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Case 1:21-cv-01794-UNA Document 1 Filed 12/22/21 Page 1 of 12 PageID #: 1
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`
`NOVARTIS PHARMACEUTICALS
`CORPORATION,
`
`
`
`
`
`TORRENT PHARMA INC., TORRENT
`PHARMACEUTICALS LTD.,
`
`
`
`Plaintiff,
`
`v.
`
`Defendants.
`
`
`
`
`
`
`
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`
`
`
`
`
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`
`
`C.A. No. _________________
`
`
`
`)
`)
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`)
`)
`)
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`)
`)
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`
`
`
`COMPLAINT AGAINST
`TORRENT PHARMA INC. AND TORRENT PHARMACEUTICALS LTD.
`
`Plaintiff Novartis Pharmaceuticals Corporation (hereinafter “Plaintiff” or “Novartis”), by
`
`its attorneys, hereby alleges as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is a patent infringement action arising under Title 35 of the United States
`
`Code and concerning an Abbreviated New Drug Application (“ANDA”) submitted to the United
`
`States Food and Drug Administration (“FDA”) by the above-named defendants seeking FDA
`
`approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of
`
`sacubitril/valsartan tablets, generic versions of Plaintiff’s ENTRESTO® tablets, 24 mg/26 mg, 49
`
`mg/51 mg, and 97 mg/103 mg, prior to the expiration of U.S. Patent No. 11,058,667 (the “’667
`
`patent”).
`
`
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`Case 1:21-cv-01794-UNA Document 1 Filed 12/22/21 Page 2 of 12 PageID #: 2
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`
`
`PARTIES
`
`2.
`
`Plaintiff Novartis is a corporation organized and existing under the laws of the
`
`State of Delaware, having a principal place of business at One Health Plaza, East Hanover, New
`
`Jersey 07936.
`
`3.
`
`On information and belief, Torrent Pharma Inc. is a corporation organized and
`
`existing under the laws of the State of Delaware, having a registered agent for the service of
`
`process at Corporation Service Company, 251 Little Falls Drive, Wilmington, Delaware 19808,
`
`and having a principal place of business at 150 Allen Road, Suite 102, Basking Ridge, New
`
`Jersey 07920. On information and belief, Torrent Pharma Inc. is a wholly-owned subsidiary of
`
`Torrent Pharmaceuticals Ltd.
`
`4.
`
`On information and belief, Torrent Pharmaceuticals Ltd. is a corporation
`
`organized and existing under the laws of India, having a principal place of business at Off.
`
`Ashram Road, Ahmedabad – 380 009, Gujarat, India.
`
`5.
`
`On information and belief, Torrent Pharma Inc. develops, manufactures,
`
`distributes, sells, and/or imports drug products for the entire United States market and does
`
`business in every state including Delaware, either directly or indirectly.
`
`6.
`
`On information and belief, Torrent Pharmaceuticals Ltd. develops, manufactures,
`
`distributes, sells, and/or imports drug products for the entire United States market and does
`
`business in every state including Delaware, either directly or indirectly.
`
`7.
`
`By letter dated November 11, 2021 (“Torrent Notice Letter”), Torrent Pharma
`
`Inc. notified Novartis that (i) Torrent Pharma Inc., on behalf of Torrent Pharmaceuticals Ltd.,
`
`had submitted to the FDA ANDA No. 213604 for sacubitril/valsartan tablets, 24 mg/26 mg, 49
`
`mg/51 mg, and 97 mg/103 mg (“Torrent ANDA Products”), seeking FDA approval to engage in
`
`
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`Case 1:21-cv-01794-UNA Document 1 Filed 12/22/21 Page 3 of 12 PageID #: 3
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`
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`the commercial manufacture, use, sale, offer for sale, and/or importation of the Torrent ANDA
`
`Products in or into the United States, including Delaware, prior to the expiration of the ’667
`
`patent, and that (ii) ANDA No. 213604 includes a certification pursuant to 21 U.S.C.
`
`§ 355(j)(2)(A)(vii)(IV) against the ’667 patent.
`
`8.
`
`Torrent Pharma Inc. has committed an act of infringement in this judicial district
`
`by filing ANDA No. 213604 with the intent to make, use, sell, offer for sale, and/or import the
`
`Torrent ANDA Products in or into this judicial district, prior to the expiration of the ’667 patent,
`
`an act of infringement that has led and will lead to foreseeable harm and injury to Novartis, a
`
`Delaware corporation.
`
`9.
`
`On information and belief, Torrent Pharmaceuticals Ltd. acted in concert with and
`
`directed Torrent Pharma Inc. in the preparation and submission of ANDA No. 213604, and, if
`
`the ANDA is approved, will direct and act in concert with Torrent Pharma Inc. to engage in the
`
`commercial manufacture, use, sale, offer for sale, and/or importation of the Torrent ANDA
`
`Products in or into the United States, including Delaware, prior to the expiration of the ’667
`
`patent.
`
`10.
`
`Torrent Pharma Inc. and Torrent Pharmaceuticals Ltd. have taken the costly,
`
`significant step of applying to the FDA for approval to engage in future activities, including the
`
`marketing of the Torrent ANDA Products, that will be purposefully directed at Delaware and
`
`elsewhere.
`
`11.
`
`On information and belief, Torrent Pharmaceuticals Ltd. has systematic and
`
`continuous contacts with Delaware; has established distribution channels for drug products in
`
`Delaware; regularly and continuously conducts business in Delaware, including by selling drug
`
`products in Delaware, either directly or indirectly through its subsidiaries, agents, or affiliates
`
`
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`Case 1:21-cv-01794-UNA Document 1 Filed 12/22/21 Page 4 of 12 PageID #: 4
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`
`
`including Torrent Pharma Inc.; has purposefully availed itself of the privilege of doing business
`
`in Delaware; and derives substantial revenue from the sale of drug products in Delaware.
`
`12.
`
`Both Torrent Pharmaceuticals Ltd., the entity identified in the Torrent Notice
`
`Letter as having submitted ANDA No. 213604 through Torrent Pharma Inc., and Torrent Pharma
`
`Inc. have agreed with Novartis to litigate any patent action(s) concerning ANDA No. 213604 in
`
`the District of Delaware, and have agreed, only for the purposes of such action(s), not to
`
`challenge personal jurisdiction or venue in the District of Delaware.
`
`13.
`
`Torrent Pharmaceuticals Ltd. and Torrent Pharma Inc. have each availed
`
`themselves of the legal protections of the State of Delaware by, among other things, admitting
`
`jurisdiction and asserting counterclaims in lawsuits filed in the United States District Court for
`
`the District of Delaware. See, e.g., Bial-Portela & Ca., et al. v. Torrent Pharms. Ltd., et al., 18-
`
`279 (D. Del.); H. Lundbeck A/S, et al. v. Torrent Pharms. Ltd., et al., 18-672 (D. Del.); Novartis
`
`Pharms. Corp. v. Alkem Labs. Ltd. et al., C.A. No. 19-1979 (D. Del.); Novartis Pharms. Corp. v.
`
`Alkem Labs. Ltd. et al., 21-1330 (D. Del.).
`
`JURISDICTION AND VENUE
`
`14.
`
`This Court has jurisdiction over the subject matter of this action under 28 U.S.C.
`
`§§ 1331, 1338(a), 2201, and 2202.
`
`15.
`
`This Court has personal jurisdiction over Torrent Pharma Inc. and Torrent
`
`Pharmaceuticals Ltd. because, on information and belief, each such Defendant has committed or
`
`has aided, abetted, contributed to, or participated in the commission of tortious acts of patent
`
`infringement in preparing and submitting ANDA No. 213604 with a certification pursuant to 21
`
`U.S.C. § 355(j)(2)(A)(vii)(IV), which acts have led to foreseeable harm and injury to Novartis, a
`
`Delaware corporation.
`
`
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`Case 1:21-cv-01794-UNA Document 1 Filed 12/22/21 Page 5 of 12 PageID #: 5
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`
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`16.
`
`This Court also has personal jurisdiction over Torrent Pharma Inc. and Torrent
`
`Pharmaceuticals Ltd. because, on information and belief, each such Defendant, upon approval of
`
`ANDA No. 213604, will commit or will aid, abet, contribute to, or participate in future tortious
`
`acts of patent infringement permitted under ANDA No. 213604 that will be purposefully directed
`
`at Delaware, including the marketing of the Torrent ANDA Products in Delaware, prior to the
`
`expiration of the ’667 patent.
`
`17.
`
`This Court also has personal jurisdiction over Torrent Pharma Inc. and Torrent
`
`Pharmaceuticals Ltd. because, on information and belief, each such Defendant’s affiliations with
`
`the State of Delaware, including Torrent Pharma Inc.’s incorporation in Delaware, and Torrent
`
`Pharmaceuticals Ltd.’s ownership of and actions in concert with Torrent Pharma Inc., are
`
`sufficiently continuous and systematic as to render each such Defendant essentially at home in
`
`this forum.
`
`18.
`
`This Court also has personal jurisdiction over Torrent Pharma Inc. and Torrent
`
`Pharmaceuticals Ltd. because each has availed itself of the legal protections of the State of
`
`Delaware, by admitting jurisdiction and asserting counterclaims in lawsuits filed in the United
`
`States District Court for the District of Delaware.
`
`19.
`
`Both Torrent Pharmaceuticals Ltd., the entity identified in the Torrent Notice
`
`Letter as having submitted ANDA No. 213604 in concert with Torrent Pharma Inc., and Torrent
`
`Pharma Inc. have agreed not to challenge personal jurisdiction and venue in the District of
`
`Delaware with respect to any patent actions concerning ANDA No. 213604. This is an action
`
`concerning ANDA No 213604.
`
`20.
`
`For these reasons, and for other reasons that will be presented to the Court if
`
`jurisdiction is challenged, the Court has personal jurisdiction over Defendants.
`
`
`ME1 38750891v.1
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`Case 1:21-cv-01794-UNA Document 1 Filed 12/22/21 Page 6 of 12 PageID #: 6
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`
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`21.
`
`Venue is proper in this Court over Torrent Pharma Inc. and Torrent
`
`Pharmaceuticals Ltd. because Torrent Pharma Inc. is incorporated in the State of Delaware and
`
`therefore resides in this judicial district, and Torrent Pharmaceuticals Ltd. is a foreign entity who
`
`may be sued in any judicial district, including Delaware. 28 U.S.C. § 1400(b); 28 U.S.C. §
`
`1391(c)(3).
`
`THE PATENT-IN-SUIT AND ENTRESTO®
`
`22.
`
`The ’667 patent, titled “Sacubitril-Valsartan Dosage Regimen for Treating Heart
`
`Failure,” was duly and legally issued on July 13, 2021. A true and correct copy of the ’667 patent
`
`is attached hereto as Exhibit A.
`
`23.
`
`Novartis owns the ’667 patent.
`
`24.
`
`The ’667 patent claims, inter alia, a regimen for treating chronic heart failure with
`
`reduced ejection fraction, comprising administering to a human patient in need thereof a twice-
`
`daily target dose of 200 mg of (i) sacubitril or a pharmaceutically acceptable salt thereof with (ii)
`
`valsartan or a pharmaceutically acceptable salt thereof; wherein (i) and (ii) are provided in a 1:1
`
`molar ratio and wherein the twice daily target dose of 200 mg is reached after a titration with a
`
`twice daily starting dose of 50 mg of (i) and (ii) in a 1:1 molar ratio for a specified period of time
`
`followed by a twice daily dose of 100 mg of (i) and (ii) in a 1:1 molar ratio for a specified period
`
`of time and wherein the human patient is not taking an ACE inhibitor or an ARB or is taking a
`
`low dose of an ACE inhibitor or an ARB before initiating treatment with (i) and (ii).
`
`25.
`
`Novartis is the holder of New Drug Application (“NDA”) No. 207620 by which
`
`the FDA granted approval for the commercial manufacturing, marketing, sale, and use of
`
`ENTRESTO® (sacubitril and valsartan) tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg.
`
`ENTRESTO® currently is indicated to reduce the risk of cardiovascular death and hospitalization
`
`
`ME1 38750891v.1
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`Case 1:21-cv-01794-UNA Document 1 Filed 12/22/21 Page 7 of 12 PageID #: 7
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`
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`for heart failure in adult patients with chronic heart failure, and for the treatment of symptomatic
`
`heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one
`
`year and older.
`
`26.
`
`The ENTRESTO® label provides specific instructions for titration for human
`
`patients who are not taking an ACE inhibitor or an ARB or taking a low dose of an ACE
`
`inhibitor or an ARB before treatment with ENTRESTO® is initiated.
`
`27.
`
`One or more claims of the ’667 patent cover the use of ENTRESTO®.
`
`28.
`
`The FDA’s official publication of approved drugs (the “Orange Book”) lists the
`
`’667 patent in connection with ENTRESTO®.
`
`INFRINGEMENT BY TORRENT OF THE PATENT-IN-SUIT
`
`Plaintiff incorporates paragraphs 1 – 28 as if fully set forth herein.
`
`On information and belief, Torrent Pharma Inc., on behalf of Torrent
`
`29.
`
`30.
`
`Pharmaceuticals Ltd., submitted to the FDA ANDA No. 213604 under the provisions of 21
`
`U.S.C. § 355(j) seeking approval to engage in the commercial manufacture, use, sale, offer for
`
`sale, and/or importation of the Torrent ANDA Products prior to the expiration of the ’667 patent.
`
`31.
`
`By filing their ANDA under 21 U.S.C. § 355(j) for the purpose of obtaining
`
`approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of
`
`the Torrent ANDA Products in or into the United States prior to the expiration of the ’667 patent,
`
`Torrent Pharma Inc. and/or Torrent Pharmaceuticals Ltd. have committed an act of infringement
`
`under 35 U.S.C. § 271(e)(2).
`
`32.
`
`This action was commenced within 45 days of Plaintiff’s receipt of the Torrent
`
`Notice Letter.
`
`
`ME1 38750891v.1
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`7
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`Case 1:21-cv-01794-UNA Document 1 Filed 12/22/21 Page 8 of 12 PageID #: 8
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`
`
`33.
`
`On information and belief, the use of the Torrent ANDA Products in the United
`
`States in accordance with and as directed by Torrent’s labeling for those products, if approved,
`
`will directly infringe one or more claims of the ’667 patent.
`
`34.
`
`On information and belief, the Torrent ANDA Products, to be approved, must
`
`contain instructions for practicing a regimen for the treatment of chronic heart failure with
`
`reduced ejection faction comprising administering to a human patient in need thereof a twice-
`
`daily target dose of 200 mg of (i) sacubitril or a pharmaceutically acceptable salt thereof with (ii)
`
`valsartan or a pharmaceutically acceptable salt thereof; wherein (i) and (ii) are provided in a 1:1
`
`molar ratio and wherein the twice daily target dose of 200 mg is reached after a titration with a
`
`twice daily starting dose of 50 mg of (i) and (ii) in a 1:1 molar ratio for a specified period of time
`
`followed by a twice daily dose of 100 mg of (i) and (ii) in a 1:1 molar ratio for a specified period
`
`of time and wherein the human patient is not taking an ACE inhibitor or an ARB or is taking a
`
`low dose of an ACE inhibitor or an ARB before initiating treatment with (i) and (ii), which
`
`administration will constitute direct infringement of one or more claims of the ’667 patent. On
`
`information and belief, if the Torrent ANDA Products are approved, physicians, other medical
`
`providers, caregivers and/or patients following said instructions will directly infringe one or
`
`more claims of the ’667 patent. On information and belief, if the Torrent ANDA Products are
`
`approved, Torrent Pharma Inc. and/or Torrent Pharmaceuticals Ltd. will actively encourage,
`
`recommend, or promote this infringement with knowledge of the ’667 patent, and with
`
`knowledge and intent that their acts will induce infringement of one or more claims of the ’667
`
`patent.
`
`35.
`
`On information and belief, if the Torrent ANDA Products are approved, Torrent
`
`Pharma Inc. and/or Torrent Pharmaceuticals Ltd. will commercially manufacture, sell, offer for
`
`
`ME1 38750891v.1
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`8
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`Case 1:21-cv-01794-UNA Document 1 Filed 12/22/21 Page 9 of 12 PageID #: 9
`
`
`
`sale, and/or import those products, which must be specifically labeled for use in a regimen for
`
`the treatment of chronic heart failure with reduced ejection fraction comprising administering to
`
`a human patient in need thereof a twice-daily target dose of 200 mg of (i) sacubitril or a
`
`pharmaceutically acceptable salt thereof with (ii) valsartan or a pharmaceutically acceptable salt
`
`thereof; wherein (i) and (ii) are provided in a 1:1 molar ratio and wherein the twice daily target
`
`dose of 200 mg is reached after a titration with a twice daily starting dose of 50 mg of (i) and (ii)
`
`in a 1:1 molar ratio for a specified period of time followed by a twice daily dose of 100 mg of (i)
`
`and (ii) in a 1:1 molar ratio for a specified period of time and wherein the human patient is taking
`
`neither an ACE inhibitor nor an ARB or is taking a low dose of an ACE inhibitor or an ARB
`
`before initiating treatment with (i) and (ii), as recited in one or more claims of the ’667 patent.
`
`On information and belief, if the Torrent ANDA Products are approved, those products will
`
`constitute a material part of a regimen for the treatment of chronic heart failure with reduced
`
`ejection fraction comprising administering to a human patient in need thereof a twice-daily target
`
`dose of 200 mg of (i) sacubitril or a pharmaceutically acceptable salt thereof with (ii) valsartan or
`
`a pharmaceutically acceptable salt thereof; wherein (i) and (ii) are provided in a 1:1 molar ratio
`
`and wherein the twice daily target dose of 200 mg is reached after a titration with a twice daily
`
`starting dose of 50 mg of (i) and (ii) in a 1:1 molar ratio for a specified period of time followed
`
`by a twice daily dose of 100 mg of (i) and (ii) in a 1:1 molar ratio for a specified period of time
`
`and wherein the human patient is not taking an ACE inhibitor or an ARB or is taking a low dose
`
`of an ACE inhibitor or an ARB before initiating treatment with (i) and (ii), as recited in one or
`
`more claims of the ’667 patent. On information and belief, if the Torrent ANDA Products are
`
`approved, physicians, caregivers and/or patients following the approved instructions in the
`
`Torrent ANDA Products will directly infringe one or more claims of the ’667 patent. On
`
`
`ME1 38750891v.1
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`9
`
`

`

`Case 1:21-cv-01794-UNA Document 1 Filed 12/22/21 Page 10 of 12 PageID #: 10
`
`
`
`information and belief, if the Torrent ANDA Products are approved, Torrent Pharma Inc. and/or
`
`Torrent Pharmaceuticals Ltd. will contributorily infringe one or more claims of the ’667 patent
`
`and will do so with knowledge of the ’667 patent, and that the Torrent ANDA Products are
`
`especially made or especially adapted for use in infringing one or more claims of the ’667 patent
`
`and are not suitable for substantial non-infringing use.
`
`36.
`
`Plaintiff will be substantially and irreparably damaged by Torrent Pharma Inc.’s
`
`and Torrent Pharmaceuticals Ltd.’s infringement of the ’667 patent.
`
`37.
`
`Plaintiff is entitled to the relief provided by 35 U.S.C. § 271(e)(4) and 35 U.S.C.
`
`§ 283, including an order of this Court that the effective date of any approval of ANDA No.
`
`213604 be a date that is no earlier than May 9, 2036, the expiration of the ’667 patent, or a date
`
`no earlier than the expiry of any other patent extension or exclusivity to which Plaintiff is
`
`entitled, and an award of damages for any commercial sale or use of the Torrent ANDA Products
`
`and any act committed by Torrent Pharma Inc. and/or Torrent Pharmaceuticals Ltd. with respect
`
`to the subject matter claimed in the ’667 patent, which act is not within the limited exclusions of
`
`35 U.S.C. § 271(e)(1).
`
`38.
`
`On information and belief, Torrent Pharma Inc. and/or Torrent Pharmaceuticals
`
`Ltd. have taken and continue to take active steps towards the commercial manufacture, use, sale,
`
`offer for sale, and/or importation of the Torrent ANDA Products, including seeking approval of
`
`those products under ANDA No. 213604.
`
`39.
`
`There is a substantial and immediate controversy between Plaintiff and Torrent
`
`Pharma Inc. and Torrent Pharmaceuticals Ltd. concerning the ’667 patent. Plaintiff is entitled to
`
`declaratory judgment under 28 U.S.C. §§ 2201 and 2202 that the use of the Torrent ANDA
`
`Products will directly infringe one or more claims of the ’667 patent and Torrent Pharma Inc.
`
`
`ME1 38750891v.1
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`10
`
`

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`Case 1:21-cv-01794-UNA Document 1 Filed 12/22/21 Page 11 of 12 PageID #: 11
`
`
`
`and/or Torrent Pharmaceuticals Ltd. will induce infringement of and/or contributorily infringe
`
`one or more claims of the ’667 patent.
`
`PRAYER FOR RELIEF
`
`
`
`WHEREFORE, Plaintiff prays that this Court grant the following relief:
`
`40.
`
`Judgment that defendants Torrent Pharma Inc. and Torrent Pharmaceuticals Ltd.
`
`have infringed one or more claims of the ’667 patent by filing ANDA No. 213604;
`
`41.
`
`A permanent injunction restraining and enjoining defendants Torrent Pharma Inc.
`
`and Torrent Pharmaceuticals Ltd. and their officers, agents, attorneys, and employees, and those
`
`acting in privity or concert with them, from engaging in the commercial manufacture, use, sale,
`
`or offer for sale in the United States, or importation into the United States, of the Torrent ANDA
`
`Products prior to the expiration of the ’667 patent, inclusive of any extensions and additional
`
`periods of exclusivity;
`
`42.
`
`An order that the effective date of any approval of ANDA No. 213604 be a date
`
`that is not earlier than the expiration date of the ’667 patent, inclusive of any extensions and
`
`additional periods of exclusivity;
`
`43.
`
`Declaratory judgment that the use of the Torrent ANDA Products will directly
`
`infringe one or more claims of the ’667 patent;
`
`44.
`
`Declaratory judgment that the commercial manufacture, sale, offer for sale, and/or
`
`importation of the Torrent ANDA Products will induce infringement of and/or contributorily
`
`infringe one or more claims of the ’667 patent;
`
`45.
`
`Damages or other monetary relief from defendants Torrent Pharma Inc. and
`
`Torrent Pharmaceuticals Ltd. for the infringement, inducement of infringement and contributory
`
`infringement of the ’667 patent;
`
`
`ME1 38750891v.1
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`11
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`Case 1:21-cv-01794-UNA Document 1 Filed 12/22/21 Page 12 of 12 PageID #: 12
`
`
`
`46.
`
`A declaration that this case is an exceptional case pursuant to 35 U.S.C. § 285 and
`
`an award of attorney’s fees;
`
`47.
`
`Plaintiff’s costs and expenses in this action; and
`
`48.
`
`Such other and further relief as the Court may deem just and proper.
`
`
`
`MCCARTER & ENGLISH, LLP
`
`By: /s/ Daniel M. Silver
`Daniel M. Silver (#4758)
`Alexandra M. Joyce (#6423)
`Renaissance Centre
`405 N. King Street, 8th Floor
`Wilmington, Delaware 19801
`(302) 984-6300
`dsilver@mccarter.com
`ajoyce@mccarter.com
`
`
`
`
`
`Attorneys for Plaintiff Novartis
`Pharmaceuticals Corporation
`
`
`
`
`
`Dated: December 22, 2021
`
`
`
`
`
`OF COUNSEL:
`
`Nicholas N. Kallas
`Christina Schwarz
`Christopher E. Loh
`Susanne L. Flanders
`Jared L. Stringham
`Shannon K. Clark
`Laura K. Fishwick
`Gregory J. Manas
`VENABLE LLP
`1290 Avenue of the Americas
`New York, New York 10104
`(212) 218-2100
`nkallas@venable.com
`cschwarz@venable.com
`cloh@venable.com
`slflanders@venable.com
`jlstringham@venable.com
`skclark@venable.com
`lfishwick@venable.com
`gjmanas@venable.com
`
`
`ME1 38750891v.1
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`12
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`

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