Case 2:09-cv-00097-JRG Document 243 Filed 08!08!11 Page 1 of 156 PageID #: 6520
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`IN THE UNITED STATES DISTRICT COURT
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`FOR THE EASTERN DlSTRlCT OF TEXAS
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`MARSHALL DIVISION
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`Civil Docket No.
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`2:09—CV—
`97
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`Texas
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`Marshall,
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`August 4,
`1:15 P.M.
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`2011
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`ALLERGAN,
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`INC.
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`VS.
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`SANDOZ,
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`INC.
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`TRANSCRIPT OF BENCH TRIIAL
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`BEFORE
`THE HONORABLE JUDGE T.
`JOHN WARD
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`UNITED STATES DISTRICT J
`UDGE
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`APPEARANCES:
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`FOR THE PLAINTIFF:
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`MS.
`JUANITA
`BROOKS
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`MR.
`ROGER DENNING
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`Fish & Richardson
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`12390 El Camino Real
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`CA
`92130
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`San Diego,
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`MR.
`JONATHAN SINGER
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`MS.
`DEANNA REICHEL
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`Fish & Richardson
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`60 South Sixth Street
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`3200 RBC Plaza
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`MN
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`Minneapolis,
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`55402
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`SHEAR
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`MR. W. CHAD
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`Fish & Richardson
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`1717 Main Street
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`Suite 5000
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`Dallas, TX
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`75201
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`APPEARANCES CONTINUED ON NEXT PAGE:
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`COURT REPORTERS:
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`MS.
`MS.
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`CSR
`CSR
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`SUSAN SIMMONS,
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`SHELLY HOLMES,
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`Official Court Reporters
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`Suite 125
`100 East Houston,
`75670
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`Marshall,
`TX
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`903/935-3868
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`(Proceedings recorded by mechanical stenography,
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`transcript produced on CAT system.)
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`Page 1 of 156
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`S ENJU EXHIBIT 2137
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`LUPIN V. SENJU
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`IPR2015-01100
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`Page 1 of 156
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`SENJU EXHIBIT 2137
`LUPIN v. SENJU
`IPR2015-01100
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`Case 2:09-cv—O0097—JRG Document 243 Filed 08)'08I11 Page 2 of 156 PageID #: 6521
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` 2 APPEARANCES CONTINUED:
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`3 FOR THE PLAINTIFF:
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`MS.
`SUSAN COLETTI
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`MS. A. MARTINA HUFNAL
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`MR. SANTOSH CONTINHO
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`Fish & Richardson
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`222 Delaware Avenue
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`17th Floor
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`Wilmington, DE
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`19899
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`MR. GREGORY LOVE
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`Stevens Love Firm
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`111 West Tyler Street
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`Longview,
`TX
`75601
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`MR. WILLIAM E.
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`The Davis Firm
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`111 West Tyler Street
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`Longview,
`TX
`75601
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`"BO" DAVIS, III
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`MR. BARRY P. GOLOB
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`MR. KERRY B. MCTIGUE
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`MR. W. BLAKE COBLENTZ
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`Duane Morris
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`505 9th Street, NW
`Suite 1000
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`Washington, DC
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`10 FOR THE DEFENDANTS:
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`{Sandoz, et al)
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`MR. RICHARD T. RUZICH
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`Duane Morris
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`190 South LaSalle Street
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`Suite 3700
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`Chicago,
`IL
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`(Apotex)
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`MR. HARRY L. GILLAM,
`Gillam & Smith
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`303 South Washington Avenue
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`Marshall,
`TX
`75670
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`JR.
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`MR. STEPHEN P. BENSON
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`MR. DENNIS C. LEE
`Katten Muchin Rosenman
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`525 West Monroe Street
`Suite 1600
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`Chicago,
`IL
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`60661
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`Page 2 of 156
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`Page 2 of 156
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`Case 2:09-cv-00097-JRG Document 243 Filed 08l08!11 Page 3 of 156 PageID #: 6522
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`1 APPEARANCES CONTINUED:
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`2 FOR THE DEFENDANTS:
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`(Watson)
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`MR. LARRY PHILLIPS
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`Siebman Reynolds Burg &
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`Phillips
`300 North Travis Street
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`Sherman, TX
`75090
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`MR. GARY E. HOOD
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`Polsinelli Shughart
`161 North Clark Street
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`Suite 4200
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`Chicago,
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`MS. ROBYN H. AST
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`Polsinelli Shughart
`100 South 4th Street
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`Suite 1000
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`St. Louis, MO
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`63102
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`:5:9:‘kit1!'*k9r9:9:9<‘k:l'9:‘k‘k'k‘k'k'k*k‘J:‘k'k9:9r9r1l'*
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`P R O C E E D I N G S
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`COURT SECURITY OFFICER: All rise.
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`THE COURT: Please be seated.
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`Proceed.
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`MR. DENNING:
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`Thank you, Your Honor.
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`18 ROBERT J. NOECKER, M.D., PLAINTIFF'S WITNESS, PREVIOUSLY
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`L9
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`SWORN
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`DIRECT EXAMINATION (CONTINUING)
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`21 BY MR. DENNING:
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`Q.
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`A.
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`Good afternoon, Dr. Noecker.
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`Good afternoon.
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`The next reference that the Defendants looked
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`25 at with their experts yesterday that
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`I want
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`to show you
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`Page 3 of 156
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`Page 3 of 156
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`Case 2:09—cv-00097-JRG Document 243 Filed 08l08!11 Page 4 of 156 Pagelt) #: 6523
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`is DTXIL55 .
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`155.
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`I believe this is the Airaksinen article?
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`Yes.
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`And this is one in which they compared two
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`different concentrations of
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`the Timpilo drug to —— to
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`Pilocarpine;
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`is that correct?
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`Yes.
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`And you already testified about Timpilo and
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`Pilocarpine and the effects of —— the adverse effects of
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`Pilocarpine on the eye, correct?
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`Q.
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`That's correct.
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`Was —— did the addition of Timolol to
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`Pilocarpine and Timpilo make it better?
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`A.
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`Q.
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`It did not seem to be.
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`Did not
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`seem to.
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`If we could look at the graph on Page 589,
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`please, and we see on the left—hand side on the top,
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`looks like the —— a Timpilo with .5% Timolol and 2%
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`Pilocarpine;
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`the middle one is .5% Timolol and 4%
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`Pilocarpine; and then the bottom is Pilocarpine by
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`Do you see that?
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`I do.
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`And what does this graph show you?
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`Poor control of intraocular pressure.
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`It's
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`itself.
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`Page 4 of 156
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`Page 4 of 156
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`Case 2:O9~cv-0009?-JRG Document 243 Filed 08/08f11 Page 5 of 156 PageID #: 6524
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`important —— so this graph we have to be a little bit
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`careful with, because unlike the other graphs we
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`looked
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`at earlier, which are frequently across times of day by
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`hour,
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`this drop on this graph is mean average.
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`So in this study,
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`they put a drop in of the
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`medication and then they checked —— they checked the eye
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`pressure, put a drop in, and then checked the eye
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`pressure two hours later.
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`And then this data is mean
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`IOP of
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`those two morning timepoints.
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`So this is a study where they only collected
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`morning data,
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`so it doesn't tell us anything about
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`effect on afternoon data.
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`And then they had a run—in period on the
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`betawblocker.
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`And this is over a three—week —— this is
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`days,
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`21 days to 42 days of average IOP.
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`So, once
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`it should be capturing the best
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`timepoint, and
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`then the morning —— the morning, you know,
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`less
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`effective timepoint.
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`So it doesn't tell us anything about afternoon
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`pressure.
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`But when you look at this,
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`the eye pressures
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`are all over the board.
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`So this is even day—to—day.
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`So
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`this is not
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`some fluctuation we were talking earlier
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`about within the day.
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`You know,
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`this patient started,
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`if this was a
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`in my practice, once again, Patient Mrs. Jones‘
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`Page 5 of 156
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`Case 2:09~cv«0O09?—.JRG Document 243 Filed 08f08!11 Page 6 of 156 PageID #: 6525
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`pressure is in the 205, we put you on this drug or two
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`drugs.
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`We don't know what your eye pressure is going to
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`be the next
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`time you come in.
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`Maybe one time it's 18, kind of below the
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`overflow limit.
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`The next
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`time, it's above on the next
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`visit.
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`So this is not somebody we say, okay, see you in
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`six months.
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`I'm sure everything will be fine.
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`So this is P%or eye pressure control, and
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`we —— you know, we wouldn't use this, because it's
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`showing the poor IOP control of this combination drug.
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`Q.
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`Thank you, Dr. Noecker.
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`And just to —- before we move on, what does
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`Airaksinen teach a person of ordinary skill in the art
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`about combining Brimonidine and Timolol
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`in a fixed
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`combination drug?
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`A.
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`Nothing.
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`And it might give you pause about
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`combination drugs in general.
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`Q.
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`Thank you, Dr. Noecker.
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`Let's move on to Defense Exhibit 148, which
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`was the Clineschmidt article.
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`MR. DENNING:
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`Thank you, Mr. Exline.
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`Q.
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`(By Mr. Denning) This is the article in which
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`they were comparing Cosopt on the one arm versus BID
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`Timolol and TID Dorzolamide monotherapies;
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`is that
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`right?
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`Page 6 of 156
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`Page 6 of 156
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`Case 2:09-cv-0009?-JRG Document 243 Filed 08!08i11 Page 7 of 156 Page|D #: 6526
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`That's correct.
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`And if we turn to Table 3 of this study —~
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`MR. DENNING: Which appears on —— on Page
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`1955, Mr. Exline.
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`Q.
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`(By Mr. Denning) —e what
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`time periods are they
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`measuring with this study?
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`They're looking at
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`the pre—dose in the
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`mornings of 8:00 a.m., putting the drop in, and then two
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`hours, once again, at
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`the time we'd expected to be the
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`So morning time points,
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`two hours
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`apart.
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`Q.
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`Okay. Does this Show anything about that
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`afternoon trough at all in this paper?
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`It doesn't give us any afternoon information.
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`Okay. Well,
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`let's look at what it shows
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`Q.
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`for the morning pressure.
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`MR. DENNING:
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`If we could go and,
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`Mr. Exline, highlight on the bottom for month 3 and the
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`change,
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`the second to the rightmost column, and then
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`highlight for the combination and for Dorzolamide —— I'm
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`Sorry —— second to the right, Mr. Exline.
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`There you go. Right there.
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`Q.
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`(By Mr. Denning} So what —— what do we see
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`here as the comparison between Dorzolamide as a
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`monotherapy and then the Cosopt combination?
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`Page 7 of 156
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`Page 7 of 156
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`Case 2:09—cv~00097~.JRG Document 243 Filed 08i08l11 Page 8 of 156 PageID #: 6527
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`A.
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`So the combination of Cosopt combination drug
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`had a —— a mean change of minus 4.4, kind of
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`the best --
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`timepoint,
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`the 10:00 a.m.
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`timepoint.
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`Q.
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`Would you r" and compared to 2 points lower
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`for Dorzolamide;
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`is that right?
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`better.
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`Correct.
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`So about
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`2 milliliters of mercury
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`So when determining how much benefit Timolol is
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`giving us, adding on top of
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`the Dorzolamide, it's about
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`2 millimeters is what we see in this study.
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`Q.
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`And what —— what
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`impact does it have that this
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`is at hour 2 versus if it were at hour 8?
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`A.
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`this is the best
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`timepoint,
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`Once again,
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`because it only goes —— gets worse from here.
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`So this
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`kind of tells us a best—case scenario,
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`that
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`two hours
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`post—dosing is as good as it's going to get.
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`So we ——
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`by inference, we would suspect that it will be less of a
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`beneficial effect in the afternoon.
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`Okay.
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`We don't know exactly how much, but that's --
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`A.
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`it's going to be the best. That's all we can tell you.
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`Q.
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`Okay.
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`And at hour
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`0 up above for the same --
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`for the same 2
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`in month 3, we see a difference from 2.8
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`to 1.4;
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`is that right?
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`A.
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`Q.
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`That's right.
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`It's about 1.4, 1—l/2, yes.
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`Okay. Earlier when we
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`looked at
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`the
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`Page 8 of 156
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`Page 8 of 156
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`Case 2:09-cv-0009"/—JRG Document 243 Filed 08!O8l11 Page 9 of 156 PageID #: 6528
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`demonstrative from opening that showed the afternoon
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`trough, do you remember
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`that?
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`A.
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`Q.
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`Yes.
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`And there was a —— the afternoon trough was
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`about 3.25,
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`I
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`think,
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`in that demonstrative.
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`Do you remember
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`that?
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`I think it was 3.5.
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`MR. DENNING: Mr. Exline, are you able to
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`pull that up?
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`A.
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`You're talking about
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`the difference between
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`TID Brimonidine and BID Brimonidine?
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`Q.
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`(By Mr. Denning] That's —— that's exactly
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`right. That's what
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`I was talking about.
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`A.
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`I recall it being 3.5 millimeters of mercury.
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`That's 3.25 --
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`Q.
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`I think you may remember
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`from Ms. Batoosingh‘s
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`testimony when they looked at the actual underlying
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`document.
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`It was —— it was different.
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`Perhaps.
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`But
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`in any event, does —— the 1.5 to
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`A.
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`Q.
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`2 millimeters of mercury benefit that we just saw from
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`the Clineschmidt paper with regard to Cosopt, would that
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`be enough to make up any afternoon trough in the
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`difference between Brimonidine BID and TID?
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`A.
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`Like I said, it doesn't give us really any
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`Page 9 of 156
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`Page 9 of 156
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`Case 2:09-cv-0009?-JRG Document 243 Filed O8/08!11 Page 10 of 156 Page|D #: 6529
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`10
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`information regarding Brimonidine, but if you were to
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`make the inference about what's the benefit of adding
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`the Timolol
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`in terms of eye pressure reduction,
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`the most
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`these other papers indicate it might be in the best,
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`best—oase scenario only at
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`the morning is 1-1/2 to
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`2—ish,
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`so not at the magnitude.
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`But, really,
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`the inference I
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`think you can
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`draw is that magnitude may fall short.
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`It's not going
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`to be —— adding Timolol is just not going to be
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`adequate.
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`Q.
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`Okay.
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`So what would one of —— what,
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`if
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`anything, would one of skill in the art learn from
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`Clineschmidt about
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`the ability to reduce the number of
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`doses of Brimonidine from three doses to two doses by
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`adding Timolol
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`in combination?
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`A.
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`That it would not be adequate to make up for
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`the deficit we see in the afternoon —— that afternoon
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`dip in IOP control.
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`Q.
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`Okay.
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`You may set that exhibit aside.
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`Dr. Tanna also looked at DTXZOO, and let's
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`look at that briefly,
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`if we could, please. This is the
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`Boyle reference?
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`Yes.
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`Now, again,
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`this is a study looking at Cosopt,
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`A.
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`Q.
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`correct?
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`Page 10 of 156
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`Page 10 of 156
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`Case 2:09-cv-00097-JRG Document 243 Filed O8:’08!11 Page 11 of 156 PageID #: 6530
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`11
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`Correct.
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`And Cosopt, meaning the combination of
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`A.
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`Q.
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`Dorzolamide and Timolol, correct?
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`That's correct.
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`Okay. What does that teach you as a person of
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`A.
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`Q.
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`skill in the art about combining Brimonidine and
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`Timolol?
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`A.
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`It doesn't teach you anything, because
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`different ~— Dorzolamide and Brimonidine are different
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`drugs.
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`MR. DENNING: And, again,
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`if we can --
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`Mr. Exline,
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`if you could look at Table 2, which is on
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`Page 1948.
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`Q.
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`the only time
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`(By Mr. Denning) Again,
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`measurements made with —— in the Boyle paper were at
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`hour 0 and hour 2;
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`is that correct?
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`That's correct.
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`So does that tell us any meaningful
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`A.
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`Q.
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`information about what
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`the midday IOP control would be,
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`even for this combination?
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`A.
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`All you can do is surmise that it's not going
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`to be as good in terms of eye pressure lowering.
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`Q.
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`Okay.
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`And does the Boyle paper about Cosopt
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`and the 0- and 2-hour measurements, what does that teach
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`a person of skill in the art,
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`if anything, about
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`the ——
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`Page 11 of 156
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`Page 11 of 156
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`Case 2:09-cv-00097-JRG Document 243 Filed 08!O8l11 Page 12 of 156 Page|D #: 6531
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`combining Brimonidine and Timolol and the effects that
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`that might be,
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`if they were in a Combination drug
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`together?
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`A.
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`Nothing specific to the Brimonidine/Timolol
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`combination, but, once again, specific to the addition
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`as Brimonidine —— or Timolol as a tool,
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`it will fall --
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`it may fall short or probably will fall short
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`in the
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`afternoon.
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`Q.
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`Okay.
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`And if you could look at Table 5
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`in
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`this paper as well.
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`This -— this one deals with the ocular and
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`local adverse experiences.
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`Do you see that?
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`Yes.
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`And can you tell me, are there any —— did the
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`A.
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`Q.
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`combination in this study experience any reduction in
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`adverse experiences than the individual
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`therapies?
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`A.
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`It didn't —— it didn't reduce any.
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`It may
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`have stung a little bit more.
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`Q.
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`It may have stung a little bit more.
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`Okay.
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`Thank you.
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`You can set —— you can set
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`And the last one of the articles that they
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`showed yesterday that I'm going to show you is DTX201.
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`MR. DENNING:
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`If you could pull that up?
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`(By Mr. Denning) This is the Hutzelmann
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`Page 12 of 156
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`Page 12 of 156
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`Case 2:09-cv-00097-JRG Document 243 Filed 08!08l11 Page 13 of 156 Page|D #: 6532
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`13
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`reference.
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`Yes.
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`And this study, again, compared Cosopt on the
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`Q.
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`one arm versus Dorzolamide BID/Timolol BID concomitant
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`therapy, correct?
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`Yes.
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`And, again,
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`if we
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`look at —~ if we
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`look at
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`Q.
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`Table 2, which appears on Page 1251 --
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`A.
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`Q.
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`Yes.
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`—— we can see that they, again,
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`took the
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`measurements only at hour 0 and hour 2;
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`is that right?
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`A.
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`Q.
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`That's correct. Yes.
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`I'm sorry.
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`So, again, it tells us nothing
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`about
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`the afternoon trough;
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`is that correct?
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`Right,
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`same story.
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`Okay.
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`And if we
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`look at the mean change.
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`MR. DENNING:
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`I'm sorry, Mr. Exline.
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`A.
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`Q.
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`Please go back to that table.
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`Thank you.
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`Q.
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`(By Mr. Denning} If we look at the change
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`column,
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`second from the right, at month 3, we see the
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`combination and the concomitant are both at
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`the exact
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`same pressure reduction;
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`is that right?
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`A.
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`Right.
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`So in terms of efficacy, it's neutral
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`for the morning.
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`Page 13 of 156
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`Page 13 of 156
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`Case 2:09-cv—00097—JRG Document 243 Filed 08:‘08l11 Page 14 of 156 Page|D #: 6533
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`14
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`Q.
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`Okay.
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`So based on what you read in
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`Hutzelmann, Dr. Noecker, what does it teach,
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`if
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`anything, one of skill in the art about combining
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`Brimonidine and Timolol
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`in a single combination
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`treatment for intraooular pressure?
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`A.
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`There's certainly nothing here specific for
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`Brimonidine.
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`And in terms of the addition of Timolol
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`in
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`a fixed combination, it doesn't
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`seem like it's going to
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`solve efficacy problems.
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`Q.
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`Okay.
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`So you can set that one aside as well,
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`Dr. Noecker.
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`We've been through most of the art that the
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`Defendants relied on yesterday at trial.
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`Have you
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`reviewed all of
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`the art that Dr. Tanna and Dr. Laskar
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`talked about yesterday?
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`Yes.
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`And in your opinion, Dr. Noeoker, as one of
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`Q.
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`skill in the art, do these references —— would these
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`references motivate a person of skill to develop a
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`single composition drug of 0.2% Brimonidine and 0.5%
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`No.
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`Why not?
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`I have not seen compelling information that
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`Timolol?
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`Q.
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`A.
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`would lead me to —— looking at
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`the —— all this prior
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`Page 14 of 156
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`Page 14 of 156
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`Case 2:09~cv~00097-JRG Document 243 Filed OBIOBI11 Page 15 of 156 Page|D #: 6534
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`15
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`art,
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`that there's a benefit
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`to doing so. Basically,
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`looking at Timolol
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`to solve efficacy problems that are
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`associated with Brimonidine.
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`Q.
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`And in your opinion, Dr. Noecker, do these
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`references provide a motivation to one of skill in the
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`art that making a fixed combination of 0.2% Brimonidine
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`and 0.5% Timolol could allow you to reduce the number of
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`dosage of Brimonidine from three doses a day to two
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`doses a day without
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`losing efficacy?
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`A.
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`No,
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`I don't see any evidence here that would
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`lead me to believe that,
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`that you could successfully
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`reduce the dosing interval from three times a day to
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`twice a day —~
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`Okay.
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`+— of Brimonidine.
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`Thank you, Dr. Noecker.
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`Q.
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`A.
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`Q.
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`We need to do one more —— one more run through
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`the claims now in light of all of these references.
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`MR. DENNING:
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`So, Mr. Exline,
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`if you
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`could please pull up AGX512.
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`And I
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`think we can be even
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`more efficient than last time.
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`Q.
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`(By Mr. Denning) So here we have ——
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`MR. DENNING:
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`Do we have the other 512,
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`There we go.
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`Thank you.
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`Page 15 of 156
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`Page 15 of 156
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`Case 2:09-cv-00097-JRG Document 243 Filed 08I08!11 Page 16 of 156 PagelD #: 6535
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`1 6
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`Q.
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`(By Mr. Denning) Here we have all of
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`the
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`asserted ~— all the claims at
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`issue of the four patents
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`that we're talking about. And, again, we have
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`highlighted all of
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`the limitations that relate to the
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`.2% Brimonidine and .5% Timolol.
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`And my question w— those limitations appear in
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`Claim 1 of the '976,
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`1 and 7 of the ‘258,
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`4 of
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`the 'l49,
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`and l and 4 of the '463.
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`My question for you, Dr. Noecker, on the
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`obviousness analysis,
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`is there anything in
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`Desantis/Timmermans,
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`in light of all of
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`the other
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`that would
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`references that you've seen in this Court,
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`have taught one of skill in the art to choose the
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`specific combination of 0.2% Brimonidine and 0.5%
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`Timolol
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`in a single combination?
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`A.
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`I don't see any teaching in this prior art
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`that would lead me to do so.
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`MR. DENNING: Okay.
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`If we could pull up
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`the AGX5l3, please, Mr. Exline.
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`Q.
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`(By Mr. Denning) Now, we have put up only the
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`claims that have the preservative BAK in it as well as
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`the concentrations.
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`And I want to direct your attention
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`to Claim 2 of the ‘258,
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`8 of the ‘258,
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`2 of
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`the '463,
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`and 5 of the '463, each of which additionally claim the
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`limitation of BAK preservative, Benzalkonium Chloride
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`Page 16 of 156
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`Page 16 of 156
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`Case 2:09-c\/-0009?-.JRG Document 243 Fifed 08!08!11 Page 17 of 156 PagelD #: 6536
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`1 7
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`preservative, at 0.001% to 0.01%.
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`And looking at those four claims, Dr. Noecker,
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`is there anything in Desantis/Timmermans,
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`in light of
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`all of
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`the other references that you have seen in this
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`courtroom,
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`that would teach one of skill in the art
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`to
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`choose a specific combination of 0.2% Brimonidine and
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`0.5% Timolol
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`in a composition with 0.001% to 0.01%
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`Benzalkonium Chloride?
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`No.
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`And with respect to claims 3 and 9 of the ‘258
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`A.
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`Q.
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`and 3 and 6 of
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`the '463, each of which include the
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`limitation of BAK at a concentration of 0.005%, my
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`question, Dr. Noecker,
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`is,
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`is there anything in
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`DeSantis/Timmermans,
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`in light of all of the references
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`that you've seen in this courtroom,
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`that would teach one
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`of skill in the art to choose a specific combination of
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`0.2% Brimonidine and 0.5% Timolol with a preservative
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`concentration of 0.005% Benzalkonium Chloride?
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`A.
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`No.
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`MR. DENNING:
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`And finally,
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`if we could go
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`to 514, Mr. Exline.
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`Q.
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`{By Mr. Denning} We have Claim 4 of the 'l49
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`patent displayed, and this is the one that talks about a
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`method of reducing the number of daily topical
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`ophthalmic doses of Brimonidine administered topically
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`Page 17 of 156
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`Page 17 of 156
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`Case 2:09~cv-0009?-JRG Document 243 Filed O8!08!11 Page 18 of 156 Page|D #: 6537
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`l8
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`to an eye of the person in need thereof for the
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`treatment of glaucoma or ocular hypertension from three
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`to two times a day without
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`loss of efficacy.
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`And with respect to that limitation,
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`Dr. Noecker, my question is,
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`is there anything in
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`Desantis/Timmermans,
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`in light of all of
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`the other
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`references that you've —~ you've seen in this courtroom,
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`that would teach one of skill in the art a method of
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`reducing the dose of Brimonidine from three doses to two
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`doses without reducing efficacy in the treatment of
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`glaucoma or ocular hypertension?
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`No.
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`And why not?
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`Many of the ~~ much of the prior art does not
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`A.
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`really address the key timepoint, which is that
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`afternoon trough, which is what's led to the labeling of
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`Brimonidine.
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`So we really don't have a lot of
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`the Timolol
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`to the Brimonidine would allow us to reduce
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`the dosing interval without
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`losing efficacy.
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`Q.
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`So now,
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`looking back at 512, 513, and 514, my
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`ultimate question, Dr. Noecker,
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`is,
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`in light of the
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`DeSantis/Timmermans reference and all of the other prior
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`art that you've seen in this courtroom,
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`is it —— what is
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`your opinion regarding whether these claims of these
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`Page 18 of 156
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`Page 18 of 156
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`Case 2:09-cv-00097-JRG Document 243 Filed 08l08!11 Page 19 of 156 PagelD #: 6538
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`19
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`four patents would be obvious to one of ordinary skill
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`in the art in 2002?
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`They would not be obvious.
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`Now,
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`in addition to —— to doing your
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`anticipation and —— and obviousness analysis, have you
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`also considered what are called objective considerations
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`of non—obviousness?
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`Yes.
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`Okay.
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`Q.
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`MR. DENNING:
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`If you could —— if you
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`Could please pull up AGXlllR.
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`Q.
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`(By Mr. Denning) Okay.
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`This is the —— this is
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`the graph we've seen a couple times in your examination,
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`and this is where you show the afternoon trough and the
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`difference between Alphagan TID and Alphagan BID,
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`Yes.
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`Okay. With that in mind,
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`if you could please
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`correct?
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`grab PTX?7 from your PTX binder.
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`Okay.
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`And this is the Sherwood paper as it's been
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`called, correct?
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`That's correct.
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`And what are the treatment arms in this study?
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`This had Combigan, which was twice daily fixed
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`Page 19 of 156
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`Page 19 of 156
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`Case 2:09—cv—0009?-JRG Document 243 Filed 08208111 Page 20 of 156 Page-ID #: 6539
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`20
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`combination Brimonidine/Timolol.
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`And then we had
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`monotherapy with Timolol
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`twice a day.
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`And then we had
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`Brimonidine monotherapy used three times a day.
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`Those
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`are three treatment groups.
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`Q.
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`Okay.
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`So we're comparing on the one hand
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`Combigan in which patients are getting Brimonidine twice
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`a day.
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`And on the other hand, we're giving this
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`therapy in which they're
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`getting Brimonidine three times a day;
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`is that correct?
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`They're getting monotherapy three times a day.
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`Thank you for correcting me.
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`Q.
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`So there are three arms in this study.
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`On the
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`they're getting Combigan, which has
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`one hand,
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`Brimonidine,
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`two times a day.
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`On the second hand,
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`they're getting Brimonidine three times a day.
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`And then
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`on the third hand,
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`they're getting Timolol without any
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`Brimonidine;
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`is that correct?
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`Q.
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`That's correct.
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`Okay.
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`Thank you for correcting me.
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`MR. DENNING:
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`If we could