Trials@uspto.gov
`571-272-7822
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` Paper 11
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`Date: February 3, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMNEAL PHARMACUTICALS LLC,
`Petitioner,
`
`v.
`
`HOSPIRA INC.,
`Patent Owner.
`
`
`
`Case IPR2016-01580
`Patent 8,648,106 B2
`
`
`
`
`Before MICHAEL J. FITZPATRICK, SHERIDAN K. SNEDDEN, and
`ZHENYU YANG, Administrative Patent Judges.
`
`FITZPATRICK, Administrative Patent Judge.
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`571-272-7822
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` Paper 11
`
`Date: February 3, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMNEAL PHARMACUTICALS LLC,
`Petitioner,
`
`v.
`
`HOSPIRA INC.,
`Patent Owner.
`
`
`
`Case IPR2016-01580
`Patent 8,648,106 B2
`
`
`
`
`Before MICHAEL J. FITZPATRICK, SHERIDAN K. SNEDDEN, and
`ZHENYU YANG, Administrative Patent Judges.
`
`FITZPATRICK, Administrative Patent Judge.
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`IPR2016-01580
`Patent 8,648,106 B2
`
`
`I.
`
`INTRODUCTION
`
`Petitioner, Amneal Pharmaceuticals LLC filed a Petition to institute
`an inter partes review of claims 1–9 of U.S. Patent No. 8,648,106 B2
`(Ex. 1001, “the ’106 patent”) pursuant to 35 U.S.C. § 311(a). Paper 2
`(“Pet.”). Patent Owner, Hospira Inc., filed a Preliminary Response under 35
`U.S.C. § 313. Paper 9 (“Prelim. Resp.”).
`We have authority to determine whether to institute an inter partes
`review. 35 U.S.C. § 314(b); 37 C.F.R. § 42.4(a). Upon consideration of the
`Petition and Preliminary Response, and for the reasons explained below, we
`determine that the information presented does not show a reasonable
`likelihood that Petitioner would prevail with respect to any claim challenged
`in the Petition. See 35 U.S.C. § 314(a); 37 C.F.R § 42.108. The Petition is
`denied.
`
`A. Related Matters
`Patent Owner has asserted the ’106 patent in Hospira, Inc. v. Amneal
`Pharmaceuticals LLC, No. 1:15-cv-00697 (D. Del.). Pet. 74; Paper 4, 2.
`Petitioner has filed petitions for inter partes reviews of U.S. Patent
`Nos. 8,338,470 B1, 8,455,527 B1, and 8,242,158 B1, which are related to
`the ’106 patent. Pet. 6–7; see also Cases IPR2016-01578, IPR2016-01579,
`IPR2016-01577.
`
`B. The ’106 Patent
`
`4-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole is known shorthand as
`medetomidine. Ex. 1001, 1:26–27. It is a racemic mixture of two
`
`2
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`
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`IPR2016-01580
`Patent 8,648,106 B2
`
`enantiomers: levomedetomidine and dexmedetomidine. Id.; Ex. 2005 ¶25.1
`The ’106 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.” Ex. 1001, 1:19–22.
`The ’106 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
`1:28–50. The ’106 patent also acknowledges prior patents disclosing
`medical administration of dexmedetomidine, including via epidural,
`parenteral, intravenous, oral, hypodermic, and transmucosal routes. Id. at
`1:34–60 (citing various U.S. patents).
`
`C. The Challenged Claims
`
`Of the challenged claims, claim 1 is independent. It is illustrative and
`reproduced below.
`A ready to use liquid pharmaceutical composition
`1.
`for parenteral administration
`to a subject, comprising
`dexmedetomidine or a pharmaceutically acceptable salt thereof
`disposed within a sealed glass container, wherein the liquid
`pharmaceutical composition when stored in the glass container
`for at least five months exhibits no more than about 2% decrease
`in the concentration of dexmedetomidine.
`
`D. Asserted Grounds of Unpatentability
`
`Petitioner asserts the following grounds of unpatentability:
`
`
`1 Exhibit 2005 is a declaration by Robert Linhardt, Ph.D.
`3
`
`
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`IPR2016-01580
`Patent 8,648,106 B2
`
`References
`2010 Precedex Label (Ex. 1007)3 and
`Palmgren (Ex. 1017)4
`Aantaa (Ex. 1006),5 2010 Precedex Label,
`and Palmgren
`2010 Precedex Label, De Giorgi
`(Ex. 1015),6 Eichhorn (Ex. 1016),7
`Palmgren, and Lavoisier (Ex. 1018)8
`Pet. 11–12.
`
`Basis2
`§ 103(a)
`
`Claims
`1–9
`
`§ 103(a)
`
`1–9
`
`§ 103(a)
`
`1–9
`
`
`2 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29,
`which was enacted September 16, 2011, made amendments to 35 U.S.C.
`§§ 102 and 103. AIA § 3(b) and (c). Those amendments became effective
`eighteen months later on March 16, 2013. Id. at § 3(n). Because the
`application from which the ’106 patent issued was filed before March 16,
`2013, any citations herein to 35 U.S.C. §§ 102 and 103 are to their pre-AIA
`versions.
`3 The 2010 Precedex Label is an FDA-approved label for Precedex, which is
`the commercial or brand name for dexmedetomidine-HCl. Ex. 1007, l. 7.
`Petitioner alleges it was published September 2010.
`4 Palmgren, 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).
`5 U.S. Patent No. 6,716,867 B1, issued April 6, 2004.
`6 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).
`7 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).
`8 Lavoisier product sheet for NaCl 0.9% injectable solution (June 2009).
`4
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`IPR2016-01580
`Patent 8,648,106 B2
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`
`II. ANALYSIS
`
`A. Claim Construction
`
`“A claim in an unexpired patent that will not expire before a final
`written decision is issued shall be given its broadest reasonable construction
`in light of the specification of the patent in which it appears.” 37 C.F.R.
`§ 42.100(b). Pursuant to that standard, the claim language should be read in
`light of the specification, as it would be interpreted by one of ordinary skill
`in the art. In re Suitco Surface, Inc., 603 F.3d 1255, 1260 (Fed. Cir. 2010).
`Thus, we generally give claim terms their ordinary and customary meaning.
`See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007) (“The
`ordinary and customary meaning ‘is the meaning that the term would have to
`a person of ordinary skill in the art in question.’” (quoting Phillips v. AWH
`Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc))). A patentee,
`however, may rebut this presumption by acting as his own lexicographer,
`providing a definition of the term in the specification with “reasonable
`clarity, deliberateness, and precision.” In re Paulsen, 30 F.3d 1475, 1480
`(Fed. Cir. 1994).
`The parties propose express constructions for two limitations,
`“dexmedetomidine” and “ready to use,” both of which appear in claim 1 and
`are incorporated by the remainder of the claims of the ’106 patent. We need
`not construe these limitations, however, as a different limitation of claim 1 is
`dispositive of the Petition. That limitation is “wherein the liquid
`pharmaceutical composition when stored in the glass container for at least
`five months exhibits no more than about 2% decrease in the concentration of
`dexmedetomidine.” As explained below, none of Petitioner’s grounds show
`5
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`IPR2016-01580
`Patent 8,648,106 B2
`
`this limitation is met by the prior art.
`
`B. Obviousness over 2010 Precedex Label and Palmgren
`
`In assessing obviousness, “the scope and content of the prior art are to
`be determined; differences between the prior art and the claims at issue are
`to be ascertained; and the level of ordinary skill in the pertinent art
`resolved.” Graham v. John Deere Co., 383 U.S. 1, 17 (1966).9
`
`1. Disclosure of 2010 Precedex Label
`The 2010 Precedex Label is a drug label for Food and Drug
`Administration-approved “Precedex (dexmedetomidine hydrochloride)
`injection.” Ex. 1007, l. 7. It discloses Precedex “[f]or intravenous infusion
`following dilution.” Id. at line 8.
`Precedex is supplied in 2mL glass vials at a concentration of 100
`mcg/mL, which are “[s]tore[d] at controlled room temperature, 25°C (77°F)
`with excursions allowed from 15 to 30°C (59 to 86°F).” Id. at ll. 698–701.
`The drug “must be diluted in 0.9% sodium chloride solution to achieve
`required concentration (4 mcg/mL) prior to administration.” Id. at ll. 175–
`76.
`
`
`9 Additionally, secondary considerations such as “commercial success, long
`felt but unsolved needs, failure of others, etc., might be utilized to give light
`to the circumstances surrounding the origin of the subject matter sought to
`be patented. As indicia of obviousness or nonobviousness, these inquiries
`may have relevancy.” Graham, 383 U.S. at 17–18. In its Preliminary
`Response, however, Patent Owner does not argue that any secondary
`considerations evidence supports non-obviousness of the challenged claims.
`6
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`IPR2016-01580
`Patent 8,648,106 B2
`
`
`2. Disclosure of Palmgren
` Palmgren discloses results of experiments on adsorption of certain
`acidic and basic drugs to various containers. Ex. 1017, Abstract. Palmgren
`reported that loss in basic drugs, including medetomidine, to polystyrene and
`polycarbonate was much higher than to glass and polypropylene tubes. Id.
`at 374.
`
`3. Application of the Prior Art to the Challenged Claims
`Petitioner argues that the subject matter of claims 1–9 would have
`been obvious to a person of ordinary skill in the art in view of the teachings
`of the 2010 Precedex Label and Palmgren. Pet. 15–31. In brief, Petitioner
`argues that a person of ordinary skill in the art would have diluted Precedex,
`according to the 2010 Precedex Label, to a liquid composition having a
`dexmedetomidine-HCl concentration of 4 mcg/mL, which would make the
`drug “ready to use” (see, e.g., Ex. 1001, 2:19–21, 26:41–43 (claim 6)) and
`contain the so-diluted liquid in a “sealed glass container,” thereby satisfying
`those limitations of claim 1. Id. at 17–19.
`Claim 1, however, additionally recites “wherein the liquid
`pharmaceutical composition when stored in the glass container for at least
`five months exhibits no more than about 2% decrease in the concentration of
`dexmedetomidine.” Petitioner presents various arguments with respect to
`this limitation but none is sufficient. Id. at 20–23.
`First, Petitioner argues that “Precedex™ concentrate disclosed in the
`2010 Precedex Label was determined to be stable for two years.” Id. at 20
`(citing Ex. 1013, 8). This argument is inapposite because it speaks to the
`
`7
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`IPR2016-01580
`Patent 8,648,106 B2
`
`concentrated form of dexmedetomidine-HCl disclosed in the 2010 Precedex
`Label, which is outside the scope of claim 1, and not to a “ready to use”
`diluted form. Moreover, Petitioner has not shown that “stable” is equivalent
`in meaning to “no more than about 2% decrease in the concentration of
`dexmedetomidine,” as recited in claim 1. In fact, Petitioner’s own
`understanding of “stable” affords up to a 10% decrease in concentration.
`See id. at 20–21 (“Based on FDA requirements for drug stability, one of skill
`in the art would expect at most a 10% decrease in concentration.”) (citing
`Ex. 1003 ¶¶66–68).
`Second, Petitioner reargues that a person of ordinary skill in the art
`would have a reason to use a glass container for the “ready to use”
`dexmedetomidine-HCl composition because glass yields superior stability
`results. Pet. 21. We agree with that proposition, but it does not account for
`the limitation at issue—that “the liquid pharmaceutical composition when
`stored in the glass container for at least five months exhibits no more than
`about 2% decrease in the concentration of dexmedetomidine.”
`Third, Petitioner asserts that this limitation is inherently met, stating:
`“It is irrelevant that the 2010 Precedex Label does not explicitly disclose this
`inherent property of the Precedex® solutions therein.” Pet. 22. But, like its
`“stable for two years” argument, Petitioner’s inherency argument speaks to
`the concentrated form of dexmedetomidine-HCl disclosed in the 2010
`Precedex Label, which is outside the scope of claim 1, and not to a “ready to
`use” diluted form. Moreover, the stated basis for Petitioner’s inherency
`assertion is that “the Precedex™ solutions disclosed in the 2010 Precedex
`Label were stored under identical conditions – sterile, in a sealed glass
`
`8
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`IPR2016-01580
`Patent 8,648,106 B2
`
`container – as those in Example 1 of the ’106 patent which exhibited no
`more than about 2% decrease in the concentration.” Id. at 22 (citing Ex.
`1001, 13:35–43; Ex. 1007, ll. 207–08, 697–701). But, the conditions were
`not identical; they employed different concentrations and temperatures.
`More specifically, the 2010 Precedex Label discloses glass vial storage of
`dexmedetomidine-HCl at a concentration of 100 mcg/mL concentration and
`a temperature of “25°C (77°F) with excursions allowed from 15 to 30°C (59
`to 86°F),” whereas Example 1 of the ’106 patent presents five-month
`stability data for dexmedetomidine-HCl at a concentration of just 4 mcg/mL
`and at a temperature of 40°C. Compare Ex. 1007, lines 697–701, with Ex.
`1001, 13:28–37, 45–47, 14:4–14.
`Further, Example 1 of the ’106 patent indicates that the difference in
`temperature, from 40°C to 25°C, is quite significant to the stability of
`dexmedetomidine-HCl. As part of Example 1, concentration loss of
`dexmedetomidine-HCl was measured after two weeks of glass vial storage at
`25°C, which is the only time duration that was tested at 25°C. Ex. 1001,
`14:4–14. The measured loss was 1.8%. Id. at 14:14 (reporting 98.2%
`potency). In contrast, only 0.6% was lost after 1 month of glass vial storage
`at 40°C, which is the shortest time duration tested at 40°C. Id. at 14:14
`(reporting 99.4% potency).
`In sum, Petitioner has not shown that the relied-upon prior art teaches
`“wherein the liquid pharmaceutical composition when stored in the glass
`container for at least five months exhibits no more than about 2% decrease
`in the concentration of dexmedetomidine,” or that it is inherent. That
`limitation is recited by claim 1 and incorporated by all other challenged
`
`9
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`IPR2016-01580
`Patent 8,648,106 B2
`
`claims via their dependency on claim 1. Accordingly, there is not a
`reasonable likelihood of Petitioner prevailing in challenging any of claims
`1–9 as unpatentable over 2010 Precedex Label and Palmgren.
`
`C. The Remaining Grounds
`
`Petitioner challenges claims 1–9 as unpatentable over Aantaa, the
`2010 Precedex Label, and Palmgren as well as over the 2010 Precedex
`Label, De Giorgi, Eichhorn, Palmgren, and Lavoisier. Pet. 11–12. In both
`of these additional grounds, Petitioner relies on the same flawed inherency
`argument. See Pet. 37–38, 56. Accordingly, there likewise is not a
`reasonable likelihood of Petitioner prevailing in challenging claims 1–9 on
`either of these remaining grounds.
`
`III. CONCLUSION
`
`We have considered the information presented in the Petition and
`Preliminary Response and determine that there is not a reasonable likelihood
`that Petitioner would prevail with respect to any claim challenged in the
`Petition. See 35 U.S.C. § 314(a); 37 C.F.R. § 42.108.
`
`IV. ORDER
`
`Accordingly, it is
`ORDERED that the Petition is denied.
`
`10
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`
`
`IPR2016-01580
`Patent 8,648,106 B2
`
`For Petitioner:
`
`Paul Tully
`Kevin Noonan
`Andrea Orth
`MCDONNELL BOEHNEN HULBERT & BERGHOFF LLP
`tully@mbhb.com
`noonan@mbhb.com
`orth@mbhb.com
`
`
`
`For Patent Owner:
`
`Sandra Lee
`Eliot Williams
`Stephen Hash
`BAKER BOTTS L.L.P.
`sandra.lee@bakerbotts.com
`eliot.williams@bakerbotts.com
`stephen.hash@bakerbotts.com
`
`
`
`
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`11
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