Paper No. ___
`Date Filed: June 14, 2016
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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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`AMERIGEN PHARMACEUTICALS LIMITED,
`Petitioner
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`v.
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`JANSSEN ONCOLOGY, INC.,
`Patent Owner
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`________________
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`Case IPR2016-00286
`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: June 14, 2016
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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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`AMERIGEN PHARMACEUTICALS LIMITED,
`Petitioner
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`v.
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`JANSSEN ONCOLOGY, INC.,
`Patent Owner
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`________________
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`Case IPR2016-00286
`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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`IPR2016-00286
`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, 1025, 1028, 1032, 1033, 1040 through 1067 and portions of
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`Exhibit 1002, which were submitted by Petitioner Amerigen Pharmaceuticals
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`Limited (“Amerigen”) during the preliminary proceedings in this inter partes
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`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 May 31, 2016. Paper No. 14. Janssen’s objections provide
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`notice to Amerigen that Janssen may move to exclude these exhibits under 37
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`C.F.R. § 42.64(c).
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`Exhibit 1017, and 1040-67 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), Dr. McDuff states that his testimony is directed
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`to the “evaluat[ion] of aspects of commercial success, from an economic
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`perspective, [related] to Zytiga (abiraterone acetate) and U.S. Patent No.
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`2
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`IPR2016-00286
`Patent 8,822,438
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`8,822,438.” 1 Thus, Exhibit 1017, as well as Exhibits 1040 through 1067 cited
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`therein, do not pass the test of relevant evidence under Federal Rule of Evidence
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`401 because they do not pertain to “prior art consisting of patents or printed
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`publications” as required by the statute governing inter partes reviews. As such,
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`these exhibits are not admissible under Federal 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 Amerigen
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`relies on Exhibit 1033 to support its positions regarding commercial success under
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`the Graham factors,2 Janssen objects under Federal Rule of Evidence 402 for the
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`1 Exhibit 1017 (Declaration of DeForest McDuff, Ph.D.) at ¶ 6 (describing
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`scope and content of declaration).
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`2 See Paper 1 (Petition) at p. 50, and Ex. 1002 (Declaration of Dr. Scott R.
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`Serels, M.D.) at ¶¶ 85-87.
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`3
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`IPR2016-00286
`Patent 8,822,438
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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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`In this proceeding, Amerigen 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. Amerigen, however, has not put forth sufficient evidence to
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`support a finding that these exhibits are what Amerigen 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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`4
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`IPR2016-00286
`Patent 8,822,438
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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, 1056, and 1066 are also
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`incomplete and Janssen additionally objects to these exhibits under Federal Rule of
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`Evidence 106.
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`Exhibits 1017 [B-1 and B-2], 1019, 1032, 1042-1044, 1058-1064, and 1067 Lack
`Authentication
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`Patent Owner objects to Exhibits 1017 [B-1 and B-2], 1019, 1032, 1042-
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`1044, 1058-1064, and 1067 at least because they have not been authenticated as
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`required by Federal Rule of Evidence 901. Petitioner has failed to provide
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`evidence regarding the origin of the documents and to establish whether the
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`documents are true and correct copies. For example, Exhibit 1032 purports to be
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`the “Taxotere® Prescribing Information”, but this exhibit lacks proper
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`authentication and foundation at least because the circumstances surrounding the
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`source and the accuracy of the “Taxotere® Prescribing Information” has not been
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`established. See Ex. 1002 at ¶ 81. Exhibits 1042-1044 and 1058-1063, which
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`appear to be financial analyst reports, similarly lack proper authentication and
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`foundation at least because the circumstances surrounding the preparation of each
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`of the documents have not been explained, and the accuracy of the information
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`found in each of the documents has not been established. In addition, Exhibit
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`IPR2016-00286
`Patent 8,822,438
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`1017, Attachments B1 and B2, which appear to be summary tables of the ‘438 file
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`history and sales for select oncology drugs in 2013 and 2014, lack proper
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`authentication and foundation at least because the circumstances surrounding the
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`preparation of each of the attachments have not been explained, and the accuracy
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`of the information found in each of the documents has not been established.
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`Exhibits 1025, 1042, 1054, and 1067 are Incomplete
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`Patent Owner objects to Exhibits 1025, 1042, 1054, and 1067 under Federal
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`Rule of Evidence 106 as they appear to be excerpts of larger documents or books.
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`For example, Exhibit 1042 contains page 612 and pages 1006-1009, omitting
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`significant portions of the document including the cover page, date of publication,
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`authorship, and context for the excerpted pages. In addition, Exhibit 1025 contains
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`pages 547-549 and 2142-2147 of “Kasper, D.L. et al. (Eds.), Harrison’s Principles
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`of Internal Medicine (16th edition (2005)),” however, does not contain the full
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`chapters cited. Further, Patent Owner objects to Exhibit 1025 on the basis of
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`Federal Rule of Evidence 1003 as the photocopy proffered is in substantial portions
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`illegible such that “the circumstances make it unfair to admit the duplicate.”
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`6
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`IPR2016-00286
`Patent 8,822,438
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`Exhibits 1033, 1040-1045, 1049-1052, 1055, 1056, 1058-1064, 1066, and 1067
`are More Prejudicial than Probative
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`Patent Owner objects to Exhibits 1033, 1040-1045, 1049-1052, 1055, 1056,
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`1058-1064, 1066, and 1067 at least because they are not relevant to this proceeding
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`as required by Federal Rule of Evidence 402, or, alternatively, because any
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`probative value of these documents is substantially outweighed by the danger of
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`confusing the issues under Federal Rule of Evidence 403. Specifically, these
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`exhibits are not relevant to this proceeding and are of little probative value because
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`they are not “prior art consisting of patents or printed publications” as required by
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`35 U.S.C. § 311(b) but contain highly prejudicial statements related to what was
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`known in the art after the ‘438 invention was made constituting impermissible
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`hindsight.
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`Exhibits 1042-1044, 1049, 1055, 1056, 1058-1063, and 1067 are Hearsay
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`Patent Owners object to Exhibits 1042-1044, 1049, 1055, 1056, 1058-1063,
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`and 1067 under Federal Rules of Evidence 801 and 802. These exhibits contain
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`out-of-court statements by non-parties that the petitioner apparently seeks to use to
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`prove the truth of the matter asserted, and petitioner does not provide any basis for
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`the Patent Trial and Appeal Board to conclude that they fall within any hearsay
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`7
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`objection.
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`IPR2016-00286
`Patent 8,822,438
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`Selected Paragraphs of Exhibit 1002 are Irrelevant
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`In addition, Patent Owner objects to the use of paragraphs 11, 12, 15, 17, 19,
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`20, 24, 25, 29, 33, 37-44, 50-55, 57, and 59-66 of Exhibit 1002 under Federal
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`Rules of Evidence 401, 402, and 403. In particular, paragraphs 11, 12, 15, 17, 19,
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`20, 24, 25, 29, 33, 37-44, 50-55, 57, and 59-66 are not substantively relied on, or
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`even cited, in the Petition. Accordingly, the aforementioned paragraphs of Exhibit
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`1002 do not appear to make any fact of consequence in determining this action
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`more or less probable than it would be without them and are thus irrelevant and not
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`admissible. Further, permitting reference to or reliance on these paragraphs from
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`the declaration of Dr. Serels in other submissions of petitioner would also be
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`impermissible, misleading, irrelevant, and unfairly prejudicial to Patent Owner. To
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`the extent petitioner attempts to rely on or submit these aforementioned portions of
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`Exhibit 1002 in the future as evidence in support of new substantive positions,
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`doing so would be untimely, in violation of the applicable rules governing this
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`proceeding, and unfairly prejudicial to Patent Owner.
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`Respectfully submitted,
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`By: /Dianne B. Elderkin/
`Dianne B. Elderkin (Lead Counsel)
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`Date: June 14, 2016
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`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
`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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`9
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`IPR2016-00286
`Patent 8,822,438
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`IPR2016-00286
`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 June 14, 2016 by filing this
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`document through the Patent Review Processing System, as well as delivering a
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`copy via electronic mail to counsel of record for the Petitioner at the following
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`William Hare
`Gabriela Materassi
`McNeeley Hare & War LLP
`bill@miplaw.com
`materassi@miplaw.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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`10
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`addresses:
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`Date: June 14, 2016
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