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Case 1:16-cv-00030-UNA Document 1 Filed 01/21/16 Page 1 of 12 PageID #: 1
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`CUBIST PHARMACEUTICALS LLC,
`
`
`
`
`
`Plaintiff,
`
`
`
`v.
`
`
`
`
`
`
`DR. REDDY’S LABORATORIES, LTD. and
`DR. REDDY’S LABORATORIES, INC.,
`
`
`
`C.A. No.
`
`
`
`
`
`
`
`
`
`))))))))))
`
`
`COMPLAINT
`
`
`
`
`
`Defendants.
`
`
`
`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 Dr. Reddy’s Laboratories,
`
`Ltd. (“DRL Ltd.”) and Dr. Reddy’s Laboratories, Inc. (“DRL Inc.”) (collectively, “DRL” or
`
`“Defendants”) of Abbreviated New Drug Application (“ANDA”) No. 208375 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, with its principal place of
`
`business at 65 Hayden Avenue, Lexington, Massachusetts.
`
`3.
`
`Upon information and belief, Defendant DRL Ltd. is a corporation organized and
`
`existing under the laws of India, with its principal place of business at 8-2-337, Road No. 3,
`
`Banjara Hills, Hyderabad, Telangana 500 034, India. Upon information and belief, DRL Ltd.,
`
`
`
`

`
`Case 1:16-cv-00030-UNA Document 1 Filed 01/21/16 Page 2 of 12 PageID #: 2
`
`itself and through its subsidiaries and agents, including DRL Inc., manufactures, distributes
`
`and/or imports generic drugs for sale and use throughout the United States, including in this
`
`judicial district.
`
`4.
`
`Upon information and belief, Defendant DRL Inc. is a corporation organized and
`
`existing under the laws of New Jersey, with its registered office at 107 College Road East,
`
`Princeton, NJ 08540. Upon information and belief, DRL Inc. manufactures and/or distributes
`
`generic drugs for sale and use throughout the United States and in this judicial district at the
`
`direction, under the control, and for the direct benefit of DRL Ltd.
`
`5.
`
`Upon information and belief, DRL Ltd. and DRL Inc. acted collaboratively in the
`
`preparation and submission of ANDA No. 208375. Upon information and belief, DRL’s
`
`preparation and submission of ANDA No. 208375 was done at the direction, under the control,
`
`and for the direct benefit of DRL Ltd.
`
`6.
`
`Upon information and belief, following any FDA approval of ANDA No.
`
`208375, DRL Ltd., itself and through its subsidiaries and agents, including DRL Inc., will make,
`
`use, offer to sell, and/or sell the generic products that are the subject of ANDA No. 208375
`
`throughout the United States, including in the State of Delaware, and/or import such generic
`
`products into the United States.
`
`JURISDICTION AND VENUE
`
`7.
`
`This action arises under the patent laws of the United States of America and this
`
`Court has jurisdiction over the subject matter of this action pursuant to 28 U.S.C. §§ 1331,
`
`1338(a), 2201, and 2202.
`
`8.
`
`9.
`
`Venue is proper in this district pursuant to 28 U.S.C. §§ 1391 and 1400(b).
`
`The court has personal jurisdiction over each of the Defendants because, among
`
`other things, they have each committed, or aided, abetted, contributed to and/or participated in
`
`2
`
`

`
`Case 1:16-cv-00030-UNA Document 1 Filed 01/21/16 Page 3 of 12 PageID #: 3
`
`the commission of, a tortious act of patent infringement that has led to foreseeable harm and
`
`injury to Cubist, a Delaware corporation, which sells CUBICIN® throughout the United States,
`
`including the State of Delaware. This Court also has personal jurisdiction over the Defendants
`
`by virtue of, among other things, their systematic and continuous contacts with Delaware as set
`
`forth below, and for other reasons that will be presented to the Court if jurisdiction is challenged.
`
`10.
`
`Upon information and belief, DRL Ltd., itself and through its subsidiaries and
`
`agents, including DRL Inc., currently manufactures and distributes for sale dozens of drug
`
`products throughout the United States, including in this judicial district.
`
`11.
`
`Upon information and belief, DRL Ltd. directs the operations, management and
`
`activities of DRL Inc. in the United States.
`
`12.
`
`Upon information and belief, DRL Ltd., directly or through DRL Inc., routinely
`
`files ANDAs seeking FDA approval to market its drug products in the United States.
`
`13.
`
`Upon information and belief, DRL Ltd. and DRL Inc. collaborate in the
`
`manufacture, marketing, and sale of many pharmaceutical products (including generic drug
`
`products manufactured and sold pursuant to approved ANDAs) throughout the United States,
`
`including in this judicial district.
`
`14.
`
`Upon information and belief, DRL Inc. sells generic drug products in the United
`
`States, including in this judicial district, that are manufactured by DRL Ltd.
`
`15.
`
`DRL has taken advantage of the jurisdiction of this Court by affirmatively filing
`
`counterclaims and requesting entry of judgment in other actions before this Court, including
`
`Teva Pharmaceuticals USA, Inc. et al. v. Dr. Reddy’s Laboratories, Ltd., et al., No. 15-cv-306-
`
`GMS (D. Del.); Cephalon, Inc. v. Dr. Reddy’s Laboratories, Ltd. et al., No. 15-cv-179 (GMS)
`
`3
`
`

`
`Case 1:16-cv-00030-UNA Document 1 Filed 01/21/16 Page 4 of 12 PageID #: 4
`
`(D. Del.); and Allos Therapeutics, Inc. et al. v. Teva Pharmaceuticals USA, Inc. et al., No. 14-
`
`778-RGA (D. Del.).
`
`16.
`
`This Court has personal jurisdiction over DRL Inc. by virtue of, among other
`
`things, its systematic and continuous contacts with Delaware.
`
`17.
`
`This Court has personal jurisdiction over DRL Ltd. by virtue of, among other
`
`things, its systematic and continuous contacts with Delaware.
`
`18.
`
`In the alternative, this Court may exercise personal jurisdiction over DRL Ltd.
`
`pursuant to Federal Rule of Civil Procedure 4(k)(2) because (a) Plaintiffs’ claims arise under
`
`federal law; (b) DRL Ltd. is a foreign company not subject to personal jurisdiction in the courts
`
`of any state; and (c) DRL Ltd. has sufficient contacts with the United States as a whole,
`
`including but not limited to marketing and/or selling generic pharmaceutical products that are
`
`distributed and sold throughout the United States, such that this Court’s exercise of jurisdiction
`
`over DRL Ltd. satisfies due process.
`
`BACKGROUND
`
`19.
`
`CUBICIN® (daptomycin for injection) is an intravenous bactericidal antibiotic
`
`approved by the FDA for the treatment of complicated skin and skin structure infections caused
`
`by certain Gram-positive microorganisms, such as Staphylococcus aureus, including methicillin-
`
`resistant strains, also known as MRSA. CUBICIN® is also approved for the treatment of
`
`S. aureus bloodstream infections (bacteremia), including right-sided infective endocarditis
`
`caused by MRSA.
`
`20.
`
`Cubist sells CUBICIN® in the United States pursuant to a New Drug Application
`
`that has been approved by the FDA.
`
`4
`
`

`
`Case 1:16-cv-00030-UNA Document 1 Filed 01/21/16 Page 5 of 12 PageID #: 5
`
`21.
`
`United States Patent No. 6,468,967 (“the ’967 patent”), entitled “Methods for
`
`Administration of Antibiotics” (Exhibit A hereto), was duly and legally issued on October 22,
`
`2002. The ’967 patent, which is owned by Cubist, will expire on September 24, 2019.
`
`22.
`
`United States Patent No. 6,852,689 (“the ’689 patent”), entitled “Methods for
`
`Administration of Antibiotics” (Exhibit B hereto), was duly and legally issued on February 8,
`
`2005. The ’689 patent, which is owned by Cubist, will expire on September 24, 2019.
`
`23.
`
` United States Patent No. 8,058,238 (“the ’238 patent”), entitled “High Purity
`
`Lipopeptides” (Exhibit C hereto), was duly and legally issued on November 15, 2011. The ’238
`
`patent, which is owned by Cubist, will expire on November 28, 2020.
`
`24.
`
`United States Patent No. 8,129,342 (“the ’342 patent”), entitled “High Purity
`
`Lipopeptides” (Exhibit D hereto), was duly and legally issued on March 6, 2012. The ’342
`
`patent, which is owned by Cubist, will expire on November 28, 2020.
`
`25.
`
`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
`
`publication, Approved Drug Products with Therapeutic Equivalence Evaluations, referred to as
`
`the “Orange Book.”
`
`26.
`
`By letter dated December 9, 2015 (the “Notice Letter”), DRL notified Cubist that
`
`it had submitted to the FDA ANDA No. 208375 for daptomycin for injection, for intravenous
`
`use, a generic version of CUBICIN® (“DRL’s ANDA Product”).
`
`27.
`
`In the Notice Letter, DRL stated that its ANDA included certifications pursuant to
`
`21 U.S.C. § 355(j)(2)(A)(vii)(IV) with respect to the ’967, ’689, ’238, and ’342 patents and
`
`alleged that the ’967, ’689, ’238, and ’342 patents are invalid, unenforceable, and/or will not be
`
`infringed by the commercial manufacture, use, offer for sale, or sale of DRL’s ANDA Product.
`
`5
`
`

`
`Case 1:16-cv-00030-UNA Document 1 Filed 01/21/16 Page 6 of 12 PageID #: 6
`
`28.
`
`On December 8, 2014, the United States District Court for the District of
`
`Delaware entered an order in Cubist Pharmaceuticals, Inc. v. Hospira, Inc., C.A. No. 12-367-
`
`GMS (consolidated), which, in relevant part, held certain claims of the ’967, ’689, ’238, and
`
`‘342 patents invalid.
`
`29.
`
`On November 12, 2015, the United States Court of Appeals for the Federal
`
`Circuit issued an opinion in Cubist Pharmaceuticals, Inc. v. Hospira, Inc., Nos. 2015-1197,
`
`2015-1204, and 2015-1259, affirming the District Court’s decision.
`
`30.
`
`Because Cubist believes the judgment of invalidity is incorrect, on December 14,
`
`2015, Cubist filed a combined petition for panel rehearing and rehearing en banc in the United
`
`States Court of Appeals for the Federal Circuit, in which it requested reconsideration of certain
`
`issues in the appeal. No mandate in the appeal has issued.
`
`31.
`
`This action is being commenced before the expiration of forty-five days from the
`
`date of the receipt of the Notice Letter.
`
`COUNT I
`Infringement of U.S. Patent No. 6,468,967
`
`32.
`
`Plaintiff incorporates each of the preceding paragraphs 1 – 31 as if fully set forth
`
`herein.
`
`patent.
`
`33.
`
`The use of DRL’s ANDA Product is covered by one or more claims of the ’967
`
`34.
`
`35.
`
`DRL had knowledge of the ’967 patent when it submitted its ANDA to the FDA.
`
`DRL’s submission of ANDA No. 208375 for the purpose of obtaining approval to
`
`engage in the commercial manufacture, use, offer for sale, and/or sale of DRL’s ANDA Product
`
`before the expiration of the ’967 patent was an act of infringement of the ’967 patent.
`
`6
`
`

`
`Case 1:16-cv-00030-UNA Document 1 Filed 01/21/16 Page 7 of 12 PageID #: 7
`
`36.
`
`The commercial manufacture, use, offer for sale, sale and/or importation of
`
`DRL’s ANDA Product would infringe one or more claims of the ’967 patent.
`
`37.
`
`Upon information and belief, use of DRL’s ANDA Product in accordance with
`
`and as directed by DRL’s proposed labeling for that product would infringe one or more claims
`
`of the ’967 patent.
`
`38.
`
`Upon information and belief, DRL intends to engage in the manufacture, use,
`
`offer for sale, sale, and/or importation of DRL’s ANDA Product with its proposed labeling
`
`immediately and imminently upon approval of ANDA No. 208375.
`
`39.
`
`Upon information and belief, DRL 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.
`
`40.
`
`Upon information and belief, DRL knows that DRL’s ANDA Product and its
`
`proposed labeling are especially made or adapted for use in infringing the ’967 patent, and that
`
`DRL’s ANDA Product and its proposed labeling are not suitable for substantial noninfringing
`
`use. Upon information and belief, DRL plans and intends to, and will, contribute to the
`
`infringement of the ’967 patent immediately and imminently upon approval of ANDA No.
`
`208375.
`
`41.
`
`The foregoing actions by DRL constitute and/or would constitute infringement of
`
`the ’967 patent, active inducement of infringement of the ’967 patent, and/or contribution to the
`
`infringement by others of the ’967 patent.
`
`42.
`
`Upon information and belief, DRL acted without a reasonable basis for believing
`
`that it would not be liable for infringing the ’967 patent, actively inducing infringement of the
`
`’967 patent, and/or contributing to the infringement by others of the ’967 patent.
`
`7
`
`

`
`Case 1:16-cv-00030-UNA Document 1 Filed 01/21/16 Page 8 of 12 PageID #: 8
`
`43.
`
`Unless DRL 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
`
`44.
`
`Plaintiff incorporates each of the preceding paragraphs 1 – 43 as if fully set forth
`
`herein.
`
`patent.
`
`45.
`
`The use of DRL’s ANDA Product is covered by one or more claims of the ’689
`
`46.
`
`47.
`
`DRL had knowledge of the ’689 patent when it submitted its ANDA to the FDA.
`
`DRL’s submission of ANDA No. 208375 for the purpose of obtaining approval to
`
`engage in the commercial manufacture, use, offer for sale, and/or sale of DRL’s ANDA Product
`
`before the expiration of the ’689 patent was an act of infringement of the ’689 patent.
`
`48.
`
`The commercial manufacture, use, offer for sale, sale and/or importation of
`
`DRL’s ANDA Product would infringe one or more claims of the ’689 patent.
`
`49.
`
`Upon information and belief, use of DRL’s ANDA Product in accordance with
`
`and as directed by DRL’s proposed labeling for that product would infringe one or more claims
`
`of the ’689 patent.
`
`50.
`
`Upon information and belief, DRL intends to engage in the manufacture, use,
`
`offer for sale, sale, and/or importation of DRL’s ANDA Product with its proposed labeling
`
`immediately and imminently upon approval of ANDA No. 208375.
`
`51.
`
`Upon information and belief, DRL 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.
`
`8
`
`

`
`Case 1:16-cv-00030-UNA Document 1 Filed 01/21/16 Page 9 of 12 PageID #: 9
`
`52.
`
`Upon information and belief, DRL knows that DRL’s ANDA Product and its
`
`proposed labeling are especially made or adapted for use in infringing the ’689 patent, and that
`
`DRL’s ANDA Product and its proposed labeling are not suitable for substantial noninfringing
`
`use. Upon information and belief, DRL plans and intends to, and will, contribute to the
`
`infringement of the ’689 patent immediately and imminently upon approval of ANDA No.
`
`208375.
`
`53.
`
`The foregoing actions by DRL 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.
`
`54.
`
`Upon information and belief, DRL 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.
`
`55.
`
`Unless DRL 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
`
`56.
`
`Plaintiff incorporates each of the preceding paragraphs 1 – 55 as if fully set forth
`
`herein.
`
`57.
`
`58.
`
`DRL’s ANDA Product is covered by one or more claims of the ’238 patent.
`
`DRL’s submission of ANDA No. 208375 for the purpose of the obtaining
`
`approval to engage in the commercial manufacture, use, offer for sale, and/or sale of DRL’s
`
`ANDA Product before the expiration of the ’238 patent was an act of infringement of the ’238
`
`patent.
`
`9
`
`

`
`Case 1:16-cv-00030-UNA Document 1 Filed 01/21/16 Page 10 of 12 PageID #: 10
`
`59.
`
`The commercial manufacture, use, offer for sale, sale and/or importation of
`
`DRL’s ANDA Product would infringe one or more claims of the ’238 patent.
`
`60.
`
`Upon information and belief, DRL intends to engage in the manufacture, use,
`
`offer for sale, sale, and/or importation of DRL’s ANDA Product immediately and imminently
`
`upon approval of ANDA No. 208375.
`
`61.
`
`The foregoing actions by DRL constitute and/or would constitute infringement of
`
`the ’238 patent.
`
`62.
`
`Unless DRL is enjoined from infringing the ’238 patent, Cubist will suffer
`
`irreparable injury. Cubist has no adequate remedy at law.
`
`COUNT IV
`Infringement of U.S. Patent No. 8,129,342
`
`63.
`
`Plaintiff incorporates each of the preceding paragraphs 1 – 62 as if fully set forth
`
`herein.
`
`64.
`
`65.
`
`DRL’s ANDA Product is covered by one or more claims of the ’342 patent.
`
`DRL’s submission of ANDA No. 208375 for the purpose of the obtaining
`
`approval to engage in the commercial manufacture, use, offer for sale, and/or sale of DRL’s
`
`ANDA Product before the expiration of the ’342 patent was an act of infringement of the ’342
`
`patent.
`
`66.
`
`The commercial manufacture, use, offer for sale, sale and/or importation of
`
`DRL’s ANDA Product would infringe one or more claims of the ’342 patent.
`
`67.
`
`Upon information and belief, DRL intends to engage in the manufacture, use,
`
`offer for sale, sale, and/or importation of DRL’s ANDA Product immediately and imminently
`
`upon approval of ANDA No. 208375.
`
`10
`
`

`
`Case 1:16-cv-00030-UNA Document 1 Filed 01/21/16 Page 11 of 12 PageID #: 11
`
`68.
`
`The foregoing actions by DRL constitute and/or would constitute infringement of
`
`the ’342 patent.
`
`69.
`
`Unless DRL is enjoined from infringing the ’342 patent, Cubist will suffer
`
`irreparable injury. Cubist has no adequate remedy at law.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiff prays that this Court grant the following relief:
`
`(a)
`
`A judgment that DRL’s submission of ANDA No. 208375 was an act of
`
`infringement of the ’967, ’689, ’238, and ’342 patents, and that DRL’s manufacture, use, offer to
`
`sell, sale, or importation of DRL’s ANDA Product prior to the expiration of the ’967, ’689, ’238,
`
`and ’342 patents, will infringe, actively induce infringement, and/or contribute to the
`
`infringement of the ’967, ’689, ’238, and ’342 patents;
`
`(b)
`
`An Order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective date of
`
`any FDA approval of DRL’s ANDA No. 208375, or any product or compound that infringes the
`
`’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 DRL, and its affiliates and subsidiaries, and each
`
`of its officers, agents, servants and employees, from making, using, offering to sell, selling,
`
`marketing, distributing, or importing DRL’s ANDA Product, or any product or compound that
`
`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
`
`plaintiff pursuant to 35 U.S.C. § 285;
`
`(e)
`
`Plaintiff’s reasonable costs of suit incurred; and
`
`11
`
`

`
`Case 1:16-cv-00030-UNA Document 1 Filed 01/21/16 Page 12 of 12 PageID #: 12
`
`(f)
`
`Such further and other relief as this Court deems proper and just.
`
`
`
`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
`
`12

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