Page 1
`
` IN THE UNITED STATES DISTRICT COURT
` FOR THE DISTRICT OF NEW JERSEY
`
` _________________________
` )
` HORIZON PHARMA, INC., )
` HORIZON PHARMA USA, INC.,) Civil Action Nos.:
` and POZEN INC, )
` ) 3:15-cv-03324 (MLC)(DEA)
` Plaintiffs, )
` ) 3:16-cv-04918 (MLC)(DEA)
` vs. )
` ) 3:16-cv-09035 (MLC)(DEA)
` DR. REDDY'S LABORATORIES )
` INC. and DR. REDDY'S )
` LABORATORIES, )
` )
` Defendants. )
` _________________________)
`
` CAPTION CONTINUED ON PAGE 2
`
` VIDEOTAPED DEPOSITION OF EVERARDUS ORLEMANS, Ph.D.
` Chapel Hill, North Carolina
` Thursday, October 12, 2017
`
` Reported by: Cindy A. Hayden, RMR-CRR
`
`Job No. 132124
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` IN THE UNITED STATES DISTRICT COURT
` FOR THE DISTRICT OF NEW JERSEY
`
` _________________________
` )
` HORIZON PHARMA, INC., )
` HORIZON PHARMA USA, INC.,) Civil Action Nos.:
` and POZEN INC, )
` ) 3:15-cv-03324 (MLC)(DEA)
` Plaintiffs, )
` ) 3:16-cv-04918 (MLC)(DEA)
` vs. )
` ) 3:16-cv-09035 (MLC)(DEA)
` DR. REDDY'S LABORATORIES )
` INC. and DR. REDDY'S )
` LABORATORIES, )
` )
` Defendants. )
` _________________________)
`
` CAPTION CONTINUED ON PAGE 2
`
` VIDEOTAPED DEPOSITION OF EVERARDUS ORLEMANS, Ph.D.
` Chapel Hill, North Carolina
` Thursday, October 12, 2017
`
` Reported by: Cindy A. Hayden, RMR-CRR
`
`Job No. 132124
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`Page 2
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` IN THE UNITED STATES DISTRICT COURT
` FOR THE DISTRICT OF NEW JERSEY
`_________________________
` )
`HORIZON PHARMA, INC., )
`HORIZON PHARMA USA, INC. ) Civil Action Nos.:
`and POZEN INC., )
` ) 3:15-cv-03327 (MLC)(DEA)
` Plaintiffs, )
` ) 3:16-cv-04921 (MLC)(DEA)
`vs. )
` )
`MYLAN PHARMACEUTICALS )
`INC., MYLAN LABORATORIES )
`LIMITED, and MYLAN INC., )
` )
` Defendants. )
`_________________________)
` )
`HORIZON PHARMA, INC., )
`HORIZON PHARMA USA, INC. )
`and POZEN INC., ) Civil Action Nos.:
` )
` Plaintiffs, ) 3:15-cv-03326 (MLC) (DEA)
` ) 3:16-cv-04920 (MLC) (DEA)
`vs. )
` )
`LUPIN LTD., and, )
`LUPIN PHARMACEUTICALS )
`INC., )
` Defendants. )
`_________________________)
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` October 12, 2017
` 9:08 a.m.
`
` Videotaped Deposition of Everardus Orlemans,
`Ph.D., held at Courtyard Chapel Hill, 100
`Marriott Way, Chapel Hill, North Carolina,
`pursuant to the Federal Rules of Civil Procedure,
`before Cindy A. Hayden, a Registered Merit
`Reporter, Certified Realtime Reporter, and Notary
`Public of the State of North Carolina, who
`officiated in administering the oath to the
`witness.
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` A P P E A R A N C E S
`On behalf of Plaintiff Horizon Pharma, Inc.
`Horizon Pharma USA, Inc., and
`the Witness:
` COOLEY
` 3175 Hanover Street
` Palo Alto, CA 94304
` BY: SUSAN KRUMPLITSCH, ESQ.
`
`On behalf of Plaintiff Pozen Inc.:
` BAKER BOTTS
` (Via telephone)
` 98 San Jacinto Boulevard
` Austin, TX 78701
` BY: JEFFREY GRITTON, ESQ.
`
`On behalf of Defendants Dr. Reddy's Laboratories,
`Inc. and Dr. Reddy's Laboratories Ltd.:
` BUDD LARNER
` 150 John F. Kennedy Parkway
` Short Hills, NJ 07078
` BY: DMITRY SHELHOFF, ESQ.
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` A P P E A R A N C E S (Cont.'d)
`
`On behalf of Defendants Mylan Pharmaceuticals
`Inc., Mylan Laboratories Ltd. and Mylan Inc.:
`
` PERKINS COIE
` One East Main Street
` Madison, WI 53703
` BY: MELODY GLAZER, ESQ.
`
`ALSO PRESENT: SCOTT SWING, Legal Video Specialist
`
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` E. Orlemans
`-----------------------------------------------
` P R O C E E D I N G S
` 9:08 a.m.
`-----------------------------------------------
` THE VIDEOGRAPHER: Starting of
` Number 1 on the record at 9:08 a.m. This
` is the videotaped deposition of -- would
` the witness please pronounce his name for
` the record, please?
` THE WITNESS: Everardus Orlemans.
` THE VIDEOGRAPHER: Thank you. This
` is in the United States District Court for
` the District of New Jersey. There's three
` case names. The first case name has three
` case numbers. I'll read that one first.
` Civil Action Numbers 3:15-cv-03324
` (MLC)(DEA). The second case number is
` 3:16-cv-04918 (MLC)(DEA). The third case
` number 3:16-cv-09035 (MLC)(DEA).
` The second case name, the case
` numbers are, two of them: 3:15-cv-03327
` (MLC)(DEA). The second case number
` 3:16-cv-04921 (MLC)(DEA).
` The third case name has two case
`
`Patent Owners' Ex. 2018
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`Page 6 of 173
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` E. Orlemans
`numbers. The first one is 3:15-cv-03326
`(MLC)(DEA). The next case number
`3:16-cv-04920 (MLC)(DEA).
` Today's date and time are indicated
`on the video screen. We are located today
`at 100 Marriott Way in Chapel Hill, North
`Carolina.
` The court reporter today is Cindy
`Hayden in association with TSG Reporting.
`My name is Scott Swing. I'm a certified
`legal video specialist, and I'm also here
`on behalf of TSG Reporting.
` At this time, counselors in the room
`will identify themselves and who they
`represent, starting with the noticing
`attorney first please.
` MR. SHELHOFF: Dmitry Shelhoff from
`the law firm of Budd Larner representing
`Dr. Reddy's Labs, Ltd., and Dr. Reddy's
`Labs, Inc.
` MS. GLAZER: Melody Glazer of
`Perkins Coie on behalf of Mylan.
` MS. KRUMPLITSCH: Susan Krumplitsch
`of Cooley representing the witness,
`
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` E. Orlemans
` Dr. Orlemans, and Plaintiff Horizon.
` THE VIDEOGRAPHER: On the phone?
` MR. GRITTON: This is Jeff Gritton
` from Baker Botts on behalf of Plaintiff
` Pozen.
` THE VIDEOGRAPHER: At this time our
` court reporter will administer the oath and
` then we may proceed.
` * * *
`Whereupon,
` EVERARDUS ORLEMANS, Ph.D.,
`after having been previously duly sworn or
`affirmed, was examined and did continue to
`testify under oath as follows:
` THE VIDEOGRAPHER: You may proceed,
` Counselor.
` MR. SHELHOFF: Just for the clarity
` of the record, this notice -- deposition
` notice has been amended, and the caption
` that's been just read is an old caption.
` So the case has been transferred from
` Trenton to Newark, and the legal -- the
` case under which the parties customarily
` file documents is now 2:16-CV-4918. So the
`
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` E. Orlemans
` case is pending before Judge Chesler and
` Magistrate Judge Waldor in Newark.
` Marking as Exhibit 1 Amended Notice
` of Deposition of Everardus Orlemans.
` (DEFENDANT'S EXHIBIT 1, Amended
` Notice of Deposition of Everardus Orlemans,
` was marked for identification.)
` EXAMINATION
`BY MR. SHELHOFF:
` Q. Hello, Dr. Orlemans.
` A. Hello.
` Q. So I believe we've met before,
`almost exactly three years ago.
` A. Uh-huh.
` Q. And you've been deposed in the
`predecessor case to this. So this case is sort
`of a continuation of that case, but there are
`new parties now.
` A. Okay.
` Q. And that's why we invited you to
`come here again. And -- so is it your
`understanding that you will be deposed here
`today pursuant to this Notice of Deposition?
` MS. KRUMPLITSCH: Objection.
`
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` E. Orlemans
`BY MR. SHELHOFF:
` Q. Dr. Orlemans, what is your
`understanding whom are you represented today
`by, if by anybody?
` A. By Susan, as she said, and by Jeff.
` Q. Okay.
` MR. SHELHOFF: Question to counsel:
` Is Dr. Orlemans represented both by Cooley
` LLP and Baker Botts, LLP?
` MS. KRUMPLITSCH: Dmitry, you don't
` get to ask me questions during the
` deposition.
` MR. SHELHOFF: Well, I think we're
` entitled to know this information. You can
` refuse to answer. That's fine.
` MS. KRUMPLITSCH: I'm not being
` deposed, Dmitry.
`BY MR. SHELHOFF:
` Q. So you can set that aside.
` MR. SHELHOFF: Marking as Exhibit 2
` U.S. Patent Number 9,220,698 issued
` December 29th, 2015.
` (DEFENDANT'S EXHIBIT 2, U.S. Patent
` Number 9,220,698, was marked for
`
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` E. Orlemans
` identification.)
`BY MR. SHELHOFF:
` Q. Dr. Orlemans, are you the named
`inventor on this patent?
` A. Yes, that's correct. One of them.
` Q. And have you seen this patent before
`today?
` A. It was a long time ago. Yes.
` Q. Okay. Can you tell me how you
`prepared for today's deposition, if you had any
`preparation?
` A. We did have preparation.
` MS. KRUMPLITSCH: And hold on. I'm
` just going to caution the witness not to
` disclose the contents of any communication
` that you had with attorneys in preparing
` for this deposition.
` THE WITNESS: Right. Yes, so we did
` have some preparation, yes.
`BY MR. SHELHOFF:
` Q. Just very generally have you -- whom
`have you met with and for how long and when?
` MS. KRUMPLITSCH: Objection.
`BY MR. SHELHOFF:
`
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` E. Orlemans
` Q. When -- when did you meet with Susan
`here?
` A. Yesterday.
` Q. Okay. And for how long did you
`prepare?
` A. A few hours.
` Q. Okay. Was -- was she the only
`attorney who prepared you?
` A. Mainly, yes.
` Q. Was there anybody else?
` A. Jeff was on the phone.
` Q. Okay. So did -- did you have any
`preparation for this deposition except
`yesterday in addition to yesterday?
` A. No.
` MR. SHELHOFF: I'm marking as
` Exhibit 3 U.S. Patent Number 9,393,208
` issued July 19th, 2016.
` MS. KRUMPLITSCH: Dmitry, do you
` have a copy for me?
` Thank you.
` (DEFENDANT'S EXHIBIT 3, U.S. Patent
` Number 9,393,208, was marked for
` identification.)
`
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` E. Orlemans
`BY MR. SHELHOFF:
` Q. Dr. Orlemans, are you the named
`inventor on the '208 patent?
` A. Yes, that appears so. Yes.
` Q. And have you seen this patent prior
`to today?
` A. No. Maybe the contents, but not the
`patent.
` Q. Okay. So I'm going to ask you just
`momentarily about the '698 patent. You
`mentioned that you saw that earlier prior to
`today, but with respect to '208 you're saying
`that you're not sure if you saw that prior to
`today?
` A. I can't --
` MS. KRUMPLITSCH: Objection.
` Mischaracterizes the witness' testimony.
` You may answer.
` THE WITNESS: I can't recall,
` Dmitry.
`BY MR. SHELHOFF:
` Q. Okay. Well, do you recall seeing
`the '698 patent?
` A. I believe so, yes.
`
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` E. Orlemans
` Q. Do you recall seeing the '208
`patent?
` MS. KRUMPLITSCH: Objection.
`BY MR. SHELHOFF:
` Q. Do you recall seeing the '208 patent
`prior to today?
` A. Asked and answered, right?
` MS. KRUMPLITSCH: You have to answer
` his questions, Dr. Orlemans. But can I
` just interrupt? I just want to make sure
` that Dr. Orlemans understands when Dmitry
` says the '208 patent he's referring to
` Exhibit 3. The '698 patent is the
` shorthand for Exhibit 2 --
` THE WITNESS: Right.
` MS. KRUMPLITSCH: -- for clarity.
` THE WITNESS: Yeah. So I can't
` recall this one.
`BY MR. SHELHOFF:
` Q. So you cannot recall whether you
`have seen the '208 patent prior to today?
` MS. KRUMPLITSCH: Objection. Asked
` and answered.
`BY MR. SHELHOFF:
`
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` E. Orlemans
` Q. Could you please answer the
`question?
` A. So I can't recall this one. I would
`need to read it, you know, still.
` MR. SHELHOFF: I'm marking as
` Exhibit 4 U.S. Patent Number 8,577,285
` issued October 15th, 2013.
` (DEFENDANT'S EXHIBIT 4, U.S. Patent
` Number 8,557,285, was marked for
` identification.)
`BY MR. SHELHOFF:
` Q. Dr. Orlemans, have you seen this
`patent prior to today?
` A. I can't recall.
` MR. SHELHOFF: I'm marking as
` Exhibit 5 U.S. Patent Number, 6,926,907
` issued August 9th, 2005.
` (DEFENDANT'S EXHIBIT 5, U.S. Patent
` Number 6,926,907, was marked for
` identification.)
`BY MR. SHELHOFF:
` Q. Dr. Orlemans, have you seen the '907
`patent prior to today?
` A. I can't recall that one either.
`
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` E. Orlemans
` Q. I'm marking as Exhibit 6 a document
`which is titled, in part, "PN 400 Naproxen and
`Esomeprazole P400-104," bearing Bates numbers
`PZ00034117 to PZ00034197. So I notice that the
`Bates numbers on the document, some were cut
`off, but that's how the document has been used
`three years ago during the prior deposition of
`October 21st, 2014.
` (DEFENDANT'S EXHIBIT 6, Clinical
` Study Report - PN400-104, was marked for
` identification.)
`BY MR. SHELHOFF:
` Q. So, Dr. Orlemans, have you seen the
`document marked Exhibit 6 prior to today?
` A. If this is an exact copy of what we
`used in the New Drug Application, yes, because
`I signed this one, right?
` Q. Yeah. So if you could turn to
`second page of the document, that would be
`bearing Bates numbers PZ00034118. So here at
`the bottom of the page, is this your signature?
` A. Yes, it is.
` Q. And the document is dated 26
`September 2008?
`
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` E. Orlemans
` A. Yep, correct.
` Q. And you signed this document in your
`capacity as senior vice president, clinical
`research for Pozen, Inc.?
` A. Yes, that's correct.
` Q. Could you just very generally
`explain why was your -- your signature is not
`the only one on the page, right?
` A. Yeah, that's -- that's visible,
`right?
` Q. So there are several other people
`from Pozen which also signed this page, right?
` A. Uh-huh. Correct.
` Q. So could you just very generally
`explain why was your signature required on this
`report -- on this clinical study report?
` A. Because I have to -- somebody has to
`approve the report, right? Someone has to
`approve the report. And the other ones are the
`writers. I'm sorry. The other ones are the
`writers of the report.
` Q. Okay. And can you just very
`generally explain what -- what is the nature of
`this document?
`
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` E. Orlemans
` A. This is a clinical study report that
`is the result of a clinical study that we
`performed in healthy volunteers.
` Q. And what is the study initiation
`date?
` A. On the report it says April 3, 2007.
` Q. And what is the PN400-104 study
`completion date?
` A. On the report it says 25 June 2007.
` Q. And what is the release date of the
`PN400-104 clinical study report date?
` A. 26 September 2008, right, when we
`signed.
` Q. If you please turn to the third page
`of the PN400-104 report at PZ00034119.
` A. Uh-huh.
` Q. On that page do you see the name of
`Philip Miner? It's in the middle.
` A. Yes, I do.
` Q. And -- so the page describes Philip
`Miner as an investigator, correct?
` A. That's correct. Yes.
` Q. Could you explain what it means in
`the context of this report?
`
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` E. Orlemans
` MS. KRUMPLITSCH: Objection. Form.
`BY MR. SHELHOFF:
` Q. Can you explain who Philip Miner is?
` A. So Dr. Philip Miner is the lead
`investigator for our study.
` Q. Was he an employee of Pozen at -- in
`2007, 2008?
` A. No.
` Q. Is he an outside consultant?
` A. No.
` Q. Is he a medical doctor?
` A. Yes.
` Q. Is he a principal research
`investigator?
` A. Yes, that's correct.
` Q. Did Pozen contract Philip Miner to
`perform the clinical study which is reflected
`in the clinical study report PN400-104?
` MS. KRUMPLITSCH: Objection. Vague.
`BY MR. SHELHOFF:
` Q. Can you explain what's the role of
`Philip -- why -- why Philip Miner's name is in
`this report?
` A. So --
`
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` E. Orlemans
` MS. KRUMPLITSCH: Objection. Asked
` and answered.
` You can still answer.
` THE WITNESS: So Philip Miner was
` basically contracted by Pozen to run the
` study, to execute the clinical part of the
` study, to be more precise.
`BY MR. SHELHOFF:
` Q. And where was the study conducted?
` A. The study center it says also on the
`same page is Oklahoma.
` Q. Was Philip Miner responsible for
`enrolling patients in Pozen's -- of the study?
` MS. KRUMPLITSCH: Objection.
` THE WITNESS: Yes. That is --
` MS. KRUMPLITSCH: Hold on.
` Objection.
` MR. SHELHOFF: I'll just rephrase.
`BY MR. SHELHOFF:
` Q. Was Philip Miner responsible for
`enrolling patients in order to conduct the
`clinical study PN400-104?
` A. So, Philip Miner and his staff
`likely also were involved in finding healthy
`
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`volunteers for the study, not patients.
` Q. And the distinction -- could you
`explain the distinction you've drawn between
`the healthy volunteers and patients?
` A. This is a Phase I study in healthy
`volunteers because the purpose of the study was
`to do both -- obtain both the pharmacodynamic
`measurements -- sorry. It's in the objective
`of the study on the same page. So this is a
`study to find out what the effect is of PN400.
`So this one of the first studies that was done
`actually to find out what the effect is of the
`tablet on the intragastric pH, on the acidity
`of --
` MS. KRUMPLITSCH: Intragastric pH.
` THE WITNESS: Sorry about my crooked
` voice. And also we did some
` pharmacokinetics.
`BY MR. SHELHOFF:
` Q. What was your role at Pozen in 2007
`and 2008?
` A. I was, I believe, VP and senior VP
`of clinical research.
` Q. And what did your duties involve?
`
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` A. My role at that time was to make
`sure that the studies were executed properly,
`clinical studies.
` Q. What was your role specifically in
`connection with the clinical study PN400-104?
` A. So I helped with the design of the
`study, and basically I gave direction to my
`team to find a good investigator for the study,
`and oversee if, you know, the study is
`conducted in accordance with the guidelines of
`the FDA, Code of Federal Regulations.
` Q. So as part of your duties -- as part
`of your duties at Pozen during the years 2007,
`2008, was that communication with the FDA part
`of your duties?
` A. No, because for communications with
`the FDA we had a regulatory affairs senior vice
`president.
` Q. Did you have any experience
`communicating with the FDA?
` MS. KRUMPLITSCH: Objection. Vague.
`BY MR. SHELHOFF:
` Q. When you were at Pozen, were you
`involved in any way in communicating with the
`
`Patent Owners' Ex. 2018
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` E. Orlemans
`FDA?
` MS. KRUMPLITSCH: Same objection.
`BY MR. SHELHOFF:
` Q. You can answer.
` A. I was in meetings, you know, with
`FDA, usually telephone conferences, yes.
` Q. So I believe recently we received
`your updated CV, and I believe it states that
`you left Pozen in 2010. However, during your
`prior deposition you stated that you recall
`that you left Pozen at the end of the year
`2011. Do you recall more accurately when
`exactly did you leave Pozen?
` MS. KRUMPLITSCH: Objection.
` THE WITNESS: You know -- let me
` see? I believe it was 2010, at the end of
` 2010, but I'm not sure. Because what also
` happened was he asked -- John Plachetka,
` the CEO of Pozen, asked me back for help
` with another project.
`BY MR. SHELHOFF:
` Q. So was -- John Plachetka asking you
`for help on another project, how does that
`influence the date of your departure from
`
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` E. Orlemans
`Pozen?
` MS. KRUMPLITSCH: Objection. Form.
`BY MR. SHELHOFF:
` Q. I guess the question is regardless
`of what John Plachetka told you, when did you
`leave Pozen?
` MS. KRUMPLITSCH: Same objection.
` THE WITNESS: I think I already said
` it, right? I don't -- I'm not quite sure
` anymore.
`BY MR. SHELHOFF:
` Q. So to the best of your recollection,
`you believe it's the end of 2010?
` A. Possibly, yes. I don't recall.
` Q. Did you have any contact with John
`Plachetka between October 21st, 2014, the date
`of your last deposition in the prior case, and
`today?
` A. No.
` Q. Did you have contact with any of the
`Pozen's employees between October 21st, 2014,
`and today?
` A. Any of -- any of the former
`employees you mean, yes.
`
`Patent Owners' Ex. 2018
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`Page 24 of 173
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` E. Orlemans
` Q. I understand that Pozen was acquired
`by another company; is that your understanding
`as well?
` A. I don't know because it happened
`when I was gone.
` Q. So going back to Exhibit 6, the
`clinical study report for PN400-104, on the
`third page of the report at PZ00034119, it
`states that "A non-EC naproxen formulation was
`inadvertently used instead of the
`protocol-planned EC naproxen"; do you see that?
` A. Yes.
` Q. Can you just very generally explain
`what it means in the context of this clinical
`study report, PN400-104?
` MS. KRUMPLITSCH: Objection. Form.
`BY MR. SHELHOFF:
` Q. I'll just rephrase.
` Why was there a need to put this
`qualification in the PN400-104?
` A. In the study report you mean?
` Q. Yes.
` A. So -- because, you know, the
`investigator and his study staff is to supposed
`
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` E. Orlemans
`to follow the protocol. You can't deviate, and
`it this case -- you cannot deviate from the
`protocol because that's -- that's agreed upon
`by -- not just by the investigator who signs
`the document for it, but also by the internal
`review board of the hospital. And they
`inadvertently took the wrong form of naproxen
`in the study. Since that is something we found
`out later, when we got the pharmacokinetic
`data, we decided, you know, to put in the study
`report because it was, you know, not
`protocol-planned. A mistake from the site, the
`study site.
` Q. So -- so it was a mistake to use
`non-EC naproxen in the PN400-104, correct?
` A. Yes. That's what it says.
` Q. And it was a deviation from the
`approved protocol for the clinical study
`PN400-104 to use a nonenteric-coated naproxen
`formulation, correct?
` A. That's correct, yes.
` Q. Did the idea for the clinical study
`PN400-104 come from AstraZeneca?
` A. I cannot recall that. Sorry.
`
`Patent Owners' Ex. 2018
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` E. Orlemans
` Q. At the time when PN400-104 clinical
`study report was issued, which is 26
`September 2008, do you recall whether
`AstraZeneca was involved in any way with this
`report?
` A. They were not involved with the
`report. Of course, they have seen it.
`Obviously they got a copy, but they were not
`involved -- you mean -- you mean in the writing
`of it? The answer is no.
` Q. Did you provide the data from the
`clinical study PN400-104 to AstraZeneca?
` A. Yes.
` Q. Did you discuss with AstraZeneca the
`data from the clinical study PN400-104?
` A. Yes.
` MS. KRUMPLITSCH: Objection.
`BY MR. SHELHOFF:
` Q. Did you speak with Mark Sostek about
`the data in the clinical study PN400-104?
` MS. KRUMPLITSCH: Objection.
`BY MR. SHELHOFF:
` Q. Do you know who Mark Sostek is?
` A. Yes, I know who Mark Sostek is.
`
`Patent Owners' Ex. 2018
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` E. Orlemans
` Q. Can you tell us who is he?
` A. He was the medical expert on the
`site of AstraZeneca for this project.
` Q. And did you work with Mark Sostek
`with AstraZeneca on the -- this report?
` A. I think I already answered --
`answered that twice. So they did -- of course
`they got a copy and reviewed it, but we wrote
`the report and signed it off. That was the
`agreement we had with AstraZeneca.
` Q. Can you explain the nature of the
`agreement you had with AstraZeneca which you
`just mentioned?
` MS. KRUMPLITSCH: Objection. Vague.
` MR. SHELHOFF: Well, Dr. Orlemans
` just mentioned an agreement.
`BY MR. SHELHOFF:
` Q. Could you just explain what
`agreement you meant?
` MS. KRUMPLITSCH: Same objection.
` THE WITNESS: The only thing -- what
` I tried to say was we had some verbal
` agreement obviously that we would share
` information since they were our
`
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` E. Orlemans
` co-development partner.
`BY MR. SHELHOFF:
` Q. Okay. So AstraZeneca was Pozen's
`co-development partner, right?
` A. Correct.
` Q. And they were a co-development
`partner for the Vimovo proposed project,
`correct?
` A. Yes, that's correct.
` Q. And this clinical study report
`PN400-104, it was done as part of that
`collaboration between Pozen and AstraZeneca
`towards development of the Vimovo product,
`correct?
` MS. KRUMPLITSCH: Objection. Vague.
`BY MR. SHELHOFF:
` Q. You can still answer.
` A. It was part of a number of protocols
`that we were also supposed to execute according
`to FDA, not just -- it's not just AstraZeneca.
`This is also something for the FDA.
` Q. Was clinical study report PN400-104
`intended for submission to the FDA?
` A. Yes, it was.
`
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` E. Orlemans
` Q. Was it, in fact, submitted to the
`FDA?
` A. It was.
` Q. Did AstraZeneca know that PN400-104
`was intended for submission to the FDA?
` MS. KRUMPLITSCH: Objection. Vague.
`BY MR. SHELHOFF:
` Q. Did you discuss with AstraZeneca
`that PN400-104 would be submitted to the FDA?
` A. Sorry. Could you repeat that
`because --
` Q. Did you -- did you discuss with
`AstraZeneca that the clinical study report
`PN400-104 would be submitted to the FDA?
` MS. KRUMPLITSCH: Objection. Vague
` as to time.
`BY MR. SHELHOFF:
` Q. When was the clinical study report
`PN400-104 submitted to the FDA?
` A. So the report itself must have been
`submitted after September 26, '08.
` Q. Did AstraZeneca know that PN400-104
`clinical study report was submitted to the FDA?
` MS. KRUMPLITSCH: Same objection.
`
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` E. Orlemans
` THE WITNESS: So it's
` co-development, and we share information;
` so, yes, I would assume, but you need to
` ask AstraZeneca, obviously.
`BY MR. SHELHOFF:
` Q. Right. So did you --
` A. I would assume that they know about
`it, yes.
` Q. Did you discuss with Mark Sostek
`that the clinical study report PN400-104 would
`be submitted to the FDA?
` MS. KRUMPLITSCH: Same objection.
` THE WITNESS: Again, you know, you
` need to ask AstraZeneca, obviously, but you
` can draw your conclusions yourself, right?
` If you are a co-development partner, you
` share information.
` MS. KRUMPLITSCH: I'm going to
` caution the witness not to speculate.
`BY MR. SHELHOFF:
` Q. Did AstraZeneca review the data
`reflected in the clinical study report
`PN400-104 before you signed it on September 26,
`2008?
`
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` A. I don't know that. You need to ask
`AstraZeneca. I really don't know that.
` Q. Previously in 2014 you testified
`that the idea behind the PN400-104 clinical
`study come from AstraZeneca.
` A. Uh-huh.
` Q. Do you -- do you recall that that's
`what happened?
` MS. KRUMPLITSCH: Objection. Form.
`BY MR. SHELHOFF:
` Q. Do you think that your prior
`testimony is accurate?
` MS. KRUMPLITSCH: Objection.
`BY MR. SHELHOFF:
` Q. Does it -- does it reflesh --
`refresh your recollection if I told you that
`previously you testified that the idea for the
`clinical study PN400-104 came from AstraZeneca?
` A. I believe so, yes.
` Q. So is PN400-104 clinical study a
`Phase I study?
` A. Yes, that's correct.
` Q. And what does Phase I study aim to
`achieve, very generally?
`
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` MS. KRUMPLITSCH: Objection.
`BY MR. SHELHOFF:
` Q. What are Phase I studies?
` A. Generally, Phase I studies are
`studies in healthy volunteers, generally. It
`depends, obviously, on the indication -- to get
`a first read of the product performance,
`especially safety. And sometimes it's
`pharmacokinetics.
` Q. Do Phase I studies such as PN400-104
`require submission to the FDA?
` MS. KRUMPLITSCH: Objection.
`BY MR. SHELHOFF:
` Q. Does the FDA require submission of
`Phase I studies such as PN400-104?
` MS. KRUM
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