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 8 , 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 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 - Te l l , 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 s t a t e s Di s t .~..--~-~~R-ed_d....:y_E_x_h_ib_it_1_0_3o ____ ___.
`Tr enton , New 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 . 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 8 , 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 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 - Te l l , 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 s t a t e s Di s t .~..--~-~~R-ed_d....:y_E_x_h_ib_it_1_0_3o ____ ___.
`Tr enton , New Jersey
`
`
`
`1
`
`2
`
`3
`
`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`1
`
`4 HELSINN HEALTHCARE , S . A. and
`ROCHE PALO ALTO , LLC ,
`
`CIVIL ACTION NUMBER :
`
`11- 3962
`
`TRIAL
`
`5
`
`6
`
`Plaintiffs ,
`
`- vs-
`
`7
`DR . REDDY ' S LABORATORIES , LTD .,
`8 DR . REDDY ' S LABORATORIES ,
`INC . ,
`TEVA PHARMACEUTICALS USA,
`I NC . ,
`9 and TEVA PHARMACEUTICAL
`INDUSTRIES , LTD .
`10
`
`Defendants .
`
`THE HONORABLE MARY L . COOPER
`UNI TED STATES DISTRICT JUDGE
`
`11
`Clarkson S . Fisher United States Courthouse
`12
`402 East State Street
`Trenton , New Jersey 08608
`13
`June 8 , 20 1 5
`14 BE F 0 R E :
`15
`16
`17
`18
`19
`20
`21
`22
`23 Certified as True and Correct as required by Titl e 28 , U. S . C.,
`Section 753
`24
`2 5
`
`/S/ Regina A. Berenato- Tell, CCR, CRR, RMR, RPR
`/S/ Carol Farrell, CCR, CRR, RMR, CCP, RPR, RSA
`
`United States District Court
`Trenton , New Jersev
`
`Exh. 1030
`
`
`
`A P P E A RAN C E S:
`
`2
`
`1
`
`2
`
`8
`
`PAUL HASTINGS
`3 BY :
`JOSEPH O' MALLEY , ESQUIRE
`ERIC W. DITTMANN , ESQUIRE
`4
`ISAAC S . ASHKENAZI , ESQUIRE
`SAUL EWING
`5 BY : CHARLES M. LIZZA, ESQUIRE
`Attorneys for the Plaintiffs
`6
`7 BUDD LARNER
`BY :
`STUART D. SENDER, ESQUIRE
`MICHAEL H.
`IMBACUAN, ESQUI RE
`HUA HOWARD WANG , ESQUIRE
`9
`CONSTANCE S . HUTTNER, ESQUIRE
`KENNETH E . CROWELL , ESQUIRE
`10 Attorneys for the Defendant , Dr . Reddy ' s Laboratories
`11 WINSTON & STRAWN
`BY :
`JOVIAL WONG , ESQUIRE
`GEORGE LOMBARDI , ESQUIRE
`JULIA MANO JOHNSON, ESQUI RE
`BRENDAN F . BARKER, ESQUIRE
`LITE DePALMA, GREENBERG , LLC
`BY : MAYRA V. TARANTINO , ESQUIRE
`Attorneys for the Defendant, Teva
`
`12
`13
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`20
`21
`
`22
`
`23
`24
`25
`
`United States District Court
`Trenton , New Jersev
`
`Exh. 1030
`
`
`
`3
`~--------------------------Colloquy --------------------------~
`
`I N D E X
`
`1
`
`2
`
`3
`
`4
`
`VOIR DIRECT
`DIRE
`
`CROSS REDIRECT RECROSS
`
`David G. Frame
`By Mr . Imbacuan
`By Mr. Ashkenazi
`
`5 WITNESS
`6
`
`7
`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. 1030
`
`
`
`107
`r---------------------------Frame - D i rect --------------------------~
`
`1
`It was just inverted .
`same curve .
`2 Q. Maybe we could look at those .
`3 A.
`4
`
`THE COURT :
`
`I remember .
`
`Sure .
`
`5
`
`MR .
`
`IMBACUAN : Okay .
`
`6 BY MR .
`
`IMBACUAN :
`
`7 Q .
`
`8 A .
`9 Q.
`10
`11
`
`Dr . Frame , Chelly is a study using oral pal onosetron ?
`
`That ' s correct .
`
`How does the -- the results in Chelly
`
`THE COURT : Wasn ' t that a PONV?
`
`THE WI TNESS : That was PONV, yes .
`
`12
`13 BY MR .
`
`MR .
`
`I MBACUAN : Yes .
`
`IMBACUAN :
`
`14 Q .
`
`How did the resu lts in Chel l y relate to I . V.
`
`15 administration of palonosetron?
`16 A.
`17 okay? And the reason for that is ,
`
`So , an I . V . dose will never be more than an oral dose ,
`
`i s if I g i ve you a pill ,
`
`18
`
`r i ght , the pill has to get absorbed . So some pil l s don ' t get
`
`19 a hundred percent absorbed, right? Some get 20 percent
`20 absorbed , some get 50 percent absorbed, right? But , by
`
`2 1 definition , when I give you an I . V. injection, the whole
`
`2 2
`
`amount of the drug goes d i rectly i nto your -- into your blood,
`
`23
`r i ght? So if I give you a pill and let ' s say it ' s only 50
`24 percent absorbed , your I . V. dose , your equi valent I . V. dose
`2 5 would be half of your oral dose .
`
`If the oral dose got fully
`
`United States District Court
`Trenton , New Jersev
`
`Exh. 1030
`
`
`
`108
`r---------------------------Frame - D i rect --------------------------~
`
`1 absorbed , 100 percent absorbed, then your I . V. dose would be
`
`2
`
`3
`
`4
`
`the same as your oral dose .
`
`Is that clear?
`
`THE COURT : All of that i s clear .
`
`THE WITNESS :
`
`So an I . V.
`
`5
`THE COURT : So , in fact , the real dosage that you ' re
`6 getting from an I . V. is never higher than
`
`7
`
`8
`
`right?
`
`9
`10
`11 BY MR .
`
`THE WI TNESS :
`
`-- than the oral .
`
`THE COURT : You put the same dosage into a pill,
`
`THE WITNESS : Correct .
`
`IMBACUAN :
`
`So , based on the fact in Chelly that the
`
`12 Q .
`13 1-microgram-per-kilogram dose was effective in an oral
`14 an oral dose of pal onosetron , how would that relate to an I . V.
`
`in
`
`15 dose?
`
`16 A . Right .
`
`So your I . V. dose would not be more than
`
`17 1 microgram per kilogram or approxi mately 0 . 07 milligrams .
`
`18 Okay? It could be less , right? Because we -- I don ' t have on
`
`19 here what the absorption of palonosetron is , so it could be
`20
`
`less than that if palonosetron di dn ' t get fully absorbed .
`
`21 Most of the HT 3 antagonists have between 50 and 80 percent
`22 absorption .
`
`So
`
`23 Q .
`24
`25
`
`THE COURT :
`
`If used orally .
`
`THE WITNESS : Yes .
`
`United States District Court
`Trenton , New Jersev
`
`Exh. 1030
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