581
`
`IN THE UNITED STATES DISTRICT COURT
`IN AND FOR THE DISTRICT OF DELAWARE
`
`: CIVIL ACTION
`:
`:
`:
`:
`:
`:
`
`- VOLUME C -
`
`::
`
`::
`
`:
`: NO. 11-1077-RGA
`: CONSOLIDATED
`:
`: CIVIL ACTION
`:
`:
`:
`:
`:
`:
`:
`
`NOVARTIS PHARMACEUTICALS
`CORPORATION, NOVARTIS
`AG, NOVARTIS PHARMA AG,
`NOVARTIS INTERNATIONAL
`PHARMACEUTICALS LTD, and
`LTS LOHMANN
`THERAPIE-SYSTEME AG,
`Plaintiffs,
`
`vs.
`PAR PHARMACEUTICAL,
`INC.,
`Defendant.
`------------------------
`NOVARTIS PHARMACEUTICALS
`CORPORATION, NOVARTIS
`AG, NOVARTIS PHARMA AG,
`NOVARTIS INTERNATIONAL
`PHARMACEUTICALS LTD, and
`LTS LOHMANN
`THERAPIE-SYSTEME AG,
`Plaintiffs
`
`::
`
`:
`:
`:
`: NO. 11-1112-RGA
`
`vs.
`WATSON LABORATORIES,
`INC., WATSON PHARMA,
`INC., and WATSON
`PHARMACEUTICALS, INC.,
`Defendants.
`Wilmington, Delaware
`Wednesday, August 28, 2013
`8:33 o'clock, a.m.
`- - -
`BEFORE: HONORABLE RICHARD G. ANDREWS, U.S.D.C.J.
`
`::
`
`Hawkins Reporting Service
`715 N. King Street - Wilmington, Delaware
`
`19801
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`NOVARTIS EXHIBIT 2053
`Noven v. Novartis and LTS Lohmann
`IPR2014-00550
`Page 1 of 6
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`IN AND FOR THE DISTRICT OF DELAWARE
`
`: CIVIL ACTION
`:
`:
`:
`:
`:
`:
`
`- VOLUME C -
`
`::
`
`::
`
`:
`: NO. 11-1077-RGA
`: CONSOLIDATED
`:
`: CIVIL ACTION
`:
`:
`:
`:
`:
`:
`:
`
`NOVARTIS PHARMACEUTICALS
`CORPORATION, NOVARTIS
`AG, NOVARTIS PHARMA AG,
`NOVARTIS INTERNATIONAL
`PHARMACEUTICALS LTD, and
`LTS LOHMANN
`THERAPIE-SYSTEME AG,
`Plaintiffs,
`
`vs.
`PAR PHARMACEUTICAL,
`INC.,
`Defendant.
`------------------------
`NOVARTIS PHARMACEUTICALS
`CORPORATION, NOVARTIS
`AG, NOVARTIS PHARMA AG,
`NOVARTIS INTERNATIONAL
`PHARMACEUTICALS LTD, and
`LTS LOHMANN
`THERAPIE-SYSTEME AG,
`Plaintiffs
`
`::
`
`:
`:
`:
`: NO. 11-1112-RGA
`
`vs.
`WATSON LABORATORIES,
`INC., WATSON PHARMA,
`INC., and WATSON
`PHARMACEUTICALS, INC.,
`Defendants.
`Wilmington, Delaware
`Wednesday, August 28, 2013
`8:33 o'clock, a.m.
`- - -
`BEFORE: HONORABLE RICHARD G. ANDREWS, U.S.D.C.J.
`
`::
`
`Hawkins Reporting Service
`715 N. King Street - Wilmington, Delaware
`
`19801
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`NOVARTIS EXHIBIT 2053
`Noven v. Novartis and LTS Lohmann
`IPR2014-00550
`Page 1 of 6
`
`
`
`749
`
`Q. Good afternoon, Dr. Tiemessen.
`A. Good afternoon.
`Q. Please tell us a little about yourself.
`A. I'm Henricus, also go by Harry, Tiemessen,
`and I am born, raised, and educated in Holland,
`and currently I work for Novartis Pharma in Basel
`in Switzerland, and I work there as a senior
`fellow in the department developing injectables
`and topical formulations.
`Q. Would you please review your education and
`training for us?
`A. I did my bachelor and master degree in
`Nijmejn, N-i-j-m-e-j-n, and afterwards I did my
`Ph.D. in University of Leiden, L-e-i-d-e-n.
`I did Ph.D. focusing on the
`development of topical formulations for drug
`delivery, and I was also dealing with the study
`of permeation of skins, through skin, in order to
`mimic the situation in man.
`Q. And since graduating with your Ph.D., has
`there been a particular focus to your
`professional life?
`A. I have been working as a pharmaceutical
`scientist formulator expert since then.
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`NOVARTIS EXHIBIT 2053
`Noven v. Novartis and LTS Lohmann
`IPR2014-00550
`Page 2 of 6
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`750
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`Q. What did you do following your doctoral
`studies?
`A. After my Ph.D., I went to work for Sandoz
`in Basel, Switzerland.
`Q. When was that?
`A. That was in 1989.
`Q. What is Sandoz?
`A. Sandoz is the predecessor to Ciba-Geigy --
`Novartis. They merged with Ciba-Geigy early in
`'97 in order to form Novartis.
`Q. Why did you join Sandoz?
`A. When I had finished my Ph.D., there were
`not that many opportunities in Holland, then I
`started to look around in Europe, then I found
`the work that I could do at Sandoz the most
`interesting, particularly in the field of
`transdermal drug delivery.
`Q. What was your title when you first joined
`Sandoz?
`A. When I started Sandoz, I was head of
`formulation group.
`Q. What were your responsibilities?
`A. There, I was formulation expert for the
`rivastigmine transdermal drug delivery project,
`
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`NOVARTIS EXHIBIT 2053
`Noven v. Novartis and LTS Lohmann
`IPR2014-00550
`Page 3 of 6
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`756
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`Garinot. He was the analytical expert situated
`in France. And we had Karen Ann Bergmann. She
`was project team leader. And that role was
`taken over by Mr. Ogorka in early '96.
`And Mr. Richter was also -- Fritz, he
`was my department head.
`Q. Okay. That was from the Novartis side; is
`that right?
`A. That's correct. Yeah.
`Q. What about the LTS side?
`A. The LTS side we had Mr. Asmussen, the
`department head, the department of development.
`We had Michael Horstmann. He was the RD head.
`And in '95, I was working together
`with Kai Kopke. He was the project leader at the
`Lohmann site.
`Q. Thank you. Can you tell us a little bit
`about the makeup of the team in terms of their
`educational background and experience?
`A. They were all Ph.D.s in their areas. And,
`in addition, they had quite some development
`experience.
`Q. Now I would like you to take us back to
`1989 through 1988 -- 1998 and walk us through the
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`NOVARTIS EXHIBIT 2053
`Noven v. Novartis and LTS Lohmann
`IPR2014-00550
`Page 4 of 6
`
`
`
`770
`
`MR. FIGG: Well, that was the point
`I was wanting to make clear on the record that
`I'm not sure why this is being offered. But if
`that is the reason it's being offered, I would
`object to it.
`
`THE COURT: Okay. Do you have
`anything to say in response, Mr. Prugo?
`MR. PRUGO: It's the context behind
`the invention. Okay.
`THE COURT: All right. Keep going.
`
`BY MR. PRUGO:
`Q. So you see the word stability that's
`referred to in this document. Is that a
`reference to oxidative degradation?
`A. No. This is referencing to stability in
`general. The chemical stability in general and
`also the physical stability in general.
`Q. And can you characterize the team's
`expectations regarding encountering the stability
`issue?
`A. In fact, we didn't expect stability issues
`to come because, at that point in time, we had a
`lot of experience with oral forms which were in
`the development. And at that point in time, we
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`NOVARTIS EXHIBIT 2053
`Noven v. Novartis and LTS Lohmann
`IPR2014-00550
`Page 5 of 6
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`
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`771
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`also had quite experience with the chemical
`stability of the first generation, the first
`lead formulation.
`MR. FIGG: Your Honor, I don't want
`to continue to interrupt, but may I have a
`continuing objection to this kind of testimony on
`the grounds that it is irrelevant to the issue of
`obviousness, what the expectations of these
`particular individuals --
`THE COURT: And I'll give you the
`continuing objection. And if you have some other
`objection that comes up, feel free to stand up.
`MR. FIGG: Thank you.
`THE COURT: Okay. Go ahead, Mr.
`
`Prugo.
`
`MR. PRUGO: Your Honor, plaintiffs
`move to introduce JTX 191, which is the technical
`development plan into evidence.
`MR. FIGG: Which one?
`MR. PRUGO: 191. JTX 191.
`MR. FIGG: Well, subject to my
`objections that the inventors' path to the
`invention is not relevant and the subject matter
`about the hurdles they envisioned and what they
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`NOVARTIS EXHIBIT 2053
`Noven v. Novartis and LTS Lohmann
`IPR2014-00550
`Page 6 of 6
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