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`C.A. No. 14-1171-GMS
`(CONSOLIDATED)
`
`IN RE COPAXONE 40 MG
`CONSOLIDATED CASES
`
`IN THE UNITED STATES DISTRICT COURT
`IN AND FOR THE DISTRICT OF DELAWARE
`- - -
`)
`)
`- - -
`Wilmington, Delaware.
`Tuesday, September 27, 2016
`9:00 a.m.
`Day 2 of Bench Trial
`- - -
`BEFORE: HONORABLE GREGORY M. SLEET, U.S.D.C.J.
`APPEARANCES:
`JOHN W. SHAW, ESQ., and
`KAREN E. KELLER, ESQ.
`Shaw Keller LLP
`-and-
`PAUL W. WARE, ESQ.,
`DARYL WIESEN, ESQ.,
`JOHN T. BENNETT, ESQ.,
`ELIZABETH J. HOLLAND, ESQ.,
`NICHOLAS K. MITROKOSTAS, ESQ., and
`WILLIAM JAMES, ESQ.,
`Goodwin Procter LLP
`(Washington, D.C.)
`-and-
`STEPHEN B. BRAUERMAN, ESQ., and
`SARA BRUSSIERE, ESQ.
`Bayard P.A.
`
`Counsel for Plaintiffs
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`Case 1:14-cv-01171-GMS Document 283 Filed 12/08/16 Page 1 of 235 PageID #: 7723
`
`C.A. No. 14-1171-GMS
`(CONSOLIDATED)
`
`IN RE COPAXONE 40 MG
`CONSOLIDATED CASES
`
`IN THE UNITED STATES DISTRICT COURT
`IN AND FOR THE DISTRICT OF DELAWARE
`- - -
`)
`)
`- - -
`Wilmington, Delaware.
`Tuesday, September 27, 2016
`9:00 a.m.
`Day 2 of Bench Trial
`- - -
`BEFORE: HONORABLE GREGORY M. SLEET, U.S.D.C.J.
`APPEARANCES:
`JOHN W. SHAW, ESQ., and
`KAREN E. KELLER, ESQ.
`Shaw Keller LLP
`-and-
`PAUL W. WARE, ESQ.,
`DARYL WIESEN, ESQ.,
`JOHN T. BENNETT, ESQ.,
`ELIZABETH J. HOLLAND, ESQ.,
`NICHOLAS K. MITROKOSTAS, ESQ., and
`WILLIAM JAMES, ESQ.,
`Goodwin Procter LLP
`(Washington, D.C.)
`-and-
`STEPHEN B. BRAUERMAN, ESQ., and
`SARA BRUSSIERE, ESQ.
`Bayard P.A.
`
`Counsel for Plaintiffs
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`APPEARANCES CONTINUED:
`FREDERICK L. COTTRELL, III, ESQ.
`Richards, Layton & Finger, P.A.
`-and-
`DAVID L. ANSTAETT, ESQ.
`Perkins Coie LLP
`(Madison, WI)
`-and-
`SHANNON M. BLOODWORTH, ESQ.,
`BRANDON M. WHITE, ESQ.,
`EMILY J. GREB, ESQ., and
`ROBERT D. SWANSON, ESQ.
`Perkins Coie, LLP
`(Washington, D.C.)
`
`Counsel for Defendants
`Mylan, Inc. and
`Mylan Pharmaceuticals, Inc.
`DOMINICK T. GATTUSO, ESQ.
`Procter Heyman & Enerio LLP
`-and-
`WILLIAM A. RAKOCZY, ESQ.,
`DEANNE M. MAZZOCHI, ESQ.,
`RACHEL PERNIC WALDRON, ESQ.,
`MATTHEW V. ANDERSON, ESQ.,
`THOMAS H. ERLICH, ESQ.
`ERIN FORBES, ESQ., and
`CHRIS GALLIGAN, ESQ.
`Rakoczy Molino Mazzochi & Siwik LLP
`(Chicago, IL)
`
`Counsel for Defendants
`Sandoz Inc. and Momenta
`Pharmaceuticals, Inc.
`RICHARD W. RILEY, ESQ.
`Duane Morris LLP
`-and-
`CHRISTOPHER S. KROON, ESQ., and
`ANTHONY J. FITZPATRICK, ESQ.
`Duane Morris LLP
`(Boston, MA)
`
`Counsel for Defendants
`Amneal Pharmaceuticals LLC
`and Amneal Pharmaceuticals
`Company GmbH
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`APPEARANCES CONTINUED:
`DAVID BILSON, ESQ.
`Phillips, Goldman, McLaughlin & Hall, P.A.
`-and-
`HANK HECKEL, ESQ.
`Budd Larner
`(Short Hills, NJ)
`Counsel for Defendant DRL
`NEAL C. BELGAM, ESQ.
`Smith Katzenstein & Jenkins LLP
`-and-
`E. ANTHONY FIGG, ESQ.,
`ELIZABETH R. BRENNER-LEIFER, ESQ., and
`BRETT A. POSTAL, ESQ.
`Rothwell, Figg, Ernst & Manbeck, P.C.
`(Washington, D.C.)
`Counsel for Defendants
`Synthon Pharmaceuticals, Inc.,
`Synthon B.V., and Synthon s.r.o.,
`and Pfizer
`- - -
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`
`THE COURT: Please, take your seats. Over the
`course of the evening -- I understand you have some issues
`you want to discuss with me -- please e-mail Mr. Buckson, so
`he can e-mail me, and I will be in the office, in chambers
`in time to be out here at 8:30, because I think it was only
`when we came out to chat that we were informed you had some
`issues. That cuts into our time, which I am going to take
`away from you.
`What are the issues?
`THE COURT: Mr. Figg.
`MR. FIGG: Good morning, Your Honor.
`There is an issue regarding plaintiffs'
`infringement expert, Dr. Wynn, who is scheduled to testify
`today.
`
`We have had correspondence back and forth over
`the last couple of days with the plaintiffs on this.
`The issue is this, Dr. Wynn, as I say, is one of
`the primary plaintiffs' witnesses on the infringement issue.
`But the plaintiffs also included in his expert testimony
`information about obviousness, namely, his view on the
`secondary factors.
`THE COURT: Counsel, if there are seats in the
`well, that's where I prefer you sit. That's an
`accommodation to you. Really, you are not my jury. So go
`back to the well, please. I know those seats are more
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`Case 1:14-cv-01171-GMS Document 283 Filed 12/08/16 Page 5 of 235 PageID #: 7727
`
`comfortable, I get that.
`MR. FIGG: Your Honor, we asked them if they
`intended to have Dr. Wynn talk about obviousness during the
`infringement case or if they intended to recall him.
`They said they wanted to talk about obviousness
`during their infringement case and they reserve the right to
`recall him. We don't think that's appropriate. The Court's
`schedule in the pretrial order that everybody has agreed to
`is very clear. They put on their infringement case, and we
`respond to their infringement case. We put on our
`obviousness case, they respond to our obviousness case.
`They put on their secondary factors case.
`THE COURT: We talked about this. Right?
`MR. FIGG: Yes. Our point -- we are respectful
`of Dr. Wynn's schedule. I understand that he wants to get
`done and leave today. That is fine. But they should make
`the choice. Either they elicit the anticipatory obviousness
`testimony today and live with it or they put their
`obviousness case on when they are supposed to in the
`schedule. I don't think they should have it both ways.
`THE COURT: Okay.
`Mr. Ware.
`MR. WARE: Your Honor, I think that's a fair
`point. What I have said is, first of all, the testimony
`from Dr. Wynn with respect to secondary considerations will
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`Case 1:14-cv-01171-GMS Document 283 Filed 12/08/16 Page 6 of 235 PageID #: 7728
`
`be brief and confined to the usual factors.
`I have said we would not expect, except under
`the most extraordinary circumstance, to have to call him
`back, but that I didn't want to foreclose that possibility.
`So my representation is that before I would
`assume that we could even do that, I would be prepared to
`come to the Court and give an explanation of why that was
`appropriate in light of this accommodation that's been made.
`I think there is a 99 percent chance we would
`never need to call him back. But I don't want to foreclose
`it because we are taking him out of order.
`However, I agree that absent lightning striking,
`we shouldn't have the right to call him back. And I
`wouldn't ask the Court to do that.
`THE COURT: Mr. Figg.
`MR. FIGG: Your Honor, you probably could
`understand my anxiety about a 99 percent chance.
`THE COURT: There is a one percent possibility.
`MR. FIGG: Yes. I don't know whether it is 99
`or 10 or 25. But if they hear something during our
`obviousness case that they want Dr. Wynn to respond to, then
`they should put him, his testimony in the order so that he
`can do that.
`
`THE COURT: I think Mr. Ware would agree with
`
`that.
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`Case 1:14-cv-01171-GMS Document 283 Filed 12/08/16 Page 7 of 235 PageID #: 7729
`
`MR. WARE: I certainly agree with that
`principle. I am making a representation that it would only
`be under some unforeseen, extraordinary circumstance, at
`which point I would come to the Court and say, I think this
`is justified. And you might say, I don't. And that's a
`risk that we are prepared to take.
`THE COURT: Both of you are well known to me. I
`am not in the habit of seeing you engage in gamesmanship,
`neither one of you. I wouldn't expect that to be the case.
`MR. FIGG: I am respectful of that, Your Honor.
`Thank you. I understand that there will be a showing of
`good cause.
`
`THE COURT: Absolutely.
`Anything else?
`MR. WARE: Your Honor, I gather there has been
`some objection to our use of two joint trial exhibits with
`Dr. Wynn. In a nutshell, each of these has to do with
`instructions given to Principal Investigators for purposes
`of a clinical trial. The documents, one document is a log
`of an actual call among Principal Investigators during which
`some instructions are given with respect to the dosing of
`patients prior to the clinical trial. The other is a list
`of attendees.
`I don't intend to ask Dr. Wynn anything about
`the documents.
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`Case 1:14-cv-01171-GMS Document 283 Filed 12/08/16 Page 8 of 235 PageID #: 7730
`
`They are joint trial exhibits. They are going
`to be used with defendants' expert. But I am going to
`simply identify the fact they exist during the course of his
`testimony so the record will reflect that they are there and
`they relate to this subject. I don't know why that is
`controversial.
`THE COURT: Mr. Figg?
`MR. FIGG: I think our concern with the
`documents, Your Honor, is they weren't discussed in Dr.
`Wynn's expert report. As far as we can tell, no one has
`laid a foundation. They don't identify who they are from,
`who created them. And as far as we can tell, there is no
`foundation laid by any witness. And certainly, Dr. Wynn is
`an expert who was not involved in these details, historical
`details. So he can't lay a foundation. I think that was
`our main concern.
`THE COURT: These are joint trial exhibits.
`MR. WARE: Yes. I don't intend to ask him
`anything about the documents. I intend to say, at the time
`of this testimony, for purposes of the record, Your Honor,
`Joint Trial Exhibit 7042 and 7043 or whatever they are
`reflect the conversations about which the witness has just
`testified. But I am not going to ask him about the
`documents because he has never seen the documents. It's
`really just for clarification.
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`Case 1:14-cv-01171-GMS Document 283 Filed 12/08/16 Page 9 of 235 PageID #: 7731
`
`THE COURT: He is not going to ask him about
`
`them.
`
`MR. FIGG: Your Honor, I am sorry if I am
`interrupting anybody.
`THE COURT: Go ahead.
`MR. FIGG: Based on Mr. Ware's representation
`that he is not going to ask Dr. Wynn anything substantively
`about these documents, we are okay.
`THE COURT: Okay.
`MR. WARE: I misspoke. They are in his report.
`But I am not going to ask him --
`MR. FIGG: Actually, I was the one who misspoke.
`THE COURT: Anything else?
`MR. WARE: Nothing.
`THE COURT: Mr. Ware.
`MR. WARE: Teva calls John Hassler.
`... JOHN HASSLER, having been duly sworn as a
`witness, was examined and testified as follows ...
`THE COURT: Good morning, Mr. Hassler.
`THE WITNESS: Good morning, Your Honor.
`DIRECT EXAMINATION
`
`BY MR. WARE:
`Good morning, sir. Would you state your name for the
`Q.
`Court, please?
`John Hassler.
`A.
`
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`Case 1:14-cv-01171-GMS Document 283 Filed 12/08/16 Page 10 of 235 PageID #: 7732
`Hassler - direct
`How are you employed, Mr. Hassler?
`I am the senior vice president and general manager for
`
`Tell us briefly what the central nervous system unit
`
`Q.
`A.
`Teva.
`When you say Teva, do you work for a specific business
`Q.
`unit or division of Teva?
`Yes.
`A.
`What is that?
`Q.
`I lead the central nervous system business unit for
`A.
`Teva.
`Q.
`is?
`I manage our U.S. branded central nervous system
`A.
`products, which focus on pain, migraine, multiple sclerosis
`and neurodegenerative disease.
`What are your responsibilities as general manager of
`Q.
`the business?
`I am responsible for sales and marketing.
`A.
`How long have you been in that position?
`Q.
`Since January of 2015.
`A.
`And can you tell us when you joined Teva in any
`Q.
`capacity in any part of the organization?
`In 1996, I joined a joint venture partnership between
`A.
`Teva and MarionMerrell Dow called Teva Marion Partners and
`was responsible for managing the pre-launch and launch of
`Copaxone in that capacity.
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`Case 1:14-cv-01171-GMS Document 283 Filed 12/08/16 Page 11 of 235 PageID #: 7733
`Hassler - direct
`What was your responsibility during that launch?
`Q.
`To manage the marketing activities for Copaxone.
`A.
`What did you do following that responsibility until
`Q.
`you became general manager? Perhaps you told us when you
`became general manager. But if not, when did you assume the
`current position you hold?
`In January of 2015.
`A.
`Can you fill us in on the position you held within
`Q.
`Teva from 1996 until your current position as senior vice
`president and general manager of CNS?
`In 1999, I moved to our Canadian business, and I
`A.
`managed Teva Marion Partners Canada at that time, from 1999
`until 2003. And during that time period the name of the
`company changed to Teva Neuroscience Canada.
`In 2003, I returned to the United States, and I
`was vice president of administration and planning, which
`meant that I had human resources, finance, IT, and training
`and development that reported to me in that capacity.
`And in 2007, I moved back into a marketing
`leadership role, managing the marketing activities for Teva
`Neuroscience, up through the merger with Cephalon in 2015,
`when I became the general manager for Teva's CNS business
`unit.
`When Teva first launched Copaxone 20 milligrams, can
`Q.
`you tell us when that was?
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`Case 1:14-cv-01171-GMS Document 283 Filed 12/08/16 Page 12 of 235 PageID #: 7734
`Hassler - direct
`We launched in April of 1997.
`A.
`At that time, were there competitors in the market,
`Q.
`that is, other disease modifying therapies for multiple
`sclerosis?
`Yes. There were two other competitors, Avonex and
`A.
`Betaseron, both of those were Interferon products.
`And in what way, in an overarching sense, did
`Q.
`Interferons differ from glatiramer therapy?
`They are very different. They are a different
`A.
`compound that works differently in the body. One of the
`most typical side effects that you see with Interferon
`therapy are flu-like symptoms. And those are not associated
`with Copaxone or glatiramer.
`MR. WHITE: Objection, foundation, Your Honor.
`He is not a medical doctor.
`THE COURT: We know that. Overruled.
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`BY MR. WARE:
`How did Copaxone 20 milligram perform in the market?
`Q.
`Initially, Copaxone was considered to be a second-line
`A.
`agent. And then over time it became a first line agent.
`And in 2008, it actually became the most commonly used
`product in the category and the market leader.
`When you say a second-line therapy, what does that
`Q.
`mean in the industry?
`Well, physicians would gravitate toward one of the
`A.
`
`
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`Hassler - direct
`Interferons as a first choice before they would use
`Copaxone, unless there were specific reasons that they
`didn't think an Interferon would be an appropriate choice
`for a given patient, in which case they would use Copaxone.
`At some time did Copaxone become a first-line therapy?
`Q.
`Yes. Over time and as the product became better known
`A.
`and better characterized, Copaxone did become a first-line
`therapy, and then following head-to-head trials that showed
`that Copaxone was not less effective than the Interferons,
`it actually became the product of choice.
`Have other competitors entered the market since that
`Q.
`time, including oral medications?
`Yes. There have been two other Interferons that have
`A.
`entered the market since the time that we were talking
`about. There have been monoclonal antibodies, drugs like
`Tysabri that have been in the market. And then in 2010,
`between 2010 and 2013, we saw three orally administered
`products enter the MS market.
`When other therapies come into a market like the
`Q.
`glatiramer acetate market or the disease modifying therapy
`market for MS, what is the effect on market shares across
`the board, just in general?
`Because none of these therapies cure or completely
`A.
`arrest the disease, patients are frequently looking for new
`options that will manage their disease better.
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`Hassler - direct
`So as new products enter the market, the market
`tends to become more fragmented and we see shares split.
`And the older products tend to lose share when that occurs.
`We heard a lot of testimony yesterday with respect to
`Q.
`Teva development efforts. I don't want you to go into any
`detail about that. But are you aware whether or not Teva
`undertook additional efforts to improve Copaxone after 1996?
`Yes, many.
`A.
`Generally, what were the goals of those efforts?
`Q.
`The goals were to improve the treatment of MS patients
`A.
`by improving the efficacy, tolerability, and convenience of
`the products that we were working on, that we were trying to
`introduce into the market.
`Until 40 milligram Copaxone was introduced into the
`Q.
`market, did Teva succeed in making substantive improvement
`to the glatiramer Copaxone 20 milligrams?
`No, we were not successful. Glatiramer could be
`A.
`unpredictable. And despite our best efforts, we weren't
`able to achieve the objectives that we had sought out with
`several of those trials.
`At some time did you become aware that 40 milligram
`Q.
`Copaxone, or 40 milligram three times a week dosing of
`Copaxone product was under development at the company?
`Yes.
`A.
`Approximately when did you learn that?
`Q.
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`Hassler - direct
`I believe it was sometime in the later 2000s.
`A.
`What were the circumstances under which you learned
`Q.
`it, and why was it relevant to your function?
`When I moved back into the marketing function, this
`A.
`was one of the brands that I was managing. And what I
`learned about it was that we were planning to study 40
`milligram three times a week administration of Copaxone
`versus placebo in an attempt to demonstrate safety,
`efficacy, and tolerability of that formulation with that
`dosage schedule.
`Did that occur in a particular trial of which you
`Q.
`became aware?
`Yes. It was called the GALA trial.
`A.
`Now, I want to talk to you a little bit about
`Q.
`marketing strategy. When Teva introduces an improved
`therapy like Copaxone 40 milligram, what obstacles are there
`to a drug company getting that product accepted in the
`marketplace?
`With any new product introduction, we have got to
`A.
`create awareness of the efficacy safety, tolerability and
`convenience of that product among physicians and patients.
`And with a chronic disease, something like MS, we have also
`got to make sure that we communicate where this fits into
`the treatment regimen, and that patients are going to be
`able to use this for a long period of time.
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`Case 1:14-cv-01171-GMS Document 283 Filed 12/08/16 Page 16 of 235 PageID #: 7738
`Hassler - direct
`Another variable that we face is making sure
`that patients have physical and financial access to a new
`drug when it's introduced into the marketplace.
`So we need to make sure that we get it into
`distribution outlets where the can actually acquire the
`product, and that they can get reimbursement for the product
`so that they don't face financial barriers that eliminate
`their ability to acquire it.
`When you talk about financial access, are you talking
`Q.
`about health insurance and its potential coverage or not of
`the product?
`Yes. There are different barriers that insurance
`A.
`companies can put in place that can make it more difficult
`for patients to access the product.
`Tell us what those barriers are as described here, or
`Q.
`summarized here?
`Typically, those barriers fall into four broad
`A.
`buckets. Denial of coverage is one, where the insurance
`company simply denies to cover the new product that's being
`introduced.
`
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`They can also place the product in tiers that
`require high co-pays or high out-of-pocket expense for the
`patients.
`
`They can require prior authorization that
`requires the physician's office to document additional
`
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`Case 1:14-cv-01171-GMS Document 283 Filed 12/08/16 Page 17 of 235 PageID #: 7739
`Hassler - direct
`information on patients. And it creates a marked burden on
`the offices to be able to write the product. They can also
`require step-through requirements that require the patients
`to use another product, typically a cheaper product for the
`insurance company, before they get access to a new product.
`With respect to Copaxone 40 milligram, subsequent to
`Q.
`its introduction, what steps did Teva take to address any
`potential barriers to access posed by insurers or others?
`We worked with the insurance companies to explain the
`A.
`benefits of this product and position it so that they
`understood what this could mean to patients who would
`benefit from it.
`We also implemented, in essence, a parity
`pricing type of strategy, with the intent of making sure
`that 40 milligram would be equally accessible as 20
`milligram from a payor's standpoint.
`Then finally, for those payors or -- or for
`those insurance companies that had very high co-pays, we
`implemented a coupon program that would help buy down the
`out-of-pocket costs for patients that wanted to initiate
`treatment with this product.
`With respect to the pricing strategy, did you price 40
`Q.
`milligram Copaxone the same as the existing 20 milligram
`Copaxone?
`The wholesale acquisition cost of 40 milligram was two
`A.
`
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`Case 1:14-cv-01171-GMS Document 283 Filed 12/08/16 Page 18 of 235 PageID #: 7740
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`percent less than the wholesale acquisition cost for 20
`milligram. But the intent, through various discounts and
`rebates, was to try to ensure that we could get formulary
`coverage that would be equal to the 20 milligrams. So in
`essence we were trying to manage a parity pricing type of
`strategy.
`When you say the wholesale acquisition cost for 40
`Q.
`milligram was within two percent lower than 20 milligram,
`what is the relevance in the real world of the wholesale
`acquisition cost? Does that have anything to do with what
`people pay or even insurers pay?
`No.
`A.
`Why not?
`Q.
`Because there are various discounts and rebates that
`A.
`we negotiate, or that are mandated in the federal sector
`that buy down that price that the insurance companies
`actually pay. And what patients actually see has to do with
`what their insurance will cover and how much of the
`remaining costs get passed along to the patient. And we try
`to address that through a coupon program to make sure that
`patients would have access to the product.
`As a result of the pricing strategies you have
`Q.
`described, was there any point at which Teva's pricing
`strategy led payors to provide better coverage for Copaxone
`40 milligram than they did for 20 milligram?
`
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`Case 1:14-cv-01171-GMS Document 283 Filed 12/08/16 Page 19 of 235 PageID #: 7741
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`No, I am not aware of any circumstances where there
`A.
`was better coverage for 40 milligram than 20.
`Our goal was to get equal coverage so that
`insurance wasn't a barrier, that the price of the product
`wasn't a barrier. We wanted physicians and patients to be
`able to choose which product would be best to them.
`You mentioned co-pays and coupons. Tell us what
`Q.
`strategy you employed with respect to coupons when 40
`milligram Copaxone was launched? What is a coupon and how
`does it work?
`A coupon is essentially a means of reducing the cost
`A.
`to the patient when they go to buy their drug at the
`pharmacy or when they have mail ordered from their pharmacy.
`A coupon can be applied that will help buy down the cost to
`a certain level.
`Go ahead.
`Q.
`When we launched Copaxone, several other products
`A.
`within the category were offering coupons with a zero dollar
`co-pay. So we wanted to be competitive with 40 milligram
`with those competitors. So we also offered a zero dollar
`coupon on 40 milligram.
`At the time that you offered zero dollar coupons for
`Q.
`Copaxone 40 milligram, what was the co-pay with respect to
`20 milligram Copaxone?
`Historically, we had offered a $35 co-pay or
`A.
`
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`263
`Case 1:14-cv-01171-GMS Document 283 Filed 12/08/16 Page 20 of 235 PageID #: 7742
`Hassler - direct
`out-of-pocket coupon for the majority of 20 milligram
`patients.
`Did you make any determination at that time whether
`Q.
`the 35 dollar co-pay was in any sense a barrier to patients?
`No. What we saw from the research that we had
`A.
`conducted was that it didn't affect adoption or adherence to
`20 milligram therapy to have a co-pay differential between
`zero and $35.
`Let me go back to a second issue that you raised,
`Q.
`namely, physician and patient awareness. I want to ask you
`what the marketing messages were so that you could achieve
`that awareness.
`What were the considerations at that time and
`how did you get physicians and patients to become aware of
`the product?
`We focused our marketing message around safety,
`A.
`efficacy, and tolerability of the product. And we
`incorporated the package insert into all of our promotional
`material, particularly the leave-behind materials that we
`would provide for patients and physicians.
`We also emphasized the convenience of a three
`times a week dosing schedule in allowing patients the
`opportunity to adapt the dosing to their needs as opposed to
`having to comply to a more rigorous dosing schedule where
`they had to adapt their lifestyle to the drug.
`
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`Case 1:14-cv-01171-GMS Document 283 Filed 12/08/16 Page 21 of 235 PageID #: 7743
`Hassler - direct
`Directing your attention to Plaintiffs' Exhibit 652,
`Q.
`and to part of those materials, this is graphic PDX-3.5, can
`you tell us what that is? First of all, who is the audience
`to whom this is directed?
`This would have been part of our professional
`A.
`campaign. So this would have been directed at neurologists.
`And it announces the availability of three times a week
`Copaxone 40 milligram. And messages, the proven message is
`a mix of safety and tolerability.
`I notice there is a footnote next to tolerability. To
`Q.
`what does that refer?
`It refers the physician back to the prescribing
`A.
`information of the product for the product where a more
`complete set of the data is available.
`The footnote says please see prescribing information
`Q.
`available at this presentation?
`Yes.
`A.
`That is referring to the package insert?
`Q.
`Yes.
`A.
`What was the importance of this message in
`Q.
`communicating with physicians, from your point of view?
`It emphasized the fact that Copaxone 40 milligram had
`A.
`been studied in a well-controlled trial, and it had proven
`that it was an effective medication at modifying the course
`of MS through reduction and relapse rate, and that it also
`
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`Case 1:14-cv-01171-GMS Document 283 Filed 12/08/16 Page 22 of 235 PageID #: 7744
`Hassler - direct
`was safe and very well tolerated.
`Let me direct your attention to Exhibit 652 and to a
`Q.
`portion of that which is marked as a graphic, PDX-3.6. To
`whom is this directed?
`This is another element in the promotional -- in the
`A.
`professional campaign. This would have been directed toward
`neurologists.
`Do these exhibits we have looked at, including this,
`Q.
`are these part of the your commercial campaign for Copaxone
`40 milligram?
`Yes, they are.
`A.
`Do they include the message that you were trying to
`Q.
`communicate?
`Yes. In this case we were highlighting specific
`A.
`features with regard to the demonstrated tolerability
`profile of 40 milligram. And in this case, we were focused
`on adverse events that were typically more serious, or had
`more severe consequences. So those adverse events that
`required patients to discontinue from the trial were only
`three percent, and injection site atrophy and necrosis,
`which can be disfiguring side effects, were, atrophy was at
`a .5 percent and there were no incidences in the trial of
`necrosis, which is different than the experience that we had
`with 20 milligram.
`Again, the data here is derived from what source?
`Q.
`
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`266
`Case 1:14-cv-01171-GMS Document 283 Filed 12/08/16 Page 23 of 235 PageID #: 7745
`Hassler - direct
`This is coming out of the GALA trial, and is reflected
`A.
`in the prescribing information for Copaxone 40 milligram.
`Well, you have limitations on what you can say in
`Q.
`promotional materials. Isn't that correct?
`Yes.
`A.
`And essentially, what are those limitations? What are
`Q.
`they confined by?
`We are restricted by the FDA in terms of our
`A.
`commercial speech, in terms of what we can say about the
`product and the claims that we can make.
`In many cases we are communicating the data that
`are available for a given product, and relying on the health
`care professional to make informed decisions about how to
`interpret that data.
`In addition to communicating with physicians, did you
`Q.
`also do messaging or communicating with patients?
`We did.
`A.
`Let me direct your attention to Plaintiffs' Exhibit
`Q.
`651 and to a graphic identified as PDX-3.7. Can you tell us
`to whom this is directed and what the message is?
`This would have been part of our direct to patient
`A.
`communication campaign. This was really focused on the
`convenience of the three times a week dosing schedule.
`It allowed patients to choose the days on which
`they would dose the medication, provided that they had one
`
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`Case 1:14-cv-01171-GMS Document 283 Filed 12/08/16 Page 24 of 235 PageID #: 7746
`Hassler - direct
`day in between each of those doses. And it allowed patients
`to adapt to their work schedules, or if a patient happened
`to be traveling on a weekend and they didn't want to carry
`the medication with them, it gave them that opportunity.
`So it provided a great deal more flexibility and
`convenience for patients who were trying to manage this
`condition.
`How do you actually communicate with patients.
`Q.
`Physicians you will visit. Right? Your personnel actually
`go to their offices, talk with them and make presentations.
`Right?
`Yes.
`A.
`How do you communicate with patients or prospective
`Q.
`patients?
`There is information that is provided digitally so
`A.
`that patients can access information over the Internet.
`We also have patient programs, where we sponsor
`programs to help educate patients on available MS treatment,
`and specifically on Copaxone.
`Earlier you mentioned what you referred to as the GALA
`Q.
`trial. I think you said some of the data from that trial
`was actually in the package insert. Is that correct?
`Yes. The GALA trial formed the basis of the FDA
`A.
`approval, so that data is included in the package insert.
`Was there a subsequent study, data from which is not
`Q.
`
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`Case 1:14-cv-01171-GMS Document 283 Filed 12/08/16 Page 25 of 235 PageID #: 7747
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`in the package insert, which relates to comparison between
`glatiramer acetate 20 milligram and glatiramer acetate 40
`milligram three times a week?
`Yes. There was another study called Glacier that also
`A.
`evaluated 40 milligram. In that case, it was an evaluation
`with patients who had been on 20 milligram for an extended
`period of time. And then they were either randomized to 40
`milligram or maintained on 20 milligram.
`Did you play any role in the Glacier trial itself?
`Q.
`I supported the idea of developing this data. But I
`A.
`didn't play any role in the clinical development or
`execution of that trial.
`Following the Glacier trial, did you become aware of
`Q.
`the results?
`Yes.
`A.
`And from your point of view, and from the marketing
`Q.
`point of view, what was the importance of the Glacier trial?
`Well, we had data in the GALA trial that showed the
`A.
`frequency of injection related adverse events and the
`severity of some of those -- of those events was less in the
`GALA trial with 40 milligram than we had seen previously in
`multiple trials and with common knowledge in the marketplace
`of 20 milligram.
`So we had a good indication that 40 milligram
`was going to be better tolerated. But we wanted to show
`
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`Case 1:14-cv-01171-GMS Document 283 Filed 12/08/16 Page 26 of 235 PageID #: 7748
`Hassler - direct
`specifically in patients who had been on Copaxone 20
`milligram for an extended period of time that they, too,
`would benefit in terms of the improved tolerability.
`In fact, the Glacier trial demonstrated that
`there was a 50-percent reduction in injection related
`adverse events and the moderate to severe injection related
`adverse events were 60 percent less.
`Why was that significant? These were by definition
`Q.
`patients who were initially on 20 milligrams and then
`switched to 40 milligrams at som
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