Trials@uspto.gov
`571-272-7822
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`Paper 10
`Date: September 6, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`FRESENIUS KABI USA, LLC,
`Petitioner,
`
`v.
`
`HOSPIRA INC.,
`Patent Owner.
`
`
`Case IPR2017-01055
`Patent 8,338,470 B1
`
`
`
`
`Before MICHAEL J. FITZPATRICK, SHERIDAN K. SNEDDEN, and
`ZHENYU YANG, Administrative Patent Judges.
`
`PER CURIAM.
`
`Opinion Concurring filed by Administrative Patent Judge FITZPATRICK
`
`
`DECISION
`Denying Inter Partes Review; Dismissing Motion for Joinder
`37 C.F.R. §§ 42.108, 42.122
`
`
`
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`571-272-7822
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`Paper 10
`Date: September 6, 2017
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`FRESENIUS KABI USA, LLC,
`Petitioner,
`
`v.
`
`HOSPIRA INC.,
`Patent Owner.
`
`
`Case IPR2017-01055
`Patent 8,338,470 B1
`
`
`
`
`Before MICHAEL J. FITZPATRICK, SHERIDAN K. SNEDDEN, and
`ZHENYU YANG, Administrative Patent Judges.
`
`PER CURIAM.
`
`Opinion Concurring filed by Administrative Patent Judge FITZPATRICK
`
`
`DECISION
`Denying Inter Partes Review; Dismissing Motion for Joinder
`37 C.F.R. §§ 42.108, 42.122
`
`
`
`
`
`
`IPR2017-01055
`Patent 8,338,470 B1
`
`INTRODUCTION
`
`I.
`
`Petitioner, Fresenius Kabi USA, LLC (“Fresnius Kabi”), filed a
`Petition to institute an inter partes review of claims 1–7 of U.S. Patent No.
`8,338,470 B1 (Ex. 1001, “the ’470 patent”) pursuant to 35 U.S.C. § 311(a).
`Paper 2 (“Pet.”). Petitioner also filed a Motion for Joinder (Paper 4,
`“Mot.”), seeking to be joined to Amneal Pharmaceuticals LLC v. Hospira,
`Inc., Case No. IPR2016-01578 (the “Amneal IPR”). Patent Owner, Hospira
`Inc., filed a Preliminary Response under 35 U.S.C. § 313. Paper 8 (“Prelim.
`Resp.”).
`As explained below, we deny the Motion for Joinder and the Petition.
`
`A. Related Matters
`The Amneal IPR was instituted on February 9, 2017. IPR2016-
`01578, Paper 11. It was terminated on May 26, 2017, pursuant to a joint
`motion of the parties and in light of their settlement. IPR2016-01578,
`Paper 19.
`Patent Owner has asserted the ’470 patent against both Amneal and
`current Petitioner, Fresenius Kabi. See Hospira, Inc. v. Amneal
`Pharmaceuticals LLC, No. l:15-cv-00697 (D. Del.) (complaint served Aug.
`11, 2015); Hospira Inc. v. Fresenius Kabi USA, LLC, 1:16-cv-00651 (N.D.
`Ill.) (complaint served January 15, 2016). Pet. 63; Paper 6, 2.
`
`B. The ’470 Patent
`The ’470 patent relates to ready-to-use liquid pharmaceutical
`compositions of dexmedetomidine for parenteral administration to a subject.
`Ex. 1001, Abstract, 26:22–27. Dexmedetomidine is an enantiomer of
`
`2
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`IPR2017-01055
`Patent 8,338,470 B1
`
`medetomidine (or racemic 4-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole).
`Id. at 1:20–30. The ’470 patent describes the invention as “patient-ready,
`premixed formulations of dexmedetomidine, or a pharmaceutically
`acceptable salt thereof, that can be used, for example, in perioperative care
`of a patient or for sedation.” Id. at 1:13–16.
`The ’470 patent defines the terms “premix” or “premixture” as
`follows: “The terms ‘premix’ or ‘premixture’ as used herein refers to a
`pharmaceutical formulation that does not require reconstitution or dilution
`prior to administration to a patient.” Id. at 3:51–53.
`The ’470 patent defines the term “ready to use” as follows:
`[T]he compositions of the present invention can be
`formulated as “ready to use” compositions which
`refer to premixed compositions that are suitable for
`administration to a patient without dilution. For
`example, in certain embodiments, the compositions
`of the present invention are “ready to use” upon
`removing the compositions from a sealed container
`or vessel.
`Id. at 3:59–65.
`The ’470 patent discloses that the dexmedetomidine compositions
`may be disposed in a container. Id. at 9:11–13. The ’470 patent discloses
`that the containers may be glass vials, ampoules, syringes, and plastic
`flexible containers, such as polyvinyl chloride (PVC), VisIV, polypropylene,
`and CR3 containers. Id. at 9:17–29.
`The ’470 patent discloses numerous suitable concentrations for the
`premixed dexmedetomidine compositions. Id. at 7:64–8:16.
`
`3
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`IPR2017-01055
`Patent 8,338,470 B1
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`C. Illustrative Claims
`Petitioner challenges claims 1–7 of the ’470 patent. Independent
`claim 1 is illustrative of the challenged claims and is reproduced below:
`1. A ready to use liquid pharmaceutical composition for
`parenteral
`administration
`to
`a
`subject,
`comprising
`dexmedetomidine or a pharmaceutically acceptable salt thereof
`at a concentration of about 0.005 to about 50 μg/mL disposed
`within a sealed glass container.
`
`Claims 2–7 depend from claim 1, either directly or indirectly.
`
`Basis Claims challenged
`
`D. The Asserted Grounds
`Petitioner challenges claims 1−7 of the ’470 patent on the following
`grounds. Pet. 14–15.
`Ground
`Reference[s]
`2010 Precedex Label1 and
`Palmgrén2
`Aantaa,3 2010 Precedex Label,
`and Palmgrén
`
`1
`
`2
`
`§ 103 1−7
`
`§ 103 1−7
`
`
`1 2010 Precedex™ Label (Ex. 1007, “2010 Precedex Label”).
`2 Palmgrén, Joni J. et al., Drug adsorption to plastic containers and
`retention of drugs in cultured cells under in vitro conditions, 64 EUROPEAN
`JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS 369–78 (June 29,
`2006) (Ex. 1017, “Palmgrén”).
`3 Aantaa et al., U.S. Patent No. 6,716,867, issued Apr. 6, 2004 (Ex. 1006,
`“Aantaa”).
`
`4
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`IPR2017-01055
`Patent 8,338,470 B1
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`Ground
`
`3
`
`Reference[s]
`2010 Precedex Label, De
`Giorgi, 4 Eichhorn, 5
`Palmgrén, Lavoisier6
`
`Basis Claims challenged
`
`§ 103 1–7
`
`
`These are the same grounds Amneal raised in its Petition. We
`instituted the Amneal IPR, however, on only the third-listed ground above:
`“obviousness of claims 1–7 of the ʼ470 patent over the combination of 2010
`Precedex Label, De Giorgi, Eichhorn, Palmgrén, and Lavoisier.” IPR2016-
`01578, Paper 11, 16.
`
`II. ANALYSIS
`A. The Motion for Joinder is Moot
`Petitioner’s Motion for Joinder seeks joinder with the Amneal IPR.
`Mot. 1. The Amneal IPR is no longer pending. See IPR2016-01578,
`Paper 19. Hence, there is no proceeding for Petitioner to join. Accordingly,
`we dismiss the Motion for Joinder as moot.
`
`
`
`4 De Giorgi, Isabella et al., Risk and pharmacoeconomic analyses of the
`injectable medication process in the paediatric and neonatal intensivecare
`units, vol. 22 no. 3 INTERNATIONAL JOURNAL FOR QUALITY IN HEALTH CARE
`170–78 (2010) (Ex. 1015, “De Giorgi”).
`5 Eichhorn, John H., APSF Hosts Medication Safety Conference: Consensus
`Group Defines Challenges and Opportunities for Improved Practice, vol. 25
`no. 1 THE OFFICIAL JOURNAL OF THE ANESTHESIA PATIENT SAFETY 1, 3–8
`(Spring 2010) (Ex. 1016, “Eichhorn”).
`6 Lavoisier Sodium Chloride Product Sheet, June 2009 (Ex. 1018,
`“Lavoisier”).
`
`5
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`IPR2017-01055
`Patent 8,338,470 B1
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`B. The Petition is Time-Barred under 35 U.S.C. § 315(b)
`Section 315(b) bars institution of inter partes review when the petition
`is filed more than one year after the petitioner is served with a complaint
`alleging infringement of the patent. 35 U.S.C. § 315(b); 37 C.F.R. §
`42.101(b). The one-year time bar, however, does not apply to a request for
`joinder. 35 U.S.C. § 315(b) (final sentence); 37 C.F.R. § 42.122(b). Thus,
`absent joinder of this proceeding to IPR2016-01578, the Petition is barred
`under § 315(b). The decision to grant joinder is discretionary. 35 U.S.C.
`§ 315(c).
`Petitioner concedes that it was served with a complaint alleging
`infringement of the ’470 patent more than one year before it filed its
`Petition. See Pet. 2 n.1 (Petitioner “was served with a complain[t] asserting
`infringement of the ’470 patent more than one year before filing the
`Petition.”), 63 (“The Complaint alleging infringement of the ’470 patent
`against Fresenius Kabi was filed and served on January 15, 2016.”). Despite
`the late filing, Petitioner argues that it “is not barred from bringing this
`Petition . . . as [it] concurrently seeks joinder with IPR2016-01578.” Pet. 2
`n.1 (citing 35 U.S.C. § 315(b)–(c)).
`As discussed above, Petitioner’s Motion for Joinder is dismissed as
`moot because there is no instituted inter partes review for Petitioner to join.
`Accordingly, the Petition is late, and no inter partes review may be
`instituted. 35 U.S.C. § 315(b).
`
`III. CONCLUSION
`
`We dismiss the Motion for Joinder as moot as there is no instituted
`inter partes review for Petitioner to join. We deny the Petition because it
`6
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`IPR2017-01055
`Patent 8,338,470 B1
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`was not filed within the time limits imposed under 35 U.S.C. § 315(b).
`
`IV. ORDER
`
`Accordingly, it is
`ORDERED that the Motion for Joinder is dismissed as moot.
`FURTHER ORDERED that the Petition for inter partes review of
`claims 1–7 of the ’470 patent is denied.
`
`
`7
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`Paper 10
`
`
`
`
`Trials@uspto.gov
`Date: September 6, 2017
`
`
`
`
`571-272-7822
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`FRESENIUS KABI USA, LLC,
`Petitioner,
`
`v.
`
`HOSPIRA INC.,
`Patent Owner.
`
`
`Case IPR2017-01055
`Patent 8,338,470 B1
`
`
`
`
`Before MICHAEL J. FITZPATRICK, SHERIDAN K. SNEDDEN, and
`ZHENYU YANG, Administrative Patent Judges.
`
`FITZPATRICK, Administrative Patent Judge, concurring.
`
`
`
`I join the majority’s decision to dismiss the Motion for Joinder as
`moot. I concur with the majority’s decision to deny the Petition as time-
`barred, but I would do so under a different interpretation of
`35 U.S.C. § 315(b).
`
`
`
`
`IPR2017-01055
`Patent 8,338,470 B1
`
`Section 315(b) states the following:
`An inter partes review may not be instituted if the
`petition requesting the proceeding is filed more than
`1 year after the date on which the petitioner, real
`party in interest, or privy of the petitioner is served
`with a complaint alleging infringement of the
`patent. The time limitation set forth in the
`preceding sentence shall not apply to a request for
`joinder under subsection (c).
`35 U.S.C. § 315(b).
`Petitioner concedes that it was served with a complaint alleging
`infringement of the ’470 patent more than one year before it filed its
`Petition. See Pet. 2 n.1 (Petitioner “was served with a complain[t] asserting
`infringement of the ’470 patent more than one year before filing the
`Petition.”), 63 (“The Complaint alleging infringement of the ’470 patent
`against Fresenius Kabi was filed and served on January 15, 2016.”).
`Accordingly, its Petition is late, and no inter partes review may be instituted.
`35 U.S.C. § 315(b) (1st sentence). This should be the end of the analysis.
`However, Petitioner argues that it “is not barred from bringing this
`Petition, even though it was served with a complain[t] asserting infringement
`of the ’470 patent more than one year before filing the Petition, as
`[Petitioner] concurrently seeks joinder with IPR2016-01578.” Pet. 2 n.1
`(citing 35 U.S.C. § 315(b)–(c)). My colleagues likewise interpret § 315(b),
`holding as follows:
`The one-year time bar, however, does not apply to
`a request for joinder. 35 U.S.C. § 315(b) (final
`sentence); 37 C.F.R. § 42.122(b). Thus, absent
`joinder of this proceeding to IPR2016-01578, the
`Petition is barred under § 315(b).
`2
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`IPR2017-01055
`Patent 8,338,470 B1
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`Supra, 6.
`Section 315(b), however, does not include any exception for a late-
`filed petition to institute an inter partes review. It merely states that the time
`bar “shall not apply to a request for joinder.” 35 U.S.C. § 315(b) (2nd
`sentence). A “request for joinder” is distinct from a “petition to institute an
`inter partes review.” The former is provided for by 35 U.S.C. § 315(c). The
`latter is provided for by 35 U.S.C. § 311(a).
`The one-year time limitation set forth in the first sentence of § 315(b)
`applies to every petition for an inter partes review, without exception.
`Although the majority here deny the Petition as time-barred under
`§ 315(b), a pre-requisite to their denial is that the Motion for Joinder is also
`denied. See supra, 6. In my view, the majority effectively rewrite the
`second sentence of § 315(b) as follows (underlined text not appearing in the
`statute): The time limitation set forth in the preceding sentence shall not
`apply to a petition accompanied by a request for joinder under subsection (c)
`if that request is granted.
`I would deny the Petition as time-barred irrespective of whether the
`Motion for Joinder was filed, let alone granted. The Motion for Joinder is
`not relevant to whether the Petition is time-barred under § 315(b).
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`IPR2017-01055
`Patent 8,338,470 B1
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`PETITIONER:
`
`Imron Aly
`Jason Harp
`SCHIFF HARDIN LLP
`ialy@schiffhardin.com
`jharp@schiffhardin.com
`
`PATENT OWNER:
`
`Sandra Lee
`Eliot Williams
`BAKER BOTTS L.L.P.
`sandra.lee@bakerbotts.com
`eliot.williams@bakerbotts.com
`
`4
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