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`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`__________________________________
`HELSINN HEALTHCARE, S.A. and
`ROCHE PALO ALTO, LLC,
`Plaintiffs,
`-vs-
`DR. REDDY'S LABORATORIES, LTD.,
`DR. REDDY'S LABORATORIES, INC.,
`TEVA PHARMACEUTICALS USA, INC.,
`and TEVA PHARMACEUTICAL
`INDUSTRIES, LTD.
`Defendants.
`__________________________________
`Clarkson S. Fisher United States Courthouse
`402 East State Street
`Trenton, New Jersey 08608
`June 5, 2015
`B E F O R E:
`
`CIVIL ACTION NUMBER:
`11-3962
`
`TRIAL
`
`THE HONORABLE MARY L. COOPER
`UNITED STATES DISTRICT JUDGE
`
`Certified as True and Correct as required by Title 28, U.S.C.,
`Section 753
`/S/ Regina A. Berenato-Tell, CCR, CRR, RMR, RPR
`/S/ Carol Farrell, CCR, CRR, RMR, CCP, RPR, RSA
`
`Dr. Reddy’s Laboratories, Ltd., et al.
`v.
`United States District Court
`Helsinn Healthcare S.A., et al.
`Trenton, New Jersey
`U.S. Patent No. 9,(cid:20)(cid:26)(cid:22),(cid:28)(cid:23)(cid:21)
`Reddy Exhibit 1049
`
`1 2 3 4 5 6 7 8 9
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`
`

`
`1
`
`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`__________________________________
`HELSINN HEALTHCARE, S.A. and
`ROCHE PALO ALTO, LLC,
`Plaintiffs,
`-vs-
`DR. REDDY'S LABORATORIES, LTD.,
`DR. REDDY'S LABORATORIES, INC.,
`TEVA PHARMACEUTICALS USA, INC.,
`and TEVA PHARMACEUTICAL
`INDUSTRIES, LTD.
`Defendants.
`__________________________________
`Clarkson S. Fisher United States Courthouse
`402 East State Street
`Trenton, New Jersey 08608
`June 5, 2015
`B E F O R E:
`
`CIVIL ACTION NUMBER:
`11-3962
`
`TRIAL
`
`THE HONORABLE MARY L. COOPER
`UNITED STATES DISTRICT JUDGE
`
`Certified as True and Correct as required by Title 28, U.S.C.,
`Section 753
`/S/ Regina A. Berenato-Tell, CCR, CRR, RMR, RPR
`/S/ Carol Farrell, CCR, CRR, RMR, CCP, RPR, RSA
`
`United States District Court
`Trenton, New Jersey
`
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`12
`13
`14
`15
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`25
`
`Exh. 1049
`
`

`
`2
`
`A P P E A R A N C E S:
`PAUL HASTINGS
`JOSEPH O'MALLEY, ESQUIRE
`BY:
`ERIC W. DITTMANN, ESQUIRE
`SAUL EWING
`CHARLES M. LIZZA, ESQUIRE
`BY:
`Attorneys for the Plaintiffs
`
`BUDD LARNER
`BY: STUART D. SENDER, ESQUIRE
`MICHAEL H. IMBACUAN, ESQUIRE
`HUA HOWARD WANG, ESQUIRE
`CONSTANCE S. HUTTNER, ESQUIRE
`KENNETH E. CROWELL, ESQUIRE
`Attorneys for the Defendant, Dr. Reddy's Laboratories
`WINSTON & STRAWN
`BY: JOVIAL WONG, ESQUIRE
`GEORGE LOMBARDI, ESQUIRE
`JULIA MANO JOHNSON, ESQUIRE
`BRENDAN F. BARKER, ESQUIRE
`LITE DePALMA, GREENBERG, LLC
`BY: MAYRA V. TARANTINO, ESQUIRE
`Attorneys for the Defendant, Teva
`
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`
`United States District Court
`Trenton, New Jersey
`
`Exh. 1049
`
`

`
`3
`
`I N D E X
`
`WITNESS
`VOIR
`DIRE
`Lee Edwin Kirsch
`5
`By Mr. Wong
`By O'Malley
`
`DIRECT
`
`CROSS REDIRECT RECROSS
`
`18
`
`92
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`United States District Court
`Trenton, New Jersey
`
`Exh. 1049
`
`

`
`Kirsch - Direct
`
`19
`
`eight asserted claims?
`A. Yes. Claim 7 in the '219 patent really contains the
`elements that are relevant.
`Q. And we'll get to each of these elements in a bit, but
`what is your general opinion regarding each of the components
`listed here for Claim 7?
`A. Well, it's my opinion that these elements are a
`description or involve the description of a common -- commonly
`used conditions and components in I.V. formulations that are
`used for their common uses. So, in my opinion, this patent is
`invalid because of obviousness.
`Q. Now, have you considered who a person of ordinary skill
`in the art would be with respect to the four patents?
`A. Yes, I have.
`Q. And who would that person be?
`A. The person of ordinary skill in the art, a POSA, would be
`a formulation scientist typically with a Ph.D. in
`pharmaceutics or a related field and would have a couple of
`years of experience in developing I.V. formulations.
`Q. Okay. Now, in your opinion, would this POSA have actual
`experience preparing formulations at the bench?
`A. Yes.
`Q. And what is the scope of resources that a POSA would draw
`upon when developing a formulation?
`A. Well, a POSA would have their training and background,
`
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`United States District Court
`Trenton, New Jersey
`
`Exh. 1049
`
`

`
`Kirsch - Direct
`
`20
`
`their academic training and experience. They would draw on
`the pharmaceutical science literature, general textbooks.
`They would draw upon research articles and abstracts
`and other sources of information that gave them some idea of
`the current state of knowledge of palonosetron and related
`compounds, compounds that had a chemical or therapeutic
`similarity to palonosetron.
`Q. Okay. And in the course of --
`THE COURT: And patents, of course.
`THE WITNESS: And patents, yes, they would certainly
`look at patents.
`MR. WONG: Thank you.
`BY MR. WONG:
`Q. In the course of a POSA's practice, would he or she
`collaborate with others of ordinary skill in the art?
`A. Yes, certainly they would. I mean, one of the mechanisms
`for that interaction, of course, is a project team; but even
`in the absence of a project team, they would draw upon the
`knowledge and expertise of clinicians and pharmacologists and
`other scientists in the field.
`Q. So, that would be the same whether the POSA is working in
`industry or is in academia?
`A. Yes, absolutely.
`Q. Now, in forming your opinions in this case, what is the
`relevant date that you tied your opinions to?
`
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`United States District Court
`Trenton, New Jersey
`
`Exh. 1049

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