Case 1:21-cv-00425-UNA Document 1 Filed 03/24/21 Page 1 of 20 PageID #: 1
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`C.A. No. _______________________
`
`ASTELLAS PHARMA INC., ASTELLAS
`IRELAND CO., LTD. and ASTELLAS
`PHARMA GLOBAL DEVELOPMENT,
`INC.,
`
`Plaintiffs,
`
`v.
`
`AUROBINDO PHARMA LTD.,
`AUROBINDO PHARMA USA, INC.,
`AUROLIFE PHARMA LLC, ACTAVIS
`ELIZABETH LLC, ACTAVIS LLC, TEVA
`PHARMACEUTICALS USA, INC.,
`ZYDUS PHARMACEUTICALS (USA),
`INC., CADILA HEALTHCARE LTD.
`(d/b/a ZYDUS CADILA), LUPIN LTD. and
`LUPIN PHARMACEUTICALS, INC.
`
`Defendants.
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiffs Astellas Pharma Inc., Astellas Ireland Co., Ltd. and Astellas Pharma Global
`
`Development, Inc. (collectively, “Astellas” or “Plaintiffs”), by their undersigned attorneys, hereby
`
`allege as follows:
`
`NATURE OF ACTION
`
`1.
`
`This is an action for patent infringement of United States Patent No. 10,842,780
`
`(“the ’780 Patent”), arising under the United States patent laws, Title 35, United States Code. This
`
`action relates to the Abbreviated New Drug Applications (“ANDAs”) submitted by the above-
`
`named Defendants under Section 505(j) of the Federal Food, Drug and Cosmetic Act (“FDCA”),
`
`21 U.S.C. § 355(j), seeking United States Food and Drug Administration (“FDA”) approval to
`
`market generic pharmaceutical products.
`
`

`

`Case 1:21-cv-00425-UNA Document 1 Filed 03/24/21 Page 2 of 20 PageID #: 2
`
`THE PARTIES
`
`A.
`
`Astellas Pharma Inc., Astellas Ireland Co., Ltd. and Astellas Pharma Global
`Development, Inc.
`
`2.
`
`Plaintiff Astellas Pharma Inc. (“API”) is a corporation organized and existing under
`
`the laws of Japan, having its principal place of business at 2-5-1, Nihonbashi-Honcho, Chuo-Ku,
`
`Tokyo 103-8411, Japan. API was formed on April 1, 2005, from the merger of Yamanouchi
`
`Pharmaceutical Co., Ltd. and Fujisawa Pharmaceutical Co., Ltd.
`
`3.
`
`Plaintiff Astellas Ireland Co., Ltd. (“AICL”) is a corporation organized and existing
`
`under the laws of Ireland, having its principal place of business at Damastown Road, Damastown
`
`Industrial Park, Mulhuddart, Dublin 15, Ireland. AICL is a subsidiary of Plaintiff API.
`
`4.
`
`Plaintiff Astellas Pharma Global Development, Inc. (“APGD”) is a corporation
`
`organized and existing under the laws of the State of Delaware, having its principal place of
`
`business at 1 Astellas Way, Northbrook, Illinois 60062. APGD is a subsidiary of Plaintiff API.
`
`B.
`
`Aurobindo Pharma Ltd., Aurobindo Pharma USA, Inc. and Aurolife Pharma LLC
`(collectively, “Aurobindo”)
`
`5.
`
`On information and belief, Defendant Aurobindo Pharma Ltd. is a corporation
`
`organized and existing under the laws of India, having a principal place of business at Plot No. 2,
`
`Maitrivihar, Ameerpet, Hyderabad-500038, Telangana, India. On information and belief,
`
`Aurobindo Pharma Ltd. is in the business of, inter alia, developing, manufacturing and/or
`
`distributing generic drug products for marketing, sale, and/or use throughout the United States
`
`including in this judicial district.
`
`6.
`
`On information and belief, Defendant Aurobindo Pharma USA, Inc. is a
`
`corporation organized and existing under the laws of Delaware, having a principal place of
`
`business at 6 Wheeling Road, Dayton, New Jersey 08810. On information and belief, Aurobindo
`
`Pharma USA, Inc. is in the business of, inter alia, developing, manufacturing and/or distributing
`
`2
`
`

`

`Case 1:21-cv-00425-UNA Document 1 Filed 03/24/21 Page 3 of 20 PageID #: 3
`
`generic drug products for marketing, sale, and/or use throughout the United States including in
`
`this judicial district.
`
`7.
`
`On information and belief, Defendant Aurolife Pharma LLC is a limited liability
`
`company organized and existing under the laws of Delaware, having a principal place of business
`
`at 2400 Route 130 North, Dayton, New Jersey 08810. On information and belief, Aurolife Pharma
`
`LLC is in the business of, inter alia, developing, manufacturing and/or distributing generic drug
`
`products for marketing, sale, and/or use throughout the United States including in this judicial
`
`district.
`
`8.
`
`By a letter dated March 9, 2021, (“Aurobindo’s Notice Letter”) Aurobindo notified
`
`Plaintiffs that Aurobindo had submitted to FDA ANDA No. 209413 for 50 mg mirabegron
`
`extended-release tablets (“Aurobindo ANDA”), a drug product that is a generic version of
`
`Myrbetriq® extended-release tablets, in the 50 mg strength (“Aurobindo’s ANDA Product”). On
`
`information and belief, the purpose of Aurobindo’s submission of the Aurobindo ANDA was to
`
`obtain approval under the FDCA to engage in the commercial manufacture, use, offer for sale,
`
`and/or sale of Aurobindo’s ANDA Product prior to the expiration of the ’780 Patent.
`
`9.
`
`In Aurobindo’s Notice Letter, Aurobindo notified Plaintiffs that, as a part of the
`
`Aurobindo ANDA, Aurobindo had filed a certification of the type described in Section
`
`505(j)(2)(A)(vii)(IV) of the FDCA, 21 U.S.C. § 355(j)(2)(A)(vii)(IV), with respect to the ’780
`
`Patent, asserting it is invalid, unenforceable, and/or will not be infringed by the commercial
`
`manufacture, use, and sale of Aurobindo’s ANDA Product.
`
`10.
`
`On information and belief, and consistent with their past practices, Aurobindo
`
`Pharma Ltd., Aurobindo Pharma USA, Inc. and Aurolife Pharma LLC acted collaboratively in the
`
`preparation and submission of ANDA No. 209413.
`
`3
`
`

`

`Case 1:21-cv-00425-UNA Document 1 Filed 03/24/21 Page 4 of 20 PageID #: 4
`
`11.
`
`On information and belief, and consistent with their past practices, following any
`
`FDA approval of ANDA No. 209413, Aurobindo Pharma Ltd., Aurobindo Pharma USA, Inc. and
`
`Aurolife Pharma LLC will work in concert with one another to make, use, offer to sell, and/or sell
`
`the generic drug products that are the subject of ANDA No. 209413 throughout the United States,
`
`and/or import such generic drug products into the United States, including in this judicial district.
`
`C.
`
`Actavis Elizabeth LLC, Actavis LLC and Teva Pharmaceuticals USA, Inc.
`(collectively, “Actavis”)
`
`12.
`
`On information and belief, Defendant Actavis Elizabeth LLC is a limited liability
`
`company organized and existing under the laws of Delaware, having a principal place of business
`
`at 200 Elmora Avenue, Elizabeth, New Jersey, 07202. On information and belief, Actavis
`
`Elizabeth LLC is in the business of, inter alia, developing, manufacturing and/or distributing
`
`generic drug products for marketing, sale, and/or use throughout the United States including in
`
`this judicial district.
`
`13.
`
`On information and belief, Defendant Actavis LLC is a limited liability company
`
`organized and existing under the laws of Delaware, having a principal place of business at Morris
`
`Corporate Center Ill, 400 Interpace Parkway, Parsippany, New Jersey 07054. On information and
`
`belief, Actavis LLC is in the business of, inter alia, developing, manufacturing and/or distributing
`
`generic drug products for marketing, sale, and/or use throughout the United States including in
`
`this judicial district.
`
`14.
`
`On information and belief, Defendant Teva Pharmaceuticals USA Inc. (“Teva”) is
`
`a corporation organized and existing under the laws of Delaware, having a principal place of
`
`business at 400 Interpace Parkway, Parsippany, New Jersey 07054. On information and belief,
`
`Teva is in the business of, inter alia, developing, manufacturing and/or distributing generic drug
`
`4
`
`

`

`Case 1:21-cv-00425-UNA Document 1 Filed 03/24/21 Page 5 of 20 PageID #: 5
`
`products for marketing, sale, and/or use throughout the United States including in this judicial
`
`district.
`
`15.
`
`On information and belief, on or about August 2, 2016, Teva acquired Actavis’s
`
`Generics business, including Actavis Elizabeth LLC and Actavis LLC.
`
`16.
`
`On information and belief, Actavis Elizabeth LLC is a wholly owned subsidiary of
`
`Actavis LLC, which is a wholly owned subsidiary of Teva.
`
`17.
`
`By a letter dated March 16, 2021 (“Actavis’s Notice Letter”), Actavis notified
`
`Plaintiffs that Actavis had submitted to FDA ANDA No. 209368 for Mirabegron Extended-
`
`Release Tablets, 25 mg and 50 mg (“Actavis ANDA”), a drug product that is a generic version of
`
`Myrbetriq® extended-release tablets, in the 25 mg and 50 mg strengths (“Actavis’s ANDA
`
`Product”). On information and belief, the purpose of Actavis’s submission of the Actavis ANDA
`
`was to obtain approval under the FDCA to engage in the commercial manufacture, use, offer for
`
`sale, and/or sale of Actavis’s ANDA Product prior to the expiration of the ’780 Patent.
`
`18.
`
`In Actavis’s Notice Letter, Actavis notified Plaintiffs that, as a part of the Actavis
`
`ANDA, Actavis had filed a certification of the type described in Section 505(j)(2)(A)(vii)(IV) of
`
`the FDCA, 21 U.S.C. § 355(j)(2)(A)(vii)(IV), with respect to the ’780 Patent, asserting that it is
`
`invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use, and sale
`
`of Actavis’s ANDA Product.
`
`19.
`
`On information and belief, and consistent with their past practices, Actavis
`
`Elizabeth LLC and Actavis LLC acted collaboratively in the preparation and submission of ANDA
`
`No. 209368.
`
`20.
`
`On information and belief, and consistent with their past practices, following any
`
`FDA approval of ANDA No. 209368, Actavis Elizabeth LLC, Actavis LLC and Teva will work
`
`5
`
`

`

`Case 1:21-cv-00425-UNA Document 1 Filed 03/24/21 Page 6 of 20 PageID #: 6
`
`in concert with one another to make, use, offer to sell, and/or sell the generic drug products that
`
`are the subject of ANDA No. 209368 throughout the United States, and/or import such generic
`
`drug products into the United States, including in this judicial district.
`
`D.
`
`Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Ltd. (d/b/a Zydus Cadila)
`(collectively, “Zydus”)
`
`21.
`
`On information and belief, Defendant Zydus Pharmaceuticals (USA) Inc. is a
`
`corporation organized and existing under the laws of New Jersey, having a principal place of
`
`business at 73 Route 31 North, Pennington, New Jersey 08534. On information and belief, Zydus
`
`Pharmaceuticals (USA) Inc. is in the business of, inter alia, developing, manufacturing and/or
`
`distributing generic drug products for marketing, sale, and/or use throughout the United States
`
`including in this judicial district.
`
`22.
`
`On information and belief, Defendant Cadila Healthcare Ltd. (d/b/a Zydus Cadila)
`
`(“Zydus Cadila”) is a corporation organized and existing under the laws of India, having a principal
`
`place of business at Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj
`
`(Gandhinagar), Nr. Vaishnodevi Circle, S. G. Highway, Ahmedabad 382 481, India. On
`
`information and belief, Zydus Cadila is in the business of, inter alia, developing, manufacturing
`
`and/or distributing generic drug products for marketing, sale, and/or use throughout the United
`
`States including in this judicial district.
`
`23.
`
`By a letter dated March 3, 2021 (“Zydus’s Notice Letter”), Zydus notified Plaintiffs
`
`that Zydus had submitted to FDA ANDA No. 209488 for mirabegron extended-release oral tablets,
`
`25 mg and 50 mg (“Zydus ANDA”), a drug product that is a generic version of Myrbetriq®
`
`extended-release tablets, in the 25 mg and 50 mg strengths (“Zydus’s ANDA Product”). On
`
`information and belief, the purpose of Zydus’s submission of the Zydus ANDA was to obtain
`
`6
`
`

`

`Case 1:21-cv-00425-UNA Document 1 Filed 03/24/21 Page 7 of 20 PageID #: 7
`
`approval under the FDCA to engage in the commercial manufacture, use, offer for sale, and/or sale
`
`of Zydus’s ANDA Product prior to the expiration of the ’780 Patent.
`
`24.
`
`In Zydus’s Notice Letter, Zydus notified Plaintiffs that, as a part of the Zydus
`
`ANDA, Zydus had filed a certification of the type described in Section 505(j)(2)(A)(vii)(IV) of
`
`the FDCA, 21 U.S.C. § 355(j)(2)(A)(vii)(IV), with respect to the ’780 Patent, asserting that it is
`
`invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use, and sale
`
`of Zydus’s ANDA Product.
`
`25.
`
`On information and belief, and consistent with their past practices, Zydus
`
`Pharmaceuticals (USA) Inc. and Zydus Cadila acted collaboratively in the preparation and
`
`submission of ANDA No. 209488.
`
`26.
`
`On information and belief, and consistent with their past practices, following any
`
`FDA approval of ANDA No. 209488, Zydus Pharmaceuticals (USA) Inc. and Zydus Cadila will
`
`work in concert with one another to make, use, offer to sell, and/or sell the generic drug products
`
`that are the subject of ANDA No. 209488 throughout the United States, and/or import such generic
`
`drug products into the United States, including in this judicial district.
`
`E.
`
`Lupin Ltd. and Lupin Pharmaceuticals, Inc. (collectively, “Lupin”)
`
`27.
`
`On information and belief, Defendant Lupin Ltd. is a corporation organized and
`
`existing under the laws of India, having a principal place of business at 3rd Floor, Kalpataru Inspire,
`
`Off. Western Expressway Highway, Santacruz (East), Mumbai 400 055, India. On information
`
`and belief, Lupin Ltd. is in the business of, inter alia, developing, manufacturing and/or
`
`distributing generic drug products for marketing, sale, and/or use throughout the United States
`
`including in this judicial district.
`
`28.
`
`On information and belief, Defendant Lupin Pharmaceuticals, Inc. is a corporation
`
`organized and existing under the laws of Delaware, having a principal place of business at
`
`7
`
`

`

`Case 1:21-cv-00425-UNA Document 1 Filed 03/24/21 Page 8 of 20 PageID #: 8
`
`Harborplace Tower, 111 South Calvert Street, 21st Floor, Baltimore, MD 21292. On information
`
`and belief, Lupin Pharmaceuticals Inc. is in the business of, inter alia, developing, manufacturing
`
`and/or distributing generic drug products for marketing, sale, and/or use throughout the United
`
`States including in this judicial district.
`
`29.
`
`By a letter dated February 8, 2021 (“Lupin’s Notice Letter”) Lupin notified
`
`Plaintiffs that Lupin had submitted to FDA ANDA No. 209485 for mirabegron “in the form of
`
`extended release tablets, each containing either 25 mg or 50 mg mirabegron as the active
`
`ingredient.” (“Lupin ANDA”), a drug product that is a generic version of Myrbetriq® extended-
`
`release tablets, in the 25 mg and 50 mg strengths (“Lupin’s ANDA Product”). On information and
`
`belief, the purpose of Lupin’s submission of the Lupin ANDA was to obtain approval under the
`
`FDCA to engage in the commercial manufacture, use, offer for sale, and/or sale of Lupin’s ANDA
`
`Product prior to the expiration of the ’780 Patent.
`
`30.
`
`In Lupin’s Notice Letter, Lupin notified Plaintiffs that, as a part of the Lupin
`
`ANDA, Lupin had filed a certification of the type described in Section 505(j)(2)(A)(vii)(IV) of the
`
`FDCA, 21 U.S.C. § 355(j)(2)(A)(vii)(IV), with respect to the ’780 Patent, asserting that it is
`
`invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use, and sale
`
`of Lupin’s ANDA Product.
`
`31.
`
`On information and belief, and consistent with their past practices, Lupin Ltd. and
`
`Lupin Pharmaceuticals Inc. acted collaboratively in the preparation and submission of ANDA No.
`
`209485.
`
`32.
`
`On information and belief, and consistent with their past practices, following any
`
`FDA approval of ANDA No. 209485, Lupin Ltd. and Lupin Pharmaceuticals Inc. will work in
`
`concert with one another to make, use, offer to sell, and/or sell the generic drug products that are
`
`8
`
`

`

`Case 1:21-cv-00425-UNA Document 1 Filed 03/24/21 Page 9 of 20 PageID #: 9
`
`the subject of ANDA No. 209485 throughout the United States, and/or import such generic drug
`
`products into the United States, including in this judicial district.
`
`JURISDICTION AND VENUE
`
`33.
`
`This Court has jurisdiction over the subject matter of this action under 28 U.S.C.
`
`§§ 1331, 1338(a), 2201 and 2202.
`
`34.
`
`This Court has personal jurisdiction over each Defendant because, among other
`
`things, each has committed, or aided, abetted, contributed to, or participated in the commission of,
`
`tortious acts of patent infringement in filing each ANDA that has led to foreseeable harm and
`
`injury to Plaintiffs, and will imminently commit, or aid, abet, contribute to, or participate in the
`
`commission of, a tortious act of patent infringement by selling its ANDA Product which will lead
`
`to foreseeable harm and injury to Plaintiffs.
`
`35.
`
`This Court also has personal jurisdiction over each Defendant because each of its
`
`affiliations with the State of Delaware, including in many instances by virtue of its incorporation
`
`in Delaware or the incorporation in Delaware of subsidiaries, are so continuous and systematic as
`
`to render each Defendant essentially at home in this forum.
`
`36.
`
`This Court also has personal jurisdiction over Aurobindo Pharma Ltd., Cadila
`
`Healthcare Ltd. and Lupin Ltd. pursuant to Fed. R. Civ. P. 4(k)(2) because (a) Astellas’s claims
`
`arise under federal law; (b) as foreign defendants, Aurobindo Pharma Ltd., Cadila Healthcare Ltd.
`
`and Lupin Ltd. are not subject to jurisdiction in any state’s courts of general jurisdiction; and (c)
`
`Aurobindo Pharma Ltd., Cadila Healthcare Ltd. and Lupin Ltd. have sufficient contacts within the
`
`United States as a whole, including but not limited to preparing and submitting an ANDA to FDA
`
`and/or manufacturing and/or selling pharmaceutical products distributed throughout the United
`
`States, such that this Court’s exercise of jurisdiction over Aurobindo Pharma Ltd., Cadila
`
`Healthcare Ltd. and Lupin Ltd. satisfies due process.
`
`9
`
`

`

`Case 1:21-cv-00425-UNA Document 1 Filed 03/24/21 Page 10 of 20 PageID #: 10
`
`37.
`
`This Court also has personal jurisdiction over each Defendant because each has
`
`frequently availed itself of the legal protections of the State of Delaware by, among other things,
`
`selecting the State of Delaware as the place of incorporation for itself and their subsidiaries and
`
`admitting jurisdiction and asserting counterclaims in lawsuits filed in the United States District
`
`Court for the District of Delaware, including in related Myrbetriq® litigations. See e.g. Astellas
`
`Pharma Inc. et al. v. Sandoz Inc. et al., C.A. No. 20-1589-JFB-CJB (D. Del.), D.I. 47, 52, 78;
`
`Acadia Pharmaceuticals Inc. v. Zydus Pharmaceuticals (USA) Inc. et al., C. A. No. 20-1021 (D.
`
`Del.), D.I. 9; Astellas Pharma Inc. et al. v. Aurobindo Pharma Ltd. et al., C.A. No. 16-942 (D.
`
`Del.), D.I. 22; Astellas Pharma Inc. et al. v. Lupin Ltd. et al., C.A. No. 16-908 (D. Del.), D.I. 20;
`
`Astellas Pharma Inc. et al. v. Actavis Elizabeth LLC. et al., C.A. No. 16-905 (D. Del.), D.I. 21.
`
`38.
`
`For these reasons, and for other reasons that will be presented to the Court if
`
`jurisdiction is challenged, the Court has personal jurisdiction over each Defendant.
`
`39.
`
`Venue is proper in this Court pursuant to 28 U.S.C. §§ 1391 and 1400(b) and/or
`
`Fed. R. Civ. P. 4(k)(2).
`
`MYRBETRIQ® TABLETS
`
`40.
`
`APGD holds approved New Drug Application (“NDA”) No. 202611 for
`
`Myrbetriq® extended-release tablets, 25 mg and 50 mg, which contain the active ingredient,
`
`mirabegron. FDA approved NDA No. 202611 on June 28, 2012 for both the 25 mg and 50 mg
`
`extended-release Myrbetriq® tablets.
`
`41. Mirabegron has been referred to chemically as, inter alia, (R)-2-(2-aminothiazol-
`
`4-yl)-4’-[2-(2-hydroxy-2-phenylethyl)amino]ethyl]acetic acid anilide, (R)-2-(2-aminothiazol-4-
`
`yl)-4’-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetanilide, and 2-(2-aminothiazol-4-yl)-N-[4-
`
`(2-{[(2R)-2-hydroxy-2-phenylethyl]amino}ethyl)phenyl]acetamide. Mirabegron can be depicted
`
`as, inter alia, the following formula:
`
`10
`
`

`

`Case 1:21-cv-00425-UNA Document 1 Filed 03/24/21 Page 11 of 20 PageID #: 11
`
`42. Myrbetriq® extended-release tablets, containing 25 mg or 50 mg of mirabegron
`
`(“Myrbetriq® Tablets”), are indicated for the treatment of overactive bladder (“OAB”) with
`
`symptoms of urge urinary incontinence, urgency, and urinary frequency.
`
`43. Myrbetriq® Tablets comprise a sustained release hydrogel-forming formulation
`
`containing, inter alia, polyethylene oxide and polyethylene glycol as inactive ingredients within
`
`the tablet formulation, which function as a means for forming a hydrogel and a means for ensuring
`
`penetration of water into the tablets.
`
`44.
`
`For quality control purposes in the U.S. market, Myrbetriq® Tablets are subjected
`
`to dissolution testing using the United States Pharmacopeia (“USP”) Apparatus I. A dissolution
`
`test evaluates the rate and extent that a compound forms a solution under carefully controlled
`
`conditions. Within the context of regulatory approval, the USP dissolution test helps safeguard
`
`against the release of drug products that do not perform acceptably. USP Apparatus I (basket) and
`
`II (paddle) provide a platform to evaluate the in vitro performance of dosage forms using
`
`standardized conditions. These two apparatus, and associated procedures, have become widely
`
`used and accepted.
`
`45. When measured in accordance with the United States Pharmacopeia (“USP”)
`
`dissolution apparatus II, using 900 mL of USP buffer and having a pH of 6.8 at a paddle rotation
`
`speed of 200 rpm (“USP II Method”), the Myrbetriq® Tablets release 39% or less of mirabegron
`
`after 1.5 hours, and at least 75% mirabegron after 7 hours.
`
`11
`
`

`

`Case 1:21-cv-00425-UNA Document 1 Filed 03/24/21 Page 12 of 20 PageID #: 12
`
`THE PATENT-IN-SUIT
`
`46.
`
`The United States Patent & Trademark Office (“PTO”) duly and legally issued the
`
`’780 Patent, entitled “Pharmaceutical Composition for Modified Release,” on November 24, 2020.
`
`A true and correct copy of the ’780 Patent is attached as Exhibit A.
`
`47.
`
`The ’780 Patent is listed in FDA’s Approved Drug Products with Therapeutic
`
`Equivalence Evaluations (the “Orange Book”) in connection with Myrbetriq® Tablets.
`
`48.
`
`49.
`
`50.
`
`API is the record owner and assignee of the ’780 Patent.
`
`The ’780 Patent will expire no earlier than September 28, 2029.
`
`AICL is the exclusive licensee of the ’780 Patent with the rights to develop, import,
`
`market, sell, distribute, and promote any and all pharmaceutical formulations in finished package
`
`forms which contain mirabegron as the active ingredient in the United States.
`
`51.
`
`APGD has contracted with AICL to, inter alia, clinically develop mirabegron,
`
`prepare and submit NDA No. 202611 for marketing approval of Myrbetriq® Tablets in the United
`
`States.
`
`52.
`
`AICL has contracted with Astellas Pharma US, Inc., a subsidiary of API to, inter
`
`alia, market and sell Myrbetriq® Tablets, in the United States on its behalf.
`
`53. Myrbetriq® Tablets are covered by one or more claims of the ’780 Patent.
`
`MIRABEGRON ANDA FILERS
`
`54.
`
`In June 2013, FDA issued a notice in the Federal Register (78 Fed. Reg. 37230 at
`
`31 (June 20, 2013)) regarding bioequivalence guidance to be published on its website for
`
`mirabegron ANDAs. On its website, FDA lists the following dissolution requirements for
`
`mirabegron ANDA filers in order to establish bioequivalence with Myrbetriq® Tablets
`
`(“Mirabegron Bioequivalence Guidance”):
`
`12
`
`

`

`Case 1:21-cv-00425-UNA Document 1 Filed 03/24/21 Page 13 of 20 PageID #: 13
`
`55.
`
`On information and belief, each mirabegron ANDA filer will be required to meet
`
`this dissolution method, or an equivalent dissolution method, to meet its bioequivalence
`
`requirements for its proposed ANDA product using Myrbetriq® Tablets as the reference standard.
`
`On information and belief, a proposed mirabegron ANDA product will have equivalent dissolution
`
`properties to Myrbetriq® Tablets as measured by USP Apparatus I and II.
`
`CLAIMS FOR RELIEF
`
`COUNT I: INFRINGEMENT OF THE ’780 PATENT BY AUROBINDO
`
`56.
`
`Plaintiffs incorporate by reference and reallege paragraphs 1 through 55 above as
`
`though fully restated herein.
`
`57.
`
`Aurobindo, by filing ANDA No. 209413, has necessarily represented to FDA that,
`
`upon approval, Aurobindo’s ANDA Product will have the same active ingredient, method of
`
`administration, dosage form, and dosage amount as Myrbetriq® Tablets, and will be bioequivalent
`
`to Myrbetriq® Tablets.
`
`58.
`
`Aurobindo has indicated, including inter alia via Aurobindo’s Notice Letter, its
`
`intent to engage in the commercial manufacture, use, offer for sale, sale, marketing, distributing,
`
`and/or importation of Aurobindo’s ANDA Product prior to the expiration of the ’780 Patent.
`
`59.
`
`On information and belief, and as required by the Mirabegron Bioequivalence
`
`Guidance, Aurobindo uses the dissolution method (or its equivalent) to establish Aurobindo’s
`
`ANDA Product is bioequivalent to Myrbetriq® Tablets. On information and belief, Aurobindo’s
`
`ANDA Product will have equivalent dissolution properties, as measured by USP Apparatus I and
`
`13
`
`

`

`Case 1:21-cv-00425-UNA Document 1 Filed 03/24/21 Page 14 of 20 PageID #: 14
`
`II, to Myrbetriq® Tablets, which uses a hydrogel formulation. On information and belief, because
`
`of the dissolution requirements contained within the Mirabegron Bioequivalence Guidance,
`
`including the use of Myrbetriq® Tablets as the reference standard, Aurobindo’s ANDA Product
`
`uses a hydrogel formulation, the same as or equivalent to the Myrbetriq® Tablets formulation, that
`
`is covered by one or more claims of the ’780 Patent.
`
`60.
`
`On information and belief, Aurobindo relied on, inter alia, Aurobindo’s dissolution
`
`data to conclude that Aurobindo’s ANDA Product is bioequivalent to Astellas’s Myrbetriq®
`
`Tablets.
`
`61.
`
`In Aurobindo’s Notice Letter, Aurobindo does not deny that Aurobindo’s ANDA
`
`Product is covered by one or more claims of the ’780 Patent.
`
`62.
`
`Aurobindo’s submission of ANDA No. 209413 seeking approval to engage in the
`
`commercial manufacture, use, offer to sell, or sale of Aurobindo’s ANDA Product, prior to the
`
`expiration of the ’780 Patent, constitutes infringement of one or more of the claims of the ’780
`
`Patent under 35 U.S.C. § 271(e)(2)(A).
`
`63.
`
`Unless Aurobindo is enjoined by the Court, Plaintiffs will be substantially and
`
`irreparably harmed by Aurobindo’s infringement of the ʼ780 Patent. Plaintiffs do not have an
`
`adequate remedy at law.
`
`64.
`
`Plaintiffs are commencing this action within 45 days of receiving Aurobindo’s
`
`Notice Letter pursuant to 21 U.S.C. § 355(j)(5)(B)(iii).
`
`COUNT II: INFRINGEMENT OF THE ’780 PATENT BY ACTAVIS
`
`65.
`
`Plaintiffs incorporate by reference and reallege paragraphs 1 through 64 above as
`
`though fully restated herein.
`
`66.
`
`Actavis, by filing ANDA No. 209368, has necessarily represented to FDA that,
`
`upon approval, Actavis’s ANDA Product will have the same active ingredient, method of
`
`14
`
`

`

`Case 1:21-cv-00425-UNA Document 1 Filed 03/24/21 Page 15 of 20 PageID #: 15
`
`administration, dosage form, and dosage amount as Myrbetriq® Tablets, and will be bioequivalent
`
`to Myrbetriq® Tablets.
`
`67.
`
`Actavis has indicated, including inter alia via Actavis’s Notice Letter, its intent to
`
`engage in the commercial manufacture, use, offer for sale, sale, marketing, distributing, and/or
`
`importation of Actavis’s ANDA Product prior to the expiration of the ’780 Patent.
`
`68.
`
`On information and belief, and as required by the Mirabegron Bioequivalence
`
`Guidance, Actavis uses the dissolution method (or its equivalent) to establish Actavis’s ANDA
`
`Product is bioequivalent to Myrbetriq® Tablets. On information and belief, Actavis’s ANDA
`
`Product will have equivalent dissolution properties, as measured by USP Apparatus I and II, to
`
`Myrbetriq® Tablets, which uses a hydrogel formulation. On information and belief, because of
`
`the dissolution requirements contained within the Mirabegron Bioequivalence Guidance, including
`
`the use of Myrbetriq® Tablets as the reference standard, Actavis’s ANDA Product uses a hydrogel
`
`formulation, the same as or equivalent to the Myrbetriq® Tablets formulation, that is covered by
`
`one or more claims of the ’780 Patent.
`
`69.
`
`In Actavis’s Notice Letter, Actavis does not deny that Actavis’s ANDA Product is
`
`covered by one or more claims of the ’780 Patent.
`
`70.
`
`Actavis’s submission of ANDA No. 209368 seeking approval to engage in the
`
`commercial manufacture, use, offer to sell, or sale of Actavis’s ANDA Product, prior to the
`
`expiration of the ’780 Patent, constitutes infringement of one or more of the claims of the ’780
`
`Patent under 35 U.S.C. § 271(e)(2)(A).
`
`71.
`
`Unless Actavis is enjoined by the Court, Plaintiffs will be substantially and
`
`irreparably harmed by Actavis’s infringement of the ʼ780 Patent. Plaintiffs do not have an
`
`adequate remedy at law.
`
`15
`
`

`

`Case 1:21-cv-00425-UNA Document 1 Filed 03/24/21 Page 16 of 20 PageID #: 16
`
`72.
`
`Plaintiffs are commencing this action within 45 days of receiving Actavis’s Notice
`
`Letter pursuant to 21 U.S.C. § 355(j)(5)(B)(iii).
`
`COUNT III: INFRINGEMENT OF THE ’780 PATENT BY ZYDUS
`
`73.
`
`Plaintiffs incorporate by reference and reallege paragraphs 1 through 72 above as
`
`though fully restated herein.
`
`74.
`
`Zydus, by filing ANDA No. 209488 has necessarily represented to FDA that, upon
`
`approval, Zydus’s ANDA Product will have the same active ingredient, method of administration,
`
`dosage form, and dosage amount as Myrbetriq® Tablets, and will be bioequivalent to Myrbetriq®
`
`Tablets.
`
`75.
`
`Zydus has indicated, including inter alia via Zydus’s Notice Letter, its intent to
`
`engage in the commercial manufacture, use, offer for sale, sale, marketing, distributing, and/or
`
`importation of Zydus’s ANDA Product prior to the expiration of the ’780 Patent.
`
`76.
`
`On information and belief, and as required by the Mirabegron Bioequivalence
`
`Guidance, Zydus uses the dissolution method (or its equivalent) to establish Zydus’s ANDA
`
`Product is bioequivalent to Myrbetriq® Tablets. On information and belief, Zydus’s ANDA
`
`Product will have equivalent dissolution properties, as measured by USP Apparatus I and II, to
`
`Myrbetriq® Tablets, which uses a hydrogel formulation. On information and belief, because of
`
`the dissolution requirements contained within the Mirabegron Bioequivalence Guidance, including
`
`the use of Myrbetriq® Tablets as the reference standard, Zydus’s ANDA Product uses a hydrogel
`
`formulation, the same as or equivalent to the Myrbetriq® Tablets formulation, that is covered by
`
`one or more claims of the ’780 Patent.
`
`77.
`
`On information and belief, Zydus relied on, inter alia, Zydus’s dissolution data to
`
`conclude that Zydus’s ANDA Product is bioequivalent to Astellas’s MYRBETRIQ® Tablets.
`
`16
`
`

`

`Case 1:21-cv-00425-UNA Document 1 Filed 03/24/21 Page 17 of 20 PageID #: 17
`
`78.
`
`In Zydus’s Notice Letter, Zydus does not deny that Zydus’s ANDA Product is
`
`covered by one or more claims of the ’780 Patent.
`
`79.
`
`Zydus’s submission of ANDA No. 209488 seeking approval to engage in the
`
`commercial manufacture, use, offer to sell, or sale of Zydus’s ANDA Product, prior to the
`
`expiration of the ’780 Patent, constitutes infringement of one or more of the claims of the ’780
`
`Patent under 35 U.S.C. § 271(e)(2)(A).
`
`80.
`
`Unless Zydus is enjoined by the Court, Plaintiffs will be substantially and
`
`irreparably harmed by Zydus’s infringement of the ʼ780 Patent. Plaintiffs do not have an adequate
`
`remedy at law.
`
`81.
`
`Plaintiffs are commencing this action within 45 days of receiving Zydus’s Notice
`
`Letter pursuant to 21 U.S.C. § 355(j)(5)(B)(iii).
`
`COUNT IV: INFRINGEMENT OF THE ’780 PATENT BY LUPIN
`
`82.
`
`Plaintiffs incorporate by reference and reallege paragraphs 1 through 81 above as
`
`though fully restated herein.
`
`83.
`
`Lupin, by filing ANDA No. 209485, has necessarily represented to FDA that, upon
`
`approval, Lupin’s ANDA Product will have the same active ingredient, method of administration,
`
`dosage form, and dosage amount as Myrbetriq® Tablets, and will be bioequivalent to Myrbetriq®
`
`Tablets.
`
`84.
`
`Lupin has indicated, including inter alia via Lupins’s Notice Letter, its intent to
`
`engage in the commercial manufacture, use, offer for sale, sale, marketing, distributing, and/or
`
`importation of Lupin’s ANDA Product prior to the expiration of the ’780 Patent.
`
`85.
`
`On information and belief, and as required by the Mirabegron Bioequivalence
`
`Guidance, Lupin uses the dissolution method (or its equivalent) to establish Lupin’s ANDA
`
`Product is bioequivalent to Myrbetriq® Tablets. On information and belief, Lupin’s ANDA
`
`17
`
`

`

`Case 1:21-cv-00425-UNA Document 1