IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`Page 1
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`AMNEAL PHARMACEUTICALS, LLC, )
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`and AMNEAL PHARMACEUTICALS OF ) IPR2018-00608
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`NEW YORK, LLC, ) Patent No.
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` ) 9,161,926
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` Petitioners, )
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` )
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`vs. )
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` )
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`ALMIRALL, LLC, )
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` )
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` Patent Owner. )
`
`_________________________________)
`
` DEPOSITION OF ALEXANDER M. KLIBANOV, PH.D.
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` San Diego, California
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` Wednesday, March 13, 2019
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`Stenographically reported by:
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`Tricia Rosate, RDR, RMR, CRR, CCRR
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`CSR No. 10891
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`Job No. 156070
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`TSG Reporting - Worldwide 877-702-9580
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`AMN1058
`Amneal v. Almirall, LLC
`IPR2018-00608
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`A P P E A R A N C E S:
`For the Petitioners:
` STERNE, KESSLER, GOLDSTEIN & FOX
` 1100 New York Avenue
` Washington, D.C. 20005
` BY: DENNIES VARUGHESE, Pharm.D.
` ADAM LaROCK, ESQ.
`
`For the Patent Owner:
` FENWICK & WEST
` 1191 Second Avenue
` Seattle, Washington 98101
` BY: ELIZABETH HAGAN, PH.D.
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` SAN DIEGO, CALIFORNIA; WEDNESDAY, MARCH 13, 2019
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` 8:58 A.M. - 1:20 P.M.
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` - - - -
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` Wednesday, March 13, 2019
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` 8:58 a.m.
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` DEPOSITION OF ALEXANDER M. KLIBANOV, PH.D.,
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`taken at Regus, 350 Tenth Avenue, Suite 1000, San Diego,
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`California, commencing at 8:58 a.m. and concluding at
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`1:20 p.m., Wednesday, March 13, 2019, before
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`Tricia Rosate, RDR, RMR, CRR, CCRR, CSR 10891,
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`a Certified Shorthand Reporter.
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` I N D E X
`WITNESS: Alexander M. Klibanov, Ph.D.
`EXAMINATION PAGE
`By Mr. Varughese ........................ 5
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` ALEXANDER M. KLIBANOV, PH.D.,
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` having been first duly sworn, testified as follows:
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` EXAMINATION
`
`BY MR. VARUGHESE:
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` Q. Good morning, Dr. Klibanov.
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` A. Good morning, Mr. Varughese.
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` Q. Can you state your name for the record, your
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`full name.
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` A. Alexander M. Klibanov, K-l-i-b-a-n-o-v.
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` Q. And have you testified before in deposition?
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` A. Yes.
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` Q. About how many times?
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` A. Quite a few times.
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` Q. Would you say more than ten?
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` A. Over what period of time?
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` Q. Your career.
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` A. Yes.
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` Q. More than 20?
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` A. Yes.
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` Q. More than 30?
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` A. I'm not sure.
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` Q. Fair to say between 20 and 30, roughly?
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` E X H I B I T S
`EXHIBIT DESCRIPTION PAGE
`Exhibit 1001 United States Patent 42
` No. 9,161,926
`
`Exhibit 1004 Patent, WO 2009/061298 50
`
`Exhibit 1017 Certification and Request 99
` For Prioritized Examination
`Exhibit 1051 List of clerical errors 9
`Exhibit 2003 Declaration of Professor 7
` Alexander M. Klibanov In
` Support of Patent Owner's
` Response to Petition For
` Inter Partes Review
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` A. May be fair. I don't know how accurate it is.
` Q. Of those cases, how many were patent cases?
` A. All.
` Q. How many times have you testified at trial,
`would you say?
` A. Over what period of time?
` Q. Your career.
` A. I would say maybe between a dozen and two dozen
`times.
` Q. Okay. So you're generally familiar with the
`process of a deposition. I'll ask you questions. You'll
`let me finish asking the questions. You'll answer the
`questions. If you don't understand the questions, you'll
`ask me for clarification?
` A. Well, I -- what you just said sort of seems
`inherently unfair because you said that I'll let you
`finish your question, but you didn't say that you'll let
`me finish my answer.
` Q. I didn't say I wouldn't let you finish the
`answer, either.
` A. But if you found it necessary to say that I'll
`let you finish your answer -- your question, then it
`seems reasonable for you to say that you'll let me finish
`my answer.
` Q. I think that sounds reasonable. So it looks
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`like you and I are both two reasonable guys here today,
`huh?
` A. I can only speak for myself.
` Q. Okay.
` MR. VARUGHESE: Can I get a copy of the
`declaration?
` Q. Dr. Klibanov, I'm going to mark -- or I'm going
`to hand you what's been marked as Almirall Exhibit 2003.
` A. Thank you.
` (Exhibit 2003 was referenced.)
`BY MR. VARUGHESE:
` Q. Do you recognize this document?
` A. It seems to be a copy of my IPR declaration
`minus the exhibits and attachments. And so, before you
`continue, let me just say that there is a clerical error
`that I found in my declaration in preparation for my
`deposition, a clerical error that unfortunately is
`repeated several times, for which I apologize, and I'd
`like to correct this clerical error for the record before
`we proceed with the deposition.
` Q. Sure. Please.
` Before you start, Dr. Klibanov, I just want to
`note for the record that you took out a piece of paper
`that looks like you have some notes on it. I'm going to
`ask that that be marked at this deposition.
`
`Page 9
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`Page 8
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` A. I'll be flattered.
` Q. Okay. Please proceed.
` A. So, as I said, it's basically one error, which
`unfortunately was repeated several times, and the error
`itself is that it says "comprising"; whereas, in fact, it
`should have said "consisting of."
` In one instance, which I will specifically
`denote, it's actually "comprise," which actually should
`have been "consists of."
` And this clerical error is made in the following
`places in my declaration. First there's page 9 -- and
`so, as I state them, I will also correct them in the copy
`of the declaration that I have in front of me.
` So the first one is page 9, paragraph 14, third
`bullet point on that page, second line. So instead of
`"comprising," it should be "consisting of."
` The second is page 61, paragraph 137, third
`bullet point, second line. Again, same clerical error,
`"consisting of" should be instead of "comprising."
` Next one is -- next page is page 79 --
` Q. Hang on. Before you move on --
` Thank you. Go ahead.
` A. The next one is then page 79, title of the
`subsection there. It's subsection 3, the second line.
`Again, instead of "comprising," it should have been
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`"consisting of."
` Next one on the same page, page 79,
`paragraph 170, both in the first and the third lines.
`Instead of "comprising," it should be "consisting of."
` Next one is page 80, paragraph 171. In the
`first line, it says "comprise," which should be "consists
`of" -- "consist of."
` And in the third line, instead of "comprising,"
`it should be "consisting of."
` Next one is page 82, paragraph 176. It's the
`sixth line. Again, instead of "comprising," it should be
`"consisting of."
` The next line is -- and that's the last page
`where this clerical error has been made. It's page 91.
`First of all, the title of subsection 3, instead of
`"comprising," "consisting of."
` Also paragraph 195, the third line, instead of
`"comprising," "consisting of."
` And, finally, paragraph 196, third line, instead
`of "comprising," again, "consisting of."
` So that's all. And I apologize for this
`clerical error, and I am pleased to hand over to you the
`notes that I made for myself.
` MR. LaROCK: That will be AMN1051.
` (Exhibit AMN1051 was marked for identification.)
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`BY MR. VARUGHESE:
` Q. Thank you for that, Dr. Klibanov.
` Is there any other errors that you wish to
`correct in your declaration?
` A. Well, first of all, I don't view those as
`errors. I think it's one clerical error that
`unfortunately was repeated several times.
` And, second of all, the answer to your question
`is no.
` Q. When did you -- strike that.
` I'm going to refer to it as an error. Do you
`want me to call it something else? Is it an error?
` A. I would like to call it a clerical error.
` Q. Okay. When did you become aware of this
`clerical error?
` A. When I started preparing for this deposition the
`other day.
` Q. Do you remember which day?
` A. I believe it was -- so today is Wednesday, so
`that was Monday.
` Q. Was it brought to your attention by an attorney
`or anyone else?
` A. No. I discovered it myself, and then yesterday,
`when I was preparing for this deposition with Dr. Hagan
`here, I mentioned it to her.
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` Q. And who wrote these errors in the first -- these
`clerical errors in the first place? Was that you, or was
`it somebody else?
` A. I'm not sure I understand the question.
` Q. What part don't you understand?
` A. You said, "Who wrote these errors?" And it just
`doesn't make sense to me.
` Q. Someone wrote the declaration; right?
` A. I wrote my declaration. Yes.
` Q. So you typed up every word of this declaration?
` A. No. I typed many words of this declaration.
`Some others, I dictated or explained what I want stated.
` Q. Okay. Did anyone else type or dictate any part
`of this declaration?
` A. I presume that a secretary in the law firm did
`some typing because, as I said, I only typed portions of
`this declaration. But whoever typed whatever portion,
`it's my responsibility, and that's why I sincerely
`apologize for that.
` Q. And so these nine clerical errors, did you type
`or dictate those errors, or did somebody else?
` A. There's no nine clerical errors. There is one
`clerical error that was repeated several times. And I
`don't remember the exact nitty-gritty of that.
` Q. Repeated nine times; correct?
`
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` A. Well, there are nine bullet points. In some of
`those places, it was actually more than once.
` Q. So more than nine. Yes?
` A. I mean, I just said that there are nine places
`where -- nine pages where this clerical error is made
`and, in some of them, more than once.
` Q. So more than nine instances, that clerical error
`appears in your declaration; correct?
` A. Correct.
` Q. Let's turn to page 13 of your declaration.
` A. Just a second. I'm looking at the bottom of the
`page, and there are two sets of numbers. There is one
`number that was actually my number that I put there, and
`then there's another one that says, for example, "7 of
`108." So when you refer to page number, what number do
`you refer to?
` Q. Fair enough. Thanks for that. I'm going to be
`referring to what you called your number, which, for the
`record, will be the number on top.
` So there are two numbers. The bottom number is
`what we're going to call the Bates number, and the top
`number is what we're going to refer to as your number.
`So I'll be referring to your number unless I say
`otherwise.
` A. So, actually, they are both at the bottom of the
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`page, but one is higher than the other; right?
` Q. Correct.
` A. Okay.
` Q. Yeah.
` A. So page 9?
` Q. Page 13.
` A. Oh, 13. I'm sorry.
` Q. No problem.
` So, specifically, I want to draw your attention
`to the remainder of paragraph 27 in your declaration.
` You see the very first line. There's a phrase
`there. It says "wherein the composition does not
`comprise adapalene"? Do you see that?
` A. Yes.
` Q. So is this the last part of claim 1 of the '926
`patent?
` A. Yes, that is the end of claim 1 of the '926
`patent.
` Q. And would you agree if I were to say that that's
`the last limitation of claim 1 of the '926 patent?
` A. So where the last limitation starts with the
`word "wherein"?
` Q. Correct.
` A. I mean, again, I'm not an attorney or a legal
`expert, but it seems reasonable to me.
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` Q. Okay. That last limitation -- and I'm going to
`repeat it for the record -- "wherein the composition does
`not comprise adapalene," what does that limitation mean
`to you?
` A. That the claim composition doesn't comprise
`adapalene.
` Q. So would that be adapalene and dapsone in a
`single formulation, that the claimed composition does not
`have both of those actives in a single formulation?
` A. I'm sorry. I don't understand the question.
` Q. What part don't you understand?
` A. The question makes no sense to me.
` Q. Well, help me help you understand. So tell me
`what doesn't -- what you don't understand about it.
` A. If I don't understand something, I don't know
`what it means. So, I mean, I can't help you because I
`don't know what it is that you want to ask me. It
`specifically says "wherein the composition does not
`comprise adapalene." So it means that the claim
`composition does not comprise adapalene. I think it's
`crystal clear.
` Q. So, Dr. Klibanov, I just want to be very up
`front with you. We have a limited amount of time for
`this deposition. I'm going to be asking you quite a bit
`of complicated questions. If you're going to simply say
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`Page 16
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`understand my notice; that, if you do waste our time
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`here, we will bring you back here again for a second
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`deposition, and we will let the board decide whether you
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`you don't know to a bunch of them and we're going to use
`up all our time, we're going to ask the board to bring
`you back for a second deposition or we may call the board
`today.
` So it's up to you. I'm not here to play any
`word games with you. I'm going to use plain English. If
`there's a part of my question you don't understand,
`please let me know what part of that you don't
`understand. Is that okay?
` A. Okay. Let me say, first of all, you don't need
`to threaten me.
` Second of all, I'm not afraid of your threats.
`We'll spend whatever time we have here. My objective --
`since I, in contrast to you, am under oath here, my
`objective is to give the best -- the most precise answers
`I can, and we will spend whatever time we need, whether
`it's today or subsequently.
` If I don't understand the question and the
`question doesn't make sense to me, I don't know how to
`explain to you what it is about the question that I don't
`understand. As I already said, it doesn't make sense to
`me. And I'm not playing word games with me [as said].
`I'm sure you will not be playing word games with me.
` Q. So, Dr. Klibanov, I wasn't making threats. I
`was putting you on notice, and it appears that you
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`are being reasonable or not.
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` A. Okay. And I resent the statement that I'm
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`wasting anybody's time. I think you are actually wasting
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`time now by arguing about things that are not worth
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`arguing about.
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` Q. So let's go back to my question.
`
` The word "composition," do you have an
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`understand whether that's talking about a single
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`formulation or not?
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` A. It refers to what was in line 1 of claim 1,
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`where it says "A topical pharmaceutical composition
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`comprising:" and then it says, again, the limitation that
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`we're discussing now "wherein the composition."
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` So that's that same composition that mentioned
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`in the first line of the claim.
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` Q. So I'm going to ask my question again.
`
` Does the word "composition" in claim 1, to you,
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`mean a single formulation?
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` MS. HAGAN: Objection. Asked and answered.
`
` THE WITNESS: I mean, to me, the word
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`"composition" in this claim, and typically in general, is
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`synonymous with the word "formulation." So we're talking
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`about this particular -- composition of this particular
`formulation.
`BY MR. VARUGHESE:
` Q. Okay. So let's say there's a formulation that
`has dapsone as the only active ingredient. Would that
`meet that limitation, in your opinion?
` MS. HAGAN: Objection. Vague.
` THE WITNESS: So it contains dapsone as the sole
`active pharmaceutical ingredient, and it also contains
`the excipients that are listed in claim 1, but it does
`not contain adapalene.
` Is that the question?
`BY MR. VARUGHESE:
` Q. No.
` My question was: Let's say we have a
`pharmaceutical formulation that has dapsone as the only
`active ingredient. Would that meet that limitation?
` A. But it can also contain excipients; correct?
` Q. Sure.
` A. Well, as I just said, if it contains dapsone as
`the only active ingredient and it also contains the
`excipients that are listed, then it will meet this
`limitation because it clearly will not comprise
`adapalene.
` Q. So let's say we have a formulation that has
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`of two words. Okay. So Dr. Michniak-Kohn, so two words.
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`The first one is M-i-c-h-n-i-a-k, hyphen, Kohn, K-o-h-n.
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` And there was also another expert on behalf of
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`Amneal. Dr. Gilmore, G-i-l-m-o-r-e.
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` So the focus of my declaration was to address
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`the points that they have addressed in their declarations
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`alleging the obviousness of the '926 patent. I do not
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`recall them focusing on this particular point.
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` Q. Now, you understand that this is a declaration
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`that you've provided in this inter partes review;
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`correct?
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` A. Yes.
`
` Q. And this inter partes review is over the '926
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`patent; correct?
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` A. That's correct.
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` Q. And you submitted this declaration for the
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`board -- and by "the board," I mean the Patent Trial and
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`Appeal Board that is presiding over this inter partes
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`review -- to consider; correct?
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` A. Correct.
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` Q. And you've held yourself out as an expert in,
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`dapsone as one active ingredient and has another active
`ingredient, and I'll say, for example, clindamycin.
` Would that meet that limitation of claim 1?
` MS. HAGAN: Objection to form.
` THE WITNESS: I mean, I haven't specifically
`considered that question, but it seems to me that since,
`in the first line of the claim, it says "comprising,"
`then I -- just sitting here looking at it, thinking about
`this question, I don't see a reason why it wouldn't
`contain -- it could not contain another active ingredient
`as long as this active ingredient is not adapalene.
` But, as I said, I hadn't really considered this
`question in preparation of my declaration.
`BY MR. VARUGHESE:
` Q. But you have looked at the claims in preparation
`for your declaration in this deposition; right?
` A. I certainly have.
` Q. Okay. And you've compared the claims to other
`teachings and literature in the art?
` MS. HAGAN: Objection to form.
` THE WITNESS: That is correct; however, the
`point of my declaration was really respond [as said] to
`Dr. Michniak-Kohn declaration. Let me spell the name for
`the court reporter here.
` So it's basically -- it's a name which consists
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` A. I just want --
` MS. HAGAN: Objection to form.
` THE WITNESS: I just want to present my
`declaration to the board, and the board will see whatever
`it sees fit.
`BY MR. VARUGHESE:
` Q. Well, do you want the board to believe you?
` MS. HAGAN: Objection to form.
` THE WITNESS: I cannot dictate the board what to
`do. I certainly did my best to provide the best facts
`and analysis in response to Dr. Michniak-Kohn's and
`Dr. Gilmore's declarations. And I hope that the board
`believes me, but the board will decide what the board
`wants to do.
`BY MR. VARUGHESE:
` Q. Great.
` And you want the board to believe that you're an
`expert in the field of pharmaceutical formulations;
`correct?
` MS. HAGAN: Objection to form.
` THE WITNESS: I think I presented the evidence
`to that effect. And, again, I will let the board decide
`for itself.
`BY MR. VARUGHESE:
` Q. And as an expert in pharmaceutical formulations,
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`among other things, pharmaceutical formulation; correct?
`
` A. Yes.
`
` Q. And you want the board to credit your opinions;
`
`correct?
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`Page 21
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`you can't tell me whether that limitation encompasses a
`formulation that has dapsone and another ingredient like
`clindamycin?
` MS. HAGAN: Objection to form.
` THE WITNESS: First of all, I already answered
`that question, and I specifically told you two things:
`that, first, I didn't consider that issue because
`Dr. Michniak-Kohn and Dr. Gilmore have not focused it,
`and my declaration was in response to theirs.
` And second of all, I said that, sitting here
`today, without having considered that previously, I don't
`see a reason why -- since there is a word "comprising" in
`the first line of the claim, why another active
`pharmaceutical ingredient in addition to dapsone could
`not be present as long as it's not adapalene.
`BY MR. VARUGHESE:
` Q. Okay. So that limitation, would you agree that
`it excludes any formulation that has dapsone and
`adapalene as two active ingredients?
` A. When you're saying "that limitation," you're
`referring to "wherein the composition does not comprise
`adapalene"?
` Q. Correct.
` A. I mean, I just -- this limitation to me just
`says that adapalene is not present.
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` Q. So do you agree or disagree with my question?
` MS. HAGAN: Objection to form.
` THE WITNESS: I would not agree with your
`question as stated.
`BY MR. VARUGHESE:
` Q. What part of my question do you disagree with?
` A. I don't see what dapsone has to do with this
`particular limitation. This limitation does not mention
`dapsone. Dapsone is mentioned previously in the claim;
`and, therefore, to me, this limitation is specifically
`directed to adapalene.
` Q. This limitation doesn't say anything about
`excipients, either; right?
` A. That's correct.
` Q. But in answering my previous question, you
`talked about excipients in other parts of the claim,
`didn't you?
` A. But I'm talk --
` MS. HAGAN: Objection to form.
` THE WITNESS: Excuse me.
` I'm talking about active pharmaceutical
`ingredients now, and even previously I specifically said,
`in addition to active pharmaceutical ingredients, there
`are also some excipients.
`///
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`BY MR. VARUGHESE:
` Q. So the claim covers a dapsone formulation.
`Would you at least agree with me on that?
` And if you haven't considered that, that's fine,
`too.
` A. The claim -- claim 1 of the '926 patent covers
`an adapalene formulation. Correct.
` Q. And this limitation --
` A. I'm sorry. A dapsone formulation. I stand
`corrected.
` Q. Sure. Thank you.
` And this limitation that we've been discussing,
`the quote "wherein the composition does not comprise
`adapalene," that's a limitation of claim 1; correct?
` A. As I understand it, it's a limitation of
`claim 1. Yes.
` Q. And my question to you, as someone who's holding
`himself out as an expert to the board, is whether that
`limitation would exclude a formulation that has dapsone
`and adapalene as two active ingredients.
` A. And, as I already said -- and I will say it once
`again -- I read this limitation as directed only to
`adapalene. It doesn't say anything about dapsone; and,
`therefore, in my opinion, just as I said a moment ago,
`this particular limitation simply excludes adapalene as
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`an active pharmaceutical ingredient.
` Q. It excludes adapalene in a formulation as an
`active pharmaceutical ingredient?
` A. It excludes adapalene in a formulation or in a
`composition as an active pharmaceutical ingredient.
` Q. How about co-administration with adapalene in a
`separate formulation? And to be more specific, what I'm
`talking about is you have one tube of medicine that has
`dapsone and you have a separate tube of medicine that has
`adapalene and a patient is co-administering those.
` Would that limitation exclude that, or do you
`not have an opinion about that?
` MS. HAGAN: Objection to form.
` You may answer.
` THE WITNESS: I don't have a considered opinion
`on that because it seems to me -- but it seems to me that
`this particular claim deals with one specific composition
`or specific formulation, and that's the formulation
`that's in question here.
` It doesn't talk about administration. It
`doesn't talk about other formulations that -- or
`compositions that may be co-administered.
`BY MR. VARUGHESE:
` Q. So you don't know whether that limitation
`excludes co-administration with adapalene?
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` MS. HAGAN: Objection to form.
` THE WITNESS: I have nothing to add to the
`answer that I just provided.
`BY MR. VARUGHESE:
` Q. Okay. Could you turn to page 18, paragraph 41,
`of your declaration, sir.
` A. Okay. Let me read this paragraph to myself.
` Yes, sir.
` Q. So this paragraph, 41, you discuss your views on
`what a person of ordinary skill in the art would be for
`this '926 patent; correct?
` A. Yes. It's one of the two paragraphs where I
`discuss this issue.
` Q. Okay. And then you provide two different
`potential definitions of a -- and -- strike that.
` For simplicity, can I refer to a person of
`ordinary skill in the art as a POSA?
` A. That's fine with me.
` Q. So you provide two definitions of what a POSA
`would be for this case there; correct?
` A. I wouldn't put it that way.
` Q. How would you put it?
` A. Well, I would say that I give, here, three
`alternative scenarios, all three of which would fall
`under what I would consider, in the context of the '926
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`patent, to be a POSA.
` Q. So in paragraph 41, do you see you have a little
`(i) there?
` A. Yes.
` Q. And later on, you have a little (ii) there?
` A. Correct.
` Q. So is that not, (i) and (ii), different
`definitions? Is that something else now?
` A. Well, if you read the one under (i,) it says
`"a bachelor- or master-level degree in chemistry," and
`(ii) says "a doctoral degree in chemistry," and so forth.
` So the three scenarios that I just mentioned are
`a bachelor's degree with some experience, a master's
`degree and some experience, and a doctoral degree and
`some experience.
` Q. So why didn't you use three Roman numerals
`there? Why did you use two?
` MS. HAGAN: Objection to form.
` THE WITNESS: I mean, I frankly hadn't given it
`a tremendous amount of thought, but that just seems like
`a reasonable way to divide it.
`BY MR. VARUGHESE:
` Q. So you're saying that you have three different
`definitions there; is that correct?
` A. Again, I -- nothing to add to what I already
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`said. I said it could be a bachelor-level scientist in
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`the corresponding disciplines with at least three
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`levels of -- three years of experience; it could be a
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`master's-level scientist in the disciplines listed and at
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`least three years of experience; and it could be a
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`doctoral degree -- doctoral-level degree scientist with
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`some experience in the corresponding areas.
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` Q. And so I'm counting three definitions. One,
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`two, three. Are you not going to agree with those three
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`there, or you don't like that?
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` A. Well, I was --
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` MS. HAGAN: Objection to form.
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` THE WITNESS: I was the one who said it in the
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`first place. You said two, and I corrected you by
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`saying, "No, it's not two. It's three."
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` So you're repeating what I said previously. I
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`certainly agree with what I said previously.
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`BY MR. VARUGHESE:
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` Q. I was trying to have just a clean record. So I
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`asked you, "Is there three definitions?" And you seemed
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`to disagree. So I guess we're back to agreeing now?
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` MS. HAGAN: Objection to form.
`
` THE WITNESS: Okay. I stand by what I said
`
`initially to your question. We have three possibilities,
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`all of which would fall under what I would view as a POSA
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`in the case of the '926 patent.
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`BY MR. VARUGHESE:
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` Q. And in all three definitions, you include that
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`the POSA might have at least three years of experience in
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`pharmaceutical formulations.
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` Do you see that?
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` A. I do not see that. In fact, it's demonstrably
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`wrong.
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` Q. Okay. What's wrong?
`
` A. In the first two, it says "plus at least three
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`years of experience."
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` In the third one, it says "plus some
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`experience."
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` It doesn't say "three years."
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` Q. Okay. So what is it -- in the third definition,
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`how many years of pharmaceutical formulations experience?
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` A. It could be one or two years. I mean, it's less
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`than three.
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` Q. Could it be less than one?
`
` A. I would say one or two years.
`
` Q. Have you given it thought before today?
`
` A. Yes.
`
` Q. Why didn't you include a specific time frame?
`
` A. I didn't think --
`
` MS. HAGAN: Objection to form.
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` THE WITNESS: Excuse me.
` I can't answer that question. I thought that
`it's very clear. When read in the context and when read
`with a mind willing to understand, I think it will be
`clear that since -- for a bachelor's or master's degree,
`it will be at least three years of experience; for a
`doctoral degree, which is a higher level of education,
`when I say "some," it will be less than three; and
`therefore we're talking about one or two.
`BY MR. VARUGHESE:
` Q. So can you explain what your definition of
`pharmaceutical formulations experience would be?
` A. Somebody who has worked or at least have studied
`drug delivery, pharmaceutical formulations, or a related
`field.
` Q. So someone who has experience in formulating
`drugs?
` A. It could be. Yes.
` Q. Would that person also have experience
`formulating topical drugs?
` A. Not necessarily.
` Q. So you don't think that someone needs to have
`experie