Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`Paper 11
`Entered: February 9, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`AMNEAL PHARMACEUTICALS LLC,
`Petitioner,
`
`v.
`
`HOSPIRA, INC,
`Patent Owner.
`_______________
`
`Case IPR2016-01578
`Patent 8,338,470 B1
`_______________
`
`
`Before MICHAEL J. FITZPATRICK, SHERIDAN K. SNEDDEN, and
`ZHENYU YANG, Administrative Patent Judges.
`
`Opinion for the Board filed by Administrative Patent Judge SNEDDEN.
`
`Opinion Concurring filed by Administrative Patent Judge FITZPATRICK.
`
`SNEDDEN, Administrative Patent Judge.
`
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`

`

`IPR2016-01578
`Patent 8,338,470 B1
`
`I. INTRODUCTION
`
`Amneal Pharmaceuticals LLC (“Petitioner”) filed a Petition to
`
`institute an inter partes review of claims 17 (Paper 2; “Pet.”) of US
`
`8,338,470 B1 (Ex. 1001; “the ’470 patent”). Hospira, Inc. (“Patent Owner”)
`
`filed a Patent Owner Preliminary response. Paper 9 (“Prelim. Resp.”).
`
`We have authority to determine whether to institute an inter partes
`
`review under 35 U.S.C. § 314 and 37 C.F.R. § 42.4(a). Upon consideration
`
`of the Petition and the Preliminary Response, and for the reasons explained
`
`below, we determine that Petitioner has shown that there is a reasonable
`
`likelihood that it would prevail with respect to at least one of the challenged
`
`claims. We thus institute an inter partes review of claims 1–7 of the ’470
`
`patent.
`
`A.
`
`Related Proceedings
`
`Patent Owner has asserted the ’470 patent in Hospira, Inc. v. Amneal
`
`Pharmaceuticals LLC, No. 1:15-cv-00697 (D. Del.). Pet. 61; Paper 6, 2.
`
`Petitioner has sought inter partes review for related patents in the
`
`following proceedings: Case IPR2016-01577 (U.S. Patent No. 8,242,158
`
`B2), Case IPR2016-01579 (U.S. Patent No. 8,455,527 B2), and Case
`
`IPR2016-01580 (U.S. Patent No. 8,648,106 B2).
`
`B. The ’470 patent (Ex. 1001)
`
`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
`
`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,
`
`2
`
`

`

`IPR2016-01578
`Patent 8,338,470 B1
`
`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.
`
`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:
`
`3
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`

`

`IPR2016-01578
`Patent 8,338,470 B1
`
`
`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.
`
`D. The Asserted Grounds
`
`Petitioner challenges claims 17 of the ’470 patent on the following
`
`grounds. Pet. 13–14.
`
`Ground
`
`Reference[s]
`
`Basis Claims challenged
`
`1
`
`2
`
`2010 Precedex Label1 and
`Palmgrén2
`Aantaa,3 2010 Precedex Label,
`and Palmgrén
`
`§ 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
`
`

`

`IPR2016-01578
`Patent 8,338,470 B1
`
`
`Ground
`
`Reference[s]
`
`Basis Claims challenged
`
`2010 Precedex Label, De
`Giorgi, 4 Eichhorn, 5
`Palmgrén, Lavoisier6
`
`§ 103 1–7
`
`3
`
`
`
`Petitioner supports its challenge with the Declarations of James Cain,
`
`MD, MBA, FAAP (Ex. 1002) and Alpaslan Yaman, Ph.D. (Ex. 1003).
`
`II. ANALYSIS
`
`A. Claim Interpretation
`
`We interpret claims using the “broadest reasonable construction in
`
`light of the specification of the patent in which [they] appear[].” 37 C.F.R.
`
`§ 42.100(b); Cuozzo Speed Techs. LLC v. Lee, 136 S. Ct. 2131, 2144–46
`
`(2016). Under the broadest reasonable construction standard, claim terms
`
`are generally given their “ordinary and customary meaning,” as would be
`
`understood by one of ordinary skill in the art at the time of the invention. In
`
`re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007) (quoting
`
`Phillips v. AWH Corp, 415 F.3d 1303, 1312 (Fed. Cir. 2005)).
`
`
`
`4 De Giorgi, Isabella et al., Risk and pharmacoeconomic analyses of the
`injectable medication process in the paediatric and neonatal intensive
`care 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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`IPR2016-01578
`Patent 8,338,470 B1
`
`
`The parties address express constructions for two terms,
`
`“dexmedetomidine” and “ready to use,” both of which appear in claim 1 and
`
`are incorporated by the remainder of the claims of the ’470 patent. As set
`
`forth below, we determine that no terms require an express construction for
`
`purposes of this Decision.
`
`Petitioner proposes an express construction for “dexmedetomidine,”
`
`to which Patent Owner agrees. Pet. 13; Prelim. Resp. 12. We determine that
`
`an express construction for “dexmedetomidine” is unnecessary for the
`
`purposes of determining whether to institute an inter partes review.
`
` Independent claim 1 recites “[a] ready to use liquid pharmaceutical
`
`composition for parenteral administration to a subject.” The parties present
`
`competing constructions for “ready to use.” Petitioner, relying on extrinsic
`
`evidence, argues that “ready to use” should be construed such that the
`
`composition “requir[es] no further dilution or reconstitution before
`
`administration to a patient.” Pet. 11 (citing Ex. 1002, ¶¶ 31; Ex. 1003, ¶ 48;
`
`Ex. 1044). As Petitioner notes (see Pet. 11–12), the ’470 patent defines
`
`“ready to use” compositions as “premixed compositions that are suitable for
`
`administration to a patient without dilution.” Ex. 1001, 3:56–63.
`
`The ’470 patent further provides:
`
`The terms “premix” or “premixture” as used herein refers [sic]
`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.
`
`Id. at 3:51–58. Patent Owner, noting this additional disclosure, argues that
`
`“ready to use” means “formulated such that it is suitable for administration
`
`6
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`

`IPR2016-01578
`Patent 8,338,470 B1
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`to a patient upon manufacture without dilution or reconstitution by a
`
`clinician, hospital personnel, caretaker, patient, or any other individual.”
`
`Prelim. Resp. 9 (emphasis added) (citing Ex. 1001, 3:51–53; 2:65–3:6).
`
`Both of the parties’ constructions for “ready to use” find support in the
`
`specification, as set forth in specification excerpts quoted above. The
`
`distinction between the two is whether the composition must be ready-to-use
`
`upon manufacture, or if it can become ready-to-use subsequent to its
`
`manufacture, including shortly before its administration to a patient. On the
`
`record presented, we need not and do not resolve this distinction. That is
`
`because, regardless of whether the ready-for-use formulation must be
`
`suitable for administration upon manufacture, as Patent Owner argues, we
`
`determine Petitioner has established a reasonable likelihood that it would
`
`prevail in its obviousness challenge. Wellman, Inc. v. Eastman Chem. Co.,
`
`642 F.3d 1355, 1361 (Fed. Cir. 2011) (instructing that claim terms need only
`
`be construed to the extent necessary to resolve the controversy).
`
`B. Prior Art
`
`Petitioner relies upon the following prior art in its challenges.
`
`1. 2010 Precedex Label (Ex. 1007)7
`
`The 2010 Precedex Label discloses Precedex™ as the trade name for
`
`a formulation of dexmedetomidine hydrochloride. Ex. 1007, 13.
`
`
`
`7 Petitioner asserts that 2010 Precedex Label “was published September
`
`2010.” Pet. 15. Patent Owner does not challenge, and based on the current
`
`record, we have no reason to doubt, that Precedex Label qualifies as prior art
`
`under 35 U.S.C. § 102(b).
`
`7
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`

`IPR2016-01578
`Patent 8,338,470 B1
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`Precedex™ is a drug product provided in glass vial at a concentration of 200
`
`μg/2 mL (100 μg/mL). Id. at 4. The 2010 Precedex Label discloses that
`
`Precedex™ “must be diluted in 0.9% sodium chloride solution to achieve
`
`required concentration (4 mcg/mL) prior to administration.” Id. at 3. The
`
`total volume of the disclosed preparation is 50 mL. Id.
`
`The 2010 Precedex Label discloses that Precedex™ has a “potential
`
`for absorption” when used with some types of natural rubber. Id. at 4.
`
`
`
`2. Palmgrén (Ex. 1017)
`
`Palmgrén discloses results of experiments on adsorption of drugs,
`
`including medetomidine, to various plastic containers. Ex. 1017, Abstract.
`
`Palmgrén discloses that medetomidine was “known to interact with PVC and
`
`polystyrene plastic” and examined medetomidine performance in glass and
`
`polypropylene as compared to modified polystyrene. Id. at 370. Palmgrén
`
`discloses that
`
`the loss of basic drugs to polystyrene well plates and [modified
`polystyrene]-tubes in water was a rapid process. All the drug
`losses were achieved within the first 15 min (Fig. 2). After 4.5 h,
`the relative amount remaining in [modified polystyrene] tubes in
`aqueous solution was 64.7 ± 6.8%, 38.4 ± 9.1%, 31.9 ± 6.7%,
`and 23.5 ± 6.1% for metoprolol, medetomidine, propranolol, and
`midazolam, respectively (Table 4) . . . As seen in Table 4, the
`loss of basic drugs to [modified polystyrene]-plastic was much
`higher than to glass and PP-tubes.
`
`Ex. 1017, 374.
`
`3. De Giorgi (Ex. 1015)
`
`De Giorgi discloses the results of a study designed to analyze safety
`
`risks in injectable medications for patients in the pediatric and neonatal
`
`intensive care units. Id. at Abstract. De Giorgi discloses the frequency and
`
`8
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`

`IPR2016-01578
`Patent 8,338,470 B1
`
`severity of thirty different types of medication errors observed in the study.
`
`The authors determined that microbial contamination, dosage errors, and
`
`dilution errors were among the top errors observed. Id. at 173. De Giorgi
`
`concludes that “the involvement of a clinical pharmacist and the introduction
`
`of ready-to-use syringes for selected drugs have been shown to be the most
`
`cost-effective tool” for addressing safety risks in injectable medications. Id.
`
`at 177.
`
`4. Eichhorn (Ex. 1016)
`
`Eichhorn provides a summary of the discussions at a medication
`
`safety conference related to a “new paradigm” to address “persistent
`
`problems of medication safety in the operating room.” Ex. 1016, 1.
`
`Eichhorn discloses different types of medication errors, such as wrong drug
`
`or dose or route, and adverse reactions. Id. at 4–5. Eichhorn discloses a
`
`preference away from “[r]outine provider-prepared medications,” and
`
`toward “[s]tandardized pre-prepared medication kits by case type.” Id. at 1.
`
`Eichhorn further discloses the concept of “ready-to-use” medications for use
`
`“in the operating room . . . that are prepared by outsource specialty
`
`companies who do that exclusively” for the purpose of decreasing
`
`medication errors in the operating room. Id. at 5.
`
`Eichhorn further references a 2008 national consensus conference on
`
`the safety of intravenous drug delivery systems and notes that “there was a
`
`clear preference for manufacturer prepared completely ready-to-use
`
`[intravenous] medication in all settings.” Id.
`
`9
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`

`IPR2016-01578
`Patent 8,338,470 B1
`
`
`5. Lavoisier (Ex. 1018)8
`
`Lavoisier is a product sheet for a 0.9% sodium chloride solution as an
`
`injectable solution. Ex. 1018, 1. The product sheet discloses various forms
`
`of packaging for the product, including glass ampoules at a volume of 2 ml,
`
`5 ml, 10 ml, or 20 ml. Id.
`
`C. Ground 3: Obviousness of Claims 17 over the Combination of
`2010 Precedex Label, De Giorgi, Eichhorn, Palmgrén, and
`Lavoisier
`
`Petitioner contends that claims 17 are rendered obvious by the
`
`combined teachings of 2010 Precedex Label, De Giorgi, Eichhorn,
`
`Palmgrén, and Lavoisier. Pet. 39–51. Petitioner sets forth the foregoing
`
`teachings of 2010 Precedex Label, De Giorgi, Eichhorn, Palmgrén, and
`
`Lavoisier and provides a detailed discussion and claim charts explaining
`
`how each claim limitation of the challenged claims is disclosed by the
`
`combination of references. Id. In particular, Petitioner contends that the
`
`2010 Precedex Label discloses “a liquid formulation of dexmedetomidine
`
`hydrochloride stored in a glass vial at a concentration of 200 μg/2 mL (100
`
`μg/mL), which is intended for parenteral administration via intravenous
`
`infusion.” Id. at 40 (citing Ex. 1007, Sec. 2.4, Sec. 3, Sec. 11). Petitioner
`
`further contends that the 2010 Precedex Label discloses “preparation of a 4
`
`
`
`8 Lavoisier bears a mark of “DATE OF REVISION June 2009.” Ex. 1018,
`
`2. Petitioner appears to rely on that information to support its assertion that
`
`Lavoisier qualifies as prior art under 35 U.S.C. § 102(b). Pet. 17. Patent
`
`Owner does not challenge, and based on the current record, we have no
`
`reason to doubt, the prior-art status of Lavoisier.
`
`10
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`

`IPR2016-01578
`Patent 8,338,470 B1
`
`μg/mL solution of Precedex for parenteral administration by diluting 2 mL
`
`of Precedex in 48 mL of 0.9% sodium chloride injection to a total of 50
`
`mL.” Id. at 40–41 (citing Ex. 1007, Sec. 2.4).
`
`Petitioner relies on De Giorgi, Eichhorn, and Lavoisier to support
`
`their argument that one of skill in the art would have been motivated to
`
`prepare ready-to-use (or premixed), diluted solutions of Precedex at the 4
`
`μg/mL concentration as instructed in the 2010 Precedex Label, because “[De
`
`Giorgi, Eichhorn, and Lavoisier] establish that, at the time of filing, those of
`
`skill in the art recognized the need for and indeed had been advocating for
`
`additional standardization of drug preparation methods.” Id. at 44. For
`
`example, with reference to Eichhorn, Petitioner contends as follows:
`
`Eichhorn reported that a January 26, 2010 consensus
`conference by the Anesthesia Patient Safety Foundation “to
`develop new strategies for ‘predictable prompt improvement’ of
`medication safety in the operating room,” recommended that
`“[r]outine provider-prepared medications should be discontinued
`whenever possible. …
`[and s]tandardized pre-prepared
`medication kits by case type should be used whenever possible.”
`Ex. 1016, p. 1. Eichhorn also referred to “a 2008 national
`consensus conference on the safety of intravenous drug delivery
`systems, [where] there was a clear preference for manufacturer-
`prepared completely ready-to-use IV medication in all settings.”
`Id., p. 5.
`
`Id. at 45 (bracketed material and ellipses added by Petitioner).9
`
`
`
`With reference to Lavoisier, Petitioner contends that 0.9% sodium
`
`chloride solutions were routinely available in sealed glass containers for use
`
`as an injectable solution. Id. at 45 (citing Ex. 1018; Ex. 1003 ¶ 90).
`
`
`
`9 A manufacturer-prepared composition would fall within the scope of a
`“ready to use” composition under the claim construction proposed by either
`Petitioner or Patent Owner. Pet. 11–13; Prelim. Resp. 9–12.
`
`11
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`

`IPR2016-01578
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`
`Petitioner further contends that “[De Giorgi] disclosed the benefits of
`
`avoiding microbial contamination by using pre-prepared medications
`
`packaged in sterile, sealed glass containers.” Id. at 46 (citing Ex. 1015,
`
`Abstract).
`
`With regard to the limitation of claim 1 requiring the recited
`
`composition to be “disposed within a sealed glass container,” Petitioner
`
`argues as follows:
`
`First, the 2010 Precedex Label disclosed that Precedex has a
`“potential for absorption” when used with some types of natural
`rubber. Ex. 1007, Sec. 206, ll. 203-206. Second, Palmgren (Ex.
`1017), disclosed that it was well known in the art that
`medetomidine, a racemic mixture containing dexmedetomidine,
`interacts with plastics found in infusion bags (e.g., PVC) and
`intravenous tubing, which can lead to drug loss and treatment
`failure. Ex. 1017, p. 370. Accordingly, a POSA would have a
`reasoned basis for using a sealed glass container when
`formulating dexmedetomidine solutions because both Palmgren
`and the Precedex 2010 Label disclosed the use and suitability of
`glass containers to do so, and also because doing so would avoid
`potentially adverse interactions with other materials. Ex. 1003,
`¶¶ 52–63.
`
`Pet. 41–42; see also id. at 46 (“Palmgren disclosed the advantages of
`
`resistance to drug loss by using sealed glass containers (Ex. 1017, pp. 374-
`
`376).”).
`
`Patent Owner argues that 2010 Precedex Label does not disclose a
`
`ready to use dexmedetomidine composition and that “[t]he addition of [De]
`
`Giorgi, Eichhorn, and Lavoisier to this combination cannot remedy this
`
`deficiency.” Prelim. Resp. 52. Patent Owner supports this position arguing
`
`1) that “[De] Giorgi does not disclose the use of sealed glass containers” and
`
`“failed to provide any motivation to formulate a ready to use
`
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`IPR2016-01578
`Patent 8,338,470 B1
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`dexmedetomidine composition at the claimed concentrations disposed within
`
`a sealed glass container” (id. at 52–54), and 2) that Eichhorn does not
`
`disclose the use of sealed glass containers, does not mention
`
`dexmedetomidine specifically, and does not provide a clear motivation to
`
`prepare a ready to use dexmedetomidine composition in a sealed glass
`
`containers (id. at 55–56).
`
`We do not find these arguments persuasive. “Non-obviousness cannot
`
`be established by attacking references individually where the rejection is
`
`based upon the teachings of a combination of references.” In re Merck &
`
`Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Thus, it follows that Petitioner’s
`
`obviousness challenge cannot be rebutted by individually attacking the
`
`relied-upon combined teachings. A reference “must be read, not in isolation,
`
`but for what it fairly teaches in combination with the prior art as a whole.”
`
`Id. With regard to the “sealed glass container” limitation, Petitioner
`
`persuasively argues that “a POSA would have a reasoned basis for using a
`
`sealed glass container when formulating dexmedetomidine solutions because
`
`both Palmgren and the Precedex 2010 Label disclosed the use and suitability
`
`of glass containers to do so, and also because doing so would avoid
`
`potentially adverse interactions with other materials.” Pet. 41–42 (citing Ex.
`
`1003 ¶¶ 52–63; Ex. 1007, Sec. 206; Ex. 1017, 370).
`
`Petitioner relies on De Giorgi to establish that it was known that
`
`microbial contamination and dilution errors were both common and that
`
`“using ready-to-use injectable drugs, such as vancomycin syringes, offers a
`
`safe alternative to reduce both microbiological contamination and dilution
`
`errors.” Pet. 16 (citing Ex. 1015, 176). Eichhorn is relied on for its
`
`disclosure of strategies to improve medication safety and its
`
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`IPR2016-01578
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`recommendation that “[r]outine provider-prepared medications should be
`
`discontinued whenever possible. … [and s]tandardized pre-prepared
`
`medication kits by case type should be used whenever possible.” Pet. 45
`
`(quoting Ex. 1016, 1 (bracketed material and ellipses added by Petitioner)).
`
`On the current record, we find these disclosures relevant to the issue of
`
`whether a person of ordinary skill in the art would have been motivated to
`
`modify the disclosures of 2010 Precedex Label and Palmgrén to arrive at the
`
`invention of the challenged claims.
`
`Patent Owner argues a person of ordinary skill in the art would have
`
`faced difficulties in modifying 2010 Precedex Label and Palmgrén to arrive
`
`at the composition of the challenged claims. For example, Patent Owner
`
`argues that “[De] Giorgi analyzed about 60 different injectable drugs in total
`
`. . . , but importantly, estimated that only ‘15 drugs could be provided in
`
`ready to use syringes (CIVAS).’” Prelim. Resp. 54 (citing Ex. 1015, 171–
`
`72). Patent Owner further argues that “Eichhorn offers an array of strategies
`
`to address medication safety concerns,” and that, while
`
`for
`Eichhorn acknowledges “a clear preference
`manufacturer-prepared completely ready-to-use IV medication
`in all settings,” [Eichhorn] cited “increased cost and potential
`inapplicability” as drawbacks of this preference. Ex. 1016, p. 5.
`Thus, Eichhorn acknowledges that this approach is not feasible
`for all drugs.
`
`Id. at 56.
`
`
`
`With reference to Lavoisier, Patent Owner further argues as follows:
`
`Lavoisier taught that “[w]hen a drug is added to this solution,
`admixture should be dispensed instantly.” Ex. 1018, p. 1
`(emphasis added). As such, this reference explicitly teaches
`away from adding a drug to the sodium chloride solution and
`
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`
`storing the resulting admixture in the containers provided by
`Lavoisier . . . .
`
`Petitioner argues that 0.9% sodium chloride solution is
`routinely used in the industry because 0.9% sodium chloride is
`an isotonic solution suitable for formulation of parenteral drugs.
`Pet., p. 47. However, at the time of the invention, it was not
`predictable or expected
`that dexmedetomidine could be
`formulated with 0.9% sodium chloride solution at the claimed
`concentrations in a ready to use composition. In particular, it was
`not expected that dexmedetomidine could be formulated in a
`stable form that was ready to use upon manufacture at
`concentrations lower than 100 μg/mL. Rather, the McCormick
`FDA Memorandum taught that the concentrated form of
`dexmedetomidine “is prepared for use by diluting it with sterile
`0.9% sodium chloride solution for injection after which it is
`stable for 24 hours” (Ex. 1013, p. 8), and the Rappaport FDA
`Memorandum
`further cautioned
`that administration of
`dexmedetomidine for greater
`than 24 hours cannot be
`recommended without “appropriate studies to assure persistent
`effectiveness.” Ex. 1019, p. 29.
`
`Id. at 58–59.
`
`Upon consideration of the arguments presented and evidence of
`
`record, we find that Petitioner has offered sufficient evidence to institute
`
`trial, and Patent Owner’s arguments do not persuade us that we should
`
`decline to go forward with a trial. We determine that Petitioner has
`
`demonstrated a reasonable likelihood that claims 1–7 would have been
`
`obvious over the teachings of 2010 Precedex Label, De Giorgi, Eichhorn,
`
`Palmgrén, and Lavoisier.
`
`D. Petitioner’s Remaining Grounds
`
`Petitioner asserts that the subject matter of claims 1–7 would have
`
`been obvious in view of the combination of references set forth in Grounds 1
`
`and 2. Pet. 18–38. In view of our instituting an inter partes review of all of
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`IPR2016-01578
`Patent 8,338,470 B1
`
`these claims on another ground, as set forth above, we deny institution on
`
`these additional grounds. See 37 C.F.R. § 42.108(a)-(b).
`
`III. CONCLUSION
`
`We conclude that Petitioner has established a reasonable likelihood of
`
`prevailing on its assertions that claims 1–7 of the ’470 patent are
`
`unpatentable as obvious.
`
`At this stage of the proceeding, the Board has not made a final
`
`determination as to the patentability of any challenged claim or the
`
`construction of any claim term. Thus, our view with regard to any
`
`conclusion reached in the foregoing could change upon consideration of
`
`Patent Owner’s merits response and upon completion of the record.
`
`IV.
`
` ORDER
`
`In consideration of the foregoing, it is hereby:
`
`ORDERED that the Petition is granted with regard to the following
`
`asserted ground: obviousness of claims 1–7 of the ʼ470 patent over the
`
`combination of 2010 Precedex Label, De Giorgi, Eichhorn, Palmgrén, and
`
`Lavoisier.
`
`FURTHER ORDERED that pursuant to 35 U.S.C. § 314(a), inter
`
`partes review of the ʼ470 patent is hereby instituted commencing on the
`
`entry date of this Order, and pursuant to 35 U.S.C. § 314(c) and 37 C.F.R.
`
`§ 42.4, notice is hereby given of the institution of a trial.
`
`FURTHER ORDERED that the trial is limited to the ground listed in
`
`the Order. No other grounds are authorized.
`
`
`
`16
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`

`

`Trials@uspto.gov
`Tel: 571-272-7822
`
`
`Paper 11
`Entered: February 9, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMNEAL PHARMACUTICALS LLC,
`Petitioner,
`
`v.
`
`HOSPIRA INC.,
`Patent Owner.
`
`
`Case IPR2016-01579
`Patent 8,455,527 B1
`
`
`
`
`Before MICHAEL J. FITZPATRICK, SHERIDAN K. SNEDDEN, and
`ZHENYU YANG, Administrative Patent Judges.
`
`FITZPATRICK, Administrative Patent Judge, concurring.
`
`
`
`In light of Petitioner’s evidence in support of a legal conclusion that
`
`the subject matter of the challenged claims would have been obvious even
`
`under Patent Owner’s construction of the claims and, in particular, of the
`
`term “ready to use,” the Board’s Opinion does not construe fully the term
`
`“ready to use.”
`
`Nonetheless, I would construe the term in Petitioner’s favor, as
`
`referring to “premixed compositions that are suitable for administration to a
`
`patient without dilution, such that they do not require reconstitution or
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`

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`IPR2016-01578
`Patent 8,338,470 B1
`
`dilution prior to administration to a patient.” See Ex. 1001, 3:51–53, 3:60–
`
`62.
`
`Patent Owner’s proposed construction—“formulated such that it is
`
`suitable for administration to a patient upon manufacture without dilution or
`
`reconstitution by a clinician, hospital personnel, caretaker, patient, or any
`
`other individual” (see Prelim. Resp. 9)—oversteps in reading additional
`
`features into the claim that the specification describes as exemplary only.
`
`See Ex. 1001, 3:53–58 (“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.” (emphasis added)).
`
`If, during the inter partes review, Patent Owner reargues its
`
`construction of “ready to use,” it should additionally argue how that
`
`construction would affect patentability. Under Patent Owner’s construction,
`
`I would interpret claim 1 as a product-by-process claim. In which case, for
`
`patentability purposes, it likely would not matter how, when, or by whom
`
`the composition was made. See In re Thorpe, 777 F.2d 695, 697 (Fed. Cir.
`
`1985) (“The patentability of a product does not depend on its method of
`
`production.”).
`
`2
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`

`

`IPR2016-01578
`Patent 8,338,470 B1
`
`
`
`
`
`
`
`PETITIONER:
`
`Paul Tully
`tully@mbhb.com
`
`Kevin Noonan
`noonan@mbhb.com
`
`Andrea Orth
`orth@mbhb.com
`
`
`
`
`PATENT OWNER:
`
`Sandra Lee
`sandra.lee@bakerbotts.com
`
`Eliot Williams
`eliot.williams@bakerbotts.com
`
`Stephen Hash
`stephen.hash@bakerbotts.com
`
`
`
`3
`
`