Case 3:21-cv-08717 Document 1 Filed 04/08/21 Page 1 of 13 PageID: 1
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`
`
`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
`
`Attorneys for Plaintiff Azurity Pharmaceuticals, Inc.
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`
`CIVIL ACTION NO.: ____________
`
`
`
`)))))))))
`
`AZURITY PHARMACEUTICALS, INC.,
`
`Plaintiff,
`
`v.
`
`AMNEAL PHARMACEUTICALS, LLC,
`
`Defendant.
`
`
`
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`For its Complaint against Defendant Amneal Pharmaceuticals LLC (“Amneal”), Plaintiff
`
`Azurity Pharmaceuticals, Inc. (“Azurity”), by and through its attorneys, alleges as follows:
`
`The Nature of the Action
`
`1.
`
`This is an action for infringement of United States Patent Nos. 10,695,329 (“the
`
`’329 patent”), 10,799,453 (“the ’453 patent”), 10,894,039 (“the ’039 patent”), and 10,952,998
`
`(“the ’998 patent”) (collectively, the “Katerzia Patents”), arising under the patent laws of the
`
`United States, Title 35, United States Code. This action arises out of the filing by Amneal of
`
`Abbreviated New Drug Application (“ANDA”) No. 215035 with the U.S. Food and Drug
`
`Administration (“FDA”) seeking approval of a generic version of Azurity’s oral liquid
`
`formulation that is the subject of New Drug Application (“NDA”) No. 211340, hereinafter
`
`referred to as Azurity’s “Katerzia® product.” Azurity seeks all available relief under the patent
`
`
`
`
`1
`
`
`
`
`
`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
`
`Attorneys for Plaintiff Azurity Pharmaceuticals, Inc.
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`
`CIVIL ACTION NO.: ____________
`
`
`
`)))))))))
`
`AZURITY PHARMACEUTICALS, INC.,
`
`Plaintiff,
`
`v.
`
`AMNEAL PHARMACEUTICALS, LLC,
`
`Defendant.
`
`
`
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`For its Complaint against Defendant Amneal Pharmaceuticals LLC (“Amneal”), Plaintiff
`
`Azurity Pharmaceuticals, Inc. (“Azurity”), by and through its attorneys, alleges as follows:
`
`The Nature of the Action
`
`1.
`
`This is an action for infringement of United States Patent Nos. 10,695,329 (“the
`
`’329 patent”), 10,799,453 (“the ’453 patent”), 10,894,039 (“the ’039 patent”), and 10,952,998
`
`(“the ’998 patent”) (collectively, the “Katerzia Patents”), arising under the patent laws of the
`
`United States, Title 35, United States Code. This action arises out of the filing by Amneal of
`
`Abbreviated New Drug Application (“ANDA”) No. 215035 with the U.S. Food and Drug
`
`Administration (“FDA”) seeking approval of a generic version of Azurity’s oral liquid
`
`formulation that is the subject of New Drug Application (“NDA”) No. 211340, hereinafter
`
`referred to as Azurity’s “Katerzia® product.” Azurity seeks all available relief under the patent
`
`
`
`
`1
`
`
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`Case 3:21-cv-08717 Document 1 Filed 04/08/21 Page 2 of 13 PageID: 2
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`
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`laws of the United States, 35 U.S.C. § 100 et. seq., and other applicable laws for Amneal’s
`
`infringement of the Katerzia Patents.
`
`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,
`
`Massachusetts, 01801.
`
`3.
`
`On information and belief, Amneal is a limited liability company organized and
`
`existing under the laws of the State of Delaware, with a principal place of business at 400
`
`Crossing Boulevard, Third Floor, Bridgewater, NJ 08807-2863. On information and belief,
`
`Amneal is in the business of, among other things, developing, manufacturing, and selling generic
`
`copies of branded pharmaceutical products for the U.S. market.
`
`Jurisdiction and Venue
`
`4.
`
`This action arises under the patent laws of the United States of America,
`
`35 U.S.C. § 1, et seq. This Court has subject matter jurisdiction over the action under 28 U.S.C.
`
`§§ 1331, 1338(a) (patent infringement). Relief is sought under 35 U.S.C. § 271(e).
`
`5.
`
`This Court has personal jurisdiction over Amneal because, on information and
`
`belief, Amneal is a limited liability company operating a principal place of business at 400
`
`Crossing Boulevard, Third Floor, Bridgewater, NJ 08807-2863.
`
`6.
`
`7.
`
`Venue is proper in this Court under 28 U.S.C. §§ 1391 and 1400(b).
`
`Azurity’s Katerzia® Product
`
`Azurity’s Katerzia® product is an FDA approved and labeled calcium channel
`
`blocker indicated for treatment of hypertension in adults and pediatric patients 6 years of age and
`
`older. Katerzia® is also indicated for treatment of coronary artery disease, including chronic
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`-2-
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`
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`stable angina, vasospastic angina, and angiographically documented coronary artery disease in
`
`patients without heart failure or an ejection fraction < 40%.
`
`8.
`
`Azurity is the holder of approved NDA No. 211340.
`
`Patents-In-Suit
`
`9.
`
`The ’329 patent, entitled “Amlodipine Formulations,” was duly and legally issued
`
`on June 30, 2020. A true and correct copy of the ’329 patent is attached to this Complaint as
`
`Exhibit A.
`
`10.
`
`The face of the ’329 patent names Scott Brauer and Gerold L. Mosher as
`
`inventors and Silvergate Pharmaceuticals, Inc. (“Silvergate”) as assignee. Silvergate assigned all
`
`interest in the ’329 patent to Azurity. Azurity, as assignee, holds all rights to sue and to recover
`
`for infringement of the ’329 patent.
`
`11.
`
`Pursuant to 21 U.S.C. § 355, the ’329 patent is listed in the Approved Drug
`
`Products with Therapeutic Equivalence Evaluations (“the Orange Book”), in connection with
`
`Azurity’s Katerzia® product.
`
`12.
`
`13.
`
`Azurity’s Katerzia® product is covered by at least one claim of the ’329 patent.
`
`The ’453 patent, entitled “Amlodipine Formulations,” was duly and legally issued
`
`on October 13, 2020. A true and correct copy of the ’453 patent is attached to this Complaint as
`
`Exhibit B.
`
`14.
`
`The face of the ’453 patent names Scott Brauer and Gerold L. Mosher as
`
`inventors and Silvergate as assignee. Silvergate assigned all interest in the ’453 patent to
`
`Azurity. Azurity, as assignee, holds all rights to sue and to recover for infringement of the ’453
`
`patent.
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`-3-
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`15.
`
`Pursuant to 21 U.S.C. § 355, the ’453 patent is listed in the Orange Book in
`
`connection with Azurity’s Katerzia® product.
`
`16.
`
`17.
`
`Azurity’s Katerzia® product is covered by at least one claim of the ’453 patent.
`
`The ’039 patent, entitled “Amlodipine Formulations,” was duly and legally issued
`
`on January 19, 2021. A true and correct copy of the ’039 patent is attached to this Complaint as
`
`Exhibit C.
`
`18.
`
`The face of the ’039 patent names Scott Brauer and Gerold L. Mosher as
`
`inventors and Silvergate as assignee. Silvergate assigned all interest in the ’039 patent to
`
`Azurity. Azurity, as assignee, holds all rights to sue and to recover for infringement of the ’039
`
`patent.
`
`19.
`
`Pursuant to 21 U.S.C. § 355, the ’039 patent is listed in the Orange Book in
`
`connection with Azurity’s Katerzia® product.
`
`20.
`
`The use of Azurity’s Katerzia® product is covered by at least one claim of the
`
`’039 patent.
`
`21.
`
`The ’998 patent, entitled “Amlodipine Formulations,” was duly and legally issued
`
`on March 23, 2021. A true and correct copy of the ’998 patent is attached to this Complaint as
`
`Exhibit D.
`
`22.
`
`The face of the ’998 patent names Scott Brauer and Gerold L. Mosher as
`
`inventors and Silvergate as assignee. Silvergate assigned all interest in the ’998 patent to
`
`Azurity. Azurity, as assignee, holds all rights to sue and to recover for infringement of the ’998
`
`patent.
`
`23.
`
`Pursuant to 21 U.S.C. § 355, the ’998 patent is listed in the Orange Book in
`
`connection with Azurity’s Katerzia® product.
`
`
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`-4-
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`24.
`
`Azurity’s Katerzia® product is covered by at least one claim of the ’998 patent.
`
`Infringement by Amneal
`
`25.
`
`By letter dated February 23, 2021 (the “Notice Letter”), Amneal notified Azurity
`
`that it had submitted ANDA No. 215035 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)(iv)(I) and 21 C.F.R. §314.95(c)(1))
`
`seeking approval to engage in the commercial manufacture, use, and sale of a generic version of
`
`Azurity’s Katerzia® product (the “Amneal ANDA Product”) before the expiration of the ’329
`
`and ’453 patents.
`
`26.
`
`On information and belief, Amneal is seeking FDA approval to engage in the
`
`commercial manufacture, use, and sale of the Amneal ANDA Product before the expiration of
`
`the ’329. ’453, ’039 and ’998 patents.
`
`27.
`
`On information and belief, Amneal intends to engage in commercial manufacture,
`
`use, and sale of the Amneal ANDA Product promptly upon receiving FDA approval of its
`
`ANDA.
`
`28.
`
`By filing ANDA No. 215035, Amneal has necessarily represented to FDA that the
`
`Amneal ANDA Product has the same active ingredient as Azurity’s Katerzia® product, as well as
`
`the same dosage form, route of administration, use, and strength as Azurity’s Katerzia® product,
`
`and that it is bioequivalent to Azurity’s Katerzia® product.
`
`FIRST COUNT
`
`Infringement of the ’329 Patent Under 35 U.S.C. § 271 (e)(2)(A)
`
`29.
`
`30.
`
`Azurity incorporates each of the preceding paragraphs as if fully set forth herein.
`
`Amneal submitted ANDA No. 215035 to FDA under section 505(j) of the FDCA
`
`to obtain approval to engage in the commercial manufacture, use, offer for sale, sale, or
`
`
`
`-5-
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`
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`importation of the Amneal ANDA Product throughout the United States. By submitting their
`
`ANDA, Amneal has committed an act of infringement of the ’329 patent under 35 U.S.C. § 271
`
`(e)(2)(A).
`
`31.
`
`If Amneal’s ANDA is approved by FDA, the commercial manufacture, use, offer
`
`to sell, or sale within the United States, and/or importation into the United States of the Amneal
`
`ANDA Product will constitute acts of infringement of the ’329 patent under 35 U.S.C. § 271(a)-
`
`(c).
`
`32.
`
`On information and belief, Amneal had actual and constructive knowledge of the
`
`’329 patent prior to filing ANDA No. 215035 and was aware that filing this ANDA with FDA
`
`constituted an act of infringement of the ’329 patent. Further, on information and belief, Amneal
`
`had specific intent to infringe the ’329 patent when it filed ANDA No. 215035. Moreover, there
`
`are no substantial non-infringing uses for the Amneal ANDA Product other than as the
`
`formulation claimed in the ’329 patent.
`
`33.
`
`The commercial manufacture, use, offer for sale, sale, and/or importation of the
`
`Amneal ANDA Product in violation of Azurity’s patent rights will cause irreparable harm to
`
`Azurity if Amneal’s infringement of the ’329 patent is not enjoined by this Court. Azurity does
`
`not have an adequate remedy at law.
`
`SECOND COUNT
`
`Infringement of the ’453 Patent Under 35 U.S.C. § 271 (e)(2)(A)
`
`34.
`
`35.
`
`Azurity incorporates each of the preceding paragraphs as if fully set forth herein.
`
`Amneal submitted ANDA No. 215035 to FDA under section 505(j) of the FDCA
`
`to obtain approval to engage in the commercial manufacture, use, offer for sale, sale, or
`
`importation of the Amneal ANDA Product throughout the United States. By submitting the
`
`
`
`-6-
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`
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`
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`ANDA, Amneal has committed an act of infringement of the ’453 patent under 35 U.S.C. § 271
`
`(e)(2)(A).
`
`36.
`
`If Amneal’s ANDA is approved by FDA, the commercial manufacture, use, offer
`
`to sell, or sale within the United States, and/or importation into the United States of the Amneal
`
`ANDA Product will constitute acts of infringement of the ’453 patent under 35 U.S.C. § 271(a)-
`
`(c).
`
`37.
`
`On information and belief, Amneal had actual and constructive knowledge of the
`
`’453 patent prior to filing ANDA No. 215035 and was aware that filing this ANDA with FDA
`
`constituted an act of infringement of the ’453 patent. Further, on information and belief, Amneal
`
`had specific intent to infringe the ’453 patent when it filed ANDA No. 215035. Moreover, there
`
`are no substantial non-infringing uses for the Amneal ANDA Product other than as the product
`
`claimed in the ’453 patent.
`
`38.
`
`The commercial manufacture, use, offer for sale, sale, and/or importation of the
`
`Amneal ANDA Product in violation of Azurity’s patent rights will cause irreparable harm to
`
`Azurity if Amneal’s infringement of the ’453 patent is not enjoined by this Court. Azurity does
`
`not have an adequate remedy at law.
`
`THIRD COUNT
`
`Infringement of the ’039 Patent Under 35 U.S.C. § 271 (e)(2)(A)
`
`39.
`
`40.
`
`Azurity incorporates each of the preceding paragraphs as if fully set forth herein.
`
`Amneal submitted ANDA No. 215035 to FDA under section 505(j) of the FDCA
`
`to obtain approval to engage in the commercial manufacture, use, offer for sale, sale, or
`
`importation of the Amneal ANDA Product throughout the United States. By submitting the
`
`
`
`-7-
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`
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`ANDA, Amneal has committed an act of infringement of the ’039 patent under 35 U.S.C. § 271
`
`(e)(2)(A).
`
`41.
`
`If Amneal’s ANDA is approved by FDA, the commercial manufacture, use, offer
`
`to sell, or sale within the United States, and/or importation into the United States of the Amneal
`
`ANDA Product will constitute acts of infringement of the ’039 patent under 35 U.S.C. § 271(a)-
`
`(c).
`
`42.
`
`On information and belief, upon FDA approval of Amneal’s ANDA, Amneal will
`
`intentionally encourage acts of direct infringement with knowledge of the ’039 patent and with
`
`knowledge that its acts are encouraging infringement.
`
`43.
`
`On information and belief, if Amneal’s ANDA is approved by FDA, Amneal will
`
`contributorily infringe one or more claims of the ’039 patent by making, using offering to sell,
`
`selling, and/or importing Amneal’s ANDA Product in the United states. On information and
`
`belief, Amneal has had and continues to have knowledge that Amneal’s ANDA Product is
`
`especially adapted for a use that infringes one or more claims of the ’039 patent and there is no
`
`substantial non-infringing use for Amneal’s ANDA Product.
`
`44.
`
`The commercial manufacture, use, offer for sale, sale, and/or importation of the
`
`Amneal ANDA Product in violation of Azurity’s patent rights will cause irreparable harm to
`
`Azurity if Amneal’s infringement of the ’039 patent is not enjoined by this Court. Azurity does
`
`not have an adequate remedy at law.
`
`FOURTH COUNT
`
`Infringement of the ’998 Patent Under 35 U.S.C. § 271 (e)(2)(A)
`
`45.
`
`Azurity incorporates each of the preceding paragraphs as if fully set forth herein.
`
`
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`-8-
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`Case 3:21-cv-08717 Document 1 Filed 04/08/21 Page 9 of 13 PageID: 9
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`46.
`
`Amneal submitted ANDA No. 215035 to FDA under section 505(j) of the FDCA
`
`to obtain approval to engage in the commercial manufacture, use, offer for sale, sale, or
`
`importation of the Amneal ANDA Product throughout the United States. By submitting the
`
`ANDA, Amneal has committed an act of infringement of the ’998 patent under 35 U.S.C. § 271
`
`(e)(2)(A).
`
`47.
`
`If Amneal’s ANDA is approved by FDA, the commercial manufacture, use, offer
`
`to sell, or sale within the United States, and/or importation into the United States of the Amneal
`
`ANDA Product will constitute acts of infringement of the ’998 patent under 35 U.S.C. § 271(a)-
`
`(c).
`
`48.
`
`On information and belief, upon FDA approval of Amneal’s ANDA, Amneal will
`
`intentionally encourage acts of direct infringement with knowledge of the ’998 patent and with
`
`knowledge that its acts are encouraging infringement.
`
`49.
`
`On information and belief, if Amneal’s ANDA is approved by FDA, Amneal will
`
`contributorily infringe one or more claims of the ’998 patent by making, using offering to sell,
`
`selling, and/or importing Amneal’s ANDA Product in the United states. On information and
`
`belief, Amneal has had and continues to have knowledge that Amneal’s ANDA Product is
`
`especially adapted for a use that infringes one or more claims of the ’998 patent and there is no
`
`substantial non-infringing use for Amneal’s ANDA Product.
`
`50.
`
`The commercial manufacture, use, offer for sale, sale, and/or importation of the
`
`Amneal ANDA Product in violation of Azurity’s patent rights will cause irreparable harm to
`
`Azurity if Amneal’s infringement of the ’998 patent is not enjoined by this Court. Azurity does
`
`not have an adequate remedy at law.
`
`
`
`-9-
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`Case 3:21-cv-08717 Document 1 Filed 04/08/21 Page 10 of 13 PageID: 10
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`Prayer for Relief
`
`Azurity respectfully requests the following relief:
`
`a)
`
`A judgment that Amneal has infringed the ’329, ’453, ’039, and ’998 patents
`
`under 35 U.S.C. § 271(e)(2)(A) by submitting ANDA No. 215035 under Section 505(j) of the
`
`FDCA, and that Amneal’s making, using, offering to sell, or selling in the United States, or
`
`importing into the United States of the Amneal ANDA Product will infringe one or more claims
`
`of the ’329, ’453, ’039, and ’998 patents;
`
`b)
`
`c)
`
`A finding that the ’329, ’453, ’039, and ’998 patents are valid and enforceable;
`
`An order under 35 U.S.C. § 271(e)(4)(A) that the effective date of any FDA
`
`approval of ANDA No. 215035 shall be a date which is not earlier than the latest expiration date
`
`of the ’329, ’453, ’039, and ’998 patents, as extended by any applicable periods of exclusivity;
`
`d)
`
`An order under 35 U.S.C. § 27l(e)(4)(B) permanently enjoining Amneal, 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, or any drug product for
`
`which the use of the drug product is covered by the ’329, ’453, ’039, or ’998 patent, including
`
`the Amneal 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.
`
`DATED: April 8, 2021
`
`Respectfully submitted,
`
`
`
`
`-10-
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`Case 3:21-cv-08717 Document 1 Filed 04/08/21 Page 11 of 13 PageID: 11
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`OF COUNSEL:
`
`Wendy L. Devine
`WILSON, SONSINI, GOODRICH & ROSATI P.C.
`One Market Plaza
`Spear Tower, Suite 3400
`San Francisco, CA 94105-1126
`Telephone: (415) 947-2000
`
`Natalie J. Morgan
`WILSON, SONSINI, GOODRICH & ROSATI P.C.
`12235 El Camino Real
`San Diego, CA 92130-3002
`Telephone: (858) 350-2300
`
`
`
`
`
`
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`SAIBER LLC
`
`/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
`
`Attorneys for Plaintiff Azurity
`Pharmaceuticals, Inc.
`
`
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`-11-
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`Case 3:21-cv-08717 Document 1 Filed 04/08/21 Page 12 of 13 PageID: 12
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`LOCAL CIVIL RULE 11.2 CERTIFICATION
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`Pursuant to Local Civil Rule 11.2, the undersigned counsel hereby certifies that
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`this matter in controversy not is the subject of any other action in any other court, or of any
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`pending arbitration or administrative proceeding.
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`Dated: April 8, 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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`-12-
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`Case 3:21-cv-08717 Document 1 Filed 04/08/21 Page 13 of 13 PageID: 13
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`LOCAL CIVIL RULE 201.1 CERTIFICATION
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`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
`
`and injunctive and other equitable relief, and therefore this action is not appropriate for
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`compulsory arbitration.
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`Dated: April 8, 2021
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`Respectfully submitted,
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`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
`
`-13-
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