HIGHLY CONFIDENTIAL
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`Page 1
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`UNITED STATES DISTRICT COURT
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`FOR THE DISTRICT OF NEW JERSEY
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`Civ. A. NO:
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`3:15—CV-5723 (PGS/LHGI
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`UNITED THERAPEUTICS I
`
`I I
`
`I J
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`I I
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`CORPORATION,
`
`Plaintiff,
`
`v.
`
`WATSON LABORATORIES,)
`
`I I
`
`I
`
`Defendant.
`
`INC.,
`
`HIGHLY
`
`CONFIDENTIAL
`
`VIDEO DEPOSITION Of DR. LEWIS J. RUBIN
`
`New York, New York
`
`Thursday, January 26, 2017
`
`Reported by:
`
`Eileen Mulvenna, CSR/RMR/CRR
`
`www.vcritcxt.com
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`888-391-33?6
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`Veritcxt Legal Solutions
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`UNITED THERAPEUTICS, EX. 2204
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR2017-01622
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`Page 1
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`UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF NEW JERSEY
`
`Civ. A. NO:
`
`3:15—CV-5723 (PGS/LHGI
`
`UNITED THERAPEUTICS I
`
`I I
`
`I J
`
`I I
`
`CORPORATION,
`
`Plaintiff,
`
`v.
`
`WATSON LABORATORIES,)
`
`I I
`
`I
`
`Defendant.
`
`INC.,
`
`HIGHLY
`
`CONFIDENTIAL
`
`VIDEO DEPOSITION Of DR. LEWIS J. RUBIN
`
`New York, New York
`
`Thursday, January 26, 2017
`
`Reported by:
`
`Eileen Mulvenna, CSR/RMR/CRR
`
`www.vcritcxt.com
`
`888-391-33?6
`
`Veritcxt Legal Solutions
`
`UNITED THERAPEUTICS, EX. 2204
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR2017-01622
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`January 26, 2017
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`9:00 a.m.
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`VIDEOTAPED DEPOSITION of DR. LEWIS J. RUBIN,
`
`Nonparty witness in the above—captioned matter,
`
`taken by Defendants, pursuant
`
`to Subpoena, held at
`
`the offices of Winston & Strawn, 200 Park Avenue,
`
`New York, New York, before Eileen Mulvenna,
`
`CSR/RMR/CRR, Certified Shorthand Reporter,
`
`Registered Merit Reporter, Certified Realtime
`
`Reporter, and Notary Public of the State of New
`
`York.
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`WATSON LABORATORIES v. UNITED THERAPEUTICS, |PR2017-01622
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`WATSON LABORATORIES v. UNITED THERAPEUTICS, |PR2017—01622
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`Page 14
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`employee to the Food and Drug Administration as an
`
`advisor in this field as well.
`
`Q.
`
`Did you say you've been involved in
`
`one way or another with clinical research for every
`
`drug that‘s on the market
`
`to treat pulmonary
`
`arterial hypertension?
`
`A.
`
`Q.
`
`A.
`
`Yes.
`
`Approximately how many drugs is that?
`
`I believe there are 13. One approval
`
`is for a combination, and I was the principal
`
`investigator for that combination development as
`
`well.
`
`Q.
`
`Do you have any experience in drug
`
`development outside of the human clinical research
`
`context?
`
`A.
`
`Q.
`
`No.
`
`In your experience in clinical
`
`research for pulmonary hypertension drugs, could you
`
`describe what experience you have specifically with
`
`regards to medical —— medical devices used to
`
`deliver those drugs?
`
`A.
`
`Sure.
`
`The first drug that was approved for
`
`pulmonary hypertension is a drug called epoprostenol
`
`or Flolan or prostacyclin. That drug has to be
`
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`The compound was used, still is used for parenteral
`
`therapy, still contains the metacresol because it
`
`has to have a preservative.
`
`Q.
`
`You weren‘t
`
`involved in developing
`
`the -— strike that.
`
`You weren't
`
`involved in work related
`
`to synthesizing the API treprostinil for UTC's
`
`products; correct?
`
`A.
`
`Correct.
`
`MR.
`
`JACKSON: Objection;
`
`form.
`
`THE WITNESS: Sorry.
`
`Correct.
`
`BY MR. COOPER:
`
`Q.
`
`Were you involved in developing the
`
`15 manufacturing process that UTC used for making the
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`treprostinil used in any of its products?
`
`A.
`
`Q.
`
`treprostinil.
`
`NO.
`
`You referred to a metacresol—free
`
`Does that refer to the solution of
`
`treprostinil that's used in Tyvaso?
`
`A.
`
`Q.
`
`Yes.
`
`So were you —— strike that.
`
`So you were involved in developing the
`
`formulation of treprostinil solution that's put into
`
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`Page 75
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`ampules and used in Tyvaso;
`
`is that correct?
`
`MR.
`
`JACKSON: Objection;
`
`form.
`
`THE WITNESS: Well, as part of the
`
`work that we were then doing as under the
`
`services contract —— and when I say "we," I
`
`mean me and my colleagues at the University
`
`of Giessen —— at some point, it became clear
`
`that metacresol was a problem with the
`
`inhaled delivery and that it needed to be
`
`removed.
`
`Interestingly, it also markedly
`
`changed the pharmacologic characteristics of
`
`the delivery system.
`
`BY MR. COOPER:
`
`Q.
`
`A.
`
`In what way?
`
`The transfer from the alveolar
`
`compartment to the vascular compartment was slowed
`
`considerably by removal of the metacresol. And so
`
`you had,
`
`again, much less risk of spillover and
`
`problems,
`
`a longer duration of action and more of a
`
`local and reservoir effect.
`
`Q.
`
`Were you involved in determining the
`
`drug concentration in the formulation of the
`
`treprostinil solution that's used for Tyvaso?
`
`A.
`
`No,
`
`I don't believe so.
`
`Q.
`Do you know how the drug concentration
`
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`for the formulation of the treprostinil solution in
`
`Tyvaso was determined?
`
`A.
`
`Q
`
`A.
`
`Q
`
`How the concentration was determined?
`
`Yes.
`
`No.
`
`Do you know whether —- strike that.
`
`Did you test different drug
`
`concentrations for Tyvaso?
`
`A.
`
`Q.
`
`I don‘t recall if we did or not.
`
`Were you involved in development of
`
`the delivery device for Tyvaso?
`
`A.
`
`Q.
`
`Yes.
`
`Could you describe your involvement
`
`in
`
`the development of the delivery device for Tyvaso?
`
`A.
`
`Well,
`
`the delivery device was key to
`
`the success of this treatment. And, again, my
`
`colleagues from Giessen had quite a bit of expertise
`
`in that matter, more than I did, but we both
`
`together had the concept of identifying a device
`
`that would provide a smaller degree of variability
`
`per dose, a droplet delivery that was within the
`
`range we wanted to achieve with a very high degree
`
`of delivery to the alveolar compartment as opposed
`
`to ending up in the upper airways. And the device
`
`that ultimately was identified was the Opti—Neb,
`
`
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`which was produced by a company in Germany by the
`
`name of NEBU—TEC.
`
`Q.
`
`Who identified the —— who first
`
`identified the Opti—Neb device?
`
`A.
`
`I think it was Werner Seeger or ——
`
`and/or members of his group.
`
`Q.
`
`Had Dr. Seeger or members of his group
`
`used the Opti—Neb device in any of their clinical
`
`research previously?
`
`MR.
`
`JACKSON: Objection;
`
`form.
`
`THE WITNESS:
`
`I don't recall. You'd
`
`have to ask them.
`
`BY MR . COOPER:
`
`Q.
`
`Had you ever used the Opti—Neb device
`
`before your work with Tyvaso?
`
`A.
`
`Q.
`
`No.
`
`Had you ever used any NEBU-TEC device
`
`before your work with Tyvaso?
`
`A.
`
`No.
`
`I'm sorry, but
`
`I do recall —— I
`
`did study different concentrations of Tyvaso, but
`
`that was much later.
`
`That was when we were trying
`
`to develop specifically a metered—dose inhaler—type
`
`delivery.
`
`So we looked at higher concentrations so
`
`we could deliver it over a shorter period of time,
`
`but that was considerably later.
`
`
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`instrumental
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`in the selection
`
`and development of the delivery device,
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`the
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`nebulizer,
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`
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`critical in further developing the
`
`concept, particularly focusing on the delivery
`
`mechanism, which is a critical element of the
`
`patents.
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`
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`l
`
`3
`
`STATE OF NEW YORK
`
`)
`
`SS:
`
`COUNTY OF NEW YORK
`
`)
`
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`I, Eileen Mulvenna, Notary Public within
`
`and for the State of New York, do hereby certify:
`
`That
`
`I reported the proceedings in the
`
`within entitled matter, and that the within
`
`transcript is a true record of said proceedings.
`
`I further certify that
`
`I am not related
`
`to any of the parties to the action by blood or
`
`marriage, and that I am in no way interested in the
`
`outcome of this matter.
`
`IN WITNESS WHEREOF,
`
`I have hereunto
`
`set my hand this 7th of February, 2017.
`
`Eileen Mulvenna, CSR/RMR/CRR
`
`unwunverflextconl
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`Veritext Legal Solutions
`
`UNITED THERAPEUTICS, EX. 2204
`WATSON LABORATORIES v. UNITED THERAPEUTICS, |PR2017—O1622
`Page31of31
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