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`Paper No. ___
`Date Filed: May 3, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________________
`
`MYLAN PHARMACEUTICALS INC., ACTAVIS LABORATORIES FL,
`INC., AMNEAL PHARMACEUTICALS LLC, AMNEAL
`PHARMACEUTICALS OF NEW YORK, LLC, DR. REDDY’S
`LABORATORIES, INC., DR. REDDY’S LABORATORIES, LTD., SUN
`PHARMACEUTICALS INDUSTRIES, LTD, SUN PHARMACEUTICALS
`INDUSTRIES, INC., TEVA PHARMACEUTICALS USA, INC., WEST-
`WARD PHARMACEUTICAL CORP., AND HIKMA
`PHARMACEUTICALS, LLC,
`Petitioner,
`
`v.
`
`JANSSEN ONCOLOGY, INC.
`Patent Owner.
`
`_______________________
`
`Case IPR2016-013321
`Patent 8,822,438 B2
`
`_______________________
`
`
`PATENT OWNER’S MOTION FOR OBSERVATIONS
`ON CROSS-EXAMINATION
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`
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`1 Case IPR2017-00853 has been joined with this proceeding.
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`IPR2016-01332
`U.S. Patent 8,822,438
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`Deposition of Dr. Garnick
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`I. Docetaxel
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`1.
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`In Exhibit 2185, p. 54, l. 20, through p. 55, l. 4, the witness testified:
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`Q. Do you agree, upon the approval of docetaxel chemotherapy, the field
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`became focused on finding additional chemotherapy treatments that would
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`improve survival?
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`A.
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`In general, we're constantly trying to improve therapies for our patients with
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`prostate cancer.
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`Q. So my statement is correct.
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`A. Yes.
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`This testimony is relevant to Paper 35 (“PO Response”) at p. 42 (“future
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`clinical trials focused on building on the survival improvement seen with
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`docetaxel-based therapy.”). This testimony is relevant to Dr. Garnick’s opinions at
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`¶¶ 39 and 113 of his reply declaration (Ex. 1104), and Dr. Rettig’s opinions at ¶¶
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`61, 188, and 220 of his declaration (Ex. 2038).
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`II. Abiraterone Acetate and Prednisone
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`In Exhibit 2185, p. 51, l. 21 through p. 52, l. 1, the witness testified:
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`2.
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`Q. Do you agree that the approval of abiraterone acetate in combination with
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`prednisone was also a significant milestone in the treatment of metastatic
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`castration-resistant prostate cancer patients?
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`IPR2016-01332
`U.S. Patent 8,822,438
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`A. Yes.
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`This testimony is relevant to Dr. Garnick’s opinions at ¶ 96 of his opening
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`declaration (Ex. 1002), Dr. Rettig’s declaration at ¶¶ 51, 220, and 210-213 (Ex.
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`2038), and the PO Response at p. 54. This testimony is further relevant to Dr.
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`Garnick’s deposition testimony at 139:13-140:16 (Ex. 2126).
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`III. Attard (2009)
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`3.
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`In Exhibit 2185, p. 95, ll. 7-11, the witness testified:
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`Q. So over 95 percent of patients in the Attard 2009 study, who received a
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`thousand milligrams of abiraterone acetate, did not receive prior treatment with
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`ketoconazole, correct?
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`A. That's what it says.
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`This testimony is relevant to Dr. Garnick’s opinions at fn. 4, ¶¶ 97-99, and ¶
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`101 of his reply declaration (relying on the fact that “Attard 2009 enrolled patients
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`who were previously on ketoconazole” as a basis for his opinion that it is improper
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`to compare results from COU-AA-001 with COU-AA-002) (Ex. 1104). This
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`testimony is further relevant to Dr. McKeague’s opinions at ¶ 47 of his declaration
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`(opining the same) (Ex. 1091). This testimony is relevant to Ex. 2015 (Attard
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`2009) at 3744.
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`4. In Exhibit 2185, p. 100, ll. 4-23, the witness testified:
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`Q. Okay. Just reading the sentence as it appears in Attard 2009, where the
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`IPR2016-01332
`U.S. Patent 8,822,438
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`researchers report that they have not previously observed, and to their knowledge,
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`there are no published reports of secondary responses to reinstitution of single
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`agent dexamethasone in patients who have previously experienced progression on
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`this therapy, do you understand that to be an accurate statement concerning what is
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`described in 2009?
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`Mr. Beel: Objection to form and foundation.
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`A. There's no reason for me to doubt what's stated there.
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`This testimony is relevant to Dr. Garnick’s opinions at ¶¶ 104-106 of his
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`reply declaration (Ex. 1104). This testimony is further relevant to Dr. Rettig’s
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`opinions at ¶¶ 196-202 of his declaration (opining that the dexamethasone
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`extension study results were incorporated into design of Phase III trials of
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`abiraterone acetate in combination with prednisone) (Ex. 2038), and Ex. 2015
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`(Attard 2009) at 3747.
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`IV. Trump
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`5. In Exhibit 2185, p. 104, ll. 13-19, the witness testified:
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`Q. So on page 1097, in the right-hand column, third full paragraph it states,
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`“Overall, ketoconazole plus hydrocortisone would have to be judged ineffective as
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`secondary hormone therapy for most patients with advanced prostatic cancer,”
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`correct?
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`A. Yes.
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`This testimony is relevant to Dr. Garnick’s opinions at ¶¶ 17, 20, and 35 of
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`his reply declaration (Ex. 1104). This testimony is also relevant to Ex. 1107
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`(Trump) at 1097, and Dr. Rettig’s declaration at ¶¶ 186-188 and 225 (Ex. 2038).
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`V. Sonino
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`6. In Exhibit 2185, p. 108, l. 19 through p. 109, l. 5, the witness testified:
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`Q. Do you see where it says, “Since ketoconazole interferes with C17-20 lyase,
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`and is a more potent inhibitor of cholesterol side-chain cleavage activity, it can be
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`expected that patients treated with the agent will be free of side effects such as
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`mineralocorticoid excess.” Do you see that?
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`Mr. Beel: Objection to form and foundation. Outside the scope of the declaration.
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`A. Yes.
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`Q. This was part of what was known in the art as of August 2006, correct?
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`A. Yes.
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`This testimony is relevant to Dr. Garnick’s opinions at ¶ 79 of his reply
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`declaration (Ex. 1104), ¶¶ 33, 41, and 44 of his opening declaration (Ex. 1002), his
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`testimony at p. 37 l. 17 - p. 38 l. 12 (Ex. 2126), and Ex. 2163 (Sonino) at 815. This
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`testimony is further relevant to the PO Response at § IV.A.2.a.
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`VI. Gerber
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`7. In Exhibit 2185, p. 129, ll. 4-9, the witness testified:
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`Q.
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`Is it correct that Gerber does not teach that the prednisone was administered
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`IPR2016-01332
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`for purpose of treating the prostate cancer?
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`Mr. Beel: Objection to form and foundation. Calls for a legal conclusion.
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`A. Yeah. Yes.
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`This testimony is relevant to Dr. Garnick’s opinions at, for example, ¶¶ 24,
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`36, 38, and 53 of his reply declaration (Ex. 1104), and Dr. Rettig’s declaration at ¶
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`77 (Ex. 2038). This testimony is further relevant to the PO Response at § III.C.1.
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`VII. ZYTIGA 2015 Package Insert
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`8. In Exhibit 2185, p. 148, ll. 11-18, the witness testified:
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`Q. When you prescribe abiraterone acetate in combination with prednisone for
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`the treatment of metastatic castration-resistant prostate cancer, do you typically
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`prescribe it as it is indicated in the Zytiga package insert?
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`Mr. Beel: Objection, form, and outside the scope of the expert declaration.
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`A. Yes.
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`This testimony is relevant to the PO Response at p. 62. This testimony is
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`relevant to Dr. Garnick’s opinions at ¶108 of his reply declaration (Ex. 1104), Ex.
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`2163 (ZYTIGA Package Insert) at 1 and 2, and PO Response at § V.D.1 (nexus
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`between claimed invention and commercial success).
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`Deposition of Dr. Bantle
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`VIII. Adrenal Insufficiency versus Mineralocorticoid Excess.
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`9 (a). In Exhibit 2188, on p. 21, ll. 10-17, the witness testified:
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`Q. Can a patient with low adrenal reserve not develop adrenal insufficiency?
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`A. Yes, I think hypothetically it’s possible for someone to exist for many years
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`indefinitely with low adrenal reserve and without decompensating to complete
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`adrenal insufficiency.
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`This testimony is relevant to Dr. Bantle’s opinions at ¶¶ 44-47, 49, and 50-
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`55 of his declaration regarding interpretation of Synacthen data in O’Donnell and
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`its implications (Ex. 1097). Further, this testimony is relevant to Paper No. 65
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`(PO’s Identification of New Arguments and Evidence in Petitioners’ Reply) at 1-2.
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`9 (b). In Exhibit 2188, on p. 23, ll. 20-24, the witness testified:
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`Q. And mineralocorticoid excess is not the same as adrenal insufficiency; is that
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`right?
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`A. Yes. They’re different disorders, sort of opposite disorders producing
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`opposite sorts of problems.
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`This testimony is relevant to Dr. Bantle’s opinions at ¶¶ 58-59 of his
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`declaration (Ex. 1097), Dr. Garnick’s testimony at p. 82, ll. 15-19 (Ex. 2126), and
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`Paper No. 65 (PO’s Identification of New Arguments and Evidence in Petitioners’
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`6
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`Reply) at 1-2.
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`10. In Exhibit 2188, on p. 102, l. 20 through p. 103, l. 4, the witness testified:
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`Q.
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`So is it fair to say that there’s nothing reported in the O’Donnell reference
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`that would have suggested to a person of ordinary skill that abiraterone acetate
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`caused mineralocorticoid excess during the time period that the study was
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`performed?
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`Ms. Greb: Objection. Vague.
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`A. Yes. I don’t see any suggestion in the data presented or the discussion
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`subsequently that mineralocorticoid excess was present or a problem.
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`This testimony is relevant to Dr. Bantle’s opinions at ¶ 60 of his declaration
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`(Ex. 1097), Dr. Rettig’s opinions at ¶¶ 109-123 of his declaration (Ex. 2038), Dr.
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`Garnick’s deposition testimony at p. 153 ll. 11-17, p. 155 l. 18 - p. 156 l. 24, and p.
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`89 l. 16 - p. 90 l. 23 (Ex. 2126), and the PO Response at §§ III.A and IV.
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`IX. Ketoconazole’s Mechanism of Steroidogenesis Inhibition
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`11. In Exhibit 2188, on p. 47, l. 15 through p. 48, l. 9, the witness testified:
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`Q. Of the pathways for the production of cortisol that are being inhibited by
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`ketoconazole, which pathway contributes the most to the inhibition of the
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`production of cortisol?
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`Ms. Greb: Objection. Vague. Outside the scope of the report.
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`A.
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`The glucocorticoid pathway, of course.
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`Q. And which conversion is that?
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`A. Well – There are at least three spots where ketoconazole is interfering with
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`cortisol productions. The first step, the desmolase conversion of cholesterol to
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`pregnenolone, then the step were pregnenolone is converted to 17-
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`hydroxyypregnenolone, or alternatively the step where progesterone is converted
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`to 17-hydroxyprogesterone, and then finally the step where 11-deoxycortisol is
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`converted to cortisol.
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`This testimony is relevant to Dr. Bantle’s opinions at ¶¶ 22, 44 and Exhibit C
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`of his declaration regarding differences between abiraterone acetate and
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`ketoconazole in inhibiting androgen synthesis (Ex. 1097). Further, this testimony
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`is relevant to PO Response at pp. 14-16, Ex. 2180, and Ex. 2182.
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`12. In Exhibit 2188, on p. 40, ll. 12-17, the witness testified:
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`Q. And a person of ordinary skill in the art would have known that
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`ketoconazole would reduce levels of cortisol in a matter of days; is that correct?
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`Ms. Greb: Objection. Vague.
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`A. Yes. I think that’s true.
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`This testimony is relevant to Dr. Bantle’s opinions at ¶ 72 of his declaration
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`(opining clinical symptoms relating to cortisol reduction were likely after 11 days
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`of treatment with abiraterone acetate) (Ex. 1097); see also ¶¶ 44, 46-47, 48-54, and
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`56-62 of his declaration (interpreting the results of O’Donnell based on experience
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`with ketoconazole) (Ex. 1097). This testimony is further relevant to Dr. Rettig’s
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`opinions at ¶¶ 109-119 of his declaration (Ex. 2038), and the PO Response at §§
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`III.A and IV.
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`X. Aminoglutethimide Mechanism of Steroidogenesis Inhibition
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`13 (a). In Exhibit 2188, on p. 54, ll. 17-23, the witness testified:
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`Q. Okay. So from this, a person of ordinary skill in the art in August of 2006
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`knew that aminoglutethimide, like ketoconazole, inhibited the biosynthesis of all
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`adrenal steroids; correct?
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`Ms. Greb: Objection. Misstates prior testimony.
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`A. Yes.
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`13 (b). In Exhibit 2188, on p. 56, ll. 14-20, the witness testified:
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`Q. Aminoglutethimide was not known to inhibit CYP17, was it?
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`Ms. Greb: Objection. Vague. Outside the scope of the expert report.
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`A.
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`I can’t answer that question with certainty, but it’s my belief it did not
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`inhibit the CYP17 enzyme.
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`This testimony is relevant to Dr. Bantle’s declaration at ¶¶ 46-47, 48-54, and
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`56-62 (analogizing aminoglutethimide’s co-administration with glucocorticoid
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`replacement to abiraterone acetate) (Ex. 1097); and Ex. 2181 and Ex. 2182.
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`XI. Data Reviews
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`14.
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`In Exhibit 2188, on p. 89, l. 11 through p. 90, l. 12, the witness testified:
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`Q. What is the difference between a clinical trial and a data review?
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`Ms. Greb: Objection. Vague. Outside the scope.
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`A. Well, the differences are quite substantial. A clinical trial would pose a
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`hypothesis and typically evaluated by randomly assigning patients to one of several
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`treatments, and then objectively looking at which treatment was best and
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`confirming or denying the hypothesis. A data – I’m sorry, can you tell me again
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`the term you used for the other sort of study?
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`Q. A data review.
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`A. Data review would usually be a compilation of retrospective medical records
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`– or I said that poorly – medical records looked at to gain information about what
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`had happened in the past to try to determine what might be the best way to handle a
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`situation. And such reviews are fraught with scientific problems and issues. It’s
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`easy for bias to be introduced. It’s easy for the wrong conclusion to be reached
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`because the sample evaluated is not a random sample, so its applicability would be
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`highly limited, if any applicability at all. I would view that sort of data review as a
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`method to develop a hypothesis that would then be tested in a clinical trial.
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`This testimony is relevant to the PO Response at p. 9 (describing Gerber as a
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`“retrospective chart review”) and pp. 28-29 (regarding how a POSA would have
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`understood the effects of ketoconazole in mCRPC). This testimony is relevant to ¶
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`44 of Dr. Bantle’s declaration (Ex. 1097), ¶¶ 32-38 of Dr. Garnick’s reply
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`declaration (Ex. 1104), and the Petition at pp. 12, 5, 20, 21, and 33-35.
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`XII. Role of Corticosterone
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`15. In Exhibit 2188, on p. 26, ll. 8-16, the witness testified:
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`Q.
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`But corticosterone can play a role in preventing the development of adrenal
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`insufficiency; isn’t that correct?
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`Ms. Greb: Objection. Vague.
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`A.
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`I think potentially corticosterone could prevent adrenal insufficiency if
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`present in very large amounts. And I would add I don’t know of good literature
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`that would address how effective it would be or what amounts would be necessary.
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`This testimony is relevant to Dr. Bantle’s opinions at ¶¶ 85-88 of his
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`declaration (Ex. 1097), and Dr. Auchus’s declaration at ¶¶ 45-47 (Ex. 2040).
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`Deposition of Dr. Ivan T. Hofmann
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`XIII. Commercial Success – Sales and Use
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`16.
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`In Exhibit 2187, p. 80, ll. 11-19, the witness testified:
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`Q. Well, that -- that was my question, whether you did an independent analysis
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`of the extent of on-label use. . . .
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`A.
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`I don’t think I did beyond – I didn’t do an independent analysis of that
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`beyond the consideration of what he included in his declarations.
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`This testimony is relevant to Dr. Hofmann’s opinions at ¶¶ 23 and 30 of his
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`declaration (Ex. 1017) and ¶¶ 32-36 of his reply declaration (Ex. 1134).
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`XIV. Commercial Success – Nexus
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`17.
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`Q.
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`In Exhibit 2187, p. 65, l. 7 through p. 66, l. 1, the witness testified:
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`I mean is efficacy a -- a fundamental factor in driving commercial
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`performance of pharmaceutical therapies in general? . . .
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`A.
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`. . . I think, with serious advanced-stage cancer, it certainly is. . . .
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` This testimony is relevant to Dr. Hofmann’s opinions at ¶¶ 35-37 of his
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`declaration (Ex. 1134). This testimony is further relevant to PO Response at § C.1
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`(discussing nexus between claimed invention and commercial success), and Dr.
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`Rettig’s opinions at ¶¶ 214-219 of his declaration (Ex. 2038).
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`XV. Commercial Success – ’213 Patent Licensing
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`18.
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`In Exhibit 2187, p. 21, ll. 6-12, the witness testified:
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`Q.
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`Is it your understanding that in the -- at least in the 2002 time frame, BTG
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`was seeking licensees for the ’213 patent?
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`A.
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`It's certainly published. I mean, it seems that according to this document,
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`that there was an interest in partnering with respect to the ’213 patent.
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`This testimony is relevant to Dr. Hofmann’s opinions at ¶ 24 and fn. 23 of
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`his declaration (regarding whether the ’213 patent was a “blocking” patent) (Ex.
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`1017), and is also relevant to Dr. Rettig’s declaration at ¶¶ 222-224 (Ex. 2038).
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`Deposition of Dr. McKeague
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`XVI. Lack of Knowledge
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`19.
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`In Exhibit 2186, on 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
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`the 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, 16, and
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`30 (regarding the bases for his opinions and whether the clinical trial results
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`demonstrated unexpected clinical efficacy) (Ex. 1091). Further, this testimony is
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`relevant to Dr. Rettig’s opinions at ¶¶ 194-213 of his declaration (Ex. 2038).
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`XVII. Confidence Intervals
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`20 (a). In Exhibit 2186, on 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.
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`Statistical significance is best assessed directly in terms of the question
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`being asked with the data. And if you have the data, of course, there are many
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`approaches that can be used.
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`20 (b). In Exhibit 2186, on 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.
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`That's a very broad question. I was not asked to do that.
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`20 (c). In Exhibit 2186, on 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 opinions in his declaration at
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`¶¶ 33-35, 38, and 39 (regarding whether overlapping confidence intervals indicate
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`no statistically significant difference) (Ex. 1091). This testimony is relevant to
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`Exhibits 2183 and 2184. This testimony is further relevant to Dr. Rettig’s opinions
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`at ¶¶ 194-213 of his declaration (Ex. 2038).
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`21 (a). In Exhibit 2186, on 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.
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`I just said my point is there's an overlap. I think you're right. Do I talk about
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`the extent of the overlap, no. I just say there is an overlap.
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`21 (b). In Exhibit 2186, on p. 95, ll. 1-6, the witness testified:
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`Q. And do you believe the information on the CLINICALTRIALS.GOV
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`website 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.
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`I do not say that here.
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`This testimony is relevant to Dr. McKeague’s opinions in his declaration at
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`¶¶ 33-39 (regarding representation of amount of COU-AA-001 and COU-AA-002
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`confidence interval overlap and whether other data should be used in a comparison
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`of the study results) (Ex. 1091), and is further relevant to Dr. Rettig’s opinions at
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`¶¶ 194-213 of his declaration (Ex. 2038).
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`XVIII. Cross Study Comparison
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`22.
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`In Exhibit 2186, on 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
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`levels 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.
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`I haven't been asked to think about it.
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`This testimony is relevant to Dr. McKeague’s opinions in his declaration at
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`¶¶ 44-50 (regarding assessment of “meaningful differences” in cross-study
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`comparisons) (Ex. 1091). This testimony is also relevant to Dr. Rettig’s opinion at
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`¶¶ 194-213 of his declaration (Ex. 2038), and to the PO Response at § V.A.
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`Respectfully submitted,
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`
`
`/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)
`Bindu Donovan (pro hac vice)
`Paul J. Zegger (Reg. No. 33,821)
`Todd L. Krause (Reg. No. 48,860)
`Alyssa B. Monsen (pro hac vice)
`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
`
`IPR2016-01332
`U.S. Patent 8,822,438
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`
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`Dated: May 3, 2017
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`16
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`IPR2016-01332
`U.S. Patent 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 Observations on Cross-Examination was served on counsel of
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`record on May 3, 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 Petitioners
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`at the following addresses:
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`Brandon M. White – bmwhite@perkinscoie.com
`Crystal R. Canterbury – ccanterbury@perkinscoie.com
`Bryan D. Beel – bbeel@perkinscoie.com
`Shannon Bloodworth – sbloodworth@perkinscoie.com
`Emily J. Greb – egreb@perkinscoie.com
`Robert D. Swanson – rswanson@perkinscoie.com
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`Samuel S. Park – spark@winston.com
`Ryan B. Hauer – rhauer@winston.com
`Jovial Wong – jwong@winston.com
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`
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`Respectfully submitted,
`
`
`/Dianne B. Elderkin/
`Dianne B. Elderkin
`Registration No. 28,598
`Counsel for Patent Owner
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`17
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`Date: May 3, 2017
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