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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`-------------------------------------
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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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`-------------------------------------
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`Case No.: IPR2017-01055
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`Patent No. 8,338,470
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`-------------------------------------
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`MOTION FOR JOINDER UNDER 35 U.S.C. § 315(c) AND
`37 C.F.R. §§ 42.22 AND 42.122(b)
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`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`
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`TABLE OF CONTENTS
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`Introduction ...................................................................................................... 2
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`Statement of the Precise Relief Requested ...................................................... 3
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`
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`I.
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`II.
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`III. Governing Law, Rules, and Precedent ............................................................ 3
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`IV. Statement of Material Facts ............................................................................. 5
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`V. Argument ......................................................................................................... 6
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`A. No New Grounds of Unpatentability Are Asserted in this
`Petition. .................................................................................................. 7
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`B.
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`C.
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`Joinder Is Appropriate Under the Governing Law, Rules,
`and Precedent. ....................................................................................... 7
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`Joinder Will Have a Minimal Impact on the Trial
`Schedule and Costs for the Existing IPR .............................................. 9
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`D.
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`Procedures to Simplifying Briefing and Discovery ............................ 11
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`VI. Conclusion ..................................................................................................... 12
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`
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`Motion for Joinder
`Inter Partes Review of U.S. Patent No. 8,338,470
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`I.
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`INTRODUCTION
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`Fresenius Kabi USA, LLC (“Fresenius Kabi”) moves for joinder of the
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`accompanying Inter Partes Review (“IPR”) Petition, filed March 8, 2017,
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`Fresenius Kabi USA, LLC v. Hospira, Inc., Case No. IPR2017-01055, with Amneal
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`Pharmaceuticals LLC v. Hospira, Inc., Case No. IPR2016-01578, for at least the
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`following reasons: (1) joinder is appropriate under the governing law, rules, and
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`precedent of this Board; (2) this Motion for Joinder is timely filed; (3) the two
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`proceedings concern the same parties, same patent, and same prior art; (4)
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`Fresenius Kabi relies in whole on the same evidence and same declaration
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`testimony in both proceedings; (5) joinder would neither complicate the issues nor
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`unduly delay the existing schedule of IPR2016-01578; (6) joinder would
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`significantly simplify briefing and discovery in the two IPRs, and will have no
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`impact on the existing schedule; and (7) joinder will not prejudice any party.
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`Finally, joinder here will secure a just, speedy, and inexpensive resolution in both
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`proceedings, more so than in the absence of joinder, by avoiding having the Board
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`preside over two separate proceedings involving identical and duplicative filings
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`and reviews of the same issues.
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`2
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`Motion for Joinder
`Inter Partes Review of U.S. Patent No. 8,338,470
`STATEMENT OF THE PRECISE RELIEF REQUESTED
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`II.
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`Fresenius Kabi requests joinder under 35 U.S.C. § 315(c) and 37 C.F.R §§
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`42.22 and 42.122(b) of the concurrently-filed petition for IPR of claims 1-7 of U.S.
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`Patent No. 8,338,470 (“the ’470 patent”) with the related and instituted IPR,
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`Amneal Pharmaceuticals LLC v. Hospira, Inc., Case No. IPR2016-01578 (“the
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`Amneal IPR”).
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`Fresenius Kabi notified counsel for Petitioner Amneal Pharmaceuticals LLC
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`(“Amneal”) and Patent Owner Hospira, Inc. (“Hospira”) in the Amneal IPR of this
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`Motion, requesting their consent for Joinder. Amneal has provided its consent, but
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`Hospira has not to date.
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`III. GOVERNING LAW, RULES, AND PRECEDENT
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`Title 35 U.S.C. § 315(c) states:
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`If the Director institutes an inter partes review, the Director, in his or
`her discretion, may join as a party to that inter partes review any
`person who properly files a petition under section 311 that the
`Director, after receiving a preliminary response under section 313 or
`the expiration of the time for filing such a response, determines
`warrants the institution of an inter partes review under section 314.
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`Title 37 C.F.R. § 42.122(b) states:
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`Joinder may be requested by a patent owner or petitioner. Any request
`for joinder must be filed, as a motion under §42.22, no later than one
`month after the institution date of any inter partes review for which
`joinder is requested. The time period set forth in §42.101(b) shall not
`apply when the petition is accompanied by a request for joinder.
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`3
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`Motion for Joinder
`Inter Partes Review of U.S. Patent No. 8,338,470
`The Board has repeatedly allowed joinder of IPR proceedings when a second
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`petition raises the same ground(s) of unpatentability as those instituted in a first
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`proceeding. See, e.g., Wockhardt Bio AG v. Jazz Pharms., Inc., IPR2015-01813,
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`Paper 10 (PTAB Oct. 30, 2015); Mylan Pharms. Inc. v. Novartis AG, et al.,
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`IPR2015-00268, Paper 17 (PTAB Apr. 10, 2015); Apple, Inc. v. Smartflash LLC,
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`CBM2015-00119, Paper 11 (PTAB Aug. 6, 2015); LG Elec., Inc. v. Innovative
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`Display Techs. LLC, IPR2015-00493, Paper 10 (July 15, 2015); Cisco Sys., Inc., et
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`al. v. Straight Path IP Grp., Inc., IPR2015-01006, Paper 12 (PTAB June 5, 2015).
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`Indeed, there is a “policy preference for joining a party that does not present
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`new issues that might complicate or delay an existing proceeding.” See Dell Inc. v.
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`Network-1 Sec. Solutions, Inc., IPR2013-00385, Paper 17 at 10 (PTAB July 29,
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`2013) (citing 157 CONG. REC. S1376 (daily ed. Mar. 8, 2011) (statement of Sen.
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`Kyl) (“The Office anticipates that joinder will be allowed as of right – if an inter
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`partes review is instituted on the basis of a petition, for example, a party that files
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`an identical petition will be joined to that proceeding, and thus allowed to file its
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`own briefs and make its own arguments.”) (emphasis added)).
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`That is precisely the situation here. Fresenius Kabi’s concurrently-filed
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`Petition is essentially identical to the petition filed in the instituted Amneal IPR. In
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`accordance with the Board’s governing law and rules, each of the factors
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`supporting joinder are present in this Motion for Joinder: (1) reasons why joinder is
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`4
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`Motion for Joinder
`Inter Partes Review of U.S. Patent No. 8,338,470
`appropriate; (2) the lack of any new grounds of unpatentability being raised in the
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`subsequent petition; (3) what impact (if any) there will be on the trial schedule for
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`the existing review; and (4) how briefing and/or discovery may be simplified to
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`minimize schedule impact. Kyocera Corp. v. Softview, LLC, IPR2013-00004,
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`Paper 15 at 4 (PTAB April 24, 2013); see also Samsung Elecs. Co. Ltd. v. Unifi
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`Sci. Batteries, LLC, IPR2013-00236, Paper 22 at 3 (PTAB Oct. 17, 2013).
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`Each of these factors is addressed below.
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`IV. STATEMENT OF MATERIAL FACTS
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`• On January 15, 2016, Hospira sued Fresenius Kabi for infringement of
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`the ’470 patent in the United States District Court for the Northern
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`District of Illinios1;
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`• On August 10, 2016, Amneal requested IPR of claims 1-7 of the ’470
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`patent under three grounds of unpatentability. See IPR2016-01570,
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`Paper 2;
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`1 Fresenius Kabi is not barred from filing its Petition, even though it was served
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`with a complaint asserting infringement of the ’470 patent more than one year
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`before filing the Petition, because Fresenius Kabi concurrently seeks joinder with
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`IPR2016-01578. See 35 U.S.C. § 315(b)-(c); e.g., Aurobindo Pharma U.S.A., Inc.
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`v. AstraZeneca AB, IPR2016-01117, Paper 12 at 7-9 (PTAB Oct. 21, 2016).
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`5
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`Motion for Joinder
`Inter Partes Review of U.S. Patent No. 8,338,470
`• On November 10, 2016, Hospira filed its Patent Owner Preliminary
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`Response. See id., Paper 9;
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`• On February 9, 2017, the Board instituted the Amneal IPR on one
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`ground asserting that claims 1-7 of the ’470 patent would have been
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`obvious over the prior art pursuant to 35 U.S.C. § 103. See id., Papers
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`11, 12. This ground is: 2010 Precedex Label in view of De Giorgi,
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`Eichhorn, Palmgren, and Lavoisier. Id., Paper 11 at 15;
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`• Fresenius Kabi’s Petition that accompanies the present Motion for
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`Joinder was filed within one month of the February 9, 2017 decision
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`to institute the Amneal IPR, and includes only the same grounds of
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`unpatentability that were included in the Amneal IPR Petition; and
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`• Fresenius Kabi’s Petition that accompanies the present Motion for
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`Joinder and accompanying evidence are the same as the instituted
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`Amneal IPR Petition, aside from procedural sections that, for
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`example, identify Fresenius Kabi, any real parties in interest, and its
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`standing.
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`V. ARGUMENT
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`This Motion for Joinder addresses the criteria identified by the Board in
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`Kyocera Corp., IPR2013-00004, Paper 15. Each factor is addressed below and all
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`compel granting the instant motion.
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`6
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`Motion for Joinder
`Inter Partes Review of U.S. Patent No. 8,338,470
`A. No New Grounds of Unpatentability Are Asserted in this Petition.
`Fresenius Kabi’s Petition does not assert any grounds of unpatentability
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`additional to those asserted in the Amneal IPR. Fresenius Kabi challenges the same
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`’470 patent claims based on the same arguments, evidence, and ground of
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`unpatentability on which the Board instituted review in the Amneal IPR. For
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`efficiency, Fresenius Kabi does not include additional prior art or combinations in
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`its Petition, which it will continue to assert separately in its ongoing civil litigation
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`with Hospira. See Shaw Indus. Grp., Inc. v. Automated Creel Sys., Inc., 817 F.3d
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`1293, 1300 (Fed. Cir. 2016).
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`B.
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`Joinder Is Appropriate Under the Governing Law, Rules, and
`Precedent.
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`The Board has authority to join a properly-filed IPR petition to an instituted
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`IPR proceeding. See 35 U.S.C. § 315(c). Fresenius Kabi’s Petition is properly filed
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`under 35 U.S.C. § 311 and timely under 37 C.F.R. § 42.122(b), that is, within one
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`month of the Board’s February 9, 2017 decision to institute the Amneal IPR. See
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`Amneal IPR, IPR2016- 01578, Paper 11.
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`Further, joinder is appropriate according to the Board’s rationale applied in
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`previous cases. As discussed above, the Board has granted numerous requests for
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`joinder of IPR proceedings under circumstances similar to the instant proceeding.
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`For example, in LG Electronics, the Board granted joinder of a second petition
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`challenging the same claims on the same Grounds as that instituted in the first
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`Motion for Joinder
`Inter Partes Review of U.S. Patent No. 8,338,470
`proceeding. See LG Elec., IPR2015-00493, Paper 10. This rationale has been
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`applied by the Board in other cases. See, e.g., ION Geophysical, et al. v.
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`WesternGeco LLC, IPR2015-00565, Paper 14 at 4-5 (PTAB Apr. 23, 2015)
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`(granting joinder when both patent owner and previous petitioner opposed because
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`it “facilitates scheduling of the joined actions and minimizes delay”); Wockhardt
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`Bio AG, IPR2015-01813, Paper 10; Mylan Pharms., IPR2015-00268, Paper 17;
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`Apple, Inc., CBM2015-00119, Paper 11; Cisco Sys., IPR2015-01006, Paper 12.
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`And the Board’s consistent reasoning is equally applicable here: Fresenius
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`Kabi’s Petition challenges the same claims at issue in the existing trial; relies on
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`the same prior art as the existing trial; and relies on the same testimony from the
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`same expert witness as in the existing trial. Thus, in accordance with the Board’s
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`previously applied rationale, joinder of these proceedings is appropriate and will
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`“secure the just, speedy, and inexpensive resolution in every proceeding.” 37
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`C.F.R. § 42.1(b).
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`Further, Hospira has asserted the ’470 patent against Fresenius Kabi in
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`concurrent district court litigation. See Hospira, Inc. v. Fresenius Kabi USA, LLC,
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`16-cv-0651 (N.D. Ill.). Fresenius Kabi and Amneal have coordinated fact
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`discovery in their separate suits by jointly taking depositions of Hospira’s fact
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`witnesses. As such, allowing Fresenius Kabi to participate in the Amneal IPR will
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`allow Fresenius Kabi and Hospira to resolve the underlying litigation between the
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`Motion for Joinder
`Inter Partes Review of U.S. Patent No. 8,338,470
`parties in a cost effective, expeditious manner should Amneal seek to terminate its
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`participation in the Amneal IPR based on settlement or other factors.
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`Moreover, any opposition by Hospira, to the extent it files any, cannot
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`dispute the overwhelming efficiencies that will be promoted by joinder. In fact,
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`these parties have not to date articulated any reason why joinder is not appropriate
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`or would otherwise present any undue burden. Indeed, without joinder, it will be
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`the Board that will be burdened by having needlessly to adjudicate and preside
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`over two proceedings involving the same patent, same issues, same patent owner,
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`same evidence, and same expert declarations. Therefore, granting joinder will
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`avoid wasteful duplicative filings and reviews of the same issues across multiple
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`proceedings. See, e.g., Wockhardt Bio AG, IPR2015-01813, Paper 10 at 4.
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`C.
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`Joinder Will Have a Minimal Impact on the Trial Schedule and
`Costs for the Existing IPR
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`Joinder will have minimal—indeed, likely no—impact on the trial schedule
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`and costs for the existing Amneal IPR because of the substantial overlap between
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`the two petitions. Based on Fresenius Kabi’s review of the papers Amneal has
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`submitted to date in the instant IPR, Fresenius Kabi’s substantive interests
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`completely align with Amneal’s, and Fresenius Kabi foresees no substantive issues
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`or arguments on which it would depart from Amneal’s submissions going forward.
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`Accordingly, Fresenius Kabi is prepared to adopt any papers submitted by
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`Amneal the joined IPR proceeding. Thus, even though Amneal has not yet agreed
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`Motion for Joinder
`Inter Partes Review of U.S. Patent No. 8,338,470
`to coordinate with Fresenius Kabi on joint submissions, their agreement is not
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`necessary because any filing will be public and Fresenius Kabi is willing to agree
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`to adopt Amneal’s filings, including the testimony from the same expert
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`witness(es) as in the instituted trial. See ION Geophysical, IPR2015-00565, Paper
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`14 at 4-5; See Wockhardt Bio AG, IPR2015-01813, Paper 10 at 3.
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`To the extent that a modest adjustment might be required—and Fresenius
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`Kabi foresees no such need—Title 35 U.S.C. § 316(a)(11) allows the Director to
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`“adjust the time periods … in the case of joinder.” See also, 37 C.F.R. § 42.100(c).
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`Accordingly, the Board has granted extensions in other trial schedules to
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`accommodate joinder. See Ariosa Diagnostics v. Isis Innovation Ltd., IPR2013-
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`00250, Paper 24 at 5 (PTAB Sept. 3, 2013) (“while some adjustments to the
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`schedule have been necessary, there is not undue delay.”); see also Microsoft Corp.
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`v. Proxyconn, Inc., IPR2013-00109, Paper 15 at 4-5 (PTAB Feb. 25, 2013);
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`Samsung Elec. Co., Ltd. v. Virginia Innovation Sci., Inc., IPR2014-00557, Paper 10
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`at 18 (PTAB June 13, 2014).
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`And any “alleged” prejudice or burden to Hospira—if not entirely
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`nonexistent—is outweighed by the public interest in obtaining a speedy and
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`efficient resolution of all the patentability issues of the ’470 patent in a single
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`proceeding, with minimal burden on this Board.
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`10
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`Motion for Joinder
`Inter Partes Review of U.S. Patent No. 8,338,470
`Procedures to Simplifying Briefing and Discovery
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`D.
`Briefing and discovery in the joined proceeding can be simplified to
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`minimize any impact to the schedule or the volume of materials submitted to the
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`Board. Given that Fresenius Kabi and Amneal will rely upon the same prior art and
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`the same bases for rejection of the same claims using the same expert(s), Fresenius
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`Kabi envisions few, if any, differences in position.
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`In the unlikely event that there might be a procedural issue or statement by
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`Amneal in the joined IPR with which Fresenius Kabi disagrees—and to be sure
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`Fresenius Kabi foresees none at this time—Fresenius Kabi will request a
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`conference call to seek permission and explain its reasons to submit a short
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`separate filing, if needed, of no more than 3-5 pages directed to points of
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`procedural disagreement with the other petitioners, at the Board’s discretion. Cf.
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`Apple, Inc., CBM2015-00119, Paper 11 at 5-6. And Fresenius Kabi accepts that it
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`will not be permitted any separate arguments in furtherance of those advanced in
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`Amneal’s filings. See, e.g., Motorola Mobility LLC v. Softview LLC, IPR2013-
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`00256, Paper 10 at 9 (PTAB June 20, 2013). The Board can also allow the patent
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`owner a corresponding number of pages to respond to any separate filings. See
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`Dell Inc., IPR2013-00385, Paper 17 at 8; Motorola Mobility, IPR2013-00256,
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`Paper 10 at 8-9.
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`11
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`Motion for Joinder
`Inter Partes Review of U.S. Patent No. 8,338,470
`Additionally, Fresenius Kabi will not seek to submit any new expert
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`declarations from those entered by Amneal, except to the extent that for some
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`unlikely reason Fresenius Kabi is precluded from relying on Amneal’s experts’
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`declarations, e.g., if Amneal settles with Hospira and contractually bind their
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`experts from continuing in the IPR with Fresenius Kabi. Further, Fresenius Kabi
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`agrees that it will not seek additional time at any deposition and that Amneal will
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`be permitted to ask questions before Fresenius Kabi. And Fresenius Kabi agrees
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`that it will not seek any additional time at any oral argument. Indeed, Fresenius
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`Kabi intends to maintain a secondary role in the joined proceeding. Fresenius Kabi
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`will assume a primary role only if Amneal ceases to participate in the IPR, or to the
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`extent Amneal willingly seeks more prominent participation from Fresenius Kabi’s
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`counsel. These concessions by Fresenius Kabi remove any alleged “complication
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`or delay” caused by joinder, while providing the parties an opportunity to address
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`all issues that may arise and avoiding any undue burden on Hospira, Amneal, and
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`the Board. See, e.g., Motorola Mobility, IPR2013-00256, Paper 10 at 9.
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`VI. CONCLUSION
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`For the foregoing reasons, Fresenius Kabi requests that its Petition for IPR
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`of the ’470 patent be granted, and that the Board grant this Motion and join this
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`proceeding with the Amneal IPR. Joinder will ensure a just, speedy, and
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`12
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`Motion for Joinder
`Inter Partes Review of U.S. Patent No. 8,338,470
`inexpensive resolution in both proceedings, and it will promote efficiency by
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`avoiding duplicative filings and reviews of the same issues.
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`Respectfully submitted,
`/Imron T. Aly/
`Imron T. Aly
`ialy@schiffhardin.com
`USPTO Reg. No. 48,706
`
`
`
`
`Date: March 8, 2017
`
`Imron T. Aly
`Email: ialy@schiffhardin.com
`USPTO Reg. No. 48,706
`
`Jason Harp
`Email: jharp@schiffhardin.com
`USPTO Reg. No. 42,634
`
`Schiff Hardin LLP
`233 South Wacker Drive
`Chicago, Illinoi 60606
`Phone: (312) 258-5500
`Fax: (312) 258-5600
`
`Attorneys for Petitioner, Fresenius Kabi USA, LLC
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`13
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`
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`CERTIFICATE OF SERVICE
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`In accordance with 37 C.F.R. § 42.105, I hereby certify that on March 8,
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`2017, a true copy of the accompanying MOTION FOR JOINDER UNDER 35
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`U.S.C. § 315(c) AND 37 C.F.R. §§ 42.22 AND 42.122(b) was served via
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`electronic mail (e-mail) to Sandra Lee, Eliot Williams, and Stephen Hash at
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`sandra.lee@bakerbotts.com, eliot.williams@bakerbotts.com, and
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`stephen.hash@bakerbotts.com under 37 C.F.R. §§ 42.6(e)(1) and 42.105(b), as
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`agreed upon by the parties.
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`
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`Date: March 8, 2017
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`Respectfully submitted,
`/Imron T. Aly/
`Imron T. Aly
`ialy@schiffhardin.com
`USPTO Reg. No. 48,706
`
`
`Imron T. Aly
`Email: ialy@schiffhardin.com
`USPTO Reg. No. 48,706
`
`Jason Harp
`Email: jharp@schiffhardin.com
`USPTO Reg. No. 42,634
`
`Schiff Hardin LLP
`233 South Wacker Drive
`Chicago, Illinoi 60606
`Phone: (312) 258-5500
`Fax: (312) 258-5600
`
`Attorneys for Petitioner, Fresenius Kabi USA, LLC
`
`
`
`