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 16 , 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 a l.
`U.S. Patent No. 8,729,094
`Un i ted S t a t e s Dis t._ ____ R_e_d_dy:;...._E_xh_ib_i_t 1_0_4_6 ____ _,
`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 16 , 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 a l.
`U.S. Patent No. 8,729,094
`Un i ted S t a t e s Dis t._ ____ R_e_d_dy:;...._E_xh_ib_i_t 1_0_4_6 ____ _,
`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 16 , 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. 1046
`
`
`
`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. 1046
`
`
`
`3
`~--------------------------Colloquy --------------------------~
`
`I N D E X
`
`1
`
`2
`
`3
`
`4
`
`5 WITNESS
`DIRECT
`6 GORDON L. AMIDON
`By Mr . Dittmann
`7 By Mr. Lombardi
`(Videotape Deposition of Patrick DeLuca)
`
`CROSS
`
`REDIRECT RECROSS
`
`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. 1046
`
`
`
`106
`r---------------------------Amidon - Cross --------------------------~
`
`1 A. Yes .
`2 Q. And we know , we know today that when you use the EDTA, it
`3 does improve stability; is that right?
`4 A. Well ,
`the formula is -- is unknown , but it does appear to improve
`5
`
`I believe that the EDTA -- what EDTA is doing in
`
`the stability .
`
`6
`7 Q . Okay . All right . And just l et ' s
`
`l ook at Amidon
`
`8 Demonstrative Number 3 .
`
`I ' m going back to that Wells article
`
`9 or chapter that you and I talked about earlier this morning,
`10 Doctor .
`11 A .
`12 Q .
`13 prior art for purposes of this case, and it says at the top
`14
`
`Uh-huh .
`
`And this is another table from Wells , which is in the
`
`"Simple strategies for improving drug stabi l ity . " And it
`
`15 says , for one of them of the degradation processes talks about
`16 is oxidation, and one of four that it mentions is the strategy
`1 7
`
`is to chelate metal ions , and it specifically cal ls out EDTA;
`
`18
`
`i s that right?
`
`19 A . Uh-huh , yes . There ' s several approaches, but that ' s one
`20 of them .
`
`2 1 Q. And then for demonstrative -- well , and this is something
`
`2 2
`
`that you see throughout the literature is reference to EDTA ' s
`
`23 use if there ' s some metal ion effect; isn ' t that right?
`24 A .
`2 5 Q .
`
`That ' s one of the uses of EDTA, yes.
`
`Okay . That ' s a common use .
`
`United States District Court
`Trenton , New Jersev
`
`Exh. 1046
`
`
`
`107
`r---------------------------Ami don - Cross --------------------------~
`
`1 A. A common use .
`
`It ' s in the Handbook of Pharmaceutical
`
`2 Excipients , yes .
`
`3 Q.
`4 A .
`
`5 Q.
`
`Okay .
`
`I mean , there are other chelati ng agents , as well .
`
`Okay . Let ' s look at Amidon Demonstrative Number 6 .
`
`And do you see this is just a bunch of di f ferent
`
`6
`7 articles . Let me call out Connors , 1986 . That ' s your book,
`
`8
`
`r ight?
`
`Uh- huh , yes .
`
`9 A.
`10 Q .
`11 pharmaceutically are " a nd I ' m going to skip the word, but EDTA
`
`" The most effective chel ating agents used
`
`in parentheses?
`
`12
`13 A .
`
`Yes.
`
`14 Q .
`
`" EDTA and citric acid are the two most useful agents ."
`
`15
`
`Do you see that?
`
`16 A. Uh-huh , yes . Well, there ' s multiple agents that can be
`
`17 used and, yes ,
`
`i t does -- citric acid, EDTA are the most
`
`18 useful .
`
`19 Q . All right. And then l et ' s look at Won . We won ' t go
`
`20
`
`through all these , but look at Won i n the lower right . Won
`
`21 says, "A variety of chel ating agents are availabl e for use in
`
`22 aqueous solutions ." That ' s what you just told us, right?
`
`23 A .
`24 Q .
`
`25 A .
`
`Uh-huh .
`
`Yes?
`
`Yes .
`
`I ' m sorry .
`
`United States District Court
`Trenton , New Jersev
`
`Exh. 1046
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