throbber
Filed: May 10, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
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`
`
`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,
`
`Petitioners
`
`v.
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`JANSSEN ONCOLOGY, INC.,
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`Patent Owner
`
`Case IPR2016-013321
`Patent 8,822,438 B2
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`
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`
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`PETITIONERS’ RESPONSE TO 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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`

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`Petitioners hereby respond to Patent Owner’s Motion for Observations on
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`Cross Examination (“OCE”). Paper No. 70.
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`Response to OCE 3-6: Patent Owner’s Observations 3-6 misstate the record
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`when they assert that Dr. Garnick “testified” as described. These Observations are
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`not the “testimony” of Dr. Garnick. Instead, Patent Owner has cited transcript
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`passages where its attorney read into the record either a portion or a paraphrase of
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`a portion of a document and asked Dr. Garnick to confirm the substance or
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`language of the passage. Patent Owner then reported Dr. Garnick’s simple act of
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`confirming the attorney’s statement as Dr. Garnick’s “testimony” on the issue. For
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`example, the entirety of the cited question and answer in Observation 5 is:
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`Q. So on page 1097, in the right-hand column, third full paragraph it
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`states, “Overall, ketoconazole plus hydrocortisone would have to be
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`judged ineffective as secondary hormone therapy for most patients
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`with advanced prostatic cancer,” correct?
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`A. Yes.
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`Ex. 2185 at 104:13-19. In view of Patent Owner’s improper use of the observation
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`procedure, which is designed to highlight allegedly relevant “testimony,”
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`Observations 3-6 should be stricken from the record.
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`Response 1: Dr. Garnick’s testimony is nothing more than an acknowledgement of
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`the core purpose of scientific and medical research: the development of additional
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`therapies to treat conditions. To the extent Patent Owner is implying that the next
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`developments were directed only at “chemotherapy,” rather than other treatment
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`modalities, Dr. Garnick’s complete testimony establishes that implication as false.
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`Dr. Garnick testified that enzalutamide (now marketed as Xtandi®, which is not a
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`chemotherapy agent), was already in the prior art before the priority date of U.S.
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`Patent No. 8,822,438 (“’438 patent”). Ex. 2185 at 46:20-47:15, 53:15-54:4. This
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`testimony also refutes Patent Owner’s assertion that abiraterone was the next-
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`discovered drug shown to provide a survival benefit; in fact, enzalutamide was
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`known first and has been shown to provide a survival benefit.
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`Response 2: Patent Owner’s cite is irrelevant. The approval of abiraterone acetate
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`with prednisone (under New Drug Application No. 202379)—the only approval of
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`any abiraterone acetate product—occurred on April 28, 2011, long after the ’438
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`patent’s claimed priority date of 2006, and therefore (even if a “milestone”) it
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`bears no significance to the ’438 patent’s obviousness. In addition, abiraterone
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`acetate, a compound known in the prior art, provides the patient benefit to which
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`Dr. Garnick refers. Ex. 1002 ¶¶ 78-93; Ex. 1104 ¶¶ 89-111. Further, as Dr.
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`Garnick testified, enzalutamide (now marketed as Xtandi®, another effective non-
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`chemotherapy treatment for mCRPC), was also in the prior art and met any clinical
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`need that abiraterone acetate would have satisfied. Ex. 2185 at 46:20-47:15,
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`53:15-54:4.
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`2
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`Response 3: Patent Owner’s cite confirms that Dr. Garnick was correct when he
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`stated, in his reply declaration, that “Attard 2009 enrolled patients who were
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`previously on ketoconazole.” Ex. 1104 ¶ 99. In the same sentence, Dr. Garnick
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`noted that Ryan 2011, another alleged anchor of Dr. Rettig’s opinion on
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`unexpected results, did not enroll patients who were previously on ketoconazole.
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`Id. As Dr. Garnick noted, this is just one of “several of the weaknesses of Dr.
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`Rettig’s cross-study comparisons from the viewpoint of a medical practitioner.”
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`Id. at ¶ 97 n.4. As Dr. Garnick and Dr. McKeague noted in their reply
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`declarations, the sum total of these several weaknesses (of which Patent Owner
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`cited only one) renders invalid Dr. Rettig’s conclusion on unexpected results
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`because it makes clear that Dr. Rettig did not perform a credible comparison of
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`available clinical data. Ex. 1104 ¶¶ 98-101; Ex. 1091 ¶¶ 44-52.
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`Response 4: The alleged “testimony” is simply a request that Dr. Garnick confirm
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`what is written in Attard 2009 and does not involve Dr. Garnick giving
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`particularized testimony based on his expertise. In addition, the quoted portion of
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`Attard 2009 has no nexus to the claims because it relates to the use of
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`dexamethasone after abiraterone acetate, not the claimed abiraterone acetate-
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`prednisone co-therapy. Ex. 1104 ¶¶ 105, 120; Ex. 1091 ¶¶ 30, 48, 57-59.
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`Response 5: Janssen’s citation is not Dr. Garnick’s testimony—Dr. Garnick
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`simply confirms what is written in Trump. Janssen takes a single quotation out of
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`context, ignoring the widespread practice in the prior art of prescribing
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`ketoconazole and a glucocorticoid to advanced prostate cancer patients. Ex. 1104
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`¶¶ 19-21. As Dr. Garnick testified, Gerber discloses the effective combination of
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`ketoconazole and prednisone to treat castration-resistant prostate cancer, regardless
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`of whether ketoconazole and hydrocortisone was used in the same way with the
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`same effectiveness. Ex. 2185 at 135:4-136:3; Ex. 1104 ¶¶ 12, 24, 32-38.
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`Response 6: Again, Dr. Garnick merely confirms what is written in Sonino and
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`does not give affirmative testimony. Sonino also was not cited in Dr. Garnick’s
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`reply declaration, so any testimony regarding Sonino is outside the scope of his
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`declaration, an objection that was preserved in the record. Ex. 2185 at 109:1.
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`Further, regardless of its specific side effect profile, ketoconazole was known to
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`inhibit adrenal steroid synthesis and require concomitant glucocorticoid therapy.
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`Ex. 1097 ¶¶ 38-42, 52-55, 62-66; Ex. 1104 ¶¶ 5, 11-13, 16-23, 25-27. Finally, as
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`Dr. Garnick and Dr. Bantle explain, the prior art disclosed that abiraterone was
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`expected to cause mineralocorticoid excess, necessitating the use of concomitant
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`glucocorticoid replacement therapy. Ex. 1097 ¶¶ 25-26, 43, 56-59; Ex. 1104
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`¶¶ 71-79; Ex. 2185 at 166:18-167:21.
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`Response 7: Patent Owner’s cite is irrelevant. The Board’s claim construction
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`does not require that prednisone be used to “treat” prostate cancer, in the limited
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`sense of providing an antitumor or anticancer effect (as Patent Owners have
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`4
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`repeatedly asserted, despite the Board’s ruling in Amerigen (IPR2016-00286)).
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`Indeed, under the correct understanding of the term “treat,” approved by the Board,
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`Gerber teaches the use of prednisone to treat prostate cancer because Gerber
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`teaches administration of prednisone with a steroid synthesis inhibitor to address
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`side effects. Ex. 2185 at 128:18-22 (“[Q.] So based on your review of Gerber, you
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`concluded that the patients in Gerber were receiving prednisone as glucocorticoid
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`replacement therapy in order to address side effects, correct? [A.] Yes.”); Ex. 1104
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`¶ 33.
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`Response 8: Janssen omits Dr. Garnick’s complete testimony, which observes that
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`many physicians administer glucocorticoids other than prednisone with abiraterone
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`acetate, or prednisone in amounts different than Zytiga®’s label. Ex. 2185 at
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`149:1-12 (“Some of my colleagues administer abiraterone acetate with
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`hydrocortisone. Some may use five milligrams, and two and a half milligrams of
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`prednisone. So it’s - you know, it’s administration with a glucocorticoid. Not
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`necessarily requiring prednisone.”). Dr. Garnick’s complete testimony contradicts
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`Dr. Rettig’s broad proclamation that “[d]octors prescribe ZYTIGA® therapy for
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`mCRPC patients because of the observed enhanced survival benefit of the
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`combination of abiraterone acetate and prednisone in mCRPC patients.” Ex. 2038
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`¶ 219.
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`Response 9: Janssen incorrectly implies that abiraterone acetate patients with low
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`adrenal reserve do not need replacement glucocorticoid therapy. Rather, any
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`significant physiological stress to a patient with low adrenal reserve can be fatal.
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`Ex. 1097 ¶ 54. Moreover, the O’Donnell Synacthen data showing low adrenal
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`reserve further
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`indicated the presence of either adrenal
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`insufficiency or
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`mineralocorticoid excess, both requiring glucocorticoid supplementation. Id.
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`¶¶ 50-62. Skilled artisans at the priority date, as Attard 2005 notes, would
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`therefore have been concerned about adrenal insufficiency, low adrenal reserve,
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`and mineralocorticoid excess, all three of which would have counseled toward
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`administration of a glucocorticoid like prednisone. Ex. 1023 at 5 (“Patients will be
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`closely monitored for the development of glucocorticoid insufficiency or
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`hypertension.”); Ex. 1097 ¶¶ 43-66.
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`Response 10: Janssen improperly draws broad conclusions from a very narrow
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`question. Dr. Bantle agreed only that abiraterone acetate did not cause
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`mineralocorticoid excess during the 12-day O’Donnell study period. As Dr. Bantle
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`explained in his declaration, mineralocorticoid excess takes substantial time to
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`develop, so the O’Donnell patients’ lack of mineralocorticoid excess was not
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`definitive. Ex. 1097 ¶¶ 72, 74. And even though the O’Donnell patients had not
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`developed mineralocorticoid excess by the study’s conclusion, “the clinical results
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`in O’Donnell would have further concerned a person of ordinary skill in the art
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`(“POSA”)
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`that patients administered abiraterone acetate may develop
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`mineralocorticoid excess.” Id. ¶¶ 59-60.
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`Response 11: The cited testimony is irrelevant. Petitioners do not dispute which
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`enzymes are inhibited by ketoconazole and abiraterone acetate. Both drugs were
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`known to inhibit production of cortisol, in part because of CYP17 inhibition
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`(abiraterone acetate is a 10-times greater inhibitor of CYP17 than ketoconazole).
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`Ex. 1097 ¶¶ 44-49, 90. That knowledge, with O’Donnell’s disclosures, would
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`have motivated skilled artisans to administer abiraterone acetate with prednisone:
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`Q Is it your opinion, based on the data as it exists in the O’Donnell
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`reference, that a person of ordinary skill in the art would necessarily
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`administer prednisone
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`the next
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`time she or he administered
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`abiraterone acetate to a patient?
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`A Yes, based on three things: First, the experience with ketoconazole
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`which is a drug of the same class known to produce adrenal
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`insufficiency; second, based on the very abnormal Synacthen test
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`results documenting these patients had adrenal dysfunction; and third,
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`by the concluding sentence in the abstract, which is probably the most
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`important part of the whole manuscript where O’Donnell says,
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`“Adrenal cortical suppression may necessitate” --
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`Q Sorry, Doctor, can you tell me where you are?
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`A I’m reading the last sentence of the abstract on the first page --
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`Q The abstract, okay.
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`A -- which I think is the most important part of the manuscript and the
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`part most likely to be read by anyone who picks up on this article. He
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`says or she, I’m not sure which, “Adrenocortical suppression may
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`necessitate
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`concomitant
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`administration
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`of
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`replacement
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`glucocorticoid.” Knowing those three things, I would say were I to
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`prescribe abiraterone and not administer concomitant glucocorticoid,
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`and if that patient should develop adrenal insufficiency and have a bad
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`outcome, I would be guilty of malpractice.
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`Ex. 2188 at 104:6-105:10.
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`Response 12: The cited testimony does not undermine Dr. Bantle’s opinions.
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`Janssen asserts that, despite O’Donnell’s consistently abnormal Synacthen test
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`results, a POSA would have known that abiraterone acetate does not cause adrenal
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`insufficiency, low adrenal reserve, or mineralocorticoid excess because the
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`O’Donnell patients did not yet have clinical symptoms after 12 days of treatment.
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`Paper 35 at 20-24. Dr. Bantle explained that these three conditions are all slow-
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`developing, and initial symptoms may be subclinical and non-specific, so a POSA
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`would not have ruled out these complications based solely on the lack of reported
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`symptoms after 12 days of abiraterone acetate treatment. Ex. 1097 ¶¶ 72-74. That
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`ketoconazole reduces cortisol levels “in a matter of days” (as opposed to weeks)
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`does not mean that ketoconazole causes clinically-apparent adrenal insufficiency in
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`12 days. Id. And importantly, this fact about ketoconazole would not cause skilled
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`artisans to ignore the abnormal Synacthen tests or O’Donnell’s repeated teachings
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`that “[a]drenocortical suppression may necessitate concomitant administration of
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`replacement glucocorticoid.” Id. ¶¶ 43-66; Ex. 1003 at 1 (abstract); see also Ex.
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`2188 at 104:6-105:10.
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`Response 13: The testimony Janssen cites is irrelevant. As Dr. Garnick and Dr.
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`Bantle discussed in their declarations, and reaffirmed in their depositions, a POSA
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`would have considered abiraterone acetate, ketoconazole, and aminoglutethimide
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`to treat prostate cancer via the same drug class mechanism: inhibition of adrenal
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`steroid synthesis. Ex. 1104 ¶¶ 18-31; Ex. 1097 ¶¶ 44-49; Ex. 2185 at 151:4-20;
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`Ex. 2188 at 61:15-63:5. Skilled artisans understood that adrenal steroid synthesis
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`inhibitors had undesirable collateral impacts on production of other steroids
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`besides testosterone, and thus required replacement glucocorticoid therapy. Ex.
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`1104 ¶¶ 18-31; Ex. 1097 ¶¶ 44-49. Contrary to the implication of Janssen’s motion
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`for observation, Petitioners do not dispute abiraterone acetate, ketoconazole, and
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`aminoglutethimide’s precise effects on adrenal steroid synthesis. Rather, Dr.
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`Bantle explains that even if a POSA reviewed the exact enzymes abiraterone
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`acetate, ketoconazole, and aminoglutethimide were known to inhibit, that prior art
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`would have only further motivated skilled artisans to administer abiraterone acetate
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`with a glucocorticoid. Ex. 1097 ¶¶ 50-66.
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`Response 14: Janssen omits that Dr. Bantle’s testimony on the risk of bias in data
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`reviews is most relevant to Dr. Rettig’s unexpected results opinions—Dr. Rettig
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`retrospectively cherry-picked data across multiple studies to reach conclusions in
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`litigation which were never drawn in the literature. See Ex. 1091 (McKeague
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`Decl.). Additionally, Janssen’s questions were divorced from any context. When
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`asked directly whether a POSA administered glucocorticoids with ketoconazole,
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`Dr. Bantle testified that “I would again repeat I think the standard of care at that
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`point in time—and I think even at the present time—would be to administer
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`prednisone with [ketoconazole]. For instance, if you look at the Gerber citation
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`that predated O’Donnell, prednisone was given with ketoconazole. It was part of
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`what they considered to be the standard and appropriate treatment.” Ex. 2188 at
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`106:18-107:9; see also id. at 109:19-114:20. Janssen asserts that Dr. Bantle’s
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`testimony undermines Dr. Garnick’s opinions. But it did not: Dr. Garnick
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`explained at length that “Gerber provides an extraordinary amount of useful
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`clinical information . . . .” Ex. 2185 at 135:4-136:7.
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`Response 15: Janssen quotes Dr. Bantle out of context to imply that corticosterone
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`could compensate for reduced cortisol levels induced by abiraterone acetate. In the
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`same line of questioning, Dr. Bantle explained “that normally production of
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`corticosterone is trivial, so it doesn’t contribute in any meaningful way,” Ex. 2188
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`at 26:5-7, that “it would take a very large amount of corticosterone, and I think no
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`one could tell you how much would be necessary and if the adrenal glands could
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`produce that much,” id. at 28:7-10, and that corticosterone “has less glucocorticoid
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`activity than cortisol,” id. at 28:17-18. See id. at 25:21-26:16, 27:24-28:18.
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`Moreover, Dr. Bantle notes in his declaration that “[i]f overproduction of
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`corticosterone compensates for the reduction in cortisol, the patient would likely
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`suffer from mineralocorticoid excess.” Ex. 1097 ¶ 88 (citing Ex. 1023 (Attard
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`2005) at 3 (“To produce enough corticosterone to compensate for the absence of
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`cortisol, more intermediate steroids might be generated. . . . This ACTH-driven
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`overproduction of mineralocorticoids often leads to hypertension.”)). Janssen
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`never questioned Dr. Bantle on this ultimate opinion.
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`Response 16: The testimony Janssen cites is legally irrelevant. Patent Owner must
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`demonstrate commercial success, not Petitioner. See, e.g., Novartis AG v. Torrent
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`Pharms. Ltd., 853 F.3d 1316, 1330-31 (Fed. Cir. 2017). Mr. Hofmann analyzed all
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`the evidence offered by Dr. Vellturo and Janssen, and concluded it was insufficient
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`to establish commercial success. Ex. 1134 ¶¶ 18-44; Ex. 2187 at 14:8-13.
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`Response 17: As Mr. Hofmann explained, there is no dispute that efficacy and
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`other previously-known features drive Zytiga® prescriptions. Ex. 2187 at 65:7-
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`67:5. But abiraterone acetate’s efficacy was known in the prior art, so it has no
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`nexus to the claims. Ex. 1134 ¶¶ 21-24; Ethicon Endo-Surgery, Inc. v. Covidien
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`LP, 812 F.3d 1023, 1034 (Fed. Cir. 2016). Dr. Vellturo did not apportion the
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`demand for Zytiga® that is due to abiraterone acetate’s anti-tumor benefits. Ex.
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`1134 ¶ 23. And Janssen’s assertion that prednisone adds to abiraterone acetate’s
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`anti-tumor effect remains wholly unproven. See Ex. 1091 ¶¶ 29-61; Ex. 1104
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`11
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`¶¶ 95-106.
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`Response 18: Janssen’s citation is extremely misleading. Both Mr. Hofmann and
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`Dr. Vellturo’s testimony is unequivocal that, as of 2004 and through the priority
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`date, the ’213 patent blocked others from pursuing the claimed invention. Ex.
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`2187 at 19:1-22, 22:16-23:3, 24:12-25:9, 26:8-27:14, 30:14-31:22; Ex. 1136 at
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`19:16-22, 27:4-28:17; Ex. 1134 ¶¶ 8-17. Given that key prior art like O’Donnell
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`(Ex. 1003) and Attard 2005 (Ex. 1023) was not published until after the blocking
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`patent issued, a motivation to pursue the claimed invention was not fully realized
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`in the “2002 time frame” to which Janssen refers.
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`Response 19: Dr. McKeague is highly qualified to provide biostatistical opinions,
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`and his opinions concern biostatistics. Ex. 1091 ¶¶ 2-6; Ex. 2186 at 15:9-21 (“My
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`role in this is to analyze the nature of Dr. Rettig’s declaration in this case . . .
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`concerning biostatistical issues.”). Dr. Rettig’s opinions regarding the alleged anti-
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`cancer effect of prednisone administered with abiraterone acetate are based on
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`fallacious and unreliable uses of data, so Dr. McKeague’s opinions are relevant
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`and appropriate. Ex. 1091 ¶¶ 16, 29-61.
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`Response 20(a)-(c): Janssen omits the very next question and answer following its
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`observation 20(a):
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`Q. So overlapping confidence intervals do not necessarily mean that
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`there is no statistically significant difference; correct?
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`THE WITNESS: Well, the implication is actually the other way
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`around. The implication is there’s not enough evidence of a
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`significant difference. That’s the conclusion. And if you read my
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`report, indeed, what I’m saying is Dr. Rettig does not provide enough
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`evidence to conclude a statistically significant, and that’s, indeed,
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`what we see in these confidence intervals. The overlapping confidence
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`interval is a sign there’s not enough evidence to conclude a difference.
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`Ex. 2186 at 51:9-22 (objection omitted). In addition, Dr. McKeague could not
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`access the data underlying the studies on which Dr. Rettig relied. Only Janssen
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`possessed the underlying data, which either Janssen withheld from Dr. Rettig, or
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`Dr. Rettig withheld from Petitioners and the Board. And when Janssen asked Dr.
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`McKeague whether he could “have calculated whether or not there is a statistically
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`significant difference between the two groups . . . given the data that [he] cite[d] in
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`[his] declaration,” Dr. McKeague replied that “[i]t’s not clear.” Id. at 89:2-11. As
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`Dr. McKeague explained, demonstrating that the median TTPP values are
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`statistically significantly different was “Dr. Rettig’s homework, which he did not
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`do.” Id. at 90:14-91:4. “Dr. Rettig only looked at the point estimates, which, of
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`course, is not a rigorous way of assessing the evidence for his claim of unexpected
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`results. But we can assess the evidence in support of unexpected results by seeing
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`whether the confidence intervals overlap, and indeed, they do to a significant
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`degree.” Id. at 53:14-20.
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`Response 21(a): As explained in Response 20, the fact that the confidence
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`intervals overlap, regardless of the amount of overlap, demonstrates that “there’s
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`not enough evidence of a significant difference” between Dr. Rettig’s proffered
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`median TTPP estimates. Ex. 2186 at 51:9-22. Dr. McKeague also testified that
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`the confidence intervals overlap “to a significant degree.” Id. at 53:14-20. With
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`respect to the “error” referred to in Janssen’s question, Dr. McKeague in his
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`deposition acknowledged and corrected a single typographical error in two of his
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`figures. Id. at 163:3-165:6; Ex. 1146. Dr. McKeague also noted that these
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`corrections do not affect his opinion. Ex. 2186 at 165:2-6.
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`Response 21(b): Janssen blatantly omits Dr. McKeague’s full answer. Dr.
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`McKeague goes on to testify:
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`All I say is there is a glaring inconsistency. I notice that the
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`information on the CLINICALTRIALS.GOV website certainly came
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`long after the publication itself. So that we can conjecture. We can
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`speculate various explanations. Maybe there was some problem with
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`the data analysis. Maybe the data changed, and they’re getting the
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`correct value in the CLINICALTRIALS.GOV value, which is, of
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`course, substantially larger than the value in the paper. The median
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`TTPP.
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`Ex. 2186 at 95:1-15; see also 95:17-98:11. The clinicaltrials.gov data—which
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`refute Dr. Rettig’s unexpected results opinion—are important because the trial
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`results Janssen reported to the FDA conflict with those Dr. Rettig presents. Ex.
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`1091 ¶ 36. Only Janssen can know why the trial results it gave to Dr. Rettig differ
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`from those it reported to the FDA, and which is more reliable.
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`Response 22: Janssen omits Dr. McKeague’s testimony that the difference in
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`baseline PSA level between the studies Dr. Rettig compares is “a meaningful
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`difference” and “especially problematic because it’s related to the outcome, the
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`end point of the studies, which is—well, the primary end point—both the primary
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`and the secondary end points are related to PSA levels, and here we see the
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`subjects, the patients in the actual studies had very substantially different baseline
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`PSA. Therefore, how can we make comparisons between those two studies about
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`an end point that is PSA related when the two patient populations are very
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`different[?]” Ex. 2186 at 120:13-121:2. As a biostatistician, Dr. McKeague
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`explains that a biostatistician is alarmed when there is a substantial difference in
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`the primary variable’s baseline values, and that any reliable analysis would
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`demonstrate that the difference is not statistically significant. Ex. 1091 ¶ 50. Dr.
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`Garnick, an oncologist, provides the opinion that the difference in baseline PSA
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`levels is scientifically significant. Ex. 1104 ¶ 98. Dr. McKeague also notes that
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`“one of the publications cited by Dr. Rettig indicates that different baseline PSA
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`levels are significant.” Ex. 1091 ¶ 51 (emphasis in original).
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`15
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`Dated: May 10, 2017
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`
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`
`
`/Brandon M. White/
`Brandon M. White
`Reg. No. 52,354
`Perkins Coie LLP
`700 13th St., NW, Suite 600
`Washington, D.C. 20005
`Telephone: (202) 654-6206
`E-mail: bmwhite@perkinscoie.com
`
`Attorney for Mylan Pharmaceuticals Inc.
`
`16
`
`

`

`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that the foregoing Petitioners’ Response to
`
`Patent Owner’s Motion for Observations on Cross-Examination was served
`
`electronically via email as follows:
`
`Patent Owners:
`
`Dianne B. Elderkin
`Barbara L. Mullin
`Ruben H. Munoz
`Akin Gump Strauss Hauer & Feld LLP
`JANS-ZYTIGA@akingump.com
`
`Todd L. Krause
`David T. Pritikin
`Bindu Donovan
`Paul J. Zegger
`Sidley Austin LLP
`ZytigaIPRTeam@sidley.com
`
`
`
`
`Petitioners:
`
`Samuel S. Park
`Jovial Wong
`Ryan B. Hauer
`Winston & Strawn LLP
`spark@winston.com
`jwong@winston.com
`rhauer@winston.com
`
`
`
`
`
`
`Dated: May 10, 2017
`
`
`
`/Brandon M. White/
`Brandon M. White
`
`Attorney for Mylan Pharmaceuticals Inc.
`
`
`
`1
`
`

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