Case 1:21-cv-01141-UNA Document 1 Filed 08/05/21 Page 1 of 10 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`ASTELLAS PHARMA INC., ASTELLAS
`IRELAND CO., LTD. and ASTELLAS
`PHARMA GLOBAL DEVELOPMENT,
`INC.,
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`Plaintiffs,
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`v.
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`APOTEX INC. and APOTEX CORP.
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`Defendant.
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`C.A. No. _______________________
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`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiffs Astellas Pharma Inc., Astellas Ireland Co., Ltd. and Astellas Pharma Global
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`Development, Inc. (collectively, “Astellas” or “Plaintiffs”), by their undersigned attorneys, hereby
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`allege as follows:
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`NATURE OF ACTION
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`1.
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`This is an action for patent infringement of United States Patent No. 10,842,780
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`(“the ’780 Patent”), arising under the United States patent laws, Title 35, United States Code. This
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`action relates to the Abbreviated New Drug Application (“ANDA”) submitted by the above-named
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`Defendants under Section 505(j) of the Federal Food, Drug and Cosmetic Act (“FDCA”), 21
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`U.S.C. § 355(j), seeking United States Food and Drug Administration (“FDA”) approval to market
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`a generic pharmaceutical product.
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`

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`THE PARTIES
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`A.
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`Astellas Pharma Inc., Astellas Ireland Co., Ltd. and Astellas Pharma Global
`Development, Inc.
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`2.
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`Plaintiff Astellas Pharma Inc. (“API”) is a corporation organized and existing under
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`the laws of Japan, having its principal place of business at 2-5-1, Nihonbashi-Honcho, Chuo-Ku,
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`Tokyo 103-8411, Japan. API was formed on April 1, 2005, from the merger of Yamanouchi
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`Pharmaceutical Co., Ltd. and Fujisawa Pharmaceutical Co., Ltd.
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`3.
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`Plaintiff Astellas Ireland Co., Ltd. (“AICL”) is a corporation organized and existing
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`under the laws of Ireland, having its principal place of business at Damastown Road, Damastown
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`Industrial Park, Mulhuddart, Dublin 15, Ireland. AICL is a subsidiary of Plaintiff API.
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`4.
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`Plaintiff Astellas Pharma Global Development, Inc. (“APGD”) is a corporation
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`organized and existing under the laws of the State of Delaware, having its principal place of
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`business at 1 Astellas Way, Northbrook, Illinois 60062. APGD is a subsidiary of Plaintiff API.
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`B.
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`Apotex Inc. and Apotex Corp. (collectively, “Apotex”)
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`5.
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`On information and belief, Defendant Apotex Inc. is a corporation organized and
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`existing under the laws of Canada, having a principal place of business at 150 Signet Drive,
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`Toronto, Ontario M9L 1T9, Canada. On information and belief, Apotex Inc. is in the business of,
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`inter alia, developing, manufacturing and/or distributing generic drug products for marketing, sale,
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`and/or use throughout the United States including in this judicial district.
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`6.
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`On information and belief, Defendant Apotex Corp. is a corporation organized and
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`existing under the laws of Delaware, having a principal place of business at 2400 N. Commerce
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`Parkway, Suite 400, Weston, Florida 33326. On information and belief, Apotex Corp. is in the
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`business of, inter alia, developing, manufacturing and/or distributing generic drug products for
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`marketing, sale, and/or use throughout the United States including in this judicial district.
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`2
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`7.
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`By a letter dated June 22, 2021, (“Apotex’s Notice Letter”) Apotex notified
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`Plaintiffs that Apotex had submitted to FDA ANDA No. 209434 for mirabegron extended-release
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`tablets, 25 mg and 50 mg (“Apotex ANDA”), a drug product that is a generic version of
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`Myrbetriq® extended-release tablets, in the 25mg and 50mg strengths (“Apotex’s ANDA
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`Product”). On information and belief, the purpose of Apotex’s submission of the Apotex ANDA
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`was to obtain approval under the FDCA to engage in the commercial manufacture, use, offer for
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`sale, and/or sale of Apotex’s ANDA Product prior to the expiration of the ’780 Patent.
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`8.
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`In Apotex’s Notice Letter, Apotex notified Plaintiffs that, as a part of the Apotex
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`ANDA, Apotex had filed a certification of the type described in Section 505(j)(2)(A)(vii)(IV) of
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`the FDCA, 21 U.S.C. § 355(j)(2)(A)(vii)(IV), with respect to the ’780 Patent, asserting it is invalid,
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`unenforceable, and/or will not be infringed by the commercial manufacture, use, and sale of
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`Apotex’s ANDA Product.
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`JURISDICTION AND VENUE
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`9.
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`This Court has jurisdiction over the subject matter of this action under 28 U.S.C.
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`§§ 1331, 1338(a), 2201 and 2202.
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`10.
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`This Court has personal jurisdiction over Apotex because, among other things,
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`Apotex has committed, or aided, abetted, contributed to, or participated in the commission of,
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`tortious acts of patent infringement in filing the Apotex ANDA that has led to foreseeable harm
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`and injury to Plaintiffs, and will imminently commit, or aid, abet, contribute to, or participate in
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`the commission of, a tortious act of patent infringement by selling Apotex’s ANDA Product which
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`will lead to foreseeable harm and injury to Plaintiffs.
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`11.
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`This Court also has personal jurisdiction over Apotex because its affiliations with
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`the State of Delaware, including by virtue of Apotex Corp.’s incorporation in Delaware, are so
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`continuous and systematic as to render Apotex essentially at home in this forum.
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`12.
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`This Court also has personal jurisdiction over Apotex Inc. pursuant to Fed. R. Civ.
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`P. 4(k)(2) because (a) Astellas’s claims arise under federal law; (b) as a foreign defendant, Apotex
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`Inc. is not subject to jurisdiction in any state’s courts of general jurisdiction; and (c) Apotex Inc.
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`has sufficient contacts within the United States as a whole, including but not limited to preparing
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`and submitting an ANDA to FDA and/or manufacturing and/or selling pharmaceutical products
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`distributed throughout the United States, such that this Court’s exercise of jurisdiction over Apotex
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`Inc. satisfies due process.
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`13.
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`This Court also has personal jurisdiction over Apotex because it has frequently
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`availed itself of the legal protections of the State of Delaware by, among other things, Apotex
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`Corp. selecting the State of Delaware as its place of incorporation, and by Apotex admitting
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`jurisdiction and asserting counterclaims in lawsuits filed in the United States District Court for the
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`District of Delaware. See, e.g., Bial Portela & CA SA et al. v. Apotex Inc. et al., C.A. No. 21-
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`00187 (D. Del.), D.I. 6; Intercept Pharm., Inc. et al. v. Apotex Inc. et al., C.A. No. 20-1105 (D.
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`Del.), D.I. 10.
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`14.
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`For these reasons, and for other reasons that will be presented to the Court if
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`jurisdiction is challenged, the Court has personal jurisdiction over Apotex.
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`15.
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`Venue is proper in this Court pursuant to 28 U.S.C. §§ 1391 and 1400(b) and/or
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`Fed. R. Civ. P. 4(k)(2).
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`MYRBETRIQ® TABLETS
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`16.
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`APGD holds approved New Drug Application (“NDA”) No. 202611 for
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`Myrbetriq® extended-release tablets, 25 mg and 50 mg, which contain the active ingredient,
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`mirabegron. FDA approved NDA No. 202611 on June 28, 2012 for both the 25 mg and 50 mg
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`extended-release Myrbetriq® tablets.
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`4
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`17. Mirabegron has been referred to chemically as, inter alia, (R)-2-(2-aminothiazol-
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`4-yl)-4’-[2-(2-hydroxy-2-phenylethyl)amino]ethyl]acetic acid anilide, (R)-2-(2-aminothiazol-4-
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`yl)-4’-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetanilide, and 2-(2-aminothiazol-4-yl)-N-[4-
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`(2-{[(2R)-2-hydroxy-2-phenylethyl]amino}ethyl)phenyl]acetamide. Mirabegron can be depicted
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`as, inter alia, the following formula:
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`18. Myrbetriq® extended-release tablets, containing 25 mg or 50 mg of mirabegron
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`(“Myrbetriq® Tablets”), are indicated for the treatment of overactive bladder (“OAB”) with
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`symptoms of urge urinary incontinence, urgency, and urinary frequency.
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`19. Myrbetriq® Tablets comprise a sustained release hydrogel-forming formulation
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`containing, inter alia, polyethylene oxide and polyethylene glycol as inactive ingredients within
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`the tablet formulation, which function as a means for forming a hydrogel and a means for ensuring
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`penetration of water into the tablets.
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`20.
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`For quality control purposes in the U.S. market, Myrbetriq® Tablets are subjected
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`to dissolution testing using the United States Pharmacopeia (“USP”) Apparatus I. A dissolution
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`test evaluates the rate and extent that a compound forms a solution under carefully controlled
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`conditions. Within the context of regulatory approval, the USP dissolution test helps safeguard
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`against the release of drug products that do not perform acceptably. USP Apparatus I (basket) and
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`II (paddle) provide a platform to evaluate the in vitro performance of dosage forms using
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`standardized conditions. These two apparatus, and associated procedures, have become widely
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`used and accepted.
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`21. When measured in accordance with the United States Pharmacopeia (“USP”)
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`dissolution apparatus II, using 900 mL of USP buffer and having a pH of 6.8 at a paddle rotation
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`speed of 200 rpm (“USP II Method”), the Myrbetriq® Tablets release 39% or less of mirabegron
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`after 1.5 hours, and at least 75% mirabegron after 7 hours.
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`THE PATENT-IN-SUIT
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`22.
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`The United States Patent & Trademark Office (“PTO”) duly and legally issued the
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`’780 Patent, entitled “Pharmaceutical Composition for Modified Release,” on November 24, 2020.
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`A true and correct copy of the ’780 Patent is attached as Exhibit A.
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`23.
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`The ’780 Patent is listed in FDA’s Approved Drug Products with Therapeutic
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`Equivalence Evaluations (the “Orange Book”) in connection with Myrbetriq® Tablets.
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`24.
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`25.
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`API is the record owner and assignee of the ’780 Patent.
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`The ’780 Patent will expire no earlier than September 28, 2029 and has pediatric
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`exclusivity through March 28, 2030.
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`26.
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`AICL is the exclusive licensee of the ’780 Patent with the rights to develop, import,
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`market, sell, distribute, and promote any and all pharmaceutical formulations in finished package
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`forms which contain mirabegron as the active ingredient in the United States.
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`27.
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`APGD has contracted with AICL to, inter alia, clinically develop mirabegron,
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`prepare and submit NDA No. 202611 for marketing approval of Myrbetriq® Tablets in the United
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`States.
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`28.
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`AICL has contracted with Astellas Pharma US, Inc., a subsidiary of API to, inter
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`alia, market and sell Myrbetriq® Tablets, in the United States on its behalf.
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`29. Myrbetriq® Tablets are covered by one or more claims of the ’780 Patent.
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`6
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`MIRABEGRON ANDA FILERS
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`30.
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`In June 2013, FDA issued a notice in the Federal Register (78 Fed. Reg. 37230 at
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`31 (June 20, 2013)) regarding bioequivalence guidance to be published on its website for
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`mirabegron ANDAs. On its website, FDA lists the following dissolution requirements for
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`mirabegron ANDA filers in order to establish bioequivalence with Myrbetriq® Tablets
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`(“Mirabegron Bioequivalence Guidance”):
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`31.
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`On information and belief, each mirabegron ANDA filer will be required to meet
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`this dissolution method, or an equivalent dissolution method, to meet its bioequivalence
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`requirements for its proposed ANDA product using Myrbetriq® Tablets as the reference standard.
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`On information and belief, a proposed mirabegron ANDA product will have equivalent dissolution
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`properties to Myrbetriq® Tablets as measured by USP Apparatus I and II.
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`CLAIMS FOR RELIEF
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`COUNT I: INFRINGEMENT OF THE ’780 PATENT BY APOTEX
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`32.
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`Plaintiffs incorporate by reference and reallege paragraphs 1 through 31 above as
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`though fully restated herein.
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`33.
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`Apotex, by filing ANDA No. 209434, has necessarily represented to FDA that,
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`upon approval, Apotex’s ANDA Product will have the same active ingredient, method of
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`administration, dosage form, and dosage amount as Myrbetriq® Tablets, and will be bioequivalent
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`to Myrbetriq® Tablets.
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`34.
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`Apotex has indicated, including inter alia via Apotex’s Notice Letter, its intent to
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`engage in the commercial manufacture, use, offer for sale, sale, marketing, distributing, and/or
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`importation of Apotex’s ANDA Product prior to the expiration of the ’780 Patent’s patent term
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`and pediatric exclusivity period.
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`35.
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`On information and belief, and as required by the Mirabegron Bioequivalence
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`Guidance, Apotex uses the dissolution method (or its equivalent) to establish Apotex’s ANDA
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`Product is bioequivalent to Myrbetriq® Tablets. On information and belief, Apotex’s ANDA
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`Product will have equivalent dissolution properties, as measured by USP Apparatus I and II, to
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`Myrbetriq® Tablets, which uses a hydrogel formulation. On information and belief, because of
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`the dissolution requirements contained within the Mirabegron Bioequivalence Guidance, including
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`the use of Myrbetriq® Tablets as the reference standard, Apotex’s ANDA Product uses a hydrogel
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`formulation, the same as or equivalent to the Myrbetriq® Tablets formulation, that is covered by
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`one or more claims of the ’780 Patent.
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`36.
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`On information and belief, Apotex relied on, inter alia, Apotex’s dissolution data
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`to conclude that Apotex’s ANDA Product is bioequivalent to Astellas’s Myrbetriq® Tablets.
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`37.
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`In Apotex’s Notice Letter, Apotex does not deny that Apotex’s ANDA Product is
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`covered by one or more claims of the ’780 Patent.
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`38.
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`Apotex’s submission of ANDA No. 209434 seeking approval to engage in the
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`commercial manufacture, use, offer to sell, or sale of Apotex’s ANDA Product, prior to the
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`expiration of the ’780 Patent, constitutes infringement of one or more of the claims of the ’780
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`Patent under 35 U.S.C. § 271(e)(2)(A).
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`39.
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`Unless Apotex is enjoined by the Court, Plaintiffs will be substantially and
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`irreparably harmed by Apotex’s infringement of the ʼ780 Patent. Plaintiffs do not have an adequate
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`remedy at law.
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`40.
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`Plaintiffs are commencing this action within 45 days of receiving Apotex’s Notice
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`Letter pursuant to 21 U.S.C. § 355(j)(5)(B)(iii).
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`PRAYER FOR RELIEF
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`WHEREFORE, Plaintiffs API, AICL, and APGD, pray for a judgment in their favor and
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`against Apotex, and respectfully request the following relief:
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`A.
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`A judgment that Apotex’s submission and maintenance of its ANDA (i.e., the
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`Apotex ANDA) constituted an act of infringement of the ʼ780 Patent;
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`B.
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`A judgment (or a declaration) that Apotex’s making, using, offering to sell, or
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`selling in the United States or importing into the United States of its Proposed ANDA Product
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`(i.e., Apotex’s ANDA Product) will infringe the ’780 Patent;
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`C.
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`A permanent
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`injunction restraining and enjoining Apotex,
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`its affiliates,
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`subsidiaries, officers, agents, attorneys and employees, and those acting in privity or concert with
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`Apotex, from engaging in the commercial manufacture, use, offer for sale, or sale within the United
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`States, or importation into the United States, of its Proposed ANDA Product until the expiration
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`of the ’780 Patent, including its pediatric exclusivity period and any other extensions and/or
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`periods of exclusivity to which Plaintiffs and/or the ’780 Patent are or become entitled;
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`D.
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`An order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective date of
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`any approval of Apotex’s ANDA shall be a date that is not earlier than the expiration date of the
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`’780 Patent, including its pediatric exclusivity period and any other extensions and/or periods of
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`exclusivity to which Plaintiffs and/or the ’780 Patent are or become entitled;
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`E.
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`Damages, including monetary and other relief, to Plaintiffs if Apotex engages in
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`commercial manufacture, use, offers to sell, sale, or importation into the United States of its
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`Proposed ANDA Product, prior to the expiration date of the ’780 Patent, including its pediatric
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`exclusivity period and any other extensions and/or additional periods of exclusivity to which
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`Plaintiffs are or become entitled;
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`F.
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`A declaration that this case is “exceptional” within the meaning of 35 U.S.C. § 285
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`and an award of reasonable attorney fees, costs, expenses, and disbursements of this action; and
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`G.
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`Such other and further relief as the Court may deem just and proper.
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`MCCARTER & ENGLISH, LLP
`/s/ Daniel M. Silver
`Daniel M. Silver (#4758)
`Alexandra M. Joyce (#6423)
`Renaissance Centre
`405 N. King Street, 8th Floor
`Wilmington, Delaware 19801
`(302) 984-6300
`dsilver@mccarter.com
`ajoyce@mccarter.com
`Attorneys for Plaintiffs
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`Dated: August 5, 2021
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`OF COUNSEL:
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`Simon D. Roberts
`Jason A. Leonard
`Nitya Anand
`Vincent Li
`HOGAN LOVELLS US LLP
`390 Madison Avenue
`New York, NY 10017
`(212) 918-3000
`simon.roberts@hoganlovells.com
`jason.leonard@hoganlovells.com
`nitya.anand@hoganlovells.com
`vincent.li@hoganlovells.com
`Celine Jimenez Crowson
`HOGAN LOVELLS US LLP
`Columbia Square
`555 Thirteenth Street, NW
`Washington, D.C. 20004
`(202) 637-5600
`celine.crowson@hoganlovells.com
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