Case 1:14-cv-01117-GMS Document 1 Filed 09/02/14 Page 1 of 22 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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`C.A. No. ___________
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`CEPHALON, INC.,
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`Plaintiff,
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`v.
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`NANG KUANG PHARMACEUTICAL CO., LTD.
`and CANDA NK-1, LLC,
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`
`
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`Defendants.
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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 Defendants Nang Kuang Pharmaceutical Co., LTD (“Nang Kuang”) and CANDA NK-1,
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`LLC (“CANDA”) (collectively, “CANDA/Nang Kuang” or “Defendants”).
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`This is an action by Cephalon against Defendants for infringement of United States
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`Patent No. 8,445,524 (“the ’524 patent”), United States Patent No. 8,436,190 (“the ’190 patent”),
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`U.S. Patent No. 8,609,863 (“the ’863 patent”), and United States Patent No. 8,791,270 (“the ’270
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`patent”). This action arises out of Nang Kuang’s filing of an Abbreviated New Drug Application
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`(“ANDA”) seeking approval by the United States Food and Drug Administration (“FDA”) to sell
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`generic versions of TREANDA®, Cephalon’s innovative treatment for chronic lymphocytic
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`leukemia and non-Hodgkin’s lymphoma, prior to the expiration of the ’524 patent, the ’190
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`patent, the ’863 patent and the ’270 patent.
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`THE PARTIES
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`Cephalon, Inc.
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`1.
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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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`
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`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`C.A. No. ___________
`
` )
`
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`CEPHALON, INC.,
`
`
`
`Plaintiff,
`
`v.
`
`
`
`
`NANG KUANG PHARMACEUTICAL CO., LTD.
`and CANDA NK-1, LLC,
`
`
`
`
`Defendants.
`
`COMPLAINT
`
`Cephalon, Inc. (“Cephalon” or “Plaintiff”) brings this action for patent infringement
`
`against Defendants Nang Kuang Pharmaceutical Co., LTD (“Nang Kuang”) and CANDA NK-1,
`
`LLC (“CANDA”) (collectively, “CANDA/Nang Kuang” or “Defendants”).
`
`This is an action by Cephalon against Defendants for infringement of United States
`
`Patent No. 8,445,524 (“the ’524 patent”), United States Patent No. 8,436,190 (“the ’190 patent”),
`
`U.S. Patent No. 8,609,863 (“the ’863 patent”), and United States Patent No. 8,791,270 (“the ’270
`
`patent”). This action arises out of Nang Kuang’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 ’524 patent, the ’190
`
`patent, the ’863 patent and the ’270 patent.
`
`THE PARTIES
`
`Cephalon, Inc.
`
`1.
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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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`Case 1:14-cv-01117-GMS Document 1 Filed 09/02/14 Page 2 of 22 PageID #: 2
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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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`Defendants
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`2.
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`On information and belief, Defendant Nang Kuang Pharmaceutical Co., LTD is a
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`Taiwanese pharmaceutical company with its principal place of business at No. 1001, Zhongshan
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`Rd, Xinhua Dist, Tainan City, Taiwan.
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`3.
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`On information and belief, Nang Kuang is in the business of making and selling
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`generic pharmaceutical products, which it distributes, markets, and/or sells in the State of
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`Delaware, and throughout the United States.
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`4.
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`On information and belief, Defendant CANDA NK-1, LLC is a Texas limited
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`liability company having its offices at 1404 S. New Road, Waco, TX 76711.
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`5.
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`On information and belief, CANDA owns the rights to ANDA No. 206554, which
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`was filed by Nang Kuang. On information and belief, CANDA is in the business of making and
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`selling generic pharmaceutical products, which it distributes, markets, and/or sells in the State of
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`Delaware, and throughout the United States.
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`JURISDICTION AND VENUE
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`Subject Matter Jurisdiction
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`6.
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`7.
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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 Defendants
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`8.
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`On information and belief, this Court has personal jurisdiction over Nang Kuang
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`because Nang Kuang: (1) conducts business in this Judicial District and (2) has engaged in
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`2
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`Case 1:14-cv-01117-GMS Document 1 Filed 09/02/14 Page 3 of 22 PageID #: 3
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`continuous and systematic contacts with the State of Delaware and/or purposefully has availed
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`itself of this forum by, among other things, making, marketing, shipping, using, offering to sell
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`or selling, or causing others to use, offer to sell, or sell, Nang Kuang pharmaceutical products in
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`this Judicial District, and deriving substantial revenue from such activities. On information and
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`belief, Nang Kuang also has committed, or aided, abetted, contributed to and/or participated in
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`the commission of, the tortious action of patent infringement that has led to foreseeable harm and
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`injury to Cephalon, which manufactures TREANDA® for sale and use throughout the United
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`States, including the State of Delaware.
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`9.
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`On information and belief, this Court has personal jurisdiction over CANDA NK-
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`1, LLC because CANDA NK-1, LLC: (1) conducts business in this Judicial District and (2) has
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`engaged in continuous and systematic contacts with the State of Delaware and/or purposefully
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`has availed itself of this forum by, among other things, making, marketing, shipping, using,
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`offering to sell or selling, or causing others to use, offer to sell, or sell, CANDA NK-1, LLC
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`pharmaceutical products in this Judicial District. On information and belief, CANDA NK-1,
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`LLC also has committed, or aided, abetted, contributed to and/or participated in the commission
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`of, the tortious action of patent infringement that has led to foreseeable harm and injury to
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`Cephalon, which manufactures TREANDA® for sale and use throughout the United States,
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`including the State of Delaware.
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`Venue
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`10.
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`Venue is proper in this Judicial District under 28 U.S.C. §§ 1391 and 1400(b).
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`3
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`Case 1:14-cv-01117-GMS Document 1 Filed 09/02/14 Page 4 of 22 PageID #: 4
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`The ’524 Patent
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`BACKGROUND
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`11.
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`The ’524 patent, entitled “Solid Forms of Bendamustine Hydrochloride,” was
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`duly and lawfully issued on May 21, 2013 to inventors Laurent D. Courvoisier, Robert E.
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`McKean, Hans-Joachim Jänsch, and Veronique Courvoisier.
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`12.
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`The named inventors of the ’524 patent assigned their rights in the ’524 patent to
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`Cephalon.
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`13.
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`Cephalon is the sole owner by assignment of all rights, title and interest in the
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`’524 patent.
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`14.
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`The ’524 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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`15.
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`The ’524 patent will expire on March 26, 2029. A true and accurate copy of the
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`’524 patent is attached hereto as Exhibit A.
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`The ’190 Patent
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`16.
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`The ’190 patent, entitled “Bendamustine Pharmaceutical Compositions,” was duly
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`and lawfully issued on May 7, 2013 to inventors Jason Edward Brittain and Joe Craig Franklin.
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`17.
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`The named inventors of the ’190 patent assigned their rights in the ’190 patent to
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`Cephalon.
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`18.
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`Cephalon is the sole owner by assignment of all rights, title and interest in the
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`’190 patent.
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`19.
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`The ’190 patent is listed in the Orange Book with respect to TREANDA®.
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`4
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`Case 1:14-cv-01117-GMS Document 1 Filed 09/02/14 Page 5 of 22 PageID #: 5
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`20.
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`The ’190 patent will expire on October 26, 2030. A true and accurate copy of the
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`’190 patent is attached hereto as Exhibit B.
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`The ’863 Patent
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`21.
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`The ’863 patent, entitled “Bendamustine Pharmaceutical Compositions,” was duly
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`and lawfully issued on December 17, 2013 to inventors Jason Edward Brittain and Joe Craig
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`Franklin.
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`22.
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`The named inventors of the ’863 patent assigned their rights in the ’863 patent to
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`Cephalon.
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`23.
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`Cephalon is the sole owner by assignment of all rights, title and interest in the
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`’863 patent.
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`24.
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`25.
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`The ’863 patent is listed in the Orange Book with respect to TREANDA®.
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`The ’863 patent will expire on January 12, 2026. A true and accurate copy of the
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`’863 patent is attached hereto as Exhibit C.
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`The ’270 Patent
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`26.
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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 Edward Brittain and Joe Craig Franklin.
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`27.
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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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`28.
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`Cephalon is the sole owner by assignment of all rights, title and interest in the
`
`’270 patent.
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`29.
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`30.
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`The ’270 patent is listed in the Orange Book with respect to TREANDA®.
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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 D.
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`5
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`Case 1:14-cv-01117-GMS Document 1 Filed 09/02/14 Page 6 of 22 PageID #: 6
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`The TREANDA® Drug Product
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`31.
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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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`32.
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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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`33.
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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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`34.
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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 CANDA/Nang Kuang ANDA
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`35.
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`Nang Kuang filed with FDA an Abbreviated New Drug Application under 21
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`U.S.C. § 355(j) seeking approval to manufacture, use, offer for sale, sell and import into the
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`United States a bendamustine hydrochloride for injection, 25 mg/vial and 100 mg/vial
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`(“Defendants’ Bendamustine Product”) prior to the expiration of the ’524 patent, the ’190 patent
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`and the ’863 patent.
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`36.
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`FDA assigned the ANDA for Defendants’ Bendamustine Product the number
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`206554.
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`37.
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`Nang Kuang also filed with FDA, pursuant to 21 U.S.C. § 355(j)(2)(B)(iv), a
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`certification alleging that the claims of the ’524 patent, ’190 patent and the ’863 patent are
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`invalid, unenforceable and/or would not be infringed by the manufacture, use, importation, sale
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`6
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`Case 1:14-cv-01117-GMS Document 1 Filed 09/02/14 Page 7 of 22 PageID #: 7
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`or offer for sale of Defendants’ Bendamustine Product (“CANDA/Nang Kuang’s Paragraph IV
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`Certification”).
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`38.
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`By letter dated July 22, 2014, CANDA/Nang Kuang notified Cephalon that it had
`
`filed ANDA No. 206554.seeking approval to market Defendants’ Bendamustine Product prior to
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`the expiration of the ’524 patent, the ’190 patent and the ’863 patent (“CANDA/Nang Kuang
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`Notice Letter”).
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`39.
`
`On August 13. 2014, pursuant to an Offer of Confidential Access, Cephalon
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`received portions of the ANDA filed by CANDA/Nang Kuang, and Cephalon reviewed those
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`portions of the ANDA with respect to the ’524 patent, the ’190 patent and the ’863 patent only.
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`40.
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`This Action is being commenced before the expiration of forty-five days from the
`
`date of receipt of the CANDA/Nang Kuang Notice Letter.
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`COUNT I FOR INFRINGEMENT OF U.S. PATENT NO. 8,445,524 BY DEFENDANTS
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`41.
`
`The allegations of the proceeding paragraphs 1–40 are re-alleged and incorporated
`
`herein by reference.
`
`42.
`
`The use of Defendants’ Bendamustine Product is covered by one or more claims
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`of the ’524 patent.
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`43.
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`The commercial manufacture, use, offer for sale, sale, marketing, distribution
`
`and/or importation of Defendants’ Bendamustine Product would infringe one or more claims of
`
`the ’524 patent.
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`44.
`
`Under 35 U.S.C. § 271(e)(2)(A), CANDA/Nang Kuang’s submission to FDA of
`
`the CANDA/Nang Kuang ANDA to obtain approval for Defendants’ Bendamustine Product with
`
`a Paragraph IV Certification related thereto before the expiration of the ’524 patent constitutes an
`
`act of infringement, and if approved, the commercial manufacture, use, offer to sell, sale, or
`
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`7
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`Case 1:14-cv-01117-GMS Document 1 Filed 09/02/14 Page 8 of 22 PageID #: 8
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`importation of Defendants’ Bendamustine Product containing bendamustine hydrochloride,
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`would infringe one or more claims of the ’524 patent.
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`45.
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`Defendants were aware of the ’524 patent when engaging in these knowing and
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`purposeful activities and were aware that filing the CANDA/Nang Kuang ANDA with
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`CANDA/Nang Kuang’s Paragraph IV Certification with respect to the ’524 patent constituted an
`
`act of infringement of the ’524 patent.
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`46.
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`On information and belief, Defendants’ 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 ’524 patent.
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`47.
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`On information and belief, the manufacture of Defendants’ Bendamustine Product
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`is made using the solid form of bendamustine hydrochloride described in one or more claims of
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`the ’524 patent.
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`48.
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`Defendants’ use of the solid form of bendamustine hydrochloride in the
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`manufacture of Defendants’ Bendamustine Product infringes one or more claims of the ’524
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`patent.
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`49.
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`On information and belief, Defendants plan and intend to, and will, infringe the
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`’524 patent immediately and imminently upon approval of the CANDA/Nang Kuang ANDA.
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`50.
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`On information and belief, Defendants, under 35 U.S.C. § 271(b), acted in
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`concert, actively supported, participated in, encouraged, and/or induced the infringement of one
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`or more claims of the ’524 patent.
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`51.
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`On information and belief, Defendants plan and intend to, and will, actively
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`induce infringement of the ’524 patent when the CANDA/Nang Kuang ANDA is approved, and
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`plan and intend to, and will, do so immediately and imminently upon approval.
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`8
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`Case 1:14-cv-01117-GMS Document 1 Filed 09/02/14 Page 9 of 22 PageID #: 9
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`52.
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`On information and belief, Defendants know that the solid form of bendamustine
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`hydrochloride used to manufacture Defendants’ Bendamustine Product is especially made or
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`adapted for use in infringing the ’524 patent and that the solid form of bendamustine
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`hydrochloride used to manufacture Defendants’ Bendamustine Product is not suitable for
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`substantial non-infringing uses. On information and belief, Defendants plan and intend to, and
`
`will, contribute to the infringement of the ’524 patent immediately and imminently upon
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`approval of the CANDA/Nang Kuang ANDA.
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`53.
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`The foregoing actions by Defendants constitute and/or would constitute
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`infringement of the ’524 patent, active inducement of infringement of the ’524 patent and/or
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`contribution to the infringement by others of the ’524 patent.
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`54.
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`On information and belief, Defendants acted without a reasonable basis for
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`believing that it would not be liable for infringing the ’524 patent, actively inducing infringement
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`of the ’524 patent and/or contributing to the infringement by others of the ’524 patent.
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`55.
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`Cephalon will be substantially and irreparably harmed by Defendants’ infringing
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`activities unless the Court enjoins those activities. Cephalon will have no adequate remedy at
`
`law if Defendants are not enjoined from the commercial manufacture, use, offer to sell, sale in
`
`and importation into the United States of Defendants’ Bendamustine Product.
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`56.
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`Defendants’ activities render this case an exceptional one, and Cephalon is
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`entitled to an award of their reasonable attorney fees under 35 U.S.C. § 285.
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`COUNT II FOR DECLARATORY JUDGMENT OF
`INFRINGEMENT OF U.S. PATENT NO. 8,445,524 BY DEFENDANTS
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`57.
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`The allegations of the proceeding paragraphs 1–56 are re-alleged and incorporated
`
`
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`herein by reference.
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`9
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`Case 1:14-cv-01117-GMS Document 1 Filed 09/02/14 Page 10 of 22 PageID #: 10
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`58.
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`On information and belief, Defendants plan to begin manufacturing, marketing,
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`selling, offering to sell and/or importing Defendants’ Bendamustine Product soon after FDA
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`approval of the CANDA/Nang Kuang ANDA.
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`59.
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`Such conduct will constitute direct infringement of one or more claims on the
`
`’524 patent under 35 U.S.C. § 271(a), inducement of infringement of the ’524 patent under 35
`
`U.S.C. § 271(b), and contributory infringement under 35 U.S.C. § 271(c).
`
`60.
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`Defendants’ infringing patent activity complained of herein is imminent and will
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`begin following FDA approval of the CANDA/Nang Kuang ANDA.
`
`61.
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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 Cephalon and Defendants as to liability for the infringement of
`
`the ’524 patent. Defendants’ actions have created in Cephalon a reasonable apprehension of
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`irreparable harm and loss resulting from Defendants’ threatened imminent actions.
`
`62.
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`On information and belief, Defendants will knowingly and willfully infringe the
`
`’524 patent.
`
`63.
`
`Cephalon will be irreparably harmed if Defendants are not enjoined from
`
`infringing the ’524 patent.
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`COUNT III FOR INFRINGEMENT OF U.S. PATENT NO. 8,436,190 BY DEFENDANTS
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`64.
`
`The allegations of the proceeding paragraphs 1–63 are re-alleged and incorporated
`
`herein by reference.
`
`65.
`
`The use of Defendants’ Bendamustine Product is covered by one or more claims
`
`of the ’190 patent.
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`10
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`Case 1:14-cv-01117-GMS Document 1 Filed 09/02/14 Page 11 of 22 PageID #: 11
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`66.
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`The commercial manufacture, use, offer for sale, sale, marketing, distribution
`
`and/or importation of Defendants’ Bendamustine Product would infringe one or more claims of
`
`the ’190 patent.
`
`67.
`
`Under 35 U.S.C. § 271(e)(2)(A), CANDA/Nang Kuang’s submission to FDA of
`
`the CANDA/Nang Kuang ANDA to obtain approval for Defendants’ Bendamustine Product with
`
`a Paragraph IV Certification related thereto before the expiration of the ’190 patent constitutes an
`
`act of infringement, and if approved, the commercial manufacture, use, offer to sell, sale, or
`
`importation of Defendants’ Bendamustine Product containing bendamustine hydrochloride,
`
`would infringe one or more claims of the ’190 patent.
`
`68.
`
`Defendants were aware of the ’190 patent when engaging in these knowing and
`
`purposeful activities and were aware that filing the CANDA/Nang Kuang ANDA with
`
`CANDA/Nang Kuang’s Paragraph IV Certification with respect to the ’190 patent constituted an
`
`act of infringement of the ’190 patent.
`
`69.
`
`On information and belief, Defendants’ Bendamustine Product contains the same
`
`active pharmaceutical ingredient, bendamustine hydrochloride, as that used in Cephalon’s
`
`TREANDA® products and claimed in the ’190 patent.
`
`70.
`
`On information and belief, the manufacture of Defendants’ Bendamustine Product
`
`is made by lyophilizing the bendamustine hydrochloride pharmaceutical compositions described
`
`in one or more claims of the ’190 patent.
`
`71.
`
`Defendants’ use of a lyophilized bendamustine hydrochloride pharmaceutical
`
`composition in the manufacture of Defendants’ Bendamustine Product infringes one or more
`
`claims of the ’190 patent.
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`11
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`Case 1:14-cv-01117-GMS Document 1 Filed 09/02/14 Page 12 of 22 PageID #: 12
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`72.
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`On information and belief, Defendants plan and intend to, and will, infringe the
`
`’190 patent immediately and imminently upon approval of the CANDA/Nang Kuang ANDA.
`
`73.
`
`On information and belief, Defendants, 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 ’190 patent.
`
`74.
`
`On information and belief, Defendants plan and intend to, and will, actively
`
`induce infringement of the ’190 patent when the CANDA/Nang Kuang ANDA is approved, and
`
`plan and intend to, and will, do so immediately and imminently upon approval.
`
`75.
`
`On information and belief, Defendants know that the lyophilized bendamustine
`
`hydrochloride pharmaceutical composition used to manufacture Defendants’ Bendamustine
`
`Product is especially made or adapted for use in infringing the ’190 patent and that the
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`bendamustine hydrochloride pharmaceutical composition used to manufacture Defendants’
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`Bendamustine Product is not suitable for substantial non-infringing uses. On information and
`
`belief, Defendants plan and intend to, and will, contribute to the infringement of the ’190 patent
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`immediately and imminently upon approval of the CANDA/Nang Kuang ANDA.
`
`76.
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`The foregoing actions by Defendants constitute and/or would constitute
`
`infringement of the ’190 patent, active inducement of infringement of the ’190 patent and/or
`
`contribution to the infringement by others of the ’190 patent.
`
`77.
`
`On information and belief, Defendants acted without a reasonable basis for
`
`believing that they would not be liable for infringing the ’190 patent, actively inducing
`
`infringement of the ’190 patent and/or contributing to the infringement by others of the ’190
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`patent.
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`12
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`Case 1:14-cv-01117-GMS Document 1 Filed 09/02/14 Page 13 of 22 PageID #: 13
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`78.
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`Cephalon will be substantially and irreparably harmed by Defendants’ infringing
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`activities unless the Court enjoins those activities. Cephalon will have no adequate remedy at
`
`law if Defendants are not enjoined from the commercial manufacture, use, offer to sell, sale in
`
`and importation into the United States of Defendants’ Bendamustine Product.
`
`79.
`
`Defendants’ activities render this case an exceptional one, and Cephalon is
`
`entitled to an award of their reasonable attorney fees under 35 U.S.C. § 285.
`
`COUNT IV FOR DECLARATORY JUDGMENT OF
`INFRINGEMENT OF U.S. PATENT NO. 8,436,190 BY DEFENDANTS
`
`80.
`
`The allegations of the proceeding paragraphs 1–79 are re-alleged and incorporated
`
`
`
`herein by reference.
`
`81.
`
`On information and belief, Defendants plan to begin manufacturing, marketing,
`
`selling, offering to sell and/or importing Defendants’ Bendamustine Product soon after FDA
`
`approval of the CANDA/Nang Kuang ANDA.
`
`82.
`
`Such conduct will constitute direct infringement of one or more claims on the
`
`’190 patent under 35 U.S.C. § 271(a), inducement of infringement of the ’190 patent under 35
`
`U.S.C. § 271(b), and contributory infringement under 35 U.S.C. § 271(c).
`
`83.
`
`Defendants’ infringing patent activity complained of herein is imminent and will
`
`begin following FDA approval of the CANDA/Nang Kuang ANDA.
`
`84.
`
`As a result of the foregoing facts, there is a real, substantial, and continuing
`
`justiciable controversy between Cephalon and Defendants as to liability for the infringement of
`
`the ’190 patent. Defendants’ actions have created in Cephalon a reasonable apprehension of
`
`irreparable harm and loss resulting from Defendants’ threatened imminent actions.
`
`85.
`
`On information and belief, Defendants will knowingly and willfully infringe the
`
`’190 patent.
`
`
`
`13
`
`
`
`Case 1:14-cv-01117-GMS Document 1 Filed 09/02/14 Page 14 of 22 PageID #: 14
`
`86.
`
`Cephalon will be irreparably harmed if Defendants are not enjoined from
`
`infringing the ’190 patent.
`
`COUNT V FOR INFRINGEMENT OF U.S. PATENT NO. 8,609,863 BY DEFENDANTS
`
`87.
`
`The allegations of the proceeding paragraphs 1–86 are re-alleged and incorporated
`
`herein by reference.
`
`88.
`
`The use of Defendants’ Bendamustine Product is covered by one or more claims
`
`of the ’863 patent.
`
`89.
`
`The commercial manufacture, use, offer for sale, sale, marketing, distribution
`
`and/or importation of Defendants’ Bendamustine Product would infringe one or more claims of
`
`the ’863 patent.
`
`90.
`
`Under 35 U.S.C. § 271(e)(2)(A), CANDA/Nang Kuang’s submission to FDA of
`
`the CANDA/Nang Kuang ANDA to obtain approval for CANDA/Nang Kuang’s Bendamustine
`
`Product with a Paragraph IV Certification related thereto before the expiration of the ’863 patent
`
`constitutes an act of infringement, and if approved, the commercial manufacture, use, offer to
`
`sell, sale, or importation of Defendants’ Bendamustine Product containing bendamustine
`
`hydrochloride, would infringe one or more claims of the ’863 patent.
`
`91.
`
`Defendants were aware of the ’863 patent when engaging in these knowing and
`
`purposeful activities and were aware that filing the CANDA/Nang Kuang ANDA with
`
`CANDA/Nang Kuang’s Paragraph IV Certification with respect to the ’863 patent constituted an
`
`act of infringement of the ’863 patent.
`
`92.
`
`On information and belief, Defendants’ Bendamustine Product contains the same
`
`active pharmaceutical ingredient, bendamustine hydrochloride, as that used in Cephalon’s
`
`TREANDA® products and claimed in the ’863 patent.
`
`
`
`14
`
`
`
`Case 1:14-cv-01117-GMS Document 1 Filed 09/02/14 Page 15 of 22 PageID #: 15
`
`93.
`
`On information and belief, the manufacture of Defendants’ Bendamustine Product
`
`is made by lyophilizing a bendamustine hydrochloride pharmaceutical composition covered by
`
`one or more claims of the ’863 patent.
`
`94.
`
`Defendants’ use of a lyophilized bendamustine hydrochloride pharmaceutical
`
`composition in the manufacture of Defendants’ Bendamustine Product infringes one or more
`
`claims of the ’863 patent.
`
`95.
`
`On information and belief, Defendants plan and intend to, and will, infringe the
`
`’863 patent immediately and imminently upon approval of the CANDA/Nang Kuang ANDA.
`
`96.
`
`On information and belief, Defendants, 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 ’863 patent.
`
`97.
`
`On information and belief, Defendants plan and intend to, and will, actively
`
`induce infringement of the ’863 patent when the CANDA/Nang Kuang ANDA is approved, and
`
`plan and intend to, and will, do so immediately and imminently upon approval.
`
`98.
`
`On information and belief, Defendants know that the lyophilized bendamustine
`
`hydrochloride pharmaceutical composition used to manufacture Defendants’ Bendamustine
`
`Product is especially made or adapted for use in infringing the ’863 patent and that the
`
`lyophilized bendamustine hydrochloride pharmaceutical composition used to manufacture
`
`Defendants’ Bendamustine Product is not suitable for substantial non-infringing uses. On
`
`information and belief, Defendants plan and intend to, and will, contribute to the infringement of
`
`the ’863 patent immediately and imminently upon approval of the CANDA/Nang Kuang ANDA.
`
`
`
`15
`
`
`
`Case 1:14-cv-01117-GMS Document 1 Filed 09/02/14 Page 16 of 22 PageID #: 16
`
`99.
`
`The foregoing actions by Defendants constitute and/or would constitute
`
`infringement of the ’863 patent, active inducement of infringement of the ’863 patent and/or
`
`contribution to the infringement by others of the ’863 patent.
`
`100. On information and belief, Defendants acted without a reasonable basis for
`
`believing that they would not be liable for infringing the ’863 patent, actively inducing
`
`infringement of the ’863 patent and/or contributing to the infringement by others of the ’863
`
`patent.
`
`101. Cephalon will be substantially and irreparably harmed by Defendants’ infringing
`
`activities unless the Court enjoins those activities. Cephalon will have no adequate remedy at
`
`law if Defendants are not enjoined from the commercial manufacture, use, offer to sell, sale in
`
`and importation into the United States of Defendants’ Bendamustine Product.
`
`102. Defendants’ activities render this case an exceptional one, and Cephalon is
`
`entitled to an award of their reasonable attorney fees under 35 U.S.C. § 285.
`
`COUNT VI FOR DECLARATORY JUDGMENT OF
`INFRINGEMENT OF U.S. PATENT NO. 8,609,863 BY DEFENDANTS
`
`103. The allegations of the proceeding paragraphs 1–102 are re-alleged and
`
`
`
`incorporated herein by reference.
`
`104. On information and belief, Defendants plan to begin manufacturing, marketing,
`
`selling, offering to sell and/or importing Defendants’ Bendamustine Product soon after FDA
`
`approval of the CANDA/Nang Kuang ANDA.
`
`105. Such conduct will constitute direct infringement of one or more claims of the ’863
`
`patent under 35 U.S.C. § 271(a), inducement of infringement of the ’863 patent under 35 U.S.C.
`
`§ 271(b), and contributory infringement under 35 U.S.C. § 271(c).
`
`
`
`16
`
`
`
`Case 1:14-cv-01117-GMS Document 1 Filed 09/02/14 Page 17 of 22 PageID #: 17
`
`106. Defendants’ infringing patent activity complained of herein is imminent and will
`
`begin following FDA approval of the CANDA/Nang Kuang ANDA.
`
`107. As a result of the foregoing facts, there is a real, substantial, and continuing
`
`justiciable controversy between Cephalon and Defendants as to liability for the infringement of
`
`the ’863 patent. Defendants’ actions have created in Cephalon a reasonable apprehension of
`
`irreparable harm and loss resulting from Defendants’ threatened imminent actions.
`
`108. On information and belief, Defendants will knowingly and willfully infringe the
`
`’863 patent.
`
`109. Cephalon will be irreparably harmed if Defendants are not enjoined from
`
`infringing the ’863 patent.
`
`COUNT VII DECLARATORY JUDGMENT OF
`INFRINGEMENT OF U.S. PATENT NO. 8,791,270 BY DEFENDANTS
`
`110. The allegations of the proceeding paragraphs 1–109 are re-alleged and
`
`incorporated herein by reference.
`
`111. The use of Defendants’ Bendamustine Product is covered by one or more claims
`
`of the ’270 patent.
`
`112. The commercial manufacture, use, offer for sale, sale, marketing, distribution
`
`and/or importation of Defendants’ Bendamustine Product would infringe one or more claims of
`
`the ’270 patent.
`
`113. On information and belief, Defendants plan to begin manufacturing, marketing,
`
`selling, offering to sell and/or importing Defendants’ Bendamustine Product soon after FDA
`
`approval of the CANDA/Nang Kuang ANDA.
`
`
`
`17
`
`
`
`Case 1:14-cv-01117-GMS Document 1 Filed 09/02/14 Page 18 of 22 PageID #: 18
`
`114. 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).
`
`115. Defendants’ infringing patent activity complained of herein is imminent and will
`
`begin following FDA approval of the CANDA/Nang Kuang ANDA.
`
`116. As a result of the foregoing facts, there is a real, substantial, and continuing
`
`justiciable controversy between Plaintiff and Defendants as to liability for the infringement of
`
`the ’270 patent. Defendants’ actions have created in Plaintiff a reasonable apprehension of
`
`irreparable harm and loss resulting from Defendants’ threatened imminent actions.
`
`117. On information and belief, Defendants’ Bendamustine Product contains the same
`
`active pharmaceutical ingredient, bendamustine hydrochloride, as that used in Cephalon’s
`
`TREANDA® products and claimed in the ’270 patent.
`
`118. On information and belief, Defendants’ 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.
`
`119. On information and belief, Defendants’ 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.
`
`120. On information and belief, Defendants’ Bendamustine Product infringes one or
`
`more claims of the ’270 patent.
`
`121. On information and belief, Defendants plan and intend to, and will, infringe the
`
`’270 patent immediately and imminently upon approval of the CANDA/Nang Kuang ANDA.
`
`
`
`18
`
`
`
`Case 1:14-cv-01117-GMS Document 1 Filed 09/02/14 Page 19 of 22 PageID #: 19
`
`122. On information and belief, Defendants, 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.
`
`123. On information and belief, Defendants plan and intend to, and will, actively
`
`induce infringement of the ’270 patent when the CANDA/Nang Kuang ANDA is approved, and
`
`plan and intend to, and will, do so immediately and imminently upon approval.
`
`124. The foregoing actions by Defendants 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.
`
`125. On information and belief, Defendants will knowingly and willfully infringe the
`
`’270 patent.
`
`126. Cephalon will be substantially and irreparably harmed by Defendants’ infringing
`
`activities unless the Court enjoins those activities. Cephalon will have no adequate remedy at
`
`law if Defendants are not enjoined from the commercial manufacture, use, offer to sell, sale in
`
`and importation into the United States of Defendants’ Bendamustine Product.
`
`127. Defendants’ 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, Cephalon respectfully request the following relief:
`
`a.
`
`a judgment that the ’524 patent, ’190 patent, the ’863 patent and the ’270 patent
`
`are valid and enforceable;
`
`b.
`
`a judgment that Nang Kuang’s submission of the CANDA/Nang Kuang ANDA
`
`No. 206554, including any amendments, was an act of
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