UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`1
`
`Mylan Technologies, Inc., )
` )
` Petitioner, ) Case No.
` ) IPR2017-00200
`vs. )
` )
`MonoSol RX, LLC, )
` )
` Patent Owner. )
`______________________________)
`
` VIDEOTAPED DEPOSITION OF GRAHAM BUCKTON, Ph.D.
` San Diego, California
` July 17, 2017
` 9:09 a.m.
`
` Reported by:
` Tricia Rosate, RDR, RMR, CRR, CCRR
` Job No. 51121
`
`Mylan v. MonoSol
`IPR2017-00200
`MonoSol Ex. 2008
`Page 1
`
`

`

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`1
` VIDEOTAPED DEPOSITION OF GRAHAM BUCKTON, PhD,
`2
`taken at 11682 El Camino Real, San Diego, California,
`3
`commencing at 9:09 a.m. and concluding at 2:42 p.m.,
`4 Monday, July 17, 2017, before Tricia Rosate, RDR, RMR,
`5
`CRR, CCRR, CSR 10891, a Certified Shorthand Reporter.
`
`678
`
` I N D E X
`9 WITNESS: Graham Buckton, PhD
`10
`EXAMINATION PAGE
`11
`By Mr. Brahma ............................... 6, 151
`12
`By Mr. Mills ............................... 177
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`
` E X H I B I T S
`EXHIBIT DESCRIPTION PAGE
`Exhibit 1 Declaration of Graham Buckton, PhD 8
`Exhibit 2 Research paper "In-Vitro studies 14
` on Buccal strips of Glibenclamide
` using Chitosan"
`Exhibit 3 International Application Publication 14
` Under The Patent Cooperation Treaty
` (PCT), International Publication
` Number: WO 00/42992
`
`Exhibit 4 United States Patent No. 174
` US 8,603,514 B2
`
`5
` SAN DIEGO, CALIFORNIA; MONDAY, JULY 17, 2017
` 9:09 A.M. - 2:42 P.M.
` - - - -
` THE VIDEOGRAPHER: This begins the
`videotaped deposition of Graham Buckton in the matter
`of Mylan Technologies, Inc., vs. MonoSol RX, LLC, in
`the United States Patent and Trademark Office before
`the Patent and Appeal Board.
` This deposition is being held at
`11682 El Camino Real, Suite 400, San Diego,
`California 92130, on July 17, 2017, at approximately
`9:09 a.m.
` My name is David Wright from the firm
`David Feldman Worldwide, and I am the legal video
`specialist. The court reporter is Tricia Rosate in
`association with David Feldman Worldwide.
` Will counsel please introduce themselves.
` MR. BRAHMA: Charan Brahma from
`Troutman Sanders on behalf of patent owner and real
`party in interest.
` MR. CROCKETT: Craig Crockett from
`Troutman Sanders.
` MR. LADOW: Daniel Ladow, Troutman Sanders.
` MR. ELIKAN: Jeffrey Elikan, Covington &
`Burling.
`
`2 (Pages 2 to 5)
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`A P P E A R A N C E S:
`For the Petitioner MYLAN TECHNOLOGIES, INC.:
` WILSON SONSINI GOODRICH & ROSATI
` 701 Fifth Avenue
` Suite 5100
` Seattle, Washington 98104-7036
` 206/833-2500
` BY: JAD A. MILLS, ESQ.
` jmills@wsgr.com
` - and -
` WILSON SONSINI GOODRICH & ROSATI
` 12235 El Camino Real
` Suite 200
` San Diego, California 92130-3002
` 858/350-2300
` BY: ELHAM FIROUZI STEINER, ESQ.
` esteiner@wsgr.com
` - and -
` WILSON SONSINI GOODRICH & ROSATI
` One Market Plaza
` Spear Tower
` Suite 3300
` San Francisco, California 94105-1126
` 415/947-2000
` BY: DAVID M. HANNA, ESQ.
` dhanna@wsgr.com
` T.O. KONG, ESQ.
` tkong@wsgr.com
`
`For the Patent Owner and Real Party In Interest
` MONOSOL RX, LLC:
` TROUTMAN SANDERS, LLP
` 580 California Street
` Suite 1100
` San Francisco, California 94104-1032
` 415/477-5700
` BY: CHARANJIT BRAHMA, ESQ.
` charanjit.brahma@troutmansanders.com
` CRAIG C. CROCKETT, ESQ.
` craig.crockett@troutmansanders.com
`
`2
`
`3
`
`A P P E A R A N C E S (Continued):
`For the Patent Owner and Real Party In Interest
` MONOSOL RX, LLC:
`
` TROUTMAN SANDERS, LLP
` 875 Third Avenue
` New York, New York 10022
` 212/704-6000
` BY: DANIEL A. LADOW, ESQ.
` daniel.ladow@troutmansanders.com
`
`For MONOSOL RX, LLC:
` STEPTOE & JOHNSON, LLP
` 115 South LaSalle Street
` Suite 3100
` Chicago, Illinois 60603
` 312/577-1300
` BY: JOHN L. ABRAMIC, ESQ.
` jabramic@steptoe.com
`
`For INDIVIOR INC. & INDIVIOR UK LIMITED:
` COVINGTON & BURLING, LLP
` One City Center
` 850 Tenth Street, NW
` Washington, D.C. 20001-4956
` 202/662-6000
` BY: JEFFREY B. ELIKAN, ESQ.
` jelikan@cov.com
`
`Also Present:
` DAVID WRIGHT, The Videographer
`
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`DAVID FELDMAN WORLDWIDE, INC.
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
`
`Page 2
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`

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`6
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` MR. ABRAMIC: John Abramic from Steptoe &
`2
`Johnson on behalf of MonoSol.
`3
` MR. MILLS: Jad Mills here on behalf of
`4 Mylan Technologies, Inc., and with the witness. And
`5
`also with me are my colleagues Elham Steiner and
`6
`David Hanna, each of us for Wilson Sonsini Goodrich &
`7
`Rosati.
`8
` Before we be- -- begin the questioning, I
`9
`just want to make a record. The parties have not
`10
`reached an agreement about the videotaping of the
`11
`deposition or the use of the videotape in the IPR
`12
`proceeding.
`13
` THE VIDEOGRAPHER: Will the court reporter
`14
`please swear in the witness.
`15
` GRAHAM BUCKTON, PhD,
`16
` having been first duly sworn, testified as follows:
`17
` EXAMINATION
`18
`BY MR. BRAHMA:
`19
` Q Good morning, Dr. Buckton.
`20
` A Good morning.
`21
` Q You understand that this inter partes review
`22
`is about the '514 patent; correct?
`23
` A I do.
`24
` Q Okay. And you've also discussed that
`25
`separately in a separate District Court litigation;
`
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`right?
` A That's correct.
` Q Okay. And in that District Court
`litigation, there's also an expert report you've
`recently received from a Dr. Langer about the
`validity of the '514 patent; right?
` A That's correct.
` Q You've had a chance to review that; is that
`right?
` A I've begun reviewing it, but I will be
`reviewing it in the coming weeks or days or -- well,
`not weeks. Days.
` Q Okay. So I'm going to try and limit my
`questioning today to the scope of the inter partes
`review as opposed to the District Court litigation.
` A Understood.
` Q Do you understand that?
` A Sorry. I interrupted you. Sorry.
` Understood. Yes.
` Q And with respect to your work in this
`inter partes review, you prepared a declaration;
`right?
` A That's correct.
` Q And I see you have a document in front of
`you. Is that your declaration?
`
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` A It is.
` Q Okay. Would you mind if I looked at that?
` A Very well. I haven't yet, but you can.
` Q I -- I was just trying to --
` A I didn't bring it with me. It's not mine.
` Q Oh, okay. Oh, okay.
` A But you are very welcome to it.
` Q Is this a -- is this just a clean copy, as
`far as you know?
` A I believe so.
` Q Okay. I was -- to the extent that there are
`any notations on it or anything --
` A No. No. No. No. It's not mine.
` Q Okay.
` A But it is now.
` Q There you go.
` All right. Why don't we actually go ahead
`and mark that as our first exhibit.
` MR. MILLS: And for the record, the exhibit
`is already marked as Mylan Exhibit 1001.
` MR. BRAHMA: 1002; right?
` MR. MILLS: Sorry. Yes. 1002.
` (Exhibit 1 was marked for identification.)
`BY MR. BRAHMA:
` Q And, actually, since you have your own copy,
`9
`
`I will just hang on to this one.
` A Is that --
` Q And can you just --
` Well, can you confirm that it is the same?
`I'll give you what I have, and if there's any
`difference --
` A These look different sizes. Maybe they're
`not. Maybe it's just different quality of paper.
`That might be the -- might be the --
` Q Why don't you go ahead and check really
`quickly and --
` A Sure.
` Q -- let me know if there's any difference.
` A I would say they're the same.
` Q Okay.
` A They just look different.
` Q Okay.
` MR. MILLS: It appears that one of them is
`printed one-sided.
` THE WITNESS: Ah. Double-sided and --
`double-sided and single-sided. That would be the
`difference.
`BY MR. BRAHMA:
` Q Yes. So someone was very environmentally
`conscious.
`
`3 (Pages 6 to 9)
`
`DAVID FELDMAN WORLDWIDE, INC.
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
`
`Page 3
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`

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` A Yeah.
` Q So Deposition Exhibit 1, Mylan -- which has
`previously been marked as Mylan Exhibit 1002 in the
`IPR, is that a true and correct copy of the
`declaration that you submitted in the inter partes
`review proceeding?
` A I think it is. Yes.
` Q Okay. Do you understand that this
`declaration was submitted to the Patent Trial and
`Appeal Board along with a petition for inter partes
`review?
` A I think that's right. Yes.
` Q Did you ever see that petition?
` A I think I probably did. I don't remember
`when, but I think I probably did.
` Q Did you see it after you had submitted your
`declaration?
` A I don't remember when, to be honest. So --
`but I -- I -- I have a -- a recollection I may have
`seen it at some stage, but I really can't help you
`with when I saw it.
` Q Okay. And do you understand that there was
`a decision issued by the Patent Trial and Appeal
`Board instituting the inter partes review?
` A Yes.
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`think that's true.
` Q Okay.
` A If it's not true, it's not a deliberate
`attempt to --
` But I -- as far as I remember sitting here
`today, I think that's true.
` Q Okay. Understood.
` In your declaration, you have a list of
`exhibits starting on page 64 and going to page 65.
` A Yes.
` Q Is that a complete list of the materials
`that you considered as part of preparing your
`declaration in the inter partes review proceeding?
` A I think so, but I'm not sure. I don't know
`if there was anything else I considered, but I -- I
`think these are the ones that I've talked about and
`relied upon.
` Q Okay.
` A I don't remember if there was anything else
`or not. I can't think of anything just at the moment
`as to what it would have been.
` Q Okay. Is there anyplace you recorded what
`else you may have considered other than these
`exhibits that were specifically cited in your
`declaration?
`
`13
`
` Q Which is why we're here today.
` A Yes.
` Q Have you seen that decision?
` A I have.
` Q Okay. Have you also seen materials from the
`prior District Court litigations relating to the '514
`patent?
` A Not as far as I'm aware.
` Q Okay.
` A But maybe if you can point me to anything
`that's from that. Maybe I -- I have without knowing,
`but I -- I -- as far as I'm aware, no.
` Q So let me back up a step.
` Are you aware that there have been other
`District Court litigations involving the '514 patent
`and its validity?
` A Yes. I've been told there have been, and
`I -- I think --
` Various people have made reference to it, so
`I think there have been. Yes.
` Q Okay. So am I understanding correctly that,
`as far as you know, you haven't seen any expert
`reports or trial testimony from those prior
`District Court litigations?
` A Sitting here today, as best I remember, I
`
`1
` A No. I don't have any recollection of there
`2
`being any, but I -- I --
`3
` So "I don't know" is the answer, but I have
`4
`no record of any others. No.
`5
` Q Okay. And one other question about
`6 materials you've considered. You understand that,
`7
`before the Patent Trial and Appeal Board issued its
`8
`decision to institute this inter partes review
`9
`proceeding, MonoSol filed a preliminary patent owner
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`response?
`11
` A It's not ringing a bell, I'm afraid.
`12
` Q Okay.
`13
` A But it doesn't -- it doesn't mean anything
`14
`to me as that. If you were to show me a document, I
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`could let you know if I've seen such a thing, but
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`I -- I -- it doesn't ring a bell as you -- you
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`mention the word.
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` Q Okay. So as far as you know right now, you
`19
`didn't review patent owner's preliminary response; is
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`that right?
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` A If you show it to me, maybe I -- I could
`22
`tell you, "Yes, I recognize having seen that."
`23
` Q Okay.
`24
` A But sitting here just now, I don't remember
`25
`if I've seen such a thing. It doesn't mean I
`4 (Pages 10 to 13)
`
`DAVID FELDMAN WORLDWIDE, INC.
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
`
`Page 4
`
`

`

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`
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`haven't, I'm sorry to say, but I have no recollection
`2
`of it. But --
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` Q Okay. Fair enough.
`4
` MR. BRAHMA: I'm going to mark this as
`5
`Deposition Exhibit 2. It's previously been submitted
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`as Mylan Exhibit 1005.
`7
` (Exhibit 2 was marked for identification.)
`8
` THE WITNESS: Thank you.
`9
` MR. BRAHMA: And I'm also going to have
`10
`marked Deposition Exhibit 3, which was previously
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`submitted as Mylan Exhibit 1006.
`12
` (Exhibit 3 was marked for identification.)
`13
` THE WITNESS: Thank you. Thank you.
`14
`BY MR. BRAHMA:
`15
` Q And as we previously discussed, in the
`16
`inter partes review proceeding, you argue that the
`17
`claims of the '514 patent that are at issue are
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`invalid as obvious in light of the combination of the
`19
`Ilango reference, which is Deposition Exhibit 2,
`20 Mylan Exhibit 1005, and the Chen reference, which is
`21
`Deposition Exhibit 3, previously marked as
`22 Mylan Exhibit 1006; right?
`23
` A Yes. The combination of those two you said.
`24
`Yes.
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` Q Okay.
`
`1
` A Drug release is part of it. Yes.
`2
` Q Yeah. Why don't I point you to something
`3 more specific.
`4
` So if you look at the -- the paragraph right
`5
`at the top of the cover page.
`6
` A The "As glibenclamide"? That one?
`7
` Q Yes. That paragraph right at the top.
`8
` A Yes.
`9
` Q So it says, "The objective of this work is
`10
`to investigate the possibility of obtaining a slow
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`release, relatively constant effective levels of
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`glibenclamide from buccal strips using chitosan";
`13
`right?
`14
` A Yes.
`15
` Q Okay. This article, the focus of it isn't
`16
`about maintaining drug content uniformity in
`17
`pharmaceutical films; right?
`18
` MR. MILLS: Objection to form.
`19
` THE WITNESS: Well, it goes on to say that
`20
`attempts were made to develop suitable chitosan-based
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`buccal strips and to characterize it using different
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`in vitro methods and look at their suitability.
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` So was your question that it was just about
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`release or --
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`///
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` A Yes.
` Q Had you --
` First, can you confirm, is
`Deposition Exhibit 2 a true and correct copy of the
`Ilango reference that you relied upon?
` A Yes.
` Q And is Deposition Exhibit 3 a true and
`correct copy of the Chen reference that you relied
`on?
` A It looks like it is. Yes.
` Q Okay.
` A Yes.
` Q Prior to your work on the inter partes
`review proceeding or the District Court litigation
`relating to the '514 patent, had you ever seen either
`of these two references before?
` A Not as far as I remember. No.
` Q Okay. So let's start with the Ilango
`reference, Deposition Exhibit 2.
` The Ilango reference discusses an
`investigation of films made to compare drug release
`characteristics; is that right?
` A That is part of it. There are drug
`release --
` Q I apologize. Why don't I --
`
`1
`BY MR. BRAHMA:
`2
` Q Well, my question was: The focus of this
`3
`Ilango reference wasn't about maintaining drug
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`content uniformity in pharmaceutical films; right?
`5
` A It depends what you mean by "focus." I
`6 mean, that's obviously a precursor to the -- the
`7
`testing of the product. So you make a product with
`8
`suitable properties, and then you test the product,
`9
`so there will be different aspects to it.
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` Q Okay. And the Ilango reference doesn't talk
`11
`about the -- the factors that may possibly cause a
`12
`loss of drug content uniformity during the casting
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`and drying of pharmaceutical films; right?
`14
` MR. MILLS: Objection. Form.
`15
` THE WITNESS: It talks about a method, and
`16
`the method describes properties, which obviously are
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`the properties that are related to making the
`18
`product.
`19
` What was your question? Does -- does it
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`talk about those? It does talk about those by virtue
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`of them being there, but was there a more detailed
`22
`part of the question?
`23
`BY MR. BRAHMA:
`24
` Q Well, the question I was asking was that
`25
`this Ilango reference -- it doesn't talk about the
`5 (Pages 14 to 17)
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`DAVID FELDMAN WORLDWIDE, INC.
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
`
`Page 5
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`factors that may possibly cause a loss of drug
`content uniformity during the casting and drying of a
`pharmaceutical film; right?
` MR. MILLS: Same objection.
` THE WITNESS: Well, to the extent it
`describes aspects in here which are key to making the
`film, I think it does talk about those.
`BY MR. BRAHMA:
` Q Aspects -- you said, "aspects in here which
`are key to making the film." Are you take -- talking
`about aspects of the manufacturing process?
` A The method. Yeah, the -- as it describes
`how it makes it.
` Q All right. So let's go through its
`discussion of how it makes it.
` A Yes.
` Q And am I correct that what you're referring
`to starts on this first page, page 232, under the
`heading "Methods"?
` A Yes.
` Q Okay. And the description of how the
`chitosan buccal strips were prepared starts in that
`second column. There's a sentence that says, "The
`chitosan buccal strips were prepared by casting
`technique"; is that right?
`
`1
` Q So let's look at those two bits that you
`2
`pointed out.
`3
` The first one you said was propylene
`4
`glycol --
`5
` The -- the quote from the paper is
`6
`"Propylene glycol (5 percent volume by volume) was
`7
`used as a plasticizer and penetration enhancer"; is
`8
`that right?
`9
` A That's what it says. Yes.
`10
` Q Okay. When it says "Propylene glycol
`11
`(5 percent volume by volume)," that's a solution of
`12
`propylene glycol that has a concentration of
`13
`5 percent in water; is that right?
`14
` A That's right.
`15
` Q Okay. And the Ilango paper doesn't say how
`16 much propylene glycol is used in the formulation used
`17
`to make the film; right?
`18
` MR. MILLS: Objection. Form.
`19
` THE WITNESS: It does. The composition of
`20
`the films are in Table 1 over the page.
`21
`BY MR. BRAHMA:
`22
` Q And so your understanding is that, when it
`23
`says --
`24
` Well, let me orient first.
`25
` So Table 1, you're talking about Table 1 on
`
`19
`
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`
` A Yes.
` Q Okay. And just to take a step back. So
`this paper talks about making films that are --
` A So sorry. Just in case I misunderstood your
`previous question, did you say it starts there?
` Q Yeah. That's right.
` A There is information before that, isn't
`there, in terms of how you make up the solutions
`and -- which is part of the method that you would
`use.
` Q Okay. So let's look -- look at the
`sentences that are before that, then.
` So where -- where would you start? In this
`"Methods" section at the very top?
` A Yes. I think so. So, yeah, it says that
`there was a -- a sudden propylene glycol solution,
`and it says that a certain concentration of chitosan
`was used in -- in a certain concentration of acetic
`acid. So those bits --
` Q Okay.
` A -- were before the bit that we -- we just
`started on, so that they are --
` Q Okay.
` A -- parts of the method of making the
`product.
`
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`page 233; right?
` A Yes.
` Q Okay. And the title of that table is
`"Table 1: Composition of glibenclamide buccal
`strips"; right?
` A Correct.
` Q Okay. And so when it says "Propylene glycol
`5 percent" for the various strips that are listed in
`that table, your understanding is that that means
`that 5 percent of the -- the solution that's used to
`cast the films is made of propylene glycol? Is that
`right?
` MR. MILLS: Objection. Form.
` THE WITNESS: Not of the solution that's
`made --
` I think 5 percent of the -- of the film is
`that. So I don't think it's doing 5 percent in
`relation, for example, to the amount of water that's
`present, which isn't in that list. So I think you
`have to take that percentage there, but not counting
`the water that's part of that formulation, which
`would be drying, for example.
`BY MR. BRAHMA:
` Q Okay. So is it your understanding, then,
`that for the Eudragit strips, they contain 5 percent
`6 (Pages 18 to 21)
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`ethanol?
` A There's 5 percent ethanol there to dissolve
`the Eudragit, I believe, yes.
` Q Okay. But you're saying that's the
`composition of the strip after it's been dried to --
` A No. I'm sorry.
` Q -- remove the solvent; right?
` A I'm sorry. That -- that won't be there in
`the final product. That will be dried.
` Q Okay. So these compositions in Table 1 are
`compositions not for the final dried product; right?
` MR. MILLS: Objection. Form.
` THE WITNESS: The -- as it happens, the one
`for the chitosan ones, I think will be. The ones for
`the Eudragit one, the ethanol will dry away. You're
`quite right.
`BY MR. BRAHMA:
` Q Okay. And there's no explanation in Ilango
`for why in this Table 1 composition of glibenclamide
`strips it would give something other than the final
`dried film composition for the Eudragit strips.
`Is -- is there any explanation of that?
` A There isn't, as far as I know, but I think
`it's clear that the 5 percent ethanol will not
`survive through to the final dried strip.
`
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` Well, if you take -- yes, a unit strip.
`Yes.
` Q Okay. How large is a unit strip?
` A I haven't done --
` MR. MILLS: Objection. Form.
` THE WITNESS: I haven't done the calculation
`in terms of what a unit strip in a mold would be. I
`haven't looked at that. So I don't know the answer
`exactly.
`BY MR. BRAHMA:
` Q Okay. If you look back at page 232, you see
`at the bottom of Column 2 there, it says strips
`having an oval form of 4 centimeters length and
`3 centimeters width and 40 microns thickness; right?
` A Yes.
` Q Okay. So that gives you the volume of each
`strip; right?
` A No. That -- that's the volume --
` I'm sorry. That's the volume --
` Yes. This is the volume of the -- what's
`been cut from the original mold. Yes. That's the
`strip, the kind of dosage form strip. Yes. I'm
`sorry.
` Q So -- so just so that we have our
`terminology straight, so in the mold, they pour an
`25
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` Q So when, in the chitosan composition given
`in Table 1, it says 5 percent, that's the 5 percent
`after the water that's used to dissolve the acetic
`acid has been evaporated away? Is that right?
` MR. MILLS: Objection.
`BY MR. BRAHMA:
` Q Under your understanding?
` MR. MILLS: Objection. Form.
` THE WITNESS: So there are two 5 percents in
`that table, but the 5 percent in relation to the
`acetic acid one --
` Was your question: Is that, after you've
`dried off the water, what remains in the film?
` Was that -- was that your question? I've
`paraphrased it. Was that -- was that what you've
`asked me?
`BY MR. BRAHMA:
` Q Yeah. Let me try and clarify. So your
`understanding is that, for the chitosan -- chitosan
`strips, 5 percent of the final weight of the strip
`will be acetic acid?
` A Yes.
` Q And your understanding is that each strip
`will contain 500 milligrams of polyvinylpyrrolidone?
` A Yes.
`
`1
`amount of matrix and dry it to make a cast film;
`2
`right?
`3
` A Yes.
`4
` Q And then they cut from that cast film a
`5
`strip that's 4 centimeters length by 3 centimeters
`6
`width and 40 micron thickness; right?
`7
` MR. MILLS: Objection. Form.
`8
` THE WITNESS: Okay. So I think there is a
`9
`confusion in terms of terminology, because "strip," I
`10
`think, has been used in the previous table we just
`11
`looked at in terms of what was cast and then also
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`used in terms of what was cut. So we need to be
`13
`clear that there was a larger thing from which
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`smaller things are cut.
`15
`BY MR. BRAHMA:
`16
` Q Okay. So when you say the strip is used in
`17
`the context of Table 1 to refer to what was cast, you
`18 mean that when they use -- when they talk about the,
`19
`quote/unquote, composition of glibenclamide buccal
`20
`strips in Table 1, they're talking about the solution
`21
`that's poured into a mold?
`22
` A I believe so. Just give me one minute just
`23
`to have a look at the document, but I believe that's
`24
`true. And I'll just -- I'll just check.
`25
` Yes. I do believe that's right. Yes.
`7 (Pages 22 to 25)
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`1
` Q Okay. And that's different from the
`2
`composition of the dried smaller strip that's cut
`3
`from the molded film later on; right?
`4
` A That's correct.
`5
` MR. MILLS: Objection.
`6
` THE WITNESS: Sorry.
`7
` MR. MILLS: Form.
`8
` THE WITNESS: So could -- could you ask the
`9
`question again? I got confused with the --
`10
`BY MR. BRAHMA:
`11
` Q Sure.
`12
` That's -- that composition that's shown in
`13
`Table 1 of the solution that is poured into a mold,
`14
`that's different from the composition of the dried
`15
`strip that is cut from a film that's dried in each
`16 mold; right?
`17
` MR. MILLS: Objection. Form.
`18
` THE WITNESS: The relative proportions of
`19
`the things there are the same, but the size of it is
`20
`smaller when you've cut part of the larger strip out.
`21
`BY MR. BRAHMA:
`22
` Q Okay. Ilango doesn't say how many strips
`23
`are produced by a -- a batch of solution that's made
`24
`according to the composition in Table 1; right?
`25
` A So we should be clear on the terminology of
`
`28
`1
`understand the process clearly, so in each mold there
`2
`is a drying or evaporation process that occurs, and
`3
`that results in the -- what they call the dried strip
`4
`in that sentence that you just pointed to; right?
`5
` A Correct.
`6
` Q Okay. And then, from that dried strip,
`7
`which is the entirety of what's dried in the mold,
`8
`they cut a 4-by -- 4-by-3-centimeter oval; is that
`9
`right?
`10
` MR. MILLS: Objection. Form.
`11
` THE WITNESS: They don't cut "a," but they
`12
`cut individual dosage units, so there's nothing to
`13
`say that it's one. But they do cut dosage units from
`14
`that larger strip.
`15
`BY MR. BRAHMA:
`16
` Q Okay. So in Ilango, is there anything to
`17
`say that they cut more than one oval from what's in a
`18 mold?
`19
` A I don't think it's saying how many they cut
`20
`from each mold, but there's nothing to suggest it is
`21
`one or that it's -- you know, the number of
`22
`individual dosages that you cut from a mold isn't
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`specified, but there's no reason to believe it's just
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`one.
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` Q Okay. So that's not clear; is that right?
`
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`the strip, which is unfortunate. But --
` Q Right.
` A -- Ilango says you -- you prepare a dried
`strip, and then you cut out strips having the smaller
`size. So the -- the term is used for both. So I
`guess we need to be clear amongst ourselves which one
`we're talking about. So --
` Q Okay. So the -- let me just make sure that
`I understand what you're saying is the confusion. So
`you're saying that Ilango, in some places, refers to
`the term "strip" as the -- as what is dried in the
`entire mold; right?
` A Yes.
` Q Okay. And in other places, it refers to the
`strip as the portion that's been cut into the oval
`shape; right?
` A Correct. So if you look at the bottom of
`page 232, on the right-hand side, about four or five
`lines up, it starts with "The dried strip thus
`obtained was cut into regular [sic] size," and it
`goes on and says, "Strips having a" --
` So it's using the word "strip" as the -- the
`larger one and then also the units, which are being
`cut from the larger one.
` Q Okay. So -- so to make sure that I
`
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` A I don't think it's material in terms of --
` They are clear in terms of they've made a --
`a larger dried strip, as they call it, and from that,
`they have cut individual dosage units, and those
`dosage units can come from as many strips as you --
`you would wish to make.
` Q Well, so there you said that it's clear that
`they made a larger dried strip, and from that, they
`cut individual dosage units, plural; is that right?
` A I -- I -- I just said -- maybe the plurals
`and the singulars we're going to go through, but I --
`there's nothing to suggest that they cut just one
`from each larger film.
` Q Okay.
` A They make a multitude of dosage units. It's
`abundantly clear. There's no doubt about that.
` As to how many they cut from each individual
`cast film, that isn't clear, but I don't think it's
`material to the outcome of the -- of the product
`anyway. Whether they cut one or -- or more than one,
`it doesn't really seem, to me, to alter the -- the
`nature of what they're talking about.
` Q Does the Ilango reference specify where they
`cut the dosage units from that they take from a
`particular molded film?
`8 (Pages 26 to 29)
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` A No. They just say they cut from the molded
`2
`film.
`3
` Q Okay. Does the Ilango reference specify how
`4
`big the mold is?
`5
` A The external dimensions of the mold are --
`6
`other than we know they were making a 40-micron-thick
`7
`film, I don't think the -- if you like, the X and Y
`8
`dimensions are reported.
`9
` Q Okay. And the Ilango reference doesn't
`10
`specify how many molds are filmed using the --
`11
` A Sorry. I -- I didn't quite hear the middle,
`12
`just before you carry on, rather than you get to the
`13
`end and ask you to repeat it.
`14
` Q Sure. Sure. Let me start over.
`15
` So you said before that Table 1 gives the --
`16
`the composition of the solution that is poured into
`17
`the molds; right?
`18
` A Yes.
`19
` Q Okay. And Ilango doesn't specify how many
`20 molds are filled using this -- using a batch of this
`21
`composition in Table 1 for any of the films; right?
`22
` A Not sure -- I'm not sure I entirely
`23
`understood the question, but -- but just -- I'll
`24
`answer what