UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` MYLAN PHARMACEUTICALS, INC.
` Petitioner
` - vs. -
` YEDA RESEARCH AND DEVELOPMENT CO. LTD.,
` Patent Owner
` Case IPR2015-00643 (8,232,250)
` Case IPR2015-00644 (8,399,413)
` Case IPR2015-00830 (8,969,302)
`
` DEPOSITION OF JOEL W. HAY, Ph.D.
` Los Angeles, California
` Monday, April 4, 2016
`
`REPORTED BY:
`CLAY J. FRAZIER
`CSR NO. 13401, RMR, CRR
`
`The Little Reporting Company
` (646) 650-5055 | www.littlereporting.com
`
`MYLAN PHARMS. INC. EXHIBIT 1141 Page 1
`
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` MYLAN PHARMACEUTICALS, INC.
` Petitioner
` - vs. -
` YEDA RESEARCH AND DEVELOPMENT CO. LTD.,
` Patent Owner
` Case IPR2015-00643 (8,232,250)
` Case IPR2015-00644 (8,399,413)
` Case IPR2015-00830 (8,969,302)
`
` DEPOSITION OF JOEL W. HAY, Ph.D.
` Los Angeles, California
` Monday, April 4, 2016
`
`REPORTED BY:
`CLAY J. FRAZIER
`CSR NO. 13401, RMR, CRR
`
`The Little Reporting Company
` (646) 650-5055 | www.littlereporting.com
`
`MYLAN PHARMS. INC. EXHIBIT 1141 Page 1
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`
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`2
`
`MYLAN PHARMACEUTICALS, )
`INC., )
` )
` Petitioner, )
` )
` vs. ) Case No. IPR2015-00643
` ) (8,232,250), et al.
` )
`YEDA RESEARCH AND )
`DEVELOPMENT CO. LTD., )
` )
` Patent Owner. )
`___________________________ )
`
` Deposition of JOEL W. HAY, taken on behalf
` of the Patent Owner Yeda, commencing at
` 9:02 a.m., Monday, April 4, 2016, at
` 601 S. Figueroa Street, 41st Floor,
` Los Angeles, California, before
` Clay J. Frazier, CSR No. 13401, RMR, CRR,
` a Certified Shorthand Reporter in and for
` the County of Los Angeles, State of
` California.
`
`The Little Reporting Company
` (646) 650-5055 | www.littlereporting.com
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`MYLAN PHARMS. INC. EXHIBIT 1141 Page 2
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`3
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`APPEARANCES:
`FOR THE PATENT OWNER YEDA:
` GOODWIN PROCTOR LLP
` BY: NICK MITROKOSTAS, Esq.
` DARYL L. WIESEN, Esq.
` 53 State Street
` Exchange Place
` Boston, Massachusetts 02109
` (617) 570-1000
` Nmitrokostas@goodwinproctor.com
` Dwiesen@goodwinproctor.com
`
`FOR MYLAN & THE DEPONENT:
` PERKINS COIE
` BY: BRANDON M. WHITE
` ROBERT D. SWANSON, Esq.
` 700 13th Street, NW
` Suite 600
` Washington, DC 20005-3960
` (202) 654-6206
` BMWhite@perkinscoie.com
` RSwanson@perkinscoie.com
`
`FOR AMNEAL PHARMACEUTICALS:
` DUANE MORRIS
` BY: VINCENT L. CAPUANO, Ph.D., Esq.
` 100 High Street
` Suite 2400
` Boston, Massachusetts 02110-1724
` (857) 488-4250
` Vcapuano@duanemorris.com
`
`ALSO PRESENT:
` Matthew Greinert, In-house Counsel, Mylan
`
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` (646) 650-5055 | www.littlereporting.com
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`MYLAN PHARMS. INC. EXHIBIT 1141 Page 3
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`
` I N D E X
` EXAMINATION: PAGE
` BY MR. MITROKOSTAS 5
`
`4
`
` E X H I B I T S
` PAGE
`Exhibit 2149 - IMS Institute HSRN Data Brief: 17
` National Sales Perspectives
` (2 pages)
`Exhibit 2150 - FiercePharma H.P. Acthar Gel web 50
` printout (2 pages)
`Exhibit 2151 - Competition, Market Power, and 63
` Pricing in Brand Name
` Pharmaceutical Markets article
` (2 pages)
`Exhibit 2152 - Disease-Modifying Therapies for 87
` MS packet (27 pages)
`Exhibit 2153 - Form 20F - Teva Pharmaceuticals 96
` (256 pages)
`
` INFORMATION REQUESTED
` (NONE)
`
` QUESTIONS MARKED
` (NONE)
`
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` (646) 650-5055 | www.littlereporting.com
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`MYLAN PHARMS. INC. EXHIBIT 1141 Page 4
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` LOS ANGELES, CALIFORNIA; MONDAY, APRIL 4, 2016
` 9:02 A.M.
`
`5
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` JOEL W. HAY,
` having declared under penalty of perjury to tell the
` truth, was examined and testified as follows:
`
` EXAMINATION
` BY MR. MITROKOSTAS:
` Q Good morning, Dr. Hay.
` A Good morning.
` Q Do you prefer doctor or professor?
` A Whatever you want.
` Q Okay. You've been deposed a number of times;
` correct?
` A Yes.
` Q So I'm not going to go over the ground rules
` for a deposition, but if you have any questions or if a
` question's unclear to you throughout the deposition, I
` assume you're going to let me know.
` A Okay.
` Q All right.
` MR. CAPUANO: I'm sorry. Should we enter our
` appearances and do that?
` THE REPORTER: I have your appearances, but if
`
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` you would like to state them for the record, I can take
` them down.
` MR. CAPUANO: No. I'll just say -- this is
` Vince Capuano for Amneal. I'll just say there's more
` than one petitioner. If one petitioner makes an
` objection, we'd like an agreement that it applies to
` both.
` MR. MITROKOSTAS: Yeah, that's fine. That's
` acceptable to us.
` BY MR. MITROKOSTAS:
` Q Dr. Hay, you've testified in deposition or at
` trial in a number of patent litigation cases; correct?
` A Yes.
` Q And in nearly all of those cases you testified
` on behalf of the patent challenger; correct?
` A No.
` Q How many cases have you testified on behalf of
` the patent owner?
` A Probably three to five.
` Q And if we focus solely on pharmaceutical
` patent litigation matters, have you ever testified for
` a patent owner in a pharmaceutical patent litigation?
` A Yes.
` Q How many times?
` A Three to five.
`
`The Little Reporting Company
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`
`MYLAN PHARMS. INC. EXHIBIT 1141 Page 6
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` Q And did those cases involve commercial
` success?
` A Some of them, yeah.
` Q How many involved the issue of commercial
` success?
` A I don't specifically recall, but I think all
` of them.
` Q Have you ever offered the opinion that a
` pharmaceutical product is a commercial success?
` A Yes.
` Q You're an economist; correct?
` A Yes.
` Q And as an economist, you regularly use IMS
` data in analyzing sales of a pharmaceutical product;
` correct?
` MR. WHITE: Objection to form.
` THE WITNESS: I use lots of different data.
` Certainly IMS is one of the data sets I use on
` occasion.
` BY MR. MITROKOSTAS:
` Q IMS is a reliable data source?
` MR. WHITE: Objection to form.
` THE WITNESS: It's reliable within the bounds
` of what it does in some cases. It certainly has
` limitations for the purposes of this case, as I've
`
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`
`MYLAN PHARMS. INC. EXHIBIT 1141 Page 7
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` described in my declaration.
` BY MR. MITROKOSTAS:
` Q But economists generally use IMS data in
` analyzing pharmaceutical market issues; right?
` MR. WHITE: Objection to form. Foundation.
` THE WITNESS: Well, you know, I don't want to
` speak for all economists. I certainly use what I
` can -- what data I can find that I believe to be the
` best data for what it is I'm trying to accomplish.
` And as I've said, I've noticed and reported in
` my declaration on limitations of the IMS data for this
` particular application.
` BY MR. MITROKOSTAS:
` Q I want you to focus just on the use of IMS
` data generally in pharmaceutical market analysis.
` You agree that IMS Health is a major
` third-party data collection service; correct?
` MR. WHITE: Objection to form. Foundation.
` THE WITNESS: Yeah. I mean, IMS data are
` developed and prepared and used for a number of
` different purposes. Their primary focus is not
` research purposes. They have strengths and weaknesses
` in different applications. And it sort of depends on
` which application you want to look at.
`
`The Little Reporting Company
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`
`MYLAN PHARMS. INC. EXHIBIT 1141 Page 8
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` BY MR. MITROKOSTAS:
` Q IMS data is widely used in the pharmaceutical
` industry; correct?
` MR. WHITE: Objection to form. Foundation.
` THE WITNESS: I mean, the primary purpose of
` IMS data is in most cases as a proprietary data set
` that is developed and purchased by drug companies for
` the purposes of monitoring sales of pharmaceutical
` products. That doesn't mean that it doesn't have
` strengths and weaknesses.
` BY MR. MITROKOSTAS:
` Q My question was whether IMS data is widely
` used in the pharmaceutical industry.
` MR. WHITE: Objection to form. Foundation.
` Asked and answered.
` THE WITNESS: It's widely used for purposes
` other than the kinds of research that economists that
` work on pharmaceutical markets use it for. The primary
` use is not that.
` BY MR. MITROKOSTAS:
` Q Well, pharmaceutical companies widely use IMS
` data to analyze sales of a pharmaceutical product;
` correct?
` MR. WHITE: Objection. Form. Foundation.
` Scope.
`
`The Little Reporting Company
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`
`MYLAN PHARMS. INC. EXHIBIT 1141 Page 9
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` THE WITNESS: I wouldn't say they primarily
` use it to analyze sales. I would say they primarily
` use it to look at things like marketing and promotion.
` You know, sales is just one of the components that they
` look at.
` MR. MITROKOSTAS: Right.
` BY MR. MITROKOSTAS:
` Q But you agree that pharmaceutical companies
` use IMS data to evaluate sales of a pharmaceutical
` product; correct?
` MR. WHITE: Objection to form.
` THE WITNESS: Some do, some don't. It depends
` on the kinds of products they're selling. It depends
` on whether their products are distributed in many cases
` by specialty pharma, pharmaceutical companies.
` It depends on whether they have injectables or
` Part D drugs. It depends on the comprehensiveness and
` reliability of the IMS data. If the IMS data is
` reliable, then they would use it. If it's not, they
` would consider other data sources.
` BY MR. MITROKOSTAS:
` Q And are you aware that Petitioner Mylan has
` relied on IMS sales data to evaluate the sales of
` Copaxone?
` MR. WHITE: Objection. Form. Foundation.
`
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`MYLAN PHARMS. INC. EXHIBIT 1141 Page 10
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` THE WITNESS: That very well may be the case.
` But the purposes for which Mylan uses the data
` may be different from the purposes that I or a
` pharmaceutical economist would use it.
` MR. MITROKOSTAS: Right.
` BY MR. MITROKOSTAS:
` Q But you agree that it's appropriate for
` pharmaceutical companies and, in fact, pharmaceutical
` companies use IMS data to evaluate sales of a
` pharmaceutical product.
` MR. WHITE: Objection to form. Foundation.
` Relevance.
` THE WITNESS: No. I mean, as I say, you don't
` just use something in a cookie-cutter way. You look at
` its strengths and weaknesses, whether it's IMS data or
` Wolters Kluwer data or First Database data or some
` other data set.
` You look at their strengths and weaknesses,
` and you evaluate each data set in the context of that.
` BY MR. MITROKOSTAS:
` Q But it's not your opinion, Dr. Hay, that data
` generated from IMS is entirely useless in the
` pharmaceutical space; correct?
` MR. WHITE: Objection to form.
` THE WITNESS: I don't know what entirely
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`MYLAN PHARMS. INC. EXHIBIT 1141 Page 11
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` useless means. I know that there's evidence in this
` case, for example, that it doesn't accurately cover
` many of the important drugs in a comprehensive manner
` in the MS space.
` MR. MITROKOSTAS: We'll get to your opinion on
` that matter in a moment.
` BY MR. MITROKOSTAS:
` Q But you agree that IMS data can be used to
` evaluate sales and market share of pharmaceutical
` products?
` MR. WHITE: Objection to form. Asked and
` answered.
` THE WITNESS: Not in a vacuum.
` BY MR. MITROKOSTAS:
` Q So you won't -- you believe that you cannot
` use IMS data to evaluate sales and market share of a
` pharmaceutical product?
` A No, that's not what I said.
` What I said is if I'm trying to evaluate some
` aspect of a pharmaceutical market or something about
` pharmaceutical economics, I try and get as many data
` sets as I can, and I look at the strengths and
` weaknesses of each of them, and I then use them
` carefully with full cognizance of the strengths and
` weaknesses of each of those databases.
`
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`MYLAN PHARMS. INC. EXHIBIT 1141 Page 12
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` And I listed several. There's many others as
` well. And I would want to look at all of them.
` Q For purposes of offering opinions in this
` case, did you look at any of those data sets that you
` identified in your testimony today?
` A I certainly asked counsel for any data sets
` they could give me on -- that were relevant to my
` opinions.
` Q Dr. Hay, you identified a number of data sets
` that you said one could look at to evaluate market
` share in the pharmaceutical space. Did you look at any
` of those data sets before offering your opinions in
` this case?
` A I asked counsel for all the data sets they
` could give me.
` Q And so you did not look at any other -- any
` data sets that you've identified?
` A Well, I couldn't even look at the IMS data
` because it wasn't made available to me. So I don't
` know what was said about IMS data in this case because
` I didn't see any IMS data.
` Q Did you ask to see IMS data?
` A Absolutely. I asked to see any data that's
` relevant to my opinions.
` Q Do you have an understanding that counsel --
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`MYLAN PHARMS. INC. EXHIBIT 1141 Page 13
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` that your counsel was authorized to share the IMS data
` with you in this proceeding?
` MR. WHITE: Objection. Blatantly
` mischaracterizes the record in this case.
` MR. MITROKOSTAS: It's -- Brandon, it's not a
` mischaracterization. State your objection and let me
` ask the witness questions.
` BY MR. MITROKOSTAS:
` Q Dr. Hay, do you understand that your counsel
` was authorized to share with you the IMS data that
` Dr. Grabowski relied on?
` MR. WHITE: Objection to form. Foundation.
` Relevance. Scope.
` THE WITNESS: I asked counsel for any data
` they had, including IMS data. I didn't get any data.
` BY MR. MITROKOSTAS:
` Q And so you did not review any data prior to
` formulating your opinions in this case; correct?
` A I evaluated the data that I list in the
` attachment to my report.
` I evaluated what was purported to be
` Dr. Grabowski's assessment of IMS data. But I never
` did get any access to any IMS data.
` BY MR. MITROKOSTAS:
` Q Dr. Hay, you understand that IMS uses
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`MYLAN PHARMS. INC. EXHIBIT 1141 Page 14
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` different audits; correct?
` A I believe that that terminology is used, yes.
` Q What is an audit?
` A They change the names of these things on a
` fairly frequent basis, so I don't really keep up with
` it. But I think there's something called the National
` Prescription Audit.
` Q Is it fair to characterize it as a data set
` that's generated by one of the methodologies the IMS
` uses?
` A Yeah, I think that's correct.
` Q Okay. And are you aware that there's also a
` National Sales Perspective data set or audit that IMS
` uses?
` A I think National Sales Perspective is a name
` that there's -- they've been using more recently, yes.
` Q And National Sales Perspective data is
` different from the NPA audit that you mentioned;
` correct?
` A As far as I know. Like I say, they change
` these things on a pretty frequent basis, so I don't
` keep track of the jargon of what they call these
` different data sets.
` But, yeah, it's my understanding that in the
` relevant time frame there were differences.
`
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`MYLAN PHARMS. INC. EXHIBIT 1141 Page 15
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` Q And you understand that MSP data the IMS
` generates is collected from sales of pharmaceutical
` manufacturers to their customers; right?
` MR. WHITE: Objection. Form. Foundation.
` THE WITNESS: I think that sounds correct.
` BY MR. MITROKOSTAS:
` Q And so the MSP data set from IMS indicates
` sales made by pharmaceutical manufacturers and also by
` wholesalers and drug chain distributors and hospitals,
` et cetera, to their customers; right?
` MR. WHITE: Objection. Foundation.
` THE WITNESS: Within the limitations of the
` universe that IMS has, yes.
` BY MR. MITROKOSTAS:
` Q And you agree that sales by manufacturers to
` specialty pharmacies would be captured in the MSP data
` set; correct?
` A No. I mean, we know for a fact that they
` didn't catch the Tysabri data. There's plenty of
` evidence that they didn't capture other data as well.
` Q Now I want you to focus on the MSP data set,
` Dr. Hay.
` MSP data is gathered by pharmaceutical
` manufacturers; correct?
` MR. WHITE: Objection. Form. Foundation.
`
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`MYLAN PHARMS. INC. EXHIBIT 1141 Page 16
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` THE WITNESS: I don't specifically recall.
` You'd have to give me a list of what they said they
` used to capture that data.
` (Exhibit 2149 was marked for
` identification.)
` BY MR. MITROKOSTAS:
` Q Dr. Hay, the court reporter has handed you
` what's been marked as Exhibit 2149 in this proceeding,
` which is the data brief from IMS on the National Sales
` Perspective data set.
` Do you have that in front of you?
` A Yes.
` MR. WHITE: For the record, object to
` Exhibit 2149 on relevance, on hearsay, on authenticity,
` and that it wasn't produced as part of Dr. Grabowski's
` report.
` BY MR. MITROKOSTAS:
` Q Dr. Hay, you see here that it says in
` Exhibit 2149 that:
` "MSP is considered the industry
` standard for measuring pharmaceutical
` spending. This is because MSP captures
` 100 percent of the total US
` pharmaceutical market measuring sales
` at actual transaction prices rather
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` than using average wholesale price."
` Do you see that?
` A Well, first of all, I don't see a date on
` this. I have no idea when this was written, when this
` was published. I don't know where it came from.
` And I don't know that this has been an
` independently audited and adjudicated statement. I
` don't know, you know, who came up with this.
` Q Do you have any reason to doubt that this came
` from IMS? Exhibit 2149.
` A Well, I don't know if any other independent
` organization agrees with what whoever said this said.
` And, like I say, there's no date on it.
` This could have been something they wrote five
` years ago, ten years ago, 20 years ago, last week. I
` have no clue when this was done.
` Q And so you don't agree then with what IMS is
` describing in Exhibit 2149 that the MSP data set
` captures 100 percent of total U.S. pharmaceutical
` market sales?
` MR. WHITE: Objection to form.
` MR. CAPUANO: Mischaracterizes the document.
` THE WITNESS: Well, you know, the words are
` what the words are. I don't know the date of this. I
` don't know who did it, for what purposes, whether it's
`
`The Little Reporting Company
` (646) 650-5055 | www.littlereporting.com
`
`MYLAN PHARMS. INC. EXHIBIT 1141 Page 18
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` a public website, whether it's a private site. I have
` no clue, you know, what the validity and reliability
` are of these words and when they were written.
` BY MR. MITROKOSTAS:
` Q So, Dr. Hay, let me just make sure the record
` is clear.
` Prior to forming your opinions in this case,
` you didn't evaluate the standard that IMS uses for each
` of the audits that it gathers data for for the
` pharmaceutical market?
` MR. WHITE: Objection to form. Foundation.
` There's no IMS data in this case.
` THE WITNESS: The data that was provided that
` was purported to be from IMS -- although I never
` actually saw any IMS data. But the data that
` Dr. Grabowski purports to be from IMS did not include
` any sales for Tysabri and included limited sales for
` other products as well.
` So whatever is said here is not relevant to
` what I was asked to opine on.
` BY MR. MITROKOSTAS:
` Q Dr. Hay, you criticize Dr. Grabowski's
` reliance on the IMS data that he used in forming his
` opinions; correct?
` MR. CAPUANO: Objection. Form.
`
`The Little Reporting Company
` (646) 650-5055 | www.littlereporting.com
`
`MYLAN PHARMS. INC. EXHIBIT 1141 Page 19
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` Mischaracterizes the record.
` THE WITNESS: I mean, we can go through my
` declaration, and we can see what I said about
` Dr. Grabowski's opinions.
` The fact is that he has a graph of the sales
` of drugs in the MS category, and he excludes Tysabri
` and even has a footnote saying he couldn't get that
` from IMS.
` BY MR. MITROKOSTAS:
` Q So it's your opinion that Dr. Grabowski
` excluded Tysabri in his entire analysis in his
` declaration; is that right?
` MR. WHITE: Objection to form.
` THE WITNESS: I mean, the words "Tysabri" are
` in his report. And there may be something that he says
` about it, but it's not in his exhibits of sales.
` BY MR. MITROKOSTAS:
` Q So, in your opinion, Dr. Grabowski did not
` rely on sales of Tysabri in forming his opinions in
` analyzing data in this case?
` MR. WHITE: Objection to form.
` THE WITNESS: I don't recall where he shows
` the sales of Tysabri.
` BY MR. MITROKOSTAS:
` Q Dr. Hay, I'm handing you what has previously
`
`The Little Reporting Company
` (646) 650-5055 | www.littlereporting.com
`
`MYLAN PHARMS. INC. EXHIBIT 1141 Page 20
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` been marked and filed as Yeda Exhibit No. 2112, which
` is one of the documents you reviewed in this case.
` Do you remember this document?
` A I believe so.
` Q And this is a graph that Dr. Grabowski
` prepared evaluating multiple sclerosis drugs' share of
` wholesale dollar sales from the fourth quarter 2009 to
` the third quarter 2015; correct?
` A Right. This is a share of dollar sales. When
` we talk about prescriptions, he excludes Tysabri.
` Q Okay. But you understand that Dr. Grabowski
` evaluated Tysabri in his analysis; correct?
` MR. WHITE: Objection to form. Foundation.
` THE WITNESS: No, absolutely not.
` Because, as I say numerous times, he ignored
` rebates, discounts, givebacks, chargebacks, and other
` differences between the kind of pricing that IMS has
` for different drugs and the pricing that exists in
` reality.
` BY MR. MITROKOSTAS:
` Q I don't want to focus on pricing and rebates
` and coupons for the moment. I'm asking you about
` Exhibit 2112.
` And you agree that in Exhibit 2112
` Dr. Grabowski evaluates the market share of Tysabri in
`
`The Little Reporting Company
` (646) 650-5055 | www.littlereporting.com
`
`MYLAN PHARMS. INC. EXHIBIT 1141 Page 21
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` sales dollars as compared to other MS drugs; correct?
` MR. WHITE: Objection to form.
` THE WITNESS: No. Because, as I just said,
` these numbers are not reliable because they exclude
` discounts, rebates, chargebacks, kickbacks, bundling,
` and other price differences that make none of these
` market share dollars relevant.
` BY MR. MITROKOSTAS:
` Q Dr. Hay, to be clear, you agree that Tysabri
` is evaluated among all the other MS drugs evaluated by
` Dr. Grabowski in Exhibit 2112 with respect to market
` share in dollars?
` MR. WHITE: Objection to form. Asked and
` answered.
` THE WITNESS: This is not a reliable
` assessment of the market share dollars of these
` products.
` BY MR. MITROKOSTAS:
` Q So you disagree that -- you believe that
` Dr. Grabowski did not include Tysabri in his analysis
` of market share in dollars?
` A Not in any reliable way.
` As I said over and over again in my
` declaration, you can't look at these numbers and come
` up with a reliable market share for any of the drugs
`
`The Little Reporting Company
` (646) 650-5055 | www.littlereporting.com
`
`MYLAN PHARMS. INC. EXHIBIT 1141 Page 22
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` because these are based on published prices like AWP.
` They're not based on the true prices, so these are not
` accurate. They're not reliable.
` Q Your criticism is with respect to all of the
` IMS data; correct?
` A Well, certainly Teva could have given us in
` exquisite detail the rebates and discounts on its own
` Copaxone products.
` Dr. Grabowski failed to even ask or examine
` that. There are other ways he may have been able to
` triangulate some of the discounts for these other
` drugs, but -- as I also mention in my report.
` But he didn't bother to get the ones that he
` could have gotten.
` Q Did you ask counsel to assist you in
` identifying coupons and rebates for MS pharmaceutical
` products prior to forming your opinions in this case?
` MR. CAPUANO: Just caution the witness not to
` get into the confidential communications, privileged
` communications that he may or may not have had with
` counsel.
` BY MR. MITROKOSTAS:
` Q Did you evaluate or look into coupons and
` rebates and discounts for MS drugs prior to forming
` your opinions in this proceeding?
`
`The Little Reporting Company
` (646) 650-5055 | www.littlereporting.com
`
`MYLAN PHARMS. INC. EXHIBIT 1141 Page 23
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` A Yeah, I believe I mentioned a number of
` documents that I considered and actually quoted in my
` declaration relating to the issue of discounts and
` rebates.
` Q And so did you look into the discounts given
` for each of the drugs identified by Dr. Grabowski in
` his report with respect to those drugs?
` A I asked for whatever information they had
` available on certainly discounts, rebates, and other
` price offsets.
` Q You asked whom?
` A I asked counsel.
` MR. CAPUANO: Objection. Sorry. Go ahead.
` I just want to caution the witness not to
` discuss confidential communications with counsel.
` THE WITNESS: Okay.
` BY MR. MITROKOSTAS:
` Q Dr. Hay, I'm going to hand you what has
` previously been marked and filed as Mylan or
` Exhibit 1099.
` Do you recognize this document?
` A It appears to be the declaration I filed in
` this case.
` Q And you have a footnote on the cover of this
` declaration, footnote 2, that states "A word-for-word
`
`The Little Reporting Company
` (646) 650-5055 | www.littlereporting.com
`
`MYLAN PHARMS. INC. EXHIBIT 1141 Page 24
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` identical declaration is being filed in each
` proceeding"; is that correct?
` A Yes.
` Q And so you filed the identical declaration in
` each of the three proceedings -- each of the
` proceedings involving the three patents; correct?
` A That's my understanding.
` Q All right. And so if I ask you questions
` about this declaration, can we agree that your answers
` would not change if I showed you one of the identical
` declarations from the other two proceedings?
` A I guess not being a lawyer, that sounds
` reasonable to me. But, you know, it's hard for me
` to --
` MR. WHITE: We'll just stipulate that the same
` document is filed in all three IPRs.
` MR. MITROKOSTAS: Thank you.
` And you agree that any answer he gives today
` would apply equally to the other two declarations in
` the other two proceedings; correct?
` MR. WHITE: It should, unless your question is
` something specific, unique about those cases. I can't
` imagine what that would be.
` MR. MITROKOSTAS: Okay.
` MR. WHITE: So, yeah, generally that's right.
`
`The Little Reporting Company
` (646) 650-5055 | www.littlereporting.com
`
`MYLAN PHARMS. INC. EXHIBIT 1141 Page 25
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` BY MR. MITROKOSTAS:
` Q So why don't we turn to paragraph 35 of your
` declaration, Dr. Hay.
` You state in the second sentence Tysabri
` generates more than a billion dollars in sales
` annually; correct?
` A Yes.
` Q You don't contend that the sales of Tysabri
` are more than Copaxone, do you?
` MR. WHITE: Objection to form.
` THE WITNESS: Well, I guess it depends on,
` again, whether we're talking about sales measured at
` average wholesale price or true sales. And I don't
` know what the true sales of Tysabri are. Or, for that
` matter, the true sales of Copaxone. Teva could have
` provided the true sales of Copaxone, but they didn't.
` BY MR. MITROKOSTAS:
` Q Well, you understand and I think you state
` that pharmaceutical companies typically don't reveal,
` publicly, information with respect to the pricing of
` their product to particular distributors; is that
` correct?
` A It's my understanding that this is not a
` public proceeding that we're engaged in here. Isn't
` this confidential?
`
`The Little Reporting Company
` (646) 650-5055 | www.littlereporting.com
`
`MYLAN PHARMS. INC. EXHIBIT 1141 Page 26
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` Q Can you answer my question, Dr. Hay?
` Is it true that typically pharmaceutical
` companies don't report publicly the pricing of their
` products?
` A Well, I wasn't referring to publicly. I'm
` talking about what I was asked to opine on in this
` case.
` It's my understanding that, having signed
` confidentiality agreements and orders, I am able to get
` access to confidential information.
` Q I'm asking you, Dr. Hay, whether
` pharmaceutical companies typically report publicly the
` pricing of their products.
` Can you answer that question, please.
` MR. WHITE: Objection to form.
` THE WITNESS: Could you repeat the question,
` please.
` BY MR. MITROKOSTAS:
` Q Pharmaceutical companies do not typically
` report publicly the pricing of their products?
` MR. CAPUANO: Same objection.
` THE WITNESS: It's certainly the case that in
` many situations rebates and discounts are offered on a
` confidential basis by pharmaceutical companies.
`
`The Little Reporting Company
` (646) 650-5055 | www.littlereporting.com
`
`MYLAN PHARMS. INC. EXHIBIT 1141 Page
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