Case 1:14-cv-01042-GMS Document 1 Filed 08/12/14 Page 1 of 8 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
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`FOR THE DISTRICT OF DELAWARE
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`CEPHALON, INC.,
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`EAGLE PHARMACEUTICALS, INC.,
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`Plaintiff,
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`v.
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`Defendant.
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`) C.A. No. ___________
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`COMPLAINT
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`Cephalon, Inc. (“Cephalon” or “Plaintiff”) brings this action for patent infringement
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`against Defendant Eagle Pharmaceuticals, Inc. (“Eagle” or “Defendant”).
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`1.
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`This is an action by Cephalon against Defendant for infringement of United States
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`Patent No. 8,791,270 (“the ’270 patent”). This action arises out of Defendant’s filing of a New
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`Drug Application (“NDA”) seeking approval by the United States Food and Drug Administration
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`(“FDA”) to sell liquid concentrate versions of TREANDA®, Cephalon’s innovative treatment for
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`chronic lymphocytic leukemia and non-Hodgkin’s lymphoma, prior to the expiration of the ’270
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`patent.
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`Cephalon, Inc.
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`THE PARTIES
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`2.
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`Plaintiff Cephalon, Inc. is a corporation operating and existing under the laws of
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`Delaware, with its principal place of business at 41 Moores Road, Frazer, Pennsylvania 19355.
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`Cephalon is engaged in the business of research, development, manufacture, and sale of
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`innovative pharmaceutical products throughout the world.
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`IN THE UNITED STATES DISTRICT COURT
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`FOR THE DISTRICT OF DELAWARE
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`CEPHALON, INC.,
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`EAGLE PHARMACEUTICALS, INC.,
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`Plaintiff,
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`v.
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`Defendant.
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`)
`)
`)
`)
`) C.A. No. ___________
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`)
`)
`)
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`COMPLAINT
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`Cephalon, Inc. (“Cephalon” or “Plaintiff”) brings this action for patent infringement
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`against Defendant Eagle Pharmaceuticals, Inc. (“Eagle” or “Defendant”).
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`1.
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`This is an action by Cephalon against Defendant for infringement of United States
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`Patent No. 8,791,270 (“the ’270 patent”). This action arises out of Defendant’s filing of a New
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`Drug Application (“NDA”) seeking approval by the United States Food and Drug Administration
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`(“FDA”) to sell liquid concentrate versions of TREANDA®, Cephalon’s innovative treatment for
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`chronic lymphocytic leukemia and non-Hodgkin’s lymphoma, prior to the expiration of the ’270
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`patent.
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`Cephalon, Inc.
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`THE PARTIES
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`2.
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`Plaintiff Cephalon, Inc. is a corporation operating and existing under the laws of
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`Delaware, with its principal place of business at 41 Moores Road, Frazer, Pennsylvania 19355.
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`Cephalon is engaged in the business of research, development, manufacture, and sale of
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`innovative pharmaceutical products throughout the world.
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`Case 1:14-cv-01042-GMS Document 1 Filed 08/12/14 Page 2 of 8 PageID #: 2
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`Eagle Pharmaceuticals, Inc.
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`3.
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`Upon information and belief, Defendant Eagle Pharmaceuticals, Inc. is a
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`corporation operating and existing under the laws of Delaware, with its principal place of
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`business at 470 Chestnut Ridge Road, Woodcliff Lake, New Jersey 07677. Eagle has designated
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`Corporation Service Company at 2711 Centerville Rd., Suite 400, Wilmington, DE 19808 for
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`receipt of service in the State of Delaware.
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`JURISDICTION AND VENUE
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`Subject Matter Jurisdiction
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`4.
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`5.
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`This action for patent infringement arises under 35 U.S.C. § 271.
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`This Court has jurisdiction over the subject matter of this action pursuant to 28
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`U.S.C. §§ 1331 and 1338(a), and the Declaratory Judgment Act, 28 U.S.C §§ 2201 and 2202.
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`Personal Jurisdiction Over Eagle
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`6.
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`Upon information and belief, this Court has personal jurisdiction over Eagle at
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`least because Eagle: (1) is incorporated in Delaware and conducts business in this Judicial
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`District; and (2) has engaged in continuous and systematic contacts with Delaware and/or
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`purposefully availed itself of this forum by, among other things, making, shipping, using,
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`offering to sell or selling, or causing others to use, offer to sell, or sell, Eagle pharmaceutical
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`products in this Judicial District, and deriving substantial revenue from such activities.
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`7.
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`Upon information and belief, this Court also has personal jurisdiction over
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`Defendant because it previously has been sued in this district, did not challenge this Court’s
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`assertion of personal jurisdiction over it, and availed itself of this forum by asserting
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`counterclaims for the purpose of litigating a patent infringement dispute. See Cephalon, Inc. v.
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`Eagle Pharmaceuticals, Inc., C.A. No. 13-1738 (D. Del).
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`2
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`Case 1:14-cv-01042-GMS Document 1 Filed 08/12/14 Page 3 of 8 PageID #: 3
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`Venue
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`8.
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`Venue is proper in this Judicial District under 28 U.S.C. §§ 1391 and 1400(b).
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`The Patent-in-Suit
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`BACKGROUND
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`9.
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`The ’270 patent, entitled “Bendamustine Pharmaceutical Compositions,” was duly
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`and lawfully issued on July 29, 2014 to inventors Jason E. Brittain and Joe C. Franklin.
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`10.
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`The named inventors of the ’270 patent assigned their rights in the ’270 patent to
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`Cephalon.
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`11.
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`Cephalon is the sole owner by assignment of all rights, title and interest in the
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`’270 patent.
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`12.
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`The ’270 patent is listed in FDA publication “Approved Drug Products with
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`Therapeutic Equivalence Evaluations,” commonly referred to as “The Orange Book” (“Orange
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`Book”), with respect to TREANDA®.
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`13.
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`The ’270 patent will expire on January 12, 2026. A true and accurate copy of the
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`’270 patent is attached hereto as Exhibit A.
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`The TREANDA® Drug Product
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`14.
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`Cephalon researched, developed, applied for and obtained FDA approval to
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`manufacture, sell, promote and/or market bendamustine hydrochloride products known as
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`TREANDA®.
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`15.
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`Cephalon has been selling, promoting, distributing and marketing TREANDA® in
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`the United States since 2008.
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`16.
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`TREANDA® is indicated to treat chronic lymphocytic leukemia and non-
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`Hodgkin’s lymphoma.
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`3
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`Case 1:14-cv-01042-GMS Document 1 Filed 08/12/14 Page 4 of 8 PageID #: 4
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`17.
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`Cephalon holds New Drug Application No. 22249 and No. 22303 under Section
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`505(a) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 355(a), for multiple
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`TREANDA® products used for treating chronic lymphocytic leukemia and non-Hodgkin’s
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`lymphoma.
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`The Eagle NDA and Eagle’s Bendamustine Product
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`18.
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`Eagle filed with FDA in Rockville, Maryland, a New Drug Application under 21
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`U.S.C. § 355(b)(2) seeking approval to manufacture, use, offer for sale, sell in and import into
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`the United States a 100 mg/4 mL (25 mg/mL) liquid concentrate bendamustine hydrochloride
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`product (“Eagle’s Bendamustine Product”) prior to the expiration of the ’270 patent.
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`19.
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`20.
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`FDA assigned the NDA for Eagle’s Bendamustine Product the number 205580.
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`Upon information and belief, Eagle has received tentative approval from FDA for
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`Eagle’s Bendamustine Product.
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`21.
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`Upon information and belief, the U.S. Patent Office has issued patent 8,609,707
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`for Eagle’s Bendamustine Product. (See http://eaglepharm.investorhq.businesswire.com/press-
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`release/eagle-pharmaceuticals-receives-tentative-approval-patented-ready-dilute-bendamustine-
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`h.)
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`22.
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`Upon information and belief, the U.S. Patent and Trademark Office has published
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`U.S. Patent Application Publication No. 2013/0210879, which discloses Eagle’s Bendamustine
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`Product.
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`The Ongoing Litigation
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`23.
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`In connection with its NDA, Eagle also filed with FDA, pursuant to 21 U.S.C.
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`§ 355(b)(2)(A)(iv), a certification alleging that the claims of another Cephalon patent, U.S.
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`Patent No. 8,445,524 (“the ’524 patent”) are invalid, unenforceable and/or would not be
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`4
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`Case 1:14-cv-01042-GMS Document 1 Filed 08/12/14 Page 5 of 8 PageID #: 5
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`infringed by the manufacture, use, importation, sale or offer for sale of Eagle’s Bendamustine
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`Product (“Eagle’s Paragraph IV Certification”).
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`24.
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`By letter dated September 6, 2013, Eagle notified Cephalon that it had filed NDA
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`205580 seeking approval to market Eagle’s Bendamustine Product prior to the expiration of the
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`’524 patent (“Eagle Notice Letter”).
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`25.
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`Pursuant to an Offer of Confidential Access, Cephalon reviewed portions of the
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`NDA filed by Eagle for information related to the ’524 patent.
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`26.
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`On October 21, 2013, Cephalon sued Eagle for patent infringement of the ’524
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`patent in the District of Delaware. See Cephalon, Inc. v. Eagle Pharmaceuticals, Inc., C.A. No.
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`13-1738 (D. Del). That action was commenced before the expiration of forty-five days from the
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`date of receipt of the Eagle Notice Letter.
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`COUNT I DECLARATORY JUDGMENT OF
`INFRINGMENT OF U.S. PATENT NO. 8,791,270 BY EAGLE
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`The allegations of the proceeding paragraphs 1–26 are re-alleged and incorporated
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`27.
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`herein by reference.
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`28.
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`Cephalon notified Eagle of the issuance of the ’270 patent before filing this
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`action.
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`29.
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`Upon information and belief, Eagle’s Bendamustine Product contains the same
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`active pharmaceutical ingredient, bendamustine hydrochloride, as that used in Cephalon’s
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`TREANDA® products and claimed in the ’270 patent.
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`30.
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`Upon information and belief, Eagle’s Bendamustine Product is the pharmaceutical
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`composition of bendamustine hydrochloride, containing less than or equal to 4.0% (area percent
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`of bendamustine) of bendamustine degradants, recited in one or more claims of the ’270 patent.
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`5
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`Case 1:14-cv-01042-GMS Document 1 Filed 08/12/14 Page 6 of 8 PageID #: 6
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`31.
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`Upon information and belief, Eagle’s Bendamustine Product is the pharmaceutical
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`composition of bendamustine hydrochloride, containing not more than the amount of the HP1
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`degradant recited in one or more claims of the ’270 patent.
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`32.
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`Upon information and belief, Eagle’s Bendamustine Product infringes one or
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`more claims of the ’270 patent.
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`33.
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`The commercial manufacture, use, offer for sale, sale, marketing, distribution
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`and/or importation of Eagle’s Bendamustine Product would infringe one or more claims of the
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`’270 patent.
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`34.
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`Upon information and belief, Eagle plans to begin manufacturing, marketing,
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`selling, offering to sell and/or importing Eagle’s Bendamustine Product soon after FDA approval
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`of the Eagle NDA.
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`35.
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`Upon information and belief, Eagle plans and intends to, and will, actively induce
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`infringement of the ’270 patent when the Eagle NDA is approved, and plans and intends to, and
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`will, do so immediately and imminently upon final approval.
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`36.
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`Upon information and belief, Eagle has received tentative approval from FDA for
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`Eagle’s Bendamustine Product.
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`37.
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`The foregoing actions by Eagle constitute and/or would constitute infringement of
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`the ’270 patent, active inducement of infringement of the ’270 patent and/or contribution to the
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`infringement by others of the ’270 patent.
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`38.
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`Defendant’s infringing patent activity complained of herein is imminent and will
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`begin following FDA approval of the Eagle NDA.
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`39.
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`As a result of the foregoing facts, there is a real, substantial, and continuing
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`justiciable controversy between Plaintiff and Defendant as to liability for the infringement of the
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`6
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`Case 1:14-cv-01042-GMS Document 1 Filed 08/12/14 Page 7 of 8 PageID #: 7
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`’270 patent. Defendant’s actions have created in Plaintiff a reasonable apprehension of
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`irreparable harm and loss resulting from Defendant’s threatened imminent actions.
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`40.
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`Upon information and belief, Eagle will knowingly and willfully infringe the ’270
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`patent.
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`41.
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`Plaintiff will be substantially and irreparably harmed by Eagle’s infringing
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`activities unless the Court enjoins those activities. Plaintiff will have no adequate remedy at law
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`if Eagle is not enjoined from the commercial manufacture, use, offer to sell, sale in and
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`importation into the United States of Eagle’s Bendamustine Product.
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`42.
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`Eagle’s activities render this case an exceptional one, and Plaintiff is entitled to an
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`award of their reasonable attorney fees under 35 U.S.C. § 285.
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`PRAYER FOR RELIEF
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`WHEREFORE, Plaintiff respectfully request the following relief:
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`a.
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`b.
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`a judgment that the ’270 patent is valid and enforceable;
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`a judgment that the making, using, offering to sell, selling, marketing,
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`distributing, or importing of Eagle’s Bendamustine Products prior to the expiration of the ’270
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`patent will infringe, actively induce infringement and/or contribute to the infringement of one or
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`more claims of the ’270 patent;
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`c.
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`an Order pursuant to 35 U.S.C. § 283 permanently enjoining Eagle and all persons
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`acting in concert with Eagle from commercially manufacturing, using, offering for sale, selling,
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`marketing, distributing, or importing Eagle’s Bendamustine Products, or any product or
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`compound the use of which infringes the ’270 patent, or inducing or contributing to the
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`infringement of the ’270 patent until after the expiration of the ’270 patent;
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`7
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`Case 1:14-cv-01042-GMS Document 1 Filed 08/12/14 Page 8 of 8 PageID #: 8
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`d.
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`an Order enjoining Eagle and all persons acting in concert with Eagle from
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`seeking, obtaining, or maintaining approval of the Eagle NDA No. 205580 before the expiration
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`of the ’270 patent;
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`e.
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`an award of Plaintiff’s damages or other monetary relief to compensate Plaintiff if
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`Eagle engages in the commercial manufacture, use, offer to sell, sale or marketing or distribution
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`in, or importation into the United States of Eagle’s Bendamustine Products, or any product or
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`compound the use of which infringes the ’270 patent, or the inducement or contribution of the
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`foregoing, prior to the expiration of the ’270 patent in accordance with 35 U.S.C. § 271(e)(4)(C);
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`f.
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`a judgment that this is an exceptional case and awarding Plaintiff its attorneys’
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`fees under 35 U.S.C. § 285;
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`an award of Plaintiff’s reasonable costs and expenses in this action; and
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`an award of any further and additional relief to Plaintiff as this Court deems just
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`g.
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`h.
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`and proper.
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`OF COUNSEL:
`David M. Hashmall
`Calvin E. Wingfield Jr.
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018
`(212) 813-8800
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`Daryl L. Wiesen
`Emily L. Rapalino
`Nicholas K. Mitrokostas
`GOODWIN PROCTER LLP
`Exchange Place
`Boston, MA 02109
`(617) 570-1000
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`Dated: August 12, 2014
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`Respectfully submitted,
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`/s/ Karen E. Keller
`John W. Shaw (No. 3362)
`Karen E. Keller (No. 4489)
`Stephanie E. O’Byrne (No. 4446)
`SHAW KELLER LLP
`300 Delaware Ave., Suite 1120
`Wilmington, DE 19801
`(302) 298-0700
`jshaw@shawkeller.com
`kkeller@shawkeller.com
`sobyrne@shawkeller.com
`Attorneys for Plaintiff Cephalon, Inc.
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`8
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