1
`
`2
`
`3
`
`UNI TED STATES DI STRICT COURT
`FOR THE DISTRI CT OF NEW JERSEY
`
`1
`
`4 HELSINN HEALTHCARE , S . A. a nd
`ROCHE PALO ALTO , LLC ,
`
`CIVIL ACTION NUMBER:
`
`11- 3962
`
`TRIAL
`
`5
`
`6
`
`Plain t i ffs ,
`
`- vs-
`
`7
`DR . RE DDY ' S LABORATORIES , LTD.,
`8 DR . RE DDY' S LABORATORIES ,
`I NC .,
`TEVA PHARMACEUTI CALS USA,
`I NC .,
`9 and TEVA PHARMACEUTICAL
`I NDUSTRI ES , LTD .
`10
`
`Defendants .
`
`11
`Clarkson S . Fis he r United States Courtho u se
`12
`402 East St a t e Street
`Tren ton, New Jer sey 08608
`13
`June 10 , 2015
`14 BE F 0 R E:
`15
`16
`17
`18
`19
`20
`21
`22
`23 Certi f i e d as True and Correct a s requi r ed b y Ti t l e 28 , U. S . C. ,
`Secti o n 753
`24
`25
`
`THE HONORABLE MARY L . COOPER
`UNI TED STATES DISTRI CT J UDGE
`
`/S/ Re g i na A. Berenat o - Tell , CCR, CRR, RMR, RPR
`/S/ Carol Farrell, CCR, CRR, RMR, CI'P RPR R~A
`Dr. Reddy's Laboratories, Ltd., et al.
`v.
`Helsinn Healthcare S.A., et al.
`U.S. Patent No. 8,729,094
`Reddy Exhibit 1029
`..L..__-.,.--.._ .,...'-'-r. 'v-rurT:""T"""T
`.L<.-' - - - - - - - - - - - - '
`
`. t d St t
`D .
`~ s 1'--r.L--r-r
`n ~ e
`a e s
`U
`
`Tr enton , Ne w Jersey
`
`
`
`
`
`2
`
`3
`
`UNI TED STATES DI STRICT COURT
`FOR THE DISTRI CT OF NEW JERSEY
`
`1
`
`4 HELSINN HEALTHCARE , S . A. a nd
`ROCHE PALO ALTO , LLC ,
`
`CIVIL ACTION NUMBER:
`
`11- 3962
`
`TRIAL
`
`5
`
`6
`
`Plain t i ffs ,
`
`- vs-
`
`7
`DR . RE DDY ' S LABORATORIES , LTD.,
`8 DR . RE DDY' S LABORATORIES ,
`I NC .,
`TEVA PHARMACEUTI CALS USA,
`I NC .,
`9 and TEVA PHARMACEUTICAL
`I NDUSTRI ES , LTD .
`10
`
`Defendants .
`
`11
`Clarkson S . Fis he r United States Courtho u se
`12
`402 East St a t e Street
`Tren ton, New Jer sey 08608
`13
`June 10 , 2015
`14 BE F 0 R E:
`15
`16
`17
`18
`19
`20
`21
`22
`23 Certi f i e d as True and Correct a s requi r ed b y Ti t l e 28 , U. S . C. ,
`Secti o n 753
`24
`25
`
`THE HONORABLE MARY L . COOPER
`UNI TED STATES DISTRI CT J UDGE
`
`/S/ Re g i na A. Berenat o - Tell , CCR, CRR, RMR, RPR
`/S/ Carol Farrell, CCR, CRR, RMR, CI'P RPR R~A
`Dr. Reddy's Laboratories, Ltd., et al.
`v.
`Helsinn Healthcare S.A., et al.
`U.S. Patent No. 8,729,094
`Reddy Exhibit 1029
`..L..__-.,.--.._ .,...'-'-r. 'v-rurT:""T"""T
`.L<.-' - - - - - - - - - - - - '
`
`. t d St t
`D .
`~ s 1'--r.L--r-r
`n ~ e
`a e s
`U
`
`Tr enton , Ne w Jersey
`
`
`
`
`
`1
`
`2
`
`3
`
`UNI TED STATES DI STRICT COURT
`FOR THE DISTRI CT OF NEW JERSEY
`
`1
`
`4 HELSINN HEALTHCARE , S . A. a nd
`ROCHE PALO ALTO , LLC ,
`
`CIVIL ACTION NUMBER:
`
`11- 3962
`
`TRIAL
`
`5
`
`6
`
`Plain t i ffs ,
`
`- vs-
`
`7
`DR . REDDY ' S LABORATORIES , LTD.,
`8 DR . RE DDY' S LABORATORIES ,
`INC . ,
`TEVA PHARMACEUTI CALS USA,
`I NC . ,
`9 and TEVA PHARMACEUTICAL
`I NDUSTRI ES , LTD .
`10
`
`Defendants .
`
`THE HONORABLE MARY L . COOPER
`UNI TED STATES DISTRI CT J UDGE
`
`11
`Clar kson S . Fis he r United St ates Courtho u se
`12
`402 East Stat e Street
`Tren ton, New Jer sey 08608
`13
`June 10 , 2015
`14 BE F 0 R E :
`15
`16
`17
`18
`19
`20
`21
`22
`23 Certi f i ed as True and Correct as requi r ed b y Ti t l e 28 , U. S . C. ,
`Secti o n 753
`24
`2 5
`
`/S/ Re g i na A. Berenat o - Tell , CCR, CRR, RMR, RPR
`/S/ Carol Farrell, CCR, CRR, RMR, CCP , RPR, RSA
`
`Un i ted States Di stri ct Court
`Tr enton , New Jersev
`
`Exh. 1029
`
`
`
`A P P E A RAN C E S:
`
`2
`
`1
`
`2
`
`PAUL HASTINGS
`3 BY :
`JOSEPH O' MALLEY, ESQUIRE
`ERIC W. DITTMANN, ESQUIRE
`4
`ANGELA NI , ESQUIRE
`SAUL EWING
`5 BY : CHARLES M. LIZZA, ESQUIRE
`Attorneys for t h e Plaintiffs
`
`6
`7 BUDD LARNER
`BY :
`STUART D. SENDER, ESQUIRE
`MICHAEL H.
`IMBACUAN, ESQUI RE
`HUA HOWARD WANG , ESQUIRE
`CONSTANCE S . HUTTNER, ESQUIRE
`KENNETH E . CROWELL , ESQUIRE
`ANDREW ALLEN, ESQUIRE
`Attorneys for the Defendant , Dr . Reddy ' s Laboratories
`
`8
`
`9
`10
`11
`WINSTON & STRAWN
`12 BY :
`JOVIAL WONG , ESQUIRE
`GEORGE LOMBARDI, ESQUIRE
`13
`JULIA MANO JOHNSON, ESQUIRE
`BRENDAN F . BARKER, ESQUIRE
`14 LI TE DePALMA, GREENBERG , LLC
`BY : MAYRA V. TARANTINO , ESQUIRE
`15 Attorneys for the Defendant, Teva
`16
`17
`
`18
`
`19
`20
`21
`22
`23
`24
`25
`
`United States Di stri ct Court
`Trenton , New Jersev
`
`Exh. 1029
`
`
`
`3
`
`I N D E X
`
`266
`
`111
`
`276
`
`1
`2
`3
`4
`5
`6
`
`WITNESS
`
`4
`
`14
`
`VOIR DIRECT CROSS REDIRECT RECROSS
`DIRE
`KEITH CANDIOTTI
`7 By Mr. Dittman
`By Ms. Huttner
`8
`9
`10
`11
`12
`13
`14
`15
`16
`1 7
`18
`19
`20
`2 1
`2 2
`23
`24
`2 5
`
`United States District Court
`Trenton , New Jersev
`
`Exh. 1029
`
`
`
`82
`r------------------------Candiotti - Di rect -----------------------,
`
`1 BY MR . DITTMANN :
`
`2 Q .
`
`And just to finish and we ' ll move on from this section,
`
`3 do you have an opinion as to whether a POSA i n 2003 would have
`4 pursued a dose that treated all PONV patients as opposed to
`
`just certain subpopulation groups?
`
`5
`6 A .
`7 cover as many people as reasonabl y -- a dose that would cover
`
`So , as I was making clear, you ' d pick a drug that would
`
`8 as many people as reasonably poss i ble .
`
`It would be very
`
`9 difficult to clinically utilize a drug that was keyed only to
`10 certain subpopulations .
`11 Q .
`
`Thank you .
`
`So , Doctor , we have been talking so far about a PONV
`
`12
`13 dose .
`14 produ ct to treat CINV, do you have any opini on as to the dose
`
`If a POSA was focused on developing a palonosetron drug
`
`15
`
`they would have pursued?
`
`16 A .
`
`So , even during this time period , it was known that
`
`17 CINV -- chemotherapy is a major toxi n , and the doses are
`
`18 a l most always o r basically always h i gher , and anywhere from a
`
`19 multiple o f 2 to 10 perhaps , so if 2 milligrams , using that
`
`20 dose , is necessary to treat a 70 - k i logram person , in
`
`21 chemotherapy, you would use multipl es of that , be it 4 up to
`
`22 20 milligrams , as it were . That would be a reasonable
`
`23 assumption , consistent with the other known setrons at the
`
`t i me .
`
`24
`25
`
`THE COURT : Your answer assumed that the 2 milligrams
`
`United States District Court
`Trenton , New Jersev
`
`Exh. 1029
`
`
`
`83
`r------------------------Candiotti - Di rect -----------------------,
`
`1 was being used for the PONV situation?
`
`2
`
`THE WITNESS : At the minimum .
`
`So , based on Tang, if
`
`3 we assume 2 milligrams or more for PONV, CINV is going to be
`4
`
`even higher , at least equal or higher , at least 2 milligrams
`
`5 or a multiple thereof, and I would expect a multiple, based on
`6 all the other setrons of the day .
`7 BY MR. DITTMANN :
`
`8 Q . Dr . Candiotti , did you hear Dr . Frame testify on Monday
`
`that the CINV dose would have been understood in 2003 to be
`
`9
`10
`roughly 2 to 10 times higher than the PONV dose?
`11 A .
`12 Q .
`13 A .
`14 effective, typically, the CINV dose is , again, anywhere from 2
`
`I did hear him say that, yes, sir.
`
`Do you agree with Dr . Frame on this point?
`
`I do agree that if you find your PONV dose that ' s
`
`to 10 times higher .
`
`15
`16 Q .
`
`Can we please bring up PTX-099. Can you tell us what
`
`17 this is , Doctor?
`18 A. This is an article by Dr . Alon on the use of tropisetron.
`19 Q. And if we can look at the bottom, do we have a date for
`20
`this article?
`21 A.
`22 Q.
`23 of the
`24
`25 BY MR. DITTMANN :
`
`Published in A and A in 1998 .
`
`Can we please turn to Page 6 of the document, at the end
`
`THE COURT : Have we heard about tropisetron?
`
`United States District Court
`Trenton , New Jersev
`
`Exh. 1029
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