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
`
`Dr. Reddy's Laboratories, Ltd., et al.
`v.
`Helsinn Healthcare S.A., et al.
`U.S. Patent No. 8,729,094
`Un i ted States Di st1
`ReddyExhibit1032
`Tr ent on , New J bc:....,.....,
`L:::>..,..,, e...,..~ y~----=--------____J
`
`
`
`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
`
`Dr. Reddy's Laboratories, Ltd., et al.
`v.
`Helsinn Healthcare S.A., et al.
`U.S. Patent No. 8,729,094
`Un i ted States Di st1
`ReddyExhibit1032
`Tr ent on , New J bc:....,.....,
`L:::>..,..,, e...,..~ y~----=--------____J
`
`
`
`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. 1032
`
`
`
`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. 1032
`
`
`
`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. 1032
`
`
`
`108
`r------------------------Candiotti - Di rect -----------------------,
`
`1
`they reflected here, some of the exemplary sizes at this time?
`2 A . Right .
`
`So , like I said, this would have been the size of
`
`3 Kytril -- excuse me
`4
`
`THE COURT :
`
`granisetron .
`
`1 milliliter .
`
`5
`THE WITNESS :
`1 milliliter . This would have been
`6 ondansetron , is actually the ondansetron vial , 2 milliliters .
`7 And while this is Aloxi®, dolasetron i s no longer availabl e in
`
`8
`
`the U. S .
`
`9
`This is -- would be representative of the size .
`10 Actually, it was even a slightly smaller bottle than this, so
`
`11 you can see the size that we tend to cluster to clinically
`12 what we use .
`13
`14 bottle, the 5- milliliter bottle,
`
`THE COURT : And you were just holding up the Aloxi®
`
`r ight?
`
`15
`
`16
`
`17
`
`18
`
`19
`20
`
`THE WITNESS : Yes , as a representative .
`
`The dolasetron bottle was actually slightly smaller
`
`than the Aloxi® bottle .
`
`THE COURT : But it contai ned 5 milliliters?
`
`THE WITNESS : Yes, your Honor .
`
`THE COURT : Okay .
`
`21 BY MR . DITTMANN :
`22 Q . And j u st so the record is clear, the 1- milliliter vial is
`23 PDX-415 . The 2-mi11iliter bottle is PDX-416, and the
`24 5- milliliter vial is PDX- 417 .
`25
`
`Doctor , these volume sizes we ' re seeing here on
`
`United States District Court
`Trenton , New Jersev
`
`Exh. 1032
`
`
`
`109
`r--------------------------Candiotti - Di rect -------------------------,
`
`1
`
`PDX-413 , are they consistent with your opinion as to the
`
`2 volumes that a POSA would have preferred to the extent they
`
`3 were pursuing a palonosetron product in the 2003 time period?
`4 A .
`
`I think this is reflective of what was clinically
`
`Yes .
`
`5 available, what we clinically preferred, and if you were to
`6 bring another agent of this type to the market , there would be
`7 no reason that you wouldn ' t want to make it approximately the
`
`8
`
`same size .
`
`9 Q.
`10
`
`Please turn --
`
`THE COURT : So , are these what the market wants in
`
`11
`the way of volume of at least the setron drugs, as far as you
`12 can tell what a POSA would be thinking?
`13
`14 They haven ' t really changed the injection, the single vial
`
`THE WITNESS : Yes , and these are proven over time .
`
`15 bolus injection sizes .
`
`16
`
`As far back as I recall ondansetron has looked ,
`
`17 basically, just like this . So , there ' s a reason for it . As I
`
`18 said, especially anesthesiologists, we don ' t like infusions or
`
`19 drips for the most part . We prefer bolus injection, single
`20 draw . That ' s easy . This is easy .
`21
`
`100 ccs , you ' d have to stick multiple times into the
`
`22 bottle, and -- if you were going to inject it . You ' d have to
`
`23 fill maybe a 20-cc syringe five times to do it .
`24
`25
`
`too , right?
`
`THE COURT : And your time is valuable in the O. R . ,
`
`United States District Court
`Trenton , New Jersev
`
`Exh. 1032
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