Case 1:15-cv-00404-GMS Document 1 Filed 05/19/15 Page 1 of 32 PageID #: 1
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`CEPHALON, INC.,
`
`
`
`
`
`APOTEX INC. and APOTEX CORP.,
`
`
`v.
`
`Plaintiff,
`
`Defendants.
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`
`
`C.A. No. ___________
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiff Cephalon, Inc. (“Cephalon” or “Plaintiff”) brings this action for patent
`
`infringement against Defendants Apotex, Inc. and Apotex Corp. (“Apotex” or “Defendants”).
`
`1.
`
`This is an action by Cephalon against Apotex for infringement of U.S. Patent
`
`Nos. 8,445,524 (“the ’524 patent”), 8,436,190 (“the ’190 patent”), 8,609,863 (“the ’863 patent”),
`
`8,791,270 (“the ’270 patent”), 8,669,279 (“the ’279 patent”), 8,883,836 (“the ’836 patent”), and
`
`8,895,756 (“the ’756 patent”). This action arises out of Apotex’s filing of its Abbreviated New
`
`Drug Application (“ANDA”) No. 204230 (“Apotex’s ANDA”) seeking approval by the
`
`U.S.Food and Drug Administration (“FDA”) to sell generic versions of TREANDA®, Cephalon’s
`
`innovative drug for the treatment of patients with chronic lymphocytic leukemia and non-
`
`Hodgkin’s lymphoma, prior to the expiration of the ’524, ’190, ’863, ’270, ’279, ’836, and ’756
`
`patents.
`
`PLAINTIFF CEPHALON, INC.
`
`THE PARTIES
`
`2.
`
`Cephalon 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
`
`
`
`

`

`Case 1:15-cv-00404-GMS Document 1 Filed 05/19/15 Page 2 of 32 PageID #: 2
`
`
`
`engaged in the business of research, development, manufacture, and sale of innovative
`
`pharmaceutical products throughout the world.
`
`DEFENDANTS APOTEX, INC. AND APOTEX CORP.
`
`3.
`
`On information and belief, Apotex Inc. is a corporation organized and existing
`
`under the laws of Canada, with its principal place of business at 150 Signet Drive, Toronto,
`
`Ontario, M9L 1T9, Canada.
`
`4.
`
`On information and belief, Apotex Corp. is a corporation organized and existing
`
`under the laws of the State of Delaware, with a place of business at 2400 North Commerce
`
`Parkway, Suite 400, Weston, Florida 33326.
`
`5.
`
`On information and belief, Apotex Corp. is a wholly owned subsidiary of Apotex
`
`Inc.
`
`6.
`
`On information and belief, Apotex Corp. serves as Apotex Inc.’s United States
`
`sales agent and distributor for generic pharmaceuticals, which it distributes in the State of
`
`Delaware and throughout the United States. On information and belief, Apotex Inc. conducts its
`
`North American operations, in part, through Apotex Corp. On information and belief, together,
`
`Apotex Inc. and Apotex Corp. collaborate in the manufacture, marketing, and sale of
`
`pharmaceutical products (including generic drug products manufactured and sold pursuant to
`
`approved Abbreviated New Drug Applications) within the United States generally, and the State
`
`of Delaware specifically.
`
`SUBJECT MATTER JURISDICTION
`
`JURISDICTION AND VENUE
`
`7.
`
`8.
`
`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.
`
`2
`
`

`

`Case 1:15-cv-00404-GMS Document 1 Filed 05/19/15 Page 3 of 32 PageID #: 3
`
`
`
`PERSONAL JURISDICTION
`
`9.
`
`On information and belief, this Court has personal jurisdiction over Apotex Corp.
`
`because Apotex Corp. is incorporated in Delaware and therefore subject to the jurisdiction of this
`
`Court. As a domestic corporation, Apotex Corp. is registered to do business with the Delaware
`
`Department of State Division of Corporations. Furthermore, Apotex Corp. markets and sells
`
`generic drugs within the State of Delaware and throughout the United States. On information
`
`and belief, Apotex Corp. avails itself of the benefits and protections of the laws of the State of
`
`Delaware. For example, upon information and belief, Apotex Corp. is registered with the
`
`Delaware Board of Pharmacy pursuant to 24 Del. C. § 2540. On information and belief, Apotex
`
`Corp. has appointed a registered agent in Delaware (located at The Corporation Trust Company,
`
`Corporation Trust Center, 1209 Orange Street, Wilmington, DE 19801) for the receipt of service
`
`of process.
`
`10.
`
`On information and belief, this Court has personal jurisdiction over Apotex Inc.
`
`because Apotex Inc.: (1) 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 through its wholly owned subsidiary Apotex Corp. by, among other things, making,
`
`marketing, shipping, using, offering to sell or selling, or causing others to use, offer to sell or
`
`sell, Apotex Inc. pharmaceutical products in this Judicial District, and deriving substantial
`
`revenue from such activities. Apotex Inc. 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.
`
`11.
`
`This Court also has personal jurisdiction over Apotex Inc. under Federal Rule of
`
`Civil Procedure 4(k)(2) because this action arises under federal law and, on information and
`
`3
`
`

`

`Case 1:15-cv-00404-GMS Document 1 Filed 05/19/15 Page 4 of 32 PageID #: 4
`
`
`
`belief, Apotex Inc., as a Canadian company, is not subject to the jurisdiction of the courts of
`
`general jurisdiction of any state and the exercise of personal jurisdiction over Apotex Inc. is
`
`consistent with the Constitution and the laws of the United States.
`
`12.
`
`On information and belief, this Court also has personal jurisdiction over Apotex
`
`because Apotex previously has been sued in this Judicial District, did not challenge this Court’s
`
`exertion of personal jurisdiction over it, and availed itself of this forum by asserting
`
`counterclaims for the purpose of litigating a patent infringement dispute. See Otsuka
`
`Pharmaceutical Co. v. Apotex Inc. & Apotex Corp., C.A. No. 15-109 (D. Del.); Aptalis
`
`Pharmatech, Inc. & Ivax International GmbH v. Apotex Inc. & Apotex Corp., C.A. No. 14-1038
`
`(D. Del).
`
`VENUE
`
`13.
`
`Venue is proper in this Judicial District under 28 U.S.C. §§ 1391 and 1400(b).
`
`THE ’524 PATENT
`
`BACKGROUND
`
`14.
`
`The ’524 patent, entitled “Solid Forms of Bendamustine Hydrochloride,” was
`
`duly and lawfully issued on May 21, 2013 to inventors Laurent D. Courvoisier, Robert E.
`
`McKean, and Hans-Joachim Jӓnsch.
`
`15.
`
`The named inventors of the ’524 patent assigned their rights in the ’524 patent to
`
`Cephalon.
`
`16.
`
`Cephalon is the sole owner by assignment of all rights, title and interest in the
`
`’524 patent.
`
`17.
`
`The ’524 patent is listed in FDA publication “Approved Drug Products with
`
`Therapeutic Equivalence Evaluations” (“the Orange Book”) with respect to TREANDA®.
`
`18.
`
`The ’524 patent will expire on March 26, 2029.
`
`4
`
`

`

`Case 1:15-cv-00404-GMS Document 1 Filed 05/19/15 Page 5 of 32 PageID #: 5
`
`
`
`19.
`
`A true and accurate copy of the ’524 patent is attached hereto as Exhibit A.
`
`THE ’190 PATENT
`
`20.
`
`The ’190 patent, entitled “Bendamustine Pharmaceutical Compositions,” was duly
`
`and lawfully issued on May 7, 2013 to inventors Jason Edward Brittain and Joe Craig Franklin.
`
`21.
`
`The named inventors of the ’190 patent assigned their rights in the ’190 patent to
`
`Cephalon.
`
`22.
`
`Cephalon is the sole owner by assignment of all rights, title and interest in the
`
`’190 patent.
`
`23.
`
`24.
`
`25.
`
`The ’190 patent is listed in the Orange Book with respect to TREANDA®.
`
`The ’190 patent will expire on October 26, 2030.
`
`A true and accurate copy of the ’190 patent is attached hereto as Exhibit B.
`
`THE ’863 PATENT
`
`26.
`
`The ’863 patent, entitled “Bendamustine Pharmaceutical Compositions,” was duly
`
`and lawfully issued on December 17, 2013 to inventors Jason Edward Brittain and Joe Craig
`
`Franklin.
`
`27.
`
`The named inventors of the ’863 patent assigned their rights in the ’863 patent to
`
`Cephalon.
`
`28.
`
`Cephalon is the sole owner by assignment of all rights, title and interest in the
`
`’863 patent.
`
`29.
`
`30.
`
`31.
`
`The ’863 patent is listed in the Orange Book with respect to TREANDA®.
`
`The ’863 patent will expire on January 12, 2026.
`
`A true and accurate copy of the ’863 patent is attached hereto as Exhibit C.
`
`5
`
`

`

`Case 1:15-cv-00404-GMS Document 1 Filed 05/19/15 Page 6 of 32 PageID #: 6
`
`
`
`THE ’270 PATENT
`
`32.
`
`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.
`
`33.
`
`The named inventors of the ’270 patent assigned their rights in the ’270 patent to
`
`Cephalon.
`
`34.
`
`Cephalon is the sole owner by assignment of all rights, title and interest in the
`
`’270 patent.
`
`35.
`
`36.
`
`37.
`
`The ’270 patent is listed in the Orange Book with respect to TREANDA®.
`
`The ’270 patent will expire on January 12, 2026.
`
`A true and accurate copy of the ’270 patent is attached hereto as Exhibit D.
`
`THE ’279 PATENT
`
`38.
`
`The ’279 patent, entitled “Solid Forms of Bendamustine Hydrochloride,” was
`
`duly and lawfully issued on March 11, 2014 to inventors Martin Ian Cooper, Laurent D.
`
`Courvoisier, Mark Eddleston, and Robert E. McKean.
`
`39.
`
`The named inventors of the ’279 patent assigned their rights in the ’279 patent to
`
`Cephalon.
`
`40.
`
`Cephalon is the sole owner by assignment of all rights, title and interest in the
`
`’279 patent.
`
`41.
`
`42.
`
`43.
`
`The ’279 patent is listed in the Orange Book with respect to TREANDA®.
`
`The ’279 patent will expire on March 26, 2029.
`
`A true and accurate copy of the ’279 patent is attached hereto as Exhibit E.
`
`6
`
`

`

`Case 1:15-cv-00404-GMS Document 1 Filed 05/19/15 Page 7 of 32 PageID #: 7
`
`
`
`THE ’836 PATENT
`
`44.
`
`The ’836 patent, entitled “Solid Forms of Bendamustine Hydrochloride,” was
`
`duly and lawfully issued on November 11, 2014 to inventors Martin Ian Cooper, Laurent D.
`
`Courvoisier, Mark Eddleston, and Robert E. McKean.
`
`45.
`
`The named inventors of the ’836 patent assigned their rights in the ’836 patent to
`
`Cephalon.
`
`46.
`
`Cephalon is the sole owner by assignment of all rights, title and interest in the
`
`’836 patent.
`
`47.
`
`48.
`
`49.
`
`The ’836 patent is listed in the Orange Book with respect to TREANDA®.
`
`The ’836 patent will expire on March 26, 2029.
`
`A true and accurate copy of the ’836 patent is attached hereto as Exhibit F.
`
`THE ’756 PATENT
`
`50.
`
`The ’756 patent, entitled “Bendamustine Pharmaceutical Compositions,” was duly
`
`and lawfully issued on November 25, 2014 to inventors Jason E. Brittain and Joe C. Franklin.
`
`51.
`
`The named inventors of the ’756 patent assigned their rights in the ’756 patent to
`
`Cephalon.
`
`52.
`
`Cephalon is the sole owner by assignment of all rights, title and interest in the
`
`’756 patent.
`
`53.
`
`54.
`
`55.
`
`The ’756 patent is listed in the Orange Book with respect to TREANDA®.
`
`The ’756 patent will expire on January 12, 2026.
`
`A true and accurate copy of the ’756 patent is attached hereto as Exhibit G.
`
`7
`
`

`

`Case 1:15-cv-00404-GMS Document 1 Filed 05/19/15 Page 8 of 32 PageID #: 8
`
`
`
`THE TREANDA® DRUG PRODUCT
`
`56.
`
`Cephalon researched, developed, applied for and obtained FDA approval to
`
`manufacture, sell, promote and/or market bendamustine hydrochloride products known as
`
`TREANDA®.
`
`57.
`
`Cephalon has been selling, promoting, distributing, and marketing TREANDA® in
`
`the United States since 2008.
`
`58.
`
`TREANDA® is indicated to treat patients with chronic lymphocytic leukemia and
`
`indolent B-cell non-Hodgkin’s lymphoma that has progressed during or within six months of
`
`treatment with rituximab or a rituximab-containing regimen.
`
`59.
`
`Cephalon holds New Drug Application Nos. 22249 and 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 patients with chronic lymphocytic leukemia and indolent B-cell non-
`
`Hodgkin’s lymphoma that has progressed during or within six months of treatment with
`
`rituximab or a rituximab-containing regimen.
`
`APOTEX’S ANDA
`
`60.
`
`Apotex 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 an IV powder for infusion, containing 25 mg of bendamustine HCl and 100 mg
`
`bendamustine HCl (“Apotex’s Bendamustine Product”) prior to the expiration of the patents-in-
`
`suit.
`
`61.
`
`FDA assigned the ANDA for Apotex’s Bendamustine Product the number
`
`204230.
`
`62.
`
`By letter dated April 7, 2015, Apotex notified Cephalon that it had filed Apotex’s
`
`ANDA with a Paragraph IV certification related thereto seeking approval to market Apotex’s
`
`8
`
`

`

`Case 1:15-cv-00404-GMS Document 1 Filed 05/19/15 Page 9 of 32 PageID #: 9
`
`
`
`Bendamustine Product prior to the expiration of the ’524 and ’190 patents (“Apotex’s Notice
`
`Letter”).
`
`63.
`
`On May 19, 2015, pursuant to an Offer of Confidential Access, Cephalon
`
`received protions of the ANDA filed by Apotex, and Cephalon reviewed those portions of the
`
`ANDA.
`
`64.
`
`This action is being commenced before the expiration of forty-five days from the
`
`date of receipt of Apotex’s Notice Letter.
`
`COUNT I FOR INFRINGEMENT OF U.S. PATENT NO. 8,445,524
`
`65.
`
`The allegations of the preceding paragraphs 1–64 are re-alleged and incorporated
`
`herein by reference.
`
`66.
`
`The use of Apotex’s Bendamustine Product is covered by one or more claims of
`
`the ’524 patent.
`
`67.
`
`The commercial manufacture, use, offer for sale, sale, marketing, distribution
`
`and/or importation of Apotex’s Bendamustine Product would infringe one or more claims of the
`
`’524 patent.
`
`68.
`
`Under 35 U.S.C. § 271(e)(2)(A), Apotex’s submission to FDA of Apotex’s
`
`ANDA to obtain approval for Apotex’s 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 importation of Apotex’s
`
`Bendamustine Product containing bendamustine hydrochloride, would infringe one or more
`
`claims of the ’524 patent under 35 U.S.C. § 271(a).
`
`69.
`
`Apotex was aware of the ’524 patent when engaging in these knowing and
`
`purposeful activities and was aware that filing Apotex’s ANDA with Apotex’s Paragraph IV
`
`Certification with respect to the ’524 patent constituted an act of infringement of the ’524 patent.
`
`9
`
`

`

`Case 1:15-cv-00404-GMS Document 1 Filed 05/19/15 Page 10 of 32 PageID #: 10
`
`
`
`70.
`
`On information and belief, Apotex’s Bendamustine Product contains the same
`
`active pharmaceutical ingredient, bendamustine hydrochloride, as that used in Cephalon’s
`
`TREANDA® products and claimed in the ’524 patent.
`
`71.
`
`On information and belief, the manufacture of Apotex’s Bendamustine Product is
`
`made using the solid form of bendamustine hydrochloride described in one or more claims of the
`
`’524 patent.
`
`72.
`
`Apotex’s use of the solid form of bendamustine hydrochloride in the manufacture
`
`of Apotex’s Bendamustine Product infringes one or more claims of the ’524 patent.
`
`73.
`
`On information and belief, Apotex plans and intends to, and will, infringe the
`
`’524 patent immediately and imminently upon approval of Apotex’s ANDA.
`
`74.
`
`On information and belief, Apotex, 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 ’524 patent.
`
`75.
`
`On information and belief, Apotex plans and intends to, and will, actively induce
`
`infringement of the ’524 patent when Apotex’s ANDA is approved, and plans and intends to, and
`
`will, do so immediately and imminently upon approval.
`
`76.
`
`On information and belief, Apotex knows that the solid form of bendamustine
`
`hydrochloride used to manufacture Apotex’s Bendamustine Product is especially made or
`
`adapted for use in infringing the ’524 patent and that the solid form of bendamustine
`
`hydrochloride used to manufacture Apotex’s Bendamustine Product is not suitable for substantial
`
`non-infringing uses. On information and belief, Apotex plans and intends to, and will, contribute
`
`to the infringement of the ’524 patent under 35 U.S.C. § 271(c) immediately and imminently
`
`upon approval of Apotex’s ANDA.
`
`10
`
`

`

`Case 1:15-cv-00404-GMS Document 1 Filed 05/19/15 Page 11 of 32 PageID #: 11
`
`
`
`77.
`
`The foregoing actions by Apotex constitute and/or would constitute infringement
`
`of the ’524 patent, active inducement of infringement of the ’524 patent and/or contribution to
`
`the infringement by others of the ’524 patent.
`
`78.
`
`On information and belief, Apotex acted without a reasonable basis for believing
`
`that it would not be liable for infringing the ’524 patent, actively inducing infringement of the
`
`’524 patent and/or contributing to the infringement by others of the ’524 patent.
`
`79.
`
`Cephalon will be substantially and irreparably harmed by Apotex’s infringing
`
`activities unless the Court enjoins those activities. Cephalon will have no adequate remedy at law
`
`if Apotex is not enjoined from the commercial manufacture, use, offer to sell, sale in and
`
`importation into the United States of Apotex’s Bendamustine Product.
`
`80.
`
`Apotex’s 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 II FOR DECLARATORY JUDGMENT OF
`INFRINGEMENT OF U.S. PATENT NO. 8,445,524
`
`81.
`
`The allegations of the preceding paragraphs 1–80 are re-alleged and incorporated
`
`herein by reference.
`
`82.
`
`On information and belief, Apotex plans to begin manufacturing, marketing,
`
`selling, offering to sell and/or importing Apotex’s Bendamustine Product soon after FDA
`
`approval of Apotex’s ANDA.
`
`83.
`
`Such conduct will constitute direct infringement of one or more claims of 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).
`
`84.
`
`Apotex’s infringing patent activity complained of herein is imminent and will
`
`begin following FDA approval of Apotex’s ANDA.
`
`11
`
`

`

`Case 1:15-cv-00404-GMS Document 1 Filed 05/19/15 Page 12 of 32 PageID #: 12
`
`
`
`85.
`
`As a result of the foregoing facts, there is a real, substantial, and continuing
`
`justiciable controversy between Cephalon and Apotex as to liability for the infringement of the
`
`’524 patent. Apotex’s actions have created in Cephalon a reasonable apprehension of irreparable
`
`harm and loss resulting from Apotex’s threatened imminent actions.
`
`86.
`
`On information and belief, Apotex will knowingly and willfully infringe the ’524
`
`patent.
`
`87.
`
`Cephalon will be irreparably harmed if Apotex is not enjoined from infringing the
`
`’524 patent.
`
`COUNT III FOR INFRINGEMENT OF U.S. PATENT NO. 8,436,190
`
`88.
`
`The allegations of the preceding paragraphs 1–87 are re-alleged and incorporated
`
`herein by reference.
`
`89.
`
`The use of Apotex’s Bendamustine Product is covered by one or more claims of
`
`the ’190 patent.
`
`90.
`
`The commercial manufacture, use, offer for sale, sale, marketing, distribution
`
`and/or importation of Apotex’s Bendamustine Product would infringe one or more claims of the
`
`’190 patent.
`
`91.
`
`Under 35 U.S.C. § 271(e)(2)(A), Apotex’s submission to FDA of Apotex’s
`
`ANDA to obtain approval for Apotex’s 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 Apotex’s
`
`Bendamustine Product containing bendamustine hydrochloride, would infringe one or more
`
`claims of the ’190 patent under 35 U.S.C. § 271(a).
`
`12
`
`

`

`Case 1:15-cv-00404-GMS Document 1 Filed 05/19/15 Page 13 of 32 PageID #: 13
`
`
`
`92.
`
`Apotex was aware of the ’190 patent when engaging in these knowing and
`
`purposeful activities and was aware that filing Apotex’s ANDA with Apotex’s Paragraph IV
`
`Certification with respect to the ’190 patent constituted an act of infringement of the ’190 patent.
`
`93.
`
`On information and belief, Apotex’s Bendamustine Product contains the same
`
`active pharmaceutical ingredient, bendamustine hydrochloride, as that used in Cephalon’s
`
`TREANDA® products and claimed in the ’190 patent.
`
`94.
`
`On information and belief, the manufacture of Apotex’s Bendamustine Product is
`
`made by lyophilizing the bendamustine hydrochloride pharmaceutical compositions described in
`
`one or more claims of the ’190 patent.
`
`95.
`
`Apotex’s use of a lyophilized bendamustine hydrochloride pharmaceutical
`
`composition in the manufacture of Apotex’s Bendamustine Product infringes one or more claims
`
`of the ’190 patent.
`
`96.
`
`On information and belief, Apotex plans and intends to, and will, infringe the
`
`’190 patent immediately and imminently upon approval of Apotex’s ANDA.
`
`97.
`
`On information and belief, Apotex, 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.
`
`98.
`
`On information and belief, Apotex plans and intends to, and will, actively induce
`
`infringement of the ’190 patent when Apotex’s ANDA is approved, and plans and intends to, and
`
`will, do so immediately and imminently upon approval.
`
`99.
`
`On information and belief, Apotex knows that the lyophilized bendamustine
`
`hydrochloride pharmaceutical composition used to manufacture Apotex’s Bendamustine Product
`
`is especially made or adapted for use in infringing the ’190 patent and that the bendamustine
`
`13
`
`

`

`Case 1:15-cv-00404-GMS Document 1 Filed 05/19/15 Page 14 of 32 PageID #: 14
`
`
`
`hydrochloride pharmaceutical composition used to manufacture Apotex’s Bendamustine Product
`
`is not suitable for substantial non-infringing uses. On information and belief, Apotex plans and
`
`intends to, and will, contribute to the infringement of the ’190 patent under 35 U.S.C. § 271(c)
`
`immediately and imminently upon approval of Apotex’s ANDA.
`
`100. The foregoing actions by Apotex 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.
`
`101. On information and belief, Apotex acted without a reasonable basis for believing
`
`that it 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 patent.
`
`102. Cephalon will be substantially and irreparably harmed by Apotex’s infringing
`
`activities unless the Court enjoins those activities. Cephalon will have no adequate remedy at law
`
`if Apotex is not enjoined from the commercial manufacture, use, offer to sell, sale in and
`
`importation into the United States of Apotex’s Bendamustine Product.
`
`103. Apotex’s 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
`
`104. The allegations of the preceding paragraphs 1–103 are re-alleged and incorporated
`
`herein by reference.
`
`105. On information and belief, Apotex plans to begin manufacturing, marketing,
`
`selling, offering to sell and/or importing Apotex’s Bendamustine Product soon after FDA
`
`approval of Apotex’s ANDA.
`
`14
`
`

`

`Case 1:15-cv-00404-GMS Document 1 Filed 05/19/15 Page 15 of 32 PageID #: 15
`
`
`
`106. Such conduct will constitute direct infringement of one or more claims of 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).
`
`107. Apotex’s infringing patent activity complained of herein is imminent and will
`
`begin following FDA approval of Apotex’s ANDA.
`
`108. As a result of the foregoing facts, there is a real, substantial, and continuing
`
`justiciable controversy between Cephalon and Apotex as to liability for the infringement of the
`
`’190 patent. Apotex’s actions have created in Cephalon a reasonable apprehension of irreparable
`
`harm and loss resulting from Apotex’s threatened imminent actions.
`
`109. On information and belief, Apotex will knowingly and willfully infringe the ’190
`
`patent.
`
`110. Cephalon will be irreparably harmed if Apotex is not enjoined from infringing the
`
`’190 patent.
`
`COUNT V FOR INFRINGEMENT OF U.S. PATENT NO. 8,609,863
`
`111. The allegations of the preceding paragraphs 1–110 are re-alleged and incorporated
`
`herein by reference.
`
`112. The use of Apotex’s Bendamustine Product is covered by one or more claims of
`
`the ’863 patent.
`
`113. The commercial manufacture, use, offer for sale, sale, marketing, distribution
`
`and/or importation of Apotex’s Bendamustine Product would infringe one or more claims of the
`
`’863 patent.
`
`114. Under 35 U.S.C. § 271(e)(2)(A), Apotex’s submission to FDA of Apotex’s
`
`ANDA to obtain approval for Apotex’s Bendamustine Product before the expiration of the ’863
`
`patent constitutes an act of infringement, and if approved, the commercial manufacture, use,
`
`15
`
`

`

`Case 1:15-cv-00404-GMS Document 1 Filed 05/19/15 Page 16 of 32 PageID #: 16
`
`
`
`offer to sell, sale, or importation of Apotex’s Bendamustine Product containing bendamustine
`
`hydrochloride, would infringe one or more claims of the ’863 patent under 35 U.S.C. § 271(a).
`
`115. Apotex was aware of the ’863 patent when engaging in these knowing and
`
`purposeful activities and was aware that filing Apotex’s ANDA constituted an act of
`
`infringement of the ’863 patent.
`
`116. On information and belief, Apotex’s Bendamustine Product contains the same
`
`active pharmaceutical ingredient, bendamustine hydrochloride, as that used in Cephalon’s
`
`TREANDA® products and claimed in the ’863 patent.
`
`117. On information and belief, the manufacture of Apotex’s Bendamustine Product is
`
`made by lyophilizing a bendamustine hydrochloride pharmaceutical composition covered by one
`
`or more claims of the ’863 patent.
`
`118. Apotex’s use of a lyophilized bendamustine hydrochloride pharmaceutical
`
`composition in the manufacture of Apotex’s Bendamustine Product infringes one or more claims
`
`of the ’863 patent.
`
`119. On information and belief, Apotex plans and intends to, and will, infringe the
`
`’863 patent immediately and imminently upon approval of Apotex’s ANDA.
`
`120. On information and belief, Apotex, 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.
`
`121. On information and belief, Apotex plans and intends to, and will, actively induce
`
`infringement of the ’863 patent when Apotex’s ANDA is approved, and plans and intends to, and
`
`will, do so immediately and imminently upon approval.
`
`16
`
`

`

`Case 1:15-cv-00404-GMS Document 1 Filed 05/19/15 Page 17 of 32 PageID #: 17
`
`
`
`122. Upon information and belief, Apotex knows that the lyophilized bendamustine
`
`hydrochloride pharmaceutical composition used to manufacture Apotex’s 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 Apotex’s
`
`Bendamustine Product is not suitable for substantial non-infringing uses. On information and
`
`belief, Apotex plans and intends to, and will, contribute to the infringement of the ’863 patent
`
`under 35 U.S.C. § 271(c) immediately and imminently upon approval of Apotex’s ANDA.
`
`123. The foregoing actions by Apotex 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.
`
`124. On information and belief, Apotex acted without a reasonable basis for believing
`
`that it 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.
`
`125. Cephalon will be substantially and irreparably harmed by Apotex’s infringing
`
`activities unless the Court enjoins those activities. Cephalon will have no adequate remedy at law
`
`if Apotex is not enjoined from the commercial manufacture, use, offer to sell, sale in and
`
`importation into the United States of Apotex’s Bendamustine Product.
`
`126. Apotex’s 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
`
`127. The allegations of the preceding paragraphs 1–126 are re-alleged and incorporated
`
`herein by reference.
`
`17
`
`

`

`Case 1:15-cv-00404-GMS Document 1 Filed 05/19/15 Page 18 of 32 PageID #: 18
`
`
`
`128. On information and belief, Apotex plans to begin manufacturing, marketing,
`
`selling, offering to sell and/or importing Apotex’s Bendamustine Product soon after FDA
`
`approval of Apotex’s ANDA.
`
`129. 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).
`
`130. Apotex’s infringing patent activity complained of herein is imminent and will
`
`begin following FDA approval of Apotex’s ANDA.
`
`131. As a result of the foregoing facts, there is a real, substantial, and continuing
`
`justiciable controversy between Cephalon and Apotex as to liability for the infringement of the
`
`’863 patent. Apotex’s actions have created in Cephalon a reasonable apprehension of irreparable
`
`harm and loss resulting from Apotex’s threatened imminent actions.
`
`132. On information and belief, Apotex will knowingly and willfully infringe the ’863
`
`patent.
`
`133. Cephalon will be irreparably harmed if Apotex is not enjoined from infringing the
`
`’863 patent.
`
`COUNT VII FOR INFRINGEMENT OF U.S. PATENT NO. 8,791,270
`
`134. The allegations of the preceding paragraphs 1–133 are re-alleged and incorporated
`
`herein by reference.
`
`135. The use of Apotex’s Bendamustine Product is covered by one or more claims of
`
`the ’270 patent.
`
`136. The commercial manufacture, use, offer for sale, sale, marketing, distribution
`
`and/or importation of Apotex’s Bendamustine Product would infringe one or more claims of the
`
`’270 patent.
`
`18
`
`

`

`Case 1:15-cv-00404-GMS Document 1 Filed 05/19/15 Page 19 of 32 PageID #: 19
`
`
`
`137. Under 35 U.S.C. § 271(e)(2)(A), Apotex’s submission to FDA of Apotex’s
`
`ANDA to obtain approval for Apotex’s Bendamustine Product before the expiration of the ’270
`
`patent constitutes an act of infringement, and if approved, the commercial manufacture, use,
`
`offer to sell, sale, or importation of Apotex’s Bendamustine Product containing bendamustine
`
`hydrochloride, would infringe one or more claims of the ’270 patent under 35 U.S.C. § 271(a).
`
`138. On information and belief, Apotex’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.
`
`139. Apotex was aware of the ’270 patent when engaging in these knowing and
`
`purposeful activities and was aware that filing Apotex’s ANDA constituted an act of
`
`infringement of the ’270 patent.
`
`140. On information and belief, Apotex’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.
`
`141. On information and belief, Apotex’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.
`
`142. On information and belief, Apotex’s Bendamustine Product infringes one