`
`Civil Action
`
`IN THE UNITED STATES DISTRICT COURT
`IN AND FOR THE DISTRICT OF DELAWARE
`- - -
`SALIX PHARMACEUTICALS, INC. and )
`DR. FALK PHARMA GmbH,
`Plaintiffs,
`
`))
`
`No. 14-213-GMS
`
`)
`- - -
`Wilmington, Delaware
`Monday, November 16, 2015
`9:00 a.m.
`Trial Day 1
`- - -
`BEFORE: HONORABLE GREGORY M. SLEET, U.S.D.C.J.
`APPEARANCES:
`MARY W. BOURKE, ESQ.,
`DANA KATHRYN SEVERANCE, ESQ.,
`DANIEL ATTAWAY, ESQ., and
`KRISTEN HEALEY CRAMER, ESQ.
`Womble Carlyle Sandridge & Rice, LLP
`-and-
`TRYN T. STIMART, ESQ.
`Womble Carlyle Sandridge & Rice, LLP
`(Tysons Corner, VA)
`Counsel for Plaintiffs
`
`))
`
`))
`
`))
`
`v.
`NOVEL LABORATORIES, INC.,
`Defendant.
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`Dr. Falk Ex. 2023
`GeneriCo v. Dr. Falk IPR2016-00297
`Page 1
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`34
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`founders of Salix Pharmaceuticals.
`THE COURT: Dr. Johnson, please come on up.
`... LORIN KEITH JOHNSON, having been duly sworn
`as a witness, was examined and testified as follows ...
`THE COURT: Good morning, Doctor.
`MS. BOURKE: Your Honor, may I approach with the
`
`exhibits?
`
`you.
`
`THE COURT: Mr. Buckson will take those from
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`DIRECT EXAMINATION
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`BY MS. BOURKE:
`Good morning, Doctor.
`Q.
`Could you please introduce yourself to the
`
`Court?
`A.
`
`Good morning, Your Honor.
`THE COURT: You can focus on Ms. Bourke. Don't
`feel that you are ignoring me.
`THE WITNESS: Good morning, Your Honor. I am
`Dr. Lorin Johnson.
`BY MS. BOURKE:
`Could you briefly describe your educational background
`Q.
`for the Court?
`Yes. I received my Ph.D. in molecular biology from
`A.
`the University of Southern California in 1976. I spent a
`four-year postdoctoral period at the University of
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`Dr. Falk Ex. 2023
`GeneriCo v. Dr. Falk IPR2016-00297
`Page 2
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`49
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`Johnson - direct
`California Biotechnology.
`A.
`If you turn to PTX-885-6 of that document, please. If
`Q.
`you look at the proposed indication there. Do you see that,
`Doctor?
`Yes.
`A.
`And what the typical proposed indication at this point
`Q.
`in time?
`The proposed indication for mesalamine pellets is for
`A.
`the maintenance of remission of ulcerative colitis.
`What was the change in thinking that occurred from
`Q.
`November 2002 to July 2003?
`So, as I stated before, our original intent was to
`A.
`develop the product for active disease, and test twice a day
`versus once a day treatment.
`We actually, in reviewing the information and
`considering the program in more detail, determined that we
`might have a greater possibility of success by focus on the
`maintenance of remission. That is because in active disease
`there is a lot of transit going through the colon. Patients
`can have ten to 12 bowel movements per day. It was our
`concern that a single dose might not be resident in the
`colon for a long enough period of time, whereas in
`maintenance of remission, the symptoms have been brought
`under control and there is generally a normal stool
`frequency.
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`Dr. Falk Ex. 2023
`GeneriCo v. Dr. Falk IPR2016-00297
`Page 3