HIGHLY CONFIDENTIAL - OUTSIDE COUNSEL EYES ONLY
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`Page 229
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` HIGHLY CONFIDENTIAL
` OUTSIDE COUNSELS' EYES ONLY
`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`-----------------------------x
`HELSINN HEALTHCARE S.A.
`AND ROCHE PALO ALTO LLC,
` Civil Action No.
` Plaintiffs, 11-CV-03962
` (MLC)(DEA)
` vs. Civil Action No.
` 11-CV-05579
`DR. REDDY'S LABORATORIES, (MLC)(DEA)
`LTD., DR. REDDY'S LABORATORIES,
`INC., SANDOZ INC., TEVA
`PHARMACEUTICALS USA, INC.,
`AND TEVA PHARMACEUTICAL
`INDUSTRIES, INC.,
` Defendants.
`-----------------------------x
` HIGHLY CONFIDENTIAL
` OUTSIDE COUNSELS' EYES ONLY
` Continued Videotaped Deposition of
` BERTRAM SPILKER, held at the offices of
` Paul Hastings, LLP, 75 East 55th Street,
` New York, New York, pursuant to notice,
` commencing January 17, 2014 at
` 10:32 a.m., on the above date, before
` Jennifer Ocampo-Guzman, a Certified
` Real-Time Shorthand Reporter and Notary
` Public of the State of New York.
`JOB NO. 138621
` MAGNA LEGAL SERVICES
` (866) 624-6221
`
`Magna Legal Services
`
`Helsinn Healthcare Exhibit 2019
`Dr. Reddy's Laboratories, Ltd., et al. v. Helsinn Healthcare S.A.
`Trial PGR2016-00008
`
`Page 1 of 3
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`

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`HIGHLY CONFIDENTIAL - OUTSIDE COUNSEL EYES ONLY
`Page 230
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`Page 232
`1 Highly Confidential/Outside Counsels' Eyes Only
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` THE VIDEOGRAPHER: We are now on
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` the record and recording. This is going
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` to begin disk 1 in volume 2, in the
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` deposition of Bertram Spilker, in the
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` matter of Helsinn Healthcare S.A., et
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` al, versus Dr. Reddy's Laboratories Ltd,
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` et al., in the US District Court for the
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` District of New Jersey, number
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` 11-CV-03962, and related cases. Today
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` is January 17, 2014. The time is
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` 10:32 a.m.
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` This deposition is being taken at
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` 75 East 55th Street in New York at the
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` request of Eric Dittmann of Paul
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` Hastings.
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` The videographer is James Christe.
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` The court reporter is Jennifer
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` Ocampo-Guzman. The court reporter has
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` already noted everyone's appearance and
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` she can -- actually the witness has been
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` sworn in from yesterday.
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` B E R T R A M S P I L K E R, called as a
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` witness, having been previously duly sworn,
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` was examined and continued to testify as
`Page 233
`
`A P P E A R A N C E S:
` PAUL HASTINGS, LLP
` Attorneys for Plaintiffs
` 75 East 55th Street
` New York, New York 10022
` (212) 318-6689
` BY: ERIC W. DITTMANN, ESQ.
` Ericdittmann@paulhastings.com
` -and-
` BY: DANA WEIR, ESQ.
` Danaweir@paulhastings.com
`
` WINSTON & STRAWN LLP
` Attorneys for Defendant
` Teva Pharmaceuticals USA, Inc., and
` Teva Pharmaceutical Industries, Inc.
` 35 West Wacker Drive
` Chicago, Illinois 60601-9703
` (312) 558-5600
` BY: BRENDAN BARKER, ESQ.
` bbarker@winston.com
`
`Page 231
`
`APPEARANCES (Continued):
`
` MORRISON FORRESTER LLP
` Attorneys for Defendant Sandoz Inc.
` 1290 Avenue of the Americas
` New York, New York 10104-0050
` (212) 336-4068
` BY: JAYSON L. COHEN, ESQ.
` jcohen@mofo.com
`
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`Magna Legal Services
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` JAMES CHRISTE, Videographer
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` BUDD LARNER PC
` Attorneys for Defendants
` 150 John F. Kennedy Parkway
` Short Hills, New Jersey 07078
` (973) 315-4477
` BY: H. HOWARD WANG, ESQ.
` hwang@buddlarner.com
` (Via telephone)
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` follows:
` EXAMINATION BY
` MR. DITTMANN (Continued):
` Q. Good morning, Dr. Spilker.
` A. Good morning.
` Q. You understand you are still under
` oath today?
` A. I understand.
` Q. Would you please turn to paragraph
` 163 of your opening report, Exhibit 1. We're
` going to shift gears a little bit from what
` we were talking about yesterday and focus on
` your opinions relating to the offer for sale
` or sale component of the on-sale bar.
` And specifically in your expert
` report in paragraph 163 you state, "In my
` experience, in the pharmaceutical business,
` the pharmaceutical company-contract
` manufacturer relationship is fundamentally a
` commercial one." Do you see that?
` A. Yes.
` Q. Do you consider all such
` transactions between such parties involving
` the exchange of money to be commercial for
`2 (Pages 230 to 233)
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`Page 2 of 3
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`HIGHLY CONFIDENTIAL - OUTSIDE COUNSEL EYES ONLY
`Page 322
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`Page 324
` A. Well, I mean when FDA approves the
` product, it issues often an SBA, summary
` basis of approval, that will indicate to the
` public some information.
` Q. And when was Aloxi approved by the
` FDA?
` A. I know it was applied for in late
` '02. I would imagine it was later '03, but
` I'm not 100 percent certain as we sit here
` now, but after the critical date.
` Q. The patents-in-suit were applied
` for on January 30, 2003, correct?
` A. Yes.
` Q. FDA approval of Aloxi came after
` that?
` A. Yes.
` Q. So to confirm, all of the alleged
` sales and offer for sales that you discuss in
` your expert reports concerning SP, Oread and
` MGI were not available to the public before
` the patents-in-suits were applied for,
` correct?
` MR. COHEN: Objection,
` mischaracterizes his testimony.
`
`Page 325
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` words are here.
` Q. Any other basis supporting your
` view?
` A. Yeah -- I mean, yes. It says, in
` one of the examples I gave you is when there
` is an unexpectedly strong sales of the
` product, and in the middle of the second
` paragraph of 4.2, it says HBP shall not be
` obligated to supply more than 100 percent
` within the applicable accounting period --
` Q. Dr. Spilker, I think you've
` wondered off away from my question. My
` question was: Other than what you've
` identified as the text in Exhibit 26 and
` what's done in the pharmaceutical industry,
` do you have any other basis to support your
` interpretation?
` A. No, that's what I'm replying on.
` Q. Do you believe that an offer by MGI
` to purchase Palonosetron solutions under this
` Exhibit 26 would be an on-sale bar?
` A. Yes.
` Q. Whether or not Helsinn accepted it,
` correct?
`
`Page 323
`
` A. Yes.
` Q. Turn to your opening expert report,
` paragraph 48, and I'm interested in the
` second sentence. I just want to confirm that
` you understand that, your standard for the
` on-sale bar is that it applies even if the
` sale took place in secret, correct?
` A. Yes.
` Q. Do you agree that all of the
` alleged offers for sale and sales discussed
` in your expert reports were confidential?
` A. Yes.
` MR. COHEN: Objection.
` Q. None of them were available to the
` public before the patents-at-issue in this
` case were applied for in 2003, correct?
` MR. COHEN: Objection, to the
` extent it calls for a legal conclusion.
` A. I think the offers for sale in this
` case with Oread, SP and MGI were under
` confidentiality, yes.
` Q. And that's true until the
` patents-in-suit were applied for in 2003,
` correct?
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` A. Yes.
` Q. Please turn to paragraph 76 in your
` opening report.
` Oh, you know what, sorry, it's the
` reply report. My bad.
` MR. COHEN: What was it, 76?
` A. It's page 32.
` Q. Yes, page 32 of Exhibit 2.
` Do you have an opinion on whether
` in the manufacturing process and impurities
` can affect the stability of a given
` formulation?
` A. Are we speaking of this particular
` product or any product?
` Q. You can start with Palonosetron.
` A. It's saying can affect, meaning the
` possibility -- I would say there is no data
` presented, at least nothing that I saw that
` would indicate if that, if it was likely or
` whatever, so I think Peck's argument is not
` making any meaningful statement.
` Q. I understand that paragraph 76,
` that you say his statement is irrelevant to
` the issues in this case. I'm just trying to
`25 (Pages 322 to 325)
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`Page 3 of 3