Case No. IPR2022-00722
`Peterson, Ph.D., Blake Robert
`
`April 25, 2023
`
`1
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`~~~~~~~~~~~~~~~~~~~~
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`~~~~~~~~~~~~~~~~~~~~
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`V.
`BAUSCH HEALTH IRELAND LIMITED,
`Patent Owner.
`~~~~~~~~~~~~~~~~~~~~
`Case No. IPR2022-00722
`U.S. Patent No. 7,041,786
`~~~~~~~~~~~~~~~~~~~~
`Videotaped Deposition of
`BLAKE ROBERT PETERSON, Ph.D.
`
`April 25, 2023
`9:11 a.m. EST
`
`Taken at:
`The Blackwell Inn and Pfahl Conference Center
`2110 Tuttle Park Place
`Columbus, Ohio
`
` Denise M. Munguia, RDR, CRR, CRC, CLR
`California CSR #14033
`
`202-220-4158
`
`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2069, Page 1 of 140
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`Peterson, Ph.D., Blake Robert
`
`April 25, 2023
`
`1
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`~~~~~~~~~~~~~~~~~~~~
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`~~~~~~~~~~~~~~~~~~~~
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`V.
`BAUSCH HEALTH IRELAND LIMITED,
`Patent Owner.
`~~~~~~~~~~~~~~~~~~~~
`Case No. IPR2022-00722
`U.S. Patent No. 7,041,786
`~~~~~~~~~~~~~~~~~~~~
`Videotaped Deposition of
`BLAKE ROBERT PETERSON, Ph.D.
`
`April 25, 2023
`9:11 a.m. EST
`
`Taken at:
`The Blackwell Inn and Pfahl Conference Center
`2110 Tuttle Park Place
`Columbus, Ohio
`
` Denise M. Munguia, RDR, CRR, CRC, CLR
`California CSR #14033
`
`202-220-4158
`
`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2069, Page 1 of 140
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`Case No. IPR2022-00722
`Peterson, Ph.D., Blake Robert
`
`April 25, 2023
`
`2
`
`APPEARANCES:
`On behalf of the Petitioner:
` Wilson Sonsini Goodrich & Rosati, by
` RICHARD TORCZON, ESQ.
` TASHA M. THOMAS, ESQ. (Remotely)
` 1700 K Street, NW, Fifth Floor
` Washington, D.C. 20006-3817
` 202.973.8800
` rtorczon@wsgr.com
` tthomas@wsgr.com
` - and -
` Wilson Sonsini Goodrich & Rosati, by
` JAD MILLS, ESQ. (Remotely)
` 701 Fifth Avenue, Suite 5100
` Seattle, Washington 98104-7036
` 206.883.2500
` jmills@wsgr.com
`On behalf of the Patent Owner:
` Finnegan, Henderson, Farabow, Garrett & Dunner,
` LLP, by
` JUSTIN J. HASFORD, ESQ. (Remotely)
` KYU YUN KIM, ESQ. (Remotely)
` 901 New York Avenue, NW
` Washington, D.C. 20001-4413
` 202.408.4000
` justin.hasford@finnegan.com
` kyu.kim@finnegan.com
`On behalf of the Joined Petitioner MSN:
` Merchant & Gould, by
` ANDREW O. LARSEN, ESQ. (Remotely)
` 500 Fifth Avenue, Suite 5100
` New York, New York 10110
` 212.223.6658
` alarsen@merchantgould.com
` ~ ~ ~ ~ ~
`ALSO PRESENT:
` Beth Finkelstein, Esq. (Remotely)
` Isaac Horner, exhibit tech (Remotely)
` Phillip Park, videographer
` ~ ~ ~ ~ ~
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`Bausch Health Ireland Exhibit 2069, Page 2 of 140
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`Case No. IPR2022-00722
`Peterson, Ph.D., Blake Robert
`
`April 25, 2023
`
`3
`
` I N D E X
` EXAMINATION OF ROBERT BLAKE PETERSON, Ph.D.
` BY MR. HASFORD 5
` BY MR. TORCZON 111
` BY MR. HASFORD 114
`
` EXHIBITS PRESENTED
` Exhibit 1063 - Second Declaration of Blake 7
` R. Peterson, Ph.D.
` Exhibit 2024 - Declaration of Stephen G. 8
` Davies, D.Phil.
` Exhibit 1065 - Urbanski 37
` Exhibit 1066 - Evans 52
` Exhibit 2035 - Jonson 2001 73
` Exhibit 2012 - Hamra 1993 85
` Exhibit 1006 - Li 86
` Exhibit 2045 - Harms 2009 91
` Exhibit 2010 - Marx 1998 105
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`Bausch Health Ireland Exhibit 2069, Page 3 of 140
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`Case No. IPR2022-00722
`Peterson, Ph.D., Blake Robert
`
`April 25, 2023
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` THE VIDEOGRAPHER: This is the videotaped
`deposition of Blake R. Peterson, Ph.D., volume two,
`taken in the matter of Mylan Pharmaceuticals
`Incorporated versus Bausch Health Ireland Limited for
`the U.S. Patent and Trademark Office before the Patent
`Trial and Appeal Board as Case Number IPR2022-00722.
`This deposition is being held at the Blackwell Inn at
`two -- 2110, sorry, that's 2110 Tuttle Place, Columbus,
`Ohio 43210 on Tuesday, April 25th, 2023 at 9:11 a.m.
` My name is Phillip Park, I am the videographer,
`and our reporter is Denise Munguia, and -- Munguia --
`Munguia, and we are representing Henderson Reporting.
` Will counsel please introduce themselves and
`state their affiliations for the record?
` MR. HASFORD: Justin Hasford of Finnegan on
`behalf of Patent Owner. I'm joined here with my
`colleague Kyu Yun Kim also of Finnegan on behalf of the
`Patent Owner.
` MR. TORCZON: Okay. And I'm Richard Torczon,
`I'm appearing on behalf of Mylan, and we also have Tasha
`Thomas and Jad Mills from the Wilson Sonsini firm and
`Beth Finkelstein from Mylan.
` MR. LARSEN: And, yes, this is Andrew Larsen of
`Merchant & Gould on behalf of Joined Petitioner MSN.
` THE VIDEOGRAPHER: Okay. Is that everybody?
`
`202-220-4158
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`Bausch Health Ireland Exhibit 2069, Page 4 of 140
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`Case No. IPR2022-00722
`Peterson, Ph.D., Blake Robert
`
`April 25, 2023
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`All right. Will the reporter please swear in the
`witness?
` BLAKE ROBERT PETERSON, Ph.D., of lawful age,
`called for examination, as provided by the Ohio Rules of
`Civil Procedure, being by me first duly sworn, as
`hereinafter certified, deposed and said as follows:
` THE VIDEOGRAPHER: You may proceed.
` EXAMINATION OF BLAKE ROBERT PETERSON, Ph.D.
`BY MR. HASFORD:
`Q Good morning, Doctor.
`A Good morning.
`Q Would you please state your name and an address
`for the record?
`A Yes. My name is Blake Robert Peterson. My
`address is 4010 Fairfax Drive, Columbus, Ohio 43220.
`Q You are the same Dr. Blake Peterson who
`previously was cross-examined in this case, correct?
`A Yes, that's correct.
`Q Let me tell you how today's cross-examination
`will proceed. I represent Patent Owner in this
`proceeding. Today I will ask you questions and I ask
`that you answer my questions truthfully and accurately.
` If you need a break, please let me know. If I
`have asked a question, I would ask that you first answer
`the question and then we can take a break.
`
`202-220-4158
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`Bausch Health Ireland Exhibit 2069, Page 5 of 140
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`
`
`Case No. IPR2022-00722
`Peterson, Ph.D., Blake Robert
`
`April 25, 2023
`
`6
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` If for any reason you do not understand a
`question that I ask, please let me know. If you answer
`a question, I will assume that you understood the
`question. Is that okay?
`A Yes.
`Q Is there any reason why you cannot testify
`truthfully and accurately today?
`A No.
`Q Because I am taking your testimony remotely
`today, will you please confirm that you will not
`communicate with Mylan's counsel during today's
`cross-examination?
`A I confirm.
`Q Unless specified otherwise today, my questions
`and your answers should be from the perspective of a
`person of ordinary skill in the art as of 2002. Is that
`okay?
`A Yes.
`Q We're going to bring up Exhibit 1063. Let me
`know when you have that on your screen, Doctor.
`A Okay.
`Q If you have a hard copy in front of you as well,
`that's fine. It's your second declaration in this case.
`A So the folder is empty. It says, "This folder
`is empty." So I don't see it.
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`Bausch Health Ireland Exhibit 2069, Page 6 of 140
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`
`
`Case No. IPR2022-00722
`Peterson, Ph.D., Blake Robert
`
`April 25, 2023
`
`7
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` MR. HASFORD: Isaac, would you help him bring
`that up on his screen?
` MR. HORNER: Yeah, if you just refresh, Doctor.
` THE WITNESS: Refresh. Okay. I apologize. I'm
`a Macintosh person, and so sometimes the PC is a little
`unusual for me.
` I see it now. Okay.
` (Mylan Exhibit 1063 was presented for
` purposes of identification.)
`BY MR. HASFORD:
`Q Turn, if you would, to page 123 of Exhibit 1063.
`Let me know when you are there.
`A 123. Okay.
` Yes, I'm there.
`Q Does your electronic signature appear on page
`123 of Exhibit 1063?
`A Yes, it does.
`Q If I refer to Exhibit 1063 as your second
`declaration, will you understand what I mean?
`A Yes.
`Q Let's go to paragraph 8. It starts on page 3.
` Let me know when you are there.
`A Okay. I'm there.
`Q Please read paragraph 8 to yourself and let me
`know when you're ready.
`
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`Bausch Health Ireland Exhibit 2069, Page 7 of 140
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`
`
`Case No. IPR2022-00722
`Peterson, Ph.D., Blake Robert
`
`April 25, 2023
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`A Okay. I'm ready. I have read it.
`Q So let's now bring up Exhibit 2024 on your
`screen.
`A So this --
`Q Exhibit 2024 --
`A Okay.
`Q -- is the declaration of Stephen Graham Davies.
`A Yes, I see it. It's up on my screen.
` (Mylan Exhibit 2024 was presented for
` purposes of identification.)
`BY MR. HASFORD:
`Q Okay. Very good. Turn, if you would, to
`paragraph 31.
`A What page is that on? If you don't mind.
`Q That's going to be on page 13. It starts on
`page 13, I should say.
`A Okay.
` MR. TORCZON: Isaac, this is Rick Torczon. I'm
`not seeing the new exhibit. I'm still just seeing the
`old exhibit.
` MR. HASFORD: You don't see it on your screen,
`Rick?
` MR. TORCZON: Yeah, I'm not sure where it is.
` MR. HASFORD: Isaac, would you --
` MR. HORNER: Yeah, you may just have to refresh
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`Bausch Health Ireland Exhibit 2069, Page 8 of 140
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`
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`Case No. IPR2022-00722
`Peterson, Ph.D., Blake Robert
`
`April 25, 2023
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`the page, sir.
` MR. TORCZON: Okay.
` All right.
` THE WITNESS: Okay. I see it.
`BY MR. HASFORD:
`Q Doctor, do you have it there?
`A You would like me to read paragraph 31?
`Q To yourself, please.
`A Okay.
` Okay. I have read it.
`Q Dr. Davies did not opine that a person of
`ordinary skill in the art would lack an advanced degree
`in peptide chemistry and/or peptide engineering,
`correct?
`A That's correct.
`Q Dr. Davies opined that a person of ordinary
`skill in the art could include someone experienced in
`peptide chemistry and/or peptide engineering, including
`someone with a Ph.D., correct?
`A That's correct.
`Q You are not an expert in the biochemistry of
`GC-C receptors, correct?
`A Well, I have been studying GC-C receptors at
`this point for over a year, and so I'm very familiar
`with GC-C receptors.
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`Bausch Health Ireland Exhibit 2069, Page 9 of 140
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`
`
`Case No. IPR2022-00722
`Peterson, Ph.D., Blake Robert
`
`April 25, 2023
`
`10
`Q You have never held yourself out as an expert in
`the biochemistry of GC-C receptors, correct?
`A I -- I feel that I have a very high level of
`expertise with respect to GC-C receptors based on the
`literature reviews that I have conducted.
`Q You have never been qualified by any court or by
`the U.S. Patent and Trademark Office as an expert in the
`biochemistry of GC-C receptors, correct?
`A That's correct.
` MR. TORCZON: Objection. Relevance.
`BY MR. HASFORD:
`Q You can, you can actually put Dr. Davies's
`declaration aside at this point.
`A Okay.
`Q Have you yourself ever conducted a T84 cell
`bioassay?
` MR. TORCZON: Objection. Relevance.
` THE WITNESS: I have conducted countless
`different whole cell assays. That particular specific
`assay I have not conducted in my laboratory, no.
`BY MR. HASFORD:
`Q In assessing the results of T84 cell bioassay,
`is it appropriate to compare data obtained at different
`conditions across separate experiments?
`A Is it appropriate to compare data with different
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`Bausch Health Ireland Exhibit 2069, Page 10 of 140
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`
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`Case No. IPR2022-00722
`Peterson, Ph.D., Blake Robert
`
`April 25, 2023
`
`11
`conditions? It can be, if the experiments are carefully
`conducted.
`Q In your view, what is the smallest difference in
`potency that a T84 cell bioassay has the capacity to
`distinguish?
` MR. TORCZON: Objection. Relevance.
` THE WITNESS: Well, it depends on the number of
`replicates employed. The more replicates, the more
`reliable the assay, and the greater statistical power
`there is to distinguish small changes in assay results.
`So it depends incredibly on the number of replicates.
`BY MR. HASFORD:
`Q What is the purpose of using heat treatment
`before conducting a T84 cell bioassay?
` MR. TORCZON: Same objection.
` THE WITNESS: It depends on what you are
`specifically talking about. It can be a way to
`stabilize the assay to make it more reliable.
`BY MR. HASFORD:
`Q Are there any other purposes of using heat
`treatment before conducting a T84 cell bioassay?
` MR. TORCZON: Same objection.
` THE WITNESS: Well, can you clarify when the
`heat treatment would be applied?
`BY MR. HASFORD:
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`Bausch Health Ireland Exhibit 2069, Page 11 of 140
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`
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`Case No. IPR2022-00722
`Peterson, Ph.D., Blake Robert
`
`April 25, 2023
`
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`Q At any time before conducting the T84 cell
`bioassay.
` MR. TORCZON: Same objection.
` THE WITNESS: Well, the heat treatment would
`need to be applied at the right stage to be a meaningful
`treatment, but it can be used, as I said, to stabilize
`the assay to prevent hydrolysis of cyclic GMP, for
`example.
`BY MR. HASFORD:
`Q Are there any other reasons for using heat
`treatment before conducting a T84 cell bioassay?
` MR. TORCZON: Same objection.
` THE WITNESS: Well, the -- in my declaration, I
`looked at heat treated samples that were analyzed to
`examine the stability of different peptides, peptide
`hormones. And so one could look at, one could look at
`heat treatment as a strategy to assess the stability of
`peptides prior to bioassay.
`BY MR. HASFORD:
`Q Turn, if you would, to paragraph 10 on page 5 of
`your second declaration.
` And let me know when you're there.
`A Having trouble getting this track pad to work.
`Here we go.
` Page 5 of the second declaration, you said?
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`Bausch Health Ireland Exhibit 2069, Page 12 of 140
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`Case No. IPR2022-00722
`Peterson, Ph.D., Blake Robert
`
`April 25, 2023
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`Q That's correct. Page 5 of your second
`declaration, paragraph 10. Down toward the bottom of
`the page.
`A Yes, I see it.
`Q Read that first sentence to yourself, if you
`would, and let me know when you're ready.
`A Yes, I have read it.
`Q The '786 patent is directed to compounds for
`oral administration, correct?
`A It's directed toward analogs of uroguanylin.
`Yes, they, they do talk about oral administration in
`that patent application.
`Q The '786 patent is not directed to compounds for
`intravenous administration, correct?
`A Not that I recall.
`Q The '786 patent is not directed to compounds for
`mucosal administration, correct?
` MR. TORCZON: Objection. Foundation.
` THE WITNESS: Yeah, I -- I don't recall the
`limitations in that, in that case. I'm not sure if it
`is specifically directed to mucosal administration.
`BY MR. HASFORD:
` MR. HASFORD: And just for the court reporter's
`benefit, it's the '786 patent, not the '76 patent.
`BY MR. HASFORD:
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`202-220-4158
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`Bausch Health Ireland Exhibit 2069, Page 13 of 140
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`Case No. IPR2022-00722
`Peterson, Ph.D., Blake Robert
`
`April 25, 2023
`
`14
`Q Does the '786 patent set forth a rational design
`for plecanatide?
` MR. TORCZON: Objection. Form.
` THE WITNESS: Rational design, can you clarify
`what you mean?
`BY MR. HASFORD:
`Q Do you have an understanding of the phrase
`"rational design"?
`A Rational design can mean different things,
`depending on the context.
`Q Have you -- have you ever used the phrase
`"rational design"?
`A I have, yes, and it can mean different things in
`different contexts. Could you, could you clarify what
`you mean by that?
`Q Have you used the phrase "rational design" in
`connection with your opinions in this case?
`A I -- I don't recall. Can you show me in my
`declaration where I might have used that phrase?
`Q Generally speaking, what is your understanding
`of a rational design?
`A Well, in drug discovery, there are different
`approaches one can take to identify biologically active
`compounds. One approach is to use computational design,
`for example, if you have information about the structure
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`Bausch Health Ireland Exhibit 2069, Page 14 of 140
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`Case No. IPR2022-00722
`Peterson, Ph.D., Blake Robert
`
`April 25, 2023
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`15
`of a receptor and the ligand, you can rationally design
`analogs, that is use known information to try to
`optimize the structures of inhibitors or activators of
`receptors. That would be an example of rational design.
` You can also use screening approaches, which are
`not considered as rational in the sense that one tests
`many different molecules to find one with a desired
`activity.
`Q Take a look, if you would, at paragraph 11 on
`page 6 of your second declaration.
`A I see it, yes.
`Q And let me direct your attention to the second
`sentence that begins "Currie explained." Do you see
`that?
`A Yes, I see it. Yep.
`Q Read that sentence to yourself and then let me
`know when you are ready.
`A Okay. I have read it.
`Q Is it your understanding that guanylin is not an
`endogenous stimulator of intestinal guanylate cyclase?
`A No, that's not my understanding.
`Q In connection with your work in this case, have
`you had any communications with Dr. Mark Currie?
`A No, I have not.
`Q Aside from your work on this case, have you ever
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`202-220-4158
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`www.hendersonlegalservices.com
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`Bausch Health Ireland Exhibit 2069, Page 15 of 140
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`Case No. IPR2022-00722
`Peterson, Ph.D., Blake Robert
`
`April 25, 2023
`
`16
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`had any communications with Dr. Mark Currie?
`A No, I have not.
`Q Are you aware that Dr. Currie selected a prior
`art enterotoxin and modified it to make linaclotide
`which became marketed as Linzess?
`A Yes, I'm aware of that.
`Q Are you aware that Linzess is considered
`suitable for treating chronic idiopathic constipation?
` MR. TORCZON: Objection. Relevance.
` THE WITNESS: I haven't really studied Linzess,
`but I -- I believe that's true.
`BY MR. HASFORD:
`Q Oral administration of human uroguanylin at a
`high dose will result in toxicity, correct?
` MR. TORCZON: Objection. Foundation.
`Relevance.
` THE WITNESS: I have never seen data that
`suggests that.
`BY MR. HASFORD:
`Q At what dose does oral administration of human
`uroguanylin result in toxicity?
` MR. TORCZON: Same objections.
` THE WITNESS: I have not seen data supporting
`the toxicity of human uroguanylin because human
`uroguanylin is a natural hormone and is, I think, for
`
`202-220-4158
`
`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2069, Page 16 of 140
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`Case No. IPR2022-00722
`Peterson, Ph.D., Blake Robert
`
`April 25, 2023
`
`17
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`that reason less likely to be toxic.
`BY MR. HASFORD:
`Q Do you know one way or another the dose at which
`oral administration of human uroguanylin would result in
`toxicity?
` MR. TORCZON: Same objections.
` THE WITNESS: As I said, I have not seen
`toxicity data on human uroguanylin.
`BY MR. HASFORD:
`Q Are you familiar with paracetamol?
`A I am.
`Q Oral administration of paracetamol at a high
`dose will result in liver failure and possibly death,
`correct?
` MR. TORCZON: Objection. Foundation.
`Relevance.
` THE WITNESS: That is correct.
`BY MR. HASFORD:
`Q Chemotherapy is efficacious because it destroys
`cancer cells, correct?
` MR. TORCZON: Same objections.
` THE WITNESS: That's correct. It can be
`efficacious. Not always, but it can be.
`BY MR. HASFORD:
`Q Chemotherapy at a high dose will destroy normal
`
`202-220-4158
`
`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2069, Page 17 of 140
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`Case No. IPR2022-00722
`Peterson, Ph.D., Blake Robert
`
`April 25, 2023
`
`18
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`cells, correct?
` MR. TORCZON: Same objections.
` THE WITNESS: It -- it depends incredibly on the
`nature of the chemotherapy you are describing. At a
`high dose, water can be toxic. Any, any compound can be
`toxic at a high enough dose.
`BY MR. HASFORD:
`Q In approving a drug product, the FDA considers
`clinical study results, correct?
` MR. TORCZON: Objection. Scope. Foundation.
`Relevance.
` THE WITNESS: That's correct.
`BY MR. HASFORD:
`Q In approving a drug product, the FDA considers
`the extent of adverse side effects that occur during
`clinical studies, correct?
` MR. TORCZON: Same objections.
` THE WITNESS: That's correct.
`BY MR. HASFORD:
`Q The FDA would not approve a drug product at
`higher than the minimum effective dose because higher
`doses can cause unnecessary side effects, correct?
` MR. TORCZON: Same objections.
` THE WITNESS: It depends on what specific drug
`you are talking about. I mean I'm not an expert on FDA,
`
`202-220-4158
`
`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2069, Page 18 of 140
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`Case No. IPR2022-00722
`Peterson, Ph.D., Blake Robert
`
`April 25, 2023
`
`19
`the FDA approval process, and so I don't really have an
`opinion about that.
`BY MR. HASFORD:
`Q Well, lowering the dose of an active ingredient
`generally decreases side effects, correct?
` MR. TORCZON: Same objections.
` THE WITNESS: That can be true.
`BY MR. HASFORD:
`Q A drug containing a more potent active
`ingredient generally will be administered at a lower
`dose than a drug containing a less potent active
`ingredient, correct?
` MR. TORCZON: Same objections.
` THE WITNESS: That depends on the drug and the
`condition that's treated.
`BY MR. HASFORD:
`Q Generally speaking, a drug containing a more
`potent active ingredient would be administered at a
`lower dose than a drug containing a less potent active
`ingredient, correct?
` MR. TORCZON: Same objections, plus asked and
`answered.
` THE WITNESS: Not necessarily. It depends on.
`BY MR. HASFORD:
`Q Administering --
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`202-220-4158
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`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2069, Page 19 of 140
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`Case No. IPR2022-00722
`Peterson, Ph.D., Blake Robert
`
`April 25, 2023
`
`20
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`A -- what you're treating.
`Q Oh, sorry. Go ahead.
`A It depends on what you're treating. It depends
`on which, which drugs you are comparing.
`Q Administering a drug at a lower dose generally
`will cause less strain on a patient's metabolism,
`correct?
` MR. TORCZON: Objection. Foundation. Scope.
`Relevance.
` THE WITNESS: I'm not sure what you mean by
`"strain on metabolism." Can you clarify that?
`BY MR. HASFORD:
`Q I'll actually ask you something different.
` If a drug received FDA approval where other drug
`candidates had failed, would that constitute a
`difference in kind?
` MR. TORCZON: Objection. Scope. Foundation.
` THE WITNESS: Not, not necessarily.
`BY MR. HASFORD:
`Q It is your opinion that if a GC-C receptor
`agonist markedly stimulates intestinal fluid secretion,
`it is not a good candidate for oral administration to
`treat constipation because of concerns over causing
`diarrhea as a side effect, correct?
` MR. TORCZON: Objection. Misstates testimony.
`
`202-220-4158
`
`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2069, Page 20 of 140
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`Case No. IPR2022-00722
`Peterson, Ph.D., Blake Robert
`
`April 25, 2023
`
`21
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` THE WITNESS: Can you rephrase that?
`BY MR. HASFORD:
`Q Sure. It is your opinion that if a GC-C
`receptor agonist markedly stimulates intestinal fluid
`secretion, it is not a good candidate for oral
`administration to treat constipation because of concerns
`over causing diarrhea as a side effect, correct?
` MR. TORCZON: Same objection.
` THE WITNESS: No, that's not correct.
`BY MR. HASFORD:
`Q With peptides, how can aspartimide impurities be
`removed by purification methods?
` MR. TORCZON: Objection. Scope.
` THE WITNESS: In some cases aspartimide
`impurities can be removed, for example, by reverse phase
`HPLC. In other cases they are sufficiently problematic
`that it's very difficult to produce a material that
`generates those impurities.
`BY MR. HASFORD:
`Q How can aspartimide impurities be removed from
`peptides by reverse phase HPLC?
` MR. TORCZON: Same objection.
` THE WITNESS: Well, if it is possible to
`separate them by reverse phase HPLC, one can use a
`reverse phase HPLC instrument to separate the impurities
`
`202-220-4158
`
`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2069, Page 21 of 140
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`Case No. IPR2022-00722
`Peterson, Ph.D., Blake Robert
`
`April 25, 2023
`
`22
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`from the desired product.
`BY MR. HASFORD:
`Q How can aspartimide formation in peptides be
`reduced or avoided using protecting groups?
` THE COURT REPORTER: I'm sorry, protecting?
` THE WITNESS: Protecting groups.
` THE COURT REPORTER: Thank you.
` MR. HASFORD: Protecting groups.
` THE WITNESS: One can reduce side reactions in
`chemical synthesis in general by using protecting groups
`in some cases. They -- they can limit the undesired
`pathways that lead to undesired products.
`BY MR. HASFORD:
`Q High-performance liquid chromatography, or HPLC,
`is an analytical chemistry technique used to separate
`compounds in a chemical mixture, correct?
`A That is correct.
`Q HPLC can be used for research purposes, correct?
`A That is correct.
`Q HPLC can be used for manufacturing purposes,
`correct?
`A That is correct.
`Q What are some of the different considerations
`for using HPLC on a research scale versus using HPLC on
`a manufacturing scale?
`
`202-220-4158
`
`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2069, Page 22 of 140
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`Case No. IPR2022-00722
`Peterson, Ph.D., Blake Robert
`
`April 25, 2023
`
`23
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` MR. TORCZON: Objection. Scope. Relevance.
` THE WITNESS: HPLC is better suited to smaller
`scales, and so on a manufacturing scale, it might not be
`a cost-effective method.
`BY MR. HASFORD:
`Q When developing a drug product, is a goal to
`make the drug as pure as possible, correct?
`A Generally speaking, that's true, but as long as
`one has a sufficient level of purity and knows the
`impurities present, that material can be suitable as a
`drug.
`Q When developing a drug product, why is it
`generally a goal to make the drug as pure as possible?
` MR. TORCZON: Objection. Scope.
` THE WITNESS: Well, purity of drugs can be
`related to reproducibility of biological effects, and
`so, generally speaking, in drug development, one wants,
`you know, the greatest reproducibility of the
`pharmacological effect, and so, generally speaking, high
`purity is important.
`BY MR. HASFORD:
`Q When developing a drug, the starting material
`should have the highest possible purity, correct?
` MR. TORCZON: Objection. Foundation.
`Relevance.
`
`202-220-4158
`
`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2069, Page 23 of 140
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`Case No. IPR2022-00722
`Peterson, Ph.D., Blake Robert
`
`April 25, 2023
`
`24
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` THE WITNESS: In general, when one wants to do
`chemical synthesis of any type, typically one wants the
`highest purity starting materials possible to avoid
`having to remove impurities at a later stage.
`BY MR. HASFORD:
`Q For a given peptide, how does the rate of
`topoisomeric interconversion differ from the extent of
`topoisomeric interconversion?
` MR. TORCZON: Objection. Scope. Form.
`Foundation.
` THE WITNESS: Well, the rate relates to the
`amount of conversion over time, and so one might require
`a long period of time to measure a substantial or
`significant amount of interconversion.
` MR. HASFORD: And for the court reporter's
`benefit, that's spelled T-O-P-O-I-S-O-M-E-R-I-C.
` THE WITNESS: Topoisomeric, is that what you're
`saying.
`BY MR. HASFORD:
`Q How does --
`A Go ahead.
`Q Okay. Thank you.
` How does topoisomeric interconversion make it
`more difficult to use a compound for synthetic drug
`development?
`
`202-220-4158
`
`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2069, Page 24 of 140
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`Case No. IPR2022-00722
`Peterson, Ph.D., Blake Robert
`
`April 25, 2023
`
`25
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` MR. TORCZON: Objection. Foundation. Scope.
` THE WITNESS: Well, it may or may not make it
`more difficult.
`BY MR. HASFORD:
`Q How can isomeric interconversion make it more
`difficult to use a compound for synthetic drug
`development?
` MR. TORCZON: Objection. Foundation. Scope.
`Form.
` THE WITNESS: Well, a single topoisomer could be
`referred to as a more pure form of a compound.
`BY MR. HASFORD:
`Q If a peptide has an aspartate at one position
`and another peptide has an identical sequence except for
`a glutamate instead of aspartate at the same position,
`those two peptides are different chemical compounds,
`correct?
`A That is correct.
`Q The glutamate and aspartate residues on those
`different chemical compounds result in different
`environments, correct?
`A Could you repeat that?
`Q Certainly. The glutamate and aspartate residues
`on those different chemicals compounds result in
`different environments, correct?
`
`202-220-4158
`
`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2069, Page 25 of 140
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`Case No. IPR2022-00722
`Peterson, Ph.D., Blake Robert
`
`April 25, 2023
`
`26
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` MR. TORCZON: Objection. Foundation.
`Relevance.
` THE WITNESS: I'm not sure what you mean by
`"different environments." Could you clarify that?
`BY MR. HASFORD:
`Q Have you used the term "environments" in
`connection with peptide drug development?
`A Not in -- well, I don't think the way that you
`are describing. Environment usually, from a chemical
`perspective, refers to a local aspect of molecular
`structure. So I'
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