Paper No. ___
`Date Filed: May 5, 2017
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`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________________
`
`WOCKHARDT BIO AG,
`Petitioner,
`
`v.
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`JANSSEN ONCOLOGY, INC.
`Patent Owner.
`
`_______________________
`
`Case IPR2016-01582
`Patent 8,822,438 B2
`
`_______________________
`
`PATENT OWNER’S MOTION FOR OBSERVATION
`ON CROSS-EXAMINATION
`
`
`
`
`
`
`
`
`Date Filed: May 5, 2017
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________________
`
`WOCKHARDT BIO AG,
`Petitioner,
`
`v.
`
`JANSSEN ONCOLOGY, INC.
`Patent Owner.
`
`_______________________
`
`Case IPR2016-01582
`Patent 8,822,438 B2
`
`_______________________
`
`PATENT OWNER’S MOTION FOR OBSERVATION
`ON CROSS-EXAMINATION
`
`
`
`
`
`
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`IPR2016-01582
`Patent No. 8,822,438
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`Deposition of Dr. Godley
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`I. Approval of Docetaxel
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`1 (a). In Exhibit 2185, p. 68, l. 1 through p. 69, l. 5 the witness testified:
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`Q. When did you stop using ketoconazole? . . .
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`Mr. Powers: Objection, relevance.
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`A. I -- ketoconazole was effectively replaced as a therapy in my practice when
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`Taxotere became available.
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`Q. Why was that?
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`Mr. Powers: Objection to form.
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`A. That was because Taxotere was well-tolerated, had more palliative benefit to
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`patient and had a survival benefit. So when patients failed hormonal therapy, it was
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`a clear choice, clearer choice, to use Taxotere rather than ketoconazole.
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`Q.
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`. . . After the approval of Taxotere, were your fellow oncologists also
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`showing a preference to use Taxotere over ketoconazole?
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`Mr. Powers: Objection, foundation, relevance, scope.
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`A. That is my -- that is my impression, is that Taxotere quickly became part of the
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`standard of care and ketoconazole became much less used.
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`1 (b). In Exhibit 2185, page 71, ll. 6-10 the witness testified:
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`Q. After the approval of Taxotere, were researchers in the field of prostate cancer
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`pursuing further research to build on the survival benefit observed with
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`chemotherapy such as Taxotere?
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`A. I think they were.
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`This testimony is relevant to the state of the art at the time of the invention,
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`Ex. 1104 at ¶ 21, Ex. 2161 at 78:14-24, ¶¶ 61 and 221-231 of Dr. Rettig’s
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`declaration (Ex. 2038), and Paper No. 43 (“PO Response”) at § IV.A.1.
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`II. Claim Construction Applied in Analysis
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`2 (a). In Exhibit 2185, page 35, ll. 4-11 the witness testified:
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`Q. So what is your understanding, sir, of the meaning of the phrase, Minimization
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`or spread of cancer, in the context of the claims of the ’438 patent?
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`A. My understanding is that it means that the cancer, in this case prostate cancer, is
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`either not growing or growing more slowly as a consequence or as part of
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`treatment.
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`2 (b). In Exhibit 2185, page 36, l. 17 through page 37, l. 1 the witness testified:
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`Q. [D]oes the board's construction of treatment require a showing of minimization
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`or delay of the spread of cancer?
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`A. The board's construction of treatment does not require the minimization or delay
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`of the spread of cancer.
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`This testimony is relevant to ¶¶ 3-4 of Dr. Godley’s reply declaration and
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`impacts Dr. Godley’s analysis of the prior art at ¶¶ 25 and 27 (Ex. 1104). It is
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`further relevant to §§ II, III, and IV.B. of the PO Response, and Dr. Rettig’s
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`opinions at ¶¶ 77, 69-76, 196, and 225 of his declaration (Ex. 2038).
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`III. Attard (2009)
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`3.
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`In Exhibit 2185, p. 88, l. 17 through p. 89, l. 5 the witness testified:
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`Q. [D]o you agree that prior ketoconazole therapy would not have had an impact
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`on the time to PSA progression for 95 percent of patients enrolled in the Attard
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`2009 study?
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`Mr. Powers: Objection, form.
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`A. Since the authors document that greater than 95 percent of patients did not
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`receive ketoconazole, it would be unlikely that ketoconazole would have affected
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`the results of the abiraterone acetate therapy intervention in this study.
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`This testimony is relevant to ¶¶ 41 and 43 of Dr. Godley’s reply declaration
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`(discussing comparison of results from COU-AA-001 and COU-AA-002 studies)
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`(Ex. 1104), and Dr. McKeague’s declaration at ¶¶ 44-47 (opining the same) (Ex.
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`1106). This testimony is also relevant to Ex. 1022 (Attard 2009) at 3744.
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`4.
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`In Exhibit 2185, p. 55, l. 15 through p. 57, l. 12 the witness testified:
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`Q. . . . (Reading) We have not previously observed, and to our knowledge there
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`are no published reports of secondary responses to reinstitution of single-agent
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`dexamethasone in patients who had previously experienced progression on this
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`therapy. Correct?
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`A. Correct. . . .
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`Q. And then it says: (Reading) These data suggest that AR may be activated by
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`elevated hormone levels upstream of CYP17 and supports the future evaluation of
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`a combination of abiraterone acetate with low-dose corticosteroids to maximize
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`efficacy and minimize toxicity. Correct?
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`A. That is what they say, yes.
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`Q. And then it continues: (Reading) Abiraterone acetate is now being evaluated in
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`combination with corticosteroids in a 1,180-patient, multicenter, double-blind
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`randomized Phase III study comparing abiraterone acetate plus prednisone which
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`is prednisone plus placebo in CRCP patients who have previously received
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`docetaxel. Correct?
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`A. That is correct.
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`This testimony is relevant to Dr. Godley’s reply declaration at ¶¶ 37-38, 40,
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`and 42 (Ex. 1104), Dr. Rettig’s declaration at ¶¶ 196-202 (discussing incorporation
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`of dexamethasone extension study results into Phase III abiraterone
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`acetate/prednisone trials) (Ex. 2038), and Ex. 1022 (Attard 2009) at 3747.
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`IV. Skepticism
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`5. In Exhibit 2185, p. 145, ll. 13- 20 the witness testified:
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`Q. Do you agree that as of August 2006 the role of the endocrine environment and
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`mCRPC was not widely understood, and there was skepticism that further
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`reduction of testosterone to sub castrate levels would benefit patients with
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`mCRPC?
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`Mr. Powers: Objection, form.
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`A. I think that's an accurate statement.
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`This testimony is relevant to Dr. Rettig’s declaration at ¶¶ 56-59, 219 and
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`260-263 (Ex. 2038), and Dr. Godley’s reply declaration at ¶¶ 45 (Ex. 1104).
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`V. Reid (2010)
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`6. In Exhibit 2185, p. 76, l. 21 through p. 77, l. 5 the witness testified:
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`Q. But just for my -- just to clarify. The -- about 40 percent of patients in the
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`COU-AA-003 study received --
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`A. Also received.
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`Q. -- a combination of abiraterone acetate and steroids from the start, correct?
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`A. That is correct.
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`This testimony is relevant to the Petitioner’s reply at p. 21, at ¶¶ 113-114
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`and Dr. McKeague’s declaration at ¶ 41 (characterizing COU-AA-003 study as an
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`abiraterone acetate monotherapy study) (Ex. 1106); see also ¶¶ 42-43 (Ex. 1106).
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`VI. Gerber
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`7 (a). In Exhibit 2185, p. 133, l. 6 through p. 134, l. 6 the witness testified:
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`Q. -- you agree that in Gerber the patients were given prednisone as glucocorticoid
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`replacement therapy to address side effects, correct? . . .
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`A. . . . They -- they indicate that the prednisone was given as a replacement
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`therapy so -- and suggesting that is to overt cortisol deficiency.
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`7 (b). In Exhibit 2185, page 137, ll. 15-21 the witness testified:
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`Q. But in the remaining patients in Gerber that did not show a reduction that met –
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`the reduction of PSA that met the Prostate Cancer Working Group criteria, it
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`would be questionable whether there was evidence of minimization or delay in the
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`spread of the cancer, correct?
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`A. Correct.
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`This testimony is relevant to Dr. Godley’s declaration at ¶¶ 8 and 14 of (Ex.
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`1104), and Dr. Rettig’s declaration at ¶¶ 80-88 and 172-193 (Ex. 2038). This
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`testimony is further relevant to Dr. Godley’s deposition testimony at 28:7-12,
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`28:20-23, 37:20-38:7, 43:16-24, 136:20-137:7, 59:7-24, and 61:1-7. (Ex. 2161).
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`VII. Garnick Declaration from Mylan IPR
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`8.
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`In Exhibit 2185, p. 140, l. 18 through p. 141, l. 4 the witness testified:
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`Q. Dr. Garnick who himself says he's an expert in the field of prostate cancer says
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`effects on PSA are not appropriate markers of clinical benefit, correct?
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`A. I see that. And I think that is accurate that he is saying because effects from
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`PSA are not appropriate markers of clinical benefit. So I see where he is saying
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`that.
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`This testimony is relevant to Dr. Godley’s declaration at ¶¶ 23-25 (opining
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`prednisone was shown to treat prostate cancer based on a PSA decline) (Ex. 1104),
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`Ex. 1006, Ex. 1004, Dr. Rettig’s declaration at ¶¶ 62-68, 93-97, and 207-208
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`(discussing PSA declines in prior art) (Ex. 2038), Dr. Garnick’s reply declaration
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`at ¶ 96 (Ex. 2177), and Ex. 1083 at 2576 (lack of response in measurable disease).
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`VIII. Abiraterone Acetate and Prednisone
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`9 (a). In Exhibit 2185, p. 142, ll. 9-13, the witness testified:
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`Q. The FDA approval for abiraterone acetate and prednisone for the treatment of
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`mCRPC was a significant development in the field of prostate cancer, correct?
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`A. I would agree with that.
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`9 (b). In Exhibit 2185, p. 143, l. 14 through p. 144, l. 4 the witness testified:
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`Q. Is it your practice to prescribe abiraterone acetate for the treatment of mCRPC
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`in combination with prednisone as indicated in the package insert for Zytiga?
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`A. It is.
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`Q. Is it your understanding that other oncologists also prescribe abiraterone acetate
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`in combination with prednisone as indicated in the Zytiga package insert?
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`A. That is my understanding.
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`This testimony is relevant to Dr. Godley’s declaration at ¶¶ 45 and 47 (Ex.
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`1104). It is also relevant to Ex. 1052 (Zytiga Package Insert).
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`IX. Drug Selectivity, Specificity and Potency
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`10. In Exhibit 2185, p. 148, ll. 7-10, the witness testified:
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`Q. But a more selective drug would have fewer side effects from undesirable
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`pathways being blocked, correct?
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`A. That is correct.
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`11. In Exhibit 2185, p. 149, ll. 7-13 the witness testified:
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`Q. And increasing the potency of a drug does not necessarily result in an increase
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`in efficacy, correct?
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`A. That is correct.
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`Q. And a POSA, as of August 2006, would have understood that, correct?
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`A. I believe that they would have.
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`This testimony is relevant to Dr. Godley’s reply declaration at ¶ 27 (equating
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`potency of inhibition with efficacy) (Ex. 1104); see also ¶ 47 (Ex. 1104) and
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`106:8-15 (Ex. 2161). It is also relevant to at ¶¶ 27-30 and 32-33 (Ex. 2038).
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`X. Barrie ’213 Patent
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`12. In Exhibit 2185, p. 176, l. 8 through p. 177, l. 4 the witness testified:
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`Q. [T]he ’213 patent does not state that mineralocorticoid levels were tested,
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`correct?
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`A. As far as I can tell, mineralocorticoid levels were not tested. . . .
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`Q. So the ’213 patent does not contain any clinical data relating to the
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`administration of abiraterone acetate in humans, correct?
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`A. That is my understanding, that these are all laboratory studies of various sorts.
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`This testimony is relevant to Dr. Godley’s deposition testimony at 139:11-
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`140:3 (Ex. 2161), the PO Response at § III.B.2, and Dr. Rettig’s declaration (Ex.
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`2038) at ¶¶ 106-111 and 123; see also id. at ¶¶ 147 and 150-160.
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`XI. Abiraterone’s Anti-Cancer Effect Would Dwarf Prednisone’s
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`13. In Exhibit 2185, p. 184, l. 9 through p. 184, l. 20 the witness testified:
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`Q. [W]ould a person of ordinary skill in the art in 2006 have believed that when
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`prednisone was combined with abiraterone acetate, it would have an anticancer
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`effect?
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`A. The prednisone alone -- the -- the additional effect of the prednisone?
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`Q. In combination with abiraterone acetate?
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`A. In 2006 I would -- my opinion would be that a person of ordinary skill in the
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`art would think that the anticancer effect of abiraterone would dwarf the anticancer
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`effect of prednisone. . .
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`This testimony is relevant to Ex. 1104 at ¶ 45, Ex. 1002 at ¶¶ 86, 94, and
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`116; Ex. 2161 at 66:11-15, 120:1-4, 120:12-17, 122:5-7, 143:6-147:5, and 147:10-
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`148:22, the PO Response at § III.C.3, and Ex. 2038 at ¶¶ 209-220.
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`XII. CYP17 Deficiency
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`14.
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`In Exhibit 2185, p. 99, l. 18 through p. 100, l. 15, the witness testified:
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`Q. . . . Patients with congenital [CYP17] deficiency are lacking a functional
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`CYP17 enzyme, meaning they do not produce cortisol or androgens. Correct?
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`A. Correct.
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`Q. . . . However, these patients rarely develop symptoms of adrenal insufficiency
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`because they still produce corticosterone, a weak glucocorticoid. Correct?
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`A. Correct.
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`This testimony is relevant to ¶ 32 of Dr. Godley’s reply declaration (Ex.
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`1104), ¶¶ 15 and 60-63 of Dr. Auchus’s declaration (Ex. 2040), ¶¶ 34-37, 39-49,
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`100, and 159 of Dr. Rettig’s declaration (Ex. 2038), and 35:14-18 of Ex. 2161.
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`Deposition of Dr. McKeague
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`XIII. Lack of Knowledge
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`15. In Exhibit 2186, p. 15, l. 23 through p. 16, l. 7 the witness testified:
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`Q. So what is your understanding of the state of the art with respect to the
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`treatment of metastatic castration-resistant prostate cancer as of August 2006?
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`Mr. Swanson: Object to form. Calls for a legal conclusion.
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`A: Yes. I'm not going to answer that because I don't have an understanding of the
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`field as an expert in that field. I have an understanding as a layman essentially.
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`This testimony is relevant to Dr. McKeague’s declaration at ¶¶ 12 and 16
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`(regarding the bases for his opinions and whether the clinical trial results
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`demonstrated unexpected clinical efficacy) (Ex. 1106), and Dr. Rettig’s opinions at
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`¶¶ 78-79 and 232-251 of his declaration. (Ex. 2038).
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`XIV. Confidence Intervals
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`16 (a). In Exhibit 2186, p. 50, l. 21 through p. 51, l. 3 the witness testified:
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`Q. So is it fair to say that there can be situations in which there are overlapping
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`confidence intervals but statistical significance does exist?
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`Mr. Swanson: Object to form.
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`A. Statistical significance is best assessed directly in terms of the question being
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`asked with the data. And if you have the data, of course, there are many approaches
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`that can be used.
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`16 (b). In Exhibit 2186, p. 88, ll. 1-6 the witness testified:
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`Q. Could you have calculated whether or not the data sets are statistically
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`significantly different?
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`Mr. Swanson: Object to form. Outside the scope.
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`A. That's a very broad question. I was not asked to do that.
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`16 (c). In Exhibit 2186, p. 94, ll. 2-11 the witness testified:
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`Q. But you don't know, one way or the other, whether or not the median TTPP
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`values are statistically significantly different. Is that fair to say?
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`Mr. Swanson: Object to form. Asked and answered. Outside the scope.
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`A. Yeah, it's outside the scope. This is coming back to the scope of my report,
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`which is assessing the evidence for whether there is a statistically significant
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`difference.
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`This testimony is relevant to Dr. McKeague’s declaration at ¶¶ 33-35, 38,
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`and 39 (regarding whether overlapping confidence intervals indicate no statistically
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`significant difference) (Ex. 1106), Ex. 2183, Ex. 2184, and Dr. Rettig’s declaration
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`at ¶¶ 232-251 (Ex. 2038).
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`17 (a). In Exhibit 2186, p. 86, ll. 18-22 the witness testified:
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`Q. And that error is misleading with respect to the amount of overlap?
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`A. I just said my point is there's an overlap. I think you're right. Do I talk about the
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`extent of the overlap, no. I just say there is an overlap.
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`17 (b). In Exhibit 2186, p. 95, ll. 1-6 the witness testified:
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`Q. And do you believe the information on the CLINICALTRIALS.GOV website
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`is more reliable than the information that's reported in the peer reviewed
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`publications?
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`Mr. Swanson: Object to form.
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`A. I do not say that here.
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`This testimony is relevant to Dr. McKeague’s declaration at ¶¶ 34, 35 and 37
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`(regarding confidence interval overlap and data in COU-AA-001 and COU-AA-
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`002 studies) (Ex. 1106), and Dr. Rettig’s declaration at ¶¶ 234-251 (Ex. 2038).
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`XV. Cross Study Comparison
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`18.
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` In Exhibit 2186, p. 122, ll. 10-18 the witness testified:
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`Q. So how would you determine whether or not the median base line PSA levels
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`are compatible?
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`Mr. Swanson: Object to form. Outside the scope.
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`A. That's a hypothetical question. How would I do it.
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`Q. Yes. You're an expert. So I'm asking you.
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`A. I haven't been asked to think about it.
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`This testimony is relevant to Dr. McKeague’s declaration at ¶ 50 (regarding
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`assessment of cross-study comparisons) (Ex. 1106), Dr. Rettig’s opinion at ¶¶ 234-
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`251 of his declaration (Ex. 2038), and to the PO Response at § V.A.
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`Deposition of Dr. Robert D. Stoner
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`XVI. Commercial Success – Nexus
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`19. In Exhibit 2187, p. 114, ll. 12-18 the witness testified:
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`Q. I'm just asking you whether you did or didn't do an analysis of your own to
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`determine the extent of on-label use?
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`A. I'm telling you that I didn't do it, and I gave you two reasons why I didn't do it.
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`This testimony is relevant to Dr. Stoner’s declaration at ¶¶ 32-33 (regarding
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`Vellturo’s analysis of on-label use) (Ex. 1103).
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`XVII. Commercial Success –Market Shares
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`20. In Exhibit 2187, p. 51, l. 18 through p. 52, l. 4 the witness testified:
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`Q. All right. Did you look at page 196, the second paragraph, second sentence,
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`where it says, quite, "Given the limitations on available data, it is entirely
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`reasonable that an analysis of commercial success should consider and place
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`significant weight on the traditional measures such as market share or revenue
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`growth." Did I read that correctly?
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`A. Correct.
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`This testimony is relevant to Ex. 1077 at ¶¶ 63-66, and to Ex. 1114 at p. 196.
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`21 (a). In Exhibit 2187, p. 25, ll. 14-22 the witness testified:
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`Q. What market does Zytiga® compete in?
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`A. I haven't made a definitive conclusion as to what the proper product market in
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`an antitrust sense would be for Zytiga®. Generally, Zytiga® competes in the
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`prostate cancer space. More specifically, it competes for -- in the space that's
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`sometimes called metastatic castrate-resistant prostate cancer.
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`21 (b). In Exhibit 2187, p. 39, ll. 7-11 the witness testified:
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`Q. Okay. It's not incorrect to evaluate market share based on patient usage?
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`A. As one -- as one way to look at the market, but I would want to look at it in
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`other ways as well.
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`21 (c). In Exhibit 2187, p. 33, ll. 16-20 the witness testified:
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`Q. But Dr. Vellturo's selection of looking at the mCRPC market was not arbitrary,
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`correct?
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`A. That's one market I would want to look at.
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`21 (d). In Exhibit 2187, p. 43, ll. 12-19 the witness testified:
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`Q. All right. So your conclusion that Zytiga® has been losing market share due to
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`competition from Xtandi® was based on data that you had reported in your initial
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`declaration which had data through the first half of 2015?
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`A. Correct.
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`Q. Have you updated that?
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`A. I have not.
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`This testimony is relevant to Dr. Stoner’s declaration at ¶¶ 66-70 (opining on
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`market share) (Ex. 1077).
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`XVIII. Commercial Success – ’213 Patent Licensing and Exclusivity
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`22 (a). In Exhibit 2187, p. 87, ll. 10-13 the witness testified:
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`Q. Well, they were making it known – BTG was making it known that they wanted
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`to license the ’213 patent back in 2002, right?
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`A. That's correct.
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`This testimony is relevant to ¶¶ 22-26 and 44, fn. 8 of Dr. Stoner’s reply
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`declaration (Ex. 1103), and ¶ 42 of his opening declaration (Ex. 1077).
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`Dated: May 5, 2017
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`Respectfully submitted,
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`By: /Dianne B. Elderkin/
`Dianne B. Elderkin (Reg. No. 28,598)
`delderkin@akingump.com
`Barbara L. Mullin (Reg. No. 38,250)
`bmullin@akingump.com
`Ruben H. Munoz (Reg. No. 66,998)
`rmunoz@akingump.com
`AKIN GUMP STRAUSS HAUER &
`FELD LLP
`Two Commerce Square
`2001 Market Street, Suite 4100
`Philadelphia, PA 19103
`Tel: (215) 965-1200
`Fax: (215) 965-1210
`
`David T. Pritikin (pro hac vice)
`dpritikin@sidley.com
`Bindu Donovan (pro hac vice)
`bdonovan@sidley.com
`Paul Zegger (Reg. No. 33,821)
`pzegger@sidley.com
`Todd Krause (Reg. No. 48,860)
`tkrause@sidley.com
`Alyssa B. Monsen (pro hac vice)
`amonsen@sidleyaustin.com
`SIDLEY AUSTIN LLP
`787 Seventh Avenue
`New York, NY 10019
`Tel.: (212) 839-5300
`Fax: (212) 839-5599
`ZytigaIPRTeam@sidley.com
`Counsel for Patent Owner
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`IPR2016-01582
`Patent No. 8,822,438
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing Patent
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`Owner’s Motion for Observation on Cross-Examination was served on counsel of
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`record on May 5, 2017 by filing this document through the End-to-End System, as
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`well as delivering a copy via electronic mail to counsel of record for the Petitioner
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`and Patent Co-Owner at the following addresses:
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`Dennies Varughese - dvarughe-PTAB@skgf.com
`Deborah A. Sterling - dsterlin-PTAB@skgf.com
`Christopher M. Gallo - cgallo-PTAB@skgf.com
`Ralph W. Powers III – tpowers-PTAB@skgf.com
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`Anthony C. Tridico - anthony.tridico@finnegan.com
`Jennifer H. Roscetti - jennifer.roscetti@finnegan.com
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`Date: May 5, 2017
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`Respectfully submitted,
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`By: /Dianne B. Elderkin/
`Dianne B. Elderkin
`Registration No. 28,598
`Counsel for Patent Owner
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`17
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