Case 2:21-cv-17926-KM Document 1 Filed 09/30/21 Page 1 of 18 PageID: 1
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`
`
`Liza M. Walsh
`Christine I. Gannon
`William T. Walsh, Jr.
`WALSH PIZZI O’REILLY FALANGA LLP
`Three Gateway Center
`100 Mulberry Street, 15th Floor
`Newark, NJ 07102
`(973) 757-1100
`
`
`Counsel for Plaintiff
`Bristol-Myers Squibb Company
`
`
`IN THE UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`BRISTOL-MYERS SQUIBB COMPANY,
`
`
`Plaintiff,
`
`
`v.
`
`ALEMBIC GLOBAL HOLDING SA,
`ALEMBIC PHARMACEUTICALS, LTD.
`and ALEMBIC PHARMACEUTICALS,
`INC.,
`
`
`Defendants.
`
`
`Civil Action No. ___________
`
`
`
`
`Electronically Filed
`
`
`COMPLAINT
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`
`
`
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`Plaintiff, Bristol-Myers Squibb Company, by its undersigned attorneys, for their Complaint
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`against Defendants, Alembic Pharmaceuticals, Ltd., Alembic Global Holdings SA, and Alembic
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`Pharmaceuticals, Inc., (collectively, “Alembic” or “Defendants”), hereby alleges as follows:
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`NATURE OF THE ACTION
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`1.
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`This is an action for patent infringement arising under the Food and Drug Laws and
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`Patent Laws of the United States, Titles 21 and 35 of the United States Code, respectively, arising
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`from Defendants’ submissions of an Abbreviated New Drug Application (“ANDA”) to the Food
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`and Drug Administration (“FDA”) seeking approval to manufacture and sell a generic version of
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`Plaintiff’s SPRYCEL® (dasatinib) tablets prior to the expiration of United States Patent Nos.
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`7,491,725 and/or 8,680,103.
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`THE PARTIES
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`2.
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`Plaintiff Bristol-Myers Squibb Company (“BMS”) is a corporation organized and
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`existing under the laws of the State of Delaware, having a principal place of business at Route 206
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`and Province Line Road, Princeton, New Jersey 08540.
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`3.
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`On information and belief, Defendant Alembic Pharmaceuticals, Ltd. (“Alembic
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`Ltd.”) is a corporation organized and existing under the laws of India, having a principal place of
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`business at Alembic Road, Vadodara 390 003, Gujarat, India.
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`4.
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`On information and belief, Defendant Alembic Global Holding SA (“Alembic
`
`Global”) is a corporation organized and existing under the laws of Switzerland, having a principal
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`place of business at Rue Fritz-Courvoisier 40, 2300 La Chaux-de-Fonds, Switzerland. On
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`information and belief, Alembic Global is a wholly-owned subsidiary of Alembic Ltd. and operates
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`under the control and direction of Alembic Ltd.
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`5.
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`On information and belief, Defendant Alembic Pharmaceuticals, Inc. (“Alembic
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`Inc.”) is a Delaware corporation having a principal place of business at 750 Route 202,
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`Bridgewater, New Jersey 08807. On information and belief, Alembic Inc. is a wholly-owned
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`subsidiary of Alembic Global and operates under the control of Alembic Global and Alembic Ltd.
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`6.
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`On information and belief, Alembic Inc. is acting on behalf of, at the direction, and
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`for the benefit, of Alembic Global and Alembic Ltd., and is controlled and/or dominated by
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`Alembic Global and Alembic Ltd. with respect to ANDA No. 216261 (the “Alembic ANDA”).
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`7.
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`Alembic Ltd., Alembic Global and Alembic Inc. are collectively referred to
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`hereinafter as “Alembic.”
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`8.
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`On information and belief, Alembic Ltd. is in the business of, among other things,
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`developing, preparing, manufacturing, selling, marketing, and distributing generic drugs,
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`including distributing, selling, and marketing generic drugs throughout the United States,
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`including within the state of New Jersey, through its own actions and through the actions of its
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`agents and subsidiaries, including Alembic Global and Alembic Inc., from which Alembic Ltd.
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`derives a substantial portion of its revenue.
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`9.
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`On information and belief, Alembic Inc. is in the business of, among other things,
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`developing, preparing, manufacturing, selling, marketing, and distributing generic drugs,
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`including distributing, selling, and marketing generic drugs throughout the United States,
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`including within the state of New Jersey.
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`10.
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`On information and belief, Alembic Inc. is registered to do business in New Jersey
`
`under entity identification number 0101031141.
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`11.
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`On information and belief, Alembic Inc. is currently registered as “Manufacturer
`
`and Wholesale” by the New Jersey Department of Health under Registration No. 5004785.
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`12.
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`On information and belief, Alembic Ltd. is listed as the applicant of the Alembic
`
`ANDA and has sent notice to BMS stating that Alembic Ltd. included a certification in the
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`Alembic ANDA, pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV).
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`13.
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`On information and belief, Alembic Ltd. acted in concert with Alembic Global and
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`Alembic Inc. to prepare and submit the Alembic ANDA for Alembic Ltd.’s 20 mg, 50 mg, 70 mg,
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`80 mg, 100 mg and 140 mg dasatinib tablets (“Alembic ANDA Products”).
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`14.
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`On information and belief, Alembic Ltd. acted in concert with Alembic Global and
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`Alembic Inc. to prepare and submit the Alembic ANDA for the Alembic ANDA Products, which
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`was done at the direction of, under the control of, and for the direct benefit of Alembic Ltd.
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`15.
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`On information and belief, following FDA approval of the Alembic ANDA,
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`Alembic Ltd., will manufacture and supply the approved generic product to Alembic Global and/or
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`Alembic Inc., which will in turn market and sell the product throughout the United States,
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`including New Jersey, at the direction, under the control, and for the direct benefit of Alembic Ltd.
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`JURISDICTION AND VENUE
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`16.
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`This action arises under the patent laws of the United States, 35 U.S.C. §§ 100 et
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`seq., generally, and 35 U.S.C. § 271(e)(2), specifically, and this Court has jurisdiction over the
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`subject matter of this action under 28 U.S.C. §§ 1331 and 1338(a).
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`17.
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`Venue is proper in this Court as to Alembic Ltd. because, among other things,
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`Alembic Ltd. is a foreign corporation not residing in any United States district and may be sued in
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`any judicial district. 28 U.S.C. § 1391(c); see also 28 U.S.C. § 1400(b).
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`18.
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`Venue is proper in this Court as to Alembic Global because, among other things,
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`Alembic Global is a foreign corporation not residing in any United States district and may be sued
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`in any judicial district. 28 U.S.C. § 1391(c); see also 28 U.S.C. § 1400(b).
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`19.
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`Venue is proper in this Court as to Alembic Inc. because, among other things,
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`Alembic Inc. has a regular and established place of business in this district, and has committed or
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`aided, abetted, contributed to, and/or participated in the commission of, acts of infringement of the
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`asserted patent that will lead to foreseeable harm and injury to BMS by filing or assisting in filing
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`the Alembic ANDA in New Jersey with the intention of seeking to market the Alembic ANDA
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`Products nationwide, including within New Jersey. 28 U.S.C. § 1400(b).
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`20. Moreover, Alembic has not contested venue in New Jersey in one or more prior
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`cases arising out of the filing of its ANDAs. See, e.g., Actelion Pharm., Ltd. et al. v. MSN Pharm.,
`
`Inc. et al. No. 20-03859, Dkt. 22 (D.N.J. Jun. 12, 2020) (Alembic Ltd. and Alembic Inc.); Duke
`
`University et al., v. Alembic Pharm. Ltd. et al., No. 17-07453, Dkt. 14 (D.N.J. Dec. 26, 2017)
`
`(Alembic Ltd. and Alembic Inc.); Otsuka Pharm. Co., Ltd. v. Alembic Pharm. Ltd. et al., No. 14-
`
`07405, Dkt. 32 (D.N.J. Mar. 16, 2015) (Alembic Ltd., Alembic Global, and Alembic Inc.); Otsuka
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`Pharm. Co., Ltd. v. Alembic Pharm. Ltd. et al., No. 14-02982, Dkt. 11 (D.N.J. Oct. 27, 2014)
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`(Alembic Ltd., Alembic Global, and Alembic Inc.).
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`PERSONAL JURISDICTION OVER ALEMBIC LTD.
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`Plaintiff realleges paragraphs 1-20 as if fully set forth herein.
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`This Court has personal jurisdiction over Alembic Ltd. because, inter alia, Alembic
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`21.
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`22.
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`Ltd., on information and belief: (1) has substantial, continuous, and systematic contacts with this
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`State, either directly or through at least one of its wholly-owned subsidiaries or agents; (2) intends
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`to market, sell, and/or distribute the Alembic ANDA Products to residents of this State upon
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`approval of the Alembic ANDA, either directly or through at least one of its wholly-owned
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`subsidiaries or agents; and (3) enjoys substantial income from sales of its generic pharmaceutical
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`products in this State on its own and through Alembic Inc.
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`23.
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`This Court has personal jurisdiction over Alembic Ltd. because, inter alia, Alembic
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`Ltd. itself, and through its wholly owned subsidiary Alembic Inc., purposely availed itself of the
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`benefits and protections of New Jersey’s laws such that it should reasonably anticipate being sued
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`in this Court. On information and belief, Alembic Ltd. itself, and through its wholly owned
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`subsidiary Alembic Inc., develops, manufactures, imports, markets, distributes, uses, offers to sell,
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`and/or sells generic drugs throughout the United States, including in the State of New Jersey, and
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`therefore transacts business within the State of New Jersey related to BMS’s claims, and/or has
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`engaged in systematic and continuous business contacts within the State of New Jersey.
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`24.
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`On information and belief, Alembic Ltd. is subject to personal jurisdiction in New
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`Jersey because it controls and dominates Alembic Inc. and therefore the activities of Alembic Inc.
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`in this jurisdiction are attributed to Alembic Ltd.
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`25.
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`Furthermore, this Court has personal jurisdiction over Alembic Ltd. because, on
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`information and belief, Alembic Ltd. has participated in the preparation and/or submission of
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`ANDA No. 216261 within this jurisdiction.
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`26.
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`On information and belief, Alembic Ltd. has not contested jurisdiction in New
`
`Jersey in one or more prior cases arising out of the filing of its ANDAs, and it has filed
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`counterclaims in such cases. See, e.g., Actelion Pharm., Ltd. et al. v. MSN Pharm., Inc. et al. No.
`
`20-03859, Dkt. 21 (D.N.J. Jun. 12, 2020); Duke University et al., v. Alembic Pharm. Ltd. et al.,
`
`No. 17-07453, Dkt. 14 (D.N.J. Dec. 26, 2017); Otsuka Pharm. Co., Ltd. v. Alembic Pharm. Ltd. et
`
`al., No. 14-07405, Dkt. 32 (D.N.J. Mar. 16, 2015); Otsuka Pharm. Co., Ltd. v. Alembic Pharm.
`
`Ltd. et al., No. 14-02982, Dkt. 11 (D.N.J. Oct. 27, 2014).
`
`27.
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`On information and belief, Alembic Ltd. has consented to jurisdiction in New
`
`Jersey and initiated litigation in this Judicial district in, at least, Alembic Pharm., Ltd. v. Novartis
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`Pharm. Corp., No. 19-20890, Dkt. 1 (D.N.J. Nov. 27, 2019).
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`28.
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`Alternatively, to the extent the above facts do not establish personal jurisdiction
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`over Alembic Ltd., this Court may exercise jurisdiction over Alembic Ltd. pursuant to Fed. R. Civ.
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`P. 4(k)(2) because: (a) Plaintiff’s claims arise under federal law; (b) Alembic Ltd. would be a
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`foreign defendant not subject to personal jurisdiction in the courts of any State; and (c) Alembic
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`Ltd. has sufficient contacts with the United States as a whole, including, but not limited to, filing
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`6
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`ANDAs with the FDA and manufacturing and selling generic pharmaceutical products that are
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`distributed throughout the United States, such that this Court’s exercise of jurisdiction over
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`Alembic Ltd. satisfies due process, and is consistent with the United States Constitution and Laws.
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`PERSONAL JURISDICTION OVER ALEMBIC GLOBAL
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`Plaintiff realleges paragraphs 1-28 as if fully set forth herein.
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`On information and belief, Alembic Global develops, manufactures, and/or
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`29.
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`30.
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`distributes generic drugs for sale and use throughout the United States, including in this judicial
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`district.
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`31.
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`This Court has personal jurisdiction over Alembic Global because, inter alia,
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`Alembic Global, on information and belief: (1) has substantial, continuous, and systematic contacts
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`with this State, either directly or through at least one of its subsidiaries or agents; (2) intends to
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`market, sell, or distribute the Alembic ANDA Products to residents of this State upon approval of
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`the Alembic ANDA; (3) makes its generic drug products available in this State; and (4) enjoys
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`substantial income from sales of its generic pharmaceutical products in this State.
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`32.
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`Furthermore, this Court has personal jurisdiction over Alembic Global because, on
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`information and belief, Alembic Global has participated in the preparation and/or submission of
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`ANDA No. 216261 within this jurisdiction.
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`33.
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`Alternatively, to the extent the above facts do not establish personal jurisdiction
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`over Alembic Global, this Court may exercise jurisdiction over Alembic Global pursuant to Fed.
`
`R. Civ. P. 4(k)(2) because: (a) Plaintiff’s claims arise under federal law; (b) Alembic Global would
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`be a foreign defendant not subject to personal jurisdiction in the courts of any State; and (c)
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`Alembic Global has sufficient contacts with the United States as a whole, including, but not limited
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`to, manufacturing and selling generic pharmaceutical products that are distributed throughout the
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`United States, such that this Court’s exercise of jurisdiction over Alembic Global satisfies due
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`process.
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`34.
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`35.
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`PERSONAL JURISDICTION OVER ALEMBIC INC.
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`Plaintiff realleges paragraphs 1-33 as if fully set forth herein.
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`On information and belief, Alembic Inc. develops, manufactures, and/or distributes
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`generic drugs for sale and use throughout the United States, including in the State of New Jersey
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`and therefore transacts business within the State of New Jersey related to BMS’s claims, and/or
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`has engaged in systematic and continuous business contacts within the State of New Jersey.
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`36.
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`On information and belief, Alembic Inc., directly or indirectly, manufactures,
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`markets, imports and sells generic drugs throughout the United States and in this judicial district.
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`See, e.g., Corporate Profile, ALEMBICUSA.COM, https://www.alembicusa.com/corporate-
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`profile.aspx (last visited Sept. 24, 2021).
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`37.
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`This Court has personal jurisdiction over Alembic Inc. because, inter alia, Alembic
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`Inc., on information and belief: (1) has substantial, continuous, and systematic contacts with this
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`State, either directly or through at least one of its subsidiaries or agents; (2) intends to market, sell,
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`or distribute the Alembic ANDA Products to residents of this State upon approval of the Alembic
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`ANDA; (3) makes its generic drug products available in this State; and (4) enjoys substantial
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`income from sales of its generic pharmaceutical products in this State.
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`38.
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`This Court has personal jurisdiction over Alembic Inc. because Alembic Inc. is a
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`corporation with a regular and established place of business in New Jersey.
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`39.
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`On information and belief, Alembic Inc. is registered as “Manufacturer and
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`Wholesale” with the State of New Jersey’s Department of Health under Registration No. 5004785.
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`40.
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`On information and belief, Alembic Inc. is registered with the State of New Jersey
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`as a business operating in New Jersey under Business ID No. 0101031141.
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`41.
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`On information and belief, Alembic Inc. has not contested jurisdiction in New
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`Jersey in one or more prior cases arising out of the filing of its ANDAs. See, e.g., Actelion Pharm.,
`
`Ltd. et al. v. MSN Pharm., Inc. et al. No. 20-03859, Dkt. 21 (D.N.J. Jun. 12, 2020); Duke University
`
`et al., v. Alembic Pharm. Ltd. et al., No. 17-07453, Dkt. 14 (D.N.J. Dec. 26, 2017); Otsuka Pharm.
`
`Co., Ltd. v. Alembic Pharm. Ltd. et al., No. 14-07405, Dkt. 32 (D.N.J. Mar. 16, 2015).
`
`BACKGROUND
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`U.S. PATENT NO. 7,491,725
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`42.
`
`On February 17, 2009, the USPTO duly and legally issued United States Patent
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`No. 7,491,725 (“the ’725 patent”) entitled “Process for preparing 2-aminothiazole-5-aromatic
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`carboxamides as kinase inhibitors” to inventors Jean Lajeunesse, John D. DiMarco, Michael
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`Galella, and Ramakrishnan Chidambaram. A true and correct copy of the ’725 patent is attached
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`as Exhibit 1. The ’725 patent is assigned to BMS.
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`U.S. PATENT NO. 8,680,103
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`43.
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`On March 25, 2014, the USPTO duly and legally issued United States Patent
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`No. 8,680,103 (“the ’103 patent”) entitled “Process for preparing 2-aminothiazole-5-aromatic
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`carboxamides as kinase inhibitors” to inventors Jean Lajeunesse, John D. DiMarco, Michael
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`Galella, and Ramakrishnan Chidambaram. A true and correct copy of the ’103 patent is attached
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`as Exhibit 2. The ’103 patent is assigned to BMS.
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`SPRYCEL®
`BMS is the holder of New Drug Application (“NDA”) No. 029186 for dasatinib,
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`44.
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`for oral use, in 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg dosages, which is sold under
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`the trade name SPRYCEL®.
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`45.
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`Pursuant to 21 U.S.C. § 355(b)(1), and attendant FDA regulations, the ’725 and
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`’103 patents are among the patents listed in the Orange Book with respect to SPRYCEL®.
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`46.
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`The ’725 and ’103 patents cover the SPRYCEL® product.
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`ACTS GIVING RISE TO THIS ACTION
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`COUNT I—INFRINGEMENT OF THE ’725 PATENT
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`Plaintiff realleges paragraphs 1-46 as if fully set forth herein.
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`On information and belief, Alembic submitted the Alembic ANDA to the FDA,
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`47.
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`48.
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`pursuant to 21 U.S.C. § 355(j), seeking approval to market the Alembic ANDA Products.
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`49.
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`Alembic has represented that the Alembic ANDA refers to and relies upon the
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`SPRYCEL® NDA, and contains data that, according to Alembic, demonstrate the bioavailability
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`or bioequivalence of the Alembic ANDA Products to SPRYCEL®.
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`50.
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`Plaintiff received a letter from Alembic on or about August 20, 2021 stating that
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`Alembic had included a certification in the Alembic ANDA, pursuant to 21 U.S.C.
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`§ 355(j)(2)(A)(vii)(IV), that, inter alia, certain claims of the ’725 and ’103 patents are either
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`invalid or will not be infringed by the commercial manufacture, use, or sale of the Alembic ANDA
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`Products (the “Alembic Paragraph IV Certification”). Alembic intends to engage in the
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`commercial manufacture, use, offer for sale, and/or sale of the Alembic ANDA Products prior to
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`the expiration of the ’725 and ’103 patents.
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`51.
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`Subsequent to sending the Alembic Paragraph IV Certification, Alembic has not
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`provided information relevant to an infringement analysis of the ’725 and ’103 patents, including
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`samples of its ANDA products. See Hoffman-La Roche, Inc. v. Invamed, Inc., 213 F.3d 1359,
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`1363-1364 (Fed. Cir. 2000).
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`52.
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`Alembic has infringed at least one claim of the ’725 patent, pursuant to 35 U.S.C.
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`§ 271(e)(2)(A), by submitting, or causing to be submitted the Alembic ANDA, by which Alembic
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`seeks approval from the FDA to engage in the manufacture, use, offer to sell, sale, or importation
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`of the Alembic ANDA Products prior to the expiration of the ’725 patent.
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`53.
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`Alembic has declared its intent to manufacture, use, offer to sell, or sell in the
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`United States or to import into the United States, the Alembic ANDA Products in the event that
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`the FDA approves the Alembic ANDA. Accordingly, an actual and immediate controversy exists
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`regarding Alembic’s infringement of the ’725 patent under 35 U.S.C. §§ 271 (a), (b) and/or (c).
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`54.
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`Alembic’s manufacture, use, offer to sell, or sale of the Alembic ANDA Products
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`in the United States or importation of the Alembic ANDA Products into the United States during
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`the term of the ’725 patent would further infringe, literally or under the doctrine of equivalents, at
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`least one claim of the ’725 patent under 35 U.S.C. §§ 271 (a), (b) and/or (c).
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`55.
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`On information and belief, the Alembic ANDA Products, when offered for sale,
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`sold, and/or imported, and when used as directed, would be used in a manner that would directly
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`infringe at least one of the claims of the ’725 patent either literally or under the doctrine of
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`equivalents.
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`56.
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`On information and belief, the use of the Alembic ANDA Products constitutes a
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`material part of at least one of the claims of the ’725 patent; Alembic knows that the Alembic
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`ANDA Products are especially made or adapted for use in infringing at least one of the claims of
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`the ’725 patent, either literally or under the doctrine of equivalents; and the Alembic ANDA
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`Products are not staple articles of commerce or commodities of commerce suitable for substantial
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`noninfringing use.
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`57.
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`On information and belief, the offering to sell, sale, and/or importation of the
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`Alembic ANDA Products would contributorily infringe at least one of the claims of the ’725
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`patent, either literally or under the doctrine of equivalents.
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`58.
`
`On information and belief, Alembic had knowledge of the ’725 patent and, by its
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`promotional activities and package inserts for its ANDA Products, knows or should know that they
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`will aid and abet another’s direct infringement of at least one of the claims of the ’725 patent,
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`either literally or under the doctrine of equivalents.
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`59.
`
`On information and belief, the offering to sell, sale, and/or importation of the
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`Alembic ANDA Products by Alembic would actively induce infringement of at least one of the
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`claims of the ’725 patent, either literally or under the doctrine of equivalents.
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`60.
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`Plaintiff will be substantially and irreparably harmed if Alembic is not enjoined
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`from infringing the ’725 patent.
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`61.
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`This is an exceptional case within the meaning of 35 U.S.C. § 285, which warrants
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`reimbursement of BMS’s reasonable attorney fees.
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`62.
`
`On information and belief, based on the information provided by Alembic to date,
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`the factual contentions in paragraph 48-61 have evidentiary support. On information and belief,
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`the factual contentions in paragraphs 48-61 will have further evidentiary support following a
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`reasonable opportunity for further investigation or discovery.
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`COUNT II—INFRINGEMENT OF THE ’103 PATENT
`
`Plaintiff realleges paragraphs 1-51 as if fully set forth herein.
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`Alembic has infringed at least one claim of the ’103 patent, pursuant to 35 U.S.C.
`
`63.
`
`64.
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`§ 271(e)(2)(A), by submitting, or causing to be submitted the Alembic ANDA, by which Alembic
`
`seeks approval from the FDA to engage in the manufacture, use, offer to sell, sale, or importation
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`of the Alembic ANDA Products prior to the expiration of the ’103 patent.
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`65.
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`Alembic has declared its intent to manufacture, use, offer to sell, or sell in the
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`United States or to import into the United States, the Alembic ANDA Products in the event that
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`the FDA approves the Alembic ANDA. Accordingly, an actual and immediate controversy exists
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`regarding Alembic’s infringement of the ’103 patent under 35 U.S.C. §§ 271 (a), (b), and/or (c).
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`66.
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`Alembic’s manufacture, use, offer to sell, or sale of the Alembic ANDA Products
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`in the United States or importation of the Alembic ANDA Products into the United States during
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`the term of the ’103 patent would further infringe at least one claim of the ’103 patent under 35
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`U.S.C. §§ 271 (a), (b), and/or (c).
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`67.
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`On information and belief, the Alembic ANDA Products, when offered for sale,
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`sold, and/or imported, and when used as directed, would be used in a manner that would directly
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`infringe at least one of the claims of the ’103 patent either literally or under the doctrine of
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`equivalents.
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`68.
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`On information and belief, the use of the Alembic ANDA Products constitutes a
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`material part of at least one of the claims of the ’103 patent; Alembic knows that its ANDA
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`Products are especially made or adapted for use in infringing at least one of the claims of the ’103
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`patent, either literally or under the doctrine of equivalents; and its ANDA Products are not staple
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`articles of commerce or commodities of commerce suitable for substantial noninfringing use.
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`69.
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`On information and belief, the offering to sell, sale, and/or importation of the
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`Alembic ANDA Products would contributorily infringe at least one of the claims of the ’103
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`patent, either literally or under the doctrine of equivalents.
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`70.
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`On information and belief, Alembic had knowledge of the ’103 patent and, by its
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`promotional activities and package inserts for its ANDA Products, knows or should know that they
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`will aid and abet another’s direct infringement of at least one of the claims of the ’103 patent,
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`either literally or under the doctrine of equivalents.
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`71.
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`On information and belief, the offering to sell, sale, and/or importation of the
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`Alembic ANDA Products by Alembic would actively induce infringement of at least one of the
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`claims of the ’103 patent, either literally or under the doctrine of equivalents.
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`72.
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`Plaintiff will be substantially and irreparably harmed if Alembic is not enjoined
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`from infringing the ’103 patent.
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`73.
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`This is an exceptional case within the meaning of 35 U.S.C. § 285, which warrants
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`reimbursement of BMS’s reasonable attorney fees.
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`74.
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`On information and belief, based on the information provided by Alembic to date,
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`the factual contentions in paragraph 63-73 have evidentiary support. On information and belief,
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`the factual contentions in paragraphs 63-73 will have further evidentiary support following a
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`reasonable opportunity for further investigation or discovery.
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`75.
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`The foregoing factual contentions in paragraphs 1-74 have evidentiary support, or
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`likely will have evidentiary support after a reasonable opportunity for further investigation and
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`discovery.
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`PRAYER FOR RELIEF
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`WHEREFORE, Plaintiff respectfully requests that the Court enter judgment against
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`Alembic and for the following relief:
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`a. A Judgment be entered that Alembic has infringed at least one claim of the ’725 patent by
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`submitting the Alembic ANDA;
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`b. A Judgment be entered that Alembic has infringed at least one claim of the ’103 patent by
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`submitting the Alembic ANDA;
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`c. A Judgment be entered that this case is exceptional, and that Plaintiff is entitled to its
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`reasonable attorneys’ fees pursuant to 35 U.S.C. § 285;
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`d. That Alembic, its officers, agents, servants, employees, and those persons acting in active
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`concert or participation with all or any of them be preliminarily and permanently enjoined
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`from: (i) engaging in the commercial manufacture, use, offer to sell, or sale within the United
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`States, or importation into the United States, of drugs or methods of administering drugs
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`claimed in the ’725 and ’103 patents, and (ii) seeking, obtaining or maintaining approval of
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`ANDAs until the expiration of the ’725 and ’103 patents or such other later time as the Court
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`may determine;
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`e. A judgment ordering that pursuant to 35 U.S.C. § 271(e)(4)(A), the effective date of any
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`approval of Alembic’s ANDA under § 505(j) of the Federal Food, Drug and Cosmetic Act (21
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`U.S.C. § 355(j)) shall not be earlier than the latest of the expiration dates of the ’725 and ’103
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`patents, including any extensions;
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`f. That Plaintiff be awarded monetary relief if Alembic commercially uses, offers to sell, or sells
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`its respective proposed generic versions of SPRYCEL® or any other product that infringes or
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`induces or contributes to the infringement of the ’725 and ’103 patents, within the United
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`States, prior to the expiration of those patents, including any extensions, and that any such
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`monetary relief be awarded to Plaintiff with prejudgment interest;
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`g. Costs and expenses in this action; and
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`h. Such other and further relief as the Court deems just and appropriate.
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`Respectfully submitted,
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`
`/s/Liza M. Walsh
`Liza M. Walsh
`Christine I. Gannon
`William T. Walsh, Jr.
`WALSH PIZZI O’REILLY FALANGA LLP
`Three Gateway Center
`100 Mulberry Street, 15th Floor
`Newark, New Jersey 07102
`(973) 757-1100
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`Dated: September 30, 2021
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`OF COUNSEL:
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`Leora Ben-Ami
`Jeanna M. Wacker
`Sam Kwon
`Christopher Ilardi
`KIRKLAND & ELLIS LLP
`601 Lexington Avenue
`New York, NY 10022
`(212) 446-4800
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`CERTIFICATION PURSUANT TO LOCAL CIVIL RULES 11.2 AND 40.1
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`I hereby certify that, to the best of my knowledge, the matter in controversy is not the
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`subject of any other pending or anticipated litigation in any court or arbitration proceeding, nor are
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`there any non-parties known to Plaintiff that should be joined to this action. In addition, I recognize
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`a continuing obligation during the course of this litigation to file and to serve on all other parties
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`and with the Court an amended certification if there is a change in the facts stated in this original
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`certification.
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`Dated: September 30, 2021
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`WALSH PIZZI O’REILLY FALANGA LLP
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`s/Liza M. Walsh
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`Liza M. Walsh
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`CERTIFICATION PURSUANT TO LOCAL CIVIL RULE 201.1
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`I hereby certify that the above-captioned matter is not subject to compulsory arbitration
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`in that the Plaintiff seeks, inter alia, injunctive relief.
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`Dated: September 30, 2021
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`WALSH PIZZI O’REILLY FALANGA LLP
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`s/Liza M. Walsh
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`Liza M. Walsh
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