Trials@uspto.gov
`571-272-7822
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` Paper No. 10
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` Entered: August 29, 2018
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`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMNEAL PHARMACEUTICALS LLC AND
`AMNEAL PHARMACEUTICALS OF NEW YORK, LLC,
`Petitioner,
`
`v.
`
`ALLERGAN, INC.,
`Patent Owner.
`____________
`
`Case IPR2018-00608
`Patent 9,161,926 B2
`____________
`
`Before SHERIDAN K. SNEDDEN, TINA E. HULSE, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`SNEDDEN, Administrative Patent Judge.
`
`
`
`DECISION
`Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`
`
`
`571-272-7822
`
`
`
`
`
`
`
`
`
`
`
`
` Paper No. 10
`
`
` Entered: August 29, 2018
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMNEAL PHARMACEUTICALS LLC AND
`AMNEAL PHARMACEUTICALS OF NEW YORK, LLC,
`Petitioner,
`
`v.
`
`ALLERGAN, INC.,
`Patent Owner.
`____________
`
`Case IPR2018-00608
`Patent 9,161,926 B2
`____________
`
`Before SHERIDAN K. SNEDDEN, TINA E. HULSE, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`SNEDDEN, Administrative Patent Judge.
`
`
`
`DECISION
`Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`I.
`
`INTRODUCTION
`Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals of New
`York, LLC (collectively, “Petitioner”), filed a Petition requesting an inter
`partes review of claims 1–6 of U.S. Patent No. 9,161,926 B2 (Ex. 1001, “the
`’926 patent”). Paper 2 (“Pet.”). Biogen, Inc. (“Patent Owner”) filed a
`Preliminary Response. Paper 8 (“Prelim. Resp.”). We have authority to
`determine whether to institute an inter partes review under 35 U.S.C. § 314,
`which provides that an inter partes review may not be instituted unless the
`information presented in the petition “shows that there is a reasonable
`likelihood that the petitioner would prevail with respect to at least 1 of the
`claims challenged in the petition.” See also 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 established
`a reasonable likelihood that it would prevail with respect to at least one
`challenged claim. We thus institute an inter partes review of the challenged
`claims on all grounds set forth in the Petition.
`
`A. Related Matters
`The parties represent that they are not aware of any other judicial or
`administrative matter involving the ’926 patent. Pet. 6: Paper 4.
`
`B. The ’926 patent
`The ’926 patent describes compositions containing the drug dapsone,
`which are useful for treating a variety of dermatological conditions. Ex.
`1001, Abst. The ’926 patent discloses that “[u]se of the polymeric viscosity
`builder provides compositions with increased concentrations of diethylene
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`Patent 9,161,926 B2
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`glycol monoethyl ether relative to compositions without the polymeric
`viscosity builder.” Id. at Abst.
`The ’926 patent describes the invention as follows:
`it has been found that use of a polymeric viscosity builder
`minimizes the intensity of yellowing of the composition caused
`by the increased solubility of dapsone in diethylene glycol
`monoethyl ether. In addition, the polymeric viscosity builder
`influences dapsone crystallization. This, in turn, results in
`compositions with improved aesthetics (i.e., reduction in particle
`size which minimizes “gritty” feeling upon application).
`Id. at 2:46–53.
`According to one embodiment, the compositions include about 5%
`w/w to about 10% w/w dapsone, a first solubilizing agent (i.e., diethylene
`glycol monoethyl ether), optionally at least one second solubilizing agent, a
`polymeric viscosity builder, and water. Id. at 2:54–59.
`Example 1 of the ’926 patent “show[s] the impact of
`acrylamide/sodium acryloyldimethyltaurate copolymer based thickener on
`dapsone particle size.” Id. at 12:23–26. The results disclosed in that
`example show that larger crystals were observed in the sample with
`carbomer homopolymer type C, as compared to an acrylamide/sodium
`acryloyldimethyltaurate copolymer based thickener. Id. at 12:23–35.
`
`C. Illustrative Claims
`Independent claims 1 and 5, reproduced below, are illustrative:
`1. A topical pharmaceutical composition comprising:
`about 7.5% w/w dapsone;
`about 30% w/w to about 40% w/w diethylene glycol
`monoethyl ether;
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`about 2% w/w to about 6% w/w of a polymeric viscosity
`builder consisting of acrylamide/sodium acryloyldimethyl
`taurate copolymer; and
`water;
`wherein the composition does not comprise adapalene.
`
`
`
`5. A topical pharmaceutical composition comprising:
`about 7.5% w/w dapsone;
`about 30% w/w diethylene glycol monoethyl ether;
`about 4% w/w of a polymeric viscosity builder consisting
`of acrylamide/sodium acryloyldimethyl taurate copolymer; and
`water;
`wherein the composition does not comprise adapalene.
`
`
`Ex. 1001, 15:21–16:14–21.
`
`D. Evidence Relied Upon
`Petitioner relies upon the following prior art references:
`Ex. 1004, International Patent Application Publication No. WO
`2009/061298 (“Garrett”).
`Ex. 1005, International Application Publication No. WO 2010/072958,
`English Translation at pages 38–72 (“Nadau-Fourcade”).
`Ex. 1015, Bonacucina, G., et al., Characterization and Stability of Emulsion
`Gels Based on Acrylamide/Sodium Acryloyldimethyl Taurate Copolymer, 10
`AAPS PHARMASCITECH 368–75 (2009) (“Bonacucina”).
`Petitioner also relies upon the Declarations of Bozena B. Michniak-
`Kohn, Ph.D. (Ex. 1002) and Dr. Elaine Gilmore, M.D., Ph.D (Ex. 1018) to
`support its contentions.
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`E. Asserted Grounds of Unpatentability
`Petitioner asserts the following grounds of unpatentability (Pet. 20–
`
`21):
`
`References
`Basis
`§ 103(a) Garrett and Nadau-Fourcade
`§ 103(a) Garrett and Bonacucina
`
`Ground Claims
`1
`1–6
`2
`1–6
`II. ANALYSIS
`A. Claim Construction
`In an inter partes review, the Board interprets claim terms in an
`unexpired patent according to 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, 2142 (2016)
`(affirming applicability of broadest reasonable construction standard to inter
`partes review proceedings). Under that standard, and absent any special
`definitions, we give claim terms their ordinary and customary meaning, as
`would be understood by one of ordinary skill in the art at the time of the
`invention, in the context of the entire disclosure. In re Translogic Tech.,
`Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Any special definitions for
`claim terms must be set forth with reasonable clarity, deliberateness, and
`precision. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
`We determine that no explicit construction of any claim term is
`necessary to determine whether to institute a trial in this case. See Nidec
`Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013,
`1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in
`controversy, and only to the extent necessary to resolve the controversy.’”
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`(quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803
`(Fed. Cir. 1999))).
`
`B. Asserted Prior Art
`1. Garrett
`Garrett discloses a topical pharmaceutical composition containing
`dapsone useful for treating glucose-6-phosphate dehydrogenase-deficient
`patients. Ex. 1004, 3:9–10, 11:14–16. In particular, Garrett discloses “a
`pharmaceutical carrier system comprising a dermatological composition that
`is a semi-solid aqueous gel, wherein dapsone is dissolved in the gel such that
`the dapsone has the capacity to cross the stratum corneum layer of the
`epidermis, and wherein the composition also contains dapsone in a
`microparticulate state that does not readily cross the stratum corneum of the
`epidermis.” Id. at Abst. That is, “the composition may include dissolved
`dapsone and microparticulate dapsone.” Id. at 3.
`With regard to the concentrations of dapsone, diethylene glycol
`monoethyl ether, and water in the disclosed compositions, Garrett discloses
`the following:
`In one preferred embodiment, the composition includes about
`0.5% to 4.0% carbomer; about 53.8% to 84.2% water; about
`10% to 30% ethoxydiglycol; about 0.2% methylparaben; about
`5% to 10% dapsone in a microparticulate and dissolved state;
`and about 0.1% to 2% sodium hydroxide solution.
`Id. at 4:2–5 (emphasis added); see also Ex. 1018 ¶ 23 (indicating that the
`chemical names “ethoxydiglycol” and “diethylene glycol monoethyl ether”
`refer to the same compound).
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`
`Garrett further discloses the use of polymer thickeners in its
`compositions. In particular, Garrett discloses:
` Polymer
`Thickening agents include polymer thickeners.
`thickeners that may be used include those known to one skilled
`in the art, such as hydrophilic and hydroalcoholic gelling agents
`frequently used in the cosmetic and pharmaceutical industries. .
`. . Preferably, the gelling agent comprises between about 0.2%
`to about 4% by weight of the composition.
`Id. at 13:3–11 (emphasis added).
`Garrett discloses the role of the solvent system for the dapsone
`microparticulate compositions in the following manner:
`The solvent or mixed solvent system is important to the
`formation of the microparticulate to dissolved dapsone ratio. The
`formation of the microparticulate, however, should not interfere
`with the ability of the polymer thickener or preservative systems
`to perform their functions.
`Id. at 14:15–19. Garrett also discloses that “[t]he relative percentages for
`each of the reagents used in the present invention may vary depending upon
`. . . the desired ratio of microparticulate to dissolved dapsone.” Id. at 18:17–
`20.
`
`Garrett does not disclose specifically the use of acrylamide/sodium
`acryloyldimethyl as a polymeric thickener or gelling agent.
`
`2. Nadau-Fourcade
`Nadau-Fourcade discloses “a topical pharmaceutical composition
`containing, as an active pharmaceutical ingredient, a water-sensitive
`compound in a dissolved form in a physiologically acceptable medium, . . .
`the method of preparing it, and . . . its use in dermatology.” Ex. 1005, 38:4–
`6. Nadau-Fourcade discloses the use of hydrophilic-phase gelling agents in
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`its compositions and expressly identifies polyacrylamides as preferred
`gelling agents. Id. at 47:11–12, 48:5–6 (“Preferred gelling agents include
`. . . polyacrylamides, for instance Sepineo P 600® or Simulgel 600
`PHA®.”). Nadau-Fourcade further discloses that “[t]he gelling agent . . .
`may be used at preferential concentrations ranging from 0.001% to 15% and
`more preferentially ranging from 0.01% to 5%.” Id. at 48:8–9.
`
`3. Bonacucina
`Bonacucina discloses that “Sepineo P 600 is a prime candidate for use
`in the formulation of gels and emulsion gels with rheological properties
`suitable for topical administration.” Ex. 1015, Abst. In particular,
`Bonacucina discloses that
`Sepineo P 600, a concentrated dispersion of acrylamide/sodium
`acryloyldimethyl taurate copolymer in isohexadecane, has self-
`gelling and thickening properties and the ability to emulsify oily
`phases, which make it easy to use in the formulation of gels and
`o/w emulsion gels. In this paper, gels were prepared using a
`Sepineo P 600 concentration between the 0.5% and 5% (w/w) . .
`. . [T]he elastic properties of the gel-like structure even at
`elevated polymer concentrations were not strongly long-lasting,
`as demonstrated by the increase of the viscous contribution in the
`low frequency range during acoustic spectroscopy analysis. This
`fact could indicate that the gel structure is characterized by weak
`polymer–polymer interactions, an advantageous characteristic
`for topical administration, as the sample is thus easier to rub into
`the skin. . . . Thus, Sepineo P 600 gel and emulsion gel are very
`effective systems for use in topical and other types of
`applications.
`
`Id.
`
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`
`Bonacucina further discloses that
`Sepineo® P 600 thickens and gels well, a property that depends
`strongly on polymer concentration. Concentration increases
`from 0.5% (w/w) to 5% (w/w) modified the viscoelastic
`properties of the Sepineo® samples, changing the typical
`behavior of a concentrated non-entangled solution to that of a
`‘gel-like’ sample.”
`Id. at 7.
`
`C. Petitioner’s Ground 1: Obviousness over the Combination of
`Garrett and Nadau-Fourcade
`Petitioner asserts that claims 1–6 are unpatentable under § 103 as
`obvious in view of the combination of Garrett and Nadau-Fourcade. Pet.
`21–40. In support of its assertion that the combination of Garrett and
`Nadau-Fourcade renders claims 1–6 obvious, Petitioner sets forth the
`foregoing teachings of Garrett and Nadau-Fourcade and provides a detailed
`claim chart explaining how each claim limitation is disclosed in the
`combination of references. Id. Specifically, Petitioner contends that Garrett
`discloses a “topical pharmaceutical composition” of “about 7.5% w/w
`dapsone,” “water,” and “about 30% w/w to about 40% w/w ethoxydiglycol.”
`Id. at 24–30 (citing Ex. 1004, 3:33–4:15; Ex. 1002 ¶¶ 50–54).
`With regard to the specific thickening agent required by the claims,
`Petitioner contends that “[i]t would have been obvious to a [person of
`ordinary skill in the art] to substitute the claimed acrylamide copolymer for
`the thickening agent disclosed in Garrett because such thickening agents
`were known in the art to be predictable and interchangeable.” Pet. 31 (citing
`Ex. 1002 ¶¶ 56–57). In this regard, Petitioner contends that both Garrett and
`Nadau-Fourcade “relate to topical pharmaceutical compositions of drugs that
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`are insoluble in water and are within the pertinent art to the claims of the
`’926 patent.” Id. Petitioner also notes that Garrett discloses dapsone
`compositions containing polymeric thickeners, and specifically teaches that
`“polymeric thickeners that may be used include those known to one skilled
`in the art, such as hydrophilic and hydroalcohol gelling agents frequently
`used in the cosmetic and pharmaceutical industries.” Id. at 31 (quoting Ex.
`1004, 13:2–25). By comparison, Petitioner notes that Nadau-Fourcade
`discloses polyacrylamides (i.e., Sepineo® P 600 or Simulgel® 600 PHA)1 as
`“preferred” gelling agents for use in the hydrophilic-phase of topical
`pharmaceutical compositions of water-insoluble drugs. Pet. 31–32 (citing
`Ex. 1002 ¶56; Ex. 1005, 47:12–32, 48:1–7).
`Based on the disclosures of the cited prior art, summarized above,
`Petitioner contends that it would have been obvious to substitute the
`thickening agents disclosed in Garrett for the polyacrylamide thickening
`agents of Nadau-Fourcade because “[w]here two known alternatives are
`interchangeable for a desired function, an express suggestion to substitute
`one for the other is not needed to render a substitution obvious.” Id. at 32
`(quoting Conopco, Inc. v. Procter & Gamble Co., IPR2013-00505, Paper 69,
`at 21-23 (P.T.A.B. Feb. 10, 2015)); see also KSR, 550 U.S. at 417 (holding
`that a claim is obvious if it is no “more than the predictable use of prior art
`
`
`1 Petitioner contends that “Nadau-Fourcade shows that Sepineo® P 600 or
`Simulgel® 600 PHA are commercial grade acrylamide/sodium
`acryloyldimethyl taurate copolymers.” Pet. 32, n.5 (citing Ex. 1005, 48:5–
`7).
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`elements according to their established functions,” even without an express
`suggestion to combine).
`With regard to the amount of thickening agent in the composition,
`Petitioner further contends as follows:
`modification of the amount of copolymer was known in the art.
`Dr. Michniak-Kohn explains that modifying the amount of a
`thickening agent is well-known and routine in the development
`of topical compositions, and would have had a known impact on
`the viscosity of the composition. (AMN1002, ¶58). Consistent
`with this understanding, Garrett teaches that “the relative
`percentages for [the thickening agent] may vary depending on …
`gel viscosity,” which a [person of ordinary skill in the art] would
`have understood to mean that modifications to the amount of
`thickening agent are routine, well-understood, and predictable.
`(AMN1004, 18:17-22). Thus, a [person of ordinary skill in the
`art] in 2012 would have had a reason to use between about 2%
`w/w to about 6% w/w of the claimed acrylamide copolymer in
`Garrett’s composition, with a reasonable expectation of success,
`thus rendering the claimed invention obvious.
`Id. at 33–34.
`With regard to the negative limitation expressly excluding adapalene
`from the recited composition, Petitioner contends that “none of Garrett’s
`compositions include adapalene.” Id. at 30 (citing Ex. 1002 ¶ 54, Ex. 1004,
`Abst., 3:33-4:15, 14:20-15:18, Sud-Chemie, Inc. v. Multisorb Techs., Inc.,
`554 F.3d 1001, 1004-05 (Fed. Cir. 2009) (finding prior art reference that did
`not require adhesive coatings on films to teach “uncoated” films, even
`though the reference “fail[ed] to specifically refer to the films as
`uncoated.”)).
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`
`D. Petitioner’s Ground 2: Obviousness over the Combination of
`Garrett and Bonacucina
`For substantially similar reasons, Petitioner contends that claims 1–6
`are unpatentable under § 103 as obvious in view of the combination of
`Garrett and Bonacucina. Pet. 52–54. For this ground, Petitioner substitutes
`Nadau-Fourcade for Bonacucina for, inter alia, its disclosure of the recited
`acrylamide copolymer in topical compositions. Pet. 47 (citing Ex. 1015, 1;
`Ex. 1002 ¶ 84).
`In particular, Petitioner contends that Bonacucina discloses the
`product Sepineo P 600 as “a concentrated dispersion of acrylamide/sodium
`acryloyldimethyl taurate copolymer in isohexadecane” that “has self-gelling
`and thickening properties . . . which make[s] it easy to use in the formulation
`of gels and [oil-in-water] emulsion gels.” Id. at 48 (citing Ex. 1015, Abst.).
`Petitioner contends that Bonacucina also discloses that the acrylamide
`copolymer has weak polymer-polymer interactions resulting in compositions
`that are “easier to rub into the skin”—an “advantageous characteristic for
`topical administration.” Id. (citing Ex. 1015, Abst.).
`Petitioner further contends that Bonacucina discloses
`acrylamide/sodium acryloyldimethyl taurate copolymer concentrations up to
`5% w/w were useful for topical applications, which encompasses the
`claimed range of “about 4% w/w.” Id. at 50 (citing Ex. 1015, 7
`(“Concentration increases from 0.5% (w/w) to 5% (w/w) modified the
`viscoelastic properties of the Sepineo® samples, changing the typical
`behavior of a concentrated non-entangled solution to that of a ‘gel-like’
`sample.”); see also Ex. 1002 ¶¶ 83, 83, 88, and 89.
`
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`
`In combining the references, Petitioner contends as follows:
`Because [the recited] components are used in the claims for the
`same purpose as they had been successfully used in the prior art
`. . ., a [person of ordinary skill in the art] would have reasonably
`expected those components to be acceptable and suitable for the
`claimed composition.”).
`Id. at 52.
`
`E. Patent Owner’s Contentions
`Patent Owner sets forth several arguments to support its position that
`Petitioner fails to establish a reasonable likelihood that challenged claims 1–
`6 of the ’926 patent would have been obvious over either the combination of
`Garrett and Nadau-Fourcade or the combination of Garrett and Bonacucina.
`Prelim. Resp. 2–18.
`With respect to the ground based on the combination of Garrett and
`Nadau-Fourcade, Patent Owner contends that “Petitioner presents no
`evidence that a person of ordinary skill in the art would have known that the
`claimed copolymer possessed properties that made it a suitable substitute for
`Garrett’s Carbopol.” Id. at 2. In particular, Patent Owner contends that
`Petitioner offers no evidence, however, that its proposed
`Carbopol substitute—Sepineo (a product which includes the
`claimed copolymer)—was also recognized at the time of the
`invention as being capable of “play[ing] a role” in the formation
`of microparticulate dapsone. Petitioner’s evidence shows, at
`best, that Sepineo was included with Carbopol in Nadau-
`Fourcade’s listing of gelling agents, e.g. Pet. 32 (citing Ex. 1005,
`47:12–32 and 48:1–7), but not that these agents were known to
`be interchangeable for the function of dapsone microparticulate
`formation.
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`Id. at 3. Thus, “Petitioner has not in fact offered any evidence that Carbopol
`and Sepineo were known alternatives interchangeable for the function that
`Garrett and Petitioner demand of Carbopol, specifically, dapsone
`microparticulate formation.” Id. at 4.
`Patent Owner further argues that “Petitioner fails to provide specific
`evidence addressing why one of ordinary skill in the art would replace a key
`ingredient that is involved in forming Garrett’s microparticulate reservoir.”
`Id. at 6. Patent Owner contends that Petitioner’s argument that Garrett’s
`thickening agents, Carbopol, and the recited acrylamide copolymer “are
`known thickening agents being used in their known amounts for their
`intended purpose—to thicken the composition and stabilize the undissolved
`dapsone” (Pet. 37) misses the mark because Garrett is not merely using
`Carbopol as a thickening agent. Rather, Patent Owner contends that Garrett
`discloses that Carbopol “plays a role” in the formation of the
`microparticulate dapsone. Prelim. Resp. 9 (citing Ex. 1002 ¶ 81; Pet. 46,
`47). Patent Owner further contends that “Petitioner nowhere demonstrates,
`or even alleges, that the claimed copolymer was known to be capable of
`fulfilling an ‘intended purpose’ of microparticulate dapsone formation.” Id.
`Moreover, Patent Owner argues as follows:
`Garrett emphasizes that its main purpose is to provide a reservoir
`of undissolved dapsone. Ex. 1004, 11:24–27 (explaining that
`microparticulate dapsone “serve[s] as a reservoir”). Petitioner
`proposes replacing the very ingredient that Garrett, Petitioner,
`and Dr. Michniak-Kohn agree “plays a role” in forming that
`reservoir: the Carbopol. Ex. 1002 ¶ 81 (cited at Pet. 46, 47); see
`Ex. 1004, 11:24–27. Yet Petitioner has not shown that Carbopol
`and Sepineo, although both identified by Nadau-Fourcade as
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`gelling agents, were known to be interchangeable for the function
`of triggering microparticulate dapsone formation.
`
`In the absence of such evidence, Petitioner fails to show
`that a person of ordinary skill would have had a reasonable
`expectation of successfully obtaining Garrett’s microparticulate
`dapsone by using the claimed copolymer in Sepineo.
`Id. at 8.
`Patent Owner further contends that
`Nadau-Fourcade specifically seeks to avoid crystallization. Ex.
`1005, 41:13–14 (explaining that its claimed compositions have
`“no crystallization of the active ingredient” visible even on
`microscopic examination); infra Section II(A)(3) at p. 13.
`Consistent with this directive, Nadau-Fourcade provides no
`teaching that its “gelling agent” ingredients function as an active
`ingredient microparticulate trigger. See, e.g., Ex. 1005, 47:12–
`48:7.
`Id. at 10–11. In particular, Patent Owner directs our attention to the
`following disclosure in Nadau-Fourcade:
`The problem that this invention proposes to solve herein is thus
`to develop an aqueous pharmaceutical composition of an oil-in-
`water emulsion type, which is physically and chemically stable
`and contains at least one water-sensitive active ingredient, in
`dissolved form. . . . The term ‘dissolved form of the active
`ingredient’ means a dispersion of the active ingredient in
`molecular form in a liquid, with no crystallization of the active
`ingredient being visible to the naked eye or even under a cross-
`polarized optical microscope.
`Id. at 13–4 (quoting Ex. 1005, 40:28–30, 41:12–14 (emphases added); see
`also Ex. 1005, 39:16–18 (“degradation and/or crystallization of the active
`ingredient . . . runs counter to the desired objective”). Patent Owner
`contends that “Petitioner fails to explain how one of ordinary skill in the art
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`would have reconciled Nadau-Fourcade’s express teaching against
`crystallization with Garrett’s express teaching for crystallization.” Prelim.
`Resp. 14.
`Patent Owner contends that “because a combination of Garrett and
`Nadau-Fourcade would render both references unsuitable for their respective
`intended purposes, the Petition falls short of showing the ordinarily skilled
`artisan had sufficient reason to combine them.” Id. (citing In re Gordon,
`733 F.2d 900, 902 (Fed. Cir. 1984) (proposed modification cannot render the
`prior art unsatisfactory for its intended purpose)).
`Patent Owner relies largely upon the same arguments with respect to
`the ground based on the combination of Garrett and Bonacucina. Id. at 14–
`15. Additionally, specific to Bonacucina, Patent Owner contends that
`Bonacucina contains no teaching of an active ingredient, much
`less Sepineo’s function with regard to any active. Instead,
`Bonacucina confines itself to “characteriz[ing] the Sepineo gel
`systems as well as to study how the addition of oil affects gel
`characteristics” without actives present.
` Ex. 1015, 7.
`Bonacucina does not address how Sepineo would behave in the
`presence of dapsone or other actives.
`Id. at 16.
`
`F. Analysis
`Upon consideration of the respective 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. In particular, we are not persuaded
`that the evidence of record demonstrates that the “intended purpose” of the
`thickening agents disclosed in Garrett is microparticulate dapsone formation.
`16
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`IPR2018-00608
`Patent 9,161,926 B2
`
`Rather, Garrett teaches that the solvent system “is important to the formation
`of the microparticulate to dissolved dapsone ratio” and guides a person of
`ordinary skill in the art that the formation of the microparticulate “should not
`interfere with the ability of the polymer thickener or preservative systems to
`perform their functions.” Ex. 1004, 14:15–19. Thus, after considering the
`teachings of Garrett in its entirety, it appears that the intended purpose of the
`thickening agents disclosed in Garrett is simply the known purpose of
`thickening agents—i.e., adding viscosity to the formulation.
`We recognize that Garrett teaches that the ratio between solvent and
`thickening agents has the effect of influencing the desired ratio of
`microparticulate to dissolved dapsone. Ex. 1004, 18:17–20 (“The relative
`percentages for each of the reagents used in the present invention may vary
`depending upon . . . the desired ratio of microparticulate to dissolved
`dapsone.”). While that desired outcome may limit the thickening agents
`ultimately deemed suitable for the compositions disclosed in Garrett, it does
`not change the primary viscosity-adding function of the thickening agents
`useful for Garrett’s composition. In this regard, Garrett discloses that the
`thickening agents preferably comprise between about 0.2% to about 4% by
`weight of the composition, which overlaps the recited range of “about 2%
`w/w to about 6% w/w” in claim 1 and encompasses the recited amount of
`“about 4% w/w of a polymeric viscosity builder” in claim 5. In re Geisler,
`116 F.3d 1465, 1471 (Fed. Cir. 1997) (“[W]here there is a range disclosed in
`the prior art, and the claimed invention falls within that range, there is a
`presumption of obviousness.”). Both Nadau-Fourcade and Bonacucina
`disclose that acrylamide/sodium acryloyldimethyl taurate copolymer is
`17
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`IPR2018-00608
`Patent 9,161,926 B2
`
`capable of functioning as a gelling agent within the ranges disclosed by
`Garrett and claimed in the ’926 patent. Ex. 1005, 48:8–9; Ex. 1015, 7. As
`such, the evidence of record suggests that a person of ordinary skill in the art
`would have found it obvious to optimize the amount of the claimed
`copolymer in order to achieve in the desired ratio of microparticulate to
`dissolved dapsone within Garrett’s composition. Ex. 1004, 18:17–20; Ex.
`1002 ¶ 52.
`We recognize Patent Owner’s arguments that Nadau-Fourcade
`specifically seeks to avoid crystallization (Prelim. Resp. 10–11); however,
`that teaching appears to be specific for the active ingredients disclosed in
`Nadau-Fourcade. Nadau-Fourcade does not suggest avoiding crystallization
`in dapsone formulations.
`We recognize Patent Owner’s arguments that “Bonacucina does not
`address how Sepineo would behave in the presence of dapsone or other
`actives” (id. at 16). Here, we note that Garrett is being relied upon by
`Petitioner for compositions comprising microparticulate dapsone. Our
`inquiry is thus whether a person of ordinary skill in the art would have had a
`reasonable expectation of success of using the acrylamide copolymer
`disclosed in Nadau-Fourcade and Bonacucina in the compositions disclosed
`in Garrett. In this regard, on the current record, we are persuaded by
`Petitioner’s argument that the claimed acrylamide copolymer was a known
`thickening agent in topical pharmaceutical compositions and that “[w]here
`two known alternatives are interchangeable for a desired function, an
`express suggestion to substitute one for the other is not needed to render a
`substitution obvious.” Pet. 32.
`
`18
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`IPR2018-00608
`Patent 9,161,926 B2
`
`
`Having considered the arguments and evidence presented in the
`Petition, we determine that Petitioner has established a reasonable likelihood
`that it would prevail in showing claims 1–6 are unpatentable as obvious over
`either the combination of Garrett and Nadau-Fourcade and/or the
`combination of Garrett and Bonacucina.2
`
`III. CONCLUSION
`After considering the evidence and arguments presented in the
`Petition and Preliminary Response, we determine that Petitioner has
`demonstrated a reasonable likelihood of success in proving that claims 1–6
`of the ’926 patent are unpatentable.
`At this preliminary stage in the proceeding, we have not made a final
`determination with respect to the patentability of any challenged claim or the
`construction of any claim term. Any findings of fact and conclusions of law
`made herein are not final, but are made for the sole purpose of determining
`whether Petitioner meets the threshold for initiating review. Any final
`decision shall be based on the full trial record, including any response timely
`filed by Patent Owner. Any arguments not raised by Patent Owner in a
`
`
`2 Patent Owner also argues that Petitioner relies on Exhibit 1026 (the
`“Sepineo brochure”) in its obviousness case but fails to show that it is a
`prior-art printed publication. Prelim. Resp. 16–18. While Exhibit 1026 is
`cited in the Petition (Pet. 37, 47, 49, 50, and 53), it does not appear to be a
`critical reference for Petitioner’s obviousness challenges. To the extent that
`Exhibit 1026 is relevant to Petitioner’s obviousness contentions, the parties
`are invited to further address the issue of whether it qualifies as a prior art
`printed publication in their post-institution submissions.
`19
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`IPR2018-00608
`Patent 9,161,926 B2
`
`timely-filed response shall be deemed waived, even if they were presented in
`the Preliminary Response.
`
`IV. ORDER
`Accordingly, it is
`ORDERED that pursuant to 35 U.S.C. § 314(a), an inter partes
`review of claims 1–6 of U.S. Patent No. 9,161,926 B2 is instituted with
`respect to all grounds set forth in the Petition; and
`FURTHER ORDERED that, pursuant to 35 U.S.C. § 314(c) and 37
`C.F.R. § 42.4, inter partes review of the ’926 patent shall commence on the
`entry date of this Order, and notice is hereby given of the institution of a
`trial.
`
`
`PETITIONER:
`
`Dennies Varughese
`Adam C. LaRock
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`dvarughe-ptab@skgf.com
`alarock-ptab@skgf.com
`
`
`
`PATENT OWNER:
`
`Scott E. Kamholz
`Jessica L. Parezo
`COVINGTON & BURLING LLP
`skamholz@cov.com
`jparezo@cov.com
`
`20
`
`
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