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