`
`Merck KGaA et al. v. Hopewell Pharma Ventures, Inc. et al.
`Highly Confidential - Under the Protective Order
`
`Nicholas Bodor, Pharm. D.
`
`Page 1
`
` IN THE UNITED STATES DISTRICT COURT
` FOR THE DISTRICT OF DELAWARE
`-----------------------------x
`MERCK KGaA, MERCK SERONO SA, :
`and ARES TRADING SA, :
` :
` Plaintiffs, : Civil Action No.
` vs. :
` : 1:22-cv-01365
`HOPEWELL PHARMA VENTURES, : GBW-CJB
`INC., et al., :
` :
` Defendants. :
`-----------------------------x
`
` ** HIGHLY CONFIDENTIAL **
` ** UNDER THE PROTECTIVE ORDER **
`
` REMOTE VIDEOTAPED DEPOSITION OF
` NICHOLAS BODOR, Pharm. D.
` Thursday, April 18, 2024
` 9:58 a.m. Eastern Daylight Time
`
`REPORTER: Dawn A. Jaques, CSR, CLR
`
`______________________________________________________
` DIGITAL EVIDENCE GROUP
` 1730 M Street, NW, Suite 812
` Washington, D.C. 20036
` (202) 232-0646
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2024
`
`202-232-0646
`
`EXHIBIT 1041, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`4/18/2024
`
`Merck KGaA et al. v. Hopewell Pharma Ventures, Inc. et al.
`Highly Confidential - Under the Protective Order
`
`Nicholas Bodor, Pharm. D.
`
`Page 2
`
`APPEARANCES:
`On behalf of the Plaintiffs:
` WILMER CUTLER PICKERING HALE & DOOR
` By: Asher S. McGuffin, ESQ.
` 60 State Street
` Boston, Massachusetts 02109
` (617) 526-6201
` asher.mcguffin@wilmerhale.com
`
` WILMER CUTLER PICKERING HALE & DORR
` By: Mary Pheng, ESQ.
` 250 Greenwich Street, 45th Floor
` New York, New York 10007
` (212) 295-6408
` mary.pheng@wilmerhale.com
`
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`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2024
`
`202-232-0646
`
`EXHIBIT 1041, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`4/18/2024
`
`Merck KGaA et al. v. Hopewell Pharma Ventures, Inc. et al.
`Highly Confidential - Under the Protective Order
`
`Nicholas Bodor, Pharm. D.
`
`Page 3
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`APPEARANCES (Continued):
`On behalf of Defendants Aurobindo Pharma U.S.A
`Inc. and Aurobindo Pharma Limited:
` PERGAMENT & CEPEDA LLP
` By: Thomas Gabriel, ESQ.
` Dmitry V. Shelhoff, ESQ.
` Catharina J. Chin Eng, ESQ.
` 25A Hanover Road, Suite 104
` Florham Park, New Jersey 07932
` (973) 998-7722
` tgabriel@pergamentcepeda.com
` dshelhoff@pergamentcepeda.com
` cchineng@pergamentcepeda.com
`
`On behalf of Defendants Apotex Inc. and
`Apotex Corp.:
` TAFT STETTINIUS & HOLLISTER LLP
` By: Ian Scott, ESQ.
` 200 Massachusetts Avenue, NW, Suite 500
` Washington, D.C. 20001
` (917) 534-7181
` iscott@taftlaw.com
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2024
`
`202-232-0646
`
`EXHIBIT 1041, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`4/18/2024
`
`Merck KGaA et al. v. Hopewell Pharma Ventures, Inc. et al.
`Highly Confidential - Under the Protective Order
`
`Nicholas Bodor, Pharm. D.
`
`Page 4
`
`APPEARANCES (Continued):
`On behalf of Defendants Apotex Inc. and
`Apotex Corp.:
` TAFT STETTINIUS & HOLLISTER LLP
` By: Jaimin H. Shah, ESQ.
` 111 E Wacker Drive
` Suite 2600
` Chicago, Illinois 60601-4208
` (312) 836-4171
` jshah@taftlaw.com
`
`VIDEOGRAPHER AND DIGITAL EXHIBIT TECHNICIAN:
` Henry Marte, Digital Evidence Group
`
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`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2024
`
`202-232-0646
`
`EXHIBIT 1041, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`4/18/2024
`
`Merck KGaA et al. v. Hopewell Pharma Ventures, Inc. et al.
`Highly Confidential - Under the Protective Order
`
`Nicholas Bodor, Pharm. D.
`
`Page 5
`
` I-N-D-E-X
`WITNESS: PAGE:
`Nicholas Bodor, Pharm.C.
` Examination by Mr. Gabriel 8, 84, 94
` Examination by Mr. McGuffin 58, 92
`
` E-X-H-I-B-I-T-S
`BODOR DEPOSITION EXHIBIT: PAGE:
`Exhibit 1 PCT WO 2004/087101 (56 pages)
` (Previously marked Hopewell
` Exhibit 1022)
` MAVMRK_003937937 - 003937992 14
`
`Exhibit 2 PCT WO 2004/087100 (63 pages)
` (No Bates number) 38
`
`Exhibit 3 U.S. Patent 8,623,408
` (No Bates number) (22 pages) 39
`
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`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2024
`
`202-232-0646
`
`EXHIBIT 1041, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`4/18/2024
`
`Merck KGaA et al. v. Hopewell Pharma Ventures, Inc. et al.
`Highly Confidential - Under the Protective Order
`
`Nicholas Bodor, Pharm. D.
`
`Page 6
`
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` P R O C E E D I N G S
` THE VIDEOGRAPHER: Okay, we are now
` on the record. My name is Henry Marte. I'm a
` videographer on behalf of Digital Evidence
` Group. Today's date is April 18th, 2024, and
` the time is 9:58 a.m.
` This deposition is being held in the
` matter of Merck, et al., v. Hopewell
` Pharmaceutical Ventures, Inc., et al. The
` deponent today is Dr. Nicholas Bodor.
` All parties to this deposition are
` appearing remotely and have agreed to the
` witness being sworn in remotely.
` Counsel, please identify themselves
` for the record, after which the court reporter
` will administer the oath to the witness.
` MR. GABRIEL: Good morning,
` everyone.
` MR. McGUFFIN: Oh, sorry, go ahead.
` MR. GABRIEL: Good morning. My name
` is Thomas Gabriel from Pergament & Cepeda
` on behalf of Defendant Aurobindo.
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2024
`
`202-232-0646
`
`EXHIBIT 1041, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`4/18/2024
`
`Merck KGaA et al. v. Hopewell Pharma Ventures, Inc. et al.
`Highly Confidential - Under the Protective Order
`
`Nicholas Bodor, Pharm. D.
`
`Page 7
`
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` Also with me remotely is Cathy
` Chin Eng, also from the same firm.
` MR. SHELHOFF: I'm Dmitry Shelhoff
` from Pergament & Cepeda, also on behalf
` of Aurobindo defendant.
` MR. SCOTT: Yeah, you got Ian Scott
` of Taft Stettinius & Hollister,
` representing Apotex, and I'm here also
` with Jaimin Shah of Taft.
` MR. McGUFFIN: And I'm Asher S.
` McGuffin of Wilmer Cutler Pickering
` Hale & Dorr on behalf of Dr. Bodor.
` I'm almost also joined by my
` colleague, Mary Pheng, and I'm also on
` behalf Merck Group.
` THE REPORTER: Okay, Dr. Bodor, if
` you will please raise your right hand to
` be sworn.
` (The witness was administered the oath.)
` MR. McGUFFIN: And before we get
` going, I just want to quickly note on the
` record that counsel have discussed that
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2024
`
`202-232-0646
`
`EXHIBIT 1041, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`4/18/2024
`
`Merck KGaA et al. v. Hopewell Pharma Ventures, Inc. et al.
`Highly Confidential - Under the Protective Order
`
`Nicholas Bodor, Pharm. D.
`
`Page 8
`
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` because of Dr. Bodor's health, he is
` going to try to -- we're going to try to
` keep this deposition under one hour in
` length, and we expect parties to try to
` stick to that agreement, subject to any
` technical issues or any problems that
` arise.
` MR. GABRIEL: Yes, thank you,
` Counsel.
` And I also assume, for example, if
` you need to take any breaks, that
` wouldn't be included in the one-hour
` limit.
` MR. McGUFFIN: Sure.
` MR. GABRIEL: Thank you.
` EXAMINATION BY COUNSEL FOR DEFENDANT AUROBINDO
` BY MR. GABRIEL:
` Q Well, thank you, Dr. Bodor, for
` coming today. We understand that you
` previously provided a declaration in
` connection with IPR proceedings before the
` U.S. Patent Office relating to Merck's patents
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2024
`
`202-232-0646
`
`EXHIBIT 1041, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`4/18/2024
`
`Merck KGaA et al. v. Hopewell Pharma Ventures, Inc. et al.
`Highly Confidential - Under the Protective Order
`
`Nicholas Bodor, Pharm. D.
`
`Page 9
`
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` in IPR2023-0048 and IPR2023-00481.
` Does that sound correct?
` A Yes.
` Q And you also sat for a deposition in
` connection with those IPR proceedings earlier
` this year in February 2024; is that correct?
` A Yes.
` Q And you understand that you're here
` to testify in connection with the US patent
` litigation involving Merck's US patents
` 7,713,947 and 8,377,903; is that correct?
` A Yes.
` Q So since you've been deposed before,
` I won't go through the usual ground rules, but
` I just ask if you don't understand any of my
` questions, please let me know and I will
` rephrase; otherwise, I will assume that you
` understand my question. Is that fair?
` A Yes. Can I ask you something?
` Somehow I can't see you from your nose up.
` Q Sure, sure. Thank you for letting
` me know.
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2024
`
`202-232-0646
`
`EXHIBIT 1041, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`4/18/2024
`
`Merck KGaA et al. v. Hopewell Pharma Ventures, Inc. et al.
`Highly Confidential - Under the Protective Order
`
`Nicholas Bodor, Pharm. D.
`
`Page 10
` And, lastly, is there any reason why
` you cannot give truthful testimony today?
` A There is no reason.
` Q Great, thank you.
` So let's focus on the time period
` around the year 2000. In your IPR
` declaration, you stated that around that time
` in 2000, IVAX obtained the rights to develop
` cladribine for the treatment of MS, which
` previously belonged to Scripps and J&J.
` Does that sound correct?
` A Yes.
` Q So pursuant to obtaining those
` rights, are you aware of any information that
` IVAX may have obtained from Scripps relating
` to cladribine?
` MR. McGUFFIN: I object to form.
` THE WITNESS: I don't know. What I
` know what I described last time, that the
` Senior Vice President for Clinical
` Affairs, Dr. Steve Marcus, came to me and
` said that IVAX is in process of acquiring
`
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`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2024
`
`202-232-0646
`
`EXHIBIT 1041, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`4/18/2024
`
`Merck KGaA et al. v. Hopewell Pharma Ventures, Inc. et al.
`Highly Confidential - Under the Protective Order
`
`Nicholas Bodor, Pharm. D.
`
`Page 11
`
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` cladribine from Scripps for MS use, and
` IVAX is interested to do so if an oral
` formulation can be developed.
` And he asked me if -- at that time,
` I was just a new Senior VP for Chemical
` Research, and they asked me if I think we
` can do it, and I said yes.
` BY MR. GABRIEL:
` Q And that was in around the year
` 2000; is that correct?
` A Maybe it was 2001. 2000 was when we
` started, actually, and I think it's 2001. I
` don't remember the exact date.
`
`
`
`
`
`
`
`
` MR. McGUFFIN: If you could just
` pause, Dr. Bodor, to let me get my
` objection on the record before you start
` talking, that would be great.
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2024
`
`202-232-0646
`
`EXHIBIT 1041, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`4/18/2024
`
`Merck KGaA et al. v. Hopewell Pharma Ventures, Inc. et al.
`Highly Confidential - Under the Protective Order
`
`Nicholas Bodor, Pharm. D.
`
`Page 12
`
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` THE WITNESS: Okay.
` BY MR. GABRIEL:
` Q Thank you. So you mentioned about
` Dr. Marcus coming to you about developing an
` oral formulation, so that's your understanding
` of when the oral development of the
` formulation began?
` MR. McGUFFIN: Object to form.
` THE WITNESS:
`
`
`
`
` BY MR. GABRIEL:
` Q Okay. And besides Dr. Marcus,
` Dr. Dandiker was the other member of the team
` that you were working with on that project?
` A Dr. Dandiker came on the scene
` long -- later, and I actually didn't meet him
` for quite some time. He was located in
` Waterford, Ireland, another subsidiary of
` IVAX, and I understand that he started to work
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2024
`
`202-232-0646
`
`EXHIBIT 1041, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`4/18/2024
`
`Merck KGaA et al. v. Hopewell Pharma Ventures, Inc. et al.
`Highly Confidential - Under the Protective Order
`
`Nicholas Bodor, Pharm. D.
`
`Page 13
`
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` on it based on what I suggested to do.
` And I met him just once quite a bit
` later, I'd say in 2003 or something like that.
` Once he came to visit me in my office, that's
` all.
` MR. McGUFFIN: Yeah, just quickly
` object to form to the previous question.
` BY MR. GABRIEL:
` Q Thank you, Dr. Bodor.
` And did you have any other
` discussions with Dr. Dandiker other than that
` conversation in your office that you just
` mentioned?
` A Not as I recall, no.
` Q Any email correspondence with
` Dr. Dandiker other than that conversation?
` A I don't remember anything.
` Q All right. So let's turn to your
` PCT application.
` Henry, if you can pull up -- I
` believe it's Tab B.
` THE VIDEOGRAPHER: Tab B, right, as
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2024
`
`202-232-0646
`
`EXHIBIT 1041, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`4/18/2024
`
`Merck KGaA et al. v. Hopewell Pharma Ventures, Inc. et al.
`Highly Confidential - Under the Protective Order
`
`Nicholas Bodor, Pharm. D.
`
`Page 14
`
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` in bravo?
` MR. GABRIEL: Tab B, yes. And let's
` mark this as Exhibit 1.
` (Bodor Exhibit 1 was marked
` for identification.)
` BY MR. GABRIEL:
` Q Henry, I'm not seeing it fully on my
` screen with the Bates number on that. Is
` that -- thanks.
` So this document is PCT
` International Publication WO 2004/08710182.
` Dr. Bodor, do you recognize this
` document?
` A Yes.
` Q This is your Bodor -- is it okay if
` I refer to this application as the Bodor PCT?
` A Okay.
` Q So your work on cladribine, oral
` cladribine, led up to the invention disclosed
` in this document; is that correct?
` MR. McGUFFIN: Object to form.
` THE WITNESS: Could you repeat it?
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2024
`
`202-232-0646
`
`EXHIBIT 1041, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`4/18/2024
`
`Merck KGaA et al. v. Hopewell Pharma Ventures, Inc. et al.
`Highly Confidential - Under the Protective Order
`
`Nicholas Bodor, Pharm. D.
`
`Page 15
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` BY MR. GABRIEL:
` Q Is it fair to say that your work on
` the cladribine oral project led up to this --
` the invention disclosed in this PCT, in the
` Bodor PCT?
` MR. McGUFFIN: Object to form.
` THE WITNESS: Yes.
` BY MR. GABRIEL:
` Q Is it okay -- and the formulation
` disclosed in the Bodor PCT relates to a
` complex cladribine-cyclodextrin complex; is
` that correct?
` A I call it "complex-complex."
` Q Great, because that's what I was
` going to refer to it too for simplicity,
` "complex-complex." Going forward, we'll refer
` to it as that.
` And you and Dr. Dandiker are the
` sole named inventors on the complex-complex?
` A Yes.
` Q And just to get a sense of time
` frame, so IVAX acquired the rights in 2000.
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2024
`
`202-232-0646
`
`EXHIBIT 1041, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`4/18/2024
`
`Merck KGaA et al. v. Hopewell Pharma Ventures, Inc. et al.
`Highly Confidential - Under the Protective Order
`
`Nicholas Bodor, Pharm. D.
`
`Page 16
`
` My understanding -- and is it your
` understanding that Serono and IVAX entered
` into a Product Development Agreement around
` 2002?
` MR. McGUFFIN: Object to form.
` THE WITNESS: Well, I frankly don't
` know when actually IVAX acquired the
` project, and I don't know when agreement
` with Serono took place.
` BY MR. GABRIEL:
` Q Yeah. I believe in your declaration
` you referred to it as in the year of 2002.
` But at the time that they entered
` into an agreement, do you have any
` understanding of where the development of the
` oral cladribine project was?
` MR. McGUFFIN: Object to form.
` THE WITNESS: My recollection is
` that all the experiment, the
` physicochemical development, took place
` in Ireland, in Waterford.
`
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`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2024
`
`202-232-0646
`
`EXHIBIT 1041, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`4/18/2024
`
`Merck KGaA et al. v. Hopewell Pharma Ventures, Inc. et al.
`Highly Confidential - Under the Protective Order
`
`Nicholas Bodor, Pharm. D.
`
`Page 17
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` BY MR. GABRIEL:
` Q The formulation for the
` complex-complex, was that completed prior to
` the agreement with Merck? Serono, I should
` say.
` MR. McGUFFIN: Object to form.
` THE WITNESS: I told you I don't
` know when any agreement took place. I
` was not involved in the agreement part.
` BY MR. GABRIEL:
` Q Okay. So in your prior deposition,
` I believe you testified that the goal of the
` oral formulation for cladribine was to
` achieve a bioavailability of more than 30%; is
` that correct?
` A That was my understanding, yes.
` Q Would you agree that -- sorry to cut
` you off.
` A The important thing was also to be
` reproducible, or consistent to the person,
` because cladribine being sensitive to stomach
` acid, there is -- I believe there is
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2024
`
`202-232-0646
`
`EXHIBIT 1041, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`4/18/2024
`
`Merck KGaA et al. v. Hopewell Pharma Ventures, Inc. et al.
`Highly Confidential - Under the Protective Order
`
`Nicholas Bodor, Pharm. D.
`
`Page 18
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` variations from people to people.
` Q Thank you for that.
` Would you agree also that one
` couldn't determine the actual bioavailability
` of the complex-complex until you conducted
` human clinical trials?
` MR. McGUFFIN: Object to form.
` THE WITNESS: As I said in my
` deposition, we have done animal studies
` for bioavailability, and then did the
` analysis of the blood samples collected
` from clinical bioavailability studies
` done in Europe in different locations.
` BY MR. GABRIEL:
` Q And those clinical studies, those
` were studies in humans, correct?
` A Yes.
` Q So my question is you wouldn't know,
` would you -- you would agree that you wouldn't
` know the actual bioavailability of the
` complex-complex until you actually completed
` and analyzed the human clinical studies; is
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2024
`
`202-232-0646
`
`EXHIBIT 1041, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`4/18/2024
`
`Merck KGaA et al. v. Hopewell Pharma Ventures, Inc. et al.
`Highly Confidential - Under the Protective Order
`
`Nicholas Bodor, Pharm. D.
`
`Page 19
`
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` that correct?
` MR. McGUFFIN: Object to form. It
` calls for an opinion, not for the
` witness's -- his actual knowledge of what
` he knew and when.
` THE WITNESS: Actually, I mentioned
` before the bioavailability studies
` started with animal; namely, beagle dogs.
`
`
` And after the beagle dog studies
` demonstrated bioavailability over 30%,
` that's when I don't know who organized
` the human bioavailability studies.
` BY MR. GABRIEL:
` Q And can you confirm if you met the
` goal of achieving over 30% before a dosing in
` human subjects?
` MR. McGUFFIN: Object to form.
` THE WITNESS: First of all, the 30%
` is just a guideline. It's not a -- it
` was never stated that this is what we
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2024
`
`202-232-0646
`
`EXHIBIT 1041, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`4/18/2024
`
`Merck KGaA et al. v. Hopewell Pharma Ventures, Inc. et al.
`Highly Confidential - Under the Protective Order
`
`Nicholas Bodor, Pharm. D.
`
`Page 20
` have to do. Generally accepted that you
` have to achieve at least 30%, and --
` BY MR. GABRIEL:
` Q Well --
` A As I said, we did it -- or my
` people, my group in
` did the animal
` studies, and then did the analysis and the
` evaluation of the blood samples collected from
` human studies done in Europe, in
` and
`
`. I can't remember.
` Q So just to go back again, so is it
` fair to say, although maybe the dog studies
` gave you an indication of what the
` bioavailability could be, you couldn't
` determine the actual bioavailability in humans
` until you conducted the human clinical
` studies?
` MR. McGUFFIN: Object to form, calls
` for an opinion.
` THE WITNESS: I'm sorry, I really
` don't understand the question.
` I thought I was clear that we have
`
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`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2024
`
`202-232-0646
`
`EXHIBIT 1041, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`4/18/2024
`
`Merck KGaA et al. v. Hopewell Pharma Ventures, Inc. et al.
`Highly Confidential - Under the Protective Order
`
`Nicholas Bodor, Pharm. D.
`
`Page 21
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` done animal studies, followed by human
` studies, and that's how it was
` established what the bioavailability is.
` And all those studies, actually, are
` summarized in our final patent issued,
` I think in 2011.
` BY MR. GABRIEL:
` Q And I believe you testified those
` studies are also in the Bodor PCT here,
` correct?
` A I'm sorry, I don't remember. I
` never focused on the PCT, more the US patent
` application.
` Q Okay.
` A After --
` Q Yeah, let's take a look at the
` document, Doctor. Thank you.
` Henry, if you can --
` MR. McGUFFIN: I would just ask,
` I think you cut Dr. Bodor off there, or
` were you done speaking, Dr. Bodor?
` THE WITNESS: Yes.
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2024
`
`202-232-0646
`
`EXHIBIT 1041, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`4/18/2024
`
`Merck KGaA et al. v. Hopewell Pharma Ventures, Inc. et al.
`Highly Confidential - Under the Protective Order
`
`Nicholas Bodor, Pharm. D.
`
`Page 22
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` MR. McGUFFIN: Sorry.
` BY MR. GABRIEL:
` Q Henry, if you can turn to page 36 of
` this document appearing on the top. (PDF 38)
` So, Dr. Bodor, are these -- I think,
` I believe, in Example 4 and Example 5 shown
` here, are these the clinical studies that
` you're referring to that were --
` A Yes.
` Q -- conducted on oral cladribine?
` And Example 5 is a clinical -- a
` human clinical study, and that -- and that --
` is that correct?
` A Yes.
` MR. McGUFFIN: Object to form.
` BY MR. GABRIEL:
` Q And in this study, the patients --
` the test administration drug and the reference
` drug were administered in patients with MS?
` Strike that.
` So in this example, the clinical
` study referenced here, the test and the
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2024
`
`202-232-0646
`
`EXHIBIT 1041, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`4/18/2024
`
`Merck KGaA et al. v. Hopewell Pharma Ventures, Inc. et al.
`Highly Confidential - Under the Protective Order
`
`Nicholas Bodor, Pharm. D.
`
`Page 23
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` reference drugs were dosed in patients with
` MS; is that correct?
` A That's correct.
` Q Okay. If we can scroll down to the
` next page, so the table appearing on page 38.
` (PDF page 40 of Exhibit 1)
` Doctor, focusing on Table VII here,
` in these results reported here, the 10 mg
` version of the complex-complex was
` demonstrated to have a bioavailability of
` about 40%; is that correct?
` It's Table VIII, if you can scroll
` down, Henry.
` A Yes, close to 40%.
` MR. McGUFFIN: Yeah, object to form.
` BY MR. GABRIEL:
` Q And the 40% -- if I refer to it as
` 40% or .4, that's okay, Dr. Bodor?
` A It's okay what?
` Q So the bioavailability here that's
` shown is in reference to the same dose
` administered by IV; is that correct?
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2024
`
`202-232-0646
`
`EXHIBIT 1041, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`4/18/2024
`
`Merck KGaA et al. v. Hopewell Pharma Ventures, Inc. et al.
`Highly Confidential - Under the Protective Order
`
`Nicholas Bodor, Pharm. D.
`
`Page 24
` A As you know, looking at the example,
` these were a three-way crossover study. So
` all patients received different
` formulations --
` THE REPORTER: I'm sorry, Dr. Bodor.
` I'm sorry to interrupt. I didn't
` understand.
` "As you know, looking at the
` example," I didn't understand what you
` said after that.
` THE WITNESS: I was saying that
` these were three-way crossover studies,
` so the patients served their own control,
` so it was a very good and informative
` study.
` BY MR. GABRIEL:
` Q And the 40% bioavailability of the
` oral formulation of the complex-complex, that
` was relative to the comparable IV dose; is
` that correct?
` A Yes, compared to the IV infusion.
` Q Thank you.
`
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`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2024
`
`202-232-0646
`
`EXHIBIT 1041, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`4/18/2024
`
`Merck KGaA et al. v. Hopewell Pharma Ventures, Inc. et al.
`Highly Confidential - Under the Protective Order
`
`Nicholas Bodor, Pharm. D.
`
`Page 25
` And these tests -- the table here as
` well, the results of the table -- strike that.
` The results shown here in Table VII
` also show that the bioavailability of the
` complex-complex was linear as well; is that
` correct?
` MR. McGUFFIN: Object to form.
` THE WITNESS: What? What was the
` question? It is what?
` BY MR. GABRIEL:
` Q That the bioavailability was linear.
` MR. McGUFFIN: Object to form.
` THE WITNESS: Linear?
` BY MR. GABRIEL:
` Q Yes, that's my question.
` Is that correct?
` A I don't know what you mean by
` "linear."
` Q That the dose was similar across
` different -- that the bioavailability was
` similar across different dose ranges.
` MR. McGUFFIN: Object to form.
`
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`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2024
`
`202-232-0646
`
`EXHIBIT 1041, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`4/18/2024
`
`Merck KGaA et al. v. Hopewell Pharma Ventures, Inc. et al.
`Highly Confidential - Under the Protective Order
`
`Nicholas Bodor, Pharm. D.
`
`Page 26
`
` THE WITNESS: Yeah, the
` bioavailability was different depending
` on the dose -- on the formulation.
` BY MR. GABRIEL:
` Q But it was about 40% across doses;
` is that correct?
` MR. McGUFFIN: Object to form.
` THE WITNESS: About 40% of the
` complex-complex.
` Of course, with the IV infusion, you
` cannot talk about percentage because it's
` hundred percent.
` BY MR. GABRIEL:
` Q So you would agree that the
` bioavailability of the complex-complex was an
` important property of your invention; is that
` correct?
` MR. McGUFFIN: Object to form, calls
` for an opinion.
` THE WITNESS: That was the objective
` of my invention.
`
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`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2024
`
`202-232-0646
`
`EXHIBIT 1041, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`4/18/2024
`
`Merck KGaA et al. v. Hopewell Pharma Ventures, Inc. et al.
`Highly Confidential - Under the Protective Order
`
`Nicholas Bodor, Pharm. D.
`
`Page 27
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` BY MR. GABRIEL:
` Q And would you agree that you would
` also need to know the bioavailability of your
` complex-complex in order to determine the
` amount of the complex-complex to administer to
` a patient?
` MR. McGUFFIN: Object to form, calls
` for an opinion.
` THE WITNESS: Just not as an expert
` in clinical trials. I say of course it's
` important to know how much each dose for
` each tablet or capsule is in terms of
` cladribine in the blood.
` BY MR. GABRIEL:
` Q Thank you. And once you know the
` bioavailability, you could use that
` bioavailability ratio to determine the oral
` dose that was equivalent to a corresponding
` IV dose; is that correct?
` MR. McGUFFIN: Object to form,
` calls -- sorry.
` Object to form, calls for an
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2024
`
`202-232-0646
`
`EXHIBIT 1041, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`4/18/2024
`
`Merck KGaA et al. v. Hopewell Pharma Ventures, Inc. et al.
`Highly Confidential - Under the Protective Order
`
`Nicholas Bodor, Pharm. D.
`
`Page 28
`
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` opinion.
` THE WITNESS: Yes, that is the
` general concept of developing any kind of
` oral formulation for any drug.
` BY MR. GABRIEL:
` Q Great, thank you.
` So let's also -- keeping on the
` Bodor PCT, it's your understanding that the
` complex-complex that's disclosed in the
` Bodor PCT was being developed for the
` treatment of MS; is that correct?
` MR. McGUFFIN: Object to form.
` THE WITNESS: Well, I learned about
` this later. I was not involved in the
` development. And, remember, I left IVAX
` in 2005, and I don't know who then
` continued to development.
`
`
`
`
`
`
`
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2024
`
`202-232-0646
`
`EXHIBIT 1041, Petitioner TWi
`IPR2023-00049, -00050
`
`
`
`4/18/2024
`
`Merck KGaA et al. v. Hopewell Pharma Ventures, Inc. et al.
`Highly Confidential - Under the Protective Order
`
`Nicholas Bodor, Pharm. D.
`
`Page 29
`
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`
`
` BY MR. GABRIEL:
` Q Understood, thank you.
` Dr. Bodor, have you read the claims
` that are recited in the Bodor PCT?
` A I read -- yes, I read all the
` claims.
` Q And does the Bodor PCT have claims
` directed to the method or treatment of MS?
` MR. McGUFFIN: Object to form, calls
` for an opinion.
` THE WITNESS: As I remember, one of
` the claims is method of use for
`