`
`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`__________________________________
`HELSINN HEALTHCARE, S.A. and
`ROCHE PALO ALTO, LLC,
`Plaintiffs,
`-vs-
`DR. REDDY'S LABORATORIES, LTD.,
`DR. REDDY'S LABORATORIES, INC.,
`TEVA PHARMACEUTICALS USA, INC.,
`and TEVA PHARMACEUTICAL
`INDUSTRIES, LTD.
`Defendants.
`__________________________________
`Clarkson S. Fisher United States Courthouse
`402 East State Street
`Trenton, New Jersey 08608
`June 2, 2015
`B E F O R E:
`
`CIVIL ACTION NUMBERS:
`11-3962
`
`TRIAL
`
`THE HONORABLE MARY L. COOPER
`UNITED STATES DISTRICT JUDGE
`
`Certified as True and Correct as required by Title 28, U.S.C.,
`Section 753
`/S/ Regina A. Berenato-Tell, CCR, CRR, RMR, RPR
`/S/ Carol Farrell, CCR, CRR, RMR, CCP, RPR, RSA
`
`Dr. Reddy’s Laboratories, Ltd., et al.
`v.
`United States District Court
`Helsinn Healthcare S.A., et al.
`U.S. Patent No. 9,(cid:20)(cid:26)(cid:22),(cid:28)(cid:23)(cid:21)
`Trenton, New Jersey
`Reddy Exhibit 1046
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`1
`
`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`__________________________________
`HELSINN HEALTHCARE, S.A. and
`ROCHE PALO ALTO, LLC,
`Plaintiffs,
`-vs-
`DR. REDDY'S LABORATORIES, LTD.,
`DR. REDDY'S LABORATORIES, INC.,
`TEVA PHARMACEUTICALS USA, INC.,
`and TEVA PHARMACEUTICAL
`INDUSTRIES, LTD.
`Defendants.
`__________________________________
`Clarkson S. Fisher United States Courthouse
`402 East State Street
`Trenton, New Jersey 08608
`June 2, 2015
`B E F O R E:
`
`CIVIL ACTION NUMBERS:
`11-3962
`
`TRIAL
`
`THE HONORABLE MARY L. COOPER
`UNITED STATES DISTRICT JUDGE
`
`Certified as True and Correct as required by Title 28, U.S.C.,
`Section 753
`/S/ Regina A. Berenato-Tell, CCR, CRR, RMR, RPR
`/S/ Carol Farrell, CCR, CRR, RMR, CCP, RPR, RSA
`
`United States District Court
`Trenton, New Jersey
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
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`20
`21
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`23
`24
`25
`
`Exh. 1046
`
`
`
`2
`
`A P P E A R A N C E S:
`PAUL HASTINGS
`BY:
`JOSEPH O'MALLEY, ESQUIRE
`ERIC W. DITTMANN, ESQUIRE
`ISAAC S. ASHKENAZI, ESQUIRE
`SAUL EWING
`CHARLES M. LIZZA, ESQUIRE
`BY:
`Attorneys for the Plaintiffs
`
`BUDD LARNER
`BY: STUART D. SENDER, ESQUIRE
`MICHAEL H. IMBACUAN, ESQUIRE
`H. HOWARD WANG, ESQUIRE
`CONSTANCE S. HUTTNER, ESQUIRE
`KENNETH E. CROWELL, ESQUIRE
`Attorneys for the Defendant, Dr. Reddy's Laboratories
`WINSTON & STRAWN
`BY: JOVIAL WONG, ESQUIRE
`GEORGE LOMBARDI, ESQUIRE
`JULIA MANO JOHNSON, ESQUIRE
`BRENDAN F. BARKER, ESQUIRE
`LITE DePALMA, GREENBERG, LLC
`BY: MAYRA V. TARANTINO, ESQUIRE
`Attorneys for the Defendant, Teva
`
`1 2 3 4 5 6 7 8 9
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`10
`11
`12
`13
`14
`15
`16
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`25
`
`United States District Court
`Trenton, New Jersey
`
`Exh. 1046
`
`
`
`3
`
`I N D E X
`
`WITNESS
`
`DIRECT
`
`CROSSREDIRECT
`
`RECROSS
`
`OPENING ARGUMENTS:
`By Mr. Lombardi, 13
`By Ms. O'Malley 61
`GIORGIO CALDERARI
`By Mr. Lombardi 105
`
`1 2 3 4 5 6 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 Jersey
`
`Exh. 1046
`
`
`
`Opening Argument - Mr. O'Malley
`
`90
`
`MR. O'MALLEY: Yes, right.
`THE COURT: -- or both?
`MR. O'MALLEY: Yes, we believe with respect to '219,
`if you accept our legal argument, '219 is safe, and we're done
`talking.
`Now, they have this SEC argument I'll mention on the
`next slide.
`With respect to the earlier patents, these SP and
`Oread agreements were so-called CMO agreements. Those are
`service agreements. I'll talk a little bit more about that in
`a moment.
`
`The MGI agreement was not a commercial offer for sale
`of the claimed invention, and why not? Because the claimed
`invention, as we'll point out, didn't exist at that time.
`They had -- Helsinn had no idea what would be approved by the
`FDA. They went into Phase III with two different
`formulations, and, furthermore, didn't know if either would be
`approved.
`So at that point in time, they did not have a
`formulation, did not know what it would be that would be
`suitable for treating CINV.
`And then, finally, the claimed inventions were not
`shown to work for their intended purpose before the critical
`date. And, finally, after that, we will show you that the
`Patent Office agreed with us.
`
`1 2 3 4 5 6 7 8 9
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`10
`11
`12
`13
`14
`15
`16
`17
`18
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`20
`21
`22
`23
`24
`25
`
`United States District Court
`Trenton, New Jersey
`
`Exh. 1046
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