Trials@uspto.gov
`571-272-7822
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`Paper 9
`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 IPR2017-01056
`Patent 8,455,527 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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`
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`Paper 9
`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 IPR2017-01056
`Patent 8,455,527 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
`
`
`
`
`
`
`IPR2017-01056
`Patent 8,455,527 B1
`
`INTRODUCTION
`
`I.
`
`Petitioner, Fresenius Kabi USA, LLC (“Fresnius Kabi”), filed a
`Petition to institute an inter partes review of claims 1–11 and 13 of U.S.
`Patent No. 8,455,527 B1 (Ex. 1001, “the ’527 patent”) pursuant to 35 U.S.C.
`§ 311(a). Paper2 (“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.”).
`For the reasons provided below, we dismiss the Motion for Joinder
`and deny the Petition.
`
`A. Related Matters
`The Amneal IPR was instituted on February 9, 2017. IPR2016-
`01579, Paper 11. It was terminated on May 19, 2017, pursuant to a joint
`motion of the parties and in light of their settlement. IPR2016-01579,
`Paper 17.
`Patent Owner has asserted the ’527 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. 65; Paper 6, 2.
`
`B. The ’527 patent
`4-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole is known shorthand as
`medetomidine. Ex. 1001, 1:24–25. It is a racemic mixture of two
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`2
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`IPR2017-01056
`Patent 8,455,527 B1
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`enantiomers: levomedetomidine and dexmedetomidine. Id. The ’527 patent
`focuses on the latter enantiomer, dexmedetomidine, and “relates to 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 1:17–20.
`The ’527 patent acknowledges that, before the claimed invention, both
`medetomidine and dexmedetomidine were known to be α2-adrenoceptor
`agonists and used as antihypertensive, sedative, and analgesic agents. Id. at
`1:26–47. The ’527 patent also acknowledges prior patents disclosing
`medical administration of dexmedetomidine, including via epidural,
`parenteral, intravenous, oral, hypodermic, and transmucosal routes. Id. at
`1:32–57 (citing various U.S. patents).
`
`C. Illustrative Claims
`Of the challenged claims, claim 1 is independent. It is illustrative and
`reproduced below:
`1. A method of providing sedation to a patient in need thereof,
`the method comprising administering to the patient an
`effective amount of a composition, wherein the composition
`comprises
`dexmedetomidine or
`a
`pharmaceutically
`acceptable salt thereof at a concentration of about 0.005 to
`about 50 µg/mL, wherein the composition is a ready to use
`liquid
`pharmaceutical
`composition
`for
`parenteral
`administration to the patient disposed within a sealed glass
`container
`D. The Asserted Grounds
`Petitioner asserts the following grounds of unpatentability. Pet. 14–
`
`15.
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`3
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`IPR2017-01056
`Patent 8,455,527 B1
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`Ground
`
`1
`
`2
`
`3
`
`Reference[s]
`2010 Precedex Label1 and
`Palmgrén2
`Aantaa,3 2010 Precedex Label,
`and Palmgrén
`2010 Precedex Label, De
`Giorgi, 4 Eichhorn, 5
`Palmgrén, Lavoisier6
`
`Basis Claims challenged
`
`§ 103 1−11, 13
`
`§ 103 1−11, 13
`
`§ 103 1−11, 13
`
`
`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 1−11, 13 of the ʼ527 patent over the combination of
`2010 Precedex Label, De Giorgi, Eichhorn, Palmgrén, and Lavoisier.”
`IPR2016-01579, Paper 11, 15.
`
`
`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 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”).
`
`4
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`IPR2017-01056
`Patent 8,455,527 B1
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`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 IPR2016-01579,
`Paper 19. Hence, there is no proceeding for Petitioner to join. Accordingly,
`we dismiss the Motion for Joinder as moot.
`
`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 IPR2016-01579, 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 ’527 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 ’527 patent more than one year before filing the
`Petition.”), 65 (“The Complaint alleging infringement of the ’527 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 IPR2016-0157[9].” Pet. 2
`n.1 (citing 35 U.S.C. § 315(b)–(c)).
`As discussed above, Petitioner’s Motion for Joinder is dismissed as
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`IPR2017-01056
`Patent 8,455,527 B1
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`moot because there is no instituted inter partes review for Petitioner to join.
`Thus, the Petition is statutorily barred, and no inter partes review may be
`instituted. 35 U.S.C. § 315(b).
`
`III. 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 1–11 and 13 of the ’527 patent is denied.
`
`
`6
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`Paper 9
`
`
`
`
`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 IPR2017-01056
`Patent 8,455,527 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).
`
`
`
`
`IPR2017-01056
`Patent 8,455,527 B1
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`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 ’527 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 ’527 patent more than one year before filing the
`Petition.”), 65 (“The Complaint alleging infringement of the ’527 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 ’527 patent more than one year before filing the Petition, as
`[Petitioner] concurrently seeks joinder with IPR2016-01577 [sic, -01579].”
`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 IPR2016-01579, the
`Petition is barred under § 315(b).
`2
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`IPR2017-01056
`Patent 8,455,527 B1
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`Supra, 5.
`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, 5. 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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`3
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`IPR2017-01056
`Patent 8,455,527 B1
`
`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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