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
`
`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 1028
`
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`
`
`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 1028
`
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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. 1028
`
`
`
`2
`
`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. 1028
`
`
`
`3
`
`I N D E X
`
`VOIR DIRECT CROSS REDIRECT
`DIRE
`4
`
`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. 1028
`
`
`
`Candiotti - Direct
`
`18
`
`saw the slide on the screen, but the slides are
`demonstratives, and he didn't get a chance to say how he would
`define the person of ordinary skill in the art for purposes of
`these four patents.
`So, I'd suggest you go back and get his testimony on
`that, because the slide is just a demonstrative.
`MR. DITTMANN: Sure.
`BY MR. DITTMANN:
`Q. Dr. Candiotti, you discussed the definition of a POSA we
`see on PDX-403, correct?
`A. Yes.
`Q. And you understand this is a definition that was offered
`by Dr. Amidon in connection with his expert reports, correct?
`A. I do.
`Q. And do you agree with this definition?
`A. I do agree with it.
`THE COURT: And what is, it for the record? Just
`read it out from the slide.
`MR. DITTMANN: Oh, for the record, the definition of
`a person of ordinary skill in the art is "Someone who is
`actively involved in the development of pharmaceutical
`products which involves collaborative teamwork among persons
`with relevant experience. This person would have a degree in
`chemistry, pharmaceutical chemistry, pharmacy, medicine,
`clinical pharmacology, or another pharmaceutical
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`United States District Court
`Trenton, New Jersey
`
`Exh. 1028
`
`
`
`Candiotti - Direct
`
`19
`
`science-related field and experience in designing, developing,
`evaluating, and/or testing pharmaceutical formulations with a
`B.S. or master's degree in, and two to three years experience,
`or a Ph.D. or M.D. degree and one to two years of experience."
`Thank you, your Honor.
`THE COURT: Do you subscribe to that, sir?
`THE WITNESS: I do.
`THE COURT: Okay. Go on.
`MR. DITTMANN: Thank you.
`Can we go back to PDX-405, please.
`BY MR. DITTMANN:
`Q. And can you explain what we see here with respect to the
`other patents-in-suit besides the '219 patent, Doctor?
`A. So, the other three patents, basically, refer again to a
`pharmaceutical agent for reducing emesis and reducing the
`likelihood of emesis at a concentration of .05 milligrams per
`mL of palonosetron.
`Q. And, again, these are the portions of the claims on which
`you focus your testimony today, correct?
`A. Yes, sir. I'm clinically oriented, and that's what I
`focused on.
`MR. DITTMANN: Could we please bring up PDX-402
`
`again?
`BY MR. DITTMANN:
`Q. And I would like to start, Doctor, with your first
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`United States District Court
`Trenton, New Jersey
`
`Exh. 1028
`
`
`
`Candiotti - Direct
`
`20
`
`opinion listed here on the slide, that a POSA would not have
`been motivated in 2003 to pursue palonosetron.
`Do you have a slide discussing the types of classes of
`drugs that were used to treat PONV in the 2003 time period at
`issue in this case?
`A. Yes, I do.
`MR. DITTMANN: Can we please bring up PDX-406.
`BY MR. DITTMANN:
`Q. And can you please explain what we see here on the slide?
`A. So, I believe something similar was presented to the
`Court the other day. This is simply just showing the classes
`of medications that we use to either prevent or treat:
`Phenothiazines, butyrophenones, dopamine antagonists,
`steroids, antihistamines, 5-HT3 receptor antagonists, which of
`relevance are the drugs ondansetron, granisetron and
`dolasetron. These three drugs were on the market at that time
`and available for use.
`Q. And we see here that ondansetron was introduced in 1991.
`At this time when the first setron was introduced, how was
`this class of drugs perceived by the medical community?
`A. They were quite welcome. Nausea and vomiting, emesis,
`was a problem, both a significant problem for chemotherapy
`patients and post-operative patients. Whether the drugs
`were -- had superior efficacy or not depends on how you look
`at it, but for sure they had better side effects.
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`United States District Court
`Trenton, New Jersey
`
`Exh. 1028
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