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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., )
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` Petitioners )
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` vs. )
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` BAUSCH HEALTH IRELAND LIMITED, )
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` Patent Owner )
`
` ___________________________________
`
` CASE IPR2022-00722
`
` Patent 7,041,786
`
` - C O N F I D E N T I A L -
`
` Deposition of Scott A. Waldman, Ph.D.
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` March 8, 2023
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` 9:13 a.m.
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` Reported by: Bonnie L. Russo
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` Job No. 5768848
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`Veritext Legal Solutions
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`MYLAN EXHIBIT - 1062
`Mylan Pharmaceuticals, Inc. v. Bausch Health Ireland, Ltd.
`IPR2022-00722
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` Deposition of Scott A. Waldman, 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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` A P P E A R A N C E S :
` O n b e h a l f o f t h e P e t i t i o n e r :
` T A S H A T H O M A S , E S Q U I R E
` J A D M I L L S , E S Q U I R E
` R I C H A R D T O R C Z O N , E S Q U I R E
` W I L S O N S O N S I N I G O O D R I C H & R O S A T I
` 1 7 0 0 K S t r e e t , N . W . , 5 t h F l o o r
` W a s h i n g t o n , D . C . 2 0 0 0 6
` t t h o m a s @ w s g r . c o m
` j m i l l s @ w s g r . c o m
` r t o r c z o n @ w s g r . c o m
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` O n b e h a l f o f t h e P a t e n t O w n e r :
` J U S T I N J . H A S F O R D , E S Q U I R E
` K A S S A N D R A O F F I C E R , E S Q U I R E
` F I N N E G A N , H E N D E R S O N , F A R A B O W ,
` G A R R E T T & D U N N E R , L L P
` 9 0 1 N e w Y o r k A v e n u e , N . W .
` W a s h i n g t o n , D . C . 2 0 0 0 1
` j u s t i n . h a s f o r d @ f i n n e g a n . c o m
` k a s s a n d r a . o f f i c e r @ f i n n e g a n . c o m
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` C O N T E N T S
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` EXAMINATION OF SCOTT A. WALDMAN, Ph.D. PAGE
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` BY MS. THOMAS 5
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`Page 4
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` EXHIBITS
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` PREVIOUSLY MARKED EXHIBITS:
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` Exhibit 2025 Declaration of
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` Scott A. Waldman, Ph.D.
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` Exhibit 2030 Curriculum Vitae of
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` Scott A. Waldman, Ph.D.
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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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` (9:13 a.m.)
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` SCOTT A. WALDMAN, 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 MS. THOMAS:
`
` Q. Good morning, Dr. Waldman.
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` A. Good morning.
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` Q. Please state your full name.
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` A. Scott Arthur Waldman.
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` Q. Before today have you ever testified
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` in a deposition?
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` A. No.
`
` Q. So I'll skip my next question.
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` So just a little bit of
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` housekeeping. The board has some rules. The
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` board requires you to ask me, rather than
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` counsel to your right, for clarifications,
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` definitions, or explanations of any words,
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` questions, or documents presented during the
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` cross-examination.
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` Will you follow these instructions?
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` A. Yes.
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` Q. If you do not ask for a
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` clarification, would it be fair to assume that
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` you understood the question that was asked and
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` answered it appropriately?
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` A. Yes.
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` Q. Will you give audible, verbal
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` answers so the court reporter can accurately
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` produce a clean transcript?
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` A. Yes.
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` Q. Will you wait until I've completed
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` my questions so we are not speaking over each
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` other?
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` A. Yes.
`
` Q. I will extend that same courtesy to
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` you.
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` A. Thank you.
`
` Q. So we're going to take short breaks
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` approximately once an hour, but if you need a
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` break sooner, will you let me know?
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` A. Yes.
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` Q. But if you ask for a break while a
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` question is pending, you must answer the
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` question before you break.
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` Do you understand?
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` A. Yes.
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` Q. Great. And do you understand that
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` unless counsel instructs you not to answer you
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` must answer the pending question?
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` A. Yes.
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` Q. Great. Is there any reason why you
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` cannot provide truthful, accurate testimony
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` today?
`
` A. No.
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` Q. Are you taking any medication or
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` suffering any infirmity that might affect your
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` testimony?
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` A. No.
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` Q. Do you understand that you are here
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` today to provide testimony in IPR 2022-00722?
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` A. Yes.
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` Q. And I see you've brought some
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` materials with you relating to the case today.
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` I see something in front of you. Is that --
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` A. Yes.
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` Q. Can you tell me what those materials
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` are.
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` A. One is my -- they're both my
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` declarations. One is a supplemental
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` declaration.
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` Q. Okay. And those are the only
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` materials you have with you?
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` A. (Witness nodding head.)
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` Q. Has --
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` MR. HASFORD: You just need to --
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` THE WITNESS: Yes.
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` MR. HASFORD: -- make sure you
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` answer verbally.
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` BY MS. THOMAS:
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` Q. Yes. Yes.
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` A. Looking right at you.
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` Q. Thank you.
`
` Have you or anyone else added any
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` markings to those documents that you have in
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` front of you?
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` A. No.
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` Q. Okay. So they're clean documents?
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` A. Yes.
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` Q. Great. So I take it you understand
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` that this deposition is part of a proceeding
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` before the Patent Trial and Appeal Board; is
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` that correct?
`
` A. Yes.
`
` Q. Do you understand that this
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` proceeding involves a review of U.S. Patent
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` No. 7,041,786?
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` A. Yes.
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` Q. So if I say the "'786 patent" or the
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` "involved patent," will you understand what I
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` am referring to?
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` A. Yes.
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` MS. THOMAS: Great. All right. So
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` I would like to hand you Exhibit 2030.
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` (Deposition Exhibit 2030 was marked
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` for identification.)
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` BY MS. THOMAS:
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` Q. So this is Exhibit 2030. Do you
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` recognize this exhibit?
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` A. Yes.
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` Q. It's quite a big exhibit.
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` So this exhibit is your CV, correct?
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` A. Yes.
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` Q. Okay. So I would like to just ask
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` you some questions on this document. We'll
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` start with Page 2.
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` So I am looking at the heading
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` titled: "Certification and Licensure."
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` A. Good.
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` Q. So you list certification in 1994 as
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` a diplomate of the American Board of Clinical
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` Pharmacology; is that correct?
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` A. Yes.
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` Q. Is your certification in this regard
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` still active as of today?
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` A. Yes.
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` Q. You also list certification in 1990
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` and recertification in 2000 as a diplomate of
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` that right?
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` A. Yes.
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` Q. Is your certification for that
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` active as of today?
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` A. No.
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` Q. Okay. You don't list here any
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` certification in the specialty of
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` gastroenterology; is that correct?
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` A. Correct.
`
` Q. I would like to hop over to Page 34
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` of your CV.
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` A. Okay.
`
` Q. So at that heading, the first
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` heading there --
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` A. Uh-huh.
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` Q. -- you list your consulting and
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` board service, correct?
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` A. Uh-huh.
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` Q. And you have --
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` A. Yes. Sorry.
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` Q. And then you list -- one subsection
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` of that is listed as current?
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` A. Yes. So this is an old CV.
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` Q. It's an old CV?
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` A. It's an older CV.
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` Q. Older?
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` A. Yes.
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` Q. So there are updates to your CV?
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` A. Oh, yeah.
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` Q. Are there any updates in particular
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` to this section?
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` A. Yes, of course.
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` Q. Okay. So you have even more
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` consulting and board service that you would add
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` here?
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` A. Actually, I would remove.
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` Q. Oh, you would remove?
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` A. Yeah. Yeah. I don't think there is
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` anything to add. I think that there are things
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` to remove.
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` Q. Okay.
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` A. There are -- there are definitely
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` things to remove.
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` Q. Okay. And by "removing" you would
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` mean things listed under current --
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` A. That are not current anymore.
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` Q. -- would be moved to past?
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` A. Yeah. Yeah.
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` Q. Okay. So what would -- what would
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` those be?
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` A. Salix, Genesis, RayzeBio, MLH
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` Exploration, therapeutics -- Therapeutic
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` Architects.
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` I, actually, don't know if I am
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` still on the Netherlands Scientific Board. I
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` haven't talked to them in forever.
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` The only -- the only things that I
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` can categorically say are active are the
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` Marriott Foundation, The Delaware ACCEL, and
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` TDT, Targeted Diagnostics and Therapeutics.
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` Those are the only ones that I know are active
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` right now.
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` Q. You can say confidently are
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` active --
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` A. Yes --
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` Q. -- as current?
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` A. -- yes. Yes.
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` Q. Okay. So as I understand it if you
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` were to provide an updated CV, you -- your
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` updated CV would move Salix, Genesis, RayzeBio,
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` MLH, Therapeutic Architects to past --
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` A. Yeah.
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` Q. -- is that correct?
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` A. Yes.
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` Q. And then the Netherlands --
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` A. It's questionable.
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` Q. -- is -- you would have to check in?
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` A. I'd have -- I'd have to check it
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` with the Netherlands.
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` Q. Okay. So I will put a question mark
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` on my copy.
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` A. Sure. Fair enough.
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` Q. Okay. So just exploring this a bit
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` more --
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` A. Yep.
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` Q. -- so understanding that while Salix
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` Pharmaceuticals is listed under current -- it
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` should be listed under past -- I would just
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` like to confirm with you then, what would the
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` time line be in terms of updating?
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` MR. HASFORD: I'll just object to
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` the form of the question.
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` THE WITNESS: Can you be more
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` specific in your question.
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` BY MS. THOMAS:
`
` Q. So thank you.
`
` So you list Salix Pharmaceuticals,
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` Incorporated, that you were a consultant for
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` Salix; is that correct?
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` A. Yes.
`
` Q. And you list that you started as a
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` consultant in the year 2021 --
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` A. Yes.
`
` Q. -- is that correct?
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` Can you give me an approximate time
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` frame in 2021 when you engaged as a consultant
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` for Salix.
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` A. I'm going to guess it's 2021 and
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` maybe part of 2022. I honestly don't remember
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` to tell you the truth. I haven't spoken to
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` them in -- I don't know if they're still in
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` existence. They may be Bausch at this point.
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` I don't know.
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` Q. So you know -- okay. So you know
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` you started as a consultant in 2021, and you
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` aren't sure, but you think it extended into
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` 2022 about?
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` A. Maybe. Possibly.
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` Q. So would it be fair to say you were
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` a consultant with Salix for approximately a
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` year or --
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` A. Maybe.
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` Q. Okay. Okay. During your time as
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` consultant for Salix, were you compensated for
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` your work?
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` A. Probably, although I don't remember.
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` Q. What kind of work did you do as a
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` consultant for Salix?
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` A. I'm going to -- I'm going to guess
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` that I was consulting with them on plecanatide,
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` Trulance.
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` Q. And just to -- circle back. Just to
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` confirm, you can firmly say you were
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` compensated but you don't know the amount --
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` A. No.
`
` Q. -- of compensation?
`
` A. I could guess an amount. I'll guess
`
` around 5 to $10,000. It was a very short -- it
`
` was a very short-duration interaction.
`
` Q. Prior to 2021 did you have any other
`
` relationship with Salix apart from being a
`
` consultant?
`
` A. Be more -- ask -- be more specific
`
` in your question. What are -- what are you
`
` looking for?
`
` Q. Prior to 2021 did Salix -- did you
`
` work Salix with terms of research projects?
`
` A. I -- not Salix that I remember, no.
`
` Q. Did you -- prior to 2021 did you
`
` attend lectures or present any --
`
` A. If you --
`
` Q. -- lectures on behalf of Salix?
`
` MR. HASFORD: Just let her finish
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` your question before you answer.
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` THE WITNESS: You bet.
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` That's likely what I did.
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` BY MS. THOMAS:
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` Q. Okay. So just to be clear prior to
`
` 2021, you feel it is likely that you attended
`
` lectures or presented lectures on behalf of
`
` Salix?
`
` A. Yes.
`
` Q. Okay. Are you familiar with a
`
` company Synergy Pharmaceuticals?
`
` A. Yes.
`
` Q. And prior to 2021, did you have a
`
` relationship with Synergy Pharmaceuticals?
`
` A. Yes.
`
` Q. And in terms of Synergy
`
` Pharmaceuticals, did you participate in
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` research projects on behalf of Synergy?
`
` A. Yes.
`
` Q. And did you also attend lectures or
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` present lectures on behalf of Synergy?
`
` A. Yes.
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` Q. Okay. So I would like to, I guess,
`
` explore the latter part, so let's hop over to
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`Page 19
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` Page 4.
`
` A. Page 4?
`
` Q. Page 4 of your CV, yes. And I am
`
` focusing on the header: "Presentations."
`
` A. Uh-huh.
`
` Q. So I assuming this is a
`
` comprehensive list that may -- well, okay.
`
` I'll ask you at the outset. Is this an
`
` outdated list of presentations that you have
`
` given?
`
` A. Yes.
`
` Q. Okay. So you have -- since I think
`
` this -- the most recently you have listed is
`
` September 2022.
`
` Since September 2022 approximately
`
` how many presentations have you given?
`
` A. One.
`
` Q. One. Okay.
`
` Can you tell me the name of the
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` presentation or the nature of it.
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` A. Yeah. I repeat this a lot, so it --
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` "Bench to Bedside and Beyond: Translational
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` Research." You see the 10-19?
`
` Q. Yeah. Uh-huh.
`
` A. Essentially that sort of title for
`
` the presentation.
`
` Q. Okay. And was it on behalf of -- I
`
` see in -- for October 2019 it was for Janssen
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` in Titusville, New Jersey.
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` Do you recall this one presentation
`
` and where it was?
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` A. Wistar Institute in Philadelphia.
`
` Q. Okay. So thank you for the
`
` updating.
`
` So I am going to kind of go down --
`
` let's see. So I have a question on this
`
` February 2018 presentation entitled:
`
` "Differentiating Therapies for CIC and IBS-C."
`
` Do you see that?
`
` A. I do.
`
` Q. It says: "Synergy advisory
`
` meeting."
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` Is that in connection with Synergy
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`Page 21
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` Pharmaceuticals?
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` A. Yes.
`
` Q. Okay. So you state there that you
`
` had presented -- you made a presentation at a
`
` Synergy advisory meeting in Dallas, Texas on
`
` February 23rd to 24th of 2018; is that correct?
`
` A. Yes.
`
` Q. Were you compensated for that
`
` presentation?
`
` A. I believe so.
`
` Q. Do you recall how much?
`
` A. I'm going to guess somewhere between
`
` 2500 and 5,000.
`
` Q. And then -- let's see -- a little
`
` bit down --
`
` A. Uh-huh.
`
` Q. -- it's the second January 2018
`
` entitled: "GUCY2C Ligands to Treat Visceral
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` Pain. Key Opinion Leaders Meeting at Synergy
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` Pharmaceuticals, New York, New York in January
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` 2018."
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` Do you see that?
`
` A. I do.
`
` Q. And so I am assuming that's another
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` presentation this time probably at their
`
` headquarters in New York or...?
`
` A. No. It was in a hotel if I remember
`
` correctly.
`
` Q. Okay. Okay. And same question as
`
` before: Were you compensated for this
`
` presentation?
`
` A. Yes.
`
` Q. And do you recall --
`
` A. About the same.
`
` Q. About the same?
`
` A. Yeah, it's always the same. Very
`
` similar.
`
` Q. Let's see. Okay. So on the next
`
` page, Page 5, this one I'm not sure just
`
` because it uses similar terminology.
`
` In October 2017 you made a similar
`
` presentation, "GUCY2C Ligands to Treat Chronic
`
` Constipation Syndromes, Synergy Satellite
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` Meeting."
`
` A. I do.
`
` Q. Is that in connection with Synergy
`
` Pharmaceuticals?
`
` A. Yes.
`
` Q. Okay. So -- so it would be correct
`
` to say that on -- in October 2017 you made a --
`
` you presented on this topic on behalf of
`
` Synergy Pharmaceuticals at American College of
`
` Gastroenterology national meeting in Orlando?
`
` A. Can I clarify the answer?
`
` Q. Yes.
`
` A. Yes. It was -- the location was at
`
` that meeting. The symposium was held by
`
` Synergy.
`
` Q. Okay.
`
` A. It wasn't part of the main -- this
`
` may be a detail you don't care about, but it
`
` wasn't part of the main American -- American
`
` College of Gastroenterology national meeting.
`
` It wasn't part of that main meeting. It was a
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` satellite meeting.
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` Q. I see. Okay. A satellite meeting
`
` okay. Thank you.
`
` And, again, I assume you were
`
` compensated for that?
`
` A. I assume also.
`
` Q. And same assumption, but around the
`
` same range --
`
` A. Yeah.
`
` Q. -- of 2500 to 5,000?
`
` A. Yes.
`
` Q. Okay. And then we can just say in
`
` July -- is it fair to say in July 2017 you also
`
` did a similar presentation of a satellite
`
` meeting at an American Neurogastroenterology
`
` and Motility Society --
`
` A. Yes.
`
` Q. -- larger meeting?
`
` A. Yes.
`
` Q. Okay. And would it be safe to -- I
`
` was -- I will stop my question. It sounds like
`
` you --
`
` A. Can I correct?
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` Q. Yes, please.
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` A. Again, it's the same qualifier.
`
` It's a satellite meeting from -- from the main
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`Page 25
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` meeting.
`
` Q. Yes. Yes.
`
` A. Okay --
`
` Q. I appreciate that qualification.
`
` It's good that you're putting that on the
`
` record.
`
` So -- and just to just button up
`
` everything, I'm going to make the same
`
` assumption: You were compensated, and you were
`
` compensated -- you don't quite remember but in
`
` the range of 2500 to 5,000?
`
` A. Yeah.
`
` Q. And then, again, I see another. In
`
` June 2017 you did another presentation GUCY2C
`
` ligands to treat visceral pain at a Synergy
`
` advisory meeting in Washington, D.C.?
`
` A. Uh-huh. Yes.
`
` Q. And that has -- and so we will stick
`
` with the same assumptions --
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` A. Yes.
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` Q. -- you were compensated for at a fee
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`Page 26
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` of 2500 to 5,000.
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` Let's see.
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` MR. HASFORD: Is there a question
`
` pending?
`
` BY MS. THOMAS:
`
` Q. Correct?
`
` A. Correct. Sorry.
`
` Q. No. No. I should have ended it
`
` with a question.
`
` A. Got to put the question mark at the
`
` end.
`
` Q. We're helping each other out here.
`
` Okay. So we talked -- so I have
`
` circled three presentations in 2017 -- oh, I'm
`
` sorry. I missed one.
`
` In February 2017 there is another
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` Synergy advisory meeting, this time on GUCY2C
`
` ligands to treat chronic constipation syndrome,
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` correct?
`
` A. Yes.
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` Q. Again, we can assume the same
`
` assumptions we have been assuming in that you
`
` were compensated at a fee of 2500 to 5,000; is
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`Page 27
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` that right?
`
` A. Yes.
`
` Q. So going through this, I see four
`
` presentations in 2017 I have circled and I
`
` think two in 2018; is that fair to say?
`
` A. I -- you're -- you've counted --
`
` Q. Certainly.
`
` A. -- I have not.
`
` Q. So in addition to your compensation
`
` with regard to the 2500 to $5,000 for the
`
` presentation, were you also compensated for
`
` flights and lodging and food?
`
` A. Yes.
`
` Q. And is it fair to say that Synergy
`
` compensated for that?
`
` A. Yes.
`
` Q. Okay. To the best of your
`
` recollection, how much would you say in total
`
` you received compensation from Synergy in 2017?
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` MR. HASFORD: Object to the form of
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` the question.
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` THE WITNESS: In 2017? I don't
`
` know. 10 to $15,000, 10,000. I really don't
`
` remember. I mean, it's six years ago.
`
` BY MS. THOMAS:
`
` Q. In 2017 did you -- in addition to
`
` these presentations, did you do any consulting
`
` work on behalf of Synergy?
`
` A. I don't remember. I literally don't
`
` remember. Not to my recollection.
`
` Q. And then, finally, 2018 how much
`
` compensation did you receive from Synergy
`
` Pharmaceuticals?
`
` A. I'll guesstimate the same thing, 10,
`
` $15,000 maybe.
`
` Q. Okay. I'm going to hand you another
`
` exhibit.
`
` A. Am I -- am I coming back to this
`
` one?
`
` Q. Keep it near you.
`
` A. Okay.
`
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` Q. You never know what will happen.
`
` A. Okay.
`
` MS. THOMAS: Yeah. We will do
`
` confidential if that's all right.
`
` Confidential, and we'll just mark --
`
` MR. HASFORD: Okay. And we can
`
` designate --
`
` MS. THOMAS: Mark it, yeah.
`
` MR. HASFORD: -- the transcript
`
` confidential under the protective order then.
`
` (Deposition Exhibit 2025 was marked
`
` for identification.)
`
` MS. THOMAS: So I am handing you
`
` Exhibit 2025, confidential version.
`
` MR. HASFORD: I assume you have no
`
` objection to the designation under the
`
` protection order; is that fair to say?
`
` MR. MILLS: I would say eventually
`
` it might be good to get a redacted version to
`
` submit to the Court, but we don't have any
`
` objection to designating it now.
`
` MR. HASFORD: That's fine. We can
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` deal with that whenever.
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` MR. MILLS: Yeah.
`
` BY MS. THOMAS:
`
` Q. Okay, Dr. Waldman.
`
` A. Yes.
`
` Q. Okay. Do you recognize this
`
` exhibit?
`
` A. Yes.
`
` Q. And this is your declaration,
`
` correct?
`
` A. Yes.
`
` Q. So just to start, how much did you
`
` spend preparing your declaration?
`
` A. Hours and hours --
`
` Q. Hours?
`
` A. -- indeterminable -- yes, a lot of
`
` hours.
`
` Q. Plural?
`
` A. Yes.
`
` Q. Do you have an idea of how many
`
` hours? Is it more than 40 hours?
`
` A. No. I would say it was on the order
`
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` of 10 to 15 hours.
`
` Q. In preparing your declaration, did
`
` you consult with anyone?
`
` A. Yes.
`
` Q. And who did you consult with?
`
` A. The two people on my right.
`
` Q. Anyone else?
`
` A. There were others at the meetings,
`
` but these -- these are the folks that I
`
` interacted with consistently.
`
` Q. And the others at the meetings, do
`
` you mean other attorneys?
`
` A. Other -- yes, other attorneys -- I
`
` presume they were attorneys, other folks from
`
` the firm.
`
` Q. Okay. Did you consult with anyone
`
` that you mentioned in your declaration
`
` referring -- say Dr. Shailubhai?
`
` A. No.
`
` Q. Did you consult with Dr. Davies?
`
` A. No.
`
` Q. In preparing your declaration, did
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`CONFIDENTIAL DESIGNATION REMOV
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