Paper No. 10
`
`Trials@uspto.gov
` Entered: May 6, 2016
`571-272-7822
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`GRAY SQUARE PHARMACEUTICALS, LLC,
`Petitioner,
`
`v.
`
`POZEN, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-00191
`Patent 7,332,183 B2
`____________
`
`
`Before DONNA M. PRAISS, JO-ANNE M. KOKOSKI, and
`JEFFREY W. ABRAHAM, Administrative Patent Judges.
`
`ABRAHAM, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`
`Trials@uspto.gov
` Entered: May 6, 2016
`571-272-7822
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`GRAY SQUARE PHARMACEUTICALS, LLC,
`Petitioner,
`
`v.
`
`POZEN, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-00191
`Patent 7,332,183 B2
`____________
`
`
`Before DONNA M. PRAISS, JO-ANNE M. KOKOSKI, and
`JEFFREY W. ABRAHAM, Administrative Patent Judges.
`
`ABRAHAM, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`
`IPR2016-00191
`Patent 7,332,183 B2
`
`
`I. INTRODUCTION
`Gray Square Pharmaceuticals, LLC1 (“Petitioner”), filed a Petition
`seeking inter partes review of claims 1 and 2 of U.S. Patent No. 7,332,183
`B2 (Ex. 1001, “the ’183 patent”). Paper 1 (“Pet.”). Pozen, Inc. (“Patent
`Owner”) filed a Patent Owner Preliminary Response to the Petition. Paper 9
`(“Prelim. Resp.”). After considering the Petition and Preliminary Response,
`we determine that Petitioner has not established a reasonable likelihood of
`prevailing with respect to any of the challenged claims of the ’183 patent.
`See 35 U.S.C. § 314(a). Accordingly, we deny the Petition, and do not
`institute inter partes review.
`
`
`II. BACKGROUND
`A. Related Proceedings
`Patent Owner states that there are currently no judicial or
`administrative matters that would affect, or be affected by a decision in this
`case. Paper 6, 3. Petitioner identifies several previously-filed district court
`and Federal Circuit matters involving the ’183 patent. Pet. 3.
`
`
`B. The ’183 Patent
`The ’183 patent, titled “Multilayer Dosage Forms Containing NSAIDs
`and Triptans,” is directed to the treatment of migraine and other pain relief.
`Ex. 1001, 1:1–15. The ’183 patent discloses pharmaceutical tablets
`containing naproxen and a triptan, wherein substantially all of the triptan is
`
`
`1 As of the November 12, 2015 filing date of the Petition, Petitioner operated
`under the name Graybar Pharmaceuticals, LLC. Pet. 3. Petitioner changed
`its name to Gray Square Pharmaceuticals, LLC on January 6, 2016. Paper 7.
`
`
`
`2
`
`
`
`IPR2016-00191
`Patent 7,332,183 B2
`
`found in one layer, and substantially all of the naproxen is found in a second,
`separate layer. Id. at 1:66–2:6. The layers are in a “side-by-side
`arrangement such that the dissolution of the naproxen occurs independently
`of the dissolution of triptan.” Id. at 2:7–9. According to the ’183 patent, a
`bilayer tablet dosage form having separate layers of naproxen and triptan has
`“surprisingly better properties” than other tablet arrangements. Id. at 2:9–
`11, 1:60–65 (noting advantages in terms of release properties, stability, and
`pharmacokinetic profile that “could not have been predicted a priori”).
`
`
`C. Challenged Claims
`Petitioner challenges claims 1 and 2 of the ’183 Patent, which are
`reproduced below:
`1. A multilayer pharmaceutical tablet comprising naproxen and
`a triptan and, wherein:
`a) substantially all of said triptan is in a first layer of said
`tablet and substantially all of said naproxen is in a second,
`separate layer; and
`b) said first layer and said second layer are in a side by
`side arrangement such that the dissolution of said naproxen
`occurs independently of said triptan.
`
`2. The tablet of claim 1, wherein said naproxen is in the form
`of naproxen sodium at between 200 and 600 mg.
`
`
`
`D. References
`Petitioner relies on the following references:
`Plachetka, U.S. Patent No. 6,060,499, issued May 9, 2000
`(“Plachetka,” Ex. 1007).
`Desai, U.S. Patent No. 5,756,125, issued May 26, 1998 (“Desai,”
`Ex. 1009).
`
`
`
`3
`
`
`
`IPR2016-00191
`Patent 7,332,183 B2
`
`
`Ouali et al., U.S. Patent No. 6,183,779 B1, issued Feb. 6, 2001
`(“Ouali,” Ex. 1011).
`Elger et al., U.S. Patent No. 4,844,907, issued July 4, 1989
`(“Elger,” Ex. 1012).
`Devane et al., U.S. Patent No. 6,730,325 B2, issued May 4, 2004
`(“Devane,” Ex. 1013).
`
`
`E. The Asserted Grounds
`Petitioner asserts the following grounds of unpatentability:
`Statutory
`Claims
`Basis
`Challenged
`§103
`1 and 2
`
`Plachetka and Ouali
`
`References
`
`Plachetka and Elger
`
`Devane and Elger
`
`Plachetka and Desai
`
`§103
`
`§103
`
`§103
`
`1 and 2
`
`1 and 2
`
`1 and 2
`
`
`Petitioner also relies on the declaration of Dr. Arthur H. Kibbe, Ph.D.
`Ex. 1002 (“Kibbe Declaration”).
`
`
`III. ANALYSIS
`A. Claim Construction
`In an inter partes review, claim terms in an unexpired patent are
`interpreted according to their broadest reasonable construction in light of the
`specification of the patent in which they appear. 37 C.F.R. § 42.100(b);
`Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,766 (Aug. 14,
`2012); In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1278 (Fed. Cir.
`2015), cert. granted sub nom. Cuozzo Speed Techs. LLC v. Lee, 136 S. Ct.
`
`
`
`4
`
`
`
`IPR2016-00191
`Patent 7,332,183 B2
`
`890 (mem.) (2016) (No. 15-446). Claim terms generally should be given
`their ordinary and customary meaning, except “1) when a patentee sets out a
`definition and acts as his own lexicographer, or 2) when the patentee
`disavows the full scope of a claim term either in the specification or during
`prosecution.” Thorner v. Sony Computer Entm’t Am. LLC, 669 F.3d 1362,
`1365 (Fed. Cir. 2012). “To act as its own lexicographer, a patentee must
`‘clearly set forth a definition of the disputed claim term’ other than its plain
`and ordinary meaning.” Id. (quoting CCS Fitness, Inc. v. Brunswick Corp.,
`288 F.3d 1359, 1366 (Fed. Cir. 2002)).
`An extraneous limitation should not be read into the claims from the
`specification. E.g., E.I. du Pont de Nemours & Co. v. Phillips Petroleum
`Co., 849 F.2d 1430, 1433 (Fed. Cir. 1988). An extraneous limitation is one
`the presence of which in a claim is unnecessary for the purpose of making
`sense of the claim. See, e.g., In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir.
`1994); Renishaw PLC, v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1249
`(Fed. Cir. 1998).
`Petitioner proposes constructions under a broadest reasonable
`interpretation for “side-by-side arrangement” and “naproxen.” Pet. 26–28.
`We determine that no express claim construction of these terms is required
`for purposes of this decision.
` Patent Owner proposes a construction under the broadest reasonable
`interpretation for “dissolution of said naproxen occurs independently of said
`triptan.” Prelim. Resp. 21–24. Patent Owner contends that this phrase
`means “the naproxen and triptan are in an immediate release form in the first
`and second layer such that their dissolution occurs at approximately the
`same rate as if the drugs were given separately.” Id. at 21–22. In support of
`
`
`
`5
`
`
`
`IPR2016-00191
`Patent 7,332,183 B2
`
`this construction, Patent Owner points to the statement in the Specification
`that “[t]he layers should be arranged such that the individual therapeutic
`agents dissolve independently of one another, i.e., dissolution should occur
`at approximately the same rate as would occur if the drugs were given
`separately.” Id. at 22 (quoting Ex. 1001, 2:46–49) (emphasis in Prelim.
`Resp.). Patent Owner also argues that the Specification “makes clear that
`the active ingredients need to release immediately for migraine relief” (id. at
`22–23 (quoting Ex. 1001, 9:19–25, 10:11–16)), and that the Applicants
`made it clear during prosecution that the claims cover a single dosage form
`having two immediate release layers (id. at 23–24 (citing Ex. 1004, 7)).
`Petitioner does not propose an express construction for this phrase,
`but, as discussed in more detail below, considers ingredients in a bilayer
`tablet that dissolve “at the same time” to dissolve “independently.” See, e.g.,
`Pet. 20, 21.
`Based on our review of the Specification, we are persuaded that Patent
`Owner acted as its own lexicographer by defining “dissolve independently”
`in the Specification. Specifically, as noted by Patent Owner, the ’183 patent
`explains that
`The layers should be arranged such that the individual
`therapeutic agents dissolve independently of one another, i.e.,
`dissolution should occur at approximately the same rate as
`would occur if the drugs were given separately. In this context,
`“approximately the same rate” indicates that the time for
`complete dissolution of agent when drugs are given in the
`combination tablet should require the same amount of time ±
`10% as when the same amount of agent is given alone.
`Ex. 1001, 2:46–54.
` Patent Owner’s proposed interpretation, however, goes beyond the
`Specification’s definition, and requires that the naproxen and triptan are in
`
`
`
`6
`
`
`
`IPR2016-00191
`Patent 7,332,183 B2
`
`an immediate release form. Although the Specification does refer to a
`bilayer tablet as providing “more rapid release of each component” than
`other tablet configurations, and states that “[r]apid or immediate release . . .
`is advantageous” (id. at 10:5–12), the Specification does not include the term
`“immediate release” in its definition of “dissolve independently.” Further,
`the Specification appears to differentiate between independent and
`immediate release by stating that a bilayer tablet can provide “independent
`and immediate release of each component.” Id. at 3:61–64 (emphasis
`added). Because the claim expressly requires only that the two components
`dissolve independently, and defines that term without reference to
`immediate dissolution, we see no reason to import a limitation from the
`Specification into the claim and require that the naproxen and triptan be in
`immediate release form. See In re Paulsen, 30 F.3d at 1480; Renishaw PLC,
`158 F.3d at 1249.
` Nor are we persuaded by Patent Owner’s arguments that statements
`made during prosecution of the application that issued as the ’183 patent
`support a construction requiring naproxen and triptan to be in an immediate
`release form. In context, the reference to immediate release made during
`prosecution appears in a sentence directed towards distinguishing the
`claimed invention over a prior art reference based on the fact that the prior
`art reference combined different formulations of a single drug in a single
`dosage form, whereas the rejected claims combined two separate drugs in a
`single dosage form. Ex. 1004, 7. Thus, although we do not disagree with
`Patent Owner’s assertion “that the claims cover a single dosage form
`configuration having two immediate release layers” (Prelim. Resp. 23),
`Patent Owner has not directed us to evidence sufficient to demonstrate the
`
`
`
`7
`
`
`
`IPR2016-00191
`Patent 7,332,183 B2
`
`claims are limited to only those tablet configurations having two immediate
`release layers. See Biogen Idec, Inc. v. GlaxoSmithKline LLC, 713 F.3d
`1090, 1095 (Fed. Cir. 2013) (discussing clear and unmistakable disavowals
`during patent prosecution).
` Based upon this record, we find that the broadest reasonable
`interpretation of the phrase “dissolution of said naproxen occurs
`independently of said triptan” is a dissolution profile such that complete
`dissolution of naproxen and triptan when the drugs are given in the
`combination tablet requires the same amount of time ± 10% as when the
`same amount of naproxen or triptan is given alone.
`
`
`B. Obviousness over Plachetka and Ouali
`Petitioner argues that the subject matter of claims 1 and 2 would have
`been obvious in view of Plachetka and Ouali. Pet. 28–40.
`Plachetka discloses a method of treating migraine headaches
`comprising co-timely administration of an NSAID, such as naproxen or
`naproxen sodium, and a 5-HT agonist, such as sumatriptan. Ex. 1007, 1:13–
`41. Plachetka discloses many dosage forms that can be used to co-
`administer naproxen and sumatriptan (id. at 12:56–13:5), including a single
`tablet formulation (e.g., id. at 10:65–67, 11:22–25, 12:4–13).
`
`Ouali discloses a composition for the oral administration of an
`NSAID, such as naproxen, and a prostaglandin. Ex. 1011, Abstract, 4:44.
`Ouali teaches that NSAIDs exhibit some undesirable side effects, such as
`gastrointestinal bleeding, ulceration, and perforation, and refers to several
`prior art references disclosing attempts to reduce these undesirable
`gastrointestinal effects through co-administration of an NSAID and a
`
`
`
`8
`
`
`
`IPR2016-00191
`Patent 7,332,183 B2
`
`prostaglandin. Id. at 1:34–39, 55–64. According to Ouali, however,
`“prostaglandins are unstable compounds and degrade readily in the presence
`of NSAIDs, thus requiring a stabilizing agent . . . which can, in turn, lessen
`the activity of an NSAID.” Id. at 1:65–2:3. Ouali thus seeks to provide a
`composition in which the prostaglandin is stabilized and the efficacy of the
`NSAID is maintained. Id. at 2:14–23. In one preferred embodiment, the
`stabilized prostaglandin and NSAID are combined into a bilayer tablet. Id.
`at Abstract, 4:22–35; Fig. 1.
` Petitioner argues that Ouali teaches or otherwise renders obvious the
`“first layer and said second layer are in a side by side arrangement such that
`the dissolution of said naproxen occurs independently of said triptan”
`limitation in claim 1. Pet. 34–36, 38. According to Petitioner, Ouali
`combines naproxen sodium with prostaglandin and its stabilizing agent into
`a bilayer tablet “precisely because they dissolve independently from each
`other.” Id. at 35 (citing Ex. 1002 ¶ 61). Petitioner points to Ouali’s teaching
`that it was known that prostaglandins degrade in the presence of NSAIDs
`and that stabilizing agents lessen the efficacy of the NSAID, and contends
`that Ouali uses a bilayer tablet configuration “to avoid the deleterious affects
`[sic] on each chemical’s release by virtue of their interaction when they
`dissolve at the same time—i.e., ‘independently’.” Id. at 35–36 (citing Ex.
`1011, 1:65–2:3; Ex. 1002 ¶¶ 61–62). Petitioner thus argues that, in view of
`Ouali, a person of ordinary skill in the art would have known that bilayer
`tablets allowed for the independent dissolution of the ingredients in each
`layer. Id. at 36 (also stating, “it was not an unexpected or surprising result
`that bilayer tablets yield independent dissolution of the ingredients in each
`respective layer”).
`
`
`
`9
`
`
`
`IPR2016-00191
`Patent 7,332,183 B2
`
`In so arguing, Petitioner equates dissolving “at the same time” to
`
`dissolving “independently.” See, e.g., Pet. 34–38. As noted above,
`however, the broadest reasonable construction of “dissolution of said
`naproxen occurs independently of said triptan” is a dissolution profile such
`that complete dissolution of naproxen and triptan when the drugs are given
`in the combination tablet requires the same amount of time ± 10% as when
`the same amount of naproxen or triptan is given alone. Based on our review
`of the record, including the declaration submitted by Petitioner, we are
`persuaded that Petitioner fails to identify sufficient evidence demonstrating
`that Ouali discloses or suggests bilayer tablets having a dissolution profile
`such that complete dissolution of the ingredients when given in the
`combination tablet requires approximately the same amount of time as when
`the ingredients are given alone.
`For example, Petitioner does not direct us to any test results
`comparing dissolution rates of Ouali’s ingredients combined in a multilayer
`tablet with dissolution rates of those same ingredients on their own.
`Additionally, Petitioner fails to explain adequately how Ouali’s disclosure
`that “prostaglandins degrade readily in the presence of NSAIDs” constitutes
`a teaching that prostaglandins and NSAIDs, when administered in a bilayer
`tablet, would require the same amount of time to dissolve as if the two
`ingredients were administered alone. Furthermore, Petitioner does not direct
`us to any evidence in Plachetka that cures this deficiency.
`We note that the declaration provided by Dr. Kibbe simply mirrors the
`statements made in the Petition, without providing additional analysis or
`references to prior art disclosures that explain adequately why a person of
`ordinary skill in the art would have known that the time required for
`
`
`
`10
`
`
`
`IPR2016-00191
`Patent 7,332,183 B2
`
`dissolution of the prostaglandins and NSAID when administered in Ouali’s
`bilayer tablet formulation is approximately the same as the amount of time
`required for the dissolution of these ingredients when they are administered
`alone. Compare Ex. 1002 ¶¶ 61–62 with Pet. 35–36.
`
`Nor are we persuaded by Petitioner’s conclusory statement that
`independent dissolution of ingredients in a bilayer tablet is an inherent
`property of that formulation. Pet. 38 (citing Ex. 1002 ¶ 68, Ex. 1011).
`Neither Petitioner nor Dr. Kibbe supports this conclusion with evidence
`sufficient to demonstrate that the property of independent dissolution is
`necessarily present in bilayer tablets. Akamai Technologies, Inc. v. Cable &
`Wireless Internet Services, 344 F.3d 1186, 1192 (Fed. Cir. 2003).
`
`Therefore, on this record, Petitioner has not established sufficiently
`that Plachetka and Ouali disclose or suggest every element of claim 1 or
`claim 2, and we determine that Petitioner does not show a reasonable
`likelihood of prevailing on its assertion that claims 1 and 2 are obvious in
`view of Plachetka and Ouali.
`
`
`C. Obviousness over Plachetka and Elger
`Petitioner argues that the subject matter of claims 1 and 2 would have
`been obvious in view of Plachetka and Elger. Pet. 40–47.
`
`Elger discloses a pharmaceutical composition in the form of a
`bilayered tablet containing a narcotic analgesic and an NSAID, such as
`naproxen. Ex. 1012, Abstract, 2:16–25. Elger recognizes that prior art
`tablets containing narcotic analgesics and NSAIDs “exhibit serious
`incompatibility, poor crushing strength and long disintegration problems.”
`Id. at 1:35–40. Elger teaches that its inventors were able to overcome these
`
`
`
`11
`
`
`
`IPR2016-00191
`Patent 7,332,183 B2
`
`problems by (1) separating the ingredients into a multi-phase, layered tablet,
`(2) removing stearic acid and/or stearate salts from the composition, and (3)
`adding at least one self-lubricating, direct compression aid. Id. at 3:26–43.
`
`With regard to the independent dissolution limitation of claims 1 and
`2, Petitioner contends that Elger teaches “a bilayer tablet with two active
`ingredients where each ingredient dissolves at approximately the same time,
`i.e., independently.” Pet. 21. Additionally, Petitioner argues that it would
`have been obvious to a person of ordinary skill in the art to include naproxen
`and triptan in first and second layers in a side by side arrangement such that
`the dissolution of naproxen occurs independently of triptan because Elger
`teaches that a bilayer tablet formulation allows for reduced release times for
`the ingredients in each layer, including incompatible ingredients that
`otherwise require long disintegration times. Id. at 42–44, 47.
`
` We are not persuaded by Petitioner’s arguments. Once again,
`Petitioner’s argument is based, at least in part, on its understanding that
`dissolving “at the same time” is equivalent to dissolving independently. As
`noted above, however, the broadest reasonable construction of “dissolution
`of said naproxen occurs independently of said triptan” is a dissolution profile
`such that complete dissolution of naproxen and triptan when the drugs are
`given in the combination tablet requires the same amount of time ± 10% as
`when the same amount of naproxen or triptan is given alone. Based on our
`review of the record, including the declaration submitted by Petitioner, we
`determine that Petitioner fails to identify sufficient evidence demonstrating
`that Elger discloses bilayer tablets having a dissolution profile such that
`complete dissolution of the ingredients when given in the combination tablet
`requires approximately the same amount of time as when the ingredients are
`
`
`
`12
`
`
`
`IPR2016-00191
`Patent 7,332,183 B2
`
`given alone.
`For example, Petitioner does not direct us to any test results
`comparing dissolution rates of Elger’s ingredients combined in a multilayer
`tablet with dissolution rates of those same ingredients on their own.
`Petitioner also fails to explain adequately how Elger’s disclosure of tablets
`exhibiting reduced release times for the ingredients in each layer constitutes
`a teaching that narcotic analgesics and NSAIDs, when administered in a
`bilayer tablet, would require the same amount of time to dissolve as if the
`two ingredients were administered alone. Additionally, as was the case with
`Petitioner’s contentions based on the combination of Plachetcka and Ouali,
`Petitioner does not direct us to any evidence in Plachetka that cures this
`deficiency. We further note that the declaration provided by Dr. Kibbe
`simply mirrors the statements made in the Petition, without providing
`additional analysis or references to prior art disclosures that explain
`adequately why a person of ordinary skill in the art would have known that
`Elger’s bilayer tablets allowed for the independent dissolution of the
`ingredients in each layer. Compare Ex. 1002 ¶¶ 71–77 with Pet. 41–43.
`
`Nor are we persuaded by Petitioner’s statement that “[a] bilayer
`formulation of two active ingredients was known to be equivalent, and
`interchangeable, with a patient taking the two ingredients separately, but at
`the same time.” Pet. 45. As support for this statement, Petitioner cites to
`paragraph 81 of the Kibbe Declaration, which simply repeats the statement
`without adding any explanation. Such unsupported conclusory statements
`are entitled to little weight. Rohm and Haas Co. v. Brotech Corp., 127 F.3d
`1089, 1092 (Fed. Cir. 1997). Furthermore, this statement, even if true, does
`not constitute sufficient evidence demonstrating a dissolution profile such
`
`
`
`13
`
`
`
`IPR2016-00191
`Patent 7,332,183 B2
`
`that complete dissolution of two ingredients when they are given in a
`combination tablet requires the same amount of time ± 10% as when the
`same amount of ingredients are given alone.
`
` Therefore, on this record, Petitioner has not established sufficiently
`that Plachetka and Elger disclose or suggest every element of claim 1 or
`claim 2, and we determine that Petitioner does not show a reasonable
`likelihood of prevailing on its assertion that claims 1 and 2 are obvious in
`view of Plachetka and Elger.
`
`
`D. Obviousness over Devane and Elger
`Petitioner argues that the subject matter of claims 1 and 2 would have
`been obvious in view of Devane and Elger. Pet. 47–50.
`Devane discloses a multiparticulate, modified release composition
`having a first and second component, wherein the active ingredient in the
`first and second components can be the same or different. Ex. 1013,
`Abstract, 4:10–16. Devane teaches that a multilayer tablet is a suitable
`dosage form (id. at 10:41–42), and includes naproxen and sumatriptan
`among the list of drugs that the claimed invention may be used to deliver (id.
`at 6:30–32, 6:45–47).
`Petitioner again relies on Elger as disclosing or suggesting the
`independent dissolution limitation of claims 1 and 2. See Pet. 49–50.
`Petitioner’s argument is no more persuasive here than it was when presented
`in combination with Plachetka. Additionally, Petitioner does not direct us to
`any evidence in Devane that cures the deficiencies of Elger. Thus, for the
`same reasons presented above, based on this record, Petitioner has not
`established sufficiently that Devane and Elger disclose or suggest every
`
`
`
`14
`
`
`
`IPR2016-00191
`Patent 7,332,183 B2
`
`element of claim 1 or claim 2, and we determine that Petitioner does not
`show a reasonable likelihood of prevailing on its assertion that claims 1 and
`2 are obvious in view of Devane and Elger.
`
`
`E. Obviousness over Plachetka and Desai
`Petitioner argues that the subject matter of claims 1 and 2 would have
`been obvious in view of Plachetka and Desai. Pet. 51–59.
`Desai is directed to “multilayer controlled release preparations
`containing a layer of compressed delayed and immediate release granulates
`of naproxen and a layer of naproxen sodium.” Ex. 1009, 3:21–24.
`According to Desai, this type of dosage form immediately releases the
`naproxen sodium to achieve a desired therapeutic plasma level in less than 1
`hour, and subsequently releases the naproxen granulates to maintain
`therapeutic blood levels for a duration of 24 hours. Id. at 3:24–30. Desai
`teaches that its composition can be prepared in the form of a bilayer tablet.
`Id. at Fig. 1.
` With regard to the independent dissolution limitation of claims 1 and
`2, Petitioner argues that, as Desai recognizes, naproxen was known to have a
`low water solubility. Pet. 52 (citing Ex. 1009, 1:33–35), 58. In view of this,
`Petitioner contends that
`[b]ecause naproxen and the triptan, when formulated
`together, are competing for solvent, then the slow
`dissolution rate of naproxen could slow the dissolution
`rate of the triptan. (Ex. 1002, Kibbe Decl. ¶89). When
`naproxen and the triptan are formulated in separate
`layers, however, they no longer compete with each other
`as much for the solvent (which is principally water), and
`therefore, the triptan would go into solution faster. (Id.).
`
`
`
`15
`
`
`
`IPR2016-00191
`Patent 7,332,183 B2
`
`Id. at 52. Petitioner also argues that Desai’s bilayer formulation provides for
`immediate release of naproxen sodium, which provides for faster pain relief.
`Id. at 58. Thus, Petitioner concludes that it would have been obvious to a
`person of ordinary skill in the art to include naproxen and triptan in first and
`second layers in a side by side arrangement such that the dissolution of
`naproxen occurs independently of triptan. Id. at 58–59.
`We are not persuaded by Petitioner’s argument. As noted above, the
`broadest reasonable construction of “dissolution of said naproxen occurs
`independently of said triptan” is a dissolution profile such that complete
`dissolution of naproxen and triptan when the drugs are given in the
`combination tablet requires the same amount of time ± 10% as when the
`same amount of naproxen or triptan is given alone. Based on our review of
`the record, including the declaration submitted by Petitioner, we determine
`that Petitioner fails to identify sufficient evidence demonstrating that Desai
`discloses bilayer tablets having a dissolution profile such that complete
`dissolution of the ingredients when given in the combination tablet requires
`approximately the same amount of time as when the ingredients are given
`alone.
`For example, Petitioner does not direct us to any test results
`comparing dissolution rates of Desai’s ingredients combined in a multilayer
`tablet with dissolution rates of those same ingredients on their own.
`Additionally, Petitioner fails to explain adequately how Desai’s disclosure of
`multilayer controlled release preparations that provide both immediate and
`delayed release of naproxen sodium and naproxen constitutes a teaching that
`these two ingredients, when administered in a bilayer tablet, would require
`the same amount of time to dissolve as when the two ingredients are
`
`
`
`16
`
`
`
`IPR2016-00191
`Patent 7,332,183 B2
`
`administered alone. Furthermore, Petitioner does not direct us to any
`evidence in Plachetka that cures this deficiency.
`We also note that the declaration provided by Dr. Kibbe simply
`mirrors the statements made in the Petition, without providing additional
`analysis or references to prior art disclosures that explain adequately why a
`person of ordinary skill in the art would have known that Desai’s bilayer
`tablets allowed for the independent dissolution of the ingredients in each
`layer. Compare Ex. 1002 ¶¶ 100–101 with Pet. 57–58.
`Therefore, on this record, Petitioner has not established sufficiently
`that Plachetka and Desai disclose or suggest every element of claim 1 or
`claim 2, and we determine that Petitioner does not show a reasonable
`likelihood of prevailing on its assertion that claims 1 and 2 are obvious in
`view of Plachetka and Desai.
`
`
` ORDER
`IV.
`For the reasons given, it is hereby
`ORDERED that the Petition is denied.
`
`
`
`
`
`
`
`17
`
`
`
`IPR2016-00191
`Patent 7,332,183 B2
`
`
`PETITIONER:
`Zachary Silbersher
`Sergey Kolmykov
`Kroub, Sibersher & Kolmykov PLLC
`zsilbersher@kskiplaw.com
`skolmykov@kskiplaw.com
`
`PATENT OWNER:
`Dominick A. Conde
`Brendan M. O’Malley, Ph.D.
`FITZPATRICK CELLA, HARPER & SCINTO
`PozenIPR@fchs.com
`
`Stephen M. Hash, Ph.D.
`Jeffrey S. Gritton
`BAKER BOTTS LLP
`PozenIPR@bakerbotts.com
`
`
`
`18
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
