Trials@uspto.gov
`571-272-7822
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`Paper No. 9
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`
`
` Entered: September 6, 2017
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMNEAL PHARMACEUTICALS LLC,
`Petitioner,
`
`v.
`
`HOSPIRA, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-01054
`Patent 8,242,158 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
`
`
`
`
`
`571-272-7822
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`
`
`
`
`
`
`
`
`
`Paper No. 9
`
`
`
` Entered: September 6, 2017
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMNEAL PHARMACEUTICALS LLC,
`Petitioner,
`
`v.
`
`HOSPIRA, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-01054
`Patent 8,242,158 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
`
`
`
`
`
`
`IPR2017-01054
`Patent 8,242,158 B1
`
`
`INTRODUCTION
`On March 8, 2017, Fresenius Kabi USA, LLC (“Petitioner”) filed a
`Petition for an inter partes review of claims 1–4 of U.S. Patent
`No. 8,242,158 B1 (“the ’158 patent,” Ex. 1001). Paper 2 (“Pet.”). Petitioner
`concurrently filed a Motion for Joinder (Paper 4, “Mot.”), seeking to be
`joined to Amneal Pharmaceuticals LLC v. Hospira, Inc., Case No. IPR2016-
`01577 (the “Amneal IPR”). Hospira Inc. (“Patent Owner”) timely filed a
`Preliminary Response. Paper 8 (“Prelim. Resp.”). We review the Petition
`under 35 U.S.C. § 314.
`For the reasons provided below, we dismiss the Motion for Joinder
`and deny the Petition.
`A. Related Proceedings
`According to the parties, Patent Owner has asserted the ’158 patent in
`Hospira, Inc. v. Amneal Pharmaceuticals LLC, No. 1:15-cv-00697 (D. Del.),
`and Hospira Inc. v. Fresenius Kabi USA, LLC, 1:16-cv-00651 (N.D. Ill.)
`Pet. 54; Paper 6, 2.
`The ’158 patent is also the subject of the Amneal IPR. In that case,
`we instituted trial on February 9, 2017 (IPR2016-01577, Paper 11), but
`terminated it on May 19, 2017, because the parties settled their dispute
`(IPR2016-01577, Paper 19).
`B. The ’158 Patent
`The ’158 patent relates to “pharmaceutical compositions comprising
`dexmedetomidine or a pharmaceutically acceptable salt thereof[,] wherein
`the composition is formulated as a liquid for parenteral administration to a
`subject, and wherein the composition is disposed within a sealed container
`2
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`IPR2017-01054
`Patent 8,242,158 B1
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`as a premixture.” Ex. 1001, Abstract; see also id. at 1:6–8 (“The present
`invention relates to patient-ready, premixed formulations of
`dexmedetomidine, or a pharmaceutically acceptable salt thereof.”).
`Dexmedetomidine is an enantiomer of medetomidine. Id. at 1:22–23.
`Before the ’158 patent, both medetomidine and dexmedetomidine were
`known as α2-adrenoceptor agonists for general sedation/analgesia and the
`treatment of hypertension or anxiety. Id. at 1:14–25. According to the ’158
`patent, before its invention, “dexmedetomidine ha[d] been provided as a
`concentrate that must be diluted prior to administration to a patient. The
`requirement of a dilution step in the preparation of the dexmedetomidine
`formulation is associated with additional costs and inconvenience, as well as
`the risk of possible contamination or overdose due to human error.” Id. at
`1:48–53. The ’158 patent purportedly provides a dexmedetomidine
`formulation that avoids the expense, inconvenience, delay, and risk of
`contamination or overdose. Id. at 1:53–55.
`C. Illustrative Claim
`Claim 1, the sole independent claim, is illustrative and is reproduced
`below:
`A ready to use liquid pharmaceutical composition for
`1.
`parenteral
`administration
`to
`a
`subject,
`comprising
`dexmedetomidine or a pharmaceutically acceptable salt thereof
`at a concentration of about 4 µg/mL disposed within a sealed
`glass container.
`
`3
`
`
`
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`IPR2017-01054
`Patent 8,242,158 B1
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`
`D. Asserted Grounds of Unpatentability
`Petitioner asserts the following grounds, each of which challenges the
`patentability of claims 1–4:
`Basis
`§ 103
`§ 103
`§ 103
`
`References
`Precedex Label1 and Palmgrén 2
`The ’867 patent,3 Precedex Label, and Palmgrén
`Precedex Label, De Giorgi,4 Eichhorn,5
`Palmgrén, and Lavoisier6
`In support of their respective positions, Petitioner relies on the
`Declarations of Dr. James Gordon Cain (Ex. 1002) and Dr. Alpaslan Yaman
`(Ex. 1003).
`
`ANALYSIS
`A. The Motion for Joinder is Moot
`Petitioner seeks joinder with the Amneal IPR. Mot. 1. The Amneal
`IPR has been terminated. See IPR2016-01577, Paper 19. Hence, there is no
`
`1 Prescribing Information for Precedex (dexmedetomidine hydrochloride)
`injection (Ex. 1007).
`2 Palmgrén 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 (2006) (Ex. 1017).
`3 Aantaa et al., U.S. Patent No. 6,716,867, issued Apr. 6, 2004 (Ex. 1006).
`4 De Giorgi et al., Risk and Pharmacoeconomic Analyses of the Injectable
`Medication Process in the Paediatric and Neonatal Intensive Care Units, 22
`INTERNATIONAL JOURNAL FOR QUALITY IN HEALTH CARE 170–78 (2010)
`(Ex. 1015).
`5 Eichhorn, John H., APSF Hosts Medication Safety Conference: Consensus
`Group Defines Challenges and Opportunities for Improved Practice, 25
`APSF NEWSLETTER 1, 3–8 (2010).
`6 Product sheet for Lavoisier sodium chloride 0.9% injectable solution
`(2009).
`
`4
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`IPR2017-01054
`Patent 8,242,158 B1
`
`pending 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). The one-year time
`bar, however, does not apply to a request for joinder. Id. (last sentence).
`The decision to grant joinder is discretionary. Id. § 315(c).
`Petitioner concedes that it was served with a complaint alleging
`infringement of the ’158 patent more than one year before it filed its
`Petition. Pet. 2 n.1, see also id. at 54 (“The Complaint alleging infringement
`of the ’158 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
`IPR2016-01577.” Id. at 2 n.1.
`As discussed above, Petitioner’s Motion for Joinder is dismissed as
`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).
`
`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 1–4 of the ’158 patent is denied.
`
`5
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`
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`
`
`Trials@uspto.gov
`571-272-7822
`
`
`
`
`
`
`
`
`
`
`Paper No. 9
`
`
`
` Entered: 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 IPR2017-01054
`Patent 8,242,158 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).
`
`
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`IPR2017-01054
`Patent 8,242,158 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 ’158 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 ’158 patent more than one year before filing the
`Petition.”), 54 (“The Complaint alleging infringement of the ’158 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 ’158 patent more than one year before filing the Petition, as
`[Petitioner] concurrently seeks joinder with IPR2016-01577.” Pet. 2 n.1
`(citing 35 U.S.C. § 315(b)–(c)). My colleagues likewise interpret § 315(b),
`holding as follows:
`
`Petitioner’s Motion for Joinder is dismissed as 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).
`Supra, 5 (underlining added).
`
`2
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`IPR2017-01054
`Patent 8,242,158 B1
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`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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`IPR2017-01054
`Patent 8,242,158 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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`
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