Case 1:21-cv-00712-UNA Document 1 Filed 05/19/21 Page 1 of 26 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. __________
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`)))))))
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`Defendants.
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`Plaintiffs Amgen Inc. (“Amgen”) and KAI Pharmaceuticals, Inc. (“KAI”) (collectively
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`“Plaintiffs”) by their attorneys, hereby allege as follows:
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`NATURE OF THE ACTION
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`1.
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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, that arises out of the submission by defendants MSN Laboratories
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`Private Limited (“MSN Labs”), MSN Pharmaceuticals Inc. (“MSN Pharma”), and MSN Life
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`Sciences Private Limited (“MSN Life”) (collectively, “MSN”) of Abbreviated New Drug
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`Application (“ANDA”) No. 215877 to the U.S. Food and Drug Administration (“FDA”) seeking
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`approval to manufacture and sell a generic version of Parsabiv® (etelcalcetide) injection for
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`intravenous use at strengths of 2.5 mg/0.5 mL, 5 mg/mL, and 10 mg/2 mL (“MSN’s Proposed
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`ANDA Product”) prior to the expiration of U.S. Patent Nos. 8,377,880 (“the ’880 patent”),
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`8,999,932 (“the ’932 patent”), 9,278,995 (“the ’995 patent”), 9,701,712 (“the ’712 patent”),
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`9,820,938 (“the ’938 patent”), and 10,344,765 (“the ’765 patent”) (collectively, “the Asserted
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`Patents”). MSN notified Plaintiffs that it had submitted this ANDA by a letter received April 8,
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`2021 (“Notice Letter”). Upon information and belief, MSN’s Proposed ANDA Product will be
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`AMGEN INC. and
`KAI PHARMACEUTICALS, INC.,
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`Plaintiffs,
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`v.
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`MSN LABORATORIES PRIVATE LIMITED,
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`MSN PHARMACEUTICALS INC. and
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`MSN LIFE SCIENCES PRIVATE LIMITED,
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`)
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`COMPLAINT
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`Case 1:21-cv-00712-UNA Document 1 Filed 05/19/21 Page 2 of 26 PageID #: 2
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`marketed as a competing product to Parsabiv® (etelcalcetide), a product developed by Plaintiffs
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`for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease
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`on hemodialysis.
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`PARTIES
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`2.
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`Plaintiff Amgen is a corporation organized and existing under the laws of Delaware,
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`having its corporate offices and a place of business at One Amgen Center Drive, Thousand Oaks,
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`CA 91320.
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`3.
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`Plaintiff KAI is a corporation organized and existing under the laws of Delaware,
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`having a place of business at One Amgen Center Drive, Thousand Oaks, CA 91320. KAI is a
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`wholly owned subsidiary of Amgen.
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`4.
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`Upon information and belief, Defendant MSN Labs is a private limited company
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`organized and existing under the laws of the Republic of India, having a place of business at MSN
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`House, Plot No. C-24, Sanathnagar Industrial Estate, Hyderabad, Telangana 500018, India. Upon
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`information and belief, MSN Labs is in the business of, among other things, manufacturing and
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`selling generic versions of branded pharmaceutical drugs through various operating subsidiaries
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`throughout the United States, including in Delaware.
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`5.
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`Upon information and belief, Defendant MSN Pharma is a corporation organized
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`and existing under the laws of Delaware, having its corporate offices and a place of business at
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`20 Duke Road, Piscataway, NJ 08854. Upon information and belief, MSN Pharma is a wholly
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`owned subsidiary of MSN Labs. Upon information and belief, MSN Pharma is the designated
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`U.S. agent for MSN Labs in accordance with 21 C.F.R. §§ 314.50(a)(5) and 314.94(a)(1) for
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`ANDA No. 215877. Upon information and belief, MSN Pharma is in the business of, among other
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`2
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`things, manufacturing and selling generic versions of branded pharmaceutical products throughout
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`the United States, including in Delaware.
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`6.
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`Upon information and belief, Defendant MSN Life is a private limited company
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`organized and existing under the laws of the Republic of India, having a place of business at
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`Sy No. 21/A & 21AA, Mambapur, Gummadidala, Sangreddy, Telangana 502313, India. Upon
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`information and belief, MSN Life is a wholly owned subsidiary of MSN Labs. Upon information
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`and belief, MSN Life is the holder of FDA Drug Master File No. 35097 for MSN’s Proposed
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`ANDA Product. Upon information and belief, MSN Life is in the business of, among other things,
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`manufacturing and selling generic versions of branded pharmaceutical products throughout the
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`United States, including in Delaware.
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`7.
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`Upon information and belief, MSN Labs, MSN Pharma, and MSN Life collaborate
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`with respect to the development, regulatory approval, marketing, sale, and/or distribution of
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`pharmaceutical products. Upon further information and belief, MSN Labs, MSN Pharma, and
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`MSN Life are agents of each other and/or operate in concert as integrated parts of the same
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`business group.
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`8.
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`Upon information and belief, MSN Labs, MSN Pharma, and MSN Life acted in
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`concert to develop MSN’s Proposed ANDA Product that is the subject of ANDA No. 215877 and
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`to seek regulatory approval from the FDA to market and sell MSN’s Proposed ANDA Product
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`throughout the United States, including in Delaware.
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`9.
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`Upon information and belief, MSN Labs, MSN Pharma, and MSN Life intend to
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`act collaboratively to obtain approval for MSN’s ANDA No. 215877, and, in the event the FDA
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`approves that ANDA, to commercially manufacture, use, offer for sale, sell, and/or import MSN’s
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`Proposed ANDA Product in the United States, including in Delaware.
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`3
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`JURISDICTION AND VENUE
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`10.
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`This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331, 1338(a),
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`2201, and 2202.
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`11.
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`This Court has personal jurisdiction over MSN Pharma because, on information
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`and belief, MSN Pharma is a corporation organized and existing under the laws of Delaware, is
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`qualified to do business in Delaware, and has appointed a registered agent for service of process
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`in Delaware. Therefore, MSN Pharma has consented to general jurisdiction in Delaware.
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`12.
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`This Court has personal jurisdiction over MSN Labs and MSN Life because, inter
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`alia, MSN Labs and MSN Life, themselves and through their affiliates and subsidiaries including
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`MSN Pharma, have purposefully availed themselves of the benefits and protections of Delaware’s
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`laws such that they should reasonably anticipate being haled into court here. On information and
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`belief, MSN Labs and MSN Life, themselves and through their affiliates and subsidiaries including
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`MSN Pharma, develop, manufacture, import, market, offer to sell, sell, and/or distribute a broad
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`range of generic pharmaceutical products throughout the United States, including in Delaware, and
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`therefore transact business within Delaware relating to Plaintiffs’ claims, and/or have engaged in
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`systematic and continuous business contacts within Delaware.
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`13.
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`In addition, this Court has personal jurisdiction over MSN Labs and MSN Life
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`because, among other things, on information and belief: (1) MSN Labs, MSN Life, and their
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`affiliate MSN Pharma submitted MSN’s ANDA for the purpose of seeking approval to engage in
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`the commercial manufacture, use, sale, or offer for sale of MSN’s Proposed ANDA Product in the
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`United States, including in Delaware; and (2) upon approval of MSN’s ANDA, MSN Labs, MSN
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`Life, and their affiliate MSN Pharma, themselves and through their affiliates and subsidiaries, will
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`market, distribute, offer for sale, sell, and/or import MSN’s Proposed ANDA Product in the United
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`4
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`States, including in Delaware, and will derive substantial revenue from the use or consumption of
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`MSN’s Proposed ANDA Product in Delaware. On information and belief, upon approval of
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`MSN’s ANDA, MSN’s Proposed ANDA Product will, among other things, be marketed,
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`distributed, offered for sale, sold, and/or imported in Delaware; prescribed by physicians practicing
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`in Delaware; dispensed by pharmacies located within Delaware; and/or used by patients in
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`Delaware, all of which would have substantial effects on Delaware.
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`14.
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`In addition, this Court has personal jurisdiction over MSN Labs and MSN Life
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`because they have committed, aided, abetted, induced, contributed to, or participated in the
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`commission of the tortious act of patent infringement that has led and/or will lead to foreseeable
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`harm and injury to Amgen and KAI, both Delaware corporations.
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`15.
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`In addition, this Court has personal jurisdiction over MSN Labs and MSN Life
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`because they regularly engage in patent litigation concerning MSN’s ANDA products in this
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`District, do not contest personal jurisdiction in this District, and have purposefully availed
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`themselves of the rights and benefits of this Court by asserting claims and/or counterclaims in this
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`District. See, e.g., Otsuka Pharmaceutical Co., Ltd. et al. v. MSN Laboratories Private Ltd., MSN
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`Pharmaceuticals Inc. and MSN Life Sciences Pvt. Ltd., C.A. No. 20-01428 (D. Del.); Intercept
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`Pharmaceuticals, Inc. et al. v. MSN Laboratories Private Ltd., MSN Pharmaceuticals, Inc. and
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`MSN Life Sciences Private Ltd., C.A. No. 20-01214 (D. Del.).
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`16.
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`In addition, to the extent personal jurisdiction does not exist over MSN Labs and
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`MSN Life in Delaware, this Court has personal jurisdiction over them under Federal Rule of Civil
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`Procedure 4(k)(2) because MSN Labs and MSN Life are not subject to jurisdiction in any state’s
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`courts of general jurisdiction and exercising jurisdiction over them is consistent with the United
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`States Constitution and laws.
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`5
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`17.
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`For at least the above reasons, it would not be unfair or unreasonable for MSN Labs,
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`MSN Life, and MSN Pharma to litigate this action in this District, and MSN Labs, MSN Life, and
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`MSN Pharma are subject to personal jurisdiction in this District.
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`18.
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`Venue is proper in this Court under 28 U.S.C. § 1391(c) with respect to MSN Labs
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`at least because, on information and belief, MSN Labs is a foreign corporation that may be sued
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`in any judicial district.
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`19.
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`Venue is proper in this Court under 28 U.S.C. § 1391(c) with respect to MSN Life
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`at least because, on information and belief, MSN Life is a foreign corporation that may be sued in
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`any judicial district.
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`20.
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`Venue is proper in this Court under 28 U.S.C. § 1400(b) with respect to MSN
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`Pharma at least because, on information and belief, MSN Pharma is a corporation organized and
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`existing under the laws of Delaware and therefore resides in Delaware for purposes of venue.
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`BACKGROUND
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`PARSABIV® (ETELCALCETIDE)
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`21.
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`On February 7, 2017, the FDA granted approval to market Parsabiv® (etelcalcetide)
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`for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease
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`on hemodialysis.
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`22.
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`The active pharmaceutical ingredient in Parsabiv® is etelcalcetide, which was
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`invented by scientists at KAI and developed by KAI and Amgen. Etelcalcetide is a synthetic
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`peptide calcium-sensing receptor agonist. It is a calcimimetic agent that allosterically modulates
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`the calcium-sensing receptor (“CaSR”). Etelcalcetide binds to the CaSR and enhances activation
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`of the receptor by extracellular calcium. Activation of the CaSR on parathyroid chief cells
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`decreases parathyroid hormone (“PTH”) secretion.
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`6
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`23.
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`Parsabiv® (etelcalcetide) is FDA approved for intravenous injection. It is FDA
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`approved as a sterile, preservative-free, ready-to-use clear and colorless solution in a single-dose
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`vial containing 5 mg/mL of etelcalcetide. Each vial contains 2.5, 5, or 10 mg etelcalcetide. Each
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`vial is formulated with 0.85% weight/volume sodium chloride, 10 mM succinic acid, and adjusted
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`to pH 3.3 with sodium hydroxide and/or hydrochloric acid.
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`24.
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`Amgen, itself or through a subsidiary, markets Parsabiv® (etelcalcetide) in the
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`United States pursuant to approved New Drug Application (“NDA”) No. 208325.
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`25.
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`KAI, a wholly owned subsidiary of Amgen, is the holder of approved NDA No.
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`208325 for Parsabiv® (etelcalcetide).
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`26.
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`The Asserted Patents are listed for NDA No. 208325 for Parsabiv® (etelcalcetide)
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`in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly
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`known as the “Orange Book.”
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`27.
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`The ’880 patent, titled “Therapeutic Agents for Reducing Parathyroid Hormone
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`Levels,” was duly and legally issued on February 19, 2013. A copy of the ’880 patent is attached
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`as Exhibit A.
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`28.
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`29.
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`Plaintiffs own and have rights to the ’880 patent.
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`There is an actual case or controversy between the parties regarding MSN’s liability
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`for its infringement of the ’880 patent.
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`30.
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`The ’932 patent, titled “Therapeutic Agents for Reducing Parathyroid Hormone
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`Levels,” was duly and legally issued on April 7, 2015. A copy of the ’932 patent is attached as
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`Exhibit B.
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`31.
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`Plaintiffs own and have rights to the ’932 patent.
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`7
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`32.
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`There is an actual case or controversy between the parties regarding MSN’s liability
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`for its infringement of the ’932 patent.
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`33.
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`The ’995 patent, titled “Therapeutic Agents for Reducing Parathyroid Hormone
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`Levels,” was duly and legally issued on March 8, 2016. A copy of the ’995 patent is attached as
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`Exhibit C.
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`34.
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`35.
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`Plaintiffs own and have rights to the ’995 patent.
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`There is an actual case or controversy between the parties regarding MSN’s liability
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`for its infringement of the ’995 patent.
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`36.
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`The ’712 patent, titled “Therapeutic Agents for Reducing Parathyroid Hormone
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`Levels,” was duly and legally issued on July 11, 2017. A copy of the ’712 patent is attached as
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`Exhibit D.
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`37.
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`38.
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`Plaintiffs own and have rights to the ’712 patent.
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`There is an actual case or controversy between the parties regarding MSN’s liability
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`for its infringement of the ’712 patent.
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`39.
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`The ’938 patent, titled “Stable Liquid Formulation of AMG 416 (Etelcalcetide),”
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`was duly and legally issued on November 21, 2017. A copy of the ’938 patent is attached as
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`Exhibit E.
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`40.
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`41.
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`Plaintiffs own and have rights to the ’938 patent.
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`There is an actual case or controversy between the parties regarding MSN’s liability
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`for its infringement of the ’938 patent.
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`42.
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`The ’765 patent, titled “Stable Liquid Formulation of AMG 416 (Etelcalcetide),”
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`was duly and legally issued on July 9, 2019. A copy of the ’765 patent is attached as Exhibit F.
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`43.
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`Plaintiffs own and have rights to the ’765 patent.
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`8
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`44.
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`There is an actual case or controversy between the parties regarding MSN’s liability
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`for its infringement of the ’765 patent.
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`MSN’S ANDA
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`On April 8, 2021, Plaintiffs received MSN’s Notice Letter, which informed
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`45.
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`Plaintiffs that MSN seeks through ANDA No. 215877 approval to engage in the commercial
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`manufacture, use, sale, or offer for sale of MSN’s Proposed ANDA Product prior to the expiration
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`of the Asserted Patents. According to the Notice Letter, included within ANDA No. 215877 is a
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`certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“Paragraph IV Certification”) that the
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`Asserted Patents are invalid, unenforceable, and/or will not be infringed by the commercial
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`manufacture, use, sale, or offer for sale of MSN’s Proposed ANDA Product.
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`46.
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`This action is being filed within 45 days of Plaintiffs’ receipt of MSN’s Notice
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`Letter.
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`47. MSN was aware of the Asserted Patents when ANDA No. 215877 was filed with a
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`Paragraph IV Certification.
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`48.
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`On information and belief, etelcalcetide is the active ingredient in MSN’s Proposed
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`ANDA Product. On information and belief, MSN’s Proposed ANDA Product is a pharmaceutical
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`formulation comprising etelcalcetide in an aqueous solution having a pH of 2.0 to 5.0.
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`49.
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`On information and belief, ANDA No. 215877 refers to and relies upon the NDA
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`for Parsabiv® (etelcalcetide) and contains data that, according to MSN, demonstrate
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`bioequivalence of MSN’s Proposed ANDA Product and Parsabiv® (etelcalcetide), see 21 U.S.C.
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`§ 355(j)(2); 21 C.F.R. § 314.94(a)(7), or MSN has sought a waiver of the requirement to
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`demonstrate bioequivalence of MSN’s Proposed ANDA Product and Parsabiv® (etelcalcetide).
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`9
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`50.
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`On information and belief, MSN intends to have healthcare providers use MSN’s
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`Proposed ANDA Product, if approved, as set forth in MSN’s Proposed ANDA Product label. On
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`information and belief, MSN’s Proposed ANDA Product label will instruct healthcare providers
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`to prescribe MSN’s Proposed ANDA Product in the manner set forth in the label.
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`COUNT I
`(Infringement of the ’880 Patent)
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`51.
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`52.
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`Plaintiffs incorporate each of the preceding paragraphs as if fully set forth herein.
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`Claim 1 of the ’880 patent covers “[a] compound comprising Ac-c(C)arrrar-NH2
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`(SEQ ID NO:3) [etelcalcetide].”
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`53.
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`Upon information and belief, MSN’s Proposed ANDA Product is covered by one
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`or more claims of the ’880 patent, including at least claim 1, because it contains etelcalcetide.
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`54.
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`Upon information and belief, the manufacture, use, sale, offer for sale, or
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`importation of MSN’s Proposed ANDA Product, or the use of MSN’s Proposed ANDA Product
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`in accordance with and as directed by MSN’s proposed labeling for that product, will infringe one
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`or more claims of the ’880 patent, including at least claim 1, either literally or under the doctrine
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`of equivalents.
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`55.
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`Upon information and belief, MSN filed as part of ANDA No. 215877 a Paragraph
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`IV Certification, asserting that the claims of the ’880 patent are invalid, unenforceable, and/or not
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`infringed by the manufacture, use, sale, or offer for sale of MSN’s Proposed ANDA Product.
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`56.
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`MSN did not contend in its Notice Letter that MSN’s Proposed ANDA Product,
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`or the use of MSN’s Proposed ANDA Product in accordance with and as directed by MSN’s
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`proposed labeling for that product, would not infringe the claims of the ’880 patent.
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`10
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`57.
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`MSN has no reasonable basis to believe that MSN’s Proposed ANDA Product, or
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`the use of MSN’s Proposed ANDA Product in accordance with and as directed by MSN’s proposed
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`labeling for that product, would not infringe one or more valid claims of the ’880 patent.
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`58.
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`The purpose of filing ANDA No. 215877 was to obtain approval under the FDCA
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`to engage in the commercial manufacture, use, offer for sale, and/or sale of MSN’s Proposed
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`ANDA Product prior to the expiration of the ’880 patent.
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`59. MSN’s submission of ANDA No. 215877 for the purpose of obtaining approval to
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`engage in the commercial manufacture, use, sale and/or offer for sale of MSN’s Proposed ANDA
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`Product prior to the expiration of the ’880 patent is an act of infringement of the ’880 patent under
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`35 U.S.C. § 271(e)(2)(A).
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`60.
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`Upon information and belief, MSN intends to engage in the commercial
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`manufacture, use, sale and/or offer for sale of MSN’s Proposed ANDA Product and the proposed
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`labeling therefor immediately and imminently upon the approval of ANDA No. 215877 and any
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`amendments thereto, i.e., prior to the expiration of the ’880 patent.
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`61.
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`Upon information and belief, MSN has knowledge of the ’880 patent at least
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`because the ’880 patent is listed in the FDA’s Orange Book: Approved Drug Products with
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`Therapeutic Equivalence Evaluations for Amgen’s Parsabiv® (etelcalcetide) drug product.
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`Notwithstanding this knowledge, MSN continues to assert its intent to engage in the manufacture,
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`use, offer for sale, and/or sale of MSN’s Proposed ANDA Product and the proposed labeling
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`therefor immediately and imminently upon the approval of ANDA No. 215877 and any
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`amendments thereto.
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`62.
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`Upon information and belief, MSN plans and intends to, and will, actively induce
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`infringement of the ’880 patent when ANDA No. 215877 and any amendments thereto are
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`11
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`approved, and will do so with specific intent to induce infringement of the ’880 patent. Further
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`upon information and belief, MSN plans and intends to, and will, do so immediately and
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`imminently upon approval.
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`63.
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`The foregoing actions by MSN constitute and/or will constitute infringement of
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`the ’880 patent and active inducement of infringement of the ’880 patent, either literally or under
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`the doctrine of equivalents.
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`64.
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`Unless MSN is enjoined from infringing the ’880 patent and actively inducing
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`infringement of the ’880 patent, Plaintiffs will suffer irreparable injury. Plaintiffs have no
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`adequate remedy at law.
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`COUNT II
`(Infringement of the ’932 Patent)
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`65.
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`66.
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`Plaintiffs incorporate each of the preceding paragraphs as if fully set forth herein.
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`Claim 1 of the ’932 patent covers “[a] conjugate, comprising a peptide and a
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`conjugating group, wherein the peptide comprises the amino acid sequence carrrar (SEQ ID NO:2),
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`and wherein the peptide is linked to the conjugating group by a disulfide bond.”
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`67.
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`Claim 11 of the ’932 patent covers “[a] method of treating secondary
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`hyperparathyroidism (SHPT) in a subject, comprising administering to the subject a
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`therapeutically effective amount of a conjugate comprising a peptide and a conjugating group,
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`wherein the peptide comprises the amino acid sequence carrrar (SEQ ID NO:2), and wherein the
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`peptide is linked to the conjugating group by a disulfide bond.”
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`68.
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`Upon information and belief, MSN’s Proposed ANDA Product is covered by one
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`or more claims of the ’932 patent, including at least claims 1 and 11, because it contains
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`etelcalcetide, which is a conjugate comprising a peptide and a conjugating group, wherein the
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`peptide comprises the amino acid sequence carrrar and wherein the peptide is linked to the
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`12
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`conjugating group by a disulfide bond, and will be used in a method of treating secondary
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`hyperparathyroidism.
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`69.
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`Upon information and belief, the manufacture, use, sale, offer for sale, or
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`importation of MSN’s Proposed ANDA Product, or the use of MSN’s Proposed ANDA Product
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`in accordance with and as directed by MSN’s proposed labeling for that product, will infringe one
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`or more claims of the ’932 patent, including at least claims 1 and 11, either literally or under the
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`doctrine of equivalents.
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`70.
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`Upon information and belief, MSN filed as part of ANDA No. 215877 a Paragraph
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`IV Certification, asserting that the claims of the ’932 patent are invalid, unenforceable, and/or not
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`infringed by the manufacture, use, sale, or offer for sale of MSN’s Proposed ANDA Product.
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`71.
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`MSN did not contend in its Notice Letter that MSN’s Proposed ANDA Product,
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`or the use of MSN’s Proposed ANDA Product in accordance with and as directed by MSN’s
`
`proposed labeling for that product, would not infringe claims 1-4, 6, 7, 9-12, 14, 16-19, 21, 23,
`
`and 24 of the ’932 patent.
`
`72.
`
`MSN has no reasonable basis to believe that MSN’s Proposed ANDA Product, or
`
`the use of MSN’s Proposed ANDA Product in accordance with and as directed by MSN’s proposed
`
`labeling for that product, would not infringe one or more valid claims of the ’932 patent.
`
`73.
`
`The purpose of filing ANDA No. 215877 was to obtain approval under the FDCA
`
`to engage in the commercial manufacture, use, offer for sale, and/or sale of MSN’s Proposed
`
`ANDA Product prior to the expiration of the ’932 patent.
`
`74. MSN’s submission of ANDA No. 215877 for the purpose of obtaining approval to
`
`engage in the commercial manufacture, use, sale and/or offer for sale of MSN’s Proposed ANDA
`
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`Case 1:21-cv-00712-UNA Document 1 Filed 05/19/21 Page 14 of 26 PageID #: 14
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`
`
`Product prior to the expiration of the ’932 patent is an act of infringement of the ’932 patent under
`
`35 U.S.C. § 271(e)(2)(A).
`
`75.
`
`Upon information and belief, MSN intends to engage in the commercial
`
`manufacture, use, sale and/or offer for sale of MSN’s Proposed ANDA Product and the proposed
`
`labeling therefor immediately and imminently upon the approval of ANDA No. 215877 and any
`
`amendments thereto, i.e., prior to the expiration of the ’932 patent.
`
`76.
`
`Upon information and belief, MSN has knowledge of the ’932 patent at least
`
`because the ’932 patent is listed in the FDA’s Orange Book: Approved Drug Products with
`
`Therapeutic Equivalence Evaluations for Amgen’s Parsabiv® (etelcalcetide) drug product.
`
`Notwithstanding this knowledge, MSN continues to assert its intent to engage in the manufacture,
`
`use, offer for sale, and/or sale of MSN’s Proposed ANDA Product and the proposed labeling
`
`therefor immediately and imminently upon the approval of ANDA No. 215877 and any
`
`amendments thereto.
`
`77.
`
`Upon information and belief, MSN plans and intends to, and will, actively induce
`
`infringement of the ’932 patent when ANDA No. 215877 and any amendments thereto are
`
`approved, and will do so with specific intent to induce infringement of the ’932 patent. Further
`
`upon information and belief, MSN plans and intends to, and will, do so immediately and
`
`imminently upon approval.
`
`78.
`
`Upon information and belief, MSN knows that MSN’s Proposed ANDA Product is
`
`especially made or adapted for use in infringing the ’932 patent, and that MSN’s Proposed ANDA
`
`Product is not suitable for substantial noninfringing use. Upon information and belief, MSN plans
`
`and intends to, and will, contribute to infringement by others of the ’932 patent immediately and
`
`imminently upon approval of ANDA No. 215877 and any amendments thereto.
`
`14
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`
`
`79.
`
`The foregoing actions by MSN constitute and/or will constitute infringement of
`
`the ’932 patent, active inducement of infringement of the ’932 patent, and contribution to the
`
`infringement by others of the ’932 patent, either literally or under the doctrine of equivalents.
`
`80.
`
`Unless MSN is enjoined from infringing the ’932 patent, actively inducing
`
`infringement of the ’932 patent, and contributing to infringement by others of the ’932 patent,
`
`Plaintiffs will suffer irreparable injury. Plaintiffs have no adequate remedy at law.
`
`COUNT III
`(Infringement of the ’995 Patent)
`
`81.
`
`82.
`
`Plaintiffs incorporate each of the preceding paragraphs as if fully set forth herein.
`
`Claim 1 of the ’995 patent covers “[a] compound comprising a peptide and a
`
`conjugating group, wherein the peptide comprises an amino acid sequence having the formula X1-
`
`X2-X3-X4-X5-X6-X7 wherein X1 is D-cysteine; X2 is an amino acid selected from the group
`
`consisting of D-arginine and D-alanine; X3 is D-arginine; X4 is an amino acid selected from the
`
`group consisting of D-arginine and D-alanine; X5 is D-arginine; X6 is a non-cationic amino acid;
`
`X7 is D-arginine; wherein when X2 is D-arginine, X4 is D-alanine and when X2 is D-alanine, X4 is
`
`D-arginine; and wherein the peptide X1 residue is linked to the conjugating group by a disulfide
`
`bond.”
`
`83.
`
`Upon information and belief, MSN’s Proposed ANDA Product is covered by one
`
`or more claims of the ’995 patent, including at least claim 1, because it contains etelcalcetide,
`
`which comprises a peptide and a conjugating group, wherein the peptide comprises an amino acid
`
`sequence having the formula X1-X2-X3-X4-X5-X6-X7, wherein X1 is D-cysteine; X2 is D-alanine;
`
`X3 is D-arginine; X4 is D-arginine; X5 is D-arginine; X6 is a non-cationic amino acid; X7 is D-
`
`arginine; and wherein the peptide X1 residue is linked to the conjugating group by a disulfide bond.
`
`15
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`Case 1:21-cv-00712-UNA Document 1 Filed 05/19/21 Page 16 of 26 PageID #: 16
`
`
`
`84.
`
`Upon information and belief, the manufacture, use, sale, offer for sale, or
`
`importation of MSN’s Proposed ANDA Product, or the use of MSN’s Proposed ANDA Product
`
`in accordance with and as directed by MSN’s proposed labeling for that product, will infringe one
`
`or more claims of the ’995 patent, including at least claim 1, either literally or under the doctrine
`
`of equivalents.
`
`85.
`
`Upon information and belief, MSN filed as part of ANDA No. 215877 a Paragraph
`
`IV Certification, asserting that the claims of the ’995 patent are invalid, unenforceable, and/or not
`
`infringed by the manufacture, use, sale, or offer for sale of MSN’s Proposed ANDA Product.
`
`86.
`
`MSN did not contend in its Notice Letter that MSN’s Proposed ANDA Product,
`
`or the use of MSN’s Proposed ANDA Product in accordance with and as directed by MSN’s
`
`proposed labeling for that product, would not infringe claims 1-4, 11-13, 17, and 35 of the
`
`’995 patent.
`
`87.
`
`MSN has no reasonable basis to believe that MSN’s Proposed ANDA Product, or
`
`the use of MSN’s Proposed ANDA Product in accordance with and as directed by MSN’s proposed
`
`labeling for that product, would not infringe one or more valid claims of the ’995 patent.
`
`88.
`
`The purpose of filing ANDA No. 215877 was to obtain approval under the FDCA
`
`to engage in the commercial manufacture, use, offer for sale, and/or sale of MSN’s Proposed
`
`ANDA Product prior to the expiration of the ’995 patent.
`
`89. MSN’s submission of ANDA No. 215877 for the purpose of obtaining approval to
`
`engage in the commercial manufacture, use, sale and/or offer for sale of MSN’s Proposed ANDA
`
`Product prior to the expiration of the ’995 patent is an act of infringement of the ’995 patent under
`
`35 U.S.C. § 271(e)(2)(A).
`
`16
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`Case 1:21-cv-00712-UNA Document 1 Filed 05/19/21 Page 17 of 26 PageID #: 17
`
`
`
`90.
`
`Upon information and belief, MSN intends to engage in the commercial
`
`manufacture, use, sale and/or offer for sale of MSN’s Proposed ANDA Product and the proposed
`
`labeling therefor immediately and imminently upon the approval of ANDA No. 215877 and any
`
`amendments thereto, i.e., prior to the expiration of the ’995 patent.
`
`91.
`
`Upon information and belief, MSN has knowledge of the ’995 patent at least
`
`because the ’995 patent is listed in the FDA’s Orange Book: Approved Drug Products with
`
`Therapeutic Equivalence Evaluations for Amgen’s Parsabiv® (etelcalcetide) drug product.
`
`Notwithstanding this knowledge, MSN continues to assert its intent to engage in the manufacture,
`
`use, offer for sale, and/or sale of MSN’s Proposed ANDA Product and the proposed labeling
`
`therefor immediately and imminently upon the approval of ANDA No. 215877 and any
`
`amendments thereto.
`
`92.
`
`Upon information and belief, MSN plans and intends to, and will, actively induce
`
`infringement of the ’995 patent when ANDA No. 215877 and any amendments thereto are
`
`approved, and will do so with specific intent to induce infringement of the ’995 patent. Further
`
`upon information and belief, MSN plans and intends to, and will, do so immediately and
`
`imminently upon approval.
`
`93.
`
`The foregoing actions by MSN constitute and/or will constitute infringement of
`
`the ’995 patent and active inducement of infringement of the ’995 patent, either literally or under
`
`the doctrine of equivalents.
`
`94.
`
`Unless MSN is enjoined from infringing the ’995 patent and actively inducing
`
`infringement of the ’995 patent, Plaintiffs will suffer irreparable injury. Plaintiffs have no
`
`adequate remedy at law.
`
`
`
`
`
`17
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`Case 1:21-cv-00712-UNA Document 1 Filed 05/19/21 Page 18 of 26 PageID #: 18
`
`
`
`COUNT IV
`(Infringement of the ’712 Patent)
`
`95.
`
`96.
`
`Plaintiffs incorporate each of the preceding paragraphs as if fully set forth herein.
`
`Claim 8 of the ’712 patent covers “[a] pharmaceutically acceptable salt of a peptide
`
`comprising Ac-c(C)arrrar-NH2 (SEQ ID NO:3) [etelcalcetide].”
`
`97.
`
`Claim 15 of the ’712 patent covers “[a] method of treating secondary
`
`hyperparathyroidism (SHPT) in a subject, comprising administering to the subject a
`
`therapeutically effective amount of the salt of claim 8.”
`
`98.
`
`Upon information and belief, MSN’s Proposed ANDA Product is covered by one
`
`or more claims of the ’712 patent, including at least clai