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Case 1:14-cv-02758-PAC Document 149 Filed 02/24/17 Page 1 of 196
`H1J7KOW1
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`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 19, 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 149 Filed 02/24/17 Page 2 of 196
`H1J7KOW1
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`397
`
`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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` SOUTHERN DISTRICT REPORTERS, P.C.
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`Case 1:14-cv-02758-PAC Document 149 Filed 02/24/17 Page 3 of 196
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`(Trial resumed)
`
`THE COURT: Before we resume with the excitement of
`
`reading depositions, with regard to Mr. Maddox's letter of
`
`January 7 and the response of Mr. Conlin of January 19, the
`
`objection raised by Kowa is sustained.
`
`When you are reading the depositions -- who are the
`
`readers? Come on up. Would you please state the deponent, who
`
`the deponent works for and who is conducting the examination.
`
`MR. RUTKOWSKI: Yes. I am, your Honor.
`
`THE COURT: I know you are, but the party conducting
`
`the examination, the role that you're playing, you have to
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`disclose it.
`
`MR. RUTKOWSKI: As a brief housekeeping matter, for
`
`the four deposition transcript excerpts we read in yesterday,
`
`at this time we'd like to move in exhibits corresponding with
`
`those.
`
`THE COURT: Tell me what they are.
`
`MR. RUTKOWSKI: I will, your Honor. For the Sawai
`
`deponent Mami Katsumoto, Exhibits PTX-0143, PTX-0720 and
`
`PTX-0714.
`
`THE COURT: Any objection? They are received in
`
`evidence.
`
`(Plaintiff's Exhibits 0143, 0720 and 0714 received in
`
`evidence)
`
`MR. RUTKOWSKI: Thank you. For the Apotex deponent
`
` SOUTHERN DISTRICT REPORTERS, P.C.
` (212) 805-0300
`
`

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`Case 1:14-cv-02758-PAC Document 149 Filed 02/24/17 Page 4 of 196
`H1J7KOW1
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`399
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`Kiran Krishnan, nothing at this time, your Honor; those are
`
`have already been entered elsewhere.
`
`THE COURT: OK.
`
`MR. RUTKOWSKI: For the Apotex defendant
`
`Balasubramanyam Nataraj, Exhibits PTX-0072, PTX-0103.
`
`THE COURT: Any objection? They are received in
`
`evidence.
`
`(Plaintiff's Exhibits 0072 and 0103 received in
`
`evidence)
`
`MR. RUTKOWSKI: Thank you, your Honor. For the Apotex
`
`deponent Ramachandra Reddy, Exhibits PTX-0077, PTX-0086,
`
`PTX-0045 and PTX-0065.
`
`THE COURT: Any objections? Those exhibits are
`
`received in evidence.
`
`(Plaintiff's Exhibits 0077, 0086, 0045 and 0065
`
`received in evidence)
`
`MR. RUTKOWSKI: Thank you, your Honor. At this point
`
`we will be resuming with the deposition of G.P. Sing, an
`
`employee of Lupin.
`
`THE COURT: G.P. Sing?
`
`MR. RUTKOWSKI: G.P. Sing, correct, your Honor.
`
`THE COURT: What page is he in?
`
`MR. RUTKOWSKI: He is tab 4 -- 5. And we will start
`
`on page 4, your Honor.
`
`"G.P. SING, called as a witness, having been duly
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` SOUTHERN DISTRICT REPORTERS, P.C.
` (212) 805-0300
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`Case 1:14-cv-02758-PAC Document 149 Filed 02/24/17 Page 5 of 196
`H1J7KOW1
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`400
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`sworn by the notary public, was examined and testified as
`
`follows:"
`
`Skipping ahead to page 51:
`
`"Q. So, again, looking at Exhibit 6, on the second page there
`
`is a similar statement to what we just discussed about
`
`polymorphism wherein the first point it talks about certain
`
`types of crystalline forms of pitavastatin calcium as per
`
`literature, and then in the second bullet it talks about
`
`Annexure I. Do you see that?
`
`"A. Yes.
`
`"Q. Then on the next page it says -- it provides further
`
`details of Lupin's pitavastatin calcium. Do you see that?
`
`"A. Yes.
`
`"Q. It says that the polymorph is substantially amorphous,
`
`correct?
`
`"A. Yes.
`
`"Q. Then it describes a method of preparation. Do you see
`
`that?
`
`"A. Yes.
`
`"Q. And in the box for method of preparation it says, prepared
`
`from pitavastatin tertiary butyl ester by first forming the
`
`corresponding sodium salt followed by treatment with aqueous
`
`calcium acetate and stirring for three to four hours. The
`
`isolated material is dried at 65 to 70 degrees Celsius till
`
`water content is no more than four percent. This form contains
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` SOUTHERN DISTRICT REPORTERS, P.C.
` (212) 805-0300
`
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`Case 1:14-cv-02758-PAC Document 149 Filed 02/24/17 Page 6 of 196
`H1J7KOW1
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`401
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`less than five percent water. Do you see that?
`
`"A. Yes.
`
`"Q. And that description of the method of preparation that I
`
`just described, does that align with the manufacturing process
`
`that is described in Exhibit 5?
`
`"A. Yes."
`
`Jumping ahead a bit to 54:
`
`"Q. Is the water content step and parameter that's described
`
`here on Bates 217 of Exhibit 5, does that correspond to the
`
`description of the water content in Exhibit 6?
`
`"A. Yes.
`
`"Q. So in order to achieve Lupin's form or Lupin's polymorphic
`
`form of pitavastatin calcium, the isolated pitavastatin
`
`material needs to be dried until the water content is less than
`
`four percent?
`
`"A. Yes."
`
`Jumping ahead to 74:
`
`"Q. So is it your testimony that Lupin's pitavastatin calcium
`
`is partly amorphous and partly crystalline?
`
`"A. We say substantial amorphous.
`
`"Q. But the fact that there are defined peaks suggests that
`
`there is at least some crystallinity present in Lupin's
`
`pitavastatin calcium, correct?
`
`"A. Yes.
`
`"Q. And you can have a sample in which both crystallinity and
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` SOUTHERN DISTRICT REPORTERS, P.C.
` (212) 805-0300
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`Case 1:14-cv-02758-PAC Document 149 Filed 02/24/17 Page 7 of 196
`H1J7KOW1
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`402
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`amorphism coexist, correct? It is possible to have a sample in
`
`which both crystallinity and amorphism exist, correct?
`
`"A. Yes."
`
`Nothing further for that witness, your Honor, at this
`
`time.
`
`THE COURT: Any exhibits?
`
`MR. RUTKOWSKI: Yes, your Honor, PTX-0417 and
`
`PTX-0396.
`
`THE COURT: Without objection, received in evidence.
`
`(Plaintiff's Exhibits 0417 and 0396 received in
`
`evidence)
`
`MR. RUTKOWSKI: Thank you, your Honor. Apologies,
`
`your Honor. I did not indicate who took that deposition. That
`
`deposition was taken by Thomas Wintner.
`
`THE COURT: Mr. Wintner is an attorney for the
`
`plaintiff.
`
`MR. RUTKOWSKI: Yes, plaintiff's attorney, your Honor.
`
`THE COURT: OK. What is next?
`
`MR. RUTKOWSKI: Moving on to the next tab, this would
`
`be Nobuko Sugimoto, a Sawai employee. This deposition was
`
`taken by plaintiffs, Peter Cuomo, the attorney.
`
`Starting on page 5:
`
`"Q. Could you please state your name for the record.
`
`"A. My name is Nobuko Sugimoto, N-O-B-U-K-O, S-U-G-I-M-O-T-O."
`
`Moving ahead to page 16:
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` SOUTHERN DISTRICT REPORTERS, P.C.
` (212) 805-0300
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`Case 1:14-cv-02758-PAC Document 149 Filed 02/24/17 Page 8 of 196
`H1J7KOW1
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`403
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`"Q. What is your current position at Sawai Pharmaceuticals?
`
`"A. I'm the manager of the intellectual property department. "
`
`"CHECK INTERPRETER: General manager. General
`
`manager."
`
`Moving ahead to page 104:
`
`"Q. Ms. Sugimoto, is Souichi Hosaka one of the inventors
`
`listed on the face of the patent application?
`
`"A. Yes.
`
`"Q. Ms. Sugimoto, is this all related to the formulation
`
`development study we just discussed?
`
`"A. Yes. However, this is based on the data for development
`
`for Japanese development.
`
`"CHECK INTERPRETER. This application is based on the
`
`data for the Japanese product development.
`
`"Q. OK. Ms. Sugimoto, if you turn to the claims, are there
`
`claims here that claiming a pitavastatin product having a pH
`
`range?
`
`"A. It defines the pH range of pitavastatin.
`
`"Q. And was the data used to formulate the pharmaceutical drug
`
`that's the subject of Sawai's ANDA application in this case?
`
`"A. No. The formulation for U.S. product is slightly
`
`different; therefore, I believe that all the tests were
`
`performed separately.
`
`"Q. Ms. Sugimoto, is there any difference between the API of
`
`the pitavastatin calcium product in Japan and the one proposed
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`Case 1:14-cv-02758-PAC Document 149 Filed 02/24/17 Page 9 of 196
`H1J7KOW1
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`404
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`in the ANDA application in this case?
`
`"A. Are you asking about the API manufacturer?
`
`"Q. No. I'm asking about the API itself, if there are any
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`differences between the API that is used in the pitavastatin
`
`calcium product in Japan and the API that is proposed to be
`
`used in the ANDA application of this case.
`
`"A. No, there is no difference."
`
`Jumping ahead a bit to 110:
`
`"Q. Ms. Sugimoto, is it true that Sawai does not claim
`
`anywhere in here that it does not make form A?
`
`"A. That is correct.
`
`"Q. And, Ms. Sugimoto, is form A described outside of the '993
`
`patent, for instance, in literature?
`
`"A. Yes, there is.
`
`"Q. Ms. Sugimoto, when Sawai uses x-ray crystallography to
`
`produce x-ray diffraction patterns of its proposed API, is this
`
`pattern what Sawai gets every time?
`
`"A. Yes.
`
`"Q. Ms. Sugimoto, is it true even when Sawai is testing
`
`different lots of its proposed API product?
`
`"A. That's true."
`
`Moving ahead to 144:
`
`"(Sugimoto Exhibit 11 was marked for identification.)
`
`"Q. Ms. Sugimoto, do you recognize this document?
`
`"A. Yes.
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` SOUTHERN DISTRICT REPORTERS, P.C.
` (212) 805-0300
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`Case 1:14-cv-02758-PAC Document 149 Filed 02/24/17 Page 10 of 196
`H1J7KOW1
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`"Q. And what is it?
`
`"A. It is part of Sawai's ANDA application.
`
`"Q. And were the contents of this submission true and accurate
`
`when Sawai submitted this to the FDA?
`
`"A. Yes, it's accurate.
`
`"Q. Ms. Sugimoto, do you know who performed the tests that led
`
`to the conclusion on this page that Sawai's drug substance is
`
`considered as form A?
`
`"A. Yes.
`
`"Q. And who is that person?
`
`"A. Staff in the physicochemistry group.
`
`"CHECK INTERPRETER: Chemical.
`
`"A. Physicochemical group.
`
`"Q. And, Ms. Sugimoto, who determined that Sawai's drug
`
`substance is considered as form A?
`
`"A. It was made a by a person who is in charge of the
`
`physicochemical group. I believe they determined that based on
`
`the scientific viewpoint."
`
`Jumping ahead to 149:
`
`"Q. And, Ms. Sugimoto, where it says here that the
`
`pitavastatin calcium bulk powder is form A, is that consistent
`
`with your understanding?
`
`"A. Yes, it's consistent with my understanding."
`
`Moving ahead to 170:
`
`"Q. Ms. Sugimoto, what is Sawai's factual basis for the
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`Case 1:14-cv-02758-PAC Document 149 Filed 02/24/17 Page 11 of 196
`H1J7KOW1
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`statement that Sawai's proposed pitavastatin calcium API is
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`polymorph is not forms B through F?
`
`"A. It results from the conversation with attorney based on
`
`the 2-theta values and relative intensity of the x-ray powder
`
`diffractive patterns.
`
`"Q. And, Ms. Sugimoto, when you say it results from the
`
`conversation with an attorney based on the 2-theta values and
`
`relative intensity of the x-ray diffractive patterns, are you
`
`referring to the x-ray diffraction pattern shown on page 31?
`
`"A. It is a part of the patterns, but there are others.
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`"MS. MURAKAMI: This is one of them, but there are
`
`others as well."
`
`I believe that was a check translator, Ms. Murakami.
`
`"Q. And, Ms. Sugimoto, didn't you testify yesterday that the
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`x-ray diffraction pattern that Sawai sees for its proposed
`
`pitavastatin calcium API is always the same even between
`
`different lots?
`
`"A. What I testified yesterday was that even with API from
`
`different lots, their 2-theta values match within the range of
`
`the error, but when it comes to relative intensity, I don't
`
`know the error range, so I don't know.
`
`"THE INTERPRETER: The witness asked me to ask the
`
`interpreter to add the word "approximately."
`
`"CHECK INTERPRETER: Yesterday I testified that APIs
`
`from the different lot are much -- is approximately much --
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`Case 1:14-cv-02758-PAC Document 149 Filed 02/24/17 Page 12 of 196
`H1J7KOW1
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`much is in -- in terms of the 2-theta value in -- in the margin
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`of error range. However, for the relative intensity, I do not
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`know this margin of error range, so I don't know.
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`"Q. Ms. Sugimoto, with which attorney did Sawai have a
`
`conversation to determine that its proposed API for
`
`pitavastatin calcium was not forms B through F?
`
`"A. Sawai had a conversation with attorneys at Sughrue.
`
`"Q. And, Ms. Sugimoto, did those attorneys make the
`
`determination that Sawai's proposed API for pitavastatin
`
`calcium was not forms B through F?
`
`"A. Yes, they did.
`
`"Q. Ms. Sugimoto, when you said that the attorneys at Sughrue
`
`made the determination that Sawai's proposed API for
`
`pitavastatin calcium was not forms B through F, was that based
`
`upon the XRD diffractogram on page 31?
`
`"A. Yes."
`
`Skipping ahead to 177:
`
`"Q. Yes. And to rephrase my question, was the entire factual
`
`basis the conclusion by your attorneys?
`
`"A. First of all, I looked at the 2-theta values in the x-ray
`
`diffracto -- position of 2-theta values in the x-ray pattern,
`
`and they didn't match with those 2-theta values -- position of
`
`2-theta values of B and F -- B through F. And I also take -- I
`
`also took -- took a look at the chart or the pattern and review
`
`the relative intensity and compare that with the one -- I'm
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`Case 1:14-cv-02758-PAC Document 149 Filed 02/24/17 Page 13 of 196
`H1J7KOW1
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`408
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`sorry. I made a comparison of the relative intensity in the
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`pattern, and I felt that those are different. But the final
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`determination was relied upon by attorneys at Sughrue.
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`"CHECK INTERPRETER: First we took a look at the
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`position of 2-theta value in x-ray -- e-ray diagram. Diagram.
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`And then we confirm that the position of 2-theta value from B
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`to F doesn't match. And then we took a look at the relative
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`intensity and compared the chart pattern, whole chart pattern
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`and the patterns of the patent, and we had a very good feeling
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`that they were different. However, as for the final
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`determination, we trusted or we relied on Sughrue's attorney."
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`THE COURT: Could you just tell me what the check
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`interpreter is?
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`MR. RUTKOWSKI: What's that?
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`THE COURT: What is the check interpreter?
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`These are conducted in Japanese.
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`MR. RUTKOWSKI: Correct, your Honor.
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`THE COURT: And so they have an interpreter who
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`interprets the question and gets the answer? And there's a
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`second interpreter there?
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`MR. RUTKOWSKI: Yes. And my understanding is -- and
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`it may have varied based on depositions slightly -- but
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`generally at least one of the parties had their own check
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`interpreter to perform a check on the --
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`THE COURT: And this check interpreter is independent
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`Case 1:14-cv-02758-PAC Document 149 Filed 02/24/17 Page 14 of 196
`H1J7KOW1
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`409
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`or works for Sawai?
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`MR. RUTKOWSKI: The check interpreter was hired by the
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`individual party.
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`THE COURT: By Sawai or by Kowa? Do you know?
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`MR. RUTKOWSKI: In this case I'm not a hundred percent
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`sure, your Honor.
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`MR. CONLIN: Your Honor, in the old days we used to
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`have a neutral interpreter, and then both sides had a check
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`interpreter. But things have changed, and so these days the
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`parties -- the person who is defending the witness hires an
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`interpreter, and then the other party gets a check interpreter.
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`And these things are complicated, so quite often they have to
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`work together to find out what the exact answer was.
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`THE COURT: Well, my experience in taking depositions
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`in Japan is the interpreter worked for the company which was
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`being deposed and he would substitute his answer for the answer
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`of the deposed witness if he didn't like it.
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`MR. CONLIN: That's not the case. In fact these
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`interpreters are very sought after, and they are independent.
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`In fact the check interpreter who was at that deposition is in
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`the back of the room, I think, your Honor. Anyway, that's the
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`way it works these days.
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`MR. RUTKOWSKI: If I may, your Honor, if I may in this
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`case --
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`THE COURT: You wanted to say something?
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`Case 1:14-cv-02758-PAC Document 149 Filed 02/24/17 Page 15 of 196
`H1J7KOW1
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`410
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`MR. DZWONCZYK: To answer your Honor's question, in
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`this case the official interpreter was hired by plaintiffs who
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`took the deposition, and the check interpreter was hired by
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`Sawai who defended the deposition, and they conferred.
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`THE COURT: Thank you very much.
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`MR. RUTKOWSKI: I will also note that in this case the
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`transcript identifies two check interpreters on page 3 and the
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`main interpreter.
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`THE COURT: Thank you very much.
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`MR. RUTKOWSKI: Ms. Murakami that I mentioned
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`previously is one of those check interpreters.
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`THE COURT: Thank you.
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`MR. RUTKOWSKI: Moving ahead to 242. I apologize.
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`MS. YOUNG: I believe we still need to read 199.
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`MR. RUTKOWSKI: Thank you.
`
`"Q. Ms. Sugimoto, when Sawai told the FDA that its
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`pitavastatin calcium bulk powder is form A and was judged as
`
`form A by comparing the data to this patent, do you have any
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`reason to believe that this was not an accurate statement?
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`"A. It is -- it is accurate based on the fact that the
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`comparison between the x-ray diffraction pattern 2-theta values
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`comparing -- position of 2-theta values comparing Sawai's x-ray
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`patterns 2-theta positions and the x-ray pattern 2-theta values
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`in the patent, it is correct."
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`Then moving on to 242:
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`Case 1:14-cv-02758-PAC Document 149 Filed 02/24/17 Page 16 of 196
`H1J7KOW1
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`411
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`"Q. Ms. Sugimoto, when you testified earlier that "we thought
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`about the ways to change the crystalline form of the API," was
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`form B one of those crystalline forms?
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`"A. There was such an idea to change the crystalline form of
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`API at one point, but we abandoned that idea shortly after
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`that.
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`"Q. And why did you abandon that idea?
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`"A. That was because as I mentioned earlier regarding the
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`consultation with regulatory expert.
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`"CHECK INTERPRETER: U.S. regulatory expert.
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`"A. Changing the crystal form in the course of formulation
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`manufacturing processes the method itself, it's not applicable
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`to ANDA. That's why we abandoned that idea."
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`That brings us to the end, your Honor, of Sugimoto's
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`testimony. At this point we would like to move in Exhibits
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`PTX-0537, PTX-0691. Strike that, your Honor. That one has
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`already been at admitted. It's just 0537.
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`THE COURT: Any objection?
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`MR. MADDOX: No.
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`THE COURT: 537 is received.
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`(Plaintiff's Exhibit 0537 received in evidence)
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`MR. RUTKOWSKI: Thank you, your Honor. Moving on to
`
`the next deponent, the next tab. This is Lupin Limited's
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`employee, Dr. Upadhyay. Sorry, he may not be a doctor. This
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`was taken by plaintiffs.
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`Case 1:14-cv-02758-PAC Document 149 Filed 02/24/17 Page 17 of 196
`H1J7KOW1
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`412
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`Starting on page 5:
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`"THE REPORTER: Please state your full name for the
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`record.
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`"THE WITNESS: Yeah, Pritesh Upadhyay.
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`"Q. And have you been employed by Lupin limited for 29 years?
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`"A. Yes.
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`"Q. And what is your current title at Lupin? And I use -- at
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`Lupin Limited?
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`"A. I am senior vice president, analytical research.
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`"Q. And for how long have you held that title?
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`"A. About three years.
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`"Q. OK. So going back to -- you said you were a senior vice
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`president of analytical research for three years. What title
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`did you hold before that?
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`"A. Vice president, analytical research.
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`"Q. And prior to your title of vice president of analytical
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`research, did you hold another title?
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`"A. Yes.
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`"Q. And what was that?
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`"A. Senior general manager.
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`"Q. Would that be senior general meeting of analytical
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`research?
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`"A. Yes.
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`"Q. And approximately what timeframe were you a senior general
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`manager of analytical research?
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`Case 1:14-cv-02758-PAC Document 149 Filed 02/24/17 Page 18 of 196
`H1J7KOW1
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`413
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`"A. Difficult to remember.
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`"Q. More than five years?
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`"A. Yes."
`
`Moving on to 13:
`
`"Q. As general manager of analytical research even, was
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`your -- did your responsibilities include analyzing XRD, powder
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`XRD spectra?
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`"A. Yes.
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`"Q. Did you oversee technicians who actually did perform
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`powder x-ray diffraction experiments?
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`"A. I supervised.
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`"Q. And did you approve of the methods that were employed to
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`carry out the powder x-ray diffractions?
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`"A. Yes."
`
`On to 17:
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`"Q. Does Lupin only use the instrument by PANalytical to carry
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`out its x-ray diffraction experiments?
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`"A. Yes.
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`"Q. Approximately how many diffractograms have you analyzed
`
`during your career at Lupin?
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`"A. I have not analyzed.
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`"Q. Thousands? Hundreds? Ballpark?
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`"A. By myself?
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`"Q. By yourself or as part of a team.
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`"A. More than that.
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`Case 1:14-cv-02758-PAC Document 149 Filed 02/24/17 Page 19 of 196
`H1J7KOW1
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`414
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`"Q. More than that?
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`"A. (Witness nodding.)
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`"Q. More than thousands?
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`"A. More than 10,000 plus.
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`"Q. Right. And then a diffractogram is produced from that
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`experiment.
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`"Do you actually analyze the diffractogram that is
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`produced from the x-ray diffraction experiments and interpret
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`that?
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`"A. Yes."
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`Moving ahead to 52:
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`"Q. Do you recognize what has been marked as Singh Exhibit 16?
`
`"A. Yes.
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`"Q. What is it?
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`"A. It looks like laboratory notebook of synthesis team.
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`"Q. Do you recognize what is marked as Singh Exhibit 25?
`
`"A. Yes.
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`"Q. What is that?
`
`"A. These are the chromatograms.
`
`"(Witness reviewing document.)
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`"A. And here are the powder x-ray.
`
`"Q. So Exhibit 16 is a laboratory notebook of the synthesis
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`team; is that correct?
`
`"A. Yes.
`
`"Q. In preparing for today's deposition, did you review any
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`Case 1:14-cv-02758-PAC Document 149 Filed 02/24/17 Page 20 of 196
`H1J7KOW1
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`415
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`laboratory notebooks of the synthesis team?
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`"A. No.
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`"Q. And what is the relationship between the laboratory
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`synthesis notebook of Singh Exhibit 16 and the doc -- the
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`diffractogram that's shown at Singh Exhibit 25 at 34002?
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`"A. Because as far as analysis part is concerned, I don't know
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`about the synthesis part or the synthesis laboratory
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`information. I know only about the analytical information.
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`"Q. OK. Isn't it true that if we go to Singh Exhibit 25,
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`34002, that the reference "882/151" is, in fact, the experiment
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`that is shown in Singh Exhibit 16 on Bates number 33478 where
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`you also see in "882/151"?
`
`"A. Yes.
`
`"Q. OK. So the relationship is that the laboratory synthesis
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`notebook in Exhibit 16 provides the basis for the
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`diffractograms that are shown in Singh Exhibit 25 on Bates
`
`numbers 34002 through 34008; is that correct?
`
`"(Witness reviewing documents.)
`
`"A. Looks like.
`
`"Q. And we know this because in both in Singh Exhibit 16 and
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`Singh Exhibit 25 they both have the designation "882/1551."
`
`Isn't that the common link between these two?
`
`"A. Yes.
`
`"Q. OK. If we go to 33479 -- let's go back to -- "882" stands
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`for the laboratory notebook, is that correct? The 882/151,
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`Case 1:14-cv-02758-PAC Document 149 Filed 02/24/17 Page 21 of 196
`H1J7KOW1
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`416
`
`that's the number of the notebook.
`
`"A. I think G.P. Singh may be the right person. But it looks
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`like. Because these are the laboratory notebook of synthesis
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`team.
`
`"Q. Right. So -- OK.
`
`"Can you read the conclusion described on 33481? I
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`believe it's -- please correct me if I'm wrong, it's
`
`"Conclusion: The yield and purity is good, the polymorph is
`
`mix of form A, B and amorphous."
`
`"Did I read that correctly?
`
`"A. Yes.
`
`"Q. And would you agree that this statement is a
`
`characterization of the pitavastatin calcium described on 33478
`
`by XRD?
`
`"A. Maybe.
`
`"Q. Well, you would agree that experiment 151 appearing on
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`Bates numbers 33478 through 33481 is -- reflects testing of
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`pitavastatin calcium by powder x-ray diffraction, correct?
`
`"A. Looks like.
`
`"Q. And the powder -- the diffractograms produced from these
`
`powder x-ray diffraction experiments are actually shown in what
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`has been marked as Singh Exhibit 25 bearing Bates numbers 34002
`
`through 34008, correct?
`
`"A. Yes. Batch number same.
`
`"Q. The diffractogram appearing on 34006 and 34008, that
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`H1J7KOW1
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`417
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`diffractogram is, in fact, the subject of the conclusion "the
`
`yield and purity is good. The polymorph is mix of form A, B
`
`and amorphous"; isn't that true?
`
`"A. I don't know how they conclude. I don't know."
`
`Moving on to 64:
`
`"Q. Would you disagree that what appears on -- what appears on
`
`Bates number 34006 is, in fact, a mix of crystalline material
`
`and amorphous material, namely form A, form B and amorphous?
`
`"A. Can you reframe the question?
`
`"Q. Sure. You review thousands of diffractograms; isn't that
`
`true?
`
`"A. Yes.
`
`"Q. We see -- in peaks, we -- I direct your attention to
`
`34006. There are peaks that appear in that diffractogram;
`
`isn't that true?
`
`"A. Yes.
`
`"Q. And those peaks show that the sample contains crystalline
`
`material, correct?
`
`"A. Yes.
`
`"Q. And the hump that goes from approximately 15/2 degrees
`
`theta to 30/2 degrees theta, shows that there are -- is
`
`amorphous material in the sample as well, correct?
`
`"A. Yes.
`
`"Q. So, in fact, this sample contains amorphous material and
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`crystalline material; isn't that true?
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`Case 1:14-cv-02758-PAC Document 149 Filed 02/24/17 Page 23 of 196
`H1J7KOW1
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`418
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`"A. Yes.
`
`"Q. OK. So you do not disagree that what is shown on 34006 is
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`a mixture of form A, form B and amorphous. Correct?
`
`"A. I'm saying that it's the substantial amorphous material.
`
`"Q. And when you say "substantial amorphous material," by that
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`do you mean that it is a mixture of amorphous material and
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`crystalline material?
`
`"A. Yes.
`
`"Q. And is that how Lupin has used the term "substantially
`
`amorphous" in its ANDA? By that I mean, has -- does Lupin when
`
`it says something is "substantially amorphous" mean it is a
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`mixture of amorphous material and crystalline material?
`
`"A. Yes.
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`MR. RUTKOWSKI: And at this point Lupin has designated
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`an errata transcript statement. The line at "Yes" was in the
`
`errata changed to "It means that it has features of both
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`amorphous material and crystalline material."
`
`"Q. Now, if we go to 33479, I want you to -- direct your
`
`attention to the bottom of that page. It says "done by,"
`
`"witnessed by" and "reviewed by." Do you see those three
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`columns?
`
`"A. Yes.
`
`"Q. Do you recognize those signatures, whose signature that is
`
`adjacent to "done by"?
`
`"A. No.
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` SOUTHERN DISTRICT REPORTERS, P.C.
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`Case 1:14-cv-02758-PAC Document 149 Filed 02/24/17 Page 24 of 196
`H1J7KOW1
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`419
`
`"Q. Do you recognize whose signature that is adjacent to
`
`"witnessed by"?
`
`"A. No.
`
`"Q. And do you recognize the signature that appears adjacent
`
`to "reviewed by"?
`
`"A. No.
`
`"Q. Who would know? Who would I ask at Lupin who would know
`
`what these signatures are?
`
`"A. Doctor G.P. Singh is the right person because it's the
`
`laboratory notebook of synthesis.
`
`"Q. Do you recognize what has been previously marked as Singh
`
`Exhibit 6 and Singh Exhibit 7?
`
`"A. Yes.
`
`"Q. What are they? Let's start with Singh exhibit -- what are
`
`they?
`
`"(Witness reviewing document.)
`
`"A. These are ANDA documents.
`
`"Q. So -- and what is -- OK. So let's -- Exhibit 7 was -- was
`
`produced to us as part of the DMF.
`
`"A. OK.
`
`"Q. But what are these -- what do these documents show?
`
`"A. Which document?
`
`"Q. Let's start with Exhibit Singh 6?
`
`"A. It shows the general properties of pitavastatin.
`
`"Q. And one of those parties is the characterization or an
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`Case 1:14-cv-02758-PAC Document 149 Filed 02/24/17 Page 25 of 196
`H1J7KOW1
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`420
`
`x-ray diffraction pattern of the API that's put into the
`
`tablet; is that correct? And I direct your attention to Bates
`
`numbers 17474 through 17476.
`
`(Witness reviewing document.)
`
`"A. Yes.
`
`"Q. And if we go to -- and this is

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