1
`
`2
`
`3
`
`UNITED STATES DI STRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`1
`
`4 HELSINN HEALTHCARE , S . A. and
`ROCHE PALO ALTO , LLC ,
`
`5
`
`6
`
`Plaintiffs ,
`
`- vs-
`
`CIVIL ACTION NUMBER :
`
`11- 3962
`
`TRIAL
`
`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 .
`
`11
`Clarkson S . Fisher United States Courthouse
`12
`402 East State Street
`Trenton , New Jersey 08608
`13
`June 10 , 2015
`14 BE F 0 R E:
`
`THE HONORABLE MARY L . COOPER
`UNI TED STATES DISTRICT JUDGE
`
`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
`25
`
`/S/ Regi na A. Berenato- 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
`
`U n i ted s t a t e s Dis (J..._ _ __ _ R_e_d....:dy:__Ex_h_ib_it_1_0_4_7 ___ ____.
`Trenton , New Jersey
`
`
`
`2
`
`3
`
`UNITED STATES DI STRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`1
`
`4 HELSINN HEALTHCARE , S . A. and
`ROCHE PALO ALTO , LLC ,
`
`5
`
`6
`
`Plaintiffs ,
`
`- vs-
`
`CIVIL ACTION NUMBER :
`
`11- 3962
`
`TRIAL
`
`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 .
`
`11
`Clarkson S . Fisher United States Courthouse
`12
`402 East State Street
`Trenton , New Jersey 08608
`13
`June 10 , 2015
`14 BE F 0 R E:
`
`THE HONORABLE MARY L . COOPER
`UNI TED STATES DISTRICT JUDGE
`
`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
`25
`
`/S/ Regi na A. Berenato- 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
`
`U n i ted s t a t e s Dis (J..._ _ __ _ R_e_d....:dy:__Ex_h_ib_it_1_0_4_7 ___ ____.
`Trenton , New 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. 1047
`
`
`
`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. 1047
`
`
`
`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. 1047
`
`
`
`141
`.----------------Candiot ti - eros s --------------.
`
`1 earlier , but I asked you whether in your own work outside of
`
`2
`
`thi s case you had relied on the BSA met hod to estimate human
`
`3 doses from animal data .
`4
`
`Do you recall that?
`
`You did ask me that .
`
`5 A.
`6 Q .
`7 your mouth , but I think you told me that you had never done
`
`And I think , and , again ,
`
`I don ' t want t o put words in
`
`8
`
`that .
`
`I had never done that .
`
`9 A.
`10 Q .
`11 enti tled " Diabeti c Neuropathic Pain Development i n Type II
`
`All right . Now , do you recall wri t i ng an article
`
`12 Diabetic Mouse Model And the Prophylactic and Therapeutic
`13 Effects of Co-Enzyme QlO " ?
`
`14 A .
`
`Yes .
`
`MS . HUTTNER : Okay . And i f we can have Candiotti ,
`
`I guess ,
`
`I ' m sorry, it ' s Demo 8 .
`
`15
`16
`17 BY MS. HUTTNER :
`
`I ' m sorry, Demo 7 .
`
`18 Q.
`
`19 A .
`20 Q .
`
`This is the -- the cover page o f that article, correct?
`
`It is .
`
`And your name i s highli ghted t here , and there ' s no
`
`21 question that ' s you , righ t?
`
`22 A .
`I am the senior author on that paper .
`23 Q . Okay . And if we can take a look at the next demo , which
`24
`25
`
`And , by the way , this was an article you published in
`
`i s taken from Page 170 of this art i cle .
`
`United States District Court
`Trenton , New Jersev
`
`Exh. 1047
`
`
`
`.-----------------Candi ott i
`
`142
`- Cross ----------------,
`
`1 2013 in the Journal of Neurobiology of Disease , right?
`
`2 A .
`
`That is correct .
`
`And on Page 170 , carrying over to Page 171 , which I ' ve
`
`3 Q .
`4 put up here on Demo 9, you wrote , " CoQ10 was dissolved in
`
`5 olive oil to produce concentrations of :
`30 milligrams per
`6 milliliter for the 100 - milligram- per- kilogram dose and
`7 60 milligrams per milliliter for the
`
`8
`
`200- milligram- per- kilogram dose , correct?
`
`9 A. That is correct .
`10 Q .
`
`And you then went on to say , " These doses " -- and just
`
`11
`for context , in this study you were giving doses of co-enzyme
`12 Q 10 to male mice , right?
`13 A .
`
`I don ' t remember if it was male mice or not.
`
`14 Q . Well , whether they were male or female , they were mice ,
`
`15
`
`r i ght?
`
`16 A .
`To mice .
`17 Q . Okay . And you gone on , on Page 170 to 171 , to say,
`
`18
`
`" These doses represent the equival ent human doses of
`
`19 8 milligrams per kilogram and 16 mi l ligrams per kilogram,
`
`20 respectively , based on body surface area ," and you cite to an
`21 article by Reagan-Shaw from 2008 , correct?
`
`22 A .
`
`That ' s what it says ; however ,
`
`I ' m not the first author .
`
`I didn ' t do it .
`
`23
`24 Q .
`
`I ' m sorry, didn ' t you say that you were the senior
`
`25 author? Did I mishear you?
`
`United States District Court
`Trenton , New Jersev
`
`Exh. 1047
`
`
`
`.-----------------Candi ott i
`
`143
`- Cross ----------------,
`
`1 A. Yes, I ' m the senior author , but Dr . Zhang did this .
`
`2 Q .
`
`You ' re saying -- you didn ' t approve of that , is that what
`
`3
`you ' re saying?
`4 A .
`
`No,
`
`I reviewed it .
`
`I read it .
`
`I ' ve d i scu ssed the model ,
`
`5
`the process , but I didn ' t do the BSA calculations . Dr . Zhang
`6 did .
`7 very good at t his .
`
`She ' s a Ph . D. and does a lot of animal work, and she ' s
`
`8
`
`And to be honest with you ,
`
`I had no reason to question
`
`9
`it , and I ' ve never -- I believe your question was have I ever
`10 used the BSA method to cal culate from an animal to a human ,
`
`11 and t h e answer i s no, I have never done that.
`12 Q .
`13 A .
`
`But your name --
`
`Dr . Zhang did .
`
`14 Q .
`
`Sorry . Your name is nonetheless attached to an article
`
`15 where it was done ; you would agree with that .
`16 A.
`17 this .
`
`Oh, that ' s true , but I ' ll be honest with you ,
`
`I don ' t know how to do this off the top of my head, but
`
`I didn ' t do
`
`18 when my Ph.D., Dr . Zhang, works f or me directly, comes to me
`
`19 and says Dr . Candiotti ,
`20
`
`the conversion numbers, I say thank you .
`
`I ' ve done the calcul ations . This is
`
`21 Q. Okay . And you understood when you reviewed this article
`
`22
`
`that the BSA method, that the body surface area method that
`
`23 she ' s referring to there is the same body surface area method
`24
`that Dr . Frame testified about ,
`25 A .
`
`That would be my understanding .
`
`r ight?
`
`United States District Court
`Trenton , New Jersev
`
`Exh. 1047
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