1
`
`2
`
`3
`
`UNITED STATES DI STRICT COURT
`FOR THE DISTRI CT 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 Healithcare S.A., et al.
`U.S. Patent No. 8,729,094
`U n i ted S t a t e s Dis ...__ ____ R_e_dd--=y'--E_x_h_ib_it_1_0_26 ____ __.
`Trenton , New Jersey
`
`
`
`2
`
`3
`
`UNITED STATES DI STRICT COURT
`FOR THE DISTRI CT 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 Healithcare S.A., et al.
`U.S. Patent No. 8,729,094
`U n i ted S t a t e s Dis ...__ ____ R_e_dd--=y'--E_x_h_ib_it_1_0_26 ____ __.
`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 10 , 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. 1026
`
`
`
`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. 1026
`
`
`
`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. 1026
`
`
`
`18
`r------------------------Candiotti - Di rect -----------------------,
`
`1
`
`saw the slide on the screen , but the slides are
`
`2 demonstratives , and he didn ' t get a chance to say how he would
`
`3 define the person of ordinary skill in the art for purposes of
`4
`
`these four patents .
`
`5
`6
`
`7
`
`So ,
`
`I ' d suggest you go back and get his testimony on
`
`that , because the slide is j ust a demonstrative .
`
`MR . DI TTMANN : Sure .
`
`8 BY MR . DITTMANN :
`
`9 Q. Dr . Candiotti , you discussed the definition of a POSA we
`10 see on PDX- 403 , correct?
`11 A .
`12 Q .
`13 by Dr . Amidon in connection with his expert reports , correct?
`
`And you understand this is a definition that was offered
`
`Yes .
`
`14 A .
`
`I do .
`
`15 Q .
`
`16 A .
`
`And do you agree with this defini t i on?
`
`I do agree with it .
`
`17
`
`18
`
`THE COURT : And what is ,
`
`i t for the record? Just
`
`read it out from the slide .
`
`19
`20 a person of ordinary skill in the art is " Someone who is
`
`MR . DI TTMANN : Oh , for the record, the definition of
`
`21 actively involved in the development of pharmaceutical
`
`22 products which involves collaborat i ve teamwork among persons
`
`23 with relevant experience . This person would have a degree in
`24 chemistry, pharmaceutical chemistry, pharmacy, medicine,
`2 5 clinical pharmacology, or another pharmaceutical
`
`United States District Court
`Trenton , New Jersev
`
`Exh. 1026
`
`
`
`19
`r------------------------Candiotti - Di rect -----------------------,
`
`1
`
`science-related field and experience in designing, developing ,
`
`2 evaluating , and/or testing pharmaceutical formulations with a
`
`3 B . S . or master ' s degree in , and two to three years experience ,
`4 or a Ph . D. or M. D. degree and one to two years of experience ."
`
`5
`
`6
`
`7
`
`8
`
`Thank you , your Honor .
`
`THE COURT : Do you subscribe to that , sir?
`
`THE WITNESS :
`
`I do .
`
`THE COURT : Okay . Go on .
`
`9
`10
`11 BY MR . DITTMANN :
`
`MR . DITTMANN : Thank you .
`
`Can we go back to PDX- 405 , please .
`
`And can you explain what we see here with respect to the
`
`12 Q .
`13 other patents-in-suit besides the ' 219 patent, Doctor?
`
`14 A .
`
`So, the other three patents , basical l y , refer again to a
`
`15 pharmaceutical agent for reducing emesis and redu cing the
`16
`17 mL of palonosetron .
`
`likelihood of emesis at a concentration of . 05 milligrams per
`
`18 Q. And, again , these are the portions of the claims on which
`
`19 you focus your testimony today, correct?
`
`20 A .
`
`Yes , sir .
`
`I ' m clini cally ori ented, and that ' s what I
`
`2 1
`
`22
`
`focused on .
`
`MR . DITTMANN : Could we please bri ng up PDX- 402
`
`23 again?
`24 BY MR . DITTMANN :
`2 5 Q .
`
`And I would like to start , Doctor , with your first
`
`United States District Court
`Trenton , New Jersev
`
`Exh. 1026
`
`
`
`20
`r--------------------------Candiotti - Di rect -------------------------,
`
`1 opinion listed here on the slide, that a POSA would not have
`
`2 been motivated in 2003 to pursue palonosetron .
`
`3
`Do you have a slide discussing the types of classes of
`4 drugs that were used to treat PONV in the 2003 time period at
`
`5
`6 A .
`
`issue in this case?
`
`Yes ,
`
`I do .
`
`7
`
`MR. DITTMANN: Can we please bring up PDX-406.
`
`8 BY MR . DITTMANN :
`
`9 Q .
`10 A .
`
`And can you please explain what we see here on the slide?
`
`So ,
`
`I believe something similar was presented to the
`
`11 Court the other day . This is simply just showing the classes
`12 of medications that we use to either prevent or treat :
`13 Phenothiazines , butyrophenones, dopamine antagoni sts,
`14 steroids , antihistamines , 5- HT3 receptor antagonists , which of
`15 relevance are the drugs ondansetron , granisetron and
`16 dolasetron. These three drugs were on the market at that time
`17 and available for use .
`
`18 Q. And we see here that ondansetron was introduced in 1991.
`
`They were quite welcome . Nausea and vomiting, emesis,
`
`19 At this time when the first setron was introduced, how was
`20
`this class of drugs perceived by the medical community?
`21 A .
`22 was a problem, both a significant problem for chemotherapy
`23 patients and post-operative patients . Whether the drugs
`24 were -- had superior efficacy or not depends on how you look
`25 at it, but for sure they had better side effects .
`
`United States District Court
`Trenton , New Jersev
`
`Exh. 1026
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