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`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`__________________________________
`HORIZON PHARMA, INC. and POZEN,
`INC.,
`
`Plaintiffs,
`-vs-
`DR. REDDY'S LABORATORIES, INC.,
`et al.,
`
`CIVIL ACTION NUMBER:
`3:11-CV-02317(MLC)
`TRIAL
`VOLUME 1
`
`Defendants.
`__________________________________
`Clarkson S. Fisher United States Courthouse
`402 East State Street
`Trenton, New Jersey 08608
`January 12, 2017
`THE HONORABLE MARY L. COOPER
`B E F O R E:
`UNITED STATES DISTRICT JUDGE
`
`A P P E A R A N C E S:
`MCCARTER & ENGLISH
`BY:
`JOHN E. FLAHERTY, ESQUIRE
`ATTORNEYS FOR PLAINTIFF, HORIZON
`FINNEGAN HENDERSON
`BY:
`JAMES B. MONROE, ESQUIRE
`DANIELLE C. PFIFFERLING, ESQUIRE
`ATTORNEY FOR PLAINTIFF, HORIZON
`
`(Continued)
`
`Certified as True and Correct as required by Title 28, U.S.C.,
`Section 753
`/S/ Carol Farrell, CCR, CRCR, CRR, FCRR, RMR, CCP
`/S/ Karen Friedlander, CRR, RMR
`/S/ Regina A. Berenato-Tell, CCR, CRR, RDR
`
`United States District Court
`Trenton, New Jersey
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`A P P E A R A N C E S: (Continued)
`
`COOLEY LLP
`BY:
`ELLEN SCORDINO, ESQUIRE
`SUSAN KRUMPLITSCH
`ATTORNEYS FOR PLAINTIFF, HORIZON
`BAKER BOTTS, LLP
`BY:
`STEPHEN M. HASH, Ph.D.
`JEFF GRITTON, ESQUIRE
`ATTORNEYS FOR PLAINTIFF, POZEN
`BUDD LARNER, P.C.
`BY:
`ALAN H. POLLACK, ESQUIRE
`STUART D. SENDER, ESQUIRE
`ALFRED HANK HECKEL, ESQUIRE
`ATTORNEYS FOR DEFENDANT, DR. REDDY'S
`RIVKIN RADLER, LLP
`BY:
`GREGORY D. MILLER, ESQUIRE
`ATTORNEY FOR DEFENDANT, MYLAN
`PERKINS COIE, LLP
`BY:
`SHANNON M. BLOODWORTH, ESQUIRE
`AUTUMN N. NERO, ESQUIRE
`BRYAN D. BEEL, Ph.D.
`ROBERT D. SWANSON, ESQUIRE
`ATTORNEYS FOR DEFENDANT, MYLAN
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`I N D E X
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`Examinations
`JOHN R. PLACHETKA
`DIRECT EXAMINATION OF JOHN R. PLACHETKA BY MR. HASH:
`CROSS EXAMINATION OF DR. PLACHETKA BY MS. BLOODWORTH:
`CROSS EXAMINATION OF DR. PLACHETKA BY MR. SENDER:
`CONTINUED CROSS EXAMINATION OF JOHN PLACHETKA BY MR.
`SENDER:
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`(In open court on January 12, 2017, at 9:42 a.m.)
`THE COURT: Good morning, everyone.
`RESPONSE: Good morning, your Honor.
`THE COURT: We are here for a trial in Horizon and
`Pozen versus at this point Dr. Reddy's Labs and Mylan, and I
`understand you have already given your appearances to the
`Courtroom Deputy, but let's everyone be seated except counsel
`who will state your appearances now for the record.
`MR. FLAHERTY: Your Honor, John Flaherty from
`McCarter & English for the plaintiffs.
`And with me today on behalf of Pozen from Baker &
`Botts, we have Stephen Hash, and with him is Jeffrey Gritton.
`On behalf of Horizon, plaintiff Horizon, from the
`Finnegan firm, we have James Monroe, and with him is Danielle
`Pfifferling.
`And from the Cooley firm, Ellen Scordino, and Susan
`Krumplitsch.
`THE COURT: Thank you, sir.
`MR. MILLER: Good morning, your Honor. Gregory
`Miller from Rivkin Radler LLP on behalf of the Mylan
`defendants.
`And with me today we have Shannon Bloodworth, Autumn
`Nero, and Bryan Beel, all from the Perkins Coie law firm.
`MULTIPLE COUNSEL: Good morning, Your Honor.
`THE COURT: Good morning.
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`MR. SENDER: Good morning, Your Honor. Stuart Sender
`from Budd Larner representing the Dr. Reddy's defendants, and
`with me this morning from my firm is Alan Pollack and Hank
`Heckel.
`
`THE COURT: Welcome.
`We are going to take a witness out of turn this
`morning; is that right?
`MR. MONROE: That's correct, Your Honor.
`MS. BLOODWORTH: Yes, Your Honor.
`THE COURT: Are there any preliminaries that you need
`to raise before we call the first witness?
`MS. BLOODWORTH: Your Honor, we -- this is Shannon
`Bloodworth for the defendants, and I speak on our behalf.
`We do have some objections to Dr. Plachetka's slides
`that we would like to raise with your Honor. We had a meet
`and confer with plaintiffs last evening, and we have not been
`able to reach a resolution.
`It is our understanding that Dr. Plachetka is in the
`courtroom, so we would either ask that he be removed for the
`discussion or that we move to sidebar.
`THE COURT: How far into his testimony would we get
`before any of these disputed slides are reached?
`MS. BLOODWORTH: By my count, I believe it's the
`second slide.
`MR. HASH: Ten minutes, your Honor.
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`THE COURT: Okay. Well, we had better hash it out
`then before we begin the testimony. Is that all right with
`the plaintiffs' side?
`MR. HASH: Yes, Your Honor.
`THE COURT: Okay. Now, I don't see any reason to
`leave Dr. Plachetka out of the courtroom. The courtroom is
`filled with people today. And -- it's fine with me if the
`objection is aired in open court.
`MS. BLOODWORTH: It wasn't a confidentiality
`objection, Your Honor.
`My concern was that we would be discussing how
`Dr. Plachetka would be talking about these slides and he would
`be hearing our colloquy and perhaps be led in his testimony
`potentially. But we can proceed.
`THE COURT: No, let's just go ahead.
`MS. BLOODWORTH: Okay.
`So, your Honor, for Dr. Plachetka's testimony, maybe
`it would be helpful to have the slides.
`THE COURT: Okay. Go ahead. You can just go head
`and hand them to us.
`MS. BLOODWORTH: So, your Honor, the first objection
`that we would like to discuss is a slide, it looks like a
`chart, I believe it's Slide 3 in what was handed to you.
`MR. HASH: That would be PX-7, your Honor.
`MS. BLOODWORTH: PDX-7.
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`7
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`THE COURT: Off the record until we find these
`
`things.
`
`(Discussion held off the record.)
`THE COURT: PDX-7, correct?
`MS. BLOODWORTH: Yes.
`THE COURT: Okay. Now let's go on the record.
`MS. BLOODWORTH: Okay. Thank you, your Honor.
`Looking at PD -- as in "dog," -X-7, this is a chart, a
`demonstrative proposed by plaintiffs, titled "P," as in
`"Paul," "-N," as in "Nancy," "100-103 Study Results."
`This study, PN 100-103, and the chart in the form it
`appears, we believe are going to be offered by plaintiffs to
`use as unexpected results of Vimovo. Now, Dr. Plachetka was
`not disclosed to talk about unexpected results. This study,
`PN 100-103, was never disclosed to defendants as a portion of
`the unexpected results case in the discovery. And our opinion
`is that it's improper expert testimony as well.
`Additionally, PTX- --
`THE COURT: Just a second. You're saying that this
`study did not come to you in discovery?
`MS. BLOODWORTH: It was produced in discovery, but it
`was not a response to any interrogatories in unexpected -- on
`unexpected results or secondary considerations that we served.
`So it came on the exhibit list --
`THE COURT: What about obviousness?
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`8
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`MS. BLOODWORTH: About obviousness? No. There's
`never been any sort of allegation in this case that
`lansoprazole study has any basis for any unexpected results or
`any basis, actually, for Vimovo. So we deposed Dr. Plachetka
`and didn't ask him about it.
`And, worse, we have our experts that are going to
`start tomorrow and it's not in their expert reports, either,
`to rebut it. So we'll have unrebutted fact -- purportedly
`fact testimony on a study for an issue in the trial that has
`not been disclosed to us properly either under the pretrial
`disclosure period or the expert disclosure period. So we
`would object to that line of testimony.
`And we'd also object to the underlying exhibit by
`Dr. Plachetka which is PTX- -- PT-, as in "Tom," -X-178 which
`would be used for the same purpose without the demonstrative.
`THE COURT: Ms. Bloodworth, when we go over to the
`next demonstrative slide, Demonstrative Slide 8, you're still
`in that same PN 100-103 study; is that right?
`MS. BLOODWORTH: I was not disclosed that slide,
`then, your Honor, last night. I only have one slide.
`THE COURT: Well, there we are.
`MR. HASH: Your Honor, PDX-8 -- I'm sorry. PDX-8,
`your Honor, is simply a callout from the PN 100 clinical study
`report, and according to the pretrial order, it does not need
`to be disclosed as a demonstrative because it's simply a
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`9
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`callout.
`
`THE COURT: Okay. So 8 is not of concern. We'll
`focus our attention on 7 at the moment.
`MR. HASH: It shouldn't be of a concern, your Honor,
`because it's simply a callout --
`THE COURT: But my ruling on 7 will cover 8 at this
`point, either way.
`MR. HASH: I mean, I think they're apples and
`oranges. I'm not sure what -- I'm not exactly sure what the
`argument -- if they're trying to exclude PN 100-103 or they're
`trying to exclude Dr. Plachetka testifying about unexpected
`results associated with PN 100-103.
`MS. BLOODWORTH: Both, your Honor. The exhibit
`wasn't disclosed in response to interrogatories. It wasn't
`listed in any expert report that plaintiffs put in for
`unexpected results evidence. It wasn't listed on any
`materials reviewed by their expert. It was not listed in --
`we had no notice of it. Our experts are going to have no
`opportunity to rebut it. It's prejudicial. And --
`THE COURT: Okay. This is the beginning of the
`trial, and it's unfortunate that we're hung up right at this
`moment. I'm going to listen to your adversary for a moment
`and then I'll make at least a tentative ruling.
`MR. HASH: Your Honor, just to begin with, PN 100-103
`is on their exhibit list, so I'm a little surprised that
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`10
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`they're raising this objection.
`And I appreciate the fact that defendants consider
`this to be unexpected results. We just look at this as part
`of the story. I don't believe that Dr. Plachetka was going to
`address this with the specific intent of showing unexpected
`results; rather, just as a piece in the overall story of how
`his invention went from -- from a -- from a concept in his
`idea to make -- you know, to save people's lives to a
`pharmaceutical product that's now available and on the market.
`THE COURT: So this is going to be talking about the
`process of his inventorship?
`MR. HASH: Yes, Your Honor, the process of the
`invention and the development of the product, your Honor.
`MS. BLOODWORTH: Your Honor, we don't have any
`invention story proposed pretrial findings of fact or
`conclusions of law. We served an interrogatory that asked for
`the invention and conception reduction to practice and
`received a response that said, "We're going to rely upon the
`prima facie priority date, so we don't have to tell you
`anything else."
`This document, this study is years after the filing
`date here. And it's about a product that doesn't relate to
`Vimovo at all, which is why it's never been in this case.
`THE COURT: Then why did you list it as an exhibit?
`MS. BLOODWORTH: I have zero idea that we listed this
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`11
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`as an exhibit until he said that. I would have to know why.
`I know we objected to their listing of it in the pretrial
`order. And I know that we didn't expect that Dr. Plachetka
`would be somebody who, in the context of -- your Honor, I'm
`not objecting to Dr. Plachetka testifying about his invention
`and his patent and what he did. And that's completely
`understandable.
`This is about after-the-fact reduction -- you know,
`this is about evidence years later on a product that's not
`Vimovo. And they're going to say, "Well, compared" --
`"compared to the" -- whatever is in this chart -- I'm not even
`sure what they are going to say about it specifically. It's
`unexpected.
`THE COURT: Here's what we're going to do --
`MS. BLOODWORTH: Thank you.
`THE COURT: -- is when we get to that portion on the
`direct testimony that plaintiffs will elicit from
`Dr. Plachetka today, you can say, "Judge, this is the point at
`which our objection begins." And then I will listen in effect
`to this testimony as a proffer by them, and you can listen to
`it, and then we'll see where we go from there. But it'll --
`the testimony will be received under objection, and I may
`exclude it later or I may give you some other remedy.
`MS. BLOODWORTH: Thank you, your Honor.
`MR. HASH: Thank you, your Honor.
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`12
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`THE COURT: Did you follow that, Mr. Pollack?
`MR. POLLACK: Yes.
`THE COURT: You don't have to agree with it. I'm
`just saying this is what we're going to do in order to get
`started.
`
`Yes, Mr. Sender?
`MR. SENDER: There was another demonstrative, your
`Honor, that the defendants objected to and had a meet and
`confer last night. And it's -- I believe it's the first
`chart. We don't have them numbered, so it might be PDX-6
`because it looked like it came before 7 in the set we were
`provided last night. And this looks like improper expert
`materials.
`The invention here was, you know, a combination of
`two drugs and a formulation of drugs. And this is a mechanism
`of NSAID-related ulcer formation which is really a medical
`topic. Dr. Plachetka is not a medical doctor. Tomorrow
`you'll be hearing our first expert, Dr. Metz, who is a medical
`doctor and the plaintiffs have a medical doctor, Dr. Johnson,
`who will be testifying next week about ulcer formation and how
`these drugs actually work. But this invention doesn't really
`have to do with the specific mechanism, at least at the level
`of Dr. Plachetka as a fact witness.
`MR. HASH: Your Honor, Dr. Plachetka, as you'll see
`in a minute, Dr. Plachetka has a long experience as a clinical
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`13
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`pharmacologist. Dr. Plachetka has long experience as a
`clinical pharmacologist. This is part and parcel in an
`explanation of how he came up with this invention, is the
`mechanism of -- NSAID-induced gastric damage which is, you
`know, the linchpin of this invention.
`THE COURT: Well, I see that that's the general
`overview, and he's only going to testify according to his
`understanding from the standpoint of being a pharmaceutical
`chemist. So that objection, while reasonable, I don't think
`it troubles me to let him at least get started on this topic.
`And he's a fact witness. I understand that.
`MR. HASH: Yes, your Honor.
`THE COURT: Yes. And he'll be restricted to being a
`fact witness.
`MR. HASH: Thank you, your Honor.
`THE COURT: In a technical field.
`MR. HASH: Thank you, your Honor.
`MR. MONROE: Your Honor, James Monroe on behalf of --
`THE COURT: Yes, we know.
`MR. MONROE: Just wanted to let you know we may have
`some housekeeping matters at the end of the day, but we wanted
`to get started with the witness and not address those right
`now.
`
`THE COURT: That's fine. And our plan for the day
`is -- you've planned a direct examination of your inventor,
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`right?
`
`MR. MONROE: Yes.
`THE COURT: Okay. Do you have a rough timetable for
`how long you'll be on direct, you'd like to be?
`MR. HASH: Your Honor, I mentioned it would be an
`hour, probably, give or take.
`THE COURT: Okay. Well, I suggest we take a
`five-minute recess right now, five to eight minutes, just to
`get up and walk around and clear our heads. And then we'll
`summon the witness to the stand and we'll do his direct for
`whatever time you need. I'm not putting -- so far, I don't
`see a need to put us on a stopwatch. And then we will take a
`serious recess, 15 or 20 minutes before the cross has to
`start. That way you'll know how you're pacing yourselves.
`MR. HASH: Thank you, your Honor.
`MS. BLOODWORTH: Thank you, your Honor.
`THE COURT: Okay? Good.
`(A recess was taken at 9:58 a.m.)
`THE COURT: Mr. Hash, you may call your first
`
`witness.
`
`MR. HASH: Your Honor, plaintiffs call Dr. John
`Plachetka.
`THE DEPUTY CLERK: Please raise your right hand.
`(JOHN R. PLACHETKA, HAVING BEEN DULY SWORN/AFFIRMED, TESTIFIED
`AS FOLLOWS:)
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`PLACHETKA - DIRECT - HASH
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`15
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`THE WITNESS: I do.
`THE DEPUTY CLERK: Please state and spell your full
`name for the record.
`THE WITNESS: It's John Plachetka, P-L-A-C-H-E-T-K-A.
`(DIRECT EXAMINATION OF JOHN R. PLACHETKA BY MR. HASH:)
`Q. Good morning, Dr. Plachetka.
`A. Good morning.
`Q. Dr. Plachetka --
`THE DEPUTY CLERK: Excuse me. If you will speak up?
`The audio system isn't very strong.
`BY MR. HASH:
`Q. Good morning, Dr. Plachetka.
`A. Good morning.
`Q. In front of you have a notebook with some exhibits in it.
`I wanted to first direct you to this and ask you, are you the
`inventor of the patents-in-suit here?
`A. I am.
`Q. Okay. And if I could direct you to PTX-001, which is
`United States Patent Number U.S. 6,926,907 naming John R.
`Plachetka as the inventor.
`A. Yes.
`Q. And you are the inventor on this patent?
`A. I am.
`Q. And it's your understanding that this is one of the
`patents that's at issue in this case?
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`PLACHETKA - DIRECT - HASH
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`16
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`A. Yes.
`Q. Okay. And if I could take you to PTX-002, which is
`United States Patent 8,557,285, also naming as the inventor
`John R. Plachetka, is this your patent as well?
`A. Yes.
`Q. And is it your understanding that this is one of the
`patents-in-suit today?
`A. It is.
`Q. And you understand that you're here today because the --
`the two defendants are seeking to copy your patented drug,
`Vimovo?
`A. Yes.
`Q. If I could take you to the demonstratives of DTX-2,
`please.
`
`THE COURT: You're talking about PDX-2?
`MR. HASH: PDX-2, yes, your Honor. I apologize.
`BY MR. HASH:
`Q. Dr. Plachetka, I wanted to talk to you a little bit about
`your company, Pozen. What kind of company is Pozen?
`A. Pozen is a small pharmaceutical development company that
`was tasked with making better medicines to make people's lives
`better.
`Q. And could you briefly describe your founding of Pozen?
`A. Sure. 1996, I started Pozen out of my house in The
`Woodlands, Texas, with the intention of creating a company
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`PLACHETKA - DIRECT - HASH
`
`17
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`using an innovative business model, using outsourcing to
`develop new products in a more cost-effective manner and get
`them to market more efficiently.
`Q. And what did you do while you were at Pozen?
`A. I was the founder. I was the chief scientific officer,
`the CEO, president of the company, and chairman of the board.
`Q. And what did Pozen do during your tenure there?
`THE COURT: You're still with Pozen, right?
`THE WITNESS: No, ma'am. I've retired.
`THE COURT: Okay.
`BY MR. HASH:
`Q. So what did you do while you were at Pozen?
`A. Well, all those activities took up all my time, but we
`created a number of pharmaceutical products that have
`subsequently gotten to market. One was for the treatment of
`migraine headaches, and that product is called Treximet. And
`it is the most effective migraine medicine, oral migraine
`medicine, available today, and I'm the patent holder on that.
`I also created Vimovo, and that product has been on
`the market now for I think five years or so.
`And we most recently created and had approved another
`medicine called Yosprala, which we're very proud of. It's for
`the prevention of heart attacks and strokes.
`Q. And you mentioned Vimovo. Is it your understanding that
`Vimovo is the product at issue in this case?
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`District of New Jersey
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`Patent Owners' Ex. 2015
`IPR2018-00272
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`PLACHETKA - DIRECT - HASH
`
`18
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`A. It is.
`Q. And PDX-2 here, is this the team that worked with you on
`the development of Vimovo at Pozen?
`A. A lot of them are, yeah. This is a group shot on one of
`the days after we got our drug approved. So that's basically
`the entire company right there.
`THE COURT: Including the very small one there?
`THE WITNESS: Yeah. He was our chief legal officer.
`(Laughter.)
`BY MR. HASH:
`Q. Dr. Plachetka, I wanted to talk to you a little bit about
`your educational background. Could you describe for me your
`educational background related to drug development?
`A. Yes. My undergraduate degree is in pharmacy. I got a BS
`in pharmacy from the University of Illinois which was one of
`the top-rated colleges of pharmacy in the United States, and
`still is. But it was a great background because we had a
`broad-based college experience in pharmaceutics as well as
`compounding pharmacy, clinical pharmacy, physiology and a lot
`of biologic sciences that went into a more advanced pharmacy
`degree. After that, I went to the University of Missouri at
`Kansas City and received a Doctor of Pharmacy, which was
`primarily a clinical degree but, as I had done at Illinois, I
`also had a research component to that.
`Q. And after you got --
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`District of New Jersey
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`Patent Owners' Ex. 2015
`IPR2018-00272
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`PLACHETKA - DIRECT - HASH
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`19
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`THE COURT: When you say "clinical degree," it's my
`understanding, Doctor, that this field that you called
`"pharmacy" has gone through a number of different developments
`in the academic world and even a number of different names, so
`I'm familiar with that phenomenon. But when you say you did
`mostly emphasis on clinical when you were working on your
`Ph.D., as well as research, what do you mean by "clinical"?
`THE WITNESS: The "clinical" of pharmacy degree, the
`Doctor of Pharmacy Degree, is really a clinical degree, not a
`Ph.D. It's a Doctor of Pharmacy, and there's a distinction
`there.
`
`The clinical program involved the care of patients,
`and so in the program at University of Missouri, we were --
`"we," as the Pharm.D. students or Doctor of Pharmacy students,
`were teamed up with medical students in the care of patients
`in hospitals and clinics.
`THE COURT: Now I understand.
`THE WITNESS: Okay.
`BY MR. HASH:
`Q. So after you completed your Doctor of Pharmacy at
`University of Missouri, what did you do next?
`A. I took my first -- well, I was a resident at the Truman
`Medical Center and, again, that was more of an extension of my
`clinical background.
`Q. Okay. And after your residency in Kansas City, where did
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`Patent Owners' Ex. 2015
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`PLACHETKA - DIRECT - HASH
`
`20
`
`you go next?
`A. I took my first job at the University of Arizona as a
`assistant professor of clinical pharmacy.
`Q. And what were your responsibilities as an assistant
`professor of clinical pharmacy at the University of Arizona?
`A. The typical research, education, and teaching -- I'm
`sorry -- and patient care. I was assigned to the heart
`transplant team, the cardiothoracic surgery team, and I was
`fortunate enough to be involved in their research laboratory
`at that time as well as taking care of patients in the
`cardiothoracic surgical unit.
`Q. And how long did you stay at the University of Arizona?
`A. Three years approximately.
`Q. And what did you do -- and you left then?
`A. Right. I joined Glaxo in 1981, which at the time was a
`very small British-based pharmaceutical company that had just
`opened its office in the United States. And I was one of the
`first people hired in their Research Division.
`Q. And what were you hired at GSK to do?
`A. To help them finish the development of a drug that
`subsequently got into the market, most people heard about.
`That drug is now known as Zantac, and that was the first drug
`I worked on at Glaxo for several years.
`Q. And what kind of drug is Zantac?
`A. It's a histamine H2 blocker which is useful for the
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`District of New Jersey
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`Patent Owners' Ex. 2015
`IPR2018-00272
`Page 20 of 197
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`PLACHETKA - DIRECT - HASH
`
`21
`
`treatment of reflux esophagitis, healing duodenal ulcers or
`gastric ulcers and also to maintaining the healthy stomach and
`duodenum so those ulcers don't come back.
`Q. And did you work on other drugs while you were at GSK
`other than Zantac?
`A. I did. After Zantac, I was put into the cardiovascular
`group, actually headed that up, in which I was developing a
`product called "labetalol," which is an alpha beta blocker for
`the treatment of angina and hypertension.
`And I then took a spin through the commercial side of
`the business for a while and came back into the research arm
`and headed up the cardiovascular group and developed a couple
`of products. One was an antiplatelet agent for the treatment
`of restenosis after cardiac surgery or cardiac stents and
`angioplasty, and then the -- probably the most important drug
`that I developed in that part of my career was Imitrex.
`Imitrex was the very first migraine drug, migraine-specific
`drug, and it was wonderfully effective and something that
`we -- all of us who were involved in that program are
`extremely proud of.
`Q. And was Imitrex a successful drug?
`A. I think it was remarkably successful from a clinical
`standpoint. I could remember seeing the first few patients'
`results, and going from an excruciating migraine headache to
`complete normalcy within 10 to 15 minutes after the injection
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`Patent Owners' Ex. 2015
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`PLACHETKA - DIRECT - HASH
`
`22
`
`was something that had never been seen before. So from that
`perspective, it was very, very successful; and then, of
`course, commercially, it was successful as well.
`Q. Now, what did you do after you headed the Imitrex program
`at GSK?
`A. I left --
`THE COURT: You're calling it "GSK" which is Glaxo.
`MR. HASH: Yes, your Honor. I apologize.
`THE COURT: It went through a number of corporate
`
`changes.
`
`MR. HASH: Yes, your Honor. And actually, I guess,
`at the time it was not GSK; it was Glaxo.
`THE WITNESS: No, it was just Glaxo, right.
`THE COURT: That's fine.
`THE WITNESS: After that, I joined and ran a clinical
`research organization that we call "CROs." This was a
`contract research company. We did work for a lot of different
`pharmaceutical companies, either Phase I work, we did some
`Phase II, some Phase III work, as well as occasional Phase IV
`studies.
`BY MR. HASH:
`Q. So were you performing clinical studies for
`pharmaceutical companies at this CRO?
`A. The company did, yes. I was president of the company. I
`oversaw some of them and added my scientific expertise, but I
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`PLACHETKA - DIRECT - HASH
`
`23
`
`had an administrative role there.
`Q. Okay. Now, what did you do after you headed the CRO?
`A. After that job, I took a job as head of development at
`Texas Biotechnology Company, which was a spinout from the
`Texas Heart Institute, which is -- was a tremendous
`opportunity for me with my interest in cardiology, and was
`developing a new anticoagulant that was very, very useful in
`patients who were sensitive to Heparin and other sorts of
`anticoagulants. And that drug subsequently got to the market
`and is sold under the name of Novastan.
`Q. And what did you do after the Texas Biotech?
`A. Well, I took a little time off in preparation for
`starting my own company. I had a little bit of a consulting
`role. I was an interim CEO for about six months at a company.
`This was another contract research organization, specializing
`mostly in pharmaceutics at that time and stability work. But
`I spent the majority of the time writing my business plan and
`preparing to start Pozen.
`Q. And as you started Pozen, what was -- what was your goal
`for Pozen?
`A. It was to create new medicines and bring those medicines
`to the market and hopefully stay in business and become a
`profitable company.
`Q. Dr. Plachetka, we talked briefly about PTX-001 and
`PTX-002 which are the '907 and the '285 patents. Could you
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`PLACHETKA - DIRECT - HASH
`
`24
`
`briefly summarize for the Court your understanding of what
`those -- the patents-in-suit are directed to?
`A. Well, these patents cover a new type of an arthritis
`medicine that I created based on the concept of coordinated
`delivery of an immediate-release proton pump inhibitor or
`an --
`
`THE COURT: Slow down, please, sir --
`THE WITNESS: I'm sorry, ma'am.
`THE COURT: -- if you would. The courtroom tends to
`absorb sound, and we are on the record. We have the finest
`court reporters in the land, but I have to be able to follow
`in my head, also.
`So what I got so far was, based on the concepts that
`you're about to list, you were looking to -- these patents
`cover a new type of arthritis medicine, and the concepts
`include the coordinated delivery of an immediate-release
`proton pump inhibitor. And then that's where I stopped you.
`So could you just back up to that a little bit? You don't
`have to explain. Just give me the words first.
`THE WITNESS: Okay. I'm sorry. I'll slow down.
`THE COURT: That's fine. You can tell how slow I am
`speaking, and that's just for courtroom purposes.
`THE WITNESS: I will do my best.
`All right. Let me --
`THE COURT: I will remind you.
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`PLACHETKA - DIRECT - HASH
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`25
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`THE WITNESS: Yes, that's fine.
`Let me start over.
`BY MR. HASH:
`Q. Thank you.
`A. The patents-in-suit are, so far as I can tell, the idea
`was to create a better arthritis medicine, a pain reliever
`that did not have the GI side effects associated with the
`typical NSAID-type products. And one of the mechanisms that I
`thought about was a coordinated release of two different
`drugs. One of the drugs, on the outer layer of the tablet,
`would be an acid inhibitor, and that would be either a proton
`pump inhibitor or any type of an acid inhibitor, I guess. And
`the inner core would be a nonsteroidal product, and that would
`be, as an example of a nonsteroidal, a drug like Aleve or
`Motrin.
`
`THE COURT: So that's the pain reliever part.
`THE WITNESS: Yes, ma'am.
`BY MR. HASH:
`Q. Now, does the Vimovo product embody this concept?
`A. It does.
`Q. Now, I wanted to talk a little bit -- we talked a little
`bit about NSAIDs, and I wanted to talk about where you were in
`this 2001 time frame when you were -- you know, ultimately
`conceived of this invention. What was your view of the NSAID
`market at that time?
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`PLACHETKA - DIRECT - HASH
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`26
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`A. Well, the NSAID market at that time was undergoing a very
`significant transformation. There had been a new class of
`drugs that were introduced within the last four or five years,
`contemporaneously, and those were called "COX-2 inhibitors."
`This class of drugs was developed with the intention of
`relieving pai

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