Case 8:22-cv-00784 Document 1 Filed 04/01/22 Page 1 of 22 PageID 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE MIDDLE DISTRICT OF FLORIDA
`TAMPA DIVISION
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`AZURITY PHARMACEUTICALS,
`INC.,
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`Plaintiff,
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`)
`)
`)
`)
`)
`)
`)
`)
`)
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`
`v.
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`CORERX, INC.,
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`Defendant.
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`
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`Case No. 8:22-cv-784
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`JURY TRIAL DEMANDED
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`
`COMPLAINT FOR PATENT INFRINGEMENT
`AND BREACH OF CONTRACT
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`For its Complaint against Defendant CoreRx, Inc. (“CoreRx” or “Defendant”),
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`Plaintiff Azurity Pharmaceuticals, Inc. (“Azurity” or “Plaintiff”), by and through its
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`attorneys, alleges as follows:
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`THE NATURE OF THE ACTION
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`1.
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`This is an action for patent infringement of United States Patent Nos.
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`11,040,023 (the “’023 patent”) and 11,141,405 (the “’405 patent”) (collectively the
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`“Patents-in-Suit”) and damages under the patent laws of the United States, Title 35,
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`United States Code, that arises out of CoreRx’s manufacture, use, sale, importation,
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`and/or offer to sell and/or inducement of or contributing to others to do the foregoing
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`within the United States of the product that is the subject of Bionpharma Inc.’s
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`(“Bionpharma”) ANDA No. 212408 (“CoreRx Formulation”) prior to the expiration
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`of the Patents-in-Suit. Azurity seeks all available relief under the patent laws of the
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`1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE MIDDLE DISTRICT OF FLORIDA
`TAMPA DIVISION
`
`
`
`AZURITY PHARMACEUTICALS,
`INC.,
`
`
`Plaintiff,
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`
`
`v.
`
`
`CORERX, INC.,
`
`
`Defendant.
`
`
`
`
`
`
`Case No. 8:22-cv-784
`
`JURY TRIAL DEMANDED
`
`
`COMPLAINT FOR PATENT INFRINGEMENT
`AND BREACH OF CONTRACT
`
`For its Complaint against Defendant CoreRx, Inc. (“CoreRx” or “Defendant”),
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`Plaintiff Azurity Pharmaceuticals, Inc. (“Azurity” or “Plaintiff”), by and through its
`
`attorneys, alleges as follows:
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`THE NATURE OF THE ACTION
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`1.
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`This is an action for patent infringement of United States Patent Nos.
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`11,040,023 (the “’023 patent”) and 11,141,405 (the “’405 patent”) (collectively the
`
`“Patents-in-Suit”) and damages under the patent laws of the United States, Title 35,
`
`United States Code, that arises out of CoreRx’s manufacture, use, sale, importation,
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`and/or offer to sell and/or inducement of or contributing to others to do the foregoing
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`within the United States of the product that is the subject of Bionpharma Inc.’s
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`(“Bionpharma”) ANDA No. 212408 (“CoreRx Formulation”) prior to the expiration
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`of the Patents-in-Suit. Azurity seeks all available relief under the patent laws of the
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`1
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`Case 8:22-cv-00784 Document 1 Filed 04/01/22 Page 2 of 22 PageID 2
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`United States, 35 U.S.C. § 100 et. seq., and any other applicable laws for CoreRx’s
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`infringement of the Patents-in-Suit. This is also an action for breach of contract arising
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`out of the Litigation Settlement Agreement by and between Azurity and CoreRx,
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`dated November 24, 2021 (the “Settlement Agreement”).
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`THE PARTIES
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`2.
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`Azurity is a corporation organized and existing under the laws of the
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`State of Delaware, with a principal place of business at 8 Cabot Road, Suite 2000,
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`Woburn, MA 01801.
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`3.
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`On information and belief, CoreRx is a corporation organized and
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`existing under the laws of the State of Florida, with its principal place of business at
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`14205 Myerlake Cir., Clearwater, FL 33760. On information and belief, CoreRx is in
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`the business of, among other things, developing, manufacturing, and selling generic
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`copies of branded pharmaceutical products for the U.S. market.
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`JURISDICTION AND VENUE
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`4.
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`This action arises under the patent laws of the United States of America,
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`35 U.S.C. § 1, et seq., and from CoreRx’s manufacture, use, sale, importation, and/or
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`offer to sell and/or inducement of or contributing to others to do the foregoing within
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`the United States of the CoreRx Formulation before the expiration of the Patents-in-
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`Suit.
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`5.
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`This Court has subject matter jurisdiction over the action under 28
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`U.S.C. §§ 1331, 1338(a) (patent infringement). Relief is sought under 35 U.S.C.
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`§§ 271(a)-(c).
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`Case 8:22-cv-00784 Document 1 Filed 04/01/22 Page 3 of 22 PageID 3
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`6.
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`This Court has supplemental jurisdiction over Azurity’s breach of
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`contract claim pursuant to 28 U.S.C. § 1367. The federal and state claims alleged
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`herein are so related that they form part of the same case or controversy. Judicial
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`economy, convenience, and fairness to the parties will result if this Court asserts
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`jurisdiction over the breach of contract claims.
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`7.
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`In the alternative, this Court has subject matter jurisdiction over
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`Azurity’s breach of contract claim pursuant to 28 U.S.C. § 1332. The matter in
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`controversy exceeds the sum or value of $75,000, exclusive of interest and costs.
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`8.
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`This Court has personal jurisdiction over CoreRx because, among other
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`things, on information and belief, CoreRx is a corporation formed under the laws of
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`the State of Florida that maintains a principal place of business in Florida.
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`9.
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`Venue is proper in this Court under 28 U.S.C. §§ 1391(c) and 1400(b).
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`AZURITY’S EPANED® PRODUCT
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`10. Azurity holds approved NDA No. 208686 for a ready-to-use oral solution
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`of enalapril maleate, which is prescribed and sold under the trade name Epaned®.
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`11. Azurity’s Epaned® product is the first FDA approved ace inhibitor
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`treatment that is a ready-to-use oral solution for hypertension in children under six
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`years of age. Epaned® is also indicated to treat hypertension in adults, heart failure,
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`and asymptomatic left ventricular dysfunction.
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`Case 8:22-cv-00784 Document 1 Filed 04/01/22 Page 4 of 22 PageID 4
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`PATENTS-IN-SUIT
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`12. The ’023 patent, entitled “Enalapril Formulations,” issued on June 22,
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`2021. A true and correct copy of the ’023 patent is attached to this Complaint as
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`Exhibit A.
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`13. The ’023 patent was duly and legally issued to Azurity as the assignee
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`and Azurity owns all rights, title, and interest in the ’023 patent.
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`14. Pursuant to 21 U.S.C. § 355, the ’023 patent is listed in the Approved
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`Drug Products with Therapeutic Equivalence Evaluations (“the Orange Book”) in
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`connection with Azurity’s Epaned® product.
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`15. The ’023 patent describes stable, oral liquid formulations of enalapril.
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`16. The ’023 patent expires on March 25, 2036.
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`17. The ’405 patent, entitled “Enalapril Formulations,” issued on October
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`12, 2021. A true and correct copy of the ’405 patent is attached to this Complaint as
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`Exhibit B.
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`18. The ’405 patent was duly and legally issued to Azurity as the assignee
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`and Azurity owns all rights, title, and interest in the ’405 patent.
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`19. Pursuant to 21 U.S.C. § 355, the ’405 patent is listed in the Orange Book
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`in connection with Azurity’s Epaned® product.
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`20. The ’405 patent describes stable, oral liquid formulations of enalapril.
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`21. The ’405 patent expires on March 25, 2036.
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`Case 8:22-cv-00784 Document 1 Filed 04/01/22 Page 5 of 22 PageID 5
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`INFRINGEMENT BY CORERX
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`22. On information and belief, CoreRx developed, manufactures, and sells
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`the CoreRx Formulation.
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`23. On June 22, 2021, Azurity brought an action against Bionpharma
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`alleging that the filing of ANDA No. 212408 was an act of infringement of the ’023
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`patent because the CoreRx Formulation is covered by one or more claims in the ’023
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`patent. That case is captioned Azurity Pharmaceuticals, Inc. v. Bionpharma Inc., C.A. No.
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`21-1286-LPS (D. Del.) (“the ’023 Bionpharma Action”).
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`24. During prior litigation regarding ANDA No. 212408, CoreRx was
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`represented by the same counsel that represented Bionpharma. See Silvergate
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`Pharmaceuticals, Inc. v. Bionpharma Inc., C.A. No. 18-1962-LPS, D.I. 56 (D. Del. Mar.
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`13, 2020) & C.A. No. 19-1067-LPS, D.I. 68 (D. Del. Mar. 13, 2020).
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`25. On information and belief, CoreRx is aware of the ’023 Bionpharma
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`Action.
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`26. On October 15, 2021, Azurity brought an action against Bionpharma for
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`infringement of the ’405 patent. That case is captioned Azurity Pharmaceuticals, Inc. v.
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`Bionpharma Inc., C.A. No. 21-1455-LPS (D. Del.) (“the ’405 Bionpharma Action”).
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`27. On information and belief, CoreRx is aware of the ’405 Bionpharma
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`Action.
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`28. On information and belief, on August 10, 2021, several weeks after the
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`’023 patent legally issued from the United States Patent and Trademark Office and
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`Azurity brought suit for infringement of the ’023 patent against Bionpharma, ANDA
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`Case 8:22-cv-00784 Document 1 Filed 04/01/22 Page 6 of 22 PageID 6
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`No. 212408 was approved by FDA. Thereafter, in blatant disregard for Azurity’s
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`patent rights, Bionpharma began offering for sale and selling the CoreRx Formulation
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`which, on information and belief, was manufactured by CoreRx.
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`29. On October 26 and 27, 2021, Azurity brought actions against CoreRx for
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`the infringement of the Patents-in-Suit for CoreRx’s commercial manufacture and sale
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`of the CoreRx Formulation. Those cases are captioned Azurity Pharmaceuticals, Inc. v.
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`CoreRx, Inc., C.A. No. 21-2515 (M.D. Fla.) and Azurity Pharmaceuticals, Inc. v. CoreRx,
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`Inc., C.A. No. 21-1522 (D. Del.).
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`30. These cases were mutually dismissed without prejudice pursuant to the
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`Settlement Agreement. See Azurity Pharmaceuticals, Inc. v. CoreRx, Inc., No. 21-2515,
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`D.I. 16 (M.D. Fla. Nov. 26, 2021); Azurity Pharmaceuticals, Inc. v. CoreRx, Inc., No. 21-
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`1522, D.I. 6 (D. Del. Nov. 26, 2021).
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`31. On information and belief, CoreRx has and now continues to engage in
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`the commercial manufacture and sale of the CoreRx Formulation before the expiration
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`of the Patents-in-Suit with the knowledge and intent to infringe the Patents-in-Suit.
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`32. On information and belief, the CoreRx Formulation infringes at least one
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`claim of the Patents-in-Suit, including at least claim 1 of the ’023 patent and claim 1
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`of the ’405 patent, under at least one of 35 U.S.C. § 271(a), (b), and/or (c).
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`33. On information and belief, under 35 U.S.C. § 271(a)-(c), CoreRx has
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`knowingly, willfully, repeatedly, and continually infringed at least one claim of the
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`Patents-in-Suit, including at least claim 1 of the ’023 patent and claim 1 of the ’405
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`patent, by manufacturing, using, offering for sale, selling, and/or importing the
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`CoreRx Formulation, and/or inducement of or contributing to others to do the
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`foregoing in the United States before the expiration date of the Patents-in-Suit.
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`AZURITY AND CORERX’S CONTRACT
`34. On November 24, 2021, Azurity and CoreRx entered into the Settlement
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`Agreement. A true and correct copy of the Settlement Agreement is attached to this
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`Complaint as Exhibit C.
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`35. Pursuant to the Settlement Agreement, Azurity and CoreRx agreed to
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`“dismiss without prejudice” the prior cases for CoreRx’s alleged infringement of the
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`Patents-in-Suit, and Azurity filed the mutual dismissals on November 26, 2021. See
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`Azurity Pharmaceuticals, Inc. v. CoreRx, Inc., C.A. No. 21-2515, D.I. 16 (M.D. Fla. Nov.
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`26, 2021); Azurity Pharmaceuticals, Inc. v. CoreRx, Inc., C.A. No. 21-1522, D.I. 6 (D. Del.
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`Nov. 26, 2021).
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`36. Pursuant to the Settlement Agreement, Azurity agreed to release CoreRx
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`from liability and from the payment of damages for its alleged infringement of the
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`Patents-in-Suit in those actions on the condition that CoreRx refrain from infringing
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`the Patents-in-Suit by making, using, selling, importing, and/or offering to sell and/or
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`inducing or contributing others to do the same within the United States the CoreRx
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`Formulation. Upon CoreRx performing any of the prohibited activities, this release is
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`no longer effective.
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`37. Azurity is not barred from bringing suit against CoreRx for CoreRx’s past
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`or future infringement of the Patents-in-Suit.
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`BREACH BY CORERX
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`38. On information and belief, CoreRx has and now continues to engage in
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`the commercial manufacture and sale of the CoreRx Formulation in direct violation
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`of the Settlement Agreement.
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`39. No events under the Settlement Agreement have occurred to release or
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`excuse CoreRx’s obligations under the Settlement Agreement.
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`CLAIMS FOR RELIEF
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`Count I
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`(Infringement of the ’023 Patent Under 35 U.S.C. § 271(a))
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`40. Azurity incorporates paragraphs 1 through 39 as if fully set forth herein.
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`41. On information and belief, the CoreRx Formulation has received final
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`approval from FDA.
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`42. On information and belief, CoreRx has engaged in the commercial
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`manufacture, use, offer for sale, sale, and/or importation of the CoreRx Formulation.
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`CoreRx’s acts of infringement have irreparably injured and damaged and continue to
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`irreparably injure and damage Azurity.
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`43. The commercial manufacture, use, offer for sale, sale, and/or
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`importation of the CoreRx Formulation is an act of direct infringement of one or more
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`claims of the ’023 patent under 35 U.S.C. § 271(a), including at least claim 1 of the
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`’023 patent.
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`44. The foregoing actions by CoreRx constitute infringement of the ’023
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`patent.
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`45. CoreRx is committing those acts of infringement without license or
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`authorization.
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`46. CoreRx is committing those acts of infringement despite its knowledge
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`of both the ’023 patent and the ’023 Bionpharma Action.
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`47. Azurity is entitled to a judgement that the commercial manufacture, use,
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`offer for sale, sale, and/or importation of the CoreRx Formulation infringes the ’023
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`patent.
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`48. Azurity has suffered and will continue to suffer financial harm as a result
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`of CoreRx’s infringing activities.
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`49. The commercial manufacture, use, offer for sale, sale, and/or
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`importation of the CoreRx Formulation in violation of Azurity’s patent rights has
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`caused and is continuing to cause substantial and irreparable harm to Azurity for
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`which damages are inadequate.
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`50. Azurity is entitled to monetary damages but, because the infringement
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`by CoreRx of the ’023 patent will continue to cause Azurity irreparable injury and
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`damage for which there is no adequate remedy at law unless and until CoreRx is
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`enjoined from infringing the ’023 patent, Azurity has no complete, adequate remedy
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`at law and, therefore, is entitled to injunctive relief.
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`Count II
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`(Infringement of the ’023 Patent Under 35 U.S.C. § 271(b))
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`51. Azurity incorporates paragraphs 1 through 39 as if fully set forth herein.
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`52. On information and belief, the CoreRx Formulation has received final
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`approval from FDA.
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`53. On information and belief, CoreRx has induced and continues to induce
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`another, including Bionpharma, to engage in the commercial manufacture, use, offer
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`for sale, sale, and/or importation of the CoreRx Formulation. CoreRx’s acts of
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`infringement have irreparably injured and damaged and continue to irreparably injure
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`and damage Azurity.
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`54. On information and belief, CoreRx is inducing infringement of one or
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`more claims of the ’023 patent under 35 U.S.C. § 271(b) by inducing the making, using,
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`offering to sell, selling, and/or importation of the CoreRx Formulation in the United
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`States. On information and belief, CoreRx is intentionally encouraging acts of direct
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`infringement with knowledge of the ’023 patent and knowledge that its acts are
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`encouraging infringement.
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`55. The foregoing actions by CoreRx constitute infringement of the ’023
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`patent.
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`56. CoreRx is committing those acts of infringement without license or
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`authorization.
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`57. CoreRx is committing those acts of infringement despite its knowledge
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`of both the ’023 patent and the ’023 Bionpharma Action.
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`58. Azurity is entitled to a judgment that CoreRx has induced infringement
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`of the ’405 patent by encouraging others to use, sell, offer for sale, and/or import the
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`CoreRx Formulation in the United States before the expiration of the ’023 patent.
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`59. Azurity has suffered and will continue to suffer financial harm as a result
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`of CoreRx’s infringing activities.
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`60.
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`Inducing the commercial manufacture, use, offer for sale, sale, and/or
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`importation of the CoreRx Formulation in violation of Azurity’s patent rights has
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`caused and is continuing to cause substantial and irreparable harm to Azurity for
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`which damages are inadequate.
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`61. Azurity is entitled to monetary damages but, because the infringement
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`by CoreRx of the ’023 patent will continue to cause Azurity irreparable injury and
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`damage for which there is no adequate remedy at law unless and until CoreRx is
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`enjoined from infringing the ’023 patent, Azurity has no complete, adequate remedy
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`at law and, therefore, is entitled to injunctive relief.
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`Count III
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`(Infringement of the ’023 Patent Under 35 U.S.C. § 271(c))
`62. Azurity incorporates paragraphs 1 through 39 as if fully set forth herein.
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`63. On information and belief, the CoreRx Formulation has received final
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`approval from FDA.
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`64. On information and belief, CoreRx has engaged in the commercial
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`manufacture, use, offer for sale, sale, and/or importation of the CoreRx Formulation.
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`CoreRx’s acts of infringement have irreparably injured and damaged and continue to
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`irreparably injure and damage Azurity.
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`65. On information and belief, CoreRx is contributorily infringing one or
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`more claims of the ’023 patent under 35 U.S.C. § 271(c) by making, using, offering to
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`sell, selling, and/or importing the CoreRx Formulation in the United States. On
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`information and belief, CoreRx, through offering to sell or selling the CoreRx
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`Formulation, has offered to sell or sold, and continues to do so, within the United
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`States or import into the United States a component of a composition or material for
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`use in practicing one or more claims of the ’023 patent. On information and belief,
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`CoreRx conducts and has conducted such activities knowing such component of a
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`composition or material to be especially adapted for a use that infringes one or more
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`claims of the ’023 patent and is not a staple article or commodity of commerce suitable
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`for substantial noninfringing use.
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`66. The foregoing actions by CoreRx constitute infringement of the ’023
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`patent.
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`67. CoreRx is committing those acts of infringement without license or
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`authorization.
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`68. CoreRx is committing those acts of infringement despite its knowledge
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`of both the ’023 patent and the ’023 Bionpharma Action.
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`69. Azurity is entitled to a judgement that CoreRx has contributorily
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`infringed the ’023 patent by offering to sell or selling the CoreRx Formulation in the
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`United States before the expiration of the ’023 patent, knowing the same is especially
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`adapted for a use that directly infringes the ’023 patent and that there is no substantial
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`non-infringing use for the CoreRx Formulation.
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`70. Azurity has suffered and will continue to suffer financial harm as a result
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`of CoreRx’s infringing activities.
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`71. The commercial manufacture, use, offer for sale, sale, and/or
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`importation of the CoreRx Formulation in violation of Azurity’s patent rights has
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`caused and is continuing to cause substantial and irreparable harm to Azurity for
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`which damages are inadequate.
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`72. Azurity is entitled to monetary damages but, because the infringement
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`by CoreRx of the ’023 patent will continue to cause Azurity irreparable injury and
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`damage for which there is no adequate remedy at law unless and until CoreRx is
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`enjoined from infringing the ’023 patent, Azurity has no complete, adequate remedy
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`at law and, therefore, is entitled to injunctive relief.
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`Count IV
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`(Infringement of the ’405 Patent Under 35 U.S.C. § 271(a))
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`73. Azurity incorporates paragraphs 1 through 39 as if fully set forth herein.
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`74. On information and belief, the CoreRx Formulation has received final
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`approval from FDA.
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`75. On information and belief, CoreRx has engaged the commercial
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`manufacture, use, offer for sale, sale, and/or importation of the CoreRx Formulation.
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`CoreRx’s acts of infringement have irreparably injured and damaged and continue to
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`irreparably injure and damage Azurity.
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`76. The commercial manufacture, use, offer for sale, sale, and/or
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`importation of the CoreRx Formulation is an act of direct infringement of one or more
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`claims of the ’405 patent under 35 U.S.C. § 271(a), including at least claim 1 of the
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`’405 patent.
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`77. The foregoing actions by CoreRx constitute infringement of the ’405
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`patent.
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`78. CoreRx is committing those acts of infringement without license or
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`authorization.
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`79. CoreRx is committing those acts of infringement despite its knowledge
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`of both the ’405 patent and the ’405 Bionpharma Action.
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`80. Azurity is entitled to a judgement that the commercial manufacture, use,
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`offer for sale, sale, and/or importation of the CoreRx Formulation infringes the ’405
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`patent.
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`81. Azurity has suffered and will continue to suffer financial harm as a result
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`of CoreRx’s infringing activities.
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`82. The commercial manufacture, use, offer for sale, sale, and/or
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`importation of the CoreRx Formulation in violation of Azurity’s patent rights has
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`caused and is continuing to cause substantial and irreparable harm to Azurity for
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`which damages are inadequate.
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`83. Azurity is entitled to monetary damages but, because the infringement
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`by CoreRx of the ’405 patent will continue to cause Azurity irreparable injury and
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`damage for which there is no adequate remedy at law unless and until CoreRx is
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`enjoined from infringing the ’405 patent, Azurity has no complete, adequate remedy
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`at law and, therefore, is entitled to injunctive relief.
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`Count V
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`(Infringement of the ’405 Patent Under 35 U.S.C. § 271(b))
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`84. Azurity incorporates paragraphs 1 through 39 as if fully set forth herein.
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`85. On information and belief, the CoreRx Formulation has received final
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`approval from FDA.
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`86. On information and belief, CoreRx has induced and continues to induce
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`another, including Bionpharma, to engage in the commercial manufacture, use, offer
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`for sale, sale, and/or importation of the CoreRx Formulation. CoreRx’s acts of
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`infringement have irreparably injured and damaged and continue to irreparably injure
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`and damage Azurity.
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`87. On information and belief, CoreRx is inducing infringement of one or
`
`more claims of the ’405 patent under 35 U.S.C. § 271(b) by making, using, offering to
`
`sell, selling, and/or importing the CoreRx Formulation in the United States. On
`
`information and belief, CoreRx is intentionally encouraging acts of direct infringement
`
`with knowledge of the ’405 patent and knowledge that its acts are encouraging
`
`infringement.
`
`88. The foregoing actions by CoreRx constitute infringement of the ’405
`
`patent.
`
`89. CoreRx is committing those acts of infringement without license or
`
`authorization.
`
`90. CoreRx is committing those acts of infringement despite its knowledge
`
`of both the ’405 patent and the ’405 Bionpharma Action.
`
`
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`-15-
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`Case 8:22-cv-00784 Document 1 Filed 04/01/22 Page 16 of 22 PageID 16
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`91. Azurity is entitled to a judgment that CoreRx has induced infringement
`
`of the ’405 patent by encouraging others to use, sell, offer for sale, and/or import the
`
`CoreRx Formulation in the United States before the expiration of the ’405 patent.
`
`92. Azurity has suffered and will continue to suffer financial harm as a result
`
`of CoreRx’s infringing activities.
`
`93. The commercial manufacture, use, offer for sale, sale, and/or
`
`importation of the CoreRx Formulation in violation of Azurity’s patent rights has
`
`caused and is continuing to cause substantial and irreparable harm to Azurity for
`
`which damages are inadequate.
`
`94. Azurity is entitled to monetary damages but, because the infringement
`
`by CoreRx of the ’405 patent will continue to cause Azurity irreparable injury and
`
`damage for which there is no adequate remedy at law unless and until CoreRx is
`
`enjoined from infringing the ’405 patent, Azurity has no complete, adequate remedy
`
`at law and, therefore, is entitled to injunctive relief.
`
`Count VI
`
`(Infringement of the ’405 Patent Under 35 U.S.C. § 271(c))
`
`95. Azurity incorporates paragraphs 1 through 39 as if fully set forth herein.
`
`96. On information and belief, the CoreRx Formulation has received final
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`approval from FDA.
`
`97. On information and belief, CoreRx has engaged in the commercial
`
`manufacture, use, offer for sale, sale, and/or importation of the CoreRx Formulation.
`
`
`
`-16-
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`Case 8:22-cv-00784 Document 1 Filed 04/01/22 Page 17 of 22 PageID 17
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`CoreRx’s acts of infringement have irreparably injured and damaged and continue to
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`irreparably injure and damage Azurity.
`
`98. On information and belief, CoreRx is contributorily infringing one or
`
`more claims of the ’405 patent under 35 U.S.C. § 271(c) by making, using, offering to
`
`sell, selling, and/or importing the CoreRx Formulation in the United States. On
`
`information and belief, CoreRx, through offering to sell or selling the CoreRx
`
`Formulation, has offered to sell or sold, and continues to do so, within the United
`
`States or import into the United States a component of a composition or material for
`
`use in practicing one or more claims of the ’405 patent. On information and belief,
`
`CoreRx conducts and has conducted such activities knowing such component of a
`
`composition or material to be especially adapted for a use that infringes one or more
`
`claims of the ’405 patent and is not a staple article or commodity of commerce suitable
`
`for substantial noninfringing use.
`
`99. The foregoing actions by CoreRx constitute infringement of the ’405
`
`patent.
`
`100. CoreRx is committing those acts of infringement without license or
`
`authorization.
`
`101. CoreRx is committing those acts of infringement despite its knowledge
`
`of both the ’405 patent and the ’405 Bionpharma Action.
`
`102. Azurity is entitled to a judgment that CoreRx has contributorily infringed
`
`the ’405 patent by offering to sell or selling the CoreRx Formulation in the United
`
`States before the expiration of the ’405 patent, knowing the same is especially adapted
`
`
`
`-17-
`
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`
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`Case 8:22-cv-00784 Document 1 Filed 04/01/22 Page 18 of 22 PageID 18
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`for a use that directly infringes the ’405 patent and that there is no substantial non-
`
`infringing use for the CoreRx Formulation.
`
`103. Azurity has suffered and will continue to suffer financial harm as a result
`
`of CoreRx’s infringing activities.
`
`104. The commercial manufacture, use, offer for sale, sale, and/or
`
`importation of the CoreRx Formulation in violation of Azurity’s patent rights has
`
`caused and is continuing to cause substantial and irreparable harm to Azurity for
`
`which damages are inadequate.
`
`105. Azurity is entitled to monetary damages but, because the infringement
`
`by CoreRx of the ’405 patent will continue to cause Azurity irreparable injury and
`
`damage for which there is no adequate remedy at law unless and until CoreRx is
`
`enjoined from infringing the ’405 patent, Azurity has no complete, adequate remedy
`
`at law and, therefore, is entitled to injunctive relief.
`
`Count VII
`
`(Breach of Contract)
`106. Azurity incorporates paragraphs 1 through 39 as if fully set forth herein.
`
`107. Azurity and CoreRx entered into a valid and enforceable contract, the
`
`Settlement Agreement, on or about November 24, 2021.
`
`108. Azurity has fully performed all conditions, covenants, warranties and
`
`promises required under the Settlement Agreement or has been excused from such
`
`performance by CoreRx’s breach.
`
`
`
`-18-
`
`
`
`
`
`Case 8:22-cv-00784 Document 1 Filed 04/01/22 Page 19 of 22 PageID 19
`
`109. Pursuant to the Settlement Agreement, CoreRx was contractually
`
`obligated to refrain from making, using, selling, importing, and/or offering to sell
`
`and/or inducing or contributing to others doing the foregoing within the United States
`
`the CoreRx Formulation.
`
`110. CoreRx materially breached the Settlement Agreement in several ways,
`
`including, without limitation, by: (i) continuing to make, use, offer to sell, or sell in
`
`the United States, or import into the United States the CoreRx Formulation, (ii)
`
`continuing to induce others by encouraging others, including at least Bionpharma, to
`
`use, offer to sell, or sell in the United States, or import into the United States the
`
`CoreRx Formulation, and (iii) contributing to others, including at least Bionpharma,
`
`in doing the foregoing within the United States.
`
`111. CoreRx has not been released or excused from performance by any
`
`events under the Settlement Agreement.
`
`112. Azurity has suffered and continues to suffer financial harm as a result of
`
`CoreRx’s breach.
`
`113. Azurity has been and will be harmed irreparably as a result of CoreRx’s
`
`continued breaches of the Settlement Agreement unless the Court enjoins CoreRx
`
`from further, future breaches.
`
`PRAYER FOR RELIEF
`
`Azurity respectfully requests the following relief:
`
`a)
`
`A finding that the Patents-in-Suit are valid and enforceable;
`
`
`
`-19-
`
`
`
`
`
`Case 8:22-cv-00784 Document 1 Filed 04/01/22 Page 20 of 22 PageID 20
`
`b)
`
`A judgment that CoreRx’s making, using, offering to sell, or selling in the
`
`United States, or importing into the United States of the CoreRx Formulation directly
`
`infringes one or more claims of the Patents-in-Suit;
`
`c)
`
`A judgment that CoreRx has induced infringement of the Patents-in-Suit
`
`by encouraging others to use, sell, offer for sale, and/or import the CoreRx
`
`Formulation in the United States before the expiration of the Patents-in-Suit;
`
`d)
`
`A judgment that CoreRx has contributorily infringed the Patents-in-Suit
`
`by offering to sell or selling the CoreRx Formulation in the United States before the
`
`expiration of the Patents-in-Suit, knowing the same is especially adapted for a use that
`
`directly infringes the Patents-in-Suit and that there is no substantial non-infringing use
`
`for the CoreRx Formulation;
`
`e)
`
`f)
`
`A judgment that CoreRx’s infringement was and is willful;
`
`A finding that Azurity be awarded all damages adequate to compensate
`
`it for CoreRx’s past infringement and any continuing or future infringement of the
`
`Patents-in-Suit in addition to interest and costs;
`
`g)
`
`A permanent injunction enjoining CoreRx, and its subsidiaries, parents,
`
`officers, agents, servants, employees, licensees, representatives, and attorneys, and all
`
`other persons acting or attempting to act in active concert or participation with it or
`
`acting on its behalf, from engaging in the commercial manufacture use, offer to sell,
`
`or importation into the United States, of any drug product covered by the Patents-in-
`
`Suit, including the CoreRx Formulation, until the expiration of the Patents-in-Suit;
`
`
`
`-20-
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`
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`Case 8:22-cv-00784 Document 1 Filed 04/01/22 Page 21 of 22 PageID 21
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`h)
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`A finding that CoreRx’s infringement is willful and that the monetary
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`damages awarded to Azurity be trebled and include pre- and post-judgment interest,
`
`costs, and disbursements pursuant to 35 U.S.C. § 284;
`
`i)
`
`A finding that this action for infringement is an exceptional case under
`
`35 U.S.C. § 285, and that CoreRx is responsible for payment of Azurity’s attorneys’
`
`fees and costs;
`
`j)
`
`k)
`
`A finding that CoreRx has breached the Settlement Agreement;
`
`A judgement that Azurity be awarded damages as a result of CoreRx’s
`
`breach of the Settlement Agreement;
`
`l)
`
`An award of any such other and further relief as the Court may deem just
`
`and proper.
`
`DEMAND FOR JURY TRIAL
`
`Plaintiff Azurity hereby demands a trial by jury on all issues so triable.
`
`April 1, 2022
`
`/Woodrow H. Pollack/
`
`Woodrow H. Pollack
`Lead Counsel
`Fla. Bar No.: 026802
`SHUTTS & BOWEN, LLP
`4301 W Boy Scout Blvd, Suite 300
`Tampa, Florida 33607
`(813) 463-4894
`wpollack@shutts.com
`
`Stephen B. Gillman
`Fla. Bar No.: 196734
`SHUTTS & BOWEN, LLP
`
`
`
`-21-
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`
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`Case 8:22-cv-00784 Document 1 Filed 04/01/22 Page 22 of 22 PageID 22
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`200 South Biscayne Blvd, Suite 4100
`Miami, Florida 33131
`(305) 347-7311
`sgillman@shutts.com
`
`Wendy Devine
`Nicholas Halkowski
`Tina Hanson
`WILSON SONSINI GOODRICH
`& ROSATI
`One Market Plaza
`Spear Tower, Suite 3300
`San Francisco, CA 94150
`(415) 947-2000
`nhalkowski@wsgr.com
`wdevine@wsgr.com
`thanson@wsgr.com
`
`Natalie Morgan
`WILSON SONSINI GOODRICH
`& ROSATI
`12235 El Camino Real
`San Diego, CA 92130
`(858) 350-2300
`nmorgan@wsgr.com
`
`Ty Callahan
`WILSON SONSINI GOODRICH
`& ROSATI
`633 West Fifth Street, Suite 1550
`Los Angeles, CA 90071
`(323) 210-2900
`tcallahan@wsgr.com
`Motions for
`Special Admission Forthcoming
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