`
`CONFIDENTIAL
`Transcript of Mark Reisenauer
`
`Date: July 13, 2017
`Case: Apotex Inc., et al. -v- OSI Pharmaceuticals, Inc. (PTAB)
`
`Planet Depos
`Phone: 888.433.3767
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`WORLDWIDE COURT REPORTING | INTERPRETATION | TRIAL SERVICES
`
`APOTEX EX. 1050-001
`
`
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` _______________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` _______________
`
` APOTEX INC., APOTEX CORP., APOTEX PHARMACEUTICALS
` HOLDINGS INC., and APOTEX HOLDINGS, INC.,
` Petitioners,
` v.
` OSI PHARMACEUTICALS, INC.,
` Patent Owner.
` ______________
` U.S. Patent No. 6,900,221
` ______________
` Case No: IPR2016-01284
` ______________
` CONFIDENTIAL
` Deposition of MARK REISENAUER
` Wheeling, Illinois
` Thursday, July 13, 2017
` 10:01 a.m.
`Job No.: 146468
`Pages: 1 - 115
`Reported by: Kimberly Winkler Christopher, CSR
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`CONFIDENTIAL
`Transcript of Mark Reisenauer
`Conducted on July 13, 2017
`
`2
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` Deposition of MARK REISENAUER, held at the
`location of:
`
` THE WESTIN CHICAGO NORTH SHORE
` 601 North Milwaukee Avenue
` Wheeling, Illinois 60090
` (847) 777-6500
`
` Pursuant to notice, before Kimberly Winkler
`Christopher, a Certified Shorthand Reporter, in and
`for the State of Illinois.
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`APOTEX EX. 1050-003
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`CONFIDENTIAL
`Transcript of Mark Reisenauer
`Conducted on July 13, 2017
`
`3
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` A P P E A R A N C E S
`ON BEHALF OF THE PETITIONERS:
` KERRY B. McTIGUE, ESQUIRE
` COZEN O'CONNOR
` 1200 Nineteen Street, NW
` Washington, DC 20036
` (202) 912-4810
`
`ON BEHALF OF THE PATENT OWNER:
` TRACEY C. ALLEN, ESQUIRE
` WILMER CUTLER PICKERING HALE and DORR LLP
` 1875 Pennsylvania Avenue, NW
` Washington, DC 20006
` (202) 663-6856
` and
` ANDREA W. BURKE, ESQUIRE
` ASTELLAS US LLC
` 1 Astellas Way
` Northbrook, Illinois 60062
` (224) 205-8800
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`APOTEX EX. 1050-004
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`CONFIDENTIAL
`Transcript of Mark Reisenauer
`Conducted on July 13, 2017
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`4
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` C O N T E N T S
`EXAMINATION OF MARK REISENAUER PAGE
` By Mr. McTigue 5, 102
` By Ms. Allen 99
` E X H I B I T S
`REISENAUER DEPOSITION EXHIBIT PAGE
`Exhibit 1037 (Petitioner's Notice of
` Deposition of Mark L. Reisenauer) 8
`Exhibit 1038 (Declaration of
` Mr. Mark L. Reisenauer) 9
`Exhibit 1039 (Orange Book: Approved
` Drug Products with Therapeutic
` Equivalence Evaluations) 12
`Exhibit 1040 (Plaintiff's Post-Trial
` Answering Brief) 17
`Exhibit 1041 (OSI Pharmaceuticals, Inc.,
` Form 10-K/A) 17
`Exhibit 1042 (Tarceva Total US Net Sales) 36
`Exhibit 1043 (Tarceva US Net Sales
` Attributable to NSCLC) 48
`Exhibit 1044 (Important Correction of Drug
` Information) 62
`Exhibit 1045 (Justice News) 65
`Exhibit 1046 (LA Times article) 81
`Exhibit 1047 (Quick Minutes) 87
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`APOTEX EX. 1050-005
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`CONFIDENTIAL
`Transcript of Mark Reisenauer
`Conducted on July 13, 2017
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`5
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` P R O C E E D I N G S
` (Witness sworn.)
` MR. McTIGUE: Good morning. My name is Kerry
`McTigue. I'm from the law firm of Cozen O'Connor,
`and I am here on behalf of the Apotex entities.
` MS. ALLEN: I'm Tracey Allen from Wilmer
`Hale here on behalf of OSI, the patent owner, as
`well as Mr. Reisenauer. And with me is Andrea
`Burke, who is in-house counsel at Astellas Pharma.
` MARK REISENAUER,
`having been duly sworn, testified as follows:
`DIRECT EXAMINATION BY COUNSEL FOR THE PETITIONERS
`BY MR. McTIGUE:
` Q Mr. Reisenauer, can you please state your
`full name for the record.
` A Mark Reisenauer.
` Q And the city and state where you live?
` A Lindenhurst, Illinois.
` Q How many times have you been deposed before?
` A Twice.
` Q Were they patent cases?
` A No.
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`APOTEX EX. 1050-006
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`CONFIDENTIAL
`Transcript of Mark Reisenauer
`Conducted on July 13, 2017
`
`6
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` Q Have you ever been involved in any patent
`litigation before?
` A No.
` Q Have you been involved in any inter partes
`review proceedings before in front of the U.S. PTO?
` A No.
` Q Okay. And do you understand that your
`testimony today is under oath?
` A Yes.
` Q Is there any reason, sir, that you cannot
`testify truthfully today?
` Are you on any medications or is there any
`other medical condition that we need to know about?
` A No.
` Q I would like, since you haven't done a
`patent case before in this capacity, to just go over
`a couple ground rules with you if that's okay.
` A Okay.
` Q I'll be asking you the questions. If you're
`unclear about anything that I'm saying or you don't
`understand, just please let me know that and I'll
`rephrase the question for you so that we're making
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`CONFIDENTIAL
`Transcript of Mark Reisenauer
`Conducted on July 13, 2017
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`7
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`sure that you're understanding my question.
` Your counsel may object at times throughout
`the deposition; but unless your counsel instructs
`you not to answer a question and the question is
`still on the table, I'd ask you to answer it anyway.
`Fair enough?
` A Yes.
` Q Okay. She can only type when one of us is
`talking so I will try not to talk over you. If you
`could do me the same favor, that would be great.
`Please let me finish my questions before you answer.
`And if for some reason I think you're done and
`you're not, then we'll just -- I'll just stop and
`let you finish your answer.
` Please make sure your answers are audible.
`I know you've been shaking your head to me, which is
`fine so far; but now you're going to have to go yes
`or no, especially since we don't have a videographer
`here. The only record of this is going to be what
`counsel and you say.
` A Understood.
` Q Okay. We can also take breaks periodically.
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`APOTEX EX. 1050-008
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`CONFIDENTIAL
`Transcript of Mark Reisenauer
`Conducted on July 13, 2017
`
`8
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`This is not a test of stamina. So I will certainly
`try to take it, Ms. Allen may ask for a break; but
`it's also up to you, too, to say, If there is any
`chance I can take a bio break or there's something
`important I must attend to. Let us know and I think
`we're going to be pretty flexible on that, okay?
` A Okay.
` Q All right.
` MR. McTIGUE: I hand for the court reporter
`what I'd ask to be marked as Exhibit 1037 for the
`record.
` (Exhibit No. 137 was marked for
`identification and is attached to the transcript.)
` Q Sir, have you ever seen this document
`before?
` A Yes.
` Q What is it?
` A It is the notice of deposition of myself.
` Q And you understand pursuant to this notice
`that you are here to testify under oath for and on
`behalf of OSI Pharmaceuticals, Inc.?
` A Yes.
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`APOTEX EX. 1050-009
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`CONFIDENTIAL
`Transcript of Mark Reisenauer
`Conducted on July 13, 2017
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`9
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` Q Okay. And they are the patent owner of U.S.
`Patent No. 6,900,221.
` Is that your understanding?
` MS. ALLEN: Objection.
` A That is my general understanding as I read
`it here on the document.
` Q Sir, you also submitted a sworn declaration
`before the U.S. Patent Trial and Appeal Board
`regarding OSI's oncology product Tarceva, right?
` A Yes.
` Q Not surprisingly, I'm going to hand you a
`document next which will be Exhibit 1038.
` (Exhibit No. 1038 was marked for
`identification and is attached to the transcript.)
` Q Sir, do you recognize this document that
`I've now handed to you?
` A Yes.
` Q What is it?
` A This is a declaration that I have submitted.
` Q Does this declaration contain your opinion
`on whether Tarceva is a commercially successful
`product?
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`APOTEX EX. 1050-010
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`CONFIDENTIAL
`Transcript of Mark Reisenauer
`Conducted on July 13, 2017
`
`10
`
` MS. ALLEN: Objection.
` A Yes, it does.
` Q And turning just to the front page of the
`declaration. Do you understand that this
`declaration is submitted to the Patent Trial and
`Appeal Board on behalf of OSI Pharmaceuticals who is
`listed as the patent owner on the cover page?
` A Yes.
` Q And, again, that is for U.S. Patent No.
`6,900,221, which I may refer to throughout the day
`as the '221 patent. Is that okay?
` A Yes.
` Q All right. Now, in your declaration I see
`that there's an appendix with your resume on Pages
`10 and 11.
` Do you see that?
` A Yes.
` Q I want you to go to Page 2 with me. And I
`see from that in your resume at the bottom that in
`your education section you have a degree in
`political science; is that right?
` A Yes.
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`CONFIDENTIAL
`Transcript of Mark Reisenauer
`Conducted on July 13, 2017
`
`11
`
` Q I'd actually like to focus, though, on your
`professional experience and in particular ask you
`whether you have ever been qualified by any court or
`any administrative body to give an expert opinion on
`commercial success?
` A Could you repeat the question, please?
` Q Sure. Have you ever been qualified by any
`court or administrative body to give an expert
`opinion on commercial success?
` A By -- if I can ask a clarifying question.
`By "qualified" do you mean have I been asked by a
`court to provide testimony on commercial success?
` Q Sure. I'll rephrase it so it's clear.
` A Okay.
` Q In your professional experience have you
`ever been qualified by any court or administrative
`body to give an expert opinion on commercial success
`in any patent proceeding?
` A No.
` Q You do not provide a list of materials that
`you reviewed in forming your opinions so bear with
`me on a few questions about that.
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`APOTEX EX. 1050-012
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`CONFIDENTIAL
`Transcript of Mark Reisenauer
`Conducted on July 13, 2017
`
`12
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` Do you understand what I'm referring to when
`I discuss the Orange Book listed patents?
` A Yes.
` Q Okay. Do you have an understanding of the
`Orange Book listed patents that OSI has asserted
`cover Tarceva?
` A Not all of them.
` Q Okay.
` (Exhibit No. 1039 was marked for
`identification and is attached to the transcript.)
` Q Sir, I've handed you a Web printout that
`I'll submit to you is from the FDA titled "Orange
`Book: Approved Drug Products with Therapeutic
`Equivalence Evaluations" as it's titled.
` Do you see that?
` A Yes.
` MS. ALLEN: For the record, I'll just object
`to the exhibit. Hearsay, relevance, outside the
`scope as well as any testimony related to it.
` Q Now, if you would turn with me to the bottom
`of the first page where it talks about "Patent and
`Exclusivity for: N021743."
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`APOTEX EX. 1050-013
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`CONFIDENTIAL
`Transcript of Mark Reisenauer
`Conducted on July 13, 2017
`
`13
`
` Do you see that?
` A Yes.
` Q And under that it says "Product 001.
`Erlotinib Hydrochloride (Tarceva)."
` Do you see that?
` A Yes.
` Q Do you understand Tarceva is the brand name
`OSI uses for erlotinib hydrochloride?
` A Yes.
` Q Under that you also see columns and it goes
`on to the next page which lists patent, drug
`substance claim, and drug product claim.
` Do you see that?
` A Yes.
` Q I'm just going to take you to a couple of
`them. Under this the Orange Book listing has
`patents for a 5747498.
` Do you see that?
` A Yes.
` Q They also have patents for, going down the
`page, 6900221.
` Do you see that?
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`APOTEX EX. 1050-014
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`CONFIDENTIAL
`Transcript of Mark Reisenauer
`Conducted on July 13, 2017
`
`14
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` A Yes.
` Q We've already referred to that as the '221
`patent today, haven't we?
` A Yes.
` Q Taking you down a little bit farther to
`RE1065.
` Do you see that?
` A Is it RE41065?
` Q Yes. I apologize. RE41065.
` Do you see that?
` A Yes.
` Q And this patent it lists at least the drug
`substance and drug product under two of its columns.
` Do you see the DS and the DP?
` A Yes.
` Q Okay. Well, within the context of your
`declaration and with the exception of the cover page
`where we talked about the fact that you listed the
`'221 patent, you don't discuss any patents in your
`actual declaration; is that right?
` A Correct.
` Q Do you understand that the Tarceva product
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`Transcript of Mark Reisenauer
`Conducted on July 13, 2017
`
`15
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`you discuss in your declaration is covered by
`multiple patents at least as listed in the FDA
`Orange Book?
` A Yes.
` Q Okay. Do you understand with respect to
`U.S. Patent No. RE41065, and I'll submit to you that
`patent is the reissue of the '498 patent we looked
`at above -- do you understand that these patents
`claim an invention of one or more drug substances or
`drug compounds that include erlotinib?
` MS. ALLEN: Objection.
` A I do not.
` Q Okay. So in conducting your analysis for
`commercial success of Tarceva as related to overall
`sales, you did not address either of those two
`patents as part of your commercial success analysis?
` A All I did was provide commercial success for
`Tarceva, the molecule.
` Q You did not review RE41065 in your analysis,
`did you?
` A I did not.
` Q Okay. So you did not apportion any
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`APOTEX EX. 1050-016
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`CONFIDENTIAL
`Transcript of Mark Reisenauer
`Conducted on July 13, 2017
`
`16
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`particular Tarceva sales of the patents that the OSI
`patent claims cover for either the '498 or the
`reissued '065 patent, correct?
` MS. ALLEN: Objection.
` A Correct.
` Q And if you did not review the '498 patent or
`the reissued '065 patent, none of your analysis
`apportions the amount of commercial success of
`Tarceva to either of those two patented inventions,
`correct?
` MS. ALLEN: Objection.
` A Correct.
` Q Sir, are you aware that there was a patent
`infringement case tried in the U.S. District of
`Delaware regarding Tarceva in 2011 between OSI and
`Mylan Pharmaceuticals?
` A I have a general understanding of -- that
`that happened.
` Q You were at Astellas by 2011, were you not?
` A I was.
` Q And what was your title at Astellas in 2011?
` A Vice president oncology sales and marketing.
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`Transcript of Mark Reisenauer
`Conducted on July 13, 2017
`
`17
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` Q And in your capacity as a vice president of
`sales for oncology and marketing, were you aware
`that there was patent litigation underway about the
`Tarceva product?
` A I was aware, yes.
` Q Did you review any filings by OSI in that
`trial or the lead-up to that trial about the
`commercial success of Tarceva that you have used for
`your opinions in this declaration?
` A No.
` (Exhibit Nos. 1040 and 1041 were marked for
`identification and are attached to the transcript.)
` Q Sir, based on your previous testimony, I'm
`going to assume that you have not read OSI and
`Genentech's post-trial answer and brief to that
`trial; is that correct?
` MS. ALLEN: And for the record, I will
`object to the exhibit as hearsay, on relevance
`grounds, outside the scope of the witness's
`declaration, and outside the scope of the petition
`and instituted grounds in this proceeding and any
`testimony related to it.
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`Transcript of Mark Reisenauer
`Conducted on July 13, 2017
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`18
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` A And, yes, that is correct, I have not seen
`or read this document before.
` Q Okay. Could you turn with me to just the
`Table of Contents. And the first page of the Table
`of Contents under Statement of Facts, it says "II.
`Patents-In-Suit."
` Do you see that?
` A Yes.
` Q And the patents-in-suit are listed by OSI as
`the reissue '065 patent.
` Do you see that?
` A Yes.
` Q And the '221 patent. Do you also see that?
` A Yes.
` Q Now, those are listed at Page 4 of OSI's
`post-trial briefs. So would you turn with me to
`Page 4.
` A Yes.
` Q As opposed to going through each patent, I
`thought using the OSI summary might help us some.
`Starting with "Patents-In-Suit" and specifically
`OSI's description of the '065 patent, do you see it
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`CONFIDENTIAL
`Transcript of Mark Reisenauer
`Conducted on July 13, 2017
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`19
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`says, "The RE '065 patient is a reissue of the '498
`patent"?
` A Yes.
` Q "The '498 patent was filed on May 28, 1996
`based on a PCT application filed on June 6, 1995."
` Do you see that?
` A Yes.
` Q Going down one more sentence, Claim 1 of the
`reissued '065 patent recites compounds having a
`chemical formulation which covers, among others, the
`compound now known as erlotinib, the active
`ingredient in Tarceva.
` Do you see that?
` A Yes.
` Q Do you have any reason to believe that the
`'065 patent is not a compound patent that covers
`Tarceva based on OSI's representations in this
`filing?
` MS. ALLEN: Objection.
` A I wouldn't know.
` Q Okay. Now, the next description from OSI of
`their patents is the '221.
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`Transcript of Mark Reisenauer
`Conducted on July 13, 2017
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`20
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` Do you see that?
` A Yes.
` Q "The '221 patent was filed on November 9,
`2000."
` Do you see that?
` A Yes.
` Q And if you read with me through the next
`line -- and I won't read the whole line, but it
`recites a method for the treatment of non-small cell
`lung cancer, or NSCLC.
` Do you understand that?
` A Yes.
` Q If I use the term "NSCLC," you understand
`I'm referring to non-small cell lung cancer
`throughout the deposition; is that fair?
` A Yes.
` Q Okay. There were two patents-in-suit in
`that litigation and there are two patents-in-suit
`that we've looked at during the Orange Book.
` When you performed your commercial success
`analysis in your declaration, you never apportioned
`the commercial success that was attributable to the
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`APOTEX EX. 1050-021
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`
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`CONFIDENTIAL
`Transcript of Mark Reisenauer
`Conducted on July 13, 2017
`
`21
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`compound patent for erlotinib versus the method of
`treatment patent at issue in this proceeding, did
`you?
` MS. ALLEN: Objection.
` A No, I did not.
` Q All right. I want you to turn back to the
`index for me one more time in this filing. And I'm
`on the next page where we're now in the argument
`page. So I'm not taking you into the weeds. I want
`to focus on the Table of Contents.
` Going to the top of Page 2 of the index, do
`you read there where OSI asserts "Mylan has not met
`its burden by clear and convincing evidence that the
`RE '065 patent was obvious"?
` Do you see that?
` A Yes.
` Q And then it gives a series of arguments on
`why that is the case or at least a summary of the
`arguments it will be making.
` Do you see that?
` A Yes.
` Q In Subsection C it says, "Secondary
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`APOTEX EX. 1050-022
`
`
`
`CONFIDENTIAL
`Transcript of Mark Reisenauer
`Conducted on July 13, 2017
`
`22
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`Considerations Support Finding of Non-Obviousness,"
`starting on Page 44.
` Do you see that?
` A Yes.
` Q And it lists three different reasons why
`secondary considerations support finding of
`nonobvious, doesn't it?
` MS. ALLEN: Objection.
` A Can you repeat the question, please?
` Q And it lists under Subsection C, "Secondary
`Considerations Support Finding of Non-Obviousness,"
`three different reasons, does it not?
` A Yes.
` Q And the first of those reasons is commercial
`success of the '065 patent.
` Do you see that?
` A Yes.
` MS. ALLEN: Objection.
` Q Now --
` MS. ALLEN: Give me a second to object.
` MR. McTIGUE: Are you ready now?
` MS. ALLEN: Yes.
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`APOTEX EX. 1050-023
`
`
`
`CONFIDENTIAL
`Transcript of Mark Reisenauer
`Conducted on July 13, 2017
`
`23
`
` Q Okay. Going down to Tab II in the argument
`summary, that one deals with the '221 and
`specifically says, "Mylan has not met its burden
`that Claim 53 of the '221 patent was anticipated or
`would have been obvious."
` Do you see that?
` A Yes.
` Q Same line. We're going to go down to the
`secondary considerations that OSI say support
`findings of nonobviousness, and that's in Subsection
`D.
` Do you see that?
` A Yes.
` Q There OSI asserts four different reasons why
`secondary considerations support finding of
`nonobvious for the '221, don't they?
` MS. ALLEN: Objection.
` A That's what it says in the document, yes.
` Q And unlike in the '065 patent, during their
`2011 trial Mylan never asserted that commercial
`success was a basis for why the '221 patent was
`nonobviousness based on commercial success, right?
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`APOTEX EX. 1050-024
`
`
`
`CONFIDENTIAL
`Transcript of Mark Reisenauer
`Conducted on July 13, 2017
`
`24
`
` MS. ALLEN: Objection.
` A I don't know.
` Q Well, they didn't list it in their Table of
`Contents, did they?
` A They did not.
` MS. ALLEN: Objection.
` Q So just to be clear, I guess we'll go to
`Page 59 and look at the Mylan arguments for the
`'221.
` Are you there with me?
` A Yes.
` Q The secondary considerations support finding
`of nonobviousness for the '221 that Mylan raised --
`excuse me -- that OSI raised in this trial included
`long-felt need in their first argument, correct?
` MS. ALLEN: Objection.
` A Yes.
` Q It included failure of others, correct?
` MS. ALLEN: Objection.
` A Yes.
` Q Skepticism was their third basis for why the
`'221 was nonobviousness as a secondary
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`APOTEX EX. 1050-025
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`CONFIDENTIAL
`Transcript of Mark Reisenauer
`Conducted on July 13, 2017
`
`25
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`consideration, correct?
` A Yes.
` MS. ALLEN: Objection.
` Q Copying was their fourth basis, correct?
` MS. ALLEN: Objection.
` A Yes.
` Q Do you see in Mylan's filing, based on what
`we've reviewed in either the table of contents or
`the summary of the trial arguments that OSI
`asserted, that they at any point claimed that the
`commercial success of the '221 patent was a reason
`it was nonobviousness?
` MS. ALLEN: Objection.
` A It is not listed, no.
` Q Sir, did you ever review the OSI expert
`economist's opinions in that case on why the
`compound patent, the '065 patent, was commercially
`successful in the OSI versus Mylan Tarceva
`litigation?
` A No.
` Q You didn't conduct any analysis of
`commercial success specifically arising from the
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`APOTEX EX. 1050-026
`
`
`
`CONFIDENTIAL
`Transcript of Mark Reisenauer
`Conducted on July 13, 2017
`
`26
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`practice of the '221 patent for purposes of your
`declaration, have you?
` MS. ALLEN: Objection.
` A Remind me again. The '221 patent is which
`one?
` Q That is the method of treatment patent.
`That is not the compound patent.
` A The -- the commercial success analysis we
`did was related to Tarceva's indication to treat
`non-small cell lung cancer. So I guess by default
`it relates to that patent.
` Q Did you ever read the '221 patent?
` A No, I have not.
` Q Have you looked at the claims that have been
`asserted in the '221 patent in this case?
` A No.
` Q And, of course, you didn't read the '065
`patent either, did you?
` A I did not.
` Q So you did not differentiate commercial
`success related to the '221 patent versus other
`factors that could lead to commercial success for
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`APOTEX EX. 1050-027
`
`
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`CONFIDENTIAL
`Transcript of Mark Reisenauer
`Conducted on July 13, 2017
`
`27
`
`Tarceva?
` MS. ALLEN: Objection.
` A In terms of variables or things that
`contribute to commercial success, many were
`considered.
` Q Did you consider the '065's claims for the
`compound patent in your analysis of the commercial
`success of Tarceva?
` MS. ALLEN: Objection.
` A No.
` Q And you put no weight on OSI's expert
`opinions in the related Tarceva litigation that the
`commercial success of Tarceva derived from the '065
`patent, correct?
` MS. ALLEN: Objection.
` A Correct.
` Q In determining the commercial success of a
`product and this product Tarceva, you looked at the
`revenue stream for the Tarceva product as a whole,
`right?
` A Correct.
` Q Sir, could the level of marketing and/or
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`APOTEX EX. 1050-028
`
`
`
`CONFIDENTIAL
`Transcript of Mark Reisenauer
`Conducted on July 13, 2017
`
`28
`
`advertising expenditure substantially impact the
`commercial success of a product in your experience?
` MS. ALLEN: Objection.
` A They can certainly impact the commercial
`success, yes.
` Q Could the level of marketing and/or
`advertising expenditure substantially impact the
`commercial success of a product?
` MS. ALLEN: Objection.
` A I would say that depends because if the
`compound itself is not an efficacious or relatively
`efficacious and safe product, it doesn't matter how
`much you would spend. From a marketing and sales
`perspective it wouldn't be successful.
` Q If it was the most efficacious and safe
`product and nobody knew about it, do you think the
`marketing expenditures could substantially impact
`the commercial success where there were none?
` MS. ALLEN: Objection.
` A Repeat the question, please.
` Q If it was the most -- or if it was the most
`safe and effective product that could be sold and
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`APOTEX EX. 1050-029
`
`
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`CONFIDENTIAL
`Transcript of Mark Reisenauer
`Conducted on July 13, 2017
`
`29
`
`nobody marketed it, would in that case the lack of
`expenditures substantially impact the commercial
`success of a product?
` A That's possible.
` MS. ALLEN: Objection. Just give me a
`moment to object.
` Q So turning that the other way, if the
`marketing expenditures were extremely high
`regardless of the product, is it possible that the
`marketing expenditures could have a substantial
`impact on the commercial success of that product?
` MS. ALLEN: Objection.
` A I don't agree.
` Q Okay. Did you look at the marketing
`expenditures in relation to the sales for Tarceva in
`determining your commercial success analysis?
` A No.
` Q So as we sit here today, you don't know
`whether the level of marketing and/or advertising
`expenditures substantially impacted the commercial
`success of Tarceva because you didn't analyze it,
`right?
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`APOTEX EX. 1050-030
`
`
`
`CONFIDENTIAL
`Transcript of Mark Reisenauer
`Conducted on July 13, 2017
`
`30
`
` MS. ALLEN: Objection.
` A I would say that I knew it was a
`contributing factor as was the chemical profile of
`the product in the commercial success.
` Q And as a contributing factor it's not
`something you analyzed specifically, the marketing
`expenditures, right?
` MS. ALLEN: Objection.
` A Correct.
` Q Marketing expenditures and advertising
`expenditures are certain things that may impact the
`overall profitability of a product, correct?
` A Correct.
` Q You did no analysis on the overall return on
`investment for Tarceva to determine if it was
`commercially successful, did you?
` MS. ALLEN: Objection.
` A Correct.
` Q And you understand that Tarceva is jointly
`marketed by not only OSI but Genentech, right?
` A Yes.
` Q And, in fact, there's a third party, Roche,
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`APOTEX EX. 1050-031
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`
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`CONFIDENTIAL
`Transcript of Mark Reisenauer
`Conducted on July 13, 2017
`
`31
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`that does some marketing from a global perspective,
`right?
` A Ex-U.S, yes.
` Q So if you did no analysis of the commercial
`success related to the marketing spend for OSI, can
`I safely assume you did no analysis of the impact of
`the marketing expenditures for Genentech or Roche on
`the Tarceva sales?
` A Correct.
` Q So you don't use the overall return on
`investment generated from the sale of Tarceva in
`your analysis, do you?
` MS. ALLEN: Objection.
` A No.
` Q All right. I'd like you to go back with me
`to your declaration, which if I have it right is
`Exhibit 1038.
` If you could, sir, would you turn with me to
`Page 8 -- or excuse me -- Paragraph 8. To put it in
`context, I'll let you read Paragraph 8 to yourself.
` (Witness examining document.)
` Q In Paragraph 8, the first sentence you opine
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`APOTEX EX. 1050-032
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`
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`CONFIDENTIAL
`Transcript of Mark Reisenauer
`Conducted on July 13, 2017
`
`32
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`"Tarceva has been a very commercially successful
`product," do you not?
` MS. ALLEN: Objection.
` A Yes.
` Q And your basis for that is "since its launch
`and throughout the time period it has been on the
`market in the United States," right?
` A Yes.
` Q Let's talk about since its launch.
` You joined Astellas in 2011; isn't that
`right?
` A Yes.
` Q And is it your understanding when OSI
`launched Tarceva, it was basically the last two
`months of 2004?
` A Yes.
` Q So the first calendar year for Tarceva was
`2005 where it had full sales, right?
` A Yes.
` Q You didn't participate in preparing any of
`the accounting info for the years '04 until you
`arrived at Astellas in 2011, right?
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`APOTEX EX. 1050-033
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`
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`CONFIDENTIAL
`Transcript of Mark Reisenauer
`Conducted on July 13, 2017
`
`33
`
` A Could you repeat the question, please?
` Q Sure. Since you weren't there, you didn't
`participate in preparing any of the account
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