UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`- - - - - - - - - - - - - - x
`TWI PHARMACEUTICALS, INC., :
` Petitioner : Case IPR2023-00049
`v. : (Patent 7,713,947 B2)
`MERCK SERONO S.A., : Case IPR2023-00050
` Patent Owner. : (Patent 8,377,903 B2)
`- - - - - - - - - - - - - - x
`
` *** CONFIDENTIAL ***
`
` DEPOSITION OF
` YOGESH DANDIKER, Ph.D.
` Minneapolis, MN
` Friday, May 24, 2024
` 9:30 a.m.
`
`Reported Stenographically By:
`Amy L. Larson, RPR, CCR, CSR
`Job No. 538879
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`EXHIBIT 1043, TWi
`IPR2023-00049, -00050
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`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`- - - - - - - - - - - - - - x
`TWI PHARMACEUTICALS, INC., :
` Petitioner : Case IPR2023-00049
`v. : (Patent 7,713,947 B2)
`MERCK SERONO S.A., : Case IPR2023-00050
` Patent Owner. : (Patent 8,377,903 B2)
`- - - - - - - - - - - - - - x
`
` *** CONFIDENTIAL ***
`
` DEPOSITION OF
` YOGESH DANDIKER, Ph.D.
` Minneapolis, MN
` Friday, May 24, 2024
` 9:30 a.m.
`
`Reported Stenographically By:
`Amy L. Larson, RPR, CCR, CSR
`Job No. 538879
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`CONFIDENTIAL
`Transcript of Yogesh Dandiker, Ph.D.
`Conducted on May 24, 2024
`
`2
`
`Deposition of YOGESH DANDIKER, Ph.D., held at the
`office of:
`
` Fabyanske, Westra, Hart & Thomson, P.A.,
` 80 South Eighth Street
` Suite 1900
` Minneapolis, MN 55402
`
` Pursuant to Notice, before Amy L. Larson,
`Registered Professional Reporter, Certified
`Court Reporter, Certified Shorthand Reporter, and
`Notary Public in and for the States of Minnesota
`and Wisconsin.
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`EXHIBIT 1043, TWi
`IPR2023-00049, -00050
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`
`
`CONFIDENTIAL
`Transcript of Yogesh Dandiker, Ph.D.
`Conducted on May 24, 2024
`
`3
`
`A P P E A R A N C E S:
`ON BEHALF OF THE PETITIONER:
` PHILIP SEGREST, ESQUIRE
` HUSCH BLACKWELL, LLP
` 120 South Riverside Plaza
` Suite 2200
` Chicago, IL 60606
`
`ON BEHALF OF YOGESH DANDIKER, PH.D., AND THE
`PATENT OWNER:
` MARY PHENG, ESQUIRE
` ASHER MCGUFFIN, ESQUIRE (Boston) (via Zoom)
` WILMER CUTLER PICKERING HALE AND DORR, LLP
` 7 World Trade Center
` 250 Greenwich Street
` New York, NY 10007
`
`ALSO PRESENT:
` Malcolm Cooke, Technician
` Rachel Carrick, Technician (via Zoom)
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`IPR2023-00049, -00050
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`CONFIDENTIAL
`Transcript of Yogesh Dandiker, Ph.D.
`Conducted on May 24, 2024
`
`4
`
`INDEX:
`EXAMINATION BY: PAGE
`Mr. Segrest 5, 142
`Ms. Pheng 127
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`CONFIDENTIAL
`Transcript of Yogesh Dandiker, Ph.D.
`Conducted on May 24, 2024
`
`5
`
` P R O C E E D I N G S
`
` YOGESH DANDIKER, Ph.D.,
` after having been first duly sworn to
` tell the truth, the whole truth and
` nothing but the truth, was examined and
` testified as follows:
`
` EXAMINATION
`BY MR. SEGREST:
`Q. Good morning, Dr. Dandiker. My name is
` Philip Segrest. I'll be asking you some
` questions this morning.
` You've been deposed previously,
` right?
`A. Yes.
`Q. So it's the same type of setup. I'll ask
` questions, you'll answer questions. If for
` some reason your attorney objects to a
` question, which they may need to do, you
` should still answer unless you're
` specifically instructed by your attorney not
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`CONFIDENTIAL
`Transcript of Yogesh Dandiker, Ph.D.
`Conducted on May 24, 2024
`
`6
`
` to answer.
` If at any point you need to take a
` break, then let me know --
`A. Okay.
`Q. -- we can take a break. I'll probably ask
` you to answer any pending question --
`A. Sure.
`Q. -- before a break, but it's not meant to be
` an endurance test.
`A. Yeah.
`Q. We've got the court reporter here, who is
` taking down everything I say, everything you
` say. We need to try to not to speak over
` each other.
`A. Okay.
`Q. You need to give verbal answers, "yes" or
` "no," not nodding or shaking your head.
`A. Sure.
`Q. Do you have any questions about the
` deposition process?
`A. Not -- not at this stage, no.
`Q. Is there any reason you could not testify
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`CONFIDENTIAL
`Transcript of Yogesh Dandiker, Ph.D.
`Conducted on May 24, 2024
`
`7
`
` fully and accurately today?
`A. No.
`Q. You're not on any kind of medication that
` could affect your testimony or anything like
` that?
`A. No.
`Q. Okay. Now, are you familiar with the IPR
` cases in which you submitted a declaration,
` the reason we're here today?
`A. Yes. To some extent, yes.
`Q. And how many times have you been deposed
` before overall?
`A. Before this, twice before.
`Q. Okay. Once of those was in another IPR on
` these same patents, right?
`A. Sorry, let me just qualify that. So that is
` twice before any -- any cases related to this
` particular issue.
`Q. Okay.
`A. So they were on different products.
`Q. And have you ever testified at trial?
`A. I have not.
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`CONFIDENTIAL
`Transcript of Yogesh Dandiker, Ph.D.
`Conducted on May 24, 2024
`
`8
`
`Q. What was the first time you were deposed?
`A. You mean in terms of time?
`Q. Yeah. When was it?
`A. It must have been about five years ago, I
` guess.
`Q. And what was that about?
`A. It was about a product I developed.
`Q. Is that product public at this point?
`A. Yeah, it was -- it was a deposition related
` to venlafaxine.
`Q. And when was the next time you were deposed?
`A. So I think it was after -- about a year after
` that.
`Q. And what was that deposition about?
`A. It was similar. I can't really recall the
` product, but venlafaxine was part of that
` deposition.
`Q. And then were you also deposed in February of
` this year by Hopewell about these same
` patents?
`A. Yes.
`Q. And that's another proceeding, but you also
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`CONFIDENTIAL
`Transcript of Yogesh Dandiker, Ph.D.
`Conducted on May 24, 2024
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`9
`
` submitted a declaration in that proceeding,
` right?
`A. Yes.
`Q. Have you been deposed in any district court
` litigations about cladribine or about these
` patents?
`A. No. The only thing -- again, it's only the
` depositions which are related to these IPR
` cases. So when you say district court,
` I'm -- it was two depositions.
`Q. Okay. But these IPR proceedings are in front
` of the United States Patent and Trademark
` Office. You can also have lawsuits about
` patents, and there are some lawsuits pending
` in various courts about these patents.
` But you haven't been deposed in those
` lawsuits, right?
`A. No, I've just had two depositions so far, and
` this is the third one.
`Q. Have you been asked to collect any documents
` or have you turned over any documents to
` attorneys that you may have related to these
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`CONFIDENTIAL
`Transcript of Yogesh Dandiker, Ph.D.
`Conducted on May 24, 2024
`
`10
`
` patents?
` MS. PHENG: Objection. I just
` want to caution the witness to not reveal the
` substance of any attorney/client
` communications, but you may answer.
` MR. SEGREST: And just for the
` record, I'll point out this is a third-party
` witness. And there may be some issues
` about -- about privilege, but I think you can
` answer this question without --
` THE WITNESS: Yeah, no, I don't
` have any documents.
`BY MR. SEGREST:
`Q. Okay. What did you do to prepare for your
` testimony today?
`A. So I had -- you know, I had, you know, some
` practice sessions with my counsel.
`Q. When were those practice sessions?
`A. It was yesterday.
`Q. And how long did that take?
`A. Oh, that was about, I don't know, four hours.
`Q. With whom did you meet?
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`CONFIDENTIAL
`Transcript of Yogesh Dandiker, Ph.D.
`Conducted on May 24, 2024
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`11
`
`A. Sorry?
`Q. With whom, the names of the people that you
` were doing a practice session with?
`A. The attorney sitting here, and online with
` Asher McGuffin, who is connected.
`Q. And did you review any documents during that
` preparation time?
`A. Only what we had reviewed before.
`Q. And so does that include the declaration you
` submitted in this IPR?
`A. The focus really much more was on, you know,
` some of the other documents which had been
` provided to me previously by counsel.
`Q. Okay. Did you review any documents that are
` not cited in your declaration that you
` submitted?
`A. I did not, no.
`Q. I'm handing you what's been previously marked
` as Merck 20 --
` THE COURT REPORTER: I'm sorry,
` 2025?
` MR. SEGREST: 2055.
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`CONFIDENTIAL
`Transcript of Yogesh Dandiker, Ph.D.
`Conducted on May 24, 2024
`
`12
`
`BY MR. SEGREST:
`Q. And let me direct you to the page labeled
` number 13 at the bottom.
` So is this your signature on page 13?
`A. Yes.
`Q. And then turning back to the cover, is this
` declaration you signed one that was filed in
` IPR 2023-00049?
`A. Yes.
`Q. Okay. And if I call this Exhibit 2055, or
` 2055, you'll know what I'm referring to,
` right?
`A. Yeah.
`Q. And do you understand that IPR 2023-00049
` concerns U.S. Patent Number 7,713,947?
`A. Yeah.
`Q. Now, if I call those the '049 IPR and
` the '947 patent, will you understand what I'm
` referring to?
`A. Yeah.
`Q. Okay. Now, you see in the middle on the
` cover here that it also lists IPR 2023-00050?
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`CONFIDENTIAL
`Transcript of Yogesh Dandiker, Ph.D.
`Conducted on May 24, 2024
`
`13
`
`A. Yes.
`Q. Okay. And did you sign just this one
` declaration that was filed in both of the
` IPRs?
`A. I would say that I signed two declarations,
` and there are some changes, be it minor, in
` this one.
`Q. Okay. So the two declarations, was one of
` those for the IPRs for which you were deposed
` back in February?
`A. Yes.
`Q. Okay. And then the IPR that you're being
` deposed on today, that was the second
` declaration?
`A. Yes.
`Q. And that's this Exhibit 2055 that we're
` looking at here?
`A. Yeah.
`Q. Okay. And that's the -- that same
` declaration was filed both in IPR 2023-00049
` and IPR 2023-00050; is that correct?
` MS. PHENG: Objection to form.
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`CONFIDENTIAL
`Transcript of Yogesh Dandiker, Ph.D.
`Conducted on May 24, 2024
`
`14
`
` THE WITNESS: For this particular
` event, yes.
`BY MR. SEGREST:
`Q. Okay. And you understand IPR 2023-00050
` concerns U.S. Patent Number 8,377,903?
`A. Yes.
`Q. So if I call that the '050 IPR and the '903
` patent, will you understand what I'm talking
` about?
`A. Yeah.
` MR. SEGREST: Are you able to hear
` the witness okay?
` THE COURT REPORTER: (Nods head.)
` MR. SEGREST: Okay.
`BY MR. SEGREST:
`Q. Let's turn to page 13 again in Exhibit 2055.
` And let me direct you to paragraph 31 right
` above your signature there.
` Do you see that?
`A. Right.
`Q. Now, does the first clause in that sentence
` say that, "The statements made herein of my
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`CONFIDENTIAL
`Transcript of Yogesh Dandiker, Ph.D.
`Conducted on May 24, 2024
`
`15
`
` knowledge are true"?
`A. Yes.
`Q. Okay. And then there's the second clause
` here, right, that says, "Statements made on
` information and belief are believed to be
` true," right?
`A. Yes.
`Q. So does that mean that some of the statements
` in this declaration are based on information
` believed and not your personal knowledge?
` MS. PHENG: Objection to form.
` THE WITNESS: Yes, I would say
` that.
`BY MR. SEGREST:
`Q. Okay. Let's go back to paragraph 4 on
` page 1.
` You're being paid $800 an hour --
`A. Right.
`Q. -- on this case, right?
`A. Yes.
`Q. And how much have you been paid so far?
`A. Oh, I would say -- I don't know. It must be
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`CONFIDENTIAL
`Transcript of Yogesh Dandiker, Ph.D.
`Conducted on May 24, 2024
`
`16
`
` 10, 15,000, something like that. I really
` don't know.
`Q. Okay. And is that just for this case or is
` that for this and the other two IPRs?
`A. Oh, it is for everything.
`Q. Okay. About how many hours did you spend on
` this declaration that is Exhibit 2055 before
` it was filed?
`A. Well, this was a little easier, because I had
` already done one declaration. So it is
` really going through the previous one and
` seeing whether, you know, changes need to be
` made. So I would say three, four hours.
`Q. And how long did you spend on the previous
` one?
`A. It was several days, because there were a
` number of iterations.
`Q. Do you have an idea how many hours you spent
` on it?
`A. By "several days," I mean over several days.
` How many hours? I'd say three, four hours.
`Q. Okay. And were you also paid for your time
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`CONFIDENTIAL
`Transcript of Yogesh Dandiker, Ph.D.
`Conducted on May 24, 2024
`
`17
`
` preparing for and testifying for that
` previous deposition?
`A. Yes.
`Q. And you'll be paid for your time preparing
` for and testifying today, right?
`A. Yes.
`Q. About how much time did you spend on the
` preparation and testimony for that last
` deposition?
`A. Sorry, for the last deposition?
`Q. Yeah.
`A. So I just want to be clear, so this -- the
` first one was related to IPR, then there was
` a district court one, and then there is this
` one.
`Q. Okay.
`A. So are you referring to a district court one
` or --
`Q. No, I'm referring to the IPR one.
`A. Yeah, that was actually, I would say, I don't
` know, maybe 15 hours or so.
`Q. Okay. Were you also deposed in the district
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`CONFIDENTIAL
`Transcript of Yogesh Dandiker, Ph.D.
`Conducted on May 24, 2024
`
`18
`
` court matter?
`A. Yes.
`Q. Okay. And when was that deposition?
`A. That was -- I can't remember the exact date,
` but I would say, I don't know, a couple of
` months ago.
`Q. Okay. And were you paid at this same $800 an
` hour for that?
`A. Yes.
`Q. And about how many hours did you spend in
` your preparation for and testimony for that
` district court deposition?
`A. That was fairly short, I would say, and it
` was remote. So it was -- wasn't as much
` time, really. So there was five, six hours
` really, so less.
`Q. Were you asked about any documents during
` that deposition?
` MS. PHENG: Objection. I just
` want to caution the witness not to reveal the
` substance of any attorney/client
` communications.
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`CONFIDENTIAL
`Transcript of Yogesh Dandiker, Ph.D.
`Conducted on May 24, 2024
`
`19
`
` THE WITNESS: May I answer or --
`BY MR. SEGREST:
`Q. Yes.
`A. Yes, we did -- well, let me just again
` clarify --
` MS. PHENG: And, Dr. Dandiker, as
` well, that proceeding was sealed. So you may
` answer whether you were asked about
` documents, but please don't reveal the
` contents of any documents.
` THE WITNESS: Okay.
` Documents were referred to.
`BY MR. SEGREST:
`Q. Okay. So and without telling me the
` contents, what documents were you asked
` about?
`A. I think they were the same as the IPR.
`Q. Were you asked in that district court
` deposition about any documents that are not
` cited in your IPR declarations?
`A. No.
`Q. Other than the time relating to your
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`CONFIDENTIAL
`Transcript of Yogesh Dandiker, Ph.D.
`Conducted on May 24, 2024
`
`20
`
` declarations and the district court matter,
` have you been compensated for any other
` consulting work in relation to the
` litigations concerning these patents?
`A. No.
`Q. Have you been paid by Merck Serono for any
` other sort of consulting or other work that
` you've done for them?
`A. No.
`Q. Let's turn to paragraph 9 in your deposition
` just for reference, 9 and 10 on page 3.
` MS. PHENG: Sorry, Counsel, did
` you mean declaration?
` MR. SEGREST: Yes. I'm sorry.
` What did I say?
` MS. PHENG: I heard "deposition."
` MR. SEGREST: I definitely meant
` declaration, if I misspoke.
`BY MR. SEGREST:
`Q. So paragraphs 9 and 10 of your declaration,
` page 3.
`A. Thank you.
`
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`Transcript of Yogesh Dandiker, Ph.D.
`Conducted on May 24, 2024
`
`21
`
`Q. So did you work at IVAX from 2001 to 2004?
`A. Yes, I did.
`Q. And was your job at IVAX director of research
` and development?
`A. Yes.
`Q. Now, in paragraph -- let's turn to
` paragraph 14. Here you refer to a joint
` development agreement, right?
`A. Yes.
`Q. Okay. And it's called a product development
` and license agreement, right?
`A. Yeah.
`Q. Now, in paragraph 14 you don't cite to a copy
` of that agreement, do you?
`A. I don't.
`Q. Okay. Were you asked to review a copy of
` that agreement?
`A. No.
`Q. Do you have a copy of that agreement?
`A. I have seen it, but I -- I wasn't a party to
` any discussions regarding that document
` when -- when the agreement was made.
`
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`Conducted on May 24, 2024
`
`22
`
`Q. When have you seen that agreement?
`A. I may have seen it certainly through my time
` at IVAX, but also more recently, you know,
` during preparation with counsel.
`Q. Okay. So you did see that agreement during
` your preparation with counsel?
`A. I think I may have seen it.
`Q. Okay. That agreement is not cited anywhere
` in your declaration, is it?
`A. No.
`Q. Okay. Are there any other documents that you
` have seen in connection with this matter that
` are not cited in your declaration?
` MS. PHENG: Objection. I caution
` the witness not to reveal the substance of
` any attorney/client communication, and I'm
` going to instruct you not to answer.
` THE WITNESS: I have to go by what
` my counsel says.
` MR. SEGREST: So you're
` instructing him not to tell me whether he's
` seen any other documents that weren't cited?
`
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`Conducted on May 24, 2024
`
`23
`
` MS. PHENG: I'm instructing him
` not to provide any privileged communications
` and reveal any attorney/client
` communications, so, yes.
` MR. SEGREST: Okay. And the
` question didn't ask for him to identify the
` documents. You just -- you consider whether
` he's reviewed documents to be privileged?
` MS. PHENG: If you want to reask
` your question, then we can reevaluate it.
`BY MR. SEGREST:
`Q. Did you communicate any confidential
` information to any attorneys about those
` other documents you may have reviewed?
` MS. PHENG: Objection to form.
` THE WITNESS: Can you rephrase the
` question?
` MR. SEGREST: No.
` THE WITNESS: Can you repeat it?
` MR. SEGREST: Yes.
`BY MR. SEGREST:
`Q. Did you reveal any confidential information
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`CONFIDENTIAL
`Transcript of Yogesh Dandiker, Ph.D.
`Conducted on May 24, 2024
`
`24
`
` to attorneys about any of those other
` documents you might have reviewed?
` MS. PHENG: Objection to form.
` And same caution, please don't reveal
` the substance of any communications with
` counsel.
` THE WITNESS: I don't have any
` confidential information.
`BY MR. SEGREST:
`Q. Okay. Did you request any legal advice from
` attorneys about any of those other documents
` that you may have reviewed?
` MS. PHENG: Objection to form.
` Objection; privileged.
` Please don't reveal the substance of
` any communications with counsel. And I will
` instruct you not to answer.
` MR. SEGREST: So you understand
` this is the foundation for privilege? If he
` hasn't communicated confidential information
` or received a legal opinion, there is no
` privilege.
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`Conducted on May 24, 2024
`
`25
`
` MS. PHENG: Counsel, I --
` MR. SEGREST: I'm entitled to ask
` about that.
` MS. PHENG: Counsel, I think that
` you're pushing the boundaries here, and I
` think you're aware of our privilege
` objections in this case, and I'm going to
` instruct him not to answer.
` MR. SEGREST: Okay. I think we've
` got a call scheduled with the Board on
` Tuesday, so we'll probably want to get an
` expedited transcript and we'll raise it with
` them then.
`BY MR. SEGREST:
`Q. Getting back to that product development and
` license agreement, you didn't sign that on
` behalf of IVAX, right?
`A. No.
`Q. Do you know who did sign it?
`A. No.
`Q. And none of your testimony in this
` declaration, Exhibit 2055, cites to any
`
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`Transcript of Yogesh Dandiker, Ph.D.
`Conducted on May 24, 2024
`
`26
`
`term -- or quotes any terms from that
`
`document, right?
`
`I mean, again,
`
`to be clear,
`
`that is a
`
`business transaction, and I was aware of the
`
`transaction, but the substance or the content
`
`is really, you know, not my area.
`
`Okay.
`
`So it's not your area. And with
`
`reference to your declaration, Exhibit 2055,
`
`none of your testimony in this quotes from
`
`that document, right?
`
`Yes.
`
`Right.
`
`And you don't specify any clauses in that
`
`document that identify particular roles for
`
`IVAX and Serono at that time, right?
`
`I -- yes,
`
`that is correct,
`
`I don't reference
`
`to that document for any roles.
`
`Now,
`
`in paragraph 14,
`
`the last sentence --
`
`Right.
`
`-- you say Serono's role was to design and
`
`develop a dosing regimen for treating MS with
`
`cladribine, right?
`
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`Transcript of Yogesh Dandiker, Ph.D.
`Conducted on May 24, 2024
`
`27
`
`Now, did you supervise the people at Serono
`
`who were developing that dosing regimen?
`
`No,
`
`they're a different company.
`
`So do you have any personal knowledge of what
`
`specific individual contributed what to the
`
`development of any dosing regimen at Serono?
`
`I would -- I would hesitate to answer that.
`
`It's -- Serono is a large company. And,
`
`again,
`
`just to clarify things,
`
`IVAX
`
`predominantly was a -- company --
`
`THE COURT REPORTER:
`
`A generic
`
`company?
`
`expertise in that area, and Serono was -- was
`
`THE WITNESS:
`
`A generic company,
`
`and so they developed generic products. And
`
`my responsibility was largely developing
`
`generic products.
`
`Cladribine is -- you know, was really
`
`a one-off. And IVAX had the expertise to
`
`develop generic products, but really did not
`
`have the capability to develop cladribine.
`
`As a result,
`
`IVAX searched for partners with
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`Transcript of Yogesh Dandiker, Ph.D.
`Conducted on May 24, 2024
`
`28
`
`deemed to be that partner.
`
`Serono had a
`
`product already in multiple sclerosis on the
`
`market and, you know,
`
`they were the experts.
`
`So when it came to responsibilities,
`
`our responsibilities were more -- certainly,
`
`mine was to develop a formulation. And for
`
`IVAX as a whole is to, you know, conduct some
`
`of the early pharmacokinetic studies to prove
`
`that our formulation worked or formulations
`
`worked. And so we looked at a number of
`
`options.
`
`formulation, but also to see whether it could
`
`But when it came to developing the
`
`clinical protocols,
`
`the clinical regimen,
`
`the -- you know, doing, let's say, phase II,
`
`phase III trials,
`
`that was not our
`
`responsibility,
`
`that was Serono's, as well as
`
`the other aspects, which is, you know,
`
`regulatory, marketing, commercialization.
`
`And, you know,
`
`so that -- that is how
`
`the project came into being. And my
`
`particular role was really to develop a
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`Transcript of Yogesh Dandiker, Ph.D.
`Conducted on May 24, 2024
`
`29
`
`even be developed as an -- product.
`
`THE COURT REPORTER:
`
`A what
`
`product?
`
`THE WITNESS: Oral.
`
`THE COURT REPORTER: Oral?
`
`THE WITNESS: Yeah.
`
`So, effectively, that's how
`
`this is how it is, and the
`
`responsibilities were divided.
`
`BY MR. SEGREST:
`
`Q. Okay.
`
`Thank you for that background and
`
`explanation.
`
`Does that mean that,
`
`in answer to my
`
`question that I asked,
`
`that you don't know
`
`what particular individuals over at Serono
`
`contributed what particular details to any
`
`given dosing regimen?
`
`MS. PHENG: Objection to form.
`
`THE WITNESS: Yeah,
`
`I would agree
`
`to that to some extent, but I would qualify
`
`that by saying that drug development is a
`
`team sport. Often,
`
`there's no one individual
`
`who says, Look,
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`Transcript of Yogesh Dandiker, Ph.D.
`Conducted on May 24, 2024
`
`30
`
`whole company -- and this is a company of,
`
`you know, several thousand people -- who
`
`would say, Yes, sir. Right? There's a lot
`
`of back and forth and a lot of discussion
`
`before something is arrived at.
`
`So when you ask the question, you
`
`know, who is that person responsible for, it
`
`is usually not a person, it is a team anda
`
`team of experts. And I think it's rightly so
`
`that people have different views and express
`
`differing opinions before we come with a
`
`better solution.
`
`Some are clinical and some are also not
`
`So when you ask the question, you
`
`know, was there one single individual,
`
`I
`
`would say there was a team at Serono who came
`
`up with -- you know, with a dosing regimen,
`
`as with other things, you know.
`
`For instance,
`
`the dosing regimen is
`
`only one part of a clinical protocol, and
`
`that takes a lot of work and a lot of time
`
`and a lot of input from a lot of people.
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`Transcript of Yogesh Dandiker, Ph.D.
`Conducted on May 24, 2024
`
`31
`
`clinical.
`
`So that does not mean that it's
`
`come from one person.
`
`BY MR. SEGREST:
`
`this is the kind of
`
`Q. Okay. And on the whole team that's working
`
`on that dosing regimen over at Serono, you
`
`wouldn't know what individuals contributed
`
`what information to that, right?
`
`MS. PHENG: Objection to form.
`
`THE WITNESS:
`
`I did interact with
`
`people at Serono and -- you know, and
`
`particularly a couple of people. And most of
`
`those interactions were about, you know, our
`
`work. And it was important for both
`
`organizations to know exactly what was
`
`happening, because one company's work
`
`determined, you know,
`
`the outcome for the
`
`other company.
`
`So, yeah, for instance, when we were
`
`developing the formulations,
`
`I had a number
`
`of calls with Serono, you know,
`
`this -- I was
`
`calling, This is working,
`
`this is not
`
`working, you know,
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`Transcript of Yogesh Dandiker, Ph.D.
`Conducted on May 24, 2024
`
`32
`
`timeline we are looking for,
`
`looking at.
`
`And, you know, and they were saying, Look,
`
`this is -- these are our needs.
`
`So those kind of discussions, you
`
`know, were occurring all the time.
`
`BY MR. SEGREST:
`
`Q. Okay. And so are those kinds of discussions
`
`both Serono and IVAX keeping each other
`
`abreast of their project -- of their progress
`
`on the project?
`
`Yeah.
`
`Okay. But that doesn't include necessarily
`
`knowing what particular individual came up
`
`with some particular idea that's included,
`
`my experience, you don't say -- point the
`
`right?
`
`It's --
`
`MS. PHENG: Objection to form.
`
`THE WITNESS: Sorry.
`
`It's -- in normal course of work, and
`
`particularly, you know,
`
`I'm a scientist, and
`
`within companies you never -- certainly,
`
`in
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`Transcript of Yogesh Dandiker, Ph.D.
`Conducted on May 24, 2024
`
`33
`
`finger to one person and say, Look,
`
`this is
`
`all one person's work, because then you
`
`wouldn't need anybody, right, you just say,
`
`Look,
`
`that person develop it so nobody needs
`
`to get involved. That is really not the
`
`case.
`
`BY MR. SEGREST:
`
`Yes.
`
`I want to circle back to the --
`
`Sure.
`
`-- explanation you gave earlier.
`
`You said that IVAX was mainly a
`
`generic company?
`
`Yes.
`
`Do you mean that they mainly worked on
`
`developing generic pharmaceuticals?
`
`Yes.
`
`And so just to understand, generic
`
`pharmaceuticals, does that mean developing a
`
`generic version of something that some other
`
`company had previously developed and brought
`
`to market?
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`Conducted on May 24, 2024
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`34
`
`And so we can -- can we call that earlier
`
`version the brand version?
`
`Yes.
`
`So when you're developing a generic version,
`
`you don't have to do all of these same
`
`phase I, phase II, phase III trials, right?
`
`Yes.
`
`So the -- what you have to do is you
`
`have to have a bioequivalent product, which
`
`the context of a -- product is --
`
`THE COURT REPORTER: Did you say
`
`brown product?
`
`THE WITNESS: Brand.
`
`THE COURT REPORTER: Brand?
`
`THE WITNESS: Yeah. And in the
`
`is that why they didn't
`
`context of a brand product, it is -- you
`
`know, it's construed as phase I for a brand.
`
`For a generic, you know, often that
`
`is the only study you have to do to show your
`
`product is bioequivalent.
`
`BY MR. SEGREST:
`
`Q. And is -- so the fact that
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