Case 1:21-cv-00843-UNA Document 1 Filed 06/10/21 Page 1 of 133 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`
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`
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`C.A. No. _________________
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`
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`JURY TRIAL DEMANDED
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`Plaintiffs,
`
`
`
`v.
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`NEWRON PHARMACEUTICALS S.p.A.,
`ZAMBON S.p.A.,
`MDD US OPERATIONS, LLC,
`
`
`
`
`
`AUROBINDO PHARMA LIMITED,
`AUROBINDO PHARMA USA INC.,
`MSN LABORATORIES PRIVATE
`LIMITED,
`OPTIMUS PHARMA PVT LTD,
`PRINSTON PHARMACEUTICAL, INC.,
`RK PHARMA INC.,
`ZENARA PHARMA PRIVATE LIMITED,
`
`
`
`
`
`
`Defendants.
`
`
`
`
`
`
`
`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiffs Newron Pharmaceuticals S.p.A. (“Newron”), Zambon S.p.A. (“Zambon”), and
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`MDD US Operations, LLC (“MDD”, collectively, “Plaintiffs”), by their attorneys, hereby allege
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`as follows:
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`THE NATURE OF THE ACTION
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`This is an action for infringement of U.S. Patent Nos. 8,076,515 (“the ’515 patent”),
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`1.
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`8,278,485 (the “’485 patent”), and 8,283,380 (the “’380 patent”) (collectively, the Asserted
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`Patents”) under the Patent Laws of the United States, 35 U.S.C. § 1 et seq., including §§ 271(e)(2),
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`271(a)-(c), and for a declaratory judgment of infringement of the ’515, ’485, and ’380 patents
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`under 28 U.S.C. §§ 2201 and 2202 and 35 U.S.C. §§ 271(a)-(c). Plaintiffs institute this action to
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`enforce their patent rights covering FDA-approved XADAGO® (safinamide) tablets.
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`

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`Case 1:21-cv-00843-UNA Document 1 Filed 06/10/21 Page 2 of 133 PageID #: 2
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`
`
`A.
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`Plaintiffs
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`THE PARTIES
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`2.
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`Plaintiff Newron Pharmaceuticals S.p.A. is a joint stock company organized under
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`the laws of the Republic of Italy with its principal place of business at Via Antonio Meucci 3,
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`20091 Bresso (MI) Italy.
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`3.
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`Plaintiff Zambon S.p.A. is a company organized under the laws of Italy with its
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`principal place of business at Via Lillo del Duca 10, 20091 Bresso (MI) Italy.
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`4.
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`Plaintiff MDD US Operations, LLC is a company organized under the laws of
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`Delaware with its principal place of business at 9715 Key West Avenue, Rockville, Maryland
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`20850.
`
`B.
`
`Aurobindo
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`5.
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`On information and belief, Defendant Aurobindo Pharma Limited (“Aurobindo
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`Pharma”) is a corporation organized and existing under the laws of India with its principal place
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`of business at Plot No. 11, Water Mark Building, Hightech City Rd, Whitefields, Kondapur,
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`Hyderabad, Telangana 500084, India. On information and belief, Defendant Aurobindo Pharma
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`USA Inc. (“Aurobindo Pharma USA”, collectively, “Aurobindo”) is a corporation organized and
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`existing under the laws of Delaware with its principal place of business at 279 Princeton-
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`Hightstown Rd, East Windsor, NJ 08520-1401.
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`C. MSN
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`6.
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`On information and belief, Defendant MSN Laboratories Private Limited (“MSN”)
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`is a corporation organized and existing under the laws of India with its principal place of business
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`
`
`2
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`

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`Case 1:21-cv-00843-UNA Document 1 Filed 06/10/21 Page 3 of 133 PageID #: 3
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`at MSN House, Plot No: C-24, Industrial Estate, Sanathnagar, Hyderabad 500018 Telangana,
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`India.
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`D.
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`Optimus
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`7.
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`On information and belief, Defendant Optimus Pharma Pvt Ltd (“Optimus”) is a
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`corporation organized and existing under the laws of India with its principal place of business at
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`2nd Floor, Sy No. 37/A & 37/P, Plot No.6P, Signature Towers, Kothaguda, Kondapur, Hyderabad
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`500084, Telangana, India.
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`E.
`
`8.
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`Prinston
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`On information and belief, Defendant Prinston Pharmaceutical, Inc. (“Prinston”) is
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`a corporation organized and existing under the laws of Delaware with its principal place of
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`business at 700 Atrium Drive, Somerset, NJ 08873.
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`F.
`
`9.
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`RK Pharma
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`On information and belief, Defendant RK Pharma, Inc. (“RK Pharma”) is a
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`corporation organized and existing under the laws of Delaware with its principal place of business
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`at 401 N. Middletown Road, Building 215/215A, Pearl River, NY 10965.
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`G.
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`Zenara
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`10.
`
`On information and belief, Defendant Zenara Pharma Private Limited (“Zenara”)
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`is a corporation organized and existing under the laws of India with its principal place of business
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`at Plot 87-95, Phase III, Industrial Development Area, Cherlapalli, Hyderabad, Telangana 500051,
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`India.
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`JURISDICTION AND VENUE
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`11.
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`This Court has subject matter jurisdiction over the action under 28 U.S.C. §§ 1331
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`and 1338(a) because the action concerns a federal question arising under the Patent Laws of the
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`United States, including 35 U.S.C. § 271.
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`3
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`

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`Case 1:21-cv-00843-UNA Document 1 Filed 06/10/21 Page 4 of 133 PageID #: 4
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`A.
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`Aurobindo
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`12.
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`This Court has personal jurisdiction over Aurobindo Pharma USA because, on
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`information and belief, Aurobindo Pharma USA is a corporation organized and existing under the
`
`laws of Delaware, is qualified to do business in Delaware, and has appointed a registered agent for
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`service of process in Delaware. Therefore, Aurobindo Pharma USA has purposefully availed itself
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`to the privileges of conducting business in Delaware and consented to general jurisdiction in
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`Delaware.
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`13.
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`This Court has personal jurisdiction over Defendant Aurobindo Pharma because,
`
`inter alia, Aurobindo Pharma, itself and through its subsidiaries, agents, and/or affiliates, including
`
`Aurobindo Pharma USA, has purposefully availed itself of the benefits and protections of
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`Delaware’s laws such that it should reasonably anticipate being haled into court here. On
`
`information and belief, Aurobindo Pharma, itself and through its subsidiaries, agents, and/or
`
`affiliates, including Aurobindo Pharma USA, develops, manufactures, imports, markets, offers to
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`sell, sells, and/or distributes a broad range of generic pharmaceutical products throughout the
`
`United States, including in Delaware, and therefore transacts business within Delaware relating to
`
`Plaintiffs’ claims, and/or has engaged in systematic and continuous business contacts within
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`Delaware.
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`14.
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`In addition, this Court has personal jurisdiction over Aurobindo Pharma and
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`Aurobindo Pharma USA because, among other things, on information and belief: (1) Aurobindo
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`Pharma and its subsidiary Aurobindo Pharma USA, collectively and/or in concert with each other,
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`developed Aurobindo’s ANDA Product that is the subject of ANDA No. 215902 and filed
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`Aurobindo’s ANDA for the purpose of seeking approval to engage in the commercial manufacture,
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`use, sale or offer for sale of Aurobindo’s ANDA Product in the United States, including in
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`Delaware; (2) upon approval of Aurobindo’s ANDA, Aurobindo Pharma and its subsidiary
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`
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`4
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`Case 1:21-cv-00843-UNA Document 1 Filed 06/10/21 Page 5 of 133 PageID #: 5
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`Aurobindo Pharma USA, collectively and/or in concert with each other, intend to market,
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`distribute, offer for sale, sell, and/or import Aurobindo’s ANDA Product in the United States,
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`including in Delaware, and will derive substantial revenue from the use or consumption of
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`Aurobindo’s ANDA Product in Delaware; and (3) also upon approval of Aurobindo’s ANDA,
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`Aurobindo’s ANDA Product will, among other things, be marketed, distributed, offered for sale,
`
`sold, and/or imported in Delaware; prescribed by physicians practicing in Delaware; dispensed by
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`pharmacies located within Delaware; and/or used by patients in Delaware, all of which would have
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`substantial effects on Delaware. By filing Aurobindo’s ANDA, Aurobindo Pharma and Aurobindo
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`Pharma USA have made clear that they intend to use their distribution channels to direct sales of
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`Aurobindo’s ANDA Product into Delaware.
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`15.
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`In addition, upon information and belief, this Court has personal jurisdiction over
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`Aurobindo Pharma USA and Aurobindo Pharma because both regularly engage in patent litigation
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`concerning Aurobindo’s ANDA products in this District, have consented to jurisdiction in
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`Delaware in one or more prior cases arising out of the filing of its ANDAs, and have filed
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`counterclaims in such cases. See, e.g., UCB Inc. et al. v. Annora Pharma Pvt. Ltd. et al., C.A. No.
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`20-0987-CFC, D.I. 37 (D. Del. July 24, 2020) (Aurobindo Pharma, Ltd. and Aurobindo Pharma
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`USA, Inc.); Acadia Pharms. Inc. v. Aurobindo Pharma Ltd. et al., C.A. No. 20-0985-RGA, D.I.
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`10 (D. Del. Dec. 20, 2020) (Aurobindo Pharma, Ltd. and Aurobindo Pharma USA, Inc.); Taiho
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`Pharm. Co. v. Eugia Pharma Specialities Ltd., C.A. No. 19-2309-CFC (D. Del. Mar. 23, 2020)
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`(Aurobindo Pharma USA, Inc.); Millennium Pharm. v. Aurobindo Pharma USA, Inc., C.A. No.
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`19-0471-CFC (D. Del. Dec. 26, 2019) (Aurobindo Pharma, Ltd. and Aurobindo Pharma USA,
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`Inc.); Pfizer Inc. v. Aurobindo Pharma, Ltd., C.A. No. 19-0748-CFC (D. Del. July 8, 2019)
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`(Aurobindo Pharma, Ltd. and Aurobindo Pharma USA, Inc.).
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`
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`5
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`

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`Case 1:21-cv-00843-UNA Document 1 Filed 06/10/21 Page 6 of 133 PageID #: 6
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`16.
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`In the alternative, this Court may exercise personal jurisdiction over Aurobindo
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`Pharma pursuant to Fed. R. Civ. P. 4(k)(2) because (a) Plaintiffs’ claims arise under federal law;
`
`(b) Aurobindo Pharma is a foreign company not subject to personal jurisdiction in the courts in
`
`any state, and (c) Aurobindo Pharma has sufficient contacts with the United States as a whole,
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`including but not limited to marketing and/or selling generic pharmaceutical products that are
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`distributed and sold throughout the United States, such that this Court’s exercise of jurisdiction
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`over Aurobindo Pharma satisfies due process.
`
`17.
`
`Venue is proper in this District with respect to Aurobindo Pharma pursuant to 28
`
`U.S.C. § 1391(c)(3) because Aurobindo Pharma is a foreign corporation and may be sued in any
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`judicial district.
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`18.
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`Venue is proper in this Court with respect to Aurobindo Pharma USA pursuant to
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`28 U.S.C. §§ 1391 and 1400(b) because Aurobindo Pharma USA is a corporation organized and
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`existing under the laws of the State of Delaware.
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`B. MSN
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`19.
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`This Court has personal jurisdiction over Defendant MSN because, inter alia,
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`MSN, either directly or through its subsidiaries, agents, and/or affiliates, has purposefully availed
`
`itself of the benefits and protections of Delaware’s laws such that it should reasonably anticipate
`
`being haled into court here. On information and belief, MSN, either directly or through its
`
`subsidiaries, agents, and/or affiliates, develops, manufactures, imports, markets, offers to sell,
`
`sells, and/or distributes a broad range of generic pharmaceutical products throughout the United
`
`States, including in Delaware, and therefore transacts business within Delaware relating to
`
`Plaintiffs’ claims, and/or has engaged in systematic and continuous business contacts within
`
`Delaware.
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`
`
`6
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`20.
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`Upon information and belief, Defendant MSN is in the business of, among other
`
`things, manufacturing and selling generic versions of branded pharmaceutical drugs, either directly
`
`or through various operating subsidiaries, agents, and/or affiliates throughout the United States,
`
`including in Delaware.
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`21.
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`In addition, this Court has personal jurisdiction over MSN because, among other
`
`things, on information and belief: (1) MSN developed MSN’s ANDA product that is the subject
`
`of ANDA No. 215978 and filed MSN’s ANDA for the purpose of seeking approval to engage in,
`
`either directly or through subsidiaries, agents, affiliates, and/or alter egos, the commercial
`
`manufacture, use, sale or offer for sale of MSN’s ANDA Product in the United States, including
`
`in Delaware; (2) upon approval of MSN’s ANDA, MSN intends to, either directly or through
`
`subsidiaries, agents, affiliates, and/or alter egos, market, distribute, offer for sale, sell, and/or
`
`import MSN’s ANDA Product in the United States, including in Delaware, and will derive
`
`substantial revenue from the use or consumption of MSN’s ANDA Product in Delaware; and (3)
`
`also upon approval of MSN’s ANDA, MSN’s ANDA Product will, among other things, be
`
`marketed, distributed, offered for sale, sold, and/or imported in Delaware; prescribed by physicians
`
`practicing in Delaware; dispensed by pharmacies located within Delaware; and/or used by patients
`
`in Delaware, all of which would have substantial effects on Delaware. By filing its ANDA, MSN
`
`has made clear that it intends to use its distribution channel to direct sales of MSN’s ANDA
`
`Product into Delaware.
`
`22.
`
`In addition, this Court has personal jurisdiction over MSN because it regularly
`
`engages in patent litigation concerning MSN’s ANDA products in this District, does not contest
`
`personal jurisdiction in this District, and has purposefully availed itself of the rights and benefits
`
`of this Court by asserting claims and/or counterclaims in this District. See, e.g., Acadia Pharms.
`
`
`
`7
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`

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`Inc. v. Aurobindo Pharma Ltd. et al., C.A. No. 20-0985-RGA, D.I. 77 (D. Del. Dec. 20, 2020);
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`Genentech, Inc. v. MSN Labs. Pvt. Ltd. et al., C.A. No. 19-0205-RGA, D.I. 9 (D. Del. Jan. 31,
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`2019); Onyx Therapeutics, Inc. v. MSN Pharms. Inc. et al., C.A. No. 17-1833-LPS, D.I. 8 (D. Del.
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`Dec. 20, 2017).
`
`23.
`
`In the alternative, this Court may exercise personal jurisdiction over MSN pursuant
`
`to Fed. R. Civ. P. 4(k)(2) because (a) Plaintiffs’ claims arise under federal law; (b) MSN
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`Laboratories Private Limited is a foreign company not subject to personal jurisdiction in the courts
`
`in any state, and (c) MSN has sufficient contacts with the United States as a whole, including but
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`not limited to participating in the preparation and submission of MSN’s ANDA to the FDA, and/or
`
`marketing and/or manufacturing and/or selling generic pharmaceutical products that are
`
`distributed and sold throughout the United States, such that this Court’s exercise of jurisdiction
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`over MSN satisfies due process.
`
`24.
`
`Venue is proper in this District with respect to MSN pursuant to 28 U.S.C.
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`§ 1391(c)(3) because MSN is a foreign corporation and may be sued in any judicial district.
`
`C.
`
`Optimus
`
`25.
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`This Court has personal jurisdiction over Defendant Optimus because, inter alia,
`
`Optimus, either directly or through its subsidiaries, agents, and/or affiliates, has purposefully
`
`availed itself of the benefits and protections of Delaware’s laws such that it should reasonably
`
`anticipate being haled into court here. On information and belief, Optimus, either directly or
`
`through its subsidiaries, agents, and/or affiliates, develops, manufactures, imports, markets, offers
`
`to sell, sells, and/or distributes a broad range of generic pharmaceutical products throughout the
`
`United States, including in Delaware, and therefore transacts business within Delaware relating to
`
`Plaintiffs’ claims, and/or has engaged in systematic and continuous business contacts within
`
`Delaware.
`
`
`
`8
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`26.
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`Upon information and belief, Defendant Optimus is in the business of, among other
`
`things, manufacturing and selling generic versions of branded pharmaceutical drugs, either directly
`
`or through various operating subsidiaries, agents, and/or affiliates throughout the United States,
`
`including in Delaware.
`
`27.
`
`In addition, this Court has personal jurisdiction over Optimus because, among other
`
`things, on information and belief: (1) Optimus developed Optimus’ ANDA Product that is the
`
`subject of ANDA No. 216020 and filed Optimus’ ANDA for the purpose of seeking approval to
`
`engage in, either directly or through subsidiaries, agents, affiliates, and/or alter egos, the
`
`commercial manufacture, use, sale or offer for sale of Optimus’ ANDA Product in the United
`
`States, including in Delaware; (2) upon approval of Optimus’ ANDA, Optimus intends to, either
`
`directly or through subsidiaries, agents, affiliates, and/or alter egos, market, distribute, offer for
`
`sale, sell, and/or import Optimus’ ANDA Product in the United States, including in Delaware, and
`
`will derive substantial revenue from the use or consumption of Optimus’ ANDA Product in
`
`Delaware; and (3) also upon approval of Optimus’ ANDA, Optimus’ ANDA Product will, among
`
`other things, be marketed, distributed, offered for sale, sold, and/or imported in Delaware;
`
`prescribed by physicians practicing in Delaware; dispensed by pharmacies located within
`
`Delaware; and/or used by patients in Delaware, all of which would have substantial effects on
`
`Delaware. By filing its ANDA, Optimus has made clear that it intends to use its distribution
`
`channel to direct sales of Optimus’ ANDA Product into Delaware.
`
`28.
`
`In addition, this Court has personal jurisdiction over Optimus because it regularly
`
`engages in patent litigation concerning Optimus’ ANDA products in this District, does not contest
`
`personal jurisdiction in this District, and has purposefully availed itself of the rights and benefits
`
`of this Court by asserting claims and/or counterclaims in this District. See, e.g., Otsuka Pharm.
`
`
`
`9
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`

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`Co., Ltd. et al. v. Optimus Pharma Pvt Ltd, C.A. No. 19-2008-LPS (D. Del. Jan. 10, 2020);
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`Intercept Pharms., Inc. et al. v. Optimus Pharma Pvt Ltd et al., C.A. No. 20-1215-MN, D.I. 14 (D.
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`Del. Sept. 10, 2020).
`
`29.
`
`In the alternative, this Court may exercise personal jurisdiction over Optimus
`
`pursuant to Fed. R. Civ. P. 4(k)(2) because (a) Plaintiffs’ claims arise under federal law; (b)
`
`Optimus is a foreign company not subject to personal jurisdiction in the courts in any state, and
`
`(c) Optimus has sufficient contacts with the United States as a whole, including but not limited to
`
`participating in the preparation and submission of Optimus’ ANDA to the FDA, and/or marketing
`
`and/or manufacturing and/or selling generic pharmaceutical products that are distributed and sold
`
`throughout the United States, such that this Court’s exercise of jurisdiction over Optimus satisfies
`
`due process.
`
`30.
`
`Venue is proper in this District with respect to Optimus pursuant to 28 U.S.C.
`
`§ 1391(c)(3) because Optimus is a foreign corporation and may be sued in any judicial district.
`
`D.
`
`Prinston
`
`31.
`
`This Court has personal jurisdiction over Prinston because, on information and
`
`belief, Prinston is a corporation organized and existing under the laws of Delaware, is qualified to
`
`do business in Delaware, and has appointed a registered agent for service of process in Delaware.
`
`Therefore, Prinston has purposefully availed itself to the privileges of conducting business in
`
`Delaware and consented to general jurisdiction in Delaware.
`
`32.
`
`In addition, this Court has personal jurisdiction over Defendant Prinston because,
`
`inter alia, Prinston, either directly or through its subsidiaries, agents, and/or affiliates, has
`
`purposefully availed itself of the benefits and protections of Delaware’s laws such that it should
`
`reasonably anticipate being haled into court here. On information and belief, Prinston, either
`
`directly or through its subsidiaries, agents, and/or affiliates, develops, manufactures, imports,
`
`
`
`10
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`

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`markets, offers to sell, sells, and/or distributes a broad range of generic pharmaceutical products
`
`throughout the United States, including in Delaware, and therefore transacts business within
`
`Delaware relating to Plaintiffs’ claims, and/or has engaged in systematic and continuous business
`
`contacts within Delaware.
`
`33.
`
`Upon information and belief, Defendant Prinston is in the business of, among other
`
`things, manufacturing and selling generic versions of branded pharmaceutical drugs, either directly
`
`or through various operating subsidiaries, agents, and/or affiliates throughout the United States,
`
`including in Delaware.
`
`34.
`
`In addition, this Court has personal jurisdiction over Prinston because, among other
`
`things, on information and belief: (1) Prinston developed Prinston’s ANDA Product that is the
`
`subject of ANDA No. 215739 and filed Prinston’s ANDA for the purpose of seeking approval to
`
`engage in, either directly or through subsidiaries, agents, affiliates, and/or alter egos, the
`
`commercial manufacture, use, sale or offer for sale of Prinston’s ANDA Product in the United
`
`States, including in Delaware; (2) upon approval of Prinston’s ANDA, Prinston intends to, either
`
`directly or through subsidiaries, agents, affiliates, and/or alter egos, market, distribute, offer for
`
`sale, sell, and/or import Prinston’s ANDA Product in the United States, including in Delaware,
`
`and will derive substantial revenue from the use or consumption of Prinston’s ANDA Product in
`
`Delaware; and (3) also upon approval of Prinston’s ANDA, Prinston’s ANDA Product will, among
`
`other things, be marketed, distributed, offered for sale, sold, and/or imported in Delaware;
`
`prescribed by physicians practicing in Delaware; dispensed by pharmacies located within
`
`Delaware; and/or used by patients in Delaware, all of which would have substantial effects on
`
`Delaware. By filing its ANDA, Prinston has made clear that it intends to use its distribution
`
`channel to direct sales of Prinston’s ANDA Product into Delaware.
`
`
`
`11
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`Case 1:21-cv-00843-UNA Document 1 Filed 06/10/21 Page 12 of 133 PageID #: 12
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`35.
`
`In addition, this Court has personal jurisdiction over Prinston because it regularly
`
`engages in patent litigation concerning Prinston’s ANDA products in this District, does not contest
`
`personal jurisdiction in this District, and has purposefully availed itself of the rights and benefits
`
`of this Court by asserting claims and/or counterclaims in this District. See, e.g., Novartis Pharms.
`
`Corp. v. Apotex Inc. et al., C.A. No. 20-0133-LPS, D.I. 38 (D. Del. Jan. 28, 2020); Boehringer
`
`Ingelheim Pharm. Inc. et al. v. Prinston Pharm. Inc. et al., C.A. No. 19-1499-CFC, D.I. 10 (D.
`
`Del. Aug. 9, 2019).
`
`36.
`
`Venue is proper in this Court with respect to Prinston pursuant to 28 U.S.C. §§ 1391
`
`and 1400(b) because Prinston is a corporation organized and existing under the laws of the State
`
`of Delaware.
`
`E.
`
`RK Pharma
`
`37.
`
`This Court has personal jurisdiction over RK Pharma because, on information and
`
`belief, RK Pharma is a corporation organized and existing under the laws of Delaware, is qualified
`
`to do business in Delaware, and has appointed a registered agent for service of process in Delaware.
`
`Therefore, RK Pharma has purposefully availed itself to the privileges of conducting business in
`
`Delaware and consented to general jurisdiction in Delaware.
`
`38.
`
`This Court has personal jurisdiction over Defendant RK Pharma because, inter alia,
`
`RK Pharma either directly or through its subsidiaries, agents, and/or affiliates, has purposefully
`
`availed itself of the benefits and protections of Delaware’s laws such that it should reasonably
`
`anticipate being haled into court here. On information and belief, RK Pharma, either directly or
`
`through its subsidiaries, agents, and/or affiliates, develops, manufactures, imports, markets, offers
`
`to sell, sells, and/or distributes a broad range of generic pharmaceutical products throughout the
`
`United States, including in Delaware, and therefore transacts business within Delaware relating to
`
`
`
`12
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`Case 1:21-cv-00843-UNA Document 1 Filed 06/10/21 Page 13 of 133 PageID #: 13
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`Plaintiffs’ claims, and/or has engaged in systematic and continuous business contacts within
`
`Delaware.
`
`39.
`
`Upon information and belief, Defendant RK Pharma is in the business of, among
`
`other things, manufacturing and selling generic versions of branded pharmaceutical drugs, either
`
`directly or through various operating subsidiaries, agents, and/or affiliates throughout the United
`
`States, including in Delaware.
`
`40.
`
`In addition, this Court has personal jurisdiction over RK Pharma because, among
`
`other things, on information and belief: (1) RK Pharma developed RK Pharma’s ANDA Product
`
`that is the subject of ANDA No. 215945 and filed RK Pharma’s ANDA for the purpose of seeking
`
`approval to engage in, either directly or through subsidiaries, agents, affiliates, and/or alter egos,
`
`the commercial manufacture, use, sale or offer for sale of RK Pharma’s ANDA Product in the
`
`United States, including in Delaware; (2) upon approval of RK Pharma’s ANDA, RK Pharma
`
`intends to, either directly or through subsidiaries, agents, affiliates, and/or alter egos, market,
`
`distribute, offer for sale, sell, and/or import RK Pharma’s ANDA Product in the United States,
`
`including in Delaware, and will derive substantial revenue from the use or consumption of RK
`
`Pharma’s ANDA Product in Delaware; and (3) also upon approval of RK Pharma’s ANDA, RK
`
`Pharma’s ANDA Product will, among other things, be marketed, distributed, offered for sale, sold,
`
`and/or imported in Delaware; prescribed by physicians practicing in Delaware; dispensed by
`
`pharmacies located within Delaware; and/or used by patients in Delaware, all of which would have
`
`substantial effects on Delaware. By filing its ANDA, RK Pharma has made clear that it intends to
`
`use its distribution channel to direct sales of RK Pharma’s ANDA Product into Delaware.
`
`
`
`13
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`

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`Case 1:21-cv-00843-UNA Document 1 Filed 06/10/21 Page 14 of 133 PageID #: 14
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`41.
`
`Venue is proper in this Court with respect to RK Pharma pursuant to 28 U.S.C.
`
`§§ 1391 and 1400(b) because RK Pharma is a corporation organized and existing under the laws
`
`of the State of Delaware.
`
`F.
`
`Zenara
`
`42.
`
`This Court has personal jurisdiction over Defendant Zenara because, inter alia,
`
`Zenara, either directly or through its subsidiaries, agents, and/or affiliates, has purposefully availed
`
`itself of the benefits and protections of Delaware’s laws such that it should reasonably anticipate
`
`being haled into court here. On information and belief, Zenara, either directly or through its
`
`subsidiaries, agents, and/or affiliates, develops, manufactures, imports, markets, offers to sell,
`
`sells, and/or distributes a broad range of generic pharmaceutical products throughout the United
`
`States, including in Delaware, and therefore transacts business within Delaware relating to
`
`Plaintiffs’ claims, and/or has engaged in systematic and continuous business contacts within
`
`Delaware.
`
`43.
`
`Upon information and belief, Defendant Zenara is in the business of, among other
`
`things, manufacturing and selling generic versions of branded pharmaceutical drugs, either directly
`
`or through various operating subsidiaries, agents, and/or affiliates throughout the United States,
`
`including in Delaware.
`
`44.
`
`In addition, this Court has personal jurisdiction over Zenara because, among other
`
`things, on information and belief: (1) Zenara developed Zenara’s ANDA Product that is the subject
`
`of ANDA No. 215913 and filed Zenara’s ANDA for the purpose of seeking approval to engage in,
`
`either directly or through subsidiaries, agents, affiliates, and/or alter egos, the commercial
`
`manufacture, use, sale or offer for sale of Zenara’s ANDA Product in the United States, including
`
`in Delaware; (2) upon approval of Zenara’s ANDA, Zenara intends to, either directly or through
`
`subsidiaries, agents, affiliates, and/or alter egos, market, distribute, offer for sale, sell, and/or
`
`
`
`14
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`

`

`Case 1:21-cv-00843-UNA Document 1 Filed 06/10/21 Page 15 of 133 PageID #: 15
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`import Zenara’s ANDA Product in the United States, including in Delaware, and will derive
`
`substantial revenue from the use or consumption of Zenara’s ANDA Product in Delaware; and (3)
`
`also upon approval of Zenara’s ANDA, Zenara’s ANDA Product will, among other things, be
`
`marketed, distributed, offered for sale, sold, and/or imported in Delaware; prescribed by physicians
`
`practicing in Delaware; dispensed by pharmacies located within Delaware; and/or used by patients
`
`in Delaware, all of which would have substantial effects on Delaware. By filing its ANDA, Zenara
`
`has made clear that it intends to use its distribution channel to direct sales of Zenara’s ANDA
`
`Product into Delaware.
`
`45.
`
`In addition, this Court has personal jurisdiction over Zenara because it regularly
`
`engages in patent litigation concerning Zenara’s ANDA products in this District, does not contest
`
`personal jurisdiction in this District, and/or has purposefully availed itself of the rights and benefits
`
`of this Court by asserting claims and/or counterclaims in this District. See, e.g., Genzyme Corp.
`
`et al. v. Zenara Pharma Pvt. Ltd., C.A. No. 19-0264-CFC, D.I. 7 (D. Del. Feb. 7, 2019); Otsuka
`
`Pharm. Co., Ltd. v. Zenara Pharma Pvt. Ltd. et al., C.A. No. 20-1599-LPS (D. Del. Nov. 24,
`
`2020).
`
`46.
`
`In the alternative, this Court may exercise personal jurisdiction over Zenara
`
`pursuant to Fed. R. Civ. P. 4(k)(2) because (a) Plaintiffs’ claims arise under federal law; (b) Zenara
`
`is a foreign company not subject to personal jurisdiction in the courts in any state, and (c) Zenara
`
`has sufficient contacts with the United States as a whole, including but not limited to marketing
`
`and/or selling generic pharmaceutical products that are distributed and sold throughout the United
`
`States, such that this Court’s exercise of jurisdiction over Zenara satisfies due process.
`
`47.
`
`Venue is proper in this District with respect to Zenara pursuant to 28 U.S.C. §
`
`1391(c)(3) because Zenara is a foreign corporation and may be sued in any judicial district.
`
`
`
`15
`
`

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`Case 1:21-cv-00843-UNA Document 1 Filed 06/10/21 Page 16 of 133 PageID #: 16
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`48.
`
`Joinder of the defendants is proper pursuant to 35 U.S.C. § 299.
`
`FACTUAL BACKGROUND
`
`G.
`
`XADAGO® (safinamide) Tablets
`
`49.
`
`Newron is a biopharmaceutical company focused on the development of novel
`
`therapies for patients with diseases of the central and peripheral nervous system.
`
`50.
`
`Parkinson’s disease (PD) is the second most common chronic progressive
`
`neurodegenerative disorder in the elderly after Alzheimer’s disease, affecting 1-2% of individuals
`
`aged ≥ 65 years worldwide. [Ex. 1 (March 21, 2017 Newron Press Release).]
`
`51.
`
`Idiopathic PD, meaning PD with an unknown cause, is the most common form of
`
`Parkinsonism. Idiopathic PD is often referred to as “Parkinson’s Disease.”
`
`52.
`
`The diagnosis of PD is mainly based on observational criteria of muscular rigidity,
`
`resting tremor, or postural instability in combination with bradykinesia (i.e., slowness of
`
`movement). As the disease progresses, symptoms become more severe. [Id.]
`
`53.
`
`Levodopa (“L-dopa”) remains the most effective treatment for PD, and over 75%
`
`of patients with PD receive L-dopa. However, long-term treatment with L-dopa leads to seriously
`
`debilitating motor fluctuations, i.e., phases of normal functioning (ON-time) and decreased
`
`functioning (OFF-time). Therefore, as the disease progresses, additional medications are added
`
`on to L-dopa to help with management of these motor fluctuations. [See id.]
`
`54.
`
`In March of 2017, after extensive effort, research, and development, Newron,
`
`through its U.S. subsidiary, secured FDA approval for NDA No. 207145 for XADAGO®
`
`(safinamide) tablets, indicated as adjunctive treatment to levodopa/carbidopa in patients with PD
`
`experiencing “off” episodes. [Ex. 2 (3/21/2017 FDA Letter).]
`
`
`
`16
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`

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`Case 1:21-cv-00843-UNA Document 1 Filed 06/10/21 Page 17 of 133 PageID #: 17
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`55.
`
`The active ingredient in XADAGO® (safinamide) tablets is the mesylate salt of
`
`safinamide, or safinamide mesylate, which is a pharmaceutically acceptable acid salt of
`
`safinamide. [Ex. 3 (XADAGO® Label), § 11.]
`
`56.
`
`FDA’s approval of XADAGO® (safinamide) tablets constituted the first New
`
`Chemical Entity approved for PD patients with motor fluctuations in the United States in over a
`
`decade. [Ex. 1 (March 21, 2017 Newron Press Release).]
`
`57.
`
`A true, correct, and complete copy of the current FDA-approved Full Prescribing
`
`Information for XADAGO® (safinamide) tablets is attached as Exhibit 3.
`
`58.
`
`“XADAGO is indicated as adjunctive treatment to levodopa/carbidopa in patients
`
`with Parkinson’s disease (PD) experiencing ‘off’ episodes.” [Ex. 3 (XADAGO® Label), § 1.]
`
`59.
`
`XADAGO® (safinamide) tablets contain highly pure safinamide mesylate,
`
`including less than 0.03% (by weight) of the impurity (S)-2-[3-(3-fluorobenzyl)-4-(3-
`
`fluorobenzyloxy