Paper No. ___
`Date Filed: Jan. 25, 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.,
`Petitioner
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`v.
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`JANSSEN ONCOLOGY, INC.,
`Patent Owner
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`________________
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`Case IPR2016-01332
`Patent 8,822,438 B2
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`________________
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`PATENT OWNER’S OBJECTIONS TO EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64(b)(1)
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`Date Filed: Jan. 25, 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.,
`Petitioner
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`v.
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`JANSSEN ONCOLOGY, INC.,
`Patent Owner
`
`________________
`
`Case IPR2016-01332
`Patent 8,822,438 B2
`
`________________
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`
`PATENT OWNER’S OBJECTIONS TO EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64(b)(1)
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`IPR2016-01332
`U.S. Patent 8,822,438
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`Pursuant to 37 C.F.R. § 42.64(b)(1), Patent Owner Janssen Oncology, Inc.
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`(“Janssen”) objects under the Federal Rules of Evidence to the admissibility of
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`Exhibits 1017, 1019, 1023-1028, 1031, 1033, 1036, 1039-1041, 1045-1051, 1053-
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`1055, 1057, 1064-1066, 1078-1080 and portions of Exhibit 1002, which were
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`submitted by Petitioner Mylan Pharmaceuticals Inc. (“Mylan”) during the
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`preliminary phase of this inter partes review.
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`Janssen’s objections are timely under 37 C.F.R. § 42.64(b)(1) because they
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`are being filed and served within ten business days of the institution decision
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`issued by the Board on January 10, 2017. Paper No. 21. Janssen’s objections
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`provide notice to Mylan that Janssen may move to exclude these exhibits under 37
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`C.F.R. § 42.64(c).
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`Exhibits 1017, 1040, 1041, 1045-1051, 1053-1055, 1057, and 1064-1066 are
`Irrelevant
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`Under 35 U.S.C. § 311(b), a petitioner may request cancellation of a patent
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`claim “only on the basis of prior art consisting of patents or printed publications.”
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`In his declaration (Exhibit 1017), petitioner’s declarant Mr. Hofmann states that his
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`testimony is directed to the “evaluat[ion of] aspects of commercial success, from
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`an economic perspective, [related] to Zytiga (abiraterone acetate) and the ’438
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`1
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`IPR2016-01332
`U.S. Patent 8,822,438
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`Patent.” 1 Thus, Exhibit 1017, as well as Exhibits 1040, 1041, 1045-1051, 1053-
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`1055, 1057, and 1064-1066 cited therein, do not pass the test of relevant evidence
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`under Federal Rule of Evidence 401 because they do not pertain to “prior art
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`consisting of patents or printed publications” as required by the statute governing
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`inter partes reviews. As such, these exhibits are not admissible under Federal
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`Rule of Evidence 402.
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`Exhibits 1019, 1033 and 1064 are Irrelevant
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`Under 35 U.S.C. § 311(b), a petitioner may request cancellation of a patent
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`claim “only on the basis of prior art consisting of patents or printed publications.”
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`Exhibits 1019, 1033, and 1064 post-date the priority date of the patent under
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`review in this proceeding. As such, Exhibits 1019, 1033, and 1064 do not pass the
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`test of relevant evidence under Federal Rule of Evidence 401 and are thus not
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`admissible under Federal Rule of Evidence 402.
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`As a separate basis for excluding Exhibit 1033, to the extent that Mylan
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`relies on Exhibit 1033 to support its positions regarding commercial success under
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`1 Exhibit 1017 (Declaration of Ivan T. Hofmann, CPA/CFF, CLP) at ¶ 4
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`(describing scope and content of declaration).
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`2
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`IPR2016-01332
`U.S. Patent 8,822,438
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`the Graham factors,2 Janssen objects under Federal Rule of Evidence 402 for the
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`additional reason that evidence related to XTANDI®, or comparisons between
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`XTANDI® and ZYTIGA®, are not relevant to the commercial success of
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`ZYTIGA®.
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`Exhibits 1028, 1040, 1041, 1048, 1049, 1051, 1053, 1055, 1057 and 1066 Lack
`Authentication
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`“To satisfy the requirement of authenticating or identifying an item of
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`evidence, the proponent must produce evidence sufficient to support a finding that
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`the item is what the proponent claims it is.” Fed. R. Evid. 901(a). The Board has
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`held that “[w]hen offering a printout of a webpage into evidence to prove the
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`website’s contents, the proponent of the evidence must authenticate the information
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`from the website . . . .” Neste Oil OYJ v. REG Synthetic Fuels, LLC, IPR2013-
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`00578, slip op. 4 (PTAB Mar. 12, 2015) (Paper 53). For this reason, the Board has
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`required that “[t]o authenticate printouts from a website, the party proffering the
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`evidence must produce some statement or affidavit from someone with knowledge
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`of the website . . . .” EMC Corp. v. Personalweb Techs., LLC, Case IPR2013-
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`00084, slip op. 45-46 (PTAB May 15, 2014) (Paper 64).
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`2 See Paper 1 (Petition) at p. 52, and Ex. 1002 (Declaration of Dr. Marc B.
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`Garnick, M.D.) at ¶ 96.
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`3
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`IPR2016-01332
`U.S. Patent 8,822,438
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`In this proceeding, Mylan relies on printouts from websites that it has
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`introduced into the record as Exhibits 1028, 1040, 1041, 1048, 1049, 1051, 1053,
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`1055, 1057, and 1066. Mylan, however, has not brought forth sufficient evidence
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`to support a finding that these exhibits are what Mylan claims, or that any of these
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`exhibits is self-authenticating under Federal Rule of Evidence 902; therefore,
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`Janssen objects to the admissibility of each of these exhibits under Federal Rule of
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`Evidence 901(a). Furthermore, in addition to being unauthenticated printouts of
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`websites, Exhibits 1028, 1040, 1041, 1051, 1055, and 1066 are also incomplete
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`and Janssen additionally objects to these exhibits under Federal Rule of Evidence
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`106.
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`Exhibits 1017 [B-1], 1019, and 1064 Lack Authentication
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`Patent Owner objects to Exhibits 1017 [B-1], 1019, and 1064 at least
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`because they have not been authenticated as required by Federal Rule of Evidence
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`901. Petitioner has failed to provide evidence regarding the origin of these
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`documents and to establish whether the documents are true and correct copies. For
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`example, Exhibit 1017, Attachment B-1, which appears to be a summary table of
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`the sales for select oncology drugs in 2013 and 2014, lacks proper authentication
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`and foundation at least because the circumstances surrounding the preparation of
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`4
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`IPR2016-01332
`U.S. Patent 8,822,438
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`the attachment has not been explained, and the accuracy of the information found
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`therein has not been established.
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`Exhibits 1025 and 1054 are Incomplete
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`Patent Owner objects to Exhibits 1025 and 1054 under Federal Rule of
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`Evidence 106 because these exhibits appear to be excerpts of larger documents or
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`books.
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`Exhibits 1033, 1040, 1041, 1045, 1049-1051, 1055, 1064, and 1066 are More
`Prejudicial than Probative
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`Patent Owner objects to Exhibits 1033, 1040, 1041, 1045, 1049-1051, 1055,
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`1064, and 1066 at least because they are not relevant to this proceeding as required
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`by Federal Rule of Evidence 402, or, alternatively, because any probative value of
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`these documents is substantially outweighed by the danger of confusing the issues
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`under Federal Rule of Evidence 403. Specifically, these exhibits are not relevant to
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`this proceeding and are of little probative value because they are not “prior art
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`consisting of patents or printed publications” as required by 35 U.S.C. § 311(b) but
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`contain highly prejudicial statements related to what was known in the art after the
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`invention of U.S. Patent No. 8,822,438 (the “’438 patent”) was made that confuse
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`the issues raised in the Petition.
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`5
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`IPR2016-01332
`U.S. Patent 8,822,438
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`Exhibits 1040, 1041, 1049, 1051 and 1055 are Hearsay
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`Patent Owners object to Exhibits 1040, 1041, 1049, 1051 and 1055 under
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`Federal Rules of Evidence 801 and 802. These exhibits contain out-of-court
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`statements by non-parties that the petitioner apparently seeks to use to prove the
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`truth of the matter asserted, and petitioner does not provide any basis for the Patent
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`Trial and Appeal Board to conclude that they fall within any hearsay exception.
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`Exhibits 1023-1028, 1031, 1033, 1036, 1039-1041, 1045, 1046, 1048-1051, 1053-
`1055, 1057, 1064-1066, and 1078-1080 Are Irrelevant
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`Patent Owner objects to the use of Exhibits 1023-1028, 1031, 1033, 1036,
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`1039-1041, 1045, 1046, 1048-1051, 1053-1055, 1057, 1064-1066, and 1078-1080
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`under Federal Rules of Evidence 401, 402, and 403. In particular, these exhibits
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`are not substantively relied on, or even cited, in the Petition. Accordingly, the
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`aforementioned exhibits do not appear to make any fact of consequence in
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`determining the action more or less probable than it would be without them and are
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`thus irrelevant and not admissible.
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`Paragraph 30 of Exhibit 1002 Is Irrelevant
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`In addition, Patent Owner objects to the use of paragraph 30 of Exhibit 1002
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`under Federal Rules of Evidence 401, 402, and 403. In particular, paragraph 30 is
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`6
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`IPR2016-01332
`U.S. Patent 8,822,438
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`not substantively relied on, or even cited, in the Petition. Accordingly, the
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`aforementioned paragraph of Exhibit 1002 does not appear to make any fact of
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`consequence in determining the action more or less probable than it would be
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`without it and is thus irrelevant and not admissible. Further, permitting reference
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`to or reliance on this paragraph from the declaration of Dr. Garnick in other
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`submissions of petitioner would also be impermissible, misleading, irrelevant, and
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`unfairly prejudicial to Patent Owner. To the extent petitioner attempts to rely on or
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`submit this aforementioned portion of Exhibit 1002 in the future as evidence in
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`support of new substantive positions, doing so would be untimely, in violation of
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`the applicable rules governing this proceeding, and unfairly prejudicial to Patent
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`Owner.
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`Respectfully submitted,
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`Date: January 25, 2017
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`/Dianne B. Elderkin /
`Dianne B. Elderkin (Lead Counsel)
`Reg. No. 28,598
`Barbara L. Mullin (Back-up Counsel)
`Reg. No. 38,250
`Ruben H. Munoz (Back-up Counsel)
`Reg. No. 66,998
`AKIN GUMP STRAUSS HAUER
`& FELD LLP
`Two Commerce Square
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`IPR2016-01332
`U.S. Patent 8,822,438
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`2001 Market Street, Suite 4100
`Philadelphia, PA 19103
`Tel.: (215) 965-1340
`Fax: (215) 965-1210
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`David T. Pritikin (pro hac vice)
`Bindu Donovan (pro hac vice)
`SIDLEY AUSTIN LLP
`787 Seventh Avenue
`New York, NY 10019
`Tel.: (212) 839-5300
`Fax: (212) 839-5599
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`Counsel for Patent Owner
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`8
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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 OBJECTIONS TO EVIDENCE PURSUANT TO 37 C.F.R. §
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`42.64(b)(1) was served on counsel of record on January 25, 2017 by filing this
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`document through the End-to-End System, as well as delivering a copy via
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`electronic mail to counsel of record for the Petitioner at the following addresses:
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`Brandon M. White – bmwhite@perkinscoie.com
`Bryan D. Beel – bbeel@perkinscoie.com
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`Respectfully submitted,
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`By: /Dianne B. Elderkin/
`Dianne B. Elderkin
`Registration No. 28,598
`Counsel for Patent Owner
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`9
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`Date: January 25, 2017
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