Ex. 2006
`
`EX. 2006
`
`Trial Testimony of Dr. John Plachetka
`Trial Testimony of Dr. John Plachetka
`Oct. 12, 2010, Morning Session
`Oct. 12, 2010, Morning Session
`
`
`
`EX. 2006
`
`Trial Testimony of Dr. John Plachetka
`Trial Testimony of Dr. John Plachetka
`Oct. 12, 2010, Morning Session
`Oct. 12, 2010, Morning Session
`
`
`
`Case 6:08-cv-00437-LED Document 350 Filed 10/20/10 Page 1 of 103 PageID #: 6741
` 1 IN THE UNITED STATES DISTRICT COURT
` FOR THE EASTERN DISTRICT OF TEXAS
` 2 TYLER DIVISION
`
` 3 POZEN,INC. * Civil Docket No.
` * 6:08-CV-437
` 4 VS. *
` * Tyler, Texas
` 5 PAR PHARMACEUTICALS, INC., * October 12, 2010
` ET AL * 9:20 A.M.
` 6
` TRANSCRIPT OF BENCH TRIAL
` 7 MORNING SESSION
` BEFORE THE HONORABLE LEONARD DAVIS
` 8 UNITED STATES DISTRICT JUDGE
`
` 9 APPEARANCES:
`
` 10 FOR THE PLAINTIFF
`
` 11 MR. WILLEM G. SCHUURMAN
` MS. TRACEY B. DAVIES
` 12 MR. STEPHEN M. HASH
` MS. ERIN A. THOMSON
` 13 VINSON & ELKINS
` 2801 Via Fortuna
` 14 Suite 100
` Austin, TX 78746
` 15
` MS. STEPHANIE LOLLO
` 16 VINSON & ELKINS LLP
` 666 Fifth Ave., 26th Floor
` 17 New York, NY 10103
`
` 18 MR. COLLIN MALONEY
` IRELAND, CARROLL & KELLEY
` 19 6101 S. Broadway, Ste. 500
` Tyler, TX 75703
` 20
` COURT REPORTERS:
` 21 MS. SHEA SLOAN, CSR
` MS. SHELLY HOLMES, CSR
` 22 Official Court Reporters
` 211 West Ferguson, Third Floor
` 23 Tyler, TX 75702
` 903/590-1171
` 24
` (Proceedings recorded by mechanical stenography,
` 25 transcript produced on CAT system.)
`
`
`1
`
`
`
`Case 6:08-cv-00437-LED Document 350 Filed 10/20/10 Page 2 of 103 PageID #: 6742
` 1 FOR THE DEFENDANTS
` 2 MR. MICHAEL E. JONES
` POTTER MINTON P.C.
` 3 110 N. College
` 500 Plaza Tower
` 4 Tyler, TX 75702
`
` 5
` MR. RICHARD J. BERMAN
` 6 MS. JANINE A. CARLAN
` MR. AZIZ BURGY
` 7 MR. TIMOTHY W. BUCKNELL
` MR. JOSHUA T. MORRIS
` 8 MR. TANIEL E. ANDERSON
` ARENT FOX LLP
` 9 1050 Connecticut Ave., N.W.
` Washington, DC 20036
` 10
`
` 11 MR. DERON R. DACUS
` RAMEY & FLOCK
` 12 100 E. Ferguson, Ste. 500
` Tyler, TX 75702
` 13
`
` 14 MR. THOMAS J. PARKER
` MR. ROBERT E. HANLON
` 15 MS. NATALIE C. CLAYTON
` ALSTON & BIRD LLP
` 16 90 Park Ave.
` New York, NY 10016
` 17
`
` 18 MR. CHARLES AINSWORTH
` PARKER, BUNT & AINSWORTH, P.C.
` 19 100 E. Ferguson, Ste. 1114
` Tyler, TX 75702
` 20
`
` 21 MR. PAUL H. KOCHANSKI
` MR. MICHAEL H. TESCHNER
` 22 LERNER, DAVID, LITTENBERG,
` KRUMHOLZ & MENTLIK, LLP
` 23 600 S. Avenue W
` Westfield, NJ 07090-1497
` 24
`
` 25
`
`
`2
`
`
`
`Case 6:08-cv-00437-LED Document 350 Filed 10/20/10 Page 3 of 103 PageID #: 6743
` 1 P R O C E E D I N G S
` 2 COURT SECURITY OFFICER: All rise.
`
` 3 THE COURT: Please be seated.
`
` 4 All right. Ms. Ferguson, if you'll call
`
` 5 the case, please.
`
` 6 THE CLERK: Case No. 6:08-CV-437, Pozen,
`
` 7 Inc., vs. Par Pharmaceutical, et al.
`
` 8 THE COURT: All right. Announcements.
`
` 9 MR. MALONEY: Your Honor, Collin Maloney
`
` 10 here for Pozen. Mr. Plachetka, who is in the empty
`
` 11 chair, just had to run down the hall; but he will be
`
` 12 back momentarily.
`
` 13 I'm here with Vinson & Elkins and Bill
`
` 14 Schuurman. We have Erin Ator Thomson, Steve Hash,
`
` 15 Tracey Davies; and you'll also be hearing from Stephanie
`
` 16 Lollo, who is in the gallery.
`
` 17 Your Honor, this is Mr. Plachetka coming
`
` 18 in.
`
` 19 THE COURT: Okay. Thank you.
`
` 20 MR. JONES: Your Honor, for the record,
`
` 21 Mike Jones. I represent Par Pharmaceutical. Here on
`
` 22 behalf of Par Pharmaceutical, our corporate
`
` 23 representative is Mr. Lawrence Brown, who is the senior
`
` 24 director of intellectual property. Our lead attorney is
`
` 25 Ms. Janine Carlan. She's from Washington, D.C., with
`
`3
`
`
`
`Case 6:08-cv-00437-LED Document 350 Filed 10/20/10 Page 4 of 103 PageID #: 6744
` 1 Arent Fox.
` 2 And also presenting, or presenting the
`
` 3 evidence on behalf of Par will be Mr. Aziz Burgy,
`
` 4 Mr. Timothy Bucknell, and Mr. J. T. Morris. And they're
`
` 5 all seated back there, Your Honor.
`
` 6 THE COURT: Thank you, sir.
`
` 7 MR. DACUS: Morning, Judge. Deron Dacus
`
` 8 here with Natalie Clayton and Bob Hanlon from Alston &
`
` 9 Bird on behalf of Alphapharm. We're ready to proceed,
`
` 10 Your Honor.
`
` 11 MR. AINSWORTH: Your Honor, I'm Charlie
`
` 12 Ainsworth. I'm here with Dr. Reddy's Laboratories. And
`
` 13 with me today is Paul Kochanski; and also will be
`
` 14 questioning is Mike Teschner, who is also in the back.
`
` 15 And we're ready, Your Honor.
`
` 16 THE COURT: All right. Well, we have a
`
` 17 lot to do to get started. Anything before we go to
`
` 18 opening statements from the parties? Yes.
`
` 19 MS. CARLAN: Your Honor, Par has a few
`
` 20 issues with respect to some of the exhibits. I believe
`
` 21 with all of the exhibits -- the large number of exhibits
`
` 22 that we have in this case, there is -- we're down to
`
` 23 just four for which there is a dispute. And they are
`
` 24 actually in two categories. So we'd like to bring that
`
` 25 up at this time.
`
`4
`
`
`
`Case 6:08-cv-00437-LED Document 350 Filed 10/20/10 Page 5 of 103 PageID #: 6745
` 1 THE COURT: We -- would it -- would it be
` 2 easier to do it now or when they're ready to offer it?
`
` 3 Is it something that's going to affect --
`
` 4 MS. CARLAN: It may affect it going
`
` 5 forward if they have any part of it in some of the --
`
` 6 THE COURT: Okay. All right.
`
` 7 MS. CARLAN: The first one -- there
`
` 8 are -- PTX305 and PTX254 are exhibits that are on
`
` 9 Plaintiff's exhibit lists. There are actually
`
` 10 declarations that they would like to have in evidence.
`
` 11 Both of these declarations are
`
` 12 impermissible hearsay. They are declarations of authors
`
` 13 or co-authors on prior art references. And these
`
` 14 declarations are being offered for the truth of the
`
` 15 matter within them.
`
` 16 These -- these two people are not coming
`
` 17 here; they are not going to be testifying. So it's just
`
` 18 hearsay. It's -- it's being offered for the truth of
`
` 19 the matter. They're saying what these references mean
`
` 20 when they're not here to testify about it.
`
` 21 The other problem with these two
`
` 22 declarations is that they are both impermissible expert
`
` 23 testimony. They are both opining about the state of the
`
` 24 art and particular prior art references.
`
` 25 And finally, both of these declarations
`
`5
`
`
`
`Case 6:08-cv-00437-LED Document 350 Filed 10/20/10 Page 6 of 103 PageID #: 6746
` 1 are basically irrelevant to this case, shouldn't be
` 2 brought in because they are not something that anyone of
`
` 3 ordinary skill in the art would look at and rely on to
`
` 4 find out what these prior art references actually mean.
`
` 5 One of ordinary skill in the art would
`
` 6 look at the prior art references in view of one of
`
` 7 ordinary skill in the art and be able to interpret what
`
` 8 the references mean without these declarations.
`
` 9 So for those three reasons, we say that
`
` 10 these should not be admitted in this case.
`
` 11 THE COURT: All right. Response?
`
` 12 MR. HASH: Your Honor, Ms. Thomson is
`
` 13 prepared to respond.
`
` 14 THE COURT: All right.
`
` 15 MS. THOMSON: Your Honor, these -- these
`
` 16 declarations are submitted by authors who reviewed the
`
` 17 Defendants' expert opinions on articles that they
`
` 18 authored, Your Honor, and -- and they deemed that
`
` 19 those -- that those references were -- were
`
` 20 misinterpreted by Defendants. And so we have submitted
`
` 21 two declarations in which the authors themselves, who
`
` 22 are the best people to opine -- sorry, not to opine, but
`
` 23 to state what they actually wrote in the article,
`
` 24 explain what they wrote and explain why Defendants'
`
` 25 interpretation is incorrect.
`
`6
`
`
`
`Case 6:08-cv-00437-LED Document 350 Filed 10/20/10 Page 7 of 103 PageID #: 6747
` 1 It's our position, Your Honor, that this
` 2 is offered to show the state of the art at the time.
`
` 3 It's very relevant to this case. And we also argue,
`
` 4 Your Honor, that it falls into the residual exception
`
` 5 because there are circumstantial guarantees of
`
` 6 trustworthiness with respect to these declarations.
`
` 7 First, they were offered under penalty of
`
` 8 perjury. One of the authors, Your Honor, Dr. Tognoni
`
` 9 refused to take any compensation for his --
`
` 10 THE COURT: What about their right to
`
` 11 cross-examine these authors?
`
` 12 MS. THOMSON: Well, Your Honor, the
`
` 13 Defendants have had these declarations in their
`
` 14 possession, one for eight months, another for almost six
`
` 15 months. They've had every opportunity to contact these
`
` 16 authors and take their depositions, and they haven't
`
` 17 done so, Your Honor. We gave these declarations to the
`
` 18 Defendants a long time ago.
`
` 19 THE COURT: Okay. Response?
`
` 20 MS. CARLAN: Your Honor, as you heard
`
` 21 from both these counsel, these are being offered for the
`
` 22 truth of the matter in the declarations. The truth of
`
` 23 the matter is that the out-of-court statement is that
`
` 24 these references mean a certain thing about the state of
`
` 25 art. And our position is that is hearsay. That is the
`
`7
`
`
`
`Case 6:08-cv-00437-LED Document 350 Filed 10/20/10 Page 8 of 103 PageID #: 6748
` 1 classic definition of hearsay.
` 2 And as far as whether they have any place
`
` 3 in this -- in this court -- in this case at all, they do
`
` 4 not, because the question is what would one of ordinary
`
` 5 skill in the art reviewing these references find that
`
` 6 these references mean, not --
`
` 7 THE COURT: Okay. I'm going to
`
` 8 preliminarily rule that they're excluded. But that's
`
` 9 not without Defendants' right to offer them at a later
`
` 10 time when I can see it in the context of the testimony.
`
` 11 But it sounds to me like there's too many problems with
`
` 12 it.
`
` 13 MS. THOMSON: Your Honor, may I say one
`
` 14 more thing?
`
` 15 THE COURT: Okay.
`
` 16 MS. THOMSON: I'm sorry. To the extent
`
` 17 even if they are hearsay, our own expert relies upon
`
` 18 them, and an expert --
`
` 19 THE COURT: Okay. My ruling is still the
`
` 20 same. Thank you.
`
` 21 All right. What else?
`
` 22 MS. CARLAN: Your Honor, there are just
`
` 23 two other exhibits, and they're both basically the same
`
` 24 thing. These two exhibits are JTX63 and 64, and they
`
` 25 are surveys. And they are surveys that were conducted
`
`8
`
`
`
`Case 6:08-cv-00437-LED Document 350 Filed 10/20/10 Page 9 of 103 PageID #: 6749
` 1 by a survey company, Ipsos. And these contain various
` 2 levels of hearsay. These surveys, if they are offered
`
` 3 for the truth, any of -- of any of the statements within
`
` 4 the surveys, then it's --
`
` 5 THE COURT: Are they relied on by
`
` 6 experts?
`
` 7 MS. CARLAN: They are not.
`
` 8 THE COURT: Okay. And so they're just
`
` 9 offering the surveys without any predicate, just --
`
` 10 MS. CARLAN: I'm sorry. I misspoke.
`
` 11 There are some experts that may rely on this in the
`
` 12 economics area.
`
` 13 THE COURT: Okay. Response?
`
` 14 MS. THOMSON: Your Honor, as Ms. Carlan
`
` 15 mentioned, these exhibits are included on the joint
`
` 16 exhibit list, so these are documents that Defendants
`
` 17 themselves have identified as exhibits in this case.
`
` 18 Also, we do have an expert that relies
`
` 19 upon them, and they are -- they are reasonable documents
`
` 20 for the expert to rely upon.
`
` 21 THE COURT: Okay. Well, I'm going to
`
` 22 sustain the objection now; but, again, with this one,
`
` 23 I'll take it up at the time your expert testifies if you
`
` 24 can lay an appropriate predicate for their admission.
`
` 25 But just to offer them in a wholesale
`
`9
`
`
`
`Case 6:08-cv-00437-LED Document 350 Filed 10/20/10 Page 10 of 103 PageID #: 6750
` 1 offering at the beginning of the trial, I'll sustain the
` 2 objection.
`
` 3 Now, does either side have any, well,
`
` 4 exhibits that you wish to offer? Have y'all met and
`
` 5 conferred on those? Do you have exhibit lists of
`
` 6 unobjected-to exhibits?
`
` 7 MS. THOMSON: Your Honor, Pozen maintains
`
` 8 one objection to documents listed on Defendants' exhibit
`
` 9 list, and that is we object to the entry of their expert
`
` 10 reports into evidence.
`
` 11 THE COURT: Okay. Are you seeking to
`
` 12 introduce your expert reports into evidence?
`
` 13 MS. THOMSON: No, Your Honor, we're not.
`
` 14 THE COURT: What's your response to the
`
` 15 expert report?
`
` 16 MS. CARLAN: Your Honor, the only expert
`
` 17 report that remains on the list is the expert report of
`
` 18 Dr. Goldberg. And Dr. Goldberg will not be able to
`
` 19 testify in this -- live in this case. And I believe
`
` 20 Mr. Kochanski will address the issue with Dr. Goldberg.
`
` 21 THE COURT: All right.
`
` 22 MR. KOCHANSKI: Yes, Your Honor. If you
`
` 23 remember two weeks ago when we met in chambers, I
`
` 24 brought to the attention of the Court that Dr.
`
` 25 Goldberg's husband was dying of cancer, and there was an
`
`10
`
`
`
`Case 6:08-cv-00437-LED Document 350 Filed 10/20/10 Page 11 of 103 PageID #: 6751
` 1 issue whether Dr. Goldberg could appear at trial this
` 2 week.
`
` 3 At 2 o'clock yesterday afternoon we
`
` 4 received -- in that period of time since -- since that
`
` 5 meeting in chambers, we had arranged that Dr. Goldberg
`
` 6 would testify by video conference this coming Thursday
`
` 7 morning to provide her testimony to give the opportunity
`
` 8 to the Plaintiff to cross-examine her at that time.
`
` 9 Yesterday afternoon around 2 o'clock, I
`
` 10 received an e-mail from Dr. Goldberg where Dr. Goldberg
`
` 11 indicated to me that she had met the doctor that morning
`
` 12 and that the doctor said -- he was talking about a
`
` 13 matter of possibly days.
`
` 14 And Dr. Goldberg said that, based upon
`
` 15 her present mental state and based upon, you know, the
`
` 16 duty and obligation she knows she has to this -- to this
`
` 17 case, that she couldn't testify. She couldn't prepare,
`
` 18 she couldn't concentrate on it, and she would not be
`
` 19 able to testify at this time, this Thursday as --
`
` 20 THE COURT: Has she not been deposed
`
` 21 previously?
`
` 22 MR. KOCHANSKI: I'm sorry?
`
` 23 THE COURT: Has she not been deposed
`
` 24 previously?
`
` 25 MR. KOCHANSKI: She was deposed -- she
`
`11
`
`
`
`Case 6:08-cv-00437-LED Document 350 Filed 10/20/10 Page 12 of 103 PageID #: 6752
` 1 was deposed as an expert by Mr. Hash of the Plaintiff.
` 2 But in the deposition there wasn't a full discussion of
`
` 3 her -- of her expert report. It was more -- a lot of
`
` 4 the deposition referred to her qualifications and
`
` 5 referred to some of the opinions she had with respect to
`
` 6 combined studies.
`
` 7 We have offered a couple of scenarios to
`
` 8 talking with co-counsel, Defense co-counsel, and to the
`
` 9 Plaintiff. One scenario that we offered why
`
` 10 Dr. Goldberg's expert report is still on the exhibit
`
` 11 list is that we would -- we would agree to the entry
`
` 12 or -- and if the Plaintiff so agreed, to the entry of
`
` 13 Dr. Goldberg's expert report.
`
` 14 And as Mr. Ainsworth advised me, there
`
` 15 are certain procedures where we would be able to give a
`
` 16 five-minute summarization of what we would want the
`
` 17 Court to look at in that expert report, what we felt was
`
` 18 important, whatever. The Plaintiff would have the
`
` 19 opportunity to provide a summarization of what their
`
` 20 arguments were with respect to that expert report and
`
` 21 where they thought the weaknesses were, and, of course,
`
` 22 put on their rebuttal testimony through their expert,
`
` 23 Dr. Gennings.
`
` 24 Again, this -- this was offered
`
` 25 yesterday, and it appears, based upon the continued
`
`12
`
`
`
`Case 6:08-cv-00437-LED Document 350 Filed 10/20/10 Page 13 of 103 PageID #: 6753
` 1 objection of the Plaintiff to the admissibility of
` 2 Dr. Goldberg's expert report, that -- I have been
`
` 3 advised they don't agree to that.
`
` 4 The second -- the second thing, we've
`
` 5 discussed the manner of getting Dr. Goldberg's testimony
`
` 6 would be to leave the trial record open to give us the
`
` 7 opportunity to take her testimony. In the Jewish
`
` 8 faith -- and this will be time from the date her husband
`
` 9 died.
`
` 10 In the Jewish faith, if the Court is
`
` 11 aware or not aware, there's something called sitting
`
` 12 shiva. That would be the equivalent, in the Christian
`
` 13 faith, of a wake.
`
` 14 However, in the Jewish faith, normally
`
` 15 the body is buried within 24 to 48 hours depending upon
`
` 16 the Sabbath, whether it's the Sabbath or not. At that
`
` 17 period of time, in lieu of a wake as we have in the
`
` 18 Christian faith, the Jewish faith shiva, Dr. Goldberg
`
` 19 would be at her home taking memorial calls from her
`
` 20 friends or family, and that usually is between five to
`
` 21 seven days that -- that it occurs.
`
` 22 THE COURT: Okay. Well, what's -- I'm
`
` 23 sensitive to Dr. Goldberg's situation, you know. Why
`
` 24 don't we just proceed with the trial, and I'll entertain
`
` 25 a motion at the appropriate time to leave the record
`
`13
`
`
`
`Case 6:08-cv-00437-LED Document 350 Filed 10/20/10 Page 14 of 103 PageID #: 6754
` 1 open if that's necessary. I'm not going to just allow
` 2 her report to be introduced or any summaries.
`
` 3 We'll either go -- either side can offer
`
` 4 whatever deposition testimony there is, and at the --
`
` 5 when we see -- if she can't come as we get close to the
`
` 6 end of the case, I'll consider whether to leave the
`
` 7 record open for her.
`
` 8 MR. KOCHANSKI: Thank you, Your Honor.
`
` 9 THE COURT: I'll try to accommodate her
`
` 10 if at all possible.
`
` 11 Okay. Anything further with regard to
`
` 12 the exhibits?
`
` 13 Okay. Does either side have an agreed
`
` 14 exhibit list to tender to the Court of exhibits that
`
` 15 have been agreed to that you wish to offer into
`
` 16 evidence?
`
` 17 Okay. Let me explain what my procedure
`
` 18 normally is because I see blank looks on everybody's
`
` 19 faces.
`
` 20 But in a typical jury trial -- and I
`
` 21 would do it in a bench trial as well -- y'all should
`
` 22 have met and conferred, have an exhibit list of exhibits
`
` 23 that there's no objection to from the other side; and
`
` 24 you would now tender this list to Ms. Ferguson and to
`
` 25 the Court. We would mark it. And then I would ask if
`
`14
`
`
`
`Case 6:08-cv-00437-LED Document 350 Filed 10/20/10 Page 15 of 103 PageID #: 6755
` 1 there is any objection; and if there's not, then all
` 2 those exhibits will come in. Then we don't have to
`
` 3 offer them during the course of trial.
`
` 4 So I take it y'all don't have that
`
` 5 prepared.
`
` 6 MR. MALONEY: Your Honor, my
`
` 7 understanding is the Plaintiff has provided a joint --
`
` 8 the joint list in the Plaintiff's exhibits to -- and
`
` 9 tendered that to the Court. And those were all --
`
` 10 THE COURT: Okay. Do I have that? Can
`
` 11 you hand that up to me, please?
`
` 12 MS. CARLAN: And, Your Honor, we do have
`
` 13 a list of Defendants' exhibits as well that we would
`
` 14 tender.
`
` 15 THE COURT: All right. Let's get
`
` 16 Plaintiff's list first. All right. Do you have
`
` 17 Defendants' list? If you will bring that up and -- what
`
` 18 is that titled?
`
` 19 MS. CARLAN: Defendants' trial exhibit
`
` 20 list.
`
` 21 THE COURT: Now, are these all
`
` 22 exhibits -- let me see that exhibit list. Are these all
`
` 23 exhibits that you're going to introduce into evidence?
`
` 24 MS. CARLAN: Yes. These are all -- Your
`
` 25 Honor, these are all of the exhibits. And many of them
`
`15
`
`
`
`Case 6:08-cv-00437-LED Document 350 Filed 10/20/10 Page 16 of 103 PageID #: 6756
` 1 will be introduced into evidence; some of them will not.
` 2 THE COURT: Okay. Well, I don't want
`
` 3 this. I don't want your exhibit list from your pretrial
`
` 4 order of exhibits that may or may not be introduced.
`
` 5 But what I am looking for, and if you
`
` 6 will have it for me -- all right, if everybody will sit
`
` 7 down and pay attention -- and if you will have it for me
`
` 8 in the morning, it's whatever exhibits that are -- I'm
`
` 9 going to assume if you use it with a witness today, and
`
` 10 there's not an objection, then it's going to be
`
` 11 admitted, okay?
`
` 12 And in the morning, have a list of all of
`
` 13 those exhibits that were used today. And Plaintiff will
`
` 14 label theirs Plaintiff's Exhibit List No. 1, or
`
` 15 something to that effect; and Defendant likewise. You
`
` 16 will tender that, it will be marked, and all of those on
`
` 17 there will be admitted for the record. It's to keep the
`
` 18 record straight.
`
` 19 Also tomorrow morning, if you will have
`
` 20 an agreed list of those exhibits that you intend to use
`
` 21 tomorrow, and we'll go ahead and admit those at the
`
` 22 beginning of the trial.
`
` 23 All right. Have y'all discussed how much
`
` 24 time you want for opening statements?
`
` 25 MR. HASH: Your Honor, we're going to
`
`16
`
`
`
`Case 6:08-cv-00437-LED Document 350 Filed 10/20/10 Page 17 of 103 PageID #: 6757
` 1 take about 30 minutes.
` 2 MR. JONES: I think we're going to take
`
` 3 about 30 minutes, too, Your Honor.
`
` 4 THE COURT: Okay. Y'all have got ten
`
` 5 hours, so use your time however you want.
`
` 6 The Court will recognize Plaintiff for
`
` 7 purposes of opening statement.
`
` 8 MR. HASH: May it please the Court.
`
` 9 Stephen Hash, and I am privileged to be
`
` 10 here today representing Pozen, Incorporated. I did want
`
` 11 to express our gratitude to the Court for allotting this
`
` 12 time for us to put before you the issues. We are
`
` 13 enthusiastic about the opportunity to present Pozen's
`
` 14 story to the Court.
`
` 15 I'd first like to introduce you to
`
` 16 Dr. John Plachetka. Dr. Plachetka is the president,
`
` 17 CEO, chairman of the board, and chief scientific officer
`
` 18 at Pozen, a company he founded in 1996.
`
` 19 Dr. Plachetka has a Doctor of Pharmacy
`
` 20 degree and over 30 years of experience in developing
`
` 21 drugs. Dr. Plachetka is also the inventor of ten U.S.
`
` 22 patents.
`
` 23 Dr. Plachetka's company, Pozen, is
`
` 24 located in Chapel Hill, North Carolina. It's a
`
` 25 specialty pharmaceutical company with 30 employees, each
`
`17
`
`
`
`Case 6:08-cv-00437-LED Document 350 Filed 10/20/10 Page 18 of 103 PageID #: 6758
` 1 dedicated, like Dr. Plachetka, to transforming medicine,
` 2 to transforming people's lives. They do this through
`
` 3 developing novel therapies that treat disease and reduce
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` 4 suffering.
`
` 5 I find it incredible that such a small
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` 6 company currently has two FDA-approved drugs. The
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` 7 first, Treximet, is for the use in treating migraines.
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` 8 And the second, a drug Vimovo, which is used to treat
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` 9 rheumatoid arthritis.
`
` 10 Now, within the next few days we're going
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` 11 to hear a lot about Treximet, which is Dr. Plachetka's
`
` 12 invention. Treximet combines sumatriptan with naproxen,
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` 13 and that combination is used in the acute treatment of
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` 14 migraine.
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` 15 After extensive clinical studies, FDA
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` 16 approval, the drug was launched in May 2008. It's the
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` 17 only drug approved by the FDA that is recognized to be
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` 18 superior to Imitrex, which is sumatriptan, the gold
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` 19 standard for migraine therapy.
`
` 20 Now, the migraine condition is -- is
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` 21 incredibly serious. It's manifested with -- a migraine
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` 22 attack manifests as throbbing pain, nausea or vomiting,
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` 23 light and noise sensitivity, which is made worse by
`
` 24 movement.
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` 25 The World Health Organization considers a
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`18
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`
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`Case 6:08-cv-00437-LED Document 350 Filed 10/20/10 Page 19 of 103 PageID #: 6759
` 1 day lived with severe migraine to be as disabling as a
` 2 day with dementia, quadriplegia or acute psychosis, and
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` 3 to be more disabling than blindness, paraplegia, angina
`
` 4 or rheumatoid arthritis.
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` 5 The migraineurs suffer from these
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` 6 attacks. And when they have these attacks, they are
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` 7 unable to function. They are unable to work, they are
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` 8 unable to care for their children, they are unable to
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` 9 live their lives. Instead, they retreat into a dark --
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` 10 the darkest, quietest place they can find, curl up in a
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` 11 ball until the pain goes away.
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` 12 The cost of migraines are astounding.
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` 13 Twenty-eight million people in the United States are
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` 14 affected by the condition, and it's estimated to cost
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` 15 $23 billion a year in the United States alone.
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` 16 Now, I wanted to give the Court some
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` 17 background on the treatment options that are available
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` 18 to patients who are suffering from migraine. And I'd
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` 19 like to take you back before Dr. Plachetka's invention
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` 20 in August of -- the filing of his invention in August of
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` 21 1996.
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` 22 Now, before 1988, the options available
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` 23 to migraines
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