Case 3:21-cv-12870 Document 1 Filed 06/22/21 Page 1 of 11 PageID: 1
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`Arnold B. Calmann
`Katherine A. Escanlar
`SAIBER LLC
`One Gateway Center, 9th Floor
`Newark, NJ 07102-5308
`T: (973) 622-3333
`abc@saiber.com
`kescanlar@saiber.com
`
`Attorneys for Plaintiff Azurity Pharmaceuticals, Inc.
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
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`AZURITY PHARMACEUTICALS, INC.,
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`Plaintiff,
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`v.
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`BIONPHARMA INC.,
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`Defendant.
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`C.A. No. ___________________
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`Document Filed Electronically
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`)))))))))))))
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`COMPLAINT FOR PATENT INFRINGEMENT
`For its Complaint against Defendant Bionpharma Inc. (“Bionpharma” or “Defendant”),
`Plaintiff Azurity Pharmaceuticals, Inc. (“Azurity” or “Plaintiff”), by and through its attorneys,
`alleges as follows:
`
`THE NATURE OF THE ACTION
`1.
`This is an action for declaratory judgement of patent infringement of United States
`Patent No. 11,040,023 (the “’023 patent”) under the patent laws of the United States, Title 35,
`United States Code, and the Declaratory Judgement Act, Title 28 United States Code, that arises
`out of the filing by Defendant Bionpharma of Abbreviated New Drug Application (“ANDA”) No.
`212408 with the U.S. Food and Drug Administration (“FDA”) seeking approval of a generic
`version of Azurity’s oral solution that is the subject of New Drug Application (“NDA”) No.
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`208686, hereinafter referred to as Azurity’s “Epaned® product,” and Bionpharma’s decision to
`launch that product. Azurity seeks all available relief under the patent laws of the United States,
`35 U.S.C. § 100 et. seq., and the Declaratory Judgment Act, 28 U.S.C. § 2201, and any other
`applicable laws for Defendant’s infringement of the ’023 Patent.
`THE PARTIES
`2.
`Azurity is a corporation organized and existing under the laws of the State of
`Delaware, with a principal place of business at 8 Cabot Road, Suite 2000, Woburn MA 01801.
`3.
`Azurity
`is
`the successor-in-interest
`to Silvergate Pharmaceuticals,
`Inc.
`(“Silvergate”).1
`4.
`On information and belief, Bionpharma is a corporation organized and existing
`under the laws of the State of Delaware, with its principal place of business at 600 Alexander Rd.,
`#2-4B, Princeton, NJ 08540. On information and belief, Bionpharma is in the business of, among
`other things, developing, manufacturing, and selling generic copies of branded pharmaceutical
`products for the U.S. market.
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`JURISDICTION AND VENUE
`5.
`This action arises under the patent laws of the United States of America, 35 U.S.C.
`§ 1, et seq., and from Bionpharma’s submission of ANDA No. 212408.
`6.
`This Court has subject matter jurisdiction over the action under 28 U.S.C. §§ 1331,
`1338(a) (patent infringement) and 28 U.S.C. §2201. Relief is sought under 35 U.S.C. §§ 271(a)-
`(c) and 35 U.S.C. § 271(e).
`7.
`This Court has personal jurisdiction over Bionpharma because, among other things,
`on information and belief, Bionpharma is a corporation with its principal place of business in New
`Jersey.
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`8.
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`Venue is proper in this Court under 28 U.S.C. §§ 1391(c) and 1400(b).
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`1 For simplicity, both Azurity and Silvergate are referred to herein as “Azurity.”
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`AZURITY’S EPANED® PRODUCT
`9.
`Azurity holds approved NDA No. 208686 for a ready-to-use oral solution of
`enalapril maleate, which is prescribed and sold under the trade name Epaned®.
`10.
`Azurity’s Epaned® product is the only FDA approved and labeled ace inhibitor
`treatment that is a ready-to-use oral solution for hypertension in children. Epaned® is also
`indicated to treat hypertension in adults, heart failure, and asymptomatic left ventricular
`dysfunction.
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`PATENTS-IN-SUIT
`11.
`The ’023 Patent, entitled “Enalapril Formulations,” issued on June 22, 2021. A true
`and correct copy of the ’023 Patent is attached to this Complaint as Exhibit A.
`12.
`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.
`13.
`The ’023 patent describes stable, oral liquid formulations of enalapril.
`INFRINGEMENT BY BIONPHARMA
`14.
`By letter dated October 30, 2018, Bionpharma notified Azurity that it had submitted
`ANDA No. 212408 to FDA under Section 505(j)(2)(B) of the Federal Food, Drug and Cosmetic
`Act (“FDCA”) (21 U.S.C. § 355(j)(2)(B) and 21 C.F.R. §314.95) seeking approval to engage in
`the commercial manufacture, use, and sale of a generic version of Azurity’s Epaned® product
`(“Bionpharma ANDA Product”) before the expiration of United States Patent Nos. 9,669,008 (the
`“’008 Patent”), 9,808,442 (the “’442 Patent”), and 10,039,745 (the “’745 Patent”).2
`15.
`By letter dated April 25, 2019, Bionpharma notified Azurity that it had submitted
`ANDA No. 212408 to FDA under Section 505(j)(2)(B) of the FDCA (21 U.S.C. § 355(j)(2)(B)
`and 21 C.F.R. §314.95) seeking approval to engage in the commercial manufacture, use, and sale
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`2 On December 12, 2018, Azurity brought an action against Bionpharma for infringement of
`the ’008 Patent, ’442 Patent, and ’745 Patent in the District of Delaware. That case was captioned
`Silvergate Pharmaceuticals, Inc. v. Bionpharma Inc. C.A. No. 18-1962 (D. Del). A final
`judgment, dated April 29, 2021, is currently on appeal at the Federal Circuit.
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`of the Bionpharma ANDA Product before the expiration of United States Patent No. 10,154,987
`(the “’987 Patent”).3
`16.
`By two separate letters both dated December 4, 2020, Bionpharma notified Azurity
`that it had submitted ANDA No. 212408 to FDA under Section 505(j)(2)(B) of the FDCA (21
`U.S.C. § 355(j)(2)(B) and 21 C.F.R. §314.95) seeking approval to engage in the commercial
`manufacture, use, and sale of the Bionpharma ANDA Product before the expiration of United
`States Patent Nos. 10,772,868 (the “’868 Patent”) and 10,786,482 (the “’482 Patent”).4
`17.
`Each of the ’008, ’442, ’987, ’868, ’481, and ’023 Patents expire on March 25,
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`2036.
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`18.
`On information and belief, Bionpharma intends to engage in commercial
`manufacture, use, and sale of the Bionpharma ANDA Product promptly upon receiving FDA
`approval to do so.
`19.
`On information and belief, Bionpharma is seeking approval to engage in the
`commercial manufacture, use, and sale of the Bionpharma ANDA Product before the expiration
`of the ’023 Patent.
`20.
`On information and belief, Bionpharma’s proposed generic version of Azurity’s
`Epaned® brand product, if approved and marketed, will infringe, either literally or under the
`doctrine of equivalents, at least one claim, including at least claim 1 of the ’023 Patent, under at
`least one of 35 U.S.C. § 271(a), (b), and/or (c).
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`3 On June 7, 2019, Azurity brought an action against Bionpharma for infringement of the ’987
`Patent in the District of Delaware. That case was captioned Silvergate Pharmaceuticals, Inc. v.
`Bionpharma Inc. C.A. No. 19-1067 (D. Del) and proceeded on the same schedule as C.A. No. 18-
`1962. A final judgment, dated April 29, 2021, is currently on appeal at the Federal Circuit.
`
`4 On September 18, 2020, Azurity brought an action against Bionpharma for infringement of
`the ’868 Patent and the ’482 Patent in the District of Delaware. That case was captioned Silvergate
`Pharmaceuticals, Inc. v. Bionpharma Inc. C.A. No. 20-1256 (D. Del). The Parties filed a
`Stipulation of Dismissal on May 17, 2021 pending the outcome of the decision on appeal in C.A.
`No. 18-1962 (D. Del.) and No. 19-1067.
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`21.
`at least one claim, including at least claim 1, of the ’023 Patent by submitting, or causing to be
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`On information and belief, under 35 U.S.C. § 271(e)(2)(A), Bionpharma has infringed
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`submitted, to FDA ANDA No. 212408 seeking approval to manufacture, use, import, offer to sell or
`sell Bionpharma’s proposed generic version of Azurity’s Epaned® brand product before the expiration
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`date of the ’023 Patent. Upon information and belief, the product described in ANDA No. 212408
`would infringe, either literally or under the doctrine of equivalents, at least one claim, including at least
`claim 1 of the ’023 Patent under 35 U.S.C. § 271(e)(2)(A).
`CLAIM FOR RELIEF
`Count I
`(Infringement of the ’023 Patent Under 35 U.S.C. § 271(e)(2)(A))
`
`22.
`Azurity incorporates each of the preceding paragraphs as if fully set forth herein.
`23.
`Bionpharma submitted ANDA No. 212408 to FDA under Section 505(j) of the
`FDCA to obtain approval to engage in the commercial manufacture, use, offer for sale, sale, and/or
`importation of the Bionpharma ANDA Product throughout the United States prior to the expiration
`of the ’023 patent. By submitting the ANDA, Bionpharma has committed an act of infringement
`of the ’023 Patent under 35 U.S.C. § 271(e)(2)(A).
`24.
`There is a definite and concrete, real and substantial, justiciable, and continuing
`case or controversy existing between Azurity and Bionpharma as to the infringement of the ’023
`Patent.
`25.
`If Bionpharma’s ANDA is approved by FDA, the commercial manufacture, use,
`offer for sale, sale, and/or importation of the product that is the subject of Bionpharma’s ANDA
`No. 212408 will constitute an act of direct or indirect infringement of one or more claims of the
`’023 patent under 35 U.S.C. § 271(a)-(c).
`26.
`The commercial manufacture, use, offer for sale, sale, and/or importation of the
`Bionpharma ANDA Product in violation of Azurity’s patent rights will cause substantial and
`irreparable harm to Azurity for which damages are inadequate.
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`Count II
`(Declaratory Judgment of Infringement of the ’023 Patent)
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`27.
`28.
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`Azurity incorporates each of the preceding paragraphs as if fully set forth herein.
`These claims arise under the Declaratory Judgement Act, 28 U.S.C. §§ 2201 and
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`
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`2202.
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`29.
`There is an actual case or controversy such that the Court may entertain Azurity’s
`request for declaratory relief consistent with Article III of the United States Constitution, and that
`actual case or controversy requires a declaration of rights by this Court.
`30.
`Bionpharma has stated that “[a]ny further delay in the launch of Bionpharma’s
`ANDA is simply prejudicial to Bionpharma.” Silvergate Pharmaceuticals, Inc. v. Bionpharma
`Inc. C.A. No. 18-11962 (D. Del) E.C.F. No. 289 at 20.
`31.
`On information and belief, Bionpharma’s ANDA Product has received Tentative
`Approval from FDA.
`32.
`On information and belief, Bionpharma will engage in and/or induce another to
`engage in the commercial manufacture, use, offer for sale, sale, and/or importation of the product
`that is the subject of Bionpharma’s ANDA No. 212408 immediately and imminently upon
`approval of ANDA No. 212408.
`33.
`The commercial manufacture, use, offer for sale, sale, and/or importation of the
`product that is the subject of Bionpharma’s ANDA No. 212408 will constitute an act of direct
`infringement of one or more claims of the ’023 patent under 35 U.S.C. § 271(a).
`34.
`On information and belief, Bionpharma will induce infringement of one or more
`claims of the ’023 patent under 35 U.S.C. § 271(b) by making, using, offering to sell, selling,
`and/or importing Bionpharma’s ANDA Product in the United States. On information and belief,
`upon FDA approval of Bionpharma’s ANDA Product, Bionpharma will intentionally encourage
`acts of direct infringement with knowledge of the ’023 Patent and knowledge that its acts are
`encouraging infringement unless enjoined by the Court.
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`35.
`On information and belief, Bionpharma will contributorily infringe 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 Bionpharma’s ANDA Product in the United States, unless enjoined by this Court.
`On information and belief, Bionpharma has had, and continues to have, knowledge that
`Bionpharma’s ANDA Product is especially adapted for a use that infringes one or more claims of
`the ’023 Patent and that there is no substantial non-infringing use for Bionpharma’s ANDA
`Product.
`36.
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`The foregoing actions by Bionpharma will constitute infringement of the ’023
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`Patent.
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`Bionpharma will commit those acts of infringement without license or
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`37.
`authorization.
`38.
`Azurity is entitled to a declaratory judgement that future commercial manufacture,
`use, offer for sale, sale, and/or importation of the product that is the subject of Bionpharma’s
`ANDA No. 212408 will infringe the ’023 Patent.
`39.
`Azurity does not have an adequate remedy at law.
`40.
`The commercial manufacture, use, offer for sale, sale, and/or importation of the
`Bionpharma ANDA Product in violation of Azurity’s patent rights will cause substantial and
`irreparable harm to Azurity for which damages are inadequate.
`PRAYER FOR RELIEF
`Azurity respectfully requests the following relief:
`
`a)
`A judgment that Bionpharma has infringed the ’023 Patent under 35 U.S.C.
`§ 271(e)(2)(A) by submitting ANDA No. 212408 under Section 505(j) of the FDCA, and that
`Bionpharma’s making, using, offering to sell, or selling in the United States, or importing into the
`United States of the Bionpharma ANDA Product will infringe one or more claims of the ’023
`Patent;
`b)
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`A finding that the ’023 Patent is valid and enforceable;
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`c)
`An order under 35 U.S.C. § 271(e)(4)(A) that the effective date of any FDA
`approval of ANDA No. 212408 shall be a date which is not earlier than the latest expiration date
`of the ’023 Patent, as extended by any applicable periods of exclusivity;
`d)
`An order under 35 U.S.C. § 27l(e)(4)(B) permanently enjoining Bionpharma, 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 ’023 Patent, including the
`Bionpharma ANDA Product;
`e)
`A finding that this action for infringement is an exceptional case under 35 U.S.C.
`§ 285, and that Azurity be awarded reasonable attorneys’ fees and costs; and
`f)
`An award of any such other and further relief as the Court may deem just and
`proper.
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`Dated: June 22, 2021
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`Respectfully submitted,
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`SAIBER LLC
`Attorneys for Plaintiff
`Azurity Pharmaceuticals, Inc.
`
`/s Arnold B. Calmann
`Arnold B. Calmann
`Katherine A. Escanlar
`One Gateway Center, 9th Floor
`Newark, NJ 07102-5308
`T: (973) 622-3333
`abc@saiber.com
`kescanlar@saiber.com
`OF COUNSEL:
`
`Natalie J. Morgan
`WILSON SONSINI GOODRICH &
`ROSATI
`12235 El Camino Real
`Suite 200
`San Diego, CA 92130-3002
`(858) 350-2300
`
`Wendy L. Devine
`Kristina M. Hanson
`WILSON SONSINI GOODRICH &
`ROSATI
`One Market Plaza, Spear Tower
`Suite 3300
`San Francisco, CA 94105
`(415) 947-2000
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`LOCAL CIVIL RULE 11.2 CERTIFICATION
`Pursuant to Local Civil Rule 11.2, the undersigned counsel hereby certifies that this
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`matter in controversy is not the subject of any other action in any other court, or of any pending
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`arbitration or administrative proceeding.
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`Dated: June 22, 2021
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`Respectfully submitted,
`SAIBER LLC
`Attorneys for Plaintiff Azurity Pharmaceuticals, Inc.
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`By: /s Arnold B. Calmann
`Arnold B. Calmann
`Katherine A. Escanlar
`One Gateway Center, 9th Floor
`Newark, NJ 07102-5308
`T: (973)622-3333
`abc@saiber.com
`kescanlar@saiber.com
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`LOCAL CIVIL RULE 201.1 CERTIFICATION
`Under Local Civil Rule 201.1, the undersigned counsel for Plaintiff Azurity
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`Pharmaceuticals, Inc. hereby certifies that it seeks both monetary damages greater than $150,000
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`and injunctive and other equitable relief, and therefore this action is not appropriate for compulsory
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`arbitration.
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`Dated: June 22, 2021
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`Respectfully submitted,
`SAIBER LLC
`Attorneys for Plaintiff Azurity Pharmaceuticals, Inc.
`By: /s Arnold B. Calmann
`Arnold B. Calmann
`Katherine A. Escanlar
`One Gateway Center, 9th Floor
`Newark, NJ 07102-5308
`T: (973)622-3333
`abc@saiber.com
`kescanlar@saiber.com
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