`McDuff, Ph.D., R. DeForest Case IPR2015-01340
`November 29, 2016
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` CONFIDENTIAL PURSUANT TO PROTECTIVE ORDER
`----------------------------------------x
`MYLAN PHARMACEUTICALS INC.,
`WOCKHARDT BIO AG, TEVA PHARMACEUTICALS
`USA, INC., AUROBINDO PHARMA U.S.A., INC.,
` Petitioners,
` -against- Case IPR2015-01340
`ASTRAZENECA AB, Patent RE44,186
` Patent Owner.
`----------------------------------------x
`
` DEPOSITION OF: R. DeFOREST McDUFF, Ph.D.
` Tuesday, November 29, 2016
` New York, New York
` 9:06 a.m. - 3:09 p.m.
`
` Reported in stenotype by:
` Rich Germosen, CCR, CRCR, CRR, RMR, CCRR
` NCRA, NJ and CA Certified Realtime Reporter
` NCRA Realtime Systems Administrator
`
`
`202-220-4158
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`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
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`Page 1 of 200
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`AstraZeneca Exhibit 2220
`Mylan v. AstraZeneca
`IPR2015-01340
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` Deposition of R. DeFOREST McDUFF, Ph.D., taken in
`the above-entitled matter before RICH GERMOSEN,
`Certified Court Reporter, (License No. 30XI00184700),
`Certified Realtime Court Reporter-NJ, (License No.
`30XR00016800), California Certified Realtime Reporter,
`NCRA Registered Merit Reporter, NCRA Certified Realtime
`Reporter, NCRA Realtime Systems Administrator, taken at
`the offices of WILSON SONSINI GOODRICH & ROSATI, P.C.,
`1301 Avenue of the Americas, New York, New York 10019,
`on Tuesday, November 29, 2016, commencing at 9:06 a.m.
`
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`A P P E A R A N C E S:
`
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`WILSON SONSINI GOODRICH & ROSATI, PC
`BY: JAD A. MILLS, ESQ.
`701 Fifth Avenue, #5100
`Seattle, Washington 98104
`(206) 883.2554 / (206) 883.2699 (FAX)
`jmills@wsgr.com
`Attorneys for the Petitioner,
`Mylan Pharmaceuticals Inc.
`
`McCARTER & ENGLISH
`BY: DANIEL M. SILVER, ESQ.
`Renaissance Centre
`405 North King Street,
`8th Floor
`Wilmington, Delaware 19801
`(302) 984.6331 / (302) 691.1260 (FAX)
`dsilver@mccarter.com
`Attorneys for the Patent Owner
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`A P P E A R A N C E S: (CONT'D.)
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`FINNEGAN HENDERSON FARABOW GARRETT & DUNNER, LLP
`BY: KASSANDRA M. OFFICER, ESQ.
`901 New York Avenue, N.W.
`Washington, D.C. 20001-4413
`(202) 408.4000 / (202) 408.4400 (FAX)
`kassandra.officer@finnegan.com
`Attorneys for the Patent Owner
`
`CARLSON CASPERS VANDENBURGH LINDQUIST & SCHUMAN, PA
`BY: GARY J. SPEIER, ESQ., (via telephone)
`225 South Sixth Street
`Minneapolis, Minnesota 55402
`(612) 436.9643
`gspeier@carlsoncaspers.com
`Attorneys for Teva Pharmaceuticals U.S.A., Inc.
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` I N D E X
`WITNESS EXAMINATION
`R. DeFOREST McDUFF, Ph.D.
` BY MR. SILVER 7,114
` BY MR. MILLS 163
`
`AFTERNOON SESSION 114
`
` E X H I B I T S
`DESCRIPTION PAGE
`Exhibit 2218, excerpt of 140
` September 21, 2016 bench
` trial
`
`Exhibit 2219, multipage 143
` document entitled CVS
` Caremark value formulary
` effective as of 10/01/2016,
` not Bates stamped
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`PRODUCTION OF DOCUMENTS AND/OR INFORMATION
` Page Line
` (none)
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`DIRECTION TO WITNESS NOT TO ANSWER
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`QUESTIONS MARKED FOR LATER RULING
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`--------------------------------------------------
` P R O C E E D I N G S
` 9:06 a.m.
` New York, New York
`--------------------------------------------------
` (Whereupon, the court reporter
`administered the oath to the witness.)
`
`R. D e F O R E S T M c D U F F, Ph.D.,
`conducting business at Intensity Corporation, 420
`Boylston Street, 5th Floor, Boston, Massachusetts
`02116, having been first duly sworn or affirmed, was
`examined and testified as follows:
`EXAMINATION BY MR. SILVER:
` Q. Good morning, Dr. McDuff.
` A. Good morning.
` Q. How are you doing today?
` A. I'm doing well. Thank you.
` Q. So we just met a minute ago. My name
`is Dan Silver. I'm with the law firm of McCarter &
`English and Kassandra Officer is here with me.
`She's with the law firm of Finnegan Henderson, and
`we represent AstraZeneca.
` I assume you know why you're here
`today?
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` A. Yes.
` Q. Okay. And what is your understanding
`as to why you're here?
` A. To answer questions about the
`opinions I'm providing in this proceeding.
` Q. Okay. And I see from your CV, which
`we'll talk about in a minute, it looks like you've
`been deposed several times. Is that fair?
` A. Yes, I believe between 20 and 25
`times.
` Q. Okay. So you're generally familiar
`with how depositions proceed and the ground rules
`associated with depositions?
` A. Yes.
` Q. Okay. Is it okay with you if we skip
`the spiel at the outset about making sure we don't
`talk over each other or let me know if you need a
`break, that sort of thing?
` A. It's up to you, but that's fine with
`me.
` Q. Okay. If you have any questions for
`me, feel free to ask as we go, okay?
` A. Okay.
` Q. When you serve as an expert, do you
`review all pertinent information in reaching your
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`conclusions, and let me clarify. As a general
`matter, when you serve as an expert, do you review
`all pertinent information in reaching your
`conclusions?
` A. I certainly review information to the
`extent I feel it's necessary to provide opinions in
`a particular case.
` Q. Do you -- so you make a determination
`at the outset what information you think is going to
`be pertinent to reach your conclusions and that's
`the information that you review?
` A. I wouldn't describe it that way.
` Q. Well, let's be more specific.
` In the context of this case, do you
`feel that you reviewed all pertinent information in
`reaching your conclusions?
` A. Yes, I would generally -- generally
`agree to the extent that information was available.
` Q. Let's take a look at your declaration
`which has been marked as exhibit 1060A.
` MR. SILVER: And, Jad, I'll note for
`the record I don't recall the specifics under the
`protective order, but because we're going to be
`discussing confidential information here, you know,
`I'd like to designate the deposition pursuant to the
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`protective order.
` MR. MILLS: You want to do a blanket
`designation or might there be certain portions?
` MR. SILVER: I suspect we would be
`able to quickly identify which portions we'd want to
`keep confidential, but until we do that, I'd like to
`just do a blanket designation.
` MR. MILLS: Is there any way that we
`could do -- perhaps we could mark the transcript at
`a point where we're going on where we think it's
`confidential just so that we're not making the whole
`thing confidential?
` MR. SILVER: Yeah, we'll do our best.
` MR. MILLS: Okay.
` MR. SILVER: Okay. Thanks.
`BY MR. SILVER:
` Q. So, Dr. McDuff, I've handed you what
`has been marked as exhibit 1060A.
` A. (Reviews.)
` Q. If you could review that for me. Can
`you tell me if this is a true and correct copy of
`your November 7 declaration in this matter?
` A. It appears to be, although I would
`point out that it does not include my CV or
`supporting attachments.
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` Q. Those would be exhibits, I think,
`1061 and 1062; is that right?
` A. Yes.
` Q. Okay. So with that exception, you'd
`agree that this is a true and correct copy of your
`declaration?
` A. It appears to be, yes.
` Q. Okay. If we turn to page 27, under
`the heading: List of Exhibits, you have
`approximately three pages of exhibits listed here.
` Are these the totality of the
`materials that you reviewed in forming the opinions
`set forth in your declaration?
` A. No. This is the set of exhibits that
`is cited in my declaration or corresponding
`attachments. I reviewed additional information as
`well.
` Q. What else did you review?
` A. Well, for example, the Meyer
`declaration is not here in the list of exhibits, yet
`I did review the Meyer declaration. I reviewed
`underlying sources cited by Dr. Meyer. I
`reviewed --
` Q. Sorry, let me stop you.
` If you turn to page 28 and you look
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`at exhibit 2059A, that's the declaration of
`Christine Meyer. Is that the declaration to which
`you're referring?
` A. Yes. Thank you. I did not see that
`on first pass.
` To continue my previous answer, I
`examined the sources cited by Dr. Meyer and was
`provided with all or nearly all of the exhibits that
`have been put forth in the petition to my
`understanding by the patent holder.
` Q. Okay. Anything else that doesn't
`fall into those categories that you reviewed?
` A. Yes, certainly I have reviewed a wide
`range of academic literature relating to
`pharmaceuticals in my past experience and past work
`which do support my opinions here to some degree. I
`reviewed information in learning generally about the
`subject matter in the case, such as going to
`websites of the drugs discussed in my declaration,
`going to websites about diabetes, things of that
`nature. Those are some of the items that come to
`mind.
` Q. Anything else that you can think of
`sitting here today?
` A. Nothing else comes to mind sitting
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`here.
` Q. Okay. Do me a favor, turn to
`paragraph eight of your declaration, which is on
`page four, and take a look at the second sentence
`there. It says: The entirety of my declaration,
`including exhibits EX 1061 CV and EX 1062,
`attachments and reference materials, supplies the
`basis for my analysis and conclusions.
` Do you see that?
` A. Yes.
` Q. Okay. So what I'm trying to
`determine is if other than the things we've just
`talked about, general background information or
`maybe some of the references cited by Dr. Meyer, you
`looked at anything in forming the basis -- in
`forming your opinions that isn't identified in the
`declaration or in the list of exhibits?
` A. I believe I've already answered that.
`I'm happy to give it another try if you'd like.
` Q. I'm just asking you with specific
`reference to the statement you make in the second
`sentence of paragraph eight, is that a correct
`statement subject to the discussion we've had
`already?
` A. As indicated in paragraph eight,
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`those exhibits and the referenced materials supply
`the basis for my analysis and conclusions. In
`addition, as we've discussed, I've also reviewed
`additional information that go towards my general
`understanding and the development of my opinions.
` Q. Okay. We'll talk more about the
`preparation of your declaration in a second, but for
`now, I'd like to know whether you gathered the
`information that you reviewed in authoring this
`declaration or if it was provided to you by Mylan's
`counsel or some combination of both?
` A. Some combination of both.
` Q. Okay. Is there anything that you
`would have liked to have reviewed that you didn't
`have access to?
` A. Yes, a few items come to mind.
` Q. Did Mylan's counsel decline to
`provide you with anything that you would have liked
`to review?
` A. Not to my knowledge. What I was
`referring to is information that I understand was
`not provided by AstraZeneca in this case. For
`example, on discounts and information on early
`prescriptions and sales in the market. Those are
`some of the items that come to mind.
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` Q. Okay. But as far as you're
`concerned, either you were able to gather all of the
`information that was available to you, or if you
`wanted something from Mylan and they had access to
`it, they provided it to you?
` MR. MILLS: Objection. Form.
` A. I would say it like this, I gathered
`information to the extent I thought it was relevant
`and I was provided information from counsel. In
`addition, if I asked for information from counsel
`and they had access to that information, I was
`provided that as well.
` Q. Thank you.
` Are you aware of the existence of a
`parallel district court proceeding involving the
`'186 patent?
` A. Yes.
` Q. Did you review the entirety of the
`record in that proceeding?
` A. Not the entirety of it, no.
` Q. Did you review the entirety of the
`record generated in that proceeding on the issue of
`commercial success?
` A. Not the entirety of the record, no.
` Q. Just to be clear, you didn't review
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`the entirety of the record in that proceeding as it
`pertains to the issue of commercial success?
` A. Not the entirety of the record, no.
` Q. Okay. Is it fair to say that you
`selected portions of the record that would be
`favorable to Mylan?
` A. No.
` Q. Okay. Let's take a look at page 27
`again. Take a look at exhibit -- the listing for
`exhibit 1029. That's the cross-examination of
`Dr. Christine Meyer; right?
` A. I see that, yes.
` Q. Okay. Did you look at her direct
`examination testimony?
` A. I don't recall doing so, although I
`do believe that transcript contained the
`cross-examination of Mr. Hofmann as well.
` Q. It's your recollection that exhibit
`1029 contains the cross-examination of Dr. Hofmann
`as well?
` MR. MILLS: Objection.
` A. I would have to go back and look to
`be sure.
` Q. Okay. But suffice it to say, you
`didn't review the direct examination of Dr. Meyer in
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`the district court trial; right?
` A. I don't recall doing so.
` Q. Fair enough.
` Did you look at Dr. Meyer's expert
`report from the district court proceeding?
` A. No, nor am I aware of that report
`being available here.
` Q. We talked earlier about you gathering
`some exhibits and counsel providing some of the
`exhibits to you. How did you come across exhibit
`1029? Is that something you obtained yourself or
`did you get that from Mylan?
` A. I believe that was provided by
`counsel for Mylan.
` Q. Do you recall if you asked for
`Dr. Meyer's direct testimony?
` A. Sitting here, I don't recall one way
`or the other.
` Q. Okay. Earlier when we talked about
`reviewing pertinent information, would you have
`considered Dr. Meyer's direct testimony at trial to
`be pertinent?
` A. I would not view it as necessary in
`light of having Dr. Meyer's declaration and opinions
`that she's providing in this hearing, as well as
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`reviewing her cross-examination on similar topics
`previously.
` Q. But because you didn't look at her
`direct testimony, you don't know what's there;
`right?
` A. I have a general idea of what is
`there. I expect it to be similar to the opinions
`that she's providing here, yet not specifically.
` Q. Okay. If you look at the line item
`for exhibit number 1035, that's the reply expert
`report of Ivan T. Hofmann; right?
` A. Yes.
` Q. Did Mylan's counsel provide you with
`that document?
` A. I believe so, yes.
` Q. And Mr. Hofmann was the defendant's
`expert on the issue of commercial success in the
`district court litigation; correct?
` A. I believe so, yes.
` Q. Did you look at Mr. Hofmann's
`testimony from the trial in the district court
`litigation?
` A. His cross-examination, yes.
` Q. Okay. Is that listed in your list of
`exhibits here?
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` A. Well, I don't believe I cite to it
`specifically, which is why it's not listed here in
`the list of exhibits. As I indicated, I have some
`recollection that it may be included in exhibit
`1029, yet I would have to look to be sure.
` Q. But are you certain that you looked
`at it?
` A. Yes.
` Q. You didn't look at Dr. Meyer's report
`from the district court litigation, did you?
` A. No, nor am I aware of that being
`available in this hearing.
` Q. Did you ask for it?
` A. I don't believe so, nor do I view
`that as necessary in light of having her declaration
`which provides her opinions here.
` Q. Yet you thought it was appropriate to
`review Mr. Hofmann's expert report from the district
`court litigation; is that right?
` A. It was one piece of information that
`I reviewed in part to obtain information that was
`not available elsewhere.
` Q. So is it fair to say that you
`reviewed a greater portion of the district court
`record that is favorable to Mylan than is favorable
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`to AstraZeneca?
` MR. MILLS: Objection. Form.
` A. I wouldn't put it that way, no.
` Q. Well, it's fair to say that you did
`not consider AstraZeneca's affirmative evidence on
`the issue of commercial success in the district
`court litigation; correct?
` MR. MILLS: Objection.
` A. I think I've answered this a number
`of times now, but to repeat, I did not review
`Dr. Meyer's affirmative report in the district court
`litigation, nor did I feel it was necessary to do so
`in light of having her declaration in this
`proceeding which provided her opinions here.
` Q. Okay. You didn't review her direct
`examination testimony to the best of your
`recollection either?
` A. I don't recall reviewing her direct
`testimony, yet I did review her trial demonstratives
`and Mr. Hofmann's trial demonstratives.
` Q. Okay. Let's take a look at
`Dr. Meyer's August 2, 2016 declaration which has
`been marked as exhibit 2059A.
` A. (Reviews.)
` Q. Here is a copy for each of you.
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` Does that appear to you to be a true
`and correct copy of Dr. Meyer's declaration in this
`proceeding?
` A. Based on my brief review here, it
`appears to be.
` Q. Okay. Please turn to table one which
`is page 34 of 61.
` A. I'm there.
` Q. Okay. You don't dispute the FDA
`approval dates for each of these respective DPP-4
`inhibitors approved for sale in the United States,
`do you?
` A. No, not sitting here.
` Q. Thanks.
` Please turn to table 2A. Oh, wait.
`One question.
` When were the Nesina family of
`products approved by the FDA?
` MR. MILLS: Objection. Scope.
` A. I've not independently evaluated
`that. I don't recall doing so.
` Q. But you have no reason to dispute
`what's set forth in table one of Dr. Meyer's
`declaration which suggests that they were approved
`on January 25, 2013; correct?
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` A. I see that here in table one.
`Sitting here, I have no reason to dispute it, yet I
`can't confirm it for you either.
` Q. You had roughly three months from the
`time you received Dr. Meyer's declaration to
`formulate your responsive declaration; correct?
` A. I don't recall the exact timing.
` Q. Okay. Did you look at table one in
`the context of preparing your responsive
`declaration?
` A. Yes.
` Q. At the time you looked at table one,
`did you have any reason to dispute what was set
`forth in table one?
` A. I don't recall.
` Q. That's fine.
` Let's turn to table 2A. Table 2A is
`labeled: Total dispense prescriptions for Onglyza
`family products August 2009 through October 2015.
`Do you agree?
` A. I see that, yes.
` Q. Do you dispute any of the figures
`presented by Dr. Meyer in table 2A?
` A. Not sitting here, no.
` Q. Okay. So, for example, if we look at
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`the far right-hand column, the Onglyza family total
`for 2010, it says in the year 2010 there were
`678,307 total dispensed prescriptions.
` Do you see that?
` A. I do.
` Q. And you don't dispute that number;
`correct?
` A. Not sitting here, no.
` Q. And if we look at, for instance,
`2012, Dr. Meyer reports 2,809,002 prescriptions for
`the Onglyza family products.
` Do you see that?
` A. I do.
` Q. And sitting here today, you don't
`dispute that number, do you?
` A. Not sitting here, no.
` Q. Let's turn to table three. Table
`three is labeled: Sales dollars of Onglyza family
`products August 2009 through September 2015.
` Do you see that?
` A. I do.
` Q. Okay. Do you dispute any of the
`figures presented by Dr. Meyer in table three?
` A. Sitting here, I don't dispute the
`calculations, yet as described in my declaration, I
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`do dispute the interpretation of these as earned
`revenues.
` Q. And we'll talk about your opinions a
`little bit more later and you'll have an opportunity
`with your counsel on redirect.
` So for present purposes, I would ask
`just to focus on the questions that I'm asking. And
`right now I'm just asking about the figures as
`they're presented here in table three, and I think
`you said you don't dispute them; is that right?
` MR. MILLS: Objection. Form.
` A. I would give the same answer as my
`previous one. I don't dispute the calculations, yet
`I do dispute the interpretation.
` Q. And, like I said, we'll talk about
`that more later.
` So, for instance, you don't dispute
`that the sales of Onglyza have grown from
`approximately $150 million in 2010 to approximately
`580 million in 2014? Again, just limited to the
`figures and not the interpretation or the
`significance of the figures, you don't dispute those
`figures; correct?
` A. Well, I dispute the characterization
`in your question, which is that these are sales of
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`Onglyza. These are gross sales. They're not earned
`revenues and they wouldn't typically be described as
`the overall sales figure not in terms of what is
`earned and actually booked, but in terms of the
`calculations sitting here, I don't dispute them.
` Q. Let's make it clean. I think you
`said these are gross sales figures?
` A. Yes.
` Q. Okay. And so you don't dispute that
`the reported gross sales for Onglyza increased from
`approximately 150 million in 2010 to approximately
`$580 million in 2014; right?
` A. Well, again, subject to the
`interpretation caveats before, I don't dispute the
`calculations.
` Q. Okay. So if you look on the second
`page of table three, you don't dispute in the far
`right-hand column that total reported gross sales
`for the Onglyza and Kombiglyze family of products
`from August 2009 through September 2015 are in
`excess of $3.5 billion; correct?
` A. As a matter of calculation, I don't
`have any disputes to that calculation sitting here,
`yet those are not earned revenues as explained in my
`declaration.
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` MR. MILLS: Should we go ahead and --
` MR. SILVER: Yeah, let's see who is
`on the line.
` MR. MILLS: Hello. Could you please
`identify yourself?
` MR. SPEIER: This is Gary Speier from
`the Carlson Caspers firm. I'm going to put you on
`mute.
` MR. SILVER: For the record, who do
`they represent?
` COURT REPORTER: Teva.
`BY MR. SILVER:
` Q. Dr. McDuff, the date in table three
`comes from a company called IMS; correct?
` A. IMS Health, and I believe they
`recently had a name change, although I don't recall
`what it is sitting here.
` Q. Okay. Let's refer to them as IMS
`today because we'll be talking about them a lot, if
`that's okay with you?
` A. That's fine with me.
` Q. And IMS data is something that
`economists looking at pharmaceutical products
`typically rely on as a data point; right?
` A. It depends on one's purpose whether
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`that would be a good data source, but economists do
`rely on that data source from time to time.
` Q. And I think you rely in this case on
`IMS data, don't you?
` A. For certain calculations, yes.
` Q. This data that's reported by IMS I
`think we said is gross sales; is that right?
` A. For table three, that's correct.
` Q. Does IMS provide net sales data?
` A. Not to my knowledge. That
`information is typically reported and held by the
`companies, but not reported by IMS.
` Q. And so if you're trying to look at
`multiple pharmaceutical products in context, one way
`to do it would be to gather the available
`information from IMS to enable you to do an apples
`to apples comparison; correct?
` A. One could think about doing so. I
`did not see Dr. Meyer do so. As I point out in my
`declaration, she did not compare sales of Onglyza
`Kombiglyze to sales of any other drug, gross sales
`or net sales.
` Q. So I'm going to ask you again just
`for the present purposes focus on answering my
`questions. Your declarations are already in
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`evidence. Your counsel will have an opportunity to