Case 1:21-cv-00188-UNA Document 1 Filed 02/10/21 Page 1 of 16 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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`))))))))))))
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`
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`BIAL - PORTELA & CA S.A., BIAL -
`HOLDING, S.A., and SUNOVION
`PHARMACEUTICALS INC.,
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`
`Plaintiffs,
`
`
`
`v.
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`DR. REDDY'S LABORATORIES, LTD. and
`DR. REDDY'S LABORATORIES, INC.,
`
`
`Defendants.
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`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiffs BIAL - PORTELA & CA S.A., BIAL - HOLDING, S.A., and Sunovion
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`Pharmaceuticals Inc. (collectively, “Plaintiffs”), by their attorneys, for their Complaint against
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`Defendants Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively,
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`“DRL”), allege as follows:
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`THE PARTIES
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`1.
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`BIAL - PORTELA & CA S.A. is a Portuguese corporation having its principal
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`place of business at Avenida da Siderurgia Nacional, Coronado (São Romão and São Mamede),
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`4745 455 Trofa, Portugal.
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`2.
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`BIAL - HOLDING, S.A. is a Portuguese corporation having its principal place of
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`business at Avenida da Siderurgia Nacional, Coronado (São Romão and São Mamede), 4745 365
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`Trofa, Portugal.
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`3.
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`BIAL - PORTELA & CA S.A. and BIAL - HOLDING, S.A. (collectively, “Bial”)
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`are in the business of developing innovative therapies for epilepsy, partial-onset seizures, and
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`other related neurological conditions. Bial’s asserted patent(s) cover APTIOM®, which is
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`1
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`marketed and sold in this judicial district and throughout the United States by Sunovion
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`Pharmaceuticals Inc. for treating partial-onset seizures in patients 4 years of age and older.
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`4.
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`Sunovion Pharmaceuticals Inc. (“Sunovion”) is a corporation operating and
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`existing under the laws of the State of Delaware, with its principal place of business at 84
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`Waterford Drive, Marlborough, Massachusetts 01752.
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`5.
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`On information and belief, Dr. Reddy’s Laboratories, Ltd. is a corporation
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`organized and existing under the laws of India, with its principal place of business at Door No. 8-
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`2-337, Road No. 3, Banjara Hills, Hyderabad, Telangana 500 034 India.
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`6.
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`On information and belief, Dr. Reddy’s Laboratories, Ltd. is in the business of,
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`inter alia, manufacturing, marketing, and selling generic copies of branded pharmaceutical
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`products throughout the United States, including in the State of Delaware.
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`7.
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`On information and belief, Dr. Reddy’s Laboratories, Inc. is a corporation
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`organized and existing under the laws of New Jersey, with its principal place of business at 107
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`College Road East, Princeton, New Jersey 08540.
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`8.
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`On information and belief, Dr. Reddy’s Laboratories, Inc. is a wholly owned
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`subsidiary of Dr. Reddy’s Laboratories, Ltd.
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`9.
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`On information and belief, Dr. Reddy’s Laboratories, Inc. is in the business of,
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`inter alia, manufacturing, marketing, and selling generic copies of branded pharmaceutical
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`products throughout the United States, including in the State of Delaware, in concert with Dr.
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`Reddy’s Laboratories, Ltd.
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`10.
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`On information and belief, the acts of Dr. Reddy’s Laboratories, Ltd. complained
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`of herein were done with the cooperation, participation, and assistance of Dr. Reddy’s
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`Laboratories, Inc.
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`2
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`11.
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`On information and belief, and consistent with their practice with respect to other
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`generic products, following FDA approval of Eslicarbazepine Acetate Tablets 200, 400, 600, and
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`800 mg Abbreviated New Drug Application (“ANDA”) No. 211238, Dr. Reddy’s Laboratories,
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`Ltd. and Dr. Reddy’s Laboratories, Inc. will act in concert to distribute and sell the generic
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`product described in Eslicarbazepine Acetate Tablets 200, 400, 600, and 800 mg ANDA No.
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`211238 (“DRL’s Generic Product”) throughout the United States, including the State of
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`Delaware.
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`NATURE OF THE ACTION
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`12.
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`This is a civil action for patent infringement of U.S. Patent No. 10,912,781 (“the
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`’781 patent” or “the patent-in-suit”) arising under the United States Patent Laws, Title 35, United
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`States Code, § 1, et. seq., and in particular under 35 U.S.C. § 271. This action relates to ANDA
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`No. 211238, which DRL filed or caused to be filed under 21 U.S.C. § 355(j) with the United
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`States Food and Drug Administration (“FDA”), for approval to market in the United States a
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`generic copy of Plaintiffs’ APTIOM® product prior to the expiration of the patent-in-suit.
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`13.
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`DRL has infringed one or more claims of the ’781 patent under 35 U.S.C.
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`§ 271(e)(2)(A) by virtue of its filing of ANDA No. 211238 seeking FDA approval for the
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`commercial manufacture, use, import, offer for sale, and/or sale in the United States of DRL’s
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`Generic Product prior to the expiration of the ’781 patent, or any extensions thereof. DRL will
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`infringe one or more claims of the ’781 patent under 35 U.S.C. § 271(a), (b), or (c) should it
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`engage in the commercial manufacture, use, offer for sale, sale, distribution in, or importation
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`into the United States of DRL’s Generic Product prior to the expiration of the ’781 patent, or any
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`extensions thereof.
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`14.
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`Plaintiffs previously filed a separate action in this Court against DRL for patent
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`infringement, which included counts for infringement of U.S. Patent Nos. 9,750,747 (“the ’747
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`3
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`patent”), 8,372,431 (“the ’431 patent”), 9,206,135 (“the ’135 patent”), 9,566,244 (“the ’244
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`patent”), 9,643,929 (“the ’929 patent”), and 9,763,954 (“the ’954 patent”). Bial - Portela & CA
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`S.A., et al. v. Dr. Reddy’s Laboratories, Ltd., et al., C.A. No. 18-341-CFC (the “First Suit”) was
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`filed on March 2, 2018. The First Suit was filed in response to a letter from DRL dated January
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`17, 2018 (“DRL’s First Notice Letter”), purporting to be a “Notice of Paragraph IV
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`Certification” for ANDA No. 211238 pursuant to § 505(j)(2)(b)(iv) of the Federal Food, Drug,
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`and Cosmetic Act and 21 C.F.R. § 314.95 as to the ’747 patent, the ’431 patent, the ’135 patent,
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`the ’244 patent, the ’929 patent, and the ’954 patent. The First Suit included counts for
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`infringement of the ’747 patent, the ’431 patent, the ’135 patent, the ’244 patent, the ’929 patent,
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`and the ’954 patent.
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`15.
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`Plaintiffs previously filed a separate action in this Court against DRL for patent
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`infringement, which included counts for infringement of U.S. Patent Nos. 10,675,287 (“the ’287
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`patent”), 10,695,354 (“the ’354 patent”), and 10,702,536 (“the ’536 patent”). Bial - Portela &
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`CA S.A., et al. v. Dr. Reddy’s Laboratories, Ltd., et al., C.A. No. 20-784-CFC (the “Second
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`Suit”) was filed on June 9, 2020, and an amended complaint was filed on July 7, 2020. Plaintiffs
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`received a letter from DRL dated August 21, 2020 (“DRL’s Second Notice Letter”), purporting
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`to be a “Notice of Paragraph IV Certification” for ANDA No. 211238 pursuant to §
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`505(j)(2)(b)(iv) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 314.95 as to the
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`ʼ287, patent, the ʼ354 patent, and the ʼ536 patent. The Second Suit included counts for
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`infringement of the ʼ287 patent, the ʼ354 patent, and the ʼ536 patent.
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`16.
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`The First Suit and the Second Suit did not include counts for infringement of U.S.
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`Patent No. 5,753,646 (“the ’646 patent”), which will expire on June 27, 2021, because DRL’s
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`First Notice Letter and DRL’s Second Notice Letter did not assert noninfringement or invalidity
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`4
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`of the ’646 patent. Based on information and belief, DRL is maintaining its certification as to
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`the ’747 patent, the ’431 patent, the ’135 patent, the ’244 patent, the ’929 patent, the ’954 patent,
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`the ʼ287 patent, the ʼ354 patent, and the ʼ536 patent set out in DRL’s First Notice Letter and
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`DRL’s Second Notice Letter. Thus, Plaintiffs will continue to prosecute all infringement counts
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`presented in the First Suit and the Second Suit.
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`JURISDICTION AND VENUE
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`17.
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`Plaintiffs incorporate by reference the prior paragraphs of this Complaint as if
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`fully set forth herein.
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`18.
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`This is a civil action for patent infringement and declaratory judgment arising
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`under the patent laws of the United States, 35 U.S.C. § 1, et seq., including 35 U.S.C. § 271, and
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`the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202.
`
`19.
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`20.
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`This Court has subject matter jurisdiction under 28 U.S.C. §§ 1331 and 1338(a).
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`Venue is proper in this judicial district under 28 U.S.C. §§ 1391(b) and (c), and
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`1400(b), because Dr. Reddy’s Laboratories, Ltd. is incorporated in India and may be sued in any
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`judicial district in the United States in which it is subject to the Court’s personal jurisdiction.
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`21.
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`This Court has personal jurisdiction over Dr. Reddy’s Laboratories, Ltd., inter
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`alia, under Federal Rule of Civil Procedure 4(k)(2), because Dr. Reddy’s Laboratories, Ltd. is
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`organized under the laws of India.
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`22.
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`This Court also has personal jurisdiction over DRL because at least one provision
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`of the Delaware long-arm statute, 10 Del. C. § 3104(c), is satisfied. On information and belief,
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`DRL satisfies at least § 3104(c)(1) (“[t]ransacts any business or performs any character of work
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`or service in the State), § 3104(c)(2) (“[c]ontracts to supply services or things in this State”), §
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`3104(c)(3) (“[c]auses tortious injury in the State by an act or omission in this State), § 3104(c)(4)
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`5
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`“[c]auses tortious injury in the State or outside of the State by an act or omission outside the
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`State if the person regularly does or solicits business, engages in any other persistent course of
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`conduct in the State or derives substantial revenue from services, or things used or consumed in
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`the State”), and § 3104(c)(5) (“[h]as an interest in, uses or possesses real property in the State”).
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`23.
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`This Court also has personal jurisdiction over DRL because, inter alia, this action
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`arises from activities of DRL directed toward Delaware.
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`24.
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`Upon information and belief, the effort to seek approval for ANDA No. 211238
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`and to manufacture, import, market, and/or sell DRL’s Generic Product upon approval has been
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`a cooperative and joint enterprise and venture between Dr. Reddy’s Laboratories, Ltd. and Dr.
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`Reddy’s Laboratories, Inc.
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`25.
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`Upon information and belief, Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s
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`Laboratories, Inc. have an express and/or implied agreement to cooperate in the joint enterprise
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`and venture of preparing, filing, and maintaining ANDA No. 211238 and in commercializing
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`DRL’s Generic Product in the United States, including in this judicial district, in accordance with
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`ANDA No. 211238 upon approval.
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`26.
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`Upon information and belief, Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s
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`Laboratories, Inc. have thus been, and continue to be, joint and prime actors in the drafting,
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`submission, approval, and maintenance of ANDA No. 211238.
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`27.
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`This Court has personal jurisdiction over DRL by virtue of the fact that, inter alia,
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`DRL has committed—or aided, abetted, induced, contributed to, or participated in the
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`commission of—the tortious act of patent infringement that has led and/or will lead to
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`foreseeable harm and injury to Plaintiffs.
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`6
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`28.
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`On information and belief, and consistent with their practice with respect to other
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`generic products, following FDA approval of ANDA No. 211238, DRL will market, distribute,
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`and sell DRL’s Generic Product described in ANDA No. 211238 throughout the United States,
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`including in Delaware.
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`29.
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`This Court also has personal jurisdiction over DRL because, inter alia, DRL has
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`purposefully availed itself of the rights and benefits of Delaware law by engaging in systematic
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`and continuous contacts with Delaware. Upon information and belief, DRL, either directly or
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`through affiliates, currently sells significant quantities of generic drug products in the United
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`States and in the State of Delaware. DRL’s website states that “Generic Formulations, including
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`tablets . . . is the largest part of our business portfolio,” that its “major markets include – USA,”
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`that it has “99 generic filings pending approval from the USFDA, consisting of 97 ANDAs,” and
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`that “[o]f these, 97 ANDAs, 54 are Para IV filings and [DRL] believe[s] 30 of these have ‘First
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`to
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`File’
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`status.”
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`See
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`https://www.drreddys.com/our-products/business-focus/generics/;
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`https://www.drreddys.com/media/904784/factsheet_july_2020.pdf;
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`https://www.drreddys.com/media/884823/annualreport2020forwebsite.pdf (accessed February
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`10, 2021). On information and belief, DRL derives substantial revenue from the sale of those
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`products in Delaware and has availed itself of the privilege of conducting business within the
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`State of Delaware.
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`30.
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`This Court also has personal jurisdiction over DRL because, inter alia, it has
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`availed itself of this forum previously for the purpose of litigating a patent dispute. For example,
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`DRL has previously invoked this Court’s jurisdiction by asserting counterclaims in at least 19
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`other cases. See, e.g., 20-cv-00847, 19-cv-02045, 19-cv-01495, 18-cv-01839, 18-cv-01779, 17-
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`7
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`cv-01811, 16-cv-01267, 16-cv-01011, 16-cv-00900, 15-cv-01067, 15-cv-00670, 15-cv-00179,
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`13-cv-02082, and 13-cv-01506.
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`31.
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`This Court also has personal jurisdiction over DRL because DRL did not contest
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`jurisdiction in the First Suit or the Second Suit.
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`32.
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`For these reasons and other reasons that will be presented to the Court if
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`jurisdiction is challenged, the Court has personal jurisdiction over DRL.
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`FACTUAL BACKGROUND
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`The NDA
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`33.
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`Sunovion is the holder of New Drug Application (“NDA”) No. 022416 for
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`APTIOM® (eslicarbazepine acetate) Tablets in 200, 400, 600, and 800 mg dosage forms.
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`34.
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`The FDA approved NDA No. 022416 on November 8, 2013, for use as adjunctive
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`therapy of partial-onset seizures.
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`35.
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`The FDA approved NDA No. 022416 on August 27, 2015, for use as
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`monotherapy of partial-onset seizures.
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`36.
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`The FDA approved NDA No. 022416 on September 13, 2017, for pediatric
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`patients 4 years of age and older.
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`37.
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`APTIOM® Tablets are prescription drugs approved for the treatment of partial-
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`onset seizures in patients 4 years of age and older. Eslicarbazepine acetate is the active
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`ingredient in the APTIOM® Tablets.
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`The Patent-in-Suit
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`38.
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`The ’781 patent, titled “Pharmaceutical Composition Comprising Licarbazepine
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`Acetate,” was duly and legally issued by the United States Patent and Trademark Office on
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`February 9, 2021. A true and correct copy of the ’781 patent is attached as Exhibit A.
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`8
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`39.
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`BIAL - PORTELA & CA S.A. owns the rights to the ’781 patent. Sunovion is the
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`exclusive licensee in the United States of the ’781 patent. The ’781 patent will expire on
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`October 23, 2028.
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`40.
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`Information regarding the ’781 patent was submitted to the FDA for listing in the
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`Orange Book in connection with NDA No. 022416 for APTIOM® (Eslicarbazepine Acetate)
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`Tablets.
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`41.
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`The ’781 patent covers pharmaceutical compositions comprising licarbazepine
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`acetate.
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`The ANDA
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`42.
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`On information and belief, DRL filed ANDA No. 211238 with the FDA under 21
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`U.S.C. § 355(j) before January 17, 2018, to obtain FDA approval for the commercial
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`manufacture, use, import, offer for sale, and/or sale in the United States of (eslicarbazepine
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`acetate) Tablets in 200, 400, 600, and 800 mg dosage forms, which are generic versions of
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`Plaintiffs’ APTIOM® (eslicarbazepine acetate) Tablets in 200, 400, 600, and 800 mg dosage
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`forms.
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`43.
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`DRL’s First Notice Letter alleged that the claims of the ’747 patent, the ’431
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`patent, the ’135 patent, the ’244 patent, the ’929 patent, and the ’954 patent are invalid and/or
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`will not be infringed by the activities described in DRL’s ANDA No. 211238. DRL’s First
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`Notice Letter also informed Plaintiffs that DRL seeks approval to market DRL’s Generic Product
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`before the ’747, ’431, ’135, ’244, ’929, and ’954 patents expire.
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`44.
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`DRL’s Second Notice Letter alleged that the claims of the ʼ287 patent, the ʼ354
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`patent, and the ʼ536 patent are invalid and/or will not be infringed by the activities described in
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`9
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`DRL’s ANDA No. 211238. DRL’s Second Notice Letter also informed Plaintiffs that DRL
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`seeks approval to market DRL’s Generic Product before the ʼ287, ʼ354, and ’536 patents expire.
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`45.
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`The ʼ747 patent will expire on August 24, 2032. The ʼ431 patent will expire on
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`April 17, 2030. The ’135 and ’929 patents will expire on April 21, 2026. The ʼ244 patent will
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`expire on October 23, 2028. The ʼ954 patent will expire on September 13, 2028. The ’287,
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`ʼ354, and ʼ536 patents will expire on May 6, 2025. The ʼ781 patent will expire on October 23,
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`2028.
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`46.
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`DRL’s ANDA No. 211238 has been pending before the FDA since at least
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`January 17, 2018, the date of DRL’s First Notice Letter to Plaintiffs.
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`47.
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`On information and belief, following FDA approval of DRL’s ANDA No.
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`211238, DRL will make, use, sell, or offer to sell DRL’s Generic Product throughout the United
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`States, or import such generic products into the United States before the ’781 patent expires.
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`COUNT I
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`(INFRINGEMENT OF THE ’781 PATENT UNDER 35 U.S.C. § 271(e)(2))
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`48.
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`Plaintiffs incorporate by reference the prior paragraphs of this Complaint as if
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`fully set forth herein.
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`49.
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`On information and belief, DRL filed ANDA No. 211238 in order to obtain
`
`approval to manufacture, use, import, offer to sell, and/or sell DRL’s Generic Product in the
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`United States before the expiration of the ’781 patent.
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`50.
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`On information and belief, in its ANDA No. 211238, DRL has represented to the
`
`FDA that DRL’s Generic Product is pharmaceutically and therapeutically equivalent to
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`Plaintiffs’ APTIOM® tablets.
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`10
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`51.
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`Under 35 U.S.C. § 271(e)(2)(A), the submission to the FDA of ANDA No.
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`211238 seeking approval for the commercial manufacture, use, or sale of DRL’s Generic Product
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`before the expiration date of the ’781 patent, constitutes infringement, either literally or under the
`
`doctrine of equivalents.
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`52.
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`After FDA approval of ANDA No. 211238, DRL will infringe one or more claims
`
`of the ’781 patent, either literally or under the doctrine of equivalents under § 271(a) by making,
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`using, offering to sell, selling, and/or importing DRL’s Generic Product, and by actively
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`inducing infringement by others under § 271(b) and/or contributing to infringement under
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`§ 271(c), unless this Court orders that the effective date of any FDA approval of ANDA No.
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`211238 shall be no earlier than the expiration of the ’781 patent and any additional periods of
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`exclusivity.
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`53.
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`On information and belief, if ANDA No. 211238 is approved, DRL intends to and
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`will offer to sell, sell, and/or import in the United States DRL’s Generic Product.
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`54.
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`DRL has had and continues to have knowledge that DRL’s Generic Product is
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`especially adapted for a use that infringes the ’781 patent.
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`55.
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`On information and belief, DRL has had and continues to have knowledge that
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`there is no substantial non-infringing use for DRL’s Generic Product.
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`56.
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`On information and belief, DRL’s actions relating to DRL’s ANDA No. 211238
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`complained of herein were done by and for the benefit of DRL.
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`57.
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`Plaintiffs will be irreparably harmed if DRL is not enjoined from infringing or
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`actively inducing infringement of at least one claim of the ’781 patent. Pursuant to 35 U.S.C.
`
`§ 283, Plaintiffs are entitled to a permanent injunction against further infringement. Plaintiffs do
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`not have an adequate remedy at law.
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`COUNT II
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`(DECLARATORY JUDGEMENT OF INFRINGEMENT OF THE ’781 PATENT)
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`58.
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`Plaintiffs incorporate by reference the prior paragraphs of this Complaint as if
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`fully set forth herein.
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`59.
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`This count arises under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
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`2202.
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`60.
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`There is an actual and justiciable controversy between Plaintiffs and DRL
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`concerning infringement of the ’781 patent of sufficient immediacy and reality such that the
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`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
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`this Court.
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`61.
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`DRL has made, and continues to make, substantial preparation in the United
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`States to manufacture, offer to sell, sell and/or import DRL’s Generic Product prior to expiration
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`of the ’781 patent.
`
`62.
`
`DRL’s actions, including, but not limited to, submitting, or causing to be
`
`submitted to the FDA, ANDA No. 211238 seeking approval to manufacture, use, import, offer to
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`sell and sell DRL’s Generic Product before the expiration date of the ’781 patent and engaging in
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`litigation, indicate a refusal to change the course of their actions in the face of knowledge of the
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`’781 patent and acts by Plaintiffs.
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`63.
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`On information and belief, DRL intends to manufacture, use, import, offer to sell
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`and/or sell DRL’s Generic Product after FDA approval of ANDA No. 211238.
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`64.
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`After FDA approval of ANDA No. 211238, DRL will infringe one or more claims
`
`of the ’781 patent, either literally or under the doctrine of equivalents under § 271(a) by making,
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`12
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`using, offering to sell, selling, and/or importing DRL’s Generic Product, and/or by actively
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`inducing infringement by others under § 271(b) and/or contributing to infringement under §
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`271(c).
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`65.
`
`On information and belief, if ANDA No. 211238 is approved, DRL intends to and
`
`will offer to sell, sell, and/or import in the United States DRL’s Generic Product.
`
`66.
`
`DRL has had and continues to have knowledge that DRL’s Generic Product is
`
`especially adapted for a use that infringes the ’781 patent.
`
`67.
`
`On information and belief, DRL has had and continues to have knowledge that
`
`there is no substantial non-infringing use for DRL’s Generic Product.
`
`68.
`
`On information and belief, DRL’s actions relating to DRL’s ANDA No. 211238
`
`complained of herein were done by and for the benefit of DRL.
`
`69.
`
`Plaintiffs will be irreparably harmed if DRL is not enjoined from infringing or
`
`actively inducing infringement of at least one claim of the ’781 patent.
`
`70.
`
`Plaintiffs are entitled to a permanent injunction against further infringement.
`
`Plaintiffs do not have an adequate remedy at law.
`
`71.
`
`Plaintiffs are entitled to a declaratory judgment that future commercial
`
`manufacture, use, offer for sale, sale and/or importation of DRL’s Generic Product prior to
`
`expiration of the ’781 patent by DRL will constitute direct infringement, contributory
`
`infringement and/or active inducement of infringement of the ’781 patent.
`
`REQUEST FOR RELIEF
`
`WHEREFORE, Plaintiffs respectfully request the following relief:
`
`A.
`
`The entry of judgment under 35 U.S.C. § 271(e)(2)(A) that DRL has infringed at
`
`least one claim of the patent-in-suit through DRL’s submission of ANDA No. 211238 to the
`
`
`
`13
`
`

`

`Case 1:21-cv-00188-UNA Document 1 Filed 02/10/21 Page 14 of 16 PageID #: 14
`
`
`FDA to obtain approval to manufacture, use, import, offer to sell, and/or sell DRL’s Generic
`
`Product in the United States before the expiration of the patent-in-suit;
`
`B.
`
`The entry of judgment under 35 U.S.C. § 271(a), (b), and/or (c) that DRL’s
`
`making, using, offering to sell, selling, or importing DRL’s Generic Product prior to the
`
`expiration of the patent-in-suit will infringe, actively induce infringement, and/or contribute to
`
`the infringement of the patent-in-suit under 35 U.S.C. § 271(a), (b), and/or (c);
`
`C.
`
`The issuance of an order that the effective date of any FDA approval of DRL’s
`
`Generic Product shall be no earlier than the expiration date of the patent-in-suit and any
`
`additional periods of exclusivity, in accordance with 35 U.S.C. § 271(e)(4)(A);
`
`D.
`
`The entry of a preliminary and/or permanent injunction, enjoining DRL and all
`
`persons acting in concert with DRL from commercially manufacturing, using, offering for sale,
`
`or selling DRL’s Generic Product within the United States, or importing DRL’s Generic Product
`
`into the United States, until the expiration of the patent-in-suit, in accordance with 35 U.S.C. §§
`
`271(e)(4)(B) and 283;
`
`E.
`
`The entry of a preliminary and/or permanent injunction, enjoining DRL and all
`
`persons acting in concert with DRL from seeking, obtaining, or maintaining approval of the
`
`ANDA until the expiration of the patent-in-suit, in accordance with 35 U.S.C. §§ 271(e)(4)(B)
`
`and 283;
`
`F.
`
`The issuance of a declaration and the entry of judgment under 28 U.S.C. §§ 2201
`
`and 2202 that any future commercial manufacture, use, offer for sale, sale, and/or importation of
`
`DRL’s Generic Product prior to expiration of the patent-in-suit by DRL will constitute direct
`
`infringement, contributory infringement and/or active inducement of infringement of the patent-
`
`in-suit under 35 U.S.C. §§ 271(a)-(c);
`
`
`
`14
`
`

`

`Case 1:21-cv-00188-UNA Document 1 Filed 02/10/21 Page 15 of 16 PageID #: 15
`
`
`G.
`
`The issuance of a declaration that this is an exceptional case and an award to
`
`Plaintiffs of their costs, expenses, and disbursements in this action, including reasonable attorney
`
`fees, pursuant to 35 U.S.C. §§ 285 and 271(e)(4);
`
`H.
`
`An
`
`award
`
`to Plaintiffs of
`
`any
`
`further
`
`appropriate
`
`relief under
`
`35 U.S.C. § 271(e)(4); and
`
`I.
`
`An award to Plaintiffs of any further and additional relief that this Court deems
`
`just and proper.
`
`
`
`
`
`
`
`15
`
`

`

`Case 1:21-cv-00188-UNA Document 1 Filed 02/10/21 Page 16 of 16 PageID #: 16
`
`
`
`
`
`
`MORRIS, NICHOLS, ARSHT & TUNNELL
`LLP
`
`/s/ Jennifer Ying
`
`
`
`
`Jack B. Blumenfeld (#1014)
`Karen A. Jacobs (#2881)
`Jennifer Ying (#5550)
`1201 North Market Street, 16th Floor
`Wilmington, DE 19801
`(302) 658-9200
`jblumenfeld@mnat.com
`kjacobs@mnat.com
`
`Attorneys for Plaintiff Sunovion
`Pharmaceuticals Inc.
`
`
`
`
`
`
`ASHBY & GEDDES
`
`
`/s/ Steven J. Balick
`
`Steven J. Balick (#2114)
`Andrew C. Mayo (#5207)
`500 Delaware Avenue, 8th Floor
`P.O. Box 1150
`Wilmington, DE 19899
`(302) 654-1888
`sbalick@ashbygeddes.com
`amayo@ashbygeddes.com
`
`
`
`
`Of Counsel:
`
`James B. Monroe
`Jennifer H. Roscetti
`Charles T. Collins-Chase
`Lauren J. Dowty
`Danielle C. Pfifferling
`Meredith H. Boerschlein
`Ryan V. McDonnell
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4431
`(202) 408-4000
`
`Attorneys for Plaintiffs BIAL - PORTELA &
`CA S.A. and BIAL - HOLDING, S.A.
`
`
`Dated: February 10, 2021
`
`
`
`16
`
`