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