`
`Case No. IPR2022-00722
`
`November 1, 2022
`
`1
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
`- - - - - - - - - - - - - - - - - - - - - - - - - -X
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`- - - - - - - - - - - - - - - - - - - - - - - - - -X
`
` MYLAN PHARMACEUTICALS INC,
` Petitioner,
` v.
` BAUSCH HEALTH IRELAND LIMITED
` Patent Owner.
`- - - - - - - - - - - - - - - - - - - - - - - - - -X
` Case No. IPR2022-00722
` U.S. Patent No. 7,041,786
`
`- - - - - - - - - - - - - - - - - - - - - - - - - -X
`
` ZOOM DEPOSITION OF BLAKE R. PETERSON, Ph.D.
` Tuesday, November 1, 2022
`
`Reported by:
`Jeannette McCormick
`Job No. 52860
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2026, Page 1 of 78
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`Peterson, Blake
`
`Case No. IPR2022-00722
`
`2
` UNITED STATES PATENT AND TRADEMARK OFFICE
`
`- - - - - - - - - - - - - - - - - - - - - - - - - -X
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`- - - - - - - - - - - - - - - - - - - - - - - - - -X
`
` MYLAN PHARMACEUTICALS INC.
` Pe itioner,
` v.
` BAUSCH HEALTH IRELAND LIMITED
` Patent Owner.
`- - - - - - - - - - - - - - - - - - - - - - - - - -X
` Case No. IPR2022-00722
` U.S. Patent No. 7,041,786
`
`- - - - - - - - - - - - - - - - - - - - - - - - - -X
`
`3
` REMOTE ZOOM VIDEOTAPED DEPOSITION of BLAKE
`R. PETERSON, Ph.D., taken pursuant to Notice, held
`remotely on Tuesday, November 1, 2022, at 9:00 a.m.
`Eastern Daylight Time, before JEANNETTE MCCORMICK, a
`Certified Shorthand Reporter.
`
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`November 1, 2022
`2 (Pages 2 to 5)
`4
`
`A P P E A R A N C E S: (VIA ZOOM)
`
` F NNEGAN, HENDERSON, FARABOW, GARRETT
` & DUNNER, LLP
` (VIA ZOOM)
` Attorneys for Patent Owner
` 901 New York Avenue, NW
` Washington, D.C. 20001-4413
` BY: JUST N J. HASFORD, ESQ.
` KYU YUN K M, ESQ.
` (202) 408-4000 (Telephone)
` (202) 408-4400 (Fax)
` justin.hasford@finnegan.com
` kyu.kim@finnegan.com
`
` WILSON SONS NI GOODRICH & ROSATI, PC
` (VIA ZOOM)
` Attorneys for Petitioner
` 1700 K Street, NW, 5th Floor
` Washington, D.C. 20006
` BY: RICHARD TORCZON, ESQ.
` (202) 973-8800 (Telephone)
` rtorczon@wsgr.com
`
` WILSON SONS NI GOODRICH & ROSATI, PC
` (VIA TELEPHONE)
` Attorneys for Petitioner
` 701 Fifth Avenue, Suite 5100
` Seattle, Washington 98104-7036
` BY: JAD A. M LLS, ESQ.
` (206) 883-2500 (Telephone)
` jmills@wsgr.com
`
`A P P E A R A N C E S: (VIA ZOOM)
`
`5
`
`(CONTINUED)
`
`Also Present:
`
` Matthew Greinert (Mylan Pharmaceuticals)
`
` Phillip Park (Videographer)
`
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`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2026, Page 2 of 78
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`Peterson, Blake
`
`Case No. IPR2022-00722
`
` I N D E X
`
`WITNESS EXAMINATION BY PAGE
`
`BLAKE R. PETERSON, Ph.D.
`
` MR. HASFORD 13, 162
`
` MR. TORCZON 157
`
` E X H I B I T S
`
`PETERSON
`NUMBER DESCRIPTION PAGE
`
`Exhibit 1001 U.S. Patent No. 7,041,786
` (22 pages) 36
`
`Exhibit 1002 Declara ion of
` Blake R. Peterson, Ph.D.
` (129 pages) 37
`
`Exhibit 1005 U.S. Patent No. 5,489,670
` (Currie, et al ) (9 pages) 37
`Exhibit 1006 Purification, cDNA Sequence,
` and Tissue Distribution of
` Rat Uroguanylin (Li, et al.)
` (12 pages) 37
`
`6
`
`7
`
` I N D E X
` (CONTINUED)
`
` E X H I B I T S
`
`PETERSON
`NUMBER DESCRIPTION PAGE
`
`Exhibit 1007 Narayani 87
`Exhibit 1008 Campiere 89
`Exhibit 1009 Ekwuribe 90
`Exhibit 1010 Remington's 92
`Exhibit 1011 Rehfeld 93
`Exhibit 1012 Nelson 96
`Exhibit 1013 Segaloff 102
`Exhibit 1014 Chipens 103
`Exhibit 1015 Unson 105
`Exhibit 1016 Fan 106
`Exhibit 1017 Thomson 107
`Exhibit 1018 Joo 108
`Exhibit 1019 Hamra 1996 108
`Exhibit 1020 Nakazato 111
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`November 1, 2022
`3 (Pages 6 to 9)
`8
`
` I N D E X
` (CONTINUED)
`
` E X H I B I T S
`
`PETERSON
`NUMBER DESCRIPTION PAGE
`
`Exhibit 1021 Hamra 1997 112
`Exhibit 1022 Mergler 116
`Exhibit 1023 Wade 117
`Exhibit 1024 Lauer 118
`Exhibit 1025 Karten 121
`Exhibit 1026 French 121
`Exhibit 1027 Tager 123
`Exhibit 1028 Nobel 124
`Exhibit 1029 Galloway 124
`Exhibit 1030 Mishra 125
`Exhibit 1031 Currie 126
`Exhibit 1032 Visweswariah 127
`Exhibit 1033 Krause 128
`Exhibit 1034 Forte 133
`
` I N D E X
` (CONTINUED)
`
`9
`
` E X H I B I T S
`
`PETERSON
`NUMBER DESCRIPTION PAGE
`
`Exhibit 1035 Hyun 134
`Exhibit 1036 Nguyen 134
`Exhibit 1037 Guarino 135
`Exhibit 1038 Bakre 136
`Exhibit 1039 Lin 136
`Exhibit 1040 Tien 137
`Exhibit 1041 Muflih 138
`Exhibit 1042 Helbock 138
`Exhibit 1043 Baldrick 2000 139
`Exhibit 1044 Duncan 139
`Exhibit 1045 Gerogiannis 140
`Exhibit 1046 Mynott 1996 140
`Exhibit 1047 Mynott 1991 141
`Exhibit 1048 Rao 142
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`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2026, Page 3 of 78
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`Peterson, Blake
`
`Case No. IPR2022-00722
`
` I N D E X
` (CONTINUED)
`
`10
`
` E X H I B I T S
`
`PETERSON
`NUMBER DESCRIPTION PAGE
`
`Exhibit 1049 Jalan 142
`Exhibit 1050 Silverman 1992 143
`Exhibit 1051 Whitaker 144
`Exhibit 1052 Murphy 145
`Exhibit 1053 Forte 145
`
`Peterson 1 Mylan's Petition 152
`
`11
`
` THE VIDEOGRAPHER: This is the
` videotaped deposition of Blake R. Peterson,
` Ph.D., taken in the matter of Mylan
` Pharmaceuticals, Incorporated versus Bausch
` Health Ireland Limited, Case Number
` IPR20022-00722, for the United States Patent
` and Trademark Office as Patent Number
` 7,041,786.
` This deposition is being held at the
` Blackwell Inn Conference Center at 2110
` Tuttle Park Place, Columbus, Ohio, on
` Tuesday, November 1, 2022 at 9:23 a.m.
` My name is Phillip Park. I am the
` videographer. And the reporter is Jeannette
` McCormick. We are representing Henderson
` Legal.
` Will counsel present now or via Zoom now
` introduce themselves and state their
` relationship to the record.
` MR. HASFORD: Justin Hasford from
` Finnegan on behalf of the Patent Owner. I am
` joined by my colleague Kyu Yun Kim.
` MR. TORCZON: Richard Torczon from
` Wilson Sonsini on behalf of Mylan
` Pharmaceutical. I am joined on the telephone
`
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`November 1, 2022
`4 (Pages 10 to 13)
`12
`
` line by Jad Mills. J-A-D. M-I-L-L-S. And
` also by Matthew Greinert of Mylan.
` G-R-E-I-N-E-R-T.
` THE VIDEOGRAPHER: Thank you very much
` will the reporter now swear in the witness.
`
` BLAKE R. PETERSON, Ph.D.,
` having first been remotely duly sworn,
` testified as follows:
`
` EXAMINATION
`BY MR. HASFORD:
` Q. Good morning.
` MR. TORCZON: We had no notice of a
` video recording of this proceeding. The
` Notice of Deposition specifically says the
` cross-examination will be recorded by
` stenographic means by a Court Reporter
` licensed to administer oaths, and may also be
` recorded using audio means. Period. No
` reference to video means. We have no
` objection to the -- to the audio recording of
` this. We do object to the video recording of
` this and object to any use of the video for
` any purpose.
`
`13
` MR. HASFORD: We obviously disagree with
` your objection. I don't think it makes any
` sense to debate it any further at this point.
`
` EXAMINATION
`BY MR. HASFORD:
` Q. Good morning, Doctor.
` A. Good morning.
` Q. Would you please state your name and address
`for the record?
` A. Yes. My full name is Blake Robert Peterson.
`My address is 4010 Fairfax Drive, Columbus, Ohio
`43220.
` Q. Have you previously testified as an expert?
` A. I have previously served as an expert
`witness, but not at a deposition.
` Q. Have you previously testified as an expert in
`any trial?
` A. No.
` Q. Let me tell you how today's cross-examination
`will proceed.
` I represent the Patent Owner in this
`proceeding. Today, I will ask you questions, and I
`ask that you answer my questions truthfully and
`accurately.
`
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`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2026, Page 4 of 78
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`Peterson, Blake
`
`Case No. IPR2022-00722
`
`November 1, 2022
`5 (Pages 14 to 17)
`16
`
`14
`
` If you need a break, let me know. But if I
`have asked a question, I would ask that you please
`first answer the question and then we could take a
`break.
` 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, would you please confirm that you will not
`communicate with Mylan's counsel during today's
`cross-examination?
` A. Yes. I mean, I'd like to clarify. Counsel
`next to me will be objecting, and so that is a form
`of communication.
` Q. That wasn't my question.
` I mean, if he objects, that's something
`different. I'm talking about communication between
`you and him.
` A. Yes, I agree then.
`
`15
`
` Q. Unless specified otherwise today, my
`questions and your answers should be from a
`perspective of a person of ordinary skill in the art
`as of 2002.
` Is that okay?
` A. Yes.
` (Whereupon, Patent Owner Deposition
` Exhibit Number 1002 was marked for
` Identification.)
`BY MR. HASFORD:
` Q. Look, if you would -- if you have the
`electronic repository, you can bring it up there.
`Ms. Kim also has a hard copy, if you'd rather have
`that. It's Exh bit 1002.
` Do you have that?
` A. It's probably easier to look at the hard copy
`since this isn't my laptop.
` Q. That's fine. She can give that to you.
` A. Thank you.
` I have it.
` Q. Please turn, if you would, to page 120 of
`Exhibit 1002.
` A. I see it.
` Q. Does your electronic signature appear on page
`120 of Exhibit 1002?
`
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` A. It does.
` Q. Who prepared Exhibit 1002?
` A. I did, working with our attorneys.
` Q. Turn, if you would, to page 1, and paragraph
`1 of Exhibit 1002.
` A. I am there.
` Q. The last 2 sentences read "My research for
`over two decades has been directed toward
`understanding and developing small molecule probes
`for biological systems. This research included the
`development of small molecules and peptides that
`promote cellular uptake of proteins, the synthesis
`and evaluation of antiviral agents and anticancer
`agents, the identification of biological targets of
`small molecules and the construction of new types of
`fluorescent probes for immunology and cancer
`biology."
` Do you see that?
` A. Yes.
` Q. You have never worked on any guanylate
`cyclase receptor agonists, correct?
` A. I have studied receptor ligand interactions
`for over 30 years at this point, and have studied
`over 20 different biological receptors and hundreds
`of different ligands over the years.
`
`17
`
` I don't recalling working specifically with
`guanylate cyclase receptor agonists, but I have
`worked with related systems. I've studied cholera
`toxin, for example, which is related to pathogenic
`toxic proteins produced by E. coli, which we're
`discussing today. I've also worked with epidermal
`growth factor receptor, for example, which is a
`related system.
` Q. You have never conducted any scientific
`research on any guanylate cyclase receptors
`agonists, correct?
` A. That is correct.
` Q. You have never authored any publication on
`any guanylate cyclase receptor agonists, correct?
` A. That is correct.
` Q. You have never filed any patent application
`on any guanylate cyclase receptor agonists, correct?
` MR. TORCZON: Objection. Relevance.
` THE WITNESS: That is correct.
`BY MR. HASFORD:
` Q. You have never conducted any scientific
`research on any uroguanylin compound, correct?
` MR. TORCZON: Same objection.
` THE WITNESS: I have not.
`///
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2026, Page 5 of 78
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`Peterson, Blake
`
`Case No. IPR2022-00722
`
`November 1, 2022
`6 (Pages 18 to 21)
`20
`
`18
`
`BY MR. HASFORD:
` Q. You have never authored any publication on
`any uroguanylin compound, correct?
` MR. TORCZON: Same objection.
` THE WITNESS: That's correct.
`BY MR. HASFORD:
` Q. You have never filed any patent application
`on any uroguanylin compound, correct?
` MR. TORCZON: Same objection.
` THE WITNESS: That's correct.
`BY MR. HASFORD:
` Q. You have never conducted any scientific
`research on any guanylin compound, correct?
` MR. TORCZON: Same objection.
` THE WITNESS: That is correct.
`BY MR. HASFORD:
` Q. You have never authored any publication on
`any guanylin compound, correct?
` MR. TORCZON: Same objection.
` THE WITNESS: That is correct.
`BY MR. HASFORD:
` Q. You have never filed any patent application
`on any guanylin compound, correct?
` MR. TORCZON: Same objection.
` THE WITNESS: That's correct.
`
`19
`
`BY MR. HASFORD:
` Q. You have never conducted any scientific
`research on any heat-stable enterotoxin compound,
`correct?
` A. I have studied cholera toxins that I
`mentioned earlier, which is related.
` Q. Have you authored any publication on any
`heat-stable enterotoxin compound?
` A. I don't recall precisely, but I have reported
`data on cholera toxins, as I mentioned.
` Q. How does cholera toxin differ from the
`heat-stable enterotoxin referenced in the '786
`patent?
` A. They're both toxic proteins produced by
`pathogens, pathogenic bacteria. They differ
`structurally, but they both interact with receptors
`on membranes and cause intestinal distress.
` Q. You have never filed any patent application
`on any heat-stable enterotoxin compound, correct?
` A. That is correct.
` Q. You have never conducted any scientific
`research on any Gonadotropin-Releasing Hormone,
`correct?
` A. That is correct.
` Q. You have never authored any publication on
`
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`any Gonadotropin-Releasing Hormone, correct?
` A. That is correct.
` Q. You have never filed any patent application
`on any Gonadotropin-Releasing Hormone, correct?
` MR. TORCZON: Objection. Relevance.
` THE WITNESS: That is correct.
`BY MR. HASFORD:
` Q. You have never conducted any scientific
`research on plecanatide, correct?
` A. I have not studied plecanatide specifically,
`but as I mentioned, I've studied related receptor
`ligand interactions.
` Q. Just to be clear, have you conducted any
`scientific research on plecanatide specifically?
` MR. TORCZON: Objection. Asked and
` answered.
` THE WITNESS: I answered that
` previously.
`BY MR. HASFORD:
` Q. Well, you can't refuse to answer my
`questions. So I'll ask it again.
` Have you conducted any scientific research on
`plecanatide specifically?
` MR. TORCZON: Objection. Asked and
` answered.
`
`21
`
` THE WITNESS: I have not.
`BY MR. HASFORD:
` Q. You have never authored any publication on
`plecanatide specifically, correct?
` MR. TORCZON: Objection. Relevance.
` THE WITNESS: That is correct.
`BY MR. HASFORD:
` Q. You have never filed any patent application
`on plecanatide, correct?
` MR. TORCZON: Same objection.
` THE WITNESS: That's correct.
`BY MR. HASFORD:
` Q. Plecanatide is not an anti-inflammatory drug,
`correct?
` A. That is correct.
` Q. You consider plecanatide to be a recombinant
`of human uroguanylin, correct?
` MR. TORCZON: Objection. Misstates.
` THE WITNESS: I'm getting an error
` message on the machine that it will be
` rebooting or restarting.
`BY MR. HASFORD:
` Q. Why don't we answer this question, and then
`we can go off the record while that happens, if we
`need to.
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2026, Page 6 of 78
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`Peterson, Blake
`
`Case No. IPR2022-00722
`
`November 1, 2022
`7 (Pages 22 to 25)
`24
`
`22
`
` A. Could you restate the question, please?
` Q. Of course. You consider plecanatide to be a
`recombinant of human uroguanylin, correct?
` MR. TORCZON: Same objection.
` THE WITNESS: Plecanatide is a
` modification of human uroguanylin.
`BY MR. HASFORD:
` Q. Do you consider plecanatide to be a
`recombinant of human uroguanylin?
` MR. TORCZON: Objection. Misstates.
` Asked and answered.
` THE WITNESS: It's a modification of
` human uroguanylin.
`BY MR. HASFORD:
` Q. Is it a recombinant of human uroguanylin?
` MR. TORCZON: Objection. Misstates.
` Asked and answered.
` THE WITNESS: It is a modification of
` human uroguanylin.
`BY MR. HASFORD:
` Q. That wasn't my question, Doctor. And then
`you can't refuse to answer my question.
` Do you consider plecanatide to be a
`recombinant of human uroguanylin?
` MR. TORCZON: Same objections.
`
`23
`
` THE WITNESS: I believe I've answered
` that to the best of my ability.
`BY MR. HASFORD:
` Q. No, you actually haven't. You used the word
`recombinant in your declaration.
` MR. TORCZON: Objection.
`BY MR. HASFORD:
` Q. Do you remember that?
` A. Can you show me my declaration specifically,
`what you're referring to?
` Q. You've got it in front of you.
` A. Please show me specifically what you're
`referring to.
` Q. Take a look, if you would, at Paragraph 149
`of your declaration.
` A. Yes, I can see it.
` Q. Look at the fourth sentence. You say "And a
`skilled artisan would reasonable expect at least
`some recombinants to exceed the activity of human
`uroguanylin." Then you say "The Glu 3 substitution
`is one such recombinant, but because of the high
`homology between human and rat uroguanylin, possible
`recombinants are finite."
` Do you see that?
` A. I do.
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` Q. Why do you consider plecanatide to be a
`recombinant of human uroguanylin?
` MR. TORCZON: Objection. Misstates.
` THE WITNESS: One could use that
` terminology recombinant, but I think another
` way to descr be this is as a modification of
` human uroguanylin.
`BY MR. HASFORD:
` Q. Why did you -- go ahead.
` A. I agree that it's written that way.
` Q. Yeah. Why did you refer to plecanatide as a
`recombinant of human uroguanylin?
` A. It is a modification of human uroguanylin. I
`think that's the best way I can state that.
` Q. Why in your declaration did you refer to
`plecanatide as a recombinant of human uroguanylin?
` MR. TORCZON: Objection. Misstates.
` THE WITNESS: One can produce different
` recombinant proteins from natural sources or
` from other sources. And I think recombinant
` is one way to describe this protein, but it's
` not the only way.
`BY MR. HASFORD:
` Q. Prior to this case, you have never consulted
`for any party on any matter involving plecanatide,
`
`25
`
`correct?
` A. That's correct.
` Q. Prior to this case, you have never consulted
`for any party on any matter involving any
`uroguanylin compound, correct?
` A. I'm sorry. I'm getting an error message on
`the screen. Let me -- it's going away. It's okay.
`It's an antivirus.
` Can you repeat the question?
` Q. Certainly. Prior to this case, you have
`never consulted for any party on any matter
`involving any uroguanylin compound, correct?
` A. That's correct.
` Q. Prior to this case, you have never consulted
`for any party on any matter involving any guanylin
`compound, correct?
` A. That's correct.
` Q. Prior to this case, you have never consulted
`for any party on any matter involving the
`heat-stable enterotoxin compounds identified in the
`'786 patent specification, correct?
` A. That's correct.
` Q. Prior to this case, you have never consulted
`for any party on any matter involving any
`Gonadotropin-Releasing Hormone, correct?
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2026, Page 7 of 78
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`Peterson, Blake
`
`Case No. IPR2022-00722
`
`November 1, 2022
`8 (Pages 26 to 29)
`28
`
`26
`
` A. That's correct.
` Q. You are not a pharmaceutical formulation
`expert, correct?
` A. I am very familiar with pharmaceutical
`formulations, as a professor of medicinal chemistry
`and pharmacognosy. As a pharmacy professor for over
`13 years now, I'm very familiar with pharmaceutical
`formulations.
` Q. You have never been qualified by any court or
`by the U.S. Patent and Trademark Office as an expert
`in pharmaceutical formulation, correct?
` MR. TORCZON: Objection. Relevance.
` THE WITNESS: That's correct.
`BY MR. HASFORD:
` Q. You are not an expert in pharmacology,
`correct?
` A. That's not correct. I am very familiar with
`pharmacology. I've been doing research at the
`interface between chemistry and biology for over 20
`years.
` Q. You do not have any degrees in pharmacology,
`correct?
` A. That is correct.
` Q. You are not an expert in pharmacokinetics,
`correct?
`
`27
` A. As I said, I am a professor of pharmacy, and
`have been for over 13 years, and I am very familiar
`with pharmacokinetics.
` Q. You have never been qualified by any court or
`by the U.S. Patent & Trademark Office to be an
`expert in pharmacokinetics, correct?
` MR. TORCZON: Objection. Relevance.
` THE WITNESS: That is correct.
`BY MR. HASFORD:
` Q. But you have never been qualified by any
`court or by the U.S. Patent and Trademark Office as
`an expert in pharmacodynamics, correct?
` MR. TORCZON: Same objection.
` THE WITNESS: Qualified by a court, you
` said? Is that what you said? I had trouble
` hearing you.
`BY MR. HASFORD:
` Q. Correct. You've never been qualified by any
`court or by the U.S. Patent and Trademark Office as
`an expert in pharmacodynamics, correct?
` MR. TORCZON: Same objection.
` THE WITNESS: That is correct.
`BY MR. HASFORD:
` Q. You are not an expert in any field of
`medicine, correct?
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` A. I do research in cancer biology, and so I am
`an expert in aspects of cancer biology and other
`aspects of medicine.
` Q. You are not a medical doctor, correct?
` A. That is correct.
` MR. TORCZON: Objection. Relevance.
`BY MR. HASFORD:
` Q. You have never been qualified by any court or
`by the U.S. Patent and Trademark Office as an expert
`in any field of medicine, correct?
` MR. TORCZON: Objection. Relevance.
` THE WITNESS: That is correct.
`BY MR. HASFORD:
` Q. You are not a pharmacist, correct?
` A. That is correct.
` Q. And you are not an expert in clinical
`testing, correct?
` A. I am familiar with clinical testing as a
`professor of pharmacy.
` Q. You have never held yourself out as an expert
`in clinical testing, correct?
` MR. TORCZON: Objection. Asked and
` answered.
` THE WITNESS: I have reviewed the
` literature on clinical testing substantially
`
`29
`
` and am very familiar with that field.
`BY MR. HASFORD:
` Q. You have never been qualified by any court or
`by the U.S. Patent and Trademark Office as an expert
`in clinical testing, correct?
` MR. TORCZON: Objection. Relevance.
` THE WITNESS: That is correct.
`BY MR. HASFORD:
` Q. You are not an expert in evolutionary
`biology, correct?
` A. I am very familiar with evolutionary biology
`as a professor of pharmacy.
` Q. You do not have any degrees in evolutionary
`biology, correct?
` A. That is correct.
` Q. You have never been qualified by any court or
`by the U.S. Patent and Trademark Office as an expert
`in evolutionary biology, correct?
` MR. TORCZON: Objection. Relevance.
` THE WITNESS: That is correct.
`BY MR. HASFORD:
` Q. You have never designed a marketed drug,
`correct?
` MR. TORCZON: Objection. Relevance.
` THE WITNESS: Are you saying I have
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2026, Page 8 of 78
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`Peterson, Blake
`
`Case No. IPR2022-00722
`
`30
`
` never designed a drug that has been
` marketed -- approved by the FDA and marketed?
`BY MR. HASFORD:
` Q. That is my question.
` A. That is correct.
` Q. You have never designed a drug in which you
`replaced a single aspartic acid or aspartate residue
`with a single glutamic acid or glutamate residue,
`correct?
` A. I have designed many peptides over the years,
`some of which included those modifications. Yes.
` Q. You have never been hired for a permanent
`position at a pharmaceutical company, correct?
` A. That is correct.
` Q. You have never founded or co-founded a
`pharmaceutical company, correct?
` MR. TORCZON: Objection. Relevance.
` THE WITNESS: I co-founded a company
` that serves the pharmaceutical industry back
` in 2005.
`BY MR. HASFORD:
` Q. Have you ever founded or co-founded a
`pharmaceutical company that markets drugs?
` A. No.
` Q. You have never designed or synthesized a drug
`
`31
`
`for a pharmaceutical company, correct?
` A. I have consulted with pharmaceutical
`companies on the design and synthesis of
`pharmaceuticals.
` Q. You yourself have never actually designed or
`synthesized a drug for a pharmaceutical company,
`correct?
` MR. TORCZON: Objection. Misstates.
` Asked and answered.
` THE WITNESS: Can you restate that?
`BY MR. HASFORD:
` Q. Sure. You yourself have never actually
`designed or synthesized a drug for a pharmaceutical
`company, correct?
` MR. TORCZON: Same objections.
` THE WITNESS: I have consulted with
` pharmaceutical companies on the design of
` drugs.
`BY MR. HASFORD:
` Q. Did you do the design and synthesis yourself?
` MR. TORCZON: Same objections.
` THE WITNESS: I certainly have been
` involved in the design myself.
`BY MR. HASFORD:
` Q. Well, let me ask it this way. You have never
`
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`November 1, 2022
`9 (Pages 30 to 33)
`32
`synthesized a drug for a pharmaceutical company,
`correct?
` MR. TORCZON: Same objections.
` THE WITNESS: I've been involved in the
` design of the synthesis of agents that
` pharmaceutical companies have studied.
`BY MR. HASFORD:
` Q. Did you synthesize it yourself?
` MR. TORCZON: Same objections.
` THE WITNESS: Did I synthesize it with
` my own two hands?
`BY MR. HASFORD:
` Q. Correct.
` A. No, I did not.
` Q. Okay. In connection with your opinions in
`this case, you did not conduct any testing, correct?
` A. That is correct.
` Q. In connection with your opinions in this
`case, you did not consult with any pharmaceutical
`formulator, correct?
` A. That is correct.
` Q. You are not an expert in structural organic
`chemistry, correct?
` A. That's incorrect. My Ph.D. was in the field
`of organic chemistry.
`
`33
`
` Q. Do you hold yourself out as an expert in
`structural organic chemistry?
` MR. TORCZON: Objection. Asked and
` answered.
` THE WITNESS: Yes, I do.
`BY MR. HASFORD:
` Q. Do you hold yourself out as an expert in
`mechanistic organic chemistry?
` A. Yes, I do.
` Q. You are not a fellow of the American Chemical
`Society, correct?
` A. That's in --
` MR. TORCZON: Objection. Relevance.
` THE WITNESS: That is incorrect.
` Incorrect. I am a fellow -- well, you said a
` fellow. I'm a member of the American
` Chemical Society, I should say.
`BY MR. HASFORD:
` Q. Different question.
` You're not a fellow of the American Chemical
`Society, correct?
` MR. TORCZON: Same objection.
` THE WITNESS: That is correct.
`BY MR. HASFORD:
` Q. You do not have any degrees in peptide
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.