`
` Henry Grabowski, Ph.D.
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` MYLAN PHARMACEUTICALS,
` INC.,
` Petitioner,
` vs.
` SANOFI-AVENTIS DEUTSCHLAND
` GMBH,
` Patent Owner.
`
` Deposition of Henry Grabowski, Ph.D.
` Thursday, September 5, 2019
` At 9:12 a.m.
` Durham, North Carolina
`
`Reported by LeShaunda Cass-Byrd, CSR, RPR
`TSG Job No: 166997
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` Henry Grabowski, Ph.D.
`
`APPEARANCES OF COUNSEL:
`
`On behalf of Petitioner Mylan:
`
` JAD MILLS, Esq.
` WESLEY DERRYBERRY, Esq.
` Wilson Sonsini Goodrich & Rosati
` 1700 K Street NW
` Washington, DC 20006
`
`On behalf of Sanofi:
`
` ROBERT VLASIS, Esq.
` Weil Gotshal & Manges.
` 2001 M Street, N.W.
` Washington, DC 20036.
`
`On behalf of Petitioner Pfizer:
`
` DAN HOANG, Esq.
` Winston & Strawn
` 35 W. Wacker Drive
` Chicago, Illinois 60601
`
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` Henry Grabowski, Ph.D.
` EXAMINATION OF HENRY GRABOWSKI, Ph.D.
`By Mr. Mills 4
`By Mr. Vlasis 145
`By Mr. Mills 146
` DEPOSITION EXHIBITS
`EXHIBIT DESCRIPTION PAGE
`(No new exhibits were marked)
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` Henry Grabowski, Ph.D.
` HENRY GRABOWSKI, Ph.D.
`having been first duly sworn, was examined and
`testified as follows:
` EXAMINATION
`BY MR. MILLS:
` Q. Good morning, Dr. Grabowski.
` A. Good morning.
` Q. How are you doing?
` A. Fine.
` Q. There has been a lot of talk about a
`hurricane today. Notwithstanding the hurricane, is
`everything good to go on your end to proceed with the
`deposition?
` A. Yes.
` Q. You have been deposed before, correct?
` A. Yes.
` Q. How recently was your last deposition?
` A. About three months ago.
` Q. Do you recall the rules that apply in a
`deposition?
` A. Yes.
` Q. So I won't go through all of them because
`you know them already. But in general, we want to
`make sure that we won't speak over one another.
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` A. Yes.
` Q. Okay. If you don't understand any question
`that I am asking you, you will ask for clarification,
`correct?
` A. Yes.
` Q. If you don't ask for clarification, we can
`all assume that you understood the question, correct?
` A. Yes.
` Q. Is there any reason you can't give your
`best and most accurate testimony today?
` A. No.
` Q. There is no medication or other issue that
`would impair your testimony today?
` A. No.
` Q. How many times have you been deposed?
` A. Well, over 4 decades it might be 40 times.
` Q. Have you ever been deposed in an inter
`partes review before?
` A. Yes.
` Q. How many times?
` A. I think a few times.
` Q. Have you ever been deposed in a matter
`involving injectable insulin products before?
` A. No. Well, yes. But not at an IPR.
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` Henry Grabowski, Ph.D.
` Q. Why don't you tell me about that.
` A. Well, there were prior cases involving
`Lilly's Basaglar and Merck's biosimilar product.
` Q. So that is two cases?
` A. Yes.
` Q. And those cases are the extent of your
`prior experience being deposed on insulin injectable
`products, correct?
` A. Yes.
` Q. Who was your client on each of those
`matters?
` A. Sanofi.
` Q. Broadening the question out beyond
`depositions, in your professional work, have you done
`any other work on injectable insulin products other
`than the two matters you just mentioned for Sanofi?
` A. No.
` Q. Can you tell me briefly, what the Merck
`biosimilar matter involving Sanofi was about?
` A. It involved a biosimilar drug that would --
`or biosimilar-type drug that would have competed with
`Sanofi's Lantus drug, and it involved -- my testimony
`involved commercial success.
` Q. Did your testimony address any other
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` Henry Grabowski, Ph.D.
`objective indicia of nonobviousness other than
`commercial success in the Merck litigation?
` A. I don't believe so.
` Q. The biosimilar to the Merck-Sanofi
`litigation was a biosimilar for insulin glargine,
`correct?
` A. Yes.
` Q. Was there a pen device involved in the
`Sanofi versus Merck biosimilar litigation?
` A. Yes.
` Q. What was the pen device that was at issue?
` A. SoloSTAR.
` Q. Is it correct, then, the Sanofi versus
`Merck litigation in which you were involved, Merck's
`product was a biosimilar of insulin glargine being
`delivered using SoloSTAR pen?
` A. Well, a pen that -- as I recall the case,
`it was not a SoloSTAR pen, but a pen that violated the
`patents or the allegation was that it did not --
`Sanofi was suing for their pen device as violating
`their patents.
` Q. Do you recall whether Merck's pen in this
`litigation is a pen that was on the market?
` A. I don't believe so. But I don't recall
`
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` Henry Grabowski, Ph.D.
`exactly.
` Q. Do you have any knowledge or recollection
`that the Merck pen involved in the Sanofi litigation
`ever came on the market?
` A. I don't believe Merck ever launched a
`product with a pen in insulin glargine.
` Q. As best as you can recall, the pen involved
`in the Merck-Sanofi insulin glargine litigation never
`came on the market?
` A. That is my understanding.
` Q. Now I would like to ask you about the
`Lilly, did you say Basaglar?
` A. Yes.
` Q. So in that case, what was the subject
`matter of the dispute?
` A. It also involved the pen that Lilly was
`using a KwikPen, and it also involved the formulation
`having polysorbate.
` Q. When you say a "formulation," you are
`talking about the Basaglar?
` A. Yes.
` Q. Is Basaglar a biosimilar to insulin
`glargine?
` A. Yes, it's a biosimilar-type drug.
`
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` Henry Grabowski, Ph.D.
` Q. And do you have an understanding as to how
`the Sanofi versus Lilly litigation in which you were
`involved was resolved?
` A. It was resolved with a settlement.
` Q. Do you have knowledge regarding the terms
`of that settlement?
` A. No.
` Q. Do you have any knowledge about the terms
`of the settlement between Sanofi and Lilly regarding
`Basaglar?
` A. Only what was published in the press, that
`Lilly agreed to delay its entry for a year, and they
`would -- they would license some of the patents.
` Q. So do you have knowledge as to which
`patents were licensed to Lilly by Sanofi?
` A. No.
` Q. Dr. Grabowski, how did you prepare for your
`deposition today?
` A. I met with counsel for four hours
`yesterday, and I also did some preparation with
`Cornerstone Research which assisted me in this
`litigation.
` Q. Other than meeting with counsel for four
`hours yesterday, did you have any other preparation
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` Henry Grabowski, Ph.D.
`for the deposition with counsel?
` A. No.
` Q. Who was involved from counsel with your
`deposition preparation?
` A. Robert, who is sitting here.
` Q. And other than Robert, no one else was
`involved in your preparation with counsel yesterday,
`correct?
` A. Well, there was from Cornerstone. Anand
`sat in on the -- also on the prep.
` Q. That is A-N-A-N-D?
` A. Yes.
` Q. And what is the last name?
` A. I have to look it up. It's a long name,
`starting with a K.
` Q. Okay. And is Anand the individual who
`assisted you in doing your work for the declaration of
`this case?
` A. Yes. He was the primary individual.
` Q. Were there any other individuals who
`assisted you in preparing your declaration in this
`case?
` A. Yes. Maria Salgado, who is with
`Cornerstone, and an individual named Florian was also
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` Henry Grabowski, Ph.D.
`involved.
` Q. So those three individuals at Cornerstone
`are the only individuals at Cornerstone who assisted
`you in preparing your declaration, correct?
` A. Yes. I mean, there is a team involved
`sometimes. There is -- they use some of their inside
`people, but those are the people I interacted with.
` Q. What is Anand's job title at Cornerstone?
` A. I think he may be an associate.
` Q. What was Anand's role in helping to prepare
`your declaration?
` A. He, under my direction, did some literature
`search. He did some -- prepared some graphics, did
`number crunching. That's his -- were his main duties.
` Q. What literature searching did Anand do to
`assist you in preparing your declaration?
` A. Just pulling together the documents that
`that were relevant here. Basically, I had done prior
`reports and had done -- had reviewed most of the
`documents in prior litigation and prior reports. But
`he reassembled them. I am not sure -- I think there
`might have been one new document to look at.
` Q. And what was that document?
` A. It was a -- an article by Vanderburg that
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` Henry Grabowski, Ph.D.
`is referenced in my report.
` Q. Did you ask Anand top find the Vanderburg
`article?
` A. Yes. I asked him to assemble anything that
`went beyond what we had previously cited in terms of
`relating to injection force, and that was an article
`that I had -- I don't remember having seen in prior
`litigation.
` Q. When you say you asked him to assemble
`anything that went beyond what you had previously
`cited, are you saying that you had a draft of your
`declaration and you asked him to assemble the
`documents that were cited in that declaration,
`including any new documents that you hadn't seen
`before?
` A. Yes. I prepared an outline, and then a
`draft and the -- I started with a prior report, and I
`updated the data, and I think there was one additional
`article that's Vanderburg that we cited that I hadn't
`previously cited.
` Q. When you -- when your declaration draft
`first cited that Vanderburg article, was that an
`article that you already read before?
` A. It's possible. I read lots of material in
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`the two previous cases. But I didn't remember citing
`it in a prior case.
` Q. Okay. So you found the Vanderburg article
`referenced in your declaration. You didn't recall
`whether or not you reviewed it before, and so you
`asked Anand to get a copy of it for you; is that
`accurate?
` A. More or less, yes.
` Q. You said that Anand was involved in
`generating graphics for your declaration, correct?
` A. Yes.
` Q. What graphics did Anand generate for your
`declaration?
` A. Well, as I indicated, under my direction,
`we had already done the graphics that are in my report
`through, I believe it was through 2016. We now had
`data through 2018, so I asked him to -- you know, I
`looked over the data, I checked it over, and then I
`asked him to put in the values for 2017 and 2018.
` Q. What was the end date of the updated data
`that you had?
` A. For most cases, it was December 2018.
` Q. Now, your declaration was filed in June of
`2019, correct?
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` A. Yes.
` Q. When would the data for the first quarter
`of 2019 become available to you?
` A. I'm not certain when that would be the
`case.
` Q. Did you check to see if the first quarter
`of 2019 data was available before filing your
`declaration?
` A. I would have to go back and review the
`data. Whether -- you know, most of our data is on an
`annual basis and the last complete data was 2018 and
`we didn't want to do projections to another annual
`year based on one quarter. So what we may have in the
`data in the first quarter, I would have to go back and
`check that.
` Q. For any of the calculations that you made
`in your declaration -- well, let me withdraw that
`question and ask you a new question.
` For all of the calculations that you made
`in your declaration, did you always calculate by
`complete calendar years?
` A. No.
` Q. So in some cases, you started in the middle
`of a year if a product launched in the middle of the
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`year, for example, correct?
` A. Yes.
` Q. But you decided not to inquire as to
`whether updated data was available through the first
`quarter of 2019 for your declaration, correct?
` A. No. What I am saying is we obtained the
`data through IMS, and to the extent we were doing data
`from data launch, for instance, and not calendar
`years, we -- we included the latest data we had from
`IMS.
` Q. Right. My question is a little bit
`different. As you sit here today, you don't recall
`ever inquiring as to whether you could get the data
`from the first quarter of 2019 from IMS, correct?
` A. I don't recall inquiring, but we got a --
`I'm not sure the exact date where we got the data. It
`could have been before the end of the first quarter.
`It could have been after. And I'd have to go back and
`check to see if we have data for the first quarter.
` Q. Regardless of when you first received the
`updated data, you -- you don't remember asking about
`getting the first quarter of 2019 data before filing
`your declaration in the second quarter of 2019,
`correct?
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` A. Yeah, that's correct. And if we had it, I
`wouldn't inquire, so --
` Q. Do you think you did have it?
` A. Well, I would have to check when we got the
`information. But I think we may have it. Yes.
` Q. How did you get the IMS data that we have
`been talking about?
` A. Cornerstone requested it. I think it came
`from Sanofi by -- Sanofi subscribes to IMS. So it was
`a file. They gave us the IMS files that's Sanofi, and
`I and Cornerstone obtained and checked it out and
`extended. We already had the data through 2016.
` Q. What was the chain of custody for the IMS
`data that you relied on?
` A. I don't understand. What chain of custody?
` Q. Well, who at Cornerstone received the IMS
`data?
` A. I -- you know, it may have gone from Sanofi
`through our attorneys, through -- through the
`attorneys at Weil and then to Cornerstone and myself.
` Q. You said it may have. Is it correct that
`you don't really know the chain of custody through
`which the IMS data came to be in your declaration?
` A. I don't know of the exact date, but I know
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`that it was IMS data consistent with everything else
`we had looked at and I have used IMS over the last 30
`years and it was an IMS file.
` Q. So my question is specifically about the
`chain of custody. I think you said that you assumed
`that it went from Sanofi to Sanofi's attorneys, from
`Sanofi's attorneys to someone at Cornerstone, and then
`from someone at Cornerstone in your declaration; is
`that fair?
` A. Not completely. It -- it -- you know, I
`think we made a request through Weil's attorneys, and
`my understanding is Sanofi pays for this data. It's
`very expensive, and Sanofi provided the files that
`they obtained from IMS, and I think it probably went
`back through Weil to Cornerstone and myself. But I --
`you know, when I got the data, I reviewed it to see if
`it was consistent with our prior work and all of the
`IMS data I've used in my research and expert work and
`government work over the years.
` Q. So my question is -- I'm trying to ask you
`about the chain of custody. But I will come back to
`that in a minute. So you've said a couple of times
`that it was consistent and you checked it against the
`prior data?
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` A. Yeah.
` Q. Did you look at the prior IMS spreadsheets
`and compare them on a month-by-month basis to the data
`that came in the new spreadsheets for the same months
`to make sure that the data was all the same?
` A. Yes.
` Q. And when you have been talking about IMS
`data, is it correct that you have been talking about
`spreadsheets?
` A. Yes.
` Q. They come in an Excel file?
` A. Yes.
` Q. Does the Excel file have an indicia on that
`originates from IMS and says this is IMS data?
` A. Generally, yes.
` Q. What does that indicia look like?
` A. Well, there is usually a caption at the top
`that indicates an IMS or an IMS subsidiary.
` Q. And what does the caption say on the
`documents you relied on to make your declaration?
` A. I'd have to go back and look at it. I
`think under the marketing, it said Syneos, which was
`an IMS subsidiary, but I'd have to go back and check
`the different ones.
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` Q. So now going back to the chain of custody,
`you don't know who at Sanofi pulled the IMS data,
`correct?
` A. That is correct.
` Q. And you don't know who handled the IMS data
`in between the time when it was pulled by Sanofi and
`in between the time it arrived into your declaration,
`correct?
` A. State the question again.
` Q. You don't know who handled the IMS data
`between the time it was pulled by Sanofi and when you
`used it in your declaration?
` A. As I indicated, I think we requested it
`from the attorneys, and I think the attorneys were the
`ones that provided it. It was intermediary.
` Q. I just want to make sure I've exhausted
`your knowledge about how it came to you, and it sounds
`like what you are saying is you asked for IMS data,
`the attorneys gave you something that looks like IMS
`data, and that's the extent of your knowledge about
`the chain of custody; is that fair?
` A. Yes. But it's not something that looks
`like IMS. We checked, and we are certain it's IMS.
` Q. So with that provision, otherwise the
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`statement is a fair statement, correct?
` A. Yes.
` Q. What search parameters were used by Sanofi
`to pull the IMS data you relied on?
` MR. VLASIS: Objection, form.
` THE WITNESS: I'm not sure I
` understand your question.
`BY MR. MILLS:
` Q. Do you know how IMS data gets obtained from
`IMS?
` A. Yes.
` Q. And how does that happen?
` A. They send -- you know, I've got it in my
`research. They send you data in a spreadsheet, and
`then you can -- you can use a search tool from Excel
`that just says I want these monthly sales data for
`these products, and it will pull it into a separate
`file.
` Q. So is it correct that the IMS data
`underlying your declaration was obtained by Sanofi,
`selecting particular products in particular time
`periods for which to get sales data and prescription
`data?
` MR. VLASIS: Object to the form.
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` THE WITNESS: They may have got the
` data already in subsets. Or they may have
` broader file. But we were very specific in
` the data we requested, as indicated in my
` report, and that is the data we obtained.
`BY MR. MILLS:
` Q. When you say you were specific about the
`data that you requested, how did you request the data
`specifically?
` A. Well, we could look at my report. There
`are certain IMS codes associated with insulin
`products, fast-acting, intermediate-acting,
`long-term-acting insulin products and they are coded
`in certain IMS codes, and we wanted all of the
`products in those codes.
` Q. Is it correct that you asked Sanofi's
`attorneys to provide you with the IMS data based on
`specific IMS codes?
` A. Yes.
` Q. How did you generate the list of codes that
`you used to ask for the IMS data?
` A. IMS has a book that -- or now it's
`electronic that is -- shows you those codes, and you
`can request data based on their coding.
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` Q. You selected the codes that you would
`request personally?
` A. In conjunction with Cornerstone, yes.
` Q. You selected codes for all insulin
`injectable products, correct?
` A. Yes.
` Q. Regardless of the means of administration?
` A. They were all injectables.
` Q. So setting aside oral products, all insulin
`injectable products, whether administered by pen or by
`vial and syringe, correct?
` A. Yes.
` Q. And that is, in your opinion, the relevant
`market for performing a commercial success analysis?
` MR. VLASIS: Objection to the form.
` THE WITNESS: It is the data that is
` the appropriate data to do commercial
` success.
`BY MR. MILLS:
` Q. You agree that the insulin injectable
`market is the relevant data set for performing a
`commercial success analysis for the Lantus SoloSTAR
`products?
` A. Well, for most commercial success analysis,
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`the relevant market or the relevant data is
`long-acting injectable insulin products, but we did --
`I did, in conjunction with my team, we analyzed
`broader sales data. We had some graphs showing the
`SoloSTAR pen against all injectable insulin products,
`all injectable pen products, including those used for
`short-acting and intermediate-acting, but the focus --
`because long-acting pens, or long-acting insulin, is
`used in a different way than short-acting insulin.
`They are not close substitutes.
` Q. So you said for most commercial success
`analysis, the relevant market, or the relevant data is
`long-acting injectable insulin products?
` A. Yes. The pen and the vial that are -- that
`inject the long-acting insulin is the relevant
`analysis to undertake for commercial success. But we
`also looked at broader analyses involving short-acting
`and intermediate-acting. Whatever analysis you do, it
`turns out that Lantus SoloSTAR is the leading product
`of all -- whether you consider all -- all versions, or
`whether you confer to long-acting.
` Q. So your answers both times have been
`somewhat vague, so I'm trying to understand what you
`-- what you are talking about.
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` You keep talking about a commercial success
`analysis, and I would like you to be specific as to
`analysis for what. So I think what you're saying is
`that, in your opinion, the relevant market for
`evaluating the commercial success of the Lantus
`SoloSTAR product is long-acting insulin pens; is that
`correct?
` A. Long insulin pens and vials.
` Q. Okay.
` A. But mainly pens. You know, this is not an
`antitrust case where we define our relevant market.
`This is a commercial success analysis where you look
`at the sales of the product first. You know, what is
`it, their absolute sales and how did it grow. You
`look at its formulary situation. You look at pens in
`comparison to other pens that have -- that are
`utilized in a comparable treatment regimen, and so
`that's a market-share-type analysis. We looked at
`other indicia, but those were the main ones, and for
`most of those situations, I am looking at long-acting
`pens, but in some situations I am looking at the
`broader market.
` Q. You agree that the entire long-acting
`insulin injectable product market is an appropriate
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`market to consider for performing a commercial success
`analysis for the Lantus SoloSTAR pen, correct?
` A. Yes. In most metrics, yes.
` Q. You agree that the entire insulin
`injectable product market is an appropriate market to
`consider for performing a commercial success analysis
`for the Lantus SoloSTAR pen, correct?
` A. What was the word, appropriate or
`inappropriate?
` Q. An appropriate. Appropriate.
` A. Well, let me hear your question again.
` Q. You agree that the entire insulin product
`market -- let me withdraw that question and start
`again.
` You agree that the entire injectable
`insulin product market is an appropriate market to
`consider for performing a commercial success analysis
`for the Lantus SoloSTAR pen, correct?
` A. I wouldn't agree with that as a general
`statement.
` Q. You agree that the entire injectable
`insulin product market is an appropriate market to
`consider for performing a commercial success analysis
`for the SoloSTAR pen, correct?
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` A. Well, you would have to clarify what you
`mean by appropriate. I think it's one metric one can
`do. But it's not the primary metric that one would
`look at.
` Q. You agree that it's not inappropriate --
`hold on, sorry, let me finish the question. I'm going
`to start the question over again.
` You agree that it is not inappropriate to
`look at the entire injectable insulin product market
`to perform a commercial success analysis for the
`Lantus SoloSTAR pen, correct?
` A. It can be one complementary measure, but
`it's not the primary focus in a commercial success
`analysis. We are talking about market share here, and
`the primary focus would be other long-acting pens in
`terms of market share. But one can always broaden an
`analysis to broader field -- broader markets, and I
`have done that in one case.
` But I think given short-acting pens do not
`substitute for long-acting pens, they are used very
`differently according to Dr. Goland. Therefore, the
`primary analysis would be on long-acting pens. But
`one can do complementary analysis to say Well, how
`does this do -- how does SoloSTAR perform against all
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`pens, short-acting, intermediate, and long-acting
`insulin pen products, and it does very well in that
`circumstance. But that is not the primary focus of an
`analysis. The primary focus would be long-acting pen
`products.
` Q. You have used the term just now in your
`answer long-acting pens and short-acting pens. And I
`think I understand what you are saying, but I think we
`want to be a little -- a little bit more precise.
` When you use those terms, what you are
`saying is pens that deliver short-acting insulin and
`pens that deliver long-acting insulin; is that
`correct?
` A. Yes, that is.
` Q. And your point is that Lantus is a
`long-acting insulin?
` A. Yes.
` Q. So the SoloSTAR pen device is used to
`deliver short-acting insulin as well as long-acting
`insulin, correct?
` A. Yes, it does.
` Q. Are you aware of any reason that the
`SoloSTAR pen can't be used also to administer
`intermediate-acting insulin?
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` A. I don't have an opinion on that.
` Q. But you understand that the SoloSTAR pen is
`not a long-acting pen, correct?
` A. Well, I used that as a shorthand.
` Q. Right.
` A. Yes.
` Q. Okay. So it's a pen that can be used to
`deliver insulin, whether the insulin is short-acting
`or long-acting?
` A. Yes. My report goes into detail on that.
` Q. I thought I understood what you meant. I
`just wanted to make sure the record was clear.
` When you said that the short-acting pens
`are used differently than the long-acting pen, I don't
`think you mean that when they inject a short-acting
`insulin, that the pen operates -- the same SoloSTAR
`pen operates differently than when you inject the
`long-acting insulin. Is that what you meant?
` A. It's correct. What I am saying is short --
`when you use it like Aprida or M -- ADMELOG, which are
`SoloSTAR pens that are short-acting. They are used
`generally for, around mealtime for short-acting
`insulin, and that is very different from Basal
`insulin, which is a 24-hour long-acting glargine
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`insulin, which is the Lantus product.
` Q. So you are clear that the pen operates the
`same way regardless of whether it's delivering a
`short-acting insulin or a long-acting insulin,
`correct?
` A. Yes.
` Q. And your point is, the time, and perhaps
`the frequency of the injections will differ, depending
`on whether you are delivering short-acting insulin or
`long-acting insulin?
` A. Yes.
` Q. Okay. And what you are saying is that when
`SoloSTAR is used to deliver short-acting insulin,
`there are going to be more injections in a 24-hour
`period?
` A. Yes. One of the great innovations
`associated with Lantus is a 24-hour injection, as
`shown in the report. It was the -- this innovation
`that really caused intermediate injections to kind of
`decline significantly, and long-acting, in particular,
`Lantus grew exponentially.
` Q. You agree that the 24-hour, once daily
`administration -- my question was confusing, so I am
`going to withdraw that question and start over.
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` You agree that the capacity of Lantus to
`last f