405
`
`Civil Action
`
`No. 14-664-GMS
`Civil Action
`
`No. 14-666-GMS
`Civil Action
`
`)
`)
`
`))
`
`))
`
`)
`
`))
`
`))
`
`V.
`)
`WATSON LABORATORIES, INC.,
`ACTAVIS, INC., and ACTAVIS LLC, )
`)
`Defendants.
`)
`- - -
`ASTRAZENECA AB,
`)
`)
`Plaintiff,
`
`))
`
`))
`
`V.
`WOCKHARDT BIO AG and
`WOCKHARDT USA LLC,
`No. 14-667-GMS
`)
`Defendants.
`- - -
`Wilmington, Delaware
`Wednesday, September 21, 2016
`9:00 a.m.
`Day 3 of Bench Trial
`- - -
`BEFORE: HONORABLE GREGORY M. SLEET, U.S.D.C.J.
`CAPTION CONTINUES ON FOLLOWING PAGE
`
`)
`
`))
`
`))
`
`IN THE UNITED STATES DISTRICT COURT
`IN AND FOR THE DISTRICT OF DELAWARE
`- - -
`
`ASTRAZENECA AB,
`Plaintiff,
`
`V.
`AUROBINDO PHARMA LTD. AND
`AUROBINDO PHARMA U.S.A., INC.,
`Defendants.
`ASTRAZENECA AB,
`Plaintiff,
`
`)
`- - -
`)
`)
`
`1 2 3 4 5 6 7 8 9
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`25
`
`MYLAN - EXHIBIT 1029
`Mylan et al. v. AstraZeneca
`IPR2015-01340
`
`
`
`Civil Action
`
`No. 14-664-GMS
`Civil Action
`
`No. 14-666-GMS
`Civil Action
`
`)
`)
`
`))
`
`))
`
`)
`
`))
`
`))
`
`V.
`)
`WATSON LABORATORIES, INC.,
`ACTAVIS, INC., and ACTAVIS LLC, )
`)
`Defendants.
`)
`- - -
`ASTRAZENECA AB,
`)
`)
`Plaintiff,
`
`))
`
`))
`
`V.
`WOCKHARDT BIO AG and
`WOCKHARDT USA LLC,
`No. 14-667-GMS
`)
`Defendants.
`- - -
`Wilmington, Delaware
`Wednesday, September 21, 2016
`9:00 a.m.
`Day 3 of Bench Trial
`- - -
`BEFORE: HONORABLE GREGORY M. SLEET, U.S.D.C.J.
`CAPTION CONTINUES ON FOLLOWING PAGE
`
`)
`
`))
`
`))
`
`IN THE UNITED STATES DISTRICT COURT
`IN AND FOR THE DISTRICT OF DELAWARE
`- - -
`
`ASTRAZENECA AB,
`Plaintiff,
`
`V.
`AUROBINDO PHARMA LTD. AND
`AUROBINDO PHARMA U.S.A., INC.,
`Defendants.
`ASTRAZENECA AB,
`Plaintiff,
`
`)
`- - -
`)
`)
`
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`MYLAN - EXHIBIT 1029
`Mylan et al. v. AstraZeneca
`IPR2015-01340
`
`
`
`406
`
`Civil Action
`
`No. 14-694-GMS
`Civil Action
`
`No. 14-696-GMS
`
`Civil Action
`
`No. 14-697-GMS
`
`IN THE UNITED STATES DISTRICT COURT
`IN AND FOR THE DISTRICT OF DELAWARE
`- - -
`)
`)
`
`ASTRAZENECA AB,
`Plaintiff,
`
`))
`
`V.
`)
`SUN PHARMA GLOBAL FZE and SUN
`PHARMACEUTICAL INDUSTRIES LTD., )
`)
`Defendants.
`)
`- - -
`ASTRAZENECA AB,
`)
`)
`Plaintiff,
`
`))
`
`))
`
`))
`
`))
`
`V.
`MYLAN PHARMACEUTICALS, INC.,
`Defendant.
`
`)
`- - -
`)
`)
`
`))
`
`))
`
`))
`
`)
`- - -
`
`ASTRAZENECA AB,
`Plaintiff,
`
`V.
`AMNEAL PHARMACEUTICALS LLC,
`Defendant.
`
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`
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`407
`
`APPEARANCES:
`MICHAEL P. KELLY, ESQ., and
`DANIEL M. SILVER, ESQ.
`McCarter & English, LLP
`-and-
`CHARLES E. LIPSEY, ESQ.,
`ROBERT F. SHAFFER, ESQ.,
`DAVID M. WEINGARTEN, Ph.D., ESQ., and
`NICOLE A CONLON, Ph.D., ESQ.
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, L.L.P.
`(Washington, D.C.)
`
`Counsel for AstraZeneca AB
`KENNETH LAURENCE DORSNEY, ESQ.
`Morris James LLP
`-and-
`SAILESH K. PATEL, ESQ., and
`GEORGE YU, ESQ.
`Schiff Hardin LLP
`(New York, NY)
`
`Counsel for Aurobindo
`DOMINICK T. GATTUSO, ESQ.
`Proctor Heyman LLP
`-and-
`RALPH J. GABRIC, ESQ.,
`MARK H. REMUS, ESQ.,
`LAURA A. LYDIGSEN, ESQ., and
`JOSHUA JAMES, ESQ.
`Brinks Gilson & Lione
`(Chicago, IL)
`
`Counsel for Watson
`Laboratories and Actavis
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`
`
`408
`
`APPEARANCES CONTINUED:
`DAVID BILSON, ESQ.
`Phillips, Goldman, McLaughlin & Hall, P.A.
`-and-
`MAUREEN L. RURKA, ESQ., and
`CHRISTOPHER P. WILSON, ESQ.
`Winston & Strawn LLP
`(Chicago, IL)
`
`Counsel for Sun Pharma Global
`FZE and Sun Pharmaceutical
`and Amneal
`DAVID E. MOORE, ESQ.
`Potter Anderson & Corroon LLP
`-and-
`DOUGLAS H. CARSTEN, ESQ.,
`ELLIE F. STEINER, ESQ., and
`NELLIE AMJADA, ESQ.
`Wilson Sonsini Goodrich & Rosati
`(San Diego, CA)
`
`Counsel for Mylan
`- - -
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`
`
`409
`
`THE COURT: Good morning.
`(Counsel respond "Good morning.")
`THE COURT: Mr. Silver.
`MR. SILVER: Your Honor, we are still here.
`AstraZeneca will call Christine Meyer, who is
`our economist, Your Honor.
`THE COURT: We seem to be bleeding defendants.
`... CHRISTINE SIEGWARTH MEYER, having been duly
`sworn as a witness, was examined and testified as
`follows ...
`
`THE COURT: Good morning, Doctor.
`THE WITNESS: Good morning.
`DIRECT EXAMINATION
`
`BY MR. SILVER:
`Good morning, Dr. Meyer.
`Q.
`Good morning.
`A.
`Dr. Meyer, what is your occupation?
`Q.
`I am an economist.
`A.
`What does an economist do?
`Q.
`Generally, economists do a wide variety of things.
`A.
`You see a newspaper that day predict inflation,
`unemployment, things like that, that is a macroeconomist. I
`am a microeconomist.
`So I study firms, and in particular, you know,
`what's called industrial organization.
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`
`
`Meyer - direct
`
`439
`
`Q.
`
`Thank you, Dr. Meyer.
`MR. SILVER: No further questions at this time.
`THE COURT: Counsel, your witness.
`MR. REMUS: Your Honor, may I approach the
`
`witness?
`
`THE COURT: Yes, sir.
`MR. REMUS: Your Honor, may I proceed?
`THE COURT: Yes, sir.
`CROSS-EXAMINATION
`
`BY MR. REMUS:
`Good morning, Dr. Meyer.
`Q.
`Good morning.
`A.
`
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`
`
`440
`
`Meyer - cross
`I think we can all agree that the features of
`Q.
`saxagliptin are not the sole driver for sales of the Onglyza
`family of products --
`THE COURT: Have you two met before?
`MR. REMUS: Yes, Your Honor. I apologize. I
`had the pleasure of meeting Dr. Meyer at her deposition.
`BY MR. REMUS:
`It is good to see you again.
`Q.
`Thank you.
`A.
`Do you agree that the features of saxagliptin are not
`Q.
`the sole driver for the sales of Onglyza?
`I agree, just as I said I think two minutes ago.
`A.
`BMS and AstraZeneca spent over 500 million dollars
`Q.
`marketing those products. Correct?
`They did market the products, absolutely.
`A.
`In connection with the sales of the Onglyza family of
`Q.
`products, BMS and then AstraZeneca offer discounts to its
`customers' product?
`It's standard in this industry to offer discounts,
`A.
`yes.
`Those discounts can take different forms, whether they
`Q.
`are rebates or contractual discounts?
`That's correct.
`A.
`And sometimes they are referred to as managed
`Q.
`marketplace discounts. Is that correct?
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`441
`
`Meyer - cross
`I have heard that term used, yes.
`A.
`You will agree with me that the volume of discounts as
`Q.
`a percentage of sales has gone up every single year since
`Onglyza was launched. Correct?
`I have seen that, yes.
`A.
`The current level of discounts, the level of discounts
`Q.
`as of the last data set we have from 2015 approaches a
`60-percent discount. Correct?
`I don't know that number off the top of my head.
`A.
`In your binder could you turn to PTX-2344.
`Q.
`PTX-2344 --
`I am sorry, my binder just opened up. I have a mass
`A.
`of papers here.
`MR. SILVER: Your Honor, I am going to object
`because this is Mr. Hofmann's expert report. I think that
`is improper material for impeachment.
`THE COURT: Well, did she rely on it?
`MR. SILVER: She opined before he authored his
`
`report.
`
`THE COURT: Are you trying to refresh her
`recollection?
`MR. REMUS: Yes, I am.
`THE COURT: Why don't you just go ahead and
`refresh her recollection.
`MR. SILVER: Thank you, Your Honor.
`
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`Meyer - cross
`
`442
`
`BY MR. REMUS:
`Is your binder okay?
`Q.
`I got the binder together. We are good.
`A.
`If you could turn to, it's Page 51 of 62 in PTX-2344?
`Q.
`51.
`A.
`Yes. Page 51 of 62.
`Q.
`Okay.
`A.
`Just to confirm, you reviewed Mr. Hofmann's report in
`Q.
`the course of forming your opinions in this case. Correct?
`I did.
`A.
`You did not see any reason to disagree with any of his
`Q.
`calculations in his report?
`I did not.
`A.
`That applies to this Exhibit A, on Page 51 of 62.
`Q.
`Correct?
`Correct.
`A.
`In Exhibit A, that details the discounting, the
`Q.
`managed marketing discounts, at BMS and AstraZeneca after
`the launch of the Onglyza family of products. Correct?
`Yes.
`A.
`If you go down to the line managed market discounts as
`Q.
`a percentage of gross sales, do you see that line there?
`I do.
`A.
`If you follow all the way across to 2015, you see that
`Q.
`number 58 percent?
`
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`
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`Meyer - cross
`
`443
`
`I do.
`A.
`Does that refresh your recollection that the
`Q.
`discounting of the Onglyza products was at 58 percent in
`2015?
`I don't dispute that number.
`A.
`To make sure we understand what the number means, when
`Q.
`we are talking about discounts of 60 percent, that means
`AstraZeneca is getting 40 cents on the dollar for its
`Onglyza products. Correct?
`I wouldn't say getting 40 cents on the dollar. A firm
`A.
`decides at the same time how much to charge at a gross price
`and a discount. Every time I go to Macy's, things are on
`sale. That doesn't mean every time it's 30 percent off it's
`great. You look at the bottom-line price.
`So the discounting tells you something. I have
`to look at everything together. That is why I looked at net
`revenues. That is really a better measure of what's going
`on in the marketplace in terms of commercial success than
`just looking at discounting.
`When I took your deposition, you could not recall a
`Q.
`case in which you have testified and found commercial
`success in the face of 60-percent discounting. Correct?
`The answer to that specific question, no, I could not
`A.
`recall a case.
`Now, the reason AstraZeneca has to have such deep
`Q.
`
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`444
`
`Meyer - cross
`discounting on the Onglyza family of products is because it
`can't differentiate its products from the other DPP-4
`inhibitors. Correct?
`It has the discounting for whatever reasons it does
`A.
`when it looks at the competitive space. The DPP-4
`inhibitors certainly, from everything that I have seen, they
`are the closest competitors to saxagliptin. And, you know,
`in pharmaceuticals, discounting and rebating are a part of
`what you have to do. Again, it's the getting it on the
`shelf. If you are not on the formulary, then you are not
`going to get the sales. It's just like white bread being on
`the shelf. One of the things you have to do is do some
`discounting and rebating.
`And you agree with me that AstraZeneca is not able to
`Q.
`differentiate the Onglyza family of products from any of the
`other DPP-4 products on the market; is that correct?
`MR. SILVER: Your Honor, I'm going to object.
`This goes I think beyond the scope of the direct and also is
`asking the witness questions that I'm not sure she's
`qualified to answer as a technical matter.
`THE COURT: No. I disagree. I'm going to
`overrule it at this point.
`MR. SILVER: Thank you, your Honor.
`BY MR. REMUS:
`Do you have the question in mind?
`Q.
`
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`
`445
`
`Meyer - cross
`I do. You know, saxagliptin, as I understand it,
`A.
`is -- again, I am certainly not a chemist, I am not a
`doctor, but I have looked at a lot of documents in this
`case. Saxagliptin is a different product, right, from the
`other gliptins.
`
`As I heard Dr. Lenhard testify yesterday,
`there's a patient, for example, who is on a particular
`gliptin, and it's not working for them for whatever reason,
`and they come on and then they want to go back on to a DPP-4
`inhibitor. He's not going to put him on that same gliptin.
`He's going to put him on something else. So they are, by
`definition, different, and from Dr. Lenhard's testimony
`different. I understand that there's a lot of similarities
`between them, but that doesn't mean that they're one and the
`same.
`In marketing its products, AstraZeneca cannot claim
`Q.
`that the Onglyza family of products are more efficacious
`than any other DPP-4 inhibitor on the market; is that
`correct?
`I understand that that is the case. You know, they're
`A.
`very specific requirements that I understand have had -- in
`order to make certain marketing claims. I understand it
`can't make those marketing claims.
`And there are no statements in any of the marketing
`Q.
`materials or advertisement that suggest that Onglyza is
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`
`446
`
`Meyer - cross
`more efficacious than any other DPP-4 inhibitor; is that
`correct?
`I have not seen such data. Correct.
`A.
`Now, you also agree with me, don't you, that the
`Q.
`safety of Onglyza is no better than any other DPP-4
`inhibitor on the market?
`I agree that they're similar --
`A.
`THE COURT: You might want to -- you know the
`point of Mr. Silver's objection. You might want to rephrase
`that.
`
`MR. REMUS: I will restate the question. Thank
`
`you.
`BY MR. REMUS:
`You'll agree with me that there's nothing in the
`Q.
`promotional materials or promotional message for the Onglyza
`family of products that suggest that the Onglyza family of
`products has a better safety profile than any other DPP-4
`inhibitors?
`I have not seen anything, no.
`A.
`Now, you agree with me that the promotional message
`Q.
`for Onglyza is the same as the promotional message for all
`other DPP-4 inhibitors?
`I certainly studied the promotional message of
`A.
`Onglyza. I did not do, conduct an extensive study of
`the promotional messaging of all the other DPP-4 inhibitors.
`
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`447
`
`Meyer - cross
`MR. REMUS: Is there a PDX-26?
`BY MR. REMUS:
`Dr. Meyer, this was from your slide; is that correct?
`Q.
`Correct.
`A.
`And this is from the promotional message for the
`Q.
`Onglyza family of products?
`Correct.
`A.
`I want to compare that message that we have on PDX-26
`Q.
`to the promotional message for the competitor products.
`Let's look at DTX-1083.
`Is this in my binder?
`A.
`It is.
`Q.
`Okay.
`A.
`And so it should be the first exhibit in your binder.
`Q.
`Got it.
`A.
`DTX-1083 is a printout from the website for Januvia,
`Q.
`and if we could come back out on DTX-1083. And in the
`very first bullet point right next to it, right there.
`Perfect.
`
`So you highlighted that the Onglyza marketing
`message is that Onglyza, in addition to diet and exercise,
`has shown to lower A1C; is that correct?
`Correct.
`A.
`And in the marketing message for Januvia, it, too,
`Q.
`says, Januvia, along with diet and exercise, helps lower
`
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`
`
`448
`
`Meyer - cross
`your blood sugar; is that correct?
`I agree.
`A.
`And you would agree with me that's the same marketing
`Q.
`message?
`Well, you just pulled out one piece. I have not
`A.
`had a chance to, you know, do a side-by-side comparison of
`the entire document, but certainly I agree that both mention
`the lowering of A1C.
`MR. REMUS: Can we put up PDX-4.6 up there
`and pull up DTX-1084, which is the website for Tradjenta.
`And if we could pull up that graphic in the,
`kind of the top middle portion where it says, lower A1C, can
`help lower your A1C. Go up. Right in the middle. Keep
`going across.
`BY MR. REMUS:
`Do you see where it says, can help lower your A1C?
`Q.
`I see that.
`A.
`And, again, that's the same marketing message for
`Q.
`Onglyza; is that correct?
`Again, the same as with the previous document. I
`A.
`mean, I have not done a side-by-side comparison, but I do
`understand that A1C is one of the tests, I heard that
`yesterday, from Dr. Lenhard, one of the two main tests of,
`to test for diabetes, yes.
`MR. REMUS: You can take that down. Thank you.
`
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`
`
`Meyer - cross
`
`449
`
`BY MR. REMUS:
`Now, you agree with me, don't you, that a small market
`Q.
`share is a likely indicator that a product is not
`commercially successful as one of the objective indicia of
`nonobviousness?
`I agree that if you didn't know anything else, that,
`A.
`you know, all else being equal, a higher market share is,
`you know, more indicative of commercial success than a lower
`market share, but as I said before, it's important to take
`everything into consideration, to look at all the data in
`its totality in a marketplace context as well.
`All right. Let's go to PDX-01. Dr. Meyer you
`Q.
`mentioned that you provided testimony in the Endo case
`before the PTAB?
`Correct.
`A.
`Now, I'm happy to provide your declaration to you, but
`Q.
`I think we might be able to shortcut this. If you want your
`declaration, I will give it to you.
`Would it surprise you if your declaration in the
`Amneal case said that a small market share is a likely
`indicator that a product is not commercially successful as
`one of the objective indicia of nonobviousness?
`No, it wouldn't. As I said, it is important to take
`A.
`everything into consideration. There are very different
`facts there, obviously.
`
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`
`
`450
`
`Meyer - cross
`MR. REMUS: Can we take that down?
`BY MR. REMUS:
`You agree with me that that the Onglyza family of
`Q.
`products has never had more than a 20 percent market share
`for the DPP-4 inhibitors; is that correct?
`I would agree with that.
`A.
`And it's currently close to a ten percent market
`Q.
`share; is that correct?
`I think the last number that I saw was 12 percent.
`A.
`And that puts it in third place in the market share
`Q.
`behind Januvia and Tradjenta?
`I believe Tradjenta overtook it in market share within
`A.
`the last, you know, short while of the data that I saw.
`Obviously, it's not continuing past 2015.
`MR. REMUS: Let's go to PDX-424.
`BY MR. REMUS:
`Dr. Meyer, on PDX-424 you have thumbnails of labeling
`Q.
`for Onglyza and Kombiglyze. Looking at what you have here,
`PTX-2010 and PTX-2301, that's not the current labeling for
`Onglyza and Kombiglyze; is that correct?
`I cannot see what's on the screen. It's too blurry on
`A.
`the screen. I'm just going to look at the copy in my
`binder, if that's okay.
`THE COURT: It's a little small in the binder as
`
`well.
`
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`451
`
`Meyer - cross
`THE WITNESS: That's why I have my reading
`glasses, your Honor.
`BY MR. REMUS:
`It may be if you look to the source document,
`Q.
`PTX-2010, perhaps that's easier.
`That is what I'm looking at in my binder.
`A.
`I'm sorry. Okay.
`Q.
`Yes. On my screen, things are quite blurry,
`A.
`actually.
`
`This seems to be as of August 2015, I believe.
`I see a revision date and I see a date at the end of the
`Onglyza, one and the same of Kombiglyze. I have not been
`able to do a complete review, but my sense is that it's an
`August 2015 version.
`And you agree that is not the most current label for
`Q.
`Onglyza and Kombiglyze; correct?
`I understand it is a label.
`A.
`Either let's go to JTX-196. That should be in your
`Q.
`binder. And so --
`JTX-196?
`A.
`Yes.
`Q.
`Okay.
`A.
`So you'll agree with me that the label at JTX-196 is
`Q.
`the label that was revised in April 2016?
`I see the revision date, yes.
`A.
`
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`452
`
`Meyer - cross
`And then in the warnings and precautions section on
`Q.
`the front page, the second bullet point refers to heart
`failure.
`I see that.
`A.
`So it says, heart failure. Consider the risks and
`Q.
`benefits of Onglyza in patients who have known risk factors
`for heart failure. Monitor patients for signs and symptoms.
`Did I read that correctly?
`I saw the warnings and precautions on the top -- I see
`A.
`it down below, yes. It just took me a moment to find it. I
`see it.
`And so that's a new warning that was added this April;
`Q.
`is that correct?
`That's my understanding, yes.
`A.
`And that certainly is not an advantage for the Onglyza
`Q.
`family of products; is that correct?
`No, I would not consider that to be an advantage.
`A.
`And you agree that that warning is not present in the
`Q.
`labels for Tradjenta and Januvia; is that correct?
`I believe that is correct. I believe it is perhaps
`A.
`something similar for Nesina, but I believe that's correct.
`You referred to the first mover advantage. You would
`Q.
`agree with me that a superior product entering the market
`after the first mover can still overtake that first mover;
`is that correct?
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`453
`
`Meyer - redirect
`The first mover advantage is not something that's
`A.
`absolute, but it is an advantage that the first entrant to
`the market has.
`All right.
`Q.
`MR. REMUS: No further questions. Thank you,
`
`Dr. Meyer.
`
`THE COURT: Thank you, counsel.
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