`
`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.
`Trenton, New Jersey
`U.S. Patent No. 9,(cid:20)(cid:26)(cid:22),(cid:28)(cid:23)(cid:21)
`Reddy Exhibit 1048
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
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`16
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`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
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`10
`11
`12
`13
`14
`15
`16
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`25
`
`Exh. 1048
`
`
`
`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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`United States District Court
`Trenton, New Jersey
`
`Exh. 1048
`
`
`
`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
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`United States District Court
`Trenton, New Jersey
`
`Exh. 1048
`
`
`
`Opening Argument - Mr. O'Malley
`
`89
`
`do that, 505(b)(2), and there are generics who have tried that
`with palonosetron.
`So this copying is not mandated with respect to these
`facts and these patent claims. And, in fact, you know, this
`whole notion of copying being a secondary consideration, the
`thought behind it is, if you don't think much of our
`invention, don't use it, go do your own thing. And some
`tried.
`
`Now, I'm going to switch gears here and talk about
`the on-sale bar. And we have several arguments with respect
`to the on-sale bar. The post-AIA '219 claimed invention was
`not available to the public, and, therefore, not subject to
`the on-sale bar, that's the subject of the summary judgment
`briefing. I'm not going to spend a lot of time on the law.
`You have that in your files.
`I will comment that this notion that this patent is
`litigation inspired, I don't know what that means. Helsinn
`took advantage of lawful avenues to petition the government.
`The law had changed. We did not change the law. And now we
`believe the law, as it applies today to these patents, takes
`the on-sale bar completely off the table.
`And then our arguments are going to be that the SP and
`Oread agreements were not commercial --
`THE COURT: If you have to be under the pre-AIA
`version, is that this series of arguments or --
`
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`United States District Court
`Trenton, New Jersey
`
`Exh. 1048
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