`571-272-7822
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` Paper No. 11
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` Entered: February 9, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMNEAL PHARMACEUTICALS LLC,
`Petitioner,
`
`v.
`
`HOSPIRA, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-01577
`Patent 8,242,158 B1
`____________
`
`
`Before MICHAEL J. FITZPATRICK, SHERIDAN K. SNEDDEN, and
`ZHENYU YANG, Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
`
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
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`IPR2016-01577
`Patent 8,242,158 B1
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`INTRODUCTION
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`Amneal Pharmaceuticals LLC (“Petitioner”) filed a Petition for an
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`inter partes review of claims 1–4 of U.S. Patent No. 8,242,158 B1 (“the
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`’158 patent,” Ex. 1001). Paper 2 (“Pet.”). Hospira Inc. (“Patent Owner”)
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`timely filed a Preliminary Response. Paper 9 (“Prelim. Resp.”). We review
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`the Petition under 35 U.S.C. § 314.
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`For the reasons provided below, we determine Petitioner has satisfied
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`the threshold requirement set forth in 35 U.S.C. § 314(a). Because
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`Petitioner has established a reasonable likelihood that it would prevail in
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`showing the unpatentability of claims 1–4, we institute an inter partes
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`review of the challenged claims.
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`Related Proceedings
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`According to the parties, Patent Owner has asserted the ’158 patent in
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`Hospira, Inc. v. Amneal Pharmaceuticals LLC, No. 1:15-cv-00697 (D. Del.).
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`Pet. 53; Paper 6, 2.
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`Petitioner has filed IPR2016-01578, IPR2016-01579, and IPR2016-
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`01580, challenging related U.S. Patent Nos. 8,338,470, 8,455,527, and
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`8,648,106, respectively. Pet. 53; Paper 6, 2.
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`The ’158 Patent
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`The ’158 patent relates to “pharmaceutical compositions comprising
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`dexmedetomidine or a pharmaceutically acceptable salt thereof[,] wherein
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`the composition is formulated as a liquid for parenteral administration to a
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`subject, and wherein the composition is disposed within a sealed container
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`as a premixture.” Ex. 1001, Abstract; see also id. at 1:6–8 (“The present
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`2
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`IPR2016-01577
`Patent 8,242,158 B1
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`invention relates to patient-ready, premixed formulations of
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`dexmedetomidine, or a pharmaceutically acceptable salt thereof.”).
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`Dexmedetomidine is an enantiomer of medetomidine. Id. at 1:22–23.
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`Before the ’158 patent, both medetomidine and dexmedetomidine were
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`known as α2-adrenoceptor agonists for general sedation/analgesia and the
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`treatment of hypertension or anxiety. Id. at 1:14–25. According to the ’158
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`patent, before its invention, “dexmedetomidine ha[d] been provided as a
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`concentrate that must be diluted prior to administration to a patient. The
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`requirement of a dilution step in the preparation of the dexmedetomidine
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`formulation is associated with additional costs and inconvenience, as well as
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`the risk of possible contamination or overdose due to human error.” Id. at
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`1:48–53. The ’158 patent purportedly provides a dexmedetomidine
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`formulation that avoids the expense, inconvenience, delay, and risk of
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`contamination or overdose. Id. at 1:53–55.
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`Illustrative Claim
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`Claim 1, the sole independent claim, is illustrative and is reproduced
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`below:
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`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 g/mL disposed within a sealed
`glass container.
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`3
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`IPR2016-01577
`Patent 8,242,158 B1
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`Asserted Grounds of Unpatentability
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`Petitioner asserts the following grounds, each of which challenges the
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`patentability of claims 1–4:
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`Basis
`§ 103
`§ 103
`§ 103
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`References
`Precedex Label1 and Palmgrén 2
`The ’867 patent,3 Precedex Label, and Palmgrén
`Precedex Label, De Giorgi,4 Eichhorn,5
`Palmgrén, and Lavoisier6
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`In support of their respective positions, Petitioner relies on the
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`Declarations of Dr. James Gordon Cain (Ex. 1002) and Dr. Alpaslan Yaman
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`(Ex. 1003), and Patent Owner relies on the Declarations of Dr. Robert
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`Linhardt (Ex. 2005) and Dr. Michael Ramsay (Ex. 2006).
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`
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`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).
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`4
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`IPR2016-01577
`Patent 8,242,158 B1
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`ANALYSIS
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`Claim Construction
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`In an inter partes review, the Board interprets a claim term in an
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`unexpired patent according to its broadest reasonable construction in light of
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`the specification of the patent in which it appears. 37 C.F.R. § 42.100(b);
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`Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016). Under
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`that standard, and absent any special definitions, we assign claim terms their
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`ordinary and customary meaning, as would be understood by one of ordinary
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`skill in the art at the time of the invention, in the context of the entire patent
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`disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
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`2007).
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`The parties dispute the construction for the term “ready to use,” which
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`appears in all challenged claims. See Pet. 12–13; Prelim. Resp. 8–11.
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`According to Petitioner, an ordinary artisan “would understand the term
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`‘ready-to-use’ to mean ‘requiring no further dilution or reconstitution before
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`transfer to an administration device.’” Pet. 12. Patent Owner urges that we
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`construe the term to mean “formulated such that it is suitable for
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`administration to a patient upon manufacture without dilution or
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`reconstitution by a clinician, hospital personnel, caretaker, patient, or any
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`other individual.” Prelim. Resp. 8–9 (emphasis added).
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`The ’158 patent describes “ready to use” compositions as “premixed
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`compositions that are suitable for administration to a patient without
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`dilution.” Ex. 1001, 3:56–59. The parties appear to agree that “ready to
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`use” is equivalent to a “premixture.” See Pet. 12 n.2; Prelim. Resp. 9.
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`According to the ’158 patent,
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`5
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`IPR2016-01577
`Patent 8,242,158 B1
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`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. For example, in
`contrast to non-premixed formulations of dexmedetomidine, the
`premixed compositions provided herein are suitable for
`administration to a patient without dilution by, for example, a
`clinician, hospital personnel, caretaker, patient or any other
`individual.
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`Ex. 1001, 3:48–55.
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`The description in the ’158 patent as to the scope of “ready to use” is
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`sufficient for purposes of this decision, and we need not further address the
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`term at this time. That is because, even under Patent Owner’s proposed
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`construction (i.e., the ready-to-use formulation must be suitable for
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`administration upon manufacture), we determine Petitioner has established a
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`reasonable likelihood that it would prevail in its obviousness challenge.
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`Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011)
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`(instructing that claim terms need only be construed to the extent necessary
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`to resolve the controversy).
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`Obviousness over the Combination of Precedex Label, De Giorgi, Eichhorn,
`Palmgrén, and Lavoisier
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`Petitioner argues that claims 1–4 would have been obvious over
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`Precedex Label, in view of the knowledge of one of skill in the art at the
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`time of filing, as evidenced by De Giorgi, Eichhorn, Palmgrén, and
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`Lavoisier. Pet. 35–45. Based on the current record, we determine Petitioner
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`has established a reasonable likelihood that it would prevail in this assertion.
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`Relevant Prior Art
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`Precedex Label shows the prescribing information for “Precedex
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`(dexmedetomidine hydrochloride) injection.” Ex. 1007, 1. It bears a mark
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`IPR2016-01577
`Patent 8,242,158 B1
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`showing “Revised: 09/2010.” Id. at l. 80. Relying on that line, Petitioner
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`asserts that Precedex Label “was published September 2010.” Pet. 15 (citing
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`Ex. 1007, 1). Patent Owner does not challenge, and based on the current
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`record, we have no reason to doubt, that Precedex Label qualifies as prior art
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`under 35 U.S.C. § 102(b).
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`Precedex Label states that dexmedetomidine hydrochloride is
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`provided at a concentration of “200 mcg/2 mL (100 mcg/mL) in a glass
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`vial.” Ex. 1007, l. 40. The drug is “[f]or intravenous infusion following
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`dilution” (id. at l. 8) and “must be diluted in 0.9% sodium chloride solution
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`to achieve required concentration (4 mcg/mL) prior to administration” (id. at
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`ll. 175–76). It teaches preparing the infusion solutions at the volume of
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`50 mL. Id. at ll. 180–81.
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`Palmgrén describes the results of experiments on adsorption of certain
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`drugs, including medetomidine, to various plastic containers. Ex. 1017,
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`Abstract. According to Palmgrén, medetomidine was “known to interact
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`with PVC [polyvinylchloride] and polystyrene plastic.” Id. at 370.
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`Palmgrén reported that the loss of basic drugs, including medetomidine, to
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`modified polystyrene-plastic was much higher than to glass and
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`polypropylene. Id. at 374.
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`De Giorgi describes the results of a study designed to analyze safety
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`risks in injectable medications. Ex. 1015, Abstract. According to
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`De Giorgi, microbial contamination, dosage errors, and dilution errors are
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`among the top errors observed. Id. at 173. De Giorgi suggests that ready-to-
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`use syringes “offer a safe alternative to reduce microbiological
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`contamination and dilution errors and avoid drug wastage.” Id. at 176.
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`Eichhorn summarizes the recommendations from a consensus
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`conference to address persistent problems of medication safety in the
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`operating room. Ex. 1016, 1. According to Eichhorn, “[t]he proposed new
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`paradigm to reduce medication errors causing harm to patients in the
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`operating room is based on Standardization, Technology,
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`Pharmacy/Prefilled/Premixed, and Culture (STPC).” Id. Eichhorn
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`suggests that “providing ‘ready-to-use’ medications in the operating room
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`whenever possible that are prepared by outsource specialty companies who
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`do that exclusively should decrease medication errors in the operating
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`room.” Id. at 5.
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`Lavoisier is a product sheet for a 0.9% sodium chloride solution as an
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`injectable solution. Ex. 1018, 1. The document bears a mark of “DATE OF
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`REVISION June 2009.” Id. at 2. Petitioner appears to rely on that
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`information to support its assertion that Lavoisier qualifies as prior art under
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`35 U.S.C. § 102(b). Pet. 18 (citing Ex. 1018, 2). Patent Owner does not
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`challenge, and based on the current record, we have no reason to doubt, the
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`prior-art status of Lavoisier.
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`Lavoisier describes various forms of packaging for the product,
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`including glass ampoules in a volume of 2 ml, 5, ml, 10 ml, or 20 ml.
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`Ex. 1018, 1.
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`Analysis
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`Petitioner refers to Precedex Label for teaching “a liquid formulation
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`of dexmedetomidine hydrochloride stored in a glass vial at a concentration
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`of 200 μg/2 mL (100 μg/mL), which is intended for parenteral
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`administration via intravenous infusion.” Pet. 36 (citing Ex. 1007, ll. 175–
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`8
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`IPR2016-01577
`Patent 8,242,158 B1
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`84, 207–08, 457). Petitioner also refers to Precedex Label for teaching the
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`“preparation of a 4 μg/mL solution of Precedex for parenteral administration
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`by diluting 2 mL of Precedex in 48 mL of 0.9% sodium chloride injection to
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`a total of 50 mL.” Id. (citing Ex. 1007, ll. 175–84). Because of this explicit
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`instruction, Petitioner argues, it would have been obvious for an ordinary
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`artisan “to prepare a ready-to-use solution of dexmedetomidine
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`hydrochloride at a concentration of 4 μg/mL, for parenteral administration to
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`a patient via intravenous infusion.” Id. at 36.
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`Petitioner contends that it also would have been obvious for an
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`ordinary artisan to store the diluted dexmedetomidine solution in sealed
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`glass containers. Id. at 37. Petitioner refers to Precedex Label for teaching
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`that (1) Precedex has a “potential for absorption” when used with some
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`types of natural rubber (id. (citing Ex. 1007, ll. 203–06)); and (2) a glass vial
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`is used to store and handle Precedex (id. at 39). In addition, according to
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`Petitioner, Palmgrén teaches that (1) “it was well-known that medetomidine,
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`a racemic mixture containing the enantiomer dexmedetomidine, interacts
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`with plastics found in infusion bags and intravenous tubing, which can lead
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`to drug loss and treatment failure” (id. (citing Ex. 1017, 370)); and (2) loss
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`of medetomidine is much higher in polystyrene and polycarbonate than in
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`glass and polypropylene (id. (citing Ex. 1017, 374–76)). Thus, Petitioner
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`concludes that one of ordinary skill in the art would have had a reason to use
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`a sealed glass container to handle and store dexmedetomidine solutions. Id.
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`at 37.
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`Furthermore, Petitioner asserts that “one of skill in the art would have
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`been motivated to prepare ready to use or premixed, diluted solutions of
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`IPR2016-01577
`Patent 8,242,158 B1
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`Precedex at the 4 μg/mL concentration” because De Giorgi, Eichhorn, and
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`Lavoisier “establish that, at the time of filing, those of skill in the art
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`recognized the need for and indeed had been advocating for additional
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`standardization of drug preparation methods.” Id. at 39–40.
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`Patent Owner contends that an ordinary artisan would not have had a
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`reason to combine teachings of Precedex Label and Palmgrén. Prelim. Resp.
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`27–31. Patent Owner also argues that (1) the combination of Precedex Label
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`and Palmgrén does not teach or suggest a ready-to-use dexmedetomidine
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`composition at a concentration of about 4 g/mL disposed within a sealed
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`glass container (id. at 15–26); and (2) “[t]he addition of [De] Giorgi,
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`Eichhorn, and Lavoisier to this combination cannot remedy this deficiency”
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`(id. at 50). We are not persuaded by Patent Owner’s arguments.
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`Patent Owner asserts that an ordinary artisan would not have
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`combined the teachings of Precedex Label and Palmgrén because Palmgrén
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`“evaluated the drug loss of medetomidine due to adsorption in containers of
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`different materials, and not the adsorption of isolated dexmedetomidine.”
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`Prelim. Resp. 27. Dr. Linhardt, a declarant for Patent Owner, testifies that
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`an ordinary artisan would not “have necessarily considered sorption testing
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`on medetomidine to be determinative of what storage material should be
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`used for a dexmedetomidine formulation.” Ex. 2005 ¶ 136.
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`The opinion of Dr. Linhardt on this issue is in direct conflict with that
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`of Dr. Yaman, Petitioner’s expert. Indeed, in Dr. Yaman’s view:
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`Because dexmedetomidine is the S-enantiomer of the racemic
`medetomidine a [person of ordinary skill in the art] POSA would
`expect that dexmedetomidine would perform the same as
`medetomidine in polystyrene and glass. Enantiomeric isomers
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`Patent 8,242,158 B1
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`are optical isomers that are mirror images of each other. These
`compounds only present a difference between them with respect
`to their physiological or pharmacological affect as the body has
`enantomeric specific receptors. Otherwise, the physio-chemical
`properties such as solubility, the ability to adsorb or absorp [sic]
`and their chemical stability are the same and the optical rotation
`has no impact on these chemical and physical attributes.
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`Ex. 1003 ¶ 52. For the purpose of deciding whether to institute an inter
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`partes review, we view genuine issues of material fact created by testimonial
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`evidence in the light most favorable to Petitioner. 37 C.F.R. § 42.108(c).
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`Thus, for purposes of this Decision, we accept Petitioner’s reasoning for
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`why one of ordinary skill in the art would have combined the teachings of
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`Precedex Label and Palmgrén.
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`We also determine, for purposes of instituting an inter partes review,
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`Petitioner has presented sufficient evidence to show that the combination of
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`Precedex Label, De Giorgi, Eichhorn, Palmgrén, and Lavoisier teaches or
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`suggests all limitations of claim 1. Here, we are not persuaded by Patent
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`Owner’s arguments because they run afoul of the established principle that
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`“[n]on-obviousness cannot be established by attacking references
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`individually where the rejection is based upon the teachings of a
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`combination of references.” See In re Merck & Co., 800 F.2d 1091, 1097
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`(Fed. Cir. 1986). For example, Patent Owner emphasizes that “Petitioner
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`does not allege that [De] Giorgi, Eichhorn, or Lavoisier disclose a ready to
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`use composition comprising dexmedetomidine at 4 μg/mL.” Prelim. Resp.
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`49. Patent Owner also alleges that none of De Giorgi, Eichhorn, and
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`Lavoisier teaches dexmedetomidine specifically, and neither De Giorgi nor
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`Eichhorn teaches the use of a sealed glass container. Id. at 50–57.
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`Patent 8,242,158 B1
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`A reference “must be read, not in isolation, but for what it fairly
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`teaches in combination with the prior art as a whole.” Merck, 800 F.2d at
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`1097. Id. Patent Owner is correct that De Giorgi, Eichhorn, and Lavoisier
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`do not specifically mention dexmedetomidine or its concentration. We,
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`nevertheless, agree with Petitioner that the explicit instruction in Precedex
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`Label to prepare a 4 μg/mL solution of Precedex for parenteral
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`administration (Ex. 1007, ll. 175–84) suggests a dexmedetomidine solution
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`for parenteral administration at a concentration of 4 μg/mL, as recited in
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`claim 1. See Pet. 36–37.
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`In addition, although De Giorgi and Eichhorn may not explicitly teach
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`the use of a sealed glass container, Petitioner relies on Precedex Label,
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`Palmgrén, and Lavoisier for this limitation. We find persuasive Petitioner’s
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`position that “a POSA would have a reasoned basis for using a sealed glass
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`container when formulating dexmedetomidine solutions because both
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`Palmgren and the Precedex 2010 Label disclosed the use and suitability of
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`glass containers to do so, and also because doing so would avoid potentially
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`adverse interactions with other materials.” See Pet. 37, 39–42; Ex. 1007,
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`ll. 203–08; Ex. 1017, 370, 374–76; Ex. 1018, 1–2.
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`Moreover, Petitioner contends that De Giorgi teaches ready-to-use
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`syringes as a safe alternative to reduce microbiological contamination and
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`dilution errors, two of the most critical reasons for treatment failure
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`associated with injectable medications. Id. at 40 (citing Ex. 1015, 176).
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`Similarly, Petitioner directs our attention to the strategies to improve
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`medication safety as taught in Eichhorn and the recommendations therein
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`that “[r]outine provider-prepared medications should be discontinued
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`whenever possible,” and “[s]tandardized pre-prepared medication kits by
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`case type should be used whenever possible.” Id. at 40–41 (citing Ex. 1016,
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`1). Petitioner also emphasizes Eichhorn’s teaching on the safety of
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`intravenous drug delivery systems that “there was a clear preference for
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`manufacturer-prepared completely ready-to-use IV medication in all
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`settings.” Id. at 41 (citing Ex. 1016, 5). “[M]anufacturer-prepared
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`completely ready-to-use IV medication” is within the scope of “ready to
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`use” under the claim construction proposed by either party. Thus, we are
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`satisfied that there is a reasonable likelihood Petitioner would prevail in
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`showing the combination of the asserted prior art suggests each and every
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`limitation of claim 1, including a “ready to use liquid pharmaceutical
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`composition.”
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`Patent Owner alleges that the invention of the ’158 patent provides
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`surprising and unexpected results because “the claimed compositions are
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`surprisingly more stable in sealed glass containers and are able to be stored
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`over prolonged periods of time without significant losses in potency.”
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`Prelim. Resp. 32. Stability over prolonged periods of time, however, is not a
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`limitation in any of the challenged claims. Thus, at this preliminary stage,
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`without more evidence and/or explanation, we are not persuaded that Patent
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`Owner has established a nexus between the alleged unexpected results and
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`the merits of the claimed invention. See In re Huai-Hung Kao, 639 F.3d
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`1057, 1068 (Fed. Cir. 2011).
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`In sum, at this stage of the proceeding, we find that Petitioner has
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`offered sufficient evidence to institute an inter partes review, and Patent
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`Owner’s arguments do not persuade us that we should decline to go forward
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`with a trial. Based on the current record, we conclude that Petitioner has
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`established a reasonable likelihood of prevailing on its assertion that claim 1
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`is unpatentable as obvious over Precedex Label, Giorgi, Eichhorn, Palmgrén,
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`and Lavoisier. After considering Petitioner’s arguments and evidence with
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`respect to the remaining claims (Pet. 42–45), which Patent Owner does not
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`address separately, and we determine that Petitioner has made a sufficient
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`showing as to those claims, as well.
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`Other Grounds
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`Petitioner asserts that claims 1–4 also would have been obvious over
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`the combination of Precedex Label and Palmgrén, or the combination of the
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`’867 patent, Precedex Label, and Palmgrén. Pet. 18–35. In view of our
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`institution of an inter partes review of all challenged claims on another
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`ground, as set forth above, we deny institution on these additional grounds.
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`See 37 C.F.R. § 42.108(a)–(b).
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`CONCLUSION
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`For the foregoing reasons, the information presented in the Petition
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`and accompanying evidence establishes a reasonable likelihood that
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`Petitioner would prevail in showing the unpatentability of claims 1–4 of the
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`’158 patent.
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`At this stage of the proceeding, the Board has not made a final
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`determination as to the construction of any claim term or the patentability of
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`any challenged claim.
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`Accordingly, it is
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`ORDER
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`ORDERED that pursuant to 35 U.S.C. § 314, an inter partes review is
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`hereby instituted to determine whether claims 1–4 would have been obvious
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`over Precedex Label, in view of the knowledge of one of skill in the art at
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`the time of filing, as evidenced by De Giorgi, Eichhorn, Palmgrén, and
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`Lavoisier;
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`FURTHER ORDERED that no other ground of unpatentability is
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`authorized in this inter partes review; and
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`FURTHER ORDERED that pursuant to 35 U.S.C. § 314(a), inter
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`partes review of the ’158 patent is hereby instituted commencing on the
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`entry date of this Order, and pursuant to 35 U.S.C. § 314(c) and 37 C.F.R.
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`§ 42.4, notice is hereby given of the institution of a trial.
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`15
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`IPR2016-01577
`Patent 8,242,158 B1
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`PETITIONER:
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`Paul Tully
`tully@mbhb.com
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`Kevin Noonan
`noonan@mbhb.com
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`Andrea Orth
`orth@mbhb.com
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`PATENT OWNER:
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`Sandra Lee
`sandra.lee@bakerbotts.com
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`Eliot Williams
`eliot.williams@bakerbotts.com
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`Stephen Hash
`stephen.hash@bakerbotts.com
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`16
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