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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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`COMPLAINT
`
`AMGEN INC. and
`KAI PHARMACEUTICALS, INC.,
`
`
`Plaintiffs,
`
`
`
`v.
`
`
`AUROBINDO PHARMA LIMITED and
`AUROBINDO PHARMA USA INC.,
`
`
`Defendants.
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`Plaintiffs Amgen Inc. (“Amgen”) and KAI Pharmaceuticals, Inc. (“KAI”) (collectively
`
`“Plaintiffs”) by their attorneys, hereby allege as follows:
`
`NATURE OF THE ACTION
`
`1.
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`This is an action for patent infringement under the patent laws of the United States,
`
`Title 35, United States Code, that arises out of the submission by defendants Aurobindo Pharma
`
`Limited and Aurobindo Pharma USA Inc. (collectively “Aurobindo”) of Abbreviated New Drug
`
`Application (“ANDA”) No. 215840 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
`
`intravenous use at strengths of 2.5 mg/0.5 mL, 5 mg/mL, and 10 mg/2 mL (“Aurobindo’s Proposed
`
`ANDA Product”) prior to the expiration of U.S. Patent Nos. 9,820,938 (“the ’938 patent”) and
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`10,344,765 (“the ’765 patent”) (collectively “the Asserted Patents”). Aurobindo notified Plaintiffs
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`that it had submitted this ANDA by a letter received March 26, 2021 (“Notice Letter”). Upon
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`information and belief, Aurobindo’s Proposed ANDA Product will be marketed as a competing
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`product to Parsabiv® (etelcalcetide), a product developed by Plaintiffs for the treatment of
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`secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis.
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`Case 1:21-cv-00662-UNA Document 1 Filed 05/06/21 Page 2 of 15 PageID #: 2
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`
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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.
`
`Upon information and belief, Defendant Aurobindo Pharma Limited is a
`
`corporation organized and existing under the laws of the Republic of India, having a place of
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`business at Plot No. 11, Water Mark Building, Hitech City Road, Whitefields, Kondapur,
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`Hyderabad, Telangana 500084, India. Upon information and belief, Aurobindo Pharma Limited
`
`is in the business of, among other things, manufacturing and selling generic versions of branded
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`pharmaceutical drugs through various operating subsidiaries, including Aurobindo Pharma USA
`
`Inc., throughout the United States, including in Delaware.
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`5.
`
`Upon information and belief, Aurobindo Pharma USA Inc. is a corporation
`
`organized and existing under the laws of Delaware, having its corporate offices and a principal
`
`place of business at 279 Princeton-Hightstown Road, East Windsor, NJ 08520. Upon information
`
`and belief, Aurobindo Pharma USA Inc. is a wholly owned subsidiary of Aurobindo Pharma
`
`Limited. Upon information and belief, Aurobindo Pharma USA Inc. is in the business of, among
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`other things, manufacturing and selling generic versions of branded pharmaceutical drug products
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`throughout the United States, including in Delaware.
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`6.
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`Upon information and belief, Aurobindo Pharma Limited and Aurobindo Pharma
`
`USA Inc. collaborate with respect to the development, regulatory approval, marketing, sale, and/or
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`2
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`Case 1:21-cv-00662-UNA Document 1 Filed 05/06/21 Page 3 of 15 PageID #: 3
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`
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`distribution of pharmaceutical products. Upon further information and belief, Aurobindo Pharma
`
`Limited and Aurobindo Pharma USA Inc. are agents of each other and/or operate in concert as
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`integrated parts of the same business group.
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`7.
`
`Upon information and belief, Aurobindo Pharma Limited and Aurobindo Pharma
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`USA Inc. acted in concert to develop Aurobindo’s Proposed ANDA Product that is the subject of
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`ANDA No. 215840 and to seek regulatory approval from the FDA to market and sell Aurobindo’s
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`Proposed ANDA Product throughout the United States, including in Delaware.
`
`8.
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`Upon information and belief, Aurobindo Pharma Limited and Aurobindo Pharma
`
`USA Inc. intend to act collaboratively to obtain approval for Aurobindo’s ANDA No. 215840,
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`and, in the event the FDA approves that ANDA, to commercially manufacture, use, offer for sale,
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`sell, and/or import Aurobindo’s Proposed ANDA Product in the United States, including in
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`Delaware.
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`JURISDICTION AND VENUE
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`9.
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`This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331, 1338(a),
`
`2201, and 2202.
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`10.
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`This Court has personal jurisdiction over Aurobindo Pharma USA Inc. because, on
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`information and belief, Aurobindo Pharma USA Inc. is a corporation organized and existing under
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`the laws of the Delaware, is qualified to do business in Delaware, and has appointed a registered
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`agent for service of process in Delaware. Therefore, Aurobindo Pharma USA Inc. has consented
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`to general jurisdiction in Delaware.
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`11.
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`This Court has personal jurisdiction over Aurobindo Pharma Limited because, inter
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`alia, Aurobindo Pharma Limited, itself and through its subsidiary Aurobindo Pharma USA Inc.,
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`has purposefully availed itself of the benefits and protections of Delaware’s laws such that it should
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`3
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`
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`Case 1:21-cv-00662-UNA Document 1 Filed 05/06/21 Page 4 of 15 PageID #: 4
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`
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`reasonably anticipate being haled into court here. On information and belief, Aurobindo Pharma
`
`Limited, itself and through its subsidiary Aurobindo Pharma USA Inc., develops, manufactures,
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`imports, markets, offers to sell, sells, and/or distributes a broad range of generic pharmaceutical
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`products throughout the United States, including in Delaware, and therefore transacts business
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`within Delaware relating to Plaintiffs’ claims, and/or has engaged in systematic and continuous
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`business contacts within Delaware.
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`12.
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`In addition, this Court has personal jurisdiction over Aurobindo Pharma Limited
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`because, among other things, on information and belief: (1) Aurobindo Pharma Limited and its
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`subsidiary Aurobindo Pharma USA Inc. filed Aurobindo’s ANDA for the purpose of seeking
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`approval to engage in the commercial manufacture, use, sale, or offer for sale of Aurobindo’s
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`Proposed ANDA Product in the United States, including in Delaware; and (2) upon approval of
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`Aurobindo’s ANDA, Aurobindo Pharma Limited and its subsidiary Aurobindo Pharma USA Inc.
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`will market, distribute, offer for sale, sell, and/or import Aurobindo’s Proposed ANDA Product in
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`the United States, including in Delaware, and will derive substantial revenue from the use or
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`consumption of Aurobindo’s Proposed ANDA Product in Delaware. On information and belief,
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`upon approval of Aurobindo’s ANDA, Aurobindo’s Proposed ANDA Product will, among other
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`things, be marketed, distributed, offered for sale, sold, and/or imported in Delaware; prescribed by
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`physicians practicing in Delaware; dispensed by pharmacies located within Delaware; and/or used
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`by patients in Delaware, all of which would have substantial effects on Delaware.
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`13.
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`In addition, this Court has personal jurisdiction over Aurobindo Pharma Limited
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`because it has committed, aided, abetted, induced, contributed to, or participated in the commission
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`of the tortious act of patent infringement that has led and/or will lead to foreseeable harm and
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`injury to Amgen and KAI, both Delaware corporations.
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`4
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`Case 1:21-cv-00662-UNA Document 1 Filed 05/06/21 Page 5 of 15 PageID #: 5
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`14.
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`In addition, this Court has personal jurisdiction over Aurobindo Pharma Limited
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`because it regularly engages in patent litigation concerning Aurobindo’s ANDA products in this
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`District, does not contest personal jurisdiction in this District, and has purposefully availed itself
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`of the rights and benefits of this Court by asserting claims and/or counterclaims in this District.
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`See, e.g., Pfizer Inc. v. Aurobindo Pharma, Ltd., C.A. No. 20-01528 (D. Del.); Amgen Inc. v.
`
`Aurobindo Pharma Ltd., C.A. No. 16-00853 (D. Del.).
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`15.
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`In addition, to the extent personal jurisdiction does not exist over Aurobindo
`
`Pharma Limited in Delaware, this Court has personal jurisdiction over it under Federal Rule of
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`Civil Procedure 4(k)(2) because Aurobindo Pharma Limited is not subject to jurisdiction in any
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`state’s courts of general jurisdiction and exercising jurisdiction over it is consistent with the United
`
`States Constitution and laws.
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`16.
`
`For at least the above reasons, it would not be unfair or unreasonable for Aurobindo
`
`Pharma Limited to litigate this action in this District, and Aurobindo Pharma Limited is subject to
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`personal jurisdiction in this District.
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`17.
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`Venue is proper in this District under 28 U.S.C. § 1400(b) with respect to
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`Aurobindo Pharma USA Inc., at least because, on information and belief, Aurobindo Pharma USA
`
`Inc. is a corporation organized and existing under the laws of Delaware and therefore resides in
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`Delaware for purposes of venue.
`
`18.
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`Venue is proper in this Court under 28 U.S.C. § 1391(c) with respect to Aurobindo
`
`Pharma Limited, at least because, on information and belief, Aurobindo Pharma Limited is a
`
`foreign corporation that may be sued in any judicial district.
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`5
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`Case 1:21-cv-00662-UNA Document 1 Filed 05/06/21 Page 6 of 15 PageID #: 6
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`
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`BACKGROUND
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`PARSABIV® (ETELCALCETIDE)
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`19.
`
`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
`
`on hemodialysis.
`
`20.
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`The active pharmaceutical ingredient in Parsabiv® is etelcalcetide, which was
`
`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.
`
`21.
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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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`22.
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`Amgen, itself or through a subsidiary, markets Parsabiv® (etelcalcetide) in the
`
`United States pursuant to approved New Drug Application (“NDA”) No. 208325.
`
`23.
`
`KAI, a wholly owned subsidiary of Amgen, is the holder of approved NDA No.
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`208325 for Parsabiv® (etelcalcetide).
`
`24.
`
`The ’938 and ’765 patents are listed for NDA No. 208325 for Parsabiv®
`
`(etelcalcetide) in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations,
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`commonly known as the “Orange Book.”
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`6
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`Case 1:21-cv-00662-UNA Document 1 Filed 05/06/21 Page 7 of 15 PageID #: 7
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`25.
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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
`
`Exhibit A.
`
`26.
`
`27.
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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 Aurobindo’s
`
`liability for its infringement of the ’938 patent.
`
`28.
`
`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 B.
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`29.
`
`30.
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`Plaintiffs own and have rights to the ’765 patent.
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`There is an actual case or controversy between the parties regarding Aurobindo’s
`
`liability for its infringement of the ’765 patent.
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`AUROBINDO’S ANDA
`
`On March 26, 2021, Plaintiffs received Aurobindo’s Notice Letter, which informed
`
`31.
`
`Plaintiffs that Aurobindo seeks through ANDA No. 215840 approval to engage in the commercial
`
`manufacture, use, sale, or offer for sale of Aurobindo’s Proposed ANDA Product prior to the
`
`expiration of the Asserted Patents. According to the Notice Letter, included within ANDA No.
`
`215840 is a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“Paragraph IV
`
`Certification”) that the Asserted Patents are invalid, unenforceable, and/or will not be infringed by
`
`the commercial manufacture, use, sale, or offer for sale of Aurobindo’s Proposed ANDA Product.
`
`32.
`
`On information and belief, Aurobindo included within ANDA No. 215840 a
`
`certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(III) (“Paragraph III Certification”) that
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`Aurobindo is not seeking FDA approval to engage in the commercial manufacture, use, sale, offer
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`for sale, and/or importation of Aurobindo’s Proposed ANDA Product prior to the expiration of
`
`7
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`
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`Case 1:21-cv-00662-UNA Document 1 Filed 05/06/21 Page 8 of 15 PageID #: 8
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`
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`U.S. Patent Nos. 8,377,880, 8,999,932, 9,278,995, and 9,701,712, which are also listed in the
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`Orange Book for NDA No. 208325 for Parsabiv® (etelcalcetide).
`
`33.
`
`This action is being filed within 45 days of Plaintiffs’ receipt of Aurobindo’s Notice
`
`Letter.
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`34.
`
`Aurobindo was aware of the Asserted Patents when ANDA No. 215840 was filed
`
`with a Paragraph IV Certification.
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`35.
`
`On information and belief, etelcalcetide is the active ingredient in Aurobindo’s
`
`Proposed ANDA Product. On information and belief, Aurobindo’s Proposed ANDA Product is a
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`pharmaceutical formulation comprising etelcalcetide in an aqueous solution having a pH of 2.0 to
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`5.0.
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`36.
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`On information and belief, ANDA No. 215840 refers to and relies upon the NDA
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`for Parsabiv® (etelcalcetide) and contains data that, according to Aurobindo, demonstrate
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`bioequivalence of Aurobindo’s Proposed ANDA Product and Parsabiv® (etelcalcetide), see
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`21 U.S.C. § 355(j)(2); 21 C.F.R. § 314.94(a)(7), or Aurobindo has sought a waiver of the
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`requirement to demonstrate bioequivalence of its Proposed ANDA Product and Parsabiv®
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`(etelcalcetide).
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`37.
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`On information and belief, Aurobindo intends to have healthcare providers use its
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`Proposed ANDA Product, if approved, as set forth in its Proposed ANDA Product label. On
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`information and belief, Aurobindo’s Proposed ANDA Product label will instruct healthcare
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`providers to prescribe Aurobindo’s Proposed ANDA Product in the manner set forth in the label.
`
`COUNT I
`(Infringement of the ’938 Patent)
`
`38.
`
`Plaintiffs incorporate each of the preceding paragraphs as if fully set forth herein.
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`8
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`Case 1:21-cv-00662-UNA Document 1 Filed 05/06/21 Page 9 of 15 PageID #: 9
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`39.
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`Claim 1 of the ’938 patent covers “[a] pharmaceutical formulation comprising
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`AMG 416 [etelcalcetide] in aqueous solution, wherein the formulation has a pH of 2.0 to 5.0.”
`
`40.
`
`Upon information and belief, Aurobindo’s Proposed ANDA Product is covered by
`
`one or more claims of the ’938 patent, including at least claim 1, because it is a pharmaceutical
`
`formulation comprising etelcalcetide in an aqueous solution having a pH of 2.0 to 5.0.
`
`41.
`
`Upon information and belief, the manufacture, use, sale, offer for sale, or
`
`importation of Aurobindo’s Proposed ANDA Product, or the use of Aurobindo’s Proposed ANDA
`
`Product in accordance with and as directed by Aurobindo’s proposed labeling for that product, will
`
`infringe one or more claims of the ’938 patent, including at least claim 1, either literally or under
`
`the doctrine of equivalents.
`
`42.
`
`Upon information and belief, Aurobindo filed as part of ANDA No. 215840 a
`
`Paragraph IV Certification, asserting that the claims of the ’938 patent are invalid, unenforceable,
`
`and/or not infringed by the manufacture, use, offer for sale, or sale of Aurobindo’s Proposed
`
`ANDA Product.
`
`43.
`
`Aurobindo did not contend in its Notice Letter that Aurobindo’s Proposed ANDA
`
`Product, or the use of Aurobindo’s Proposed ANDA Product in accordance with and as directed
`
`by Aurobindo’s proposed labeling for that product, would not infringe claims 1-14 of the ’938
`
`patent.
`
`44.
`
`Aurobindo has no reasonable basis to believe that Aurobindo’s Proposed ANDA
`
`Product, or the use of Aurobindo’s Proposed ANDA Product in accordance with and as directed
`
`by Aurobindo’s proposed labeling for that product, would not infringe one or more valid claims
`
`of the ’938 patent.
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`9
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`Case 1:21-cv-00662-UNA Document 1 Filed 05/06/21 Page 10 of 15 PageID #: 10
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`45.
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`The purpose of filing ANDA No. 215840 was to obtain approval under the FDCA
`
`to engage in the commercial manufacture, use, offer for sale, and/or sale of Aurobindo’s Proposed
`
`ANDA Product prior to the expiration of the ’938 patent.
`
`46.
`
`Aurobindo’s submission of ANDA No. 215840 for the purpose of obtaining
`
`approval to engage in the commercial manufacture, use, sale and/or offer for sale of Aurobindo’s
`
`Proposed ANDA Product prior to the expiration of the ’938 patent is an act of infringement of the
`
`’938 patent under 35 U.S.C. § 271(e)(2)(A).
`
`47.
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`Upon information and belief, Aurobindo intends to engage in the commercial
`
`manufacture, use, sale and/or offer for sale of Aurobindo’s Proposed ANDA Product and the
`
`proposed labeling therefor immediately and imminently upon the approval of ANDA No. 215840
`
`and any amendments thereto, i.e., prior to the expiration of the ’938 patent.
`
`48.
`
`Upon information and belief, Aurobindo has knowledge of the ’938 patent at least
`
`because the ’938 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, Aurobindo continues to assert its intent to engage in the
`
`manufacture, use, offer for sale, and/or sale of Aurobindo’s Proposed ANDA Product and the
`
`proposed labeling therefor immediately and imminently upon the approval of ANDA No. 215840
`
`and any amendments thereto.
`
`49.
`
`Upon information and belief, Aurobindo plans and intends to, and will, actively
`
`induce infringement of the ’938 patent when ANDA No. 215840 and any amendments thereto are
`
`approved, and will do so with specific intent to induce infringement of the ’938 patent. Further
`
`upon information and belief, Aurobindo plans and intends to, and will, do so immediately and
`
`imminently upon approval.
`
`10
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`Case 1:21-cv-00662-UNA Document 1 Filed 05/06/21 Page 11 of 15 PageID #: 11
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`50.
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`The foregoing actions by Aurobindo constitute and/or will constitute infringement
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`of the ’938 patent and active inducement of infringement of the ’938 patent, either literally or
`
`under the doctrine of equivalents.
`
`51.
`
`Unless Aurobindo is enjoined from infringing the ’938 patent and actively inducing
`
`infringement of the ’938 patent, Plaintiffs will suffer irreparable injury. Plaintiffs have no
`
`adequate remedy at law.
`
`COUNT II
`(Infringement of the ’765 Patent)
`
`52.
`
`53.
`
`Plaintiffs incorporate each of the preceding paragraphs as if fully set forth herein.
`
`Claim 1 of the ’765 patent covers “[a] pharmaceutical formulation comprising
`
`AMG 416 [etelcalcetide] hydrochloride in aqueous solution, wherein the formulation has a pH of
`
`2.0 to 5.0.”
`
`54.
`
`Upon information and belief, Aurobindo’s Proposed ANDA Product is covered by
`
`one or more claims of the ’765 patent, including at least claim 1, because it is a pharmaceutical
`
`formulation comprising etelcalcetide hydrochloride in an aqueous solution having a pH of 2.0 to
`
`5.0.
`
`55.
`
`Upon information and belief, the manufacture, use, sale, offer for sale, or
`
`importation of Aurobindo’s Proposed ANDA Product, or the use of Aurobindo’s Proposed ANDA
`
`Product in accordance with and as directed by Aurobindo’s proposed labeling for that product, will
`
`infringe one or more claims of the ’765 patent, including at least claim 1, either literally or under
`
`the doctrine of equivalents.
`
`56.
`
`Upon information and belief, Aurobindo filed as part of ANDA No. 215840 a
`
`Paragraph IV Certification, asserting that the claims of the ’765 patent are invalid, unenforceable,
`
`11
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`Case 1:21-cv-00662-UNA Document 1 Filed 05/06/21 Page 12 of 15 PageID #: 12
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`
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`and/or not infringed by the manufacture, use, offer for sale, or sale of Aurobindo’s Proposed
`
`ANDA Product.
`
`57.
`
`Aurobindo did not contend in its Notice Letter that Aurobindo’s Proposed ANDA
`
`Product, or the use of Aurobindo’s Proposed ANDA Product in accordance with and as directed
`
`by Aurobindo’s proposed labeling for that product, would not infringe claims 1-14 of the ’765
`
`patent.
`
`58.
`
`Aurobindo has no reasonable basis to believe that Aurobindo’s Proposed ANDA
`
`Product, or the use of Aurobindo’s Proposed ANDA Product in accordance with and as directed
`
`by Aurobindo’s proposed labeling for that product, would not infringe one or more valid claims
`
`of the ’765 patent.
`
`59.
`
`The purpose of filing ANDA No. 215840 was to obtain approval under the FDCA
`
`to engage in the commercial manufacture, use, offer for sale, and/or sale of Aurobindo’s Proposed
`
`ANDA Product prior to the expiration of the ’765 patent.
`
`60.
`
`Aurobindo’s submission of ANDA No. 215840 for the purpose of obtaining
`
`approval to engage in the commercial manufacture, use, sale and/or offer for sale of Aurobindo’s
`
`Proposed ANDA Product prior to the expiration of the ’765 patent is an act of infringement of the
`
`’765 patent under 35 U.S.C. § 271(e)(2)(A).
`
`61.
`
`Upon information and belief, Aurobindo intends to engage in the commercial
`
`manufacture, use, sale and/or offer for sale of Aurobindo’s Proposed ANDA Product and the
`
`proposed labeling therefor immediately and imminently upon the approval of ANDA No. 215840
`
`and any amendments thereto, i.e., prior to the expiration of the ’765 patent.
`
`62.
`
`Upon information and belief, Aurobindo has knowledge of the ’765 patent at least
`
`because the ’765 patent is listed in the FDA’s Orange Book: Approved Drug Products with
`
`12
`
`
`
`Case 1:21-cv-00662-UNA Document 1 Filed 05/06/21 Page 13 of 15 PageID #: 13
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`
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`Therapeutic Equivalence Evaluations for Amgen’s Parsabiv® (etelcalcetide) drug product.
`
`Notwithstanding this knowledge, Aurobindo continues to assert its intent to engage in the
`
`manufacture, use, offer for sale, and/or sale of Aurobindo’s Proposed ANDA Product and the
`
`proposed labeling therefor immediately and imminently upon the approval of ANDA No. 215840
`
`and any amendments thereto.
`
`63.
`
`Upon information and belief, Aurobindo plans and intends to, and will, actively
`
`induce infringement of the ’765 patent when ANDA No. 215840 and any amendments thereto are
`
`approved, and will do so with specific intent to induce infringement of the ’765 patent. Further
`
`upon information and belief, Aurobindo plans and intends to, and will, do so immediately and
`
`imminently upon approval.
`
`64.
`
`The foregoing actions by Aurobindo constitute and/or will constitute infringement
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`of the ’765 patent and active inducement of infringement of the ’765 patent, either literally or
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`under the doctrine of equivalents.
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`65.
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`Unless Aurobindo is enjoined from infringing the ’765 patent and actively inducing
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`infringement of the ’765 patent, Plaintiffs will suffer irreparable injury. Plaintiffs have no
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`adequate remedy at law.
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`
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`WHEREFORE, Plaintiffs request the following relief:
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`REQUEST FOR RELIEF
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`(a)
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`A judgment that Aurobindo’s submission of ANDA No. 215840 to the FDA was
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`an act of infringement of one or more claims of the Asserted Patents;
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`(b)
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`A judgment that Aurobindo’s making, using, offering to sell, selling, marketing,
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`distributing, or importing into the United States Aurobindo’s Proposed ANDA Product prior to the
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`13
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`Case 1:21-cv-00662-UNA Document 1 Filed 05/06/21 Page 14 of 15 PageID #: 14
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`
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`expiration of the Asserted Patents will infringe and/or will actively induce infringement of one or
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`more claims of the Asserted Patents;
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`(c)
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`An Order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective date of
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`any FDA approval for Aurobindo to make, use, offer for sale, sell, market, distribute, or import
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`Aurobindo’s Proposed ANDA Product, or any product the use of which infringes the Asserted
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`Patents, be not earlier than the expiration date of the Asserted Patents, inclusive of any extension(s)
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`and additional period(s) of exclusivity;
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`(d)
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`A permanent injunction pursuant to 35 U.S.C. § 271(e)(4)(B) enjoining Aurobindo,
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`Aurobindo’s affiliates and subsidiaries, each of their officers, agents, servants and employees, and
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`any person acting in concert with Aurobindo, from making, using, selling, offering to sell,
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`marketing, distributing, or importing Aurobindo’s Proposed ANDA Product, or any product the
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`use of which infringes the Asserted Patents, or the inducement of any of the foregoing, prior to the
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`expiration date of the Asserted Patents, inclusive of any extension(s) and additional period(s) of
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`exclusivity;
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`(e)
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`A declaration that this is an exceptional case and an award of attorneys’ fees
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`pursuant to 35 U.S.C. § 285;
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`An award of Plaintiffs’ costs and expenses in this action; and
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`Such further and other relief as this Court may deem just and proper.
`
`(f)
`
`(g)
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`
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`14
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`Case 1:21-cv-00662-UNA Document 1 Filed 05/06/21 Page 15 of 15 PageID #: 15
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`OF COUNSEL:
`
`Adam L. Perlman
`Benjamin J. Behrendt
`David J. Lehr
`LATHAM & WATKINS LLP
`555 Eleventh Street, NW, Suite 1000
`Washington, DC 20004-1304
`(202) 637-2200
`
`Arlene L. Chow
`Michelle L. Ernst
`LATHAM & WATKINS LLP
`1271 Avenue of the Americas
`New York, NY 10020
`(212) 906-1200
`
`Marc N. Zubick
`LATHAM & WATKINS LLP
`330 North Wabash Avenue, Suite 2800
`Chicago, IL 60611
`(312) 876-7606
`
`Yi Sun
`LATHAM & WATKINS LLP
`12670 High Bluff Drive
`San Diego, CA 92130
`(858) 523-5415
`
`Wendy A. Whiteford
`Joseph E. Lasher
`Paula S. Fritsch
`AMGEN INC.
`One Amgen Center Drive
`Thousand Oaks, CA 91320-1789
`(805) 447-1000
`
` May 6, 2021
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`
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`/s/ Jack B. Blumenfeld
`
`
`
`
`Jack B. Blumenfeld (#1014)
`Karen Jacobs (#2881)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@morrisnichols.com
`kjacobs@morrisnichols.com
`
`Attorneys for Plaintiffs Amgen Inc. and
`KAI Pharmaceuticals, Inc.
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`15
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