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` UNITED STATES PATENT AND TRADEMARK OFFICE
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` BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
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` __________________________________
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` MYLAN PHARMACEUTICALS INC., )
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` MSN LABORATORIES PRIVATE LTD., )
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` and MSN PHARMACEUTICALS INC., )
`
` Petitioners )
`
` vs. )
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` BAUSCH HEALTH IRELAND LIMITED, )
`
` Patent Owner )
`
` ___________________________________
`
` CASE IPR2022-00722
`
` Patent 7,041,786
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` - C O N F I D E N T I A L -
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` Deposition of Kunwar Shailubhai, Ph.D.
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` February 23, 2023
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` 9:21 a.m.
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` Reported by: Bonnie L. Russo
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`22
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` Job No. 5696729
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`Veritext Legal Solutions
`215-241-1000 ~ 610-434-8588 ~ 302-571-0510 ~ 202-803-8830
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`MYLAN EXHIBIT - 1061
`Mylan Pharmaceuticals, Inc. v. Bausch Health Ireland, Ltd.
`IPR2022-00722
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` Deposition of Kunwar Shailubhai, Ph.D.
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` held at:
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` Finnegan Henderson Farabow
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` Garrett & Dunner, LLP
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` 901 New York Avenue, N.W.
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` Washington, D.C.
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` Pursuant to Notice, when were present on behalf
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` of the respective parties:
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`Page 3
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` APPEARANCES:
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` On behalf of the Petitioner:
` JAD MILLS, ESQUIRE (Via Teleconference)
` RICHARD TORCZON, ESQUIRE
` TASHA THOMAS, ESQUIRE (Via Teleconference)
` WILSON SONSINI GOODRICH & ROSATI
` 1700 K Street, N.W., 5th Floor
` Washington, D.C. 20006
` jmills@wsgr.com
` rtorczon@wsgr.com
` tthomas@wsgr.com
`
` On behalf of the Patent Owner:
` KASSANDRA OFFICER, ESQUIRE
` JUSTIN J. HASFORD, ESQUIRE
` FINNEGAN, HENDERSON, FARABOW,
` GARRETT & DUNNER, LLP
` 901 New York Avenue, N.W.
` Washington, D.C. 20001
` kassandra.officer@finnegan.com
` justin.hasford@finnegan.com
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` C O N T E N T S
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` EXAMINATION OF KUNWAR SHAILUBHAI, Ph.D. PAGE
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` BY MR. TORCZON 5
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`Page 4
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` EXHIBITS
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` PREVIOUSLY MARKED EXHIBITS:
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` Exhibit 1001 United States
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` Patent 7,041,786 B2
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` Exhibit 2023 Declaration of
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` Kunwar Shailubhai
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` Exhibit 2040 Letter dated 3-31-04
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` Exhibit 2066 Supplemental Declaration
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` of Kunwar Shailubhai
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` (Exhibits retained by counsel.)
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` P R O C E E D I N G S
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` KUNWAR SHAILUBHAI, Ph.D.,
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` was called for examination by counsel and,
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` after having been duly sworn by the Notary, was
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` examined and testified as follows:
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` EXAMINATION BY COUNSEL FOR PETITIONER
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` BY MR. TORCZON:
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` Q. Good morning, Dr. Shailubhai. How
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` are you this morning?
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` A. Good morning. I'm good. Fine.
`
` Q. Would you please state your full
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` legal name for the record.
`
` A. My full name is Kunwar Shailubhai.
`
` Q. How many times have you testified in
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` a deposition proceeding?
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` A. I recall one time long time ago.
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` Q. Okay. And you have never testified
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` at trial; is that correct?
`
` A. No, I have never been.
`
` Q. Okay. So I take it that you have
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` never testified in a patent board proceeding
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` before?
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` A. Not that I recollect.
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` Q. Okay. So the board requires you to
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` ask me, rather than Mr. Hasford there, for any
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` clarifications, definitions, explanations of
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` any words, questions, documents presented
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` during the cross-examination.
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` Will you follow these instructions?
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` A. Yes, I will.
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` Q. Okay. If you don't ask for a
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` clarification, will it be fair to assume that
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` you understood the question and answered it to
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` the best of your ability?
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` A. Yes.
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` Q. Okay. Will you give audible, verbal
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` answers so that the court reporter can produce
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` a clean transcript?
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` A. Yes, I would.
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` Q. Okay. And will you wait until I've
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` completed asking my question so that we are not
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` talking over each other?
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` A. Yes, I will.
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` Q. We will be taking short breaks
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` approximately every hour, but if you need a
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` break sooner than that, will you let me know?
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` A. That will be great.
`
` Q. Okay. And if you ask for a break
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` while a question is pending, you will need to
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` answer the question before we take the break.
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` Do you understand?
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` A. Yes, I do.
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` Q. Okay. And do you understand that
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` unless Mr. Hasford instructs you not to answer,
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` you have to answer the pending question?
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` A. Yes, I do.
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` Q. Okay. Very good.
`
` Is there any reason why you cannot
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` provide truthful, accurate testimony today?
`
` A. No.
`
` Q. Okay. Are you taking any medication
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` or suffering any infirmity that may affect your
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` testimony?
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` A. No.
`
` Q. Okay. Do you understand that you
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` are here today to provide testimony in
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` IPR2022-00722?
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` A. Yeah, that's right.
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` Q. Okay. And I see you've brought some
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` materials with you today. What are those
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` materials?
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` A. These are my declaration and
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` supplemental declaration.
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` Q. Okay. Are there any markings on
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` those declarations?
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` A. No.
`
` Q. And did you bring any other
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` materials with you today?
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` A. No.
`
` Q. Okay. Why don't we start with the
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` patent which is Exhibit 1001.
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` So, Dr. Shailubhai, do you recognize
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` this exhibit?
`
` A. Yes, I do.
`
` Q. Okay. And are you the same Kunwar
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` Shailubhai named as the first inventor on
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` United States Patent 7,041,786?
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` A. Yeah, that's right.
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` Q. Okay. If I refer to this patent as
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` the "'786 patent" or "the involved patent,"
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` will you understand what I mean?
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` A. Yes, I would.
`
` Q. Good. Do you see a filing date
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` listed on the patent? And I'll help you by
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` saying it's in the left-hand column, Item 22.
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` A. Yes, I do.
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` Q. Okay. And is the filing date listed
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` March 28, 2002?
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` A. Yeah, that's right.
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` Q. Okay. And if I call this "the
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` filing date," you will understand what I mean,
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` correct?
`
` A. That's right.
`
` Q. Okay. Do you know a Dr. Michael
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` Pennington?
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` A. Yes, I know him.
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` Q. Okay. Are you still in contact with
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` Dr. Michael Pennington?
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` A. Not recently, but I was in contact
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` with him.
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` Q. When you say "not recently," how
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` recently have you been in contact with him?
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` A. Maybe a few years ago.
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` Q. More than five?
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` A. Not more than five.
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` Q. More than two years?
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` A. I will say yes.
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` Q. Okay. Do you know where Dr.
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` Pennington is currently employed?
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` A. He, I believe, is employed by Ambio
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` Pharm.
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` Q. Could you spell that for the court
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` reporter.
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` A. A-M-B-I-O Pharm, P-H-A-R-M.
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` Q. Thank you.
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` MR. TORCZON: Let's go to Exhibit
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` 2023. And I will note on the record that this
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` exhibit has been marked confidential.
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` MR. HASFORD: And we will go ahead
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` and designate this transcript confidential
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` pursuant to the protective order.
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` BY MR. TORCZON:
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` Q. Dr. Shailubhai, do you recognize
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` this exhibit?
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` A. Yes, I do.
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` Q. Okay. And is this exhibit your
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` declaration?
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` A. Yes.
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` Q. Okay. And on the last page of this
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` exhibit, is that your signature?
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` A. Yeah, that's mine.
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` Q. Are you testifying today as an
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` expert?
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` MR. HASFORD: Object to the form of
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` the question.
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` THE WITNESS: I don't know that.
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` BY MR. TORCZON:
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` Q. I'm sorry. Can you speak up.
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` A. I don't know that.
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` Q. You don't know whether you are
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` testifying today as an expert; is that correct?
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` MR. HASFORD: Same objection.
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` THE WITNESS: I don't know that.
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` BY MR. TORCZON:
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` Q. About how much time did you spend
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` preparing your declaration?
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` A. I will say several hours.
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` Q. When you say "several hours," do you
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` mean more than ten?
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` A. Yes.
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` Q. Would you mean more than 20?
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` A. I will say less than 20.
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` Q. Would you say more than 15?
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` A. Yes.
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` Q. More than 15. Okay.
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` And did you consult with anyone
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` while preparing your declaration?
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` MR. HASFORD: I will just caution
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` you, Shailu, you can answer yes or no. Just
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` don't disclose the substance of any privileged
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` communications you may have had.
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` THE WITNESS: Yes, I did.
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` BY MR. TORCZON:
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` Q. Okay. And who did you consult while
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` you were preparing your declaration?
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` A. I consulted with Justin Hasford and
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` Kassie Officer.
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` Q. Did you consult with anyone else?
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` A. No, I did not.
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` Q. Did you review any materials that
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` are not cited in your declaration?
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` MR. HASFORD: Object to form.
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` BY MR. TORCZON:
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` Q. Strike that. Let me rephrase.
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` In preparing your declaration, did
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` you review any materials that are not cited in
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` your declaration?
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` A. No.
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` Q. In reviewing your declaration, did
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` you note any mistake that you would like to
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` correct now?
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` A. No, I did not find any mistake.
`
` Q. Okay. And in Paragraph 3 of your --
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` I'm sorry.
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` In Paragraph 4 of your declaration,
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` you say where you are currently employed. Is
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` that still true?
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` A. Yeah, that is true.
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` Q. Okay. Do you have any other
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` employers currently?
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` A. No.
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` Q. How much time did you spend
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` preparing for this deposition?
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` A. I will say several hours.
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` Q. More than eight hours?
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` A. Yes.
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` Q. More than 20 hours?
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` A. Not more than 20 hours.
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` Q. More than 15 hours?
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` A. I would say that's -- yeah,
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` probably.
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` Q. And did you consult with anyone
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` while preparing for this deposition?
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` MR. HASFORD: Same caution.
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` THE WITNESS: Yeah. I consulted
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` with Justin and Kassie.
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` BY MR. TORCZON:
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` Q. Did you consult with anyone else?
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` A. No.
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` Q. In preparing for this deposition,
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` did you review any material not cited in your
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`Page 15
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` declaration?
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` A. No.
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` Q. Were you compensated for preparing
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` your declaration?
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` A. I was compensated for the
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` consulting.
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` Q. And who provided your compensation?
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` A. For consulting, general consulting,
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` Finnegan.
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` Q. And what was the compensation?
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` A. My rate is $650 per hour.
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` Q. Were you also compensated for
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` preparing for the deposition?
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` A. No.
`
` Q. Okay. And are you being compensated
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` for appearing at this deposition?
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` A. No.
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` Q. Do you have a financial interest in
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` the '786 patent?
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` A. No.
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` Q. Do you have a financial interest in
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` Bausch?
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` A. No.
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` Q. Do you have a financial interest in
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` Salix Pharmacy --
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` A. Say that again.
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` Q. -- Salix Pharmaceuticals?
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` A. No.
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` Q. Could I get you to turn to Paragraph
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` 8 of your declaration, please.
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` A. Yeah, I'm here.
`
` Q. Okay. Were all the peptides in
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` Table 4 of the '786 patent custom synthesized?
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` Table 4 is at Column 16.
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` A. Yeah.
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` Q. Okay. And that includes SP301?
`
` A. Yes.
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` Q. And SP301 is human uroguanylin; is
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` that correct?
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` A. Yeah, that's correct.
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` Q. Did Bachem provide any of the
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` synthesized peptides used for Table 4?
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` A. Initially the peptides were
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` manufactured by Multiple Peptide System and by
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` a company Princeton Biomolecules.
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` Q. Which peptides did it -- Multiple
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` Peptide Systems supply?
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` A. All of the peptides listed in Table
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` 4.
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` Q. Okay. Then which peptides did
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` Princeton Biomolecules provide?
`
` A. I don't remember that.
`
` Q. Okay. What did Multiple Peptide
`
` Systems charge for those peptides?
`
` A. I don't recall.
`
` Q. Was it more than $1,000 per gram?
`
` A. Yes.
`
` Q. More than $10,000 per gram?
`
` A. I don't recall that.
`
` Q. Did they charge the same amount for
`
` each peptide?
`
` A. I don't remember that.
`
` Q. Okay. In Paragraph 8 do you see
`
` where it says: "The biological activity of the
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` synthetic peptides was assayed"?
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` A. Yes, I do.
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` Q. Okay. And do you see where it talks
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` about preincubating the confluent monolayers at
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` 37 degrees for ten minutes?
`
` A. Yes, I do.
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` Q. Okay. And then you see later in the
`
` sentence where it says: "Followed by
`
` incubation with peptides for 30 minutes"?
`
` A. Yeah, that's right.
`
` Q. And do you know what temperature the
`
` peptides were incubated at?
`
` A. 37 degrees celsius.
`
` Q. Okay. And do you know what the pH
`
` was?
`
` A. I don't remember.
`
` Q. So if you look earlier in that
`
` sentence where it talks about washing the
`
` confluent monolayers, it's washing them at pH
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` 7.4; is that correct?
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` A. Uh-huh. That's right.
`
` Q. And then the confluent monolayers
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` are preincubated at pH 7.4; is that correct?
`
` A. Yeah, that's correct.
`
` Q. Was the pH adjusted for the
`
` following step of incubating with peptides?
`
` A. I don't recall that.
`
` Q. Could I get you to go to the next
`
` paragraph, Paragraph 9.
`
` A. Yes, I am here.
`
` Q. Okay. If you look at the bottom of
`
` the page, do you see where it says: "I note
`
` that the P value below Table 4 contains a
`
` typographical error"?
`
` A. Yeah.
`
` Q. Did you review any data in
`
` identifying this correction?
`
` A. Yes, I did a long time ago.
`
` Q. Okay. Did you review that data in
`
` preparing for this deposition?
`
` A. I -- I looked at the data reported
`
` in study reports.
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` Q. I'm sorry. I missed the last part
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` of that.
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` A. I looked at the -- the data reported
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` in study reports.
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` Q. Did you cite that data in making
`
` this correction?
`
` A. Can you please clarify --
`
` Q. Did you cite -- sure.
`
` Did you cite -- in your declaration
`
` did you cite the data that you used to
`
` determine this correction?
`
` A. Data is -- data given here is taken
`
` from the study report -- one of the study
`
` reports.
`
` Q. And did you advise the patent office
`
` of this correction?
`
` A. I -- I don't recall that, but I am
`
` trying to remember. This mistake -- mistake in
`
` P value was detected several years ago.
`
` Q. Could I get you to turn to the very
`
` last page of the patent that's Exhibit 1001.
`
` A. You are referring to this Patent
`
` '786, right?
`
` Q. Yes, the very last page of the
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` exhibit.
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` A. What column?
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` Q. You're not there yet. Go to the
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` back.
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` So do you see a certificate of
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` correction there?
`
` A. Yes, I do.
`
` Q. And is the P value corrected in that
`
` certificate?
`
` MR. HASFORD: Object to the extent
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` it mischaracterizes the documents.
`
` THE WITNESS: I don't see the data
`
` in this page.
`
` BY MR. TORCZON:
`
` Q. Okay. Can we turn to Exhibit 2066.
`
` Okay. Dr. Shailubhai, do you
`
` recognize this exhibit?
`
` A. Yes, I do.
`
` Q. And is this your supplemental
`
` declaration?
`
` A. Yeah, I think so.
`
` Q. Okay. And if you go to the last
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` page, is that your signature?
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` A. Yeah, that's right.
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` MR. TORCZON: Okay. Due to board
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` numbering conventions, this exhibit is not in
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` the record yet, so we're going to have to
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` renumber it. And so I will tell you right now
`
` we're going to renumber it as 1059.
`
` MR. HASFORD: Okay. Do you want to
`
` call it Shailubhai Exhibit 1 for purposes of
`
` this deposition or -- it's up to you.
`
` MR. TORCZON: I am just going to
`
` call it 1059 for the board's convenience.
`
` MR. HASFORD: That's fine.
`
` BY MR. TORCZON:
`
` Q. Which leads to the next question,
`
` which is: If I refer to this exhibit as 1059,
`
` will you understand what I mean?
`
` A. I will.
`
` Q. Okay. Before Paragraph 32 of your
`
` supplemental declaration, are there any
`
` differences between Exhibit 2023 and Exhibit
`
` 1059?
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` A. What is -- Exhibit 23 you said?
`
` Q. That's your first declaration.
`
` A. Which is IPR2022-00722?
`
` Q. It's in that IPR and should be
`
` Exhibit 2023.
`
` A. 2023. Okay.
`
` They look similar to me.
`
` Q. Okay. Are you aware of any
`
` difference between those two documents before
`
` Paragraph 32?
`
` A. Before Paragraph 32. In this brief
`
` examination, I don't find any difference.
`
` Q. Okay. And to your knowledge, you
`
` are not aware of any difference -- is that
`
` correct? -- before Paragraph 32?
`
` A. I'm not aware.
`
` Q. Okay. And I should have noted when
`
` I handed it to you that it has been marked as
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` protective order material.
`
` A. What does that mean?
`
` Q. It'll make Mr. Hasford happy that I
`
` noted that.
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` MR. HASFORD: I think we've marked
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` the transcript. I assume you have no
`
` objection; is that correct?
`
` MR. TORCZON: Correct.
`
` BY MR. TORCZON:
`
` Q. Okay. Let's go to Exhibit 2040.
`
` Dr. Shailubhai, do you recognize
`
` Exhibit 2040?
`
` A. Yes, I do.
`
` Q. And could I get you to look at the
`
` middle paragraph, the one that starts "we are
`
` confident."
`
` A. Yes.
`
` Q. Do you see the sentence -- I think
`
` it's the third from the last that starts
`
` "during our initial work"?
`
` A. Can you point that out to me where
`
` exactly.
`
` Q. Sure. It should be five lines from
`
` the bottom starting in the middle. It says:
`
` "During our initial work on this product."
`
` Do you see that?
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` A. During our initial work on this
`
` product. Yes, I do now.
`
` Q. And do you see it continues: "We
`
` observed a negligible amount of the second
`
` conformer with only one primary product peak"?
`
` A. That's right.
`
` Q. Okay. Was this, the letter, the
`
` first time you became aware of a second
`
` conformer of plecanatide?
`
` MR. HASFORD: Object to the form of
`
` the question.
`
` THE WITNESS: I don't remember that.
`
` BY MR. TORCZON:
`
` Q. When did you become aware that there
`
` was a second conformer for plecanatide?
`
` MR. HASFORD: Objection. No
`
` foundation.
`
` THE WITNESS: I don't recall that.
`
` BY MR. TORCZON:
`
` Q. Are you aware that there is a second
`
` conformer for plecanatide?
`
` MR. HASFORD: Same objection.
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` THE WITNESS: I don't know that.
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` BY MR. TORCZON:
`
` Q. Okay. Is a topoisomer a conformer?
`
` MR. HASFORD: Object to the extent
`
` it calls for expert testimony.
`
` THE WITNESS: I'm not a peptide
`
` chemist.
`
` BY MR. TORCZON:
`
` Q. Have you studied the topoisomerism
`
` of uroguanylin and its analogs?
`
` A. I recall that I had reviewed
`
` articles cited in my study reports.
`
` Q. When did you study those articles?
`
` A. I don't recall the exact, precise
`
` date.
`
` Q. Was it in 2001?
`
` A. I don't recall.
`
` Q. Was it before 2001?
`
` A. I don't recall that.
`
` Q. Was it before 2002?
`
` A. I don't recall that.
`
` Q. Are you aware of any topoisomers for
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` uroguanylin?
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` A. Yes, I am aware.
`
` Q. Are you aware of any topoisomers for
`
` plecanatide?
`
` A. I don't know that.
`
` Q. When this letter talks about the
`
` second conformer --
`
` A. Uh-huh.
`
` Q. -- what do you understand that to
`
` mean?
`
` MR. HASFORD: Objection. No
`
` foundation.
`
` THE WITNESS: What I understand from
`
` this letter is SP304 was better in the
`
` synthesis, but I don't know the details. I'm
`
` not a peptide guy.
`
` BY MR. TORCZON:
`
` Q. Did you draft this exhibit?
`
` A. Which exhibit?
`
` Q. 2040.
`
` MR. HASFORD: Objection. Assumes
`
` facts not in evidence.
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` THE WITNESS: No, I did not.
`
` BY MR. TORCZON:
`
` Q. Did you provide any of the content
`
` for the letter?
`
` A. No, I did not.
`
` Q. Were the letter says: "Dear
`
` Shailu," is that referring to you?
`
` A. Yes.
`
` Q. And who else calls you Shailu?
`
` A. I would say in the biotechnology
`
` industry, people who know me, they call me
`
` Shailu.
`
` Q. Do you see at the top of Exhibit
`
` 2040 it lists a fax number?
`
` A. Yes.
`
` Q. Was this exhibit faxed to you?
`
` A. I don't recall that.
`
` Q. Do you recall where the exhibit was
`
` faxed to?
`
` A. I don't recall.
`
` Q. Do you recall whether the exhibit
`
` was faxed?
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` A. I don't recall that either.
`
` Q. Did you personally retain the
`
` original of this exhibit?
`
` A. No, I did not.
`
` Q. Who provided this exhibit to you for
`
` your supplementary declaration?
`
` A. I don't know.
`
` Q. Have you talked to Dr. Pennington
`
` about this exhibit?
`
` A. No, I did not.
`
` Q. Do you recognize the signature on
`
` this exhibit?
`
` A. All I can say is that it's supposed
`
` to be the signature of Michael Pennington.
`
` Q. Do you have any other documents with
`
` Michael Pennington's signature?
`
` A. There were, but I don't remember any
`
` of those now.
`
` Q. Do you recognize that as Michael
`
` Pennington's signature?
`
` A. As I said, it is supposed to be
`
` signature of Michael Pennington.
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` Q. Did you receive a similar offer
`
` letter from Multiple Peptide Systems?
`
` A. As I recall, the peptides were
`
` initially made by Multiple Peptide System, and
`
` there was another company as well, and later on
`
` we moved to Bachem for manufacturing.
`
` Q. Did Multiple Peptide Systems send
`
` you a letter --
`
` A. I don't recall.
`
` Q. -- like this one outlining --
`
` MR. HASFORD: Just make sure you
`
` wait for --
`
` THE WITNESS: I'm sorry. I'm sorry.
`
` MR. HASFORD: -- him to finish his
`
` question before you answer.
`
` THE WITNESS: Okay. Okay.
`
` BY MR. TORCZON:
`
` Q. Let's try that again just to make
`
` sure it's all clear.
`
` Did Multiple Peptide Systems send
`
` you a similar offer letter when you procured
`
` the peptides from them?
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` A. I don't recall that.
`
` Q. And you don't -- do you recall
`
` keeping a copy of any such letter?
`
` A. I don't recall.
`
` Q. And the same question for Princeton
`
` Biomolecules. Did you receive a letter from
`
` them stating their offer of the peptides they
`
` synthesized for you?
`
` A. I don't recall.
`
` Q. Okay. And you don't recall keeping
`
` any such letter, do you?
`
` A. I don't recall that.
`
` MR. TORCZON: Do you mind if we take
`
` a short break? Ten minutes.
`
` MR. HASFORD: Sure.
`
` (A short recess was taken.)
`
` BY MR. TORCZON:
`
` Q. Dr. Shailubhai, over the
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