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 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
`
`
`
`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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`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
`
`1
`2
`3
`4
`5
`
`6 7
`
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` 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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` 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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` 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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` 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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` 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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` 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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` 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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` 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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` 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.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` 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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` 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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` 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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` 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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` 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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` 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.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`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.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`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.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` 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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` 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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`
`
` 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
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
