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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 2105
`Par v. Novartis, IPR2016-01479
`Page 1 of 11
`
`
`
` 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 2105
`Par v. Novartis, IPR2016-01479
`Page 1 of 11
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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 2105
`Par v. Novartis, IPR2016-01479
`Page 2 of 11
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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 2105
`Par v. Novartis, IPR2016-01479
`Page 3 of 11
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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
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`NOVARTIS EXHIBIT 2105
`Par v. Novartis, IPR2016-01479
`Page 4 of 11
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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
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`NOVARTIS EXHIBIT 2105
`Par v. Novartis, IPR2016-01479
`Page 5 of 11
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`Page 93
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` M. RATAIN, M.D.
` Q. Are you an expert in the field of
`the induction of immunosuppression?
` A. Well, yes, since chemotherapy
`induces immunosuppression. Not, not -- not --
`I'm not an expert in the, in the -- in the --
`you know, using -- using immunosuppression as
`the therapeutic goal.
` Q. Okay. And are -- are you an expert
`in the field of organ transplantation?
` A. Only as it relates to patients
`who -- with organ transplants who develop
`malignancies.
` Q. Have you ever carried out a
`lymphocyte proliferation assay?
` A. No.
` Q. That's not a test that's used to
`determine anticancer activity?
` A. No.
` Q. Have you ever carried out a
`popliteal lymph node test?
` A. No.
` Q. And that's also not a test that's
`used to determine anticancer activity?
` A. I guess it could be, but I've not
`
`TSG Reporting - Worldwide 877-702-9580
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`NOVARTIS EXHIBIT 2105
`Par v. Novartis, IPR2016-01479
`Page 6 of 11
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` M. RATAIN, M.D.
`seen it used that way.
` Q. Have you ever carried out a mixed
`lymphocyte reaction assay?
` A. I have not.
` Q. And that's not a test that's used to
`determine anticancer activity?
` A. It might be, but I've -- I've not
`considered it in that context.
` Q. Have you seen it used in that
`context?
` A. Well, it's certainly -- it's
`certainly, I believe, used in assessing
`immunotoxicity of potential anticancer drugs.
` Q. Have you seen it used in the context
`of assessing the anticancer activity of a drug?
` A. As I said, it would be -- it would
`be used more in assessing the immunotoxicity,
`which just if -- if one were concerned about
`therapeutic index of a drug. I mean, it's,
`it's relevant but not -- it wouldn't predict
`for activity of the drug. It would predict for
`toxicity, which might, therefore, suggest that
`a drug should not be developed as an anticancer
`agent.
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2105
`Par v. Novartis, IPR2016-01479
`Page 7 of 11
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`Page 95
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` M. RATAIN, M.D.
` Q. Have you ever carried out a skin
`graft assay?
` A. No.
` Q. That's not a test that's used to
`determine anticancer activity?
` A. Well, again, it, it -- I mean, I
`don't know what a skin graft assay is. Skin
`biopsies can be used to determine anticancer
`activity, and they've been used in some
`studies.
` Q. All right. So my question was --
`was with respect to a skin graft assay, and you
`don't -- it's not your opinion that that can be
`used to determine anticancer activity?
` A. Well, since I don't know exactly
`what you mean by skin graft assay, I, I -- I --
`I'm not sure I can give you an accurate answer
`to the question.
` Q. It's certainly not a test that's
`commonly used to determine anticancer activity?
` A. I've not heard that phrase used in
`that context.
` Q. Okay. And, Dr. Ratain, you don't
`have a degree in medicinal chemistry, do you?
`
`TSG Reporting - Worldwide 877-702-9580
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`NOVARTIS EXHIBIT 2105
`Par v. Novartis, IPR2016-01479
`Page 8 of 11
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`Page 198
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` M. RATAIN, M.D.
` approval at the time it's discovered.
`BY MS. JACOBSEN:
` Q. Why not?
` A. Because there's a long road from
`discovery to approval. So there's, there's --
`there's no drug that you can expect FDA
`approval in the sense of more probable than not
`expected.
` Q. And at what stage do you think you
`can expect FDA approval of a drug?
` MS. DANEK: Objection. Form.
` THE WITNESS: I think you can expect
` FDA approval at the end of a well-done,
` robust Phase II trial.
`BY MS. JACOBSEN:
` Q. You would agree that a Phase III
`trial is usually required prior to FDA approval
`of a drug?
` A. FDA usually requires a Phase III
`trial. Do I, do I -- are you asking me what I
`believe should be required, or are you asking
`me what FDA policy is? What FDA regulations
`are?
` Q. I'm asking you that the FDA usually
`
`TSG Reporting - Worldwide 877-702-9580
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`NOVARTIS EXHIBIT 2105
`Par v. Novartis, IPR2016-01479
`Page 9 of 11
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` M. RATAIN, M.D.
`likely to be low or for which the best expected
`response might be stable disease require
`perspectively controlled Phase II trials
`potentially including multiple doses and/or
`placebo, correct?
` A. That would be the ideal study.
` Q. And you'd agree with me that
`progression-free survival is recommended as the
`primary endpoint in trials where tumor
`shrinkage is not anticipated?
` A. You'd have to do a randomized trial
`for progression-free survival to be a useful
`endpoint to predict Phase III approval. And I,
`I think that it's a matter of what one's trying
`to learn. Is one trying to learn whether a
`drug has activity or is one trying to learn the
`likelihood that a Phase III trial will be
`positive?
` Q. And you would agree with me that
`single-arm trials seldom allow conclusions to
`be derived regarding time-to-event endpoints
`such as survival, time to progression, or
`progression-free survival, correct?
` A. Yes.
`
`TSG Reporting - Worldwide 877-702-9580
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`NOVARTIS EXHIBIT 2105
`Par v. Novartis, IPR2016-01479
`Page 10 of 11
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` M. RATAIN, M.D.
` Q. And you'd agree with me that
`single-arm Phase II trials have fundamental
`flaws leading to greater uncertainty in their
`outcomes than in randomized studies, and this
`uncertainty could be magnified in combination
`treatment studies, correct?
` MS. DANEK: Objection to form.
` THE WITNESS: Yes.
`BY MS. JACOBSEN:
` Q. And can you turn to paragraph 40 of
`your reply expert report?
` And there you discuss something that
`we've already touched on today, and that is the
`absence of reimbursement under Medicare for
`oral cancer drugs, correct?
` A. In the absence of reimburse under
`Medicare for any oral drugs, including oral
`cancer drugs.
` Q. Understood. And it's your opinion
`that the absence of such reimbursement would
`have discouraged the development of an oral
`formulation of a cancer drug; is that correct?
` MS. DANEK: Objection to form.
` THE WITNESS: It's my opinion and,
`
`TSG Reporting - Worldwide 877-702-9580
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`NOVARTIS EXHIBIT 2105
`Par v. Novartis, IPR2016-01479
`Page 11 of 11
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