Case 1:20-cv-19379-RMB-KMW Document 1 Filed 12/16/20 Page 1 of 17 PageID: 1
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`William P. Deni, Jr.
`Charles H. Chevalier
`J. Brugh Lower
`GIBBONS P.C.
`One Gateway Center
`Newark, New Jersey 07102
`Tel: (973) 596-4500
`Fax: (973) 596-0545
`
`Attorneys for Plaintiffs
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`BAUSCH HEALTH IRELAND LIMITED,
`SALIX PHARMACEUTICALS, INC., and
`NORGINE B.V.,
`
`Plaintiffs,
`
`v.
`
`LUPIN LTD., LUPIN ATLANTIS
`HOLDINGS SA, LUPIN INC., and LUPIN
`PHARMACEUTICALS, INC.,
`
`Defendants.
`
`Civil Action No. 20-19379
`
`Document Electronically Filed
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiffs Bausch Health Ireland Limited, Salix Pharmaceuticals, Inc., and Norgine B.V.
`
`(collectively, “Plaintiffs”) by way of Complaint against Defendants Lupin Ltd., Lupin Atlantis
`
`Holdings SA, Lupin Inc., and Lupin Pharmaceuticals, Inc. (collectively, “Lupin” or “Defendants”)
`
`allege as follows:
`
`THE PARTIES
`
`1.
`
`Plaintiff Bausch Health Ireland Limited (“Bausch”) is a company organized and
`
`existing under the laws of Ireland, having an office at 3013 Lake Drive, Citywest Business
`
`Campus, Dublin 24, Ireland.
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`2.
`
`Plaintiff Salix Pharmaceuticals, Inc. (“Salix”) is a corporation organized and
`
`existing under the laws of California, having its principle place of business at 400 Somerset Blvd.,
`
`Bridgewater, NJ 08807. Salix is the registered holder of approved New Drug Application
`
`(“NDA”) No. 209381, which covers Plenvu®.
`
`3.
`
`Plaintiff Norgine B.V. (“Norgine”) is a corporation organized and existing under
`
`the laws of the Netherlands, having a corporate headquarters at Antonio Vivaldistraat 150, 1083
`
`HP Amsterdam, The Netherlands.
`
`4.
`
`Upon information and belief, Defendant Lupin Ltd. is a corporation organized and
`
`existing under the laws of India, having a corporate headquarters at B/4 Laxmi Towers, Bandra
`
`Kurla Complex, Bandra (E), Mumbai 400 051, India.
`
`5.
`
`Upon information and belief, Defendant Lupin Atlantis Holdings SA (“Lupin
`
`Atlantis”) is a corporation organized and existing under the laws of Switzerland, having a corporate
`
`headquarters at Landis & Gyr-Strasse 1, Zug, Switzerland 6300. Upon information and belief,
`
`Lupin Atlantis is a wholly-owned subsidiary of Lupin Ltd.
`
`6.
`
`Upon information and belief, Defendant Lupin Inc. is a corporation organized and
`
`existing under the laws of Delaware, having a principal place of business at 111 S. Calvert Street,
`
`21st Floor, Baltimore, MD 21202. Upon information and belief, Lupin Inc. is a wholly-owned
`
`subsidiary of Lupin Atlantis.
`
`7.
`
`Upon information and belief, Defendant Lupin Pharmaceuticals, Inc. (“Lupin
`
`Pharm.”) is a corporation organized and existing under the laws of Delaware, having a principal
`
`place of business at 111 S. Calvert Street, 21st Floor, Baltimore, MD 21202. Upon information
`
`and belief, Lupin Pharm. is a subsidiary of Lupin Ltd. (3%) and Lupin Inc. (97%).
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`NATURE OF THE ACTION
`
`8.
`
`This is an action for infringement of United States Patent Nos. 10,780,112 B2 (“the
`
`’112 patent”) and 10,792,306 B2 (“the ’306 patent”) arising under the United States patent laws,
`
`Title 35, United States Code, § 100 et seq., including 35 U.S.C. §§ 271 and 281, and for declaratory
`
`judgment of infringement under 28 U.S.C. §§ 2201 and 2202. This action relates to Lupin’s filing
`
`of an Abbreviated New Drug Application (“ANDA”) under Section 505(j) of the Federal Food,
`
`Drug, and Cosmetic Act (“the Act”), 21 U.S.C. § 355(j), seeking U.S. Food and Drug
`
`Administration (“FDA”) approval to market generic polyethylene glycol 3350 (140 g), sodium
`
`ascorbate (48.11 g), sodium sulfate (9 g), ascorbic acid (7.54 g), sodium chloride (5.2 g), and
`
`potassium chloride (2.2 g) for oral solution (“Lupin’s ANDA Product”).
`
`JURISDICTION AND VENUE
`
`9.
`
`This Court has subject matter jurisdiction under 28 U.S.C. §§ 1331, 1338(a), 2201,
`
`and 2202.
`
`10.
`
`Upon information and belief, this Court has jurisdiction over Lupin Ltd. Upon
`
`information and belief, Lupin Ltd. is in the business of, inter alia, developing, manufacturing,
`
`marketing, importing, and selling pharmaceutical products, including generic drug products. Upon
`
`information and belief, Lupin Ltd. directly or indirectly manufactures, markets, and sells generic
`
`drug products throughout the United States and in this judicial district, and this judicial district is
`
`a likely destination for Lupin’s ANDA Product. Upon information and belief, Lupin Ltd.
`
`purposefully has conducted and continues to conduct business in this judicial district. Upon
`
`information and belief, Lupin Ltd. operates a manufacturing and research facility at 400 Campus
`
`Drive, Somerset, New Jersey 08873. Upon information and belief, Lupin Ltd. has previously
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`submitted to the jurisdiction of this Court and has further previously availed itself of this Court by
`
`asserting counterclaims in other civil actions initiated in this jurisdiction.
`
`11.
`
`Upon information and belief, this Court has jurisdiction over Lupin Atlantis. Upon
`
`information and belief, Lupin Atlantis directly or indirectly manufactures, markets, and sells
`
`generic drug products, including generic drug products manufactured by Lupin Ltd., throughout
`
`the United States and in this judicial district. Upon information and belief, Lupin Atlantis
`
`purposefully has conducted and continues to conduct business in this judicial district. Upon
`
`information and belief, Lupin Atlantis operates a manufacturing and research facility at 400
`
`Campus Drive, Somerset, New Jersey 08873. Upon information and belief, Lupin Atlantis has
`
`previously submitted to the jurisdiction of this Court and has further previously availed itself of
`
`this Court by asserting counterclaims in other civil actions initiated in this jurisdiction.
`
`12.
`
`Upon information and belief, this Court has jurisdiction over Lupin Inc. Upon
`
`information and belief, Lupin Inc. directly or indirectly manufactures, markets, and sells generic
`
`drug products, including generic drug products manufactured by Lupin Ltd., throughout the United
`
`States and in this judicial district. Upon information and belief, Lupin Inc. purposefully has
`
`conducted and continues to conduct business in this judicial district. Upon information and belief,
`
`Lupin Inc. operates a manufacturing and research facility at 400 Campus Drive, Somerset, New
`
`Jersey 08873. Upon information and belief, Lupin Inc. has previously submitted to the jurisdiction
`
`of this Court and has further previously availed itself of this Court by asserting counterclaims in
`
`other civil actions initiated in this jurisdiction.
`
`13.
`
`Upon information and belief, this Court has jurisdiction over Lupin Pharm. Upon
`
`information and belief, Lupin Pharm. directly or indirectly manufactures, markets, and sells
`
`generic drug products, including generic drug products manufactured by Lupin Ltd., throughout
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`the United States and in this judicial district. Upon information and belief, Lupin Pharm.
`
`purposefully has conducted and continues to conduct business in this judicial district. Upon
`
`information and belief, Lupin Pharm. operates a manufacturing and research facility at 400
`
`Campus Drive, Somerset, New Jersey 08873. Upon information and belief, Lupin Pharm. is
`
`registered to do business in New Jersey (business identification number 0101043376) and is
`
`registered with the State of New Jersey as a manufacturer and wholesale distributor of drugs under
`
`Registration Numbers 5004060 and 5005159. Upon information and belief, Lupin Pharm. has
`
`previously submitted to the jurisdiction of this Court and has further previously availed itself of
`
`this Court by asserting counterclaims in other civil actions initiated in this jurisdiction.
`
`14.
`
`Upon information and belief, Defendants have a regular and established place of
`
`business in this judicial district because, for example, they maintain a place of business in this
`
`judicial district at 400 Campus Drive, Somerset, New Jersey 08873.
`
`15.
`
`Upon information and belief, Lupin Ltd., Lupin Atlantis, Lupin Inc., and Lupin
`
`Pharm. hold themselves out as a unitary entity for purposes of manufacturing, marketing, selling,
`
`and distributing generic products in the United States. Upon information and belief, Lupin
`
`employs “vertical integration in discovery research, process chemistry, active pharmaceutical
`
`ingredient production,
`
`formulation development
`
`and
`
`regulatory
`
`filings.”
`
`
`
`(See
`
`http://www.lupinpharmaceuticals.com/about.htm, last accessed April 1, 2019.)
`
`16.
`
`Lupin’s ANDA No. 212934 is the subject of ongoing infringement litigations in the
`
`District of New Jersey: Bausch Health Ireland Limited v. Lupin Inc., Civil Action No. 19-cv-
`
`09178-RMB-KMW and Bausch Health Ireland Limited v. Lupin Inc., Civil Action No. 20-cv-
`
`11039-RMB-KMW. Lupin has consented to personal jurisdiction and venue before this Court in
`
`Bausch Health Ireland Limited v. Lupin Inc., Civil Action No. 19-cv-09178-RMB-KMW. Lupin
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`has not yet filed its Answer to the Complaint in Bausch Health Ireland Limited v. Lupin Inc., Civil
`
`Action No. 20-cv-11039-RMB-KMW.
`
`17.
`
`Lupin Ltd. and Lupin Pharm. availed themselves of the rights, benefits, and
`
`privileges of this Court by filing a complaint in the District of New Jersey in at least the following
`
`action: Lupin Ltd. v. Merck, Sharp & Dohme Corp., Civil Action No. 10-cv-00683.
`
`18.
`
`Lupin Ltd., Lupin Atlantis, Lupin Inc., and/or Lupin Pharm. consented to or did not
`
`contest jurisdiction of this Court, for example, in at least the following District of New Jersey
`
`actions: Jazz Pharm., Inc. v. Lupin Ltd., Civil Action No. 13-cv-00391-ES-JAD (Lupin Inc.);
`
`Otsuka Pharm. Co., Ltd. v. Lupin Ltd., Civil Action No. 14-cv-07105-JBS-KMW (Lupin Ltd.,
`
`Lupin Atlantis, and Lupin Pharm.); Horizon Pharma Ireland Ltd. v. Lupin Ltd., Civil Action No.
`
`15-cv-06935-NLH-AMD (Lupin Ltd. and Lupin Pharm.); Senju Pharm. Co., Ltd. v. Lupin Ltd.,
`
`Civil Action No. 16-cv-01097-JBS-KMW (Lupin Ltd. and Lupin Pharm.); Sun Pharma Global
`
`FZE v. Lupin Ltd., Civil Action No. 18-cv-02213-FLW-TJB (Lupin Ltd. and Lupin Pharm.); Endo
`
`Pharm., Inc. v. Lupin Atlantis Holdings SA, Civil Action No. 18-cv-10952-FLW-TJB (Lupin
`
`Atlantis and Lupin Inc.); Boehringer Ingelheim Pharm., Inc. v. Lupin Atlantis Holdings SA, Civil
`
`Action No. 18-cv-12663-BRM-TJB (Lupin Ltd. and Lupin Atlantis); Valeant Pharm. N. Am. LLC
`
`v. Lupin Ltd., Civil Action No. 18-cv-13700-PGS-LHG (Lupin Ltd.); Boehringer Ingelheim
`
`Pharm., Inc. v. Lupin Atlantis Holdings SA, Civil Action No. 18-cv-16708-BRM-TJB (Lupin Ltd.
`
`and Lupin Atlantis).
`
`19.
`
`Lupin Ltd., Lupin Atlantis, Lupin Inc., and/or Lupin Pharm. availed themselves of
`
`the rights, benefits, and privileges of this Court by asserting counterclaims, for example, in at least
`
`the following District of New Jersey actions: Jazz Pharm., Inc. v. Lupin Ltd., Civil Action No. 13-
`
`cv-00391-ES-JAD (Lupin Ltd., Lupin Inc., and Lupin Pharm.); Horizon Pharma Ireland Ltd. v.
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`Lupin Ltd., Civil Action No. 15-cv-06935-NLH-AMD (Lupin Ltd.); Senju Pharm. Co., Ltd. v.
`
`Lupin Ltd., Civil Action No. 16-cv-01097-JBS-KMW (Lupin Ltd.); Sun Pharma Global FZE v.
`
`Lupin Ltd., Civil Action No. 18-cv-02213-FLW-TJB (Lupin Ltd.); Endo Pharm., Inc. v. Lupin
`
`Atlantis Holdings SA, Civil Action No. 18-cv-10952-FLW-TJB (Lupin Atlantis and Lupin Inc.);
`
`Boehringer Ingelheim Pharm., Inc. v. Lupin Atlantis Holdings SA, Civil Action No. 18-cv-12663-
`
`BRM-TJB (Lupin Atlantis); Valeant Pharm. N. Am. LLC v. Lupin Ltd., Civil Action No. 18-cv-
`
`13700-PGS-LHG (Lupin Ltd.); Boehringer Ingelheim Pharm., Inc. v. Lupin Atlantis Holdings SA,
`
`Civil Action No. 18-cv-16708-BRM-TJB (Lupin Atlantis).
`
`20.
`
`Lupin is subject to specific jurisdiction in this judicial district based on the filing of
`
`its ANDA for its generic polyethylene glycol 3350 (140 g), sodium ascorbate (48.11 g), sodium
`
`sulfate (9 g), ascorbic acid (7.54 g), sodium chloride (5.2 g), and potassium chloride (2.2 g) for
`
`oral solution.
`
`21.
`
`Lupin has taken the costly, significant step of applying to the FDA for approval to
`
`engage in future activities—including the marketing of its generic drugs—that will be purposefully
`
`directed at, upon information and belief, this judicial district and elsewhere.
`
`22.
`
`Lupin’s ANDA filings constitute formal acts that reliably indicate plans to engage
`
`in marketing of the proposed generic drugs.
`
`23.
`
`Upon information and belief, Lupin intends to direct sales of its drugs into New
`
`Jersey, among other places, once it has requested FDA approval to market them.
`
`24.
`
`Upon information and belief, Lupin will engage in marketing of Lupin’s ANDA
`
`Product in New Jersey, upon approval of its ANDA.
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`25.
`
`Lupin’s ANDA filing regarding the ’112 patent and the ’306 patent at issue here is
`
`suit-related and has a substantial connection with this judicial district because it reliably, non-
`
`speculatively predicts activities by Lupin in this judicial district.
`
`26.
`
`Upon information and belief, venue is proper in this judicial district under
`
`28 U.S.C. §§ 1391(c) and (d), and 1400(b).
`
`27.
`
`Lupin Ltd., Lupin Atlantis, Lupin Inc., and/or Lupin Pharm. did not contest venue
`
`in this judicial district in at least the following actions: Jazz Pharm., Inc. v. Lupin Ltd., Civil Action
`
`No. 13-cv-00391-ES-JAD (Lupin Inc.); Otsuka Pharm. Co., Ltd. v. Lupin Ltd., Civil Action No.
`
`14-cv-07105-JBS-KMW (Lupin Ltd. and Lupin Pharm.); Horizon Pharma Ireland Ltd. v. Lupin
`
`Ltd., Civil Action No. 15-cv-06935-NLH-AMD (Lupin Ltd. and Lupin Pharm.); Senju Pharm.
`
`Co., Ltd. v. Lupin Ltd., Civil Action No. 16-cv-01097-JBS-KMW (Lupin Ltd. and Lupin Pharm.);
`
`Sun Pharma Global FZE v. Lupin Ltd., Civil Action No. 18-cv-02213-FLW-TJB (Lupin Ltd. and
`
`Lupin Pharm.); Endo Pharm., Inc. v. Lupin Atlantis Holdings SA, Civil Action No. 18-cv-10952-
`
`FLW-TJB (Lupin Atlantis and Lupin Inc.); Boehringer Ingelheim Pharm., Inc. v. Lupin Atlantis
`
`Holdings SA, Civil Action No. 18-cv-12663-BRM-TJB (Lupin Ltd. and Lupin Atlantis); Valeant
`
`Pharm. N. Am. LLC v. Lupin Ltd., Civil Action No. 18-cv-13700-PGS-LHG (Lupin Ltd.);
`
`Boehringer Ingelheim Pharm., Inc. v. Lupin Atlantis Holdings SA, Civil Action No. 18-cv-16708-
`
`BRM-TJB (Lupin Ltd. and Lupin Atlantis).
`
`28.
`
`Venue is proper against Lupin Ltd., a foreign corporation, in any judicial district
`
`that has personal jurisdiction, including this judicial district.
`
`29.
`
`Venue is proper against Lupin Ltd. because, inter alia, it maintains a regular and
`
`established place of business in this judicial district.
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`30.
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`Venue is proper against Lupin Atlantis, a foreign corporation, in any judicial district
`
`that has personal jurisdiction, including this judicial district.
`
`31.
`
`Venue is proper against Lupin Atlantis because, inter alia, it maintains a regular
`
`and established place of business in this judicial district.
`
`32.
`
`Venue is proper against Lupin Inc. because, inter alia, it maintains a regular and
`
`established place of business in this judicial district.
`
`33.
`
`Venue is proper against Lupin Pharm. because, inter alia, it maintains a regular and
`
`established place of business in this judicial district.
`
`THE PATENT IN SUIT
`
`34.
`
`The U.S. Patent and Trademark Office (“PTO”) issued the ’112 patent on
`
`September 22, 2020. The ’112 patent claims, inter alia, kits comprising compositions for the
`
`preparation of colon cleansing solutions. Plaintiffs hold all substantial rights in the ’112 patent
`
`and have the right to sue for infringement thereof. Norgine is the assignee of the ’112 patent. A
`
`copy of the ’112 patent is attached hereto as Exhibit A.
`
`35.
`
`The PTO issued the ’306 patent on October 6, 2020. The ’306 patent claims, inter
`
`alia, kits comprising compositions for the preparation of colon cleansing solutions, kits comprising
`
`colon cleansing solutions, and methods of cleansing the colon. Plaintiffs hold all substantial rights
`
`in the ’306 patent and have the right to sue for infringement thereof. Norgine is the assignee of
`
`the ’306 patent. A copy of the ’306 patent is attached hereto as Exhibit B.
`
`36.
`
`Salix is the holder of NDA No. 209381 for Plenvu®, which the FDA approved on
`
`May 4, 2018. In conjunction with NDA No. 209381, the ’112 patent and the ’306 patent are listed
`
`in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (“the Orange
`
`Book”), together with U.S. Patent Nos. 8,999,313 B2; 9,326,969 B2; 9,592,252 B2; 9,707,297 B2;
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`and 10,016,504 B2; 10,646,512 B2, which are the subject of ongoing infringement litigations in
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`the District of New Jersey: Bausch Health Ireland Limited v. Lupin Inc., Civil Action No. 19-cv-
`
`09178-RMB-KMW and Bausch Health Ireland Limited v. Lupin Inc., Civil Action No. 20-cv-
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`11039-RMB-KMW.
`
`37.
`
`Polyethylene glycol 3350 (140 g), sodium ascorbate (48.11 g), sodium sulfate (9 g),
`
`ascorbic acid (7.54 g), sodium chloride (5.2 g), and potassium chloride (2.2 g) for oral solution is
`
`sold in the United States under the trademark Plenvu®.
`
`LUPIN’S INFRINGING ANDA SUBMISSION
`
`38.
`
`Upon information and belief, Lupin filed or cause to be filed with the FDA ANDA
`
`No. 212934, under Section 505(j) of the Act and 21 U.S.C. § 355(j).
`
`39.
`
`Upon information and belief, Lupin’s ANDA No. 212934 seeks FDA approval to
`
`engage in commercial manufacture, use, and sale in the United States of Lupin’s ANDA Product,
`
`which Lupin intends to be a generic version of Plenvu®.
`
`40.
`
`Plaintiffs received a letter from Lupin Inc. dated November 3, 2020, purporting to
`
`be a Notice of Certification for ANDA No. 212934 (“Lupin’s Notice Letter”) under Section
`
`505(j)(2)(B)(ii)–(iv) of the Act and 21 § C.F.R. 314.95(c). Lupin’s Notice Letter was addressed
`
`to Salix, Norgine, Bausch, and Bausch Health Companies Inc.
`
`41.
`
`Lupin’s Notice Letter alleges that Lupin Inc. has submitted to the FDA ANDA
`
`No. 212934 seeking to engage in the manufacture, use, and sale of Lupin’s ANDA Product.
`
`42.
`
`Lupin’s Notice Letter states that Lupin’s ANDA No. 212934 “contains the required
`
`bioavailability and/or bioequivalence data and/or bioequivalence waiver” for Lupin’s ANDA
`
`Product.
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`43.
`
`Lupin’s Notice Letter, which is required by statute and regulation to provide a full
`
`and detailed explanation regarding any non-infringement defense, does not set forth any non-
`
`infringement defense related to claims 1–30 of the ’112 patent and claims 1–30 of the ’306 patent.
`
`44.
`
`The ’112 patent and the ’306 patent are listed in the Orange Book in conjunction
`
`with NDA No. 209381 for Plenvu®.
`
`45.
`
`Upon information and belief, ANDA No. 212934 seeks approval of Lupin’s ANDA
`
`Product that is the same, or substantially the same, as Plenvu®.
`
`46.
`
`Upon information and belief, Lupin Inc.’s actions related to ANDA No. 212934
`
`complained of herein were done at the direction of, with the authorization of, or with the
`
`cooperation, the participation, the assistance of, or at least in part for the benefit of Lupin Ltd.,
`
`Lupin Atlantis, and Lupin Pharm.
`
`COUNT I FOR PATENT INFRINGEMENT
`
`Infringement of the ’112 Patent Under § 271(e)(2)
`
`Paragraphs 1–46 are incorporated herein as set forth above.
`
`Under 35 U.S.C. § 271(e)(2), Lupin has infringed at least one claim of the ’112
`
`47.
`
`48.
`
`patent by submitting, or causing to be submitted to the FDA, ANDA No. 212934 seeking approval
`
`for the commercial marketing of Lupin’s ANDA Product before the expiration date of the ’112
`
`patent.
`
`49.
`
`Upon information and belief, Lupin’s ANDA Product will, if approved and
`
`marketed, infringe at least one claim of the ’112 patent.
`
`50.
`
`Upon information and belief, Lupin will, through the manufacture, use, import,
`
`offer for sale, and/or sale of Lupin’s ANDA Product, directly infringe, contributorily infringe,
`
`and/or induce infringement of at least one claim of the ’112 patent.
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`51.
`
`If Lupin’s marketing and sale of Lupin’s ANDA Product prior to the expiration of
`
`the ’112 patent is not enjoined, Plaintiffs will suffer substantial and irreparable harm for which
`
`there is no adequate remedy at law.
`
`COUNT II FOR PATENT INFRINGEMENT
`
`Declaratory Judgment of Infringement of the ’112 Patent
`
`Paragraphs 1–51 are incorporated herein as set forth above.
`
`These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
`
`52.
`
`53.
`
`2202.
`
`54.
`
`There is an actual case or controversy such that the Court may entertain Plaintiffs’
`
`request for declaratory relief consistent with Article III of the United States Constitution, and this
`
`actual case or controversy requires a declaration of rights by this Court.
`
`55.
`
`Lupin has made, and will continue to make, substantial preparation in the United
`
`States to manufacture, use, offer to sell, sell, and/or import Lupin’s ANDA Product before the
`
`expiration date of the ’112 patent, including Lupin’s filing of ANDA No. 212934.
`
`56.
`
`Upon information and belief, any commercial manufacture, use, offer for sale, sale,
`
`and/or importation of Lupin’s ANDA Product will directly infringe, contributorily infringe, and/or
`
`induce infringement of at least one claim of the ’112 patent.
`
`57.
`
`Plaintiffs are entitled to a declaratory judgment that future commercial
`
`manufacture, use, offer of use, sale, and/or importation of Lupin’s ANDA Product will constitute
`
`infringement of at least one claim of the ’112 patent.
`
`COUNT III FOR PATENT INFRINGEMENT
`
`Infringement of the ’306 Patent Under § 271(e)(2)
`
`58.
`
`Paragraphs 1–57 are incorporated herein as set forth above.
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`Case 1:20-cv-19379-RMB-KMW Document 1 Filed 12/16/20 Page 13 of 17 PageID: 13
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`59.
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`Under 35 U.S.C. § 271(e)(2), Lupin has infringed at least one claim of the ’306
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`patent by submitting, or causing to be submitted to the FDA, ANDA No. 212934 seeking approval
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`for the commercial marketing of Lupin’s ANDA Product before the expiration date of the ’306
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`patent.
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`60.
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`Upon information and belief, Lupin’s ANDA Product will, if approved and
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`marketed, infringe at least one claim of the ’306 patent.
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`61.
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`Upon information and belief, Lupin will, through the manufacture, use, import,
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`offer for sale, and/or sale of Lupin’s ANDA Product, directly infringe, contributorily infringe,
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`and/or induce infringement of at least one claim of the ’306 patent.
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`62.
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`If Lupin’s marketing and sale of Lupin’s ANDA Product prior to the expiration of
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`the ’306 patent is not enjoined, Plaintiffs will suffer substantial and irreparable harm for which
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`there is no adequate remedy at law.
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`COUNT IV FOR PATENT INFRINGEMENT
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`Declaratory Judgment of Infringement of the ’306 Patent
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`Paragraphs 1–62 are incorporated herein as set forth above.
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`These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
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`63.
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`64.
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`2202.
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`65.
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`There is an actual case or controversy such that the Court may entertain Plaintiffs’
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`request for declaratory relief consistent with Article III of the United States Constitution, and this
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`actual case or controversy requires a declaration of rights by this Court.
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`66.
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`Lupin has made, and will continue to make, substantial preparation in the United
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`States to manufacture, use, offer to sell, sell, and/or import Lupin’s ANDA Product before the
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`expiration date of the ’306 patent, including Lupin’s filing of ANDA No. 212934.
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`Case 1:20-cv-19379-RMB-KMW Document 1 Filed 12/16/20 Page 14 of 17 PageID: 14
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`67.
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`Upon information and belief, any commercial manufacture, use, offer for sale, sale,
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`and/or importation of Lupin’s ANDA Product will directly infringe, contributorily infringe, and/or
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`induce infringement of at least one claim of the ’306 patent.
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`68.
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`Plaintiffs are entitled to a declaratory judgment that future commercial
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`manufacture, use, offer of use, sale, and/or importation of Lupin’s ANDA Product will constitute
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`infringement of at least one claim of the ’306 patent.
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`PRAYER FOR RELIEF
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`WHEREFORE, Plaintiffs respectfully request that this Court enter judgment in their favor
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`and against Lupin on the patent infringement claims set forth above and respectfully request that
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`this Court:
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`1.
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`Enter judgment that, under 35 U.S.C. § 271(e)(2), Lupin has infringed at least one
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`claim of the ’112 patent by submitting or causing to be submitted ANDA No. 212934 to the FDA
`
`to obtain approval for the commercial manufacture, use, import, offer for sale, and/or sale in the
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`United States of Lupin’s ANDA Product before the expiration of the ’112 patent;
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`2.
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`Enter judgment that, under 35 U.S.C. § 271(e)(2), Lupin has infringed at least one
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`claim of the ’306 patent by submitting or causing to be submitted ANDA No. 212934 to the FDA
`
`to obtain approval for the commercial manufacture, use, import, offer for sale, and/or sale in the
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`United States of Lupin’s ANDA Product before the expiration of the ’306 patent;
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`3.
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`Order that the effective date of any approval by the FDA of Lupin’s ANDA Product
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`be a date that is not earlier than the expiration of the ’112 patent and the ’306 patent or such later
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`date as the Court may determine;
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`Case 1:20-cv-19379-RMB-KMW Document 1 Filed 12/16/20 Page 15 of 17 PageID: 15
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`4.
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`Enjoin Lupin from the commercial manufacture, use, import, offer for sale, and/or
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`sale of Lupin’s ANDA Product until expiration of the ’112 patent and the ’306 patent or such later
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`date as the Court may determine;
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`5.
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`Enjoin Lupin and all persons acting in concert with Lupin from seeking, obtaining,
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`or maintaining approval of Lupin’s ANDA No. 212934 until expiration of the ’112 patent and the
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`’306 patent;
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`6.
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`Declare this to be an exceptional case under 35 U.S.C. §§ 285 and 271(e)(4) and
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`award Plaintiffs costs, expenses, and disbursements in this action, including reasonable attorney’s
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`fees; and
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`7.
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`Award Plaintiffs such further and additional relief as this Court deems just and
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`proper.
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`Case 1:20-cv-19379-RMB-KMW Document 1 Filed 12/16/20 Page 16 of 17 PageID: 16
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`Dated: December 16, 2020
`Newark, New Jersey
`
`s/ William P. Deni, Jr.
`William P. Deni, Jr.
`Charles H. Chevalier
`J. Brugh Lower
`GIBBONS P.C.
`One Gateway Center
`Newark, New Jersey 07102
`Tel: (973) 596-4500
`Fax: (973) 596-0545
`wdeni@gibbonslaw.com
`cchevalier@gibbonslaw.com
`jlower@gibbonslaw.com
`
`Attorneys for Plaintiffs
`
`Bryan C. Diner
`
`Justin J. Hasford
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`Tel: (202) 408-4000
`
`Attorneys for Plaintiffs Bausch Health
`Ireland Limited and Salix Pharmaceuticals, Inc.
`
`Martin H. Black (pro hac vice to be submitted)
`DECHERT LLP
`Cira Centre, 2929 Arch St.
`Philadelphia, Pennsylvania 19104-2808
`Tel: (215) 994-4000
`
`Katherine A. Helm (pro hac vice to be submitted)
`DECHERT LLP
`3 Bryant Park
`1095 Avenue of the Americas
`New York, New York 10036
`Tel: (212) 698-3500
`
`Attorneys for Plaintiff Norgine B.V.
`
`- 16 -
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`Case 1:20-cv-19379-RMB-KMW Document 1 Filed 12/16/20 Page 17 of 17 PageID: 17
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`CERTIFICATION OF NON-ARBITRABILITY
`PURSUANT TO LOCAL CIVIL RULE 201.1(d)
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`Pursuant to Local Civil Rule 201.1(d), the undersigned counsel hereby certifies that this
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`action seeks declaratory and injunctive relief and, therefore, is not subject to mandatory arbitration.
`
`I hereby certify under penalty of perjury that the foregoing is true and correct.
`
`Dated: December 16, 2020
`Newark, New Jersey
`
`
`
`s/ William P. Deni, Jr.
`William P. Deni, Jr.
`GIBBONS P.C.
`One Gateway Center
`Newark, New Jersey 07102
`Tel: (973) 596-4500
`Fax: (973) 596-0545
`wdeni@gibbonslaw.com
`
`Attorneys for Plaintiffs
`
`- 17 -
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`