Case 1:14-cv-02758-PAC Document 153 Filed 02/24/17 Page 1 of 180
`H1N7KOW1
`
`732
`
`14 Civ. 2758 (PAC)
`14 Civ. 5575 (PAC)
`14 Civ. 7934 (PAC)
`15 Civ. 3935 (PAC)
`
`
`
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF NEW YORK
`------------------------------x
`
`KOWA PHARMACEUTICALS AMERICA,
`INC., et al.,
`
`
`
` Plaintiffs,
`
`
`
` v.
`
`
`AMNEAL PHARMAEUTICALS, LLC, et
`al.,
`
`
`
` Defendants.
`
`------------------------------x
` New York, N.Y.
` January 23, 2017
` 9:30 a.m.
`
`Before:
`
`
`HON. PAUL A. CROTTY,
`
`
`
` District Judge
`
`
`APPEARANCES
`
`
`MINTZ LEVIN COHN FERRIS GLOVSKY & POPEO, P.C.
` Attorneys for Plaintiffs Kowa and Nissan
`BY: KATHLEEN B. CARR
` DAVID G. CONLIN
` JENNIFER L. DEREKA
` PETER J. CUOMO
`
`MADDOX EDWARDS, PLLC
` Attorneys for Defendant Amneal
`BY: STEVEN A. MADDOX
` JEREMY J. EDWARDS
`
`FLEMMING ZULACK WILLIAMSON ZAUDERER, LLP
` Attorneys for Defendant Sawai
`BY: CRAIG S. KESCH
` -and-
`SUGHRUE MION, PLLC
` Attorneys for Defendant Sawai
`
` SOUTHERN DISTRICT REPORTERS, P.C.
` (212) 805-0300
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`H1N7KOW1
`
`732
`
`14 Civ. 2758 (PAC)
`14 Civ. 5575 (PAC)
`14 Civ. 7934 (PAC)
`15 Civ. 3935 (PAC)
`
`
`
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF NEW YORK
`------------------------------x
`
`KOWA PHARMACEUTICALS AMERICA,
`INC., et al.,
`
`
`
` Plaintiffs,
`
`
`
` v.
`
`
`AMNEAL PHARMAEUTICALS, LLC, et
`al.,
`
`
`
` Defendants.
`
`------------------------------x
` New York, N.Y.
` January 23, 2017
` 9:30 a.m.
`
`Before:
`
`
`HON. PAUL A. CROTTY,
`
`
`
` District Judge
`
`
`APPEARANCES
`
`
`MINTZ LEVIN COHN FERRIS GLOVSKY & POPEO, P.C.
` Attorneys for Plaintiffs Kowa and Nissan
`BY: KATHLEEN B. CARR
` DAVID G. CONLIN
` JENNIFER L. DEREKA
` PETER J. CUOMO
`
`MADDOX EDWARDS, PLLC
` Attorneys for Defendant Amneal
`BY: STEVEN A. MADDOX
` JEREMY J. EDWARDS
`
`FLEMMING ZULACK WILLIAMSON ZAUDERER, LLP
` Attorneys for Defendant Sawai
`BY: CRAIG S. KESCH
` -and-
`SUGHRUE MION, PLLC
` Attorneys for Defendant Sawai
`
` SOUTHERN DISTRICT REPORTERS, P.C.
` (212) 805-0300
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`Case 1:14-cv-02758-PAC Document 153 Filed 02/24/17 Page 2 of 180
`H1N7KOW1
`
`733
`
`BY: MICHAEL DZWONCZKY AZY S. KOKABI
`
`
`APPEARANCES
`(Continued)
`
`
`KELLEY DRYE & WARREN, LLP
` Attorneys for Defendant Lupin
`BY: DOUGLASS C. HOCHSTETLER
` CONSTANTINE KOUTSOUBAS
`
`ALSO PRESENT:
`
`ANDY CEPREGI, technician
`GEOFF ROBERTS, technician
`BRIAN SPARKS, technician
`
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`Case 1:14-cv-02758-PAC Document 153 Filed 02/24/17 Page 3 of 180
`H1N7KOW1
`
`734
`
`(Trial resumed)
`
`THE COURT: Good morning. Please be seated.
`
`Mr. Maddox?
`
`MR. MADDOX: Good morning, Judge. This morning we're
`
`going to have the testimony --
`
`MR. BAUER: With the court's permission, may I request
`
`permission to address some objections that we couldn't resolve
`
`last night about the slides? Can we do that before the
`
`examination starts so we don't interrupt it?
`
`THE COURT: All right.
`
`MR. BAUER: All right. So under the court's rules,
`
`last night at 7 o'clock defendants served their demonstratives,
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`and it's an 86 page slide back, and possibly if Mr. Maddox
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`could hand up to your Honor the binder.
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`MR. MADDOX: The judge is looking at them right now.
`
`MR. BAUER: OK. If you could look at slides 348 to
`
`355, there is a series of slides that start off saying
`
`prosecution history record of the '993 patent.
`
`THE COURT: Yes.
`
`MR. BAUER: If you actually look at them, it's a
`
`thinly veiled attempt to argue inequitable conduct. For
`
`example, you can see that if we go to slide 355, the title;
`
`record suggests examiner allegedly reviewed over 85 references
`
`in a single day. That's essentially -- the witness has no
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`foundation. In fact, when he was deposed, the witness said he
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`Case 1:14-cv-02758-PAC Document 153 Filed 02/24/17 Page 4 of 180
`H1N7KOW1
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`735
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`"does not have patents on anything." And now he's getting into
`
`patent office procedure. We believe that's beyond clearly --
`
`THE COURT: Why don't you bring that out on
`
`cross-examination?
`
`MR. BAUER: OK, your Honor.
`
`THE COURT: It doesn't seem much of a basis for
`
`objection. I mean I understand your argument, but bring it out
`
`on cross-examination.
`
`MR. BAUER: Thank you, your Honor.
`
`THE COURT: OK. Mr. Maddox, you're all set?
`
`MR. MADDOX: Yes. As I was about to say, your Honor,
`
`we're going to hear from Dr. Kevin Roberts this morning, so we
`
`would like to call Dr. Kevin Roberts.
`
`THE COURT: Dr. Roberts.
`
` KEVIN ROBERTS,
`
` called as a witness by the defendants,
`
` having been duly sworn, testified as follows:
`
`THE COURT: OK, Dr. Roberts, come on up and sit down.
`
`Make yourself comfortable. Bring yourself right up to the
`
`microphone.
`
`MR. MADDOX: Dr. Roberts, there should be some water
`
`there for you.
`
`Your Honor, there are a series of exhibits we're going
`
`to be using today, and they have all been agreed except for one
`
`which I'm not going to include in this list, but I'd like to
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`Case 1:14-cv-02758-PAC Document 153 Filed 02/24/17 Page 5 of 180
`H1N7KOW1
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`736
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`give the list of exhibits that have been agreed as admissible
`
`into evidence.
`
`THE COURT: All right.
`
`MR. MADDOX: DTX-034, 056, 057, 059, 247, 351, 360,
`
`1305, 1308, 1309, 1310, 1311, 1312, 1314, 1315, 1316, 1318,
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`1319, 1327, 1332, 1334, 1335 and 1340. These are all exhibits
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`to which the plaintiff raised no objection in the process.
`
`THE COURT: And you have handed these up? These are
`
`the exhibits in volume 1 and volume 2, exhibits for direct
`
`examination of Dr. Roberts?
`
`MR. MADDOX: Yes, they are.
`
`THE COURT: Any objection?
`
`MR. BAUER: No objection, your Honor.
`
`THE COURT: They are received in evidence.
`
`MR. MADDOX: Thank you.
`
`(Defendant's Exhibits 034, 056, 057, 059, 247, 351
`
`received in evidence)
`
`(Defendant's Exhibits 360, 1305, 1308, 1309, 1310
`
`received in evidence)
`
`(Defendant's Exhibits 1311, 1312, 1314, 1315, 1316
`
`received in evidence)
`
`(Defendant's Exhibits 1318, 1319, 1327, 1332 received
`
`in evidence)
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`(Defendant's Exhibits 1334, 1335 and 1340 received in
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`evidence)
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`Case 1:14-cv-02758-PAC Document 153 Filed 02/24/17 Page 6 of 180
`H1N7KOW1 Roberts - direct
`
`737
`
`DIRECT EXAMINATION
`
`BY MR. MADDOX:
`
`Q. Dr. Roberts, could you introduce yourself to the court.
`
`A. Oh, I'm Kevin John Roberts. I'm the Brotherton professor
`
`of chemical engineering at the University of Leeds in the
`
`United Kingdom.
`
`Q. And what does your job entail there?
`
`A. I'm professor of chemical engineering. I teach chemical
`
`engineering students undergraduate and post-graduate, and I
`
`carry out research mostly in the area of crystal science,
`
`crystallography, crystallization and characterization.
`
`Q. And could you briefly hit the highlights of your
`
`educational background.
`
`A. Yes, happy to do so. So I graduated from what was then the
`
`Portsmouth Polytechnic, now University of Portsmouth, in
`
`applied physics, and stayed on there and did my doctorate in
`
`collaboration which was then the General Electric Company in
`
`crystal growth mechanisms and crystal characterization. From
`
`there I post-doc'd, working with professor John Sherwood, in
`
`the Department of Pure and Applied Chemistry at the University
`
`of Strathclyde, mostly working in the area of industrial
`
`crystallization and also in some of the earlier work on the UK
`
`Singleton radiation source for crystal characterization.
`
`From there I took a Royal Society Fellowship that led
`
`to the Technical University of Aachen, and worked in the
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`Case 1:14-cv-02758-PAC Document 153 Filed 02/24/17 Page 7 of 180
`H1N7KOW1 Roberts - direct
`
`738
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`crystallography there on solid, solid face transformations.
`
`From there was appointed back as a faculty member with tenure
`
`to the University of Strathclyde, where I've done my post-doc.
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`I stayed there for about ten or 11 years and was invited to go
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`to Edinburgh as a professor of chemical process engineering,
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`and to set up a new center in molecular and interface
`
`engineering.
`
`In 2000 I was invited again this time to the
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`University of Leeds to be head of department, where I now am,
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`and during my time there, after head of department, I served as
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`director of research, then set up the Institute for Process
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`Research and Development. And more lately I've been directing
`
`the school's doctoral training center in complex particulate
`
`products and processes.
`
`Q. Have you worked in the field of crystallography?
`
`A. I have.
`
`Q. Have you published in the field of crystallography?
`
`A. I have. I published I guess about more than 250 journal
`
`papers plus conference papers and reviews.
`
`Q. Have you taught the field of crystallography and crystal
`
`characterization?
`
`A. Yes, I've taught at undergraduate level and post-graduate
`
`level.
`
`Q. And have you supervised any the doctoral theses in the
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`area?
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`Case 1:14-cv-02758-PAC Document 153 Filed 02/24/17 Page 8 of 180
`H1N7KOW1 Roberts - direct
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`739
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`A. Yes, I have. I have supervised something around 80
`
`doctoral Ph.D.s, and probably of those, I'm not sure, but
`
`probably half a dozen are still running as current projects.
`
`Q. Now, in your binders and on the screen at the moment, you
`
`will see DTX-1305. Can you tell me what that is?
`
`A. That is my curriculum vitae.
`
`Q. Does it accurately summarize your credentials, work and
`
`awards?
`
`A. I yes, I think it does.
`
`MR. MADDOX: The defendants offer Dr. Roberts as an
`
`expert in the field of polymorphism, crystallization, crystal
`
`form characterization, crystallography, including PXRD
`
`analysis. It's our understanding this is agreed.
`
`THE COURT: Any objection?
`
`MR. BAUER: No, your Honor.
`
`THE COURT: He is recognized as an expert in the
`
`identified fields.
`
`Q. Dr. Roberts, before we begin, how many times before have
`
`you testified as an expert in a trial?
`
`A. I believe just once.
`
`Q. Now, did you prepare a set of demonstrative slides to help
`
`present your testimony today?
`
`A. Yes, I did.
`
`Q. Can we go to DDX-302. What were you asked to do in this
`
`case?
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`Case 1:14-cv-02758-PAC Document 153 Filed 02/24/17 Page 9 of 180
`H1N7KOW1 Roberts - direct
`
`740
`
`A. I was asked by counsel to provide an opinion regarding
`
`anticipation, and in particular whether example 3 of the
`
`published European patent application 0520406 -- herein after
`
`referred to as EP-406 -- inherently anticipates claims 1 and 23
`
`through 25 of the '993 patent.
`
`Q. May we have DDX-303, please. And what legal standard were
`
`you told to apply in doing your work?
`
`A. I was advised by counsel on the legal aspects of this, and
`
`their advice was that a claim is invalid if each and every
`
`element is found in a single prior art reference either
`
`explicitly or inherently.
`
`And I was also advised that a prior art reference
`
`inherently anticipates an invention if it necessarily functions
`
`in accordance with, or includes, all of the claim limitations.
`
`Q. And what conclusion did you reach?
`
`A. I reached the conclusion that it was anticipated.
`
`Q. DDX-304, please, which contains DTX-34.
`
`Dr. Roberts, what is this document?
`
`A. This is the Nissan patent EP-406. This has the full number
`
`of 0520406. Its date of publication is the 30th of December,
`
`1992, and the applicant is Nissan Chemical Industries.
`
`Q. 305, please, DDX-305 containing DTX-34 at 985. What is the
`
`EP-406? What's the subject matter of the EP-406?
`
`A. The subject matter is concerning the drug pitavastatin,
`
`which is useful for the prevention and treatment of
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`Case 1:14-cv-02758-PAC Document 153 Filed 02/24/17 Page 10 of 180
`H1N7KOW1 Roberts - direct
`
`741
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`hyperlipidemia and arteriosclerosis. And you can see here I've
`
`extracted aspects from the patent, and you can see in the first
`
`aspect I've pulled out, you can see it indicates it's
`
`prevention or treatment of hyperlipidemia, arteriosclerosis,
`
`etc. And in the second excerpt on the bottom of the page,
`
`towards the bottom of the page, you can see it refers to
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`quinoline carboxylic acid derivatives as HMG-COA reductase
`
`inhibitors.
`
`Q. Let me go to DDX-306 which contains DTX-34 at 994.
`
`Doctor, what is this? What have you extracted here?
`
`A. This is example 3 of the same patent, and basically it
`
`describes a preparative route for the preparation of
`
`pitavastatin calcium salt, and it highlights that the end
`
`product are white crystals with a melting point of 190-192
`
`deposed.
`
`Q. Is this the part of the EP-406 that you believe anticipates
`
`the claims?
`
`A. Yes, I believe it is.
`
`Q. Go to DDX-307 which contains claims 1 and 23 through 25 of
`
`the '993 patent.
`
`A. So these are the patent claims concerned for the '993
`
`patent that I believe are anticipated. Basically these are
`
`claims 1, 24, which are broadly equivalent, and 23 and 25 which
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`are broadly equivalent.
`
`Q. And in what manner does claim 1 and 24 claim form A?
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`Case 1:14-cv-02758-PAC Document 153 Filed 02/24/17 Page 11 of 180
`H1N7KOW1 Roberts - direct
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`742
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`A. So all four claims relate to the x-ray diffraction data
`
`associated with the claims. In claims 1 and 24 you see that
`
`polymorph A is claimed through a characteristic x-ray
`
`diffraction pattern.
`
`X-ray diffraction is a routine technique for the
`
`characterization of crystal forms. And in an x-ray diffraction
`
`pattern you get a pattern, or diffractogram some call, where
`
`you have an angular scale, which is the angle at which the
`
`diffraction is seen and which is usually horizontal, and a
`
`vertical scale, which is the intensity of that diffraction
`
`peak. And you can see that it gives data in terms of angles.
`
`If you just look at the first one, it starts 2-theta at five,
`
`brackets S, and that tells there is a diffraction peak at
`
`around five degrees and S is strong. You see there is a
`
`qualitative assessment of the strengths of the diffraction
`
`patterns. And claims 1 and 24 both do that. 1 describes a
`
`range of forms in the patent, and 24 is specific to form A.
`
`Then below that, matched side by side, are claims 23
`
`and 25. Here they are much the same style, but this time
`
`instead of giving a diffraction peak list and intensity
`
`evaluation, they just refer to the experimental data, which you
`
`see is referred to as figure 1 on both sides. And I will come
`
`on to both of these in the later part of my analysis.
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`Q. Can we have DDX-308, please. Doctor, can you give the
`
`court a high-level overview of the basis for your conclusion.
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`Case 1:14-cv-02758-PAC Document 153 Filed 02/24/17 Page 12 of 180
`H1N7KOW1 Roberts - direct
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`743
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`A. Yes, I can. So this forms basically three components.
`
`Firstly, plaintiff Nissan's own scientific data and
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`conclusions that they submitted to the European patent office,
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`which I give the abbreviation of EPO, basically through the
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`example 3 of EP-406 that I've just shown, and their conclusion
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`that it inevitably, directly and unambiguously produces the
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`form A of pitavastatin calcium.
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`Secondly, Nissan's --
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`THE COURT: Doctor, excuse me. The "inevitably,
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`directly and unambiguously," where is that taken from? Is that
`
`from the '406?
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`THE WITNESS: No, that's taken from the data that
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`Nissan submitted to the European patent office.
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`THE COURT: Thank you.
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`A. The second component is actually the data that underpins
`
`this submission of Nissan to the European patent office.
`
`Basically it's the lab write-ups concerned with that and the
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`conclusions regarding their own replications of their own
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`patent EP-406, so Nissan's submissions to the European patent
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`office regarding their own patent '406.
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`Thirdly, my own independent analysis of the data
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`submitted by Nissan to the European patent office in the '232.7
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`application.
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`Q. May we turn to DDX-309. Turning to your first point, Dr.
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`Roberts. In what context did Nissan make these statements?
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`Case 1:14-cv-02758-PAC Document 153 Filed 02/24/17 Page 13 of 180
`H1N7KOW1 Roberts - direct
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`744
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`Let's go to DDX-310.
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`A. So this relates to --
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`Q. Containing DTX-1327 at 922.
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`A. This relates to the European prosecution history of the
`
`'232.7 application. And the '232.7 application is the European
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`counterpart of the '993 patent that we're considering today.
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`This was published on the 26th of August, 2004, and the
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`applicant was Ciba Specialty Chemical Holdings Incorporated.
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`And herein after I referred to this as the '232.7 application.
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`The full number is 04707232.7.
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`Q. Can we have DDX-311, please. Can you give the court a
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`sense of where these statements fit in in the prosecution
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`history.
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`A. Yes. In going through the prosecution history of the
`
`'232.7 application to the European patent office, I thought it
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`useful just to give some examples from the time line. These
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`all are with respect to documents provided.
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`So, on February 12, 2003 Ciba files the '232.7
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`application; it claims form A of pitavastatin calcium and a
`
`pharmaceutical composition.
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`December 14, 2006 Nissan files a third-party
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`observation. It provides scientific data and conclusions that
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`example 3 of EP-406 teaches inevitably, directly and
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`unambiguously the form A pitavastatin hemicalcium of the '232.7
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`application.
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`Case 1:14-cv-02758-PAC Document 153 Filed 02/24/17 Page 14 of 180
`H1N7KOW1 Roberts - direct
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`745
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`Maybe just for clarity, you see sometimes calcium, you
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`sometimes seal hemicalcium. Hemi refers to half, and sometimes
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`that's abbreviated just to calcium and sometimes it says
`
`hemicalcium, but it means the same thing.
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`The next point in the time line is January the 14th,
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`2008. Nissan then takes over the ownership of the '232.7
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`application. And in February 12, 2010, the European patent
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`office by then has considered the December 14, 2006
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`observation, and accepts Nissan's evidence and conclusion as
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`already articulated, i.e., that example 3 teaches inevitably,
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`directly and unambiguously the crystalline polymorph A of
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`pitavastatin hemicalcium salt of the present application.
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`So then in August 27, 2010 Nissan now claims that
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`example 3 of D1 -- and D1 in documentation refers to EP '406;
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`it's used interchangeably from the reference list of the third
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`party submission -- it now claims that this example 3 of D1
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`cannot directly and unambiguously disclose a crystalline
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`polymorph A according to example 1 of the present application.
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`Application being the '232.7 application.
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`January 25, 2011, the EPO rejects Nissan's change of
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`position of its third-party observation.
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`Q. And you today will be focusing on the actual submissions
`
`made by Nissan in the two boxes?
`
`A. Yes, indeed.
`
`Q. May we have DDX-312, please, containing DTX-1327 at 024.
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`Case 1:14-cv-02758-PAC Document 153 Filed 02/24/17 Page 15 of 180
`H1N7KOW1 Roberts - direct
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`746
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`Doctor, what is this exhibit?
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`A. So, this is the statement made by Nissan to the European
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`patent office regarding EP-406 in respect to their validity --
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`in respect to the validity of Ciba's '232.7 application. This
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`was made in December 14, 2006, and the document was submitted
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`as a third-party observation by a patent agent Wachterhauser &
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`Hartz.
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`Q. Go to DDX-313. Doctor, how did you conclude that this
`
`third party observation was submitted by plaintiff Nissan
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`Chemicals?
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`A. From the examination of the deposition transcripts of Dr.
`
`Mikio Suzuki and Mr. Hiroshi Iwasaki as part of this case, and
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`just extracted in this slide the two components. So the first
`
`question, Dr. Suzuki was asked:
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`"Q. Without getting into your actual conversations, can you
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`give me a yes or no answer, did Nissan retain Dr. Hartz" -- Dr.
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`Hartz being the patents agent who submitted the third party
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`submission on the left-hand side -- my apologies. "Did Nissan
`
`object retain Dr. Hartz to file the third party observation
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`described in Exhibit 57?"
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`Exhibit 57 is the reference in this case to the Nissan
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`third party observation.
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`Q. And the answer?
`
`A. And he answered "Yes."
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`Similarly, Mr. Iwasaki, who is the corporate
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`Case 1:14-cv-02758-PAC Document 153 Filed 02/24/17 Page 16 of 180
`H1N7KOW1 Roberts - direct
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`747
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`representative of Nissan Chemicals, was asked the question by
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`counsel:
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`"Q. This, Exhibit 57, is the third party observation that
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`Nissan, through its representatives, submitted to the European
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`patent office, correct?"
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`And he answered:
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`"A. As far as I can understand, I think this is a third-party
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`observation submitted by Nikoli Hartz" -- that's the sender of
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`the third party -- "upon the request or based on the desire of
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`Nissan."
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`Q. And you just read from the Suzuki deposition at 251, line 3
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`through 13, and Iwasaki deposition 269:22 through 270:4. Is
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`that right?
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`A. I believe that's correct.
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`Q. The court has heard a lot of deposition testimony read, and
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`so we will do what the plaintiffs did here, just read in the
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`depositions you relied on in your analysis.
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`MR. BAUER: Your Honor, I just want to note that
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`plaintiffs have a standing objection to the deposition
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`transcripts designated by defendants for Dr. Mikio Suzuki and
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`Mr. Hiroshi Iwasaki, given that there has been a number of
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`designations by defendants and additional designations, and we
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`are still trying to sort out what the proper designations are,
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`including the ones that were submitted by defendants last night
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`very late.
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`Case 1:14-cv-02758-PAC Document 153 Filed 02/24/17 Page 17 of 180
`H1N7KOW1 Roberts - direct
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`748
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`THE COURT: All right, observations noted.
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`MR. MADDOX: I can't speak to that. These are
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`exhibits to his report.
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`So, to avoid reading more testimony, let me just give
`
`you the cites that we have relied on, and they will come in
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`through the reading of the deposition as a whole.
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`From Dr. Suzuki, page 246, line 4 through 247, line 4;
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`page 249, line 1 through page 251, line 13.
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`From Mr. Iwasaki, page 118, line 5 through 119, line
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`5; page 132, lines 4 through 10; page 158, line 13 through page
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`159, line 15; page 163, line 10 through page 164, line 10; page
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`269, line 7 through page 270, line 4. And we are doing this
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`now simply because you are going to hear them later when
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`Mr. Iwasaki is presented.
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`May we go to the next slide, DDX-315, which includes
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`DTX-1327 at 24 through 25.
`
`Q. Doctor, can you take us back into the document and tell us
`
`what you have here.
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`A. So again on the left side in the background, you can see
`
`highlighted sections from this third party observation, which
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`we now know was submitted by Nissan Chemical. The first
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`highlighted one gives their view that claims 1 and 2 are
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`anticipated by D1, D1 being the EP-406 patent application owned
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`by Nissan, and also related to example 3.
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`In the bottom section I've just picked out a couple of
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`Case 1:14-cv-02758-PAC Document 153 Filed 02/24/17 Page 18 of 180
`H1N7KOW1 Roberts - direct
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`749
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`texts. "Therefore, D1" -- EP-403 -- "example 3, teaches
`
`inevitably, directly and unambiguously the form A pitavastatin
`
`hemicalcium salt of EP 04707232.7." And they draw those points
`
`together with a conclusion that therefore claims 1, 2 and 37 of
`
`the '232.7 application lack novelty.
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`Q. Let's go to DDX-316 containing DTX-1327 at 975 and DTX 59
`
`at claims 1 and 24.
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`Doctor, can you take us through the claims that they
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`were saying in the document were either anticipated or not
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`novel.
`
`A. Yes, indeed. So here in this slide I've tried to put in a
`
`side-by-side presentation the claims of the '232.7 application
`
`submitted to the European patent office with the claims of the
`
`'993 patent submitted to the U.S. patent office.
`
`And you can see that claim 1 is equivalent to --
`
`sorry. Claim 1 of '232.7 is equivalent to claims 1 and 24 of
`
`the '993 patent. Both claim polymorph A of pitavastatin
`
`calcium, and all of them talk about the claim inherent property
`
`through its diffraction pattern, expressed in the same manner I
`
`described earlier in terms of the angular positions and the
`
`qualitative assessment of the relative intensities of peaks.
`
`And you can see I provide a legend at the bottom
`
`there -- I don't provide it; it's in the patent -- wherein --
`
`and you can see how the relative intensities of the peaks are
`
`designated: VS, very strong; S, strong; M, medium; W, weak;
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`Case 1:14-cv-02758-PAC Document 153 Filed 02/24/17 Page 19 of 180
`H1N7KOW1 Roberts - direct
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`750
`
`VW, very weak. So you see for each of the angular positions an
`
`assessment is made of the relative intensities of these peaks.
`
`And that's done in both patents.
`
`Q. And the peak lists in claim 1 of the '232.7 application, is
`
`that the same peak list as in claims 1 and 24 of the '993
`
`patent?
`
`A. Yes, it is.
`
`Q. May we go to DDX-317 containing DTX-1327 at line 4 and
`
`DTX-59 at claims 23 and 24 and DTX-1327 at 975.
`
`A. Yes. And you can see I showed earlier, these three claims
`
`of claim 2 of the '232.7 is equivalent to claims 23 and 25 of
`
`the '993. And this time the data is not provided by peak list
`
`and qualitative assessment of peak intensity but instead it's
`
`provided by the experimental diffraction patterns. And you can
`
`see now what that peak list and peak intensity list looks like
`
`in the data as you would get it off an x-ray diffraction
`
`instrument.
`
`And I have overlaid these top and bottom just so you
`
`can do the comparison by eye quite easily. And you see again
`
`the horizontal scale of the data is in angle, the vertical is
`
`in intensity, and you can see that those two are identical.
`
`Q. Did you confirm that figure 1 of the '232.7 application is
`
`the same as figure 1 of its counterpart the '993 patent?
`
`A. Yes, I did.
`
`Q. Would you turn now to DDX-318 containing DTX-1327 at 23 and
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`Case 1:14-cv-02758-PAC Document 153 Filed 02/24/17 Page 20 of 180
`H1N7KOW1 Roberts - direct
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`751
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`DTX-59 at claim 22. And what did you do here?
`
`A. So here just to show for information are the '232.7
`
`application and '993 patent, equivalents of 37 in the '232.7
`
`claim and claim 22 in the '993 patent. You can see they both
`
`claim a pharmaceutical composition. They both claim an
`
`effective amount of crystalline polymorphic form according to a
`
`claim, and they both include a pharmaceutical acceptable
`
`carrier. This you can regard as a formulation claim relating
`
`to how the active ingredient of the drug would be assembled
`
`into a practical dosage form.
`
`Q. May we have DDX-319, containing DTX-1327 at 24. Let's turn
`
`back to the Nissan third party submission, the science
`
`included. Can you explain what we have here?
`
`A. So this is a run-through of the actual statement that
`
`Nissan provided to the European patent office regarding EP '406
`
`in respect to the validity of Ciba's '232.7 application. You
`
`can see I've highlighted and blew up a block of text and then
`
`enlarged it here.
`
`Basically you see the critical first line is that
`
`Nissan confirmed that example 3 of D1 -- which is EP '406 --
`
`was faithfully carried out. EP '406 is a Nissan patent, so
`
`it's reasonable to expect that Nissan would know how to carry
`
`out example 3 of EP '406.
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`Thereafter, some process chemistry is done, and you
`
`can see it appears at the end that the hemicalcium -- one half
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`Case 1:14-cv-02758-PAC Document 153 Filed 02/24/17 Page 21 of 180
`H1N7KOW1 Roberts - direct
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`752
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`of calcium salt -- so hemicalcium salt is produced as white
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`crystals. I'm not offering an opinion today on the process
`
`chemistry; that's not my specialty. And in my analysis I've
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`deferred to the expert testimony of Dr. Sessler, who will
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`provide analysis of the synthetic and process chemistry.
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`Q. May we go to DDX-320, containing DTX-1327 at 25 and 28 to
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`29.
`
`A. So now we're coming deeper into the document of Nissan's
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`statement to the EPO, and in particular to their analysis of
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`the results of their faithful reproduction of EP '406. And you
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`see that I've highlighted a block of text under item 4. And
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`what they say is that hemicalcium salt crystals obtained were
`
`also analyzed by x-ray powder diffraction.
`
`The result is shown in figure 1 and tabulated in table
`
`1. Figure 1 is in the center of the view, and table 1 is on
`
`the right-hand side. And you can see -- I will come on to the
`
`more detailed analysis later, but qualitatively just for now
`
`you can see that the peak list is a comparison between the data
`
`in the Ciba application and in the data which Nissan have got.
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`They confirmed, and that's the highlighted text at the
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`bottom. The pattern is practically identical to that shown in
`
`EP '232.7, figure 1, form 1.
`
`Q. Can we go to DDX-321, containing DTX-1327 at 24 through 25
`
`and DTX-1327 at 71 through 72. Doctor, can you describe for us
`
`what is here in the record.
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`Case 1:14-cv-02758-PAC Document 153 Filed 02/24/17 Page 22 of 180
`H1N7KOW1 Roberts - direct
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`753
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`A. Yes. So this is all still in the same document. Nissan
`
`carried out thermal analysis of the data and compared it to the
`
`Ciba '232.7 application.
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`The first block of texts you can see I've highlighted
`
`at the top, and it says that the melting point of the obtained
`
`hemicalcium salt was measured by differential scanning
`
`calorimetry -- which I describe that shortly -- and found to be
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`96.8, which is practically identical to the melting point of 95
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`stated in the EP '232.7 application, example 1 of form 1.
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`At the bottom, you can see, I've put the Nissan third
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`party observation at the top and Ciba's '232.7 application at
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`the bottom. You can see that in that same one it highlights
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`that in the preparation through example 1 of form A in the
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`patent
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