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Paper No. 8
`Filed: June 9, 2017
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`United States Patent No. 8,338,470
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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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`
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`FRESENIUS KABI USA, LLC,
`Petitioner
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`
`v.
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`HOSPIRA, INC.,
`Patent Owner
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`
`
`Inter Partes Review No. IPR2017-01055
`Patent 8,338,470
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`
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`PATENT OWNER PRELIMINARY RESPONSE
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`PURSUANT TO 37 C.F.R. § 42.107
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`TABLE OF CONTENTS
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`I.
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`ARGUMENT ................................................................................................... 1
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`A.
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`B.
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`The Petition Is Untimely ....................................................................... 1
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`There Is No Pending IPR To Which Petitioner Could Be Joined ......... 2
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`II.
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`CONCLUSION ................................................................................................ 3
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`- ii -
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`TABLE OF AUTHORITIES
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`Page(s)
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`BOARD DECISIONS
`Apple, Inc. v. Benjamin Filmalter Grobler, IPR2014-00060, Paper 12
`(P.T.A.B. Oct. 29, 2013) ....................................................................................... 3
`
`Toyota Motor Corp. v. Am. Vehicular Scis. LLC, IPR2015-00261,
`Paper 10 (P.T.A.B. Jan. 29, 2015) ........................................................................ 3
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`Google Inc. v. PersonalWeb Techs., LLC, IPR2014-00978, Paper 11
`(P.T.A.B. Oct. 30, 2014) ....................................................................................... 3
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`Aerohive Networks, Inc. v. Chrimar Sys., Inc., IPR2016-01757, Paper
`11 (P.T.A.B. Feb. 23, 2017).................................................................................. 3
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`Facebook, Inc. v. Windy City Innovations, LLC, IPR2017-00655,
`Paper 8 (P.T.A.B. May 31, 2017) ..................................................................... 3, 4
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`STATUTES
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`21 U.S.C. § 355(j)(2)(a)(vii)(IV) ............................................................................... 1
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`35 U.S.C. § 271(e)(2) ................................................................................................. 1
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`35 U.S.C. § 315(b) ................................................................................................. 1-3
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`35 U.S.C. § 315(c) ..................................................................................................... 2
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`- iii -
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`The Board should not institute this inter partes review (IPR) because
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`Fresenius Kabi USA, LLC (“Petitioner”) is time-barred under 35 U.S.C. § 315(b).
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`Petitioner filed its Petition for inter partes review (“the Petition”) more than 1 year
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`after it was served with a complaint in district court litigation. Although the
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`Petition was accompanied by a motion for joinder with Amneal Pharmaceuticals
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`LLC v. Hospira, Inc., Case No. IPR2016-01578 (“the Amneal IPR”), the Amneal
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`IPR has since been terminated by the Board. As such, Petitioner’s motion for
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`joinder is moot as there is no proceeding for it to join, and its Petition must
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`therefore be denied as time-barred.
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`I.
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`ARGUMENT
`A. The Petition Is Untimely
`“An inter partes review may not be instituted if the petition requesting the
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`proceeding is filed more than 1 year after the date on which the petitioner, real
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`party in interest, or privy of the petitioner is served with a complaint alleging
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`infringement of the patent.” 35 U.S.C. § 315(b). Patent Owner sued Petitioner in
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`the U.S. District Court for the Northern District of Illinois for infringement of
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`several patents, including U.S. Patent No. 8,338,470 (“the ’470 Patent), based on
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`Petitioner’s filing of ANDA No. 208129 with a certification under 21 U.S.C. §
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`355(j)(2)(a)(vii)(IV) and pursuant to 35 U.S.C. § 271(e)(2). Petitioner admits that
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`it was served with the complaint alleging infringement more than one year before it
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`- 1 -
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`filed its Petition. See Paper 4 (Motion for Joinder), n.1 (“Fresenius Kabi … was
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`served with a complaint asserting infringement of the ’470 patent more than one
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`year before filing the Petition…”). Accordingly, by Petitioner’s own admission, its
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`Petition is barred under § 315(b).
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`There Is No Pending IPR To Which Petitioner Could Be Joined
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`B.
`Petitioner attempted to avoid the time bar of § 315(b) by accompanying its
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`Petition with a request for joinder under 35 U.S.C. § 315(c) of a then-pending IPR
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`brought by Amneal. See Paper 4 (Motion for Joinder). However, that IPR was
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`terminated by the Board on May 26, 2017. See IPR2016-01578, Paper
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`19. Accordingly, there is no pending IPR to which this petition could be joined.
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`There can be no joinder when there is no underlying proceeding to join.
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`Aerohive Networks, Inc. v. Chrimar Sys., Inc., IPR2016-01757, Paper 11, at *3
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`(P.T.A.B. Feb. 23, 2017) (“There is no longer any pending proceeding in the ’569
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`IPR to join that would allow Petitioner to avoid the time bar of section 315(b). As a
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`result, the Petition is barred under section 315(b).”). See also Apple, Inc. v.
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`Benjamin Filmalter Grobler, IPR2014-00060, Paper 12, at *3 (P.T.A.B. Oct. 29,
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`2013) (“[B]ecause the Board entered a judgment terminating [the underlying IPR],
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`there is no proceeding for Apple to join.”); Toyota Motor Corp. v. Am. Vehicular
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`Scis. LLC, IPR2015-00261, Paper 10, at *5 (P.T.A.B. Jan. 29, 2015) (“Because
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`IPR2014-00646 is no longer pending, it cannot serve as a proceeding to which
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`- 2 -
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`another proceeding may be joined.”); Google Inc. v. PersonalWeb Techs., LLC,
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`IPR2014-00978, Paper 11, at *6 (P.T.A.B. Oct. 30, 2014) (“Given that IPR2014-
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`00062 is no longer pending, it cannot serve as a proceeding to which another
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`proceeding may be joined. As such, the termination of IPR2014-00062 renders
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`Google’s Motion for Joinder moot.”).
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`Because there is no longer a proceeding to which Petitioner’s case can be
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`joined, Petitioner is time-barred under § 315(b) and the IPR therefore cannot be
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`instituted.
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`II. CONCLUSION
`For the foregoing reasons, the Board should deny institution of this IPR as
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`statutorily time-barred under 35 U.S.C. § 315(b).
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`
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`Date: June 9, 2017
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`Respectfully submitted,
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`
`
`/ Sandra S. Lee /
`Sandra S. Lee
`Registration No. 51,932
`Baker Botts L.L.P.
`30 Rockefeller Plaza
`New York, NY 10112
`
`Lead Counsel for Patent Owner
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`- 3 -
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`CERTIFICATE OF COMPLIANCE
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`Pursuant to 37 C.F.R. § 42.24(d), the undersigned certifies that the foregoing
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`Petition, exclusive of the exempted portions as provided in 37 C.F.R. § 42.24(a),
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`contains no more than 610 words and therefore complies with the type-volume
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`limitations of 37 C.F.R. § 42.24(b).
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`
`Date: June 9, 2017
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`
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`
`/ Sandra S. Lee / .
`Sandra S. Lee
`Registration No. 51,932
`
`Lead Counsel for Patent Owner
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`- 4 -
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`United States Patent No. 8,338,470
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`CERTIFICATE OF SERVICE
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`
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`Paper No. 8
`Filed: June 9, 2017
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`Pursuant to 37 C.F.R. §§ 42.6(e) and 42.105(a), this is to certify that I
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`caused to be served a true and correct copy of the foregoing “PATENT OWNER’S
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`PRELIMINARY RESPONSE UNDER 37 C.F.R. § 42.107” via the P.T.A.B.’s
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`E2E system and sent via email as detailed below.
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`June 9, 2017
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`Date of service:
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`Documents served: PATENT OWNER’S PRELIMINARY
`RESPONSE UNDER 37 C.F.R. § 42.107(a)
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`Person Served:
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`Imron T. Aly (ialy@schiffhardin.com)
`Jason Harp (jharp@schiffhardin.com)
`Schiff Hardin LLP
`233 South Wacker Drive
`Chicago, Illinois 60606
`Phone: (312) 258-5500
`Fax: (312) 258-5600
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`Respectfully Submitted,
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` Sandra S. Lee / .
`Sandra S. Lee
`Registration No. 51,932
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` /
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`Date: June 9, 2017
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`
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`Lead Counsel for Patent Owner
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