`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` PATENT TRIAL AND APPEAL BOARD
`
` MYLAN PHARMACEUTICALS )
` INC. and AMNEAL )
` PHARMACEUTICALS LLC, ) Case Nos.
` )
` Petitioners, ) IPR2015-00643
` ) (8,232,250 B2)
` vs. ) IPR2015-00644
` ) (8,399,413 B2)
` YEDA RESEARCH AND ) IPR2015-00830
` DEVELOPMENT CO. LTD., ) (8,969,302 B2)
` )
` Patent Owner. )
` ------------------------- )
`
` February 2, 2016
` 8:15 a.m.
`
` Deposition of TJALF ZIEMSSEN, held at
` the offices of Perkins Coie LLP, 30
` Rockefeller Center, New York, New York, before
` Laurie A. Collins, a Registered Professional
` Reporter and Notary Public of the State of New
` York.
`
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`YEDA EXHIBIT NO. 2147
`MYLAN PHARM. v YEDA
`IPR2015-00644
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` A P P E A R A N C E S:
`
` PERKINS COIE LLP
`
` Attorneys for Petitioner Mylan
`
` 700 13th Street, N.W., Suite 600
`
` Washington, D.C. 20005-3960
`
` BY: SHANNON M. BLOODWORTH, ESQ.
`
` sbloodworth@perkinscoie.com
`
` BRANDON M. WHITE, ESQ.
`
` bwhite@perkinscoie.com
`
` - and -
`
` PERKINS COIE LLP
`
` One East Main Street, Suite 201
`
` Madison, Wisconsin 53703-5118
`
` BY: DAVID L. ANSTAETT, ESQ.
`
` danstaeet@perkinscoie.com
`
` - and -
`
` PERKINS COIE LLP
`
` 1888 Century Park East, Suite 1700
`
` Los Angeles, California 90067-1721
`
` BY: COURTNEY M. PROCHNOW, ESQ.
`
` cprochnow@perkinscoie.com
`
` - and -
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`YEDA EXHIBIT NO. 2147
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`Page 3
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` A P P E A R A N C E S ( c o n t i n u e d ) :
`
` W I L S O N S O N S I N I G O O D R I C H & R O S A T I
`
` 1 2 2 3 5 E l C a m i n o R e a l , S u i t e 2 0 0
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` S a n D i e g o , C a l i f o r n i a 9 2 1 3 0 - 3 0 0 2
`
` B Y : L O R E L E I P . W E S T I N , P H . D . , E S Q .
`
` l w e s t i n @ w s g r . c o m
`
` D U A N E M O R R I S L L P
`
` A t t o r n e y s f o r P e t i t i o n e r A m n e a l
`
` 1 0 0 H i g h S t r e e t , S u i t e 2 4 0 0
`
` B o s t o n , M a s s a c h u s e t t s 0 2 2 1 0 - 1 7 2 4
`
` B Y : C H R I S T O P H E R S . K R O O N , E S Q .
`
` c s k r o o n @ d u a n e m o r r i s . c o m
`
` G O O D W I N P R O C T E R L L P
`
` A t t o r n e y s f o r P a t e n t O w n e r
`
` 9 0 1 N e w Y o r k A v e n u e , N . W .
`
` W a s h i n g t o n , D . C . 2 0 0 0 1
`
` B Y : W I L L I A M G . J A M E S , E S Q .
`
` w j a m e s @ g o o d w i n p r o c t e r . c o m
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` - a n d -
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`YEDA EXHIBIT NO. 2147
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`IPR2015-00644
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` A P P E A R A N C E S ( c o n t i n u e d ) :
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` G O O D W I N P R O C T E R L L P
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` T h e N e w Y o r k T i m e s B u i l d i n g
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` 6 2 0 E i g h t h A v e n u e
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` N e w Y o r k , N e w Y o r k 1 0 0 1 8 - 1 4 0 5
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` B Y : D A N I E L P . M A R G O L I S , P H . D . , E S Q .
`
` d m a r g o l i s @ g o o d w i n p r o c t e r . c o m
`
` - a n d -
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` G O O D W I N P R O C T E R L L P
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` E x c h a n g e P l a c e
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` 5 3 S t a t e S t r e e t
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` B o s t o n , M a s s a c h u s e t t s 0 2 1 0 9
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` B Y : J O H N T . B E N N E T T , E S Q .
`
` j b e n n e t t @ g o o d w i n p r o c t e r . c o m
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` A L S O P R E S E N T :
`
` M A T T H E W G R E I N E R T , E S Q . ( M y l a n )
`
` L O R I W O L F E , E S Q . ( T e v a )
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`YEDA EXHIBIT NO. 2147
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` T J A L F Z I E M S S E N ,
`
` called as a witness, having been duly sworn
`
` by the notary public, was examined and
`
` testified as follows:
`
` EXAMINATION BY
`
` MS. BLOODWORTH:
`
` Q. Good morning, Dr. Ziemssen. My name is
`
` Shannon Bloodworth. I'm an attorney for the
`
` petitioners, Mylan, and I work with the firm
`
` Perkins Coie.
`
` Sir, if I say Dr. Ziemssen, am I close
`
` in pronouncing your name correctly?
`
` A. It's fine, yes.
`
` Q. If I mess up, just let me know, please.
`
` And can you please state and spell your
`
` name for the record?
`
` A. T-H-A-L-F, Z-I-E-M-S-S-E-N [sic].
`
` Q. And have you ever had your deposition
`
` taken before?
`
` A. No, it's my first deposition.
`
` Q. So just to go over a little bit of the
`
` ground rules, then, I'll ask some questions.
`
` You'll have the opportunity to answer. If you
`
` don't understand any of the questions, please let
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` Ziemssen
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` me know, I'll try to clarify it or make it -- or
`
` ask a different question. However, you are
`
` supposed to be responsive to the questions that I
`
` ask.
`
` If at any time your counsel has
`
` questions, he has the opportunity at the end of
`
` the deposition after my questions to ask you
`
` questions.
`
` Obviously I have a cold today, so if
`
` you cannot hear me, please let me know. I will
`
` speak up. And if you ever need a break, feel free
`
` to take one. Just let me know. And we'll finish
`
` out the questions, and we'll go ahead and take a
`
` break.
`
` A. That's my understanding.
`
` Q. And it's my understanding we should try
`
` to get finished by 5 o'clock today because you
`
` have a flight, so we'll endeavor to do that.
`
` Aside from this matter here today, have
`
` you ever been retained by Yeda as an expert?
`
` A. What do you mean with this?
`
` Q. Have you ever been asked to provide any
`
` expert testimony in the form of a declaration or
`
` an affidavit, for instance?
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` Ziemssen
`
` A. You mean as declaration like this
`
` declaration have been?
`
` Q. Yes.
`
` A. No, it's my first declaration.
`
` Q. Okay.
`
` And aside from your interactions with
`
` Teva or Yeda for this matter, have you ever been
`
` retained by Yeda for any of your services, for any
`
` services?
`
` A. What do you mean with "retained"?
`
` Q. Have you ever had an agreement under
`
` which you performed work for Yeda?
`
` A. What kind of work do you mean?
`
` Q. Any kind of work on, say, for example,
`
` a clinical trial or other work that you would
`
` perform under a contractual obligation with Yeda.
`
` A. So I had a contract on speaking
`
` activities with Teva, not with Yeda.
`
` Q. And when did you enter into that
`
` agreement with Teva?
`
` A. Pardon?
`
` Q. When did you enter into that agreement
`
` with Teva?
`
` A. I cannot recall when it started.
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` Q. Do you recall approximately when it
`
` started? Was it before or after the year 2000?
`
` A. It was after 2000, yes.
`
` Q. Was it around two thousand -- do you
`
` recall if it was around 2010?
`
` A. I think it was earlier than 2010.
`
` Q. And what type of speaking activities
`
` did you perform?
`
` A. What do you mean with "types of
`
` activities"?
`
` Q. You said that you had a contract on
`
` speaking activities. What did you mean by that?
`
` What did that entail?
`
` A. In Germany it's the case that you are
`
` asked to give a speech, and then you get a
`
` separate contract. So you don't have a contract
`
` which is including a certain quantity of talks
`
` or -- you're asked to give a talk, and then you
`
` get a contract which has to be approved by your
`
` administration.
`
` Q. Is that contract still in good
`
` standing? Are you still under that contractual
`
` obligation with Teva?
`
` A. No. As I have stated, if I have to
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` give a speech, I get a separate contract. So I
`
` have no contract which is ongoing. For each
`
` activity I get a separate contract.
`
` Q. Okay. Thank you.
`
` Approximately how many contracts have
`
` you had? Do you recall?
`
` A. I cannot recall.
`
` Q. Was it more than ten?
`
` A. Yes, I think so.
`
` Q. More than 20?
`
` A. Yes, I think so.
`
` Q. More than 50, 5-0?
`
` A. I cannot recall.
`
` Q. Okay. So to the best of your
`
` recollection you've had approximately more than 20
`
` speaking engagements for Teva?
`
` A. That is fine, yes.
`
` Q. Were those all related to Copaxone?
`
` A. No.
`
` Q. Were some of them?
`
` A. Yes, some of them.
`
` Q. Were the others related to a different
`
` MS drug?
`
` A. Partially, yes.
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` Ziemssen
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` Q. Laquinimod?
`
` A. Yes, one of them, yes.
`
` Q. Do you recall any others?
`
` A. No, I cannot recall.
`
` Q. Doctor, I'm going to hand you what was
`
` marked as Yeda Exhibit Number 2135. It's entitled
`
` the declaration of Tjalf Ziemssen, M.D., Ph.D., in
`
` support of patent owner Yeda's response to
`
` petition for inter partes review, and it was
`
` submitted in Case Number IPR2015-00643.
`
` And, sir, if I can ask you to keep that
`
` one handy. We're going to mark your other two
`
` declarations, but we're going to refer primarily
`
` to the '250 in the 643 case.
`
` A. Okay. Good.
`
` Q. Let's also mark Yeda Exhibit Number
`
` 2135, and it's the same title for the declaration
`
` submitted in support of Case Number IPR2015-00644
`
` related to patent number 8,399,413. And also
`
` marked as Yeda Exhibit Number 2135 with the same
`
` title is your declaration submitted in support of
`
` IPR2015-00830 for U.S. patent number 8,969,302.
`
` And as I mentioned, sir, today I'm
`
` going to be referring primarily to the first
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` Ziemssen
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` document that I handed you, which is related to
`
` the '250 patent. And by that, that's the
`
` abbreviation for which we refer to U.S. patent
`
` numbers. Typically we use the last three digits.
`
` Is that familiar to you?
`
` A. I'm familiar with it, yes.
`
` Q. So when I refer to the '250 patent,
`
` you'll understand I'm referring to the one in this
`
` declaration?
`
` A. I understand, yes.
`
` Q. Now, if you ever need to answer any of
`
` my questions -- in my opinion they're pretty
`
` similar, but if you ever need to look at any of
`
` the other declarations to answer any questions,
`
` please feel free to do so.
`
` A. I will do so.
`
` Q. Okay. In the '250 patent in paragraph
`
` 20 on page 6, you mentioned --
`
` MR. JAMES: Do you mean his
`
` declaration? You said '250 patent.
`
` MS. BLOODWORTH: Did I?
`
` MR. JAMES: Yes.
`
` Q. I do mean your declaration. I don't
`
` think you wrote any of the '250 patent; correct?
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` Ziemssen
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` A. I don't think so.
`
` Q. Let's just get that clear for the
`
` record; right? Definitely your '250 declaration.
`
` You state that a copy of my current
`
` curriculum vitae is attached hereto as Exhibit
`
` 2131. So let's go ahead and get that in the
`
` record. And we'll also at the same time do 2132.
`
` I'm going to hand you what was marked
`
` Yeda Exhibit Number 2131. And again, this is in
`
` support of the '250 case declaration. It's two
`
` pages. I'm also handing you what was marked as
`
` Yeda Exhibit Number 2132, which is also two pages.
`
` Turning to Exhibit 2131, is this a
`
` current copy of your CV?
`
` A. Yes, it is.
`
` Q. Do you have a full CV?
`
` A. What do you mean with "full CV"?
`
` Q. A CV that lists all of your
`
` publications and speaking engagements and
`
` abstracts, for example.
`
` A. No, I haven't.
`
` Q. And what I also handed you marked or
`
` referred to as Exhibit 2132 in your declaration,
`
` and in paragraph 16 of your declaration, you state
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` Ziemssen
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` that Exhibit 2132 is a, quote, full listing of the
`
` clinical trials in which you participated as an
`
` investigator. Do you see that?
`
` A. Yes. But it's stated -- it's stated
`
` that it's the clinical trial over the past five
`
` years. So it's not a full list; it's the past
`
` five years.
`
` Q. Okay. So in your report you don't
`
` qualify the last five years, but that is what 2132
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` is is the last five years?
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` A. (Nods head.)
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` Q. Why did you limit it to the last five
`
` years?
`
` A. That is German standard.
`
` Q. And do you have any corrections that
`
` you would like to make to either of these two
`
` exhibits or any updates that you would like to
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` add?
`
` A. No, I have not.
`
` Q. Is Exhibit 2132 something that you
`
` maintain in your ordinary course or did you
`
` prepare this specifically for this litigation?
`
` A. What do you mean exactly with this?
`
` Q. Did you prepare this listing for this
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` declaration or is this something you keep in your
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` files?
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` A. I keep it in my files.
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` Q. And in the last I guess five years, I
`
` counted that there are approximately 31 trials
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` listed on Exhibit 2132, and two of those relate to
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` glatiramer acetate; correct?
`
` A. Yes, that is right.
`
` Q. And the two that I saw were the GALA
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` trial in the middle of the first page and the
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` FORTE trial listed as the first entry? Are those
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` two the same you found?
`
` A. That is right, FORTE and GALA.
`
` Q. The FORTE trial was more than four
`
` years ago; correct?
`
` A. I cannot recall exactly.
`
` Q. And if you turn to your declaration in
`
` paragraph 16, it shows that you list the FORTE
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` trial, a trial called COPTIMIZE, and a trial
`
` called QualiCOP.
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` Why is the COPTIMIZE trial not listed
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` on Exhibit 2132?
`
` A. Because both trials, COPTIMIZE and
`
` QualiCOP trials, are noninterventional trials,
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` observational trials. This is only a list of the
`
` clinical trials.
`
` Q. So you participate in observational
`
` trials too; correct?
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` A. That's right.
`
` Q. What is the purpose of an observational
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` trial?
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` A. You cannot say it in general what is
`
` the purpose of observational trials. It depends
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` on the trial.
`
` Q. But certainly there is a purpose to it;
`
` correct?
`
` A. Pardon?
`
` Q. There is a purpose to it?
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` MR. JAMES: Objection to the form.
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` A. What do you mean with this?
`
` Q. Well, observational trials provide some
`
` meaning to the art. There's a purpose for
`
` performing the trial; correct?
`
` A. I do not understand the wording
`
` "purpose."
`
` Q. Do they have an objective?
`
` A. Observational trials document clinical
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` parameters which are standard of care.
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` Q. Okay. And why was the COPTIMIZE
`
` observational trial conducted?
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` A. COPTIMIZE trial was conducted to
`
` document clinical parameters switching from
`
` interferons to glatiramer acetate.
`
` Q. Why would you want to document the
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` clinical parameters?
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` A. We wanted to document clinical
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` parameters to compare patients switching from
`
` interferon because of lack of efficacy versus
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` tolerability reasons.
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` Q. I think this is going to be
`
` Petitioners' Exhibit Number 1079. I'm going to
`
` hand you a document that was published in the
`
` Journal of Neurology in 2014, and it's called a
`
` two-year observational study of patients with
`
` relapsing-remitting multiple sclerosis converting
`
` to glatiramer acetate from other disease-modifying
`
` therapies: the COPTIMIZE trial. And it looks
`
` like it runs from pages 2101 through 2111.
`
` (Discussion off the record.)
`
` Q. Is this a paper that you authored that
`
` you're the primary author for relating to the
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` COPTIMIZE trial?
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` A. I was the primary author of the paper,
`
` yes.
`
` Q. How many papers did you author -- how
`
` many papers were you the author on relating to the
`
` COPTIMIZE trial?
`
` A. We have two full papers on the
`
` COPTIMIZE trial.
`
` Q. Two. Okay.
`
` And if you turn to the second page,
`
` 2102, it lists the study design under "methods."
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` And it states that COPTIMIZE was a two-year
`
` international, multicenter, prospective,
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` noninterventional, longitudinal, and observational
`
` study conducted in 148 study centers across 19
`
` countries.
`
` Who sponsored this study?
`
` A. Teva sponsored this trial.
`
` Q. And were you the lead investigator on
`
` this trial? Were you the principal investigator
`
` on the trial?
`
` A. I was the principal investigator of
`
` this trial, yes.
`
` Q. Why did Teva want a two-year
`
` international, multicenter, prospective,
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` noninterventional, longitudinal, and observational
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` study to be conducted?
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` MR. JAMES: Objection to the form.
`
` A. Pardon, I haven't got the question.
`
` Q. Why did Teva want this study to be
`
` performed?
`
` MR. JAMES: Objection to the form.
`
` A. I don't know.
`
` Q. Do you have an agreement with Teva for
`
` this study?
`
` A. I had an agreement as principal
`
` investigator of this trial.
`
` Q. And Teva paid for this trial to be
`
` conducted; correct?
`
` A. It is stated at the end of the
`
` manuscript that this study was supported by Teva
`
` Pharmaceuticals Industries.
`
` Q. And what does "supported by" mean?
`
` A. I don't know what you mean concretely.
`
` Q. Did they provide the samples for the
`
` studies and the product to be administered?
`
` A. No, they haven't.
`
` Q. Did they provide the glatiramer acetate
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` to be administered?
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` A. No, they haven't.
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` Q. Who paid for that? Did the patients
`
` pay for that?
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` A. Depending on the country, patients or
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` health insurances.
`
` Q. So when you wrote the study was
`
` sponsored by Teva, what did that mean?
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` MR. JAMES: Objection.
`
` A. So it's stated the study was supported
`
` by Teva Pharmaceuticals.
`
` Q. What kind of support did Teva provide?
`
` A. I cannot recall.
`
` Q. Clinical trials aren't cheap, though;
`
` right?
`
` MR. JAMES: Objection to the form.
`
` A. I don't know.
`
` Q. How much did you spend on this study,
`
` your group? How much did you invest, personal
`
` time, resources?
`
` A. I don't know.
`
` Q. Was it free? Did you perform the study
`
` for free?
`
` A. No, as stated, I had a contract
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` agreement with Teva.
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` Q. And in this study you say on page 2109,
`
` quote, Despite study limitations, our
`
` observations -- do you see where I am, 2109, under
`
` Table 5 in the right-hand column? You write,
`
` Despite study limitations, our observations
`
` corroborate the results of previous studies in
`
` which improved treatment response (i.e., reduced
`
` ARR, delayed disease progression) was observed in
`
` patients who converted from one DMT to another.
`
` Sub footnotes.
`
` Do you see that?
`
` A. That's stated in the paper, yes.
`
` Q. And that is you stating the
`
` observations from the COPTIMIZE trial for the
`
` public's review; correct?
`
` A. I don't understand your question.
`
` Q. This article you put out in the public
`
` literature; correct? It's in the Journal of
`
` Neurology?
`
` A. This manuscript was written by me, yes.
`
` Q. Yes. Published in the Journal of
`
` Neurology; yes?
`
` A. It was published in the Journal of
`
` Neurology.
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` Q. Okay. And you're stating your
`
` observations and what they corroborate in your
`
` mind; correct?
`
` A. That's stated in the text.
`
` Q. And you go on and you state, Our
`
` findings also emphasize the importance of changing
`
` a therapeutic regimen to improve patients'
`
` well-being (i.e., QOL -- stands for quality of
`
` life?
`
` A. That's fine.
`
` Q. Okay. The quote continues, depression,
`
` fatigue) and control disease progression while
`
` overcoming treatment barriers (i.e., intolerable
`
` AEs) that could compromise compliance among
`
` patients responding suboptimally to their current
`
` regimen and result in further disease progression.
`
` Do you see that?
`
` A. That's stated, yes.
`
` Q. So you're emphasizing in this published
`
` article the importance of changing from one regime
`
` to another; correct?
`
` A. I don't agree with the statement.
`
` Q. Our findings also emphasize the
`
` importance of changing a therapeutic regime to
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` improve patients' well-being and to control
`
` disease progression.
`
` A. That's stated in my text.
`
` Q. Did you expect persons of skill in the
`
` art reading this to follow or to be guided by your
`
` observations?
`
` MR. JAMES: Objection to the form.
`
` A. What do you mean with this question?
`
` Q. Why did you write this?
`
` A. To draw conclusions from our
`
` observation published in the manuscript.
`
` Q. And people would want to hear those
`
` conclusions -- right? -- two years' worth of work?
`
` MR. JAMES: Objection to the form.
`
` A. I don't know what you mean.
`
` Q. Well, did you think this article would
`
` not be read?
`
` A. You author an article to publish your
`
` data and to comment on this data.
`
` Q. For use by others in your field;
`
` correct?
`
` A. I don't know exactly who's reading the
`
` Journal of Neurology.
`
` Q. Okay. But if somebody is reading the
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` Journal of Neurology, would they suspect that your
`
` observations are unfounded?
`
` MR. JAMES: Objection to the form.
`
` Q. Okay. Rephrase.
`
` Would they discard your observations
`
` provided in this study?
`
` MR. JAMES: Objection to the form.
`
` A. What do you mean with "discard"?
`
` Q. You wrote this for a purpose; right?
`
` A. To comment on my results, yes.
`
` Q. Did you expect people to read this and
`
` be informed by it?
`
` A. I published this paper to present my
`
` results and to comment on the results.
`
` Q. Right. But if nobody was going to read
`
` them, you wouldn't have a reason to comment on
`
` them and publish them; right?
`
` A. I don't know what you mean.
`
` Q. Did you expect doctors to read this
`
` article and convert patients to Copaxone to be a
`
` first-line treatment for MS?
`
` A. I don't agree with the statement.
`
` Q. Did you think it would provide them
`
` helpful information if they were considering
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` switching their patients to Copaxone?
`
` A. Could you specify your question,
`
` please?
`
` Q. Let's read. You say you recommend or
`
` you state patients whose disease is progressing on
`
` their current DMT need to be converted in a timely
`
` manner, right on the paragraph we were on
`
` previously. It's the first sentence of the second
`
` full paragraph.
`
` A. Uh-huh.
`
` Q. So I'll state you write, Patients whose
`
` disease is progressing on their current DMT need
`
` to be converted in a timely manner.
`
` A. Yes, that is stated in the text.
`
` Q. Then you state, Future clinical trial
`
` design should include patients converting from one
`
` DMT to another as a study arm. These trials could
`
` contribute to the development of consensus
`
` statements, treatment algorithms, and clinical
`
` parameters for changing treatment. This is
`
` important, as converting treatments is not always
`
` necessary and is associated with significant
`
` health care costs.
`
` A. That is stated in the manuscript.
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` Q. So your recommendation is that
`
` following these observations you've published in
`
` the Journal of Neurology there should be another
`
` trial that should follow and you lay it out. You
`
` say it could contribute to the development of
`
` consensus statements and other things and you
`
` recommend that the trial design should include
`
` patients converting from one DMT to another as a
`
` study arm.
`
` MR. JAMES: Objection to the form.
`
` Q. Is that your recommendation, that
`
` future clinical trial designs should include
`
` patients converting from one DMT to another as a
`
` study arm?
`
` A. That's stated in my text, yes.
`
` Q. So you had every expectation that
`
` someone reading this would think to perform a
`
` clinical trial that is designed to include
`
` patients converting from one DMT to another as a
`
` study arm?
`
` MR. JAMES: Objection to the form.
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` A. I stated the future clinical trials
`
` should include patients conv