IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ARGENTUM PHARMACEUTICALS LLC, MYLAN PHARMACEUTICALS
`INC., BRECKENRIDGE PHARMACEUTICAL, INC., AND ALEMBIC
`PHARMACEUTICALS, LTD.,
`Petitioners,
`
`v.
`
`RESEARCH CORPORATION TECHNOLOGIES, INC.,
`Patent Owner.
`
`Case No. IPR2016-002041
`Patent No. RE 38,551
`
`PATENT OWNER’S MOTION FOR OBSERVATIONS
`REGARDING THE CROSS-EXAMINATION
`TESTIMONY OF DR. KATHRYN A. DAVIS
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`
`
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`
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`1 Case IPR2016-01101, Case IPR2016-01242, and Case IPR2016-01245 have been
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`joined with this proceeding.
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ARGENTUM PHARMACEUTICALS LLC, MYLAN PHARMACEUTICALS
`INC., BRECKENRIDGE PHARMACEUTICAL, INC., AND ALEMBIC
`PHARMACEUTICALS, LTD.,
`Petitioners,
`
`v.
`
`RESEARCH CORPORATION TECHNOLOGIES, INC.,
`Patent Owner.
`
`Case No. IPR2016-002041
`Patent No. RE 38,551
`
`PATENT OWNER’S MOTION FOR OBSERVATIONS
`REGARDING THE CROSS-EXAMINATION
`TESTIMONY OF DR. KATHRYN A. DAVIS
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1 Case IPR2016-01101, Case IPR2016-01242, and Case IPR2016-01245 have been
`
`joined with this proceeding.
`
`
`
`
`
`I.
`
`Introduction
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`
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`IPR2016-00204
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`In accordance with: (i) The Trial Practice Guide, Federal Register Vol. 77,
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`No. 157, 48756 at 48767–68 and (ii) the Scheduling Order (Paper 20) as modified
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`by the Joint Notice of Stipulation Concerning Schedule (Paper 50), Patent Owner
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`hereby submits the instant Motion for Observations Regarding the Cross-
`
`Examination Testimony of Dr. Kathryn A. Davis, taken on December 14, 2016.
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`The transcript of this testimony has been filed as Exhibit 2195.
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`Patent Owner requests that the Board enter the instant Motion and consider
`
`the observations. Observations 1–16 below pertain to the deposition testimony of
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`Dr. Kathryn Davis, obtained on December 14, 2016, after Patent Owner filed its
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`last substantive paper. In addition, and in accordance with the Trial Guide, each of
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`observations 1–16 below provides in a single paragraph a concise statement of the
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`relevance of the precisely identified testimony to a precisely identified argument.
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`II. Observations
`In Ex. 2195 at 38:12–41:18, Dr. Davis could not confirm the relevant
`1.
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`date at which she “determined whether there was a long-felt need with respect to
`
`the ’551 patent.” She explained that, “[a]lthough the patent was filed in 1996, the
`
`drug [lacosamide] did not become available for clinical use until 2009, and there
`
`were many other drugs and compounds that received patent prior and then were
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`released in the interim before the lacosamide was clinically available for use.” Id.
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`1
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`IPR2016-00204
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`at 39:8–15. This testimony is relevant to Petitioners’ argument that levetiracetam
`
`(Keppra) meets the unmet need identified by Dr. Bazil. Reply (Paper 52) at 21–22.
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`This testimony is also relevant to Patent Owner’s position that Petitioners’
`
`argument identifying Keppra (a product approved post-1996) as a product that
`
`satisfied the long-felt need is a new argument beyond the proper scope of
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`Petitioners’ Reply. See Paper 57 at 2. This testimony is relevant because it is
`
`inconsistent with Dr. Davis’ declaration,
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`in which she states
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`that she
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`“understand[s] that the year 1996 is the relevant time in determining the alleged
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`obviousness of the claims of the ’551 patent.” See Ex. 1087 (Davis Decl.), ¶ 14.
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`2.
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`In Ex. 2195 at 124:18–125:15 and 127:1–12, Dr. Davis agreed that, as
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`of 1996, levetiracetam was not FDA-approved for any indication and was not
`
`being used clinically. In addition, at 125:17–126:25, Dr. Davis could not confirm
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`that as of 1996, epileptologists considered levetiracetam “to be an effective AED
`
`that controlled seizures for many patients whose epileptic seizures previously were
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`not controlled by other AEDs,” that levetiracetam was considered “a generally
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`well-tolerated drug with minimal adverse effects,” or that “levetiracetam [was]
`
`known to lack any clinically significant interactions with other medications.” And
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`at 127:14–23, Dr. Davis agreed that “as of 1996, levetiracetam was not available as
`
`an IV formulation.” This testimony is relevant to Petitioners’ argument that
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`levetiracetam (Keppra) meets the unmet need identified by Dr. Bazil. Reply at 21–
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`2
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`IPR2016-00204
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`22. This testimony is relevant because it undercuts Petitioners’ arguments, and
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`contradicts Dr. Davis’ assertion that Keppra “was known to have favorable
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`anticonvulsant properties years before” 1999. Ex. 1087 (Davis Decl.), ¶ 46. The
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`testimony is also relevant because it contradicts her assertion that “levetiracetam
`
`has the properties of a so-called ‘ideal’ AED, and was available and used before
`
`lacosamide” (id. at ¶ 117), to the extent “before lacosamide” means before the
`
`relevant date of 1996 (see id. at ¶ 14).
`
`3.
`
`In Ex. 2195 at 127:25–137:1, Dr. Davis agreed that Exs. 1097, 1098,
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`1099, 1100, 1101, and 1103, which she cites in paragraphs 43–44 of her
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`declaration (Ex. 1087), are all reports of animal studies relating to levetiracetam
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`that did not involve humans. At 259:23–261:11, she also agreed that an abstract
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`cited in Ex. 1103 is not cited in her declaration (counsel for Petitioner Argentum
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`pointed to this abstract during redirect questioning, see Ex. 2195 at 244:14–
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`245:11). In addition, at 138:14–142:24, Dr. Davis agreed that the other exhibits
`
`cited in paragraphs 44–45 of her declaration (Ex. 1087)—Exs. 1105, 1106, and
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`1102—are human studies conducted with “small” sample sizes. She also agreed
`
`that Ex. 1106 concludes that double-blind controlled and long-term studies are
`
`required to evaluate the efficacy and safety of levetiracetam (Ex. 2195 at 139:10–
`
`22), and similarly that Ex. 1102 states that double-blind controlled and long-term
`
`studies are planned to evaluate the efficacy and safety of levetiracetam (id. at
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`3
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`IPR2016-00204
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`141:21–142:24). This testimony is relevant to, and inconsistent with, Dr. Davis’
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`and Petitioners’ argument that levetiracetam satisfied the “unmet need identified
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`by Patent Owner,” which is an AED that, among other things, has “efficacy” and
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`“minimal side effects” in humans suffering from epilepsy. Reply at 20–21; see also
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`Ex. 1087 (Davis Decl.), ¶¶ 40–46, 99. The testimony is relevant because it
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`undercuts Petitioners’ arguments that, as of 1996, levetiracetam satisfied any
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`unmet need.
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`4.
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`In Ex. 2195 at 49:24–50:3, Dr. Davis explained that her decision-
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`making process for choosing an AED for any given patient is “complex and has to
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`do with the individual patient characteristics and also the type of epilepsy they
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`have.” At 50:4–17, she agreed that there is not a “one size-fits-all in terms of an
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`antiepileptic drug across the epilepsy population.” This testimony is relevant to
`
`Petitioners’ argument that, to satisfy an unmet need, an AED must be suitable for a
`
`large proportion of epileptic patients, and that meeting the need in at least some
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`patients is not enough. See Reply at 19–20 (arguing Vimpat did not satisfy the
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`unmet need and noting “Vimpat has no more than 3.7% of prescriptions in the
`
`AED market,” and that “Vimpat is not among Dr. Bazil’s top three AEDs he
`
`prescribes”). This testimony is relevant because it is inconsistent with Petitioners’
`
`argument, and it supports Dr. Bazil’s statements that epilepsy “is an extremely
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`heterogeneous disorder” and “treatment is highly individualized,” such that “there
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`4
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`IPR2016-00204
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`is no one-size-fits-all approach to management of epilepsy.” Ex. 2038 (Bazil
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`Decl.), ¶ 46; see also id. ¶ 87.
`
`5.
`
`In Ex. 2195 at 47:11–50:3, Dr. Davis acknowledged that she does not
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`prescribe levetiracetam for all of her patients, and that some of her patients have
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`tried levetiracetam and “have had side effects, so they’re not on levetiracetam.” At
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`114:3–12, she agreed that “levetiracetam does not control seizures in every
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`patient.” In addition, at 168:5–6, she testified that “I don’t disagree that lacosamide
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`can help some patients,” and at 52:3–53:18, she explained she prescribes
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`lacosamide for “roughly 200” out of the 5,000 AED prescriptions she writes per
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`year. This testimony is relevant to Petitioners’ argument that levetiracetam meets
`
`the unmet need of an “ideal” AED, and “thus lacosamide never satisfied the
`
`alleged unmet need.” Reply at 21–22. The testimony is also relevant to Patent
`
`Owner’s position that Vimpat need not be “effective in every patient” to fulfill “an
`
`unmet need in some patients—those for whom no other AED was effective, safe,
`
`or both.” Patent Owner Response (Paper 35) at 57 (emphases in original). This
`
`testimony is relevant because it explains that levetiracetam does not work for all
`
`patients, and that lacosamide does work for some patients, and therefore it is
`
`consistent with Patent Owner’s position and is inconsistent with Dr. Davis’ and
`
`Petitioners’ assertion that levetiracetam already satisfied any long-felt need for a
`
`new AED. See Ex. 1087 (Davis Decl.), ¶¶ 95–117; see, e.g., id. at ¶ 117 (asserting
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`5
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`IPR2016-00204
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`Dr. Bazil has not established that “lacosamide fulfills a long-felt need that was not
`
`already satisfied by levetiracetam”); Reply at 21–22.
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`6.
`
`In Ex. 2195 at 114:3–12, Dr. Davis agreed that “levetiracetam does
`
`not control seizures in every patient,” and that “unfortunately one third of patients
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`are not controlled by any antiepileptic drug magic combination that we can come
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`up with.” See also id. at 118:21–119:13 (agreeing that “patients for whom
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`levetiracetam did not control their seizures” still have a need for an AED). This
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`testimony is relevant to Petitioners’ argument that “Vimpat has not solved the
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`unmet need identified by Dr. Bazil” (Reply at 20, citing Ex. 1048 (Bazil Dep. Tr.)
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`to argue “unmet need is still not fully satisfied by lacosamide today” and that
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`“AED-refractory epilepsy population remain[ed] constant for years before and
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`after lacosamide’s introduction”), and to Petitioners’ argument that Keppra
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`(levetiracetam) did satisfy the unmet need (Reply at 18–22). The testimony is
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`relevant because Petitioners argue that Vimpat does not treat every patient and
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`therefore does not “fully” satisfy the unmet need while Keppra does satisfy the
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`need, yet Dr. Davis concedes that Keppra, like Vimpat, also does not treat “every
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`patient” and that “one third of patients” remain without seizure control even after
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`Keppra.
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`7.
`
`In Ex. 2195 at 108:13–111:19, Dr. Davis agreed that the “Lennox-
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`Gastaut syndrome population is 3.63 percent of the total epilepsy population,” that
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`6
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`IPR2016-00204
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`generalized epilepsy “makes up about 2.3 percent of the totally epilepsy
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`population,” and that together both types of epilepsy “make up about 5.9 percent of
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`the epilepsy population.” This testimony is relevant because it contradicts
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`paragraph 20 of Dr. Davis’ declaration, in which she concludes that Lennox
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`Gastaut syndrome and generalized epilepsies combined make up “~20% of the
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`epilepsy population,” and that lacosamide “is not indicated in this [~20% of the
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`epilepsy] population.” Ex. 1087 (Davis Decl.), ¶ 20.
`
`8.
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`In Ex. 2195 at 52:2–14 and 105:7–106:17, Dr. Davis explained that
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`about one third of epilepsy patients are drug resistant or refractory. At 52:3–53:18,
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`she explained that she prescribes lacosamide to “roughly 200” out of 5,000 AED
`
`prescriptions per year, and that such prescriptions are “typically in the setting of
`
`multiple prior antiepileptic drug failures, and a balance of side effects and efficacy
`
`for a given patient.” In addition, at 79:14–81:15, Dr. Davis testified that
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`lacosamide is one of the drugs that is used for patients with “super-refractory status
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`epilepticus,” which “has high morbidity and mortality.” See also id. at 249:8–252:8
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`(explaining that in her clinical experience, she probably uses lacosamide in
`
`approximately 50 status epilepticus patients per year). This testimony is relevant
`
`to Patent Owner’s position that Vimpat need not be “effective in every patient” to
`
`fulfill “an unmet need in some patients—those for whom no other AED was
`
`effective, safe, or both.” Response at 57 (emphases in original). This testimony is
`
`7
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`IPR2016-00204
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`relevant because it supports Patent Owner’s position, and confirms Dr. Bazil’s
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`testimony that lacosamide is an important option for refractory patients, see Ex.
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`2038 (Bazil Decl.), ¶ 79, and for treatment of status epilepticus, see id. ¶ 53.
`
`9.
`
`In Ex. 2195 at 99:13–101:8, Dr. Davis acknowledged that lacosamide
`
`is approved for monotherapy, whereas levetiracetam is not approved for
`
`monotherapy and is only approved for adjunctive therapy. This testimony is
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`relevant to Petitioners’ argument that levetiracetam satisfied the long-felt need
`
`identified by Dr. Bazil. Reply at 20–22. This testimony is relevant because
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`Petitioners rely on Dr. Davis’ assertions that Keppra “is FDA approved for more
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`indications than Vimpat” (Ex. 1087, ¶ 47) and “has more uses than lacosamide
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`(Vimpat)” (id. at ¶ 19), but Dr. Davis ignored the distinction between monotherapy
`
`and adjunctive therapy when making such assertions.
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`10.
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`In Ex. 2195 at 55:19–24 and 60:15–61:10, Dr. Davis agreed that
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`Keppra was first approved in 1999 for partial onset seizures, and then years later in
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`2007 was approved for primary generalized tonic-clonic seizures. At 67:18–68:4
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`and 69:4–11, she also agreed that Keppra’s approval for partial onset seizures in
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`children was in 2005, four years after initial approval in 1999. With respect to
`
`lacosamide’s (or Vimpat’s) approval timeline, at 61:25–62:6 and 69:13–70:4, Dr.
`
`Davis acknowledged
`
`that
`
`lacosamide
`
`is “currently undergoing clinical
`
`development for primary generalized epilepsy,” and “for the pediatric population.”
`
`8
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`IPR2016-00204
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`At 61:12–23, she also agreed that a typical approval path for AEDs is to obtain
`
`approval for partial onset epilepsy first, and then for generalized epilepsy. This
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`testimony is relevant to Petitioners’ arguments why lacosamide (Vimpat) does not
`
`satisfy a long-felt, unmet need. Reply at 19–21. This testimony is relevant because
`
`it explains that, while lacosamide is not yet FDA-approved for generalized
`
`epilepsy, or for use in children, studies of lacosamide for treatment of generalized
`
`epilepsy and in children are currently underway under a similar timeline as was
`
`done for levetiracetam (Keppra).
`
`11.
`
`In Ex. 2195 at 72:19–73:23, Dr. Davis acknowledged that there has
`
`been “no study making a direct comparison” between
`
`lacosamide and
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`levetiracetam with respect to treating juveniles or the elderly. This testimony is
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`relevant to Dr. Davis’ statements that “lacosamide is not deemed to be superior, or
`
`even equivalent, to levetiracetam in treating juveniles for CNS disorders,” and that
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`“[l]acosamide is also not deemed superior or equivalent for elderly patients.” Ex.
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`1087 (Davis Decl.), ¶ 71. This testimony is also relevant because it is consistent
`
`with Dr. Bazil’s statement that “head-to-head comparisons between AEDS . . .
`
`have largely not been performed.” Ex. 2038 (Bazil Decl.), ¶ 88.
`
`12.
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`In Ex. 2195 at 81:19–83:15, Dr. Davis acknowledged “there’s not
`
`[been] a direct head-to-head comparison between lacosamide and levetiracetam” in
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`the setting of status epilepticus. This testimony is relevant because it contradicts
`
`9
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`IPR2016-00204
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`Dr. Davis’ statement that “the data and the medical practice almost uniformly
`
`believe that levetiracetam as being far superior to lacosamide for treating status
`
`epilepticus,” Ex. 1087, ¶ 89 (emphasis added), with no citation to any study or
`
`literature supporting that statement.
`
`13.
`
`In Ex. 2195 at 149:1–7 and 149:23–150:9, Dr. Davis explained that
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`“there’s not [been] a direct comparison” of the “side effects or efficacy of
`
`levetiracetam against lacosamide in any set of epilepsy patients.” This testimony is
`
`relevant to and contradicts Petitioners’ argument that “[l]acosamide cannot claim
`
`superiority to other AEDs because no such benefit has been demonstrated through
`
`head-to-head clinical trials” (Reply at 20, citing Ex. 1087 (Davis Decl.), ¶¶ 169–
`
`170).
`
`14.
`
`In Ex. 2195 at 152:15–162:7, Dr. Davis answered questions regarding
`
`the following statement in paragraph 126 of her declaration: “As noted by Dr.
`
`Bazil, levetiracetam has been reported to have fewer side effects than lacosamide.
`
`Exhibit 1048 [Bazil Dep. Tr.] at 229:12–232:20; Exhibit 1048 (Exhibit 29).” Her
`
`testimony at 152:15–162:7 clarified that Dr. Bazil, when being questioned about
`
`Exhibit 292 during his deposition, was only asked about the side effect identified
`
`for levetiractam on one particular page of Exhibit 29, and that “more than just one
`
`
`2 Exhibit 29 to Dr. Bazil’s deposition is also Ex. 1079. See Ex. 2195 at 153:12–15.
`
`10
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`
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`
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`IPR2016-00204
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`side effect [is] reported for levetiracetam” on other pages of Ex. 29. See Ex. 2195
`
`at 159:20–160:11. This testimony is relevant because it contradicts Dr. Davis’
`
`assertion that “levetiracetam has been reported to have fewer side effects than
`
`lacosamide.” Ex. 1087 (Davis Decl.), ¶ 126 (citing Ex. 1048 (Bazil Dep. Tr.) and
`
`Ex. 29 thereto). This testimony is also relevant because it contradicts Dr. Davis’
`
`assertion that Dr. Bazil “noted” that levetiracetam has been reported to have fewer
`
`side effects than lacosamide. Id. (citing Ex. 1048 (Bazil Dep. Tr.) at 229:12–
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`232:20). This testimony is also relevant because it contradicts Petitioners’
`
`argument that “more side effects have been identified for lacosamide than
`
`alternative AEDs, including Keppra.” Reply at 20 (also citing Ex. 1028 (Bazil Dep.
`
`Tr.) at 229:12–232:20).
`
`15.
`
`In Ex. 2195 at 170:13–171:1, Dr. Davis explained that “a single case
`
`report does not change the literature or change medical practice in almost any
`
`circumstance.” See also id. at 172:1–173:13. This testimony is relevant to
`
`Petitioners’ argument that lacosamide “has more side effects than certain
`
`alternatives” and does not satisfy an unmet clinical need (see Reply at 17–18,
`
`citing Ex. 1087, ¶ 143, where Dr. Davis relies exclusively on case reports). This
`
`testimony is relevant because it supports Dr. Bazil’s explanation that “[i]ndividual
`
`case reports are inherently limited in their significance,” and that “only after
`
`multiple case reports and careful analysis as to the cause of the [reported] problem
`
`11
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`IPR2016-00204
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`are generated does a clear causal relationship between a drug and a particular effect
`
`become clear.” Ex. 2038, ¶ 84. The testimony is also relevant because it contradicts
`
`Dr. Davis’ assertion that there are “known side effects that have been associated
`
`with lacosamide use” (Ex. 1087, ¶ 143 (emphases added))—Dr. Davis relies
`
`exclusively on case reports to support this assertion. See id. at ¶¶ 144–145 (stating
`
`“there have been reports associating lacosamide with hallucinations, pancreatitis,
`
`and cardiac issues,” and that “[p]sychosis has also reported with the use of
`
`lacosamide,” while relying exclusively on case reports for such statements).
`
`16.
`
`In Ex. 2195 at 197:1–10, 199:16–25, 204:5–210:15, and 212:15–
`
`213:13, Dr. Davis agreed that convulsions are not commonly associated with other
`
`central nervous system (CNS) indications (insomnia, bipolar disorder, depression,
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`neuropathic pain, headache, and fibromyalgia), and that treatment of these
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`indications does not require an anticonvulsant. This testimony is relevant because
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`it contradicts Petitioners’ argument that the “evidence of need” that Vimpat
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`satisfies is not commensurate in scope for claims 10–13. Reply at 19. This
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`testimony is also relevant because it contradicts Petitioners’ argument that
`
`evidence concerning lacosamide’s use for CNS disorders other than epilepsy is
`
`required to show that lacosamide satisfied an unmet clinical need. See Reply at 19
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`(“Patent Owner fails to offer evidence that Vimpat satisfies a need for CNS
`
`disorders, to which the claims 11–13 are directed.”).
`
`12
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`
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`Date: December 22 2016 Respectfully submitted,
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`IPR2016—00204
`
`
` ndr G. Reister
`
`Registration No. 36,253
`
`Jennifer L. Robbins
`
`Registration No.2 61,163
`
`Enrique D. Longton
`
`Registration No.: 47,304
`
`COVINGTON & BURLING LLP
`
`One CityCenter, 850 Tenth Street, NW
`
`Washington, DC 20001
`
`(202) 662-6000
`
`Attorneys for Patent Owner
`
`13
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6,
`
`I hereby certify that on this 22nd day of
`
`December 2016,
`
`the foregoing Patent Owner’s Motion for Observations
`
`Regarding the Cr0ss—EXamination Testimony of Dr. Kathryn A. Davis was
`
`served by electronic mail, by agreement of the parties, on the following counsel of
`
`record for Petitioners.
`
`PETITIONER (IPR20 l 6-00204)
`Matthew J. Dowd (mj dowd@dowdpl1c.com)
`DOWD PLLC
`
`William G. Jenks (wjenks@jenksiplaw.com)
`JENKS IP LAW
`
`PETITIONER (lPR20l6—O1 101)
`Steven W. Parmelee (sparmelee@wsgr.com)
`Michael T. Rosato (mrosato@wsgr.corn)
`Jad A. Mills (jmills@wsgr.com)
`WILSON SONSINI GOODRICH & ROSATI
`
`PETITIONER (IPR20 1 6-0 1242)
`Matthew L. Fedowitz (mfedowitz@merchantgouldcom)
`Daniel R. Evans (devans@merchantgould.com)
`MERCHANT & GOULD P.C.
`
`PETITIONER (IPR20l6—0l245)
`Gary J. Speier (gspeier@carlsoncaspers.corn)
`Jeffer Ali (jali@carlsoncaspers.com)
`CARLSON, CASPERS, VANDENBURGH, LINDQUIST & SCHUMAN, P.A.
`
`Date: December 22, 2016
`
`M1
`
`
`
`Robbins, Esq.
`r
`Reg. No.: 61,163
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