Case 1:21-cv-00282-UNA Document 1 Filed 02/24/21 Page 1 of 12 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`VANDA PHARMACEUTICALS INC.,
`
`Plaintiff,
`
`v.
`
`APOTEX INC. and APOTEX CORP.,
`
`Defendants.
`
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`)
`)
`)
`)
`)
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`)
`
`C.A. No. _______________
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`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiff Vanda Pharmaceuticals Inc. (“Vanda”) for its Complaint against
`
`Defendants Apotex Inc. and Apotex Corp. (“Apotex”) alleges as follows:
`
`I.
`
`THE PARTIES
`
`1.
`
`Plaintiff Vanda is a Delaware corporation with its principal place of
`
`business at 2200 Pennsylvania Ave. NW, Suite 300E, Washington, DC 20037. Vanda is a
`
`pharmaceutical company that focuses on the development and commercialization of new
`
`medicines to address unmet medical needs, including Hetlioz® (tasimelteon oral capsules), for the
`
`treatment of Non-24-Hour Sleep-Wake Disorder (“Non-24”).
`
`2.
`
`On information and belief, Apotex Inc. is a Canadian corporation with its
`
`principal place of business at 150 Signet Drive, Toronto, Ontario M9L 1T9, Canada.
`
`3.
`
`On information and belief, Apotex Corp. is a corporation organized and
`
`existing under the laws of the State of Delaware, with its principal place of business at 2400 North
`
`Commerce Parkway, Suite 400, Weston, Florida 33326.
`
`4.
`
`On information and belief, Apotex Corp. is a subsidiary of Apotex Inc.
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`VANDA PHARMACEUTICALS INC.,
`
`Plaintiff,
`
`v.
`
`APOTEX INC. and APOTEX CORP.,
`
`Defendants.
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`C.A. No. _______________
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiff Vanda Pharmaceuticals Inc. (“Vanda”) for its Complaint against
`
`Defendants Apotex Inc. and Apotex Corp. (“Apotex”) alleges as follows:
`
`I.
`
`THE PARTIES
`
`1.
`
`Plaintiff Vanda is a Delaware corporation with its principal place of
`
`business at 2200 Pennsylvania Ave. NW, Suite 300E, Washington, DC 20037. Vanda is a
`
`pharmaceutical company that focuses on the development and commercialization of new
`
`medicines to address unmet medical needs, including Hetlioz® (tasimelteon oral capsules), for the
`
`treatment of Non-24-Hour Sleep-Wake Disorder (“Non-24”).
`
`2.
`
`On information and belief, Apotex Inc. is a Canadian corporation with its
`
`principal place of business at 150 Signet Drive, Toronto, Ontario M9L 1T9, Canada.
`
`3.
`
`On information and belief, Apotex Corp. is a corporation organized and
`
`existing under the laws of the State of Delaware, with its principal place of business at 2400 North
`
`Commerce Parkway, Suite 400, Weston, Florida 33326.
`
`4.
`
`On information and belief, Apotex Corp. is a subsidiary of Apotex Inc.
`
`
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`Case 1:21-cv-00282-UNA Document 1 Filed 02/24/21 Page 2 of 12 PageID #: 2
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`5.
`
`On information and belief Apotex Corp. is the designated U.S. agent for
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`Apotex Inc. in accordance with 21 C.F.R. § 314.50(a) in connection with Abbreviated New Drug
`
`Application No. 211607 (the “Apotex ANDA”).
`
`6.
`
`On information and belief, Apotex Corp. is a generic pharmaceutical
`
`company that distributes and sells generic pharmaceutical products in the State of Delaware and
`
`throughout the United States that are manufactured by Apotex Inc. (Apotex Inc. and Apotex Corp.
`
`are collectively referred to herein as “Apotex” unless otherwise specified).
`
`II.
`
`NATURE OF THE ACTION
`
`7.
`
`This is an action arising under the patent laws of the United States (Title 35,
`
`U.S. Code, §§ 100, et seq.) based upon Apotex’s infringement of one or more claims of Vanda’s
`
`U.S. Patent No. 10,829,465 (“the ’465 patent”), which, in relevant part, generally relates to
`
`compositions comprising purified tasimelteon.
`
`8.
`
`Vanda is the holder of approved New Drug Application No. 205677 for
`
`Hetlioz® (tasimelteon) capsules, 20 mg, which was approved by the Food and Drug
`
`Administration (“FDA”) on January 31, 2014, for the treatment of Non-24 a circadian rhythm
`
`sleep disorder.
`
`9.
`
`10.
`
`Tasimelteon is the active ingredient in Hetlioz®.
`
`On information and belief, Apotex filed its ANDA under § 505(j) of the
`
`Federal Food, Drug, and Cosmetic Act (the “FFDCA”), to obtain approval to commercially
`
`manufacture and sell generic tasimelteon capsules in its 20 mg strength for the treatment of Non-
`
`24 (“Apotex’s ANDA Product”).
`
`11.
`
`On information and belief, Apotex made and included in its ANDA a
`
`certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“Paragraph IV Certification”) that, in its
`
`2
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`Case 1:21-cv-00282-UNA Document 1 Filed 02/24/21 Page 3 of 12 PageID #: 3
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`opinion and to the best of its knowledge, the ’465 patent is invalid, unenforceable, and/or that
`
`certain claims will not be infringed by Apotex’s ANDA Product.
`
`12.
`
`Vanda received written notice of Apotex’s ANDA and Paragraph IV
`
`Certification as to the ’465 patent on January 14, 2021 (“Notice Letter”), along with an enclosed
`
`statement of Apotex’s alleged factual and legal bases for stating that the ’465 patent is invalid,
`
`unenforceable, and/or will not be infringed by Apotex’s ANDA Product (“Detailed Statement”).
`
`13.
`
`Apotex’s Detailed Statement does not provide any factual bases or other
`
`statements alleging that the ’465 patent is unenforceable.
`
`14.
`
`This action is being commenced within 45 days of receipt of Apotex’s
`
`Notice Letter.
`
`15.
`
`Apotex has infringed one or more claims of the ’465 patent under 35 U.S.C.
`
`§ 271(e)(2)(A) by virtue of the filing of the Apotex ANDA with a Paragraph IV Certification and
`
`seeking FDA approval of the Apotex ANDA prior to the expiration of the ’465 patent or any
`
`extensions thereof.
`
`16.
`
`Apotex has infringed one or more claims of the ’465 patent under 35 U.S.C.
`
`§ 271(e)(2)(A) by virtue of the filing of the Apotex ANDA seeking FDA approval to commercially
`
`manufacture, use, offer for sale, sell, distribute in, or import into the United States generic
`
`tasimelteon for the treatment of Non-24 prior to the expiration of the ’465 patent or any extensions
`
`thereof.
`
`III.
`
`JURISDICTION
`
`17.
`
`This action arises under
`
`the patent
`
`laws of
`
`the United States,
`
`35 U.S.C. §§ 100, et seq., and this Court has subject matter jurisdiction over Vanda’s patent
`
`infringement claims under 28 U.S.C. §§ 1331, 1338(a), 2201, and 2202.
`
`3
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`Case 1:21-cv-00282-UNA Document 1 Filed 02/24/21 Page 4 of 12 PageID #: 4
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`18.
`
`This Court has personal jurisdiction over Apotex Corp. because Apotex
`
`Corp. is incorporated in the State of Delaware.
`
`19.
`
`On information and belief, Apotex’s registered agent for service of process
`
`is Corporate Creations Network Inc., with an address at 3411 Silverside Road #104, Tatnall
`
`Building, Wilmington, Delaware 19810.
`
`20.
`
`This Court has personal jurisdiction over Apotex Inc. under Fed. R. Civ. P.
`
`4(k) because, on information and belief, Apotex Inc. is organized under the laws of Canada.
`
`21.
`
`This Court has personal jurisdiction over Apotex Inc. because at least one
`
`of the provisions under Del. Code Ann. tit. 10, § 3104, is satisfied. On information and belief,
`
`Apotex satisfies at least § 3104(c)(1) (“[t]ransacts any business or performs any character of work
`
`or service in the State), § 3104(c)(2) (“[c]ontracts to supply services or things in this State”), §
`
`3104(c)(3) (“[c]auses tortious injury in the State by an act or omission in this State), and §
`
`3104(c)(4) (“[c]auses tortious injury in the State or outside of the State by an act or omission
`
`outside the State if the person regularly does or solicits business, engages in any other persistent
`
`course of conduct in the State or derives substantial revenue from services, or things used or
`
`consumed in the State”).
`
`22.
`
`This Court also has personal jurisdiction over Apotex Inc. because this suit
`
`arises out of and relates to Apotex Inc.’s activities, in concert with Apotex Corp., that are, and will
`
`be, directed to Delaware. On information and belief, following any FDA approval of the Apotex
`
`ANDA, Apotex Inc., in concert with Apotex Corp., will market and sell Apotex’s ANDA Product
`
`that is the subject of the infringement claims in this action in the State of Delaware and throughout
`
`the United States, including in this Judicial District.
`
`4
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`23.
`
`On information and belief, Apotex Inc., directly and through its
`
`subsidiaries, affiliates, or agents, including Apotex Corp., is in the business of manufacturing
`
`generic pharmaceuticals that it distributes or has distributed in the State of Delaware and
`
`throughout the United States.
`
`24.
`
`Apotex Inc. and Apotex Corp., acting in concert, have committed, or aided,
`
`abetted, contributed to, and/or participated in the commission of acts of patent infringement that
`
`will lead to foreseeable harm and injury to Vanda, which manufactures Hetlioz® for sale and use
`
`throughout the United States, including in this Judicial District. On information and belief, and as
`
`indicated by the Notice Letter, Apotex prepared and filed ANDA No. 211607 with the intention
`
`of seeking to market generic tasimelteon nationwide, including within this Judicial District.
`
`25.
`
`On information and belief, Apotex plans to market and sell generic
`
`tasimelteon in the State of Delaware, list generic tasimelteon on the State of Delaware’s
`
`prescription drug formulary, and seek Medicaid reimbursement for sales of Apotex’s ANDA
`
`Product in the State of Delaware, either directly or through one or more of Apotex’s wholly owned
`
`subsidiaries, agents, and/or alter egos.
`
`26.
`
`On information and belief, Apotex knows and intends that its proposed
`
`generic tasimelteon product will be distributed and sold in Delaware and will thereby displace
`
`sales of Hetlioz®, causing injury to Vanda. Apotex intends to take advantage of its established
`
`channels of distribution in Delaware for the sale of Apotex’s ANDA Product.
`
`IV.
`
`VENUE
`
`27.
`
`Venue is proper in this Judicial District under 28 U.S.C. § 1400(b) with
`
`regard to Apotex Corp., because, upon information and belief, Apotex Corp. resides in the State
`
`of Delaware and therefore Apotex’s ANDA submission is sufficiently related to this District.
`
`5
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`28.
`
`Venue is proper in this Judicial District under 28 U.S.C. § 1391 and
`
`§ 1400(b) with regard to Apotex Inc., because, upon information and belief, Apotex Inc. is
`
`incorporated in Canada and may be sued in any judicial district in the United States in which
`
`Apotex Inc. is subject to the Court’s personal jurisdiction.
`
`V.
`
`THE PATENT-IN-SUIT
`
`(U.S. PATENT NO. 10,829,465)
`
`29.
`
`30.
`
`tasimelteon.
`
`The allegations above are incorporated herein by reference.
`
`The ’465 patent covers, generally, compositions comprising purified
`
`31.
`
`As explained in the ’465 patent, “in the synthesis of tasimelteon there are
`
`certain impurities that can be formed as both by-products and degradation products, and that these
`
`impurities can be controlled or reduced to non-detectable or acceptably detectable levels.”
`
`32.
`
`Vanda is the owner of all rights, title, and interest in the ’465 patent, entitled
`
`“Highly Purified Pharmaceutical Grade Tasimelteon.” The USPTO duly and legally issued the
`
`’465 patent on November 10, 2020, to Deepak Phadke, Natalie M. Platt, and Ravi K.
`
`Pandrapragada as inventors, which was assigned to Vanda. A true and correct copy of the ’465
`
`patent is attached to this Complaint as Exhibit A.
`
`33.
`
`The ’465 patent generally claims compositions comprising purified
`
`tasimelteon.
`
`VI.
`
`COUNT I
`
`(INFRINGEMENT OF THE ’465 PATENT)
`
`34.
`
`The allegations above are incorporated herein by reference.
`
`6
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`35.
`
`Apotex filed the Apotex ANDA under § 505(j) of the FFDCA to obtain
`
`approval to commercially manufacture, use, offer to sell, and sell generic tasimelteon for the
`
`treatment of Non-24 before the expiration of the ’465 patent and any extensions thereof.
`
`36.
`
`Apotex’s Notice Letter states that Apotex filed the ANDA seeking approval
`
`to manufacture, use, offer to sell, and sell generic tasimelteon in its 20 mg strength for the treatment
`
`of Non-24 before the expiration of the ’465 patent. The Notice Letter represents that an
`
`Amendment to Apotex’s ANDA was submitted with a Paragraph IV Certification that the ’465
`
`patent purportedly is invalid, unenforceable, and/or will not be infringed by the commercial
`
`manufacture, use, or sale of Apotex’s ANDA Product.
`
`37.
`
`The ’465 patent is listed in FDA’s Approved Drug Products with
`
`Therapeutic Equivalence Evaluations for Hetlioz® in its 20 mg strength.
`
`38.
`
`39.
`
`thereof.
`
`Apotex thus has actual knowledge of the ’465 patent.
`
`Vanda has the right to enforce the ’465 patent and sue for infringement
`
`40.
`
`On information and belief, Apotex has made and will continue to make
`
`substantial and meaningful preparations to import into the United States and/or offer to sell, sell,
`
`and/or use within the United States products which are patented by the ’465 patent.
`
`41.
`
`On information and belief, Apotex’s preparations include, but are not
`
`limited to, the development of Apotex’s ANDA Product, systematically attempting to meet the
`
`applicable regulatory requirements for approval of Apotex’s ANDA Product, and engaging in
`
`litigation to manufacture, offer to sell, sell, use, and/or import Apotex’s ANDA Product prior to
`
`the expiration of the ’465 patent.
`
`7
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`42.
`
`On information and belief, Apotex intends to use a composition claimed in
`
`the ’465 patent in Apotex’s ANDA Product.
`
`43.
`
`On information and belief, the tasimelteon composition in Apotex’s ANDA
`
`Product is not materially changed by subsequent process.
`
`44.
`
`On information and belief, a tasimelteon composition of the ’465 patent is
`
`an essential part of Apotex’s ANDA Product.
`
`45.
`
`On information and belief, a tasimelteon composition of the ’465 patent in
`
`Apotex’s ANDA Product is not a trivial or non-essential component of another product.
`
`46.
`
`On information and belief, Apotex’s ANDA Product is covered by one or
`
`more claims of the ’465 patent.
`
`47.
`
`On information and belief, Apotex’s ANDA Product is not a staple article
`
`of commerce and has no substantial uses that do not infringe at least claim 1 of the ’465 patent.
`
`48.
`
`Apotex has
`
`infringed and will
`
`infringe
`
`the ’465 patent under
`
`35 U.S.C. § 271(e)(2)(A) by virtue of its submission of the Apotex ANDA, and any amendments
`
`and/or supplements thereto, to FDA seeking to obtain approval for generic tasimelteon covered by
`
`one or more claims of the ’465 patent, prior to the expiration of the ’465 patent.
`
`49.
`
`The commercial manufacture, use, offer to sell, sale, distribution, or
`
`importation of products under the Apotex ANDA would infringe directly or contribute to or induce
`
`the infringement of one or more claims of the ’465 patent, including at least claim 1 under 35
`
`U.S.C. § 271(a), (b), (c), and/or (g).
`
`50.
`
`On information and belief, Apotex will induce others to infringe and/or
`
`contribute to the infringement of at least claim 1 of the ’465 patent under 35 U.S.C. § 271(b) and/or
`
`(c) by, among other things, actively and knowingly aiding and abetting others to infringe,
`
`8
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`Case 1:21-cv-00282-UNA Document 1 Filed 02/24/21 Page 9 of 12 PageID #: 9
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`including, but not limited to the manufacturer of Apotex’s ANDA products, or its Active
`
`Pharmaceutical Ingredient (“API”), or other subsequence purchasers, distributors, or users thereof,
`
`which manufacture constitutes direct infringement of at least claim 1 of the ’465 patent.
`
`51.
`
`On information and belief, Apotex will induce others to infringe and/or
`
`contribute to the infringement of at least claim 1 of the ’465 patent under § 271(b) and/or (c) by
`
`making, using, selling, offering to sell, and/or importing Apotex’s ANDA Product and/or the API
`
`thereof.
`
`52.
`
`On information and belief, subsequent purchasers, distributors or users
`
`thereof will also directly infringe at least claim 1 of the ’465 patent.
`
`53.
`
`On information and belief Apotex will infringe at least claim 1 of the ’465
`
`patent under 35 U.S.C. § 271(g) by importing, selling, offering to sell, or using Apotex’s ANDA
`
`Product or the API for Apotex’s ANDA Product.
`
`54.
`
`On information and belief, Apotex’s ANDA Product and/or the API for
`
`Apotex’s ANDA Product is not materially changed by subsequent process.
`
`55.
`
`On information and belief, Apotex’s ANDA Product and the API for
`
`Apotex’s ANDA Product are not a trivial or non-essential component of another product.
`
`56.
`
`Vanda seeks entry of an order requiring that Apotex amend its Paragraph
`
`IV Certification
`
`in
`
`the Apotex ANDA
`
`to a certification pursuant
`
`to 21 U.S.C.
`
`§ 355(j)(2)(A)(vii)(III)
`
`(“Paragraph
`
`III Certification”)
`
`as provided
`
`in 21 C.F.R.
`
`§ 314.94(a)(12)(viii)(A).
`
`57.
`
`Vanda seeks entry of an order declaring that Apotex has infringed the ’465
`
`patent by virtue of submitting its ANDA pursuant to 35 U.S.C. § 271(e)(2)(A).
`
`9
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`58.
`
`Vanda seeks entry of an order pursuant to 35 U.S.C. § 271(e)(4), including
`
`an order of this Court that the effective date of any FDA approval of the Apotex ANDA be a date
`
`that is not earlier than the expiration of the ’465 patent or any later expiration of exclusivity for
`
`the ’465 patent to which Vanda becomes entitled.
`
`59.
`
`Vanda will be irreparably harmed if Apotex is not enjoined from infringing
`
`or actively inducing or contributing to infringement of one or more claims of the ’465 patent.
`
`Pursuant to 35 U.S.C. § 283, Vanda is entitled to a permanent injunction against further
`
`infringement. Vanda does not have an adequate remedy at law.
`
`60.
`
`On information and belief, Apotex’s statement of the factual and legal bases
`
`for its opinion regarding the invalidity and noninfringement of the ’465 patent is devoid of an
`
`objective good faith basis in either the facts or the law. This case is exceptional and Vanda is
`
`entitled to attorneys’ fees pursuant to 35 U.S.C. § 285.
`
`61.
`
`To the extent Apotex commercializes its product, Vanda will also be
`
`entitled to damages under 35 U.S.C. § 284.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Vanda respectfully requests that this Court enter judgment in its
`
`favor against Apotex and grant the following relief:
`
`A.
`
`an adjudication that Apotex has infringed directly, contributed to, or
`
`induced the infringement of one or more claims of the ’465 patent under 35 U.S.C. § 271(e)(2)(A)
`
`by submitting to FDA the Apotex ANDA to obtain approval for the commercial manufacture, use,
`
`offer for sale, sale, distribution in, or importation into the United States of generic tasimelteon for
`
`the treatment of Non-24 before the expiration of the ’465 patent;
`
`B.
`
`a declaration that Apotex will infringe directly, contribute to, or induce the
`
`infringement of one or more claims of the ’465 patent under 35 U.S.C. § 271(a), (b), (c) and/or (g)
`
`10
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`
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`Case 1:21-cv-00282-UNA Document 1 Filed 02/24/21 Page 11 of 12 PageID #: 11
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`if it markets, manufactures, uses, offers for sale, sells, distributes in, or imports into the United
`
`States generic tasimelteon for the treatment of Non-24 before the expiration of the ’465 patent;
`
`C.
`
`an order requiring that Apotex amend its Paragraph IV Certification to a
`
`Paragraph III Certification as provided in 21 C.F.R. § 314.94(a)(12)(viii)(A);
`
`D.
`
`an order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective
`
`date of any FDA approval of the Apotex ANDA for generic tasimelteon be a date that is not earlier
`
`than the date of the expiration of the ’465 patent or any later period of exclusivity to which Vanda
`
`is or may become entitled;
`
`E.
`
`a permanent injunction enjoining Apotex, its officers, agents, servants,
`
`employees, attorneys, affiliates, divisions, subsidiaries, and those persons in active concert or
`
`participation with any of them from infringing the ’465 patent, or contributing to or inducing
`
`anyone to do the same, including the manufacture, use, offer to sell, sale, distribution, or
`
`importation of any current or future versions of the product described in the Apotex ANDA;
`
`F.
`
`an order enjoining Apotex, its officers, agents, servants, employees,
`
`attorneys, affiliates, divisions, subsidiaries, and those persons in active concert or participation
`
`with any of them from infringing the ’465 patent, or contributing to or inducing anyone to do the
`
`same, including the manufacture, use, offer to sell, sale, distribution, or importation of any current
`
`or future versions of the product described in the Apotex ANDA;
`
`G.
`
`an assessment of pre-judgment and post-judgment interest and costs against
`
`Apotex, together with an award of such interest and costs, in accordance with 35 U.S.C. § 284;
`
`H.
`
`an award to Vanda of its attorneys’ fees incurred in connection with this
`
`lawsuit pursuant to 35 U.S.C. § 285; and
`
`I.
`
`such other and further relief as this Court may deem just and proper.
`
`11
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`Case 1:21-cv-00282-UNA Document 1 Filed 02/24/21 Page 12 of 12 PageID #: 12
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`/s/ Derek J. Fahnestock
`
`Karen Jacobs (#2881)
`Derek J. Fahnestock (#4705)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`kjacobs@morrisnichols.com
`dfahnestock@morrisnichols.com
`
`Attorneys for Plaintiff
`Vanda Pharmaceuticals Inc.
`
`OF COUNSEL:
`
`Nicholas Groombridge
`Eric Alan Stone
`Josephine Young
`Daniel J. Klein
`Jennifer Rea Deneault
`Michael F. Milea
`PAUL, WEISS, RIFKIND, WHARTON
`& GARRISON LLP
`1285 Avenue of the Americas
`New York, NY 10019
`(212) 373-3000
`
`February 24, 2021
`
`12
`
`
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