Case 1:13-cv-01679-GMS Document 1 Filed 10/09/13 Page 1 of 11 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`CUBIST PHARMACEUTICALS, INC.,
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`Plaintiff,
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`v.
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`STRIDES, INC. and A GILA SPECIAL TIES
`PRIVATE LIMITED,
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`Defendant.
`
`)
`)
`)
`)
`) C.A. No . - - - - - - - (cid:173)
`)
`)
`)
`)
`)
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`COMPLAINT
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`Plaintiff Cubist Pharmaceuticals, Inc., by its attorneys, 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 under the patent laws of the United
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`States, Title 35, United States Code, that arises out of the filing by Defendants Strides, Inc.
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`("Strides") and Agila Specialties Private Limited ("Agila") (collectively, "Defendants") of
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`Abbreviated New Drug Application ("ANDA") No. 205037 with the U.S. Food and Drug
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`Administration ("FDA") seeking approval to manufacture and sell a generic version of
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`CUBICIN® prior to the expiration of U.S. Patent Nos. 6,468,967; 6,852,689; 8,058,238; and
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`8,129,342.
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`PARTIES
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`2.
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`Plaintiff Cubist Pharmaceuticals, Inc. ("Cubist") is a corporation organized and
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`existing under the laws of the State of Delaware, with its principal place of business at 65
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`Hayden A venue, Lexington, Massachusetts.
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`3.
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`Upon information and belief, defendant Strides is a New Jersey corporation, with
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`its principal place ofbusiness at 201 South Main Street, Suite #3, Lambertville, NJ 08530.
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`PETITIONERS
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`4.
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`Upon information and belief, defendant Agila is a corporation organized under the
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`laws oflndia, with its principal place ofbusiness at Strides House, Bilekahalli, Bannerghatta
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`Road, Bangalore 560076 India.
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`5.
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`Upon information and belief, defendant Strides is the U.S. agent for defendant
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`Agila. Upon information and belief, defendants Strides and Agila are wholly owned subsidiaries
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`of Strides Arcolab Ltd. that act in concert with respect to collaborating in the development,
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`manufacturing, marketing, and sale of generic copies of branded pharmaceutical products,
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`including daptomycin for injection. On information and belief, defendants Strides and Agila
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`import, distribute, manufacture, market, and/or sell generic versions of branded drugs in, and
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`regularly conduct business throughout, the United States, including in Delaware.
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`JURISDICTION AND VENUE
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`6.
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`This action arises under the patent laws of the United States of America and this
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`Court has jurisdiction over the subject matter of this action pursuant to 28 U.S. C. §§ 1331,
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`1338(a), 2201, and 2202.
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`7.
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`8.
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`Venue is proper in this district pursuant to 28 U.S. C. §§ 1391 and 1400(b).
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`Defendants are subject to personal jurisdiction in Delaware because of their
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`continuous and systematic contacts with Delaware. Upon information and belief, Defendants
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`directly or indirectly purposefully offer to sell, sell, market, distribute, and/or manufacture
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`goods, including generic pharmaceutical products, for sale in the United States and Delaware;
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`derive substantial revenue from things used or consumed in Delaware; regularly do business and
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`solicit business in Delaware; and have admitted, consented to, and/or not objected to jurisdiction
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`in this Court, including, for example, in Aventis Pharma S.A. et al. v. Strides, Inc. eta!., C.A. No.
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`11-1121-GMS (D. Del.) and Senju Pharmaceutical Co., Ltd eta/. v. Strides, Inc. et al., C.A. No.
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`13-851-SLR (D. Del.).
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`9.
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`Alternatively, Agila is subject to personal jurisdiction in Delaware pursuant to
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`Fed. R. Civ. P. 4(k)(2). Agila has contacts with the United States through, among other things,
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`its having filed an ANDA with the FDA through its agent corporation, Strides, and its
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`importation, distribution, manufacture, marketing, and/or sale of generic versions of branded
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`drugs in the United States.
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`BACKGROUND
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`I 0.
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`CUBICIN® (daptomycin for injection) is an intravenous bactericidal antibiotic
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`approved by the FDA for the treatment of complicated skin and skin structure infections caused
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`by certain Gram-positive microorganisms, such as Staphylococcus aureus, including methicillin(cid:173)
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`resistant strains, also known as MRSA. CUBICIN® is also approved for the treatment of
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`S. aureus bloodstream infections (bacteremia), including right-sided infective endocarditis
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`caused by MRSA.
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`11.
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`Cubist sells CUBICIN® in the United States pursuant to a New Drug Application
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`that has been approved by the FDA.
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`12.
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`United States Patent No. 6,468,967 (''the '967 patent"), entitled "Methods for
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`Administration of Antibiotics" (Exhibit A hereto), was duly and legally issued on October 22,
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`2002. The '967 patent, which is owned by Cubist, will expire on September 24,2019.
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`13.
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`United States Patent No. 6,852,689 ("the '689 patent"), entitled .. Methods for
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`Administration of Antibiotics" (Exhibit B hereto), was duly and legally issued on February 8,
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`2005. The '689 patent, which is owned by Cubist, will expire on September 24, 2019.
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`14.
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`United States Patent No. 8,058,238 ("the '238 patent"), entitled "High Purity
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`Lipopeptides" (Exhibit C hereto), was duly and legally issued on November 15, 2011. The '238
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`patent, which is owned by Cubist, will expire on November 28, 2020.
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`15.
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`United States Patent No. 8,129,342 ("the '342 patenf'), entitled "High Purity
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`Lipopeptides" (Exhibit D hereto), was duly and legally issued on March 6, 2012. The '342
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`patent, which is owned by Cubist, will expire Oil November 28, 2020.
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`16.
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`CUBICJN®, or its use, is covered by one or more claims of the '967, '689, '238,
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`and '342 patents, which have been listed in connection with CUBICIN® in the FDA's
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`publication, Approved Drug Products with Therapeutic Equivalence Evaluations, referred to as
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`the "Orange Book."
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`17.
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`By letter dated August 26, 2013 (the "Notice Letter"), Defendants notified Cubist
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`that they had submitted to the FDA ANDA No. 205037 for Daptomycin for Injection,
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`500mglvial, a generic version of CUBICIN® ("Strides's ANDA Product").
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`18.
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`In the Notice Letter, Defendants stated that their ANDA included certifications
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`pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) with respect to the '967, '689, '238, and '342
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`patents and alleged that the '967, '689, '238, and '342 patents are invalid, unenforceable, ar1d/or
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`will not be infringed by the commercial mar1ufacture, use, offer for sale, or sale of Strides's
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`ANDA Product.
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`19.
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`This action is being commenced before the expiration of forty-five days from the
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`date of the receipt of the Notice Letter.
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`COUNT I
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`INFRINGEMENT OF U.S. PATENT NO. 6.468,967
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`20.
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`Plaintiff incorporates each of the proceeding paragraphs 1 - 19 as if fully set forth
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`herein.
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`patent.
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`21.
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`The use of Strides's ANDA Product is covered by one or more claims of the '967
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`22.
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`Defendants had knowledge of the '967 patent when they submitted their ANDA
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`to the FDA.
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`23.
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`Defendants' submission of ANDA No. 205037 for the purpose of obtaining
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`approval to engage in the commercial manufacture, use, offer for sale, and/ or sale of Strides's
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`ANDA Product before the expiration of the· '967 patent is an act of infringement of the '967
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`patent.
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`24.
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`The commercial manufacture, use, offer for sale, sale and/or importation of
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`Strides's ANDA Product would infringe one or more claims of the '967 patent.
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`25. Upon information and belief, use of Strides's ANDA Product in accordance with
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`and as directed by Defendants' proposed labeling for that product would infringe one or more
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`claims of the '967 patent.
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`26.
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`Upon information and belief, Defendants intend to engage irt the manufacture,
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`use, offer for sale, sale, and/or importation of Strides's ANDA Product with its proposed labeling
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`immediately and imminently upon approval of ANDA No. 205037.
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`27.
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`Upon information and belief, Defendants will actively induce infringement of the
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`'967 patent when their ANDA is approved, and plan and intend to, and will do so, immediately
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`and imminently upon approval.
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`28.
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`Upon information and belief, Defendants know that Strides's ANDA Product and
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`its proposed labeling are especially made or adapted for use irt infringing the '967 patent, and
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`that Strides's ANDA Product and its proposed labeling are not suitable for substantial
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`noninfringing use. Upon information and belief, Defendants plan and intend to, and will,
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`contribute to the infringement of the '967 patent immediately and imminently upon approval of
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`ANDA No. 205037.
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`29.
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`The foregoing actions by Defendants constitute and/or would constitute
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`infringement of the '967 patent, active inducement of infringement of the '967 patent, and/or
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`contribution to the infringement by others of the '967 patent.
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`30.
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`Upon information and belief, Defendants acted without a reasonable basis for
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`believing that they would not be liable for infringing the '967 patent, actively inducing
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`infringement ofthe '967 patent, and/or contributing to the infringement by others of the '967
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`patent.
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`31.
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`Unless Defendants are enjoined from infringing the '967 patent, actively inducing
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`infringement of the '967 patent, and/or contributing to the infringement by others of the '967
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`patent, Cubist will suffer irreparable injury; Cubist has no adequate remedy at law.
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`COUNT II
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`INFRINGEMENT OF U.S. PATENT NO. 6,852,689
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`32.
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`Plaintiff incorporates each of the proceeding paragraphs 1 - 31 as if fully set forth
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`herein.
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`patent.
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`33.
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`The use ofStrides;s ANDA Product is covered by one or more claims of the '689
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`34.
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`Defendants had knowledge of the '689 patent when they submitted their ANDA
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`to the FDA.
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`35.
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`Defendants' submission of ANDA No. 205037 for the purpose of obtaining
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`approval to engage in the commercial manufacture, use, offer for sale, and/or sale of Strides's
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`ANDA Product before the expiration of the '689 patent is an act of infringement of the '689
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`patent.
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`36.
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`The commercial manufacture, use, offer for sale, sale and/or importation of
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`Strides's ANDA Product would infringe one or more claims of the '689 patent.
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`37.
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`Upon information and belief, use of Strides's ANDA Product in accordance with
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`and as directed by Defendants' proposed labeling for that product would infringe one or more
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`claims of the '689 patent.
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`38.
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`Upon information and belief, Defendants intend to engage in the manufacture,
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`use, offer for sale, sale, and/or importation of Strides's ANDA Product with its proposed labeling
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`immediately and imminently upon approval of ANDA No. 205037.
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`39.
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`Upon information and belief, Defendants will actively induce infringement of the
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`'689 patent when their ANDA is approved, and plan and intend to, and will do so, immediately
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`and imminently upon approval.
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`40.
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`Upon information and belief, Defendants know that Strides's ANDA Product and
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`its proposed labeling are especially made or adapted for use in infringing the '689 patent, and
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`that Strides's ANDA Product and its proposed labeling are not suitable for substantial
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`noninfringing use. Upon information and belief, Defendants plan and intend to, and will,
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`contribute to the infringement of the '689 patent inunediately and imminently upon approval of
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`ANDA No. 205037.
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`41.
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`The foregoing actions by Defendants constitute and/or would constitute
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`infringement of the '689 patent, active inducement of infringement of the '689 patent, and/or
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`contribution to the infringement by others of the '689 patent.
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`42.
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`Upon information and belief, Defendants acted without a reasonable basis for
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`believing that they would not be liable for infringing the '689 patent, actively inducing
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`infringement of the '689 patent, and/or contributing to the infringement by others of the '689
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`patent.
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`43.
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`Unless Defendants are enjoined from infringing the '689 patent, actively inducing
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`infringement of the '689 patent, and/or contributing to the infringement by others of the '689
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`patent, Cubist will suffer irreparable injury. Cubist has no adequate remedy at law.
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`COUNT III
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`INFRINGEMENT OF U.S. PATENT NO. 8,058,238
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`44.
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`Plaintiff incorporates each of the proceeding paragraphs 1 - 43 as if fully set forth
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`herein.
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`45.
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`46.
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`Strides's ANDA Product is covered by one or more claims of the '238 patent.
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`Defendants' submission of ANDA No. 205037 for the purpose of the obtaining
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`approval to engage in the commercial manufacture, use, offer for sale, and/or sale of Strides's
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`ANDA Product before the expiration of the '238 patent is an act of infringement of the '238
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`patent.
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`47.
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`The commercial manufacture, use, offer for sale, sale and/or importation of
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`Strides's ANDA Product would infringe one or more claims of the '238 patent.
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`48.
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`Upon information and belief, Defendants intend to engage in the manufacture,
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`use, offer for sale, sale, and/or importation of Strides's ANDA Product immediately and
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`imminently upon approval of ANDA No. 205037.
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`49.
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`The foregoing actions by Defendants constitute and/or would constitute
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`infringement of the '23 8 patent.
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`50.
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`Unless Defendants are enjoined from infringing the '238 patent, Cubist will suffer
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`irreparable injury. Cubist has no adequate remedy at law.
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`COUNT IV
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`INFRINGEMENT OF U.S. PATENT NO. 8,129,342
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`51.
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`Plaintiff incorporates each of the proceeding paragraphs 1-50 as if fully set forth
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`herein.
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`52.
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`53.
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`Strides's ANDA Product is covered by one or more claims of the '342 patent.
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`Defendants' submission of ANDA No. 205037 for the purpose ofthe obtaining
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`approval to engage in the commercial manufacture, use, offer for sale, and/or sale of Strides's
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`ANDA Product before the expiration of the '342 patent is an act of infringement of the '342
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`patent.
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`54.
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`The commercial manufacture, use, offer for sale, sale and/or importation of
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`Strides's ANDA Product would infringe one or more claims of the '342 patent.
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`55. Upon information and belief, Defendants intend to engage in the manufacture,
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`use, offer for sale, sale, and/or importation of Strides's ANDA Product immediately and
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`imminently upon approval of ANDA No. 205037.
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`56.
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`The foregoing actions by Defendants constitute and/or would constitute
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`infringement of the '342 patent.
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`57.
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`Unless Defendants are enjoined from infringing the '342 patent, Cubist will suffer
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`irreparable injury. Cubist has no adequate remedy at law.
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`PRAYER FOR RELIEF
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`WHEREFORE, Plaintiff prays that this Court grant the following relief:
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`(a)
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`A judgment that Defendants' submission of ANDA No. 205037 was an act of
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`infringement of the '967, '689, '238, and '342 patents, artd that Defendants' manufacture, use,
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`offer to sell, sale, or importation of Strides's ANDA Product prior to the expiration of the '967,
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`'689, '238, and '342 patents, will infringe, actively induce infringement, and/or contribute to the
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`infringement of the '967, '689, '238, and '342 patents;
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`(b) An Order pursuant to 35 U.S.C. § 27l(e)(4)(A) providing that the effective date of
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`any FDA approval of Strides's ANDA No. 205037, or any product or compound that infringes
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`the '967, '689, '238, and '342 patents, shall not be earlier than the expiration of the '967, '689,
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`'238 and '342 patents;
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`(c)
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`An Order permanently enjoining Defendants, and their affiliates and subsidiaries,
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`and each of their officers, agents, servants and employees, from making, using, offering to sell,
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`selling, marketing, distributing, or importing Strides's ANDA Product, or any product or
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`compound that infringes the '967, '689, '238, and '342 patents, or inducing or contributing to the
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`infringement of the '967, '689, '238, and '342 patents until after the expiration of the '967, '689,
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`'238, and '342 patents;
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`(d)
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`A declaration that this is an exceptional case and an award of attorneys' fees to
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`plaintiff pursuant to 35 U.S.C. § 285;
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`(e)
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`(f)
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`Plaintiff's reasonable costs of suit incurred; and
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`Such further and other relief as this Court deems proper and just.
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`MORRIS. NICHOLS, ARSHT & TUNNELL LLP
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`~~{L-~
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`~B. Blumenfeld(#1014)
`Maryellen Noreika (#3208)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`mfioreika@mnat.com
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`Attorneys for Plaintiff
`Cubist Pharmaceuticals, Inc.
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`OF COUNSEL
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`William F. Lee
`Lisa J. Pirozzolo
`Emily Whelan
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`60 State Street
`Boston, MA 021 09
`(617) 526-6000
`
`October 9, 2013
`7637761.1
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`US 8,058,238 B2
`
`7
`known in the art. See, e.g., U.S. Pat. No. 5,202,309 and
`International PCT Application WO 00/08197. In another pre(cid:173)
`ferred embodiment, the lipopeptide is a daptomycin-related
`molecule, including, inter alia, daptomycin, A54145, a dap(cid:173)
`tomycin-related lipopeptide disclosed in U.S. Pat. Nos. 5
`4,537,717, 4,482,487, Re. 32,311, Re. 32,310, U.S. Pat. No.
`5,912,226, currently in reissue as U.S. Ser. No. 09/547,357,
`U.S. Provisional Applications Nos. 60/170,943, 60/170,946
`or 60/170,945, filed Dec. 15, 1999, U.S. Provisional Appli(cid:173)
`cation No. 60/208,222, filed May 30, 2000, all of which are 10
`specifically incorporated herein by reference, or anA-21978
`antibiotic in which the n-decanoyl fatty acid side chain of
`daptomycin is replaced by an n-octanoyl, n-nonanoyl, n-un(cid:173)
`decanoyl, n-dodecanoyl, n-tridecanoyl or n-tetradecanoyl 15
`fatty acid side chain. The daptomycin-related lipopeptides
`disclosed in 60/170,943, 60/170,946, 60/170,945, and
`60/208,222 relate to synthetic and semisynthetic lipopeptides
`in which the ornithine or kynurine residues or the fatty acid
`side chain of daptomycin are modified. In a more preferred 20
`embodiment, the lipopeptide is daptomycin. The term dapto(cid:173)
`mycin-related lipopeptide refers to compounds described
`above, and salts thereof.
`The term "daptomycin" refers to the n-decanoyl derivative
`of the factor A-21978C0 type antibiotic, or a pharmaceutical 25
`acceptable salt thereof. "Daptomycin" is synonymous with
`LY146032. See FIG. 1.
`The term "anhydro-daptomycin" refers to the daptomycin
`derivative in which the a-aspartyl group of daptomycin is
`transpeptidated to an anhydro-succinimido group. See FIG.
`3.
`
`The term "~-isomer" or "~-isomer of daptomycin" refers
`to the daptomycin derivative that contains a ~-aspartyl group
`instead of an a-aspartyl group. See FIG. 2.
`Daptomycin or a daptomycin-related lipopeptide is "sub(cid:173)
`stantially pure" when at least 95% of a sample is daptomycin
`or daptomycin-related lipopeptide. Preferably, daptomycin
`or daptomycin-related lipopeptide is "substantially pure"
`when at least 97% of a sample is daptomycin or daptomycin(cid:173)
`related lipopeptide.
`Daptomycin or daptomycin-related lipopeptide is "essen(cid:173)
`tially pure" when at least 98% of a sample is daptomycin or
`daptomycin-related lipopeptide. Preferably, daptomycin or
`daptomycin-related lipopeptide is "essentially pure" when at
`least 99% of a sample is daptomycin or daptomycin-related 45
`lipopeptide.
`Daptomycin or daptomycin-related lipopeptide is "sub(cid:173)
`stantially free" of another compound when the other com(cid:173)
`pound is present in an amount that is no more than 1% of the
`amount of the daptomycin or daptomycin-related lipopeptide 50
`preparation.
`Daptomycin or daptomycin-related lipopeptide is "essen(cid:173)
`tially free" of another compound when the other compound is
`present in an amount that is no more than 0.5% of the amount
`of the daptomycin or daptomycin-related lipopeptide prepa- 55
`ration.
`Daptomycin or daptomycin-related lipopeptide is "free" of
`another compound when the other compound is present in an
`amount that is no more than 0.1% of the amount of the
`daptomycin or daptomycin-related lipopeptide preparation.
`Alternatively, daptomycin or daptomycin-related lipopeptide
`is "free" of another compound when the compound caunot be
`detected by HPLC under conditions of maximum sensitivity
`in which a limit of detection is approximately 0.05% or less of
`the amount of the daptomycin or daptomycin-related lipopep(cid:173)
`tide preparation. Exemplary HPLC methods are described
`herein (Tables 1 and 2).
`
`8
`"Purified" daptomycin or daptomycin-related lipopeptide
`refers to substantially pure daptomycin or daptomycin-re(cid:173)
`lated lipopeptide, essentially pure daptomycin or daptomy(cid:173)
`cin-related lipopeptide, or a salt thereof, or to daptomycin,
`daptomycin-related lipopeptide, or a salt thereof which is
`substantially free, essentially free, or free of another com-
`pound.
`"Partially purified" daptomycin or daptomycin-related
`lipopeptide
`refers
`to daptomycin, daptomycin-related
`lipopeptide, or a salt thereof that is less than 90% pure.
`The purity of daptomycin, daptomycin-related lipopeptide
`or of another lipopeptide refers to the lipopeptide prior to its
`formulation in a pharmaceutical composition. The purity may
`be measured by any means including nuclear magnetic reso(cid:173)
`nance (NMR), gas chromatography/mass spectroscopy (GC/
`MS), liquid chromatography/mass spectroscopy (LC/MS) or
`microbiological assays. A preferred means for measuring the
`purity of daptomycin is by analytical high pressure liquid
`chromatography (HPLC).
`The term "micelle" refers to aggregates of amphipathic
`molecules. In an aqueous media, the lipophilic domains of the
`molecules of the aggregate are oriented toward the interior of
`the micelle and the hydrophilic domains are in contact with
`the medium. Micelle structures include, but are not limited to,
`spherical, laminar, cylindrical, ellipsoidal, vesicular (liposo(cid:173)
`mal), lamellar and liquid crystal. See FIG. 14.
`The term "mixed micelle" refers to a particular type of
`micelle in which the micelle contains more than a single type
`of amphipathic molecule. In the context of this invention,
`30 mixed micelles contain a lipopeptide and at least one other
`amphipathic molecule which may be another lipopeptide.
`Mixed micelles contain at least 10% of the lipopeptide by
`weight. In other embodiments, a mixed micelle contains at
`least 20%, 30%, 40%, 50%, 60%, 70%, 80% or 90% of the
`35 lipopeptide.
`The term "micellar solution" refers to a solution in which
`more than 50% of the lipopeptide molecules in the solution
`are present in micelles, as measured by weight. Preferably, at
`least 60%, 70%, 80%, 90% or 95% of the molecules are
`40 present in micelles. A micellar solution is retained on a ultra(cid:173)
`filtration membrane that has a 1 0, 000 dalton nominal molecu(cid:173)
`lar weight (NMW) cutoff.
`The term "critical micelle concentration" (erne) refers to
`the particular concentration of molecules, which is dependent
`upon temperature, salt concentration and the nature and type
`of amphipathic molecule. Above the erne, the unassociated
`monomers and micelles exist in equilibrium.
`The term "monomer" refers to an amphipathic molecule
`that is not part of an aggregate but that exists as a single
`molecule. In the context of this invention, the term monomer
`refers to a non-associated lipopeptide.
`The term "monomeric solution" refers to a solution in
`which more than 50% of the lipopeptide molecules are
`present as monomers as measured by weight. Preferably at
`least 60%, 70%, 80%, 90% or 95% are present as monomers.
`A monomeric solution is not retained on a ultrafiltration
`membrane that has a 10,000 dalton NMW cutoff but rather
`passes through the membrane.
`The term "low ionic strength buffer" refers to a solution
`60 that has a salt concentration below 50 mM; the term "medium
`ionic strength buffer" refers to a solution that has a salt con(cid:173)
`centration between 50-250 mM; the term "high ionic strength
`buffer" refers to a solution that has a salt concentration greater
`than250mM.
`65 Methods for Manufacturing Purified Lipopeptides
`One embodiment of the present invention is drawn to a
`process chromatography method that produces a purified
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