Source: https://www.scribd.com/doc/212875144/Cephalon-v-Emcure-Pharmaceuticals-et-al
Timestamp: 2018-02-23 07:32:31
Document Index: 684809636

Matched Legal Cases: ['§ 1391', '§ 355', '§ 355', '§ 355', '§ 271', '§ 271', '§ 285', '§ 271', '§ 271', '§ 271', '§ 271', '§ 285']

Description: Official Complaint for Patent Infringement in Civil Action No. 1:14-cv-00335-UNA: Cephalon Inc. v. Emcure Pharmaceuticals Ltd. et. al. Filed in U.S. District Court for the District of Delaware, no ...
Official Complaint for Patent Infringement in Civil Action No. 1:14-cv-00335-UNA: Cephalon Inc. v. Emcure Pharmaceuticals Ltd. et. al. Filed in U.S. District Court for the District of Delaware, no judge yet assigned. See http://news.priorsmart.com/-la6R for more info.
EMCURE PHARMACEUTICALS LTD. and EMCURE PHARMACEUTICALS USA, INC., Defendants. ) ) ) ) ) ) ) ) ) )
COMPLAINT Cephalon, Inc. (“Cephalon” or “Plaintiff”) brings this action for patent infringement against Defendants Emcure Pharmaceuticals Ltd. and Emcure Pharmaceuticals USA, Inc. (collectively, “Emcure” or “Defendants”). 1. This is an action by Cephalon against Defendants for infringement of United
States Patent No. 8,445,524 (“’524 patent”). This action arises out of Defendants’ 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 PARTIES Cephalon, Inc. 2. Plaintiff Cephalon, Inc. is a corporation operating and existing under the laws of
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, Emcure pharmaceutical products in this Judicial District, and deriving substantial revenue from such activities. Upon information and belief, Defendant Emcure 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 manufactures TREANDA®, for sale and use throughout the United States, including the State of Delaware. 11. Upon information and belief, this Court has personal jurisdiction over Defendant
Emcure Pharmaceuticals USA, Inc. because Emcure Pharmaceuticals USA, 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 by, among other things, marketing, making, shipping, using, offering to sell or selling, or causing others to use, offer to sell, or sell, Emcure pharmaceutical products in this Judicial District, and deriving substantial revenue from such activities. Upon information and belief, Defendant Emcure Pharmaceuticals USA, Inc. 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. Venue 12. Venue is proper in this Judicial District under 28 U.S.C. §§ 1391 and 1400(b).
BACKGROUND The ’524 Patent 13. 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, Hans-Joachim Jӓnsch, and Veronique Courvoisier. 14. Cephalon. 15. ’524 patent. 16. The ’524 patent is listed in FDA publication “Approved Drug Products with Cephalon is the sole owner by assignment of all rights, title and interest in the The named inventors of the ’524 patent assigned their rights in the ’524 patent to
Therapeutic Equivalence Evaluations,” commonly referred to as “The Orange Book,” with respect to TREANDA®. 17. The ’524 patent will expire on March 26, 2029. A true and accurate copy of the
’524 patent is attached hereto as Exhibit A. The TREANDA® Drug Product 18. Cephalon researched, developed, applied for and obtained FDA approval to
505(a) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 355(a), for multiple TREANDA® products used for treating chronic lymphocytic leukemia and non-Hodgkin’s lymphoma. The Emcure ANDA 22. Emcure 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 25 mg/vial and 100 mg/vial bendamustine hydrochloride powder for infusion (“Emcure’s Bendamustine Product”) prior to the expiration of the ’524 patent. 23. 205964. 24. Emcure also filed with FDA, pursuant to 21 U.S.C. § 355(j)(2)(B)(iv), a FDA assigned the ANDA for Emcure’s Bendamustine Product the number
certification alleging that the claims of the ’524 patent are invalid, unenforceable and/or would not be infringed by the manufacture, use, importation, sale or offer for sale of Emcure’s Bendamustine Product (“Emcure’s Paragraph IV Certification”). 25. By letter dated February 4, 2014, Emcure notified Plaintiff that it had filed ANDA
205964 seeking approval to market Emcure’s Bendamustine Product prior to the expiration of the ’524 patent (“Emcure Notice Letter”). 26. On March 3, 2014, pursuant to an Offer of Confidential Access, Cephalon
COUNT I FOR INFRINGEMENT OF U.S. PATENT NO. 8,445,524 BY EMCURE 28. The allegations of the proceeding paragraphs 1–27 are re-alleged and incorporated
herein by reference. 29. The use of Emcure’s Bendamustine Product is covered by one or more claims of
and/or importation of Emcure’s Bendamustine Product would infringe one or more claims of the ’524 patent. 31. Under 35 U.S.C. § 271(e)(2)(A), Emcure’s submission to FDA of the Emcure
ANDA to obtain approval for Emcure’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 Emcure’s Bendamustine Product containing bendamustine hydrochloride, would infringe one or more claims of the ’524 patent. 32. Emcure was aware of the ’524 patent when engaging in these knowing and
purposeful activities and was aware that filing the Emcure ANDA with Emcure’s Paragraph IV Certification with respect to the ’524 patent constituted an act of infringement of the ’524 patent. 33. Upon information and belief, Emcure’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. 34. Upon information and belief, the manufacture of Emcure’s Bendamustine Product
Emcure’s use of the solid form of bendamustine hydrochloride in the manufacture
of Emcure’s Bendamustine Product infringes one or more claims of the ’524 patent. 36. Upon information and belief, Emcure plans and intends to, and will, infringe the
’524 patent immediately and imminently upon approval of the Emcure ANDA. 37. Upon information and belief, Emcure, 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. 38. Upon information and belief, Emcure plans and intends to, and will, actively
induce infringement of the ’524 patent when the Emcure ANDA is approved, and plans and intends to, and will, do so immediately and imminently upon approval. 39. Upon information and belief, Emcure knows that the solid form of bendamustine
hydrochloride used to manufacture Emcure’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 Emcure’s Bendamustine Product is not suitable for substantial non-infringing uses. Upon information and belief, Emcure plans and intends to, and will, contribute to the infringement of the ’524 patent immediately and imminently upon approval of the Emcure ANDA. 40. The foregoing actions by Emcure 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. 41. Upon information and belief, Emcure acted without a reasonable basis for
Plaintiff will be substantially and irreparably harmed by Emcure’s infringing
activities unless the Court enjoins those activities. Plaintiff will have no adequate remedy at law if Emcure is not enjoined from the commercial manufacture, use, offer to sell, sale in and importation into the United States of Emcure’s Bendamustine Product. 43. Emcure’s activities render this case an exceptional one, and Plaintiff is entitled to
an award of their reasonable attorney fees under 35 U.S.C. § 285. COUNT II FOR DECLARATORY JUDGMENT OF INFRINGEMENT OF U.S. PATENT NO. 8,445,524 BY EMCURE 44. The allegations of the proceeding paragraphs 1–43 are re-alleged and incorporated
selling, offering to sell and/or importing Emcure’s Bendamustine Product soon after FDA approval of the Emcure ANDA. 46. 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). 47. Defendants’ infringing patent activity complained of herein is imminent and will
justiciable controversy between Plaintiff and Defendants as to liability for the infringement of the ’524 patent. Defendants’ actions have created in Plaintiff a reasonable apprehension of irreparable harm and loss resulting from Defendants’ threatened imminent actions. 49. ’524 patent. Upon information and belief, Emcure will knowingly and willfully infringe the
50. ’524 patent.
PRAYER FOR RELIEF WHEREFORE, Plaintiff respectfully request the following relief: a. b. a judgment that the ’524 patent is valid and enforceable; a judgment that Emcure’s submission of the Emcure ANDA No. 205964, was an
any FDA approval of the Emcure ANDA No. 205964 or any product or compound the use of which infringes the ’524 patent, shall be a date that is not earlier than the expiration of the ’524 patent; d. an Order pursuant to 35 U.S.C. § 271(e)(4)(B) permanently enjoining Emcure and
persons acting in concert with Emcure from commercially manufacturing, using, offering for sale, selling, marketing, distributing, or importing Emcure’s Bendamustine Products, or any
product or compound the use of which infringes the ’524 patent, or inducing or contributing to the infringement of the ’524 patent until after the expiration of the ’524 patent; f. an Order enjoining Emcure and all persons acting in concert with Emcure from
fees under 35 U.S.C. § 285; i. j. and proper. an award of Plaintiff’s reasonable costs and expenses in this action; and an award of any further and additional relief to Plaintiff as this Court deems just
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