Case 1:16-cv-00954-SLR Document 1 Filed 10/17/16 Page 1 of 17 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`v.
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` Defendants.
`
`
`SAWAI PHARMACEUTICAL CO., LTD.
`and SAWAI USA, INC.,
`
`
`
`
`ASTELLAS PHARMA INC., ASTELLAS
`IRELAND CO., LTD., and ASTELLAS
`PHARMA GLOBAL DEVELOPMENT,
`INC.,
`
`
`
`
` Plaintiffs,
`
`
`
`
`
`
`
`
`C.A. No. ____________________________
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`
`
`
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiffs Astellas Pharma Inc., Astellas Ireland Co., Ltd., and Astellas Pharma Global
`
`Development, Inc. (collectively, “Plaintiffs”), by their undersigned attorneys, for their Complaint
`
`against Defendants Sawai Pharmaceutical Co., Ltd. and Sawai USA, Inc. (collectively “Sawai”),
`
`hereby allege as follows:
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`THE PARTIES
`
`1.
`
`Plaintiff Astellas Pharma Inc. is a corporation organized and existing under the
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`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. Astellas Pharma Inc. was formed on April 1, 2005, from the merger of
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`Yamanouchi Pharmaceutical Co., Ltd. and Fujisawa Pharmaceutical Co., Ltd.
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`2.
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`Plaintiff Astellas Ireland Co., Ltd. (“AICL”) is a corporation organized and
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`existing under the laws of Ireland, having its principal place of business at Damastown Road,
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`Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland. AICL is a subsidiary of Plaintiff
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`Astellas Pharma Inc.
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`3.
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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
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`Astellas Pharma Inc.
`
`4.
`
`On information and belief, Defendant Sawai USA, Inc. is a corporation
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`organized and existing under the laws of Delaware, having a principal place of business in
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`Irvine, California. On information and belief, Sawai USA, Inc., by itself and/or through its
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`affiliates and agents, is in the business, inter alia, of developing, manufacturing, and obtaining
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`regulatory approval of generic copies of branded pharmaceutical products for distribution and
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`sale throughout the United States, including within this Judicial District.
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`5.
`
`On information and belief, Defendant Sawai Pharmaceutical Co., Ltd. is a
`
`corporation organized and existing under the laws of Japan, having a principal place of business
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`in Osaka, Japan. On information and belief, Sawai Pharmaceutical Co., Ltd., by itself and/or
`
`through its affiliates and agents, is in the business, inter alia, of developing, manufacturing, and
`
`obtaining regulatory approval of generic copies of branded pharmaceutical products for
`
`distribution and sale throughout the United States, including within this Judicial District.
`
`6.
`
`On information and belief, Sawai USA, Inc. is a wholly-owned subsidiary of
`
`Sawai Pharmaceutical Co., Ltd.
`
`7.
`
`On information and belief, Defendants Sawai Pharmaceutical Co., Ltd. and
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`Sawai USA, Inc. have cooperated and assisted in the preparation and filing of Sawai’s
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`Abbreviated New Drug Application (“ANDA”) No. 209446 and will be involved in the
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`manufacture, importation, marketing and sale of the drug that is the subject of ANDA No.
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`209446 if it is approved.
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`2
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`NATURE OF ACTION
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`8.
`
`This is an action for patent infringement of United States Patent Nos. 6,346,532
`
`(“the ’532 patent”), 7,342,117 (“the ’117 patent”), 7,982,049 (“the ’049 patent”), 8,835,474 (“the
`
`’474 patent”), and RE44,872 (“the ’872 patent”), arising under the United States patent laws,
`
`Title 35, United States Code. This action relates to Sawai’s filing of ANDA No. 209446 under
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`Section 505(j) of the Federal Food, Drug and Cosmetic Act (“the Act”), 21 U.S.C. § 355(j),
`
`seeking United States Food and Drug Administration (“FDA”) approval to market generic
`
`pharmaceutical products.
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`JURISDICTION AND VENUE
`
`9.
`
`This Court has jurisdiction over the subject matter of this action under 28
`
`U.S.C. §§ 1331, 1338(a), 2201 and 2202.
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`10.
`
`This Court has personal jurisdiction over each Defendant for purposes of this
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`civil action.
`
`11.
`
`This Court has jurisdiction over Sawai Pharmaceutical Co., Ltd. On
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`information and belief, Sawai Pharmaceutical Co., Ltd. is the parent corporation of Sawai USA,
`
`Inc.
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`12.
`
`This Court has jurisdiction over Sawai USA, Inc. On information and belief,
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`Sawai USA, Inc. is a Delaware company.
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`13.
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`On information and belief, Sawai, directly or through its affiliates and agents,
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`develops, formulates, manufactures, markets, and sells pharmaceutical drug products, including
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`generic drug products, throughout the United States and in this Judicial District. On information
`
`and belief, Sawai has purposefully conducted and continues to conduct business in Delaware,
`
`and Delaware is a likely destination of Sawai’s generic drug products. On information and
`
`3
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`belief, Sawai has purposefully availed itself of the rights and benefits of the laws of the State of
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`Delaware, having engaged in systematic and continuous contacts with the State of Delaware.
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`14.
`
`On information and belief, Sawai USA, Inc. and Sawai Pharmaceuticals Co.,
`
`Ltd. are agents of each other with respect to the development, regulatory approval, marketing,
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`sale and/or distribution of generic drug products. On information and belief, the acts of Sawai
`
`USA, Inc. complained of herein were done with the cooperation, participation, and assistance of,
`
`and at least in part for the benefit of Sawai Pharmaceuticals Co., Ltd.
`
`15.
`
`On information and belief, Sawai USA, Inc. filed an abbreviated new drug
`
`application seeking approval from the FDA to market and sell pharmaceutical products
`
`containing the compound mirabegron as active ingredient, for the treatment of overactive
`
`bladder, prior to the expiration of each of the ’532, ’117, ’049, ’474, and ’872 patents.
`
`16.
`
`This lawsuit arises in part from Sawai USA, Inc. sending Plaintiffs, one of
`
`which is a Delaware corporate entity, a letter dated September 12, 2016 purporting to be a
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`“Notice of Certification Under 21 U.S.C. § 355(j)(2)(B)(ii) (§505(j)(2)(B)(iv) of the Federal
`
`Food, Drug, and Cosmetic Act) and 21 C.F.R. § 314.95” (“Notice Letter”).
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`17.
`
`When the Notice Letter was sent, Sawai knew or should have known that: (i)
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`APGD is a Delaware corporation; and (ii) Plaintiffs would file suit against Sawai within 45 days
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`of receiving the Notice Letter.
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`18.
`
`Alternatively, assuming that the above facts do not establish personal
`
`jurisdiction over Sawai Pharmaceuticals Co., Ltd., this Court may exercise jurisdiction over
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`Sawai Pharmaceuticals Co., Ltd. pursuant to Federal Rule of Civil Procedure 4(k)(2) because (a)
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`Plaintiffs’ claims arise under federal law; (b) Sawai Pharmaceuticals Co., Ltd. is a foreign
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`defendant not subject to general personal jurisdiction in the courts of any state; and (c) Sawai
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`4
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`Pharmaceuticals Co., Ltd. has sufficient contacts with the United States as a whole, including but
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`not limited to preparing and submitting an ANDA to the FDA and/or manufacturing and/or
`
`selling pharmaceutical products distributed throughout the United States, such that this Court’s
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`exercise of jurisdiction over Sawai Pharmaceuticals Co., Ltd. satisfies due process
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`19.
`
`Venue is proper in this Court pursuant to 28 U.S.C. §§ 1391 and 1400(b).
`
`FACTUAL BACKGROUND
`
`A.
`
`The ’532 Patent
`
`20.
`
`The United States Patent and Trademark Office (“PTO”) duly and legally issued
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`the ’532 patent, entitled “Amide Derivatives or Salts Thereof,” on February 12, 2002. On
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`February 24, 2015, after an ex parte reexamination proceeding, the PTO duly and legally issued a
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`reexamination certificate confirming the validity and patentability of the ’532 patent. A true and
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`correct copy of the ’532 patent is attached as Exhibit A.
`
`21.
`
`The ’532 patent claims, inter alia, the compound mirabegron and compositions
`
`containing mirabegron.
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`22.
`
`The ’532 patent also claims, inter alia, a pharmaceutical composition containing
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`mirabegron as an active ingredient.
`
`23.
`
`The Approved Drug Products with Therapeutic Equivalence Evaluations
`
`(“Orange Book”) lists the expiration date of the ’532 patent as March 27, 2022.
`
`B.
`
`The ʼ117 Patent
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`24.
`
`The PTO duly and legally issued the ’117 patent, entitled “α-Form or β-Form
`
`Crystal of Acetanilide Derivative,” on March 11, 2008. A true and correct copy of the ’117
`
`patent is attached as Exhibit B.
`
`25.
`
`The ’117 patent claims, inter alia, crystal forms of mirabegron.
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`5
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`26.
`
`The Orange Book lists the expiration date of the ’117 patent as November 4,
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`2023.
`
`C.
`
`The ʼ049 Patent
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`27.
`
`The PTO duly and legally issued the ’049 patent, entitled “α-Form or β-Form
`
`Crystal of Acetanilide Derivative,” on July 19, 2011. A true and correct copy of the ’049 patent
`
`is attached as Exhibit C.
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`28.
`
`The ’049 patent claims, inter alia, pharmaceutical compositions comprising
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`crystal forms of mirabegron and a pharmaceutically acceptable carrier.
`
`29.
`
`The Orange Book lists the expiration date of the ’049 patent as November 4,
`
`2023.
`
`D.
`
`The ʼ474 Patent
`
`30.
`
`The PTO duly and legally issued the ’474 patent, entitled “Remedy for
`
`Overactive Bladder Comprising Acetic Acid Anilide Derivative As The Active Ingredient,” on
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`September 16, 2014. A true and correct copy of the ’474 patent is attached as Exhibit D.
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`31.
`
`The ’474 patent claims, inter alia, methods of treating overactive bladder by
`
`administering mirabegron.
`
`32.
`
`The Orange Book lists the expiration date of the ’474 patent as November 4,
`
`2023.
`
`E.
`
`The ʼ872 Patent
`
`33.
`
`The PTO duly and legally re-issued the ’872 patent, entitled “Remedy for
`
`Overactive Bladder Comprising Acetic Acid Anilide Derivative As The Active Ingredient,” on
`
`April 29, 2014. A true and correct copy of the ’872 patent is attached as Exhibit E.
`
`34.
`
`The ’872 patent claims, inter alia, methods of treating overactive bladder by
`
`administering mirabegron to adult subjects.
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`6
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`35.
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`The ’872 patent also claims, inter alia, methods of treating overactive bladder
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`by administering mirabegron, to non-adult subjects that are not suffering from diabetes.
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`36.
`
`The Orange Book lists the expiration date of the ’872 patent as November 4,
`
`2023.
`
`F. Myrbetriq®
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`37.
`
`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. The FDA approved NDA No. 202611 on June 28, 2012 for both the 25 mg and 50
`
`mg extended-release Myrbetriq® tablets. The ’532, ’117, ’049, ’474 and ’872 patents are listed
`
`in the Orange Book for NDA No. 202611.
`
`38.
`
`Mirabegron has been referred
`
`to chemically as,
`
`inter alia, (R)-2-(2-
`
`aminothiazol-4-yl)-4’-[2-(2-hydroxy-2-phenylethyl)amino]ethyl]acetanilide,
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`(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:
`
`
`
`39.
`
`Myrbetriq® extended-release tablets, 25 mg and 50 mg, are indicated for the
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`treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency,
`
`and urinary frequency.
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`40.
`
`Astellas Pharma Inc. is the record owner and assignee of the ’532,’117, ’049,
`
`’474 and ’872 patents.
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`7
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`41.
`
`AICL is the exclusive licensee of the ’532, ’117, ’049, ’474 and ’872 patents
`
`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.
`
`42.
`
`APGD has contracted with Astellas Pharma US, Inc., a subsidiary of Astellas
`
`Pharma Inc., to market and sell Myrbetriq® extended-release tablets, 25 mg and 50 mg, in the
`
`United States on its behalf.
`
`G.
`
`Infringement by Sawai
`
`43.
`
`On information and belief, Sawai submitted to the FDA ANDA No. 209446
`
`under Section 505(j) of the Act, 21 U.S.C. § 355(j), seeking FDA approval to engage in the
`
`commercial manufacture, use, offer for sale, sale, and/or importation of generic mirabegron
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`extended-release tablets in a 25 mg strength (“ANDA Product”), as a pharmaceutical
`
`composition in an oral dosage form for the treatment of overactive bladder prior to the expiration
`
`of the ’532, ’117, ’049, ’474 and ’872 patents. The Notice Letter does not provide notice that
`
`ANDA No. 209446 seeks FDA approval to engage in the commercial manufacture, use, offer for
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`sale, sale, and/or importation of generic mirabegron extended-release tablets in a 50 mg strength.
`
`On information and belief, upon approval of ANDA No. 209446 Sawai will not engage in the
`
`commercial manufacture, use, offer for sale, sale, and/or importation of generic mirabegron
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`extended-release tablets in a 50 mg strength.
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`44.
`
`On information and belief, Sawai intends to engage in the commercial
`
`manufacture, use, offer for sale, sale, and/or importation into the United States of the ANDA
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`Product if and when it receives FDA approval to do so.
`
`45.
`
`The Notice Letter advised Plaintiffs that Sawai submitted ANDA No. 209446 to
`
`the FDA seeking approval to manufacture, use, offer to sell, sell, and/or import the ANDA
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`8
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`Product prior to the expiration of the ’532, ’117, ’049, ’474 and ’872 patents. The Notice Letter
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`advised Plaintiffs that Sawai’s ANDA submission included a certification under 21 U.S.C. §
`
`355(j)(2)(B)(iv) that, in Sawai’s opinion, the claims of the ’532, ’117, ’049, ’474 and ’872
`
`patents are invalid, unenforceable and/or not infringed.
`
`46.
`
`The submission of ANDA No. 209446 to the FDA constituted an act of
`
`infringement by Sawai of the ’532, ’117, ’049, ’474 and ’872 patents under 35 U.S.C. §
`
`271(e)(2).
`
`47.
`
`Plaintiffs are commencing this action within 45 days of receiving the Notice
`
`Letter pursuant to 21 U.S.C. § 355(j)(5)(B)(iii).
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`CLAIMS FOR RELIEF
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`COUNT I: DIRECT INFRINGEMENT OF THE ’532 PATENT
`
`48.
`
`Plaintiffs incorporate by reference and reallege paragraphs 1 through 47 above
`
`as though fully restated herein.
`
`49.
`
`Pursuant to 35 U.S.C. § 271(e)(2), Sawai’s submission of ANDA No. 209446 to
`
`the FDA seeking approval of the ANDA Product was an act of infringement by Sawai of at least
`
`claims 1, 4, 5, 11 and 15 of the ʼ532 patent which claim the compound mirabegron, the proposed
`
`active ingredient of the ANDA Product.
`
`50.
`
`In the Notice Letter, Sawai does not deny that its ANDA Product is covered by
`
`claims 1, 4, 5, 11, and 15 of the ’532 patent.
`
`51.
`
`The ANDA Product and the use thereof would infringe the ʼ532 patent under 35
`
`U.S.C. § 271(a), including at least claims 1, 4, 5, 11 and 15 which cover, inter alia, a
`
`pharmaceutical composition containing mirabegron as an active ingredient.
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`52.
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`Unless Sawai is enjoined by the Court, Plaintiffs will be substantially and
`
`irreparably harmed by Sawai’s infringement of the ʼ532 patent. Plaintiffs do not have an
`
`adequate remedy at law.
`
`COUNT II: DIRECT INFRINGEMENT OF THE ’117 PATENT
`
`53.
`
`Plaintiffs incorporate by reference and reallege paragraphs 1 through 52 above
`
`as though fully restated herein.
`
`54.
`
`Pursuant to 35 U.S.C. § 271(e)(2), Sawai’s submission of ANDA No. 209446 to
`
`the FDA seeking approval of the ANDA Product was an act of infringement by Sawai of at least
`
`claim 1 of the ʼ117 patent, which claims a crystal form of mirabegron that is contained in the
`
`ANDA Product.
`
`55.
`
`The ANDA Product and the use thereof would infringe the ʼ117 patent under 35
`
`U.S.C. § 271(a), including at least claim 1, which covers, inter alia, a crystal form of
`
`mirabegron.
`
`56.
`
`Unless Sawai is enjoined by the Court, Plaintiffs will be substantially and
`
`irreparably harmed by Sawai’s infringement of the ʼ117 patent. Plaintiffs do not have an
`
`adequate remedy at law.
`
`COUNT III: DIRECT INFRINGEMENT OF THE ’049 PATENT
`
`57.
`
`Plaintiffs incorporate by reference and reallege paragraphs 1 through 56 above
`
`as though fully restated herein.
`
`58.
`
`Pursuant to 35 U.S.C. § 271(e)(2), Sawai’s submission of ANDA No. 209446 to
`
`the FDA seeking approval of the ANDA Product was an act of infringement by Sawai of at least
`
`claims 1, 5, 9 and 13 of the ʼ049 patent which claim pharmaceutical compositions comprising a
`
`10
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`crystal form of mirabegron and a pharmaceutically acceptable carrier contained in the ANDA
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`Product.
`
`59.
`
`The ANDA Product and the use thereof would infringe the ʼ049 patent under 35
`
`U.S.C. § 271(a), including at least claims 1, 5, 9 and 13, which cover, inter alia, pharmaceutical
`
`compositions comprising a crystal form of mirabegron and a pharmaceutically acceptable carrier.
`
`60.
`
`Unless Sawai is enjoined by the Court, Plaintiffs will be substantially and
`
`irreparably harmed by Sawai’s infringement of the ʼ049 patent. Plaintiffs do not have an
`
`adequate remedy at law.
`
`COUNT IV: DIRECT INFRINGEMENT OF THE ’474 PATENT
`
`61.
`
`Plaintiffs incorporate by reference and reallege paragraphs 1 through 60 above
`
`as though fully restated herein.
`
`62.
`
`Pursuant to 35 U.S.C. § 271(e)(2), Sawai’s submission of ANDA No. 209446 to
`
`the FDA seeking approval of the ANDA Product was an act of infringement by Sawai of at least
`
`claims 1, 3-4, 6-7, 9-10 and 12 of the ʼ474 patent which cover the method of treating overactive
`
`bladder by administering mirabegron, the use for which Sawai seeks FDA approval in its ANDA.
`
`63.
`
`Unless Sawai is enjoined by the Court, Plaintiffs will be substantially and
`
`irreparably harmed by Sawai’s infringement of the ʼ474 patent. Plaintiffs do not have an
`
`adequate remedy at law.
`
`
`
`
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`COUNT V: INDUCEMENT TO INFRINGE THE ’474 PATENT
`
`64.
`
`Plaintiffs incorporate by reference and reallege paragraphs 1 through 63 above
`
`as though fully restated herein.
`
`65.
`
`66.
`
`Sawai has knowledge of the ʼ474 patent.
`
`If the ANDA Product is approved by the FDA and is sold by Sawai, its use by
`
`healthcare providers and/or patients will directly infringe one or more claims of the ʼ474 patent,
`
`including at least claims 1, 3-4, 6-7, 9-10 and 12.
`
`67.
`
`Sawai’s proposed label for the ANDA Product explicitly instructs healthcare
`
`providers and/or patients to use the ANDA Product in a manner that will directly infringe one or
`
`more claims of the ʼ474 patent, including at least claims 1, 3-4, 6-7, 9-10 and 12.
`
`68.
`
`Any use of the ANDA Product by patients will be performed at the direction
`
`and control of healthcare providers treating overactive bladder, who in turn are instructed by
`
`Sawai in its proposed label for the ANDA Product.
`
`69.
`
`If the ANDA Product is approved by the FDA, Sawai will actively induce
`
`others including, e.g., healthcare providers and/or patients, to directly infringe one or more
`
`claims of the ʼ474 patent, including at least claims 1, 3-4, 6-7, 9-10 and 12. Sawai has acted with
`
`knowledge that the induced acts would constitute infringement of the ʼ474 patent.
`
`70.
`
`Sawai specifically intends to cause direct infringement by others, e.g.,
`
`healthcare providers and/or patients.
`
`71.
`
`If and when the FDA approves ANDA No. 209446, Sawai will take affirmative
`
`steps to induce infringement by, among other things, instructing healthcare providers and/or
`
`patients, through Sawai’s proposed label, to use the ANDA Product in a manner that directly
`
`infringes one or more claims of the ʼ474 patent, including at least claims 1, 3-4, 6-7, 9-10 and 12.
`
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`Thus, Sawai will aid, abet, urge, and/or encourage others including, e.g., healthcare providers
`
`and/or patients, to directly infringe one or more claims of the ʼ474 patent, and Sawai will
`
`affirmatively and specifically intend to cause direct infringement.
`
`72.
`
`Sawai’s actions will constitute inducement of infringement of the ’474 patent
`
`pursuant to 35 U.S.C § 271(b).
`
`COUNT VI: CONTRIBUTORY INFRINGEMENT OF THE ’474 PATENT
`
`73.
`
`Plaintiffs incorporate by reference and reallege paragraphs 1 through 72 above
`
`as though fully restated herein.
`
`74.
`
`If ANDA No. 209446 is approved by the FDA, Sawai intends to and will offer
`
`to sell, sell, and/or import into the United States the ANDA Product.
`
`75.
`
`The ANDA Product constitutes a material part of the inventions covered by the
`
`claims of the ʼ474 patent and has no substantial non-infringing uses.
`
`76.
`
`On information and belief, Sawai has had and continues to have knowledge that
`
`the ANDA Product is especially adapted for a use that infringes the ʼ474 patent, including at
`
`least claims 1, 3-4, 6-7, 9-10 and 12.
`
`77.
`
`On information and belief, Sawai has had and continues to have knowledge that
`
`there is no substantial non-infringing use for the ANDA Product.
`
`78.
`
`Sawai’s actions will constitute contributory infringement of the ’474 patent
`
`pursuant to 35 U.S.C. § 271(c).
`
`COUNT VII: DIRECT INFRINGEMENT OF THE ’872 PATENT
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`79.
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`Plaintiffs incorporate by reference and reallege paragraphs 1 through 78 above
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`as though fully restated herein.
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`80.
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`Pursuant to 35 U.S.C. § 271(e)(2), Sawai’s submission of ANDA No. 209446 to
`
`the FDA seeking approval of the ANDA Product was an act of infringement by Sawai of at least
`
`claims 1, 3-4, 6, 8-9 and 11-14 of the ʼ872 patent which cover the method of treating overactive
`
`bladder by administering mirabegron, the use for which Sawai seeks FDA approval in its ANDA.
`
`81.
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`Unless Sawai is enjoined by the Court, Plaintiffs will be substantially and
`
`irreparably harmed by Sawai’s infringement of the ʼ872 patent. Plaintiffs do not have an
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`adequate remedy at law.
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`COUNT VIII: INDUCEMENT TO INFRINGE THE ’872 PATENT
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`82.
`
`Plaintiffs incorporate by reference and reallege paragraphs 1 through 81 above
`
`as though fully restated herein.
`
`83.
`
`84.
`
`Sawai has knowledge of the ʼ872 patent.
`
`If the ANDA Product is approved by the FDA and is sold by Sawai, its use by
`
`healthcare providers and/or patients will directly infringe one or more claims of the ʼ872 patent,
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`including at least claims 1, 3-4, 6, 8-9 and 11-14.
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`85.
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`Sawai’s proposed label for the ANDA Product explicitly instructs healthcare
`
`providers and/or patients to use the ANDA Product in a manner that will directly infringe one or
`
`more claims of the ʼ872 patent, including at least claims 1, 3-4, 6, 8-9 and 11-14.
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`86.
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`Any use of the ANDA Product by patients will be performed at the direction
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`and control of healthcare providers treating overactive bladder, who in turn are instructed by
`
`Sawai in its proposed label for the ANDA Product.
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`87.
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`If the ANDA Product is approved by the FDA, Sawai will actively induce
`
`others including, e.g., healthcare providers and/or patients, to directly infringe one or more
`
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`claims of the ʼ872 patent, including at least claims 1, 3-4, 6, 8-9 and 11-14. Sawai has acted with
`
`knowledge that the induced acts would constitute infringement of the ʼ872 patent.
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`88.
`
`Sawai specifically intends to cause direct infringement by others, e.g.,
`
`healthcare providers and/or patients.
`
`89.
`
`If and when the FDA approves ANDA No. 209446, Sawai will take affirmative
`
`steps to induce infringement by, among other things, instructing healthcare providers and/or
`
`patients, through Sawai’s proposed label, to use the ANDA Product in a manner that directly
`
`infringes one or more claims of the ʼ872 patent, including at least claims 1, 3-4, 6, 8-9 and 11-14.
`
`Thus, Sawai will aid, abet, urge, and/or encourage others including, e.g., healthcare providers
`
`and/or patients, to directly infringe one or more claims of the ʼ872 patent, and Sawai will
`
`affirmatively and specifically intend to cause direct infringement.
`
`90.
`
`Sawai’s actions will constitute inducement of infringement of the ’872 patent
`
`pursuant to 35 U.S.C § 271(b).
`
`COUNT IX: CONTRIBUTORY INFRINGEMENT OF THE ’872 PATENT
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`91.
`
`Plaintiffs incorporate by reference and reallege paragraphs 1 through 90 above
`
`as though fully restated herein.
`
`92.
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`If ANDA No. 209446 is approved by the FDA, Sawai intends to and will offer
`
`to sell, sell, and/or import into the United States the ANDA Product.
`
`93.
`
`The ANDA Product constitutes a material part of the inventions covered by the
`
`claims of the ʼ872 patent and has no substantial noninfringing uses.
`
`94.
`
`On information and belief, Sawai has had and continues to have knowledge that
`
`the ANDA Product is especially adapted for a use that infringes the ʼ872 patent, including at
`
`least claims 1, 3-4, 6, 8-9 and 11-14.
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`95.
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`On information and belief, Sawai has had and continues to have knowledge that
`
`there is no substantial non-infringing use for the ANDA Product.
`
`96.
`
`Sawai’s actions will constitute contributory infringement of the ’872 patent
`
`pursuant to 35 U.S.C. § 271(c).
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`PRAYER FOR RELIEF
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`WHEREFORE, Plaintiffs Astellas Pharma Inc., AICL, and APGD, pray for a judgment
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`in their favor and against Defendants Sawai, and respectfully request the following relief:
`
`A.
`
`A judgment that, under 35 U.S.C. § 271(e)(2)(A), Sawai has infringed one or
`
`more claims of each of the ’532, ’117, ’049, ’474 and ’872 patents by Sawai’s filing of ANDA
`
`No. 209446 seeking FDA approval for the commercial manufacture, use, offer for sale, sale,
`
`and/or importation of the ANDA Product before the expiration of those patents;
`
`B.
`
`A judgment declaring that the manufacture, use, offer for sale, sale, and/or
`
`importation of the ANDA Product will infringe the ’532, ’117, ’049, ’474 and ’872 patents;
`
`C.
`
`A judgment declaring that the ’532, ’117, ’049, ’474 and ’872 patents remain
`
`valid and enforceable;
`
`D.
`
`A permanent injunction restraining and enjoining Sawai and its officers, agents,
`
`attorneys, and employees, and those acting in privity or concert therewith, from engaging in the
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`commercial manufacture, use, offer for sale, sale, and/or importation of the ANDA Product, as
`
`claimed in the ’532, ’117, ’049, ’474 and ’872 patents, until the expiration of each of the ’532,
`
`’117, ’049, ’474 and ’872 patents, or any later date of exclusivity to which Plaintiffs are or
`
`become entitled;
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`E.
`
`An order that the effective date of any approval of ANDA No. 209446 be a date
`
`that is not earlier than the expiration of the right of exclusivity under any of the ’532, ’117, ’049,
`
`’474 and ’872 patents, or any later date of exclusivity to which Plaintiffs are or become entitled;
`
`F.
`
`To the extent that Sawai has committed any acts with respect to the subject matter
`
`claimed in the ’532, ’117, ’049, ’474 and/or ’872 patents, other than those acts expressly
`
`exempted by 35 U.S.C. § 271(e)(1), an award of damages for such acts;
`
`G.
`
`A determination that this case is “exceptional” under 35 U.S.C. § 285, and an
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`award of attorney fees;
`
`H.
`
`I.
`
`An award of Plaintiffs’ costs and expenses in this action; and
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`Such other and further relief as the Court may deem just and proper.
`
`
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`
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`/s/ Jack B. Blumenfeld
`
`
`
`
`Jack B. Blumenfeld (#1014)
`Maryellen Noreika (#3208)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`mnoreika@mnat.com
`
`Attorneys for Plaintiffs Astellas Pharma Inc.,
`Astellas Ireland Co., Ltd., and Astellas Pharma
`Global Development, Inc.
`
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`
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`OF COUNSEL:
`
`Robert L. Baechtold
`John D. Murnane
`Simon D. Roberts
`Christopher P. Borello
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`(212) 218-2100
`
`October 17, 2016
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