Case 1:21-cv-00061-UNA Document 1 Filed 01/20/21 Page 1 of 15 PageID #: 1
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`AMGEN INC. and
`LES LABORATOIRES SERVIER,
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`Plaintiffs,
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiffs Amgen Inc. (“Amgen”) and Les Laboratoires Servier (“Servier,” and collectively
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`v.
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`C.A. No. _____________
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`ALEMBIC PHARMACEUTICALS
`LIMITED and ALEMBIC
`PHARMACEUTICALS, INC.,
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`Defendants.
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`with Amgen, “Plaintiffs”) bring
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`this action for patent
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`infringement against Alembic
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`Pharmaceuticals Limited and Alembic Pharmaceuticals, Inc. (collectively, “Defendants”).
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`NATURE OF THE ACTION
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`This is a civil action for patent infringement arising under the patent laws of the
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`United States, 35 U.S.C. § 1, et seq., and in particular under 35 U.S.C. § 271. This action relates
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`to Abbreviated New Drug Application (“ANDA”) No. 215238, filed by and for the benefit of
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`Defendants with the United States Food and Drug Administration (“FDA”). Through ANDA No.
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`215238, Defendants seek approval to market generic versions of Corlanor® (ivabradine) 5 mg and
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`7.5 mg tablets (the “Proposed ANDA Product”), prior to the expiration of U.S. Patent Nos.
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`7,361,649 (“the ’649 Patent”), 7,361,650 (“the ’650 Patent”), 7,867,996 (“the ’996 Patent”), and
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`7,879,842 (“the ’842 Patent”) (collectively, “the Patents-in-Suit”).
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`Case 1:21-cv-00061-UNA Document 1 Filed 01/20/21 Page 2 of 15 PageID #: 2
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`THE PARTIES
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`Plaintiff Amgen is a corporation organized and existing under the laws of Delaware,
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`having a principal place of business at One Amgen Center Drive, Thousand Oaks, California
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`91320-1799. Amgen discovers, develops, manufactures, and sells innovative therapeutic products
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`based on advances in molecular biology, recombinant DNA technology, and chemistry.
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`Plaintiff Servier is a corporation organized and existing under the laws of France,
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`having a principal place of business at 50 Rue Carnot, 92284 Suresnes Cedex, France. Servier is
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`part of the Servier Group. Servier Group discovers, develops, manufactures, and sells innovative
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`therapeutic products and is governed by a non-profit foundation.
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`On information and belief, Defendant Alembic Pharmaceuticals Limited (“Alembic
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`Ltd.”) is a corporation organized and existing under the laws of the Republic of India, having a
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`principal place of business at Alembic Road, Vadodara 390003, Gujarat, India.
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`On information and belief, Defendant Alembic Pharmaceuticals, Inc. (“Alembic
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`Inc.”) is a corporation organized and existing under the laws of Delaware, having a principal place
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`of business at 750 Route 202, Bridgewater, New Jersey 08807.
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`Ltd.
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`On information and belief, Alembic Inc. is a wholly owned-subsidiary of Alembic
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`On information and belief, Aaron S. Lukas is the agent for service of process in the
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`United States for Alembic Ltd.
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`On information and belief, Defendants collaborate with respect to the development,
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`regulatory approval, marketing, sale, and/or distribution of pharmaceutical products. On further
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`information and belief, Defendants are agents of each other and/or operate in concert as integrated
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`parts of the same business group.
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`On information and belief, Defendants acted in concert to develop the Proposed
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`ANDA Product that is the subject of ANDA No. 215238 and to seek regulatory approval from the
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`FDA to market and sell the Proposed ANDA Product throughout the United States, including
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`within this District.
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`Defendants’ ANDA No. 215238 seeks approval to commercially manufacture, use,
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`offer for sale, sell, and/or import a generic version of Amgen’s Corlanor® (ivabradine) tablets prior
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`to the expiration of the Patents-in-Suit.
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`On information and belief, Defendants intend to act collaboratively to obtain
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`approval for Defendants’ ANDA No. 215238, and, in the event the FDA approves that ANDA, to
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`commercially manufacture, use, offer for sale, sell, and/or import the Proposed ANDA Product.
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`JURISDICTION AND VENUE
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`This is an action for patent infringement under the patent laws of the United States,
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`Title 35, United States Code, arising out of the submission of Defendants’ ANDA No. 215238 to
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`the FDA.
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`This Court has subject matter jurisdiction over this action pursuant to 28 U.S.C.
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`§§ 1331 and 1338(a), and 35 U.S.C. § 1 et seq.
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`This Court has personal jurisdiction over Alembic Inc. because, on information and
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`belief, Alembic Inc. is a corporation organized and existing under the laws of Delaware.
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`This Court has personal jurisdiction over Alembic Ltd. because, inter alia, it has
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`maintained continuous and systematic contacts with this District and availed itself of the privilege
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`of doing business in this District. On information and belief, Alembic Ltd. has acted in concert
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`with Alembic Inc.: (1) to file ANDA No. 215238 seeking approval to commercially manufacture,
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`use, offer for sale, sell, and/or import the Proposed ANDA Product in the United States, including
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`in this District; (2) regularly and continuously transacted business within this District, including
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`by selling pharmaceutical products in this District either on its own or through its affiliates; and
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`(3) derived substantial revenue from the sale of those products in this District. Alternatively, this
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`Court has personal jurisdiction over Alembic Ltd. pursuant to Federal Rule of Civil Procedure
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`4(k)(2)(A).
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`On information and belief, if ANDA No. 215238 is approved, the Proposed ANDA
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`Product charged with infringing the Patents-in-Suit will be marketed, distributed, offered for sale,
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`and/or sold in this District, prescribed by physicians practicing in this District, dispensed by
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`pharmacies located within this District, and/or used by patients in this District, all of which would
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`have a substantial effect on this District.
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`This Court also has personal jurisdiction over Alembic Inc. and Alembic Ltd.
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`because they have affirmatively availed themselves of the jurisdiction of this Court through the
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`assertion of counterclaims in suits brought in this District and/or by being sued in this District
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`without challenging personal jurisdiction. See, e.g., Pfizer Inc., et al. v. Alembic Pharmaceuticals,
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`Inc., et al., Civil Action No. 20-1392 (D. Del.); Boehringer Ingelheim Pharmaceuticals Inc., et al.
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`v. Mankind Pharma Ltd., et al., Civil Action No. 18-1689 (D. Del.); H. Lundbeck A/S, et al. v.
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`Alembic Pharmaceuticals Limited, et al., Civil Action No. 18-0113 (D. Del.); Adverio Pharma
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`GmbH, et al. v. MSN Laboratories Private Limited, et al., Civil Action No. 18-0073 (D. Del.).
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`For the reasons set forth above, and for additional reasons which will be supplied
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`if Defendants challenge personal jurisdiction in this action, Defendants are subject to personal
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`jurisdiction in this District.
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`Venue is proper in this District for Alembic Inc. pursuant to 28 U.S.C. § 1400(b)
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`because Alembic Inc. is a corporation organized and existing under the laws of Delaware.
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`Venue is proper in this District for Alembic Ltd. pursuant to 28 U.S.C. § 1391(c)
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`because, inter alia, Alembic Ltd. is a corporation organized and existing under the laws of the
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`Republic of India and is subject to personal jurisdiction in this District.
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`THE PATENTS-IN-SUIT
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`The Patents-in-Suit are assigned to Servier and exclusively licensed to Amgen.
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`The ’649 Patent, entitled “-Crystalline Form of Ivabradine Hydrochloride, a
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`Process for Its Preparation and Pharmaceutical Compositions Containing It,” was duly and legally
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`issued on April 22, 2008. A copy of the ’649 Patent is attached as Exhibit A.
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`The ’650 Patent, entitled “-Crystalline Form of Ivabradine Hydrochloride, a
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`Process for Its Preparation and Pharmaceutical Compositions Containing It,” was duly and legally
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`issued on April 22, 2008. A copy of the ’650 Patent is attached as Exhibit B.
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`The ’996 Patent, entitled “-Crystalline Form of Ivabradine Hydrochloride, a
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`Process for Its Preparation and Pharmaceutical Compositions Containing It,” was duly and legally
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`issued on January 11, 2011. A copy of the ’996 Patent is attached as Exhibit C.
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`The ’842 Patent, entitled “Beta-Crystalline Form of Ivabradine Hydrochloride, a
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`Process for Its Preparation and Pharmaceutical Compositions Containing It,” was duly and legally
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`issued on February 1, 2011. A copy of the ’842 Patent is attached as Exhibit D.
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`FACTUAL BACKGROUND
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`Corlanor® (ivabradine)
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`Corlanor® (ivabradine) is a drug used to treat certain cases of chronic heart failure.
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`In chronic heart failure, a person’s heart does not adequately supply the body with blood, causing
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`fatigue and weakness. Corlanor® can reduce a patient’s risk of being hospitalized due to heart
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`failure.
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`Amgen is the holder of approved New Drug Application (“NDA”) No. 20-6143 for
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`Corlanor® (ivabradine) tablets. Pursuant to NDA No. 20-6143, Amgen markets and distributes
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`Corlanor® (ivabradine) tablets in the United States. Corlanor® is available in 5 mg and 7.5 mg
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`tablets.
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`Corlanor® (ivabradine) tablets, the active pharmaceutical ingredient ivabradine, the
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`method of manufacture, and/or their use are covered by one or more claims of the Patents-in-Suit.
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`The Patents-in-Suit have been listed for NDA No. 20-6143 in the FDA publication Approved Drug
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`Products with Therapeutic Equivalence Evaluations, which is also known as the “Orange Book.”
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`Defendants’ ANDA No. 215238
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`In a letter dated December 7, 2020 (the “Notice Letter”), Defendants stated that
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`they had submitted ANDA No. 215238 to the FDA seeking approval to commercially manufacture,
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`use, offer for sale, sell, and/or import the Proposed ANDA Product prior to the expiration of the
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`Patents-in-Suit. The Notice Letter further stated that ANDA No. 215238 contained a certification
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`pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (a “Paragraph IV Certification”) that the Patents-in-
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`Suit are invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use,
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`offer for sale, sale, and/or importation of the Proposed ANDA Product.
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`Defendants were aware of the Patents-in-Suit when they submitted ANDA No.
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`215238 with a Paragraph IV Certification.
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`On information and belief, ivabradine hydrochloride is the active ingredient in the
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`Proposed ANDA Product.
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`On information and belief, ANDA No. 215238 refers to and relies upon the NDA
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`for Corlanor® (ivabradine) and contains data that, according to Defendants, demonstrate the
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`bioequivalence of the Proposed ANDA Product and Corlanor® (ivabradine). See 21 U.S.C.
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`§ 355(j)(2); 21 C.F.R. § 314.94(a)(7).
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`On information and belief, the active ingredient in the Proposed ANDA Product—
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`ivabradine hydrochloride—exhibits a patented crystalline form.
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`On information and belief, Defendants intend to have healthcare providers use their
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`Proposed ANDA Product, if approved, as set forth in their Proposed ANDA Product label. On
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`information and belief, Defendants’ Proposed ANDA Product label will instruct healthcare
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`providers to prescribe their Proposed ANDA Product in the manner set forth in the label.
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`On information and belief, the FDA has not yet approved ANDA No. 215238.
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`Plaintiffs commenced this action within 45 days of receipt of the Notice Letter.
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`Defendants’ Notice Letter included an Offer of Confidential Access.
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`Between December 11, 2020 and January 8, 2021, Amgen and the Defendants
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`negotiated and reached an agreement to modify the Offer of Confidential Access.
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`On January 13, 2021, Defendants produced documents purportedly from their
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`ANDA No. 215238.
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`COUNT I: INFRINGEMENT OF U.S. PATENT NO. 7,361,649
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`Plaintiffs hereby reallege and incorporate the allegations of paragraphs 1 – 39 of
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`this Complaint.
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`On information and belief, the Proposed ANDA Product infringes one or more
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`claims of the ’649 Patent, either literally or under the doctrine of equivalents, by the use and/or
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`presence in the Proposed ANDA Product of an ivabradine crystalline form as covered by one or
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`more of the claims of the ’649 Patent.
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`Defendants’ submission of ANDA No. 215238 to the FDA under 21 U.S.C. § 355(j)
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`for the purpose of obtaining approval to commercially manufacture, use, offer for sale, sell, and/or
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`import the Proposed ANDA Product before the expiration of the ’649 Patent constitutes
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`infringement of the ’649 Patent under 35 U.S.C. § 271(e)(2).
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`On information and belief, Defendants plan to, intend to, and will commercially
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`manufacture, use, offer for sale, sell, and/or import the Proposed ANDA Product immediately
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`upon approval of ANDA No. 215238 and will instruct healthcare providers to use the Proposed
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`ANDA Product in accordance with the proposed product labeling.
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`On information and belief, upon FDA approval of ANDA No. 215238, Defendants
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`will infringe the ’649 Patent by making, using, offering to sell, selling, and/or importing the
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`Proposed ANDA Product in the United States, and by actively inducing and/or contributing to
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`infringement by others under 35 U.S.C. § 271(b) and/or (c).
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`On information and belief, Defendants had knowledge of the ’649 Patent when they
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`submitted ANDA No. 215238 to the FDA, Defendants knew or should have known that they will
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`induce or contribute to another’s direct infringement of the ’649 Patent, and Defendants acted with
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`the specific intent to induce or contribute to another’s direct infringement of the ’649 Patent.
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`To date, Plaintiffs have not received sufficient information, materials, and things
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`from Defendants to enable Plaintiffs to meaningfully evaluate the bases for Defendants’ assertion
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`of non-infringement of the ’649 Patent.
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`In the absence of the ability to meaningfully evaluate information related to
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`Defendants’ ANDA No. 215238, Plaintiffs resort to the judicial process and the aid of discovery
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`to obtain under appropriate judicial safeguards such information as is required to confirm their
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`belief and to present to the Court evidence that Defendants infringe one or more claims of the ’649
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`Patent.
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`Plaintiffs will be substantially and irreparably harmed by the infringing activities
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`described above unless those activities are enjoined by this Court. Plaintiffs have no adequate
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`remedy at law.
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`COUNT II: INFRINGEMENT OF U.S. PATENT NO. 7,361,650
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`Plaintiffs hereby reallege and incorporate the allegations of paragraphs 1 – 48 of
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`this Complaint.
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`On information and belief, the Proposed ANDA Product infringes one or more
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`claims of the ’650 Patent, either literally or under the doctrine of equivalents, by the use and/or
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`presence in the Proposed ANDA Product of an ivabradine crystalline form as covered by one or
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`more of the claims of the ’650 Patent.
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`Defendants’ submission of ANDA No. 215238 to the FDA under 21 U.S.C. § 355(j)
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`for the purpose of obtaining approval to commercially manufacture, use, offer for sale, sell, and/or
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`import the Proposed ANDA Product before the expiration of the ’650 Patent constitutes
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`infringement of the ’650 Patent under 35 U.S.C. § 271(e)(2).
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`On information and belief, Defendants plan to, intend to, and will commercially
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`manufacture, use, offer for sale, sell, and/or import the Proposed ANDA Product immediately
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`upon approval of ANDA No. 215238 and will instruct healthcare providers to use the Proposed
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`ANDA Product in accordance with the proposed product labeling.
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`On information and belief, upon FDA approval of ANDA No. 215238, Defendants
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`will infringe the ’650 Patent by making, using, offering to sell, selling, and/or importing the
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`Proposed ANDA Product in the United States, and by actively inducing and/or contributing to
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`infringement by others under 35 U.S.C. § 271(b) and/or (c).
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`On information and belief, Defendants had knowledge of the ’650 Patent when they
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`submitted ANDA No. 215238 to the FDA, Defendants knew or should have known that they will
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`induce or contribute to another’s direct infringement of the ’650 Patent, and Defendants acted with
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`the specific intent to induce or contribute to another’s direct infringement of the ’650 Patent.
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`To date, Plaintiffs have not received sufficient information, materials, and things
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`from Defendants to enable Plaintiffs to meaningfully evaluate the bases for Defendants’ assertion
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`of non-infringement of the ’650 Patent.
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`In the absence of the ability to meaningfully evaluate information related to
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`Defendants’ ANDA No. 215238, Plaintiffs resort to the judicial process and the aid of discovery
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`to obtain under appropriate judicial safeguards such information as is required to confirm their
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`belief and to present to the Court evidence that Defendants infringe one or more claims of the ’650
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`Patent.
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`Plaintiffs will be substantially and irreparably harmed by the infringing activities
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`described above unless those activities are enjoined by this Court. Plaintiffs have no adequate
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`remedy at law.
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`COUNT III: INFRINGEMENT OF U.S. PATENT NO. 7,867,996
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`Plaintiffs hereby reallege and incorporate the allegations of paragraphs 1 – 57 of
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`this Complaint.
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`On information and belief, the Proposed ANDA Product infringes one or more
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`claims of the ’996 Patent, either literally or under the doctrine of equivalents, by the use and/or
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`presence in the Proposed ANDA Product of an ivabradine crystalline form as covered by one or
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`more of the claims of the ’996 Patent.
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`Defendants’ submission of ANDA No. 215238 to the FDA under 21 U.S.C. § 355(j)
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`for the purpose of obtaining approval to commercially manufacture, use, offer for sale, sell, and/or
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`import the Proposed ANDA Product before the expiration of the ’996 Patent constitutes
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`infringement of the ’996 Patent under 35 U.S.C. § 271(e)(2).
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`On information and belief, Defendants plan to, intend to, and will commercially
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`manufacture, use, offer for sale, sell, and/or import the Proposed ANDA Product immediately
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`upon approval of ANDA No. 215238 and will instruct healthcare providers to use the Proposed
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`ANDA Product in accordance with the proposed product labeling.
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`On information and belief, upon FDA approval of ANDA No. 215238, Defendants
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`will infringe the ’996 Patent by making, using, offering to sell, selling, and/or importing the
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`Proposed ANDA Product in the United States, and by actively inducing and/or contributing to
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`infringement by others under 35 U.S.C. § 271(b) and/or (c).
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`On information and belief, Defendants had knowledge of the ’996 Patent when they
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`submitted ANDA No. 215238 to the FDA, Defendants knew or should have known that they will
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`induce or contribute to another’s direct infringement of the ’996 Patent, and Defendants acted with
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`the specific intent to induce or contribute to another’s direct infringement of the ’996 Patent.
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`To date, Plaintiffs have not received sufficient information, materials, and things
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`from Defendants to enable Plaintiffs to meaningfully evaluate the bases for Defendants’ assertion
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`of non-infringement of the ’996 Patent.
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`In the absence of the ability to meaningfully evaluate information related to
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`Defendants’ ANDA No. 215238, Plaintiffs resort to the judicial process and the aid of discovery
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`to obtain under appropriate judicial safeguards such information as is required to confirm their
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`belief and to present to the Court evidence that Defendants infringe one or more claims of the ’996
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`Patent.
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`Plaintiffs will be substantially and irreparably harmed by the infringing activities
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`described above unless those activities are enjoined by this Court. Plaintiffs have no adequate
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`remedy at law.
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`COUNT IV: INFRINGEMENT OF U.S. PATENT NO. 7,879,842
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`Plaintiffs hereby reallege and incorporate by reference the allegations of paragraphs
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`1 – 66 of this Complaint.
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`On information and belief, the Proposed ANDA Product infringes one or more
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`claims of the ’842 Patent, either literally or under the doctrine of equivalents, by the use and/or
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`presence in the Proposed ANDA Product of an ivabradine crystalline form as covered by one or
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`more of the claims of the ’842 Patent.
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`Defendants’ submission of ANDA No. 215238 to the FDA under 21 U.S.C. § 355(j)
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`for the purpose of obtaining approval to commercially manufacture, use, offer for sale, sell, and/or
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`import the Proposed ANDA Product before the expiration of the ’842 Patent constitutes
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`infringement of the ’842 Patent under 35 U.S.C. § 271(e)(2).
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`On information and belief, Defendants plan to, intend to, and will commercially
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`manufacture, use, offer for sale, sell, and/or import the Proposed ANDA Product immediately
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`upon approval of ANDA No. 215238 and will instruct healthcare providers to use the Proposed
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`ANDA Product in accordance with the proposed product labeling.
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`
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`On information and belief, upon FDA approval of ANDA No. 215238, Defendants
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`will infringe the ’842 Patent by making, using, offering to sell, selling, and/or importing the
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`Proposed ANDA Product in the United States, and by actively inducing and/or contributing to
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`infringement by others under 35 U.S.C. § 271(b) and/or (c).
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`On information and belief, Defendants had knowledge of the ’842 Patent when they
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`submitted ANDA No. 215238 to the FDA, Defendants knew or should have known that they will
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`induce or contribute to another’s direct infringement of the ’842 Patent, and Defendants acted with
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`the specific intent to induce or contribute to another’s direct infringement of the ’842 Patent.
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`To date, Plaintiffs have not received sufficient information, materials, and things
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`from Defendants to enable Plaintiffs to meaningfully evaluate the bases for Defendants’ assertion
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`of non-infringement of the ’842 Patent.
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`
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`In the absence of the ability to meaningfully evaluate information related to
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`Defendants’ ANDA No. 215238, Plaintiffs resort to the judicial process and the aid of discovery
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`to obtain under appropriate judicial safeguards such information as is required to confirm their
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`belief and to present to the Court evidence that Defendants infringe one or more claims of the ’842
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`Patent.
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`
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`Plaintiffs will be substantially and irreparably harmed by the infringing activities
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`described above unless those activities are enjoined by this Court. Plaintiffs have no adequate
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`remedy at law.
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`PRAYER FOR RELIEF
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`WHEREFORE, Plaintiffs respectfully request that this Court grant the following relief:
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`a)
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`Judgment that Defendants’ submission of ANDA No. 215238 to the FDA was an
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`act of infringement of one or more claims of the ’649, ’650, ’996, and ’842 Patents under 35 U.S.C.
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`§ 271(e)(2);
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`b)
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`Judgment that Defendants’ making, using, offering to sell, selling, or importing into
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`the United States of the Proposed ANDA Product prior to the expiration of the ’649, ’650, ’996,
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`and ’842 Patents, will infringe, will actively induce infringement, and/or will contribute to the
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`infringement of one or more claims of those Patents;
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`c)
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`An Order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective date of
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`any FDA approval of ANDA No. 215238 shall be a date that is not earlier than the expiration of
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`the ’649, ’650, ’996, and ’842 Patents plus any other exclusivity to which Plaintiffs are or become
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`entitled;
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`d)
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`An Order permanently enjoining Defendants, Defendants’ affiliates and
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`subsidiaries, each of its officers, agents, servants and employees, and any person acting in concert
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`with Defendants, from making, using, offering to sell, selling, or importing into the United States
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`the Proposed ANDA Product until after the expiration of the ’649, ’650, ’996, and ’842 Patents
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`plus any other exclusivity to which Plaintiffs are or become entitled;
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`e)
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`A declaration that this case is exceptional within the meaning of 35 U.S.C. § 285
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`and an award of reasonable attorneys’ fees, expenses, and disbursements of this action;
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`f)
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`g)
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`An award of Plaintiffs’ reasonable costs and expenses in this action; and
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`Such further and other relief as this Court deems proper and just.
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`14
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`

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`Case 1:21-cv-00061-UNA Document 1 Filed 01/20/21 Page 15 of 15 PageID #: 15
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
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`/s/ Brian P. Egan
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`Jack B. Blumenfeld (#1014)
`Brian P. Egan (#6227)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`began@mnat.com
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`Attorneys for Plaintiffs
`Amgen Inc. and Les Laboratoires Servier
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`OF COUNSEL:
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`Lisa B. Pensabene
`Hassen Sayeed
`Daniel O’Boyle
`Carolyn Wall
`James Li
`O’MELVENY & MYERS LLP
`7 Times Square
`New York, New York 10036
`(212) 326-2000
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`Attorneys for Plaintiffs
`Amgen Inc. and Les Laboratoires Servier
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`Wendy A. Whiteford
`Steven T. Tang
`AMGEN INC.
`One Amgen Center Drive
`Thousand Oaks, CA 91320-1789
`(805) 447-1000
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`James A. High Jr.
`AMGEN INC.
`1120 Veterans Blvd.
`South San Francisco, CA 94080
`(650) 244-2000
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`Attorneys for Plaintiff
`Amgen Inc.
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`January 20, 2021
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`15
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