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 ,
`
`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 .
`
`11
`Clarkson S . Fisher United States Courthouse
`12
`402 East State Street
`Trenton , New Jersey 08608
`13
`June 5 , 2015
`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
`25
`
`THE HONORABLE MARY L . COOPER
`UNI TED STATES DISTRICT JUDGE
`
`/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
`Un i ted S t a t e s Dis t._ ____ R_e_d_d.;;_y _E_xh_i_bi_t _1 o_2_s ____ _.
`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 ,
`
`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 .
`
`11
`Clarkson S . Fisher United States Courthouse
`12
`402 East State Street
`Trenton , New Jersey 08608
`13
`June 5 , 2015
`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
`25
`
`THE HONORABLE MARY L . COOPER
`UNI TED STATES DISTRICT JUDGE
`
`/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
`Un i ted S t a t e s Dis t._ ____ R_e_d_d.;;_y _E_xh_i_bi_t _1 o_2_s ____ _.
`Trenton , 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 5 , 2015
`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. 1025
`
`
`
`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 SAUL EWING
`BY : CHARLES M. LIZZA, ESQUI RE
`5 Attorneys for the Plaintiffs
`
`6
`BUDD LARNER
`7 BY :
`STUART D. SENDER, ESQUIRE
`MICHAEL H.
`IMBACUAN, ESQUIRE
`HUA HOWARD WANG , ESQUIRE
`CONSTANCE S . HUTTNER, ESQUIRE
`KENNETH E . CROWELL , ESQUIRE
`Attorneys for the Defendant , Dr . Reddy ' s Laboratories
`
`8
`
`9
`10
`WINSTON & STRAWN
`11 BY :
`JOVIAL WONG , ESQUIRE
`GEORGE LOMBARDI , ESQUIRE
`12
`JULIA MANO JOHNSON, ESQUI RE
`BRENDAN F . BARKER, ESQUIRE
`13 LITE DePALMA, GREENBERG , LLC
`BY : MAYRA V. TARANTINO , ESQUIRE
`14 Attorneys for t he Defendant, Teva
`
`15
`16
`17
`
`18
`
`19
`20
`21
`22
`23
`24
`25
`
`United States District Court
`Trenton , New Jersev
`
`Exh. 1025
`
`
`
`3
`
`I N D E X
`
`DIRECT
`
`CROSS REDIRECT RECROSS
`
`18
`
`92
`
`WITNESS
`
`VOIR
`5
`DIRE
`Lee Edwin Kirsch
`6 By Mr . Wong
`5
`By O' Malley
`
`1
`
`2
`
`3
`
`4
`
`7
`
`8
`
`9
`10
`11
`
`12
`13
`14
`15
`16
`17
`
`18
`
`19
`20
`21
`22
`
`23
`24
`25
`
`United States District Court
`Trenton , New Jersev
`
`Exh. 1025
`
`
`
`19
`.---------------Kirsch - Di r ect ----------------,
`
`1 eight asserted claims?
`
`2 A .
`
`Yes . Claim 7 in t he
`
`' 219 patent real l y cont ains t he
`
`3
`e l ement s that a r e relevant .
`4 Q .
`
`And we ' ll get to each of these e l ement s
`
`i n a bit , but
`
`5 what is your general opinion regarding each of the components
`6
`7 A . Well , it ' s my op ini on that these elements a r e a
`
`listed here fo r Cl aim 7?
`
`8 descrip t ion o r involve the descript i on of a common
`
`corrunon ly
`
`9 used conditions and components in I . V. formulations that a.re
`10 used for t heir common uses .
`
`So ,
`
`i n my opini on ,
`
`t his pat ent i s
`
`11
`i nvalid becau se of obv i ou s ness .
`12 Q. Now , have you con side r ed who a pe rson of ordinar y skill
`13
`in the art would be with respect to the four patents?
`14 A.
`I have .
`Yes ,
`15 Q. And who would t ha t p erson be?
`16 A.
`i n t h e art , a POSA, would be
`The p erson of ordinary s k il l
`1 7
`a f o r mu lation sci entist typically wi th a Ph . D. in
`18 phar maceutics o r a related field and would have a coup le of
`
`experience preparing formul ations at the bench ?
`
`19 years o f expe rie n ce i n devel op ing I . V. formu l ati ons .
`20 Q . Okay . Now , in your opin i on , woul d thi s POSA have act ual
`2 1
`2 2 A .
`23 Q .
`And what is t he scop e o f resour ces that a POSA would draw
`24 upon when devel oping a formulat ion?
`2 5 A . Well , a POSA would h ave their training and background ,
`
`Yes .
`
`Un i ted States Di stri ct Court
`Trenton , New Jersev
`
`Exh. 1025
`
`
`
`20
`.---------------Kirsch - Direct ---------------,
`
`1
`
`2
`
`3
`4
`
`their academic training and experience . They would draw on
`
`the pharmaceutical science literature, general textbooks .
`
`They would draw upon research arti c l es and abstracts
`
`and other sources of information that gave them some idea of
`
`the current state of knowledge of palonosetron and related
`
`compounds , compounds that had a chemical or ther apeutic
`
`5
`6
`7
`8 Q .
`
`s i milarity to pal onosetron .
`
`Okay . And in the course of --
`
`THE COURT : And patents , of course .
`
`THE WITNESS : And pat ents , yes , they would certainly
`
`9
`10
`
`l ook at patents .
`
`11
`12
`13 BY MR . WONG :
`
`MR . WONG : Thank you .
`
`14 Q .
`
`In the course of a POSA ' s practice , would he or s he
`
`15 collaborate with others of ordinary skill in the art?
`
`16 A. Yes, certainly they would .
`
`I mean , one of the mechanisms
`
`17 for that interaction, of course ,
`
`i s a project team; but even
`
`18
`
`i n t he absence of a project team, they would draw upon t he
`
`19 knowl edge and expertise o f clinici ans and pharmacol ogists and
`20 other scientists in the field.
`
`21 Q.
`
`So , that would be the same whether the POSA is working in
`
`22
`
`i ndu str y or is in academia?
`
`23 A. Yes, absolutely .
`24 Q .
`
`Now , in forming your opinions in thi s case , what is the
`
`25 relevant date that you tied your opinions to?
`
`United States Distri ct Court
`Trenton , New Jersev
`
`Exh. 1025
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