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`Filed 10/04/11 Page 1 of 100
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`196FTEV1
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`Trial
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`UNITED STATES DISTRICT COURT
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`SOUTHERN DISTRICT OF NEW YORK
`: : : : : : : : : : : : : : : : : : : : : : : : : : : : jjx
`
`TEVA PHARMACEUTICALS USA,
`INC., TEVA PHARMACEUTICALS
`INDUSTRIES LTD., TEVA
`NEUROSCIENCE,
`INC. and YEDA
`RESEARCH AND DEVELOPMENT CO.
`
`LTD.,
`
`Plaintiffs,
`
`v.
`
`SANDOZ
`INC.,
`SANDOZ,
`INTERNATIONAL GMBH, NOVARTIS
`AG, and MOMENTA
`PHARMACEUTICALS,
`
`INC.,
`
`Defendants.
`
`____________________________ __X
`
`TEVA PHARMACEUTICALS USA,
`INC., TEVA PHARMACEUTICALS
`INDUSTRIES LTD , TEVA
`NEUROSCIENCE,
`INC. and YEDA
`RESEARCH AND DEVELOPMENT Co.
`
`LTD.,
`
`O8—CV—7611
`
`(BSJ)
`
`Plaintiffs,
`
`v.
`
`O9—CV—8824
`
`(BSJ)
`
`MYLAN PHARMACEUTICALS INC.,
`MYLAN INC., NATCO PHARMA LTD.,
`
`Defendants.
`
`Non—Jury Trial
`
`Before:
`
`New York, N.Y.
`
`September 7, 2011
`9:30 a.m.
`
`HON. BARBARA S.
`
`JONES,
`
`District Judge
`
`SOUTHERN DISTRICT REPORTERS, P.C.
`(212) 805-0300
`
`MYLAN PHARMS. INC. EXHIBIT 1138 PAGE 1
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`MYLAN PHARMS. INC. EXHIBIT 1138 PAGE 1
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`Case 1:09—cv—08824—WHP Document 205 Filed 10/04/11 Page 2 of 100
`196FTEV1
`Trial
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`SOUTHERN DISTRICT REPORTERS, P.C.
`(212) 805-0300
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`MYLAN PHARMS. INC. EXHIBIT 1138 PAGE 2
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`MYLAN PHARMS. INC. EXHIBIT 1138 PAGE 2
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`Case 1:09—cv—08824—WHP Document 205 Filed 10/04/11 Page 3 of 100
`196FTEV1
`Trial
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`APPEARANCES
`
`KENYON & KENYON
`
`BY:
`
`Attorneys for Plaintiffs
`ELIZABETH J. HOLLAND, ESQ.
`WILLIAM G.
`JAMES, II, ESQ.
`CAROLYN A. BLESSING, ESQ.
`
`GOODWIN PROCTER, LLP
`
`BY:
`
`Attorneys for Plaintiffs
`DAVID M. HASHMALL, ESQ.
`JOHN T. BENNETT, ESQ.
`NICHOLAS K. MITROKOSTAS, ESQ.
`
`MORRISON & FOERSTER LLP
`
`BY:
`
`Attorneys for Defendants
`DAVID C. DOYLE, ESQ.
`KAREN L. HAGBERG, ESQ.
`ERIC M. ACKER, ESQ.
`
`PERKINS COIE LLP
`
`BY:
`
`Attorneys for Defendants
`JOHN S. SKILTON, ESQ.
`DAVID L. ANSTAETT, ESQ.
`SHANNON M. BLOODWORTH, ESQ.
`DAVID JONES, ESQ.
`
`ALSO PRESENT:
`
`CORT CHASE, Litigation Support
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`SOUTHERN DISTRICT REPORTERS, P.C.
`(212) 805-0300
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`MYLAN PHARMS. INC. EXHIBIT 1138 PAGE 3
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`MYLAN PHARMS. INC. EXHIBIT 1138 PAGE 3
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`Case 1:O9—cv—08824—WHP Document 205 Filed 10/04/11 Page 38 of 100
`197ZTEV2
`Opening — Ms. Hagberg
`
`38
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`MS. HAGBERG: As Teva tried to persuade the FDA even
`
`the most minor changes in manufacturing will produce a new
`
`molecular entity with a significantly different potency and
`
`safety and efficacy policy.
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`The evidence at this trial will prove conclusively
`
`that a person of skill in the art must know the SEC standards
`
`to have any confidence that it is producing co—polymer—l having
`
`the same molecular weight as what Teva claims it invented. And
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`that is the information that is missing from the patents.
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`Without that entablement, each of the patents is rendered
`
`invalid.
`
`Thank you for your time this morning, your Honor, and
`
`to allow me to emphasize an area of the evidence that Sandoz
`
`and Momenta believe will be very critical to this case
`
`THE COURT:
`
`Thank you, Ms. Hagberg.
`
`All right.
`
`I don't think —— do I have a list of
`
`witnesses yet?
`
`MS. HOLLAND: Yes, your Honor I believe we did send
`
`one, a list of witnesses.
`
`Do we have one —— we can get you a
`
`copy of that, your Honor.
`
`THE COURT: Okay,
`
`I'm sure it came in. We just didn't
`
`see it.
`
`MS. HOLLAND: Yeah, we'll find one.
`
`THE COURT: All right.
`
`Then are you ready to proceed?
`
`MS. HOLLAND: Yes. Mr. Hashmall is going to be
`
`SOUTHERN DISTRICT REPORTERS, P.C.
`(212) 805-0300
`
`MYLAN PHARMS. INC. EXHIBIT 1138 PAGE 4
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`MYLAN PHARMS. INC. EXHIBIT 1138 PAGE 4
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`Case 1:O9—cv—08824—WHP Document 205 Filed 10/04/11 Page 39 of 100
`197ZTEV2
`Opening — Ms. Hagberg
`
`39
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`presenting our first witness.
`
`THE COURT: Mr. Hashmall.
`
`MR. HASHMALL: Good morning, your Honor. Plaintiffs
`
`would call as our first witness Mr. John Congleton.
`
`JOHN CONGLETON,
`
`called as a witness by the plaintiff,
`
`having been duly sworn, testified as follows:
`
`DIRECT EXAMINATION
`
`BY MR. HASHMALL:
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`THE COURT:
`
`Take your seat, and spell your last
`
`name —— state your full name and spell your last name for the
`
`record.
`
`THE WITNESS:
`
`John Congleton, C—O—N—G—L—E—T—O—N.
`
`MR. HASHMALL: May I proceed, your Honor?
`
`THE COURT: You may proceed.
`
`MR. HASHMALL:
`
`Thank you.
`
`Q. Good morning.
`
`A. Good morning.
`
`Q. Mr. Congleton, could you please introduce yourself to the
`
`Court?
`
`A. Yes. My name is John Congleton.
`
`I'm senior vice—president
`
`and general manager for Teva Neuroscience.
`
`Q. Could you tell us a little bit about Teva Neuroscience, its
`
`business?
`
`A. Yes.
`
`Teva Neuroscience is focused on the commercialization
`
`SOUTHERN DISTRICT REPORTERS, P.C.
`(212) 805-0300
`
`MYLAN PHARMS. INC. EXHIBIT 1138 PAGE 5
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`MYLAN PHARMS. INC. EXHIBIT 1138 PAGE 5
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`Case 1:O9—cv—08824—WHP Document 205 Filed 10/04/11 Page 40 of 100
`197ZTEV2
`Congleton — direct
`
`40
`
`of Copaxone, as well Azilect for Teva in the United States.
`
`Q. Where is Teva Neuroscience located?
`
`A.
`
`It's located in Kansas City, Missouri.
`
`Q. Approximately, how many people does Teva Neuroscience
`
`currently employ?
`
`A. Approximately 600.
`
`Q. When was Teva Neuroscience founded?
`
`A.
`
`Teva Neuroscience was founded in 1995.
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`Q.
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`Now, what is the relationship between Teva Neuroscience and
`
`the plaintiff in this action, Teva Pharmaceutical Industries?
`
`A.
`
`Teva Neuroscience is a subsidiary of Teva Pharmaceutical
`
`Industries.
`
`Q. And you know when Teva Pharmaceutical Industries was
`
`founded?
`
`A.
`
`In 1901.
`
`Q. You mentioned that Teva Neuroscience is in the business of
`
`selling Teva's branded products,
`
`is that correct?
`
`A. Yes.
`
`Q. Does Teva also sell, Teva Pharmaceuticals also sell generic
`
`products?
`
`A. Yes, it does.
`
`Q.
`
`Do you know overall for Teva's business approximately how
`
`much of its sales derives from generic products and how much
`
`derives from branded products?
`
`A. Approximately 70 percent is from generics, and
`
`SOUTHERN DISTRICT REPORTERS, P.C.
`(212) 805-0300
`
`MYLAN PHARMS. INC. EXHIBIT 1138 PAGE 6
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`MYLAN PHARMS. INC. EXHIBIT 1138 PAGE 6
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`Case 1:O9—cv—08824—WHP Document 205 Filed 10/04/11 Page 41 of 100
`l97ZTEV2
`Congleton — direct
`
`41
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`approximately 30 percent is from brand pharmaceuticals.
`
`Q.
`
`Now, you testified that you currently, you are currently
`
`senior vice—president and general manager of Teva Neuroscience.
`
`Could you briefly describe for the Court what your
`
`responsibilities are in that position?
`
`A. Yes.
`
`I'm accountable for the sales and profits of the
`
`products that Teva Neuroscience commercializes, Copaxone and
`
`Azilect.
`
`Q. Approximately, how many people report to you currently,
`
`Mr. Congleton?
`
`A. Approximately 450.
`
`Q. And how long have you been employed by Teva Neuroscience?
`
`A.
`
`A little over 15 years.
`
`Q. Could you briefly describe your educational and
`
`professional background prior to you joining Teva Neuroscience?
`
`A. Yes.
`
`I have a bachelors degree in marketing from Kansas
`
`State University, started off in field sales in pharmaceuticals
`
`developmental roles, field sales manager position prior to
`
`joining Teva Neuroscience.
`
`Q. Could you tell us a little bit about your employment prior
`
`to joining Teva Neuroscience?
`
`A. That's the pharmaceutical sales rep, developmental role,
`
`human resource in field base sales manager.
`
`Q.
`
`Do you have any degree in chemistry or biology?
`
`A. No,
`
`I do not.
`
`SOUTHERN DISTRICT REPORTERS, P.C.
`(212) 805-0300
`
`MYLAN PHARMS. INC. EXHIBIT 1138 PAGE 7
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`Case 1:O9—cv—08824—WHP Document 205 Filed 10/04/11 Page 42 of 100
`197ZTEV2
`Congleton — direct
`
`42
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`Q.
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`Now, since joining Teva Neuroscience, what positions have
`
`you held at the company?
`
`A.
`
`I have been a field sales manager, a product manager and a
`
`marketing department,
`
`the product director for Copaxone,
`
`general manager for our Canadian Division of Teva Neuroscience,
`
`as well as my current position, general manager for the United
`
`States division.
`
`Q. Prior to you taking on your current position, could you
`
`just generally describe what your responsibilities have been
`
`with respect to Copaxone?
`
`A. Yes.
`
`I started off as a product manager prelaunch
`
`preparing that product, and moved into the director of
`
`marketing for Copaxone as well.
`
`Q. And do you continue to have responsibilities currently with
`
`respect to Copaxone?
`
`A. Yes.
`
`It's under my span of control.
`
`Q. Could you just generally describe for the Court what those
`
`responsibilities include?
`
`A. Generally it's around the development and approval of our
`
`work plan,
`
`the budget,
`
`the resources we apply against the
`
`product, as well as strategic oversight.
`
`Q.
`
`Now, you mentioned that in addition to Copaxone, Teva
`
`Neuroscience also sells markets, a product known as Azilect?
`
`Could you just briefly describe for the Court what Azilect is?
`
`A. Yes. Azilect is a medication indicated for the treatment
`
`SOUTHERN DISTRICT REPORTERS, P.C.
`(212) 805-0300
`
`MYLAN PHARMS. INC. EXHIBIT 1138 PAGE 8
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`Case 1:O9—cv—08824—WHP Document 205 Filed 10/04/11 Page 43 of 100
`l97ZTEV2
`Congleton — direct
`
`43
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`both early, as well as ajunctive for ideopathic Parkinson's
`
`disease.
`
`Q.
`
`Now, do you have a binder in front of you, Mr. Congleton
`
`with some documents in it?
`
`A. Yes,
`
`I do.
`
`Q.
`
`If you could, sir,
`
`just turn to the first tab, it's labeled
`
`as PTX 697.
`
`Do you see that?
`
`A. Yes,
`
`I do.
`
`Q. And have you seen this document before?
`
`A. Yes,
`
`I have.
`
`Q. What is it?
`
`A.
`
`It is the prescribing information for Copaxone.
`
`Q.
`
`Is this sometimes referred to as a product insert?
`
`A. Yes.
`
`Q.
`
`Is it also known as a drug label?
`
`A. Yes, it is.
`
`Q.
`
`Now, was this drug label for Copaxone approved by the Food
`
`and Drug Administration?
`
`A. Yes, it was.
`
`Q.
`
`Is this a document that was created and maintained by Teva
`
`in the ordinary course of its business?
`
`A. Yes, it was.
`
`MR. HASHMALL: Your Honor, plaintiffs move PTX—697
`
`into evidence.
`
`MR.
`
`JONES:
`
`No objection, your Honor.
`
`SOUTHERN DISTRICT REPORTERS, P.C.
`(212) 805-0300
`
`MYLAN PHARMS. INC. EXHIBIT 1138 PAGE 9
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`Case 1:O9—cv—08824—WHP Document 205 Filed 10/04/11 Page 44 of 100
`197ZTEV2
`Congleton — direct
`
`44
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`MR. DOYLE:
`
`No objection.
`
`THE COURT: All right, admitted.
`
`(Plaintiff's Exhibit PTX—697 received in evidence)
`
`Q. Mr. Congleton, what is the purpose of the product insert,
`
`which is PTX—697?
`
`A.
`
`It's to describe the use,
`
`the efficacy, safety, ability of
`
`the medicine.
`
`Q.
`
`Now, if you could look at the top column on the first page
`
`of 697. There's a heading there called "indications and
`
`usage," do you see that?
`
`A. Yes,
`
`I do.
`
`Q. All right. What does this tell the person who is reading
`
`this label?
`
`A.
`
`It would tell the physician how to use Copaxone and what
`
`patient it would be indicated for.
`
`Q. And for what conditions is Copaxone indicated?
`
`A. Copaxone is indicated for the reduction of frequent or ——
`
`reduction of the frequency of relapses in patients with
`
`relapsing—remitting form of Multiple Sclerosis, as well as for
`
`clinically isolated syndrome with one relapse and MRI
`
`indicative of MS.
`
`Q.
`
`Now, below that there is a section entitled dosage forms
`
`"dosage form and strength," do you see that?
`
`A. Yes,
`
`I do.
`
`Q. Does this tell the physician in what form Copaxone is sold?
`
`SOUTHERN DISTRICT REPORTERS, P.C.
`(212) 805-0300
`
`MYLAN PHARMS. INC. EXHIBIT 1138 PAGE 10
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`Case 1:O9—cv—08824—WHP Document 205 Filed 10/04/11 Page 45 of 100
`197ZTEV2
`Congleton — direct
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`45
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`A.
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`It does.
`
`Q. And in what form is it sold?
`
`A.
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`It's sold in prefilled syringes with one milliliter of
`
`sterile water, as well as 20 milligrams of glatiramer acetate.
`
`Q.
`
`Now, and just above that there's a section entitled "dosage
`
`and administration," do you see that?
`
`A. Yes,
`
`I do.
`
`Q. And does this tell the physician how Copaxone is to be
`
`administered?
`
`A.
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`It does.
`
`Q. And how is Copaxone to be administered?
`
`A.
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`It's to be administered with a daily injection of the
`
`prefilled syringe with the 20 milligrams of Copaxone.
`
`Q.
`
`Now, do you know, Mr. Congleton, when Copaxone was first
`
`approved for sale in the United States?
`
`A. Copaxone was approved in December of 1996.
`
`Q. And do you know, sir, when Copaxone was first offered for
`
`sale in the United States by Teva?
`
`A. Yes,
`
`I do.
`
`Q. And when was that?
`
`A. April 2nd of 1997.
`
`Q.
`
`Now,
`
`in April of 1997, you were employed by Teva
`
`Neuroscience?
`
`A. That's correct.
`
`Q. And how large was Teva Neuroscience marketing department in
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`SOUTHERN DISTRICT REPORTERS, P.C.
`(212) 805-0300
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`MYLAN PHARMS. INC. EXHIBIT 1138 PAGE 11
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`Case 1:O9—cv—08824—WHP Document 205 Filed 10/04/11 Page 46 of 100
`197ZTEV2
`Congleton — direct
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`46
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`April of 1997?
`
`A.
`
`It was two people.
`
`Q. And who were those two people, Mr. Congleton?
`
`A.
`
`I was the product manager, and I had a boss who was the
`
`head of our marketing department named John Asler.
`
`Q. And was there a sales force at Teva Neuroscience at that
`
`time?
`
`A. Yes,
`
`there was.
`
`Q. And how large was that sales farce in April of 1997?
`
`A.
`
`In April of 1997, we had 32 sales associates.
`
`Q.
`
`Now, at the time that Copaxone was launched in April of
`
`1997, were there any other MS drugs on the market?
`
`A. Yes,
`
`there were.
`
`Q. And what were those drugs?
`
`A. There was Avonex as well as Betaseron, both interferons.
`
`Q. And Copaxone is not an interferon, correct?
`
`A. That's correct.
`
`Q.
`
`How are interferons,
`
`just generally, Mr. Congleton, how are
`
`interferons different from Copaxone?
`
`A. They're a different class of drugs with a different mode of
`
`action.
`
`They have common traits, but Copaxone is in a
`
`different class onto itself with a different mode of action.
`
`Q. All right. And now you mentioned these two drugs, Avonex
`
`and Betaseron.
`
`How long had they been on the market?
`
`A. Betaseron was launched in the United States in 1993, and
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`(212) 805-0300
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`MYLAN PHARMS. INC. EXHIBIT 1138 PAGE 12
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`197ZTEV2
`Congleton — direct
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`47
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`Avonex was launched in the United States in 1996.
`
`Q.
`
`Now, are you familiar with the indicated uses for those two
`
`drugs?
`
`A. Yes,
`
`I am.
`
`Q. And what are they indicated for?
`
`A. They're also indicated for the reduction of relapses in
`
`relapse—remitting Multiple sclerosis.
`
`Q. And are you familiar with how those two drugs are to be
`
`administered?
`
`A. Yes,
`
`I am.
`
`Q. And how are those products administered?
`
`A. Avonex is a once weekly intramuscular injection, and
`
`Betaseron is an every other day subcutaneous injection.
`
`Q.
`
`Now, at the time that —— in April 1997 when Teva first
`
`started selling Copaxone, did Teva Neuroscience develop a
`
`launch plan for Copaxone?
`
`A. Yes, we did.
`
`Q. And could you just generally tell the court what a launch
`
`plan is?
`
`A.
`
`A launch plan is your effort to really raise the awareness
`
`of your molecule, help physicians and patients understand how
`
`to initiate utilization of that, as well as maintain it.
`
`So
`
`it's a communication plan that introduces your product to the
`
`appropriate audiences.
`
`Q. Were you involved in developing the launch plan for
`
`SOUTHERN DISTRICT REPORTERS, P.C.
`(212) 805-0300
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`MYLAN PHARMS. INC. EXHIBIT 1138 PAGE 13
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`Copaxone?
`
`A. Yes,
`
`I was.
`
`Q.
`
`So could you tell the Court, generally, what was that
`
`launch plan for Copaxone in April of 1997?
`
`A.
`
`In April of 1997, it was still early in the treatment of
`
`MS,
`
`so our focus was on raising the importance of treating the
`
`disease, getting patients to begin that therapy,
`
`then to convey
`
`the benefits that Copaxone could provide patients from an
`
`efficacy and safety standpoint. We utilized our sales
`
`representatives, we utilized non—sales representative activity,
`
`such as direct mail, conventions,
`
`journal advertising.
`
`Q.
`
`Now, you mention there were these two interferon drug
`
`products that are marketed at that time.
`
`How did Teva position
`
`itself with respect to those two interferon products?
`
`A. Really as the non—interferon.
`
`We had a different mode of
`
`action.
`
`The efficacy we felt was comparable.
`
`A better safety
`
`tolerability standpoint due to what the experience had been
`
`with physicians with interferon.
`
`So as a different mode of
`
`action and a different clinical profile.
`
`Q. Were there any challenges that Teva faced when it first
`
`started selling Copaxone?
`
`A. Yes,
`
`there were.
`
`Q. And could you just tell us, generally, what those
`
`challenges were?
`
`A. There were several.
`
`The first would be, again MS therapies
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`SOUTHERN DISTRICT REPORTERS, P.C.
`(212) 805-0300
`
`MYLAN PHARMS. INC. EXHIBIT 1138 PAGE 14
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`were new to both physicians and patients,
`
`so it was the need
`
`for treating MS was a challenge.
`
`The fact that the interferons were in the marketplace
`
`anywhere from four to about a year earlier than us, and had
`
`gained traction as an approach to treat MS. And then, frankly,
`
`the fact that we were a daily injectable versus less frequently
`
`administered medications.
`
`Q.
`
`Do you recall, approximately, what the U.S. sales were for
`
`Copaxone in 1997?
`
`A. Yes.
`
`Q. And what were those sales?
`
`A.
`
`$25 million dollars.
`
`Q.
`
`Now, since Copaxone was launched in 1997, have other MS
`
`drugs come on to the market?
`
`A. Yes.
`
`Q. And what currently approved drugs does Teva consider to be
`
`competitors of Copaxone?
`
`A. Current first line competitors would be Avonex and
`
`Betaseron, as well Extavia and Rebif, all four of those being
`
`interferons.
`
`Q.
`
`Now, you mentioned first line treatment. What do you mean
`
`by "first line treatment"?
`
`A. First line treatment would be a therapy that a physician
`
`would,
`
`in all likelihood, use for a newly diagnosed patient or
`
`a patient that is beginning to investigate the utilization of
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`SOUTHERN DISTRICT REPORTERS, P.C.
`(212) 805-0300
`
`MYLAN PHARMS. INC. EXHIBIT 1138 PAGE 15
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`Case 1:O9—cv—08824—WHP Document 205 Filed 10/04/11 Page 50 of 100
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`50
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`therapy to manage their MS.
`
`Q.
`
`Now,
`
`the four competitor drugs that you have identified,
`
`are those all administered by injection?
`
`A. Yes,
`
`they are.
`
`Q. And with what frequency are those four drugs administered?
`
`A.
`
`The Avonex, as I've said,
`
`is a weekly intramuscular.
`
`The
`
`other interferons are either every other day or three times a
`
`week, subcutaneously.
`
`Q.
`
`So Copaxone is still the only drug that requires
`
`administration daily?
`
`A. That's correct.
`
`Q.
`
`Now,
`
`just very generally, how has Teva's sales fared since
`
`it was —— its first year it was launched in 1997?
`
`A.
`
`It's fared very well. We have, over the course of time,
`
`grown from the third entrant into the market place into the
`
`therapy of choice almost by a factor of two currently.
`
`It
`
`built over time. Copaxone has a unique profile, unique mode of
`
`action.
`
`The experience that physicians gain,
`
`they saw the
`
`benefit that their patients were deriving. As that knowledge
`
`accumulated,
`
`that experience accumulated,
`
`the utilization of
`
`Copaxone grew.
`
`And then in 2005 with the introduction or the data
`
`from to head—to—head trials against interferons, it really
`
`continued to accelerate Copaxone's growth. Because those
`
`trials showed that Copaxone was of equal efficacacy to the
`
`SOUTHERN DISTRICT REPORTERS, P.C.
`(212) 805-0300
`
`MYLAN PHARMS. INC. EXHIBIT 1138 PAGE 16
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`Case 1:O9—cv—08824—WHP Document 205 Filed 10/04/11 Page 51 of 100
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`51
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`interferons, and that was contrary to the perception that was
`
`in the marketplace prior to that.
`
`Q.
`
`Now, as part of your responsibilities with respect to the
`
`marketing and sales of Copaxone, do you keep track of patient
`
`loyalty?
`
`A. Yes, we do.
`
`Q.
`
`Just tell the Court, what is patient loyalty?
`
`A. Loyalty in the context of pharmaceuticals really focuses on
`
`compliance, non—adherence. And compliance is over a given
`
`month, does patient take the drug as indicated,
`
`in Copaxone's
`
`case, are they injecting daily over those 30 days. Adherence
`
`is more of a longer term frame.
`
`It's over a given year how
`
`well the patient stayed on that therapy,
`
`so that they can
`
`derive the benefits intended.
`
`Q.
`
`Do you know approximately what percentage of patients
`
`started on Copaxone stay with the drug?
`
`A. Yeah, our adherence figures are approximately 85 percent at
`
`the end of the first year.
`
`Q. Could you just give us a ballpark about how many patients
`
`are currently using Copaxone?
`
`A. Approximately 100,000 at this point in time are benefiting
`
`from Copaxone.
`
`Q. And as part of its services, does Ieva Neuroscience offer
`
`any patients support programs with respect to Copaxone?
`
`A. Yes, we do.
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`SOUTHERN DISTRICT REPORTERS, P.C.
`(212) 805-0300
`
`MYLAN PHARMS. INC. EXHIBIT 1138 PAGE 17
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`MYLAN PHARMS. INC. EXHIBIT 1138 PAGE 17
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`Case 1:O9—cv—08824—WHP Document 205 Filed 10/04/11 Page 52 of 100
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`52
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`Q.
`
`Is there a name for that program?
`
`A. Yes.
`
`It's called Shared Solutions.
`
`Q.
`
`So, and could you describe for the Court what Shared
`
`Solutions is?
`
`A.
`
`Shared Solutions is a free service that we offer to all
`
`people with MS.
`
`Prior to launching the drug in 1997, we were obviously
`
`getting to know the MS marketplace,
`
`the needs of those
`
`patients. And it was clear that beyond just therapy, MS
`
`patients had emotional, psychological issues they needed to
`
`manage.
`
`We felt it was important to create a program, our
`
`service that would help manage those barriers so the patient
`
`could go —— could be as successful as possible with the
`
`medication Copaxone.
`
`So we created the service.
`
`We made it
`
`available for all people with MS.
`
`They could have access to
`
`nurses,
`
`to educational materials.
`
`If the patient was going to
`
`begin Copaxone,
`
`then they —— a door opened to other service
`
`they had access to, such as reimbursement support,
`
`injection
`
`training, free auto—ject advice, access to the nurse, as well
`
`as other educational materials. And it has been a benefit to
`
`patients only not taking Copaxone, but obviously those taking
`
`Copaxone to help them be successful with the molecule.
`
`Q. Patient does not have to be actually using Copaxone to have
`
`access t0 Teva's services?
`
`SOUTHERN DISTRICT REPORTERS, P.C.
`(212) 805-0300
`
`MYLAN PHARMS. INC. EXHIBIT 1138 PAGE 18
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`Case 1:O9—cv—08824—WHP Document 205 Filed 10/04/11 Page 53 of 100
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`53
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`A. That's correct.
`
`Q. And I'm sorry, does Teva charge the patients for these
`
`services?
`
`A. No, we do not.
`
`Q.
`
`I'd like to just talk to you a little bit, Mr. Congleton,
`
`about the details regarding Teva's promotion of Copaxone.
`
`Could you describe for the Court what Teva's promotional
`
`strategy is for Copaxone?
`
`A.
`
`It's really focused on, again, building the awareness of
`
`the need to treat MS,
`
`then convey the unique properties of
`
`Copaxone and the benefits that a physician's patient can derive
`
`from utilizing Copaxone to manage their Multiple sclerosis.
`
`Q. And who is the principal audience for Teva's promotional
`
`efforts relating to Copaxone?
`
`A. Predominantly physicians, neurologists specifically, as
`
`well as MS patients.
`
`Q. And what methods does Teva use to promote Copaxone?
`
`A. We utilize our sales force, as well as non—sales force
`
`activities,
`
`such as conferences,
`
`journal ads,
`
`the website,
`
`direct mail.
`
`Q. Are you familiar with the term of "detailing"?
`
`A. Yes,
`
`I am.
`
`Q. Could you just explain to the court what detailing means?
`
`A. Detailing is when our field base sales associates go into
`
`physicians‘ offices and talk to them about Copaxone and how it
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`SOUTHERN DISTRICT REPORTERS, P.C.
`(212) 805-0300
`
`MYLAN PHARMS. INC. EXHIBIT 1138 PAGE 19
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`MYLAN PHARMS. INC. EXHIBIT 1138 PAGE 19
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`Case 1:O9—cv—08824—WHP Document 205 Filed 10/04/11 Page 54 of 100
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`54
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`can benefit their patients who have MS.
`
`Q. All right. Does Teva do any direct consumer advertising
`
`such as TV ads or radio ads with respect to Copaxone?
`
`A. No, we do not.
`
`Q.
`
`Now,
`
`in your binder, Mr. Congleton, could you turn to the
`
`document that's labeled PTX 908? What is PTX —— 908?
`
`A.
`
`Sorry.
`
`It's a copy of a sales aid that we would give to
`
`our sales associates.
`
`Q.
`
`Do you know what year this document was created?
`
`A.
`
`I believe it's 2007.
`
`Q. And was 908 prepared under your supervision?
`
`A. Yes, it was.
`
`Q. And was this document prepared in the ordinary course of
`
`Teva's business?
`
`A. Yes, it was.
`
`MR. HASHMALL: Your Honor, plaintiffs offer PTX—908 in
`
`evidence.
`
`MR.
`
`JONES:
`
`No objection, your Honor.
`
`MR. DOYLE: Your Honor, Sandoz doesn't have an
`
`objection to the admission of the document for the purpose
`
`which I think it is being proffered, which is to indicate what
`
`Teva tells the MS community about Copaxone. But we do object
`
`to it being accepted for the truth of any matter asserted
`
`therein, because it's a sales aid, and there is no foundation,
`
`and there is no support for any of the actual information
`
`SOUTHERN DISTRICT REPORTERS, P.C.
`(212) 805-0300
`
`MYLAN PHARMS. INC. EXHIBIT 1138 PAGE 20
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`Case 1:O9—cv—08824—WHP Document 205 Filed 10/04/11 Page 55 of 100
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`55
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`contained in this document provided by this witness.
`
`THE COURT: All right.
`
`I'll admit it.
`
`(Plaintiff's Exhibit PTX—908 received in evidence)
`
`MR. HASHMALL:
`
`Thank you, your Honor.
`
`Q. And the next question, your Honor,
`
`is, for what purpose was
`
`PTX—908 created, Mr. Congleton?
`
`A.
`
`It is the primary tool that our sales representatives
`
`utilize when detailing a physician to convey the benefits of
`
`Copaxone.
`
`Q. And could you just tell us a bit how the sales
`
`representative uses this aid?
`
`A.
`
`They would set up appointments with physicians, over the
`
`course of ten to 15 minute conversation use this as a
`
`supportive document to share with them data that has been
`
`published and generated on Copaxone,
`
`to talk about its
`
`efficacy, as well as safety.
`
`Q. All right.
`
`If you could, Mr. Congleton,
`
`turn to the pages
`
`that is Bates numbers on the bottom, if you could turn to the
`
`page that has the last three digits of 909 and 910?
`
`A. Okay.
`
`Q. We have that up on the screen. This is a chart. What data
`
`is presented in this clarity, Mr. Congleton?
`
`A. This is looking at the main efficacy end points that
`
`neurologists focus on when managing MS, and specifically it's
`
`looking at the effect that Copaxone has on these efficacy end
`
`SOUTHERN DISTRICT REPORTERS, P.C.
`(212) 805-0300
`
`MYLAN PHARMS. INC. EXHIBIT 1138 PAGE 21
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`Case 1:O9—cv—08824—WHP Document 205 Filed 10/04/11 Page 56 of 100
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`56
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`points over a sustained period of time.
`
`Q. And so how would a salesperson at Teva use this information
`
`with the doctor when he's being, he or she is meeting with the
`
`doctor?
`
`A. This is one of the most
`
`important points for physicians is
`
`how does your product affect the patient over the long term.
`
`So a sales representative would share with the physician what
`
`they can expect to see as a response in their patients to the
`
`use of Copaxone in managing the disease over time.
`
`Q. And if you could, sir,
`
`turn to page with the last three
`
`digits of 912?
`
`A. Okay.
`
`Q.
`
`Do you have this, Mr. Congleton?
`
`A.
`
`I do.
`
`Q. All right. What is described on this page?
`
`A. This is describing the pivotal trial, as well as the
`
`extended version of that trial.
`
`In this particular case it's
`
`through ten years. This is the —— one of the unique aspects
`
`about Copaxone is it is prospectively followed long term to
`
`ensure that the effect is not only immediate, but also
`
`sustained in offering benefit to a neurologist's patient.
`
`Q.
`
`If you could turn, Mr. Congleton,
`
`to the page that has the
`
`last three digits 3915?
`
`A. Okay.
`
`Q. And what's described on this page, Mr. Congleton?
`
`SOUTHERN DISTRICT REPORTERS, P.C.
`(212) 805-0300
`
`MYLAN PHARMS. INC. EXHIBIT 1138 PAGE 22
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`Case 1:O9—cv—08824—WHP Document 205 Filed 10/04/11 Page 57 of 100
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`57
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`A. Again,
`
`this is additional efficacy information.
`
`It shows
`
`that not only is Copaxone effect sustained, but it also shows
`
`that it is immediate within the first three months you see a
`
`separation of the drug's effect to placebo.
`
`Q.
`
`Now, does Teva train its sales staff on how to use this
`
`document, PTX—908?
`
`A. Yes, we do.
`
`Q. Could you turn, sir,
`
`to the document that's labeled as
`
`PTX—909 in your binder.
`
`A. Okay.
`
`Q.
`
`Do you recognize this document?
`
`A.
`
`I do.
`
`Q. And what is this document?
`
`A. This is a sales aid training tool.
`
`It's internal use only.
`
`We provide it to our sales representatives in conjunction with
`
`the sales aid we just reviewed.
`
`Q. And do you know what year this document was created?
`
`A.
`
`In 2007.
`
`Q. And was this created under your supervision?
`
`A. Yes it was.
`
`Q. Was this in document created in the ordinary course of
`
`Teva's business?
`
`A. Yes, it was.
`
`MR. HASHMALL: Your Honor, we offer PTX—909 in
`
`evidence.
`
`SOUTHERN DISTRICT REPORTERS, P.C.
`(212) 805-0300
`
`MYLAN PHARMS. INC. EXHIBIT 1138 PAGE 23
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`MR.
`
`JONES:
`
`No objection, your Honor.
`
`MR. DOYLE:
`
`No objection for the purpose being --
`
`THE COURT:
`
`Purpose understanding.
`
`MR. DOYLE: Yes, your Honor.
`
`THE COURT: All right, admitted.
`
`(Plaintiff's Exhibit PTX—909 received in evidence)
`
`MR. HASHMALL:
`
`Thank you, your Honor.
`
`Q.
`
`If you could turn to the page that's has the last three
`
`digits of 350. Could you describe what
`
`type of information is
`
`on this page, Mr. Congleton?
`
`A. This is background information for sales associates to help
`
`them understand the graphic within that sales aid.
`
`Q. And is this document used to instruct them in how to use
`
`the document that we had previously looked at?
`
`A. Yes.
`
`It's a teaching aid.
`
`Q. All right.
`
`Now on the top of that page you see there is a
`
`paragraph that's labeled direction; see that?
`
`A. Yes,
`
`I do.
`
`Q. What is the purpose of this paragraph?
`
`A.
`
`It's to give the sales representative a sense for what the
`
`intents of this graphic is,
`
`the point that needs to be conveyed
`
`to the physician.
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`Q. All right. And then to the left on that page there is a
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`section there entitled message musts.
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`Do you see that?
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`A. Yes,
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`I do.
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`SOUTHERN DISTRICT REPORTERS, P.C.
`(212) 805-0300
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`MYLAN PHARMS. INC. EXHIBIT 1138 PAGE 24
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`MYLAN PHARMS. INC. EXHIBIT 1138 PAGE 24
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`Case 1:O9—cv—08824—WHP Document 205 Filed 10/04/11 Page 59 of 100
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`Congleton — direct
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`59
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`Q. What are message musts?
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`A. There is a lot of data obviously within this graphic, and
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`this is a way that we help the sales representative highlight
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`what are the key points that we'd like them to convey to the
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`physicians.
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`Q.
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`Now, PTX—908 and 909, are these typical of the types of
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`sales aids and manuals that are distributed and used by Teva
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`sales