Trials@uspto.gov
`Tel.: 571-272-7822
`
`
`
`
`Paper No. 9
`Entered: March 10, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`COALITION FOR AFFORDABLE DRUGS XI LLC,
`Petitioner,
`
`v.
`
`INSYS PHARMA, INC.,
`Patent Owner.
`______________
`
`Case IPR2015-01800
`Patent 8,486,972 B2
`_______________
`
`
`
`Before DEBORAH KATZ, GRACE KARAFFA OBERMANN,
`and SUSAN L. C. MITCHELL, Administrative Patent Judges.
`
`OBERMANN, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`Tel.: 571-272-7822
`
`
`
`
`Paper No. 9
`Entered: March 10, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`COALITION FOR AFFORDABLE DRUGS XI LLC,
`Petitioner,
`
`v.
`
`INSYS PHARMA, INC.,
`Patent Owner.
`______________
`
`Case IPR2015-01800
`Patent 8,486,972 B2
`_______________
`
`
`
`Before DEBORAH KATZ, GRACE KARAFFA OBERMANN,
`and SUSAN L. C. MITCHELL, Administrative Patent Judges.
`
`OBERMANN, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`IPR2015-01800
`Patent 8,486,972 B2
`
`
`I. INTRODUCTION
`Petitioner requests an inter partes review of claims 1–3 of U.S. Patent
`8,486,972 B2 (“the ’972 patent”). Paper 1 (“Pet.”). Patent Owner filed a
`Preliminary Response. Paper 8 (“Prelim. Resp.”). We have statutory authority
`under 35 U.S.C. § 314(a), which provides that an inter partes review may not be
`instituted unless the Petition demonstrates “a reasonable likelihood that the
`petitioner would prevail with respect to at least 1 of the claims challenged in the
`petition.” Taking account of the information presented in the Preliminary
`Response, we conclude that the Petition fails to make that showing. On this
`record, we deny the Petition and decline to institute review.
`
`Related Proceedings
`A.
`Petitioner identifies no related district court proceedings. Pet. 3. With this
`decision, we issue decisions denying inter partes review in IPR2016-01797 and
`IPR2016-01799, which involve the same parties and related patents.
`
`The ’972 Patent
`B.
`The ’972 patent relates to a sublingual formulation of fentanyl, an opioid
`receptor agonist with analgesic potency up to 100 times that of morphine.
`Ex. 1001, 1:12–13. Sublingual delivery is achieved through the mucosal
`membranes lining the floor of the mouth. Id. at 8:23–24. The ’972 patent
`describes a sublingual formulation of fentanyl useful for relieving “breakthrough
`pain” in cancer patients almost immediately after administration. Id. at 6:26–39.
`The ’972 patent distinguishes sublingual (floor of the mouth) administration
`from other routes of delivery, for example, buccal (lining of the cheeks)
`administration. Id. at 7:58–8:29. The specification recognizes solid (such as
`lozenge) and liquid (such as spray pump) forms of sublingual fentanyl. Id. at
`1:59–61; 9:9–12. The ’972 patent discloses a fentanyl formulation delivered “to
`2
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`IPR2015-01800
`Patent 8,486,972 B2
`
`the sublingual mucosa via spray,” which “results in a rapid onset of therapeutic
`effect of” the active agent. Id. at 9:43–45.
`
`C.
`
`Illustrative Claim
`
`Claims 1, the only independent claim, is illustrative and reads as follows:
`1. A unit dose of a non-propellant sublingual fentanyl formulation
`comprising discrete liquid droplets of an effective amount of fentanyl
`and a pharmaceutically acceptable
`liquid carrier, wherein
`the
`sublingual fentanyl formulation comprises:
`
`from about 01.% to about 0.8% by weight of fentanyl or a
`pharmaceutically acceptable salt thereof; from about 20% to about 60%
`weight of ethanol; and from about 4% to about 6% by weight of
`propylene glycol;
`
`wherein after sublingual administration to a human, said
`sublingual fentanyl formulation provides a mean time to maximum
`plasma concentration (Tmax) of fentanyl of from about 5 to about 120
`minutes.
`
`The Asserted Prior Art
`D.
`The Petition asserts the following references in the grounds of
`unpatentability:
`1. UK Patent App. No. GB 2399286 A, pub. Sept. 15, 2004. (Ex. 1003)
`(“Ross GB”).
`2. US Patent Pub. No. 2006/0062812 A1, pub. Mar. 23, 2006 (Ex. 1005)
`(“Ross US”).
`3. US Patent No. 5,370,862, issued Dec. 6, 1994 (Ex. 1004) (“Klokkers-
`Bethke”).
`4. US Patent Pub. No. 2002/0055496 A1, pub. May 9, 2002 (Ex. 1006)
`(“McCoy”).
`
`
`
`
`
`
`3
`
`
`
`IPR2015-01800
`Patent 8,486,972 B2
`
`
`Asserted Grounds of Unpatentability
`E.
`The Petition asserts the following grounds of unpatentability:
`
`References
`
`Ross GB, Ross US, and
`Klokkers-Bethke
`Ross GB, Ross US,
`Klokkers-Bethke,
`and McCoy
`
`Basis
`
`§ 103
`
`§ 103
`
`Claim(s)
`Challenged
`1, 3
`
`2
`
`In addition to the asserted prior art references, the Petition advances
`declaration testimony of Dr. Kinam Park. Ex. 1002.
`
`II. ANALYSIS
`
`A. Claim Construction
`In an inter partes review, we construe claim terms of an unexpired patent
`according to their broadest reasonable interpretation in light of the patent
`specification. 37 C.F.R. § 42.100(b). Under that standard, we assign terms their
`ordinary and customary meaning as understood by one of ordinary skill in the art
`in the context of the entire patent disclosure. In re Translogic Tech., Inc., 504 F.3d
`1249, 1257 (Fed. Cir. 2007). Any special definition for a claim term must be set
`forth in the specification with reasonable clarity, deliberateness, and precision. In
`re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). We construe only those terms
`necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc.,
`200 F.3d 795, 803 (Fed. Cir. 1999).
`No claim term requires express construction for the purposes of this
`decision. The prior art, itself, demonstrates the appropriate level of ordinary skill
`in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350,
`1355 (Fed. Cir. 2001) (the prior art, itself, can reflect the level of skill in the art).
`4
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`IPR2015-01800
`Patent 8,486,972 B2
`
`
`B. A Problem Common to Both Grounds Asserted in the Petition
`A problem common to both grounds asserted in the Petition is a failure to
`identify a persuasive reason why a person of ordinary skill in the art would have
`been prompted to combine the various elements of the prior art in the precise
`fashion required by the challenged claims. “[A] patent composed of several
`elements is not proved obvious merely by demonstrating that each of its elements
`was, independently, known in the prior art.” KSR Int’l Co. v. Teleflex Inc., 550
`U.S. 398, 418 (2007). “If identification of each claimed element in the prior art
`were sufficient to negate patentability, very few patents would ever issue.” In re
`Rouffet, 149 F.3d 1350, 1357 (Fed. Cir. 1998).
`Obviousness can be established when the prior art, itself, would have
`suggested the claimed subject matter. In re Rinehart, 531 F.2d 1048, 1051
`(CCPA 1976). But the Petition identifies no persuasive reason why the prior art
`would have recommended the combination of elements upon which the challenges
`depend. In that regard, the Petition strives to identify each element of the claims,
`from among disparate disclosures in the art, but neglects to explain adequately why
`one would have selected and combined those particular features to arrive at the
`sublingual fentanyl formulation required by the challenged claims. The Petition is
`replete with examples of that deficiency. We focus our analysis on one example,
`which is dispositive and requires denial of review.
`
`C. The Propylene Glycol Limitation of Claims 1, 2, and 3
`Claim 1 is directed to a sublingual fentanyl formulation comprising fentanyl
`(or a pharmaceutically acceptable salt thereof), ethanol, and propylene glycol in
`specified weight-percent amounts. Claims 2 and 3 depend from claim 1 and, thus,
`inherit those limitations. The Petition relies on the combined disclosures of
`
`
`
`5
`
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`IPR2015-01800
`Patent 8,486,972 B2
`
`Ross GB and Klokkers-Bethke to establish the obviousness of the limitation that
`requires “from about 4% to about 6% by weight” of propylene glycol.
`The Petition relies on a modification to Example 1 in Ross GB, which
`discloses a formulation that includes fentanyl base, saccharin, ethanol, menthol,
`and citrate buffer—but no propylene glycol. Pet. 30–34 (citing Ex. 1003, 11:1–9
`(Ross GB’s Example 1)). For the teaching of the propylene glycol limitation,
`Petitioner directs us to two disclosures in Ross GB that relate to propylene glycol;
`first, as a suitable solubility enhancer for fentanyl (Ex. 1003, 5:1–4), and second,
`as a suitable moisturizing agent (id. at 7:11–14). Pet. 31–32. The Petition does not
`identify in Ross GB any disclosure or suggestion of a weight-percent range of
`propylene glycol that would be useful in Ross GB’s Example 1 formulation. Id.
`Instead, the Petition directs us to Klokkers-Bethke’s disclosure of propylene
`glycol in a nitroglycerin formulation for treating angina. Pet. 32; Ex. 1004, Title,
`1:16–18. The Petition identifies no disclosure in Klokkers-Bethke that mentions
`fentanyl or pain management. Pet. 30–34. The Petition ignores that Ross GB’s
`fentanyl formulation is “preferably free of any propellant,” whereas Klokkers-
`Bethke’s nitroglycerin formulation is delivered via a closed and charged aerosol
`canister and, thus, includes propellant. Ex. 1003, 4:1; see Ex. 1004, Abstract,
`3:20–23, 4:2, 6:10; Prelim Resp. 14 (discussing that distinction between the
`applied references) (citations omitted).
`The Petition identifies Klokkers-Bethke’s disclosure of a “broad range
`of 2% to 30% by weight” for propylene glycol in the aerosol nitroglycerin
`formulation, and then argues, without adequate analysis, that an ordinary artisan,
`by routine experimentation, would have modified that range in the nitroglycerin
`formulation to reach an optimal range “of about 4% to about 6%” by weight.
`Pet. 32–34. The Petition does not direct us to a disclosed purpose for propylene
`
`
`
`6
`
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`IPR2015-01800
`Patent 8,486,972 B2
`
`glycol in Klokkers-Bethke’s nitroglycerin formulation—for example, a purpose
`comparable to one described for the fentanyl formulation of Example 1 in
`Ross GB. Id. at 31–33. The closest the Petition comes to identifying some reason
`that would have prompted one to import the optimized weight-percent of propylene
`glycol from the propellant-containing nitroglycerin formulation of Klokkers-
`Bethke, into the propellant-free fentanyl formulation of Ross GB, is in the
`argument that both formulations are “used in emergencies when the medication
`should be fast acting.” Id. at 33 (quoting Ex. 1002 ¶ 24).
`Critically lacking is any objective evidence—for example, a suggestion in
`the prior art—that a person of ordinary skill in the art would have understood that
`the amount of propylene glycol, optimized for use in an aerosol nitroglycerin
`formulation, would match the optimal amount of propylene glycol, useful in a
`propellant-free fentanyl formulation. Id. at 32–34. The Petition fails to address
`adequately how the compositional differences between the disparate formulations
`of Ross GB and Klokkers-Bethke would have informed that understanding.
`Compare Ex. 1003, 11:1–9 (Example 1 of Ross GB includes fentanyl, saccharin,
`ethanol, menthol, and citrate buffer), with Ex. 1004, 3:65–4:8 (Klokkers-Bethke’s
`formulation includes nitroglycerin, ethanol, propylene glycol, and propellant).
`Even if we set aside those shortcomings, the Petition is still deficient. As
`Patent Owner points out, the Petition is silent on “how the percentage by weight of
`propylene glycol in a closed and charged aerosol canister would change upon
`dispensation, prior to sublingual delivery.” Prelim. Resp. 14. The Petition also
`fails to take into account how the addition of propylene glycol would upset the
`weight-percent amounts of fentanyl or ethanol in Ross GB’s Example 1
`formulation, upon which the Petition relies for disclosure of the other weight-
`percent limitations of the challenged claims. Pet. 30–34.
`
`
`
`7
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`IPR2015-01800
`Patent 8,486,972 B2
`
`
`Ross GB discloses that propylene glycol is useful in fentanyl formulations
`that are “free of [] alcohol.” Prelim. Resp. 17 (quoting Ex. 1003, 5:14–15).
`Ross GB’s Example 1 formulation comprises “40% by weight of ethanol.” Pet. 31;
`Ex. 1003, 11:1–9 (Example 1). Petitioner does not explain adequately why one
`would have imported Klokkers-Bethke’s optimized amount of propylene glycol
`into the ethanol-containing formulation of Ross GB’s Example 1.
`In sum, the information presented does not show sufficiently that an
`ordinary artisan would have modified the formulation of Ross GB’s Example 1 to
`include propylene glycol in a weight-percent amount that satisfies claims 1, 2, or 3.
`Both grounds asserted in the Petition depend upon that modification. Pet. 31–33.
`On this record, the Petition fails to establish a reasonable likelihood of prevailing
`with respect to claim 1, 2, or 3.
`
`III. CONCLUSION
`Taking account of the information in the Petition and Preliminary Response,
`we decline to institute review because the information presented does not
`demonstrate a reasonable likelihood that Petitioner would prevail with respect to at
`least one of the claims challenged in the Petition. 35 U.S.C. § 314(a).
`
`IV. ORDER
`
`For the reasons given, it is
`ORDERED that the Petition is denied.
`
`
`
`
`
`8
`
`
`
`IPR2015-01800
`Patent 8,486,972 B2
`
`FOR PETITIONER:
`Gregory J. Gonsalves
`gonsalves@gonsalveslawfirm.com
`
`Christopher Casieri
`MCNEELY, HARE & WAR LLP
`chris@miplaw.com
`
`FOR PATENT OWNER:
`Gerald J. Flattmann
`Naveen Modi
`PAUL HASTINGS LLP
`CFAD-Insys@paulhastings.com
`
`
`
`
`9
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