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` IN THE UNITED STATES DISTRICT COURT FOR THE
` DISTRICT OF DELAWARE
`NOVARTIS PHARMACEUTICALS )
`CORPORATION and NOVARTIS AG, )
` )
` Plaintiffs, )
` )
` v. ) C.A. No. 14-1043-RGA
` )
`BRECKENRIDGE PHARMACEUTICAL, INC.,)
` )
` Defendant. )
`__________________________________)
`NOVARTIS PHARMACEUTICALS )
`CORPORATION and NOVARTIS AG, )
` )
` Plaintiffs, )
` )
` v. ) C.A. No. 14-1196-RGA
` )
`ROXANE LABORATORIES, INC., )
` )
` Defendant. )
`__________________________________)
`NOVARTIS PHARMACEUTICALS )
`CORPORATION and NOVARTIS AG, )
` )
` Plaintiffs, )
` )
` v. ) C.A. No. 14-1289-RGA
` )
`PAR PHARMACEUTICAL, INC., )
` )
` Defendant. )
` VIDEOTAPED DEPOSITION OF MARK J. RATAIN, M.D.
` Monday, April 11, 2016
` Chicago, Illinois
`Reporter by:
`Janice M. Kocek, CSR, CLR
`Job No. 105588
`
`TSG Reporting - Worldwide 877-702-9580
`
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`NOVARTIS EXHIBIT 2026
`Par v. Novartis, IPR 2016-01479
`Page 1 of 8
`
`
`
` IN THE UNITED STATES DISTRICT COURT FOR THE
` DISTRICT OF DELAWARE
`NOVARTIS PHARMACEUTICALS )
`CORPORATION and NOVARTIS AG, )
` )
` Plaintiffs, )
` )
` v. ) C.A. No. 14-1043-RGA
` )
`BRECKENRIDGE PHARMACEUTICAL, INC.,)
` )
` Defendant. )
`__________________________________)
`NOVARTIS PHARMACEUTICALS )
`CORPORATION and NOVARTIS AG, )
` )
` Plaintiffs, )
` )
` v. ) C.A. No. 14-1196-RGA
` )
`ROXANE LABORATORIES, INC., )
` )
` Defendant. )
`__________________________________)
`NOVARTIS PHARMACEUTICALS )
`CORPORATION and NOVARTIS AG, )
` )
` Plaintiffs, )
` )
` v. ) C.A. No. 14-1289-RGA
` )
`PAR PHARMACEUTICAL, INC., )
` )
` Defendant. )
` VIDEOTAPED DEPOSITION OF MARK J. RATAIN, M.D.
` Monday, April 11, 2016
` Chicago, Illinois
`Reporter by:
`Janice M. Kocek, CSR, CLR
`Job No. 105588
`
`TSG Reporting - Worldwide 877-702-9580
`
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`NOVARTIS EXHIBIT 2026
`Par v. Novartis, IPR 2016-01479
`Page 1 of 8
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`Page 2
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` April 11, 2016
` 9:35 a.m.
`
` The videotaped deposition of MARK J.
`RATAIN, M.D., held at the offices of LATHAM &
`WATKINS, 330 North Wabash Avenue, Chicago,
`Illinois, pursuant to Notice,
`before Janice M. Kocek, a Certified Court
`Reporter, Certified LiveNote Reporter, a and a
`Notary Public of the State of Illinois.
`
`TSG Reporting - Worldwide 877-702-9580
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`NOVARTIS EXHIBIT 2026
`Par v. Novartis, IPR 2016-01479
`Page 2 of 8
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`Page 3
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`A P P E A R A N C E S:
`
` FITZPATRICK, CELLA, HARPER & SCINTO
` Attorneys for Plaintiff Novartis
` Pharmaceuticals Corporation and Novartis AG
` 1290 Avenue of the Americas
` New York, New York 10104
` BY: CHARLOTTE JACOBSEN, ESQ.
` SUSANNE FLANDERS, ESQ.
`
` GOODWIN PROCTER
` Attorneys for Defendant Roxane Laboratories, Inc.
` 620 Eighth Avenue
` New York, New York 10018
` BY: NAOMI BIRBACH, ESQ.
` (appeared telephonically)
`
` LATHAM & WATKINS
` Attorneys for Par Pharmaceutical, Inc.
` 330 North Wabash Avenue
` Chicago, Illinois 60611
` BY: BRENDA DANEK, ESQ.
`
` ALSO PRESENT:
` RENATO VELARDE, Legal Video Specialist
`
`TSG Reporting - Worldwide 877-702-9580
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`NOVARTIS EXHIBIT 2026
`Par v. Novartis, IPR 2016-01479
`Page 3 of 8
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` M. RATAIN, M.D.
` THE VIDEOGRAPHER: This is the start
`of DVD labeled Number 1 of the videotaped
`deposition of Mark J. Ratain, M.D., in the
`matter of Novartis Pharmaceuticals
`Corporation versus Breckenridge
`Pharmaceutical, Incorporated, Case Number
`14-1043-RGA; and Novartis Pharmaceuticals
`Corporation versus Roxane Laboratories,
`Incorporated, Case Number 14-1196-RGA;
`and Novartis Pharmaceuticals Corporation
`versus Par Pharmaceuticals, Incorporated,
`Case Number 14-1289-RGA in the United
`States District Court for the District of
`Delaware.
` This deposition is being held at
`Latham & Watkins, LLP, 330 North Wabash,
`Chicago, Illinois, on April 11, 2016, at
`approximately 9:35 a.m.
` My name is Renato Velarde. I'm the
`legal video specialist from TSG Reporting,
`Incorporated, headquartered at 747 Third
`Avenue, New York, New York. The court
`reporter is Janice Kocek in association
`with TSG Reporting.
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2026
`Par v. Novartis, IPR 2016-01479
`Page 4 of 8
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` M. RATAIN, M.D.
` Will counsel please introduce
` yourself?
` MS. JACOBSEN: Charlotte Jacobsen
` from Fitzpatrick on behalf of the
` plaintiffs; and with me is
` Susanne Flanders, also from Fitzpatrick.
` MS. DANEK: Brenda Danek from
` Latham & Watkins on behalf of Par.
` MS. BIRBACH: Naomi Birbach from
` Goodwin Procter on behalf of Roxane
` Laboratories.
` THE VIDEOGRAPHER: Will the court
` reporter please swear in the witness?
` (Witness sworn.)
`M A R K J. R A T A I N , M. D. ,
` called as a witness, having been duly
` sworn by a Notary Public, was examined
` and testified as follows:
`EXAMINATION BY
`MS. JACOBSEN:
` Q. Good morning.
` A. Good morning.
` Q. Can you state your full name for the
`record?
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2026
`Par v. Novartis, IPR 2016-01479
`Page 5 of 8
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` M. RATAIN, M.D.
`conducted by others that, by giving the drug
`over a prolonged period of time, would improve
`the efficacy of the drug, the therapeutic index
`of the drug.
` Q. What is the therapeutic index?
` A. The therapeutic index is the --
`conceptually, it's the efficacy versus the
`toxicity. In other words, so if the toxicity
`is worse than the efficacy, the drug doesn't
`have any therapeutic index at all.
` There are drugs with very narrow
`therapeutic index where there are doses that
`you can administer that are efficacious, but
`you have to be careful that they're very close
`to where you get unacceptable toxicity. And
`then there's other drugs that have -- what we
`say have a broad therapeutic index where you
`don't worry too much about precision in dosing.
`Because if you err on the high side or on the
`low side, the drug will still be safe and
`effective.
` Q. And so you were changing the
`administration of vinblastine to try and
`improve the therapeutic index; is that correct?
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2026
`Par v. Novartis, IPR 2016-01479
`Page 6 of 8
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` M. RATAIN, M.D.
` MS. DANEK: Same objection.
` THE WITNESS: I can't agree with the
` generalization. I will agree with the
` specifics. So I will agree that there is
` confirmed clinical efficacy, but I can't
` agree that just because FDA has approved
` something that there is confirmed clinical
` efficacy since FDA uses an accelerated
` approval mechanism for some agents and some
` diseases and then requires confirmatory
` clinical trials thereafter.
`BY MS. JACOBSEN:
` Q. All right. So everolimus was the
`first mTOR inhibitor approved by the FDA for
`the treatment of advanced PNETs; is that
`correct?
` A. Yes.
` MS. DANEK: Objection. Form.
` THE WITNESS: Yes.
`BY MS. JACOBSEN:
` Q. Okay. And still today everolimus is
`the only mTOR inhibitor approved for the
`treatment of advanced PNETs?
` A. Yes.
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2026
`Par v. Novartis, IPR 2016-01479
`Page 7 of 8
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`Page 340
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` M. RATAIN, M.D.
`papers -- strike that.
` So you have not cited any papers
`describing the results of Phase III studies of
`temsirolimus, correct?
` A. To the best of my knowledge, Pfizer,
`Wyeth, whatever, did not pursue a Phase III
`study in neuroendocrine carcinoma.
` Q. And all of the temsirolimus
`papers -- I'm sorry. Strike that.
` All of the temsirolimus Phase II
`studies that you discuss in your reply report
`were single-arm studies, correct?
` A. No.
` Q. Which one was not?
` A. The Atkins paper.
` Q. Okay. Was the Chan study a
`single-arm study?
` A. I believe it was.
` Q. And was the Duran Phase II clinical
`study a single-arm study?
` A. Yes. That's why I wrote a letter to
`the editor.
` Q. Okay. And so they were not
`placebo-controlled trials, correct?
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2026
`Par v. Novartis, IPR 2016-01479
`Page 8 of 8
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