Case 2:21-cv-20409 Document 1 Filed 12/08/21 Page 1 of 88 PageID: 1
`
`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
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`BRISTOL-MYERS SQUIBB COMPANY,
`
`Plaintiff,
`
`v.
`
`Civil Action No. 21-20409
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`EUGIA PHARMA SPECIALTIES, LTD.,
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`Electronically Filed
`
`Defendant.
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`COMPLAINT
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`Plaintiff, Bristol-Myers Squibb Company, by its undersigned attorneys, for their Complaint
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`against Defendant, Eugia Pharma Specialties, Ltd. 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 Defendant’s submissions of an Abbreviated New Drug Application (“ANDA”) to the Food and
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`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 Eugia Pharma Specialties, Ltd. (“Eugia”) is a
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`corporation organized and existing under the laws of India, having a principal place of business at
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`Plot No. 2, Maitrivihar, Ameerpet, Hyderabad - 500038, Telangana, India. On information and belief,
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`Eugia is in the business of, among other things, developing, preparing, manufacturing, selling,
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`marketing, and distributing generic drugs, including distributing, selling, and marketing generic
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`drugs throughout the United States, including within the state of New Jersey, through its own actions
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`and through the actions of its agents and subsidiaries.
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`4.
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`On information and belief, Eugia is listed as the applicant of ANDA No. 216547 (the
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`“Eugia ANDA”) and has sent notice to BMS stating that Eugia included a certification in the Eugia
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`ANDA, pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV).
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`5.
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`On information and belief, Eugia prepared and submitted the Eugia ANDA for
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`Eugia’s 20 mg, 50 mg, 70 mg, 80 mg, 100 mg and 140 mg dasatinib tablets (“Eugia ANDA
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`Products”).
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`6.
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`On information and belief, Eugia prepared and submitted the Eugia ANDA for the
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`Eugia ANDA Products, which was done for the direct benefit of Eugia.
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`7.
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`On information and belief, following FDA approval of the Eugia ANDA, Eugia will
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`manufacture, supply, market, and sell the approved generic product throughout the United States,
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`including New Jersey.
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`2
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`JURISDICTION AND VENUE
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`8.
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`This action arises under the patent laws of the United States, 35 U.S.C. §§ 100 et seq.,
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`generally, and 35 U.S.C. § 271(e)(2), specifically, and this Court has jurisdiction over the subject
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`matter of this action under 28 U.S.C. §§ 1331 and 1338(a).
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`9.
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`Venue is proper in this Court as to Eugia because, among other things, Eugia is a
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`foreign corporation not residing in any United States district and may be sued in any judicial district.
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`28 U.S.C. § 1391(c); see also 28 U.S.C. § 1400(b).
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`10.
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`Venue is further proper in this Court as to Eugia because, among other things, Eugia
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`has committed or aided, abetted, contributed to, and/or participated in the commission of, acts of
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`infringement of the asserted patents that will lead to foreseeable harm and injury to BMS by filing
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`the Eugia ANDA with the intention of seeking to market the Eugia ANDA Products nationwide,
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`including within New Jersey. 28 U.S.C. § 1400(b).
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`11. Moreover, Eugia has not contested venue in New Jersey in other cases arising out of
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`the filing of an ANDA. See, e.g., Celgene Corp. v. Aurobindo Pharma Ltd. et al., No. 20 Civ. 315
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`(D.N.J. Mar. 27, 2020), ECF No. 14; Celgene Corp. v. Aurobindo Pharma Ltd. et al., No. 19 Civ.
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`5799 (D.N.J July 1, 2019), ECF No. 15; Celgene Corp. v. Aurobindo Pharma Ltd. et al., No. 19 Civ.
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`143 (D.N.J. Jan. 18, 2019), ECF No. 10; Boehringer Ingelheim Pharma, Inc. et al. v. Aurobindo
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`Pharma USA Inc. et al., No. 17 Civ. 7887 (D.N.J. Dec. 11, 2017), ECF No. 9; Celgene Corp. v.
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`Hetero Labs Ltd., No. 17 Civ. 3387 (D.N.J. Sept. 15, 2017), ECF No. 79.
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`PERSONAL JURISDICTION OVER EUGIA
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`Plaintiff realleges paragraphs 1-11 as if fully set forth herein.
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`This Court has personal jurisdiction over Eugia because, inter alia, Eugia, on
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`12.
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`13.
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`information and belief: (1) has substantial, continuous, and systematic contacts with this State, either
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`3
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`directly or through at least one of its wholly-owned subsidiaries or agents; (2) intends to market, sell,
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`and/or distribute the Eugia ANDA Products to residents of this State upon approval of the Eugia
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`ANDA, either directly or through at least one of its wholly-owned subsidiaries or agents; and
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`(3) enjoys substantial income from sales of its generic pharmaceutical products in this State.
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`14.
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`This Court has personal jurisdiction over Eugia because, inter alia, Eugia, itself, and
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`through its agents purposely availed itself of the benefits and protections of New Jersey’s laws such
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`that it should reasonably anticipate being sued in this Court. On information and belief, Eugia itself,
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`and through its agents, 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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`15.
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`On information and belief, Eugia has not contested jurisdiction in New Jersey in other
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`cases arising out of the filing of an ANDA, and has filed counterclaims in some cases. See, e.g.,
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`Celgene Corp. v. Aurobindo Pharma Ltd. et al., No. 20 Civ. 315 (D.N.J. Mar. 27, 2020), ECF No.
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`14; Celgene Corp. v. Aurobindo Pharma Ltd. et al., No. 19 Civ. 5799 (D.N.J July 1, 2019), ECF No.
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`15; Celgene Corp. v. Aurobindo Pharma Ltd. et al., No. 19 Civ. 143 (D.N.J. Jan. 18, 2019), ECF No.
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`10; Boehringer Ingelheim Pharma, Inc. et al. v. Aurobindo Pharma USA Inc. et al., No. 17 Civ. 7887
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`(D.N.J. Dec. 11, 2017), ECF No. 9; Celgene Corp. v. Hetero Labs Ltd., No. 17 Civ. 3387 (D.N.J.
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`Sept. 15, 2017), ECF No. 79.
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`16.
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`Alternatively, to the extent the above facts do not establish personal jurisdiction over
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`Eugia, this Court may exercise jurisdiction over Eugia pursuant to Fed. R. Civ. P. 4(k)(2) because:
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`(a) Plaintiff’s claims arise under federal law; (b) Eugia would be a foreign defendant not subject to
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`personal jurisdiction in the courts of any State; and (c) Eugia has sufficient contacts with the United
`4
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`States as a whole, including, but not limited to, filing ANDAs with the FDA and manufacturing and
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`selling generic pharmaceutical products that are distributed throughout the United States, such that
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`this Court’s exercise of jurisdiction over Eugia satisfies due process, and is consistent with the United
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`States Constitution and Laws.
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`BACKGROUND
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`U.S. PATENT NO. 7,491,725
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`17.
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`On February 17, 2009, the United States Patent & Trademark Office (“USPTO”) duly
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`and legally issued United States Patent No. 7,491,725 (“the ’725 patent”) entitled “Process for
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`preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors” to inventors Jean
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`Lajeunesse, John D. DiMarco, Michael Galella, and Ramakrishnan Chidambaram. A true and correct
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`copy of the ’725 patent is attached 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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`18.
`
`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 Galella,
`
`and Ramakrishnan Chidambaram. A true and correct copy of the ’103 patent is attached as Exhibit
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`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, for
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`19.
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`oral use, in 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg dosages, which is sold under the trade
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`name SPRYCEL®.
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`20.
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`Pursuant to 21 U.S.C. § 355(b)(1), and attendant FDA regulations, the ’725 and ’103
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`patents are among the patents listed in the Orange Book with respect to SPRYCEL®.
`5
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`21.
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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 1-21 as if fully set forth herein.
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`On information and belief, Eugia submitted the Eugia ANDA to the FDA, pursuant to
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`22.
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`23.
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`21 U.S.C. § 355(j), seeking approval to market the Eugia ANDA Products.
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`24.
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`Eugia has represented that the Eugia ANDA refers to and relies upon the SPRYCEL®
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`NDA, and contains data that, according to Eugia, demonstrate the bioavailability or bioequivalence
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`of the Eugia ANDA Products to SPRYCEL®.
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`25.
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`Plaintiff received a letter from Eugia on or about October 28, 2021 stating that Eugia
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`had included a certification in the Eugia ANDA, pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), that,
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`inter alia, certain claims of the ’725 and ’103 patents are either invalid or will not be infringed by
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`the commercial manufacture, use, or sale of the Eugia ANDA Products (the “Eugia Paragraph IV
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`Certification”). Eugia intends to engage in the commercial manufacture, use, offer for sale, and/or
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`sale of the Eugia ANDA Products prior to the expiration of the ’725 and ’103 patents.
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`26.
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`Eugia’s Paragraph IV letter includes very limited information about the nature and
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`form of the Eugia ANDA Products, including little to no information regarding how the Eugia ANDA
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`Products are manufactured, the amounts and ingredients of such Products, and the form of dasatinib
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`present in the Products.
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`27.
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`The Eugia Paragraph IV Certification offered confidential access to unspecified
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`portions of the Eugia ANDA (“Offer of Confidential Access” or “OCA”) on terms and conditions set
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`6
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`by Eugia. Eugia requested that BMS accept the terms of the OCA before receiving access to the
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`unspecified portions of the Eugia ANDA.
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`28.
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`Under 21 U.S.C. § 355(j)(5)(C)(i)(III), an offer of confidential access “shall contain
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`such restrictions as to persons entitled to access, and on the use and disposition of any information
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`accessed, as would apply had a protective order been entered for the purpose of protecting trade
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`secrets and other confidential business information.”
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`29.
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`The OCA contains unreasonable restrictions, above and beyond those that would
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`apply under a protective order, on who could view the Eugia ANDA. For example, the OCA does
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`not offer access to the entire Eugia ANDA, does not permit any access by BMS’s in-house counsel,
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`and permits only one scientific consultant to view Eugia’s ANDA. As another example, the OCA
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`requires BMS to return Eugia’s confidential information or commence suit within thirty-five (35)
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`days from the date that BMS receives Eugia’s information, despite the fact that under the Hatch-
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`Waxman Act, BMS may file an action in federal court within 45 days of receiving a Paragraph IV
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`letter, in order to receive a stay of ANDA approval for 30 months. The OCA also does not grant
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`access to Eugia’s Drug Master File (“DMF”) or samples of the Eugia ANDA Products.
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`30.
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`Since receiving the Eugia Paragraph IV Certification, BMS has attempted to negotiate
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`with Eugia to obtain a copy of the entire Eugia ANDA under terms “as would apply had a protective
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`order been entered for the purpose of protecting trade secrets and other confidential business
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`information.” BMS has also attempted to negotiate access to samples of the Eugia ANDA Products
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`and Eugia’s DMF related to the Eugia ANDA Products. These negotiations have been unsuccessful.
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`Eugia has refused to modify the restrictions of the OCA and provide access to the entirety of the
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`Eugia ANDA, or allow any BMS in-house counsel or additional scientific consultants to view the
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`Eugia ANDA. Eugia’s refusal to provide access to the entire Eugia ANDA under reasonable terms
`7
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`provides a basis to file suit. See In re Cyclobenzaprine Hydrochloride Extended Release Capsule
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`Patent Litigation, 693 F. Supp. 2d 409, 415–17 (D. Del. 2010).
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`31.
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`Eugia also has not agreed to provide any access by BMS to its DMF or samples of the
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`Eugia ANDA Products. Under the Hatch-Waxman Act, an owner of a patented drug must file an
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`action in federal court within 45 days of receiving a Paragraph IV letter (“45-day window”) in order
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`to receive certain benefits under the Act, including a stay of approval of the generic drug for 30
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`months during the pendency of litigation, as appropriate. 21 U.S.C. § 355 (c)(3)(c).
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`32.
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`BMS is not aware of any other means outside of the judicial process of obtaining
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`information regarding the Eugia ANDA Products within the 45-day statutory period. In the absence
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`of such information, BMS is required to resort to the judicial process and the aid of discovery to
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`obtain, under appropriate judicial safeguards, such information as is required to confirm its
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`allegations of infringement and to present to the Court evidence that the Eugia ANDA Products
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`infringe one or more claims of the asserted patents.
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`33.
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`Eugia’s refusal to provide these documents and samples has hindered BMS’s ability
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`to consider information that is relevant to its infringement analysis of the ’725 and ’103 patents. See
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`Hoffman-La Roche, Inc. v. Invamed, Inc., 213 F.3d 1359, 1363–64 (Fed. Cir. 2000).
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`34.
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`Eugia 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 Eugia ANDA, by which Eugia seeks
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`approval from the FDA to engage in the manufacture, use, offer to sell, sale, or importation of the
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`Eugia ANDA Products prior to the expiration of the ’725 patent.
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`35.
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`Eugia has declared its intent to manufacture, use, offer to sell, or sell in the United
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`States or to import into the United States, the Eugia ANDA Products in the event that the FDA
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`8
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`approves the Eugia ANDA. Accordingly, an actual and immediate controversy exists regarding
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`Eugia’s infringement of the ’725 patent under 35 U.S.C. §§ 271 (a), (b) and/or (c).
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`36.
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`Eugia’s manufacture, use, offer to sell, or sale of the Eugia ANDA Products in the
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`United States or importation of the Eugia ANDA Products into the United States during the term of
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`the ’725 patent would further infringe, literally or under the doctrine of equivalents, at least one claim
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`of the ’725 patent under 35 U.S.C. §§ 271 (a), (b) and/or (c).
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`37.
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`On information and belief, the Eugia ANDA Products, when offered for sale, sold,
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`and/or imported, and when used as directed, would be used in a manner that would directly infringe
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`at least one of the claims of the ’725 patent either literally or under the doctrine of equivalents.
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`38.
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`On information and belief, the use of the Eugia ANDA Products constitutes a material
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`part of at least one of the claims of the ’725 patent; Eugia knows that the Eugia ANDA Products are
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`especially made or adapted for use in infringing at least one of the claims of the ’725 patent, either
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`literally or under the doctrine of equivalents; and the Eugia ANDA Products are not staple articles of
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`commerce or commodities of commerce suitable for substantial noninfringing use.
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`39.
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`On information and belief, the offering to sell, sale, and/or importation of the Eugia
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`ANDA Products would contributorily infringe at least one of the claims of the ’725 patent, either
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`literally or under the doctrine of equivalents.
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`40.
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`On information and belief, Eugia 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, either
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`literally or under the doctrine of equivalents.
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`41.
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`On information and belief, the offering to sell, sale, and/or importation of the Eugia
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`ANDA Products by Eugia would actively induce infringement of at least one of the claims of the
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`’725 patent, either literally or under the doctrine of equivalents.
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`42.
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`Plaintiff will be substantially and irreparably harmed if Eugia is not enjoined from
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`infringing the ’725 patent.
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`43.
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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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`44.
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`On information and belief, based on the information provided by Eugia to date, the
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`factual contentions in paragraph 23-43 have evidentiary support. On information and belief, the
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`factual contentions in paragraphs 23-43 will have further evidentiary support following a reasonable
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`opportunity for further investigation or discovery.
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`COUNT II—INFRINGEMENT OF THE ’103 PATENT
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`Plaintiff realleges paragraphs 1-44 as if fully set forth herein.
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`Eugia has infringed at least one claim of the ’103 patent, pursuant to 35 U.S.C.
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`45.
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`46.
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`§ 271(e)(2)(A), by submitting, or causing to be submitted the Eugia ANDA, by which Eugia seeks
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`approval from the FDA to engage in the manufacture, use, offer to sell, sale, or importation of the
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`Eugia ANDA Products prior to the expiration of the ’103 patent.
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`47.
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`Eugia has declared its intent to manufacture, use, offer to sell, or sell in the United
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`States or to import into the United States, the Eugia ANDA Products in the event that the FDA
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`approves the Eugia ANDA. Accordingly, an actual and immediate controversy exists regarding
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`Eugia’s infringement of the ’103 patent under 35 U.S.C. §§ 271 (a), (b), and/or (c).
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`48.
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`Eugia’s manufacture, use, offer to sell, or sale of the Eugia ANDA Products in the
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`United States or importation of the Eugia ANDA Products into the United States during the term of
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`10
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`the ’103 patent would further infringe at least one claim of the ’103 patent under 35 U.S.C. §§ 271
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`(a), (b), and/or (c).
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`49.
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`On information and belief, the Eugia ANDA Products, when offered for sale, sold,
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`and/or imported, and when used as directed, would be used in a manner that would directly infringe
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`at least one of the claims of the ’103 patent either literally or under the doctrine of equivalents.
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`50.
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`On information and belief, the use of the Eugia ANDA Products constitutes a material
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`part of at least one of the claims of the ’103 patent; Eugia knows that its ANDA Products are
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`especially made or adapted for use in infringing at least one of the claims of the ’103 patent, either
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`literally or under the doctrine of equivalents; and its ANDA Products are not staple articles of
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`commerce or commodities of commerce suitable for substantial noninfringing use.
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`51.
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`On information and belief, the offering to sell, sale, and/or importation of the Eugia
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`ANDA Products would contributorily infringe at least one of the claims of the ’103 patent, either
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`literally or under the doctrine of equivalents.
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`52.
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`On information and belief, Eugia 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, either
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`literally or under the doctrine of equivalents.
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`53.
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`On information and belief, the offering to sell, sale, and/or importation of the Eugia
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`ANDA Products by Eugia would actively induce infringement of at least one of the claims of the
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`’103 patent, either literally or under the doctrine of equivalents.
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`54.
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`Plaintiff will be substantially and irreparably harmed if Eugia is not enjoined from
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`infringing the ’103 patent.
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`55.
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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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`56.
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`On information and belief, based on the information provided by Eugia to date, the
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`factual contentions in paragraph 46-55 have evidentiary support. On information and belief, the
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`factual contentions in paragraphs 46-55 will have further evidentiary support following a reasonable
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`opportunity for further investigation or discovery.
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`57.
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`The foregoing factual contentions in paragraphs 1-56 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 Eugia
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`and for the following relief:
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`a. A Judgment be entered that Eugia has infringed at least one claim of the ’725 patent by submitting
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`the Eugia ANDA;
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`b. A Judgment be entered that Eugia has infringed at least one claim of the ’103 patent by submitting
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`the Eugia ANDA;
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`c. A Judgment be entered that this case is exceptional, and that Plaintiff is entitled to its reasonable
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`attorneys’ fees pursuant to 35 U.S.C. § 285;
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`d. That Eugia, its officers, agents, servants, employees, and those persons acting in active concert
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`or participation with all or any of them be preliminarily and permanently enjoined from:
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`(i) engaging in the commercial manufacture, use, offer to sell, or sale within the United States, or
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`importation into the United States, of drugs or methods of administering drugs claimed in the
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`’725 and ’103 patents, and (ii) seeking, obtaining or maintaining approval of ANDAs until the
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`expiration of the ’725 and ’103 patents or such other later time as the Court 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 approval
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`of Eugia’s ANDA under § 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. §
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`355(j)) shall not be earlier than the latest of the expiration dates of the ’725 and ’103 patents,
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`including any extensions;
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`f. That Plaintiff be awarded monetary relief if Eugia commercially uses, offers to sell, or sells its
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`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 States,
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`prior to the expiration of those patents, including any extensions, and that any such monetary
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`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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`
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`Dated: December 8, 2021
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`Respectfully submitted,
`
`OF COUNSEL:
`
`Jeanna M. Wacker
`Sam Kwon
`Christopher Ilardi
`KIRKLAND & ELLIS LLP
`601 Lexington Avenue
`New York, NY 10022
`(212) 446-4679
`
`
`
`
`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
`
`
` Counsel for Plaintiff
` Bristol-Myers Squibb Company
`
`13
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`

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`Case 2:21-cv-20409 Document 1 Filed 12/08/21 Page 14 of 88 PageID: 14
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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
`
`subject of any other pending or anticipated litigation in any court or arbitration proceeding, but is
`
`related to the following action:
`
`Bristol-Myers Squibb Company v. Alembic Pharmaceuticals, Ltd., Alembic Global
`
`Holdings SA, and Alembic Pharmaceuticals, Inc., Civil Action No. 2:21-cv-19926, pending in the
`
`United States District Court, District of New Jersey before the Honorable Kevin McNulty, U.S.D.J.
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`
`
`Dated: December 8, 2021
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`
`
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`
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`WALSH PIZZI O’REILLY FALANGA LLP
`
`s/Liza M. Walsh
`Liza M. Walsh
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`14
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`Case 2:21-cv-20409 Document 1 Filed 12/08/21 Page 15 of 88 PageID: 15
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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.
`
`
`Dated: December 8, 2021
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`
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`WALSH PIZZI O’REILLY FALANGA LLP
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`s/Liza M. Walsh
`Liza M. Walsh
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`15
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`Case 2:21-cv-20409 Document 1 Filed 12/08/21 Page 16 of 88 PageID: 16
`Case 2:21-cv-20409 Document1 Filed 12/08/21 Page 16 of 88 PagelD: 16
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`EXHIBIT 1
`EXHIBIT 1
`
`

`

`Case 2:21-cv-20409 Document 1 Filed 12/08/21 Page 17 of 88 PageID: 17
`case 2240-20400 Document aHMPA
`
`US007491725B2
`
`a2) United States Patent
`US 7,491,725 B2
`(0) Patent No.:
`Lajeunesseet al.
`Feb. 17, 2009
`(45) Date of Patent:
`
`(54)
`
`(75)
`
`PROCESS FOR PREPARING
`2-AMINOTHIAZOLE-5-AROMATIC
`CARBOXAMIDES AS KINASE INHIBITORS
`
`Inventors: Jean Lajeunesse, Candiac (CA); John
`D. DiMarco, East Brunswick, NJ (US);
`Michael Galella, Kendall Park, NJ (US);
`Ramakrishnan Chidambaram,
`Pennington, NJ (US)
`
`(73)
`
`Assignee: Bristol-Myers Squibb Company,
`Princeton, NJ (US)
`
`(*)
`
`Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 251 days.
`
`(21)
`
`Appl. No.: 11/192,867
`
`(22)
`
`Filed:
`
`Jul. 29, 2005
`
`(65)
`
`(63)
`
`(60)
`
`Prior Publication Data
`
`US 2006/0004067 Al
`
`Jan. 5, 2006
`
`Related U.S. Application Data
`
`Continuation-in-part of application No. 11/051,208,
`filed on Feb. 4, 2005, now abandoned.
`
`Provisional application No. 60/542,490,filed on Feb.
`6, 2004, provisional application No. 60/624,937, filed
`on Nov.4, 2004, provisional application No. 60/649,
`722, filed on Feb. 3, 2005.
`
`(51)
`
`Int. Cl.
`
`(2006.01)
`A61K 31/506
`(2006.01)
`CO7D 403/04
`US. Ch. eect creecees 514/252.19; 544/295
`Field of Classification Search.
`................. 544/295;
`514/252.19
`
`See application file for complete search history.
`References Cited
`
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`WO
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`WO2005/072826
`
`8/2005
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`Byrnetal. (Sold-State Chemistry of Drugs, 2nd Edition, 1999, SSCI,
`Inc. Publishers).*
`U.S. Appl. No. 11/049,815, filed Feb. 3, 2005, Chenet al.
`Autenrieth, W., “Regarding our knowledgeofthefive isomeric acids
`C,H,O,”, Chem. Ber., vol. 38, pp. 2534-2551, English Translation.
`Eremeevet al., “Absolute Configuration of Diastereomeric Deriva-
`tives of N-Substituted Aziridine-2-Carboxylic Acids”, Chem.
`Heterocycl. Compd. Engl. Transl., vol. 20, pp. 1102-1107, 1984
`(translated from Khimiya Geterotsiklicheskikh Soedinenii, No. 10,
`pp. 1342-1348, 1984).
`Hartmann et al., “On the coupling of aryldiazonium salts with N,N-
`disubstituted 2-aminothiophenes and some of their carbocyclic and.
`heterocyclic analogues”, J. Chem. Soc.; Perkin Trans. vol. 1, pp
`4316-4320, 2000.
`Kantlehner et al., “Ein neues Herstellungsverfahren fiir 2,2,2-
`Trialkoxyacetonitrile
`und
`2-Dialkylamino-2-
`alkoxycarbonsaurenitrile”, Synthesis, pp. 358-360, 1984.
`Kantlehneret al., “Orthoamides. IL Reaction of Orthoamide Deriva-
`tives with Sulfur and Selenium, Syntheses of 1,3-Thiazole- and 1,3-
`Selenazole Derivatives”, J. prakt. Chem., vol. 338, pp. 403-413,
`1996.
`
`Knollet al., “Formylation Products ofThioamides; VII’ . Synthesis of
`New
` N-(3-AMinothioacryloyl)-formamidines
`and
`=6N,N-
`Bis[aminomethylidene]thioureas
`by Bis-iminoformylation
`of
`Thioacetamides and Thiourea with Formamide Acetals”, Synthesis
`Communications, pp. 51-53, 1984.
`Landreau et al., “[4+2] Cycloaddition Reactions Between 2,4-
`Diamino-1-Thia-3-Azabutadienes and Ketene. Synthesis of New
`1,3-Thiazin-6-ones,
`1,3-Thiazine-6-Thiones
`and
`2-Thioxopyrimidin-4-ones”, Heterocycles, vol. 53, No. 12, pp. 2667-
`2677, 2000.
`
`(Continued)
`
`Primary Examiner—Kamal A Saeed
`Assistant Examiner—Jason Nolan
`
`(74) Attorney, Agent, or Firm—Mary K. VanAtten
`
`U.S. PATENT DOCUMENTS
`
`(57)
`
`ABSTRACT
`
`The invention relates to processes for preparing compounds
`having the formula,
`
`mMib/
`
`s
`
`Kulkaet al.
`Blade et al. we. 514/248
`Daset al.
`Daset al.
`Daset al.
`Daset al.
`Daset al.
`
`Hynesetal.
`Lee
`Chenetal.
`
`12/1970
`5/1992
`7/2003
`2/2004
`3/2004
`4/2004
`4/2004
`11/2004
`1/2005
`9/2005
`
`ok
`
`A A
`
`Bl
`Al
`Al
`Al
`Al
`Al
`Al
`Al
`
`3,547,917
`5,114,940
`6,596,746
`2004/0024208
`2004/0054 186
`2004/0073026
`2004/0077875
`2004/0220233
`2005/0009891
`2005/0215795
`
`FOREIGN PATENT DOCUMENTS
`
`EP
`WO
`WO
`WO
`WO
`
`639574
`WO0062778
`WO2004071440
`WO2004085388
`WO2005013983
`
`2/1995
`10/2000
`8/2004
`10/2004
`2/2005
`
`and crystalline forms thereof, wherein Ar is aryl or het-
`eroaryl, L is an optional alkylene linker, and R,, R;, Ry,
`and R., are as defined in the specification herein, which
`compoundsare useful as kinase inhibitors, in particular,
`inhibitors of protein tyrosine kinase and p38 kinase.
`
`16 Claims, 7 Drawing Sheets
`
`

`

`Case 2:21-cv-20409 Document 1 Filed 12/08/21 Page 18 of 88 PageID: 18
`Case 2:21-cv-20409 Document1 Filed 12/08/21 Page 18 of 88 PagelD: 18
`
`US 7,491,725 B2
`Page 2
`
`OTHER PUBLICATIONS
`
`Landreauet al., “Cationic 1,3-Diazadienes in Annulation Reactions.
`Synthesis of Pyrimidine, Thiadiazinedioxide and Triazine Deriva-
`tives”, J. Heterocyclic Chem., vol. 38, pp. 93-98, 2001.
`Linet al., “The Synthesis of Substituted 2-Aminothiazoles”, J. Het-
`erocyclic Chem., vol. 16, pp. 1377-1383, 1979.
`Marsham et al., “Quinazoline Antifolate Thymidylate Synthase
`Inhibitors: Heterocyclic Benzoyl Ring Modifications”,
`J. Med.
`Chem., vol. 34, pp. 1594-1605, 1991.
`Noack et al., “Synthesis and characterization of N,N-disubstituted
`2-amino-5-acylthiophenes and 2-amino-5-acylthiazoles”, Tetrahe-
`dron, vol. 58, pp. 2137-2146, 2002.
`
`Noacket al., “Synthesis and Spectral Characterisation of a New Class
`of Heterocyclic Analogues of Crystal Violet Dyes”, Angew. Chem.
`Int. Ed., vol. 113, No. 16, pp. 3008-3011, 2001.
`Roberts et al., “Folic Acid Analogs. Modifications in the Benzene-
`Ring Region. 2. Thiazole Analogs”, J. Medicinal Chemistry, vol. 15,
`No. 12, pp. 1310-1312, 1972.
`Zhao et al.,
`“A new facile synthesis of 2-aminothiazole-5-
`carboxylates”, Tetrahedron Letters, vol. 42, pp. 2101-2102, 2001.
`Shah et al., “Overriding Imatinib Resistance with a Novel ABL
`Kinase Inhibitor’, Science, vol. 35, pp. 339-401, 2004.
`U.S. Appl. No. 11/271,626, Office Action Jan. 31, 2008.
`
`* cited by examiner
`
`

`

`Case 2:21-cv-20409 Document 1 Filed 12/08/21 Page 19 of 88 PageID: 19
`Case 2:21-cv-20409 Document1 Filed 12/08/21 Page 19 of 88 PagelD: 19
`
`U.S. Patent
`
`Feb. 17, 2009
`
`Sheet 1 of 7
`
`US 7,491,725 B2
`
`1.5418A--->mi
`
`Figure1
`
`425°C
`
`FormH1-7 T
`
`a«>aG
`
`SDB
`
`w3 =“
`
`
`
`20(deg)forCuko,2
`
`
`
`ObservedPXRD
`
`

`

`Case 2:21-cv-20409 Document 1 Filed 12/08/21 Page 20 of 88 PageID: 20
`Case 2:21-cv-20409 Document1 Filed 12/08/21 Page 20 of 88 PagelD: 20
`
`U.S. Patent
`
`Feb. 17, 2009
`
`Sheet 2 of 7
`
`US 7,491,725 B2
`
`%(
`
`) YBa
`
`OL
`
`001+~
`
`06
`
`084
`
`OL-;
`
`09
`
`IDe6L'982
`
`
`
`:tDeSZb9OGWOYSSO7YBIEM%EP'E
`
`|Dedz'Seb
`
`220%'66
`
`B/rorert
`
`(yaa) Moly 3228H
`
`Saws]WLDPE[esleqqur)
`
`OSEoot
`
`(9,)
`
`eunjesaduua|osz002OS00+os
`
`Zainbi4
`
`

`

`Case 2:21-cv-20409 Document 1 Filed 12/08/21 Page 21 of 88 PageID: 21
`Case 2:21-cv-20409 Document1 Filed 12/08/21 Page 21 of 88 PagelD: 21
`
`U.S. Patent
`
`Feb. 17, 2009
`
`Sheet 3 of 7
`
`US 7,491,725 B2
`
`
`
`ObservedPXRD
`
`1.54184--—->
`
`20(deg)torCuKe.2
`
`
`
`SimulatedPXRD
`
`FormBU-2 T=425°C
`
`
`
`24
`
`|
`
`1618
`
`Figure3if
`
`

`

`Case 2:21-cv-20409 Document 1 Filed 12/08/21 Page 22 of 88 PageID: 22
`Case 2:21-cv-20409 Document1 Filed 12/08/21 Page 22 of