CONFIDENTIAL
`Robert M. Wenslow, Ph.D. - October 22, 2020
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` ________________________________________
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ________________________________________
`
` MYLAN PHARMACEUTICALS INC., et al.,
`
` Petitioner,
`
` v.
`
` MERCK SHARP & DOHME CORP.,
`
` Patent Owner.
`
` __________________________________________
`
` Case IPR2020-00040
` Patent No. 7,326,708 B2
`
` __________________________________________
`
` C O N F I D E N T I A L
`
` DEPOSITION OF ROBERT M. WENSLOW, PH.D.
`
` APPEARING REMOTELY
`
` October 22, 2020
`
` 8:05 a.m.
`
`Reported by
`Rebecca J. Callow, RMR, CRR, RPR, CSR
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Mylan (IPR2020-00040) Ex. 1022 p. 001
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`
`Robert M. Wenslow, Ph.D. - October 22, 2020
`
`Page 1
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` ________________________________________
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ________________________________________
`
` MYLAN PHARMACEUTICALS INC., et al.,
`
` Petitioner,
`
` v.
`
` MERCK SHARP & DOHME CORP.,
`
` Patent Owner.
`
` __________________________________________
`
` Case IPR2020-00040
` Patent No. 7,326,708 B2
`
` __________________________________________
`
` C O N F I D E N T I A L
`
` DEPOSITION OF ROBERT M. WENSLOW, PH.D.
`
` APPEARING REMOTELY
`
` October 22, 2020
`
` 8:05 a.m.
`
`Reported by
`Rebecca J. Callow, RMR, CRR, RPR, CSR
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Mylan (IPR2020-00040) Ex. 1022 p. 001
`
`
`
`CONFIDENTIAL
`Robert M. Wenslow, Ph.D. - October 22, 2020
`
`Page 2
`
` REMOTE APPEARANCES
`
`ON BEHALF OF MYLAN PHARMACEUTICALS, INC.:
`
` Katten Muchin Rosenman LLP
`
` 550 South Tryon Street
`
` Suite 2900
`
` Charlotte, North Carolina 28202
`
` 704-344-3185
`
` By: Jitendra Malik, Ph.D.,
`
` jitty.malik@katten.com
`
`FOR TEVA PHARMACEUTICALS USA AND
`
`WATSON LABORATORIES, INC.:
`
` Goodwin Proctor LLP
`
` 620 Eighth Avenue
`
` The New York Times Building
`
` New York, New York 10018
`
` 212-813-8800
`
` By: Keith A. Zullow
`
` kzullow@goodwinproctor.com
`
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`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
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`
`
`CONFIDENTIAL
`Robert M. Wenslow, Ph.D. - October 22, 2020
`
`Page 3
`
` REMOTE APPEARANCES (CONTINUED)
`
`ON BEHALF OF MERCK:
`
` Williams & Connolly LLP
`
` 725 Twelfth Street, Northwest
`
` Washington, D.C. 20005
`
` 202-434-5000
`
` By: Alexander S. Zolan
`
` azolan@wc.com
`
` Shaun Mahaffy
`
` smahaffy@wc.com
`
` Tony Sheh
`
` tsheh@wc.com
`
`ON BEHALF OF FOR DR. REDDY'S LABORATORIES, INC.,
`
`DR. REDDY'S LABORATORIES, LTD.:
`
` Lerner David Littenberg Krumholz & Mentlik
`
` 20 Commerce Drive
`
` Cranford, New Jersey 07016
`
` (908) 654-5000
`
` By: Russell W. Faegenburg
`
` rfaegenburg@lernerdavid.com
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
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`
`
`CONFIDENTIAL
`Robert M. Wenslow, Ph.D. - October 22, 2020
`
`Page 4
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` REMOTE APPEARANCES (CONTINUED)
`
` MERCK & CO., INC.
`
` 2000 Galloping Hill Road
`
` Kenilworth, New Jersey 07033
`
` (908) 740-4000
`
` By: Raynard Yuro
`
` ryuro@merck.com
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`GregoryEdwards, LLC | Worldwide Court Reporting
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`
`Mylan (IPR2020-00040) Ex. 1022 p. 004
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`
`
`CONFIDENTIAL
`Robert M. Wenslow, Ph.D. - October 22, 2020
`
`Page 5
`
` I N D E X
`
` PAGE
`
`ROBERT M. WENSLOW, Ph.D.
`
`Examination by Mr. Malik ..........................7
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` * * * * *
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`
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`
`
`CONFIDENTIAL
`Robert M. Wenslow, Ph.D. - October 22, 2020
`
`Page 6
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` E X H I B I T S
`
`NO. DESCRIPTION PAGE
`
`Exhibit 1019 6/14/2011 Affidavit of Robert 112
`
` M. Wenslow (with exhibits)
`
` * * * * *
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`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
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`
`
`CONFIDENTIAL
`Robert M. Wenslow, Ph.D. - October 22, 2020
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`Page 7
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` Thursday, October 22, 2020, 8:05 a.m.
`
` P R O C E E D I N G S
`
` - - - - -
`
` ROBERT M. WENSLOW, Ph.D.,
`
` called as a witness herein, having
`
` been first duly sworn by a Notary Public,
`
` was examined and testified as follows:
`
` EXAMINATION
`
` BY MR. MALIK:
`
` Q. Good morning, Dr. Wenslow.
`
` A. Good morning.
`
` Q. Just for the record, would you mind stating
`
`your name?
`
` A. Yes. Dr. Robert Michael Wenslow, Jr.
`
` Q. Okay. And you understand that you are
`
`under oath today. Correct?
`
` A. Yes, I do.
`
` Q. And you understand the testimony that you
`
`give today is under penalty of perjury?
`
` A. Yes, I do.
`
` Q. Just going over some rules. If you need a
`
`break let me know, and I will do my best to
`
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`
`Mylan (IPR2020-00040) Ex. 1022 p. 007
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`
`
`CONFIDENTIAL
`Robert M. Wenslow, Ph.D. - October 22, 2020
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`Page 8
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`accommodate you. Fair enough?
`
` A. Fair.
`
` Q. The only rule I have is if there's a
`
`question pending, let's go ahead and deal with that.
`
` You understand today you are obligated
`
`to answer my questions?
`
` A. Yes.
`
` Q. Any reason today you cannot tell the truth?
`
` A. No.
`
` Q. If I ask a question and you don't
`
`understand, let me know and I'll try to rephrase.
`
`Fair enough?
`
` A. That is fair.
`
` Q. And if you don't ask me to rephrase, I will
`
`assume you understood the question. Fair enough?
`
` A. Fair.
`
` Q. Okay. Let me go ahead and upload in the
`
`chat room the two declarations that you submitted.
`
`Bear with me one second. I'm uploading EX2003 and
`
`I'm uploading EX2116.
`
` Dr. Wenslow, why don't you go ahead and
`
`download those two documents and let me know when
`
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`
`Mylan (IPR2020-00040) Ex. 1022 p. 008
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`
`
`CONFIDENTIAL
`Robert M. Wenslow, Ph.D. - October 22, 2020
`
`Page 9
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`you're ready to proceed.
`
` A. The documents are downloaded and open.
`
` Q. Thank you. I appreciate that.
`
` Now, I understand that you submitted
`
`two declarations in connection with this matter.
`
`Correct?
`
` A. I have submitted two declarations.
`
` Q. Okay. Let me ask you, do you have any
`
`documents in front of you or within your access?
`
`Hard copies?
`
` A. Yes. I do have the hard copies of the
`
`declarations in front of me.
`
` Q. Okay. Do you have any other documents in
`
`front of you?
`
` A. Just what relates to the declarations.
`
` Q. Okay. Fair enough.
`
` So, yeah. If you could -- obviously, I
`
`understand you may be in a room with other documents.
`
`Just if you could simply refrain from looking at
`
`anything else other than what is the two declarations
`
`and the documents referenced in the declarations.
`
`Fair enough?
`
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`
`Mylan (IPR2020-00040) Ex. 1022 p. 009
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`
`
`CONFIDENTIAL
`Robert M. Wenslow, Ph.D. - October 22, 2020
`
`Page 10
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` A. Fair.
`
` Q. And the hard copy documents that you have
`
`access to, are they marked in any way?
`
` A. They are not.
`
` Q. Okay. Good.
`
` Now, let's start with your first
`
`declaration, which is EX2003. Can you, please,
`
`confirm that EX2003 is your declaration and it bears
`
`your signature on the last page?
`
` A. It is my declaration and it is my signature
`
`on the last page.
`
` Q. And so the record is clear, the last page
`
`is, basically, page 7 at the bottom, just so the
`
`record is clear.
`
` Any corrections or amendments to the
`
`first declaration?
`
` A. There are no amendments.
`
` Q. Any corrections?
`
` A. And no corrections.
`
` Q. Okay. And you understood that the first
`
`declaration, at least up until -- well, let me
`
`strike that.
`
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`
`
`CONFIDENTIAL
`Robert M. Wenslow, Ph.D. - October 22, 2020
`
`Page 11
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` Let's go to your second declaration,
`
`2116. Please confirm for me that it bears your
`
`signature on the last page, which is page 27.
`
` A. That is my signature on page 27.
`
` Q. Okay. And any corrections or amendments or
`
`changes to EX2116?
`
` A. No corrections or amendments.
`
` Q. And I assume you stand by the statements in
`
`connection with both declarations. Correct?
`
` A. Correct.
`
` Q. And I just want to confirm that you
`
`understood that the two declarations that you
`
`submitted, EX2003 and EX2116, are -- were meant to
`
`be complete statements for issues you're offering
`
`testimony to. Correct?
`
` A. Correct.
`
` Q. And in connection with this IPR deposition,
`
`you understand that during any break, during this
`
`cross, you're not supposed to discuss -- well, it's
`
`your understanding that you're not supposed to
`
`discuss your testimony or any anticipated testimony
`
`in connection with this deposition?
`
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`
`Mylan (IPR2020-00040) Ex. 1022 p. 011
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`
`
`CONFIDENTIAL
`Robert M. Wenslow, Ph.D. - October 22, 2020
`
`Page 12
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` A. That is my understanding.
`
` Q. Okay. Are you being compensated to be here
`
`today?
`
` A. Yes, I am.
`
` Q. How much are you being compensated per
`
`hour?
`
` A. I believe it is $400 per hour.
`
` Q. Okay. And how much money have you -- and
`
`in connection with drafting the two declarations,
`
`EX2002 and EX2116, were you also compensated at a
`
`rate of $400 per hour?
`
` A. Yes, I was.
`
` Q. How much have you made to date in
`
`connection with this IPR matter?
`
` A. I do not know the exact amount.
`
` Q. Okay. And in connection with this
`
`deposition, I assume you met with your attorneys?
`
` A. Yes, I did.
`
` Q. When did you meet with your attorneys?
`
` A. We had meetings this week.
`
` Q. Okay. Approximately, how many hours did
`
`you meet with your attorney this week?
`
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`
`Mylan (IPR2020-00040) Ex. 1022 p. 012
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`
`
`CONFIDENTIAL
`Robert M. Wenslow, Ph.D. - October 22, 2020
`
`Page 13
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` A. Approximately 20 hours.
`
` Q. Okay. And, just the name, which attorneys
`
`did you meet with?
`
` A. Alex, Shaun, Tony, and Ray.
`
` Q. Okay. Fair enough.
`
` When did Merck or anyone on behalf of
`
`Merck first contact you in connection with this IPR
`
`matter? And I'm only interested in the time, I'm not
`
`interested in the nature of the communication.
`
` A. I cannot remember the exact time.
`
` Q. Okay. Have you been deposed before?
`
` A. I have not.
`
` Q. And did you write EX2003, the first
`
`declaration?
`
` A. I wrote EX2003.
`
` Q. Okay. Would it be easier if we say "first
`
`declaration" or "second declaration"? Or would you
`
`prefer EX2003 and 2116? I completely leave it to
`
`your discretion.
`
` A. First declaration will be easier for me.
`
` Q. Fair enough. For me too.
`
` So let's look at the second
`
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`
`
`CONFIDENTIAL
`Robert M. Wenslow, Ph.D. - October 22, 2020
`
`Page 14
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`declaration. I assume you also wrote that in
`
`collaboration with your attorneys?
`
` A. That is correct.
`
` Q. Okay. In your first declaration there are
`
`some documents attached to the back of it. Did you
`
`select those documents or were they just given to
`
`you?
`
` A. I was involved with the selection of those
`
`documents.
`
` Q. Were there any documents that you elected
`
`in connection with your first declaration not to
`
`include?
`
` A. No.
`
` Q. And then in connection with the second
`
`declaration, I realize there are no documents
`
`attached, but there are documents referenced within
`
`the text of the second declaration. Did you select
`
`those documents or were they given to you?
`
` A. I was involved in the selection of the
`
`documents.
`
` Q. Were there any documents that you elected
`
`not to include that you looked at in connection with
`
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`Mylan (IPR2020-00040) Ex. 1022 p. 014
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`
`
`CONFIDENTIAL
`Robert M. Wenslow, Ph.D. - October 22, 2020
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`Page 15
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`your second declaration?
`
` A. No.
`
` Q. In connection with this -- strike that.
`
` Now, according to your paragraph 9 in
`
`your first declaration, you left Merck around 2011.
`
`Correct?
`
` A. Correct.
`
` Q. And I presume the last time you saw the
`
`various documents cited in either the first or
`
`second declaration was before 2011. Correct? Other
`
`than in connection with this matter.
`
` A. To the best of my understanding, yes.
`
` Q. And since 2011, until the time when someone
`
`first contacted you in connection with this IPR
`
`matter, how much time have you spent thinking about
`
`sitagliptin?
`
` A. Can you expand on that?
`
` Q. Sure. Let me ask it this way:
`
` From the time you left Merck, until
`
`someone contacted you in connection with this IPR,
`
`how much time have you spent thinking about the
`
`issues that are discussed in your first declaration?
`
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`
`
`CONFIDENTIAL
`Robert M. Wenslow, Ph.D. - October 22, 2020
`
`Page 16
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` A. I can't estimate the number of hours I have
`
`thought about it.
`
` Q. Okay. And then if I were to ask the same
`
`question in connection with the content of your
`
`second declaration, I assume you'd answer the same
`
`way?
`
` A. Correct.
`
` Q. Okay. Other than the documents discussed
`
`in this declaration, did you review any other
`
`documents in connection with this matter?
`
` MR. ZOLAN: Objection to form.
`
` Jitty, just for his -- for the sake of
`
`the witness, when you say "this matter."
`
` MR. MALIK: IPR matter. Yeah.
`
` MR. ZOLAN: All right. And, you know,
`
`I'm going to -- I'm going to instruct the witness
`
`not to answer that question.
`
` MR. MALIK: Okay.
`
` BY MR. MALIK:
`
` Q. Let me ask it this way:
`
` Other than the documents that are cited
`
`in your declarations, are there any other documents
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`Mylan (IPR2020-00040) Ex. 1022 p. 016
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`
`
`CONFIDENTIAL
`Robert M. Wenslow, Ph.D. - October 22, 2020
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`Page 17
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`you're going to rely on in connection with this
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`inter partes review matter? Yes or no, Dr. Wenslow?
`
` A. What do you mean, "rely on"?
`
` Q. Let me ask it this way:
`
` As far as the inter partes review goes
`
`-- well, let me back up.
`
` You understand that there are two
`
`matters, an inter partes review and a litigation.
`
`Correct?
`
` A. Well, I am aware of the inter partes review
`
`and the documents associated in front of me.
`
` Q. Okay. And for the purposes of the
`
`inter partes review, the only thing that you're
`
`going to rely on in connection with your
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`declarations are the documents that are cited
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`therein. Correct? Not anything else you may have
`
`seen. Is that fair?
`
` A. That is -- besides, that is fair.
`
` Q. Okay. Fair enough.
`
` Now, in connection with this matter,
`
`have you seen anybody else's declaration other than
`
`your own?
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`
`
`CONFIDENTIAL
`Robert M. Wenslow, Ph.D. - October 22, 2020
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`Page 18
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` A. I do not believe I've seen anyone else's
`
`declaration.
`
` Q. Have you seen the declaration of
`
`Dr. Chorghade?
`
` A. I don't know who that is.
`
` Q. Dr. Matzger?
`
` A. No.
`
` Q. Dr. Myerson?
`
` A. No.
`
` Q. Have you read anyone's deposition
`
`transcript in connection with this matter?
`
` A. No.
`
` Q. Have you seen -- let me back up.
`
` Other than conversations with your
`
`attorneys -- I'm not interested in anything that --
`
`of what you said with your attorneys -- have you
`
`spoken about this matter with anyone else?
`
` A. No.
`
` Q. Let me hand you -- well, let me upload.
`
`It's a new world.
`
` Let me upload Exhibit 1001, which is
`
`the '708 patent. Let me know when you're ready to
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`
`Mylan (IPR2020-00040) Ex. 1022 p. 018
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`
`
`CONFIDENTIAL
`Robert M. Wenslow, Ph.D. - October 22, 2020
`
`Page 19
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`proceed.
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` A. I've opened it and it is in front of me
`
`currently.
`
` Q. Okay. When was the last time you talked
`
`to -- well, let me strike that.
`
` On the first page, do you see a number
`
`of named inventors that also includes your name.
`
`Correct?
`
` A. Yes.
`
` Q. When was the last time you spoke to any of
`
`the individuals listed as named inventors on the
`
`'708 patent?
`
` A. Are you referring to every single person or
`
`one person?
`
` Q. Well, I guess -- well, let me ask this.
`
` When was the last time you spoke to
`
`Mr. Cypes?
`
` A. Approximately 2017.
`
` Q. Okay. And it was not -- your conversations
`
`with Mr. Cypes, I assume, were not in connection
`
`with anything to do with this IPR matter. Correct?
`
` A. Correct.
`
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`
`
`CONFIDENTIAL
`Robert M. Wenslow, Ph.D. - October 22, 2020
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`Page 20
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` Q. And -- well, did your conversation with
`
`Mr. Cypes have anything to do with sitagliptin?
`
` A. No.
`
` Q. Let me ask you this.
`
` In context with other the inventors --
`
`Mr. Chen, Mr. Ferlita, Dr. Hansen, Mr. Lee,
`
`Ms. Vydra -- well, let me strike that.
`
` When was the last time you spoke to
`
`Mr. Chen? Let's take it slowly so we can get the
`
`record clear.
`
` A. Verbally spoke?
`
` Q. Yes. Or emailed.
`
` A. Emailed, I would say within last week.
`
` Q. Was it in connection with sitagliptin?
`
` A. No. It was not.
`
` Q. Do you and Mr. Chen stay in contact? Are
`
`you casual friends?
`
` A. We are in contact very frequently.
`
` Q. Okay. When was the last time you
`
`communicated with Mr. Ferlita?
`
` A. Russell Ferlita, the last time, I think,
`
`was approximately a year or year and a half ago.
`
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`
`Mylan (IPR2020-00040) Ex. 1022 p. 020
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`
`
`CONFIDENTIAL
`Robert M. Wenslow, Ph.D. - October 22, 2020
`
`Page 21
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` Q. Were your communications in connection with
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`sitagliptin?
`
` A. No.
`
` Q. And then when was the last time you talked
`
`to Dr. Hansen?
`
` A. Karl, approximately a week ago.
`
` Q. Okay. Was it -- did it involve -- did your
`
`conversation or communications involve sitagliptin?
`
` A. No.
`
` Q. I assume you and Dr. Hansen have stayed in
`
`touch over the years?
`
` A. Yes. We have.
`
` Q. When was the last time you spoke to
`
`Mr. Lee?
`
` A. I believe that was around 2011.
`
` Q. And I assume your conversation with Mr. Lee
`
`did not involve sitagliptin. Correct?
`
` A. Not that I recall.
`
` Q. And when was the last time you interacted
`
`with or communicated with Ms. Vydra?
`
` A. I believe I emailed her in 2015.
`
` Q. Did your communications with Ms. Vydra
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`Mylan (IPR2020-00040) Ex. 1022 p. 021
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`
`
`CONFIDENTIAL
`Robert M. Wenslow, Ph.D. - October 22, 2020
`
`Page 22
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`involve -- discuss sitagliptin?
`
` A. No.
`
` Q. Let's go to paragraph 10 of your second
`
`declaration.
`
` A. I am there.
`
` Q. Now, in connection with the second
`
`declaration, just so I understand, and just more for
`
`foundation purposes, the data that you are
`
`presenting are -- is in connection with -- and,
`
`obviously, this is a list. Let's go through each
`
`one.
`
` What you call Forms I, II, and III, and
`
`that's my understanding that they are crystalline
`
`anhydrites of the DH -- of the 1:1 DHP salt,
`
`sitagliptin?
`
` MR. ZOLAN: Object to form.
`
` A. Are you referring specifically in
`
`paragraph 10?
`
` BY MR. MALIK:
`
` Q. Yes. Well, let me ask it this way:
`
` There I see crystalline anhydrates
`
`Forms I, II, and III. Do you see that reference?
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`
`
`CONFIDENTIAL
`Robert M. Wenslow, Ph.D. - October 22, 2020
`
`Page 23
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`It's about four lines down.
`
` A. Yes, I do.
`
` Q. Okay. What are the crystalline anhydrates
`
`Forms I, II, and III? What's your understanding of
`
`them?
`
` A. The data for the crystalline anhydrates are
`
`provided on pages -- starting on page 6 to page 10.
`
` Q. Well, let me ask it this way:
`
` Those are -- Form I, Form II, and
`
`Form III are crystalline substances. Correct?
`
` A. They are crystalline.
`
` Q. And they're all the anhydrate structure of
`
`the 1:1 sitagliptin DHP salt. Correct?
`
` A. They are all anhydrates.
`
` Q. Okay. I guess, my question, just to be
`
`clear, is they're all anhydrates, but they're all
`
`anhydrates of the 1:1 sitagliptin DHP salt.
`
`Correct?
`
` A. Correct.
`
` Q. And by reference to Forms I, II, and III,
`
`those effectively are different polymorphs of the
`
`1:1 sitagliptin DHP salt. Correct?
`
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`Mylan (IPR2020-00040) Ex. 1022 p. 023
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`
`
`CONFIDENTIAL
`Robert M. Wenslow, Ph.D. - October 22, 2020
`
`Page 24
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` A. They are polymorphs.
`
` Q. What is your understanding of what a
`
`polymorph is?
`
` A. A polymorph has the same molecular
`
`structure but different crystal packing or crystal
`
`structure.
`
` Q. So another way of saying it: Within the
`
`molecule, the orientation of the individual 1:1
`
`sitagliptin DHP salt could be different and, hence,
`
`you have different polymorphs. Is that fair?
`
` A. So the unit cell would be different. That
`
`could include different orientations of the
`
`sitagliptin, different hydrogen bonding.
`
` Q. Okay. I like your answer better with
`
`reference to the unit cell.
`
` So let's continue. So we have one set
`
`of data in the second declaration directed to the
`
`three polymorphic Forms I, II, and III of the
`
`anhydrates.
`
` You also, within the declaration,
`
`provide information about the crystalline
`
`monohydrate -- correct? -- of the 1:1 sitagliptin DHP
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`Mylan (IPR2020-00040) Ex. 1022 p. 024
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`
`
`CONFIDENTIAL
`Robert M. Wenslow, Ph.D. - October 22, 2020
`
`Page 25
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`salt.
`
` A. Correct.
`
` Q. And then you also provide information in
`
`the declaration about the crystalline L-tartic salt
`
`hemihydrate of the -- well.
`
` You also provide information about the
`
`crystalline L-tartic acid salt hemihydrate. Correct?
`
` A. Or a tartaric acid salt hemihydrate of
`
`sitagliptin. Correct.
`
` Q. And the -- this has a -- when you have the
`
`tartaric acid, that is not the same thing -- that's
`
`a different salt from the phosphoric acid salt of
`
`sitagliptin. Correct?
`
` A. There is a different counterion and a
`
`different salt.
`
` Q. In this case, the tartaric acid is made
`
`from -- what? -- tartic acid? Tartaric acid?
`
` A. Can you repeat your question?
`
` Q. Sure. How is the -- strike that.
`
` And then after -- with respect to that
`
`particular salt, there's also the hemihydrate.
`
`Correct?
`
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`
`
`CONFIDENTIAL
`Robert M. Wenslow, Ph.D. - October 22, 2020
`
`Page 26
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` A. The crystalline L-tartaric acid salt is
`
`listed as a hemihydrate.
`
` Q. What is a hemihydrate?
`
` A. A hemihydrate has a half a mole of water
`
`per mole of sitagliptin.
`
` Q. Okay. And then the next entry is a
`
`crystalline benzine sulphonic acid salt anhydrate.
`
`Correct?
`
` A. Yes.
`
` Q. The counterion on this one is benzine
`
`sulphonic acid and not phosphoric acid. Correct?
`
` A. Correct.
`
` Q. And this is also an anhydrate. Correct?
`
` A. This is an anhydrate.
`
` Q. When you make reference to "anhydrate,"
`
`just so we get terminology correct throughout this
`
`deposition, what are you referring to?
`
` A. When I say "anhydrate," I mean there is no
`
`known water or solvent in the unit cell.
`
` Q. Okay. The last one is -- on there is the
`
`crystalline hydrochloric acid salt monohydrate.
`
`Correct? Listed in paragraph 10.
`
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`
`
`CONFIDENTIAL
`Robert M. Wenslow, Ph.D. - October 22, 2020
`
`Page 27
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` A. Crystalline hydrochloric acid salt
`
`monohydrate.
`
` Q. And, again, just for foundation,
`
`hydrochloric acid is not the same as phosphoric
`
`acid?
`
` A. It is not.
`
` Q. And by reference to the monohydrate, you're
`
`saying that there's one -- well, why don't you
`
`answer.
`
` What do you mean by "monohydrate"?
`
`What's your understanding of "monohydrate"?
`
` A. So the understanding of the word
`
`"monohydrate" is one mole of water per mole of
`
`sitagliptin.
`
` Q. Okay. Now, other than the compounds
`
`referenced in paragraph 10, are you relying on --
`
`are you presenting data in connection with any other
`
`sitagliptin salt?
`
` A. So are you asking that, besides the
`
`phosphoric tartaric benzine sulphonic and
`
`hydrochloric, that I have no other salts -- data for
`
`no other salts in here?
`
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`Mylan (IPR2020-00040) Ex. 1022 p. 027
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`
`
`CONFIDENTIAL
`Robert M. Wenslow, Ph.D. - October 22, 2020
`
`Page 28
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` Q. In the declaration -- correct? -- other
`
`than what's in paragraph 10.
`
` A. I'm not ...
`
` Q. Feel free to look. It's not a memory test.
`
` A. Yeah. I know. I'm looking.
`
` No.
`
` Q. Fair enough. So we have the universe of
`
`salts down. Okay.
`
` And, also, just to confirm, everything
`
`in paragraph 10, all the sitagliptin-related
`
`molecules that you mention there are salts. Correct?
`
`The freebase isn't there.
`
` A. The freebase is not there.
`
` Q. Okay. Everything is a salt -- correct? --
`
`in paragraph 10.
`
` A. Paragraph 10, everything is a salt.
`
` Q. Okay. I'm not trying to frustrate you, I'm
`
`just trying to get some foundation down.
`
` A. No. Understood.
`
` Q. Thank you for bearing with me.
`
` Let's turn to paragraph 28 of your
`
`second declaration.
`
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`
`
`CONFIDENTIAL
`Robert M. Wenslow, Ph.D. - October 22, 2020
`
`Page 29
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` A. I'm there.
`
` Q. Okay. Now, there you say, about ten lines
`
`down, "Form II, which is metastable, slowly converts
`
`to mixtures of Forms I and III with faster
`
`conversion to elevated temperatures."
`
` Do you see that sentence? And by all
`
`means, look at -- review the whole paragraph. I'm
`
`not trying to rush you.
`
` A. Yes.
`
` Q. Now, what do you mean by Form II is
`
`metastable?
`
` A. The Form II always converted to other
`
`crystal forms, whether on storage, with temperature,
`
`or applied force.
`
` Q. I guess what I'm asking is if -- when you
`
`use the word "metastable," what does that
`
`communicate? What were you trying to say?
`
` A. "Metastable" means that it is not the
`
`thermodynamically stable polymorph.
`
` Q. And so as a result of being -- as a result
`
`of Form II being metastable, it converts to Forms I
`
`and Forms III, which are both anhydrous forms of the
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`
`
`CONFIDENTIAL
`Robert M. Wenslow, Ph.D. - October 22, 2020
`
`Page 30
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`1:1 DHP sitagliptin salt. Correct?
`
` A. It depends on the temperature. But it can
`
`convert to Form I or mixtures of Form I and
`
`Form III.
`
` Q. And that -- as you, I guess, kind of
`
`alluded to, that conversion is a function of
`
`temperature. Correct?
`
` A. It can be a function of temperature. It --
`
`it can be a function of temperature.
`
` Q. Can it also be a function of something
`
`else?
`
` A. So if you look, it says "Upon further
`
`drying or storage ..."
`
` So it's not just temperature.
`
` Q. Okay. So Form II could convert to Form I
`
`and Form III upon further drying or storage.
`
`Correct?
`
` A. Yes.
`
` Q. What do you mean "upon storage" in your
`
`last answer?
`
` A. So when you actually -- if you had Form II
`
`and you had it, say, at 25 degrees, or 40/75, or any
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Mylan (IPR2020-00040) Ex. 1022 p. 030
`
`
`
`CONFIDENTIAL
`Robert M. Wenslow, Ph.D. - October 22, 2020
`
`Page 31
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`temperature for any extended periods of time, that's
`
`what I mean by "storage."
`
` Q. The fact that Form II does this would mean
`
`that it would likely fail accelerated aging tests --
`
`correct? -- of the -- just the API.
`
` MR. ZOLAN: Object to form.
`
` THE WITNESS: I'm sorry. Was there a
`
`comment, Alex?
`
` MR. MALIK: Yeah --
`
` MR. ZOLAN: Oh, go ahead.
`
` MR. MALIK: I'm sorry. I don't mean
`
`to interfere with your conversation. Go ahead.
`
` MR. ZOLAN: All I was saying is, when
`
`I object, you still need to answer the question.
`
` THE WITNESS: Okay.
`
` MR. ZOLAN: Go ahead and answer the
`
`question.
`
` A. Can you repeat the question, please?
`
` BY MR. MALIK:
`
` Q. Absolutely. Maybe I'll rephrase it a
`
`little bit. So let me -- let me make it clear.
`
` I'm going to ask questions. If your
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Mylan (IPR2020-000
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