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`2
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`IN THE UNITED STATES DISTRICT COURT
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`FOR THE EASTERN DISTRICT OF TEXAS
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`MARSHALL DIVISION
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`Civil Docket No.
`2:09—CV—97
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`Marshall, Texas
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`August 3, 2011
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`1:15 P.M.
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`3 ALLERGAN,
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`INC.
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`SANDOZ,
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`INC.
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`TRANSCRIPT OF BENCH TRIAL
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`BEFORE THE HONORABLE JUDGE T.
`JOHN WARD
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`UNITED STATES DISTRICT JUDGE
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`4
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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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`San Diego, CA
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`92130
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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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`Minneapolis, MN
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`55402
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`MR. W. CHAD SHEAR
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`Fish & Richardson
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`1717 Main Street
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`Suite 5000
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`Dallas,
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`TX
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`75201
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`10 FOR THE PLAINTIFF:
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`11
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`:3
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`14
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`15
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`1?
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`18
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`20 APPEARANCES CONTINUED ON NEXT PAGE:
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`21
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`22 COURT REPORTERS:
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`23
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`24
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`MS. SUSAN SIMMONS, CSR
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`MS. SHELLY HOLMES, CSR
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`Official Court Reporters
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`l00 East Houston, Suite 125
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`Marshall,
`75670
`TX
`903/935~3868
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`25 {Proceedings recorded by mechanical stenography,
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`transcript produced on CAT system.)
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`Page 1 of 166
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`SENJU EXHIBIT 2136
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`LUPIN V. SENJU
`IPR2015-01100
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`Page 1 of 166
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`SENJU EXHIBIT 2136
`LUPIN v. SENJU
`IPR2015-01100
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`Case 2:09-cv-O0097—JRG Document 241 Filed O8/08!11 Page 2 of 165 PagelD #: 6188
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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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`1?th 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
`T5601
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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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`"E0" 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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`20004
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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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`60603
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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
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`Katten Muchin Rosenman
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`525 West Monroe Street
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`Suite 1600
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`Chicago,
`IL
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`60661
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`APPEARANCES CONTINUED:
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`FOR THE PLAZNTIFF:
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`FOR THE DEFENDANTS:
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`(Sandoz, et al)
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`(Apotex)
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`Page 2 of 166
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`Page 2 of 166
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`Case 2:09—CV-00O97—.]F<’G Document 241 Filed 08108111 Page 3 _Of 165 PageID #2 6189
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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,
`IL
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`60601
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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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`1|r~)r*k9r‘k**k9:‘k9r**k*:l"J:‘k9:‘k‘k9:‘k‘k*"k*9:9<:1:
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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:
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`Please be seated.
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`Ms. Brooks.
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`MS. BROOKS:
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`Thank you, Your Honor.
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`ANGELO P. TANNA, M.D., DEFENDANTS' WITNESS,
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`PREVIOUSLY SWORN
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`DIRECT EXAMINATION
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`21 BY MS. BROOKS:
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`Good afternoon, Dr. Tanna.
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`Good after, Ms. Brooks.
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`Right before the lunch break,
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`I was
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`25 frantically looking for a Copy of Walters.
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`We now have
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`Page 3 of 166
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`Page 3 of 166
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`Case 2:09-cv—00O97~JRG Document 241 Filed 08l08!11 Page 4 of 165 PagelD #: 6190
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`one before you in your binder.
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`And it's DTX138.
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`Oh,
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`I'm sorry. That's the abstract actually, which you
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`did look at.
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`Now,
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`let's look at DTXl37.
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`And that is
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`the Walters paper.
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`So you say, Dr. Tanna, you had not had a
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`chance to look at this before rendering your opinion;
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`is
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`that right?
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`A.
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`No,
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`that's not true.
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`Now that
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`I see it,
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`I do
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`recognize it.
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`I have looked at this reference.
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`Q.
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`So you did consider it in rendering your
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`opinion?
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`A.
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`I did consider it, yes.
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`All right.
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`Then let's look,
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`if we could,
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`Q.
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`please, at Bates No. 346,
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`the page ending in that Bates
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`number.
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`MS. BROOKS:
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`And highlight,
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`if we could,
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`in the right—hand column where it begins similar
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`means —— mean decreases in IOP.
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`A.
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`Q.
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`346?
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`(By Ms. Brooks) Yeah, 346.
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`It should be the
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`bottom right~hand corner,
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`the Bates No. 000346.
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`Do you have that?
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`Yes,
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`I do.
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`Okay.
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`And it's also up on the screen.
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`So let's see what Walters also disclosed about
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`Page 4 of 166
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`Page 4 of 166
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`Case 2:09—cv-00097—JRG Document 241 Filed 08!U8!11 Page 5 of 165 PageID #: 6191
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`this study.
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`It says:
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`Similar mean decreases in IOP
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`were noted for both dosing regimens at hours 2, 4, and ?
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`in the diurnal measurements.
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`In the three—times-daily group,
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`an additional
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`mean decrease in IOP of 3.5 millimeters of mercury was
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`observed at hour 9, after the morning dosing, or two
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`hours following the afternoon dosing.
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`Do you see that, Dr. Tanna?
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`Yes,
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`I do.
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`So isn't it true that one of skill in the art
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`A.
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`Q.
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`would look at Walters and see that there was a
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`statistically significant decrease in IOP at 9.0 hours
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`after morning dosing on the three—times—a—day
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`Brimonidine?
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`A.
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`Yes.
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`And it is overall,
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`in my opinion,
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`that
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`three—times—a—day Brimonidine is more effective than
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`twice—a—day Brimonidine. And,
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`in fact,
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`that
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`is in my
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`expert opinion, and I used a different reference as the
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`main reference for that, specifically Konstas.
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`THE COURT: Doctor,
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`she hadn't asked you
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`any of that.
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`THE WITNESS:
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`I'm sorry, Your Honor.
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`THE COURT:
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`If they want you to repeat
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`that testimony or what's in your expert report,
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`they'll
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`ask you. But unless everybody's not listening to me,
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`Page 5 of 166
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`Page 5 of 166
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`Case 2:O9—cv—00097-JRG Document 241 Filed 08l08l11 Page 6 of 165 Page|D #: 6192
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`the Court's going to start tightening up.
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`I'm not here
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`to listen to lectures.
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`I'm here for you to answer
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`the
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`questions asked, and stop talking.
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`Are we clear?
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`THE WITNESS: Yes, Your Honor.
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`THE COURT:
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`Thank you.
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`Q.
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`(By Ms. Brooks) And let's just see if we can
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`find the graph that correlates to this data in PTX134,
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`which you don't have before you, Dr- Tanna, because it's
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`too large, but has previously been discussed with
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`Ms. Batoosingh.
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`MS. BROOKS:
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`If we can go to PTXI34 and
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`specifically at Bates No. 6?6465, Mr. Exline.
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`Q.
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`Tanna?
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`A.
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`Q.
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`(By Ms. Brooks) And do you see this graph, Dr.
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`Yes,
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`I do.
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`Could you show the Court where that
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`3.5—millimeters of mercury difference occurs between the
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`twice—a—day dosing of Alphagan and the three—times—a—day
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`dosing of Alphagan?
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`It's not doing ——
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`Here, I'll try to help you.
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`I have a pointer. May I use a laser pointer?
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`Sure.
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`Well,
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`Or did I get it close right there?
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`that's it, yes.
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`Page 6 of 166
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`Page 6 of 166
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`Case 2:09-cv-00O9?—JRG Document 241 Filed 08108111 Page 7 of 165 Page|D #: 6193
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`Q.
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`Okay.
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`And so, again, you agree that —— one of
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`skill in the art would know, based on this data,
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`that
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`there was an actual statistically significant decrease
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`in the reduction of
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`intraocular pressure at
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`approximately hour
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`9 between the three—times—a—day
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`dosing of Alphagan and the twiCe—a~day dosing?
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`Yes,
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`in this study.
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`Now, let's move to your discussion of how the
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`A.
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`Q.
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`amount of BAK that was claimed would have been obvious.
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`You said the BAR was the most common preservative;
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`is
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`that correct?
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`Most commonly used in ophthalmic formulations,
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`And,
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`in fact, we saw —~
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`MS. BROOKS: Mr. Exline, could you pull
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`up Defendants’ Slide 10 that they used in opening
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`statement? And if not,
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`I can always put it on the ELMO.
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`There we are.
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`Q.
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`(By Ms. Brooks) So this was
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`shown to the Court
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`by the Defendants in opening statement showing all the
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`different drug products that contain BAR.
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`Do you agree with that, Dr. Tanna?
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`I do.
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`But let's look at the amount of BAK in these
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`A.
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`Q.
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`various products.
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`Isn't it true that there are no less
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`Page 7 of 166
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`Page 7 of 166
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`Case 2:09-cv-00097-JRG Document 241 Filed 08f08:'11 Page 8 of 165 Page|D #: 6194
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`than six different amounts of BAK in these various
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`ophthalmic products?
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`That
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`looks right.
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`Thank you.
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`A.
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`Q.
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`Let's move on now to your discussion of other
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`combination drugs.
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`You told us about a drug called
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`Timpilo;
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`is that right?
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`I did, yes.
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`And you told us about
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`a drug called Cosopt.
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`Q.
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`Of course, we know about that, right?
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`Yes.
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`And also a drug called Xalacom;
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`is that right?
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`That's correct.
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`In fact, on Slide 36 that you used, you showed
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`Q.
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`A.
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`Q.
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`both the Timpilo,
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`the Cosopt, and the Xalacom.
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`Now,
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`in looking more closely at
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`the Timpilo
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`picture that you used,
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`that's not actually a picture of
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`Timpilo,
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`is it?
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`A.
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`I don't know that —— I can't tell from that
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`picture.
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`I don't know.
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`'Q.
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`Isn't it,
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`in fact,
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`just a picture of the
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`bottle of Pilocarpine?
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`A.
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`I don't think so, because it typically would
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`have a green cap.
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`So I can't tell from this picture.
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`I
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`am not sure what that's a picture of.
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`Page 8 of 166
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`Page 8 of 166
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`Case 2:09-cv-00097-JRG Document 241 Filed 08l08!11 Page 9 of 165 Page|D #: 6195
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`Q.
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`Okay.
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`Now, Timpilo has never been approved
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`for use in the United States, correct?
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`A.
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`I was under the impression that it was
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`in use
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`in the United States. That's my impression.
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`I could be
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`mistaken about it, but my understanding is that it was
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`in use in the United States.
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`Q.
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`Okay. What about Xalacom; has Xalacom ever
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`been approved for use in the United States?
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`No, it has not.
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`Now, while we're talking about Xalacom ——
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`MS. BROOKS: Let's just
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`leave that up
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`Q.
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`there,
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`if we could, Mr. Exline.
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`Q.
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`(By Ms. Brooks) We're going to revisit some
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`organic Chemistry.
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`Xalacom is the active ingredient
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`in
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`Latanoprost;
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`is that right?
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`That's correct.
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`And Latanoprost
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`is what's known as a
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`A.
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`Q.
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`prostaglandin analog;
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`is that Correct?
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`That
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`is correct.
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`Are the prostaglandin analogs normally your
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`A.
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`Q.
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`first Choice of medication for a new glaucoma patient?
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`For me today, yes.
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`And,
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`in fact,
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`the Latanoprost is sold here in
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`A.
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`Q.
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`the United States as Xalatan;
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`is that right?
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`Page 9 of 166
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`Page 9 of 166
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`Case 2:09-cv-00097-JRG Document 241 Filed 08!082‘11 Page 10 of 165 PageID #: 6196
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`l0
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`That's correct.
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`But
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`the Combination of Xalatan and Timolol,
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`A.
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`Q.
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`also known as Xalacom, has never been approved for use
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`in the United States;
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`is that correct?
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`That is correct.
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`And you yourself have never prescribed the use
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`A.
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`Q.
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`for Xalaoom, correct?
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`A.
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`I have never prescribed Xalaoom. That's
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`Q.
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`Now,
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`in that
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`same category of prostaglandin
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`analogs, would you put Travoprost?
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`A.
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`It is in the same category.
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`Q.
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`And that's also known as Travatan;
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`is that
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`That's correct.
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`There is no combination drug of Travatan and
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`correct?
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`Q.
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`Timolol approved for us in the United States;
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`is that
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`That is correct.
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`And also within what you would call a
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`correct?
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`Q.
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`prostaglandin analog, or we would Call a prostamide,
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`is
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`a compound Called Bimatoprost.
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`Are you familiar with that?
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`Yes,
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`I am.
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`And Bimatoprost
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`is sold here in the United
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`Page 10 of 166
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`Page 10 of 166
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`Case 2:09~cv—00097-JRG Document 241 Filed 08208111 Page 11 of 165 Page|D #: 6197
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`11
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`States by Allergan under the name Lumigan.
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`Are you familiar with that?
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`Yes,
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`I am.
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`There are no —— I
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`think you mentioned that
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`A.
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`Q.
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`Ganfort, which was a combination of Bimatoprost/Timolol
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`drug;
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`is that right?
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`Correct.
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`But Ganfort is not approved for use here in
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`A.
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`Q.
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`the United States;
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`is that correct?
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`No, it's not.
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`And just to show how subtle differences make a
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`A.
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`Q.
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`very big difference, Bimatoprost and Latanoprost, would
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`you put
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`them in the same category as far as mechanism of
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`action?
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`A.
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`There may be small differences in terms of the
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`mechanism of action.
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`I
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`think it's a matter of
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`controversy.
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`Q. Well,
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`in fact, Latanoprost is what's known as
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`17—phenyl—PGF2—alpha, correct?
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`I know there's a PGF2—alpha~agonist.
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`Okay.
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`And at the Cl position on the alpha
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`A.
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`Q.
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`chain is an ester;
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`is that right?
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`That
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`I don't know offhand.
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`So I may know a little more organic chemistry.
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`A.
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`Q.
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`What about Bimatoprost? Are you aware that if the C1
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`Page 11 of 166
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`Page 11 of 166
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`Case 2:09-cv-O0097—.JRG Document 241 Filed 08108111 Page 12 of 165 PagelD #: 6198
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`12
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`position on the alpha Chain of Bimatoprost
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`is an amide?
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`A.
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`I believe that I can picture that and agree
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`with you on that, but
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`I would have to look at
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`the
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`structure to be sure.
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`It's a complex —— it's a big
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`molecule, and I don't know offhand for sure.
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`Q.
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`Would you agree with me that an ester is
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`different than an amide?
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`It certainly is.
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`And can,
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`in fact, behave differently in situ?
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`Yes, it can.
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`Now,
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`let's go to —- back to the Timpilo.
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`You
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`should have in your binder, Dr. Tanna,
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`the label for
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`Timpilo,
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`I hope.
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`And I don't know if we numbered it
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`since it wasn't actually previously in use, but if you
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`go through your binder, you should see a label for
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`Timpilo.
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`A.
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`Q.
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`Can you tell me approximately where?
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`Oh, it's not
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`in your binder.
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`Sorry.
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`MS. BROOKS: May I approach, Your Honor?
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`THE COURT: Yes.
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`Q.
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`(By Ms. Brooks) Now, Dr. Tanna, you've
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`referred to Timpilo as a combination drug;
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`is that
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`right?
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`A.
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`It is a combination drug, yes.
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`Q. Well,
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`if we actually --
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`Page 12 of 166
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`Page 12 of 166
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`Case 2:09-cv-00097-JRG Document 241 Filed U8!08i11 Page 13 of 165 PagelD #: 6199
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`13
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`MS. BROOKS:
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`If we can go to the ELMO,
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`Mr. Exline.
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`Q.
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`(By Ms. Brooks} And here's the label for
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`Timpilo.
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`cam up there?
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`THE COURT: Not quite. Here we go.
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`COURTROOM DEPUTY:
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`Can you push the doc
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`MS. BROOKS:
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`I sure can. Let's see here.
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`COURTROOM DEPUTY:
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`Uh—huh.
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`MS. BROOKS:
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`Perhaps —— Mr. Exline, do
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`you know —— do we have the Timpilo label
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`in the system?
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`We don't? Okay.
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`It would help if I
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`turn it on.
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`I
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`apologize.
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`There we go.
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`It's my fault.
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`I'm sorry.
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`didn't even turn it on.
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`Q.
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`{By Ms. Brooks) Dr. Tanna,
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`isn't it a fact
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`that Timpilo is dispensed in what is described as a
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`unique,
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`A.
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`Q.
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`two—ohambered vial system?
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`Yes.
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`And one of
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`the chambers contains a
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`concentrated solution of Timolol and Pilocarpine at a pH
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`of approximately 3.5;
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`is that right?
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`Correct. Correct.
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`Now,
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`in relation to the pH of the eye, 3.5 is
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`A.
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`Q.
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`extremely acidic,
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`is it not?
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`Page 13 of 166
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`Page 13 of 166
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`Case 2:09-cv-00097-JRG Document 241 Filed 08108111 Page 14 of 165 Page-ID #: 6200
`1 4
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`A.
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`It is more acidic than the ocular surface and
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`the pH of the eye in general, yes.
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`Q.
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`And the need for this low pH is to prevent the
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`hydrolysis of Pilocarpine prior to dispensing;
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`is that
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`correct?
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`Q.
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`Yes.
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`So you would agree with me, Dr. Tanna,
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`that a
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`pH can have a significant effect on an active
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`ingredient?
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`A.
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`Q.
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`Yes, it can.
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`And it says the other chamber contains —— can
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`you pronounce that word for me,
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`so I make sure I say it
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`It's diluent.
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`Diluent solution with a pH of 7.8 to 8.2 for
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`right?
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`A.
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`Q.
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`Timpilo 2; and 8.5 to 9.5 for Timpilo 4.
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`Did I read that correctly?
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`Yes, you did.
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`And the two solutions are separated by an
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`Q.
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`internal plug?
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`Yes.
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`So this isn't the convenience of having two
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`Q.
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`active ingredients in one bottle, correct?
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`A.
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`It is a little more complicated than that.
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`You have to mix them together effectively by using the
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`Page 14 of 166
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`Page 14 of 166
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`Case 2:09-cv-0OO97—.]RG Document 241 Filed 0808/11 Page 15 of 165 PageID #: 6201
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`15
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`system.
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`Q.
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`And for whatever formulation reason,
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`the
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`formulators were not able to simply put
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`the Timolol and
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`the Pilooarpine into one bottle for shelf life?
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`Correct.
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`And had to go to this two—ohambered system
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`A.
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`Q.
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`with two different pHs and a plug in the middle;
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`is that
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`That's right.
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`Now, another —— so that's the
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`right?
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`A.
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`Q.
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`Pilocarpine/Timolol one.
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`You also mentioned a combination product
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`called Probeta, which is Levobunolol and Dipivefrin?
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`It's pronounced Dipivefrin {pronounces}.
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`Dipivefrin (pronounces).
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`Thank you.
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`MS. BROOKS:
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`Should I push something to
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`MR. LOVE:
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`It's there.
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`MS. BROOKS:
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`There we go.
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`think we're
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`(By Ms. Brooks) And that's called Probeta;
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`is
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`Q.
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`Q.
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`that right?
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`That's correct. That's available in Canada.
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`So that's never been approved for use here in
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`A.
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`Q.
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`the United States, correct?
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`Page 15 of 166
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`Page 15 of 166
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`Case 2:09-cv-00097-JRG Document 241 Filed 08108411 Page 16 of 165 Page|D #: 6202
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`16
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`That's correct.
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`And you yourself have never prescribed it?
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`Correct.
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`Then we have the Xalacom, which we've already
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`talked about,
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`the Ganfort which we've already talked
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`about, and then something where it's Travoprost/Timolol
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`combination;
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`is that right?
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`DuoTrav, yes.
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`DuoTrav.
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`That also has never been approved
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`Q.
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`for use in the United States, correct?
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`Q.
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`A.
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`Q.
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`That's correct.
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`And you yourself have never prescribed it?
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`That's correct.
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`Now,
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`I
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`take it you weren't part of —— well,
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`have you ever been part of an FDA approval process for a
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`A. Well, we were one of the clinical trial
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`centers for DuoTrav for one of
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`the Phase 3 studies in
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`the U.S.
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`Q.
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`So there were Phase 3 clinical trials
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`conducted on DuoTrav here in the United States, correct?
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`Q.
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`That's correct.
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`And I assume that you, as one of
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`attempted to perform those studies accurately, correct?
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`Yes, we did.
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`Case 2:O9—cv-0O097—JRG Document 241 Filed O8!08l11 Page 17 of 165 PagelD #: 6203
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`1 7*
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`And attempted to gather the best data that you
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`Correct.
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`And despite your efforts and all the other
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`centers’ efforts,
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`to this day,
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`the FDA has refused to
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`approve DuoTrav for use in the United States?
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`That's correct. They're stuck in the
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`approvable letter stage.
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`Q.
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`And that's been going on for years, has it
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`Correct.
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`Just a couple more areas to cover, Dr. Tanna.
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`A.
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`Q.
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`You showed us DTXl6? on direct examination.
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`the Larsson reference, and you said that this showed
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`that the patients —— well, actually, why don't you tell
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`us your recollection of what this study showed.
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`A. Well,
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`this looked at normal subjects, not
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`normal volunteers, and they were dosed with Timolol
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`concomitantly with Brimonidine, each on a sort of BID
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`schedule, but only a total of three doses were given.
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`And then the investigators evaluated the rate of
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`production of aqueous humor
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`in the eyes as well as the
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`intraocular pressure.
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`And what
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`they observed was
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`that
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`the intraocular pressure was lowest
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`in the group of
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`people getting both Timolol and Brimonidine, and the
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`Page 17 of 166
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`Page 17 of 166
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`Case 2:09-cv—OU097-JRG Document 241 Filed OBIOBI11 Page 18 of 165 Page|D #: 6204
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`18
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`aqueous production flow rate was also lowest in that
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`group.
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`And the pressures were higher in the other two
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`groups, people getting just Timolol or just Brimonidine.
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`Q.
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`So this would lead one to believe that there
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`be some benefit to concomitant
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`therapy with Timolol
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`Brimonidine, correct?
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`A.
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`It sort of validates and explains that when
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`you use the two together, you get a lower pressure and
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`you get an additive reduction in the production of
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`aqueous humor.
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`Q.
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`But this doesn't tell anyone of skill in the
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`art whether one would be able to successfully combine
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`these two drugs in the same bottle, correct?
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`A.
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`That
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`is correct.
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`And the individuals who were tested in this
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`Q.
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`reference were actually healthy volunteers and not
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`actually individuals suffering from glaucoma;
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`is that
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`right?
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`A.
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`That
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`is correct.
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`Q.
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`And there were only a total of
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`three doses
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`That is correct.
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`And Larsson itself,
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`this reference,
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`is
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`actually disclosed on the face of all of the patents in
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`this case;
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`is that right?
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`Page 18 of 166
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`Page 18 of 166
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`Case 2:09-cv-0009?-JRG Document 241 Filed 08!08i11 Page 19 of 165 Page|D #: 6205
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`19
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`A.
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`Q.
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`That is correct.
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`Now, let's move on.
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`You showed and discussed
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`with the Court
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`the l9T study and the 0 —— 507T study.
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`Do you remember
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`that?
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`I do.
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`Now, neither the l9T study nor the 507T study
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`are prior art to the patents—at~issue;
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`is that correct?
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`Q.
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`That
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`is correct.
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`Now, let's go,
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`if we could,
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`to your written
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`description opinion.
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`You stated in your opinion that Claims 1, 2,
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`and 3 of the 'l49 patent were invalid based on lack of
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`written description;
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`is that right?
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`That's correct.
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`You did not render that opinion in relation to
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`Claim 4, correct?
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`That is correct.
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`Now, Claims 1, 2, and 3 deal with a method of
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`treating glaucoma or ocular hypertension by topical
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`administration of about
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`.2% Brimonidine by weight
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`to an
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`eye of
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`a person in need thereof, said improvement
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`comprising topically administering to said eye in a
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`single composition about
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`.2% Brimonidine by weight and
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`.5% Timolol by weight
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`twice a day as the sole
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`active agents, wherein said method is as effective as
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`Page 19 of 166
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`Page 19 of 166
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`Case 2:09-cv-00097-JRG Document 241 Filed 08f08:'11 Page 20 of 165 PagelD #: 6206
`20
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`administration of
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`.5% Timolol
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`twice a day and .2%
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`Brimonidine three times a day to said eye, wherein the
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`two compounds are administered in separate compositions.
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`Did I get
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`the claim correct,
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`I hope?
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`Yes.
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`All right.
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`Now,
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`let's look at where the
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`effectiveness of administration is discussed in the
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`patent itself.
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`to Column 4 and
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`begin with Example 2.
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`Do you see that?
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`I do.
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`I can go to it in my own exhibit,
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`because I can't see —— okay.
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`There we go.
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`Q.
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`There we go.
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`So this is saying here,
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`this is a study that
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`it's describing, correct?
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`In Example 2, yes.
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`Yes.
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`Uh—huh.
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`And did you have an opportunity, Dr. Tanna,
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`compare the description of this study to the 13T study
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`that was submitted by Allergan to the FDA?
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`I did.
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`Now, were you here when Dr. Whitcup testified?
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`I was.
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`Did you hear Dr. Whitcup say that what
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`the FDA
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`Page 20 of 166
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`Page 20 of 166
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`Case 2:09—cv-00097-JRG Document 241 Filed OBIOSI11 Page 21 of 165 PagelD #: 6207
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`21
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`requires for initial clinical trials of a combination
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`product is that the combination product be compared to
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`each of the monotherapies?
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`Yes,
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`I heard him say that.
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`And you have no reason to disagree with that;
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`is that right?
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`I don't disagree.
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`So what
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`the FDA wanted to see was the efficacy
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`of Combigan as compared to Brimonidine three—times—a—day
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`monotherapy, correct?
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`Yes.
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`And the FDA wanted to see the efficacy of
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`Combigan as compared to twice—a—day Timolol monotherapy,
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`correct?
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`That was part of what
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`the FDA wanted to see,
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`Q.
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`And if we go on Example 2, which begins at
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`Column 4, Line 49, it goes all the way through to the
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`bottom of Column 4, all the way through to the Column 5,
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`and all the through to Column 6, 7, 8, and essentially
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`ends at Column 9 where it ends with Example 2;
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`is that
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`right, Dr. Tanna?
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`A.
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`Q.
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`That's correct.
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`And what
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`the conclusion as reported of the l3T
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`study in the patent says: Conclusions —— and I'll stick
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`Page 21 of 166
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`Page 21 of 166
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`Case 2:09-cv-00097-JRG Document 241 Filed 08!08!11 Page 22 of 165 PagelD #: 6208
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`22
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`with the right spe