`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE MIDDLE DISTRICT OF FLORIDA
`TAMPA DIVISION
`
`
`
`AZURITY PHARMACEUTICALS,
`INC.,
`
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`
`
`v.
`
`
`CORERX, INC.,
`
`
`Plaintiff,
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`Defendant.
`
`
`
`
`
`
`Case No. 8:21-cv-2515
`
`JURY TRIAL DEMANDED
`
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`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
`
`of the Patents-in-Suit. Azurity seeks all available relief under the patent laws of the
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`
`
`
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`Case 8:21-cv-02515-TPB-SPF Document 1 Filed 10/26/21 Page 2 of 13 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.
`
`THE PARTIES
`
`2.
`
`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.
`
`3.
`
`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-
`
`Suit.
`
`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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`
`
`2
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`Case 8:21-cv-02515-TPB-SPF Document 1 Filed 10/26/21 Page 3 of 13 PageID 3
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`6.
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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
`
`the State of Florida that maintains a principal place of business in Florida.
`
`7.
`
`8.
`
`Venue is proper in this Court under 28 U.S.C. §§ 1391(c) and 1400(b).
`
`AZURITY’S EPANED® PRODUCT
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`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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`9.
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`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
`
`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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`PATENTS-IN-SUIT
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`10. 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
`
`Exhibit A.
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`11. The ’023 patent was duly and legally issued to Azurity as the assignee
`
`and Azurity owns all rights, title, and interest in the ’023 patent.
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`12. 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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`13. The ’023 patent describes stable, oral liquid formulations of enalapril.
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`14. The ’023 patent expires on March 25, 2036.
`
`
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`3
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`Case 8:21-cv-02515-TPB-SPF Document 1 Filed 10/26/21 Page 4 of 13 PageID 4
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`15. 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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`16. The ’405 patent was duly and legally issued to Azurity as the assignee
`
`and Azurity owns all rights, title, and interest in the ’405 patent.
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`17. Pursuant to 21 U.S.C. § 355, the ’405 patent is listed in the Orange Book
`
`in connection with Azurity’s Epaned® product.
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`18. The ’405 patent describes stable, oral liquid formulations of enalapril.
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`19. The ’405 patent expires on March 25, 2036.
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`INFRINGEMENT BY CORERX
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`20. On information and belief, CoreRx developed, manufactures, and sells
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`the CoreRx Formulation.
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`21. 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
`
`patent because the CoreRx Formulation is covered by one or more claims in the ’023
`
`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”).
`
`22. During prior litigation regarding ANDA No. 212408, CoreRx was
`
`represented by the same counsel that represented Bionpharma. See Silvergate
`
`Pharmaceuticals, Inc. v. Bionpharma Inc., C.A. No. 18-1962-LPS, D.I. 56 (D. Del. Mar.
`
`13, 2020) & C.A. No. 19-1067-LPS, D.I. 68 (D. Del. Mar. 13, 2020).
`
`
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`4
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`Case 8:21-cv-02515-TPB-SPF Document 1 Filed 10/26/21 Page 5 of 13 PageID 5
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`23. On information and belief, CoreRx is aware of the ’023 Bionpharma
`
`Action.
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`24. On information and belief, CoreRx is aware that Azurity, in the ’023
`
`Bionpharma Action, filed a motion for preliminary injunction (“Azurity’s PI Motion”)
`
`seeking to enjoin the sale of the CoreRx Formulation.
`
`25. On information and belief, CoreRx is aware that Bionpharma, in
`
`response to Azurity’s PI Motion, does not deny that the CoreRx Formulation infringes
`
`several claims of the ’023 patent.
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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.
`
`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
`
`Action.
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`28. The Patents-in-Suit expire on March 25, 2036.
`
`29. On information and belief, on August 10, 2021, several weeks after the
`
`’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
`
`No. 212408 was approved by FDA. Thereafter, in blatant disregard for Azurity’s
`
`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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`5
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`Case 8:21-cv-02515-TPB-SPF Document 1 Filed 10/26/21 Page 6 of 13 PageID 6
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`30. On information and belief, CoreRx has and continues to engage in the
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`commercial manufacture and sale of the CoreRx Formulation before the expiration of
`
`the Patents-in-Suit with the knowledge and intent to infringe the Patents-in-Suit.
`
`31. On information and belief, the CoreRx Formulation infringes at least one
`
`claim of the Patents-in-Suit, including at least claim 1 of the ’023 patent and claim 1
`
`of the ’405 patent, under at least one of 35 U.S.C. § 271(a), (b), and/or (c).
`
`32. On information and belief, under 35 U.S.C. § 271(a)-(c), CoreRx has
`
`knowingly, willfully, repeatedly, and continually infringed at least one claim of the
`
`Patents-in-Suit, including at least claim 1 of the ’023 patent and claim 1 of the ’405
`
`patent, by manufacturing, using, offering for sale, selling, and/or importing the
`
`CoreRx Formulation, and/or inducement of or contributing to others to do the
`
`foregoing in the United States before the expiration date of the Patents-in-Suit.
`
`CLAIMS FOR RELIEF
`
`Count I
`
`(Infringement of the ’023 Patent Under 35 U.S.C. § 271(a)-(c))
`
`33. Azurity realleges and incorporates paragraphs 1 through 32 as if fully set
`
`forth herein.
`
`34. On information and belief, the CoreRx Formulation has received final
`
`approval from FDA.
`
`35. On information and belief, CoreRx has engaged in and/or induced and
`
`continues to induce another, including Bionpharma, to engage in the commercial
`
`manufacture, use, offer for sale, sale, and/or importation of the CoreRx Formulation.
`
`
`
`6
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`Case 8:21-cv-02515-TPB-SPF Document 1 Filed 10/26/21 Page 7 of 13 PageID 7
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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.
`
`36. The commercial manufacture, use, offer for sale, sale, and/or
`
`importation of the CoreRx Formulation is an act of direct infringement of one or more
`
`claims of the ’023 patent under 35 U.S.C. § 271(a), including at least claim 1 of the
`
`’023 patent.
`
`37. On information and belief, CoreRx is inducing infringement of one or
`
`more claims of the ’023 patent under 35 U.S.C. § 271(b) by inducing the making, using,
`
`offering to sell, selling, and/or importation of the CoreRx Formulation in the United
`
`States. On information and belief, CoreRx is intentionally encouraging acts of direct
`
`infringement with knowledge of the ’023 patent and knowledge that its acts are
`
`encouraging infringement.
`
`38. On information and belief, CoreRx is contributorily infringing one or
`
`more claims of the ’023 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 ’023 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
`
`
`
`7
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`Case 8:21-cv-02515-TPB-SPF Document 1 Filed 10/26/21 Page 8 of 13 PageID 8
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`claims of the ’023 patent and is not a staple article or commodity of commerce suitable
`
`for substantial noninfringing use.
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`39. The foregoing actions by CoreRx constitute infringement of the ’023
`
`patent.
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`40. CoreRx is committing those acts of infringement without license or
`
`authorization.
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`41. CoreRx is committing those acts of infringement despite its knowledge
`
`of both the ’023 patent and the ’023 Bionpharma Action.
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`42. Azurity is entitled to a judgement that the commercial manufacture, use,
`
`offer for sale, sale, and/or importation of the CoreRx Formulation infringes the ’023
`
`patent.
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`43. Azurity has suffered and will continue to suffer financial harm as a result
`
`of CoreRx’s infringing activities.
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`44. 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.
`
`45. Azurity is entitled to monetary damages but, because the infringement
`
`by CoreRx of the ’023 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 ’023 patent, Azurity has no complete, adequate remedy
`
`at law and, therefore, is entitled to injunctive relief.
`
`
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`8
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`Case 8:21-cv-02515-TPB-SPF Document 1 Filed 10/26/21 Page 9 of 13 PageID 9
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`Count II
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`(Infringement of the ’405 Patent Under 35 U.S.C. § 271(a)-(c))
`
`46. Azurity realleges and incorporates paragraphs 1 through 32 as if fully set
`
`forth herein.
`
`47. On information and belief, the CoreRx Formulation has received final
`
`approval from FDA.
`
`48. On information and belief, CoreRx has engaged in and/or induced and
`
`continues to induce another, including Bionpharma, to engage in the commercial
`
`manufacture, use, offer for sale, sale, and/or importation of the CoreRx Formulation.
`
`CoreRx’s acts of infringement have irreparably injured and damaged and continue to
`
`irreparably injure and damage Azurity.
`
`49. The commercial manufacture, use, offer for sale, sale, and/or
`
`importation of the CoreRx Formulation is an act of direct infringement of one or more
`
`claims of the ’405 patent under 35 U.S.C. § 271(a), including at least claim 1 of the
`
`’405 patent.
`
`50. 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.
`
`
`
`9
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`Case 8:21-cv-02515-TPB-SPF Document 1 Filed 10/26/21 Page 10 of 13 PageID 10
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`51. 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.
`
`52. The foregoing actions by CoreRx constitute infringement of the ’405
`
`patent.
`
`53. CoreRx is committing those acts of infringement without license or
`
`authorization.
`
`54. CoreRx is committing those acts of infringement despite its knowledge
`
`of both the ’405 patent and the ’405 Bionpharma Action Azurity is entitled to a
`
`judgement that the commercial manufacture, use, offer for sale, sale, and/or
`
`importation of the CoreRx Formulation infringes the ’405 patent.
`
`55. Azurity has suffered and will continue to suffer financial harm as a result
`
`of CoreRx’s infringing activities.
`
`
`
`10
`
`
`
`Case 8:21-cv-02515-TPB-SPF Document 1 Filed 10/26/21 Page 11 of 13 PageID 11
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`56. 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.
`
`57. 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.
`
`PRAYER FOR RELIEF
`
`Azurity respectfully requests the following relief:
`
`a)
`
`b)
`
`A finding that the Patents-in-Suit are valid and enforceable;
`
`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
`
`
`
`11
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`Case 8:21-cv-02515-TPB-SPF Document 1 Filed 10/26/21 Page 12 of 13 PageID 12
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`directly infringes the Patents-in-Suit and that there is no substantial non-infringing use
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`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;
`
`h)
`
`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
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`35 U.S.C. § 285, and that CoreRx is responsible for payment of Azurity’s attorneys’
`
`fees and costs;
`
`j)
`
`An award of any such other and further relief as the Court may deem just
`
`and proper.
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`DEMAND FOR JURY TRIAL
`
`Plaintiff Azurity hereby demands a trial by jury on all issues so triable
`
`
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`12
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`Case 8:21-cv-02515-TPB-SPF Document 1 Filed 10/26/21 Page 13 of 13 PageID 13
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`/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
`200 South Biscayne Blvd, Suite 4100
`Miami, Florida 33131
`(305) 347-7311
`sgillman@shutts.com
`
`
`
`
`Wendy Devine
`Natalie Morgan
`Tina Hanson
`Ty Callahan
`Nicholas Halkowski
`WILSON SONSINI GOODRICH
`& ROSATI
`One Market Plaza
`Spear Tower, Suite 3300
`San Francisco, CA 94150
`(415) 947-2000
`wdevine@wsgr.com
`nmorgan@wsgr.com
`thanson@wsgr.com
`tcallahan@wsgr.com
`nhalkowski@wsgr.com
`Motions for Special Admission Forthcoming
`
`Attorneys for Plaintiff
`
`
`
`
`
`October 26, 2021
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`13
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