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`CIVIL ACTION NUMBER:
` 11-3962
`
` TRIAL
`
` 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 9, 2015
`B E F O R E: 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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`Helsinn Healthcare Exhibit 2006
`Dr. Reddy's Laboratories, Ltd., et al. v. Helsinn Healthcare S.A.
`Trial PGR2016-00008
`
`Page 1 of 5
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`

`

`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
` JAMES BLISS, ESQUIRE
`SAUL EWING
`BY: CHARLES M. LIZZA, ESQUIRE
`Attorneys for the Plaintiffs
`
`BUDD LARNER
`BY: STUART D. SENDER, ESQUIRE
` MICHAEL IMBACUAN, ESQUIRE
` HUA HOWARD WANG, 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
`
`United States District Court
`Trenton, New Jersey
`
`I N D E X
`
`WITNESS VOIR DIRECT CROSS REDIRECT RECROSS
` DIRE
`
`(Video Deposition of Daniele Bonodeo), 5
`(Video Deposition of Roberta Canella), 38
`(Video Deposition of Riccardo Braglia), 50
`
`RACHID BENHAMZA
`By Mr. O'Malley 82
`By Ms. Johnson 124
`
`ZOYA IVANOVA MARRIOTT
`By Mr. Bliss 150 152
`By Mr. Sender 175
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`United States District Court
`Trenton, New Jersey
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`Colloquy
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`(In open court. June 9, 2015, 9:30 a.m.)
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`THE COURT: Good morning, everyone.
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`ALL: Good morning, your Honor.
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`THE COURT: You want to debate this issue that's
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`coming up as the stage of the trial shifts to plaintiffs'
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`side, or would you rather continue with the presentation of
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`defendants' side of the evidence first and get to this
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`argument in a break today?
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`MR. O'MALLEY: Your Honor, if possible, we'd like to
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`get some resolution on this so we can be planning our
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`presentation for the rest of the week.
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`THE COURT: This is one expert, maybe two, is it?
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`MR. O'MALLEY: Two.
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`THE COURT: On their side.
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`MR. DITTMANN: Two.
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`MR. O'MALLEY: Correct.
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`THE COURT: Okay. Mr. Lombardi, when would you like
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`to take this up?
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`MR. LOMBARDI: Your Honor, I will defer to DRL who's
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`going to be arguing this matter.
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`MR. SENDER: Your Honor, it really doesn't matter
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`because these are not experts that we are using, and it can be
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`deferred to the end, as far as we're concerned.
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`THE COURT: We have hours of depositions today and
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`then the defendants rest.
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`United States District Court
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`Trenton, New Jersey
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`Bonadeo - Deposition
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`MR. SENDER: That's correct, your Honor.
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`THE COURT: Okay. I would like to maintain my
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`5
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`concentration on the defendants' side of the case, and as soon
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`as they rest, I'll take up this issue.
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`MR. O'MALLEY: Thank you, your Honor.
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`MR. DITTMANN: Thank you, your Honor.
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`MR. LOMBARDI: Mr. Barker will introduce the first
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`deposition to you, Your Honor.
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`MR. BARKER: Good morning, your Honor.
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`So the first deposition we're going to play today is
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`excerpts from the deposition of Daniele Bonadeo. Dr. Bonadeo
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`is a Helsinn employee. He's one of the inventors in all the
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`patents-in-suit, and the excerpts will include designations
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`from plaintiffs and defendants, and they are approximately
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`about 40 minutes long.
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`THE COURT: That's fine, Mr. Barker. Thank you. Let
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`me just make a note before you start the tape.
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`Okay. Ready.
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`(Video played of DANIELE BONADEO as follows:)
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`Q.
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`A.
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`Q.
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`A.
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`Q.
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`A.
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`Good morning.
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`Good morning.
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`Please state your name for the record.
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`My name is Daniele Bonadeo.
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`And, Dr. Bonadeo, is that okay?
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`Yes, okay.
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`Trenton, New Jersey
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`Page 2 of 5
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`Marriott - Voir Dire
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`Marriott - Direct
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`150
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`152
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`First name Zoya, Z-O-Y-A, middle name I-V-A-N-O-V-A, last name
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`Marriott, M-A-R-R-I-O-T-T.
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`THE DEPUTY CLERK: Excuse me. Before you start, do
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`you have any water?
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`MR. BLISS: Water, sure.
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`THE DEPUTY CLERK: Usually it's up there.
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`MR. BLISS: This one looks unopened.
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`THE DEPUTY CLERK: Thank you.
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`MR. BLISS: Your Honor, if I may, I have exhibit
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`binders to hand up.
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`THE COURT: Fine.
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`THE DEPUTY CLERK: Do you have one for the law clerk?
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`MR. BLISS: Yes.
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`VOIR DIRE EXAMINATION BY MR. BLISS:
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`Q.
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`A.
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`Q.
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`A.
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`Q.
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`A.
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`Q.
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`A.
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`Q.
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`A.
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`Q.
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`Good afternoon, Dr. Marriott.
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`Good afternoon.
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`What kind of a doctor are you?
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`I have a Ph.D. in economics.
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`So you're not a medical doctor?
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`No, I'm not.
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`And you're not a patent expert?
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`No.
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`And you're not a formulation expert?
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`No.
`
`What do you do for a living?
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`Q.
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`A.
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`What do you do as a senior manager at Cornerstone?
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`I conduct economic analysis for complex business
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`litigation.
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`Q.
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`A.
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`What does that typically involve?
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`I usually analyze data, internal company documents,
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`academic literature, devise estimation strategies as
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`appropriate.
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`Q.
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`A.
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`Q.
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`Have you served as a testifying expert before?
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`No. It's my first time.
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`Has your work as an economist been focused on any
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`particular industry?
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`A.
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`Yes. My entire professional career has been focused on
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`life sciences industry, specifically, pharmaceuticals for the
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`most part.
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`Q.
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`Do you have any prior experience analyzing commercial
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`success in Hatch-Waxman cases?
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`A.
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`Yes. I have done so in approximately ten other matters.
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`MR. BLISS: Your Honor, we offer Dr. Marriott as an
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`expert economist on the secondary consideration of commercial
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`success.
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`MR. SENDER: I have no objection, Your Honor.
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`THE COURT: Thank you, counsel. So admitted.
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`DIRECT EXAMINATION BY MR. BLISS:
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`Q.
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`Dr. Marriott, what is your opinion on whether Aloxi® is a
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`commercially successful product?
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`United States District Court
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`Trenton, New Jersey
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`Marriott - Voir Dire
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`151
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`A.
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`I'm a senior manager at Cornerstone Research, which is an
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`economics and financial consulting company.
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`Q.
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`A.
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`Q.
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`A.
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`How long have you been with Cornerstone?
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`Almost ten years.
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`What is your role in this trial?
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`I am here to offer an opinion as to whether Aloxi® is a
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`commercially successful product, and, also, to examine the
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`extent of marketing expenditures for Helsinn.
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`Q.
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`A.
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`Q.
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`Will you be offering any opinions on the patents-in-suit?
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`No.
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`Dr. Marriott, can you please tell us about your
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`educational background?
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`A.
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`Of course. I have a Bachelor of Science degree in
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`mathematics from Novosibirsk State University in Russia, and
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`then I have a Master of Arts degree in economics from Central
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`European University in Hungary, and from there, I applied and
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`was accepted into a Ph.D. program at Boston University. And
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`five years later, I defended my dissertation and obtained my
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`doctorate in economics.
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`Q.
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`A.
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`Did you specialize in any particular branch of economics?
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`Yes. My area of specialization was industrial
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`organization. This is an area of economics that studies how
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`economic agents -- companies in particular -- compete, how
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`they decide which markets to enter, which products to produce,
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`how to price them, how much to supply, and so on.
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`Marriott - Direct
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`153
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`A.
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`Based on the analysis I conducted, I conclude that Aloxi®
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`is, in fact, a commercially successful product.
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`Q.
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`What indicators of commercial success did you consider in
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`forming your opinion?
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`A.
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`I have looked into the sales, both levels and growth
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`rates for Aloxi®. I have examined sales and growth relative
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`to other drugs on the market, looked into market share, and,
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`finally, I have looked into profitability of Aloxi® to
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`Helsinn.
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`THE COURT: Okay. One moment, please.
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`Counsel, does any one of the parties have any requests
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`that any of this information be sealed as confidential?
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`MR. BLISS: I don't believe, so but --
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`MR. O'MALLEY: No, Your Honor. It's our confidential
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`information. We have no such request.
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`THE COURT: Very well. You may proceed, counsel.
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`BY MR. BLISS:
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`Q.
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`Dr. Marriott, in your experience, are those the
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`indicators that economists typically consider in analyzing
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`commercial success?
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`A.
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`Yes, for the most part. Profitability, sometimes it's
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`hard to establish because not all companies have
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`product-specific level data on that, but the other indicators
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`are very typical.
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`Q.
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`And you mentioned market share and comparison to other
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`Page 3 of 5
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`Marriott - Direct
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`154
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`products. How did you determine the relevant market for
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`Aloxi®?
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`A.
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`So, in the Hatch-Waxman case, such as this one, the
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`economists typically look at relevant therapeutic category as
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`the relevant market. So this is what I've done here. I've
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`looked to see what drugs are in the relevant therapeutic
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`category. And to do so, I've looked at the company documents.
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`I've looked at how the data distinguishes between the drugs.
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`I've looked at the drug labels.
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`Q.
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`And what did you conclude based on your consideration of
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`those materials?
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`A.
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`So, I concluded that in this case, the relevant
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`therapeutic category was other 5-HT
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` antagonists, and, also,
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`3
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`some of the documents indicated that NK-1 antagonist, Emend,
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`can also potentially be included, so whenever I had data for
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`Emend, I've included it in the consideration.
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`Q.
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`A.
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`Emend is an NK-1 product?
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`Yes.
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`THE COURT: How do you spell that?
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`THE WITNESS: E-M-E-N-D.
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`BY MR. BLISS:
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`Q.
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`A.
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`Do NK-1s compete directly with 5-HT
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`s?
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`3
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`So, in a sense of therapeutic -- therapeutic category,
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`they do not compete directly because they are indicated to be
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`used with other 5-HT
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` drugs.
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`THE WITNESS: But it was not a disintegrating tablet,
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`just a tablet, a pill.
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`THE COURT: Um-hum.
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`THE WITNESS: So after Zofran, after ondansetron, the
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`next product was Kytril, generic name granisetron. That one
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`was approved for CINV in December, '93. And it also went
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`generic later on.
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`And then the next product was Anzemet, generic name
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`dolasetron, and that one was approved for CINV in September,
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`'97.
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`So after Aloxi®, there were also two other 5-HT
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`3
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`products that were approved. One was Sancuso. That was a
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`granisetron patch. And the other one was Zuplenz, which is an
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`ondansetron oral film.
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`THE COURT: What is an oral film?
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`THE WITNESS: It's --
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`THE COURT: I've never heard of that.
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`THE WITNESS: It's a really thin film, as far as I
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`understand. I'm not a doctor.
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`THE COURT: Right, right, right.
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`THE WITNESS: And luckily, I didn't have to take it.
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`But it's a very thin film that you put on your tongue and it
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`dissolves, so I think there's some benefits because of that.
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`So Sancuso was approved in September, 2008 for CINV,
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`and Zuplenz was approved for CINV in July 2010. And then the
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`United States District Court
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`Trenton, New Jersey
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`United States District Court
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`Marriott - Direct
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`Marriott - Direct
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`Q.
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`Does your opinion depend in any way on whether NK-1
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`antagonists are included in the relevant therapeutic category?
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`A.
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`Q.
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`No.
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`As of the time you performed your analysis, how many
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`5-HT
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` and NK-1 products were on the market?
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`3
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`A.
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`Q.
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`A.
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`I've prepared the demonstrative if that will help.
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`Please walk us through the products on this slide.
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`Sure.
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`THE COURT: So you've got 5-HT
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` antagonists and NK-1
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`3
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`antagonists on this slide, right?
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`THE WITNESS: Yes. That is correct.
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`So Aloxi®, which is the red bar, was the fourth 5-HT
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`3
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`on the market. It was approved for treatment of acute and
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`delayed CINV in July, 2003.
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`The first product on the market, the first 5-HT
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` was
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`3
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`Zofran, generic name ondansetron, and that one was approved
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`for CINV in January, '91. There was another ondansetron
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`product that was launched later on that was Zofran orally
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`disintegrating tablet, or Zofran ODT. So that one was
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`approved in January '99. Both of these drugs went generic in
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`late 2006.
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`THE COURT: Was the original Zofran an I.V. product?
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`THE WITNESS: They had both I.V. and oral
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`formulations.
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`THE COURT: Okay.
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`last bar, that's the NK-1 product, Emend. That one was
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`approved shortly before Aloxi® in March, 2003. And it entered
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`the market shortly thereafter.
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`BY MR. BLISS:
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`Q.
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`How many of the 5-HT
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` --
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`3
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`THE COURT: When you say "approved," you're using a
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`term, "approved."
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`THE WITNESS: FDA approved.
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`THE COURT: FDA approved.
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`THE WITNESS: Um-hum.
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`THE COURT: Did they enter the market once they were
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`approved, each of these ones?
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`THE WITNESS: So all of them entered the market --
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`well, I should say with an exception of the oral Aloxi®, all
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`the other drugs entered the market upon being FDA approved,
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`but sometimes there was a lag, maybe a couple of months.
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`THE COURT: Okay. So your slide here is just showing
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`us the date of the FDA approval?
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`THE WITNESS: Yes.
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`THE COURT: Thank you, Doctor.
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`THE WITNESS: Yes.
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`BY MR. BLISS:
`
`Q.
`
`How many of the 5-HT
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` products were approved to treat
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`3
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`delayed CINV?
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`A.
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`So Aloxi® is the only 5-HT
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` product that's approved
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`3
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`delayed CINV. All of the other 5-HT
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` products are approved to
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`treat acute CINV only.
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`Q.
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`So getting back to the indicators you considered, what
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`did you find with regard to the level and growth of Aloxi®
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`dollar sales?
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`A.
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`Q.
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`A.
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`I have prepared another demonstrative for that.
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`What does this demonstrative show?
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`So this demonstrative shows us annual sales of Aloxi®
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`from 2003. That's the year when it was launched on the
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`market, and through the first seven months of 2013.
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`So as you can see from this demonstrative, the first
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`full year that Aloxi® was on the market, it generated
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`$188 million in sales, and the sales continued to grow. 2006,
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`there were 326 million. 2009 there was 434, continued to
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`grow. In 2011 for 478 million. 473 in 2012, and then that
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`last bar, that's a partial year, so that's the seven months of
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`2013 during which it generated 271 million.
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`THE COURT: And why does your chart end with that
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`first half of 2013?
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`THE WITNESS: So, I filed my expert report in
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`October, 2013. These are the data that were available at the
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`time that I was preparing my report.
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`BY MR. BLISS:
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`Q.
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`Dr. Marriott, did you consider how Aloxi®'s dollar sales
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`compared to other products in the therapeutic category?
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`the market in 2007, I believe it was first quarter of 2007.
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`Q.
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`Can you explain that last point a little more? What's
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`the significance of generic entry?
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`A.
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`So, "generic" means from a pharmaceutical industry, when
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`generic drugs enter the therapeutic category, there is a lot
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`of pressure from the payors, from the insurance companies,
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`from Medicare, to switch patients to cheaper drugs.
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`So the fact that Aloxi® is able to not only maintain
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`the high level of sales but also to grow it over time speaks
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`to the value that patients realize from the drug.
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`Q.
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`Did you consider the fact that, during the time period
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`covered by your analysis, Aloxi®'s peak annual sales were not
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`as high as the peak annual sales for Zofran?
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`A.
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`Yes. It's not surprising to me really because it's a
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`well­established fact in the health economics literature, and
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`generally understood in the industry as well, that the first
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`mover in the category has an advantage. There are papers that
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`demonstrate that the first mover generally grows for longer
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`period of time, achieves higher peak levels of sales and
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`overall throughout the life cycle generates more in sales
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`compared to later entrants.
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`THE COURT: I notice that -- it's a little hard for
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`me to see when the Zofran goes generic here, just because of
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`the way the graph lines run. But does it indicate that in the
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`first quarter of 2007 is when Zofran went generic?
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`Trenton, New Jersey
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`Trenton, New Jersey
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`Marriott - Direct
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`A.
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`Yes. I guess one thing I wanted to mention, just to
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`summarize this whole growth, is that throughout this whole
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`time it generated $3.6 billion. I just thought that's an
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`important number to underline here, and the sales --
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`Q.
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`A.
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`Q.
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`A.
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`And what was the compound annual growth rate?
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`12.2 percent.
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`Thank you.
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`Sorry. And, yes, I have considered how the growth and
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`the level of sales compared to other drugs. And I have
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`demonstratives for that, as well.
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`Q.
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`So let's look at your first sales comparison. What does
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`this demonstrative show?
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`A.
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`So, this demonstrative shows the annual sales for Aloxi®
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`as well as other 5-HT
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` drugs and Emend, the NK-1 product from
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`3
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`2003, the year when Aloxi® was launched, through, again, the
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`first seven months of 2013.
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`So as you can see from this demonstrative, Aloxi®,
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`which is the red bar here, entered the rather crowded market.
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`There were drugs with substantial sales already on the market.
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`But already by 2004, 2005, it has overtaken many of the
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`previous entrants in terms of the levels of sale. Really, the
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`only exception was Zofran, which was the first entrant on the
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`market.
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`And the sales of Aloxi® continued to grow over time,
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`despite the fact that a cheaper generic ondansetron entered
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`THE WITNESS: Yes, yes.
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`THE COURT: Okay. And you've indicated that by
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`saying --
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`THE WITNESS: Actually, sorry, I take it back. I
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`think it was the last quarter of 2006 probably because if you
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`scroll down to the very top of that blue bar, there is this
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`tiny little shaded area. These are the generic ondansetron
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`sales. So I think it was approved towards the very end of the
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`year.
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`THE COURT: Oh, and so there would have
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`been branded -- what do you call them, brand or prescription?
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`THE WITNESS: Branded drug.
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`THE COURT: Branded. They are all prescription, of
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`course, whether they are generic or not?
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`THE WITNESS: Right.
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`THE COURT: But the branded sales of Zofran are
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`accompanied by a few generic sales of the Zofran generic --
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`THE WITNESS: Right.
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`THE COURT: -- in that first year where the generic
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`shows up?
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`THE WITNESS: Yes.
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`THE COURT: And then the next year which is 2007,
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`there are a few branded sales, but most of the generic Zofran
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`accounts for Zofran dollars, right?
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`THE WITNESS: Right. Most of ondansetron in that
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`United States District Court
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