Case 1:16-cv-00072-GMS Document 1 Filed 02/10/16 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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`C.A. No.
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`)))))))))
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`
`COMPLAINT
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`CUBIST PHARMACEUTICALS LLC,
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`
`
`
`
`Plaintiff,
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`
`
`v.
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`CRANE PHARMACEUTICALS LLC,
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`
`
`
`
`Defendant.
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`
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`Plaintiff Cubist Pharmaceuticals LLC, by its attorneys, alleges as follows:
`
`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
`
`States, Title 35, United States Code, that arises out of the filing by Crane Pharmaceuticals LLC
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`(“Crane” or “Defendant”) of Abbreviated New Drug Application (“ANDA”) No. 206005 with
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`the U.S. Food and Drug Administration (“FDA”) seeking approval to manufacture and sell a
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`generic version of CUBICIN® prior to the expiration of U.S. Patent Nos. 6,468,967; 6,852,689;
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`8,058,238; and 8,129,342.
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`PARTIES
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`2.
`
`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.
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`3.
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`Upon information and belief, defendant Crane is a company organized and
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`existing under the laws of the State of Delaware.
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`4.
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`Upon information and belief, following any FDA approval of ANDA No.
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`206005, defendant Crane will make, use, offer to sell, and/or sell the generic products that are the
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`
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`
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`
`
`C.A. No.
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`
`
`
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`
`
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`)))))))))
`
`
`COMPLAINT
`
`CUBIST PHARMACEUTICALS LLC,
`
`
`
`
`
`Plaintiff,
`
`
`
`v.
`
`
`
`
`
`
`CRANE PHARMACEUTICALS LLC,
`
`
`
`
`
`Defendant.
`
`
`
`Plaintiff Cubist Pharmaceuticals LLC, by its attorneys, alleges as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action for patent infringement under the patent laws of the United
`
`States, Title 35, United States Code, that arises out of the filing by Crane Pharmaceuticals LLC
`
`(“Crane” or “Defendant”) of Abbreviated New Drug Application (“ANDA”) No. 206005 with
`
`the U.S. Food and Drug Administration (“FDA”) seeking approval to manufacture and sell a
`
`generic version of CUBICIN® prior to the expiration of U.S. Patent Nos. 6,468,967; 6,852,689;
`
`8,058,238; and 8,129,342.
`
`PARTIES
`
`2.
`
`Plaintiff Cubist Pharmaceuticals LLC (“Cubist” or “Plaintiff”) is a company
`
`organized and existing under the laws of the State of Delaware.
`
`3.
`
`Upon information and belief, defendant Crane is a company organized and
`
`existing under the laws of the State of Delaware.
`
`4.
`
`Upon information and belief, following any FDA approval of ANDA No.
`
`206005, defendant Crane will make, use, offer to sell, and/or sell the generic products that are the
`
`
`
`
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`Case 1:16-cv-00072-GMS Document 1 Filed 02/10/16 Page 2 of 11 PageID #: 2
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`subject of ANDA No. 206005 throughout the United States, including in the State of Delaware,
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`and/or import such generic products into the United States.
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`JURISDICTION AND VENUE
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`5.
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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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`6.
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`7.
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`Venue is proper in this district pursuant to 28 U.S.C. §§ 1391 and 1400(b).
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`Crane is subject to personal jurisdiction in Delaware because it is a Delaware
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`company and has continuous and systematic contacts with the State of Delaware. Moreover,
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`Crane has committed, or aided, abetted, contributed to and/or participated in the commission of,
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`a tortious act of patent infringement that has led to foreseeable harm and injury to Cubist, a
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`Delaware corporation, which sells CUBICIN® throughout the United States, including the State
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`of Delaware.
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`BACKGROUND
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`8.
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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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`9.
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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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`2
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`
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`Case 1:16-cv-00072-GMS Document 1 Filed 02/10/16 Page 3 of 11 PageID #: 3
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`10.
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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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`11.
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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.
`
`12.
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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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`13.
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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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`14.
`
`CUBICIN®, or its use, is covered by one or more claims of the ’967, ’689, ’238,
`
`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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`15.
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`By letter dated December 29, 2015 (the “Notice Letter”), Defendant notified
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`Cubist that it had submitted to the FDA ANDA No. 206005 for daptomycin injectable, IV
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`(infusion), 500 mg/vial, a generic version of CUBICIN® (“Crane’s ANDA Product”).
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`16.
`
`In the Notice Letter, Defendant stated that its 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, and/or
`
`3
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`Case 1:16-cv-00072-GMS Document 1 Filed 02/10/16 Page 4 of 11 PageID #: 4
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`will not be infringed by the commercial manufacture, use, offer for sale, or sale of Crane’s
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`ANDA Product.
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`17.
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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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`18.
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`On November 12, 2015, the United States Court of Appeals for the Federal
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`Circuit (the “Federal Circuit”) issued an opinion in Cubist Pharmaceuticals, Inc. v. Hospira,
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`Inc., Nos. 2015-1197, 2015-1204, and 2015-1259, affirming the District Court’s decision. On
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`December 14, 2015, Cubist filed a combined petition for panel rehearing and rehearing en banc
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`in the Federal Circuit, in which it requested reconsideration of certain issues in the appeal. On
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`January 22, 2016, the Federal Circuit denied Cubist’s petition for rehearing, and on January 29,
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`2016, the Federal Circuit issued a mandate in this appeal.
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`19.
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`Because Cubist believes the judgment of invalidity is incorrect, Cubist intends to
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`petition the Supreme Court of the United States for a writ of certiorari to review the judgment of
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`the Federal Circuit in this case.
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`20.
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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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`21.
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`Plaintiff incorporates each of the preceding paragraphs 1 – 20 as if fully set forth
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`herein.
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`patent.
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`22.
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`The use of Crane’s ANDA Product is covered by one or more claims of the ’967
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`4
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`Case 1:16-cv-00072-GMS Document 1 Filed 02/10/16 Page 5 of 11 PageID #: 5
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`23.
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`Defendant had knowledge of the ’967 patent when it submitted its ANDA to the
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`FDA.
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`24.
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`Defendant’s submission of ANDA No. 206005 for the purpose of obtaining
`
`approval to engage in the commercial manufacture, use, offer for sale, and/or sale of Crane’s
`
`ANDA Product before the expiration of the ’967 patent was an act of infringement of the ’967
`
`patent.
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`25.
`
`The commercial manufacture, use, offer for sale, sale and/or importation of
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`Crane’s ANDA Product would infringe one or more claims of the ’967 patent.
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`26.
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`Upon information and belief, use of Crane’s ANDA Product in accordance with
`
`and as directed by Defendant’s proposed labeling for that product would infringe one or more
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`claims of the ’967 patent.
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`27.
`
`Upon information and belief, Defendant intends to engage in the manufacture,
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`use, offer for sale, sale, and/or importation of Crane’s ANDA Product with its proposed labeling
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`immediately and imminently upon approval of ANDA No. 206005.
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`28.
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`Upon information and belief, Defendant will actively induce infringement of the
`
`’967 patent when its ANDA is approved, and plan and intends to, and will do so, immediately
`
`and imminently upon approval.
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`29.
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`Upon information and belief, Defendant knows that Crane’s ANDA Product and
`
`its proposed labeling are especially made or adapted for use in infringing the ’967 patent, and
`
`that Crane’s ANDA Product and its proposed labeling are not suitable for substantial
`
`noninfringing use. Upon information and belief, Defendant plans and intends 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. 206005.
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`5
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`Case 1:16-cv-00072-GMS Document 1 Filed 02/10/16 Page 6 of 11 PageID #: 6
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`30.
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`The foregoing actions by Defendant 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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`31.
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`Upon information and belief, Defendant acted without a reasonable basis for
`
`believing that it would not be liable for infringing the ’967 patent, actively inducing infringement
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`of the ’967 patent, and/or contributing to the infringement by others of the ’967 patent.
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`32.
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`Unless Defendant is enjoined from infringing the ’967 patent, actively inducing
`
`infringement of the ’967 patent, and/or contributing to the infringement by others of the ’967
`
`patent, Cubist will suffer irreparable injury. Cubist has no adequate remedy at law.
`
`COUNT II
`Infringement of U.S. Patent No. 6,852,689
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`33.
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`Plaintiff incorporates each of the preceding paragraphs 1 – 32 as if fully set forth
`
`herein.
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`patent.
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`FDA.
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`34.
`
`The use of Crane’s ANDA Product is covered by one or more claims of the ’689
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`35.
`
`Defendant had knowledge of the ’689 patent when it submitted its ANDA to the
`
`36.
`
`Defendant’s submission of ANDA No. 206005 for the purpose of obtaining
`
`approval to engage in the commercial manufacture, use, offer for sale, and/or sale of Crane’s
`
`ANDA Product before the expiration of the ’689 patent was an act of infringement of the ’689
`
`patent.
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`37.
`
`The commercial manufacture, use, offer for sale, sale and/or importation of
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`Crane’s ANDA Product would infringe one or more claims of the ’689 patent.
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`6
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`Case 1:16-cv-00072-GMS Document 1 Filed 02/10/16 Page 7 of 11 PageID #: 7
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`38.
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`Upon information and belief, use of Crane’s ANDA Product in accordance with
`
`and as directed by Defendant’s proposed labeling for that product would infringe one or more
`
`claims of the ’689 patent.
`
`39.
`
`Upon information and belief, Defendant intends to engage in the manufacture,
`
`use, offer for sale, sale, and/or importation of Crane’s ANDA Product with its proposed labeling
`
`immediately and imminently upon approval of ANDA No. 206005.
`
`40.
`
`Upon information and belief, Defendant will actively induce infringement of the
`
`’689 patent when its ANDA is approved, and plans and intends to, and will do so, immediately
`
`and imminently upon approval.
`
`41.
`
`Upon information and belief, Defendant knows that Crane’s ANDA Product and
`
`its proposed labeling are especially made or adapted for use in infringing the ’689 patent, and
`
`that Crane’s ANDA Product and its proposed labeling are not suitable for substantial
`
`noninfringing use. Upon information and belief, Defendant plans and intends to, and will,
`
`contribute to the infringement of the ’689 patent immediately and imminently upon approval of
`
`ANDA No. 206005.
`
`42.
`
`The foregoing actions by Defendant constitute and/or would constitute
`
`infringement of the ’689 patent, active inducement of infringement of the ’689 patent, and/or
`
`contribution to the infringement by others of the ’689 patent.
`
`43.
`
`Upon information and belief, Defendant acted without a reasonable basis for
`
`believing that it would not be liable for infringing the ’689 patent, actively inducing infringement
`
`of the ’689 patent, and/or contributing to the infringement by others of the ’689 patent.
`
`7
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`Case 1:16-cv-00072-GMS Document 1 Filed 02/10/16 Page 8 of 11 PageID #: 8
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`44.
`
`Unless Defendant is enjoined from infringing the ’689 patent, actively inducing
`
`infringement of the ’689 patent, and/or contributing to the infringement by others of the ’689
`
`patent, Cubist will suffer irreparable injury. Cubist has no adequate remedy at law.
`
`COUNT III
`Infringement of U.S. Patent No. 8,058,238
`
`45.
`
`Plaintiff incorporates each of the preceding paragraphs 1 – 44 as if fully set forth
`
`herein.
`
`46.
`
`47.
`
`Crane’s ANDA Product is covered by one or more claims of the ’238 patent.
`
`Defendant’s submission of ANDA No. 206005 for the purpose of the obtaining
`
`approval to engage in the commercial manufacture, use, offer for sale, and/or sale of Crane’s
`
`ANDA Product before the expiration of the ’238 patent was an act of infringement of the ’238
`
`patent.
`
`48.
`
`The commercial manufacture, use, offer for sale, sale and/or importation of
`
`Crane’s ANDA Product would infringe one or more claims of the ’238 patent.
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`49.
`
`Upon information and belief, Defendant intends to engage in the manufacture,
`
`use, offer for sale, sale, and/or importation of Crane’s ANDA Product immediately and
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`imminently upon approval of ANDA No. 206005.
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`50.
`
`The foregoing actions by Defendant constitute and/or would constitute
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`infringement of the ’238 patent.
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`51.
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`Unless Defendant is enjoined from infringing the ’238 patent, Cubist will suffer
`
`irreparable injury. Cubist has no adequate remedy at law.
`
`8
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`Case 1:16-cv-00072-GMS Document 1 Filed 02/10/16 Page 9 of 11 PageID #: 9
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`COUNT IV
`Infringement of U.S. Patent No. 8,129,342
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`52.
`
`Plaintiff incorporates each of the preceding paragraphs 1 – 51 as if fully set forth
`
`herein.
`
`53.
`
`54.
`
`Crane’s ANDA Product is covered by one or more claims of the ’342 patent.
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`Defendant’s submission of ANDA No. 206005 for the purpose of the obtaining
`
`approval to engage in the commercial manufacture, use, offer for sale, and/or sale of Crane’s
`
`ANDA Product before the expiration of the ’342 patent was an act of infringement of the ’342
`
`patent.
`
`55.
`
`The commercial manufacture, use, offer for sale, sale and/or importation of
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`Crane’s ANDA Product would infringe one or more claims of the ’342 patent.
`
`56.
`
`Upon information and belief, Defendant intends to engage in the manufacture,
`
`use, offer for sale, sale, and/or importation of Crane’s ANDA Product immediately and
`
`imminently upon approval of ANDA No. 206005.
`
`57.
`
`The foregoing actions by Defendant constitute and/or would constitute
`
`infringement of the ’342 patent.
`
`58.
`
`Unless Defendant are enjoined from infringing the ’342 patent, Cubist will suffer
`
`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:
`
`(a)
`
`A judgment that Defendant’s submission of ANDA No. 206005 was an act of
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`infringement of the ’967, ’689, ’238, and ’342 patents, and that Defendant’s manufacture, use,
`
`offer to sell, sale, or importation of Crane’s ANDA Product prior to the expiration of the ’967,
`
`9
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`
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`Case 1:16-cv-00072-GMS Document 1 Filed 02/10/16 Page 10 of 11 PageID #: 10
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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. § 271(e)(4)(A) providing that the effective date of
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`any FDA approval of Crane’s ANDA No. 206005, 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
`
`and ’342 patents;
`
`(c)
`
`An Order permanently enjoining Defendant, and its affiliates and subsidiaries, and
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`each of its officers, agents, servants and employees, from making, using, offering to sell, selling,
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`marketing, distributing, or importing Crane’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
`
`of the ’967, ’689, ’238, and ’342 patents until after the expiration of the ’967, ’689, ’238, and
`
`’342 patents;
`
`(d)
`
`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;
`
`(e)
`
`(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.
`
`10
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`
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`Case 1:16-cv-00072-GMS Document 1 Filed 02/10/16 Page 11 of 11 PageID #: 11
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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
`
`February 10, 2016
`
`11
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`
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