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`Paper No. ___
`Date Filed: July 16, 2019
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC., ACTAVIS LABORATORIES FL, INC.,
`AMNEAL PHARMACEUTICALS LLC, AMNEAL PHARMACEUTICALS OF
`NEW YORK, LLC, DR. REDDY’S LABORATORIES, INC., DR. REDDY’S
`LABORATORIES, LTD., SUN PHARMACEUTICALS INDUSTRIES, LTD.,
`SUN PHARMACEUTICALS INDUSTRIES, INC., TEVA
`PHARMACEUTICALS USA, INC., WEST-WARD PHARMACEUTICAL
`CORP., and HIKMA PHARMACEUTICALS, LLC,
`Petitioners,
`
`v.
`
`JANSSEN ONCOLOGY, INC.
`Patent Owner.
`
`Case IPR2016-013321
`Patent 8,822,438 B2
`
`
`PATENT OWNER’S MOTION TO EXPUNGE
`UNDER 37 C.F.R. § 42.56
`
`
`1 Case IPR2017-00853 was joined with this proceeding.
`
`
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`
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`Case: IPR2016-01332
`U.S. Patent No. 8,822,438
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`I.
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`STATEMENT OF RELIEF REQUESTED
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`Pursuant to 37 C.F.R. § 42.56 and the Board’s email authorization of July
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`16, 2019, Patent Owner Janssen Oncology, Inc. (“Patent Owner”) respectfully
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`requests that the Board expunge from the record Exhibits 1134, 1143, 2044, 2092,
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`2093, and 2118—all of which contain Patent Owner’s confidential information—
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`for the reasons set forth below. Patent Owner certifies that the parties have
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`conferred in good faith, and Petitioners do not oppose this motion.
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`II.
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`PROCEDURAL BACKGROUND
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`On March 8, 2017, Patent Owner filed a motion to seal Exhibit 2044 (which
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`is the confidential version of redacted Exhibit 2115), and Exhibits 2092, 2093, and
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`2118 (which are confidential in their entirety). See Paper 34. On April 19, 2017,
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`Petitioners filed a motion to seal Exhibits 1134 and 1143 (which are the
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`confidential versions of redacted Exhibits 1145 and 1144, respectively). See Paper
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`57.
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`All of the aforementioned exhibits contain Patent Owner’s confidential
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`information. In the Final Written Decision, the Board granted Patent Owner’s and
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`Petitioners’ motions to seal. See Paper 84 at 47-48. Furthermore, the Board found
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`that “[i]n rendering [its] Final Written Decision, it was not necessary to identify,
`
`nor discuss in detail, any confidential information.” Id. at 47. The Board ordered
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`1
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`
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`Case: IPR2016-01332
`U.S. Patent No. 8,822,438
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`that the exhibits remain under seal until “the time period for filing a notice of
`
`appeal has expired or, if an appeal is taken, the appeal process has concluded.” Id.
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`On December 19, 2018, Patent Owner filed a Notice of Appeal. Paper 88.
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`On May 14, 2019, the United States Court of Appeals for the Federal Circuit (the
`
`“Federal Circuit”) issued its opinion and judgment, and on June 20, 2019, the
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`Federal Circuit issued its mandate.
`
`III. APPLICABLE LEGAL STANDARDS
`
`37 C.F.R. § 42.56 provides that “[a]fter denial of a petition to institute a trial
`
`or after final judgment in a trial, a party may file a motion to expunge confidential
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`information from the record.” The Board has previously explained that a party
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`moving to expunge has to show that: i) “any information sought to be expunged
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`constitutes confidential information[;]” and ii) the movant’s interest in expunging
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`the information “outweighs the public’s interest in maintaining a complete and
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`understandable file history.” RPX Corp. v. VirnetX Inc., IPR 2014-00171, Paper 62
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`at 3 (P.T.A.B. Sept. 9, 2014). The regulations identify confidential information as
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`“a trade secret or other confidential research, development, or commercial
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`information.” 37 C.F.R. § 42.54(a)(7). The Board must strike “a balance between
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`the public’s interest in maintaining a complete and understandable file history and
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`the parties’ interest in protecting truly sensitive information.” 77 Fed. Reg. 48756,
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`48760 (Aug. 14, 2012).
`
`
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`2
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`
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`Case: IPR2016-01332
`U.S. Patent No. 8,822,438
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`IV. REASONS FOR THE RELIEF REQUESTED
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`In its Final Written Decision, the Board stated that “confidential information
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`that is subject to a protective order ordinarily would become public 45 days after
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`final judgment in a trial, unless a motion to expunge is granted.” Paper 84 at 47.
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`Accordingly, Patent Owner moves to expunge from the record the following sealed
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`exhibits containing Patent Owner’s confidential information:
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` Internal, non-public research summaries concerning the use of Patent
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`Owner’s product: Exhibit 2092 (filed March 8, 2017); Exhibit 2093 (filed
`
`March 8, 2017).
`
` Internal, non-public technical research and development information
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`concerning Patent Owner’s product: Exhibit 2118 (filed March 8, 2017).
`
` Expert declarations and deposition transcripts referring to Patent Owner’s
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`confidential information: Reply Declaration of Ivan T. Hoffman, Exhibit
`
`1134 (filed April 19, 2017); Deposition of Richard J. Auchus, M.D.,
`
`Ph.D., Exhibit 1143 (filed April 19, 2017); Declaration of Christopher A.
`
`Vellturo, Ph.D., Exhibit 2044 (filed March 8, 2017).
`
`Patent Owner has already demonstrated, and the Board agreed, that Exhibits
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`1134, 1143, 2044, 2092, 2093, and 2118 contain confidential information. Paper 84
`
`at 47. There has been no change in confidentiality of the information contained in
`
`these exhibits. Thus, Patent Owner has met its burden of showing that “any
`
`
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`3
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`
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`Case: IPR2016-01332
`U.S. Patent No. 8,822,438
`
`information sought to be expunged constitutes confidential information.” RPX,
`
`IPR2014-00171, Paper 62 at 3.
`
`In addition, Patent Owner’s interest in expunging the confidential
`
`information in Exhibits 1134, 1143, 2044, 2092, 2093, and 2118 “outweigh[s] the
`
`public’s interest in maintaining a complete and understandable file history.” Id. As
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`stated in its Final Written Decision, the Board did not “identify, nor discuss in
`
`detail” the confidential information when rendering its decision.2 Paper 84 at 47.
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`The public, therefore, has access to all the materials relevant to the merits of this
`
`proceeding, either through publicly filed papers and exhibits or through redacted,
`
`
`2 The Final Written Decision cites paragraph 67 of Exhibit 2044, which contains
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`confidential information redacted from the public version (Exhibit 2115). See
`
`Paper 84 at 40 (citing Exhibit 2044 ¶¶ 64-68). However, Patent Owner believes
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`that this citation was made in error. The Final Written Decision refers to “evidence
`
`of market share” when referring to paragraph 67, but paragraphs 64-68 relate to
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`product pricing. Instead, paragraphs 56-60 relate to market share. The error likely
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`occurred because the Final Written Decision in IPR2016-01582 (involving the
`
`same patent) correctly refers to paragraphs 64-68 of Exhibit 2044 in that
`
`proceeding. See IPR2016-01582, Paper 72 at 40. In this proceeding, the
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`corresponding paragraphs are 56-60.
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`
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`4
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`
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`Case: IPR2016-01332
`U.S. Patent No. 8,822,438
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`public versions of Exhibit 2044 (Declaration of Christopher A. Vellturo, Ph.D. -
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`Exhibit 2115), Exhibit 1134 (Reply Declaration of Ivan T. Hoffman - Exhibit
`
`1145), and Exhibit 1143 (Deposition Transcript of Richard J. Auchus, M.D., Ph.D.
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`- Exhibit 1144). Given the confidential nature of the information in Exhibits 1134,
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`1143, 2044, 2092, 2093, and 2118, good cause exists for the Board to expunge
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`these exhibits pursuant to 37 C.F.R. § 42.56.
`
`V. CONCLUSION
`
`For the reasons set forth above, Patent Owner requests that the Board grant
`
`this motion and expunge confidential Exhibits 1134, 1143, 2044, 2092, 2093, and
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`2118 from the record.
`
`July 16, 2019
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`5
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`Respectfully submitted,
`
`By: /Dianne B. Elderkin/
`Dianne B. Elderkin (Reg. No. 28,598)
`delderkin@akingump.com
`Ruben H. Munoz (Reg. No. 66,998)
`rmunoz@akingump.com
`AKIN GUMP STRAUSS HAUER &
`FELD LLP
`Two Commerce Square
`2001 Market Street, Suite 4100
`Philadelphia, PA 19103
`Tel: (215) 965-1200
`Fax: (215) 965-1210
`JANS-ZYTIGA@akingump.com
`
`David T. Pritikin (pro hac vice)
`dpritikin@sidley.com
`Paul Zegger (Reg. No. 33,821)
`pzegger@sidley.com
`
`
`
`Case: IPR2016-01332
`U.S. Patent No. 8,822,438
`
`Alyssa B. Monsen (pro hac vice)
`amonsen@sidley.com
`SIDLEY AUSTIN LLP
`787 Seventh Avenue
`New York, NY 10019
`Tel.: (212) 839-5300
`Fax: (212) 839-5599
`ZytigaIPRTeam@sidley.com
`
`Counsel for Patent Owner
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`6
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`Case: IPR2016-01332
`U.S. Patent No. 8,822,438
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`CERTIFICATE OF SERVICE
`
`
`
`The undersigned hereby certifies that a copy of the foregoing Patent
`
`Owner’s Motion to Expunge Under 37 C.F.R. § 42.56 was served on counsel of
`
`record on July 16, 2019 by filing this document through the End-to-End System, as
`
`well as delivering a copy via electronic mail to counsel of record for the Petitioners
`
`at the following addresses:
`
`Brandon M. White – bmwhite@perkinscoie.com
`Crystal R. Canterbury – ccanterbury@perkinscoie.com
`Bryan D. Beel – bbeel@perkinscoie.com
`Shannon Bloodworth – sbloodworth@perkinscoie.com
`Emily J. Greb – egreb@perkinscoie.com
`
`Samuel S. Park – spark@winston.com
`Ryan B. Hauer – rhauer@winston.com
`Jovial Wong – jwong@winston.com
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`Respectfully submitted,
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`By: /Dianne B. Elderkin/
`Dianne B. Elderkin
`(Reg. No. 28,598)
`
`Counsel for Patent Owner
`Janssen Oncology, Inc.
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`7
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`July 16, 2019
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