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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`NOVARTIS PHARMACEUTICALS
`CORPORATION,
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`CRYSTAL PHARMACEUTICAL
`(SUZHOU) CO., LTD.,
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`Plaintiff,
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`v.
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`Defendant.
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`C.A. No. _________________
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`COMPLAINT AGAINST CRYSTAL PHARMACEUTICAL (SUZHOU) CO., LTD.
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`Plaintiff Novartis Pharmaceuticals Corporation (hereinafter “Plaintiff” or “Novartis”), by
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`its attorneys, hereby alleges as follows:
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`NATURE OF THE ACTION
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`1.
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`This is a patent infringement action arising under Title 35 of the United States
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`Code and concerning an Abbreviated New Drug Application (“ANDA”) submitted to the United
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`States Food and Drug Administration (“FDA”) by the above-named defendant seeking FDA
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`approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of
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`sacubitril/valsartan tablets, generic versions of Plaintiff’s ENTRESTO® tablets, 24 mg/26 mg, 49
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`mg/51 mg, and 97 mg/103 mg, prior to the expiration of U.S. Patent No. 11,135,192 (the “’192
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`patent”).
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`PARTIES
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`2.
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`Plaintiff Novartis is a corporation organized and existing under the laws of the
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`State of Delaware, having a principal place of business at One Health Plaza, East Hanover, New
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`Jersey 07936.
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`3.
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`On information and belief, Defendant Crystal Pharmaceutical (Suzhou) Co., Ltd.
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`(“Crystal”) is a corporation organized and existing under the laws of China, having a principal
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`place of business at B4-301 Biobay, Suzhou Industrial Park, Suzhou, China, 215123.
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`4.
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`On information and belief, Crystal develops, manufactures, distributes, sells,
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`and/or imports drugs for the entire United States market and does business in every state
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`including Delaware, either directly or indirectly.
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`5.
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`By a letter dated November 10, 2021 (“Crystal Notice Letter”), Crystal notified
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`Plaintiff that (i) the FDA deemed acceptable for filing Crystal’s ANDA No. 213605 for
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`sacubitril/valsartan tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg (“Crystal ANDA
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`Products”), through which it seeks FDA approval to engage in the commercial manufacture, use,
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`sale, offer for sale, and/or importation of the Crystal ANDA Products in or into the United
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`States, including Delaware, prior to the expiration of the ’192 patent, (ii) ANDA No. 213605
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`contains the required bioavailability and/or bioequivalence data, and that (iii) ANDA No. 213605
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`contains a Paragraph IV Certification with respect to the ’192 patent.
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`6.
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`Crystal has committed an act of infringement in this judicial district by filing
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`ANDA No. 213605 with the intent to make, use, sell, offer for sale, and/or import the Crystal
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`ANDA Products in or into this judicial district, prior to the expiration of the ’192 patent, an act
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`of infringement that has led and will lead to foreseeable harm and injury to Plaintiff Novartis, a
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`Delaware corporation.
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`7.
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`Crystal has taken the costly, significant step of applying to the FDA for approval
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`to engage in future activities, including the marketing of the Crystal ANDA Products, that will
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`be purposefully directed at Delaware and elsewhere.
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`8.
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`On information and belief, Crystal has systematic and continuous contacts with
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`Delaware; has established distribution channels for drug products in Delaware; regularly and
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`continuously conducts business in Delaware, including by selling drug products in Delaware,
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`either directly or indirectly through its subsidiaries, agents, or affiliates; has purposefully availed
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`itself of the privilege of doing business in Delaware; and derives substantial revenue from the
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`sale of drug products in Delaware.
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`9.
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`Crystal has agreed with Plaintiff to litigate any patent action(s) concerning ANDA
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`No. 213605 in the District of Delaware, and has agreed, only for the purposes of such action(s),
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`not to challenge personal jurisdiction and venue in the District of Delaware. This is an action
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`concerning ANDA No. 213605.
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`JURISDICTION AND VENUE
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`10.
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`This Court has jurisdiction over the subject matter of this action under 28 U.S.C.
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`§§ 1331, 1338(a), 2201, and 2202.
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`11.
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`This Court has personal jurisdiction over Crystal because Crystal has committed
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`tortious acts of patent infringement in preparing and submitting ANDA No. 213605 with a
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`certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), which acts have led to foreseeable
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`harm and injury to Plaintiff Novartis, a Delaware corporation.
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`12.
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`This Court also has personal jurisdiction over Crystal because, on information and
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`belief, Crystal, upon approval of ANDA No. 213605, will commit or will aid, abet, contribute to,
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`or participate in future tortious acts of patent infringement permitted under ANDA No. 213605
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`that will be purposefully directed at Delaware, including the marketing of the Crystal ANDA
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`Products in Delaware, prior to the expiration of the ’192 patent.
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`13.
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`This Court also has personal jurisdiction over Crystal because, on information and
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`belief, Crystal’s affiliations with the State of Delaware are sufficiently continuous and systematic
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`as to render Crystal essentially at home in this forum.
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`14.
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`Crystal has agreed with Plaintiff to litigate any patent action(s) concerning ANDA
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`No. 213605 in Delaware and not to contest personal jurisdiction or venue in Delaware in such an
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`action. This is an action concerning ANDA No. 213605.
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`15.
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`For these reasons, and for other reasons that will be presented to the Court if
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`jurisdiction is challenged, the Court has personal jurisdiction over Crystal.
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`16.
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`Venue is proper in this Court because Crystal is a foreign entity who may be sued
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`in any judicial district, including Delaware. 28 U.S.C. § 1391(c)(3).
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`THE PATENT-IN-SUIT AND ENTRESTO®
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`17.
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`The ’192 patent, titled “Inhibitors for Treating Diseases Characterized by Atrial
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`Enlargement or Remodeling,” was duly and legally issued on October 5, 2021. A true and correct
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`copy of the ’192 patent is attached hereto as Exhibit A.
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`18.
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`Novartis owns the ’192 patent.
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`19.
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`The ’192 patent claims, inter alia, methods for treating heart failure with
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`preserved ejection fraction (HF-PEF) in a human patient in need of such treatment comprising
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`administering to the patient 50 mg, 100 mg, or 200 mg of a combination of (i) N-(3-carboxy-l-
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`oxopropyl)-(4S)-p-phenylphenylmethyl)-4-amino-(2R)-methylbutanoic acid ethyl ester or a
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`pharmaceutically acceptable salt thereof; and (ii) valsartan or a pharmaceutically acceptable salt
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`thereof, twice daily for at least 36 weeks, wherein N-(3-carboxy-l-oxopropyl)-(4S)-p-
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`phenylphenylmethyl)-4-amino-(2R)-methylbutanoic acid ethyl ester or a pharmaceutically
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`acceptable salt thereof and valsartan or a pharmaceutically acceptable salt thereof are
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`administered in a 1:1 molar ratio.
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`20.
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`Novartis is the holder of New Drug Application (“NDA”) No. 207620 by which
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`the FDA granted approval for the commercial manufacturing, marketing, sale, and use of
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`ENTRESTO® (sacubitril and valsartan) tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg.
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`ENTRESTO® currently is indicated to reduce the risk of cardiovascular death and hospitalization
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`for heart failure in adult patients with chronic heart failure, and for the treatment of symptomatic
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`heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one
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`year and older.
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`21.
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`One or more claims of the ’192 patent cover the use of ENTRESTO®.
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`22.
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`The FDA’s official publication of approved drugs (the “Orange Book”) lists the
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`’192 patent in connection with ENTRESTO®.
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`INFRINGEMENT BY CRYSTAL OF THE PATENT-IN-SUIT
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`Plaintiff incorporates paragraphs 1 – 22 as if fully set forth herein.
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`On information and belief, Crystal submitted to the FDA ANDA No. 213605
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`23.
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`24.
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`under the provisions of 21 U.S.C. § 355(j) seeking approval to engage in the commercial
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`manufacture, use, sale, offer for sale, and/or importation of the Crystal ANDA Products prior to
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`the expiration of the ’192 patent.
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`25.
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`By filing its ANDA under 21 U.S.C. § 355(j) for the purpose of obtaining
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`approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of
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`the Crystal ANDA Products in or into the United States prior to the expiration of the ’192 patent,
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`Crystal has committed an act of infringement under 35 U.S.C. § 271(e)(2).
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`26.
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`This action was commenced within 45 days of Plaintiff’s receipt of the Crystal
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`Notice Letter.
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`27.
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`On information and belief, the use of the Crystal ANDA Products in the United
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`States in accordance with and as directed by Crystal’s labeling for those products, if approved,
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`will directly infringe one or more claims of the ’192 patent.
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`28.
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`On information and belief, the Crystal ANDA Products, to be approved, must
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`contain instructions for practicing methods of treating HF-PEF in a human patient in need of
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`such treatment comprising administering to the patient 50 mg, 100 mg, or 200 mg of a
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`combination of (i) N-(3-carboxy-l-oxopropyl)-(4S)-p-phenylphenylmethyl)-4-amino-(2R)-
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`methylbutanoic acid ethyl ester or a pharmaceutically acceptable salt thereof; and (ii) valsartan
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`or a pharmaceutically acceptable salt thereof, twice daily for at least 36 weeks, wherein N-(3-
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`carboxy-l-oxopropyl)-(4S)-p-phenylphenylmethyl)-4-amino-(2R)-methylbutanoic acid ethyl
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`ester or a pharmaceutically acceptable salt thereof and valsartan or a pharmaceutically acceptable
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`salt thereof are administered in a 1:1 molar ratio. Such administration will constitute direct
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`infringement of one or more claims of the ’192 patent. On information and belief, if the Crystal
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`ANDA Products are approved, physicians, other medical providers, caregivers and/or patients
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`following said instructions will directly infringe one or more claims of the ’192 patent. On
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`information and belief, if the Crystal ANDA Products are approved, Crystal will actively
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`encourage, recommend, or promote this infringement with knowledge of the ’192 patent, and
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`with knowledge and intent that its acts will induce infringement of one or more claims of the
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`’192 patent.
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`29.
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`On information and belief, if the Crystal ANDA Products are approved, Crystal
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`will commercially manufacture, sell, offer for sale, and/or import those products, which must be
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`Case 1:21-cv-01797-UNA Document 1 Filed 12/22/21 Page 7 of 10 PageID #: 7
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`specifically labeled for use in methods of treating HF-PEF in a human patient in need of such
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`treatment comprising administering to the patient 50 mg, 100 mg, or 200 mg of a combination of
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`(i) N-(3-carboxy-l-oxopropyl)-(4S)-p-phenylphenylmethyl)-4-amino-(2R)-methylbutanoic acid
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`ethyl ester or a pharmaceutically acceptable salt thereof; and (ii) valsartan or a pharmaceutically
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`acceptable salt thereof, twice daily for at least 36 weeks, wherein N-(3-carboxy-l-oxopropyl)-
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`(4S)-p-phenylphenylmethyl)-4-amino-(2R)-methylbutanoic acid ethyl ester or a
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`pharmaceutically acceptable salt thereof and valsartan or a pharmaceutically acceptable salt
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`thereof are administered in a 1:1 molar ratio as recited in one or more claims of the ’192 patent.
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`On information and belief, if the Crystal ANDA Products are approved, those products will
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`constitute a material part of methods of treating HF-PEF in a human patient in need of such
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`treatment comprising administering to the patient 50 mg, 100 mg, or 200 mg of a combination of
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`(i) N-(3-carboxy-l-oxopropyl)-(4S)-p-phenylphenylmethyl)-4-amino-(2R)-methylbutanoic acid
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`ethyl ester or a pharmaceutically acceptable salt thereof; and (ii) valsartan or a pharmaceutically
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`acceptable salt thereof, twice daily for at least 36 weeks, wherein N-(3-carboxy-l-oxopropyl)-
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`(4S)-p-phenylphenylmethyl)-4-amino-(2R)-methylbutanoic acid ethyl ester or a
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`pharmaceutically acceptable salt thereof and valsartan or a pharmaceutically acceptable salt
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`thereof are administered in a 1:1 molar ratio as recited in one or more claims of the ’192 patent.
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`On information and belief, if the Crystal ANDA Products are approved, physicians, other
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`medical providers, caregivers and/or patients following the approved instructions in the Crystal
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`ANDA Products will directly infringe one or more claims of the ’192 patent. On information and
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`belief, if the Crystal ANDA Products are approved, Crystal will contributorily infringe one or
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`more claims of the ’192 patent, and will do so with knowledge of the ’192 patent, and that the
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`Crystal ANDA Products are especially made or especially adapted for use in infringing one or
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`more claims of the ’192 patent and are not suitable for substantial non-infringing use.
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`30.
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`Plaintiff will be substantially and irreparably damaged by Crystal’s infringement
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`of the ’192 patent.
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`31.
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`Plaintiff is entitled to the relief provided by 35 U.S.C. § 271(e)(4), including an
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`order of this Court that the effective date of any approval of ANDA No. 213605 be a date that is
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`no earlier than August 22, 2033, the expiration of the ’192 patent, or a date no earlier than the
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`expiry of any other patent extension or exclusivity to which Plaintiff is entitled, and an award of
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`damages for any use of the Crystal ANDA Products and any act committed by Crystal with
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`respect to the subject matter claimed in the ’192 patent, which act is not within the limited
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`exclusions of 35 U.S.C. § 271(e)(1).
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`32.
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`On information and belief, Crystal has taken and continues to take active steps
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`towards the commercial manufacture, use, sale, offer for sale, and/or importation of the Crystal
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`ANDA Products, including seeking approval of those products under ANDA No. 213605.
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`33.
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`There is a substantial and immediate controversy between Plaintiff and Crystal
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`concerning the ’192 patent. Plaintiff is entitled to declaratory judgment under 28 U.S.C. §§ 2201
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`and 2202 that the use of the Crystal ANDA Products will directly infringe one or more claims of
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`the ’192 patent and Crystal will induce infringement of and/or contributorily infringe one or
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`more claims of the ’192 patent.
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`PRAYER FOR RELIEF
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`WHEREFORE, Plaintiff prays that this Court grant the following relief:
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`34.
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`Judgment that defendant Crystal has infringed one or more claims of the ’192
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`patent by filing ANDA No. 213605;
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`35.
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`A permanent injunction restraining and enjoining defendant Crystal and its
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`officers, agents, attorneys, and employees, and those acting in privity or concert with them, from
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`engaging in the commercial manufacture, use, sale, or offer for sale in the United States, or
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`importation into the United States, of the Crystal ANDA Products prior to the expiration of the
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`’192 patent, inclusive of any extensions and additional periods of exclusivity;
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`36.
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`An order that the effective date of any approval of ANDA No. 213605 be a date
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`that is not earlier than the expiration date of the ’192 patent, inclusive of any extensions and
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`additional periods of exclusivity;
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`37.
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`Declaratory judgment that the use of the Crystal ANDA Products will directly
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`infringe one or more claims of the ’192 patent;
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`38.
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`Declaratory judgment that the commercial manufacture, sale, offer for sale, and/or
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`importation of the Crystal ANDA Products will induce infringement of and/or contributorily
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`infringe one or more claims of the ’192 patent;
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`39.
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`Damages or other monetary relief from defendant Crystal for the infringement,
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`inducement of infringement and contributory infringement of the ’192 patent;
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`40.
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`A declaration that this case is an exceptional case pursuant to 35 U.S.C. § 285 and
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`an award of attorney’s fees;
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`41.
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`Plaintiff’s costs and expenses in this action; and
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`42.
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`Such other and further relief as the Court may deem just and proper.
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`MCCARTER & ENGLISH, LLP
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`By: /s/ Daniel M. Silver
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`Daniel M. Silver (#4758)
`Alexandra M. Joyce (#6423)
`Renaissance Centre
`405 N. King Street, 8th Floor
`Wilmington, Delaware 19801
`(302) 984-6300
`dsilver@mccarter.com
`ajoyce@mccarter.com
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`Attorneys for Plaintiff Novartis
`Pharmaceuticals Corporation
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`Dated: December 22, 2021
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`OF COUNSEL:
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`Nicholas N. Kallas
`Christina Schwarz
`Christopher E. Loh
`Susanne L. Flanders
`Jared L. Stringham
`Shannon K. Clark
`Laura K. Fishwick
`Gregory J. Manas
`VENABLE LLP
`1290 Avenue of the Americas
`New York, New York 10104
`(212) 218-2100
`nkallas@venable.com
`cschwarz@venable.com
`cloh@venable.com
`slflanders@venable.com
`jlstringham@venable.com
`skclark@venable.com
`lfishwick@venable.com
`gjmanas@venable.com
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