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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`CMP DEVELOPMENT, LLC,
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`
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`v.
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`AMNEAL PHARMACEUTICALS LLC,
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`Plaintiff,
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`Defendant.
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`C.A. No.
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`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiff CMP Development, LLC (“CMP”), by and through its attorneys, for its Complaint
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`against Defendant Amneal Pharmaceuticals LLC (“Amneal”), alleges as follows:
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`THE NATURE OF THE ACTION
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`1.
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`This is an action for patent infringement of United States Patent Nos. 9,757,394
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`(“the ’394 patent”), 10,493,083 (“the ’083 patent”), 10,624,906 (“the ’906 patent”), 10,660,907
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`(“the ’907 patent”), and 10,888,570 (“the ’570 patent”) (collectively, the “Patents-in-Suit”) under
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`the patent laws of the United States, Title 35, United States Code § 100 et. seq., including 35 U.S.C.
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`§§ 271 and 281.
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`2.
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`This action relates to the submission by Amneal of Abbreviated New Drug
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`Application No. 215572 to the U.S. Food and Drug Administration (“FDA”) under Section 505(j)
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`of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 355(j) (hereafter, “the Amneal ANDA”).
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`3.
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`The Amneal ANDA seeks approval from the FDA to engage in the commercial
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`manufacture, use, and/or sale of a generic form of CMP’s CaroSpir® product before expiration of
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`the Patents-in-Suit (hereafter, the “Amneal ANDA Product”).
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`4.
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`CMP seeks all available relief under the patent laws of the United States, 35 U.S.C.
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`§ 100, et seq., and other applicable laws for Amneal’s infringement of the Patents-in-Suit.
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`PARTIES
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`5.
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`CMP is a limited liability company organized and existing under the laws of the
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`State of Delaware, with a principal place of business at 8026 U.S. 264A, Farmville, NC 27828.
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`6.
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`Amneal is a limited liability company organized and existing under the laws of the
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`State of Delaware, having a principal place of business at 400 Crossing Boulevard, Third Floor,
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`Bridgewater, New Jersey 08807.
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`7.
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`Amneal is in the business of, among other things, developing, manufacturing, and
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`selling generic forms of branded pharmaceutical products in the United States market, including
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`in the State of Delaware.
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`8.
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`Amneal intends to commercially manufacture, market, offer for sale, and sell its
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`Amneal ANDA Product in the State of Delaware, in the event of FDA approval of the Amneal
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`ANDA.
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`JURISDICTION AND VENUE
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`9.
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`This action arises under the patent laws of the United States of America, 35 U.S.C.
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`§ 100, et seq. and from submission of the Amneal ANDA.
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`10.
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`This Court has subject matter jurisdiction over the action under 28 U.S.C. §§ 1331
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`and 1338(a).
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`11.
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`This Court has personal jurisdiction over Amneal because of, among other things,
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`Amneal’s persistent and continuous contacts with Delaware. Amneal has purposefully availed
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`itself of the benefits and protections of Delaware’s laws repeatedly, such that it should reasonably
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`anticipate being haled into court here.
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`12.
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`Amneal is a limited liability company formed under the laws of the State of
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`Delaware and is registered to do business in Delaware.
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`2
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`13.
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`Amneal regularly and continuously transacts business in Delaware, including by
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`selling pharmaceutical products in Delaware.
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`14.
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`On information and belief, Amneal derives substantial revenue from the sale of
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`those products in Delaware and has availed itself of the privilege of conducting business within
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`Delaware.
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`15.
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`This judicial district is a likely destination of the product that is the subject of the
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`Amneal ANDA.
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`16.
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`The Amneal ANDA relates to this litigation and is substantially connected with this
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`judicial district because it reliably and non-speculatively predicts Amneal’s intent to market and
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`sell the Amneal ANDA Product in this judicial district.
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`17.
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`Amneal has taken the significant step of applying to the FDA for approval to engage
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`in future activities—including the marketing of the Amneal ANDA Product—which will be
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`purposefully directed at the District of Delaware.
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`18.
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`Amneal intends to direct sales of its generic drugs in this judicial district once
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`Amneal receives the requested FDA approval to market the Amneal ANDA Product, as it holds
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`active pharmacy wholesale licenses in the state of Delaware and active controlled substances
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`distributor/manufacturer licenses in the state of Delaware.
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`19.
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`Amneal will engage in marketing of its Amneal ANDA Product in Delaware upon
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`approval of the Amneal ANDA.
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`20.
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`Amneal has, on several occasions, consented to personal jurisdiction of this Court
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`in ANDA-related matters.
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`21.
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`Amneal has, on several occasions, consented to Venue before this Court in ANDA-
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`related matters.
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`3
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`22.
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`Venue is proper in this Court under 28 U.S.C. §§ 1391 and 1400(b).
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`CMP’S CAROSPIR® PRODUCT
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`23.
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`CMP is the holder of New Drug Application (“NDA”) No. 209478 for CaroSpir®,
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`an oral suspension available in a dosage strength of 25 mg/5 mL (hereafter, “CaroSpir®”).
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`24.
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`25.
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`26.
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`The FDA approved CaroSpir® on August 4, 2017.
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`CaroSpir® includes spironolactone, which is an antagonist of aldosterone.
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`CaroSpir® is indicated for the treatment of heart failure, hypertension, and edema
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`caused by cirrhosis.
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`27.
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`CaroSpir® was the first, and remains the only, FDA-approved ready-to-use oral
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`suspension with spironolactone.
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`28.
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`CaroSpir® is an option for patients with dysphagia who have difficulty swallowing,
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`or who cannot swallow tablets, and thus need a liquid form of spironolactone.
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`29.
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`CaroSpir® eliminated the complexities and inconsistencies of compounding tablets
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`containing spironolactone, which could result in unstable or inconsistent dosing for the patient.
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`PATENTS-IN-SUIT
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`30.
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`Pursuant to 21 U.S.C. § 355, the ’394, ’083, ’906, ’907 and ’570 patents are listed
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`in the FDA publication entitled “Approved Drug Products with Therapeutic Equivalence
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`Evaluations” (“the Orange Book”) in connection with the CaroSpir® product.
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`31.
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`The ’394 patent, entitled “Spironolactone Aqueous Formulations,” was duly and
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`lawfully issued by the USPTO on September 12, 2017. A true and correct copy of the ’394 patent
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`is attached hereto as Exhibit A.
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`4
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`32.
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`The ’083 patent, entitled “Spironolactone Aqueous Compositions,” was duly and
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`lawfully issued by the USPTO on December 3, 2019. A true and correct copy of the ’083 patent
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`is attached hereto as Exhibit B.
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`33.
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`The ’906 patent, entitled “Spironolactone Aqueous Compositions,” was duly and
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`lawfully issued by the USPTO on April 21, 2020. A true and correct copy of the ’906 patent is
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`attached hereto as Exhibit C.
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`34.
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`The ’907 patent, entitled “Spironolactone Aqueous Compositions,” was duly and
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`lawfully issued by the USPTO on May 26, 2020. A true and correct copy of the ’907 patent is
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`attached hereto as Exhibit D.
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`35.
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`The ’570 patent, entitled “Spironolactone Aqueous Compositions,” was duly and
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`lawfully issued by the USPTO on January 12, 2021. A true and correct copy of the ’570 patent is
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`attached hereto as Exhibit E.
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`36.
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`37.
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`CMP owns all rights, title, and interests in each of the Patents-in-Suit.
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`CaroSpir® or the use of CaroSpir® is covered by at least one claim of each of the
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`Patents-in-Suit.
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`INFRINGEMENT BY AMNEAL
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`38.
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`By letter dated March 4, 2021 (“First Notice Letter”), Amneal notified CMP that it
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`had submitted ANDA No. 215572 to the FDA under Section 505(j)(2)(B) of the Federal Food,
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`Drug, and Cosmetic Act (“FDCA”) (21 U.S.C. § 355(j)(2)(B) and 21 C.F.R. § 314.95(c)) seeking
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`approval to engage in the commercial manufacture, use, and/or sale of a generic version of
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`CaroSpir® before the expiration of the Patents-in-Suit except for the ’570 patent.
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`39.
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`By letter dated March 25, 2021 (“Second Notice Letter”), Amneal notified CMP
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`that it had submitted ANDA No. 215572 to the FDA under Section 505(j)(2)(B) of the Federal
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`5
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`Food, Drug, and Cosmetic Act (“FDCA”) (21 U.S.C. § 355(j)(2)(B) and 21 C.F.R. § 314.95(c))
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`seeking approval to engage in the commercial manufacture, use, and/or sale of a generic version
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`of CaroSpir® before the expiration of the ’570 patent.
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`40.
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` The Amneal ANDA contains a certification pursuant
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`to 21 U.S.C. §
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`355(j)(2)(A)(vii)(IV) (“paragraph IV certification”), alleging that the claims of the Patents-in-Suit
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`are invalid, unenforceable and/or would not be infringed by the Amneal ANDA Product.
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`41.
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`Amneal intends to engage in commercial manufacture, use, and/or sale of the
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`Amneal ANDA Product promptly upon receiving FDA approval to do so.
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`42.
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`By submitting ANDA No. 215572, Amneal has represented to FDA that the
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`Amneal ANDA Product has the same active ingredient, the same route of administration, the same
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`dosage form, the same use, the same strength, and is bioequivalent to CaroSpir®.
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`43.
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`The Amneal ANDA Product, upon approval, will have the same active ingredient
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`as CaroSpir® in the same amount as CaroSpir®, which is 25 mg/5 mL spironolactone.
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`44.
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`The Amneal ANDA Product, upon approval, will be in the same dosage form as
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`CaroSpir®, which is an oral suspension.
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`45.
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`The Amneal ANDA Product, upon approval, will have the same or substantially
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`similar inactive ingredients as CaroSpir®.
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`46.
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`The Amneal ANDA Product, upon approval, will have the following inactive
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`ingredients: sorbic acid, potassium sorbate, citric acid anhydrous, sodium citrate, dihydrate,
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`simethicone emulsion, saccharin sodium, xanthan gum, Magnasweet 110, glycerin, banana flavor,
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`and purified water.
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`47.
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`Assuming any inactive ingredient listed in paragraph 46 of this Complaint is not
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`included in the Amneal ANDA Product, that product, upon approval, will have in place of that
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`6
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`inactive ingredient an inactive ingredient that is substantially similar to the missing inactive
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`ingredient, and which performs the same function as the missing inactive ingredient, in the same
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`way, giving the same result within the oral suspension.
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`48.
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`Upon information and belief, the Amneal ANDA Product, upon approval, will have
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`xanthan gum as one of its inactive ingredients.
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`49.
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`The Amneal ANDA Product, upon approval, will be sold with FDA-approved
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`prescribing information that informs patients and/or physicians treating those patients that the
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`product is to be used by oral administration.
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`50.
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`The Amneal ANDA Product, upon approval, will be a ready-to-use oral suspension
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`with spironolactone as the active ingredient.
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`51.
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`The Amneal ANDA Product, upon approval, will be available as an option for
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`patients needing spironolactone and who have dysphagia, who have difficulty swallowing, or who
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`cannot swallow tablets.
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`52.
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`The Amneal ANDA Product, upon approval, will not require compounding before
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`administration.
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`53.
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`The Amneal ANDA Product, upon approval, will be approved for the same uses
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`for which CaroSpir® has been approved by the FDA.
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`54.
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`55.
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`The Amneal ANDA Product, upon approval, will be bioequivalent to CaroSpir®.
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`Amneal has administered the Amneal ANDA Product by oral administration to
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`humans in order to establish that its product is bioequivalent to CaroSpir®.
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`56.
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`This action is being filed within forty-five (45) days of CMP’s receipt of the Notice
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`Letter and the Second Notice Letter.
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`7
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`CLAIMS FOR RELIEF
`Count I—Infringement of ’394 patent
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`57.
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`58.
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`CMP incorporates each of the preceding paragraphs as if fully set forth herein.
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`Amneal had actual and constructive knowledge of the ’394 patent prior to
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`submitting ANDA No. 215572, and was aware that submission of the Amneal ANDA to FDA
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`constituted an act of infringement of the ’394 patent under 35 U.S.C. § 271(e)(2)(A).
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`59.
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`Amneal’s submission of the Amneal ANDA to FDA with the corresponding
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`certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) and 21 C.F.R. § 314.94(a)(12)(i)(A)(4)
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`as to the ’394 patent constituted an act of infringement under 35 U.S.C. § 271(e)(2)(A).
`
`60.
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`Upon approval, the commercial manufacture, use, offer to sell, or sale within the
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`United States, and/or importation into the United States of the Amneal ANDA Product will
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`infringe one or more claims of the ’394 Patent under 35 U.S.C. § 271(a), either literally or under
`
`the doctrine of equivalents, by making, using, offering to sell, selling and/or importing the Amneal
`
`ANDA Product, and/or by actively inducing infringement by others under 35 U.S.C. § 271(b)
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`and/or contributing to infringement under 35 U.S.C. § 271(c), unless this Court orders that the
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`effective date of any FDA approval of the Amneal ANDA shall be no earlier than the expiration
`
`of the ’394 patent.
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`61.
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`In addition, on information and belief, Amneal had specific intent to infringe the
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`’394 patent when it filed ANDA No. 215572.
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`62.
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`There are no substantial non-infringing uses for the Amneal ANDA Product other
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`than as claimed in the ’394 patent.
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`63.
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`The commercial manufacture, use, offer for sale, sale, and/or importation of the
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`Amneal ANDA Product in violation of CMP’s patent rights will cause substantial and irreparable
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`harm to CMP for which CMP does not have an adequate remedy at law.
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`8
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`64.
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`65.
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`Count II—Infringement of the ’083 patent
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`CMP incorporates each of the preceding paragraphs as if fully set forth herein.
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`Amneal had actual and constructive knowledge of the ’083 patent prior to
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`submitting ANDA No. 215572, and was aware that submission of the Amneal ANDA to FDA
`
`constituted an act of infringement of the ’083 patent under 35 U.S.C. § 271(e)(2)(A).
`
`66.
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`Amneal’s submission of the Amneal ANDA to FDA with the corresponding
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`certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) and 21 C.F.R. § 314.94(a)(12)(i)(A)(4)
`
`as to the ’083 patent constituted an act of infringement under 35 U.S.C. § 271(e)(2)(A).
`
`67.
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`Upon approval, the commercial manufacture, use, offer to sell, or sale within the
`
`United States, and/or importation into the United States of the Amneal ANDA Product will
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`infringe one or more claims of the ’083 Patent under 35 U.S.C. § 271(a), either literally or under
`
`the doctrine of equivalents, by making, using, offering to sell, selling and/or importing the Amneal
`
`ANDA Product, and/or by actively inducing infringement by others under 35 U.S.C. § 271(b)
`
`and/or contributing to infringement under 35 U.S.C. § 271(c), unless this Court orders that the
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`effective date of any FDA approval of the Amneal ANDA shall be no earlier than the expiration
`
`of the ’083 patent.
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`68.
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`In addition, on information and belief, Amneal had specific intent to infringe the
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`’083 patent when it filed ANDA No. 215572.
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`69.
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`The commercial manufacture, use, offer for sale, sale, and/or importation of the
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`Amneal ANDA Product in violation of CMP’s patent rights will cause substantial and irreparable
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`harm to CMP for which CMP does not have an adequate remedy at law.
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`Count III—Infringement of the ’906 patent
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`70.
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`CMP incorporates each of the preceding paragraphs as if fully set forth herein.
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`9
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`71.
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`Amneal had actual and constructive knowledge of the ’906 patent prior to
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`submitting ANDA No. 215572, and was aware that submission of the Amneal ANDA to FDA
`
`constituted an act of infringement of the ’906 patent under 35 U.S.C. § 271(e)(2)(A).
`
`72.
`
`Amneal’s submission of the Amneal ANDA to FDA with the corresponding
`
`certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) and 21 C.F.R. § 314.94(a)(12)(i)(A)(4)
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`as to the ’906 patent constituted an act of infringement under 35 U.S.C. § 271(e)(2)(A).
`
`73.
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`Upon approval, the commercial manufacture, use, offer to sell, or sale within the
`
`United States, and/or importation into the United States of the Amneal ANDA Product will
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`infringe one or more claims of the ’906 Patent under 35 U.S.C. § 271(a), either literally or under
`
`the doctrine of equivalents, by making, using, offering to sell, selling and/or importing the Amneal
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`ANDA Product, and/or by actively inducing infringement by others under 35 U.S.C. § 271(b)
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`and/or contributing to infringement under 35 U.S.C. § 271(c), unless this Court orders that the
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`effective date of any FDA approval of the Amneal ANDA shall be no earlier than the expiration
`
`of the ’906 patent.
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`74.
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`In addition, on information and belief, Amneal had specific intent to infringe the
`
`’906 patent when it filed ANDA No. 215572.
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`75.
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`The commercial manufacture, use, offer for sale, sale, and/or importation of the
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`Amneal ANDA Product in violation of CMP’s patent rights will cause substantial and irreparable
`
`harm to CMP for which CMP does not have an adequate remedy at law.
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`Count IV—Infringement of the ’907 patent
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`76.
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`CMP incorporates each of the preceding paragraphs as if fully set forth herein.
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`10
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`77.
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`Amneal had actual and constructive knowledge of the ’907 patent prior to
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`submitting ANDA No. 215572, and was aware that submission of the Amneal ANDA to FDA
`
`constituted an act of infringement of the ’907 patent under 35 U.S.C. § 271(e)(2)(A).
`
`78.
`
`Amneal’s submission of the Amneal ANDA to FDA with the corresponding
`
`certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) and 21 C.F.R. § 314.94(a)(12)(i)(A)(4)
`
`as to the ’907 patent constituted an act of infringement under 35 U.S.C. § 271(e)(2)(A).
`
`79.
`
`Upon approval, the commercial manufacture, use, offer to sell, or sale within the
`
`United States, and/or importation into the United States of the Amneal ANDA Product will
`
`infringe one or more claims of the ’907 Patent under 35 U.S.C. § 271(a), either literally or under
`
`the doctrine of equivalents, by making, using, offering to sell, selling and/or importing the Amneal
`
`ANDA Product, and/or by actively inducing infringement by others under 35 U.S.C. § 271(b)
`
`and/or contributing to infringement under 35 U.S.C. § 271(c), unless this Court orders that the
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`effective date of any FDA approval of the Amneal ANDA shall be no earlier than the expiration
`
`of the ’907 patent.
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`80.
`
`In addition, on information and belief, Amneal had specific intent to infringe the
`
`’907 patent when it filed ANDA No. 215572.
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`81.
`
`The commercial manufacture, use, offer for sale, sale, and/or importation of the
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`Amneal ANDA Product in violation of CMP’s patent rights will cause substantial and irreparable
`
`harm to CMP for which CMP does not have an adequate remedy at law.
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`Count V—Infringement of the ’570 patent
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`82.
`
`CMP incorporates each of the preceding paragraphs as if fully set forth herein.
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`11
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`83.
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`Amneal had actual and constructive knowledge of the ’570 patent prior to
`
`submitting ANDA No. 215572, and was aware that submission of the Amneal ANDA to FDA
`
`constituted an act of infringement of the ’570 patent under 35 U.S.C. § 271(e)(2)(A).
`
`84.
`
`Amneal’s submission of the Amneal ANDA to FDA with the corresponding
`
`certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) and 21 C.F.R. § 314.94(a)(12)(i)(A)(4)
`
`as to the ’570 patent constituted an act of infringement under 35 U.S.C. § 271(e)(2)(A).
`
`85.
`
`Upon approval, the commercial manufacture, use, offer to sell, or sale within the
`
`United States, and/or importation into the United States of the Amneal ANDA Product will
`
`infringe one or more claims of the ’570 Patent under 35 U.S.C. § 271(a), either literally or under
`
`the doctrine of equivalents, by making, using, offering to sell, selling and/or importing the Amneal
`
`ANDA Product, and/or by actively inducing infringement by others under 35 U.S.C. § 271(b)
`
`and/or contributing to infringement under 35 U.S.C. § 271(c), unless this Court orders that the
`
`effective date of any FDA approval of the Amneal ANDA shall be no earlier than the expiration
`
`of the ’570 patent and any additional periods of regulatory exclusivity associated therewith.
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`86.
`
`In addition, on information and belief, Amneal had specific intent to infringe the
`
`’570 patent when it filed ANDA No. 215572.
`
`87.
`
`The commercial manufacture, use, offer for sale, sale, and/or importation of the
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`Amneal ANDA Product in violation of CMP’s patent rights will cause substantial and irreparable
`
`harm to CMP for which CMP does not have an adequate remedy at law.
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`PRAYER FOR RELIEF
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`CMP respectfully requests the following relief:
`
`a)
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`A judgment that Amneal has infringed the Patents-in-Suit under 35 U.S.C.
`
`§ 271(e)(2)(A) by submitting ANDA No. 215572 under Section 505(j) of the FDCA, and that
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`12
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`
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`Amneal’s making, using, offering to sell, or selling in the United States or importing into the
`
`United States of the Amneal ANDA Product will infringe one or more claims of the Patents-in-
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`Suit.
`
`b)
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`An order under 35 U.S.C. § 271(e)(4)(A) that the effective date of any FDA
`
`approval of ANDA No. 215572 shall be a date which is not earlier than the latest expiration date
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`of the Patents-in-Suit, as extended by any applicable periods of exclusivity;
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`c)
`
`An order under 35 U.S.C. § 27l(e)(4)(B) permanently enjoining Amneal, its
`
`subsidiaries, parents, officers, agents, servants, employees, licensees, representatives, and
`
`attorneys, and all other persons acting or attempting to act in active concert or participation with
`
`it or acting on its behalf, from engaging in the commercial manufacture use, offer to sell, or
`
`importation into the United States, of any drug product the use of which is covered by the Patents-
`
`in-Suit, including the Amneal ANDA Product;
`
`d)
`
`A finding that this is an exceptional case under 35 U.S.C. § 285, and that
`
`CMP be awarded reasonable attorneys’ fees and costs; and
`
`e)
`
`An award of any such other and further relief as the Court may deem just
`
`and proper.
`
`
`
`OF COUNSEL:
`
`Christopher J. Sorenson
`Karen L. Beckman
`MERCHANT & GOULD PC
`150 South Fifth St., Suite 2200
`Minneapolis, MN 55402
`csorenson@merchantgould.com
`(612) 332-5300
`csorenson@merchantgould.com
`kbeckman@merchantgould.com
`
`
`
`
`/s/ Kelly E. Farnan
`Kelly E. Farnan (#4395)
`farnan@rlf.com
`Renée Mosley Delcollo (#6442)
`delcollo@rlf.com
`Richards, Layton & Finger, P.A.
`One Rodney Square
`920 North King Street
`Wilmington, DE 19801
`(302) 651-7700
`
`Attorneys for Plaintiff CMP Development LLC
`
`
`13
`
`
`
`Case 1:21-cv-00549-UNA Document 1 Filed 04/16/21 Page 14 of 14 PageID #: 14
`
`
`
`Andrew O. Larsen
`MERCHANT & GOULD PC
`767 Third Avenue, Suite 23C
`New York, NY 10017
`(212) 223-6520
`alarsen@merchantgould.com
`
`Dated: April 16, 2021
`
`14
`
`

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