`
`Page 1
` 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.
`~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
`
` VIDEO DEPOSITION OF
` PAUL A. LASKAR, Ph.D.
` October 2, 2019
` 9:31 a.m.
`
`Reported by: Audra M. Smith, RPR, FCRR
`Video by: David Cooper
`
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`212-279-9424
`
`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2010
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 2
`
` 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
`BY: ROBERT E. COUNIHAN, ESQUIRE
`1211 Avenue of the Americas, 32nd Floor
`New York, NY 10036
`Phone: 212.921.2001
`rcounihan@fenwick.com
`
`212-279-9424
`
`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
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`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2010
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 3
`
` I N D E X
` *****
`PAUL A. LASKAR, Ph.D. PAGE
` Examination by Ms. Sutter 7
` Examination by Mr. Malik 148
` Examination by Ms. Sutter 155
` E X H I B I T S
`LASKAR EXHIBIT NUMBER DESCRIPTION PAGE
`Exhibit 1 Petition 10
`Exhibit 2 U.S. Patent Number 8,633,194 10
`Exhibit 3 Laskar CV 11
`Exhibit 4 United States Patent Number 5,698,558 12
`Exhibit 5 WO '094 Patent 12
`Exhibit 6 Handbook of Pharmaceutical
` Excipients, Third Edition 13
`Exhibit 7 European Patent Application
` Publication 0605203A2 13
`Exhibit 8 Opening Expert Report of Dr.
` Paul A. Laskar, Ph.D. in
` Case Number 18-CV-60846 in the
` United States District Court
` for the Southern District of
` Florida 18
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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 2010
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 4
`
` E X H I B I T S
`LASKAR EXHIBIT NUMBER DESCRIPTION PAGE
`Exhibit 9 Article, evaluation of the health
` aspects of methylparaben or review
` of the published literature
` by M.G. Soni, et al. 63
`Exhibit 10 Institution decision 74
`Exhibit 11 U.S. Patent 4,275,076 97
`Exhibit 12 Article, The treatment of atopic
` dermatitis with licorice gel 99
`Exhibit 13 Article, Topical disposition of two
` strengths of a I-125-rhEGF jelly in
` rat skin wounds 100
`Exhibit 14 U.S. Patent Number 5,643,584 101
`
`APOTEX EXHIBIT NUMBER DESCRIPTION PAGE
`Exhibit 1025 Case, Celanese v. Daicel 153
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2010
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 5
`
` P R O C E E D I N G S
` * * * * *
` THE VIDEOGRAPHER: We're going on the
` record at 9:31:55 a.m on October 2, 2019.
` Please note that the microphones are sensitive
` and may pick up whispering and other
` conversations. Please turn off all cell
` phones or put them away from the microphones
` as they can interfere with the deposition
` audio. Recording will continue until all
` parties agree to go off the record.
` This is Media Unit Number 1 in the video
` recorded deposition of Paul Laskar, Ph.D.
` Taken by counsel for the patent owner in the
` matter of Apotex, Inc. v. UCB BioPharma SPRL,
` Review Number IPR201900400, in the United
` States Patent and Trademark Office before the
` Patent Trial and Appeal Board. This
` deposition is being held at Katten Muchin
` Rosenman, LLP in the Conference Room F located
` at 5500 [sic] South Tryon Street, Suite 2905,
` Charlotte, North Carolina 28202. My name is
` David Cooper from Veritext. I'm the certified
` legal videographer. I'm not authorized to
` administer an oath. I'm not related to any
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
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`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2010
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 6
` parties in this action, nor am I financially
` interested in the outcome.
` Counsel and all present in the room will
` state their appearances and affiliation for
` the record. If there are any objections to
` the proceedings, please state them at the time
` of your appearance beginning with the noticing
` attorney.
` MS. SUTTER: Erica Sutter from Fenwick &
` West for the patent owner, UCB Biopharma SPRL.
` With me is my colleague Robert Counihan.
` MR. MALIK: Jitendra Malik from the law
` firm Katten, for Apotex. With me is
` Alissa Pacchioli.
` THE VIDEOGRAPHER: The court reporter,
` Audra Smith from Veritext will now swear in
` the witness.
` (The witness was sworn.)
` MR. MALIK: Just before we begin,
` pursuant to discussion with counsel regarding
` objections other than hearsay, relevance and
` foundation, when I say "form," all other
` objections are preserved. As far as document
` objections during the deposition, pursuant to
` 4264A, the parties agree to a five-day, five
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2010
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 7
` business day cure period for any supplemental
` evidence to an objection made to the -- to a
` document, but that that does not include
` bringing the witness back. And that agreement
` will be in place for all depositions going
` forward.
` Counsel, if I said that incorrectly,
` please go ahead and make any corrections.
` MS. SUTTER: I think we're good.
` * * * * *
` PAUL A. LASKAR,
`having been first duly sworn, was examined and testified
`before me as follows:
` EXAMINATION
`BY MS. SUTTER:
` Q. Good morning, Dr. Laskar, please state
` and spell your name for the record.
` A. P-A-U-L L-A-S-K-A-R.
` Q. Thank you. Can you please provide your
` business address?
` A. My business address is 603 Montecito
` Boulevard, Napa, California 94559.
` Q. And do you understand you're here today
` for a deposition?
` A. I do.
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2010
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 8
` Q. Have you ever had your deposition taken
` before?
` A. Yes, I have.
` Q. How many times?
` A. I don't recall exactly. Between United
` States and Canada, their equivalent of a
` deposition, perhaps eight or ten times.
` Q. And have you ever been deposed for a
` proceeding before the United States Patent Trial
` Appeal Board?
` A. I have.
` Q. When was the last time you were deposed?
` A. Good question. I don't recall. Couple
` years ago, I believe.
` Q. So I'm just going to go over some ground
` rules to make sure that everyone is on the same
` page. You're probably familiar with these,
` though. We can't talk over each other. Please
` give audible responses. Court reporter can't take
` down when you're nodding your head or shaking your
` head. Do you understand?
` A. I do.
` Q. I'm going to ask you questions and you're
` to answer them to the best of your ability. Your
` counsel may object, but unless you're specifically
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
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`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2010
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 9
` instructed not to answer the question, you must
` still answer my question. Do you understand?
` A. Yes, I do.
` Q. And if you need me to repeat something,
` just let me know. Otherwise, if I don't hear from
` you, I'm going to assume that you understood the
` question. Is that fair?
` A. Yes, it is.
` Q. I'll try to take a break every hour or
` so. If you need a break earlier than that, you
` can let me know. Just -- I ask that you answer
` the last question; don't leave a question pending.
` Can we agree on that?
` A. We can.
` Q. Okay. Is there any reason you cannot
` testify truthfully today?
` A. No.
` Q. And you do understand you're under oath?
` A. I do understand that.
` Q. You submitted a declaration in this
` proceeding, correct?
` A. That's correct.
` (Exhibit Number 1 was marked.)
`BY MS. SUTTER:
` Q. I've had the court reporter mark Laskar
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2010
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 10
` Exhibit 1. It's placed in front of you. Is this
` your declaration in the petition?
` A. Yes, it is.
` Q. And your declaration relates to U.S.
` Patent Number 8,633,194; is that correct?
` A. Yes, that's correct.
` Q. You'll understand if I refer to that as
` the '194 patent?
` A. I will understand that, yes.
` (Exhibit Number 2 was marked.)
`BY MS. SUTTER:
` Q. I had the court reporter mark Laskar
` Exhibit 2, the '194 patent, and placed that in
` front of you. Does that look to be the patent
` that you referred to in your declaration?
` A. Yes, it does.
` Q. And you understand that the priority date
` for the '194 patent is July 14, 2004; is that
` correct?
` A. I do understand that.
` MR. MALIK: Object to form.
`BY MS. SUTTER:
` Q. You submitted a CV in this petition as
` well, correct?
` A. Yes, I did.
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2010
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 11
`
` (Exhibit Number 3 was marked.)
`BY MS. SUTTER:
` Q. I had the court reporter mark Laskar
` Exhibit 3. It's Exhibit 1003 in the petition.
` Does that look to be your CV?
` A. Yes, it does.
` Q. Does anything need to be updated?
` A. Not substantially. Just under "Other,"
` I'm now a member of the Napa County Antismoking
` Coalition.
` Q. And your declaration states it's your
` opinion that Claims 1 through 11 of the '194
` patent are invalid as obvious; is that correct?
` A. Yes, it is.
` Q. And you proposed two grounds of
` obviousness, correct?
` A. Yes.
` Q. The first one relies on publication
` WO2004/050094. Is that correct?
` A. The patent that I refer to is the '094
` patent.
` Q. Correct. And you'll understand me then
` if I use the same terminology, '094?
` A. I will understand.
` Q. And that first ground also relies on what
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2010
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 12
` you referred to as the Handbook; it's the Handbook
` of Pharmaceutical Excipients, Third Edition, by
` Arthur Kibbe; is that correct?
` A. Yes, that's correct.
` Q. Your second ground of obviousness relies
` on three references, correct?
` A. Yes.
` Q. And that is European Patent Application
` Publication 0605203A2, or what you refer to as EP
` '203, correct?
` A. Correct.
` Q. The second one is United States Patent
` Number 5,698,558, or what you refer to as U.S.
` '558; is that correct?
` A. That's correct.
` Q. And the third reference is also the
` Handbook, correct?
` A. That's correct.
` (Exhibit Number 4 was marked.)
`BY MS. SUTTER:
` Q. Let's go ahead and mark those. So I've
` had the court reporter mark as Laskar Exhibit 4,
` the '558 patent. I had the court reporter mark as
` Exhibit 5 WO '094.
` (Exhibit Number 5 was marked.)
`
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2010
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 13
`
` (Exhibit Number 6 was marked.)
` (Exhibit Number 7 was marked.)
`BY MS. SUTTER:
` Q. I had the court reporter mark Laskar
` Exhibit 6 as the Handbook.
` Last one, Laskar Exhibit 7, is EP '203.
` So we can start with U.S. '558. Am I
` correct that you rely on U.S. '558 to argue that a
` person of ordinary skill would use levocetirizine
` instead of cetirizine in a pharmaceutical
` formulation?
` A. It is presumed that they would.
` Q. And you don't cite to any specific
` example in U.S. '558, correct?
` Strike that. You weren't referring --
` there's no specific formulation in U.S. '558 that
` you're referring to?
` A. No.
` Q. Go to WO '094. And you rely on WO '094
` for its statement regarding a pharmaceutical
` formulation that is a syrup; is that correct?
` A. Yes. As I indicate in my report, for
` example paragraph 61, I refer to a syrup
` composition.
` Q. And that is the syrup composition that's
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2010
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 14
` towards the bottom of page 4 of WO '094, right?
` A. Yes. At approximately line 33.
` Q. One of the reasons that you rely on the
` Handbook is for the statement that is in here
` twice. We can just use the first one on page 340.
` It says: Methylparaben together with
` propylparaben has been used for the preservation
` of various parenteral pharmaceutical formulations.
` Correct?
` A. Can you point me to where you're reading?
` Q. Yeah. It's on page 340, underneath that
` picture in top right corner?
` A. Right, yes.
` Q. I think it's also -- also in the
` propylparaben section as well. That one is in --
` it's in the first column on page 450, last
` paragraph.
` A. Yes. I see that, yes.
` Q. That's also a parenteral formulation,
` correct?
` A. I'm sorry?
` Q. It's also a parenteral formulation?
` A. It refers to parenteral formulations,
` yes.
` Q. In EP '203, you specifically point to
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2010
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 15
` Example 5. It's on page 11 of EP '203. And
` that's -- well, strike that.
` You rely specifically on Example 5 of EP
` '203 in your declaration, correct?
` A. Yes. As indicated in my paragraph 63,
` for example.
` Q. And Example 5 is an ophthalmic
` composition, correct?
` A. It is an ophthalmic formulation.
` Q. How did you identify these four
` references?
` A. They're -- they're pieces of prior art
` that I identified.
` Q. Did you identify them or did your counsel
` identify them?
` A. I identified them.
` Q. How did you find them?
` A. I'm very familiar with the Handbook of
` Pharmaceutical Excipients. I've used it routinely
` in my work since the first edition, and up till
` today. And in familiarizing myself with prior art
` through various search mechanisms, I identified
` some of these pieces of prior art.
` Q. Can you explain what you mean by
` different search mechanisms?
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2010
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 16
`
` A. Internet search.
` Q. And so when you said that you identified
` the references through internet searches, was that
` relating to U.S. '558, WO '049, and EP '203?
` A. Yes.
` Q. And the Handbook is one that you knew
` before?
` A. The Handbook I was familiar with, totally
` independently and --
` Q. And these four are the only references
` you rely on as the base for your grounds of
` obviousness, correct?
` MR. MALIK: Object to form.
` A. It is, as I indicated in my report for my
` analysis of obviousness, under Ground 1, it is
` '094 and the Handbook. And for Ground 2, the '203
` and '558 and the Handbook. So as indicated in my
` report, those are the references I relied on.
`BY MS. SUTTER:
` Q. So the answer is yes?
` A. Yes.
` Q. You submitted your declaration in
` connection with Apotex's petition for inter partes
` review, correct?
` A. I'm sorry?
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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 2010
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 17
` Q. You submitted your declaration in this
` proceeding in connection with Apotex's, Inc.'s
` petition for inter partes review; is that correct?
` A. Yes.
` Q. And you'll understand if I refer to
` Apotex, Inc. as just Apotex or petitioner?
` A. Yes.
` Q. And if I refer to inter partes review as
` just "the petition"?
` A. You may have to remind me.
` Q. Okay. Fair enough. Did you review
` Apotex's petition before you submitted your
` declaration?
` A. No.
` Q. Have you seen Apotex's petition?
` A. No.
` Q. What have you done in preparation for
` today's deposition?
` A. I refamiliarized myself with my
` declaration, my report; and the references,
` attachments, exhibits, your term -- I guess is the
` term used, the exhibits that I reference or
` mention in my report. I -- and then I have met
` with counsel over the last two days to review the
` information.
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2010
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 18
` Q. You also submitted an expert report in a
` district court litigation regarding the '194
` patent, correct?
` A. I don't know. I don't know. Don't
` recall.
` MR. MALIK: I object to the document.
` Move to strike on the basis of relevance.
` (Exhibit Number 8 was marked.)
`BY MS. SUTTER:
` Q. I've had the court reporter mark Laskar
` Exhibit 8. It's the Opening Expert Report of
` Dr. Paul A. Laskar, Ph.D. in Case Number
` 18-CV-60846 in the United States District Court
` for the Southern District of Florida.
` Does this refresh your recollection as to
` whether you submitted an expert report in the
` district court litigation?
` A. Yes, it does.
` Q. Is your declaration in this proceeding
` based off of your district court report?
` MR. MALIK: Object to form.
` A. I would have to review this report in
` order to make a definitive statement. But the --
` there are -- the '049, the '203 the Handbook, and
` '558 as bases for my opinions, so I would believe
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2010
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 19
` that there is a -- there is a similarity between
` the two.
`BY MS. SUTTER:
` Q. Did you write your declaration?
` A. Yes.
` Q. Did you write your -- do you recall if
` you wrote your opening report?
` A. I would have. That is my standard
` procedure.
` MR. MALIK: Objection, scope.
`BY MS. SUTTER:
` Q. How many hours did you spend drafting
` these reports?
` A. I have no recollection of this time. I
` would have to review my calendar.
` Q. Do you have an approximation?
` A. No. It would be taken from thin air.
` Q. Did you talk to anyone else in forming
` your opinions?
` A. Anyone else besides whom?
` Q. In the industry. Anyone besides counsel.
` A. No.
` Q. And did you identify other pharmaceutical
` formulations to help form your opinions?
` MR. MALIK: Objection, form.
`
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2010
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 20
` A. I'm not sure I understand the question.
`BY MS. SUTTER:
` Q. When writing your declaration, did you
` look at any other types of pharmaceutical
` formulations and consider those?
` A. That's still vague. There are several
` formulations mentioned in the prior art so,
` obviously, that prior art was part of my
` consideration. I'm not sure what else -- what
` other -- what else you're asking.
` Q. What I'm getting at is if you went and
` found pharmaceutical formulations and identified
` their compositions.
` MR. MALIK: Objection, form.
` A. Formulations of what?
`BY MS. SUTTER:
` Q. Pharmaceutical formulations other than
` what you have in the patent.
` MR. MALIK: Objection, form.
` A. Of what drug?
`BY MS. SUTTER:
` Q. Any -- any pharmaceutical formulation.
` MR. MALIK: Objection, form.
` A. I did not do any specific research of
` other formulations or drugs. As a -- someone
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2010
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 21
` who's an expert in pharmaceutical formulations,
` I'm certainly aware of a myriad of drugs and
` formulations. That's just part of my toolkit.
`BY MS. SUTTER:
` Q. And then out of your myriad of
` formulations, the key ones that you focused in on
` are the four that we've been discussing: WO '094,
` U.S. '558, the Handbook, and EP '203?
` A. And the other supporting documents that
` are referenced in my declaration.
` Q. Okay. Are you aware of what happened in
` district court litigation? Strike that.
` Prior to me showing you your report from
` the district court litigation, were you aware of
` the district court litigation regarding the '194
` patent?
` A. I was at the time. It has obviously
` skipped my mind.
` Q. Do you know if any other expert reports
` have been submitted in that litigation?
` MR. MALIK: Answer "yes" or "no." Don't
` get into communication with counsel.
` A. Not that I'm aware of.
`BY MS. SUTTER:
` Q. Have you been shown any other expert
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2010
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 22
`
` reports regarding the '194 patent?
` A. No.
` Q. And I think you've said a couple of times
` that you have experience formulating
` pharmaceuticals; is that correct?
` A. Yes.
` Q. Have any made it to market?
` A. Yes.
` Q. How many?
` A. Perhaps a dozen, I guess, something of
` that order.
` Q. What types of products are those?
` A. Ophthalmic products, dermatologicals. It
` hasn't been approved, but a liquid-filled capsule
` is at NDA stage, at NDA preparation stage, and
` then an injectable nebulize -- solution for
` nebulization that is an inhalation solution. It
` was a post-approval supplement for an oral syrup
` and an instant-release tablet. Those are the ones
` I can recall at this time.
` Q. And would you have used the Handbook in
` developing any of those?
` A. Yes. Once it became available. My
` career in the pharma industry predates the first
` edition of the Handbook. Sorry.
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2010
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 23
` Q. Fair enough. How did you -- can you give
` an example of how you used the Handbook?
` A. It depends. Obviously depends on the
` nature of the dosage form, but it's to be due --
` to familiarize myself or refamiliarize myself with
` the attributes of the monographs that are
` described in the Handbook. And that -- you know,
` some of that familiarization, refamiliarization,
` is to identify any concerns there might be and
` what might be reasonable operating ranges of -- in
` terms of the quantity of the excipients that are
` reflected here. Those would be some of the uses I
` would make -- would make use of with the handbook.
` Q. When was the last time you were involved
` in developing a liquid pharmaceutical formulation?
` A. The present.
` Q. And what aspect of the formulation are
` you involved in?
` A. The -- identifying the -- what the
` product profile is, that is what the objective is
` for the formulation; and then identifying an
` appropriate composition, that is the excipients
` that are present and their -- and their target
` levels; developing acceptance criteria, i.e.
` specifications for those formulations; aiding or
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2010
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 24
` editing, reviewing the analytical methods that
` have been developed to determine whether the
` acceptance criteria have been met or not;
` identifying contract laboratories for testing;
` contract manufacturers for manufacturing;
` developing manufacturing procedures for the
` formulation at smaller and moving to larger scale;
` putting together regulatory documents that are
` relevant, the CMC, that is Chemistry Manufacturing
` and Control sections of regulatory filings at the
` IND level and the NDA level; interacting with
` regulatory agencies such as the FDA; beginning
` prior to filing the IND through its NDA review and
` responding to questions from the FDA. And I
` basically summarized much more briefly in my CV
` than what I just articulated.
` Q. So you mentioned identifying an
` appropriate composition based on the excipients
` that are present and identifying what the product
` profile is. What -- how would you go about
` identifying the appropriate excipients in
` composition?
` A. So that is based on what the product
` profile is, what it's intended to -- what it's
` going to look like at the end of the day when its
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2010
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 25
` NDA is approved, hopefully; what excipients would
` augment the attributes of the formulation, for
` example, in a tablet composition, to identify what
` would enhance its bioavailability and/or
` stability. In the case of other dosage forms,
` there would be some other attributes. Choose -- I
` would choose excipients that are known -- either
` known to be compatible or would have a reasonable
` likelihood of being compatible with the active
` drug or drugs that are in the composition. Those
` are some of the things that -- some of the
` decisions that I would need to make. When I say
` "I would need to make," I would need to discuss,
` and as a project team, would make decisions about.
` Q. Would you consider the route of
` administration?
` A. Absolutely.
` Q. And solubility of the components?
` A. Yes.
` Q. Would you consider things that a patient
` may be more interested in, such as color of the
` product?
` A. I'm sorry?
` Q. Would you consider characteristics that a
` patient may be more interested in, such as the
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2010
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 26
`
` color of the product?
` A. Yes.
` Q. Or the taste of the product?
` A. Absolutely.
` Q. And effective amount of the drug?
` A. That's one of the first items on the
` product profile is what is the anticipated
` clinical dose or, you know, amount to be
` administered to the patient.
` Q. Have you faced any challenges when
` developing your pharmaceutical formulations?
` A. Yes.
` Q. What are some of those challenges?
` A. Incompatibility of the drug with an
` excipient. In the case of topically administered
` products, the comfort. As you identified, the
` color or its absence, and then of course just the
` stability of the drug itself under environmental
` conditions. Those are some.
` Q. Are those considerations that you'd have
` to take into account with a liquid pharmaceutical
` product as well?
` A. Yes. I was -- and my mention of this was
` quite general across the array of dosage forms
` that I've been involved in over the past decades.
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2010
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 27
` Q. And so you mentioned that the tech
` preparation would have to be taken into
` consideration, if I recall correctly. What are
` some of those different considerations that you
` might have to consider, for example, with a liquid
` pharmaceutical formulation?
` A. Are you referring to a specific type of
` liquid formulation?
` Q. I was referring to generally unless
` you -- there are specific -- let's start
` generally.
` A. One is the route of administration of
` that liquid. There are considerations to be made
` depending on the route.
` Q. Can you explain that a little bit more?
` A. The considerations that I would need to
` take into account for an ophthalmic product, for
` example, are different than I would have to take
` into account for a liquid that is topically
` applied to the skin or inhaled or injected or
` administered orally.
` Q. So can you give me some examples of what
` you would consider in an oral liquid
` pharmaceutical in comparison to a liquid topical
` formulation?
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`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2010
`
`
`
`PAUL A. LASKAR, PH.D.
`
`Page 28
` A. Liquid oral, as you've alluded to, has to
` have an acceptable taste profile in order that
` there be patient acceptance. The color is part of
` the aesthetics that would come into play for both
` oral and topical. Other aesthetics would be
` smell -- would be smell, both for oral