Case 1:21-cv-00214-UNA Document 1 Filed 02/16/21 Page 1 of 12 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. ____________________
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`v.
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`PFIZER INC., C.P. PHARMACEUTICALS
`INTERNATIONAL C.V., PF PRISM C.V.,
`PBG PUERTO RICO LLC, and PF PRISM
`IMB B.V.,
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`ZYDUS PHARMACEUTICALS (USA)
`INC. and CADILA HEALTHCARE LTD.,
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`
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`Plaintiffs,
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`Defendants.
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`COMPLAINT
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`Pfizer Inc., C.P. Pharmaceuticals International C.V., PF PRISM C.V., PBG Puerto Rico
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`LLC, and PF PRISM IMB B.V. (collectively “Plaintiffs” or “Pfizer”), for their Complaint
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`against Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Ltd. (collectively
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`“Defendants” or “Zydus”), allege as follows:
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`NATURE OF THE ACTION
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`1.
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`This is an action by Pfizer against Zydus for infringement of United States Patent
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`No. RE41,783 (“the RE’783 patent”) and United States Patent No. 6,965,027 (“the ’027 patent”).
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`2.
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`This action arises out of Zydus’s filing of Abbreviated New Drug Application
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`(“ANDA”) No. 214264 as amended, seeking approval by the United States Food and Drug
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`Administration (“FDA”) to sell generic copies of Pfizer’s 22 mg Xeljanz® XR (tofacitinib
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`extended-release tablets) prior to the expiration of, inter alia, the RE’783 and’027 patents. Zydus’s
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`proposed 22 mg tofacitinib product is referred to hereinafter as “Zydus 22 mg Generic XR
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`Tablets.”
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`1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. ____________________
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`v.
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`PFIZER INC., C.P. PHARMACEUTICALS
`INTERNATIONAL C.V., PF PRISM C.V.,
`PBG PUERTO RICO LLC, and PF PRISM
`IMB B.V.,
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`
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`
`
`ZYDUS PHARMACEUTICALS (USA)
`INC. and CADILA HEALTHCARE LTD.,
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`
`
`Plaintiffs,
`
`Defendants.
`
`COMPLAINT
`
`Pfizer Inc., C.P. Pharmaceuticals International C.V., PF PRISM C.V., PBG Puerto Rico
`
`LLC, and PF PRISM IMB B.V. (collectively “Plaintiffs” or “Pfizer”), for their Complaint
`
`against Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Ltd. (collectively
`
`“Defendants” or “Zydus”), allege as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action by Pfizer against Zydus for infringement of United States Patent
`
`No. RE41,783 (“the RE’783 patent”) and United States Patent No. 6,965,027 (“the ’027 patent”).
`
`2.
`
`This action arises out of Zydus’s filing of Abbreviated New Drug Application
`
`(“ANDA”) No. 214264 as amended, seeking approval by the United States Food and Drug
`
`Administration (“FDA”) to sell generic copies of Pfizer’s 22 mg Xeljanz® XR (tofacitinib
`
`extended-release tablets) prior to the expiration of, inter alia, the RE’783 and’027 patents. Zydus’s
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`proposed 22 mg tofacitinib product is referred to hereinafter as “Zydus 22 mg Generic XR
`
`Tablets.”
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`1
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`Case 1:21-cv-00214-UNA Document 1 Filed 02/16/21 Page 2 of 12 PageID #: 2
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`THE PARTIES
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`3.
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`Plaintiff Pfizer Inc. is a corporation organized and existing under the laws of the
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`state of Delaware and having a place of business at 235 East 42nd Street, New York, New York
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`10017.
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`4.
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`Plaintiff C.P. Pharmaceuticals International C.V. is a limited partnership
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`(commanditaire vennootschap) organized under the laws of the Netherlands, having its business
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`address at Rivium Westlaan 142, 2909 LD, Capelle aan den IJssel, the Netherlands. Pfizer Inc. is
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`the ultimate parent company of C.P. Pharmaceuticals International C.V.
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`5.
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`Plaintiff PF PRISM C.V. is a limited partnership (commanditaire vennootschap)
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`organized under the laws of the Netherlands, having its registered seat in Rotterdam, the
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`Netherlands, having its business address at Rivium Westlaan 142, 2909 LD, Capelle aan den IJssel,
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`the Netherlands, and registered at the Trade Register held by the Chamber of Commerce in
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`Rotterdam, the Netherlands, under number 51840456. Pfizer Inc. is the ultimate parent company
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`of PF PRISM C.V.
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`6.
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`Plaintiff PBG Puerto Rico LLC is a limited liability company organized and
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`existing under the laws of Puerto Rico and having its principal place of business at Professional
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`Offices Park V, 996 San Roberto Street, 4th Floor, San Juan, Puerto Rico 00926. Pfizer Inc. is the
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`ultimate parent company of PBG Puerto Rico LLC.
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`7.
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`Plaintiff PRISM IMB B.V. is a private limited liability company (besloten
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`vennootschap) under the laws of the Netherlands, having its registered seat in Rotterdam, the
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`Netherlands, and having its business address at Rivium Westlaan 142, 2909 LD, Capelle aan den
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`IJssel, the Netherlands. Pfizer Inc. is the ultimate parent company of PF Prism IMB B.V.
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`2
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`8.
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`On information and belief, defendant Zydus Pharmaceuticals (USA) Inc. is a
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`company organized and existing under the laws of New Jersey, having its principal place of
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`business at 73 Route 31 N., Pennington, NJ 08534.
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`9.
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`On information and belief, defendant Cadila Healthcare Ltd. is a company
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`organized and existing under the laws of India, having its principal place of business at Zydus
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`Corporate Park, Scheme No. 63, Survey No. 536, Kohraj (Gandhinigar), Nr. Vaishnodevi Circle,
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`Sarkhej-Gandhinagar Highway, Ahmedabad, Gujurat, India 382481.
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`10.
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`On information and belief, Cadila Healthcare Ltd. is the ultimate parent company
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`of Zydus Pharmaceuticals (USA) Inc. On information and belief, Zydus Pharmaceuticals (USA)
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`Inc. is the U.S. agent for Cadila Healthcare Ltd.
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`JURISDICTION AND VENUE
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`11.
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`This action arises under the patent laws of the United States, Title 35, United States
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`Code. The Court has subject matter jurisdiction over this action pursuant to the provisions of 28
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`U.S.C. §§ 1331, 1338(a), 2201, and 2202.
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`12.
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`This Court has personal jurisdiction over Defendants, and venue is proper in this
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`action.
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`13.
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`Zydus Pharmaceuticals (USA) Inc. is a wholly-owned subsidiary of Cadila
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`Healthcare Ltd.
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`(https://zyduscadila.com/public/pdf/financial/annual/Annual-Report-2019-
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`2020.pdf, at 56, last accessed on Feb. 3, 2021). On information and belief, Cadila Healthcare Ltd.,
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`directly or through its subsidiary Zydus Pharmaceuticals (USA) Inc., manufactures, markets,
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`imports, and sells generic drugs for distribution in Delaware and throughout the United States.
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`14.
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`On information and belief, Defendants are agents of each other and/or work in
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`concert with each other on the development, obtaining of regulatory approval, manufacture,
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`3
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`marketing, sale, and/or distribution of generic drugs, including the proposed Zydus 22 mg Generic
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`XR Tablets.
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`15.
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`In the alternative, this Court has jurisdiction over Cadila Healthcare Ltd. under
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`Federal Rule of Civil Procedure 4(k)(2). Cadila Healthcare Ltd. has contacts with the United States
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`by, inter alia, having caused the filing of ANDA No. 214264 as amended with the FDA.
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`Xeljanz XR
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`BACKGROUND
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`16.
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`The active ingredient in Pfizer’s Xeljanz XR product is tofacitinib citrate. Xeljanz
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`XR contains tofacitinib citrate in an amount equivalent to 22 mg of tofacitinib base in extended
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`release tablets formulated for once-daily administration.
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`17.
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`The FDA-approved Prescribing Information for Xeljanz XR states that tofacitinib
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`citrate has the following chemical name: (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo [2,3-d]
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`pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile, 2-hydroxy-1,2,3-propanetricarboxylate
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`(1:1).
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`18.
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`Tofacitinib citrate is an inhibitor of Janus kinases (“JAKs”) and is indicated, inter
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`alia, for the treatment of adult patients with moderately to severely active rheumatoid arthritis who
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`have had an inadequate response or intolerance to methotrexate, for the treatment of adult patients
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`with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate
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`or other disease-modifying antirheumatic drugs (“DMARDs”), and for the treatment of adult
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`patients with moderately to severely active ulcerative colitis who have an inadequate response or
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`who are intolerant to TNF blockers.
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`Orange Book Listing for Xeljanz XR
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`19.
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`Pfizer Inc. holds approved New Drug Application (“NDA”) No. 208246 for, inter
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`alia, EQ 22 mg base tofacitinib citrate extended-release tablets, which it sells under the registered
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`4
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`name Xeljanz XR. The 22 mg Xeljanz XR tablets are approved for the treatment of ulcerative
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`colitis.
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`20.
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`Pursuant to 21 U.S.C. § 355(b)(1) and the regulations the FDA has promulgated
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`pursuant thereto, the RE’783 and ’027 patents are listed in the FDA publication titled “Approved
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`Drug Products with Therapeutic Equivalence Evaluations” (the “Orange Book”) for the Xeljanz
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`XR NDA.
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`21.
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`The Orange Book lists the expiration date for the RE’783 patent as December 8,
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`2025, and the expiration date for the ’027 patent as March 25, 2023.
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`22.
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`The Orange Book lists one additional patent for the 22 mg strength of Xeljanz XR
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`that is not at issue: U.S. Patent No. 10,639,309, expiring March 14, 2034.
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`The RE’783 Patent
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`23.
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`On September 28, 2010, the United States Patent and Trademark Office (“USPTO”)
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`issued the RE’783 patent, titled “Pyrrolo[2,3-d]pyrimidine Compounds.” The RE’783 patent is a
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`reissue of U.S. Patent No. 6,627,754, which issued on September 30, 2003. The RE’783 patent is
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`duly and legally assigned to Pfizer Inc. A copy of the RE’783 patent is attached hereto as Exhibit
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`A.
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`24.
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`On December 14, 2016, the USPTO issued a Notice of Final Determination
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`extending the expiration date of the RE’783 patent to December 8, 2025.
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`25.
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`C.P. Pharmaceuticals International C.V. is the exclusive licensee of the RE’783
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`patent.
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`26.
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`C.P. Pharmaceuticals International C.V. conveyed rights under the RE’783 patent
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`to Pfizer Pharmaceuticals LLC, PF PRISM C.V., and Pfizer PFE Ireland Pharmaceuticals Holding
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`1 B.V.
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`5
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`27.
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`Pfizer Pharmaceuticals LLC has conveyed its rights to the RE’783 patent to PBG
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`Puerto Rico LLC.
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`28.
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`Pfizer PFE Ireland Pharmaceuticals Holding 1 B.V. has conveyed its rights to the
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`RE’783 patent to PF PRISM IMB B.V.
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`The ’027 Patent
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`29.
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`On November 15, 2005, the USPTO issued the ’027 patent, titled “Crystalline 3-
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`{4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxo-
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`propionitrile citrate.” The ’027 patent is duly and legally assigned to Pfizer Inc. A copy of the
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`’027 patent is attached hereto as Exhibit B.
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`30.
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`31.
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`C.P. Pharmaceuticals International C.V. is the exclusive licensee of the ’027 patent.
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`C.P. Pharmaceuticals International C.V. conveyed rights under the ’027 patent to
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`Pfizer Pharmaceuticals LLC, PF PRISM C.V., and Pfizer PFE Ireland Pharmaceuticals Holding 1
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`B.V.
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`32.
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`Pfizer Pharmaceuticals LLC has conveyed its rights to the ’027 patent to PBG
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`Puerto Rico LLC.
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`33.
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`Pfizer PFE Ireland Pharmaceuticals Holding 1 B.V. has conveyed its rights to the
`
`’027 patent to PF PRISM IMB B.V.
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`Zydus’s ANDA
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`34.
`
`By letter dated January 7, 2021 (the “Zydus Notice Letter”), and received by Pfizer
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`on January 8, 2021, Zydus notified Pfizer that it had submitted an amendment to ANDA No.
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`214264 to the FDA, seeking approval under the Federal Food, Drug and Cosmetic Act to market
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`and sell Zydus 22 mg Generic XR Tablets – generic copies of Xeljanz XR (tofacitinib citrate EQ
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`22 mg base extended-release tablets) – prior to the expiration of, inter alia, the RE’783 and ’027
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`6
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`
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`patents. The Zydus Notice Letter describes the Zydus 22 mg Generic XR Tablets as “tofacitinib
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`extended-release tablets, 22 mg.”
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`35.
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`On information and belief, Zydus 22 mg Generic XR Tablets will contain
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`tofacitinib citrate as the active ingredient.
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`36.
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`On information and belief, Cadila Healthcare Ltd. holds DMF No. 030531 for
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`tofacitinib citrate.
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`37.
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`The Zydus Notice Letter states that Zydus has amended ANDA No. 214264 “to
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`obtain approval to engage in the commercial manufacture, use or sale of” Zydus 22 mg Generic
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`XR Tablets prior to the expiration of, inter alia, the RE’783 and ’027 patents.
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`38.
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`The Zydus Notice Letter asserts that ANDA No. 214264 as amended contains a
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`“Paragraph IV” certification under 21 U.S.C. §§ 355(j)(2)(A)(vii)(IV) alleging that “no valid and
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`enforceable claim of [, inter alia, either the RE’783 patent or the ’027 patent] will be infringed by
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`the manufacture, use, sale, or offer to sell within, or importation into, the United States of” Zydus
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`22 mg Generic XR Tablets.
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`39.
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`Attached to the Zydus Notice Letter was Zydus’s Detailed Factual and Legal Bases
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`in Support of Its Paragraph IV Certification for Tofacitinib Extended-Release Tablets, 22 MG
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`(“Zydus’s Detailed Statement”) asserting the purported factual and legal bases for Zydus’s
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`contention that no valid and enforceable claim of, inter alia, either the RE’783 patent or the ’027
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`patent will be infringed by the commercial manufacture, use, or sale of Zydus 22 mg Generic XR
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`Tablets.
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`40.
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`Zydus’s Detailed Statement alleges, inter alia, that all claims of the RE’783 and
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`’027 patents are invalid. Other than with respect to claim 5 of the ’027 patent, Zydus’s Detailed
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`7
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`Statement does not contain a noninfringement argument with respect to either the RE’783 patent
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`or the ’027 patent.
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`41.
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`On information and belief, Zydus Pharmaceuticals (USA) Inc. and Cadila
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`Healthcare Ltd. collaborated and acted in concert in the decision to prepare and file and in the
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`preparation and filing of ANDA No. 214264 as amended.
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`42.
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`On information and belief, upon approval of ANDA No. 214264 as amended,
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`Zydus will sell and distribute Zydus 22 mg Generic XR Tablets in the United States.
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`COUNT I
`(Infringement of the RE’783 Patent by Zydus 22 mg Generic XR Tablets)
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`43.
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`The allegations of paragraphs 1-42 above are repeated and re-alleged as if set forth
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`fully herein.
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`44.
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`Pursuant to 35 U.S.C. § 271(e)(2)(A), Zydus Pharmaceuticals (USA) Inc.’s filing
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`of ANDA No. 214264 as amended, seeking approval to market Zydus 22 mg Generic XR Tablets
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`before the expiration of the RE’783 patent is an act of infringement of at least claim 4 of the
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`RE’783 patent entitling Pfizer to the relief provided by 35 U.S.C. § 271(e)(4), including, inter alia,
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`an order of this Court that the effective date of approval for ANDA No. 214264 as amended be a
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`date which is not earlier than the expiration date of the RE’783 patent.
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`45.
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`Zydus had knowledge of the RE’783 patent when it submitted ANDA No. 214264
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`as amended to the FDA.
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`46.
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`On information and belief, upon FDA approval, Zydus intends to engage in the
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`manufacture, use, offer for sale, sale, and/or importation of Zydus 22 mg Generic XR Tablets and
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`will thereby infringe at least claim 4 of the RE’783 patent.
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`47.
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`The foregoing actions by Zydus constitute and/or would constitute infringement of
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`at least claim 4 of the RE’783 patent.
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`8
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`48.
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`Pfizer will be substantially and irreparably harmed if Zydus is not enjoined from
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`infringing the RE’783 patent. Pfizer has no adequate remedy at law.
`
`COUNT II
`(Infringement of the ’027 Patent by Zydus 22 mg Generic XR Tablets)
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`49.
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`The allegations of paragraphs 1-48 above are repeated and re-alleged as if set forth
`
`fully herein.
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`50.
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`Pursuant to 35 U.S.C. § 271(e)(2)(A), Zydus Pharmaceuticals (USA) Inc.’s filing
`
`of ANDA No. 214264 as amended, seeking approval to market Zydus 22 mg Generic XR Tablets
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`before the expiration of the ’027 patent is an act of infringement of at least claim 1 of the ’027
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`patent entitling Pfizer to the relief provided by 35 U.S.C. § 271(e)(4), including, inter alia, an
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`order of this Court that the effective date of approval for ANDA No. 214264 as amended be a date
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`which is not earlier than the expiration date of the ’027 patent.
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`51.
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`Zydus had knowledge of the ’027 patent when it submitted ANDA No. 214264 as
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`amended to the FDA.
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`52.
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`On information and belief, upon FDA approval, Zydus intends to engage in the
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`manufacture, use, offer for sale, sale, and/or importation of Zydus 22 mg Generic XR Tablets and
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`will thereby infringe at least claim 1 of the ’027 patent.
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`53.
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`The foregoing actions by Zydus constitute and/or would constitute infringement of
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`at least claim 1 of the ’027 patent.
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`54.
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`Pfizer will be substantially and irreparably harmed if Zydus is not enjoined from
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`infringing the ’027 patent. Pfizer has no adequate remedy at law.
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`9
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`
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`COUNT III
`(Cadila Healthcare Ltd.’s Inducing of Infringement by Zydus Pharmaceuticals (USA) Inc.)
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`55.
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`The allegations of paragraphs 1-54 above are repeated and re-alleged as if set forth
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`fully herein.
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`56.
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`On information and belief, Cadila Healthcare Ltd. actively and knowingly caused
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`to be submitted, assisted with, participated in, contributed to, and/or directed the submission by
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`Zydus Pharmaceuticals (USA) Inc. of ANDA No. 214264 as amended to the FDA, knowing of the
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`RE’783 and ’027 patents.
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`57.
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`The filing by Zydus Pharmaceuticals (USA) Inc. of ANDA No. 214264 as
`
`amended, constituted direct infringement under 35 U.S.C. § 271(e)(2)(A). On information and
`
`belief, under 35 U.S.C. §§ 271(b) and 271(e)(2)(A), Cadila Healthcare Ltd. induced the
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`infringement of the RE’783 and ’027 patents by actively and knowingly causing to be submitted,
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`and/or assisting with, participating in, contributing to, and/or directing the submission of ANDA
`
`No. 214264 as amended, to the FDA knowing that the submission of ANDA No. 214264 as
`
`amended would constitute direct infringement of the RE’783 and ’027 patents.
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`PRAYER FOR RELIEF
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`WHEREFORE, Pfizer requests the following relief:
`
`A.
`
`A judgment that Zydus Pharmaceuticals (USA) Inc.’s submission of ANDA No.
`
`214264 as amended, was an act of infringement and that Zydus’s making, using,
`
`offering to sell, selling, or importing Zydus 22 mg Generic XR Tablets prior to the
`
`expiration of the RE’783 and ’027 patents will infringe each of those patents;
`
`B.
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`A judgment that Cadila Healthcare Ltd.’s knowing and purposeful activities
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`causing to be submitted, and/or assisting with, participating in, contributing to,
`
`and/or directing the filing of ANDA No. 214264 as amended, knowing that its
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`10
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`Case 1:21-cv-00214-UNA Document 1 Filed 02/16/21 Page 11 of 12 PageID #: 11
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`submission would constitute direct infringement, induced infringement of the
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`RE’783 and ’027 patents;
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`C.
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`A judgment that the effective date of any FDA approval for Zydus to make, use,
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`offer for sale, sell, market, distribute, or import Zydus 22 mg Generic XR Tablets
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`be no earlier than the dates on which the RE’783 and ’027 patents expire, or the
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`later expiration of any exclusivity to which Pfizer is or becomes entitled;
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`D.
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`A permanent injunction enjoining Zydus, its officers, agents, servants, and
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`employees, and those persons in active concert or participation with any of them,
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`from making, using, selling, offering for sale, marketing, distributing, or importing
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`Zydus 22 mg Generic XR Tablets, and from inducing or contributing to any of the
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`foregoing, prior to the expiration of the RE’783 and ’027 patents, or the later
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`expiration of any exclusivity to which Pfizer is or becomes entitled;
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`E.
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`A judgment that this case is an exceptional case under 35 U.S.C. § 285, entitling
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`Pfizer to an award of its reasonable attorneys’ fees for bringing and prosecuting this
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`action;
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`F.
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`G.
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`An award of Pfizer’s costs and expenses in this action; and
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`Such further and additional relief as this Court deems just and proper.
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`/s/ Megan E. Dellinger
`
`
`
`
`Jack B. Blumenfeld (#1014)
`Megan E. Dellinger (#5739)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@morrisnichols.com
`mdellinger@morrisnichols.com
`
`Attorneys for Plaintiffs
`
`
`
`
`OF COUNSEL:
`
`Aaron Stiefel
`Daniel P. DiNapoli
`Stephanie Piper
`Michael Sapiro
`ARNOLD & PORTER KAYE SCHOLER LLP
`250 West 55th Street
`New York, NY 10019-9710
`(212) 836-8000
`
`Soumitra Deka
`DLA PIPER LLP (US)
`555 Mission Street
`Suite 2400
`San Francisco, CA 94105-2933
`(415) 836-2500
`
`February 16, 2021
`
`
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