Case 1:21-cv-00697-RMB-JS Document 1 Filed 01/13/21 Page 1 of 40 PageID: 1
`
`Charles M. Lizza
`William C. Baton
`Sarah A. Sullivan
`SAUL EWING ARNSTEIN & LEHR LLP
`One Riverfront Plaza, Suite 1520
`Newark, NJ 07102-5426
`(973) 286-6700
`clizza@saul.com
`
`OF COUNSEL:
`
`Raymond N. Nimrod
`Colleen Tracy James
`Catherine T. Mattes
`QUINN EMANUEL URQUHART & SULLIVAN, LLP
`51 Madison Avenue
`New York, NY 10010
`
`Attorneys for Plaintiffs
`Mitsubishi Tanabe Pharma Corp.,
`Janssen Pharmaceuticals, Inc., Janssen Pharmaceutica NV,
`Janssen Research and Development, LLC,
`and Cilag GmbH International
`
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`
`
`MITSUBISHI TANABE PHARMA
`CORPORATION, JANSSEN
`PHARMACEUTICALS, INC., JANSSEN
`PHARMACEUTICA NV, JANSSEN
`RESEARCH AND DEVELOPMENT, LLC, and
`CILAG GMBH INTERNATIONAL,
`
`
`Plaintiffs,
`
`v.
`
`MACLEODS PHARMACEUTICALS, LTD. and
`MACLEODS PHARMA USA, INC.,
`
`
`Defendants.
`
`
`
`
`
`
`
`
`
`Civil Action No. _______________
`
`COMPLAINT FOR PATENT
`INFRINGEMENT
`
`(Filed Electronically)
`
`
`
`
`
`
`
`
`
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`

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`Case 1:21-cv-00697-RMB-JS Document 1 Filed 01/13/21 Page 2 of 40 PageID: 2
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`Plaintiffs Mitsubishi Tanabe Pharma Corp. (“MTPC”), Janssen Pharmaceuticals, Inc.
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`(“JPI”), Janssen Pharmaceutica NV (“JNV”), Janssen Research and Development, LLC (“JRD”),
`
`and Cilag GmbH International (“Cilag”) (collectively, “Plaintiffs”), by their attorneys, for their
`
`complaint against Defendants Macleods Pharmaceuticals, Ltd. (“Macleods India”) and Macleods
`
`Pharma USA, Inc. (“Macleods USA”) (collectively, “Macleods”), allege as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is a civil action for infringement of United States Patent Nos.
`
`7,943,582 (the “’582 patent”) and 8,513,202 (the “’202 patent”) (collectively, the “Patents-in-
`
`suit”) under the patent laws of the United States, 35 U.S.C. §100, et seq. This action arises from
`
`Macleods India’s filing of Abbreviated New Drug Application (“ANDA”) No. 215255 (“the
`
`Macleods ANDA”) with the United States Food and Drug Administration (“FDA”) seeking
`
`approval to commercially market generic versions of JPI’s 50 mg/500 mg, 50 mg/1000 mg, 150
`
`mg/500 mg, and 150 mg/1000 mg INVOKAMET® XR drug product (“the Macleods ANDA
`
`Products”) prior to the expiration of the Patents-in-suit.
`
`THE PARTIES
`
`2.
`
`MTPC is a corporation organized and existing under the laws of Japan,
`
`having an office and place of business at 3-2-10, Dosho-machi, Chuo-ku, Osaka 541-8505,
`
`Japan.
`
`3.
`
`JPI is a corporation organized and existing under the laws of the State of
`
`Pennsylvania, having its principal place of business at 1125 Trenton-Harbourton Road,
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`Titusville, New Jersey 08560.
`
`4.
`
`JNV is a corporation organized and existing under the laws of Belgium,
`
`having its principal place of business at Turnhoutseweg, 30, 2340 Beerse, Belgium.
`
`
`
`2
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`5.
`
`JRD is a corporation organized and existing under the laws of the State of
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`New Jersey, having its principal place of business at 920 Route 202, Raritan, New Jersey 08869.
`
`6.
`
`Cilag is a company organized and existing under the laws of Switzerland,
`
`having its principal place of business at Gubelstrasse 34, 6300, Zug, Switzerland.
`
`7.
`
`On information and belief, defendant Macleods India is a corporation
`
`organized and existing under the laws of India, having its principal place of business at Atlanta
`
`Arcade, Marol Church Road, Andheri (East), Mumbai, 40059, India.
`
`8.
`
`On information and belief, defendant Macleods USA is a corporation
`
`organized under the laws of the State of Delaware, having its principal place of business at 666
`
`Plainsboro Road, Building 200, Suite 230, Plainsboro, New Jersey 08536.
`
`THE PATENTS-IN-SUIT
`
`9.
`
`On May 17, 2011, the United States Patent and Trademark Office
`
`(“USPTO”) duly and lawfully issued the ’582 patent, entitled, “Crystalline form of 1-(β-D-
`
`glucopyransoyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethyl]benzene hemihydrate” to
`
`MTPC as assignee of inventors Sumihiro Nomura and Eiji Kawanishi. A copy of the ’582 patent
`
`is attached as Exhibit A.
`
`10.
`
`11.
`
`12.
`
`JPI, JRD, and Cilag are exclusive licensees of the ’582 patent.
`
`JNV is an exclusive sublicensee of the ’582 patent.
`
`On August 20, 2013, the USPTO duly and lawfully issued the ’202 patent
`
`entitled, “Crystalline form of 1-(β-D-glucopyransoyl)-4-methyl-3-[5-(4-fluorophenyl)-2-
`
`thienylmethyl]benzene hemihydrate” to MTPC as assignee of inventors Sumihiro Nomura and
`
`Eiji Kawanishi. A copy of the ’202 patent is attached as Exhibit B.
`
`13.
`
`14.
`
`JPI, JRD, and Cilag are exclusive licensees of the ’202 patent.
`
`JNV is an exclusive sublicensee of the ’202 patent.
`
`
`
`3
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`THE INVOKAMET® XR DRUG PRODUCT
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`15.
`
`JPI holds approved New Drug Application (“NDA”) No. 205879 for
`
`extended-release canagliflozin and metformin tablets, which are prescribed and sold under the
`
`trademark INVOKAMET® XR. INVOKAMET® XR is indicated as an adjunct to diet and exercise to
`
`improve glycemic control in adults with type 2 diabetes mellitus.
`
`16.
`
`The claims of the Patents-in-suit cover, inter alia, certain polymorphic
`
`forms of canagliflozin.
`
`17.
`
`Pursuant to 21 U.S.C. § 355(b)(1), and attendant FDA regulations, the
`
`Patents-in-suit are listed in the FDA publication, “Approved Drug Products with Therapeutic
`
`Equivalence Evaluations” (the “Orange Book”), with respect to INVOKAMET® XR.
`
`JURISDICTION AND VENUE
`
`18.
`
`This action arises under the patent laws of the United States, 35 U.S.C.
`
`§§ 100, et seq., and this Court has jurisdiction over the subject matter of this action under 28
`
`U.S.C. §§ 1331, 1338(a), 2201, and 2202.
`
`19.
`
`This Court has personal jurisdiction over Macleods USA because, inter
`
`alia, on information and belief, Macleods USA has its principal place of business at 666
`
`Plainsboro Road, Building 200, Suite 230, Plainsboro, New Jersey 08536. On information and
`
`belief, Macleods USA also is registered as a wholesaler in the State of New Jersey (No.
`
`5004370). See New Jersey Wholesale Drug & Medical Device Registration Verification,
`
`https://healthapps.state.nj.us/fooddrug/fdList.aspx (last visited January 13, 2021). Further, on
`
`information and belief, Macleods USA is registered as a business in the State of New Jersey (No.
`
`0101021236). See New Jersey Business Registration Certificate,
`
`https://www1.state.nj.us/TYTR_BRC/servlet/common/BRCLogin (last visited January 13,
`
`2021).
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`4
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`20.
`
`This Court has personal jurisdiction over Macleods USA because, inter
`
`alia, Macleods USA intends a future course of conduct that includes acts of patent infringement
`
`in New Jersey. These acts have led and will lead to foreseeable harm and injury to Plaintiffs in
`
`New Jersey. For example, on information and belief, following approval of the Macleods
`
`ANDA, Macleods USA will work in concert with Macleods India to make, use, offer for sale,
`
`sell, and/or import the Macleods ANDA Products in the United States, including in New Jersey,
`
`prior to the expiration of the Patents-in-suit.
`
`21.
`
`This Court also has personal jurisdiction over Macleods USA because,
`
`inter alia, this action arises from actions of Macleods USA directed toward New Jersey, and
`
`because Macleods USA has purposefully availed itself of the rights and benefits of New Jersey
`
`law by engaging in systematic and continuous contacts with the State of New Jersey. On
`
`information and belief, Macleods USA maintains its principal place of business in New Jersey
`
`and regularly and continuously transacts business within New Jersey, including by selling
`
`pharmaceutical products in New Jersey. On information and belief, Macleods USA derives
`
`substantial revenue from the sale of those products in New Jersey and has availed itself of the
`
`privilege of conducting business within New Jersey. On information and belief, Macleods USA
`
`is registered as a wholesaler in the State of New Jersey (No. 5004370). See Wholesale Drug &
`
`Medical Device Registration Verification, https://healthapps.state.nj.us/fooddrug/fdList.aspx
`
`(last visited January 13, 2021).
`
`22.
`
`On information and belief, Macleods USA has continuously placed its
`
`products into the stream of commerce for distribution and consumption in the State of New
`
`Jersey, and throughout the United States, and thus has engaged in the regular conduct of business
`
`within this Judicial District.
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`
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`5
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`23.
`
`On information and belief, Macleods USA derives substantial revenue
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`from selling generic pharmaceutical products throughout the United States, including in this
`
`Judicial District.
`
`24.
`
`On information and belief, Macleods USA has previously invoked,
`
`stipulated, and/or consented to personal jurisdiction in this Judicial District in numerous prior
`
`patent cases.
`
`25. Macleods USA has previously been sued in this Judicial District and has
`
`availed itself of New Jersey courts through the assertion of counterclaims in suits brought in
`
`New Jersey, including AstraZeneca AB, et al. v. Macleods Pharmaceuticals Ltd., et al., Civil
`
`Action No. 16-1682 (consenting to personal jurisdiction and venue for the purposes of the action
`
`and asserting counterclaims), Otsuka Pharmaceutical Co., Ltd. v. Macleods Pharmaceuticals
`
`Ltd., et al., Civil Action No. 15-5109 (consenting to personal jurisdiction and venue for the
`
`purposes of the action and asserting counterclaims) and Mitsubishi Tanabe Pharma Corp., et al.
`
`v. Macleods Pharmaceuticals Ltd., et al., Civil Action No. 17-13130 (consenting to personal
`
`jurisdiction and venue for the purposes of the action and asserting counterclaims).
`
`26.
`
`Venue is proper for Macleods USA under 28 U.S.C. § 1400(b) because,
`
`inter alia, Macleods USA has a regular and established place of business in New Jersey. On
`
`information and belief, Macleods USA participated in the preparation and submission of the
`
`Macleods ANDA with the FDA at its established place of business in New Jersey and therefore
`
`committed an act of infringement in this Judicial District. In addition, on information and belief,
`
`Macleods USA will commit further acts of infringement in this Judicial District, as set forth in
`
`paragraphs 19-25 above.
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`6
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`27.
`
`This Court has personal jurisdiction over Macleods India because, inter
`
`alia, Macleods India has committed an act of patent infringement under 35 U.S.C. § 271(e)(2)
`
`and intends a future course of conduct that includes acts of patent infringement in New Jersey.
`
`These acts have led and will lead to foreseeable harm and injury to Plaintiffs in New Jersey. For
`
`example, on information and belief, following approval of the Macleods ANDA, Macleods India
`
`will make, use, offer for sale, sell, and/or import the Macleods ANDA Products in the United
`
`States, including in New Jersey, prior to the expiration of the Patents-in-suit.
`
`28.
`
`This Court also has personal jurisdiction over Macleods India because,
`
`inter alia, this action arises from actions of Macleods India directed toward New Jersey. For
`
`example, Macleods’ counsel sent a letter dated November 30, 2020 to JPI, a corporation with its
`
`principal place of business in this Judicial District, stating that Macleods had submitted ANDA
`
`No. 215255 seeking approval to commercially manufacture, use, import, offer for sale, and sell
`
`the Macleods ANDA Products prior to the expiration of the Patents-in-suit. If Macleods
`
`succeeds in obtaining FDA approval, it would sell its Macleods ANDA Products in New Jersey
`
`and other states, causing injury to Plaintiffs in New Jersey.
`
`29.
`
`This Court also has personal jurisdiction over Macleods India because
`
`Macleods India has purposefully availed itself of the rights and benefits of New Jersey law by
`
`engaging in systematic and continuous contacts with the State of New Jersey. On information
`
`and belief, Macleods India regularly and continuously transacts business within New Jersey,
`
`including by selling pharmaceutical products in New Jersey. On information and belief,
`
`Macleods India derives substantial revenue from the sale of those products in New Jersey and
`
`has availed itself of the privilege of conducting business within New Jersey. For example,
`
`Macleods India’s website states that “Macleods has filed more than 150 Abbreviated New Drug
`
`
`
`7
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`Applications (ANDAs) and has received FDA approval on 62.” Macleods US,
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`http://www.macleodspharma.com/UnitedStates.asp (last visited January 13, 2021).
`
`30.
`
`On information and belief, Macleods India and its subsidiaries operate as a
`
`single, integrated generic pharmaceutical manufacturer. For example, on Macleods India’s
`
`website, Macleods USA is described as “the U.S. division of Macleods Pharmaceuticals, LTD
`
`[Macleods India], a developer and manufacturer of Generic Active Pharmaceutical Ingredients
`
`(API) and Finished Dosage Forms.” Macleods US, www.macleodspharma.com/UnitedStates.asp
`
`(last visited January 13, 2021). On information and belief, Macleods India’s principal place of
`
`business for its US operation is that of Macleods USA in Plainsboro, New Jersey.
`
`31.
`
`On information and belief, Macleods India controls and dominates
`
`Macleods USA. Macleods US, http://www.macleodspharma.com/UnitedStates.asp (last visited
`
`January 13, 2021) (“Macleods Pharma USA is the U.S. division of Macleods Pharmaceuticals,
`
`LTD.”). On information and belief, Macleods India holds itself out as “a vertically integrated
`
`global pharmaceutical company” with “more than 10,000 professionally qualified employees
`
`across the globe.” Id.
`
`32.
`
`On information and belief, Macleods India has continuously placed its
`
`products into the stream of commerce for distribution and consumption in the State of New
`
`Jersey, and throughout the United States, and thus has engaged in the regular conduct of business
`
`within this Judicial District.
`
`33.
`
`On information and belief, Macleods India derives substantial revenue
`
`from selling generic pharmaceutical products throughout the United States, including in this
`
`Judicial District.
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`
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`8
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`34.
`
`On information and belief, Macleods India has previously invoked,
`
`stipulated, and/or consented to personal jurisdiction in this Judicial District in numerous prior
`
`patent cases.
`
`35. Macleods India has previously been sued in this Judicial District and has
`
`availed itself of New Jersey courts through the assertion of counterclaims in suits brought in
`
`New Jersey, including AstraZeneca AB, et al. v. Macleods Pharmaceuticals Ltd., et al., Civil
`
`Action No. 16-1682 (consenting to personal jurisdiction and venue for the purposes of the action
`
`and asserting counterclaims), Otsuka Pharmaceutical Co., Ltd. v. Macleods Pharmaceuticals
`
`Ltd., et al., Civil Action No. 15-5109 (consenting to personal jurisdiction and venue for the
`
`purposes of the action and asserting counterclaims); Mitsubishi Tanabe Pharma Corp., et al. v.
`
`Macleods Pharmaceuticals Ltd., et al., Civil Action No. 17-13130 (consenting to personal
`
`jurisdiction and venue for the purposes of the action and asserting counterclaims).
`
`36.
`
`In the alternative, this Court has personal jurisdiction over Macleods India
`
`because the requirements of Federal Rule of Civil Procedure 4(k)(2)(A) are met as (a) Plaintiffs’
`
`claims arise under federal law; (b) Macleods India is a foreign defendant not subject to general
`
`personal jurisdiction in the courts of any other state; and (c) Macleods India has sufficient
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`contacts with the United States as a whole, including, but 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 exercise of jurisdiction over
`
`Macleods India satisfies due process.
`
`37.
`
`Venue is proper for Macleods India under 28 U.S.C. §§ 1391 and/or
`
`1400(b), including because, inter alia, Macleods India is a foreign corporation and is subject to
`
`personal jurisdiction in this Judicial District, as set forth above. On information and belief,
`
`9
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`Macleods India committed acts in preparation of Macleods ANDA at the established place of
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`business of Macleods USA in New Jersey and in connection with the submission of the ANDA
`
`from that place of business. Macleods India therefore committed an act of infringement in this
`
`Judicial District. In addition, on information and belief, Macleods India will commit further acts
`
`of infringement in this Judicial District, as set forth in paragraphs 27-36 above, continuously
`
`transacts business in this Judicial District, as set forth in paragraph 27-36 above, and has a
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`continuous and permanent presence in this Judicial District through its subsidiary, Macleods
`
`USA.
`
`38.
`
`On information and belief, based on the representations of Macleods’s
`
`counsel, Macleods consents to personal jurisdiction and venue for the purposes of this action.
`
`MACLEODS INDIA’S INFRINGING ANDA SUBMISSION
`
`39.
`
`On or about December 4, 2020, JPI received from Macleods India’s
`
`counsel a letter, dated November 30, 2020 (“Macleods November 30 Letter”), stating that
`
`Macleods India had submitted the Macleods ANDA to the FDA seeking approval to market the
`
`Macleods ANDA Products before the expiration of the Patents-in-suit. MTPC received the
`
`Macleods November 30 Letter on or about December 7, 2020.
`
`40. Macleods India specifically directed the Macleods November 30 Letter to
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`JPI’s headquarters in Titusville, New Jersey, within this Judicial District.
`
`41.
`
`The Macleods ANDA Products are intended to be generic versions of
`
`INVOKAMET® XR.
`
`42.
`
`On information and belief, following FDA approval of Macleod’s ANDA,
`
`Macleods India and Macleods USA will work in concert with one another to make, use, offer to
`
`sell, or sell the Macleods ANDA Products throughout the United States, or import such generic
`
`products into the United States.
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`10
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`43.
`
`The Macleods November 30 Letter alleges that the Macleods ANDA
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`Products do not infringe the Patents-in-suit. Notwithstanding these allegations, on information
`
`and belief, discovery/testing will show that the Macleods ANDA Products infringe the Patents-
`
`in-suit.
`
`
`
`herein.
`
`COUNT I
`Infringement of U.S. Patent No. 7,943,582
`by Macleods India and Macleods USA
`
`44.
`
`Plaintiffs repeat and reallege paragraphs 1-43 above as if fully set forth
`
`45.
`
`By filing its ANDA No. 215255 for the purpose of obtaining approval to
`
`engage in the commercial manufacture, use, offer for sale, sale, or importation into the United
`
`States of the Macleods ANDA Products before the expiration of the ’582 patent, Macleods India
`
`committed an act of infringement under 35 U.S.C. § 271(e)(2).
`
`46.
`
`On information and belief, discovery/testing will show that if Macleods
`
`India and/or Macleods USA commercially makes, uses, offers to sell, or sells the Macleods
`
`ANDA Products within the United States, or imports the Macleods ANDA Products into the
`
`United States, or induces or contributes to any such conduct during the term of the ’582 patent, it
`
`would further infringe at least claims 1, 6, and 7 of the ’582 patent under 35 U.S.C. §§ 271(a),
`
`(b), and/or (c).
`
`47. Macleods India has had knowledge of the ’582 patent since at least the
`
`date Macleods India sent its November 30 Notice Letter. Macleods USA will have knowledge of
`
`the ’582 patent no later than the date it is served with this complaint.
`
`
`
`11
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`48.
`
`Plaintiffs will be irreparably harmed if Macleods India and Macleods USA
`
`are not enjoined from infringing the ’582 patent. Plaintiffs do not have an adequate remedy at
`
`law.
`
`herein.
`
`COUNT II
`Infringement of U.S. Patent No. 8,513,202
`by Macleods India and Macleods USA
`
`49.
`
`Plaintiffs repeat and reallege paragraphs 1-48 above as if fully set forth
`
`50.
`
`By filing its ANDA No. 215255 for the purpose of obtaining approval to
`
`engage in the commercial manufacture, use, offer for sale, sale, or importation into the United
`
`States of the Macleods ANDA Products before the expiration of the ’202 patent, Macleods India
`
`committed an act of infringement under 35 U.S.C. § 271(e)(2).
`
`51.
`
`On information and belief, discovery/testing will show that if Macleods
`
`India and/or Macleods USA commercially makes, uses, offers to sell, or sells the Macleods
`
`ANDA Products within the United States, or imports the Macleods ANDA Products into the
`
`United States, or induces or contributes to any such conduct during the term of the ’202 patent, it
`
`would further infringe at least claims 1 and 3-5 of the ’202 patent under 35 U.S.C. §§ 271(a), (b),
`
`and/or (c).
`
`52. Macleods India has had knowledge of the ’202 patent since at least the
`
`date Macleods India sent its November 30 Notice Letter. Macleods USA will have knowledge of
`
`the ’202 patent no later than the date it is served with this complaint.
`
`53.
`
`Plaintiffs will be irreparably harmed if Macleods India and Macleods USA
`
`are not enjoined from infringing the ’202 patent. Plaintiffs do not have an adequate remedy at
`
`law.
`
`
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`12
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`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiffs respectfully request the following relief:
`
`A.
`
`A Judgment that Macleods India has infringed one or more claims of the
`
`’582 patent by filing ANDA No. 215255;
`
`B.
`
`Judgment that Macleods India and Macleods USA have infringed, and that
`
`Macleods India’s and/or Macleods USA’s making, using, offering to sell, selling, or importing
`
`the Macleods ANDA Products would constitute infringement of one or more claims of the ’582
`
`patent, and/or induce or contribute to the infringement of one or more claims of the ’582 patent
`
`pursuant to 35 U.S.C. §§ 271(a), (b) and/or (c);
`
`C.
`
`A permanent injunction restraining and enjoining Macleods India and
`
`Macleods USA, and their officers, agents, attorneys, and employees, and those acting in privity
`
`or concert with them, from engaging in the commercial manufacture, use, offer for sale, or sale
`
`within the United States, or importation into the United States, of the Macleods ANDA Products
`
`until after the expiration of the ’582 patent, or any later expiration of exclusivity to which
`
`Plaintiffs are or become entitled;
`
`D.
`
`An Order that the effective date of any approval of ANDA No. 215255
`
`relating to the Macleods ANDA Products be a date that is not earlier than the expiration date of
`
`the ’582 patent as extended plus any other regulatory exclusivity to which Plaintiffs are or
`
`become entitled;
`
`E.
`
`A Judgment that Macleods India has infringed one or more claims of the
`
`’202 patent by filing ANDA No. 215255;
`
`F.
`
`Judgment that Macleods India and Macleods USA have infringed, and that
`
`Macleods India’s and/or Macleods USA’s making, using, offering to sell, selling, or importing
`
`the Macleods ANDA Products would constitute infringement of one or more claims of the ’202
`
`
`
`13
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`

`

`Case 1:21-cv-00697-RMB-JS Document 1 Filed 01/13/21 Page 14 of 40 PageID: 14
`
`patent, and/or induce or contribute to the infringement of one or more claims of the ’202 patent
`
`pursuant to 35 U.S.C. §§ 271(a), (b) and/or (c);
`
`G.
`
`A permanent injunction restraining and enjoining Macleods India and
`
`Macleods USA, and their officers, agents, attorneys, and employees, and those acting in privity
`
`or concert with them, from engaging in the commercial manufacture, use, offer for sale, or sale
`
`within the United States, or importation into the United States, of the Macleods ANDA Products
`
`until after the expiration of the ’202 patent, or any later expiration of exclusivity to which
`
`Plaintiffs are or become entitled;
`
`H.
`
`An Order that the effective date of any approval of ANDA No. 215255
`
`relating to the Macleods ANDA Products be a date that is not earlier than the expiration date of
`
`the ’202 patent as extended plus any other regulatory exclusivity to which Plaintiffs are or
`
`become entitled;
`
`I.
`
`An award of damages or other relief, pursuant to 35 U.S.C. §
`
`271(e)(4)(C), if Macleods engages in the commercial manufacture, use, offer for sale, sale,
`
`and/or importation of its ANDA Products, or any product that infringes the Patents-in-suit, or
`
`induces or contributes to such conduct, prior to the expiration of those patents, including any
`
`additional exclusivity period applicable to those patents; and
`
`J.
`
`Such other and further relief as the Court may deem just and proper.
`
`
`
`
`
`14
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`

`

`Case 1:21-cv-00697-RMB-JS Document 1 Filed 01/13/21 Page 15 of 40 PageID: 15
`
`By: s/ Charles M. Lizza
`Charles M. Lizza
`William C. Baton
`Sarah A. Sullivan
`SAUL Ewing ARNSTEIN & LEHR LLP
`One Riverfront Plaza, Suite 1520
`Newark, NJ 07102-5426
`(973) 286-6700
`clizza@saul.com
`
`
`
`Attorneys for Plaintiffs
`Mitsubishi Tanabe Pharma Corp.,
`Janssen Pharmaceuticals, Inc., Janssen
`Pharmaceutica NV, Janssen Research
`and Development, LLC, and Cilag
`GmbH International
`
`Dated: January 13, 2021
`
`
`
`
`
`
`
`OF COUNSEL:
`
`Raymond N. Nimrod
`Colleen Tracy James
`Catherine T. Mattes
`QUINN EMANUEL
`URQUHART & SULLIVAN, LLP
`51 Madison Avenue
`New York, NY 10010
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
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`
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`
`
`
`
`15
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`

`

`Case 1:21-cv-00697-RMB-JS Document 1 Filed 01/13/21 Page 16 of 40 PageID: 16
`
`CERTIFICATION PURSUANT TO LOCAL CIVIL RULES 11.2 & 40.1
`
`
`
`I hereby certify that the matters captioned Mitsubishi Tanabe Pharma Corp., et al. v.
`
`Aurobindo Pharma USA, Inc., et al., Civil Action No. 17-5005 (RMB)(JS) (consolidated),
`
`Mitsubishi Tanabe Pharma Corp., et al. v. MSN Laboratories Private Ltd., et al., Civil Action
`
`No. 17-5302 (RMB)(JS), Mitsubishi Tanabe Pharma Corp., et al. v. Lupin Ltd., et al., Civil
`
`Action No. 18-292 (RMB)(JS), and Mitsubishi Tanabe Pharma Corp., et al. v. MSN
`
`Laboratories Private Ltd., et al., Civil Action No. 19-15616 (RMB)(JS) are related to the matter
`
`in controversy because the matter in controversy involves one of the same patents and the same
`
`plaintiffs, and because Macleods is seeking FDA approval to market generic versions of the
`
`same pharmaceutical products.
`
`
`
`I hereby certify that, to the best of my knowledge, the matter in controversy is not the
`
`subject of any other action pending in any court or of any pending arbitration or administrative
`
`proceeding.
`
`Dated: January 13, 2021
`
`
`
`
`
`
`
`OF COUNSEL:
`
`Raymond N. Nimrod
`Colleen Tracy James
`Catherine T. Mattes
`QUINN EMANUEL
`URQUHART & SULLIVAN, LLP
`51 Madison Avenue
`New York, NY 10010
`
`
`
`By: s/ Charles M. Lizza
`Charles M. Lizza
`William C. Baton
`Sarah A. Sullivan
`SAUL Ewing ARNSTEIN & LEHR LLP
`One Riverfront Plaza, Suite 1520
`Newark, NJ 07102-5426
`(973) 286-6700
`clizza@saul.com
`
`
`
`Attorneys for Plaintiffs
`Mitsubishi Tanabe Pharma Corp.,
`Janssen Pharmaceuticals, Inc., Janssen
`Pharmaceutica NV, Janssen Research
`and Development, LLC, and Cilag
`GmbH International
`
`
`
`16
`
`

`

`Case 1:21-cv-00697-RMB-JS Document 1 Filed 01/13/21 Page 17 of 40 PageID: 17
`Case 1:21-cv-00697-RMB-JS Document 1 Filed 01/13/21 Page 17 of 40 PageID: 17
`
`EXHIBIT A
`
`EXHIBIT A
`
`

`

`Case 1:21-cv-00697-RMB-JS Document 1 Filed 01/13/21 Page 18 of 40 PageID: 18
`case 1:21'CV'00697'RMB'JS “C“memlllllllllllllflllflfllfillll|1111|||l|fl|l|llllflllllfillfillfil|18
`
`USOO7943582B2
`
`(12) United States Patent
`US 7,943,582 B2
`(10) Patent N0.:
`Nomura et al.
`
`(45) Date of Patent: May 17, 2011
`
`(54) CRYSTALLINE FORM OF
`1-(B-D-GLUCOPYRANSOYL)-4-METHYL-3-
`[5-(4-FLUOROPHENYL)—2-
`THIENYLMETHYL]BENZENE
`HEMIHYDRATE
`
`(75)
`
`Inventors: Sumihiro Nomura, Osaka (JP); Eiji
`Kawanishi, Osaka (JP)
`
`(73) Assignee: Mitsubishi Tanabe Pharma
`Corporation, Osaka-Shi (JP)
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 451 days.
`
`(21) Appl.No.: 11/987,670
`
`(22)
`
`Filed:
`
`Dec. 3, 2007
`
`(65)
`
`Prior Publication Data
`
`US 2008/0146515 A1
`
`Jun. 19, 2008
`
`Related US. Application Data
`
`(60) Provisional application No. 60/868,426, filed on Dec.
`4, 2006.
`
`(30)
`
`Foreign Application Priority Data
`
`Dec. 4, 2006
`
`(JP) ................................. 2006-327019
`
`(51)
`
`Int. Cl.
`(2006.01)
`A61K 31/7034
`(2006.01)
`C07H 7/04
`(52) US. Cl.
`......................................... 514/23; 536/111
`(58) Field of Classification Search ........................ None
`See application file for complete search history.
`
`(56)
`
`References Cited
`
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`
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`
`(Continued)
`
`CA
`
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`
`(Continued)
`
`OTHER PUBLICATIONS
`
`Ahmad et 31., “Synthesis and Structure Determination of Some
`Oxadiazole-Z-Thione
`and
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`1671-1682.
`
`(Continued)
`
`Primary Examiner 7 Eric S Olson
`
`(74) Attorney, Agent, or Firm 7 Birch, Stewart, Kolasch &
`Birch, LLP
`
`(57)
`
`ABSTRACT
`
`A novel crystal form of 1-([3-D-glucopyranosyl)-4-methyl-3-
`[5-(4-fluorophenyl)-2-thienylmethyl]benzene hemihydrate,
`and having favorable characteristics, is characterized by its
`x-ray powder diffraction pattern and/or by its infra-red spec-
`trum.
`
`7 Claims, 2 Drawing Sheets
`
`X-RAY POWDER DIFFRACTION
`_
`
`_
`
`(CPS)
`25000
`
`20000 --
`
`15000 ~-
`
`10000 --
`
`5000 »
`
`~
`
`10.0000
`
`
`
`23(°)
`
`

`

`Case 1:21-cv-00697-RMB-JS Document 1 Filed 01/13/21 Page 19 of 40 PageID: 19
`Case 1:21-cv-00697-RMB-JS Document 1 Filed 01/13/21 Page 19 of 40 PageID: 19
`
`US 7,943,582 B2
`
`Page 2
`
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`7,511,022 B2
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`
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`.
`11/2001 Tom1yama et a1.
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`
`5/2002 Washburn
`2002/0052326 A1
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`2002/0111315 A1
`2/2003 Aleshin
`2003/0024914 A1
`4/2003 Gougoutas
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`5/2003 Washburn
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`3/2007 Nomura et a1.
`
`................. 514/43
`
`FOREIGN PATENT DOCUMENTS
`
`EP
`EP
`EP
`131)
`GB
`JP
`JP
`JP
`JP
`JP
`JP
`JP
`JP
`W0
`
`0355750 A1
`0579204 A3
`1338603 A1
`1528066 A1
`2359554 A
`63-233975 A
`4-253974 A
`9 263549 A
`'
`10624632 A
`2000-34230 A
`2000—34239 A
`2001-288178 A
`2003-12686 A
`WO 93/21178 A1
`
`WO 97/25033 A1
`W0
`$8 8?;;§?§§ :1
`$8
`W0 0 1/64669 A1
`W0
`W0 01/68660 A1
`W0
`W0 01/74834 A1
`W0
`WO 01/74835 A1
`W0
`W0 02/053573 A1
`W0
`W0 02/068439 A1
`W0
`W0 02/068440 A1
`W0
`W0 02/070020 A2
`W0
`W0 02/083066 A2
`W0
`W0 02/088157 A1
`W0
`W0 02/094262 A1
`W0
`W0 03/000712 A1
`W0
`W0 03/011880 A1
`W0
`W0 03/020737 A1
`W0
`W0 03/043621 A1
`W0
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