Page 1
`
` IN THE UNITED STATES DISTRICT COURT
` FOR THE DISTRICT OF NEW JERSEY
` - - -
`HELSINN HEALTHCARE, : Civil Action
`S.A., and ROCHE PALO : DOCKET NO.
`ALTO, LLC, : 12-2867 (MLC)
` :
` Plaintiffs, : CONFIDENTIAL
` :
` v. :
` :
`DR. REDDY'S :
`LABORATORIES, LTD., et :
`al., :
` :
` Defendants. :
` - - -
` Friday, April 29, 2016
` - - -
`
` Videotaped deposition of DR.
` JOANNE BROADHEAD, taken pursuant to
` notice, was held at the law offices of
` Lerner David Littenberg Krumholz &
` Mentlik, 600 South Avenue West,
` Westfield, New Jersey, beginning at 9:46
` a.m., on the above date, before Constance
` S. Kent, a Certified Court Reporter,
` Registered Professional Reporter,
` Certified LiveNote Reporter, and Notary
` Public in and for the State of New
` Jersey.
`
` * * *
` MAGNA LEGAL SERVICES
` (866) 624-6221
` www.MagnaLS.com
`
`Helsinn Healthcare Exhibit 2018
`Dr. Reddy's Laboratories, Ltd., et al. v. Helsinn Healthcare S.A.
`Trial PGR2016-00008
`
`Page 1 of 5
`
`

`
`Page 2
`
`Page 4
`
`A P P E A R A N C E S:
` PAUL HASTINGS, LLP
` BY: ERIC DITTMANN, ESQUIRE
` 200 Park Avenue
` New York, New York 10166
` 212.318.6432
` ericdittmann@paulhastings.com
` Counsel for Helsinn
` LERNER DAVID
` BY: RUSSELL W. FAEGENBURG, ESQUIRE
` 600 South Avenue West
` Westfield, New Jersey 07090
` 908.654.5000
` rfaegenburg@lernerdavid.com
` Counsel for Dr. Reddy's
`
`ALSO PRESENT:
`
` James Li
`
` Derek Rose, Video Specialist
`
`Page 3
`
` - - -
` I N D E X
` - - -
` Testimony of: JOANNE BROADHEAD
` By Mr. Dittmann 9
`
` - - -
` E X H I B I T S
` - - -
`
`NO. DESCRIPTION PAGE
`
`Exhibit Expert Report 8
`Broadhead-
`1
`
`Exhibit Reply Expert Report 8
`Broadhead-
`2
`
`Exhibit Patent 6,130,208 78
`Broadhead-
`3
`
`Exhibit Abstract, Trends in 121
`Broadhead- Stability Testing, with
`4 Emphasis on Stability
` During Distribution and
` Storage
`
`Exhibit Stability Batches 136
`Broadhead- Manufactured by SP
`5 Pharmaceuticals
`
`Exhibit Pharmaceutical Dosage 142
`Broadhead- Forms: Parenteral
`6 Medications, Volume I
`
`Exhibit Medicines Compendium 149
`Broadhead- 2002
`7
`
`1
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`
`NO. DESCRIPTION PAGE
`Exhibit Patent 9,066,980 164
`Broadhead-
`8
`Exhibit Defendant's Contested 186
`Broadhead- Facts
`9
`Exhibit Reply Expert Report of 188
`Broadhead- Patrick DeLuca, Ph.D.
`10
`Exhibit Liquid Pharmaceutical 192
`Broadhead- Formulations of
`11 Palonosetron
`Exhibit Rebuttal Expert Report 206
`Broadhead- of Gordon L. Amidon,
`12 Ph.D.
`Exhibit Letter dated 1/3/12 214
`Broadhead-
`13
`Exhibit Excerpt of Formulation 226
`Broadhead- Book for Intravenous
`14 Dosage Forms
`Exhibit Approval Letter 235
`Broadhead-
`15
`Exhibit Document dated 7/23/01, 241
`Broadhead- Lehmann to Talarico
`16
`Exhibit Revised Study Report 245
`Broadhead- dated 8/9/02
`17
`Exhibit Declaration of Daniele 252
`Broadhead- Bonadeo
`18
`
`NO. DESCRIPTION PAGE
`Exhibit Portion of Reddy's NDA 261
`Broadhead- Submission
`19
`Exhibit Long-term Stability 268
`Broadhead- Study
`20
`Exhibit Letter dated 9/1/15 271
`Broadhead-
`21
`Exhibit NDA Approval Letter 274
`Broadhead-
`22
`Exhibit Corrected Summary, 276
`Broadhead- Alternate Formulations
`23 Tried
`Exhibit Laboratory Notebook 279
`Broadhead-
`24
`Exhibit Laboratory Notebook 283
`Broadhead-
`25
`Exhibit Laboratory Notebook 284
`Broadhead-
`26
`Exhibit Warning Letter dated 300
`Broadhead- 11/5/15
`27
`Exhibit Excerpt of Laboratory 332
`Broadhead- Notebook
`28
`Exhibit Excerpt of Handbook of 334
`Broadhead- Pharmaceutical
`29 Excipients, Third
` Edition
`
`Page 5
`
`
`
`2 (Pages 2 to 5)2 (Pages 2 to 5)
`
`Page 2 of 5
`
`

`
`Page 6
`
`Page 8
`
`NO. DESCRIPTION PAGE
`Exhibit An Examination of the 337
`Broadhead- Decomposition of
`30 Dextrose Solution During
` Sterilization by W.T.
` Wing
`Exhibit Analytical Test Request 346
`Broadhead- and Report
`31
`Exhibit Analytical Test Request 350
`Broadhead- and Report
`32
`Exhibit Analytical Test Request 351
`Broadhead- and Report
`33
`Exhibit Patent 8,729,094 377
`Broadhead-
`34
`Exhibit Expert Report of Patrick 378
`Broadhead- P. DeLuca, Ph.D.
`35
`Exhibit Patent 7,947,724 386
`Broadhead-
`36
`Exhibit Exhibit 1012, 397
`Broadhead- Declaration of Dr.
`37 Joanne Broadhead in
` Support of Petition Post
` Grant Review of Claims
`
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`
` (Exhibit No. Broadhead-1,
` Expert Report, and No.
` Broadhead-2, Reply Expert Report,
` were marked for identification.)
` THE VIDEOGRAPHER: We are
` now on the record. This begins
` Videotape No. 1 in the deposition
` of Joanne Broadhead in the matter
` of Helsinn Healthcare, SA, and
` Roche Palo Alto, LLC, versus
` Dr. Reddy's Laboratories Limited,
` et al., in the United States
` District Court for the District of
` New Jersey, Civil Action
` No. 12-2867-MLC-DEA.
` Today is Friday, April 29th,
` 2016, and the time is 9:46 AM.
` This deposition is being
` taken at 600 South Avenue West in
` Westfield, New Jersey, at the
` request of Paul Hastings, LLP.
` The videographer is Derek
` Rose of Magna Legal Services, and
` the court reporter is Connie Kent
`Page 9
`
` of Magna Legal Services.
` Will counsel and all parties
` present state their appearances
` and whom they represent.
` MR. DITTMANN: Eric
` Dittmann, Paul Hastings, on behalf
` of Helsinn.
` MR. FAEGENBURG: Russ
` Faegenburg of Lerner David on
` behalf of the Dr. Reddy's
` defendants.
` THE VIDEOGRAPHER: Will the
` court reporter please swear in the
` witness?
` DR. JOANNE BROADHEAD, having
` been first duly sworn, was
` examined and testified as follows:
` - - -
` E X A M I N A T I O N
` - - -
`BY MR. DITTMANN:
` Q. Good morning, Dr. Broadhead.
` A. Good morning.
` Q. Have you been deposed
`
`
`
`3 (Pages 6 to 9)3 (Pages 6 to 9)
`
`Page 7
`
` - - -
` DEPOSITION SUPPORT INDEX
` - - -
`
`Direction to Witness Not to Answer
`Page Line Page Line Page Line
`14 11 266 13
`
`1
`2
`3
`
`45
`
`6
`7
`
`89
`
`10
`Request for Production of Documents
`11
`Page Line Page Line Page Line
`12 None
`13
`14
`15
`Stipulations
`16
`Page Line Page Line Page Line
`17 None
`18
`19
`20 Question Marked
`21
`Page Line Page Line Page Line
`22 None
`23
`24
`
`Page 3 of 5
`
`

`
`Page 174
`
`1
`BY MR. DITTMANN:
`2
` Q. Do you understand or have
`3
`any understanding that there are
`4
`chelating agents that are used in
`5
`applications other than pharmaceuticals,
`6
`for example, detergents, industrial
`7
`processes?
`8
` A. I don't have any expertise
`9
`in that, but I don't doubt that that
`10 would be true.
`11
` Q. And do you have any reason
`12
`to disagree there would be a large number
`13
`of chelating agents that could be used in
`14
`other processes besides pharmaceuticals?
`15
` A. So I'm -- my expertise is in
`16
`pharmaceuticals, so I -- I don't really
`17 want to comment on what might be the case
`18
`outside the pharmaceutical field.
`19
` Q. Fair enough.
`20
` Please turn to Paragraph 95
`21
`of your reply report. And here you were
`22
`discussing Example 13 of the prior art
`23
`'333 patent, correct?
`24
` A. Yeah. I'm just reading the
`Page 175
`
`1
`context of that.
`2
` Q. Sure, take your time.
`3
` A. Okay.
`4
` Q. I want to focus you on the
`5
`second to last sentence of that
`6
`paragraph, which states:
`7
` "Thus, such instability was
`8
`an inherent feature of the prior art
`9
`formulation."
`10
` Do you see that?
`11
` A. Yeah.
`12
` Q. What did you mean when --
`13 what did you mean by "instability was an
`14
`inherent feature"?
`15
` A. So -- so this is -- if you
`16
`go further up where it says:
`17
` "I understand that inherent
`18
`properties can be relied upon in an
`19
`obviousness analysis."
`20
` That information was
`21
`provided to me by Mr. Faegenburg about
`22
`inherent properties.
`23
` The -- the '980 patent
`24
`describes the Example 13 of the -- of the
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`Page 176
`'333 patent of not having the desired
`stability of one to two years, something
`like that. Therefore, not -- the
`stability is an inherent feature of that
`formulation which is described in the
`Berger patent. That's my interpretation.
` Q. So Example 13 had a
`particular amount of palonosetron and
`certain other ingredients in it, right?
` A. That's correct.
` Q. And that formulation has a
`particular room temperature stability,
`correct?
` A. Can I -- can I see -- can I
`just have a look at how it's described?
` MR. FAEGENBURG: In the
` Berger patent? Oh.
` THE WITNESS: Yeah, maybe
` it's the Berger patent I need to
` look at, actually.
`BY MR. DITTMANN:
` Q. Well, I can represent to you
`that the ingredients of the Berger,
`Example 13, is at the bottom of Column 1.
`Page 177
`
`1
` A. Right. Okay.
`2
` Q. So you see that?
`3
` A. And somewhere in this
`4
`paragraph, if I can just find the right
`5
`place -- so yeah, the top of Column 2, it
`6
`states that the shelf stability is less
`7
`than the one to two-year period required.
`8
` Q. So you're going by the
`9
`representation in the patent in terms of
`10
`the stability of the Example 13
`11
`formulation, correct?
`12
` A. Yeah. But the stability
`13 must be property of the formulation.
`14
` Q. Stability is an inherent
`15
`property of the formulation based on its
`16
`ingredients and the amounts of those
`17
`ingredients, correct?
`18
` A. So if -- I'm not quite sure
`19 what you're asking me. Can you -- can
`20
`you just rephrase that?
`21
` Q. Sure.
`22
` The stability of a
`23
`formulation at any given -- any given
`24
`storage condition is a function of its
`
`
`
`45 (Pages 174 to 177)45 (Pages 174 to 177)
`
`Page 4 of 5
`
`

`
`Page 178
`1
`ingredients and the amounts of those
`2
`ingredients, right?
`3
` A. Yeah. Pretty much. Yeah.
`4 Yeah. I'm -- there -- there are some
`5
`other factors that come into play. So
`6
`you know, for example, for a parenteral
`7
`product you need to be concerned about
`8
`sterility and that will be dependent on
`9
`containment closure and that sort of
`10
`thing as well.
`11
` So in terms of -- in terms
`12
`of -- if you want to limit it to sort of
`13
`chemical stability, then generally
`14
`speaking it will be determined by the
`15
`composition.
`16
` Q. And going back to your
`17
`statement that stability was an inherent
`18
`feature, are you referring to an inherent
`19
`feature being a property of the
`20
`formulation?
`21
` A. Well, yeah, in that sense,
`22
`I'm referring -- you know, the -- I'm --
`23
`based on what I understand is the patent
`24
`law around inherit properties, yes, I'm
`Page 179
`
`1
`considering the stability of that
`2
`formulation, to be a property of that
`3
`formulation.
`4
` Q. And that inherit property
`5
`you're relying upon is based on
`6
`information provided in the '980 patent,
`7
`correct?
`8
` A. The information about
`9
`stability is in the '980 patent, yes.
`10
` Q. Right. And you're relying
`11
`on that statement in the patent?
`12
` A. I'm relying on it for --
`13
`for -- where am I relying on it -- yeah,
`14
`to -- in this particular paragraph, that
`15 would be correct, yes.
`16
` Q. Okay. Can we go back to our
`17
`Claim 5 of the '980 patent? We were
`18
`talking earlier about a formulation made
`19
`according to Claim 5.
`20
` Do you remember that?
`21
` A. Yes, I do.
`22
` Q. Now, talking just about the
`23
`ingredients in Claim 5 and the amounts,
`24 would you agree that that formulation
`
`Page 180
`1 would have a particular room temperature
`2
`stability, correct?
`3
` MR. FAEGENBURG: Objection,
`4
` vague.
`5
` THE WITNESS: Well, in terms
`6
` of the reading of the claims --
`7
`BY MR. DITTMANN:
`8
` Q. I'll strike that. I'm
`9
`sorry. I'll make it easier for you.
`10 Maybe we'll just use the example for
`11
`formulation, it might be easier for you
`12
`for these questions. I don't want to bog
`13
`us down in claims for this point.
`14
` A. Okay.
`15
` Q. So the Example 4
`16
`formulation, which is at the bottom of
`17
`Column 7, right?
`18
` A. Yes.
`19
` Q. Which you understand to be
`20
`the Aloxi formulation?
`21
` A. I do understand that, yes.
`22
` Q. Okay. And would you agree
`23
`that the Example 4 formulation has a room
`24
`temperature stability property, correct?
`Page 181
`1
` A. Well, the -- there's no data
`2
`provided to show me that, and the --
`3
`the -- and it doesn't actually state
`4
`that, either, in the -- in the -- you
`5
`know, it describes it as a representative
`6
`formulation.
`7
` Q. I was just asking just if it
`8
`has a stability property, that's all.
`9
`I'm not asking if it's disclosed. I'm
`10
`asking if Example 4 -- if you made
`11
`Example 4 and tested it, it would have a
`12
`particular room temperature stability?
`13
` A. So you're not asking me
`14 whether this has 24 months or any other
`15
`shelf life?
`16
` Q. No.
`17
` A. Well, as a formulation -- I
`18 mean, this is -- this is a -- so this is
`19
`a -- you know, this is the sort of the
`20
`quantitative formula, you would have to
`21 make it as a pharmaceutical product in a
`22
`vial, sterilize it and do all that.
`23
` But assuming that that's
`24
`understood, then it would have a shelf
`
`
`
`46 (Pages 178 to 181)46 (Pages 178 to 181)
`
`Page 5 of 5