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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 16, 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.
`U.S. Patent No. 9,(cid:20)(cid:26)(cid:22),(cid:28)(cid:23)(cid:21)
`Trenton, New Jersey
`Reddy Exhibit 1037
`
`1 2 3 4 5 6 7 8 9
`
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`25
`
`

`
`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 16, 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
`
`1 2 3 4 5 6 7 8 9
`
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`25
`
`Exh. 1037
`
`

`
`2
`
`A P P E A R A N C E S:
`PAUL HASTINGS
`JOSEPH O'MALLEY, ESQUIRE
`BY:
`ERIC W. DITTMANN, ESQUIRE
`ISAAC S. ASHKENAZI, 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. 1037
`
`

`
`Colloquy
`
`I N D E X
`
`3
`
`CROSS
`
`DIRECT
`WITNESS
`GORDON L. AMIDON
`By Mr. Dittmann
`By Mr. Lombardi
`(Videotape Deposition of Patrick DeLuca)
`
`REDIRECT
`
`RECROSS
`
`1 2 3 4 5 6 7 8 9
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`United States District Court
`Trenton, New Jersey
`
`Exh. 1037
`
`

`
`Amidon - Cross
`
`106
`
`A. Yes.
`Q. And we know, we know today that when you use the EDTA, it
`does improve stability; is that right?
`A. Well, I believe that the EDTA -- what EDTA is doing in
`the formula is -- is unknown, but it does appear to improve
`the stability.
`Q. Okay. All right. And just let's look at Amidon
`Demonstrative Number 3. I'm going back to that Wells article
`or chapter that you and I talked about earlier this morning,
`Doctor.
`A. Uh-huh.
`Q. And this is another table from Wells, which is in the
`prior art for purposes of this case, and it says at the top
`"Simple strategies for improving drug stability." And it
`says, for one of them of the degradation processes talks about
`is oxidation, and one of four that it mentions is the strategy
`is to chelate metal ions, and it specifically calls out EDTA;
`is that right?
`A. Uh-huh, yes. There's several approaches, but that's one
`of them.
`Q. And then for demonstrative -- well, and this is something
`that you see throughout the literature is reference to EDTA's
`use if there's some metal ion effect; isn't that right?
`A. That's one of the uses of EDTA, yes.
`Q. Okay. That's a common use.
`
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`
`United States District Court
`Trenton, New Jersey
`
`Exh. 1037
`
`

`
`107
`
`Amidon - Cross
`A. A common use. It's in the Handbook of Pharmaceutical
`Excipients, yes.
`Q. Okay.
`A. I mean, there are other chelating agents, as well.
`Q. Okay. Let's look at Amidon Demonstrative Number 6.
`And do you see this is just a bunch of different
`articles. Let me call out Connors, 1986. That's your book,
`right?
`A. Uh-huh, yes.
`Q. "The most effective chelating agents used
`pharmaceutically are" and I'm going to skip the word, but EDTA
`in parentheses?
`A. Yes.
`Q. "EDTA and citric acid are the two most useful agents."
`Do you see that?
`A. Uh-huh, yes. Well, there's multiple agents that can be
`used and, yes, it does -- citric acid, EDTA are the most
`useful.
`Q. All right. And then let's look at Won. We won't go
`through all these, but look at Won in the lower right. Won
`says, "A variety of chelating agents are available for use in
`aqueous solutions." That's what you just told us, right?
`A. Uh-huh.
`Q. Yes?
`A.
`Yes. I'm sorry.
`
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`
`United States District Court
`Trenton, New Jersey
`
`Exh. 1037

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