Case 1:20-cv-01589-UNA Document 1 Filed 11/24/20 Page 1 of 42 PageID #: 1
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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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`C.A. No. _______________________
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`
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`SANDOZ INC., ACTAVIS ELIZABETH
`LLC, ACTAVIS LLC, TEVA
`PHARMACEUTICALS USA, INC.,
`APOTEX INC., APOTEX CORP.,
`AUROBINDO PHARMA LTD.,
`AUROBINDO PHARMA USA, INC.,
`AUROLIFE PHARMA LLC, SAWAI
`PHARMACEUTICAL CO., LTD., SAWAI
`USA, INC., PRINSTON
`PHARMACEUTICAL INC., ZHEJIANG
`HUAHAI PHARMACEUTICAL CO., LTD.,
`HUAHAI US INC., SOLCO HEALTHCARE
`US, LLC, WINDLAS HEALTHCARE, PVT.
`LTD.,WINDLAS BIOTECH LTD., ZYDUS
`PHARMACEUTICALS (USA), INC.,
`CADILA HEALTHCARE LTD. (d/b/a
`ZYDUS CADILA), LUPIN LTD. and LUPIN
`PHARMACEUTICALS, INC.
`
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`
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`
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`Defendants.
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`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiffs Astellas Pharma Inc., Astellas Ireland Co., Ltd., and Astellas Pharma Global
`
`Development, Inc. (collectively, “Astellas” or “Plaintiffs”), by their undersigned attorneys,
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`hereby allege as follows:
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`A.
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`THE PARTIES
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`Astellas Pharma Inc., Astellas Ireland Co., Ltd. and Astellas Pharma Global
`Development, Inc.
`
`1.
`
`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,
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`Chuo-Ku, Tokyo 103-8411, Japan. API was formed on April 1, 2005, from the merger of
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`Yamanouchi Pharmaceutical Co., Ltd. and Fujisawa Pharmaceutical Co., Ltd.
`
`2.
`
`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
`
`API.
`
`3.
`
`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.
`
`Sandoz Inc. (“Sandoz”)
`
`4.
`
`On information and belief, Defendant Sandoz is a corporation organized and
`
`existing under the laws of Delaware, having a principal place of business at 100 College Road
`
`West, Princeton, NJ 08540. On information and belief, Sandoz 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.
`
`5.
`
`By a letter dated September 9, 2016 (“Sandoz’s Notice Letter”), Sandoz notified
`
`Plaintiffs that Sandoz had submitted to the United States Food and Drug Administration
`
`(“FDA”) Abbreviated New Drug Application (“ANDA”) No. 209441 for mirabegron extended-
`
`release tablets, 25 mg and 50 mg (“Sandoz ANDA”), a drug product that is a generic version of
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`Myrbetriq® extended-release tablets, in the 25mg and 50mg strengths (“Sandoz’s ANDA
`
`Product”). On information and belief, the purpose of Sandoz’s submission of the Sandoz ANDA
`
`was to obtain approval under the Federal Food, Drug, and Cosmetic Act (“FDCA”) to engage in
`
`the commercial manufacture, use, offer for sale, and/or sale of Sandoz’s ANDA Product prior to
`
`November 4, 2023.
`
`6.
`
`In Sandoz’s Notice Letter, Sandoz notified Plaintiffs that, as a part of the Sandoz
`
`ANDA, Sandoz 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 some of the then-listed patents in
`
`the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluation (“Orange Book”),
`
`asserting that they are invalid, unenforceable, and/or will not be infringed by the commercial
`
`manufacture, use, and sale of Sandoz’s ANDA Product.
`
`7.
`
`On the basis of Sandoz’s Notice Letter, Plaintiffs filed suit against Sandoz for
`
`infringement of some of the then-listed patents in the Orange Book. Astellas Pharma Inc. et al.
`
`v. Sandoz Inc., C.A. No. 16-952 (D. Del.), D.I. 1.
`
`8.
`
`In its Answer, Sandoz did not dispute at least subject matter jurisdiction under 35
`
`U.S.C. § 271(e)(2)(A), personal jurisdiction or venue. Astellas Pharma Inc. et al. v. Sandoz Inc.,
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`C.A. No. 16-952 (D. Del.), D.I. 12 at ¶¶ 7-8, 13.
`
`9.
`
`Astellas and Sandoz reached a settlement and the case was dismissed. Astellas
`
`Pharma Inc. et al. v. Actavis Elizabeth LLC et al., C.A. No. 16-905-JFB-CJB (Cons.) (D. Del.),
`
`D.I. 604.
`
`C.
`
`Actavis Elizabeth LLC, Actavis LLC and Teva Pharmaceuticals USA, Inc.
`(collectively, “Actavis”)
`
`10.
`
`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
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`business at 200 Elmora Avenue, Elizabeth, New Jersey, 07202. On information and belief,
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`Actavis Elizabeth LLC is in the business of, inter alia, developing, manufacturing and/or
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`distributing generic drug products for marketing, sale, and/or use throughout the United States
`
`including in this judicial district.
`
`11.
`
`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
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`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.
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`12.
`
`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
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`business at 1090 Horsham Road, North Wales, Pennsylvania 19454. On information and belief,
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`Teva 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, on or about August 2, 2016, Teva acquired Actavis’s
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`Generics business, including Actavis Elizabeth LLC and Actavis LLC.
`
`14.
`
`On information and belief, Actavis Elizabeth LLC is a wholly owned subsidiary
`
`of Actavis LLC, which is a wholly owned subsidiary of Teva.
`
`15.
`
`By a letter dated August 24, 2016, (“Actavis’s Notice Letter”) Actavis notified
`
`Plaintiffs that Actavis had submitted to the 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
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`Myrbetriq® extended-release tablets, in the 25mg and 50mg 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 November 4, 2023.
`
`16.
`
`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 some of the then-listed patents in
`
`the Orange Book, asserting that they are invalid, unenforceable, and/or will not be infringed by
`
`the commercial manufacture, use, and sale of Actavis’s ANDA Product.
`
`17.
`
`On the basis of Actavis’s Notice Letter, Plaintiffs filed suit against Actavis for
`
`infringement of some of the then-listed patents in the Orange Book. Astellas Pharma Inc. et al.
`
`v. Actavis Elizabeth LLC. et al., C.A. No. 16-905 (D. Del.), D.I. 1.
`
`18.
`
`In its Answer, Actavis did not dispute jurisdiction or venue. Astellas Pharma Inc.
`
`et al. v. Actavis Elizabeth LLC. et al., C.A. No. 16-905 (D. Del.), D.I. 16 at ¶¶ 11-12, 14-16, 21.
`
`19.
`
`Astellas and Actavis reached a settlement and the case was dismissed. Astellas
`
`Pharma Inc. et al. v. Actavis Elizabeth LLC et al., C.A. No. 16-905-JFB-CJB (Cons.) (D. Del.),
`
`D.I. 11, 28, 587.
`
`20.
`
`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.
`
`21.
`
`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
`
`in concert with one another to make, use, offer to sell, and/or sell the generic drug products that
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`are the subject of ANDA No. 209368 throughout the United States, and/or import such generic
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`drug products into the United States, including in this judicial district.
`
`D.
`
`Apotex Inc. and Apotex Corp. (collectively, “Apotex”)
`
`22.
`
`On information and belief, Defendant Apotex Inc. is a corporation organized and
`
`existing under the laws of Canada, having a principal place of business at 150 Signet Drive,
`
`Toronto, Ontario M9L 1T9, Canada. On information and belief, Apotex 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.
`
`23.
`
`On information and belief, Defendant Apotex Corp. is a corporation organized
`
`and existing under the laws of Delaware, having a principal place of business at 2400 N.
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`Commerce Parkway, Suite 400, Weston, Florida 33326. On information and belief, Apotex
`
`Corp. 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.
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`24.
`
`By a letter dated October 10, 2016, (Apotex’s Notice Letter) Apotex notified
`
`Plaintiffs that Apotex had submitted to the FDA ANDA No. 209434 for Mirabegron Extended-
`
`Release Tablets, 25 mg and 50 mg (“Apotex ANDA”), a drug product that is a generic version of
`
`Myrbetriq® extended-release tablets, in the 25mg and 50mg strengths (“Apotex’s ANDA
`
`Product”). On information and belief, the purpose of Apotex’s submission of the Apotex ANDA
`
`was to obtain approval under the FDCA to engage in the commercial manufacture, use, offer for
`
`sale, and/or sale of Apotex’s ANDA Product prior to November 4, 2023.
`
`25.
`
`In Apotex’s Notice Letter, Apotex notified Plaintiffs that, as a part of the Apotex
`
`ANDA, Apotex 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 some of the then-listed patents in
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`the Orange Book, asserting that they are invalid, unenforceable, and/or will not be infringed by
`
`the commercial manufacture, use, and sale of Apotex’s ANDA Product.
`
`26.
`
`On the basis of Apotex’s Notice Letter, Plaintiffs filed suit against Apotex for
`
`infringement of some of the some of the then-listed patents in the Orange Book. Astellas Pharma
`
`Inc. et al. v. Apotex Inc. et al., C.A. No. 16-976 (D. Del.), D.I. 1.
`
`27.
`
`In its Answer, Apotex did not dispute jurisdiction or venue. Astellas Pharma Inc.
`
`et al. v. Apotex Inc. et al., C.A. No. 16-976 (D. Del.), D.I. 17 at ¶¶ 9-14, 16, 18-19.
`
`28.
`
`Astellas and Apotex reached a settlement and the case was dismissed. Astellas
`
`Pharma Inc. et al. v. Actavis Elizabeth LLC et al., C.A. No. 16-905-JFB-CJB (Cons.) (D. Del.)
`
`D.I. 286.
`
`29.
`
`On information and belief, and consistent with their past practices, Apotex Inc.
`
`and Apotex Corp. acted collaboratively in the preparation and submission of ANDA No. 209434.
`
`30.
`
`On information and belief, and consistent with their past practices, following any
`
`FDA approval of ANDA No. 209434, Apotex Inc. and Apotex Corp. 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. 209434 throughout the United States, and/or import such generic drug products
`
`into the United States, including in this judicial district.
`
`E.
`
`Aurobindo Pharma Ltd., Aurobindo Pharma USA, Inc. and Aurolife Pharma LLC
`(collectively, “Aurobindo”)
`
`31.
`
`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
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`distributing generic drug products for marketing, sale, and/or use throughout the United States
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`including in this judicial district.
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`32.
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`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 279 Princeton Hightstown Road, East Windsor, NJ 08520. On information and
`
`belief, Aurobindo Pharma 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.
`
`33.
`
`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.
`
`34.
`
`By a letter dated September 8, 2016, (“Aurobindo’s Notice Letter”) Aurobindo
`
`notified Plaintiffs that Aurobindo had submitted to the 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 50mg 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 November 4, 2023.
`
`35.
`
`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
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`
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`505(j)(2)(A)(vii)(IV) of the FDCA, 21 U.S.C. § 355(j)(2)(A)(vii)(IV), with respect to some of
`
`the then-listed patents in the Orange Book, asserting that they are invalid, unenforceable, and/or
`
`will not be infringed by the commercial manufacture, use, and sale of Aurobindo’s ANDA
`
`Product.
`
`36.
`
`On the basis of Aurobindo’s Notice Letter, Plaintiffs filed suit against Aurobindo
`
`for infringement of some of the then-listed patents in the Orange Book. Astellas Pharma Inc. et
`
`al. v. Aurobindo Pharma Ltd. et al., C.A. No. 16-942 (D. Del.), D.I. 1.
`
`37.
`
`In its Answer, Aurobindo did not dispute jurisdiction or venue. Astellas Pharma
`
`Inc. et al. v. Aurobindo Pharma Ltd. et al., C.A. No. 16-942 (D. Del.), D.I. 22 at ¶¶ 10-15, 20-21.
`
`38.
`
`Astellas and Aurobindo reached a settlement and the case was dismissed. Astellas
`
`Pharma Inc. et al. v. Actavis Elizabeth LLC et al., C.A. No. 16-905-JFB-CJB (Cons.) (D. Del.),
`
`D.I. 380.
`
`39.
`
`On information and belief, Aurobindo has received tentative approval for the
`
`Aurobindo ANDA.
`
`40.
`
`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.
`
`41.
`
`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.
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`F.
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`Sawai Pharmaceutical Co. Ltd. and Sawai USA Inc. (collectively, “Sawai”)
`
`42.
`
`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
`
`in Osaka, Japan. On information and belief, Sawai Pharmaceutical Co. 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.
`
`43.
`
`On information and belief, Defendant Sawai USA Inc. is a corporation organized
`
`and existing under the laws of Delaware, having a principal place of business in Irvine, CA. On
`
`information and belief, Sawai 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.
`
`44.
`
`By letters dated September 12, 2016 (“Sawai’s 2016 Notice Letter”) and July 24,
`
`2018 (“Sawai’s 2018 Notice Letter”) Sawai notified Plaintiffs that Sawai had submitted to the
`
`FDA ANDA No. 209446 for a mirabegron extended-release tablet, 25mg product (“Sawai
`
`ANDA”), a drug product that is a generic version of Myrbetriq® extended-release tablets, in the
`
`25mg strength (“Sawai’s ANDA Product”). On information and belief, the purpose of Sawai’s
`
`submission of the Sawai ANDA was to obtain approval under the FDCA to engage in the
`
`commercial manufacture, use, offer for sale, and/or sale of Sawai’s ANDA Product prior to
`
`November 4, 2023.
`
`45.
`
`In Sawai’s 2016 Notice Letter and Sawai’s 2018 Notice Letter, Sawai notified
`
`Plaintiffs that, as a part of the Sawai ANDA, Sawai 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
`
`some of the then-listed patents in the Orange Book, asserting that they are invalid,
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`unenforceable, and/or will not be infringed by the commercial manufacture, use, and sale of
`
`Sawai’s ANDA Product.
`
`46.
`
`On the basis of Sawai’s 2016 Notice Letter, Plaintiffs filed suit against Sawai for
`
`infringement of some of the then-listed patents in the Orange Book. Astellas Pharma Inc. et al. v.
`
`Sawai Pharmaceutical Co. Ltd. et al., C.A. No. 16-954 (D. Del.), D.I. 1.
`
`47.
`
`In its Answer, Sawai did not dispute jurisdiction or venue. Astellas Pharma Inc.
`
`et al. v. Sawai Pharmaceutical Co. Ltd. et al., C.A. No. 16-954 (D. Del.), D.I. 16 at ¶¶ 9-13, 18-
`
`19.
`
`48.
`
`Astellas and Sawai reached a settlement and the case was dismissed. Astellas
`
`Pharma Inc. et al. v. Actavis Elizabeth LLC et al., C.A. No. 16-905-JFB-CJB (Cons.) (D. Del.),
`
`D.I. 533.
`
`49.
`
`On information and belief, Sawai has received tentative approval for the Sawai
`
`ANDA.
`
`50.
`
`On information and belief, and consistent with their past practices, Sawai
`
`Pharmaceutical Co. Ltd. and Sawai USA Inc. acted collaboratively in the preparation and
`
`submission of ANDA No. 209446.
`
`51.
`
`On information and belief, and consistent with their past practices, following any
`
`FDA approval of ANDA No. 209446, Sawai Pharmaceutical Co. Ltd. and Sawai USA Inc. 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. 209446 throughout the United States, and/or import such
`
`generic drug products into the United States, including in this judicial district.
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`G.
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`Prinston Pharmaceutical Inc., Zhejiang Huahai Pharmaceutical Co. Ltd., Huahai
`US Inc., and Solco Healthcare US LLC (collectively, “Prinston”)
`
`52.
`
`On information and belief, Defendant Prinston Pharmaceutical Inc. is a
`
`corporation organized and existing under the laws of Delaware, having a principal place of
`
`business at 2002 Eastpark Blvd., Cranbury, New Jersey 08512. On information and belief,
`
`Prinston Pharmaceutical 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.
`
`53.
`
`On information and belief, Defendant Zhejiang Huahai Pharmaceutical Co. Ltd. is
`
`a corporation organized and existing under the laws of China, having a principal place of
`
`business at Xunqiao, Linhai, Zhejiang 317024, China. On information and belief, Zhejiang
`
`Huahai Pharmaceutical Co. 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.
`
`54.
`
`On information and belief, Defendant Huahai US Inc. is a corporation organized
`
`and existing under the laws of New Jersey, having a principal place of business at 2002 Eastpark
`
`Blvd., Cranbury, New Jersey 08512. On information and belief, Huahai US 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.
`
`55.
`
`On information and belief, Defendant Solco Healthcare US LLC is a limited
`
`liability company organized and existing under the laws of Delaware, having a principal place of
`
`business at 2002 Eastpark Blvd., Cranbury, New Jersey 08512. On information and belief, Solco
`
`Healthcare US LLC is in the business of, inter alia, developing, manufacturing and/or
`
`
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`
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`distributing generic drug products for marketing, sale, and/or use throughout the United States
`
`including in this judicial district.
`
`56.
`
`By a letter dated September 8, 2016, (“Prinston Notice Letter”) Prinston notified
`
`Plaintiffs that Prinston had submitted to the FDA ANDA No. 209475 for mirabegron extended
`
`release tablets, 25 mg and 50 mg (“Prinston ANDA”), a drug product that is a generic version of
`
`Myrbetriq® extended-release tablets, in the 25mg and 50mg strengths (“Prinston’s ANDA
`
`Product”). On information and belief, the purpose of Prinston’s submission of the Prinston
`
`ANDA was to obtain approval under the FDCA to engage in the commercial manufacture, use,
`
`offer for sale, and/or sale of Prinston’s ANDA Product prior to November 4, 2023.
`
`57.
`
`In Prinston’s Notice Letter, Prinston notified Plaintiffs that, as a part of the
`
`Prinston ANDA, Prinston 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 some of
`
`the then-listed patents in the Orange Book, asserting that they are invalid, unenforceable, and/or
`
`will not be infringed by the commercial manufacture, use, and sale of Prinston’s ANDA Product.
`
`58.
`
`On the basis of Prinston’s Notice Letter, Plaintiffs filed suit against Prinston for
`
`infringement of some of the then-listed patents in the Orange Book. Astellas Pharma Inc. et al.
`
`v. Prinston Pharmaceutical Inc. et al., C.A. No. 16-943 (D. Del.), D.I. 1.
`
`59.
`
`In its Answer, Prinston did not dispute jurisdiction or venue. Astellas Pharma
`
`Inc. et al. v. Prinston Pharmaceutical Inc., C.A. No. 16-943 (D. Del.), D.I. 16 at ¶¶ 11-13, 23.
`
`60.
`
`Astellas and Prinston reached a settlement and the case was dismissed. Astellas
`
`Pharma Inc. et al. v. Prinston Pharmaceutical Inc., C.A. No. 16-943 (D. Del.), D.I. 15; Astellas
`
`Pharma Inc. et al. v. Actavis Elizabeth LLC et al., C.A. No. 16-905-JFB-CJB (Cons.) (D. Del.),
`
`D.I. 307.
`
`
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`Case 1:20-cv-01589-UNA Document 1 Filed 11/24/20 Page 14 of 42 PageID #: 14
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`
`
`61.
`
`On information and belief, and consistent with their past practices, Prinston
`
`Pharmaceutical Inc., Zhejiang Huahai Pharmaceutical Co. Ltd., Huahai US Inc. and Solco
`
`Healthcare US LLC acted collaboratively in the preparation and submission of ANDA No.
`
`209475.
`
`62.
`
`On information and belief, and consistent with their past practices, following any
`
`FDA approval of ANDA No. 209475, Prinston Pharmaceutical Inc., Zhejiang Huahai
`
`Pharmaceutical Co. Ltd., Huahai US Inc. and Solco Healthcare US 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. 209475 throughout the United States, and/or import such generic drug
`
`products into the United States, including in this judicial district.
`
`H. Windlas Healthcare Pvt. Ltd and Windlas Biotech Ltd. (collectively, “Windlas”)
`
`63.
`
`On information and belief, Defendant Windlas Healthcare Pvt. Ltd. is a
`
`corporation organized and existing under the laws of India, having a principal place of business
`
`at Plot No. 183 & 192, Mohabewala Industrial Area, Dehradun 248 110, Uttarakhand, India. On
`
`information and belief, Windlas Healthcare Pvt. 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.
`
`64.
`
`On information and belief, Defendant Windlas Biotech Ltd. is a corporation
`
`organized and existing under the laws of India, having a principal place of business at 40/1
`
`Mohabewala Industrial Area, Dehradun 248 110, Uttarakhand, India. On information and belief,
`
`Windlas Biotech 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.
`
`
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`
`
`65.
`
`By a letter dated September 7, 2016, (“Windlas’s Notice Letter”) Windlas notified
`
`Plaintiffs that Windlas had submitted to the FDA ANDA No. 209428 for mirabegron Extended
`
`Release Tablets 25mg and 50mg (“Windlas ANDA”), a drug product that is a generic version of
`
`Myrbetriq® extended-release tablets, in the 25mg and 50mg strengths (“Windlas’s ANDA
`
`Product”). On information and belief, the purpose of Windlas’s submission of the Windlas
`
`ANDA was to obtain approval under the FDCA to engage in the commercial manufacture, use,
`
`offer for sale, and/or sale of Windlas’s ANDA Product prior to November 4, 2023.
`
`66.
`
`In Windlas’s Notice Letter, Windlas notified Plaintiffs that, as a part of the
`
`Windlas ANDA, Windlas 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 some of
`
`the then-listed patents in the Orange Book, asserting that they are invalid, unenforceable, and/or
`
`will not be infringed by the commercial manufacture, use, and sale of Windlas’s ANDA Product.
`
`67.
`
`On the basis of Windlas’s Notice Letter, Plaintiffs filed suit against Windlas for
`
`infringement of some of the then-listed patents in the Orange Book. Astellas Pharma Inc. et al. v.
`
`Windlas Healthcare Pvt. Ltd. et al., C.A. No. 16-930 (D. Del.), D.I. 1.
`
`68.
`
`In its Answer, Windlas did not dispute jurisdiction or venue. Astellas Pharma
`
`Inc. et al. v. Windlas Healthcare Pvt. Ltd. et al., C.A. No. 16-930 (D. Del.), D.I. 17 at ¶¶ 9-10,
`
`19.
`
`69.
`
`Astellas and Windlas reached a settlement and the case was dismissed. Astellas
`
`Pharma Inc. et al. v. Actavis Elizabeth LLC et al., C.A. No. 16-905-JFB-CJB (Cons.) (D. Del.),
`
`D.I. 585.
`
`
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`
`
`
`70.
`
`On information and belief, and consistent with their past practices, Windlas
`
`Healthcare Pvt. Ltd and Windlas Biotech Ltd. acted collaboratively in the preparation and
`
`submission of ANDA No. 209428.
`
`71.
`
`On information and belief, and consistent with their past practices, following any
`
`FDA approval of ANDA No. 209428, Windlas Healthcare Pvt. Ltd and Windlas Biotech Ltd.
`
`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. 209428 throughout the United States, and/or import
`
`such generic drug products into the United States, including in this judicial district.
`
`I.
`
`Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Ltd. (d/b/a Zydus Cadila)
`(collectively, “Zydus”)
`
`72.
`
`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.
`
`73.
`
`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 Tower, Satellite Cross Roads, Ahmedabad-380015, Gujarat,
`
`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.
`
`74.
`
`By a letters dated September 6, 2016 (“Zydus’s 2016 Notice Letter”) and July 6,
`
`2018 (“Zydus’s 2018 Notice Letter”), Zydus notified Plaintiffs that Zydus had submitted to the
`
`
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`Case 1:20-cv-01589-UNA Document 1 Filed 11/24/20 Page 17 of 42 PageID #: 17
`
`
`
`FDA ANDA No. 209488 for mirabegron extended-release oral tablets, 25 mg, 50 mg (“Zydus
`
`ANDA”), a drug product that is a generic version of Myrbetriq® extended-release tablets, in the
`
`25mg and 50mg strengths (“Zydus’s ANDA Product”). On information and belief, the purpose
`
`of Zydus’s submission of the Zydus ANDA was to obtain approval under the FDCA to engage in
`
`the commercial manufacture, use, offer for sale, and/or sale of Zydus’s ANDA Product prior to
`
`November 4, 2023.
`
`75.
`
`In Zydus’s 2016 Notice Letter and Zydus’s 2018 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
`
`some of the then-listed patents in the Orange Book, asserting that they are invalid,
`
`unenforceable, and/or will not be infringed by the commercial manufacture, use, and sale of
`
`Zydus’s ANDA Product.
`
`76.
`
`On the basis of Zydus’s 2016 Notice Letter, Plaintiffs filed suit against Zydus for
`
`infringement of some of the then-listed patents in the Orange Book. Astellas Pharma Inc. et al.
`
`v. Zydus Pharmaceuticals (USA) Inc. et al., C.A. No. 16-924 (D. Del.),