1
`
`
`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 2007
`Dr. Reddy's Laboratories, Ltd., et al. v. Helsinn Healthcare S.A.
`Trial PGR2016-00007
`
`Page 1 of 5
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`

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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.
`
`(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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`United States District Court
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`Trenton, New Jersey
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`Page 2 of 5
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`Benhamza - Direct
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`Benhamza - Direct
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`Benhamza.
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`THE DEPUTY CLERK: Please spell your name for the
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`record.
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`THE WITNESS: It's R-A-C-H-I-D. B-E-N-H-A-M-Z-A.
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`DIRECT EXAMINATION BY MR. O'MALLEY:
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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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`Dr. Benhamza, where do you reside?
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`I reside in Losone in Switzerland.
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`And where do you work?
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`I work in Helsinn Healthcare in Lugano in Switzerland.
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`What's your current position at Helsinn?
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`I am head of corporate product management inside the
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`commercial operations.
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`Q.
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`Dr. Benhamza, can you please provide your educational
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`background, starting from college?
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`A.
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`I am graduated in 1982 at the University of Marrakech in
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`Morocco in physics and chemistry. And I moved in the same
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`year to France in Lyon, where I was graduated in organic
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`chemistry, third cycle doctorate, and I moved also to
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`Switzerland to the University of Geneva, where I got my Ph.D.
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`in organic medicinal chemistry in 1989.
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`Q.
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`A.
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`What did you do after you received your Ph.D. in 1989?
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`A few months later, I joined Helsinn Chemicals in Biasca
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`in Switzerland.
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`Q.
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`A.
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`And that was still in 1989?
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`It was September 1989.
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`A.
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`Q.
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`A.
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`I work there for three years until 1997.
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`And what did you do when you left that company?
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`I was offered at that time to go back at that time to
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`Helsinn, but to work inside the licensing-out division, so I
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`joined Helsinn again.
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`Q.
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`A.
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`Q.
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`And that was in 1997?
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`Yes, it was September 1997.
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`And what was your position or title when you rejoined
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`Helsinn again in 1997?
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`A.
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`Q.
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`A.
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`I was a licensing-out manager.
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`And what does that mean?
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`It meant, for Helsinn, a person who will search for
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`partners to market our product in the different markets
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`worldwide. I was responsible at that time for Latin America
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`and for North America.
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`Q.
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`Did you come to have any involvement in Helsinn's
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`palonosetron project?
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`A.
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`Yes. I joined the project team of palonosetron in late
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`1989.
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`Q.
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`A.
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`Q.
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`'89?
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`No, sorry. '98.
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`Okay. What was your title when you began working on the
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`palonosetron project in 1998?
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`A.
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`Q.
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`I was still a licensing-out manager.
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`And what were you asked to do for the project?
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`United States District Court
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`United States District Court
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`Trenton, New Jersey
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`Benhamza - Direct
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`Q.
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`What did you do when you began working for Helsinn in
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`1989?
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`A.
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`I was leading a small team to develop chemical processes
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`for the production of active pharmaceutical ingredients.
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`THE COURT: How many languages do you speak, Doctor?
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`THE WITNESS: I speak four languages.
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`THE COURT: What are they?
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`THE WITNESS: So, I speak Arabic, French, Italian and
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`a little bit of English.
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`BY MR. O'MALLEY:
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`Q.
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`A.
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`Q.
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`A.
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`Did you count English?
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`If I count?
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`Did you count?
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`English, yes. It's a very important language for our
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`business.
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`Q.
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`Now, how long did you hold that particular position at
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`Helsinn at the API plant?
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`A.
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`Q.
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`A.
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`I worked at Biasca for five years.
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`And what did you do next?
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`After that, I wanted to move to some kind of commercial
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`job. I wanted to start an MBA, but then I found a position as
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`a commercial manager in another pharmaceutical company.
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`Q.
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`A.
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`Q.
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`And what was the name of that company?
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`The name of the company was Nuova Linea.
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`And how long did you work at that company?
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`Trenton, New Jersey
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`Benhamza - Direct
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`A.
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`We -- I had been asked from my management to -- to start
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`as soon as possible the search for a partner who can join us
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`for palonosetron and market the product when it will be
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`registered and available.
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`Q.
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`While working on the palonosetron project, were you
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`involved with the details of the clinical trials?
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`A.
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`I was not, of course, involved in the details of the
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`clinical trials.
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`Q.
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`A.
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`Q.
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`Okay.
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`These were the clinical people, of course.
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`While working on the palonosetron project, were you
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`involved with the details of the formulation development?
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`A.
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`Q.
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`No, I was not.
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`Now, you talked about your role was to search for a
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`licensing partner. Was that search directed to a particular
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`geographic area?
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`A.
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`Yes. There was a priority set up by our management, at
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`that time Riccardo Braglia. He wanted us to start immediately
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`with searching for a partner in the United States.
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`The reason for that is that United States was a market
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`we were not present at. It was and it is the most important
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`pharmaceutical market, so it was very important for us to go
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`there. And, basically, I think it was a kind of being the
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`third generation, we were a family-owned company, it was a
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`kind of achievement for them, for himself as his brother.
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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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`Trenton, New Jersey
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`Page 3 of 5
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`For himself, sir?
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`And his brother, Enrico Braglia, who was -- both of them
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`Q.
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`A.
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`were managing directors of the company.
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`Q.
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`Okay. Was Helsinn familiar with the U.S. market at this
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`time?
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`A.
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`No, not at all. We were completely naive from the
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`American market. I can remember at that time that the company
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`organized some specific training for us, and they flew a dozen
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`of people working on palonosetron to join a couple of days
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`training in San Francisco. I think it was in the late '99,
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`something like that.
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`Q.
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`Why was Helsinn seeking a partner in the U.S. on
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`palonosetron specifically in the late 1998 time period?
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`A.
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`This is part of the licensing activity, of course, but we
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`had really to concentrate specifically in United States
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`because we -- being the biggest market, and we were working to
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`have the product coming in this market, we wanted a company
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`who can join us, work with us to make sure that we have a
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`partner for this market, but, also, to make sure that we are
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`sharing the risk of the development of the product for this
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`specific market.
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`Q.
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`A.
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`And what do you mean by "sharing the risk"?
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`It means that when we -- when we were setting licensing
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`agreements, those licensing agreements will trigger some
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`payments from the companies and this will help us, also, to
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`Trenton, New Jersey
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`Benhamza - Direct
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`Q.
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`A.
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`And you mentioned that took some period of years?
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`Well, when we started the first research, it was late
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`'98, beginning of 1999, and when we signed the agreement with
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`MGI Pharma, it was 2001. So it was more than a couple of
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`years of search and efforts.
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`Q.
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`During that time period, from late 1998 until you signed
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`the agreement with MGI, approximately how many companies did
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`Helsinn reach out to in its search for a licensing partner for
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`palonosetron?
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`A.
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`I did -- we did many, many contacts, and there were more
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`than 50 companies which we contacted.
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`Q.
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`What type of companies did you contact in your search for
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`a licensing partner?
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`A.
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`We -- we usually -- and also in this case, we started
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`from the big pharma because we always think that the big
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`pharma are important, have what we call the marketing
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`"muscles," you know, to make success of product.
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`We contacted Bristol-Myers Squibb. We contacted
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`Pharmacia, Baxter, Amgen and others, and then subsequently we
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`moved toward small companies, start-up companies who could be
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`available to partner with us.
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`Q.
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`A.
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`Now, how did you find the companies you contacted?
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`We -- so we attended several oncology congresses where
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`companies do exhibitions usually, so we can see which company
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`were presenting there.
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`invest into our research and development at that time.
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`Q.
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`Now, what did you do first when looking for a licensing
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`partner for palonosetron in the United States?
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`A.
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`The first action we took was to contact Roche, who
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`licensed palonosetron to us because they had a first right of
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`refusal to be checked, so we checked with them first if they
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`were interested.
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`Q.
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`A.
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`And what was Roche's response?
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`Roche declined the proposal to partner in the
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`United States.
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`Q.
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`What reason, if any, did Roche give for not wanting to
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`partner with Helsinn on palonosetron?
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`A.
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`I don't really remember any reason given at that time,
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`but I can -- I can remember clearly that we could understand a
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`couple of years after that time that they had a different
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`strategy. In fact, Roche ended up acquiring Anzemet, which
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`was another antiemetic in United States.
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`Q.
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`Okay. What did you do after Roche declined to partner on
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`palonosetron?
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`A.
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`After Roche declined, then we had to start searching for
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`other companies.
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`Q.
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`We'll talk about that process in a minute. Were you
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`ultimately successful in finding a licensing partner?
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`A.
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`Yes. Fortunately, after several -- few years and a lot
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`of effort, we ended with a partnership with MGI Pharma.
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`I attended also several business development meetings,
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`where I can meet business development people also from other
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`companies.
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`But I also bought a small database, a CD, which cost at
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`that time a couple of thousand Swiss francs, with the list of
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`all the companies which potentially I could have contacted.
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`Q.
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`A.
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`Why did you purchase a database?
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`Well, it was -- it was late '98, beginning '99, and at
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`the time, there was no Internet on my computer. We -- you
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`know, we were a small company, and our management didn't want
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`us to have direct access to the Internet. So we had only one
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`computer in one specific room where everybody could go and use
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`it, so I had to find out other ways to find it.
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`Q.
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`Now, how did you initiate contact with these companies
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`you selected to reach out to?
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`A.
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`The contacts usually start by a phone call to the company
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`and asking for to talk with the business development person,
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`and maybe over the phone explain in general terms what -- why
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`I was calling, and if there is an interest I would ask to have
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`an e-mail or faxes, whatever, and then I start a contact and
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`explanation about the product.
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`Q.
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`Now, you testified that you would provide some
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`explanation of the product. What form would that take?
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`A.
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`So, it varies because it can go from an explanation by
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`phone. It sometimes is a few sentences in an e-mail, but,
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`Benhamza - Direct
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`Benhamza - Direct
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`also, we used some small documentation, like the
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`nonconfidential profile, which we sent out to some companies.
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`And, of course, if the companies are interested, then
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`we move into the confidentiality agreement, and then we
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`provide other data, as well.
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`Q.
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`You mention --
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`THE COURT: That's very common in the pharmaceutical
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`industry, that in order to open up any kind of detailed
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`discussions about a possible partnership, you will engage in
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`confidentiality agreements with no other obligation to each
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`other; is that right?
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`THE WITNESS: Yes, Your Honor. There was always a
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`need to give some initial information, which can raise the
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`interest at the beginning.
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`If the interest is confirmed, then, yes, we would
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`propose, we will discuss the confidentiality agreement, the
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`duration and so on, and then we move into more open
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`discussions because companies would need to see the
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`information to make their assessment.
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`BY MR. O'MALLEY:
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`Q.
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`Now, you mentioned a nonconfidential profile. What is
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`that?
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`A.
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`The nonconfidential profile is usually two, three pages
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`of very short description of the product. It is prepared by
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`my colleague scientists, medical communication or clinician,
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`Do you see that?
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`Yes, I can see that.
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`Is that a reference to this same nonconfidential profile
`
`A.
`
`Q.
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`you testified about a moment ago?
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`A.
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`Q.
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`Yes.
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`Now, would you please turn to the next page, Plaintiffs'
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`Trial Exhibit 321.0010.
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`What is this document?
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`A.
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`This is the nonconfidential profile of palonosetron, the
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`one we used at that time.
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`THE COURT: So, it was no secret that Helsinn had
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`acquired the worldwide rights to this molecule from Roche and
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`Syntex.
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`THE WITNESS: I -- I don't remember if we did any
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`press release, but typically an acquisition of a product is
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`not secret, Your Honor. Typically the companies will put it
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`in a press release, saying this company acquired this product
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`from this other.
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`BY MR. O'MALLEY:
`
`Q.
`
`A.
`
`Q.
`
`Now, again, this is the nonconfidential profile?
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`It is.
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`And I believe you testified that you did not prepare
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`this; is that correct?
`
`A.
`
`Yes. I am -- I mean, I am in the licensing-out division,
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`and it is not my duty to take care of such documents, so it is
`
`United States District Court
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`Trenton, New Jersey
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`United States District Court
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`Trenton, New Jersey
`
`Benhamza - Direct
`
`Benhamza - Direct
`
`91
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`93
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`and it will describe a little bit of some pieces of every
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`aspect of the product.
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`Q.
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`A.
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`Q.
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`Let's please turn to Plaintiffs' Trial Exhibit 321-0009.
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`And do you recognize this document?
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`Yes, I do.
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`And let's go to the bottom. Is this a document that was
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`sent by you?
`
`A.
`
`Q.
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`A.
`
`Q.
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`A.
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`It was a letter I sent, yes.
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`And what is the date of this letter?
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`It's dated December 15, 1999.
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`And who are you sending this letter to?
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`It was sent to Schwarz Pharma, a pharmaceutical company,
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`international pharmaceutical company.
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`Q.
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`And specifically you're sending it to a Dr. Stratton; is
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`that correct?
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`A.
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`Yes. I was contacting this person who was the
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`vice-president of corporate development, new product and
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`technology acquisitions.
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`Q.
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`And the subject of the letter reads "licensing
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`opportunity"?
`
`A.
`
`Q.
`
`It does, yes.
`
`Now, in the first paragraph it states, "Following our
`
`phone conversation of today, I am sending you some information
`
`on our company along with the nonconfidential profile of our
`
`product palonosetron, available for licensing in the U.S.A."
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`done by the team.
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`THE COURT: But you can read it -- you can read it
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`and at least understand the surface of what it says, right?
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`THE WITNESS: Absolutely, your Honor, yes. Yeah, I
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`do.
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`BY MR. O'MALLEY:
`
`Q.
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`Did you provide this nonconfidential profile to every
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`company you contacted?
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`A.
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`It was not provided to all the companies I contacted, but
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`only to the ones who had some potential interest expressed.
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`Q.
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`Now, under pharmacokinetic profile, there's a sentence,
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`and I'll read it into the record, "Palonosetron is
`
`characterized by a long-lasting half-life of approximately
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`40 hours after I.V. and oral administration and a high oral
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`bioavailability."
`
`Do you see that?
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`Yes, I can see it.
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`So, any time you sent a nonconfidential profile to a
`
`A.
`
`Q.
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`potential licensing partner, it had this particular disclosure
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`of the 40-hour half-life of palonosetron?
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`A.
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`Yes. We were very often highlighting this feature of the
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`product, which has been presented to me by my colleagues as
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`one of the important features of the product.
`
`Q.
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`Now, how did the companies respond to your offer to
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`partner with Helsinn on palonosetron?
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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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`Trenton, New Jersey
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`Page 5 of 5