Case 1:14-cv-01238-GMS Document 1 Filed 09/25/14 Page 1 of 11 PageID #: 1
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`Civil Action No. _____________
`
`)))))
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`))))
`
`COMPLAINT
`
`CEPHALON, INC.
`
`v.
`
`INNOPHARMA, INC.
`
`Plaintiff,
`
`Defendant.
`
`Cephalon, Inc. (“Cephalon” or “Plaintiff”) brings this action for patent infringement
`
`against Defendant InnoPharma, Inc. (“InnoPharma” or “Defendant”).
`
`1.
`
`This is an action by Cephalon against InnoPharma for infringement of United
`
`States Patent No. 8,791,270 (“the ’270 patent”). This action arises out of InnoPharma’s filing of
`
`an Abbreviated New Drug Application (“ANDA”) seeking approval by the United States Food
`
`and Drug Administration (“FDA”) to sell generic 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.
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`Civil Action No. _____________
`
`)))))
`
`))))
`
`COMPLAINT
`
`CEPHALON, INC.
`
`v.
`
`INNOPHARMA, INC.
`
`Plaintiff,
`
`Defendant.
`
`Cephalon, Inc. (“Cephalon” or “Plaintiff”) brings this action for patent infringement
`
`against Defendant InnoPharma, Inc. (“InnoPharma” or “Defendant”).
`
`1.
`
`This is an action by Cephalon against InnoPharma for infringement of United
`
`States Patent No. 8,791,270 (“the ’270 patent”). This action arises out of InnoPharma’s filing of
`
`an Abbreviated New Drug Application (“ANDA”) seeking approval by the United States Food
`
`and Drug Administration (“FDA”) to sell generic 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-01238-GMS Document 1 Filed 09/25/14 Page 2 of 11 PageID #: 2
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`InnoPharma, Inc.
`
`3.
`
`Upon information and belief, Defendant InnoPharma is a corporation organized
`
`and existing under the laws of the State of Delaware, with its principal place of business at 10
`
`Knightsbridge Road, Piscataway, New Jersey 08854. InnoPharma can be served via its
`
`registered agent, The Corporation Trust Company, Corporation Trust Center, 1209 Orange
`
`Street, Wilmington, Delaware 19801.
`
`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 InnoPharma
`
`6.
`
`Upon information and belief, this Court has personal jurisdiction over
`
`InnoPharma at least because InnoPharma: (1) is incorporated in Delaware and conducts business
`
`in this Judicial District; and (2) markets, distributes and/or sells generic drugs throughout the
`
`United States and within the State of Delaware and therefore purposefully avails itself of the
`
`privilege of conducting activities within the State of Delaware. InnoPharma has also committed,
`
`or aided, abetted, contributed to and/or participated in the commission of, the tortious action of
`
`patent infringement that has led to foreseeable harm and injury to Cephalon, which manufactures
`
`TREANDA®, for sale and use throughout the United States, including the State of Delaware.
`
`7.
`
`Upon information and belief, this Court also has personal jurisdiction over
`
`InnoPharma because InnoPharma previously has been sued in this Judicial District and did not
`
`challenge this Court’s exertion of personal jurisdiction over it, including in related co-pending
`
`2
`
`
`
`Case 1:14-cv-01238-GMS Document 1 Filed 09/25/14 Page 3 of 11 PageID #: 3
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`actions. See Spectrum Pharm. v. InnoPharma, Inc., C.A. No. 12-00260 (D. Del); Cumberland
`
`Pharm. v. InnoPharma, Inc., C.A. No. 12-00618 (D. Del).
`
`8.
`
`On information and belief, this Court also personal jurisdiction over InnoPharma
`
`because InnoPharma did not challenge this Court’s exercise of personal jurisdiction over it for
`
`purposes of litigating allegations of patent infringement involving the ANDA that is the subject
`
`matter of this lawsuit. See Cephalon, Inc. v. InnoPharma, Inc., C.A. No. 14-590-GMS (D. Del.);
`
`Cephalon, Inc. v. InnoPharma, Inc., C.A. No. 13-2081-GMS (D. Del.).
`
`Venue
`
`9.
`
`Venue is proper in this Judicial District under 28 U.S.C. §§ 1391 and 1400(b).
`
`The ’270 Patent
`
`BACKGROUND
`
`10.
`
`The ’270 patent, entitled “Bendamustine Pharmaceutical Compositions,” was duly
`
`and lawfully issued on July 29, 2014 to inventors Jason Edward Brittain and Joe Craig Franklin.
`
`11.
`
`The named inventors of the ’270 patent assigned their rights in the ’270 patent to
`
`Cephalon.
`
`12.
`
`Cephalon is the sole owner by assignment of all rights, title and interest in the
`
`’270 patent.
`
`13.
`
`Shortly after the ’270 patent issued, Cephalon listed the ’270 patent in FDA
`
`publication “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly
`
`referred to as “the Orange Book” (“Orange Book”), with respect to TREANDA®.
`
`14.
`
`The ’270 patent will expire on January 12, 2026. A true and accurate copy of the
`
`’270 patent is attached hereto as Exhibit A.
`
`3
`
`
`
`Case 1:14-cv-01238-GMS Document 1 Filed 09/25/14 Page 4 of 11 PageID #: 4
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`The TREANDA® Drug Product
`
`15.
`
`Cephalon researched, developed, applied for and obtained FDA approval to
`
`manufacture, sell, promote and/or market bendamustine hydrochloride products known as
`
`TREANDA®.
`
`16.
`
`Cephalon has been selling, promoting, distributing and marketing TREANDA® in
`
`the United States since 2008.
`
`17.
`
`TREANDA® is indicated to treat chronic lymphocytic leukemia and non-
`
`Hodgkin’s lymphoma.
`
`18.
`
`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 InnoPharma ANDA
`
`19.
`
`InnoPharma filed with FDA an Abbreviated New Drug Application under 21
`
`U.S.C. § 355(j) seeking approval to manufacture, use, offer for sale, sell in and import into the
`
`United States bendamustine hydrochloride powder for IV (infusion),25 mg/vial and 100 mg/vial
`
`(“InnoPharma’s Bendamustine Product”) prior to the expiration of the ’270 patent.
`
`20.
`
`FDA assigned the ANDA for InnoPharma’s Bendamustine Product the number
`
`205476.
`
`The Ongoing Litigations
`
`21.
`
`In connection with its ANDA, InnoPharma filed with FDA, pursuant to 21 U.S.C.
`
`§ 355(j)(2)(B)(iv), a certification alleging that the claims of other Cephalon patents, United
`
`States Patent No. 8,445,524 (“the ’524 patent”), United States Patent No. 8,436,190 (“the ’190
`
`4
`
`
`
`Case 1:14-cv-01238-GMS Document 1 Filed 09/25/14 Page 5 of 11 PageID #: 5
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`patent”), and United States Patent No. 8,609,863 (“the ’863 patent”), are invalid, unenforceable
`
`and/or would not be infringed by the manufacture, use, importation, sale or offer for sale of
`
`InnoPharma’s Bendamustine Product (“InnoPharma’s Paragraph IV Certification”).
`
`22.
`
`By letter dated November 8, 2013, InnoPharma notified Cephalon that it had filed
`
`ANDA No. 205476 seeking approval to market InnoPharma’s Bendamustine Product prior to the
`
`expiration of the ’524 and ’190 patents (“InnoPharma’s First Notice Letter”). InnoPharma
`
`notified Cephalon by letter dated March 26, 2014 that it had filed an amendment to ANDA No.
`
`205476 seeking approval to market InnoPharma’s Bendamustine Product prior to the expiration
`
`of the ’863 patent (“InnoPharma’s Second Notice Letter”).
`
`23.
`
`Pursuant to an Offer of Confidential Access, Cephalon received portions of the
`
`ANDA filed by InnoPharma, and Cephalon reviewed those portions of the ANDA.
`
`24.
`
`On December 23, 2013 and May 9, 2014, respectively, Cephalon sued
`
`InnoPharma for patent infringement of the ’524 patent and the ’190 patent and the ’863 patent in
`
`the District of Delaware. See Cephalon, Inc. v. InnoPharma, Inc., C.A. No. 14-590-GMS (D.
`
`Del.); Cephalon, Inc. v. InnoPharma, Inc., C.A. No. 13-2081-GMS (D. Del.). Those two actions
`
`respectively were commenced before the expiration of forty-five days from the date of receipt of
`
`InnoPharma’s First Notice Letter and InnoPharma’s Second Notice Letter, which effectively
`
`stayed FDA from granting final approval to InnoPharma’s ANDA No. 205476 prior to the
`
`expiration of 30 months from the date InnoPharma’s First Notice Letter was received by
`
`Cephalon.
`
`COUNT I: INFRINGEMENT OF U.S. PATENT NO. 8,791,270 BY INNOPHARMA
`
`25.
`
`The allegations of the preceding paragraphs 1–24 are re-alleged and incorporated
`
`herein by reference.
`
`5
`
`
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`Case 1:14-cv-01238-GMS Document 1 Filed 09/25/14 Page 6 of 11 PageID #: 6
`
`26.
`
`The ’270 patent issued on July 29, 2014, and Cephalon timely listed the ’270
`
`patent in the Orange Book.
`
`27.
`
`Cephalon notified InnoPharma of the issuance of the ’270 patent before filing this
`
`action.
`
`28.
`
`The use of InnoPharma’s Bendamustine Product is covered by one or more claims
`
`of the ’270 patent.
`
`29.
`
`The commercial manufacture, use, offer for sale, sale, marketing, distribution
`
`and/or importation of InnoPharma’s Bendamustine Product would infringe one or more claims of
`
`the ’270 patent.
`
`30.
`
`Under 35 U.S.C. § 271(e)(2)(A), InnoPharma’s submission to FDA of the
`
`InnoPharma ANDA to obtain approval for InnoPharma’s Bendamustine Product constitutes an
`
`act of infringement, and if approved, the commercial manufacture, use, offer to sell, sale, or
`
`importation of InnoPharma’s Bendamustine Product containing bendamustine hydrochloride,
`
`would infringe one or more claims of the ’270 patent.
`
`31.
`
`On information and belief, InnoPharma’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.
`
`32.
`
`On information and belief, InnoPharma’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.
`
`6
`
`
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`Case 1:14-cv-01238-GMS Document 1 Filed 09/25/14 Page 7 of 11 PageID #: 7
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`33.
`
`On information and belief, InnoPharma’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.
`
`34.
`
`On information and belief, InnoPharma’s Bendamustine Product infringes one or
`
`more claims of the ’270 patent.
`
`35.
`
`On information and belief, InnoPharma plans and intends to, and will, infringe the
`
`’270 patent immediately and imminently upon approval of the InnoPharma ANDA.
`
`36.
`
`On information and belief, InnoPharma, under 35 U.S.C. § 271(b), acted in
`
`concert, actively supported, participated in, encouraged, and/or induced the infringement of one
`
`or more claims of the ’270 patent.
`
`37.
`
`On information and belief, InnoPharma plans and intends to, and will, actively
`
`induce infringement of the ’270 patent when the InnoPharma ANDA is approved, and plan and
`
`intend to, and will, do so immediately and imminently upon approval.
`
`38.
`
`On information and belief, InnoPharma knows that InnoPharma’s Bendamustine
`
`Product is especially made or adapted for use in infringing the ’270 patent and that InnoPharma’s
`
`Bendamustine Product is not suitable for substantial non-infringing uses. On information and
`
`belief, under 35 U.S.C. § 271(c), InnoPharma plans and intends to, and will, contribute to the
`
`infringement of the ’270 patent immediately and imminently upon approval of the InnoPharma
`
`ANDA.
`
`39.
`
`The foregoing actions by InnoPharma 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.
`
`7
`
`
`
`Case 1:14-cv-01238-GMS Document 1 Filed 09/25/14 Page 8 of 11 PageID #: 8
`
`40.
`
`On information and belief, InnoPharma acted without a reasonable basis for
`
`believing that it would not be liable for infringing the ’270 patent, actively inducing infringement
`
`of the ’270 patent and/or contributing to the infringement by others of the ’270 patent.
`
`41.
`
`Cephalon will be substantially and irreparably harmed by InnoPharma’s
`
`infringing activities unless the Court enjoins those activities. Cephalon will have no adequate
`
`remedy at law if InnoPharma is not enjoined from the commercial manufacture, use, offer to sell,
`
`sale in and importation into the United States of InnoPharma’s Bendamustine Product.
`
`42.
`
`InnoPharma’s activities render this case an exceptional one, and Cephalon is
`
`entitled to an award of its reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`COUNT II: DECLARATORY JUDGMENT OF
`INFRINGEMENT OF U.S. PATENT NO. 8,791,270 BY INNOPHARMA
`
`43.
`
`The allegations of the proceeding paragraphs 1–42 are re-alleged and incorporated
`
`herein by reference.
`
`44.
`
`On information and belief, InnoPharma plans to begin manufacturing, marketing,
`
`selling, offering to sell and/or importing InnoPharma’s Bendamustine Product soon after FDA
`
`approval of the InnoPharma ANDA.
`
`45.
`
`Such conduct will constitute direct infringement of one or more claims on the
`
`’270 patent under 35 U.S.C. § 271(a), inducement of infringement of the ’270 patent under 35
`
`U.S.C. § 271(b), and contributory infringement under 35 U.S.C. § 271(c).
`
`46.
`
`InnoPharma’s infringing patent activity complained of herein is imminent and
`
`will begin following FDA approval of the InnoPharma ANDA.
`
`47.
`
`As a result of the foregoing facts, there is a real, substantial, and continuing
`
`justiciable controversy between Plaintiff and InnoPharma as to liability for the infringement of
`
`8
`
`
`
`Case 1:14-cv-01238-GMS Document 1 Filed 09/25/14 Page 9 of 11 PageID #: 9
`
`the ’270 patent. InnoPharma’s actions have created in Plaintiff a reasonable apprehension of
`
`irreparable harm and loss resulting from InnoPharma’s threatened imminent actions.
`
`48.
`
`On information and belief, InnoPharma will knowingly and willfully infringe the
`
`’270 patent.
`
`49.
`
`Cephalon will be substantially and irreparably harmed by InnoPharma’s
`
`infringing activities unless the Court enjoins those activities.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Cephalon respectfully request the following relief:
`
`a.
`
`b.
`
`a judgment that the ’270 patent is valid and enforceable;
`
`a judgment that InnoPharma’s submission of the InnoPharma ANDA No. 205476
`
`was an act of infringement of one or more claims of the ’270 patent and that the making, using,
`
`offering to sell, selling, marketing, distributing, or importing of InnoPharma’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. § 271(e)(4)(A) providing that the effective date of
`
`any FDA approval of the InnoPharma ANDA No. 205476 or any product or compound the use
`
`of which infringes the ’270 patent shall be a date that is not earlier than the expiration of the ’270
`
`patent;
`
`d.
`
`an Order pursuant to 35 U.S.C. § 271(e)(4)(B) permanently enjoining InnoPharma
`
`and all persons acting in concert with InnoPharma from commercially manufacturing, using,
`
`offering for sale, selling, marketing, distributing, or importing InnoPharma’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;
`
`9
`
`
`
`Case 1:14-cv-01238-GMS Document 1 Filed 09/25/14 Page 10 of 11 PageID #: 10
`
`e.
`
`an Order pursuant to 35 U.S.C. § 283 permanently enjoining InnoPharma and all
`
`persons acting in concert with InnoPharma from commercially manufacturing, using, offering for
`
`sale, selling, marketing, distributing, or importing InnoPharma’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;
`
`f.
`
`an Order enjoining InnoPharma and all persons acting in concert with
`
`InnoPharma from seeking, obtaining, or maintaining approval of the InnoPharma ANDA
`
`No. 205476 before the expiration of the ’270 patent;
`
`g.
`
`an award of Cephalon’s damages or other monetary relief to compensate
`
`Cephalon if InnoPharma engages in the commercial manufacture, use, offer to sell, sale or
`
`marketing or distribution in, or importation into the United States of InnoPharma’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);
`
`h.
`
`an award of Cephalon’s damages or other monetary relief to compensate
`
`Cephalon if InnoPharma engages in the commercial manufacture, use, offer to sell, sale or
`
`marketing or distribution in, or importation into the United States of InnoPharma’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;
`
`i.
`
`a judgment that this is an exceptional case and awarding Cephalon its attorneys’
`
`fees under 35 U.S.C. § 285;
`
`j.
`
`an award of Cephalon’s reasonable costs and expenses in this action; and
`
`10
`
`
`
`Case 1:14-cv-01238-GMS Document 1 Filed 09/25/14 Page 11 of 11 PageID #: 11
`
`k.
`
`an award of any further and additional relief to Cephalon as this Court deems just
`
`and proper.
`
`Dated: September 25, 2014
`
`BAYARD, P.A.
`
`OF COUNSEL:
`
`David M. Hashmall
`Calvin E. Wingfield Jr.
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`(212) 813-8800
`
`Daryl L. Wiesen
`Emily L. Rapalino
`Nicholas K. Mitrokostas
`Exchange Place
`Boston, MA 02109
`(617) 570-1000
`
`/s/ Stephen B. Brauerman
`Stephen B. Brauerman (sb4952)
`Vanessa R. Tiradentes (vt5398)
`Sara E. Bussiere (sb5725)
`222 Delaware Avenue, Suite 900
`Wilmington, DE 19801
`(302) 655-5000
`sbrauerman@bayardlaw.com
`vtiradentes@bayardlaw.com
`sbussiere@bayardlaw.com
`
`Attorneys for Plaintiff Cephalon, Inc.
`
`11
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