`
`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`
`Maureen D. Donovan
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Page 1
`
` ARGENTUM PHARMACEUTICALS LLC
` Petitioner
` v.
` CIPLA LTD.
` Patent Owner
` Patent No. 8,168,620
` IPR2017-00807
`
` Deposition of MAUREEN D. DONOVAN, PH.D., at
` the offices of Foley & Lardner, 321 North
` Clark Street, Chicago, Illinois, before
` Donna M. Kazaitis, IL-CSR, RPR, and CRR,
` commencing at the hour of 9:00 a.m. on
` Tuesday, October 24, 2017.
`
`____________________________________________________
` DIGITAL EVIDENCE GROUP
` 1730 M Street, NW, Suite 812
` Washington, D.C. 20036
` (202) 232-0646
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2017
`
`202-232-0646
`
`CIP2159
`Argentum Pharmaceuticals v. Cipla Ltd.
`IPR2017-00807
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`10/24/2017
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`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`
`Maureen D. Donovan
`
`Page 2
`
`APPEARANCES:
`ON BEHALF OF THE PETITIONER:
` FOLEY & LARDNER LLP
` BY: MICHAEL R. HOUSTON, PH.D., ESQ.
` 321 North Clark Street
` Suite 2800
` Chicago, Illinois 60654-5313
` 312.832.4378
` mhouston@foley.com
`
`ON BEHALF OF THE PATENT OWNER:
` STERNE KESSLER GOLDSTEIN FOX
` BY: UMA N. EVERETT, ESQ.
` DEBORAH STERLING, PH.D., ESQ.
` 1100 New York Avenue, NW
` Washington, DC 20005
` 202.371.2600
` ueverett@skgf.com
` dsterlin@skgf.com
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`Argentum Pharmaceuticals LLC v. Cipla Ltd.
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`Maureen D. Donovan
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`Page 3
`
` INDEX
` PAGE
`MAUREEN D. DONOVAN, PH.D.
` Examination by Ms. Everett 5
` Examination by Mr. Houston 132
`
` EXHIBITS
` PAGE
`Exhibit CIP2014 12/13/16 depo transcript, 6
` (Meda v. Apotex)
`Exhibit CIP2016 Expert Reply Report of 115
` Maureen D. Donovan, Ph.D.,
` (Meda v. Apotex)
`Exhibit CIP2019 12/14/16 trial transcript, 7
` (Meda v. Apotex)
`Exhibit CIP2020 12/15/16 trial transcript, 8
` (Meda v. Apotex)
`Exhibit CIP2030 Expert Report of 108
` Ramprakash Govindarajan, Ph.D.
`Exhibit 1002 Prosecution History 127
`Exhibit 1004 Declaration of Maureen D. 15
` Donovan, Ph.D.
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`Maureen D. Donovan
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`Page 4
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` EXHIBITS (Continued)
` PAGE
`Exhibit 1007 U.S. Patent 5,164,194, 86
` Hettche reference
`Exhibit 1008 PDR, Astelin 88
`Exhibit 1046 Imitrex label 60
`Exhibit 1048 "Efficacy of daily 67
` hypertonic saline nasal
` irrigation among patients
` with sinusitis: A
` randomized controlled
` trial," 2002
`Exhibit 1049 The Merck Index, 1989 67
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`(Witness sworn.)
` MAUREEN DONOVAN, PH.D.,
`having been first duly sworn, was examined and
`testified as follows:
` EXAMINATION
`BY MS. EVERETT:
` Q. Good morning, Dr. Donovan.
` A. Good morning.
` Q. You may recall I took your deposition
`about this time last year in the Apotex case?
` A. Yes.
` Q. So I know that you're familiar with
`the rules of the deposition, but before we go
`forward I'm just going to remind you just some
`basics.
` We obviously have a court reporter
`here today. She'll be taking down what we say.
`So I just ask that we not speak over one another.
` A. That's fine.
` Q. And if you don't understand a question
`that I ask, I would ask that you ask me to clarify
`it for the record; otherwise, I will assume you
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`understood.
` A. Okay.
` Q. Is there any reason you can't testify
`truthfully today?
` A. No.
` Q. Could you please state your full name
`for the record.
` A. Maureen Donovan.
` Q. What is your current employer?
` A. I am employed by the University of
`Iowa.
` Q. And I just mentioned I took your
`deposition last year and you were an expert
`witness in the Meda Pharmaceuticals and Cipla
`versus Apotex case; is that correct?
` A. Yes, I was.
` Q. I'm going to hand to you what's
`already been marked as CIP2014. (Document
`tendered to the witness.)
` If you can take a moment to go
`through this to confirm for me that this was your
`deposition testimony from that case, I would
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`appreciate it.
` A. Yes. With a quick review, it
`essentially looks like my deposition testimony
`from that case.
` Q. Okay. Thank you. I'm just going to
`put that to the side.
` Then we also met at trial for the
`Apotex case. Do you recall?
` A. Yes.
` Q. I'm going to hand to you what's been
`previously marked as CIP2019. (Document tendered
`to the witness.)
` Can you please go through that to
`whatever detail you need to confirm that is your
`trial testimony on Wednesday, December 14th. And
`I know you testified for a two-day period, so I
`have your second day as well and we can go through
`that in a moment.
` A. Okay. There's also Dr. Schleimer's
`testimony included in this. If that was
`intentional or not, I don't know.
` Q. And I just want you to focus on the
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`part that's yours, where you begin testifying.
` A. Okay. I see my direct testimony.
` Q. It starts on Page 72, either you can
`look at Page 72 or Page 228. Is that accurate?
` A. Yes. The only part in here is my
`direct testimony; correct?
` Q. Yes.
` A. Okay.
` Q. This is your accurate testimony from
`trial last year?
` A. You know, I'd have to read every word
`of it, but I'm going to accept that this is the
`official court recording of that testimony.
` Q. And you have no reason to doubt that
`it is actually your testimony?
` A. No, I don't.
` Q. Thank you. You can put that one to
`the side.
` I'm going to hand to you what has
`been previously marked as CIP2020. (Document
`tendered to the witness.)
` Dr. Donovan, if you can go through
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`Page 9
`this and confirm to me that this is the remainder
`of your trial testimony, I would appreciate that.
` A. It appears to be the remainder of my
`testimony, yes.
` Q. And you have no reason to doubt that
`it's not correct.
` A. No.
` Q. Dr. Donovan, when did you become
`involved -- strike that.
` You currently have been retained by
`Argentum in connection with this IPR; is that
`accurate?
` A. That's correct.
` Q. When were you retained by Argentum?
` A. Sometime earlier this year.
` Q. When were you first contacted?
` A. Again, sometime earlier this year.
` Q. January, February?
` A. Probably.
` Q. Who contacted you?
` A. Somebody from Argentum, and I don't
`remember exactly who.
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` Q. Was it Mr. Houston?
` A. No, it was not Mr. Houston in the
`initial contact.
` Q. Was it someone from the company
`Argentum?
` A. Yes, it was somebody from Argentum.
` Q. Was it Tyler Liu?
` A. I don't remember. That could very
`well be.
` Q. Do you have an agreement with
`Argentum?
` A. Yes, I do.
` Q. Who pays your -- strike that.
` Who do you send your invoices to
`for the IPR?
` A. They are sent to Argentum.
` Q. And who pays your invoices?
` A. I don't know that I really recall the
`way the check looked, but I am going to assume
`that it was an Argentum check.
` Q. Did you discuss your involvement in
`this IPR with Apotex or counsel for Apotex?
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` A. I consulted with counsel for Apotex
`before I took on the engagement for Argentum.
` Q. Who did you consult?
` A. I talked to one of the attorneys that
`was involved in the case. So I talked to Kevin
`Warner about it.
` Q. Without revealing, if you're able to
`answer without revealing any privileged
`communication, did Mr. Warner in that phone
`call -- strike that.
` How many times did you talk to
`Mr. Warner?
` A. I don't remember exactly. I think it
`may have been two times.
` Q. Okay. In the first -- what was the
`subject of your communication in the first call?
` A. I called to ask whether I was in
`conflict if I would take on this additional case.
` Q. Did he respond to you on that call?
` A. I don't recall what he said on that
`call.
` Q. You said there may have been a second
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`communication with Mr. Warner?
` A. I think the second communication
`confirmed that there wasn't a belief that I would
`be in conflict if I took on this case.
` Q. Do you recall when you had those
`conversations with Mr. Warner?
` A. It was before I signed my agreement
`with Argentum.
` Q. Are you aware of any communications
`between Argentum or counsel for Argentum and
`Apotex or counsel for Apotex?
` A. I have no basis to be aware of that.
` Q. Did Mr. Warner tell you he would speak
`to Argentum?
` A. I don't recall who he had intended to
`speak to or that he even told me.
` Q. After Mr. Warner confirmed it would
`not be a conflict, who did you speak to next that
`was connected with Argentum?
` A. I don't remember whether -- I must
`have spoken to -- I think most of my communication
`with Argentum was actually via email, and I think
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`I confirmed with them that I was willing to take
`on this matter. And shortly thereafter I started
`having conversations with the attorneys at Foley.
` Q. So when you confirmed you were willing
`to take on the matter, did you speak with someone
`at Argentum or were you speaking with counsel from
`Foley & Lardner?
` A. I don't recall.
` Q. Do you recall whether these
`conversations happened in 2016 or 2017?
` A. They happened in 2017.
` Q. Did you meet Mr. Liu at the Apotex
`trial?
` A. Not to my recollection.
` Q. Have you ever met Mr. Liu?
` A. I don't recall meeting him.
` Q. Have you ever met anyone else at
`Argentum?
` A. No, not that I recall.
` Q. Have you ever communicated with anyone
`else at Argentum?
` A. Outside of if they were copied on an
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`email.
` Q. Did anyone from Argentum or Argentum's
`counsel tell you they were going to speak with
`someone from Apotex?
` A. I don't recall that.
` Q. Do you know what steps Mr. Warner took
`or you took to confirm it was not a conflict for
`you to represent Argentum in this IPR?
` A. Again, the steps I took was to call
`the counsel I had worked with in representing
`Apotex. I don't know what steps they took to
`confirm that I was not in conflict.
` Q. Do you recall how long the timeframe
`was between the first and second conversation?
` A. It wasn't long, probably less than a
`week, but I don't remember the number of days or
`hours.
` Q. Who is your agreement -- strike that.
` You said you had an agreement that
`covers your representation -- strike that.
` You said you have an agreement that
`covers your engagement in this IPR; is that
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`correct?
` A. Yes.
` Q. Who is that with?
` A. Again, that's with Argentum.
` Q. Is it directly with Argentum?
` A. Yes, it is.
` Q. Do you know who signed that agreement?
` A. Again, I don't recall, but I think it
`was Mr. Liu or Dr. Liu, but I don't recall if
`there's other signatures or if I'm mistaken on who
`actually signed it.
` Q. Do you have a copy of that agreement?
` A. I do.
` Q. I'm going to hand to you your
`declaration which is Exhibit 1004. (Document
`tendered to the witness.)
` Is this your declaration,
`Dr. Donovan?
` A. Yes, it is.
` Q. Did you prepare this document?
` A. I prepared it in collaboration with
`counsel, yes.
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` Q. And you did your best to make sure it
`was truthful and accurate?
` A. Yes, I did.
` Q. On the last page that is your
`signature?
` A. Yes, it is.
` Q. And you signed it on February 2, 2017?
` A. Yes, I did.
` Q. So is it fair to say you spoke to
`Argentum and to Kevin Warner before February 2,
`2017?
` A. That's certainly my expectation.
` Q. Now that you've seen this, the date
`you signed, does it refresh your recollection on
`when you may have had the conversation with
`Mr. Warner?
` A. Not specifically, except it would have
`been before this.
` Q. Do you recall whether it was
`immediately after the trial in December 2016?
` A. It wasn't that close to after the
`trial, no.
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` Q. Now, I'm going to ask you to turn to
`Paragraph 12 of your declaration. It is the
`paragraph under "Summary of Opinions."
` A. Okay.
` Q. In there the first sentence says
`"Based on my investigation and analysis and for
`the reasons set forth below, it is my opinion that
`Claims 1, 4 through 6, 24 through 26, and 29 of
`the '620 Patent would have been obvious to a
`person of ordinary skill in the art at the time of
`the alleged invention," and then you go on to cite
`some references; is that accurate?
` A. Yes.
` Q. What investigation and analysis did
`you take specifically for your declaration in the
`IPR?
` A. Again, for this declaration I was told
`that I should, that essentially effective --
` MR. HOUSTON: I'm going to caution the
`witness to not reveal the substance of
`communications with attorneys, please.
` THE WITNESS: Okay. That the
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`effective date of this was about 2002 and that I
`should evaluate or that I should understand the
`state of the art, what a POSA would know in 2002,
`and then evaluate and form my opinion about the
`specific claims of the '620 Patent.
`BY MS. EVERETT:
` Q. Did you undertake any additional
`investigation or analysis over and above what you
`had done for your expert opinion in the Apotex
`trial?
` A. You know, I don't really recall what
`the overlap may have been. Certainly obviously
`there would have been overlap. There's a number
`of similar articles that I relied on for this.
`But, you know, I took on the appropriate amount of
`looking at previous, previous to 2002 materials,
`that were relevant to the claims in the '620
`Patent.
` Q. Did you go back to the materials you
`had prepared for the Apotex case to prepare your
`materials for your opinion in this IPR?
` A. I believe that most of those materials
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`are confidential. So no, I did not look at those.
` Q. Including the opinions that you
`presented in open court?
` A. I have seen those or I've seen a
`couple of versions of those again, but only what
`is available publicly or what was available as a
`part of this case. So I did not review anything
`that was submitted, anything that was used in the
`prior case.
` Q. So I just want to make sure we're on
`the same page. When you say I've seen those and
`I've seen a couple versions of those, what are you
`referring to?
` A. I've seen -- and I don't recall
`exactly which of my reports were provided to me by
`current counsel in this matter, but I have
`reviewed at least two of the reports that were
`filed in the previous matter as part of this
`matter because they were provided to me by current
`counsel.
` Q. So I just want to make sure I
`understand. So in the Apotex IPR you submitted --
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` A. In the Apotex IPR?
` Q. In the Apotex litigation. Excuse me.
` A. Okay.
` Q. In the Apotex litigation you submitted
`expert reports.
` A. Yes, I remember submitting expert
`reports.
` Q. You submitted I think three rounds of
`expert reports. And are you saying that counsel
`for Argentum provided you those, at least some of
`the expert reports you prepared in Apotex, to
`prepare your opinion for the Argentum IPR?
` A. Not to prepare my opinion, no. I've
`seen them in preparation for this deposition, but
`I did not refer to those in the preparation of my
`declaration.
` Q. And you were provided your expert
`reports by counsel for Argentum?
` A. That's who they arrived from, yes.
` Q. Do you know how counsel for Argentum
`had copies of your expert reports from the Apotex
`case?
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` A. I believe in --
` THE WITNESS: Is that privileged?
` MR. HOUSTON: Well, if it's something
`that you learned, that we told you. I think you
`can answer that question if you know.
` THE WITNESS: Okay. I think in
`conversation I learned that you had, or whomever
`you're representing, had filed them with the court
`in this IPR matter and then they were able to be
`provided to me.
`BY MS. EVERETT:
` Q. Did you in connection with your IPR
`declaration search for any additional prior art?
` A. I know that I looked at some standard
`textbooks and I probably read some additional art
`or some new art that I had not been as familiar
`with as part of the preparation for this.
` Q. And so I just want to -- one point you
`made earlier about some of these information being
`confidential. You also testified at trial; is
`that correct?
` A. Yes.
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` Q. And you know you testified publicly at
`trial?
` A. Yes.
` Q. And that the information that you
`provided or any witness provided at trial was
`public.
` A. Correct.
` Q. Are you aware of that?
` A. Uh-huh.
` Q. Did you refer back to your trial
`testimony or the testimony of anyone else in the
`Apotex trial in preparation for your declaration
`for the IPR?
` A. No, I did not.
` Q. A moment ago you testified that you
`looked at some standard textbooks and you probably
`read some additional art.
` Did you search for that art or was
`that provided to you?
` A. I don't recall. I think it's probably
`a combination.
` Q. What type of art did you search for?
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` A. Again, my search is, when I start, is
`typically in the realm of texts or treatises that
`were published around the time of the effective
`date or prior to that to understand what had been
`written as sort of general instructions to
`formulators regarding particular formulations or
`substances.
` I may have looked to become -- may
`have looked at physical properties of the
`compounds that were being described in various
`pieces of the art.
` Q. Anything else?
` A. That's all I can recall.
` Q. I'm going to have you turn to
`Paragraph 20 of your declaration. You can just
`take a moment to read that, and I have a few
`questions for you.
` A. Okay.
` Q. At the bottom of page -- sorry. Tell
`me when you're ready.
` A. That's fine, that's fine.
` Q. At the bottom of Page 7, and this
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`would be your numbers, I know there's two sets of
`numbers, but your numbers, there's a sentence
`"Nasal sprays contain a solution and/or a
`suspension of the active ingredient in a vehicle
`which may include a mixture of excipients such as
`preservatives, buffers, emulsifiers, solubilizing
`agents, viscosity modifiers, humectants, and
`others."
` A. That's what it says.
` Q. Every nasal spray does not necessarily
`contain each one of these excipients you listed;
`is that accurate?
` A. That's accurate. Every nasal spray is
`probably, has some components that are listed but
`doesn't necessarily have all of the components
`that are listed.
` Q. So a formulator would have to make a
`decision and a choice of what to include or what
`not to include?
` A. Typically, yes.
` Q. And they would do that because they
`are aiming for sort of an end product and they
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`would want a spray that achieves certain
`characteristics?
` A. Well, formulators have multiple goals
`for why they might combine materials to prepare a
`formulation. So depending on what those goals are
`drives often times what's included in that
`formulation.
` Q. Then your next sentence says "A nasal
`spray must be formulated so that" and then you
`have three characteristics and I want to take each
`of them one by one.
` The first one is "the spray pump
`can reliably deliver the same amount of active
`ingredients with each actuation."
` A. That's what it says, yes.
` Q. And why is that important?
` A. Because the dose that's administered
`is a reflection of the formulation and the device
`that it's contained in. And so we rely on the
`device to be able to reproducibly emit a
`particular volume so that we know that the dose
`being emitted is the dose that was designed in the
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`formulation to be administered.
` Q. And the formulation itself could
`effect the amount of active ingredient that's
`delivered to each actuation; is that correct?
` A. Can you reask that, please?
` Q. Sure. Are there certain properties of
`the formulation that could affect whether
`the -- strike that.
` So is it fair to say -- to give
`point 1 a shorthand we can call that dose
`uniformity?
` A. It certainly is a component of dose
`uniformity, yes.
` Q. So for dose uniformity, a moment ago
`you were talking about the spray, the qualities of
`the device. Do you recall that?
` A. I mentioned something about the device
`and the formulation acting together to determine
`the dose, yes.
` Q. And the formulation could potentially
`on its own affect whether the dose is uniform; is
`that accurate?
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` A. Well, again, it's the combination of
`the formulation and the device that's emitting
`that formulation that determine the dose that's
`emitted.
` Q. Right. So the device is because the
`dose is administered through the device, is
`that --
` A. Yes.
` Q. Okay. But the formulation itself has
`to have some sort of uniformity before it is
`sprayed through the device; is that accurate?
` A. I'm not sure that that's accurate in
`all cases, but it depends on the device design.
` Q. What do you mean "it depends on the
`device design"?
` A. There are likely devices that are
`designed to do things with whatever is intended to
`be sprayed such that they have some influence on
`the uniformity or combination or something, but
`there are more technically developed devices that
`do a number of things that perhaps the simplistic
`devices that we're most familiar with as consumers
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`don't necessarily do.
` Q. You are opining on the '620 Patent; is
`that correct?
` A. For this declaration, yes, I am
`opining on the '620 Patent.
` Q. And that's a formulation patent?
` A. I don't usually participate in
`qualifying a patent using adjectives. That's out
`of my realm.
` Q. You didn't opine on or see any claims
`directed to a device?
` A. I guess I'd have to take a look at the
`'620 Patent to determine that.
` Q. Actually, I'm going to have you look
`back to your own declaration, Page 6, where you
`describe the '620 Patent.
` A. Okay.
` Q. You can tell me when you've had a
`chance to review.
` A. All right.
` Q. Does this refresh your recollection
`that the '620 Patent is about a pharmaceutical
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`formulation?
` A. Not specifically. I would still like
`to take a look at the '620 Patent and then have
`you help me understand what you mean by
`formulation patent.
` Q. Do you see Paragraph 18 where you say
`"a pharmaceutical formulation comprising"?
` A. Well, that's a repetition of Claim 1.
`But I think there are more than one claims in the
`'620 Patent.
` Q. You don't talk about devices anywhere
`in your description of the '620 Patent; do you?
` A. In Paragraphs 18 and 19, no.
` Q. 16 through -- strike that.
` A. Or 16 through 19, no.
` Q. In your entire section in your
`description of the '620 Patent, you don't talk
`about a device; do you?
` A. I don't point out anything specific
`about devices in Paragraphs 16 through 19.
` Q. So I'd like to go back to 20 and focus
`on formulation, the effects of formulation.
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` A. So Paragraph 20? Page 20?
` Q. Paragraph 20, where we were.
` A. Okay.
` Q. So for dose uniformity, there are a
`number of factors that affect whether the
`formulation is uniform; is that true?
` MR. HOUSTON: Objection, beyond the
`scope.
` THE WITNESS: Can you repeat the
`question, please?
`BY MS. EVERETT:
` Q. I'll rephrase it.
` So in Section 1 we said for
`shorthand we can talk about dose uniformity.
` A. Well, in Section 1 I think -- why
`don't you read back to me what I said about that
`last statement?
` Q. Can you be more specific about what
`you would like read back?
` A. I said something in response about
`dose uniformity when we were talking about point
`number 1 previously and I'd like to be reminded of
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`what I said.
` (The record was read back as
` requested.)
` THE WITNESS: I said it was a
`complement of dose uniformity.
`BY MS. EVERETT:
` Q. And you referred to the device and the