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` U N I T E D S T A T E S P A T E N T A N D T R A D E M A R K O F F I C E
` B E F O R E T H E P A T E N T T R I A L A N D A P P E A L B O A R D
` C A S E I P R 2 0 1 5 - 0 0 6 4 3
` P a t e n t 8 , 2 3 2 , 2 5 0
`
`_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
`M Y L A N P H A R M A C E U T I C A L S , I N C . )
`P e t i t i o n e r )
`v s . )
`Y E D A R E S E A R C H & D E V E L O P M E N T )
`C O . L T D )
`P a t e n t O w n e r )
`_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
`
` D e p o s i t i o n o f R o b e r t W . G r i s t w o o d , P h . D .
` W a s h i n g t o n , D . C .
` J a n u a r y 1 3 , 2 0 1 6
` 9 : 1 5 a . m .
`
` V e r i t e x t L e g a l S o l u t i o n s
` M i d - A t l a n t i c R e g i o n
` 1 2 5 0 E y e S t r e e t N W - S u i t e 1 2 0 1
` W a s h i n g t o n , D . C . 2 0 0 0 5
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`Deposition of Robert W. Gristwood, Ph.D. held
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`at:
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`Page 2
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` Perkins Coie
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` 700 13th Street, N.W.
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` Washington, D.C.
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`Pursuant to Notice, when were present on behalf
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`of the respective parties:
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`YEDA EXHIBIT NO. 2145
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`Page 3
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`A P P E A R A N C E S :
`
`O n b e h a l f o f t h e P e t i t i o n e r :
` P E R K I N S C O I E
` B R A N D O N M . W H I T E , E s q .
` S H A N N O N B L O O D W O R T H , E s q .
` R O B E R T S W A N S O N , E s q .
` E M I L Y G R E B , E s q .
` D A V I D A N S T A E T T , E s q .
` 7 0 0 1 3 t h S t r e e t , N . W .
` S u i t e 6 0 0
` W a s h i n g t o n , D . C . 2 0 0 0 5
` 2 0 2 - 6 5 4 - 6 2 0 6
` b m w h i t e @ p e r k i n s c o i e . c o m
` - a n d -
` C O U R T N E Y M . P R O C H N O W , P h . D . , E s q .
` P E R K I N S C O I E
` 1 8 8 8 C e n t u r y P a r k E a s t
` S u i t e 1 7 0 0
` L o s A n g e l e s , C a l i f o r n i a 9 0 0 6 7
` 3 1 0 - 7 8 8 - 3 2 8 4
` c p r o c h n o w @ p e r k i n s c o i e . c o m
`
`O n b e h a l f o f A m n e a l :
` C H R I S T O P H E R S . K R O O N , E s q .
` D U A N E M O R R I S , L L P
` 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 1 1 0
` 8 5 7 - 4 8 8 - 4 2 7 6
` c s k r o o n @ d u a n e m o r r i s . c o m
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`1
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`2 3
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`4
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`1 0
`1 1
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`1 4
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`1 6
`1 7
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`1 8
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`1 9
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`2 0
`2 1
`2 2
`2 3
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`2 5
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`Page 4
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`A P P E A R A N C E S ( C O N T I N U E D ) :
`
`O n b e h a l f o f t h e P a t e n t O w n e r :
`
` W I L L I A M G . J A M E S , E s q .
` G O O D W I N P R O C T E R , L L P
` 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
` 2 0 2 - 3 4 6 - 4 0 0 0
` w j a m e s @ g o o d w i n p r o c t e r . c o m
` - a n d -
` D A N I E L P . M A R G O L I S , P h . D . , E s q .
` G O O D W I N P R O C T E R , L L P
` T h e N e w Y o r k T i m e s B u i l d i n g
` 6 2 0 E i g h t A v e n u e
` N e w Y o r k , N e w Y o r k 1 0 0 1 8
` 2 1 2 - 8 1 3 - 8 8 0 0
` 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 l s o P r e s e n t :
`L o r i W o l f e , S e n i o r C o u n s e l , T e v a
`P h a r m a c e u t i c a l s
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`YEDA EXHIBIT NO. 2145
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` C O N T E N T S
`E X A M I N A T I O N O F R O B E R T W . G R I S T W O O D P A G E
`B Y M R . W H I T E 7 , 1 1 7
`B Y M R . J A M E S 1 1 4
` E X H I B I T S
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`P R E V I O U S L Y M A R K E D E X H I B I T S :
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`E x h i b i t 1 0 0 3 C o r r e c t e d D e c l a r a t i o n
` o f S t e p h e n J .
` P e r o u t k a , M . D . , P h . D .
`E x h i b i t 1 0 0 7 A f f i d a v i t o f M a r l e n e B o b k a
` N D A 2 0 - 6 2 2
`E x h i b i t 1 0 2 2 A r t i c l e D r u g s o f t h e F u t u r e
`E x h i b i t 1 0 2 9 A d i s D r u g E v a l u a t i o n
` G l a t i r a m e r A c e t a t e :
` A R e v i e w o f i t s U s e i n
` R e l a p s i n g - R e m i t t i n g
` M u l t i p l e S c l e r o s i s
`E x h i b i t 1 0 4 7 C o p a x o n e D e s c r i p t i o n
`E x h i b i t 2 0 2 1 R e v i e w A r t i c l e : R i s k - B e n e f i t
` A s s e s s m e n t o f G l a t i r a m e r
` A c e t a t e i n M u l t i p l e S c l e r o s i s
`E x h i b i t 2 0 3 9 R e v i e w : I n t r a d e r m a l
` V a c c i n e D e l i v e r y : W i l l n e w
` d e l i v e r y s y s t e m s t r a n s f o r m
` v a c c i n e a d m i n i s t r a t i o n ?
`E x h i b i t 2 0 4 0 E x p e r t R e v i e w o f V a c c i n e s :
` T r a n s c u t a n e o u s i m m u n i z a t i o n
` a n d i m m u n o s t i m u l a n t
` s t r a t e g i e s : C a p i t a l i z i n g
` o n t h e i m m u n o c o m p e t e n c e
` o f t h e s k i n
`E x h i b i t 2 0 4 1 A r t i c l e : I m m u n i t y U n d e r
` t h e S k i n : P o t e n t i a l
` A p p l i c a t i o n f o r T o p i c a l
` D e l i v e r y o f V a c c i n e s
`E x h i b i t 2 0 4 2 A r t i c l e : T r a n s c u t a n e o u s
` I m m u n i z a t i o n w i t h C l o s t r i d i u m
` D i f f i c i l e T o x o i d A I n d u c e s
` S y s t e m i c a n d M u c o s a l I m m u n e
` R e s p o n s e s a n d T o x i n
` A - N e u t r a l i z i n g A n t i b o d i e s
` i n M i c e
`E x h i b i t 2 0 4 3 A r t i c l e : C u t t i n g E d g e :
` T r a n s c u t a n e o u s I m m u n i z a t i o n
` w i t h C h o l e r a T o x i n P r o t e c t s
` M i c e A g a i n s t L e t h a l M u c o s a l
` T o x i n C h a l l e n g e
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`E X H I B I T S ( C O N T I N U E D ) :
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`E x h i b i t 2 0 5 4 E x c e r p t A r t i c l e i n T h e
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` J o u r n a l o f A l l e r g y a n d
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` C l i n i c a l I m m u n o l o g y
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`E x h i b i t 2 1 3 0 C u r r i c u l u m V i t a e o f
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` D r . R o b e r t W i l l i a m G r i s t w o o d
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`E x h i b i t 2 1 3 4 D e c l a r a t i o n o f R o b e r t W i l l i a m
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` G r i s t w o o d , P h . D . i n S u p p o r t
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` o f Y e d a ' s P a t e n t
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` O w n e r R e s p o n s e
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`( E x h i b i t s i n c l u d e d w i t h t r a n s c r i p t . )
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` P R O C E E D I N G S
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`ROBERT W. GRISTWOOD, Ph.D.,
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`was called for examination by counsel and,
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`after having been duly sworn by the Notary, was
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`examined and testified as follows:
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` EXAMINATION BY COUNSEL FOR PETITIONER
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` BY MR. WHITE:
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` Q. Good morning, Dr. Gristwood.
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` A. Good morning.
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` Q. My name's Brandon White, counsel for
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`Mylan. And I'm going to be asking you some
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`questions this morning.
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` Have you been deposed before?
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` A. I have.
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` Q. Okay. So you know the process, how
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`this is going to happen?
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` A. If it's the same as it was before, I
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`guess.
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` Q. I'll go over a few ground rules with
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`you just to make sure we're on the same page.
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` I'm going to ask you some questions.
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`Your counsel may have some objections to what I
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`ask, but unless he instructs you not to answer,
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`you can go ahead and answer the question if you
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`can.
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` A. Okay.
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` Q. If there is something you don't
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`understand about my question, if you'd like
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`clarification or if you need something -- a
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`document, please let me know, and I will try to
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`get it for you if I can.
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` Please try to give audible answers.
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`No nodding of the head or "ums." The court
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`reporter is going to take everything down.
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` I will try not to talk over you,
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`and -- for the court reporter's sake mostly.
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`But if I interrupt you, please let me know, and
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`I will let you finish. So I will try not to do
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`that.
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` I will be handing you exhibits.
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`Most of them will be marked in the IPRs
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`already. So we will be referring to those
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`throughout your deposition.
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` If you want to look at anything that
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`I have given you, even though I may point you
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`to a specific section of a report or a
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`document, feel free to go ahead and look at
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`that.
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` A. Okay.
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` Q. But you understand you are here
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`today to testify with respect to three IPRs
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`filed by Mylan?
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` A. I think so, yes.
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` Q. Doctor, what I've handed you has
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`been previously marked as Yeda Exhibit 2134 in
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`IPR 2015-00643.
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` Do you recognize that as the
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`declaration you submitted in the IPR related to
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`the '250 patent?
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` A. Yes, I do.
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` Q. The document I just handed you has
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`also been identified as Yeda Exhibit 2134.
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`This is for IPR 2015-00644. And that is the
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`IPR related to the '413 patent.
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` Do you recognize that as your
`
`declaration?
`
` A. Yes.
`
` Q. The third document I have handed you
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`has also been labeled as Yeda Exhibit 2134.
`
`But this one is related to IPR 2015-00830 for
`
`the '302 patent.
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` Do you recognize that as your
`
`declaration?
`
` A. Yes.
`
` Q. I am generally going to refer to the
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`first document I handed you that was for the
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`'250 patent. It may be easier to refer to just
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`one of these rather than three. But if you
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`want to look at any of the others or if you
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`need to look at any others, feel free to do so.
`
` The document I just handed you has
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`been labeled as Yeda Exhibit 2130 in IPR
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`2015-00643.
`
` Do you recognize that as your CV?
`
` A. Yes.
`
` Q. Do you have any corrections or
`
`clarifications you need to make to your CV?
`
` A. Not to my CV.
`
` Q. Are there corrections or
`
`clarifications you need to make to your
`
`declarations?
`
` A. There's three very small corrections
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`I would like to point out, if I may.
`
` Q. Sure.
`
` A. Okay. So -- right. I got it. Page
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`12.
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` Q. And are you in the '250 declaration?
`
`Says 643 at the bottom?
`
` A. Yes.
`
` Q. Okay.
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` A. Page 12. Okay. It's the third
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`sentence. There's a statement. It says: "The
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`term bioavailable used by both Logo and Simpson
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`to describe GI can be used to refer either to
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`the fractional," remove fractional.
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` And then moving on remove drug.
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` Q. Say that again, please.
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` A. In the same sentence, so it's the --
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`the extent to which, i.e., remove drug.
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` Q. Okay.
`
` A. Okay. Page 14, third line, first
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`word, that should be "radioactivity," not
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`"reactivity."
`
` Q. Okay.
`
` A. Okay. And then on Page 16, it's a
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`small one, but the second line, that should be:
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`"Because of these differences, the only thing
`
`labeled molecules."
`
` Q. Is that it?
`
` A. I think it is. There might be one
`
`or two small typos in the report.
`
` Q. Okay. Doctor, I want to turn to
`
`your CV. Might want to get that in front of
`
`you.
`
` You have a Ph.D. in pharmacology?
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` A . Y e s .
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` Q . W h a t w a s t h e t o p i c o f y o u r t h e s i s ?
`
` A . T h e t o p i c o f m y t h e s i s .
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` Q . Y e s .
`
` A . A s I r e c a l l , i t w a s a s t u d y o f t h e
`
`d i s t r i b u t i o n o f f u n c t i o n o f h i s t a m i n e H 2
`
`r e c e p t o r s i n t h e h e a r t .
`
` Q . W a s t h a t i n a n y w a y r e l a t e d t o
`
`m u l t i p l e s c l e r o s i s ?
`
` A . N o .
`
` Q . W a s t h a t i n a n y w a y r e l a t e d t o
`
`g l a t i r a m e r a c e t a t e ?
`
` A . N o .
`
` Q . Y o u l i s t f i v e s o c i e t y m e m b e r s o n
`
`y o u r C V o n t h e f i r s t p a g e .
`
` D o y o u s e e t h a t ?
`
` A . I d o , y e s .
`
` Q . A r e a n y o f t h o s e s o c i e t i e s d i r e c t e d
`
`t o t h e s t u d y o f m u l t i p l e s c l e r o s i s ?
`
` M R . J A M E S : O b j e c t i o n t o t h e f o r m .
`
` T H E W I T N E S S : C a n y o u r e p e a t t h a t
`
`j u s t t o b e c l e a r .
`
` B Y M R . W H I T E :
`
` Q . S u r e .
`
` A r e a n y o f t h e s o c i e t i e s l i s t e d o n
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`Page 1 of your CV directed to the study of
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`multiple sclerosis?
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` A. Not specifically. They are
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`societies which cover a full range of subjects
`
`within the identified areas that they purport
`
`to cover.
`
` Q. If you turn -- I'm now on Page 1,
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`starting with your employment history.
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` A. Uh-huh.
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` Q. Your first position from 1974 to
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`1975 as a pharmacological research --
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`pharmacological research in the department of
`
`medicinal biology at Pfizer.
`
` Do you see that?
`
` A. Yes, I see that.
`
` Q. Was that your first job after
`
`obtaining your Ph.D.?
`
` A. No, no. That was my first job. I
`
`did a four-year degree course. Started in
`
`1972. Was one of the years -- it was the third
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`year -- was spent in industry. It was a
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`sandwich course. So two years study, one year
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`in industry, and then one year back to take --
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`to do the final year of the degree.
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` Q. And your time at Pfizer from 1974 to
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`1 9 7 5 , w a s a n y o f y o u r w o r k r e l a t e d t o t h e
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`t r e a t m e n t o f m u l t i p l e s c l e r o s i s ?
`
` M R . J A M E S : O b j e c t i o n t o t h e f o r m .
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` T H E W I T N E S S : N o t t h a t I k n o w o f .
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` B Y M R . W H I T E :
`
` Q . I n y o u r t i m e a t P f i z e r f r o m 1 9 7 4 t o
`
`1 9 7 5 , w a s a n y o f y o u r w o r k r e l a t e d t o
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`g l a t i r a m e r a c e t a t e ?
`
` A . N o .
`
` Q . T h e n e x t p o s i t i o n , 1 9 7 6 t o 1 9 8 8 ,
`
`c a r d i o v a s c u l a r r e s p i r a t o r y p h a r m a c o l o g i c a l
`
`b i o c h e m i c a l r e s e a r c h i n t h e p h a r m a c o l o g y
`
`d e p a r t m e n t a t S m i t h K l i n e R e s e a r c h .
`
` D o y o u s e e t h a t ?
`
` A . C o r r e c t .
`
` Q . W a s a n y o f y o u r w o r k a t S m i t h K l i n e
`
`r e s e a r c h r e l a t e d t o t h e t r e a t m e n t o f M S ?
`
` M R . J A M E S : O b j e c t i o n t o t h e f o r m .
`
` T H E W I T N E S S : A s f a r a s I k n o w , n o .
`
` B Y M R . W H I T E :
`
` Q . W a s a n y o f y o u r w o r k a t S m i t h K l i n e
`
`r e s e a r c h f r o m 1 9 7 6 t o 1 9 8 8 r e l a t e d t o
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`g l a t i r a m e r a c e t a t e ?
`
` A . N o .
`
` Q . T u r n i n g t o P a g e 2 o f y o u r C V , a
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`p o s i t i o n y o u h e l d f r o m 1 9 8 8 t o 1 9 9 3 , y o u w e r e
`
`t h e d i r e c t o r o f b i o l o g y R & D a t L a b o r a t o r i o s
`
`A l m i r a l l .
`
` D i d I c o m e c l o s e t o t h a t ?
`
` A . T h a t ' s g o o d e n o u g h .
`
` Q . W a s a n y o f y o u r t i m e f r o m - - a n y o f
`
`y o u r w o r k f r o m 1 9 8 8 t o 1 9 9 3 r e l a t e d t o t h e
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`t r e a t m e n t o f M S ?
`
` M R . J A M E S : O b j e c t i o n t o t h e f o r m .
`
` T H E W I T N E S S : I n s o f a r a s w e l o o k e d
`
`a t a n u m b e r o f d i f f e r e n t a g e n t s w i t h a n u m b e r
`
`o f d i f f e r e n t m e c h a n i s m s w i t h i n t h a t c o m p a n y .
`
`A t t h e t i m e w e w e r e n o t t h i n k i n g o f t h o s e
`
`m e c h a n i s m s i n t h e c o n t e x t o f m u l t i p l e
`
`s c l e r o s i s . S o w h e t h e r t h e r e ' s p o s s i b i l i t y a t
`
`s o m e p o i n t , t h o s e m e c h a n i s m s m i g h t h a v e b e e n
`
`i m p o r t a n t , y e s .
`
` B Y M R . W H I T E :
`
` Q . D o y o u k n o w i f a n y o f t h e a g e n t s y o u
`
`l o o k e d a t w h i l e y o u w e r e a t - - f r o m 1 9 8 8 t o
`
`1 9 9 3 w e r e u l t i m a t e l y p r o v e n s u c c e s s f u l o r
`
`u s e f u l i n t h e t r e a t m e n t o f m u l t i p l e s c l e r o s i s ?
`
` A . N o .
`
` Q . W a s a n y o f y o u r w o r k f r o m 1 9 8 8 t o
`
`1 9 9 3 r e l a t e d t o g l a t i r a m e r a c e t a t e ?
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` A. No.
`
` Q. So your next position was from 1993
`
`to 1996 as head of biology R&D at Chiroscience;
`
`Page 16
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`is that correct?
`
` A. Yes.
`
` Q. While at Chiroscience from 1993 to
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`1996, was any of your work related to the study
`
`of compounds that might be used to treat MS?
`
` MR. JAMES: Objection to the form.
`
` THE WITNESS: Again, we looked at a
`
`number of classes of therapeutics with
`
`different mechanisms which potentially might
`
`have had a role in MS.
`
` BY MR. WHITE:
`
` Q. Do you know if any of the compounds
`
`that you looked at while you were at
`
`Chiroscience ultimately proved successful of
`
`useful in treating MS?
`
` A. No. I couldn't say.
`
` Q. Was any of your work while at
`
`Chiroscience from 1993 to 1996 related to
`
`glatiramer acetate?
`
` A. No.
`
` Q. So your next position from 1996 to
`
`present, director of Cambridge BioConsultants,
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`Limited; is that right?
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` A. Correct.
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` Q. What is your role at Cambridge
`
`BioConsultants?
`
` A. Well, I'm the owner of the company,
`
`and I'm the sole consultant within the company.
`
` Q. Do you have other employees?
`
` A. No.
`
` Q. Excluding your work on these IPRs,
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`was any of your work at Cambridge
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`BioConsultants related to the study of
`
`compounds that might be used to treat MS?
`
` A. Again, I've looked at a whole host
`
`of different drugs with different mechanisms of
`
`action on behalf of clients. I can't recall if
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`multiple sclerosis was an area that I was asked
`
`to consider.
`
` Q. Excluding your work on this case,
`
`was any of your work at Cambridge
`
`BioConsultants related to glatiramer acetate?
`
` A. No.
`
` Q. From '98 to 2007, you were the
`
`director of Arachnova, Limited?
`
` A. Arachnova, Limited.
`
` Q. Arachnova, Limited.
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`Page 18
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` I s t h a t r i g h t ?
`
` A . Y e s .
`
` Q . W h a t w a s y o u r r o l e a t t h a t c o m p a n y ?
`
` A . I w a s R & D d i r e c t o r . I w a s c o f o u n d e r
`
`o f t h e c o m p a n y a n d R & D d i r e c t o r .
`
` Q . W a s a n y o f y o u r w o r k a t A r a c h n o v a
`
`f r o m 1 9 9 8 t o 2 0 0 7 r e l a t e d t o t h e s t u d y o f
`
`c o m p o u n d s t h a t m i g h t b e u s e d t o t r e a t M S ?
`
` A . G o i n g w i t h i n t h a t c o m p a n y , w e l o o k e d
`
`a t a w h o l e r a n g e o f d r u g s a t d i f f e r e n t
`
`m e c h a n i s m s o f a c t i o n . B u t I c a n ' t r e c a l l t h a t
`
`a n y o f t h o s e r e l a t e d d i r e c t l y t o m u l t i p l e
`
`s c l e r o s i s .
`
` Q . W a s a n y o f y o u r w o r k f r o m 1 9 9 8 t o
`
`2 0 0 7 a t A r a c h n o v a r e l a t e d t o g l a t i r a m e r
`
`a c e t a t e ?
`
` A . N o .
`
` Q . F r o m 2 0 0 0 t o 2 0 0 7 , y o u w e r e t h e
`
`d i r e c t o r a n d C S O o f A r a c h n o v a ; i s t h a t r i g h t ?
`
` A . C o r r e c t .
`
` Q . C S O , c h i e f s c i e n t i f i c o f f i c e r ?
`
` A . Y e s .
`
` Q . W h a t w a s y o u r r o l e a t t h a t c o m p a n y ?
`
` A . M y r o l e w i t h t h a t c o m p a n y w a s t o
`
`p a r t i c i p a t e i n t h e d e v e l o p m e n t o f c l i n i c a l
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`projects with an aim of getting those through
`
`to either out license or through to
`
`registration.
`
` Q. Was any of your work from 2000 to
`
`2007 at Arachnova related to the study of
`
`compounds that might be used to treat MS?
`
` A. Again, make the point we looked at
`
`drugs, different mechanisms. And it's possible
`
`those mechanisms might have had a use in
`
`multiple sclerosis, but the object of the
`
`developments were not related to multiple
`
`sclerosis?
`
` Q. 2000 to 2007 at Arachnova, was any
`
`of your work related to glatiramer acetate?
`
` A. No.
`
` Q. Turn now to Page 3 of your CV.
`
` A. Okay.
`
` Q. From 2000 to the present you were
`
`the CSO of Acacia Pharma PLC; is that right?
`
` A. I still am, yes.
`
` Q. What is your role at Acacia Pharma?
`
` A. As chief scientific officer, my role
`
`was to discover new projects and to participate
`
`in the preclinical aspects of development of
`
`those projects.
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`YEDA EXHIBIT NO. 2145
`MYLAN PHARM. v YEDA
`IPR2015-00644
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` Q. Is any of your work at Acacia Pharma
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`related to the study of compounds that might be
`
`Page 20
`
`used to treat MS?
`
` A. No.
`
` Q. Is any of your work at Acacia Pharma
`
`related to the study of glatiramer acetate?
`
` A. No.
`
` Q. I want to ask you about your
`
`publications that start on Page 3 of your CV
`
`and extend to Page 6 and get No. 37.
`
` So these will be your full papers
`
`and reviews; is that right?
`
` A. Yes.
`
` Q. Do any of those papers relate to the
`
`study of compounds that might be used to treat
`
`MS?
`
` MR. JAMES: Objection to the form.
`
` THE WITNESS: Can you repeat the
`
`question, please.
`
` BY MR. WHITE:
`
` Q. Absolutely.
`
` Do any of the full papers and
`
`reviews that are listed in your CV, starting on
`
`Page 3 and ending on Page 6 of Item 37 relate
`
`to the study of compounds that might be used to
`
`Veritext Legal Solutions
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`YEDA EXHIBIT NO. 2145
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`treat MS?
`
` A. Going to make the point --
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` MR. JAMES: Same objection.
`
` Just pause and give me a chance to
`
`object.
`
` THE WITNESS: I make the point
`
`there's a number of drugs that were involved in
`
`my publications. And you say might be used for
`
`any treatment of MS. I mean that's a --
`
` BY MR. WHITE:
`
` Q. Well, let me ask you a different
`
`question.
`
` Were any of the full papers and
`
`reviews listed in your CV starting on Page 3
`
`and then going to Page 6, Item 37, specifically
`
`-- were any of those papers directed
`
`specifically to a compound known to treat MS?
`
` A. No.
`
` Q. Were any of those papers -- full
`
`papers and reviews related to glatiramer
`
`acetate?
`
` A. No.
`
` Q. Was multiple sclerosis the focus of
`
`any of the papers -- or the full papers and
`
`reviews listed in your CV?
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`YEDA EXHIBIT NO. 2145
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` A . N o , t h e y w e r e n o t .
`
` Q . N o w I w a n t t o t u r n t o P a g e 6 . A n d
`
`I ' l l a s k y o u t h e s a m e s e r i e s o f q u e s t i o n s w i t h
`
`r e s p e c t t o t h e a b s t r a c t s t h a t s t a r t o n P a g e 6 ,
`
`I t e m 1 , a n d g o t h r o u g h P a g e 1 2 , I t e m 7 4 .
`
` W e r e a n y o f t h o s e a b s t r a c t s - - w a s
`
`t h e f o c u s o f a n y o f t h e a b s t r a c t s l i s t e d i n
`
`y o u r C V f o r t h e t r e a t m e n t o f M S ?
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` A . N o .
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` Q . W e r e a n y o f t h e a b s t r a c t s l i s t e d i n
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`y o u r C V r e l a t e d t o g l a t i r a m e r a c e t a t e ?
`
` A . N o .
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` Q . I f y o u c o u l d t u r n t o P a g e 1 2 o f y o u r
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`C V .
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` D o y o u s e e t h e h e a d i n g " I n v i t e d
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`L e c t u r e s " ?
`
` A . Y e s .
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` Q . A r e a n y o f t h e s e l e c t u r e s - - a n y o f
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`t h e s e i n v i t e d l e c t u r e s d i r e c t e d t o M S ?
`
` A . N o .
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` Q . W e r e a n y o f t h e s e i n v i t e d l e c t u r e s
`
`d i r e c t e d t o g l a t i r a m e r a c e t a t e ?
`
` A . N o .
`
` Q . A n d i n t h e " I n v i t e d L e c t u r e s "
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`h e a d i n g , y o u s t a t e " t h e s e i n c l u d e . "
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`Veritext Legal Solutions
`215-241-1000 ~ 610-434-8588 ~ 302-571-0510 ~ 202-803-8830
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`MYLAN PHARM. v YEDA
`IPR2015-00644
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` Are there other lectures that you
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`have been invited to that might not be listed?
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` A. These are ones I recall. If I can't
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`recall, then nothing else.
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` Q. Do you recall any lectures that you
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`have been invited to that related to the
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`treatment of MS or glatiramer acetate?
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` A. No.
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` Q. Still on Page 12 of your CV, the
`
`heading "Book Chapters," that extends just to
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`the first line of Page 13.
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` Do any of those book chapters relate
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`to glatiramer acetate?
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` A. I'm looking at the first item, which
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`is the role of histamine in the cardiovascular
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`system and acute inflammatory responses. And I
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`just say the relationship there between GI
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`injection site reactions and the involvement of
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`histamine. So there's a potential link there.
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` Q. So this is Item 1 under "Book
`
`Chapters"?
`
` A. Yes.
`
` Q. Was that chapter specific to
`
`glatiramer acetate?
`
` A. No.
`
`Veritext Legal Solutions
`215-241-1000 ~ 610-434-8588 ~ 302-571-0510 ~ 202-803-8830
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`Page 23 of 138
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`YEDA EXHIBIT NO. 2145
`MYLAN PHARM. v YEDA
`IPR2015-00644
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` Q. Were any of your book chapters
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`related or directed to the study of MS?
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` A. No.
`
` Q. Page 13 of your CV, please. You
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`have one book listed under the heading "Books."
`
` Was that book related to the study
`
`of MS?
`
` A. That book actually reviewed a
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`number -- 121 products that were developed and
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`approved. And I can't recall whether -- within
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`that 121 products, there might have been, but
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`I -- I can't recall one.
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` Q. What type of information was
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`presented in that book?
`
` A. It's quite a thick book. And it
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`really had times for development of projects
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`and times to approve listed by therapeutic
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`classes. I can't recall whether MS was
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`included in that.
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` Q. And then finally, Page 13 of your CV
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`under the heading "Ph.D. Theses Examined," you
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`list three theses there.
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` Were any of those theses directed to
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`glatiramer acetate?
`
` A. No.
`
`Veritext Legal Solutions
`215-241-1000 ~ 610-434-8588 ~ 302-571-0510 ~ 202-803-8830
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`Page 24 of 138
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`YEDA EXHIBIT NO. 2145
`MYLAN PHARM. v YEDA
`IPR2015-00644
`
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`Page 25
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`the treatment of MS?
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` A. No.
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` Q. Prior to your work on this case, had
`
`you had any experience with glatiramer acetate?
`
` A. No.
`
` Q. Prior to your work on this case, had
`
`you had any experience with drugs specifically
`
`directed to the trea