Case 1:15-cv-00178-GMS Document 1 Filed 02/23/15 Page 1 of 85 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. _______________
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`))))))))))))))))))
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`CEPHALON, INC.,
`
`Plaintiff,
`
`v.
`
`SANDOZ INC.; ACCORD HEALTHCARE,
`INC.; INTAS PHARMACEUTICALS LTD.;
`INNOPHARMA, INC.; AGILA
`SPECIALTIES INC. f/k/a STRIDES, INC.;
`ONCO THERAPIES LIMITED; GLENMARK
`PHARMACEUTICALS LTD.; GLENMARK
`GENERICS LTD.; GLENMARK GENERICS
`S.A.; GLENMARK GENERICS INC., USA;
`EUROHEALTH INTERNATIONAL SARL;
`and WEST-WARD PHARMACEUTICAL
`CORP.,
`
`Defendants.
`
`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiff Cephalon, Inc. (“Cephalon” or “Plaintiff”) brings this action for patent
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`infringement against Defendants Sandoz Inc. (“Sandoz”); Accord Healthcare, Inc. and Intas
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`Pharmaceuticals Ltd. (collectively, “Accord/Intas”); InnoPharma, Inc. (“InnoPharma”); Agila
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`Specialties Inc. f/k/a Strides, Inc. (“Agila”) and Onco Therapies Limited (“Onco”) (collectively
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`“Agila/Onco”); Glenmark Pharmaceuticals Ltd., Glenmark Generics Ltd., Glenmark Generics
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`S.A. and Glenmark Generics Inc., USA (collectively, “Glenmark”); and Eurohealth International
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`Sarl (“Eurohealth”) and West-Ward Pharmaceutical Corp. (“West-Ward”) (collectively,
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`“Eurohealth/West-Ward”), (collectively, “Defendants”).
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`1.
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`This is an action by Cephalon against Defendants for infringement of United
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`States Patent No. 8,669,279 (“the ’279 patent”), United States Patent No. 8,883,836 (“the ’836
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`patent”), and United States Patent No. 8,895,756 (“the ’756 patent”). This action arises out of
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`Defendants’ filing of their respective Abbreviated New Drug Applications (“ANDAs”) seeking
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`Case 1:15-cv-00178-GMS Document 1 Filed 02/23/15 Page 2 of 85 PageID #: 2
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`approval by the United States Food and Drug Administration (“FDA”) to sell generic versions of
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`TREANDA®, Cephalon’s innovative drug for the treatment of patients with chronic lymphocytic
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`leukemia and non-Hodgkin’s lymphoma, prior to the expiration of the ’279 patent, the ’836
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`patent, and the ’756 patent.
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`Cephalon, Inc.
`
`THE PARTIES
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`2.
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`Plaintiff Cephalon, Inc. is a corporation operating and existing under the laws of
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`Delaware, with its principal place of business at 41 Moores Road, Frazer, Pennsylvania 19355.
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`Cephalon is engaged in the business of research, development, manufacture, and sale of
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`innovative pharmaceutical products throughout the world.
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`DEFENDANTS
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`Sandoz
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`3.
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`On information and belief, Defendant Sandoz is a corporation organized and
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`existing under the laws of the State of Colorado, with its principal place of business at 506
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`Carnegie Center, Suite 400, Princeton, New Jersey.
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`Accord/Intas
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`4.
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`On information and belief, Defendant Accord Healthcare Inc. is a corporation
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`organized and existing under the laws of the State of North Carolina, with its principal place of
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`business at 1009 Slater Road, Suite 21 OB, Durham, North Carolina, 27703.
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`5.
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`On information and belief, Defendant Intas Pharmaceuticals Ltd. is a corporation
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`organized and existing under the laws of India, with its principal place of business at Chinubhai
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`Center Off. Nehru Bridge, Ashram Road, Ahmedabad 380009, Gujarat, India.
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`6.
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`On information and belief, Accord Healthcare Inc. is a wholly owned subsidiary
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`of Intas Pharmaceuticals Ltd.
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`InnoPharma, Inc.
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`7.
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`On information and belief, Defendant InnoPharma is a corporation organized and
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`existing under the laws of the State of Delaware, with its principal place of business at 10
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`Knightsbridge Road, Piscataway, New Jersey 08854.
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`Agila/Onco
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`8.
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`On information and belief, Defendant Agila is a corporation organized and
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`existing under the laws of New Jersey, with its principal place of business at 201 South Main
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`Street, Suite #3, Lambertville, New Jersey 08530.
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`9.
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`On information and belief, Defendant Onco is a corporation organized and
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`existing under the laws of India, with its principal place of business at Strides House, Bilkahalli,
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`Bannerghatta Road, Bangalore, Karnataka India 560076.
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`10.
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`On information and belief, both Agila and Onco submitted, collaborated and/or
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`acted in concert in the preparation or submission of ANDA No. 204104.
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`Glenmark
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`11.
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`On information and belief, Defendant Glenmark Pharmaceuticals Ltd. is an Indian
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`corporation having a place of business at Glenmark House, HDO – Corporate Bldg., Wing A, B.
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`D. Sawant Marg, Chakala, Off Western Express Highway, Andheri [East], Mumbai, 400 099,
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`India.
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`12.
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`On information and belief, Defendant Glenmark Generics Ltd. is an Indian
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`corporation having a place of business at Glenmark House, HDO – Corporate Bldg., Wing A, B.
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`D. Sawant Marg, Chakala, Off Western Express Highway, Andheri [East], Mumbai, 400 099,
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`India.
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`3
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`13.
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`On information and belief, Defendant Glenmark Generics S.A. is an Argentine
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`corporation having a place of business at Parque Industrial, Calle 9 Ing. Meyer Oks No 593,
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`Pilar, Argentina.
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`14.
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`On information and belief, Defendant Glenmark Generics Inc., USA is a
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`corporation organized and existing under the laws of the State of Delaware, having a principal
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`place of business at 750 Corporate Drive, Mahwah, NJ 07430.
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`15.
`
`On information and belief, Glenmark Generics Inc., USA and Glenmark Generics
`
`S.A. are wholly owned subsidiaries of Glenmark Generics Ltd.
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`16.
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`On information and belief, Glenmark Generics Ltd. is a wholly owned subsidiary
`
`of Glenmark Pharmaceuticals Ltd.
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`17.
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`On information and belief, Glenmark Generics Inc., USA acts as an agent of
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`Glenmark Pharmaceuticals Ltd.
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`Eurohealth/West-Ward
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`18.
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`On information and belief, Defendant Eurohealth is a company incorporated in
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`Switzerland with a principal place of business at Rue des Battoirs 7, 1205 Geneve, Switerland.
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`19.
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`On information and belief, Defendant West-Ward is a corporation organized and
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`existing under the laws of the State of Delaware with a principal place of business at 401
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`Industrial Way West, Eatontown, New Jersey 07724.
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`20.
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`On information and belief, West-Ward acts as a domestic marketer, manufacturer,
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`and distributor of drug products for sale and use throughout the United States for entities
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`affiliated with Hikma Pharmaceuticals PLC (“Hikma”), including Eurohealth. On information
`
`and belief, West-Ward is the authorized U.S. agent for Eurohealth. West-Ward’s website also
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`indicates that it has a sales representative for the State of Delaware. On information and belief,
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`West-Ward is a wholly owned subsidiary of Eurohealth (U.S.A.) Inc., and its parent, Hikma.
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`21.
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`On information and belief, Hikma acquired the assets of Bedford, an
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`unincorporated division of Ben Venue Laboratories, Inc., a corporation organized and existing
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`under the laws of the State of Delaware, both having a place of business at 300 Northfield Road,
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`Bedford, Ohio 44146, on or about July 15, 2014. Hikma’s website states that it acquired
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`Bedford’s “large product portfolio, intellectual property rights, contracts for products marketed
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`under license, raw material inventories, a strong R&D and business development pipeline and a
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`number of employees across key business functions.” The website also states that the Bedford
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`acquisition “brings a unique and attractive R&D pipeline of 27 products, of which 16 are filed
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`and pending approval from the US FDA. The pipeline assets focus on higher value, medically
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`necessary and acute care products, including numerous Paragraph IV opportunities.” On
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`information and belief, included in the assets that Hikma acquired is ANDA No. 206412.
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`22.
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`On information and belief, Ben Venue Laboratories, Inc. transferred all rights to
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`the ANDA No. 206412 to Defendant Eurohealth.
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`JURISDICTION AND VENUE
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`Subject Matter Jurisdiction
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`23.
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`24.
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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, Generally
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`25.
`
`On information and belief, this Court has personal jurisdiction over Defendants
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`because they did not challenge this Court’s exercise of personal jurisdiction over them for
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`purposes of litigating allegations of patent infringement involving the ANDAs that are the
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`5
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`subject matter of this lawsuit. See In re Bendamustine Consolidated Cases, C.A. No. 13-cv-
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`2046-GMS (D. Del); Cephalon, Inc. v. Sandoz Inc., C.A. Nos. 14-1239-GMS, 13-2104-GMS (D.
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`Del); Cephalon, Inc. v. Accord Healthcare Inc. et al., C.A. No. 13-2095-GMS (D. Del);
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`Cephalon, Inc. v. InnoPharma, Inc., C.A. No. 13-2081-GMS (D. Del); Cephalon, Inc. v. Agila
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`Specialties Inc. f/k/a Strides, Inc. et al., C.A. No. 13-2080-GMS (D. Del); Cephalon, Inc. v.
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`Glenmark Pharms. Ltd. et al., C.A. No. 13-2093-GMS (D. Del); Cephalon, Inc. v. Eurohealth
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`International Sarl et al., C.A. No. 14-1045-GMS (D. Del).
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`Personal Jurisdiction Over Sandoz
`
`26.
`
`On information and belief, this Court has personal jurisdiction over Sandoz
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`because Sandoz: (1) conducts business in this Judicial District and (2) has engaged in
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`continuous and systematic contacts with the State of Delaware and/or purposefully availed itself
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`of this forum by, among other things, making, marketing, shipping, using, offering to sell or
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`selling, or causing others to use, offer to sell, or sell, Sandoz pharmaceutical products in this
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`Judicial District, and deriving substantial revenue from such activities. Sandoz also has
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`committed, or aided, abetted, contributed to and/or participated in the commission of, the tortious
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`action of patent infringement that has led to foreseeable harm and injury to Cephalon, which
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`manufactures TREANDA® for sale and use throughout the United States, including the State of
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`Delaware. Further, on information and belief, Sandoz is registered with the Delaware Board of
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`Pharmacy as a “Distributor/Manufacturer” and “Pharmacy-Wholesale” of drug products.
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`27.
`
`On information and belief, this Court also has personal jurisdiction over Sandoz
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`because Sandoz previously has availed itself of this forum for the purpose of litigating its patent
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`infringement disputes. See, e.g., Sandoz Inc. v Pfizer Inc., C.A. No. 09-2457 (D. Del.).
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`Additionally, Sandoz previously has been sued in this Judicial District, did not challenge this
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`Court’s exertion of personal jurisdiction over it, and availed itself of this forum by asserting
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`6
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`counterclaims for the purpose of litigating a patent infringement dispute. See Cephalon, Inc. v.
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`Sandoz Inc., C.A. Nos. 14-1239-GMS, 13-2104-GMS (D. Del); Genzyme Corporation et al. v.
`
`Sandoz Inc., C.A. No. 13-01507 (D. Del); UCB Inc. et al. v. Sandoz Inc., C.A. No. 13-01216 (D.
`
`Del).
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`Personal Jurisdiction Over Accord/Intas
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`28.
`
`On information and belief, this Court has personal jurisdiction over Accord
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`Healthcare because Accord Healthcare: (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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`availed itself of this forum by, among other things, making, marketing, shipping, using, offering
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`to sell or selling, or causing others to use, offer to sell, or sell, Accord/Intas pharmaceutical
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`products in this Judicial District, and deriving substantial revenue from such activities. On
`
`information and belief, Accord Healthcare also has committed, or aided, abetted, contributed to
`
`and/or participated in the commission of, the tortious action of patent infringement that has led to
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`foreseeable harm and injury to Cephalon, which manufactures TREANDA® for sale and use
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`throughout the United States, including the State of Delaware.
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`29.
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`On information and belief, this Court has personal jurisdiction over Intas because
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`Intas, at least through its wholly owned subsidiary Accord Healthcare: (1) conducts business in
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`this Judicial District and (2) has engaged in continuous and systematic contacts with the State of
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`Delaware and/or purposefully availed itself of this forum by, among other things, making,
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`marketing, shipping, using, offering to sell or selling, or causing others to use, offer to sell, or
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`sell, Accord/Intas pharmaceutical products in this Judicial District, and deriving substantial
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`revenue from such activities. On information and belief, Intas also has committed, or aided,
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`abetted, contributed to and/or participated in the commission of, the tortious action of patent
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`infringement that has led to foreseeable harm and injury to Cephalon, which manufactures
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`TREANDA® for sale and use throughout the United States, including the State of Delaware.
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`30.
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`On information and belief, this Court also has personal jurisdiction over Accord
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`Healthcare and Intas because Accord Healthcare and Intas previously have been sued in this
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`Judicial District, did not challenge this Court’s exertion of personal jurisdiction over them, and
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`availed themselves of this forum by asserting counterclaims for purpose of litigating a patent
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`infringement dispute. See Cephalon, Inc. v. Accord Healthcare Inc. et al., C.A. No. 13-2095-
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`GMS (D. Del); Millennium Pharmaceuticals Inc. v. Accord Healthcare Inc., C.A. No. 12-01490
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`(D. Del); UCB Inc. et al. v. Accord Healthcare Inc. et al, C.A. No. 13-01206 (D. Del).
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`Personal Jurisdiction Over InnoPharma
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`31.
`
`On information and belief, this Court has personal jurisdiction over InnoPharma
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`at least because InnoPharma: (1) is incorporated in Delaware and conducts business in this
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`Judicial District; and (2) markets, distributes and/or sells generic drugs throughout the United
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`States and within the State of Delaware and therefore purposefully avails itself of the privilege of
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`conducting activities within the State of Delaware. InnoPharma also has committed, or aided,
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`abetted, contributed to and/or participated in the commission of, the tortious action of patent
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`infringement that has led to foreseeable harm and injury to Cephalon, which manufactures
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`TREANDA® for sale and use throughout the United States, including the State of Delaware.
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`32.
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`On information and belief, this Court also has personal jurisdiction over
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`InnoPharma because InnoPharma previously has been sued in this Judicial District and did not
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`challenge this Court’s exertion of personal jurisdiction over it. See, e.g., Cephalon, Inc. v.
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`InnoPharma, Inc., C.A. No. 13-2081-GMS (D. Del); Spectrum Pharm. v. InnoPharma, Inc.,
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`8
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`C.A. No. 12-00260 (D. Del); Cumberland Pharm. v. InnoPharma, Inc., C.A. No. 12-00618 (D.
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`Del).
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`Personal Jurisdiction Over Agila/Onco
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`33.
`
`On information and belief, this Court has personal jurisdiction over Agila
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`because, among other things, Agila markets, distributes, and/or sells generic drugs throughout
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`the United States and within the State of Delaware and therefore purposefully avails itself of the
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`privilege of conducting activities within the State of Delaware. Agila has also committed, or
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`aided, abetted, contributed to, and/or participated in the commission of, the tortious action of
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`patent infringement that has led to foreseeable harm and injury to Cephalon, which manufactures
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`TREANDA® for sale and use throughout the United States, including the State of Delaware.
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`34.
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`On information and belief, this Court has personal jurisdiction over Onco
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`because, among other things, Onco markets, distributes, and/or sells generic drugs throughout the
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`United States and within the State of Delaware and therefore purposefully avails itself of the
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`privilege of conducting activities within the State of Delaware. Onco has also committed, or
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`aided, abetted, contributed to, and/or participated in the commission of, the tortious action of
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`patent infringement that has led to foreseeable harm and injury to Cephalon, which manufactures
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`TREANDA® for sale and use throughout the United States, including the State of Delaware.
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`35.
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`On information and belief, Agila/Onco previously have been sued in this Judicial
`
`District, did not challenge this Court’s exertion of personal jurisdiction over them, and have
`
`availed themselves of this forum by asserting counterclaims for the purpose of litigating a patent
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`infringement dispute. See Cephalon, Inc. v. Agila Specialties Inc. f/k/a Strides, Inc. et al, C.A.
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`No. 13-2080-GMS (D. Del); Cubist Pharm. Inc. v. Strides Inc. et al., C.A. No. 13-01679 (D.
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`9
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`Case 1:15-cv-00178-GMS Document 1 Filed 02/23/15 Page 10 of 85 PageID #: 10
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`Del.); Aventis Pharma S.A. et al. v. Strides, Inc. et al., C.A. No. 11-01121 (D. Del.); Senju
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`Pharm. Co., Ltd. et al. v. Strides, Inc. et al., C.A. No. 13-00851 (D. Del.).
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`Personal Jurisdiction Over Glenmark
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`36.
`
`On information and belief, this Court has personal jurisdiction over Glenmark
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`Pharmaceuticals Ltd. because Glenmark Pharmaceuticals Ltd., itself and through its subsidiaries,
`
`affiliates and/or agents, in particular at least Glenmark Generics Inc., USA, (1) conducts business
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`in this Judicial District and (2) has engaged in continuous and systematic contacts with the State
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`of Delaware and/or purposefully availed itself of this forum by, among other things, marketing,
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`making, shipping, using, offering to sell or selling, or causing others to use, offer to sell, or sell,
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`Glenmark pharmaceutical products in this Judicial District, and deriving substantial revenue
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`from such activities. On information and belief, Glenmark Pharmaceuticals Ltd. also has
`
`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
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`manufactures TREANDA® for sale and use throughout the United States, including the State of
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`Delaware.
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`37.
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`On information and belief, this Court has personal jurisdiction over Glenmark
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`Generics Ltd. because Glenmark Generics Ltd., itself and through its subsidiaries, affiliates
`
`and/or agents, in particular at least Glenmark Generics Inc., USA, (1) conducts business in this
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`Judicial District and (2) has engaged in continuous and systematic contacts with the State of
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`Delaware and/or purposefully availed itself of this forum by, among other things, marketing,
`
`making, shipping, using, offering to sell or selling, or causing others to use, offer to sell, or sell,
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`Glenmark pharmaceutical products in this Judicial District, and deriving substantial revenue
`
`from such activities. On information and belief, Glenmark Generics Ltd. also has committed, or
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`10
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`aided, abetted, contributed to and/or participated in the commission of, the tortious action of
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`patent infringement that has led to foreseeable harm and injury to Cephalon, which manufactures
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`TREANDA® for sale and use throughout the United States, including the State of Delaware.
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`38.
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`On information and belief, this Court has personal jurisdiction over Glenmark
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`Generics S.A. because Glenmark Generics S.A., itself and through its subsidiaries, affiliates
`
`and/or agents, in particular at least Glenmark Generics Inc., USA, (1) conducts business in this
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`Judicial District and (2) has engaged in continuous and systematic contacts with the State of
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`Delaware and/or purposefully availed itself of this forum by, among other things, marketing,
`
`making, shipping, using, offering to sell or selling, or causing others to use, offer to sell, or sell,
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`Glenmark pharmaceutical products in this Judicial District, and deriving substantial revenue
`
`from such activities. On information and belief, Glenmark Generics S.A. also has committed, or
`
`aided, abetted, contributed to and/or participated in the commission of, the tortious action of
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`patent infringement that has led to foreseeable harm and injury to Cephalon, which manufactures
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`TREANDA® for sale and use throughout the United States, including the State of Delaware.
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`39.
`
`On information and belief, this Court has personal jurisdiction over Glenmark
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`Generics Inc., USA because, among other things, (1) it is incorporated in the state of Delaware;
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`(2) it is registered to do business in Delaware, including its appointment of a registered agent in
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`Delaware (located at National Registered Agents, Inc., 160 Greentree Drive, Suite 101, Dover,
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`DE 19904) for the receipt of service of process; (3) it sells a substantial volume of prescription
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`drugs in Delaware; (4) it has engaged in continuous and systematic contacts with the State of
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`Delaware and/or purposefully availed itself of this forum by, among other things, marketing,
`
`making, shipping, using, offering to sell or selling, or causing others to use, offer to sell, or sell,
`
`Glenmark pharmaceutical products in this Judicial District, and deriving substantial revenue
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`11
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`from such activities. On information and belief, Glenmark Generics Inc., USA. also has
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`committed, or aided, abetted, contributed to and/or participated in the commission of, the tortious
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`action of patent infringement that has led to foreseeable harm and injury to Cephalon, which
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`manufactures TREANDA® for sale and use throughout the United States, including the State of
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`Delaware.
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`40.
`
`This Court also has personal jurisdiction over Defendant Glenmark
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`Pharmaceuticals Ltd. by virtue of the incorporation of Glenmark Generics Inc., USA in the State
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`of Delaware and the fact that both Glenmark Pharmaceuticals Ltd. and Glenmark Generics Inc.,
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`USA have availed themselves of the rights and benefits of the laws of the State of Delaware by
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`engaging in systematic and continuous contacts with the State of Delaware. On further
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`information and belief, Glenmark Generics Inc., USA has a Pharmacy Wholesale License in the
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`State of Delaware as well as a Controlled Substances Distributor/Manufacturer License in the
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`State of Delaware.
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`41.
`
`On information and belief, this Court also has personal jurisdiction over
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`Defendants Glenmark Pharmaceuticals Ltd., Glenmark Generics Ltd. and Glenmark Generics,
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`USA Inc. because they previously have been sued in this Judicial District, did not challenge this
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`Court’s exertion of personal jurisdiction over them, and availed themselves of this forum by
`
`asserting counterclaims for the purpose of litigating a patent dispute. See Cephalon, Inc. v.
`
`Glenmark Pharms. Ltd. et al., C.A. No. 13-2093-GMS (D. Del); Daiichi Sankyo Inc. et al v.
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`Impax Laboratories Inc. et al., C.A. No. 10-00997 (D. Del) and C.A. No. 12-00305; Forest
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`Laboratories Inc. et al. v. Torrent Pharmaceuticals Ltd. et al., C.A. No. 12-00305 (D. Del).
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`12
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`Personal Jurisdiction Over Eurohealth and West-Ward
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`42.
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`On information and belief, this Court has personal jurisdiction over West-Ward
`
`because West-Ward: (1) is incorporated in the State of Delaware, (2) conducts business in this
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`Judicial District and (3) has engaged in continuous and systematic contacts with the State of
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`Delaware and/or purposefully availed itself of this forum by, among other things, making,
`
`marketing, shipping, using, offering to sell or selling, or causing others to use, offer to sell, or
`
`sell, Hikma pharmaceutical products in this Judicial District. On information and belief, West-
`
`Ward also has 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.
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`43.
`
`On information and belief, this Court has personal jurisdiction over Eurohealth
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`because, among other things, Eurohealth together with West-Ward, which is incorporated under
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`the laws of the State of Delaware, has purposefully availed itself of the rights and benefits of
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`Delaware law by engaging in systematic and continuous contacts with the State of Delaware. On
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`information and belief, Eurohealth regularly and continuously transacts business within the State
`
`of Delaware, including, but not limited to, shipping pharmaceuticals to West-Ward from
`
`locations outside the United States for distribution by West-Ward within the United States
`
`generally, and within this District specifically.
`
`44.
`
`This Court also has personal jurisdiction over Eurohealth under Federal Rule of
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`Civil Procedure 4(k)(2) because this action arises under federal law and, on information and
`
`belief, Eurohealth is not subject to the jurisdiction of the courts of general jurisdiction of any
`
`13
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`

`
`Case 1:15-cv-00178-GMS Document 1 Filed 02/23/15 Page 14 of 85 PageID #: 14
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`state and the exercise of personal jurisdiction over Eurohealth is consistent with the Constitution
`
`and the laws of the United States.
`
`45.
`
`Additionally, this Court has personal jurisdiction over Eurohealth and West-Ward
`
`because they previously have been sued in this Judicial District, did not challenge this Court’s
`
`exertion of personal jurisdiction over them, and availed themselves of this forum by asserting
`
`counterclaims for the purpose of litigating a patent infringement dispute. See Cephalon, Inc. v.
`
`Eurohealth International Sarl et al., C.A. No. 14-1045-GMS (D. Del).
`
`Venue
`
`46.
`
`Venue is proper in this Judicial District under 28 U.S.C. §§ 1391 and 1400(b).
`
`The ’279 Patent
`
`BACKGROUND
`
`47.
`
`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.
`
`48.
`
`The named inventors of the ’279 patent assigned their rights in the ’279 patent to
`
`Cephalon.
`
`49.
`
`Cephalon is the sole owner by assignment of all rights, title and interest in the
`
`’279 patent.
`
`50.
`
`The ’279 patent is listed in FDA publication “Approved Drug Products with
`
`Therapeutic Equivalence Evaluations,” commonly referred to as “the Orange Book” (“Orange
`
`Book”), with respect to TREANDA®.
`
`51.
`
`The ’279 patent will expire on March 26, 2029. A true and accurate copy of the
`
`’279 patent is attached hereto as Exhibit A.
`
`14
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`

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`Case 1:15-cv-00178-GMS Document 1 Filed 02/23/15 Page 15 of 85 PageID #: 15
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`The ’836 Patent
`
`52.
`
`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.
`
`53.
`
`The named inventors of the ’836 patent assigned their rights in the ’836 patent to
`
`Cephalon.
`
`54.
`
`Cephalon is the sole owner by assignment of all rights, title and interest in the
`
`’836 patent.
`
`55.
`
`56.
`
`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 B.
`
`The ’756 Patent
`
`57.
`
`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.
`
`58. The named inventors of the ’756 patent assigned their rights in the ’756 patent to
`
`Cephalon.
`
`59. Cephalon is the sole owner by assignment of all rights, title and interest in the ’756
`
`patent.
`
`60. Shortly after the ’756 patent issued, Cephalon listed the ’756 patent in the Orange
`
`Book with respect to TREANDA®.
`
`61. The ’756 patent will expire on January 12, 2026, with pediatric exclusivity until July
`
`12, 2026. A true and accurate copy of the ’756 patent is attached hereto as Exhibit C.
`
`15
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`

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`Case 1:15-cv-00178-GMS Document 1 Filed 02/23/15 Page 16 of 85 PageID #: 16
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`The TREANDA® Drug Product
`
`62.
`
`Cephalon researched, developed, applied for and obtained FDA approval to
`
`manufacture, sell, promote and/or market bendamustine hydrochloride products known as
`
`TREANDA®.
`
`63.
`
`Cephalon has been selling, promoting, distributing and marketing TREANDA® in
`
`the United States since 2008.
`
`64.
`
`TREANDA® is indicated to treat patients with chronic lymphocytic leukemia and
`
`non-Hodgkin’s lymphoma.
`
`65.
`
`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 patients with chronic lymphocytic leukemia and non-
`
`Hodgkin’s lymphoma.
`
`The Sandoz ANDA and Related Ongoing Litigations
`
`66.
`
`Sandoz 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 a bendamustine hydrochloride powder for IV (infusion), 25 mg/vial and 100 mg/vial
`
`(“Sandoz’s Bendamustine Product”) prior to the expiration of the patents-in-suit.
`
`67.
`
`FDA assigned the ANDA for Sandoz’s Bendamustine Product the number
`
`204850.
`
`68.
`
`By letter dated November 19, 2013, Sandoz notified Cephalon that it had filed
`
`ANDA No. 204850 with a Paragraph IV certification related thereto seeking approval to market
`
`Sandoz’s Bendamustine Product prior to the expiration of the ’524 patent and the ’190 patent
`
`(“Sandoz’s Notice Letter”).
`
`16
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`

`
`Case 1:15-cv-00178-GMS Document 1 Filed 02/23/15 Page 17 of 85 PageID #: 17
`
`69.
`
`On December 21, 2013, Cephalon sued Sandoz in this Court for patent
`
`infringement related to ANDA No. 204850. See Cephalon, Inc. v. Sandoz Inc., C.A. No. 13-
`
`2104-GMS (D. Del.). That action was commenced before the expiration of forty-five days from
`
`the date of receipt of Sandoz’s Notice Letter, which effectively stayed FDA from granting final
`
`approval to Sandoz’s ANDA No. 204850 prior to the expiration of 30 months from the date
`
`Sandoz’s Notice Letter was received by Cephalon.
`
`The Accord/Intas ANDA and Related Ongoing Litigations
`
`70.
`
`Accord/Intas 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 a bendamustine hydrochloride powder for IV (infusion), 25 mg/vial and 100
`
`mg/vial (“Accord/Intas’s Bendamustine Product”) prior to the expiration of the patents-in-suit.
`
`71.
`
`FDA assigned the ANDA for Accord/Intas’s Bendamustine Product the number
`
`205574.
`
`72.
`
`By letter dated November 18, 2013, Accord/Intas notified Cephalon that it had
`
`filed ANDA No. 205574 with a Paragraph IV certification related thereto seeking approval to
`
`market Accord/Intas’s Bendamustine Product prior to the expiration of the ’524 patent and the
`
`’190 patent (“Accord/Intas’s First Notice Letter”). Accord/Intas notified Cephalon by letter
`
`dated February 28, 2014 that it had filed an amendment to ANDA No. 205574 with a Paragraph
`
`IV certification related thereto seeking approval to market Accord/Intas’s Bendamustine Product
`
`prior to the expiration of the ’863 patent (“Accord/Intas’s Second Notice Letter”). Accord/Intas
`
`notified Cephalon by letter dated September 8, 2014 that it had filed an amendment to ANDA
`
`No. 205574 with a Paragraph IV certification related thereto seeking approval to market
`
`Accord/Intas’s Bendamustine Product prior to the expiration of the ’270 patent (“Accord/Intas’s
`
`Third Notice Letter”).
`
`17
`
`

`
`Case 1:15-cv-00178-GMS Document 1 Filed 02/23/15 Page 18 of 85 PageID #: 18
`
`73.
`
`On December 26, 2013, Cephalon sued Accord/Intas in this Court for patent
`
`infringement related to ANDA No. 205574. See Cephalon, Inc. v. Accord Healthcare Inc. et al.,
`
`C.A. No. 13-2095-GMS (D. Del.). That action was commenced before the expiration of forty-
`
`five days from the date of receipt of Accord/Intas’s First Notice Letter, which effectively stayed
`
`FDA from granting final approval to Accord/Intas’s ANDA No. 205574 prior to the expiration of
`
`30 months from the date Accord/Intas’s First Notice Letter was received by Cephalon.
`
`74.
`
`On February 12, 2015, Accord/Intas informed Cephalon by letter that it had
`
`amended ANDA No. 205574 to include a Paragraph IV certification related thereto seeking
`
`approval to market Accord/Intas’s Bendamustine Product prior to the expiration of the ’279
`
`patent, the ’836 patent, and the ’756 patent (“Accord/Int