`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`CUBIST PHARMACEUTICALS LLC,
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`
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`Plaintiff,
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`v.
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`
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`DR. REDDY’S LABORATORIES, LTD. and
`DR. REDDY’S LABORATORIES, INC.,
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`
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`C.A. No.
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`
`
`
`
`))))))))))
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`
`COMPLAINT
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`
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`
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`Defendants.
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`
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`Plaintiff Cubist Pharmaceuticals LLC, 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 Dr. Reddy’s Laboratories,
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`Ltd. (“DRL Ltd.”) and Dr. Reddy’s Laboratories, Inc. (“DRL Inc.”) (collectively, “DRL” or
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`“Defendants”) of Abbreviated New Drug Application (“ANDA”) No. 208375 with the U.S. Food
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`and Drug 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 LLC (“Cubist” or “Plaintiff”) is a company
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`organized and existing under the laws of the State of Delaware, with its principal place of
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`business at 65 Hayden Avenue, Lexington, Massachusetts.
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`3.
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`Upon information and belief, Defendant DRL Ltd. is a corporation organized and
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`existing under the laws of India, with its principal place of business at 8-2-337, Road No. 3,
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`Banjara Hills, Hyderabad, Telangana 500 034, India. Upon information and belief, DRL Ltd.,
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`Case 1:16-cv-00030-UNA Document 1 Filed 01/21/16 Page 2 of 12 PageID #: 2
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`itself and through its subsidiaries and agents, including DRL Inc., manufactures, distributes
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`and/or imports generic drugs for sale and use throughout the United States, including in this
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`judicial district.
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`4.
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`Upon information and belief, Defendant DRL Inc. is a corporation organized and
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`existing under the laws of New Jersey, with its registered office at 107 College Road East,
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`Princeton, NJ 08540. Upon information and belief, DRL Inc. manufactures and/or distributes
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`generic drugs for sale and use throughout the United States and in this judicial district at the
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`direction, under the control, and for the direct benefit of DRL Ltd.
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`5.
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`Upon information and belief, DRL Ltd. and DRL Inc. acted collaboratively in the
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`preparation and submission of ANDA No. 208375. Upon information and belief, DRL’s
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`preparation and submission of ANDA No. 208375 was done at the direction, under the control,
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`and for the direct benefit of DRL Ltd.
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`6.
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`Upon information and belief, following any FDA approval of ANDA No.
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`208375, DRL Ltd., itself and through its subsidiaries and agents, including DRL Inc., will make,
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`use, offer to sell, and/or sell the generic products that are the subject of ANDA No. 208375
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`throughout the United States, including in the State of Delaware, and/or import such generic
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`products into the United States.
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`JURISDICTION AND VENUE
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`7.
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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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`8.
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`9.
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`Venue is proper in this district pursuant to 28 U.S.C. §§ 1391 and 1400(b).
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`The court has personal jurisdiction over each of the Defendants because, among
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`other things, they have each committed, or aided, abetted, contributed to and/or participated in
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`2
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`Case 1:16-cv-00030-UNA Document 1 Filed 01/21/16 Page 3 of 12 PageID #: 3
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`the commission of, a tortious act of patent infringement that has led to foreseeable harm and
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`injury to Cubist, a Delaware corporation, which sells CUBICIN® throughout the United States,
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`including the State of Delaware. This Court also has personal jurisdiction over the Defendants
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`by virtue of, among other things, their systematic and continuous contacts with Delaware as set
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`forth below, and for other reasons that will be presented to the Court if jurisdiction is challenged.
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`10.
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`Upon information and belief, DRL Ltd., itself and through its subsidiaries and
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`agents, including DRL Inc., currently manufactures and distributes for sale dozens of drug
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`products throughout the United States, including in this judicial district.
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`11.
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`Upon information and belief, DRL Ltd. directs the operations, management and
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`activities of DRL Inc. in the United States.
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`12.
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`Upon information and belief, DRL Ltd., directly or through DRL Inc., routinely
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`files ANDAs seeking FDA approval to market its drug products in the United States.
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`13.
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`Upon information and belief, DRL Ltd. and DRL Inc. collaborate in the
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`manufacture, marketing, and sale of many pharmaceutical products (including generic drug
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`products manufactured and sold pursuant to approved ANDAs) throughout the United States,
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`including in this judicial district.
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`14.
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`Upon information and belief, DRL Inc. sells generic drug products in the United
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`States, including in this judicial district, that are manufactured by DRL Ltd.
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`15.
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`DRL has taken advantage of the jurisdiction of this Court by affirmatively filing
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`counterclaims and requesting entry of judgment in other actions before this Court, including
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`Teva Pharmaceuticals USA, Inc. et al. v. Dr. Reddy’s Laboratories, Ltd., et al., No. 15-cv-306-
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`GMS (D. Del.); Cephalon, Inc. v. Dr. Reddy’s Laboratories, Ltd. et al., No. 15-cv-179 (GMS)
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`3
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`
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`Case 1:16-cv-00030-UNA Document 1 Filed 01/21/16 Page 4 of 12 PageID #: 4
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`(D. Del.); and Allos Therapeutics, Inc. et al. v. Teva Pharmaceuticals USA, Inc. et al., No. 14-
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`778-RGA (D. Del.).
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`16.
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`This Court has personal jurisdiction over DRL Inc. by virtue of, among other
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`things, its systematic and continuous contacts with Delaware.
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`17.
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`This Court has personal jurisdiction over DRL Ltd. by virtue of, among other
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`things, its systematic and continuous contacts with Delaware.
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`18.
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`In the alternative, this Court may exercise personal jurisdiction over DRL Ltd.
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`pursuant to Federal Rule of Civil Procedure 4(k)(2) because (a) Plaintiffs’ claims arise under
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`federal law; (b) DRL Ltd. is a foreign company not subject to personal jurisdiction in the courts
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`of any state; and (c) DRL Ltd. has sufficient contacts with the United States as a whole,
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`including but not limited to marketing and/or selling generic pharmaceutical products that are
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`distributed and sold throughout the United States, such that this Court’s exercise of jurisdiction
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`over DRL Ltd. satisfies due process.
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`BACKGROUND
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`19.
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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-
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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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`20.
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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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`4
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`Case 1:16-cv-00030-UNA Document 1 Filed 01/21/16 Page 5 of 12 PageID #: 5
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`21.
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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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`22.
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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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`23.
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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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`24.
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`United States Patent No. 8,129,342 (“the ’342 patent”), 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 on November 28, 2020.
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`25.
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`CUBICIN®, 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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`26.
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`By letter dated December 9, 2015 (the “Notice Letter”), DRL notified Cubist that
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`it had submitted to the FDA ANDA No. 208375 for daptomycin for injection, for intravenous
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`use, a generic version of CUBICIN® (“DRL’s ANDA Product”).
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`27.
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`In the Notice Letter, DRL stated that its ANDA included certifications pursuant to
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`21 U.S.C. § 355(j)(2)(A)(vii)(IV) with respect to the ’967, ’689, ’238, and ’342 patents and
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`alleged that the ’967, ’689, ’238, and ’342 patents are invalid, unenforceable, and/or will not be
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`infringed by the commercial manufacture, use, offer for sale, or sale of DRL’s ANDA Product.
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`5
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`Case 1:16-cv-00030-UNA Document 1 Filed 01/21/16 Page 6 of 12 PageID #: 6
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`28.
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`On December 8, 2014, the United States District Court for the District of
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`Delaware entered an order in Cubist Pharmaceuticals, Inc. v. Hospira, Inc., C.A. No. 12-367-
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`GMS (consolidated), which, in relevant part, held certain claims of the ’967, ’689, ’238, and
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`‘342 patents invalid.
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`29.
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`On November 12, 2015, the United States Court of Appeals for the Federal
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`Circuit issued an opinion in Cubist Pharmaceuticals, Inc. v. Hospira, Inc., Nos. 2015-1197,
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`2015-1204, and 2015-1259, affirming the District Court’s decision.
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`30.
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`Because Cubist believes the judgment of invalidity is incorrect, on December 14,
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`2015, Cubist filed a combined petition for panel rehearing and rehearing en banc in the United
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`States Court of Appeals for the Federal Circuit, in which it requested reconsideration of certain
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`issues in the appeal. No mandate in the appeal has issued.
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`31.
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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
`Infringement of U.S. Patent No. 6,468,967
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`32.
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`Plaintiff incorporates each of the preceding 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 of DRL’s ANDA Product is covered by one or more claims of the ’967
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`34.
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`35.
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`DRL had knowledge of the ’967 patent when it submitted its ANDA to the FDA.
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`DRL’s submission of ANDA No. 208375 for the purpose of obtaining approval to
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`engage in the commercial manufacture, use, offer for sale, and/or sale of DRL’s ANDA Product
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`before the expiration of the ’967 patent was an act of infringement of the ’967 patent.
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`6
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`Case 1:16-cv-00030-UNA Document 1 Filed 01/21/16 Page 7 of 12 PageID #: 7
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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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`DRL’s ANDA Product would infringe one or more claims of the ’967 patent.
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`37.
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`Upon information and belief, use of DRL’s ANDA Product in accordance with
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`and as directed by DRL’s proposed labeling for that product would infringe one or more claims
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`of the ’967 patent.
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`38.
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`Upon information and belief, DRL intends to engage in the manufacture, use,
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`offer for sale, sale, and/or importation of DRL’s ANDA Product with its proposed labeling
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`immediately and imminently upon approval of ANDA No. 208375.
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`39.
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`Upon information and belief, DRL will actively induce infringement of the ’967
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`patent when its ANDA is approved, and plan and intends to, and will do so, immediately and
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`imminently upon approval.
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`40.
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`Upon information and belief, DRL knows that DRL’s ANDA Product and its
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`proposed labeling are especially made or adapted for use in infringing the ’967 patent, and that
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`DRL’s ANDA Product and its proposed labeling are not suitable for substantial noninfringing
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`use. Upon information and belief, DRL plans and intends to, and will, contribute to the
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`infringement of the ’967 patent immediately and imminently upon approval of ANDA No.
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`208375.
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`41.
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`The foregoing actions by DRL constitute and/or would constitute infringement of
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`the ’967 patent, active inducement of infringement of the ’967 patent, and/or contribution to the
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`infringement by others of the ’967 patent.
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`42.
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`Upon information and belief, DRL acted without a reasonable basis for believing
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`that it would not be liable for infringing the ’967 patent, actively inducing infringement of the
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`’967 patent, and/or contributing to the infringement by others of the ’967 patent.
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`7
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`Case 1:16-cv-00030-UNA Document 1 Filed 01/21/16 Page 8 of 12 PageID #: 8
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`43.
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`Unless DRL is 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
`Infringement of U.S. Patent No. 6,852,689
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`44.
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`Plaintiff incorporates each of the preceding paragraphs 1 – 43 as if fully set forth
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`herein.
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`patent.
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`45.
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`The use of DRL’s ANDA Product is covered by one or more claims of the ’689
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`46.
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`47.
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`DRL had knowledge of the ’689 patent when it submitted its ANDA to the FDA.
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`DRL’s submission of ANDA No. 208375 for the purpose of obtaining approval to
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`engage in the commercial manufacture, use, offer for sale, and/or sale of DRL’s ANDA Product
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`before the expiration of the ’689 patent was an act of infringement of the ’689 patent.
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`48.
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`The commercial manufacture, use, offer for sale, sale and/or importation of
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`DRL’s ANDA Product would infringe one or more claims of the ’689 patent.
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`49.
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`Upon information and belief, use of DRL’s ANDA Product in accordance with
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`and as directed by DRL’s proposed labeling for that product would infringe one or more claims
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`of the ’689 patent.
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`50.
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`Upon information and belief, DRL intends to engage in the manufacture, use,
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`offer for sale, sale, and/or importation of DRL’s ANDA Product with its proposed labeling
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`immediately and imminently upon approval of ANDA No. 208375.
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`51.
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`Upon information and belief, DRL will actively induce infringement of the ’689
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`patent when its ANDA is approved, and plans and intends to, and will do so, immediately and
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`imminently upon approval.
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`8
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`Case 1:16-cv-00030-UNA Document 1 Filed 01/21/16 Page 9 of 12 PageID #: 9
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`52.
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`Upon information and belief, DRL knows that DRL’s ANDA Product and its
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`proposed labeling are especially made or adapted for use in infringing the ’689 patent, and that
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`DRL’s ANDA Product and its proposed labeling are not suitable for substantial noninfringing
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`use. Upon information and belief, DRL plans and intends to, and will, contribute to the
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`infringement of the ’689 patent immediately and imminently upon approval of ANDA No.
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`208375.
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`53.
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`The foregoing actions by DRL constitute and/or would constitute infringement of
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`the ’689 patent, active inducement of infringement of the ’689 patent, and/or contribution to the
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`infringement by others of the ’689 patent.
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`54.
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`Upon information and belief, DRL acted without a reasonable basis for believing
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`that it would not be liable for infringing the ’689 patent, actively inducing infringement of the
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`’689 patent, and/or contributing to the infringement by others of the ’689 patent.
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`55.
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`Unless DRL is 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.
`
`COUNT III
`Infringement of U.S. Patent No. 8,058,238
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`56.
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`Plaintiff incorporates each of the preceding paragraphs 1 – 55 as if fully set forth
`
`herein.
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`57.
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`58.
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`DRL’s ANDA Product is covered by one or more claims of the ’238 patent.
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`DRL’s submission of ANDA No. 208375 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 DRL’s
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`ANDA Product before the expiration of the ’238 patent was an act of infringement of the ’238
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`patent.
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`9
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`Case 1:16-cv-00030-UNA Document 1 Filed 01/21/16 Page 10 of 12 PageID #: 10
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`59.
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`The commercial manufacture, use, offer for sale, sale and/or importation of
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`DRL’s ANDA Product would infringe one or more claims of the ’238 patent.
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`60.
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`Upon information and belief, DRL intends to engage in the manufacture, use,
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`offer for sale, sale, and/or importation of DRL’s ANDA Product immediately and imminently
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`upon approval of ANDA No. 208375.
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`61.
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`The foregoing actions by DRL constitute and/or would constitute infringement of
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`the ’238 patent.
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`62.
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`Unless DRL is enjoined from infringing the ’238 patent, Cubist will suffer
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`irreparable injury. Cubist has no adequate remedy at law.
`
`COUNT IV
`Infringement of U.S. Patent No. 8,129,342
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`63.
`
`Plaintiff incorporates each of the preceding paragraphs 1 – 62 as if fully set forth
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`herein.
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`64.
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`65.
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`DRL’s ANDA Product is covered by one or more claims of the ’342 patent.
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`DRL’s submission of ANDA No. 208375 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 DRL’s
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`ANDA Product before the expiration of the ’342 patent was an act of infringement of the ’342
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`patent.
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`66.
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`The commercial manufacture, use, offer for sale, sale and/or importation of
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`DRL’s ANDA Product would infringe one or more claims of the ’342 patent.
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`67.
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`Upon information and belief, DRL intends to engage in the manufacture, use,
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`offer for sale, sale, and/or importation of DRL’s ANDA Product immediately and imminently
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`upon approval of ANDA No. 208375.
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`10
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`Case 1:16-cv-00030-UNA Document 1 Filed 01/21/16 Page 11 of 12 PageID #: 11
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`68.
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`The foregoing actions by DRL constitute and/or would constitute infringement of
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`the ’342 patent.
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`69.
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`Unless DRL is 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 DRL’s submission of ANDA No. 208375 was an act of
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`infringement of the ’967, ’689, ’238, and ’342 patents, and that DRL’s manufacture, use, offer to
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`sell, sale, or importation of DRL’s ANDA Product prior to the expiration of the ’967, ’689, ’238,
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`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)
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`An Order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective date of
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`any FDA approval of DRL’s ANDA No. 208375, or any product or compound that infringes the
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`’967, ’689, ’238, and ’342 patents, shall not be earlier than the expiration of the ’967, ’689, ’238
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`and ’342 patents;
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`(c)
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`An Order permanently enjoining DRL, and its affiliates and subsidiaries, and each
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`of its officers, agents, servants and employees, from making, using, offering to sell, selling,
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`marketing, distributing, or importing DRL’s ANDA Product, or any product or compound that
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`infringes the ’967, ’689, ’238, and ’342 patents, or inducing or contributing to the infringement
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`of the ’967, ’689, ’238, and ’342 patents until after the expiration of the ’967, ’689, ’238, and
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`’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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`Plaintiff’s reasonable costs of suit incurred; and
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`11
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`Case 1:16-cv-00030-UNA Document 1 Filed 01/21/16 Page 12 of 12 PageID #: 12
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`(f)
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`Such further and other relief as this Court deems proper and just.
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`
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`/s/ Jack B. Blumenfeld
`
`Jack B. Blumenfeld (#1014)
`Maryellen Noreika (#3208)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`mnoreika@mnat.com
`
`Attorneys for Plaintiff Cubist Pharmaceuticals
`LLC
`
`
`
`OF COUNSEL:
`
`William F. Lee
`Lisa J. Pirozzolo
`Emily Whelan
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`60 State Street
`Boston, MA 02109
`(617) 526-6000
`
`January 21, 2016
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`12