Paper No. ___
`Filed: April 14, 2015
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________________
`
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`RANBAXY LABORATORIES LTD. and RANBAXY INC.,
`Petitioners,
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`v.
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`ADAMAS PHARMACEUTICALS, INC.,
`Patent Owner.
`
`_____________________________
`
`Case IPR2015-00410
`Patent No. 8,362,085
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`_____________________________
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`PATENT OWNER’S PRELIMINARY RESPONSE
`PURSUANT TO 37 C.F.R. § 42.107
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`Filed: April 14, 2015
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_____________________________
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`RANBAXY LABORATORIES LTD. and RANBAXY INC.,
`Petitioners,
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`v.
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`ADAMAS PHARMACEUTICALS, INC.,
`Patent Owner.
`
`_____________________________
`
`Case IPR2015-00410
`Patent No. 8,362,085
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`_____________________________
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`PATENT OWNER’S PRELIMINARY RESPONSE
`PURSUANT TO 37 C.F.R. § 42.107
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`TABLE OF CONTENTS
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`I.
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`II.
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`Introduction ........................................................................................................... 1
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`The Petition Failed to Name All Real Parties-In-Interest .................................... 1
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`A.
`B.
`C.
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`D.
`E.
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`Factual Background .................................................................................... 3
`The Real Party-in-Interest Requirement .................................................... 5
`Sun Pharma was a Real Party-in-Interest at the Time the
`Petition was Filed ....................................................................................... 7
`The Failure to Identify Sun Pharma is Fatal ............................................ 10
`Additional Discovery ............................................................................... 11
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`III. Conclusion .......................................................................................................... 11
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`IV. Appendix – List of Exhibits ................................................................................ 13
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`I.
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`INTRODUCTION
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`Case IPR2015-00410
`Patent 8,362,085
`Patent Owner Preliminary Response
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`The Board should not institute inter partes review of U.S. Patent No.
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`8,362,085 (the “’085 patent”) because petitioners – Ranbaxy Laboratories Ltd.
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`(“Ranbaxy Labs”) and Ranbaxy Inc. (collectively, “Petitioners”) – filed a fatally
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`flawed Petition. Specifically, Petitioners failed to name all real parties-in-interest,
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`and their belated correction of this defect is futile under 35 U.S.C. § 315(b).
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`Accordingly, institution of inter partes review should be denied.
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`II. THE PETITION FAILED TO NAME
`ALL REAL PARTIES-IN-INTEREST
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`Petitioners did not identify all real parties-in-interest in their Petition as
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`required by 35 U.S.C. § 312(a)(2) and 37 C.F.R. § 42.8(b)(1). Specifically, the
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`Petition did not identify Sun Pharmaceutical Industries Ltd. (“Sun Pharma”) as a
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`real party-in-interest, despite the fact that Ranbaxy Labs was acting as a proxy for
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`Sun Pharma and subject to its direct control at the time the Petition was filed.
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`Notably, at the time Petition was filed, both Sun Pharma and Ranbaxy were in
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`infringement litigation regarding the ‘085 patent.
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`Sun Pharma recently completed its acquisition of petitioner Ranbaxy Labs,
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`which is now defunct. Ex. 2001 p. 1 (“Ranbaxy will be delisted”). On April 8,
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`2015, Petitioners served updated Mandatory Notices, identifying for the first time
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`Sun Pharma as a real party-in-interest. Paper 15 p. 2.
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`Patent 8,362,085
`Patent Owner Preliminary Response
`Unmentioned in Petitioners’ updated Mandatory Notices, however, is the
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`fact that at the time the Petition was filed on December 17, 2014, the legal
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`relationship between Ranbaxy Labs and Sun Pharma was governed by an
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`agreement between them titled Scheme of Arrangement (the “Scheme”). See Ex.
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`2002. The Scheme created an explicit agency relationship between the entities,
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`designating Ranbaxy Labs as the agent of Sun Pharma from April 1, 2014 to
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`March 25, 2015 (the “standstill” period).
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`The Petition was filed on December 17, 2014, which was during the
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`standstill period of the Scheme, when Ranbaxy Labs was expressly designated by
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`the Scheme as acting “for and on behalf of and as an agent for [Sun Pharma].” Id.
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`p. 15. Accordingly, as provided by the Scheme, Ranbaxy Labs filed the petition
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`for inter partes review on behalf of Sun Pharma. Petitioners, however, failed to
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`identify Sun Pharma as a real party-in-interest.
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`Petitioners’ failure to identify Sun Pharma as a real party-in-interest in its
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`Petition is fatal. Petitioners’ belated identification of Sun Pharma as a real party-
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`in-interest cannot change that outcome. Specifically, Petitioners’ belated
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`identification of Sun Pharma as a real party-in-interest is futile given the pre-
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`existing litigation regarding the ‘085 patent. The earliest filing date that can be
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`accorded to the Petition is the date of the correction of the real parties-in-interest,
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`April 8, 2015. See Paper 15. That is more than one year after Sun Pharma – which
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`is now seeking to act as a petitioner and is undisputedly a real party-in-interest –
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`was constructively served and waived formal service of a complaint alleging
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`infringement of the ’085 patent. See Ex. 2003; see also 35 U.S.C. § 315(b)
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`(including service against a real party-in-interest or privy); Fed. R. Civ. P. 4(d)(4)
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`(“When the plaintiff files a waiver, proof of service is not required and these rules
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`apply as if a summons and complaint had been served at the time of filing the
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`waiver.”); Motorola Mobility LLC v. Arnouse, Case IPR2013-00010, slip op. at 6
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`(PTAB Jan. 30, 2013) (Paper 20) (holding that “in the situation where the
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`petitioner waives service of a summons, the one-year time period begins on the
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`date on which such a waiver is filed”).
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`A. FACTUAL BACKGROUND
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`Both Ranbaxy Labs and Sun Pharma are defendants in patent infringement
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`litigation in which, inter alia, the ‘085 patent has been asserted by patent owner
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`Adamas Pharmaceuticals, Inc. and its exclusive licensee, Forest Laboratories. In
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`that litigation, Sun Pharma was provided with a copy of the Complaint and
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`requested to waive service on February 10, 2014. Ex. 2004. Sun Pharma promptly
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`agreed to waive service, and that waiver was filed with the U.S. District Court for
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`the District of Delaware on February 17, 2014. Ex. 2003.
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`On April 6, 2014, Ranbaxy Labs and Sun Pharma publicly announced that
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`they had entered into final agreements under which Sun Pharma would acquire
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`Ranbaxy Labs. Ex. 2005. Sun later announced that the merger closed on March
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`25, 2015. Ex. 2001; Paper 15 p. 1. During the interim, the legal relationship
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`between Ranbaxy Labs and Sun Pharma was governed by the Scheme agreed to by
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`Ranbaxy Labs and Sun Pharma. See Ex. 2002.
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`During the relevant period, the Scheme created an explicit agency
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`relationship, with Ranbaxy Labs serving as the agent of its controlling principal,
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`Sun Pharma. In particular, the Scheme provided that “[f]or the period from the
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`Appointed Date and up to the Effective Date” (that is, from April 1, 2014 to March
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`25, 2015, the standstill period):
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`Any of the rights, powers, authorities and privileges attached or
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`related or pertaining to and exercised by or available to
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`[Ranbaxy Labs] shall be deemed to have been exercised by
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`[Ranbaxy Labs] for and on behalf of and as agent for [Sun
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`Pharma].
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` Similarly, any of the obligations, duties and
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`commitments attached, related or pertaining to the Undertaking
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`that have been undertaken or discharged by [Ranbaxy Labs]
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`shall be deemed to have been undertaken or discharged for and
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`on behalf of and as agent for [Sun Pharma]. Id. p. 15 (emphasis
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`added).
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`The Scheme further provided that:
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`The conduct of business of [Ranbaxy Labs] and [Sun Pharma]
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`in the period between the date of this Scheme and the Effective
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`Date shall be as agreed in writing between [Ranbaxy Labs] and
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`[Sun Pharma] . . . . Id.
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`Finally, the Scheme provided that any legal proceedings, such as those
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`sought by Ranbaxy Labs in the Petition, should be treated as if they had been
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`brought by Sun Pharma: “Upon coming into effect of this Scheme all suits, claims,
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`actions and proceedings by or against [Ranbaxy Labs] pending and/or arising on or
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`before the Effective Date shall be continued and be enforced by or against [Sun
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`Pharma] as effectually as if the same had been originally instituted and/or pending
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`and/or arising by or against [Sun Pharma].” Id. p. 14 (emphasis added). Indeed,
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`now that the merger has closed, Sun Pharma seeks to step into the now-defunct
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`Ranbaxy Labs’ shoes for purposes of the Petition. Paper 15 p. 2; see also Ex. 2002
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`pp. 14-15 (“[Sun Pharma] will undertake to have all legal or other proceedings
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`initiated by or against [Ranbaxy Labs] referred to in Section 5(a) above transferred
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`to its name and to have the same continued, prosecuted and enforced by or against
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`[Sun Pharma].”).
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`B. THE REAL PARTY-IN-INTEREST REQUIREMENT
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`“A petition [for inter partes review] may be considered only if . . . [it]
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`identifies all real parties in interest.” 35 U.S.C. § 312(a)(2). Identification of real
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`parties-in-interest assists “members of the Board in identifying potential conflicts”
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`and assures “proper application of the statutory estoppel provisions.” Office Patent
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`Trial Practice Guide, 77 Fed. Reg. 48,756, 48,759 (Aug. 14, 2012). The
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`requirement “seeks to protect patent owners from harassment via successive
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`petitions by the same or related parties, to prevent parties from having a ‘second
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`bite at the apple,’ and to protect the integrity of both the USPTO and Federal
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`Courts by assuring that all issues are promptly raised and vetted.” Id.
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`Real party-in-interest analysis is “highly fact-dependent” and judged by the
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`totality of the circumstances rather than any bright-line test. Id. “[A]t a general
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`level, the ‘real party-in-interest’ is the party that desires review of the patent.
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`Thus, the ‘real party-in-interest’ may be the petitioner itself, and/or it may be the
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`party or parties at whose behest the petition has been filed.” Id.
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`In determining whether a non-party was a real party-in-interest, “[a]
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`common consideration is whether the non-party exercised or could have exercised
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`control over a party’s participation in a proceeding.” Id. (emphasis added).
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`Complete control is not required, “[i]t should be enough that the nonparty has the
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`actual measure of control or opportunity to control that might reasonably be
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`expected between two formal coparties.” Id. (quoting 18A Charles Alan Wright,
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`Arthur R. Miller & Edward H. Cooper, Federal Practice & Procedure § 4451 (2d
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`ed. 2011)) (internal quotations omitted). “The non-party’s participation may be
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`overt or covert, and the evidence may be direct or circumstantial—but the evidence
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`as a whole must show that the non-party possessed effective control from a
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`practical standpoint.” Zoll Lifecor Corp. v. Philips Elec. N. Am. Corp., Case
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`IPR2013-00606, slip op. at 9 (PTAB Mar. 20, 2014) (Paper 13) (citing Gonzalez v.
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`Banco Cent. Corp., 27 F.3d 751, 759 (1st Cir. 1994)). In short, possession of
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`effective control, whether exercised or not, is sufficient to establish an entity as a
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`real party in interest.
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`C. SUN PHARMA WAS A REAL PARTY-IN-INTEREST
`AT THE TIME THE PETITION WAS FILED
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`At the time the Petition was filed on December 17, 2014, Sun Pharma was a
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`real party-in-interest under the terms of the Scheme. Accordingly, Sun Pharma
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`should have been, but was not, identified as a real party-in-interest in the Petition.
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`The Board has previously found that a non-party should have been identified
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`as a real party-in-interest in a variety of circumstances. See, e.g., Zoll, Paper 13,
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`slip op. at 10 (finding that “an involved and controlling parent corporation
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`representing the unified interests of itself and [p]etitioner” was a real party-in-
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`interest); Galderma S.A. v. Allergan Industrie, SAS, Case IPR2014-01422, slip op.
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`at 12-13 (PTAB Mar. 5, 2015) (Paper 14) (same); Zerto, Inc. v. EMC Corp., Case
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`IPR2014-01254, slip op. at 14-15 (PTAB Feb 12, 2015) (Paper 35) (same); GEA
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`Process Eng'g. Inc. v. Steuben Foods, Inc., Case IPR2014-00041, slip. op. at 14-21
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`(PTAB Feb. 11, 2015) (Paper 140) (finding a non-party that paid the petitioner’s
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`legal fees to be a real party-in-interest); RPX Corp. v. VirnetX Inc., Case IPR2014-
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`00171, slip op. at 6-10 (PTAB June 5, 2014) (Paper 49) (finding a non-party was a
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`real party-in-interest when litigating through a proxy).
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`Here, the interest of Sun Pharma was not covert. Nor does one have to look
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`to a course of conduct to discern that Sun Pharma had the ability to control
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`Ranbaxy Labs’ filing of the Petition. Instead, the Scheme agreed to by Ranbaxy
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`Labs and Sun Pharma is explicit, and makes readily apparent that Sun Pharma was
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`a real party-in-interest.
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`Given the Scheme, there can be no doubt “at whose behest” the Petition was
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`filed. See 77 Fed. Reg. at 48,759. The Scheme explicitly provides that any rights
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`exercised by Ranbaxy Labs, such as those exercised by Ranbaxy Labs in filing the
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`Petition, were exercised by Ranbaxy Labs “for and on behalf of” Sun Pharma. Ex.
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`2002 p. 15 (emphasis added). In other words, Ranbaxy Labs was acting as a proxy
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`for Sun Pharma. See, e.g., RPX Corp., Paper 49, slip op. at 6-10. This alone is
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`enough to find that Sun Pharma was a real party-in-interest.
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`Moreover, Sun Pharma also had “the power—whether exercised or not—to
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`call the shots.” See, e.g., Galderma, Paper 14, slip op. at 8 (quoting Gonzalez, 27
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`F.3d at 758). The Scheme provides that the conduct of Ranbaxy Labs’ business
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`would be as agreed in writing between Ranbaxy Labs and Sun Pharma. Ex. 2002
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`p. 15. And pursuant to the Scheme, Ranbaxy Labs was acting as Sun Pharma’s
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`agent in filing the Petition. Id. It is a fundamental aspect of any agency
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`relationship that a principal has the right to control the conduct of its agent.
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`Restatement (Second) of Agency § 14.
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`The relationship between Ranbaxy Labs and Sun Pharma was even closer
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`than the relationship between an intertwined parent and subsidiary. See, e.g.,
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`Galderma, Paper 14, slip op. at 12 (quoting Zoll, Paper 13, slip op. at 10). Indeed,
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`the explicit purpose of the Scheme was to “combine the business, activities and
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`operations of [Ranbaxy Labs] and [Sun Pharma] into a single company with effect
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`from [April 1, 2014].” Ex. 2002 p. 4 (emphasis added).1 Consistent with this
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`purpose, the Scheme states that legal proceedings brought by Ranbaxy Labs during
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`1 In contrast, the petitions in Synopsis Inc. v. Mentor Graphics Corp., Case
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`IPR2012-00042, slip op. at 14-16 (PTAB Feb. 19, 2014) (Paper 60), and Valeo
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`North America, Inc. v. Magna Elecs., Inc., Case IPR2014-00220, slip op. at 3
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`(PTAB Jan. 8, 2015) (Paper 45), were filed prior to the relevant acquisitions. Here,
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`the Petition was filed after the Scheme was entered into and took effect. See, e.g.,
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`Ex. 2002 p. 4. This case is also distinguishable from Valeo North America, Inc. v.
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`Magna Elecs., Inc., Case IPR2014-01203, slip op. at 7-8 (PTAB Jan. 28, 2015)
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`(Paper 13), where a predecessor-in-interest was inadvertently named after it had
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`ceased to exist, rather than its successor. Here, both Ranbaxy Labs and Sun
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`Pharma were extant at the time the Petition was filed.
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`the standstill period would be continued by Sun Pharma “as effectually as if the
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`same had been originally instituted” by Sun Pharma. Id. p. 14 (emphasis added).
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`Where, as here, a petition is filed on behalf of an entity and that entity has
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`the ability, whether exercised or not, to control the course of the proceeding, that
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`entity is a real party-in-interest and must be identified. Sun Pharma should have
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`been identified as a real party-in-interest in the Petition.
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`D. THE FAILURE TO IDENTIFY SUN PHARMA IS FATAL
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`The failure to identify all real parties-in-interest violates both statutory and
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`regulatory requirements. 35 U.S.C. § 312(a); 47 C.F.R. § 42.8(b)(1). Section
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`42.106(b) of 37 C.F.R. provides that “[w]here a party files an incomplete petition,
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`no filing date will be accorded[.]”
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`Here, Petitioners’ attempt to cure the omission of Sun Pharma as a real
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`party-in-interest on April 8, 2015 was futile, because Sun Pharma was
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`constructively served (via filing of a waiver of service) with a Complaint alleging
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`infringement of the ’085 patent over one year earlier, on February 17, 2014. Ex.
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`2004; Ex. 2003; see also Motorola, Paper 20, slip op. at 6 (holding that “in the
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`situation where the petitioner waives service of a summons, the one-year time
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`period begins on the date on which such a waiver is filed”). Thus, after correction,
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`the earliest filing date that arguably could be accorded to the Petition, the date of
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`the correction, April 8, 2015, does not fall within the one-year period specified by
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`35 U.S.C. § 315(b). The Petition should be denied as untimely. See, e.g.,
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`VMware, Inc. v. Good Tech. Software, Inc., Case IPR2014-01324, slip op. at 2-3
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`(PTAB Feb. 20, 2015) (Paper 28) (institution barred by acquirer’s service date).
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`E. ADDITIONAL DISCOVERY
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`Patent Owner believes the evidence submitted herewith sufficiently
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`establishes that Sun Pharma was an unnamed real party-in-interest when the
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`Petition was filed. In the absence of a specific rebuttal, no further showing is
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`required for denial of the relief requested in the Petition. Should Petitioners
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`contest that Sun Pharma was an unnamed real party-in-interest when the Petition
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`was filed, or should the Board desire further information on the issue, Patent
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`Owner may seek discovery reasonably tailored to address the issue at the
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`appropriate time.
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`III. CONCLUSION
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`Petitioners failed to identify all real parties-in-interest in the Petition as
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`required. Sun Pharma was a real party-in-interest, because at the time the Petition
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`was filed Ranbaxy Labs was acting as a proxy for Sun Pharma. Petitioners’
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`attempt to cure the Petition is futile, because the earliest filing date the Petition can
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`be accorded does not fall within the period specified by 35 U.S.C. § 315(b).
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`Accordingly, institution of inter partes review should be denied.
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`Date: April 14, 2015
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`Respectfully submitted,
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`By: /Peter J. Armenio, P.C. (Reg. No. 41,588)/
` Peter J. Armenio, P.C. (Reg. No. 41,588)
`Evangeline Shih (Reg. No. 50,170)
`QUINN EMANUEL URQUHART &
`SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`General Tel: (212) 849-7000
`Direct Tel: (212) 849-7553
`Fax: (212) 849-7100
`peterarmenio@quinnemanuel.com
`evangelineshih@quinnemanuel.com
`
`Attorneys for Adamas Pharmaceuticals,
`Inc., Forest Laboratories LLC and
`Forest Laboratories Holdings, Ltd.
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`IV. APPENDIX – LIST OF EXHIBITS
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`
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`EXHIBIT NO.
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`DESCRIPTION
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`2001
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`2002
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`2003
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`2004
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`2005
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`March 25, 2015 Press Release
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`Scheme of Arrangement
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`As-filed Waiver of Service
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`Request for Waiver of Service with Complaint
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`April 6, 2014 Press Release
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`CERTIFICATE OF SERVICE
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`I certify that the foregoing Patent Owner’s Preliminary Response Pursuant to
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`37 C.F.R. § 42.207 and accompanying Exhibits 2001-2005 were served on this
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`14th day of April, 2015, on the Petitioner at the correspondence address of the
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`Petitioner as follows:
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`John W, Bateman
`Kenyon & Kenyon LLP
`1500 K Street, NW
`Washington, DC 20005
`jbateman@kenyon.com
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`Karen C. Shen
`Kenyon & Kenyon LLP
`One Broadway
`New York, NY 10004-1007
`kshen@kenyon.com
`
`
`Date: April 14, 2015
`
`
`Respectfully submitted,
`By: /Peter J. Armenio, P.C. (Reg. No. 41,588)/
` Peter J. Armenio, P.C. (Reg. No. 41,588)
`Evangeline Shih (Reg. No. 50,170)
`QUINN EMANUEL URQUHART &
`SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`General Tel: (212) 849-7000
`Direct Tel: (212) 849-7553
`Fax: (212) 849-7100
`peterarmenio@quinnemanuel.com
`evangelineshih@quinnemanuel.com
`Attorneys for Adamas Pharmaceuticals,
`Inc., Forest Laboratories LLC and
`Forest Laboratories Holdings, Ltd.
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