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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`WOCKHARDT BIO AG,
`Petitioner
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`v.
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`JANSSEN ONCOLOGY, INC.,
`Patent Owner
`________________________
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`Case IPR2016-01582
`U.S. Patent No. 8,822,438
`________________________
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`PETITIONER’S OBJECTIONS TO PATENT OWNER’S
`EVIDENCE UNDER 37 U.S.C. § 42.64(b)(1)
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`IPR2016-01582
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`U.S. Patent No. 8,822,438
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`Petitioner Wockhardt Bio AG objects under the Federal Rules of Evidence
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`(“FRE”) and 37 C.F.R. § 42.64(b)(1) to the admissibility of the following evidence
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`submitted by Patent Owner, Janssen Oncology, Inc., with its Patent Owner
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`Response filed on March 17, 2017. These objections are made within 5 business
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`days from the March 17, 2017 service of the Patent Owner Response. Petitioner
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`serves Patent Owner with these objections to provide notice to Patent Owner that
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`Petitioner may move to exclude the challenged exhibits under 37 C.F.R. §
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`42.64(c), unless Patent Owner cures the defects identified herein.
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`Exhibit 2015
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`Exhibit 2015 purports to be the Declaration of Marc B. Garnik, M.D.,
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`previously submitted in Mylan Pharms. Inc. v. Janssen Oncology, Inc., IPR2016-
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`01332. To the extent Patent Owner relies on the contents of this document for the
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`truth of the matter asserted, Petitioner objects to such contents as inadmissible
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`hearsay under FRE 801 and 802 that does not fall under any exceptions, including
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`those of FRE 803, 804, 805 or 807. Petitioner further objects to Exhibit 2015 under
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`FRE 403 because the declaration has been filed in a proceeding to which Petitioner
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`is not a party and has had no opportunity to cross-examine the witness in this
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`proceeding to assess the basis or correctness of the opinions offered. Moreover,
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`Patent Owner has refused to provide Dr. Garnick for deposition in this proceeding.
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`Exhibit 2016
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`IPR2016-01582
`U.S. Patent No. 8,822,438
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`Exhibit 2016 purports to be the deposition transcript of Marc B. Garnick,
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`M.D. that took place on February 16, 2017 in Mylan Pharms. Inc. v. Janssen
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`Oncology, Inc., IPR2016-01332. To the extent Patent Owner relies on the contents
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`of this document for the truth of the matter asserted, Petitioner objects to such
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`contents as inadmissible hearsay under FRE 801 and 802 that does not fall under
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`any exceptions, including those of FRE 803, 804, 805 or 807. Petitioner further
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`objects to Exhibit 2016 under FRE 403 because the deposition transcript has been
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`filed in a proceeding to which Petitioner is not a party and has had no opportunity
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`to cross-examine the witness in this proceeding to assess the basis or correctness of
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`the opinions offered. Moreover, Patent Owner has refused to provide Dr. Garnick
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`for deposition in this proceeding.
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`Exhibit 2017
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`Exhibit 2017 purports to be the Declaration of Scott R. Serels, M.D.,
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`previously submitted in Amerigen Pharms. Ltd. v. Janssen Oncology, Inc.,
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`IPR2016-00286. To the extent Patent Owner relies on the contents of this
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`document for the truth of the matter asserted, Petitioner objects to such contents as
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`inadmissible hearsay under FRE 801 and 802 that does not fall under any
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`exceptions, including those of FRE 803, 804, 805 or 807. Petitioner further objects
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`to Exhibit 2017 under FRE 403 because the declaration has been filed in a
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`IPR2016-01582
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`proceeding to which Petitioner is not a party and has had no opportunity to cross-
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`examine the witness in this proceeding to assess the basis or correctness of the
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`opinions offered. Moreover, Patent Owner has refused to provide Dr. Serels for
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`deposition in this proceeding.
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`Exhibit 2018
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`Exhibit 2018 purports to be the deposition transcript of Scott R. Serels, M.D.
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`that took place on January 21, 2017 in Amerigen Pharms. Ltd. v. Janssen
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`Oncology, Inc., IPR2016-00286. To the extent Patent Owner relies on the contents
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`of this document for the truth of the matter asserted, Petitioner objects to such
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`contents as inadmissible hearsay under FRE 801 and 802 that does not fall under
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`any exceptions, including those of FRE 803, 804, 805 or 807. Petitioner further
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`objects to Exhibit 2018 under FRE 403 because the deposition transcript has been
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`filed in a proceeding to which Petitioner is not a party and has had no opportunity
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`to cross-examine the witness in this proceeding to assess the basis or correctness of
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`the opinions offered. Moreover, Patent Owner has refused to provide Dr. Serels for
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`deposition in this proceeding.
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`Exhibit 2019
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`Exhibit 2019 purports to be the Declaration of Scott R. Serels, M.D.,
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`previously submitted in Amerigen Pharms. Ltd. v. Janssen Oncology, Inc.,
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`IPR2016-01582
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`U.S. Patent No. 8,822,438
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`IPR2016-00286. To the extent Patent Owner relies on the contents of this
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`document for the truth of the matter asserted, Petitioner objects to such contents as
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`inadmissible hearsay under FRE 801 and 802 that does not fall under any
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`exceptions, including those of FRE 803, 804, 805 or 807. Petitioner further objects
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`to Exhibit 2019 under FRE 403 because the declaration has been filed in a
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`proceeding to which Petitioner is not a party and has had no opportunity to cross-
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`examine the witness in this proceeding to assess the basis or correctness of the
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`opinions offered. Moreover, Patent Owner has refused to provide Dr. Serels for
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`deposition in this proceeding.
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`Exhibit 2020
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`Exhibit 2020 purports to be the deposition transcript of Scott R. Serels, M.D.
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`that took place on August 22, 2016 in Amerigen Pharms. Ltd. v. Janssen Oncology,
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`Inc., IPR2016-00286. To the extent Patent Owner relies on the contents of this
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`document for the truth of the matter asserted, Petitioner objects to such contents as
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`inadmissible hearsay under FRE 801 and 802 that does not fall under any
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`exceptions, including those of FRE 803, 804, 805 or 807. Petitioner further objects
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`to Exhibit 2020 under FRE 403 because the deposition transcript has been filed in
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`a proceeding to which Petitioner is not a party and has had no opportunity to cross-
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`examine the witness in this proceeding to assess the basis or correctness of the
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`opinions offered. Moreover, Patent Owner has refused to provide Dr. Serels for
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`deposition in this proceeding.
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`Exhibit 2026
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`IPR2016-01582
`U.S. Patent No. 8,822,438
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`Exhibit 2026 purports to be an excerpt from REMINGTON: THE SCIENCE AND
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`PRACTICE OF PHARMACY (Alfonso R. Gennaro ed., 20th ed. 2000). Petitioner
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`objects to Exhibit 2026 under FRE 106 because the document is incomplete and
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`includes only a select portion of a larger document that in fairness should be
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`considered along with this document.
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`Exhibit 2030
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`Exhibit 2030 purports to be a letter from Waun Ki Hong, M.D., Deputy
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`Editor of Clinical Cancer Research, to Ian Judson at CRC Centre for Cancer
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`Therapeutics, dated May 12, 2003. To the extent Patent Owner relies on the
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`contents of this document for the truth of the matter asserted, Petitioner objects to
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`such contents as inadmissible hearsay under FRE 801 and 802 that does not fall
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`under any exceptions, including those of FRE 803, 804, 805 or 807.
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`Exhibit 2038
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`Exhibit 2038 is the declaration of Matthew B. Rettig, M.D. To the extent
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`Patent Owner relies on the exhibits cited therein for the truth of the matter asserted,
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`Petitioner objects to such contents as inadmissible hearsay under FRE 801 and 802.
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`Further, Petitioner objects to Dr. Rettig’s Declaration because there has not been
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`an adequate showing that his testimony is the product of reliable facts or data and
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`there is no indication that the testimony will help the Board understand the
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`evidence or determine a fact in issue. FRE 401, 403, 702. In addition, portions of
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`Dr. Rettig’s Declaration also mischaracterize the evidence and testimony of record.
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`See, e.g., ¶¶ 38, 39, 45, 47, 50, 54, 56, 73-106, 109-119, 123-133, 147-165, 172-
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`188, 195, 199-203, 206-223, 226-231, and 246. They are therefore misleading and
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`confusing to the issues at trial. FRE 403. Additionally, Petitioner objects to Dr.
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`Rettig’s Declaration to the extent it relies on Exhibits 2030, 2044, 2058, 2063, and
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`2118, each of which is objected to herein.
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`Exhibit 2040
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`Exhibit 2040 is the declaration of Richard Auchus, M.D., Ph.D. To the
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`extent Patent Owner relies on the exhibits cited therein for the truth of the matter
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`asserted, Petitioner objects to such contents as inadmissible hearsay under FRE
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`801 and 802. Further, Petitioner objects to Dr. Auchus’ Declaration because there
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`has not been an adequate showing that his testimony is the product of reliable facts
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`or data and there is no indication that the testimony will help the Board understand
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`the evidence or determine a fact in issue. FRE 401, 403, 702. In addition, portions
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`of Dr. Auchus’ Declaration also mischaracterize the evidence and testimony of
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`record. See, e.g., ¶¶ 18-37, 39-43, 45, 49, and 54-59. They are therefore misleading
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`and confusing to the issues at trial. FRE 403.
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`Exhibit 2044
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`IPR2016-01582
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`Exhibit 2044 is the declaration of Christopher A. Vellturo, Ph.D. To the
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`extent Patent Owner relies on the exhibits cited therein for the truth of the matter
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`asserted, Petitioner objects to such contents as inadmissible hearsay under FRE
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`801 and 802. Further, Petitioner objects to Dr. Vellturo’s Declaration because there
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`has not been an adequate showing that his testimony is the product of reliable facts
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`or data and there is no indication that the testimony will help the Board understand
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`the evidence or determine a fact in issue. FRE 401, 403, 702. In addition, portions
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`of Dr. Vellturo’s Declaration also mischaracterize the evidence and testimony of
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`record. See, e.g., ¶¶ 7, 8, 20-25, 27, 34-51, 61, and 68. They are therefore
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`misleading and confusing to the issues at trial. FRE 403. Petitioner objects to
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`Appendices B-E, attached to Dr. Vellturo’s declaration under FRE 1006 because
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`they are improper summaries that fail to provide their underlying information.
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`Additionally, Petitioner objects to Dr. Vellturo’s Declaration to the extent it relies
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`on Exhibits 2016, 2020, 2038, 2092, 2093, 2095, 2096, 2134, and 2135, each of
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`which is objected to herein.
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`Exhibit 2058
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` Exhibit 2058 purports to be chapters from CONCEPTS IN MEDICAL
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`PHYSIOLOGY (Julian Seifter et al. eds, edition and publication date unknown).
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`Petitioner objects to Exhibit 2058 under FRE 1002 because the excerpts from
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`Chapter 37 are not in color and cannot be discerned, and therefore it is not the
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`original of the reference from which it was created. Petitioner further objects to
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`Exhibit 2058 under FRE 1006 for being incomplete and under FRE 901 and 902
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`for lacking authentication because it lacks the bibliographic information from
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`which Petitioner can discern the authenticity of Exhibit 1006, as well as its date of
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`publication. Petitioner also objects to Exhibit 2058 because Exhibit 2058 is not a
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`“duplicate” as defined by FRE 1001(e) insofar as the exhibit is not “a copy. . .
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`which accurately reproduces the original.” Thus, under FRE 1003, Exhibit 2058 is
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`inadmissible because it is not a “duplicate.”
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`Exhibit 2063
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`Exhibit 2063 purports to be an article from the Journal of Clinical Oncology
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`by Small, E.J., et al., entitled “Antiandrogen Withdrawal Alone or in Combination
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`With Ketoconazole in Androgen-Independent Prostate Cancer Patients: A Phase III
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`Trial (CALGB 9583).” Petitioner objects to Exhibit 2063 because it is incomplete.
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`Patent Owner did not submit the “Appendix” referred to on page 1032 of Exhibit
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`2063. Therefore Exhibit 2063 is not a “duplicate” as defined by 1001(e) insofar as
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`the exhibit is not “a counterpart … that accurately reproduces the original.” Thus,
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`under FRE 1003, Exhibit 2063 is inadmissible because it is not a duplicate.
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`Exhibit 2092
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`IPR2016-01582
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`Exhibit 2092 purports to be a presentation prepared on behalf of Janssen and
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`entitled “Understanding Zytiga Users ‘Urologist Success’ Qualitative Research.”
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`Petitioner objects to this document as not properly authenticated under FRE 901
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`because Patent Owner fails to provide any evidence indicating the origin of this
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`document, nor does it provide sufficient information regarding its authenticity.
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`Further, Exhibit 2092 is not self-authenticating under FRE 902. To the extent
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`Patent Owner relies on the contents of this document for the truth of the matter
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`asserted, Petitioner objects to such contents as inadmissible hearsay under FRE
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`801 and 802 that does not fall under any exceptions, including those of FRE 803,
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`804, 805 or 807.
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`To the extent Patent Owner relies on the contents of this document to prove
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`the content of the original document, Petitioner objects to this document as not
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`being an original document under FRE 1002, an authentic duplicate under FRE
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`1003, or a document that falls under any exception to the original-document
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`requirement, including those of FRE 1004.
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`Exhibit 2093
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`Exhibit 2093 purports to be a presentation prepared by Janssen and entitled
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`“Patient Affordability 11.6.2013.” Petitioner objects to this document as not
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`properly authenticated under FRE 901 because Patent Owner fails to provide any
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`evidence indicating the origin of this document, nor does it provide sufficient
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`information regarding its authenticity. Further, Exhibit 2093 is not self-
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`authenticating under FRE 902. To the extent Patent Owner relies on the contents of
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`this document for the truth of the matter asserted, Petitioner objects to such
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`contents as inadmissible hearsay under FRE 801 and 802 that does not fall under
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`any exceptions, including those of FRE 803, 804, 805 or 807
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`To the extent Patent Owner relies on the contents of this document to prove
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`the content of the original document, Petitioner objects to this document as not
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`being an original document under FRE 1002, an authentic duplicate under FRE
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`1003, or a document that falls under any exception to the original-document
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`requirement, including those of FRE 1004.
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`Exhibit 2095
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`Exhibit 2095 purports to be a summary of data from IBM Explorys.
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`Petitioner objects to this document as not properly authenticated under FRE 901
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`because Patent Owner fails to provide any evidence indicating the origin of this
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`document, nor does it provide sufficient information regarding its authenticity.
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`Further, Exhibit 2095 is not self-authenticating under FRE 902. To the extent
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`Patent Owner relies on the contents of this document for the truth of the matter
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`asserted, Petitioner objects to such contents as inadmissible hearsay under FRE
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`801 and 802 that does not fall under any exceptions, including those of FRE 803,
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`804, 805 or 807.
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`Petitioner also objects to Exhibit 2095 under FRE 1006 because no original
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`data supposedly provided by IBM Explorys has been produced. Facially, it appears
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`to be attorney-work product. As such Exhibit 2095 is inadmissible because it is an
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`improper summary that fails to provide its underlying information.
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`Exhibit 2096
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`Exhibit 2096 purports to be a summary of data from IMS IPS Audit.
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`Petitioner objects to this document as not properly authenticated under FRE 901
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`because Patent Owner fails to provide any evidence indicating the origin of this
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`document, nor does it provide sufficient information regarding its authenticity.
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`Further, Exhibit 2096 is not self-authenticating under FRE 902. To the extent
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`Patent Owner relies on the contents of this document for the truth of the matter
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`asserted, Petitioner objects to such contents as inadmissible hearsay under FRE
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`801 and 802 that does not fall under any exceptions, including those of FRE 803,
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`804, 805 or 807
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`Petitioner also objects to Exhibit 2096 under FRE 1006 because no original
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`data supposedly provided by IMS IPS Audit has been produced. Facially, it
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`appears to be attorney-work product. As such Exhibit 2096 is inadmissible because
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`it is an improper summary that fails to provide its underlying information.
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`Exhibit 2118
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`IPR2016-01582
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`Exhibit 2118 purports to be the Declaration of Johann S. de Bono, filed in
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`BTG Int’l Ltd. v. Actavis Labs. FL, Inc., Case No. 15-cv-5909 (D.N.J.). To the
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`extent Patent Owner relies on the contents of this document for the truth of the
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`matter asserted, Petitioner objects to such contents as inadmissible hearsay under
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`FRE 801 and 802 that does not fall under any exceptions, including those of FRE
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`803, 804, 805 or 807. Petitioner further objects to Exhibit 2118 under FRE 403
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`because Petitioner has had no opportunity to cross-examine the witness in this
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`proceeding to assess the basis or correctness of the opinions offered. Moreover,
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`Patent Owner has not offered to provide Mr. de Bono for deposition in this
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`proceeding.
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`Petitioner objects to Exhibit 2118 because it is incomplete. Patent Owner did
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`not submit Exhibits A-F referred to in Exhibit 2118. Therefore Exhibit 2118 is not
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`a “duplicate” as defined by 1001(e) insofar as the exhibit is not “a counterpart …
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`that accurately reproduces the original.” Thus, under FRE 1003, Exhibit 2118 is
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`inadmissible because it is not a duplicate.
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`Exhibit 2124
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`Exhibit 2016 purports to be the deposition transcript of Mark J. Ratain, M.D.
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`that took place on January 23, 2017 in Amerigen Pharms. Ltd. v. Janssen
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`IPR2016-01582
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`Oncology, Inc., IPR2016-00286. To the extent Patent Owner relies on the contents
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`of this document for the truth of the matter asserted, Petitioner objects to such
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`contents as inadmissible hearsay under FRE 801 and 802 that does not fall under
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`any exceptions, including those of FRE 803, 804, 805 or 807. Petitioner further
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`objects to Exhibit 2124 under FRE 403 because the deposition transcript has been
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`filed in a proceeding to which Petitioner is not a party and has had no opportunity
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`to cross-examine the witness in this proceeding to assess the basis or correctness of
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`the opinions offered. Moreover, Patent Owner has refused to provide Dr. Ratain for
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`deposition in this proceeding.
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`Exhibit 2125
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`Exhibit 2016 purports to be the deposition transcript of Richard Dorin, M.D.
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`that took place on January 19, 2017 in Amerigen Pharms. Ltd. v. Janssen
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`Oncology, Inc., IPR2016-00286. To the extent Patent Owner relies on the contents
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`of this document for the truth of the matter asserted, Petitioner objects to such
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`contents as inadmissible hearsay under FRE 801 and 802 that does not fall under
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`any exceptions, including those of FRE 803, 804, 805 or 807. Petitioner further
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`objects to Exhibit 2125 under FRE 403 because the deposition transcript has been
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`filed in a proceeding to which Petitioner is not a party and has had no opportunity
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`to cross-examine the witness in this proceeding to assess the basis or correctness of
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`the opinions offered. Moreover, Patent Owner has refused to provide Dr. Dorin for
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`deposition in this proceeding.
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`Exhibit 2128
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`IPR2016-01582
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`Exhibit 2018 purports to be the deposition transcript of Ivan T. Hofmann,
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`CPA/CFF, CLP that took place on February 7, 2017 in Mylan Pharms. Inc. v.
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`Janssen Oncology, Inc., IPR2016-01332. To the extent Patent Owner relies on the
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`contents of this document for the truth of the matter asserted, Petitioner objects to
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`such contents as inadmissible hearsay under FRE 801 and 802 that does not fall
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`under any exceptions, including those of FRE 803, 804, 805 or 807. Petitioner
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`further objects to Exhibit 2128 under FRE 403 because the deposition transcript
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`has been filed in a proceeding to which Petitioner is not a party and has had no
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`opportunity to cross-examine the witness in this proceeding to assess the basis or
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`correctness of the opinions offered. Moreover, Patent Owner has refused to provide
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`Mr. Hoffman for deposition in this proceeding.
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`Exhibit 2130
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`Exhibit 2130 purports to be a conference poster, entitled “Duration of
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`Therapy For Oral Treatments in Patients With Metastatic Castration Resistant
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`Prostate Cancer.” Petitioner objects to this document as not properly authenticated
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`under FRE 901 because Patent Owner fails to provide any evidence indicating the
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`origin of this document, nor does it provide sufficient information regarding its
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`authenticity. Further, Exhibit 2092 is not self-authenticating under FRE 902. To
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`the extent Patent Owner relies on the contents of this document for the truth of the
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`matter asserted, Petitioner objects to such contents as inadmissible hearsay under
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`FRE 801 and 802 that does not fall under any exceptions, including those of FRE
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`803, 804, 805 or 807.
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`To the extent Patent Owner relies on the contents of this document to prove
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`the content of the original document, Petitioner objects to this document as not
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`being an original document under FRE 1002, an authentic duplicate under FRE
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`1003, or a document that falls under any exception to the original-document
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`requirement, including those of FRE 1004.
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`Exhibit 2134
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`Exhibit 2134 purports to be a summary of Zytiga® Market Share Data.
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`Petitioner objects to this document as not properly authenticated under FRE 901
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`because Patent Owner fails to provide any evidence indicating the origin of this
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`document, nor does it provide sufficient information regarding its authenticity.
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`Further, Exhibit 2134 is not self-authenticating under FRE 902. To the extent
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`Patent Owner relies on the contents of this document for the truth of the matter
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`asserted, Petitioner objects to such contents as inadmissible hearsay under FRE
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`801 and 802 that does not fall under any exceptions, including those of FRE 803,
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`804, 805 or 807
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`IPR2016-01582
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`Petitioner also objects to Exhibit 2134 under FRE 1006 as inadmissible
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`because it is an improper summary that fails to provide its underlying information.
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`Facially, it appears to be attorney-work product.
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`Exhibit 2135
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`Exhibit 2135 purports to be a summary of Truven Commercial and Medicare
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`Data. Petitioner objects to this document as not properly authenticated under FRE
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`901 because Patent Owner fails to provide any evidence indicating the origin of
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`this document, nor does it provide sufficient information regarding its authenticity.
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`Further, Exhibit 2134 is not self-authenticating under FRE 902. To the extent
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`Patent Owner relies on the contents of this document for the truth of the matter
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`asserted, Petitioner objects to such contents as inadmissible hearsay under FRE
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`801 and 802 that does not fall under any exceptions, including those of FRE 803,
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`804, 805 or 807
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`Petitioner also objects to Exhibit 2135 under FRE 1006 as inadmissible
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`because it is an improper summary that fails to provide its underlying information.
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`Exhibit 2153
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`Exhibit 2153 purports to be the Declaration of Ivan T. Hofmann, CPA/CFF,
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`CLP, previously submitted in Mylan Pharms. Inc. v. Janssen Oncology, Inc.,
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`IPR2016-01332. To the extent Patent Owner relies on the contents of this
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`IPR2016-01582
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`document for the truth of the matter asserted, Petitioner objects to such contents as
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`inadmissible hearsay under FRE 801 and 802 that does not fall under any
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`exceptions, including those of FRE 803, 804, 805 or 807. Petitioner further objects
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`to Exhibit 2153 under FRE 403 because the declaration has been filed in a
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`proceeding to which Petitioner is not a party and has had no opportunity to cross-
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`examine the witness in this proceeding to assess the basis or correctness of the
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`opinions offered. Moreover, Patent Owner has refused to provide Mr. Hofmann for
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`Respectfully submitted,
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`STERNE, KESSLER, GOLDSTEIN & FOX PLLC
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`deposition in this proceeding.
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`Date: March 24, 2017
`1100 New York Avenue, N.W.
`Washington, DC 20005
`(202) 371-2600
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` f
`Christopher M. Gallo
`Registration No. 70,291
`Attorney for Petitioner
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`17
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`IPR2016-01582
`U.S. Patent No. 8,822,438
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`CERTIFICATION OF SERVICE (37 C.F.R. § 42.6(e))
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`The undersigned hereby certifies that the above-captioned “Petitioner’s
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`Objections to Patent Owner’s Evidence Under 37 U.S.C. § 42.64(b)(1)” was served
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`in its entirety on March 24, 2017, upon the following parties via email:
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`Dianne B. Elderkin: delderkin@akingump.com
`Barbara L. Mullin: bmullin@akingump.com
`Ruben H. Munoz: rmunoz@akingump.com
`JANS-ZYTIGA@akingump.com
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`David. T. Pritikin: dpritikin@sidley.com
`Bindu Donovan: bdonovan@sidley.com
`Paul J. Zegger: pzegger@sidley.com
`Todd L. Krause: tkrause@sidley.com
`ZytigaIPRTeam@sidley.com
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`Anthony C. Tridico: anthony.tridico@finnegan.com
`Jennifer H. Roscetti: jennifer.roscetti@finnegan.com
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`STERNE, KESSLER, GOLDSTEIN & FOX PLLC
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`Date: March 24, 2017
`1100 New York Avenue, N.W.
`Washington, DC 20005
`(202) 371-2600
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`5165952
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`
` f
`Christopher M. Gallo
`Registration No. 70,291
`Attorney for Petitioner
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