Karl Hansen - October 8, 2020
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` IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
` ___________________
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ___________________
`
` MYLAN PHARMACEUTICALS, INC., TEVA PHARMACEUTICALS
` USA, INC., WATSON LABORATORIES, INC., DR. REDDY’S
`LABORATORIES, INC., DR. REDDY’S LABORATORIES, LTD.,
` and SUN PHARMACEUTICALS INDUSTRIES, LTD.
` Petitioner,
`
` V.
`
` MERCK SHARP & DOHME CORPORATION,
` Patent Owner.
`
` _________________________
`
` Case IPR2020-00040
` U.S. Patent 7,326,708 B2
` _________________________
`
` REMOTE ORAL DEPOSITION OF
` KARL HANSEN
` OCTOBER 8, 2020
`
` DEPOSITION of KARL HANSEN, produced as
`
`a witness at the instance of the Patent Owner, and
`
`duly sworn, was taken in the above-styled and
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`numbered cause on the 8th day of October, 2020, from
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`8:07 a.m. to 12:13 p.m., EST, before Christy R.
`
`Sievert, CSR, RPR, reported remotely by machine
`
`shorthand, taken pursuant to the provisions stated
`
`on the record or attached hereto.
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Mylan (IPR2020-00040) Ex. 1024 p. 001
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` IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
` ___________________
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ___________________
`
` MYLAN PHARMACEUTICALS, INC., TEVA PHARMACEUTICALS
` USA, INC., WATSON LABORATORIES, INC., DR. REDDY’S
`LABORATORIES, INC., DR. REDDY’S LABORATORIES, LTD.,
` and SUN PHARMACEUTICALS INDUSTRIES, LTD.
` Petitioner,
`
` V.
`
` MERCK SHARP & DOHME CORPORATION,
` Patent Owner.
`
` _________________________
`
` Case IPR2020-00040
` U.S. Patent 7,326,708 B2
` _________________________
`
` REMOTE ORAL DEPOSITION OF
` KARL HANSEN
` OCTOBER 8, 2020
`
` DEPOSITION of KARL HANSEN, produced as
`
`a witness at the instance of the Patent Owner, and
`
`duly sworn, was taken in the above-styled and
`
`numbered cause on the 8th day of October, 2020, from
`
`8:07 a.m. to 12:13 p.m., EST, before Christy R.
`
`Sievert, CSR, RPR, reported remotely by machine
`
`shorthand, taken pursuant to the provisions stated
`
`on the record or attached hereto.
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Mylan (IPR2020-00040) Ex. 1024 p. 001
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`
`
`Karl Hansen - October 8, 2020
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`Page 2
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` A P P E A R A N C E S
`
`FOR MYLAN PHARMACEUTICALS, INC.:
`
` DR. JITENDRA (“JITTY”) MALIK, Ph.D.
` Katten Muchin Rosenman, LLP
` 550 S. Tryon Street, Suite 2900
` Charlotte, North Carolina 28202
` 704-344-3185
` jitty.malik@katten.com
`
`FOR DR. REDDY'S LABORATORIES:
`
` MR. RUSSELL W. FAEGENBURG
` Lerner, David, Littenberg,
` Krumholz & Mentlik, LLP
` 20 Commerce Drive
` Cranford, New Jersey 07016
` 908-518-6367
` rfaegenburg@lernerdavid.com
`
`FOR TEVA PHARMACEUTICAL USA, INC., and WATSON
`LABORATORIES, INC.:
`
` MS. SARAH J. FISCHER
` Goodwin Procter, LLP
` 100 Northern Avenue
` Boston, Massachusetts 02210
` 617-570-3908
` sfischer@goodwinlaw.com
`
`FOR MERCK SHARP & DOHME CORPORATION:
`
` MR. ALEXANDER ZOLAN
` MR. BRUCE R. GENDERSON
` MR. SHAUN P. MAHAFFY
` MR. ANTHONY SHEH
` Williams & Connolly, LLP
` 725 Twelfth Street, N.W.
` Washington, DC 20005
` 202-434-5208
` azolan@wc.com
` bgenderson@wc.com
` smahaffy@wc.com
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`GregoryEdwards, LLC | Worldwide Court Reporting
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`Mylan (IPR2020-00040) Ex. 1024 p. 002
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`Karl Hansen - October 8, 2020
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`Page 3
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` ALSO PRESENT:
`
` RAY YURO
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`Karl Hansen - October 8, 2020
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`Page 4
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` I N D E X
` PAGE
`
`Appearances................................. 2-3
`
`Exhibits...................................... 5
`
`Proceedings................................... 6
`
`KARL HANSEN:
`
` Examination by Mr. Malik.................... 8
` Examination by Mr. Zolan................... 98
`
`Reporter's Certification................ 103-104
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`Changes and Signature................... 106-109
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`Mylan (IPR2020-00040) Ex. 1024 p. 004
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`Karl Hansen - October 8, 2020
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`Page 5
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` E X H I B I T S
`
`NUMBER DESCRIPTION PAGE
`
`Exhibit 1001 U.S. Patent 7,326,708 B2 20
`
`Exhibit 2127 Declaration 9
`
`Exhibit 2128 Lab notebook 52
`
`Exhibit 2129 Lab notebook 53
`
`Exhibit 2132 E-mail correspondence 27
` 1-3-02, Re: Fw: Acidic
` Salt Screen of L-224715
` Free Base
`
`Exhibit 2135 D-Sheet 90
`
`Exhibit 2136 D-Sheet 90
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`Mylan (IPR2020-00040) Ex. 1024 p. 005
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`Karl Hansen - October 8, 2020
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` P R O C E E D I N G S
`
` THE REPORTER: Good morning. We are
`
`now on the record.
`
` My name is Christy Sievert. I am the
`
`court reporter with Gregory Edwards, LLC.
`
` The time is 8:07 a.m. Eastern Standard
`
`time.
`
` This remote deposition being held in the
`
`matter of the Mylan Pharmaceuticals, et al., vs.
`
`Merck, Sharp & Dohme.
`
` The deponent today is Karl Hansen.
`
` All parties to this deposition are
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`appearing remotely and have agreed to the witness
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`being sworn in remotely.
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` Due to the nature of remote reporting,
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`please pause briefly before speaking to ensure all
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`parties are heard completely.
`
` (Oath administered.)
`
` THE REPORTER: Would all counsel
`
`please introduce themselves.
`
` DR. MALIK: Jitendra Malik for Mylan
`
`Pharmaceuticals of the law firm of Katten. With me,
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`Preston Imperatore, in-house counsel for Mylan, may
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`or may not join us through the course of the day.
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` MR. ZOLAN: Do the joinder petitioners
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`Karl Hansen - October 8, 2020
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`want to introduce themselves before I go?
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` MR. FAEGENBURG: Sure. Russ
`
`Faegenburg of Lerner David for the Dr. Reddy's
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`Laboratories petitioners.
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` MS. FISCHER: Sarah Fischer from
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`Goodwin Proctor for the TEVA and Watson petitioners.
`
` MR. ZOLAN: And Alexander Zolan from
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`Williams & Connolly on behalf of Merck. And with me
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`is Bruce Genderson and Shawn Mahaffy and Tony Sheh,
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`all from Williams & Connolly. And also Ray Yuro,
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`in-house counsel at Merck.
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` DR. MALIK: So just before I start,
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`it's my usual practice just to get any agreements on
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`the record between counsel. I think the only
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`agreement that I'm aware of is that we have
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`flexibility as to who may appear at the IPR who may
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`not necessarily have made appearances in connection,
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`I guess, with some of the joinder petitioners.
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`Obviously, given Mylan and Merck have counsel who
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`have made appearances, that's not an issue for
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`Mylan. And so that's the only agreement that Mylan
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`understands that we've made.
`
` And then, obviously, pursuant to the
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`scheduling order, it's Mylan's understanding that
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`this deposition is governed by Appendix D of the
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`Mylan (IPR2020-00040) Ex. 1024 p. 007
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`Karl Hansen - October 8, 2020
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`trial practice guide.
`
` So those are the only understandings Mylan
`
`has. So let's get started.
`
` KARL HANSEN,
`
` having been first duly sworn,
`
` testified as follows:
`
` EXAMINATION
`
`BY DR. MALIK:
`
` Q. Dr. Hansen, would you mind stating your
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`name for the record?
`
` A. Sure. My name is Karl Hansen.
`
` Q. And you understand that you are under oath
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`today, correct?
`
` A. Yes, I do.
`
` Q. Okay. And you understand that this
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`testimony is taken under the penalty of perjury,
`
`correct?
`
` A. Yes, I do.
`
` Q. Okay. And you understand that in
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`connection with today, I'm going to ask you a series
`
`of questions. Fair enough?
`
` A. Yes.
`
` Q. Okay. And you are obligated to answer my
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`questions. Is that your understanding?
`
` A. That is my understanding, yes.
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`Karl Hansen - October 8, 2020
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`Page 9
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` Q. Okay. Any reason today you cannot tell the
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`truth?
`
` A. No.
`
` Q. Let's see. And if I ask a question and you
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`don't ask me to rephrase, I will assume you
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`understood the question. Fair enough?
`
` A. Yeah, I think that's a fair assumption.
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` Q. How many times have you been deposed
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`before?
`
` A. This is my first time.
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` DR. MALIK: Okay. Let me put in the
`
`chat room your declaration. Bear with me one
`
`second.
`
` I've put in the chat room what's been
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`marked previously as Ex 2127.
`
` (Exhibit No. 2127 introduced.)
`
`BY DR. MALIK:
`
` Q. Let me know, Dr. Hansen, when you have that
`
`document. You may have a hard copy in front of you.
`
`It's either/or.
`
` A. I have the document open.
`
` Q. Can you confirm for me that the document
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`that I sent you marked 2127 is the declaration that
`
`you submitted in connection with this matter?
`
` A. Yes, this appears to be the document.
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`Mylan (IPR2020-00040) Ex. 1024 p. 009
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`Karl Hansen - October 8, 2020
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` Q. And on page 23 of the document, it bears
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`your signature, correct?
`
` A. Yeah, it has my signature. Yes.
`
` Q. Okay. You signed this on August 20, 2020,
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`correct? Last page.
`
` A. Yes, I did.
`
` Q. Any corrections to the document that has
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`been previously marked as Merck Exhibit 2127? Or
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`changes?
`
` A. No, not to my knowledge.
`
` Q. Okay. Now, throughout the -- I'm going to
`
`ask a series of questions, and if at anytime you
`
`need a break, let me know. The only rule I have
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`with respect to breaks is if there's a question
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`pending, let's go ahead and answer that question,
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`and then I'll do my best to accommodate you. Fair
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`enough?
`
` A. Yeah, it sounds -- sounds fair.
`
` Q. And in connection with this deposition,
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`during a break, do you understand that you are not
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`to discuss the substance of your testimony or
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`anticipated testimony in connection with this
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`matter?
`
` A. Yes, I do.
`
` Q. Okay. And just so I understand it, what
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`Karl Hansen - October 8, 2020
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`documents do you have in front of you, hard copies?
`
` A. I have a hard copy of Exhibit 2127 as well
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`as a binder provided by counsel with a copy of this
`
`and the documents that were used to prepare.
`
` Q. Okay. Are any of the -- let's start with
`
`your declaration hard copy. Is it marked in any
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`way?
`
` A. No.
`
` Q. And the documents in the binder, are they
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`marked in any way other than what's obviously
`
`natural markings in connection with the documents,
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`the native form? Your answer, sir?
`
` A. No, they're not.
`
` Q. Fair enough.
`
` And let's see. You discussed the
`
`documents that you had in that binder. Those are
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`the documents that are referenced in your
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`declaration, correct?
`
` A. Yes.
`
` Q. Other than those documents, have you seen
`
`any other documents in connection with this matter?
`
` MR. ZOLAN: Objection to form.
`
` A. Yes, I did.
`
`BY DR. MALIK:
`
` Q. Your answer, sir? Yes, you did -- you did
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`Karl Hansen - October 8, 2020
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`Page 12
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`see other documents?
`
` A. Yes.
`
` Q. Okay. What documents did you see that are
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`not referenced in your declaration?
`
` MR. ZOLAN: Objection to form. You
`
`know, I'm going to object and -- I'm going to
`
`instruct him not to answer on privilege grounds.
`
`BY DR. MALIK:
`
` Q. Okay. Let me ask it this way, Dr. Hansen:
`
`Other than the documents referenced in your
`
`declaration, you are not offering any statements for
`
`any other document other than what's in your
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`declaration; is that fair?
`
` A. Could you repeat the question?
`
` Q. Sure. There are various documents
`
`referenced in Merck Exhibit 2127, correct?
`
` A. Yes.
`
` Q. And those are the only documents that you
`
`are providing factual testimony on, correct?
`
` A. Yes.
`
` Q. Okay. And I assume in connection with this
`
`matter, you had the opportunity to review those
`
`documents in their entirety, correct?
`
` A. Yes.
`
` Q. And so any statements that you had in
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`Karl Hansen - October 8, 2020
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`Page 13
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`connection with the documents that are referenced in
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`Merck Exhibit 2127 are addressed completely and in
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`the exhibit to the extent you have anything you
`
`wanted to say about them, correct?
`
` A. Could you repeat the question?
`
` Q. Sure. Throughout your declaration, you
`
`discuss various things that you want to point out
`
`about the documents, correct?
`
` A. That's correct.
`
` Q. You had the opportunity to review the
`
`entire document. So, presumably, if there was
`
`anything else you wanted to point out, it would have
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`been in your declaration, correct?
`
` A. Could you repeat that again?
`
` Q. Sure. Let me look at the question.
`
` I'll move on. Maybe we'll make it clearer
`
`through the course of the day.
`
` Have you seen anybody else's declarations
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`submitted in connection with this matter?
`
` A. Repeat that again.
`
` Q. Sure. Obviously, you have your
`
`declaration. I understand that. But have you seen
`
`the declaration of Mr. Cypes?
`
` A. No.
`
` Q. Dr. Wenslow?
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`Karl Hansen - October 8, 2020
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`Page 14
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` A. No.
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` Q. Dr. Shultz?
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` A. No.
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` Q. Dr. Chorghade?
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` A. No.
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` Q. Dr. Matzger?
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` A. No.
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` Q. Dr. Meyerson?
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` A. No.
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` Q. Ms. Vicky Vydra? Ms. Vicky Vydra, have you
`
`seen her declaration?
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` A. I -- yes, I believe I saw her declaration.
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` Q. Okay. What about Dr. Ferlita?
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` A. No.
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` Q. Dr. Eader?
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` A. No.
`
` Q. Okay. And I think the only other one is
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`Dr. Herman. Have you seen Dr. Herman's declaration?
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` A. Yes.
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` Q. Okay. In connection with Ms. Vydra's
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`declaration, do you have anything to add to it
`
`beyond the statements she made?
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` A. No.
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` Q. In connection with Dr. Herman's
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`declaration, do you have anything to add to it
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`beyond the statements he made?
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` A. No.
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` Q. Okay. Any reason to disagree with any of
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`the statements made by Dr. Herman?
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` A. No.
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` Q. Any reason to disagree with the statements
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`made by Ms. Vydra?
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` A. No.
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` Q. Okay. Now, in connection with the
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`documents that you cite in your declaration -- well,
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`strike that.
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` Are you being compensated to be here
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`today?
`
` A. Yes.
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` Q. How much compensation are you receiving
`
`today?
`
` A. Can you be more specific?
`
` Q. Sure. Are you being compensated by the
`
`hour, or are you getting a per diem compensation?
`
` A. I'm being compensated for lost time.
`
` Q. Okay. And what is the rate for lost time?
`
` A. $500 an hour.
`
` Q. Okay. And in connection with drafting of
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`your declaration or giving your declaration -- I'm
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`not interested in the specifics of any
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`Page 16
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`conversation -- were you compensated for your
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`efforts in drafting the declaration and reviewing
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`documents in connection with the declaration?
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` A. I'm being compensated for my lost time in
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`some of the preparation and for my time today.
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` Q. Okay. Fair enough.
`
` And for the preparation, you're being
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`compensated also $500 an hour?
`
` A. Yes.
`
` Q. Okay. So in connection -- can you give me
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`an estimate -- obviously, you can't estimate for the
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`amount today. But prior to today, how much money do
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`you think you have made in connection with your
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`participation in this IPR?
`
` A. I haven't made any money. And, you know,
`
`to be honest, it just came up recently regarding
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`this.
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` Q. Okay. When were you first contacted in
`
`connection with this matter, just the time?
`
` A. I don't recall. It was some time ago.
`
` Q. Presumably before August 20, 2020?
`
` A. Yes.
`
` Q. Okay. And who contacted you?
`
` A. I don't recall.
`
` Q. Okay. And in preparation for today's
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`deposition, who did you meet with?
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` A. In preparation, I met with counsel.
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` Q. Okay. Do you know who specifically?
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` A. Mr. Zolan.
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` Q. And when did you meet with Mr. Zolan?
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` A. I met with him several times over the last
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`stretch, few weeks.
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` Q. Ballpark, how many hours have you spent
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`meeting with Mr. Zolan? Again, just the time.
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` A. To be honest, I haven't -- I haven't
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`tallied it up. It's been several hours.
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` Q. Okay. The declaration marked as Merck
`
`Exhibit 2127, did you write this declaration?
`
` A. Yes, I -- I worked with counsel to prepare
`
`this declaration.
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` Q. Okay. In connection with the documents
`
`that are referenced in Merck Exhibit 2127, did you
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`select the documents referenced therein?
`
` A. Yes, the documents that I referred, yes, I
`
`worked with counsel to -- to select those.
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` Q. And did you reject any documents that were
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`not included in Merck Exhibit 2127?
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` A. Not to my knowledge.
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` Q. The various documents cited in this
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`declaration, before Merck contacted you in
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`connection with this matter, when was the last time
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`you saw them?
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` A. Could you repeat the question?
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` Q. Sure. My understanding is that you left
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`Merck around 2006. Correct?
`
` A. That sounds about right.
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` Q. Prior to your involvement in this matter,
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`is it true that the last time you saw any of these
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`documents referenced in your declaration was before
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`2006. Correct?
`
` A. Yeah, that would be an accurate statement,
`
`yeah.
`
` Q. And so really what you're doing is
`
`testifying about events that occurred almost 16,
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`17 years ago?
`
` MR. ZOLAN: Objection; form.
`
` A. Could you say that again?
`
`BY DR. MALIK:
`
` Q. Sure. So what you're doing in connection
`
`with your declaration is testifying about events
`
`that occurred almost over 16, 17 years ago, correct?
`
` MR. ZOLAN: Object to form.
`
` A. It's true, they occurred in the past, yes.
`
`BY DR. MALIK:
`
` Q. Okay. And you're relying on your
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`recollection -- recollection from almost 16,
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`17 years ago, correct?
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` MR. ZOLAN: Object to form.
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` A. Could you restate the question again?
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`BY DR. MALIK:
`
` Q. Sure. The statements in your declaration
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`are effectively your recollection of events that
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`occurred 16, 17 years ago, correct?
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` MR. ZOLAN: Objection; form.
`
` A. It's true, they occurred in the past.
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`BY DR. MALIK:
`
` Q. Okay. Since the time you left Merck in
`
`2006 and prior to your involvement in connection
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`with this matter, how much time have you spent
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`thinking about the documents that have been
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`referenced in Exhibit 2127?
`
` A. Could you restate that?
`
` Q. Sure. You left Merck in 2006. And someone
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`from, presumably, Merck or Merck's counsel contacted
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`you relatively recently, correct?
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` MR. ZOLAN: Object to form.
`
` A. I don't understand what you mean by
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`"relative."
`
`BY DR. MALIK:
`
` Q. Sure. After you left Merck in 2006, how
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`Karl Hansen - October 8, 2020
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`much time did you spend thinking about the documents
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`that are referenced in Exhibit 2127?
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` A. I don't believe -- I mean, what do you mean
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`by "thinking"?
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` Q. Well, I guess the question is, is after
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`2006, did you spend any time reflecting on the
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`documents that are referenced in 2127, or did you
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`move on and deal with other things?
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` MR. ZOLAN: Object to form.
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` A. I don't -- I don't really recall how much
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`time I've spent thinking about the documents that
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`are referenced in the IPR.
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` DR. MALIK: Let me load another
`
`document. It's Exhibit 1001 which is the '708
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`patent.
`
` (Exhibit No. 1001 introduced.)
`
`BY DR. MALIK:
`
` Q. Let me know when you are -- you have it.
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`And, obviously, you're free to use your hard copy to
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`the extent you have them beyond the marked ones.
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` A. May I take a break before you ask your
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`question?
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` Q. Sure. Absolutely. I have no objection.
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` DR. MALIK: Counsel, do you have any
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`objection?
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`Page 21
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` MR. ZOLAN: No objection.
`
` (Break taken, 8:31 a.m. to 8:37 a.m.)
`
`BY DR. MALIK:
`
` Q. So I just provided you Exhibit 1001, which
`
`is the '708 patent. Let me know when you have
`
`downloaded it and are ready to proceed.
`
` A. I have it open.
`
` Q. When was the last time you saw this
`
`document?
`
` A. I don't recall the exact time. It was
`
`recently.
`
` Q. Okay. And you are a named inventor on the
`
`'708 patent, correct?
`
` A. Yes, I am.
`
` Q. Okay. There are other inventors there on
`
`the first page. Do you see their names?
`
` A. Yes, I do.
`
` Q. When was the last time you spoke to any of
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`them?
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` A. I don't recall exactly when the last time I
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`spoke to any of them.
`
` Q. Okay. Has it been several years?
`
` A. I think -- I think for almost all of them
`
`it's been several years.
`
` Q. Okay. So is it fair to say that in
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`connection with this IPR matter, you didn't speak to
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`any of the inventors listed on the first page of
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`Exhibit 1001?
`
` A. That is correct.
`
` Q. Okay. When was the last time you spoke to
`
`Dr. Shultz?
`
` A. I don't recall.
`
` Q. Okay. So I guess it's fair to say that you
`
`didn't speak to Dr. Shultz in connection with this
`
`IPR matter. Is that fair?
`
` A. Well, which Dr. Shultz?
`
` Q. Rebecca Shultz.
`
` A. Who?
`
` Q. Rebecca.
`
` A. Rebecca Shultz?
`
` Q. Let me -- let me get her name right. Maybe
`
`I got that wrong.
`
` A. I just want to make sure. There's many
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`Dr. Shultzes I have come across in my career. I
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`just want to make sure I --
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` Q. That's fair enough. That's fair. I
`
`appreciate that.
`
` Yes, Rebecca Lee Shultz.
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` A. Oh, Lee. Yeah, okay, that's the same
`
`Dr. Shultz. No, I haven't talked -- I couldn't tell
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`you when the last time I talked to Dr. Shultz.
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` Q. Okay. And I just want to confirm, do you
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`have access to the realtime feed in connection with
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`this deposition?
`
` A. Not to my knowledge.
`
` Q. Okay. You have a Ph.D., correct?
`
` A. That is correct.
`
` Q. Okay. What was the dissertation topic? Do
`
`you recall?
`
` A. It was asymmetric catalytic reactions.
`
` Q. Did it have anything to do with salt
`
`formation?
`
` A. It wasn't directed at salt formation, but
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`some of the salt formation and things like that were
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`done as part of my dissertation.
`
` THE REPORTER: I'm sorry, I didn't
`
`understand. And you're cutting out a little bit,
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`Dr. Hansen. Would you please repeat your answer for
`
`me, please?
`
` A. The direct topic wasn't on salt formation,
`
`but as a chemist, salt formation is an activity you
`
`would carry out during the studies I did.
`
`BY DR. MALIK:
`
` Q. Have you ever done acid-based reaction?
`
` A. Generally, yes, I have done acid-based
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`chemistry.
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` Q. And when an acid is reactive with a base,
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`you can achieve a salt, correct?
`
` MR. ZOLAN: Object to form.
`
` A. Can you be more specific?
`
`BY DR. MALIK:
`
` Q. Sure. You understand that sitagliptin is a
`
`basic compound, correct?
`
` A. What do you mean by "basic compound"?
`
` Q. It's a -- it has a pH greater than 7?
`
` A. What do you mean by "pH greater than 7"?
`
` Q. You don't know what pH means?
`
` A. I do know what pH means.
`
` Q. Okay. Do you know what pH greater than 7
`
`means?
`
` A. In what context? In the context of what?
`
` Q. Chemistry.
`
` A. I don't -- could you repeat your question?
`
` Q. Sure. Let me ask this: You understand
`
`that amines are basic, correct? Or do you have an
`
`understanding of that concept?
`
` A. Yes, it is a general concept that amines
`
`are basic.
`
` Q. Okay. And on paragraph 2 of your
`
`declaration, you have drawn out the structure of
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`sitagliptin, correct, in its phosphoric acid salt?
`
` A. That is correct.
`
` Q. And you don't disagree that the amine of
`
`sitagliptin is capable of reacting with an acid, do
`
`you, sir?
`
` A. Yes, the amine sitagliptin is capable of
`
`reacting with an acid.
`
` Q. In fact, looking at the molecule
`
`sitagliptin, the amine is the most basic site. Do
`
`you agree?
`
` A. Which amine are you referring to?
`
` Q. The NH2.
`
` A. Well, there's multiple amines there, but I
`
`think, conventionally, NH2 is a basic site.
`
` Q. Okay. Now, in your declaration,
`
`paragraph 2, you reference a one-to-one
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`stoichiometric ratio. Do you see that?
`
` A. Yes, I do.
`
` Q. What is your understanding of a one-to-one
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`stoichiometric ratio as you used it in your
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`declaration?
`
` A. That means one equal part of the DHP
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`counterion in sitagliptin free base.
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` Q. The one molecule sitagliptin reacts with
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`one molecule of, in this case, phosphoric acid?
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` A. Well, in the context in which it's written,
`
`what it refers to is the ratio in the salt.
`
` Q. Let's go to paragraph 11 of your
`
`declaration. Let me know when you are there. And
`
`by all means, feel free to review your declaration.
`
`This is not a memory test.
`
` A. (Reviews document.)
`
` Q. Let me know when you're ready to proceed.
`
` A. Go ahead.
`
` Q. Okay. In paragraph 11, you -- you refer to
`
`your colleague, Ms. Vicky Vydra, correct?
`
` A. Right.
`
` Q. In connection with the experiments that are
`
`discussed in paragraphs 11, and, I guess, 12, all
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`the way through 14, did Ms. Vydra report to you in
`
`connection with these experiments?
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` A. Could you repeat the question?
`
` Q. Sure. There are a number of experiments
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`discussed -- well, there's an experiment discussed
`
`in paragraph 11. The initial synthesis and
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`identification of sitagliptin was assigned to
`
`Ms. Vydra. Did you assign these experiments to
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`Ms. Vydra, or did somebody else?
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` MR. ZOLAN: Object to form.
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` A. I did not assign these experiments to
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`Ms. Vydra.
`
`BY DR. MALIK:
`
` Q. Do you know who assigned them to Ms. Vydra?
`
` A. No, I do not.
`
` Q. Did Ms. Vydra report to you? Was she one
`
`of your direct reports?
`
` A. No, she was not.
`
` Q. Okay. Do you know why -- well, let me --
`
`let me upload another document so that we have,
`
`again, the necessary information.
`
` (Exhibit No. 2132 introduced.)
`
` DR. MALIK: I have uploaded, for the
`
`record, Exhibit 2132.
`
`BY DR. MALIK:
`
` Q. Let me know when you have that, Dr. Hansen,
`
`and are ready to proceed. Obviously, to the extent
`
`you want to review the document, by all means, do so
`
`again. It's not a memory test.
`
` A. My apologies. This is taking a second
`
`to --
`
` Q. No, no, no. Not at all. Not at all. It's
`
`a new world with the remote depositions. So it's
`
`not as fast as we used to be.
`
` A. Okay.
`
` Q. Okay. You have in front of you
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Mylan (IPR2020-00040) Ex. 1024 p. 027
`
`
`
`Karl Hansen - October 8, 2020
`
`Page 28
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`Exhibit 2132, which is referenced in your
`
`declaration. I refer you to paragraph -- at the end
`
`of paragraph 11. Correct?
`
` A. Yes.
`
` Q. Now, this e-mail, Merck Exhibit 2123, was
`
`sent to -- from Ms. Vydra to Michael Palucki, and
`
`that it was then sent to you, correct, eventually?
`
` A. Was that 21- -- I think you said 2123.
`
` Q. I'm sorry, 2132. I apologize, I misspoke.
`
` A. Could you repeat the question?
`
` Q. Absolutely. Let's start over.
`
` So in Merck Exhibit 2132, okay, the e-mail
`
`was sent to -- from Ms. Vydra to a Michael Palucki
`
`who then sent to it you on the first page, correct?
`
` A. Correct, yeah, that's what the document
`
`says.
`
` Q. Why did Ms. Vydra not send it directly to
`
`you?
`
` A. So at the time -- you know, my recollection
`
`is that whatever cause -- that at the time, Michael
`
`was assigned to the DPP-IV program and was working
`
`on a different molecule, and as the molecule, which
`
`ult
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