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`
` IN THE UNITED STATES DISTRICT COURT
` FOR THE DISTRICT OF NEW JERSEY
` - - -
`HELSINN HEALTHCARE, SA, : Civil Action
`and ROCHE PALO ALTO. : DOCKET NO.
`LLC, : 11-CV-03962
` : (MLC)(DEA)
` Plaintiffs, :
` : 13-CV-05815
` v. : (MLC)(DEA)
` : (Consolidated)
`DR. REDDY'S :
`LABORATORIES, LTD, DR. :
`REDDY'S LABORATORIES, :
`INC., SANDOZ, INC., :
`TEVA PHARMACEUTICALS :
`USA, INC., and TEVA :
`PHARMACEUTICAL :
`INDUSTRIES, INC., :
` :
` Defendants. :
` - - -
` Wednesday, January 7, 2015
` - - -
` Videotaped deposition of MAURIE
` MARKMAN, MD taken pursuant to notice, was
` held at the law offices of Saul Ewing,
` LLP, 1500 Market Street, Philadelphia,
` Pennsylvania 19102, beginning at 9:42 AM,
` on the above date, before Constance S.
` Kent, a Registered Professional Reporter
` and Notary Public in and for the
` Commonwealth of Pennsylvania.
` * * *
` MAGNA LEGAL SERVICES
` (866) 624-6221
` www.MagnaLS.com
`
`Helsinn Healthcare Exhibit 2021
`Dr. Reddy's Laboratories, Ltd., et al. v. Helsinn Healthcare S.A.
`Trial PGR2016-00007
`
`Page 1 of 3
`
`

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`Page 2
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`Page 4
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`NO DESCRIPTION PAGE
`Exhibit 7 "Comparison of oral 147
` itasetron with oral
` ondansetron: Results of
` a double-blind,
` active-controlled phase
` II study in
` chemotherapy-naive
` patients receiving
` moderately emetogenic
` chemotherapy"
`
`Exhibit 8 "Antiemetics in 149
` development"
`Exhibit 9 Rebuttal Expert Report 156
` of Gordon L Amidon,
` Ph D
`Exhibit 10 Letter dated 1/7/98, Lee 231
` to Calderari
`
`Exhibit 11 Multinational 287
` Association of
` Supportive Care in
` Cancer (MASCC)
`Exhibit 12 Documents Reviewed 293
`Exhibit 13 Expert Report of David 295
` G Frame, Pharm D
`
`Exhibit 14 Patent 8,598,219 B2 296
`
`Exhibit 15 Dr Reddy's 302
` Laboratories, Ltd 's and
` Dr Reddy's
` Laboratories, Inc 's
` Invalidity Contentions
`
`Exhibit 16 Reply Expert Report of 304
` David G Frame, Pharm D
` With Respect to US
` Patent No 8,598,219
`
`Page 5
`
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`Direction to Witness Not to Answer
`6
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`2 (Pages 2 to 5)2 (Pages 2 to 5)
`
`A P P E A R A N C E S:
` PAUL HASTINGS, LLP
` BY: ERIC W. DITTMANN, ESQUIRE
` ANGELA C. NI, ESQUIRE
` 75 East 55th Street
` New York, New York 10022
` 212.318.6367
` ericdittmann@paulhastings.com
` angelani@paulhastings.com
` Counsel for Plaintiffs
`
` BUDD LARNER, PC
` BY: MICHAEL IMBACUAN, ESQUIRE
` 150 John F. Kennedy Parkway
` Short Hills, New Jersey 07078
` 973.379.4800
` mimbacuan@budd-larner.com
` Counsel for Defendant Dr. Reddy's
` Laboratories Ltd. and Dr. Reddy's
` Laboratories, Inc.
`
` WINSTON & STRAWN
` BY: JOVIAL WONG, ESQUIRE
` 1700 K Street, NW
` Washington, DC 20006
` 202.282.5867
` jwong@winston.com
` Counsel for Teva
`
` - - -
` I N D E X
` - - -
` Testimony of: MAURIE MARKMAN, MD
` By Mr Dittmann 8
`
` - - -
` E X H I B I T S
` - - -
`
`NO DESCRIPTION PAGE
`
`Exhibit 1 Expert Report of Maurie 6
` Markman, MD, With
` Respect to US Patent No
` 8,598,219
`Exhibit 2 Reply Expert Report of 6
` Maurie Markman, MD With
` Respect to US Patent No
` 8,598,219
`
`Exhibit 3 Discovery 17
` Confidentiality Order
`Exhibit 4 Progress in preventing 57
` chemotherapy-induced
` nausea and vomiting
`Exhibit 5 The Effect of 126
` Pharmacoeconomics on
` Company Research and
` Development Decisions
`
`Exhibit 6 Current Pharmaceutical 138
` Design, Volume 2, No 4,
` August 1996
`
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`Page 2 of 3
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`

`
`Page 178
`
`Page 180
`
` You see there there's a
`reference to what one of ordinary skill
`in the art could do without undue
`experimentation.
` Do you see that?
` A. Yes.
` Q. What's your understanding of
`undue experimentation as it applies to
`your obviousness opinions in this case?
` A. I would think it's something
`outside of what the normal, standard
`research strategy would be.
` Q. You don't have an opinion
`about what would or would not constitute
`undue experimentation to a POSA in terms
`of the number of antiemetic compounds
`they might pursue at any one time?
` A. No.
` Q. We can agree that there were
`a number of compounds that could have
`been potential antiemetic candidates in
`2002, correct?
` MR. IMBACUAN: Objection to
` the form.
`
`Page 179
` THE WITNESS: Are you
` talking specific, just -- just in
` general?
`BY MR. DITTMANN:
` Q. Well, for example, we talked
`about the class of NK-1s, correct?
` A. Yes.
` Q. We know that there were a
`decent number of NK-1s that were in
`development in 2002, right?
` A. Yes.
` Q. You've obviously offered
`opinions about a POSA would develop
`palonosetron, correct?
` A. Correct.
` Q. To make sure I understand
`this correctly, is it your opinion that
`because there are a number of options
`available to a POSA, that there needs to
`have been a reason to pursue palonosetron
`to avoid the application of hindsight --
` MR. IMBACUAN: Objection.
`BY MR. DITTMANN:
` Q. -- in your analysis,
`
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`correct?
` MR. IMBACUAN: Objection to
` the form.
` THE WITNESS: As I
` understand your question, I think
` that's fair. Because obviously I
` do appreciate the issue of
` hindsight, and so I would agree --
` I agree with your statement, yes.
` MR. DITTMANN: I'm about to
` turn to a new topic. So I propose
` now we take our lunch break. We
` can do whatever time you want. I
` can -- is that okay?
` THE WITNESS: Yes, that's
` fine with me.
` THE VIDEOGRAPHER: Going off
` the record. The time is 12:50 PM.
` (Lunch recess.)
` THE VIDEOGRAPHER: The time
` is 1:41 PM. We are back on the
` record.
`BY MR. DITTMANN:
` Q. Welcome back, Dr. Markman, I
`Page 181
`
`1
`hope you enjoyed lunch.
`2
` A. I did, thank you.
`3
` Q. Could you please turn to
`4
`paragraph 53 of your opening report,
`5
`Exhibit 1?
`6
` And is it correct here you
`7
`provide your opinion that the claim 0.25
`8 milligram dose is obvious because it was
`9
`determined through, quote, nothing more
`10
`than routine experimentation; is that
`11
`right?
`12
` A. That's correct.
`13
` Q. And your opinion is that the
`14
`clinical studies that are needed to
`15
`determine that a dose is effective are
`16
`routine?
`17
` A. In the drug development in
`18
`general, and antiemetic therapy in
`19
`particular, yes.
`20
` Q. Okay. And is it correct
`21
`that you'd also be able to determine if a
`22
`particular claim dosage is effective
`23
`through routine clinical testing in your
`24
`review?
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`46 (Pages 178 to 181)46 (Pages 178 to 181)
`
`Page 3 of 3