Case 3:22-cv-01365-MAS-LHG Document 1 Filed 03/14/22 Page 1 of 74 PageID: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
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`AERIE PHARMACEUTICALS, INC. and )
`AERIE DISTRIBUTION, INC.,
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`) C.A. No. _________________
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`Plaintiffs,
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`v.
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`MICRO LABS LIMITED and
`MICRO LABS USA, INC.,
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`Defendants.
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`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiffs Aerie Pharmaceuticals, Inc. and Aerie Distribution, Inc. (collectively hereinafter,
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`“Aerie”), 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 arising under the patent laws of the United
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`States, Title 35, United States Code and for declaratory judgment pursuant to the Declaratory
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`Judgment Act, 28 U.S.C. §§ 2201, et seq. This action relates to the Abbreviated New Drug
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`Application (“ANDA”) submitted by Micro Labs Limited (“MLL”) and Micro Labs USA, Inc.
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`(“ML USA”) (collectively, “Micro Labs”) to the U.S. Food and Drug Administration (“FDA”) for
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`approval to engage in the commercial manufacture, use, or sale of netarsudil ophthalmic solution,
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`0.02%, a generic version of Aerie’s RHOPRESSA® (ANDA No. 216972), prior to the expiration
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`of U.S. Patent Nos. 8,394,826 (“the ’826 patent”), 10,174,017 (“the ’017 patent”), 10,654,844
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`(“the ’844 patent”), 11,028,081 (“the ’081 patent”), 9,415,043 (“the ’043 patent”), 9,931,336 (“the
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`’336 patent”), 11,185,538 (“the ’538 patent”), and 10,588,901 (“the ’901 patent”).
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`2.
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`This action also relates to the ANDA submitted by MLL and ML USA to the FDA
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`for approval to engage in the commercial manufacture, use, or sale of netarsudil and latanoprost
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`1
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`ophthalmic solution, 0.02%/0.005%, a generic version of Aerie’s ROCKLATAN® (ANDA No.
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`216971), prior to the expiration of the ’826 patent, the ’017 patent, the ’844 patent, the ’081 patent,
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`the ’043 patent, the ’336 patent, the ’538 patent, the ’901 patent, U.S. Patent No. 9,993,470 (“the
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`’470 patent”), and U.S. Patent No. 11,197,853 (“the ’853 patent”).
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`THE PARTIES
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`3.
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`Plaintiff Aerie Pharmaceuticals, Inc. is a company organized and existing under the
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`laws of the State of Delaware, having corporate headquarters at 550 Hills Drive, 3rd Floor,
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`Bedminster, New Jersey 07921.
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`4.
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`Plaintiff Aerie Distribution, Inc. is a company organized and existing under the
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`laws of the State of Delaware, having corporate headquarters at 4301 Emperor Boulevard, Suite
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`400B, Durham, North Carolina 27703.
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`5.
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`Aerie is an ophthalmic pharmaceutical company that discovers, develops,
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`manufactures, and markets novel treatments for diseases of the eye with significant unmet need.
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`6.
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`On information and belief, Defendant MLL is a company organized and existing
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`under the laws of the Republic of India, having a place of business at 31, Race Course Road,
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`Bangalore, India 560 001. On information and belief, MLL is in the business of, among other
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`things, manufacturing and selling generic versions of branded pharmaceutical drugs through
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`various operating subsidiaries, including ML USA, throughout the United States, including in New
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`Jersey.
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`7.
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`On information and belief, Defendant ML USA is a company organized and
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`existing under the laws of New Jersey, having a place of business at 106 Allen Road, Suite 102,
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`Basking Ridge, New Jersey 07920. On information and belief, ML USA is in the business of,
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`2
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`among other things, manufacturing and selling generic versions of branded pharmaceutical drugs
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`throughout the United States, including in New Jersey.
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`8.
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`On information and belief, ML USA is a wholly owned subsidiary of MLL, and is
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`controlled and/or dominated by MLL.
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`9.
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`On information and belief, MLL and ML USA collaborate with respect to the
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`development, regulatory approval, marketing, sale, and/or distribution of pharmaceutical products.
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`On further information and belief, MLL and ML USA are agents of each other and/or operate in
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`concert as integrated parts of the same business group. On information and belief, MLL and ML
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`USA acted in concert to develop the products that are the subject of Micro Labs’ ANDA Nos.
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`216971 and 216972 and to seek regulatory approval from the FDA to market and sell such products
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`throughout the United States, including in New Jersey.
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`10.
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`On information and belief, MLL and ML USA intend to act collaboratively to
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`obtain approval for Micro Labs’ ANDA Nos. 216971 and 216972, and, in the event the FDA
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`approves those ANDAs, to commercially manufacture, use, offer for sale, sell, and/or import the
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`products that are the subjects of such ANDAs in the United States, including in New Jersey.
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`11.
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`On information and belief, Micro Labs assembled and caused to be submitted to
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`the FDA ANDA Nos. 216971 and 216972 pursuant to 21 U.S.C. § 355(j) (§ 505(j) of the FDCA)
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`(hereinafter “Micro Labs’ ANDAs”). ANDA No. 216791 (“Micro Labs’ Netarsudil/Latanoprost
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`ANDA”) concerns a proposed drug product, netarsudil and latanoprost ophthalmic solution at eq
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`0.02% base and 0.005% (“Micro Labs’ Proposed Netarsudil/Latanoprost Product”); ANDA No.
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`216792 (“Micro Labs’ Netarsudil ANDA”) concerns a proposed drug product, netarsudil
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`ophthalmic solution at eq 0.02% base (“Micro Labs’ Proposed Netarsudil Product”) (collectively
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`hereinafter “Micro Labs’ ANDAs” and “Micro Labs’ Proposed ANDA Products”). Micro Labs’
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`3
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`ANDAs refer to and rely upon Aerie’s NDA No. 208254 for RHOPRESSA® and NDA No. 208259
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`for ROCKLATAN®.
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`12.
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`By letter dated January 31, 2022 (“Micro Labs’ Notice Letter”), Micro Labs
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`notified Aerie Pharmaceuticals, Inc. that, as a part of its ANDAs, Micro Labs had filed
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`certifications of the type described in Section 505(j)(2)(A)(vii)(IV) of the FDCA, 21 U.S.C. §
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`355(j)(2)(A)(vii)(IV) with respect to the ’826 patent, the ’017 patent, the ’844 patent, the ’081
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`patent, the ’043 patent, the ’336 patent, the ’538 patent, the ’901 patent, the ’470 patent, and the
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`’853 patent, asserting that the ’826 patent, the ’017 patent, the ’844 patent, the ’081 patent, the
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`’043 patent, the ’336 patent, the ’538 patent, the ’901 patent, the ’470 patent, and the ’853 patent
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`are invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use, and
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`sale of Micro Labs’ Proposed ANDA Products. The ’826 patent, the ’017 patent, the ’844 patent,
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`the ’081 patent, the ’043 patent, the ’336 patent, the ’538 patent, and the ’901 patent are listed in
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`the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange
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`Book”) for RHOPRESSA®. The ’826 patent, the ’017 patent, the ’844 patent, the ’081 patent, the
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`’043 patent, the ’336 patent, the ’538 patent, the ’901 patent, the ’470 patent, and the ’853 patent
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`are listed in the Orange Book for ROCKLATAN®.
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`JURISDICTION AND VENUE
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`13.
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`This action arises under the patent laws of the United States, 35 U.S.C. §§ 100, et
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`seq., and this Court has jurisdiction over the subject matter of this action under 28 U.S.C. §§ 1331,
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`1338(a), 2201, and 2202. Venue is proper in this Court under 28 U.S.C. §§ 1391 and 1400(b).
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`14.
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`This Court has personal jurisdiction over MLL because, inter alia, MLL has
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`purposefully availed itself of the benefits and protections of New Jersey’s laws such that it should
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`reasonably anticipate being haled into court here. On information and belief, MLL develops,
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`4
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`manufactures, imports, markets, offers to sell, sells, and/or distributes a broad range of generic
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`pharmaceutical products throughout the United States, including in New Jersey, and therefore
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`transacts business within New Jersey relating to Aerie’s claims, and/or has engaged in systematic
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`and continuous business contacts within New Jersey.
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`15.
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`In addition, this Court has personal jurisdiction over MLL because, among other
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`things, on information and belief, (1) MLL and its subsidiary ML USA filed Micro Labs’ ANDA
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`for the purpose of seeking approval to engage in the commercial manufacture, use, sale, or offer
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`for sale of Micro Labs’ Proposed ANDA Products in the United States, including in New Jersey,
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`and (2) upon approval of Micro Labs’ ANDAs, MLL and its subsidiary ML USA will market,
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`distribute, offer for sale, sell, and/or import Micro Labs’ Proposed ANDA Products in the United
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`States, including in New Jersey, and will derive substantial revenue from the use or consumption
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`of Micro Labs’ Proposed ANDA Products in New Jersey. On information and belief, upon
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`approval of Micro Labs’ ANDAs, Micro Labs’ Proposed ANDA Products will, among other
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`things, be marketed, distributed, offered for sale, sold, and/or imported in New Jersey; prescribed
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`by physicians practicing in New Jersey; dispensed by pharmacies located within New Jersey;
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`and/or used by patients in New Jersey, all of which would have substantial effects on New Jersey
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`and lead to foreseeable harm and injury to Aerie.
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`16.
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`In addition, this Court has personal jurisdiction over MLL because it regularly
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`engages in patent litigation concerning Micro Labs’ ANDA products in this District, does not
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`contest personal jurisdiction in this District, and has purposefully availed itself of the rights and
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`benefits of this Court by asserting claims and/or counterclaims in this District. See, e.g., Allergan
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`Sales, LLC et al. v. Micro Labs Ltd. and Micro Labs USA, Inc., C.A. No. 19-cv-09759-ES-SCM,
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`5
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`D.I. 10 (D.N.J. June 3, 2019); Takeda GmbH et al. v. Micro Labs USA, Inc. and Micro Labs Ltd.,
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`C.A. No. 15-cv-07921-FLW-DEA, D.I. 7 (D.N.J. Nov. 18, 2015).
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`17.
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`In the alternative, MLL is subject to jurisdiction throughout the United States, and
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`specifically in the State of New Jersey pursuant to Fed. R. Civ. P. 4(k)(2).
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`18.
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`This Court has personal jurisdiction over ML USA because, on information and
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`belief, ML USA is a company organized and existing under the laws of New Jersey and is qualified
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`to do business in New Jersey. Therefore, ML USA has consented to general jurisdiction in New
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`Jersey.
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`19.
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`For at least the above reasons, and for other reasons that will be presented to the
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`Court if jurisdiction is challenged, it would not be unfair or unreasonable for Micro Labs to litigate
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`this action in this District, and Micro Labs is subject to personal jurisdiction in this District.
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`20.
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`Venue is proper in this district for MLL under 28 U.S.C. §§ 1391 and 1400(b)
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`because, inter alia, MLL is a corporation existing under the laws of India and may be sued in any
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`judicial district. 28 U.S.C. § 1391(c)(3).
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`21.
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`Venue is proper in this district for ML USA under 28 U.S.C. § 1400(b) because,
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`inter alia, ML USA is a company organized and existing under the laws of the State of New Jersey.
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`RHOPRESSA®
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`22.
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`Aerie Pharmaceuticals, Inc. holds approved NDA No. 208254 for netarsudil
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`mesylate solution/drops EQ 0.02% base, which is prescribed and sold in the United States under
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`the trademark RHOPRESSA®. The FDA approved NDA No. 208254 on December 18, 2017.
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`23.
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`RHOPRESSA® is indicated for the reduction of elevated intraocular pressure
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`(“IOP”) in patients with open-angle glaucoma or ocular hypertension.
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`24.
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`RHOPRESSA® contains netarsudil as a dimesylate salt (netarsudil dimesylate),
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`which can be referred to by the chemical name (S)-4-(3-amino-1-(isoquinolin-6-yl-amino)-1-
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`oxopropan-2-yl) benzyl 2,4-dimethylbenzoate dimesylate and has the following chemical
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`structure:
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`25.
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`RHOPRESSA® is supplied as a sterile, isotonic, buffered aqueous solution of
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`netarsudil dimesylate. It is intended for topical application in the eye. Each mL of RHOPRESSA®
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`contains 0.2 mg of netarsudil (equivalent to 0.28 mg of netarsudil dimesylate).
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`ROCKLATAN®
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`26.
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`Aerie Pharmaceuticals, Inc. holds approved NDA No. 208259 for latanoprost;
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`netarsudil dimesylate solution/drops 0.005%; EQ 0.02% base, which is prescribed and sold in the
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`United States under the trademark ROCKLATAN®. The FDA approved NDA No. 208259 on
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`March 12, 2019.
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`27.
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`ROCKLATAN® is a fixed dose combination of netarsudil (a Rho kinase inhibitor)
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`and latanoprost (a prostaglandin F2α analogue) indicated for the reduction of elevated IOP in
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`patients with open-angle glaucoma or ocular hypertension.
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`28.
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`ROCKLATAN® contains netarsudil as a dimesylate salt (netarsudil dimesylate),
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`which can be referred to by the chemical name (S)-4-(3-amino-1-(isoquinolin-6-yl-amino)-1-
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`7
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`oxopropan-2-yl) benzyl 2,4-dimethylbenzoate dimesylate and has the following chemical
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`structure:
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`29.
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`ROCKLATAN® contains latanoprost, which is a prostaglandin F2α analogue and
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`can be referred to by the chemical name isopropyl-(Z)-7[1R,2R,3R,5S) 3,5-dihydroxy-2-[(3R)-3-
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`hydroxy-5-phenylpentyl]cyclopentyl]-5-heptenoate. It has the following chemical structure:
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`30.
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`ROCKLATAN® is supplied as a sterile, isotonic, buffered aqueous solution of
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`netarsudil mesylate and latanoprost. Each mL of ROCKLATAN® contains 0.2 mg of netarsudil
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`(equivalent to 0.28 mg of netarsudil dimesylate) and 0.05 mg latanoprost.
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`THE PATENTS-IN-SUIT
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`31.
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`United States Patent No. 8,394,826 (copy attached as Exhibit A) is entitled “Dual
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`Mechanism Inhibitors for the Treatment of Disease” and was duly and legally issued by the United
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`States Patent and Trademark Office on March 12, 2013. It is owned by Aerie Pharmaceuticals,
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`8
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`Inc. and licensed exclusively to Aerie Distribution, Inc. The ’826 patent is directed to, inter alia,
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`netarsudil, pharmaceutical compositions containing netarsudil, methods for treating eye disease,
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`including glaucoma or neurodegenerative eye disease, methods of modulating kinase activity, and
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`methods of reducing IOP, including the uses of ROCKLATAN® and RHOPRESSA® in
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`accordance with the labelings approved by the FDA. It is listed in the Orange Book for
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`ROCKLATAN® and RHOPRESSA®.
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`32.
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`United States Patent No. 10,174,017 (copy attached as Exhibit B) is entitled “Dual
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`Mechanism Inhibitors for the Treatment of Disease” and was duly and legally issued by the United
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`States Patent and Trademark Office on January 8, 2019. It is owned by Aerie Pharmaceuticals,
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`Inc. and licensed exclusively to Aerie Distribution, Inc. The ’017 patent is related to the ’826
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`patent through a series of continuation and divisional applications and relies on the same
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`provisional application as the ’826 patent. The ’017 patent is directed to, inter alia, netarsudil,
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`pharmaceutical compositions containing netarsudil, methods for treating eye disease, including
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`glaucoma, neurodegenerative eye disease, or ocular hypertension, methods of modulating kinase
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`activity, and methods of reducing IOP, including the uses of ROCKLATAN® and RHOPRESSA®
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`in accordance with the labelings approved by the FDA. It is listed in the Orange Book for
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`ROCKLATAN® and RHOPRESSA®.
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`33.
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`United States Patent No. 10,654,844 (copy attached as Exhibit C) is entitled “Dual
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`Mechanism Inhibitors for the Treatment of Disease” and was duly and legally issued by the United
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`States Patent and Trademark Office on May 19, 2020. It is owned by Aerie Pharmaceuticals, Inc.
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`and licensed exclusively to Aerie Distribution, Inc. The ’844 patent is related to the ’826 patent
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`through a series of continuation and divisional applications and relies on the same provisional
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`application as the ’826 and ’017 patents. The ’844 patent is directed to, inter alia, netarsudil,
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`9
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`pharmaceutical compositions containing netarsudil, and methods of treating eye disease, including
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`glaucoma and ocular hypertension, including the uses of ROCKLATAN® and RHOPRESSA® in
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`accordance with the labelings approved by the FDA. It is listed in the Orange Book for
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`ROCKLATAN® and RHOPRESSA®.
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`34.
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`United States Patent No. 11,028,081 (copy attached as Exhibit D) is entitled “Dual
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`Mechanism Inhibitors for the Treatment of Disease” and was duly and legally issued by the United
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`States Patent and Trademark Office on June 8, 2021. It is owned by Aerie Pharmaceuticals, Inc.
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`and licensed exclusively to Aerie Distribution, Inc. The ’081 patent is a continuation of the ’844
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`patent and relies on the same provisional application as the ’844, ’826, and ’017 patents. The ’081
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`patent is directed to, inter alia, methods of treating glaucoma or ocular hypertension including the
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`uses of ROCKLATAN® and RHOPRESSA® in accordance with the labelings approved by the
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`FDA. It is listed in the Orange Book for ROCKLATAN® and RHOPRESSA®.
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`35.
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`United States Patent No. 9,415,043 (copy attached as Exhibit E) is entitled
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`“Combination Therapy” and was duly and legally issued by the United States Patent and
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`Trademark Office on August 16, 2016. It is owned by Aerie Pharmaceuticals, Inc. and licensed
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`exclusively to Aerie Distribution, Inc. The ’043 patent is directed to, inter alia, netarsudil
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`dimesylate and is listed in the Orange Book for ROCKLATAN® and RHOPRESSA®.
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`36.
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`United States Patent No. 9,931,336 (copy attached as Exhibit F) is entitled
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`“Combination Therapy” and was duly and legally issued by the United States Patent and
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`Trademark Office on April 3, 2018. It is owned by Aerie Pharmaceuticals, Inc. and licensed
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`exclusively to Aerie Distribution, Inc. The ’336 patent is a continuation of the ’043 patent and
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`relies on the same provisional patent application. The ’336 patent is directed to, inter alia,
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`compositions containing netarsudil dimesylate, and methods of treating ocular disorders, including
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`10
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`the uses of ROCKLATAN® and RHOPRESSA® in accordance with the labelings approved by the
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`FDA. It is listed in the Orange Book for ROCKLATAN® and RHOPRESSA®.
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`37.
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`United States Patent No. 11,185,538 (copy attached as Exhibit G) is entitled
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`“Compositions for Treating Glaucoma or Reducing Intraocular Pressure” and was duly and legally
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`issued by the United States Patent and Trademark Office on November 30, 2021. It is owned by
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`Aerie Pharmaceuticals, Inc. and licensed exclusively to Aerie Distribution, Inc. The ’538 patent
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`relates to the ’043 and ’336 patents through a series of continuation applications and relies on the
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`same provisional patent application as the ’043 and ’336 patents. The ’538 patent is directed to
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`pharmaceutical compositions containing netarsudil dimesylate. It is listed in the Orange Book for
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`ROCKLATAN® and RHOPRESSA®.
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`38.
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`United States Patent No. 10,588,901 (copy attached as Exhibit H) is entitled
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`“Combination Therapy” and was duly and legally issued by the United States Patent and
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`Trademark Office on March 17, 2020. It is owned by Aerie Pharmaceuticals, Inc. and licensed
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`exclusively to Aerie Distribution, Inc. The ’901 patent is a continuation of the ’470 patent and
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`relies on the same provisional patent application as the ’043, ’336, ’538, and ’470 patents. The
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`’901 patent is directed to, inter alia, netarsudil dimesylate, compositions containing netarsudil
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`dimesylate or netarsudil dimesylate and latanoprost, and methods of treating ocular disorders and
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`reducing IOP, including the uses of ROCKLATAN® and RHOPRESSA® in accordance with the
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`labelings approved by the FDA. It is listed in the Orange Book for ROCKLATAN® and
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`RHOPRESSA®.
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`39.
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`United States Patent No. 9,993,470 (copy attached as Exhibit I) is entitled
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`“Combination Therapy” and was duly and legally issued by the United States Patent and
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`Trademark Office on June 12, 2018. It is owned by Aerie Pharmaceuticals, Inc. and licensed
`
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`11
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`exclusively to Aerie Distribution, Inc. The ’470 patent relies on the same provisional patent
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`application as the ’043, ’336, ’538, and ’901 patents. The ’470 patent is directed to pharmaceutical
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`compositions containing, inter alia, netarsudil dimesylate and latanoprost, and methods of treating
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`ocular disorders, including the use of ROCKLATAN® in accordance with the labeling approved
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`by the FDA. It is listed in the Orange Book for ROCKLATAN®.
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`40.
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`United States Patent No. 11,197,853 (copy attached as Exhibit J) is entitled
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`“Combination Therapy” and was duly and legally issued by the United States Patent and
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`Trademark Office on December 14, 2021. It is owned by Aerie Pharmaceuticals, Inc. and licensed
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`exclusively to Aerie Distribution, Inc. The ’853 patent relates to the ’043 and ’336 patents through
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`a series of continuation applications and relies on the same provisional patent application as the
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`’043, ’336, ’538, ’901, and ’470 patents. The ’853 patent is directed to pharmaceutical
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`compositions containing, inter alia, netarsudil dimesylate and latanoprost. It is listed in the Orange
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`Book for ROCKLATAN®.
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`41.
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`The submission of Micro Labs’ ANDAs and Micro Labs’ intention to commercially
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`manufacture, use, offer for sale, sell, and/or import Micro Labs’ Proposed ANDA Products upon
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`receiving FDA approval create an actual case or controversy with respect to infringement of the
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`’826 patent, the ’017 patent, the ’844 patent, the ’081 patent, the ’043 patent, the ’336 patent, the
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`’538 patent, the ’901 patent, the ’470 patent, and the ’853 patent.
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`COUNT I: INFRINGEMENT OF
`U.S. PATENT NO. 8,394,826 BY MICRO LABS’ ANDA NO. 216972
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`42.
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`Aerie incorporates each of the preceding paragraphs 1 – 41 as if fully set forth
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`herein.
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`43.
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`On information and belief, Micro Labs submitted ANDA No. 216972 to the FDA
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`under the provisions of 21 U.S.C. § 355(j).
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`12
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`44. Micro Labs, via its Notice Letter, has indicated its intent to engage in the
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`commercial manufacture, use, offer for sale, sale, marketing, distribution, and/or importation of
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`its Proposed Netarsudil Product prior to the expiration of the ’826 patent.
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`45.
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`On information and belief, Micro Labs intends to engage in the commercial
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`manufacture, use, offer for sale, sale, marketing, distribution, and/or importation of its Proposed
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`Netarsudil Product with proposed labeling immediately and imminently upon final approval of its
`
`Netarsudil ANDA.
`
`46.
`
`On information and belief, Micro Labs made and included in its Netarsudil ANDA
`
`a Paragraph IV Certification stating that, in Micro Labs’ opinion, the ’826 patent is invalid,
`
`unenforceable and/or not infringed.
`
`47.
`
`By submitting and maintaining its Netarsudil ANDA for the purpose of obtaining
`
`approval to engage in the commercial manufacture, use, offer to sell, or sale of its Proposed
`
`Netarsudil Product prior to the expiration of the ’826 patent, Micro Labs has committed an act of
`
`infringement of one or more claims of the ’826 patent under 35 U.S.C. § 271(e)(2)(A).
`
`48. Micro Labs’ Notice Letter states that Micro Labs’ Proposed Netarsudil Product
`
`contains
`
`(S)-4-(3-amino-1-(isoquinolin-6-yl-amino)-1-oxopropan-2-yl)
`
`benzyl
`
`2,4-
`
`dimethylbenzoate dimesylate, commonly known as netarsudil dimesylate (a pharmaceutically
`
`acceptable salt of netarsudil), and that the dosage form is an ophthalmic solution.
`
`49.
`
`Thus, on information and belief, Micro Labs’ Proposed Netarsudil Product will
`
`directly infringe one or more of the claims of the ’826 patent under 35 U.S.C. § 271(a), either
`
`literally or under the doctrine of equivalents.
`
`50.
`
`On information and belief, Micro Labs’ Netarsudil ANDA seeks FDA approval of
`
`Micro Labs’ Proposed Netarsudil Product for the reduction of elevated IOP in patients with open-
`
`
`
`
`
`13
`
`

`

`Case 3:22-cv-01365-MAS-LHG Document 1 Filed 03/14/22 Page 14 of 74 PageID: 14
`
`
`
`angle glaucoma or ocular hypertension, and the recommended dosage of Micro Labs’ Proposed
`
`Netarsudil Product will be one drop in the affected eye(s) once daily in the evening.
`
`51.
`
`On information and belief, Micro Labs’ Proposed Netarsudil Product is especially
`
`made or adapted for use in infringing the ’826 patent, and Micro Labs’ Proposed Netarsudil
`
`Product is not suitable for any substantial noninfringing use.
`
`52.
`
`Thus, on information and belief, Micro Labs will contribute to the infringement of
`
`one or more claims of the ’826 patent under 35 U.S.C. § 271(c).
`
`53.
`
`On information and belief, Micro Labs’ Proposed Netarsudil Product, if approved
`
`and marketed, will be accompanied by a product label that will induce physicians to treat ocular
`
`(eye) disorders, including glaucoma or neurodegenerative eye disease, reduce IOP, and modulate
`
`kinase activity, comprising administering netarsudil dimesylate topically to an eye of the subject,
`
`and thereby induce infringement of the methods of one or more claims of the ’826 patent under 35
`
`U.S.C. § 271(b).
`
`54.
`
`On information and belief, Micro Labs will sell its Proposed Netarsudil Product
`
`with instructions encouraging or promoting its use by physicians or patients in a manner that will
`
`induce the infringement of one or more claims of the ’826 patent under 35 U.S.C. § 271(b).
`
`55.
`
`Accordingly, unless enjoined by this Court, upon FDA approval of ANDA No.
`
`216972, Micro Labs will make, use, offer to sell, or sell Micro Labs’ Proposed Netarsudil Product
`
`within the United States, or will import Micro Labs’ Proposed Netarsudil Product into the United
`
`States, and will thereby infringe, or induce or contribute to infringement of, one or more claims of
`
`the ’826 patent.
`
`56.
`
`On information and belief, Micro Labs has actual knowledge of the ’826 patent, as
`
`demonstrated by at least Micro Labs’ certification of the type described in Section
`
`
`
`
`
`14
`
`

`

`Case 3:22-cv-01365-MAS-LHG Document 1 Filed 03/14/22 Page 15 of 74 PageID: 15
`
`
`
`505(j)(2)(A)(vii)(IV) of the FDCA, 21 U.S.C. § 355(j)(2)(A)(vii)(IV) described in Micro Labs’
`
`Notice Letter, and was aware that the filing of ANDA No. 216972 would constitute an act of
`
`infringement of the ’826 patent. Micro Labs has no reasonable basis for asserting that the
`
`commercial manufacture, use, offer for sale, or sale of Micro Labs’ Proposed Netarsudil Product
`
`would not infringe one or more claims of the ’826 patent.
`
`57.
`
`If Micro Labs’ infringement of the ’826 patent is not permanently enjoined, Aerie
`
`will suffer substantial and irreparable harm for which there is no remedy at law.
`
`COUNT II: INFRINGEMENT OF
`U.S. PATENT NO. 8,394,826 BY MICRO LABS’ ANDA NO. 216971
`
`58.
`
`Aerie incorporates each of the preceding paragraphs 1 – 57 as if fully set forth
`
`herein.
`
`59.
`
`On information and belief, Micro Labs submitted ANDA No. 216971 to the FDA
`
`under the provisions of 21 U.S.C. § 355(j).
`
`60. Micro Labs, via its Notice Letter, has indicated its intent to engage in the
`
`commercial manufacture, use, offer for sale, sale, marketing, distribution, and/or importation of
`
`its Proposed Netarsudil/Latanoprost Product prior to the expiration of the ’826 patent.
`
`61.
`
`On information and belief, Micro Labs intends to engage in the commercial
`
`manufacture, use, offer for sale, sale, marketing, distribution, and/or importation of its Proposed
`
`Netarsudil/Latanoprost Product with proposed labeling immediately and imminently upon final
`
`approval of its Netarsudil/Latanoprost ANDA.
`
`62.
`
`On
`
`information and belief, Micro Labs made and
`
`included
`
`in
`
`its
`
`Netarsudil/Latanoprost ANDA a Paragraph IV Certification stating that, in Micro Labs’ opinion,
`
`the ’826 patent is invalid, unenforceable and/or not infringed.
`
`
`
`
`
`15
`
`

`

`Case 3:22-cv-01365-MAS-LHG Document 1 Filed 03/14/22 Page 16 of 74 PageID: 16
`
`
`
`63.
`
`By submitting and maintaining its Netarsudil/Latanoprost ANDA for the purpose
`
`of obtaining approval to engage in the commercial manufacture, use, offer to sell, or sale of its
`
`Proposed Netarsudil/Latanoprost Product prior to the expiration of the ’826 patent, Micro Labs
`
`has committed an act of infringement of one or more claims of the ’826 patent under 35 U.S.C. §
`
`271(e)(2)(A).
`
`64. Micro Labs’ Notice Letter states that Micro Labs’ Proposed Netarsudil/Latanoprost
`
`Product contains (S)-4-(3-amino-1-(isoquinolin-6-yl-amino)-1-oxopropan-2-yl) benzyl 2,4-
`
`dimethylbenzoate dimesylate, commonly known as netarsudil dimesylate (a pharmaceutically
`
`acceptable salt of netarsudil), and isopropyl-(Z)-7[1R,2R,3R,5S) 3,5-dihydroxy-2-[(3R)-3-
`
`hydroxy-5-phenylpentyl]cyclopentyl]-5-heptenoate, commonly known as latanoprost, and that the
`
`dosage form is an ophthalmic solution.
`
`65.
`
`Thus, on information and belief, Micro Labs’ Proposed Netarsudil/Latanoprost
`
`Product will directly infringe one or more of the claims of the ’826 patent under 35 U.S.C. § 271(a),
`
`either literally or under the doctrine of equivalents.
`
`66.
`
`On information and belief, Micro Labs’ Netarsudil/Latanoprost ANDA seeks FDA
`
`approval of Micro Labs’ Proposed Netarsudil/Latanoprost Product for the reduction of elevated
`
`IOP in patients with open-angle glaucoma or ocular hypertension, and the recommended dosage
`
`of Micro Labs’ Proposed Netarsudil/Latanoprost Product will be one drop in the affected eye(s)
`
`once daily in the evening.
`
`67.
`
`On information and belief, Micro Labs’ Proposed Netarsudil/Latanoprost Product
`
`is especially made or adapted for use in infringing the ’826 patent, and Micro Labs’ Proposed
`
`Netarsudil/Latanoprost Product is not suitable for any substantial noninfringing use.
`
`
`
`
`
`16
`
`

`

`Case 3:22-cv-01365-MAS-LHG Document 1 Filed 03/14/22 Page 17 of 74 PageID: 17
`
`
`
`68.
`
`Thus, on information and belief, Micro Labs will contribute to the infringement of
`
`one or more claims of the ’826 patent under 35 U.S.C. § 271(c).
`
`69.
`
`On information and belief, Micro Labs’ Proposed Netarsudil/Latanoprost Product,
`
`if approved and marketed, will be accompanied by a product label that will induce physicians to
`
`treat ocular (eye) disorders, including glaucoma or neurodegenerative eye disease, reduce IOP,
`
`and modulate kinase activity, comprising administering netarsudil dimesylate topically to an eye
`
`of the subject, and thereby induce infringement of the methods of one or more claims of the ’826
`
`patent under 35 U.S.C. § 271(b).
`
`70.
`
`On
`
`information
`
`and belief, Micro Labs will
`
`sell
`
`its Proposed
`
`Netarsudil/Latanoprost Product with instructions encouraging or promoting its use by physicians
`
`or patients in a manner that will induce the infringement of one or more claims of the ’826 patent
`
`under 35 U.S.C. § 271(b).
`
`71.
`
`Accordingly, unless enjoined by this Court, upon FDA approval of ANDA No.
`
`216971, Micro Labs will make, use, offer
`
`to sell, or sell Micro Labs’ Proposed
`
`Netarsudil/Latanoprost Product within the United States, or will import Micro Labs’ Proposed
`
`Netarsudil/Latanoprost Product into the United States, and will thereby infringe, or induce or
`
`contribute to infringement of, one or more claims of the ’826 patent.
`
`72.
`
`On information and belief, Micro Labs has actual knowledge of the ’826 patent, as
`
`demonstrated by at least Micro Labs’ certification of the type described in Section
`
`505(j)(2)(A)(vii)(IV) of the FDCA, 21 U.S.C. § 355(j)(2)(A)(vii)(IV) described in Micro Labs’
`
`Notice Letter, and was aware that the filing of ANDA No. 216971 would constitute an act of
`
`infringement of the ’826 patent. Micro Labs has no reasonable basis for asserting that the
`
`
`
`
`
`17
`
`

`

`Case 3:22-cv-01365-MAS-LHG Document 1 Filed 03/14/22 Page 18 of 74 PageID: 18
`
`
`
`commercial manufacture, use, offer
`
`for sale, or sale of Micro Labs’ Proposed
`
`Netarsudil/Latanoprost Product would not infringe one or more claims of the ’826 patent.