`
`Meese, Claus
`
`January 20, 2015
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`PFIZER INC. and UCB EHARMA GMBH
`Plaintiffs
`
`vs.
`
`C.V. NO.
`
`I3-lllO(GMS)
`
`ALKEM LABORATORIES LTD., CONSOLIDATED
`Et al.
`
`Defendants.
`
`CONFIDENTIAL ATTORNEYS EYES ONLY
`
`Videotaped Deposition of Claus Meese
`
`Vol
`
`1
`
`Taken at the offices of:
`
`McDermott Will & Emery
`Avenue des Nerviens 9-31
`1040 Brussels
`
`Tuesday, 20th January 2015
`
`At 9.49 a.m.
`
`202-220-415 8
`
`Henderson Legal Services, Inc.
`wwwhendersonlegalservices.com
`
`Restricted Confidential - Subject to Protective Order
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1076 — Page 1
`PFE01330530
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1076 - Page 1
`
`
`
`CONFIDENTIAL - ATTORNEYS‘ EYES ONLY
`
`Meese, Claus
`
`January 20, 2015
`
`PT 01932091?
`
`A. Yes.
`
`Q.
`
`Do you recognize the handwriting on
`
`this document?
`
`A. Yes.
`
`Q.
`
`Is that your handwriting?
`
`A. Yes, it is.
`
`Q. And in this you are referring in
`
`this handwritten section, you are referring to SPM
`
`8228,
`
`the statement that X is chloride;
`
`is that
`
`correct?
`
`A. YES.
`
`Q. Does tha' mean that this was the
`
`hydrochloride salt tha' you were looking at?
`
`A. Yes.
`
`Q. And you state that this salt is
`
`amorph us and hagioscopic;
`
`is that correct?
`
`A.
`
`It is not precise. Once a salt is
`
`formed it is highly crystalline, but if it is
`
`exposed to moisture,
`
`traces of water, it is
`
`hagioscopic, yes. Let me say it gives a syrup.
`
`Q. And so you proposed looking at
`
`roughly 20 other salts to improve the
`
`physiochemical properties;
`
`is that Correct?
`
`A. Yes.
`
`202-220-415 8
`
`Henderson Legal Services, Inc.
`wwwhendersonlegalservices.com
`
`Restricted Confidential - Subject to Protective Order
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1076 — Page 2
`F'FEO‘I330638
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1076 - Page 2
`
`
`
`CONFIDENTIAL - ATTORNEYS‘ EYES ONLY
`
`Meese, Claus
`
`January 20, 2015
`
`Q. And did you have specific salts in
`
`mind already when you made this proposal?
`
`A. No, not yet. That was on top of our
`
`salt screening programme at that time.
`
`Q. Were you involved in the salt
`
`screening programme?
`
`A. Yes.
`
`Q. What was your role?
`
`A. First of all I gave the co—workers
`
`the description for the initial experiments on a
`
`lab scale such as solvent concentrations, solvent
`
`mixtures in order to get precipitations matching
`
`time and temperatures.
`
`Q. Anything else?
`
`A.
`
`I involved a number of external
`
`CROs, among them the University of Wuppertal,
`
`Germany, and we needed simply manpower because
`
`it's laborious to make all those experiments.
`
`Q. Anything else?
`
`A. And there was a brief involvement of
`
`the University of Groningen in the Netherlands,
`
`Holland. That is also in order to make some
`
`experiments. And I told them which acids should
`
`be tested first, so the necessities or which assay
`
`should be used and with what are the solvents, and
`
`202-220-415 8
`
`Henderson Legal Services, Inc.
`wwwhendersonlegalservices.com
`
`Restricted Confidential - Subject to Protective Order
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1076 — Page 3
`PFE01330639
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1076 - Page 3
`
`
`
`CONFIDENTIAL - ATTORNEYS‘ EYES ONLY
`
`Meese, Claus
`
`January 20, 2015
`
`some of the reaction conditions also were given to
`
`the partners.
`
`They started the work for us.
`
`Q. And which acids did you think should
`
`be tested first?
`
`A.
`
`A large Variety of inorganic acids,
`
`but also organic acids such as citric acid or
`
`tartaric risk acid, of course mendelic acid. And
`
`I remember I have to look at more than 100 acids.
`
`Q. Right.
`
`I am going to hand you a
`
`document that will be marked as Meese Exhibit 30,
`
`bearing Bates numbers PT 01718486 through PT
`
`01718498.
`
`(Exhibit 30 marked for identification)
`
`A.
`
`Thank you.
`
`Q.
`
`Dr Meese, do you understand these to
`
`be the minutes of the CMC sub team.taken on
`
`October 8th, 1999?
`
`A.
`
`Umm hmm.
`
`Q.
`
`And did you attend this meeting?
`
`A. Yes,
`
`I did.
`
`Q.
`
`What does CMC sub team mean?
`
`A. That means that the project was
`
`pretty far developed and this sub team takes care
`
`primarily of chemistry. Yes, it seems CMC is
`
`clear.
`
`202-220-415 8
`
`Henderson Legal Services, Inc.
`wwwhendersonlegalservices.com
`
`Restricted Confidential - Subject to Protective Order
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1076 — Page 4
`PFE01330640
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1076 - Page 4
`
`
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