CASE IPR2022-007221
`Epstein, M.D., Michael Samuel
`
`April 11, 2023
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` UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`MYLAN PHARMACEUTICALS INC., MSN LABORATORIES
` PRIVATE LTD., and MSN PHARMACEUTICALS INC.,
`Petitioner,
`v.
`BAUSCH HEALTH IRELAND LIMITED,
`Patent Owner.
`_____________
`CASE IPR2022-007221
`Patent 7,041,786
`_____________
`
`VIDEOTAPED DEPOSITION OF
`MICHAEL SAMUEL EPSTEIN, M.D.
`
`APRIL 11, 2023
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`202-220-4158
`
`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2070, Page 1 of 84
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`Epstein, M.D., Michael Samuel
`
`April 11, 2023
`
`1
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` UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`MYLAN PHARMACEUTICALS INC., MSN LABORATORIES
` PRIVATE LTD., and MSN PHARMACEUTICALS INC.,
`Petitioner,
`v.
`BAUSCH HEALTH IRELAND LIMITED,
`Patent Owner.
`_____________
`CASE IPR2022-007221
`Patent 7,041,786
`_____________
`
`VIDEOTAPED DEPOSITION OF
`MICHAEL SAMUEL EPSTEIN, M.D.
`
`APRIL 11, 2023
`
`202-220-4158
`
`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2070, Page 1 of 84
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`
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`CASE IPR2022-007221
`Epstein, M.D., Michael Samuel
`
`April 11, 2023
`
`2
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` A P P E A R A N C E S
`On behalf of Petitioner Mylan Pharmaceuticals Inc.
` WILSON SONSINI GOODRICH & ROSATI
` BY: RICHARD TORCZON, ESQUIRE
` TASHA M. THOMAS, ESQUIRE
` 1700 K Street, NW
` Washington, D.C. 2006-3817
` 202.973.8800
` rtorczon@wsgr.com
` tthomas@wsgr.com
`
` (By phone)
` WILSON SONSINI GOODRICH & ROSATI
` BY: JAD A. MILLS, ESQUIRE
` 701 Fifth Avenue, Suite 5100
` Seattle, Washington 98104-7036
` 206.883.2500
` jmills@wsgr.com
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`Bausch Health Ireland Exhibit 2070, Page 2 of 84
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`CASE IPR2022-007221
`Epstein, M.D., Michael Samuel
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`April 11, 2023
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`3
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` A P P E A R A N C E S (Continued)
`On behalf of Petitioner MSN Laboratories Private Ltd.
` (By phone)
` MERCHANT & GOULD, P.C.
` BY: ANDREW O. LARSEN, ESQUIRE
` 500 Fifth Avenue, Suite 4100
` New York, New York 10100
` 212.223.6520
` alarsen@merchantgould.com
`
`On behalf of Patent Owner
` FINNEGAN HENDERSON FARABOW GARRETT &
` DUNNER, LLP
` BY: KASSANDRA OFFICER, ESQUIRE
` JUSTIN J. HASFORD, ESQUIRE
` 901 New York Avenue, NW
` Washington, D.C. 2001-4413
` 202.408.4000
` kassandra.officer@finnegan.com
` justin.hasford@finnegan.como
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`Bausch Health Ireland Exhibit 2070, Page 3 of 84
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`CASE IPR2022-007221
`Epstein, M.D., Michael Samuel
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`April 11, 2023
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`4
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` A P P E A R A N C E S (Continued)
`Also present
`Matthew Greinert, Esquire, Mylan Pharmaceuticals Inc.
`(By phone)
`
`Drew Beltz, videographer
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`Bausch Health Ireland Exhibit 2070, Page 4 of 84
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`CASE IPR2022-007221
`Epstein, M.D., Michael Samuel
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`April 11, 2023
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`5
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` * I N D E X *
`MICHAEL SAMUEL EPSTEIN, M.D. PAGE
` DIRECT EXAMINATION BY MS. OFFICER 7
`
` * INDEX OF PREVIOUSLY MARKED EXHIBITS *
`NO. DESCRIPTION PAGE
`Exhibit 1064 Declaration of Michael S. 19
` Epstein, M.D.
`Exhibit 1070 Rate Control in Drug Therapy 41
`Exhibit 2025 Declaration of Scott A. 48
` Waldman, M.D. PH.D., FDP, FAHA,
` FNAI, FASPET
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`Bausch Health Ireland Exhibit 2070, Page 5 of 84
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`CASE IPR2022-007221
`Epstein, M.D., Michael Samuel
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`April 11, 2023
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` P R O C E E D I N G S
` - - - -
` THE VIDEOGRAPHER: Here begins volume 1,
`tape 1 in the videotaped deposition of Michael S.
`Epstein, M.D., taken in the matter of Mylan
`Pharmaceuticals Inc. versus Bausch Health Ireland
`Limited in the United States Patent Office and
`Trademark Office, Case Number IPR2022-00722.
` Today's date is April 11, 2023. The
`time is 9:13. This deposition is being held at
`1700 K Street, Northwest, Fifth Floor, Washington,
`D.C. 20006. The court reporter is Ann Medis.
`The videocamera operator is Drew Beltz. Both are
`on behalf of Henderson Legal Services.
` Will counsel and others please introduce
`themselves and state whom they represent.
` MS. OFFICER: Kassandra Officer and
`Justin Hasford from Finnegan on behalf of the
`patent owner.
` MR. TORCZON: Richard Torczon and Tasha
`Thomas on behalf of Mylan. We also have Jad Mills
`on the line also from Wilson Sonsini, and Matt
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`202-220-4158
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`www.hendersonlegalservices.com
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`Bausch Health Ireland Exhibit 2070, Page 6 of 84
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`CASE IPR2022-007221
`Epstein, M.D., Michael Samuel
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`April 11, 2023
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`Greinert from Mylan.
` THE VIDEOGRAPHER: Will the court
`reporter please swear in the witness.
` MR. LARSEN: And if I could just put in
`an appearance. This is Andrew Larsen from
`Merchant & Gould on behalf of joined petitioner,
`MSN.
` MICHAEL SAMUEL EPSTEIN,
` having been first duly sworn, was examined
` and testified as follows:
` DIRECT EXAMINATION
`BY MS. OFFICER:
` Q. Good morning, Dr. Epstein. Would you
`please state your full name for the record.
` A. Michael Samuel Epstein.
` Q. And what is the address at which you
`reside?
` A. 185 Masters Way, Grasonville, Maryland.
` Q. I'll be taking your deposition today.
`Do you understand that you're testifying in
`connection with IPR2022-00722?
` A. Yes, I do.
`
`202-220-4158
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`www.hendersonlegalservices.com
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`Bausch Health Ireland Exhibit 2070, Page 7 of 84
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`CASE IPR2022-007221
`Epstein, M.D., Michael Samuel
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`April 11, 2023
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` Q. And you understand that your testimony
`will be transcribed and made public in these
`proceedings?
` A. I do.
` Q. And do you understand that your
`testimony is under oath?
` A. I do.
` Q. And you understand that the oath is the
`same that would apply in a courtroom before a
`judge?
` A. I do.
` Q. How many times have you been deposed
`previously?
` A. Probably a half a dozen.
` Q. In those half a dozen matters, were any
`patent matters?
` A. There were four patent matters, I
`believe.
` Q. And what was the nature of the other two
`matters?
` A. One was poisoning/toxicity, and one was
`a vehicular homicide.
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`202-220-4158
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`www.hendersonlegalservices.com
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`Bausch Health Ireland Exhibit 2070, Page 8 of 84
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`CASE IPR2022-007221
`Epstein, M.D., Michael Samuel
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`April 11, 2023
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` Q. And in the four patent cases, did you
`testify as an expert witness?
` A. I did, yes.
` Q. And in the poisoning/toxicity case, did
`you testify as an expert witness?
` A. Yes, I did.
` Q. And how about in the vehicular homicide
`case?
` A. Yes, also.
` Q. Have you ever testified at trial?
` A. Yes.
` Q. How many times?
` A. Twice, I believe.
` Q. And what were the nature of the two
`matters you testified at trial in?
` A. One was an intellectual property case,
`and the other was the vehicular homicide case, I
`believe.
` Q. And when was this IP case?
` A. It was about three years ago, I believe.
` Q. And how about the vehicular homicide
`case?
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`202-220-4158
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`www.hendersonlegalservices.com
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`Bausch Health Ireland Exhibit 2070, Page 9 of 84
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`CASE IPR2022-007221
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`April 11, 2023
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` A. That was about eight years ago.
` Q. Eight?
` A. Uh-huh. Approximately.
` Q. And in the IP case where you testified
`at trial three years ago, what was the subject
`matter of that case?
` A. It was -- a laboratory test was in
`question.
` Q. What kind of laboratory test?
` A. It was a test for -- a blood test for
`irritable bowel syndrome.
` Q. And I'm going to go back to the three
`other patent matters that you had depositions in.
`Can you describe the technology at issue in each
`of those proceedings?
` A. Yeah. I can remember two of them, too.
`I just can't remember because it was a long time
`ago. One had to do with coating technology, drug
`coating, pharmaceutical drug coating. And the
`other had to do with invention of the patent, who
`invented the particular patent.
` Q. And in the case involving coating
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`Bausch Health Ireland Exhibit 2070, Page 10 of 84
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`Epstein, M.D., Michael Samuel
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`April 11, 2023
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`technology, did that involve peppermint oil?
` A. That did not involve peppermint oil.
` Q. And how about the invention case?
` A. No. That involved a hepatitis drug.
` Q. Have you ever testified or submitted a
`declaration in a Patent Office proceeding other
`than in this case?
` A. No, ma'am, I have not.
` Q. How about an interference?
` A. No, ma'am.
` Q. How about any reexaminations?
` A. No, I have not.
` Q. With respect to the coating technology
`that was at issue in one of the patent cases you
`testified on, can you describe what kind of
`coating that was?
` A. It was a -- basically a polymorphic fat
`coating that was developed by an Italian firm.
` Q. And what was the purpose of the
`polymorphic fat coating?
` A. It -- to slow dissolution of a drug
`throughout the GI tract.
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`202-220-4158
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`Bausch Health Ireland Exhibit 2070, Page 11 of 84
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`CASE IPR2022-007221
`Epstein, M.D., Michael Samuel
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`April 11, 2023
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` Q. And why would you want to slow
`dissolution of the drug?
` A. In this case, to get more drug to the
`more distal small bowel in order to deliver it to
`the site where it was needed.
` Q. And what was the drug at issue?
` A. Well, it's any -- many different drugs
`use that technology, so there was not one specific
`drug.
` Q. And what was the date of the patent at
`issue?
` MR. TORCZON: Objection. Relevance.
` THE WITNESS: I honestly don't remember.
`I'm sorry. Yeah, I don't remember. It's been a
`long time.
`BY MS. OFFICER:
` Q. And then speaking now on the blood test
`work that you did for the --
` A. Yes.
` Q. -- IBS drug, what was the IBS drug at
`issue?
` A. It wasn't a drug. It was a laboratory
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`202-220-4158
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`Bausch Health Ireland Exhibit 2070, Page 12 of 84
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`CASE IPR2022-007221
`Epstein, M.D., Michael Samuel
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`April 11, 2023
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`13
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`blood test.
` Q. So it was the diagnostic?
` A. Correct.
` Q. And what type of IBS was the diagnostic
`used for?
` MR. TORCZON: Objection. Scope.
` THE WITNESS: All types of IBS.
`BY MS. OFFICER:
` Q. Including IBS-C?
` A. Yes.
` Q. IBS-M?
` A. I don't think they specified IBS-M, but
`I don't recall that it excluded that. So I mean
`to say I'm not sure, but I don't think it -- I
`don't -- I think it did include all types of IBS.
` Q. Including IBS-D?
` A. Yes.
` Q. And how did the diagnostic work?
` MR. TORCZON: Objection. Scope.
` THE WITNESS: It tested for the level of
`two chemicals in the blood.
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`Bausch Health Ireland Exhibit 2070, Page 13 of 84
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`BY MS. OFFICER:
` Q. What two chemicals?
` MR. TORCZON: Same objection.
` THE WITNESS: You know, I'd have to go
`back and look at my notes because I can't remember
`the chemicals, I hate to say.
`BY MS. OFFICER:
` Q. Where did the chemicals originate from?
` MR. TORCZON: Same objection.
` THE WITNESS: They were serum levels,
`serum -- serum inflammatory blood levels.
`BY MS. OFFICER:
` Q. Forgive my ignorance. When you say
`"serum inflammatory blood levels," are you
`referring to antibodies in the blood?
` MR. TORCZON: Same objection.
` THE WITNESS: No. These would not be
`antibodies. These would be inflammatory
`biomarkers. There's many hundreds of them in the
`body.
`BY MS. OFFICER:
` Q. So this particular test looked for two
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`Bausch Health Ireland Exhibit 2070, Page 14 of 84
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`CASE IPR2022-007221
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`April 11, 2023
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`biomarkers?
` A. Correct.
` MR. TORCZON: Same objection.
`BY MS. OFFICER:
` Q. How was this test administered?
` MR. TORCZON: Same objection.
` THE WITNESS: It was a serum test. You
`would draw blood just...
`BY MS. OFFICER:
` Q. Did the test require the patient to be
`in a fasting state?
` MR. TORCZON: Same objection.
` THE WITNESS: I don't recall, but I
`don't believe so. I'm not certain.
`BY MS. OFFICER:
` Q. And just so you're familiar with the
`format of the deposition today, I'll be asking
`several questions, and I ask that you provide
`answers. Please provide audible answers so that
`they may be transcribed.
` Is that okay?
` A. Certainly. Thank you.
`
`202-220-4158
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`www.hendersonlegalservices.com
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`Bausch Health Ireland Exhibit 2070, Page 15 of 84
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`CASE IPR2022-007221
`Epstein, M.D., Michael Samuel
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`April 11, 2023
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` Q. And your counsel may object to some
`questions, but you still need to answer each
`question unless I -- unless you're specifically
`instructed not to answer.
` Is that okay?
` A. Understood.
` Q. I also ask that we avoid talking over
`each other. Again, the deposition is being
`transcribed, and it will be difficult to know who
`said what if we talk over each other.
` Is that okay?
` A. Absolutely.
` Q. If I ask a question that you don't
`understand, please ask me for clarification.
` Is that okay?
` A. Certainly.
` Q. And if you don't ask for clarification,
`I'm going to assume that you understood the
`question being asked.
` Is that okay?
` A. Understood.
` Q. And we'll try to take breaks about every
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`Bausch Health Ireland Exhibit 2070, Page 16 of 84
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`60 minutes or so. Before we take a break, I'd
`like you to complete your answer to the pending
`question.
` Is that okay?
` A. Sure.
` Q. Anything that would prevent you from
`providing truthful and accurate testimony today?
` A. No.
` Q. What did you do to prepare for today's
`deposition?
` A. Read through documents, looked at a
`report from Dr. Waldman, reviewed a number of
`documents and discussed the case with the
`attorneys we have here today plus Jad Mills.
` Q. And about how long did you prepare for
`your deposition?
` A. Between 15 to 20 hours.
` Q. And how long did you meet with your
`attorneys?
` MR. TORCZON: Objection. Form.
` THE WITNESS: On more than one occasion
`or one occasion?
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`202-220-4158
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`www.hendersonlegalservices.com
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`Bausch Health Ireland Exhibit 2070, Page 17 of 84
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`CASE IPR2022-007221
`Epstein, M.D., Michael Samuel
`
`April 11, 2023
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`BY MS. OFFICER:
` Q. In preparation for today's deposition.
` A. Well, we just -- they asked me
`questions. So I guess that's a meeting. So
`probably three -- probably eight hours total.
` Q. And when did you meet with counsel in
`preparation for your deposition today?
` A. Several weeks ago briefly on the phone,
`and then longer period, maybe three or four weeks
`ago, and then yesterday we met as well.
` Q. And when you met yesterday, how long did
`you meet?
` A. Probably six hours.
` Q. And the other two meetings that you had,
`were those to prepare your declaration?
` A. Yes.
` Q. You mentioned you reviewed documents.
`Did you review anything not cited in your report?
` A. No, I did not.
` Q. Did you have any discussions that were
`about this case and not with counsel?
` A. No, I have not.
`
`202-220-4158
`
`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2070, Page 18 of 84
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`CASE IPR2022-007221
`Epstein, M.D., Michael Samuel
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`April 11, 2023
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` Q. And I'm going to hand you a copy of the
`declaration that you submitted in IPR2022-00722.
`And this has been previously marked as
`Exhibit 1064.
` A. Yeah.
` Q. Are you familiar with Exhibit 1064?
` A. Yes, I am.
` Q. Can you please turn to page 24.
` A. Okay.
` Q. Is that your signature there?
` A. That is.
` Q. Does Exhibit 1064 set forth your
`opinions in IPR2022-00722?
` A. It does.
` Q. Do you have any opinions that are not
`set forth in Exhibit 1064?
` A. No, I do not.
` Q. And can you turn over to page 25 of your
`declaration.
` A. Okay.
` Q. Does the list of exhibits on page 25
`encompass everything you reviewed in forming your
`
`202-220-4158
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`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2070, Page 19 of 84
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`CASE IPR2022-007221
`Epstein, M.D., Michael Samuel
`
`April 11, 2023
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`opinions?
` A. Yes, it does.
` Q. Did you review anything else in forming
`your opinions?
` A. No, I didn't.
` Q. You didn't review the petition; correct?
` A. The petition? No, I did not.
` Q. You didn't review Dr. Peterson's
`declaration in support of the petition; is that
`correct?
` A. Correct. That's correct.
` Q. And you didn't review patent owner's
`preliminary response; is that correct?
` A. That is correct.
` Q. And you didn't review patent owner's
`response; is that correct?
` A. That's correct.
` Q. And you didn't review Dr. Davis'
`declaration in support of the patent owner's
`response?
` A. That's correct.
` Q. And you also didn't review the Board's
`
`202-220-4158
`
`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2070, Page 20 of 84
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`CASE IPR2022-007221
`Epstein, M.D., Michael Samuel
`
`April 11, 2023
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`institution decision; is that correct?
` A. The what? I'm sorry.
` Q. The Board's institution decision.
` A. The Board's institution -- no. I'm
`sorry. No, I did not.
` Q. Please take a look at paragraph 7 on
`page 3 of your declaration. Does this describe
`what you were asked to do in this case?
` A. Yes.
` Q. You were asked to review the declaration
`of Dr. Waldman and provide opinions regarding the
`testimony Dr. Waldman provides; correct?
` A. That's correct.
` MR. TORCZON: Asked and answered.
`BY MS. OFFICER:
` Q. You were asked to provide an opinion on
`whether the challenged claims of the '786 patent
`would have been obvious; is that correct?
` MR. TORCZON: Objection. Asked and
`answered.
` THE WITNESS: Only what's in connection
`with paragraph 7.
`
`202-220-4158
`
`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2070, Page 21 of 84
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`
`
`CASE IPR2022-007221
`Epstein, M.D., Michael Samuel
`
`April 11, 2023
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`BY MS. OFFICER:
` Q. And in connection with paragraph 7, you
`were not asked to provide an opinion on whether
`the challenged claims of the '786 patent would
`have been obvious; is that correct?
` MR. TORCZON: Same objection.
` THE WITNESS: That's correct.
`BY MS. OFFICER:
` Q. You did not submit a declaration in
`support of the petition; is that correct?
` A. That's correct.
` Q. When were you retained for this case?
` A. That's a good question. It may have
`been around two months ago or so, I think.
` Q. So suffice it to say in 2023?
` A. Affirmative, yes.
` Q. Did you consult with Dr. Peterson before
`he submitted his declaration in support of the
`petition?
` A. No.
` Q. Do you have a Ph.D. in chemistry?
` A. No, I do not.
`
`202-220-4158
`
`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2070, Page 22 of 84
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`CASE IPR2022-007221
`Epstein, M.D., Michael Samuel
`
`April 11, 2023
`
`23
`
` Q. Do you have a master's in chemistry?
` A. No, I do not.
` Q. Do you have a B.S. in chemistry?
` A. No.
` Q. Do you have a Ph.D. in protein
`engineering?
` A. No, I do not.
` Q. Do you have a master's in protein
`engineering?
` MR. TORCZON: Objection. Relevance.
` THE WITNESS: No, I do not.
`BY MS. OFFICER:
` Q. Do you have a B.S. in protein
`engineering?
` A. No, I do not.
` MR. TORCZON: Same objection.
`BY MS. OFFICER:
` Q. Do you have any degrees in
`pharmaceutical chemistry?
` MR. TORCZON: Same objection.
` THE WITNESS: No, I do not.
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`202-220-4158
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`www.hendersonlegalservices.com
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`Bausch Health Ireland Exhibit 2070, Page 23 of 84
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`
`
`CASE IPR2022-007221
`Epstein, M.D., Michael Samuel
`
`April 11, 2023
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`BY MS. OFFICER:
` Q. Do you have any degrees in pharmacy?
` MR. TORCZON: Same objection.
` THE WITNESS: No, I do not.
`BY MS. OFFICER:
` Q. Do you have any degrees in clinical
`pharmacology?
` MR. TORCZON: Same objection.
` THE WITNESS: No, I do not.
`BY MS. OFFICER:
` Q. Do you consider yourself an expert in
`the development of pharmaceutical formulations?
` A. I have worked extensively in -- for
`industry in development of products in all phases
`of development as a senior clinical research
`scientist. I work closely with chemists. I work
`closely with Phase I teams, and I coordinate -- I
`have coordinated all aspects of the research.
` Q. Have you ever been qualified by any
`court or by the U.S. Patent and Trademark Office
`in the development of pharmaceutical formulations?
` MR. TORCZON: Objection. Form and
`
`202-220-4158
`
`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2070, Page 24 of 84
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`CASE IPR2022-007221
`Epstein, M.D., Michael Samuel
`
`April 11, 2023
`
`25
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`relevance.
` THE WITNESS: A court or a patent
`office? Not to my knowledge, no.
` MR. TORCZON: The first objection was
`form.
`BY MS. OFFICER:
` Q. And I'll just reask. Have you ever been
`qualified as an expert by any court or by the U.S.
`Patent and Trademark Office in the development of
`pharmaceutical formulations?
` MR. TORCZON: Same objections.
` THE WITNESS: No.
`BY MS. OFFICER:
` Q. Do you consider yourself an expert in
`guanylin cyclase C receptors?
` A. An expert, no.
` Q. And is it okay if I refer to guanylin
`cyclase C receptors as "GCC receptors"?
` A. Certainly.
` Q. And you've never developed a GCC
`receptor agonist; is that correct?
` A. Well, I worked closely with companies
`
`202-220-4158
`
`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2070, Page 25 of 84
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`
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`CASE IPR2022-007221
`Epstein, M.D., Michael Samuel
`
`April 11, 2023
`
`26
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`that develop those.
` Q. But you personally have never developed
`a GCC receptor agonist?
` A. That is correct.
` Q. And you are experienced with GCC
`receptor agonists as limited to the administration
`of GCC agonists; is that correct?
` A. No. I was involved very early on in the
`clinical research, the protocols, and the science
`behind GCC receptors, but I was not the developer.
`You know, I was not the Phase I scientist who
`developed these agonists. But I worked in the
`clinical side of things after the molecule had
`been developed.
` Q. Are you an inventor on any patents
`related to GCC receptor agonists?
` A. No.
` Q. Do you contend that you invented the
`administration of GCC receptor agonists for the
`treatment of constipation?
` A. Invented?
` MR. TORCZON: Objection. Relevance.
`
`202-220-4158
`
`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2070, Page 26 of 84
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`CASE IPR2022-007221
`Epstein, M.D., Michael Samuel
`
`April 11, 2023
`
`27
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` THE WITNESS: No.
`BY MS. OFFICER:
` Q. You've administered GCC receptor
`agonists to patients; is that correct?
` A. Yes, frequently.
` Q. And the two FDA approved GCC receptor
`agonists are Linzess and Trulance; is that right?
` A. Yes. That's their trade names. That is
`correct.
` Q. Are you aware of any patient deaths
`resulting from the administration of Linzess?
` A. Not directly, no.
` Q. Are you aware of any patient deaths
`resulting from the administration of Trulance?
` A. No.
` Q. And you're opining from the perspective
`of a medical doctor with knowledge and experience
`in treating GI disorders and with experience
`designing and running clinical trials; is that
`correct?
` A. That is correct.
` Q. In your opinion, is a medical doctor
`
`202-220-4158
`
`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2070, Page 27 of 84
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`CASE IPR2022-007221
`Epstein, M.D., Michael Samuel
`
`April 11, 2023
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`with knowledge and experience in treating GI
`disorders limited to a gastroenterologist?
` A. Repeat the question. I'm sorry.
` Q. In your opinion, is a medical doctor
`with knowledge and experience in treating GI
`disorders limited to a gastroenterologist?
` A. No.
` Q. Do you agree that a family practitioner
`also has knowledge -- strike that.
` Do you agree that a family practitioner
`may also have knowledge and experience in treating
`GI disorders?
` A. Yes, but on a limited basis.
` Q. What do you mean by "limited basis"?
` A. Most family doctors that see GI
`disorders end up referring them to us for
`treatment.
` Q. But family practitioners do treat GI
`disorders?
` A. They do treat some, yes.
` Q. Do you agree that the ordinarily skilled
`gastroenterologist may not have experience
`
`202-220-4158
`
`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2070, Page 28 of 84
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`CASE IPR2022-007221
`Epstein, M.D., Michael Samuel
`
`April 11, 2023
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`designing and running clinical trials?
` MR. TORCZON: Objection. Relevance.
` THE WITNESS: The ordinary skilled? I
`would say that not all gastroenterologists have
`the skill set to design clinical studies of
`trials. That's true.
`BY MS. OFFICER:
` Q. Do you agree that the ordinarily skilled
`gastroenterologist would not have been aware of
`human uroguanylin in 2002?
` A. I can't answer that question. I mean, I
`think uroguanylin was known, particularly in
`reference to -- you know, there was -- the
`parallel to that was that the stable enterotoxin
`was well known, and people did know about guanylin
`and uroguanylin receptors. I would say they
`probably did know about this compound. I mean,
`it's just one more cycle in the body, and those
`are all the things that gastroenterologists study.
`So I would -- I would disagree with that.
` Q. So I just want to make sure I have your
`testimony correct. Your testimony is that an
`
`202-220-4158
`
`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2070, Page 29 of 84
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`CASE IPR2022-007221
`Epstein, M.D., Michael Samuel
`
`April 11, 2023
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`ordinarily skilled gastroenterologist would have
`been aware of human uroguanylin in 2002?
` A. I think they would have been aware of
`it.
` Q. How about a family practitioner treating
`GI disorders?
` MR. TORCZON: Objection. Relevance.
` THE WITNESS: I mean, I'm not a family
`practitioner, so I can't say what their training
`exactly is, to be honest with you, but I would --
`I would doubt they'd be aware of that.
`BY MS. OFFICER:
` Q. Would an ordinarily skilled
`gastroenterologist rely on the Food and Drug
`Administration to evaluate the stability of
`pharmaceutical drug products?
` A. Can you repeat that question?
` Q. Would an ordinarily skilled
`gastroenterologist rely on the U.S. Food and Drug
`Administration to evaluate the stability of
`pharmaceutical drug products?
` MR. TORCZON: Objection. Foundation.
`
`202-220-4158
`
`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2070, Page 30 of 84
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`CASE IPR2022-007221
`Epstein, M.D., Michael Samuel
`
`April 11, 2023
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` THE WITNESS: That's such a broad
`question. I can't answer that question because
`there's many facets that go into that. I work for
`the FDA advisory committee that gives the
`recommendations to approve drugs for GI and
`urologic drugs. And we review many different
`lines of evidence.
` So is it solely the FDA's purview? Many
`different -- there's many different -- hundreds of
`steps to get to that point. So I wouldn't say
`it's just the FDA. It's the clinical studies.
`It's the research. It's the science. It's the PK
`data. It's, you know, the chemistry, all that.
`BY MS. OFFICER:
` Q. And so I want to be clear. I'm not
`asking you about you in particular, Dr. Epstein.
`I'm asking about the ordinarily skilled
`gastroenterologist and would that ordinarily
`skilled gastroenterologist rely on the FDA's
`determination of the stability of a pharmaceutical
`drug product.
` MR. TORCZON: Same objection.
`
`202-220-4158
`
`www.hendersonlegalservices.com
`
`Bausch Health Ireland Exhibit 2070, Page 31 of 84
`Mylan v. Bausch Health Ireland - IPR2022-00722
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`CASE IPR2022-007221
`Epstein, M.D., Michael Samuel
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`April 11, 2023
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` THE WITNESS: No. Because when we go to
`our medical meetings, we see all the science
`that's been published, an
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