HIGHLY CONFIDENTIAL - OUTSIDE COUNSEL EYES ONLY
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`Page 1
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`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`- - - - - - - - - - - - - - - - - - - - - - -x
`HELSINN HEALTHCARE, S.A. and ROCHE PALO
`ALTO, LLC,
`
` Plaintiffs,
` -against-
`DR. REDDY'S LABORATORIES, LTD., DR. REDDY'S
`LABORATORIES, INC., SANDOZ INC., TEVA
`PHARMACEUTICALS USA, INC., and TEVA PHARMACEUTICAL
`INDUSTRIES, LTD.,
`
` Defendants.
` - - - - - - - - - - - - - - - - - - - - - -x
` CONFIDENTIAL
`
` Videotaped deposition of BERTRAM SPILKER,
`taken pursuant to Notice, was held at the Law
`Offices of PAUL HASTINGS, 75 East 55th Street, New
`York, New York, commencing January 16, 2014,
`10:00 a.m., on the above date, before Amanda
`McCredo, a Court Reporter and Notary Public in the
`State of New York.
` - - -
`
` MAGNA LEGAL SERVICES
` 1200 Avenue of the Americas
` New York, New York 10026
` (866) 624-6221
`
`Magna Legal Services
`
`Healthcare Exhibit 2020
`Dr. Reddy's Laboratories, Ltd., et al. v. Helsinn Healthcare S.A.
`Trial PGR2016-00008
`
`Page 1 of 5
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`

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`HIGHLY CONFIDENTIAL - OUTSIDE COUNSEL EYES ONLY
`Page 2
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`Page 3
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`Page 5
`
` specific agreement about whether or not
` discussions between an expert and the attorney
` are discoverable on breaks. We thought it
` would be useful to just make an agreement one
` way or the other, so that both sides knew.
` It would be fine either way with us. We
` either agree we're not going to ask about those
` kinds of discussions, or we're going to agree
` those kind of discussions are not going to
` happen.
` MR. DITTMANN: I certainly think that a
` witness shouldn't be talking about the
` substance of the testimony during the breaks,
` once they're sworn is.
` MR. COHEN: Okay.
` MR. DITTMANN: Is that what you're asking?
` MR. COHEN: That's fine, yeah. As long as
` we -- so I think we'd like to have an agreement
` that given that's the case, the parties will
` operate under that agreement. And so that way
` there won't be an issue about asking about
` those questions during the -- about what
` happens during the break.
` MR. DITTMANN: Also, I'd note as a
` housekeeping matter, this is the first
`2 (Pages 2 to 5)
`
` S T I P U L A T I O N S
` IT IS HEREBY STIPULATED AND AGREED by and
` between the attorneys for the respective
` parties herein; that filing, sealing, and
` certification be and the same are hereby
` waived.
`
` IT IS FURTHER STIPULATED AND AGREED that
` all objections, except as to the form of the
` question shall be reserved to the time of the
` trial.
`
` IT IS FURTHER STIPULATED AND AGREED that
` the within deposition may be signed and sworn
` to before any officer authorized to administer
` an oath, with the same force and effect as if
` signed and sworn to before the Court.
`
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`Magna Legal Services
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`Page 4
`1
` THE VIDEOGRAPHER: We're now on the record
`2
` and recording. This is going to begin disc
`3
` number 1 in the deposition of Bertram Spilker
`4
` in the matter of Helsinn Healthcare S.A.,
`5
` et al. vs. Dr. Reddy's Laboratories, et al. in
`6
` the U.S. District Court for the District of New
`7
` Jersey, Number 11-CV-03962, and related cases.
`8
` Today is January 16, 2014. The time is
`9
` 10:00 a.m. This deposition is being taken at
`10
` 75 East 55th Street in New York at the request
`11
` of Eric Dittmann of Paul Hastings.
`12
` The videographer is James Christe, and the
`13
` court reporter is Amanda McCredo. The court
`14
` reporter has already noted everyone's
`15
` appearance, and so she can now swear in today's
`16
` witness.
`17
` Thank you.
`18
`B E R T R A M S P I L K E R, the witness herein,
`19
` after having been first duly sworn by a
`20
` Notary Public of the State of New York,
`21
` was examined and testified as follows:
`22
`EXAMINATION BY
`23 MR. DITTMANN:
`24
` MR. COHEN: One housekeeping matter before
`25
` we begin. I think the parties haven't had any
`
`A P P E A R A N C E S:
`PAUL HASTINGS
` Attorneys for Plaintiffs
` 75 East 55th Street
` New York, New York 10022
`BY: ERIC DITTMANN, ESQUIRE
` ELINA SAVIHARJU, ESQUIRE
`
`1
`2
`3
`4
`
`56
`
`BUDD LARNER, A Professional Corporation
` Attorneys for Defendants
`7
` DR. REDDY'S LABORATORIES, LTD., DR.
` REDDY'S LABORATORIES, INC.
`8
` 150 JFK Parkway
` Short Hills, New Jersey 07078
`9
`BY: HOWARD WANG, ESQUIRE
`10
`11 MORRISON FOERSTER
` Attorneys for Defendant
`12
` SANDOZ INC.
` 1290 Avenue of the Americas
`13
` New York, New York 10104
`BY: JAYSON L. COHEN, ESQUIRE
`14
`15
`16
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`25
`
`WINSTON & STRAWN
` Attorneys for Defendants
` TEVA PHARMACEUTICALS USA, INC., and
` TEVA PHARMACEUTICAL INDUSTRIES, LTD.
` 35 West Wacher Drive
` Chicago, Illinois 60601
`BY: BRENDAN BARKER, ESQUIRE
`
`Page 2 of 5
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`

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`HIGHLY CONFIDENTIAL - OUTSIDE COUNSEL EYES ONLY
`Page 58
`
`Page 60
`
`1
`"using" is very vague.
`2
` Q Let me try to be a little bit more clear
`3
`then.
`4
` I want you to consider just a set of
`5
`instructions on a piece of paper that says, You can
`6 make new formulation X by this method and use it to
`7
`treat emesis, okay?
`8
` A Okay.
`9
` Q Based on that document alone, without any
`10
`testing of the new proposed formulation, would a
`11
`patent application be filed in the pharmaceutical
`12
`industry?
`13
` A It really does depend upon a number of
`14
`other factors. Say that one item in the
`15
`formulation, the salt used of the drug, which was a
`16
`case I'm thinking of in my mind where it turned out
`17
`to be somewhat toxic, so they just changed the salt.
`18
` So if you just change the salt to a
`19
`hydrochloride salt or to some other salt, that might
`20
`be sufficient to file the patent, because they would
`21
`have known that it didn't have the toxicity that
`22
`this other salt did, and they would know the
`23
`scientific reason why they changed it and that they
`24
`had confidence that they knew the result would not
`25
`lead to toxicity.
`
`Page 59
` Q And you think that would be worthy of a
`patent application?
` A I think it would be critical. I'm saying
`it's possible.
` Q Okay. Can you think of another instance
`besides possibly a change in a salt form where a
`patent application would be filed on merely a piece
`of paper describing the idea?
` MR. COHEN: Objection; incomplete
` hypothetical.
` Q For a new formulation?
` MR. COHEN: Objection; incomplete
` hypothetical.
` A The answer is yes, because if you go to
`the definition of "ready for patenting," it says
`that you don't need to reduce it to practice. You
`can just have a chemist describe a new formulation
`for any a variety of reasons, and that might be
`sufficient to file a patent.
` So I think the answer is clearly that you
`don't necessarily need testing, which could be
`considered as part of reducing it to practice.
` Q To make sure I understand, your opinion is
`that you don't need testing of a pharmaceutical drug
`product in order for that product to be ready for
`
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`
`1
`patenting, in your view?
`2
` A I did not say that.
`3
` Q I'm trying to understand what you're
`4
`saying.
`5
` A I said that in some cases, in some cases
`6
`it's necessary to have testing to some degree, could
`7
`be animal testing, in order to be confident that you
`8
`have enough information so that you are ready for
`9
`patenting. In other case, chemists or others in a
`10
`company, formulation experts, may have identified a
`11
`problem and would not need to have any testing.
`12
` Q Do you believe, in this particular case,
`13
`that the claimed formulations quired testing in
`14
`order to determine they were ready for patenting?
`15
` A Yes.
`16
` Q Let's then turn to your opening report.
`17
`I'll get to it in a second. Paragraph 47, page 17.
`18
`I think it will be easier to use paragraph 46. I
`19 want to focus on the second part of the
`20
`ready-for-patenting test that you discuss in this
`21
`paragraph.
`22
` Based on what you just told me, would you
`23
`agree that the second part of the
`24
`ready-for-patenting test doesn't have an application
`25
`in this particular case?
`
`Page 61
`1
` A I cannot think of an example where point
`2
`number 2 in paragraph 46 would have an application
`3
`in this test, but I reserve the right to come up
`4 with one if something occurs to me at a later time.
`5
` Q Just to clarify, you just said "test"; you
`6 mean case, in this case, right?
`7
` A In this case, yes, sorry.
`8
` Q So sitting here today, you cannot think of
`9
`a reason why the second part of the
`10
`ready-for-patenting test in paragraph 46 of your
`11
`opening report has any relevance to this case?
`12
` A Actually, I mean, it is relevant, because
`13
`if they just had that in the patents-in-suit, then I
`14
`think it does have relevance. I take it back.
`15
`Because that would -- obviously, hadn't thought of
`16
`it in the way you mentioned, because I believe the
`17
`claimed invention was reduced to practice before the
`18
`critical date, which is the first point. So that's
`19 where I spent a lot of my time thinking about this
`20
`case.
`21
` But if you look at the patents-in-suit,
`22
`they describe and give examples which would be the
`23
`descriptions and/or drawings of the claimed
`24
`invention dated before it was sufficiently detailed.
`25 And the descriptions and drawings of the claimed
`16 (Pages 58 to 61)
`
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`

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`HIGHLY CONFIDENTIAL - OUTSIDE COUNSEL EYES ONLY
`Page 62
`invention at Syntex, insofar as the manufacturing
`instructions, were sufficiently detailed to have
`allowed Oread to have made the product.
` So just now focusing on the manufacturing
`part, that was really the process that Oread
`followed, what Syntex had already put in the
`formulation book.
` So now, I guess, having thought this
`through a little bit more, I think that point
`number 2 does have bearing in this case.
` Q Okay. So let's talk about that then.
` Earlier, you said that with respect to the
`claim formulations in this case, you would need to
`have testing to know if it was ready for patenting,
`right? You just said that five minutes ago?
` A Testing to know if it was ready for
`patenting -- testing -- okay.
` Q So then let's focus on the second part of
`your ready-for-patenting test in paragraph 46.
` Can you confirm for me that this second
`part of the test doesn't require any testing of the
`proposed new drug formulation?
` A That's true about the testing of the
`proposed, but it depends what you mean by testing.
`I was differentiating the testing from the
`
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`Page 63
`1 manufacturing, and the second part says, "to have
`2
`enabled a person of ordinary skill in the art to
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`practice the claimed invention."
`4
` And I'm saying the Syntex formulation look
`5
`was sufficient to have allowed a person of ordinary
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`skill in the art to have manufactured the product
`7
`which would have been necessary if you were going to
`8
`test it.
`9
` Q Right. You would need to be able to make
`10
`the product first?
`11
` A Yes.
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` Q And then you would test it to determine if
`13
`it had any usefulness or had favorable properties,
`14
`right?
`15
` MR. COHEN: Objection.
`16
` A Yes. If you cannot make it or have it,
`17
`you cannot test it.
`18
` Q Right. And as you testified earlier, you
`19
`would need to test the proposed new formulation to
`20
`determine whether it was worthy of patent
`21
`application; i.e., ready for patenting, correct?
`22
` MR. COHEN: Objection; mischaracterizes
`23
` his prior testimony. Calls for a legal
`24
` conclusion.
`25
` A It seems to me to say that it was reduced
`
`Page 64
`1
`to practice, you would need to -- I think what
`2
`you're doing is changing ready-for-patenting to what
`3
`I would call reduced-to-practice.
`4
` And I would say you would have had to have
`5
`tested it in order to reduce it to practice, not
`6
`that it was ready for patenting. And if you used
`7
`that phrase before, then I must have interpreted it
`8
`in terms of reduced to practice, because that does
`9
`require that you have had made the product.
`10
` Q So let me make sure I understand your
`11
`opinions in this case, for the Court.
`12
` Your opinion is that a set of
`13 manufacturing instructions of how to make a
`14
`palonosetron formulation without anything else is
`15
`sufficient to satisfy the ready-for-patenting test?
`16
` MR. COHEN: Objection; mischaracterizing
`17
` his prior testimony and his opinions.
`18
` A I suppose -- I am not a legal expert to
`19
`understand the full interpretation of the word
`20
`"practice the claimed invention," and I was taking
`21
`that to have said, at least initially, you have to
`22
`have manufactured it; so that a legal expert might
`23
`question my use of the association with .2 with
`24 manufacturing.
`25
` But, in this particular case, obviously,
`Page 65
`1
`it was manufactured, and it was manufactured,
`2
`depending upon how you use that word, it was
`3 manufactured by 1995.
`4
` Q And your opinion is that because the
`5
`claimed palonosetron product was manufactured by
`6
`1995, that fact alone made it ready for patenting?
`7
`That's your analysis, correct?
`8
` MR. COHEN: Objection; mischaracterizes
`9
` prior testimony.
`10
` A Now you really are taking one aspect of
`11
`the ready-for-patenting criteria and saying it was
`12
`ready for patenting at a time based on a point that
`13
`I was not limiting myself to. So I did not -- I
`14
`don't agree with your last comment.
`15
` Q Okay. I'm not trying to say what your
`16
`opinions are limited to; I'm trying to understand
`17
`what you believe and don't believe. Okay?
`18
` I want to understand, do you have an
`19
`opinion that merely making the claimed formulations,
`20
`alone, with nothing more, is sufficient to satisfy
`21
`the ready-for-patenting test?
`22
` MR. COHEN: Objection to the extent it
`23
` calls for a legal conclusion.
`24
` A It is my opinion that just manufacturing
`25
`the product alone is not sufficient for
`17 (Pages 62 to 65)
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`HIGHLY CONFIDENTIAL - OUTSIDE COUNSEL EYES ONLY
`Page 66
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`Page 68
`stated you were further informed by counsel about
`the definitions of the following terms, including
`reduction of practice, what information did you
`obtain from counsel that was different from what you
`previously had?
` A There weren't --
` MR. COHEN: Objection; mischaracterizes
` prior testimony.
` A There weren't any differences; it was more
`an issue that I was informed about writing down
`these definitions.
` Q You state in your report that you were
`further informed by counsel, right?
` A That's the word. I think that was -- it
`could have been a word that was inadvertently
`inserted, or sentences inserted. Reading it now --
`I would say that -- my opening report was not as
`clear about these definitions.
` In discussing the other experts, Peck and
`others, it was necessary to make sure that the
`definitions were precisely identified. And that was
`what was done here.
` I think this is a turn of phrase that is
`being taken out of context, as I stated a moment
`ago, because I don't believe that I was given any
`Page 69
`
`1
`ready-for-patenting.
`2
` Q In this case, correct?
`3
` A In this case.
`4
` Q Can you turn to your reply report, please,
`5
`paragraph six. It's on page 2.
`6
` A Right.
`7
` Q It states, "In addition to the legal
`8
`standards I discussed in my opening report, I have
`9
`been further informed by counsel about the
`10
`definitions of the following terms as they relate to
`11
`this case."
`12
` Do you see that?
`13
` A Yes.
`14
` Q What further information were you given by
`15
`counsel after your opening report?
`16
` A I think it was primarily a question that I
`17
`should indicate the definitions, which I put here,
`18
`so that it was more clear in going from A to E,
`19
`paragraph seven to 11, specifically what we're
`20
`dealing with when we use these terms in reference to
`21 my comments on Dr. Peck and the other experts for
`22
`the other side in terms of their reports.
`23
` I don't think that I was provided any
`24
`different definitions, I think it was really that we
`25
`should actually list those and describe them here.
`Page 67
`1
` Q Maybe to make things a bit simpler, if you
`2
`turn to the reduction of practice definition in
`3
`paragraph eight, the second part of that test is the
`4
`portion of the test that you testified earlier
`5
`should have been added to your opening report,
`6
`correct?
`7
` A Yes.
`8
` Q And you learned about the second part of
`9
`this test in discussions with counsel in preparing
`10
`your reply expert report?
`11
` MR. COHEN: Objection; mischaracterizes
`12
` prior testimony.
`13
` A I didn't say that at all.
`14
` Q What's different about your definition of
`15
`reduction of practice in paragraph eight of your
`16
`reply report versus the definition that you said was
`17
`erroneous in your opening report?
`18
` A I would say that this second part was
`19
`inadvertently left out of the first opening report.
`20
` Q Okay.
`21
` So then is that the portion that you
`22
`explain in paragraph six that's based on what you
`23 were further informed by counsel about?
`24
` A I don't believe that's the case.
`25
` Q Okay. Well, then tell me, since you
`
`1
`further instructions or definitions.
`2
` Q So this paragraph six of your reply report
`3
`is incorrect? It's not true what you state there?
`4
` A I would -- I have defined it in terms of
`5
`how I recall it, which was that I was informed by
`6
`them, further informed by them that a description of
`7
`the definitions of the following terms was necessary
`8
`as they relate to this case, my opening report and
`9 my reply report.
`10
` If you were to go through and identify --
`11
`to me, this is a grammatical issue that we're trying
`12
`to discuss. And I think you could find other
`13
`grammatical issues. I think this is not an error,
`14 mistake, or anything like that, but just a minor or
`15
`trivial grammatical issue.
`16
` Q So you were informed by counsel that these
`17
`definitions were necessary to include in your reply
`18
`report, correct?
`19
` MR. COHEN: Objection; mischaracterizes
`20
` prior testimony.
`21
` A I would say that they were important to
`22
`include. I don't think that they were necessary,
`23
`but I think they were important to include so that
`24
`it's clear that when I make certain comments about
`25
`Peck and others, that it's clear which definitions
`18 (Pages 66 to 69)
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