` A. Yes.
` Q. Do you understand "said mixture" to be
` referring to the preservative mixture preceding
` that?
` A. I read that as referring to the mixture
` of methyl and propylparaben, yeah.
` Q. Well, it says "said mixture," right?
` MS. PACCHIOLI: Object to form.
` A. And as I read "said mixture," in my
` reading of it is that it refers to methyl and
` propylparaben.
`
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2037 Page 24
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 188
`
`BY MS. SUTTER:
` Q. So if sugar is present, do you read the
` claims as requiring sugar plus methylparaben and
` propylparaben to be an amount of more than zero
` and up to 0.75 milligrams per milliliter of the
` composition?
` MS. PACCHIOLI: Object to question.
`BY MS. SUTTER:
` Q. Do you need the question repeated?
` A. I do.
` MS. PACCHIOLI: Same objection.
` A. I don't read Claim 1 as requiring sucrose
` in the composition at all.
`BY MS. SUTTER:
` Q. But it could be present in the
` composition and still be in Claim 1, right?
` MS. PACCHIOLI: Object to form.
` A. Sure. Sucrose could be, as could a
` number of other ingredients.
`BY MS. SUTTER:
` Q. So my question is, if hypothetically the
` formulation contains sugar, then does the amount
` of sugar, methylparaben, and propylparaben need to
` be in an amount of more than zero and up to 0.75
` milligrams per milliliter?
`
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2037 Page 25
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 189
`
` MS. PACCHIOLI: Object to form.
` A. I don't read Claim 1 that way.
`BY MS. SUTTER:
` Q. Can you explain to me what your reading
` is?
` A. It's silent in terms of -- with regard to
` the amount of sucrose present.
` Q. So what must be present in an amount of
` more than zero and up to 0.75 milligrams per
` milliliter of the composition?
` MS. PACCHIOLI: Same objection.
` A. That -- in my reading of Claim 1, that
` that zero milligrams per milliliter up to 0.75
` milligrams per milliliter refers to the sum of the
` quantity of methylparaben and propylparaben.
`BY MS. SUTTER:
` Q. So it's your opinion that the
` preservative mixture referenced in Claim 1
` includes the mixture of methylparaben and
` propylparaben and can also include other
` preservatives?
` MS. PACCHIOLI: Object to form.
` A. As I read claim -- as I read Claim 1 in
` its entirety, it enables the inclusion of other
` ingredients having a preservative effect.
`
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2037 Page 26
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 190
`
`BY MS. SUTTER:
` Q. In paragraph 14 of your report, you note
` that syrups are a preferred embodiment. Why is
` that relevant to your opinion?
` MS. PACCHIOLI: Object to form.
` A. As I indicated, I think, in paragraph 13,
` that the term "comprising" is open ended, and that
` therefore within the comprising group, there could
` be sugar present.
` THE COURT REPORTER: Did you say "within
` the comprising group there could be sugar
` present"?
` THE WITNESS: Using the meaning of
` "comprising," that means that there could be
` sugar present.
` And then in 14, that if sugar is present
` or sweetener is present, that is most often
` referred to pharmaceutically as a syrup.
`BY MS. SUTTER:
` Q. I'm going to hand you what's been marked
` as Exhibit 1002. This is your original
` declaration, correct?
` A. Yes.
` Q. I'd like you to go to page 26, paragraph
` 61. And you identified an example of composition
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2037 Page 27
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 191
` which is a syrup containing levocetirizine,
` dihydrochloride, methyl and propylparaben,
` saccharinum and purified water, correct?
` A. Yes.
` Q. And saccharinum is a sugar?
` MS. PACCHIOLI: Object to form.
` A. Saccharinum, in my old Latin, it refers
` to sucrose or sugar.
`BY MS. SUTTER:
` Q. Would the addition of saccharinum affect
` the basic and novel characteristics of this
` composition?
` MS. PACCHIOLI: Object to form.
` A. You're referring to the composition of --
`BY MS. SUTTER:
` Q. That you identified.
` A. -- 61?
` Q. Correct.
` A. I think it depends.
` Q. What does it depend on?
` MS. PACCHIOLI: Object to form.
` A. The amount, the concentration of
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