`
`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 10, 2015
`B E F O R E:
`
`CIVIL ACTION NUMBER:
`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 1044
`
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`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 10, 2015
`B E F O R E:
`
`CIVIL ACTION NUMBER:
`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
`
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`Exh. 1044
`
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`2
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`A P P E A R A N C E S:
`PAUL HASTINGS
`JOSEPH O'MALLEY, ESQUIRE
`BY:
`ERIC W. DITTMANN, ESQUIRE
`ANGELA NI, ESQUIRE
`SAUL EWING
`CHARLES M. LIZZA, ESQUIRE
`BY:
`Attorneys for the Plaintiffs
`
`BUDD LARNER
`BY: STUART D. SENDER, ESQUIRE
`MICHAEL H. IMBACUAN, ESQUIRE
`HUA HOWARD WANG, ESQUIRE
`CONSTANCE S. HUTTNER, ESQUIRE
`KENNETH E. CROWELL, ESQUIRE
`ANDREW ALLEN, 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
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`United States District Court
`Trenton, New Jersey
`
`Exh. 1044
`
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`3
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`I N D E X
`
`VOIR DIRECT CROSS REDIRECT
`DIRE
`4
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`14
`
`111
`
`RECROSS
`
`276
`
`266
`
`WITNESS
`KEITH CANDIOTTI
`By Mr. Dittman
`By Ms. Huttner
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`United States District Court
`Trenton, New Jersey
`
`Exh. 1044
`
`
`
`Candiotti - Direct
`
`108
`
`they reflected here, some of the exemplary sizes at this time?
`A. Right. So, like I said, this would have been the size of
`Kytril -- excuse me -- granisetron.
`THE COURT: 1 milliliter.
`THE WITNESS: 1 milliliter. This would have been
`ondansetron, is actually the ondansetron vial, 2 milliliters.
`And while this is Aloxi®, dolasetron is no longer available in
`the U.S.
`This is -- would be representative of the size.
`Actually, it was even a slightly smaller bottle than this, so
`you can see the size that we tend to cluster to clinically
`what we use.
`THE COURT: And you were just holding up the Aloxi®
`bottle, the 5-milliliter bottle, right?
`THE WITNESS: Yes, as a representative.
`The dolasetron bottle was actually slightly smaller
`than the Aloxi® bottle.
`THE COURT: But it contained 5 milliliters?
`THE WITNESS: Yes, your Honor.
`THE COURT: Okay.
`BY MR. DITTMANN:
`Q. And just so the record is clear, the 1-milliliter vial is
`PDX-415. The 2-milliliter bottle is PDX-416, and the
`5-milliliter vial is PDX-417.
`Doctor, these volume sizes we're seeing here on
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`United States District Court
`Trenton, New Jersey
`
`Exh. 1044
`
`
`
`Candiotti - Direct
`
`109
`
`PDX-413, are they consistent with your opinion as to the
`volumes that a POSA would have preferred to the extent they
`were pursuing a palonosetron product in the 2003 time period?
`A. Yes. I think this is reflective of what was clinically
`available, what we clinically preferred, and if you were to
`bring another agent of this type to the market, there would be
`no reason that you wouldn't want to make it approximately the
`same size.
`Q. Please turn --
`THE COURT: So, are these what the market wants in
`the way of volume of at least the setron drugs, as far as you
`can tell what a POSA would be thinking?
`THE WITNESS: Yes, and these are proven over time.
`They haven't really changed the injection, the single vial
`bolus injection sizes.
`As far back as I recall ondansetron has looked,
`basically, just like this. So, there's a reason for it. As I
`said, especially anesthesiologists, we don't like infusions or
`drips for the most part. We prefer bolus injection, single
`draw. That's easy. This is easy.
`100 ccs, you'd have to stick multiple times into the
`bottle, and -- if you were going to inject it. You'd have to
`fill maybe a 20-cc syringe five times to do it.
`THE COURT: And your time is valuable in the O.R.,
`too, right?
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`United States District Court
`Trenton, New Jersey
`
`Exh. 1044