Case 1:13—cv—O2046—GMS Document 34 Filed 11/06/14 Page 1 of 16 Page|D #: 285
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`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
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`CEPHALON, INC.,
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`Plaintiff,
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`V.
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`C.A. No. 13-2046-GMS
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`HETERO LABS LTD. and HETERO USA, INC.,
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`Defendants.
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`AMENDED COMPLAINT
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`Cephalon, Inc. (“Cephalon” or “Plaintiff’) brings this action for patent infringement
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`against Defendants Hetero Labs Ltd. and Hetero USA, Inc. (“Hetero” or “Defendants”).
`
`1.
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`This is an action by Cephalon against Hetero for infringement of United States
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`Patent No. 8,445,524 (“the ’524 patent”) and United States Patent No. 8,791,270 (“the ’27O
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`patent”). This action arises out of Hetero’s filing of an Abbreviated New Drug Application
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`(“ANDA”) seeking approval by the United States Food and Drug Administration (“FDA”) to sell
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`generic versions of TREANDA®, Cephalon’s innovative treatment for chronic lymphocytic
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`leukemia and non-Hodgkin’s lymphoma, prior to the expiration of the ’524 patent and the ’27O
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`patent.
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`Cephalon, Inc.
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`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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`FRESENIUS KABI 1002-OOO1
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`€€€€€€€€€
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`Case 1:13—cv—O2046—GMS Document 34 Filed 11/06/14 Page 2 of 16 Page|D #: 286
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`Hetero Labs Ltd. and Hetero USA, Inc.
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`3.
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`On information and belief, Defendant Hetero USA, Inc. (“Hetero 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 1035 Centennial Avenue, Piscataway, New Jersey 08854, and is registered to
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`do business in Delaware, including its appointment of a registered agent in Delaware (located at
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`W/K Incorporating Services, Inc., 3500 South DuPont Highway, Dover, DE 19901) for the
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`receipt of service of process.
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`4.
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`On information and belief, Defendant Hetero Labs Ltd (“Hetero Labs”) is a
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`corporation organized and existing under the laws of India, with its principal place of business at
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`7-2-A2, Hetero Corporate Industrial Estates, Sanath Nagar, Hyderabad — 500 018 A.P India.
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`5.
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`6.
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`On information and belief, Hetero Labs is a parent company of Hetero USA.
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`On information and belief, Hetero USA acts as an agent of Hetero Labs.
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`JURISDICTION AND VENUE
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`Subject Matter Jurisdiction
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`7.
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`8.
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`This action for patent infringement arises under 35 U.S.C. § 271.
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`This Court has jurisdiction over the subject matter of this action pursuant to 28
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`U.S.C. §§ 1331 and 1338(a), and the Declaratory Judgment Act, 28 U.S.C §§ 2201 and 2202.
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`Personal Jurisdiction Over Hetero
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`9.
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`On information and belief, this Court has personal jurisdiction over Defendants
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`Hetero Labs and Hetero USA.
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`10.
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`On information and belief, Hetero USA is a Delaware corporation, is registered to
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`do business in Delaware, and is the U.S. regulatory agent for Hetero Labs Limited Unit VI.
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`FRESENIUS KABI 1002-OOO2
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`

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`Case 1:13—cv—O2046—GMS Document 34 Filed 11/06/14 Page 3 of 16 Page|D #: 287
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`11.
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`On information and belief, Hetero Labs Limited Unit V1 is a division or part of
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`Defendant Hetero Labs Ltd. Hetero Labs’s website, located at http://www.heterodrugs.com/mfg-
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`formulation-facilities.shtml, describes Unit VI as a formulation facility of Hetero Labs.
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`12.
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`On information and belief, Hetero USA is in the business of marketing and selling
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`generic prescription pharmaceutical drugs that it distributes in the State of Delaware and
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`throughout the United States. On information and belief, Hetero USA, either directly or through
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`one or more of its subsidiaries, agents, and/or distributors, markets, sells, and/or distributes a
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`substantial volume of its pharmaceutical products in the State of Delaware. On information and
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`belief, the acts of Hetero USA complained of herein were done at the direction of, with the
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`authorization of, and/or with the cooperation, participation, and assistance of Hetero Labs.
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`13.
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`On information and belief, this Court has personal jurisdiction over Defendant
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`Hetero USA because, among other things, Hetero USA (1) is incorporated in the State of
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`Delaware; (2) conducts business in this Judicial District; and (3) has engaged in continuous and
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`systematic contacts with Delaware and/or purposefully availed itself of this forum by, among
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`other things, marketing, distributing, making, shipping, using, offering to sell or selling, or
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`causing others to use, offer to sell, or sell Hetero pharmaceutical products in this Judicial
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`District, and deriving substantial revenue from such activities. On information and belief, Hetero
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`USA also has committed, or aided, abetted, contributed to and/or participated in the commission
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`of the tortious act of patent infringement that has led to foreseeable harm and injury to Cephalon,
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`which manufactures TREANDA® for sale and use throughout the United States, including the
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`State of Delaware.
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`14.
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`On information and belief, Hetero Labs formulates, develops, markets, and sells
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`active pharmaceutical ingredients (“API”), pharmaceutical formulations, and/or pharmaceutical
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`FRESENIUS KABI 1002-OOO3
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`

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`Case 1:13—cv—O2046—GMS Document 34 Filed 11/06/14 Page 4 of 16 Page|D #: 288
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`products containing such API or pharmaceutical formulations. Hetero Labs, through its U.S.
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`regulatory agent, Hetero USA, routinely files Abbreviated New Drug Applications seeking FDA
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`approval to market its products in the United States.
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`15.
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`On information and belief, Hetero Labs, directly or through Hetero USA and/or
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`through one or more of its wholly owned subsidiaries, affiliates, agents, distributors, or parent
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`corporation is in the business of formulating, manufacturing, marketing, and selling generic
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`prescription pharmaceutical drugs that it distributes in Delaware and throughout the United
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`States. On information and belief, Hetero Labs, either directly or through Hetero USA and/or
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`through one or more of its subsidiaries, agents, and/or distributors, formulates, manufactures,
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`markets, sells, and/or distributes a substantial volume of its pharmaceutical products in
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`Delaware.
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`16.
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`Hetero USA’s acts and continuous and systematic contacts with the State of
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`Delaware, as an agent of Hetero Labs, are also attributable to Hetero Labs for jurisdictional
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`purposes.
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`17.
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`On information and belief, this Judicial District is a likely destination of products
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`that will be manufactured and sold as a result of FDA approval of Hetero’s Abbreviated New
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`Drug Application No. 204081, which is the subject of this lawsuit.
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`18.
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`On information and belief, this Court has personal jurisdiction over Hetero Labs
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`because, among other things (1) its presence in Delaware, including through Hetero USA, and
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`(2) its course of conduct that is designed to cause the perfonnance of tortious acts that will result
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`in the foreseeable harm in Delaware.
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`19.
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`Further, On information and belief, this Court has personal jurisdiction over
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`Hetero Labs and Hetero USA because both companies previously have been sued in this Judicial
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`FRESENIUS KABI 1002-OOO4
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`

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`Case 1:13—cv—O2046—GMS Document 34 Filed 11/06/14 Page 5 of 16 Page|D #: 289
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`District, did not challenge this Court’s exertion of personal jurisdiction over it, and have availed
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`themselves of this forum by asserting counterclaims for the purpose of litigating a patent
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`infringement dispute. See, e.g., AbbWe Inc. v. Hetero USA Inc. et al, C.A. No. 13-852 (D. Del);
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`Ktssei Pharma Co. Ltd. et al v. Hetero USA Inc., et al., C.A. No. 13-1091 (D. Del); UCB Inc. et
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`al v. Hetero USA Inc. et al, C.A. No. 13-1213-LPS (D. Del.); Forest Labs., Inc. et al. v. Torrent
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`Pharmas Ltd., et al., C.A. No. 12-305 (D. Del.).
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`Venue
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`20.
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`Venue is proper in this Judicial District under 28 U.S.C. §§ 1391 and 1400(b).
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`The ’524 Patent
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`BACKGROUND
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`21.
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`The ’524 patent, entitled “Solid Forms of Bendamustine Hydrochloride,” was
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`duly and lawfully issued on May 21, 2013 to inventors Laurent D. Courvoisier, Robert E.
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`McKean, and Hans-Joachim Jansch.
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`22.
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`The named inventors of the ’524 patent assigned their rights in the ’524 patent to
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`Cephalon.
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`23.
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`Cephalon is the sole owner by assignment of all rights, title and interest in the
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`’524 patent.
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`24.
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`The ’524 patent is listed in FDA publication “Approved Drug Products with
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`Therapeutic Equivalence Evaluations,” commonly referred to as “the Orange Book” (“Orange
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`Book”), with respect to TREANDA®.
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`25.
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`The ’524 patent will expire on March 26, 2029. A true and accurate copy of the
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`’524 patent is attached hereto as Exhibit A.
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`FRESENIUS KABI 1002-0005
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`

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`The ’270 Patent
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`26.
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`The ’270 patent, entitled “Bendamustine Pharmaceutical Compositions,” was duly
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`and lawfully issued on July 29, 2014 to inventors Jason E. Brittain and Joe C. Franklin.
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`27.
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`The named inventors of the ’270 patent assigned their rights in the ’270 patent to
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`Cephalon.
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`28.
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`Cephalon is the sole owner by assignment of all rights, title and interest in the
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`’270 patent.
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`29.
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`The ’270 patent is listed in the Orange Book with respect to TREANDA®.
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`30.
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`The ’270 patent will expire on January 12, 2026. A true and accurate copy of the
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`’270 patent is attached hereto as Exhibit B.
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`The TREANDA® Drug Product
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`3 l.
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`Cephalon researched, developed, applied for and obtained FDA approval to
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`manufacture, sell, promote and/or market bendamustine hydrochloride products known as
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`TREANDA®.
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`32.
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`Cephalon has been selling, promoting, distributing, and marketing TREANDA®
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`in the United States since 2008.
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`33.
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`TREANDA® is indicated to treat chronic lymphocytic leukemia and non-
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`Hodgkin’ s lymphoma.
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`34.
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`Cephalon holds New Drug Application No. 22249 and No. 22303 under Section
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`505(a) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355(a), for multiple
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`TREANDA® products used for treating chronic lymphocytic leukemia and non-Hodgkin’s
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`lymphoma.
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`FRESENIUS KABI 1002-0006
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`

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`Case 1:13—cv—O2046—GMS Document 34 Filed 11/06/14 Page 7 of 16 Page|D #: 291
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`The Hetero ANDA
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`35.
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`Hetero filed with FDA an Abbreviated New Drug Application under 21 U. S.C.
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`§ 3550) seeking approval to manufacture, use, offer for sale, sell in and import into the United
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`States bendamustine hydrochloride injection, for intravenous infusion, 25 mg/vial and 100
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`mg/vial (“Hetero’s Bendamustine Product”) prior to the expiration of the ’524 patent and the
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`’270 patent.
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`36.
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`FDA assigned the ANDA for Hetero’s Bendamustine Product the number
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`204081 .
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`37.
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`Hetero also filed with FDA, pursuant to 21 U.S.C. § 355(j)(2)(B)(iv), a
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`certification alleging that the claims of the ’524 patent and the ’270 patent are invalid,
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`unenforceable and/or would not be infringed by the manufacture, use, importation, sale or offer
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`for sale of Hetero’s Bendamustine Product (“Hetero’s Paragraph IV Certification”).
`
`38.
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`By letter dated November 6, 2013, Hetero notified Cephalon that it filed ANDA
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`No. 204081 seeking approval to market Hetero’s Bendamustine Product prior to the expiration of
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`the ’524 patent (“Hetero’s First Notice Letter”). By letter dated October 6, 2014, Hetero notified
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`Cephalon that Hetero planned to submit an amendment to ANDA No. 204081 seeking approval
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`to market Hetero’s Bendamustine Product prior to the expiration of the ’270 patent (“Hetero’ s
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`Second Notice Letter”).
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`39.
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`On December 11, 2013, pursuant to an Offer of Confidential Access, Cephalon
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`received portions of the ANDA filed by Hetero, and Cephalon reviewed those portions of the
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`ANDA.
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`FRESENIUS KABI 1002-OOO7
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`

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`40.
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`Cephalon filed this Action before the expiration of forty-five days from the date
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`of receipt of the Hetero’s First Notice Letter. This Amended Complaint is being filed before the
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`expiration of forty-five days from the date of receipt of the Hetero’s Second Notice Letter.
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`COUNT I FOR INFRINGEMENT OF U.S. PATENT NO. 8,445,524 BY HETERO
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`41.
`
`The allegations of the preceding paragraphs 1-40 are re-alleged and incorporated
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`herein by reference.
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`42.
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`The use of Hetero’s Bendamustine Product is covered by one or more claims of
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`the ’524 patent.
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`43.
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`The commercial manufacture, use, offer for sale, sale, marketing, distribution
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`and/or importation of Hetero’s Bendamustine Product would infringe one or more claims of the
`
`’524 patent.
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`44.
`
`Under 35 U.S.C. § 27l(e)(2)(A), Hetero’s submission to FDA of the Hetero
`
`ANDA to obtain approval for Hetero’ s Bendamustine Product with a Paragraph IV Certification
`
`related thereto before the expiration of the ’524 patent constitutes an act of infringement, and if
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`approved, the commercial manufacture, use, offer to sell, sale, or importation of Hetero’s
`
`Bendamustine Product containing bendamustine hydrochloride, would infringe one or more
`
`claims ofthe ’524 patent under 35 U.S.C. § 27l(a).
`
`45.
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`Hetero was aware of the ’524 patent when engaging in these knowing and
`
`purposeful activities and was aware that filing the Hetero ANDA with Hetero’ s Paragraph IV
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`Certification with respect to the ’524 patent constituted an act of infringement of the ’524 patent.
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`46.
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`On information and belief, Hetero’s Bendamustine Product contains the same
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`active pharmaceutical ingredient, bendamustine hydrochloride, as that used in Cephalon’s
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`TREANDA® products and claimed in the ’524 patent.
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`FRESENIUS KABI 1002-OOO8
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`

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`47.
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`On information and belief, the manufacture of Hetero’ s Bendamustine Product is
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`made using the solid form of bendamustine hydrochloride described in one or more claims of the
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`’524 patent.
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`48.
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`Hetero’s use of the solid form of bendamustine hydrochloride in the manufacture
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`of Hetero’s Bendamustine Product infringes one or more claims of the ’524 patent.
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`49.
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`On information and belief, Hetero plans and intends to, and will, infringe the ’524
`
`patent immediately and imminently upon approval of the Hetero ANDA.
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`50.
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`On information and belief, Hetero, under 35 U.S.C. § 27l(b), acted in concert,
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`actively supported, participated in, encouraged, and/or induced the infringement of one or more
`
`claims of the ’524 patent.
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`51.
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`On information and belief, Hetero plans and intends to, and will, actively induce
`
`infringement of the ’524 patent when the Hetero ANDA is approved, and plans and intends to,
`
`and will, do so immediately and imminently upon approval.
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`52.
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`On information and belief, Hetero knows that the solid form of bendamustine
`
`hydrochloride used to manufacture Hetero’s Bendamustine Product is especially made or
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`adapted for use in infringing the ’524 patent and that the solid form of bendamustine
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`hydrochloride used to manufacture Hetero’s Bendamustine Product is not suitable for substantial
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`non-infringing uses. On information and belief, Hetero plans and intends to, and will, contribute
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`to the infringement of the ’524 patent, under 35 U.S.C. § 27l(c), immediately and imminently
`
`upon approval of the Hetero ANDA.
`
`53.
`
`The foregoing actions by Hetero constitute and/or would constitute infringement
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`of the ’524 patent, active inducement of infringement of the ’524 patent and/or contribution to
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`the infringement by others of the ’524 patent.
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`FRESENIUS KABI 1002-0009
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`

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`54.
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`On information and belief, Hetero acted without a reasonable basis for believing
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`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.
`
`55.
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`Cephalon will be substantially and irreparably harmed by Hetero’s infringing
`
`activities unless the Court enjoins those activities. Cephalon will have no adequate remedy at
`
`law if Hetero is not enjoined from the commercial manufacture, use, offer to sell, sale in and
`
`importation into the United States of Hetero’s Bendamustine Product.
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`56.
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`Hetero’s activities render this case an exceptional one, and Cephalon is entitled to
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`an award of their reasonable attorney fees under 35 U.S.C. § 285.
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`COUNT II FOR DECLARATORY JUDGMENT OF
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`INFRINGEMENT OF U.S. PATENT NO. 8,445,524 BY HETERO
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`57.
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`The allegations of the preceding paragraphs 1-56 are re-alleged and incorporated
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`herein by reference.
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`58.
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`On information and belief, Hetero plans to begin manufacturing, marketing,
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`selling, offering to sell and/or importing Hetero’s Bendamustine Product soon after FDA
`
`approval of the Hetero ANDA.
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`59.
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`Such conduct will constitute direct infringement of one or more claims on the
`
`’524 patent under 35 U.S.C. § 27l(a), inducement of infringement of the ’524 patent under 35
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`U.S.C. § 27l(b), and contributory infringement under 35 U.S.C. § 27l(c).
`
`60.
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`Hetero’s infringing patent activity complained of herein is imminent and will
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`begin following FDA approval of the Hetero ANDA.
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`61.
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`As a result of the foregoing facts, there is a real, substantial, and continuing
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`justiciable controversy between Cephalon and Hetero as to liability for the infringement of the
`
`10
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`FRESENIUS KABI 1002-0010
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`

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`’524 patent. Hetero’s actions have created in Cephalon a reasonable apprehension of irreparable
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`harm and loss resulting from Hetero’s threatened imminent actions.
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`62.
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`On information and belief, Hetero will knowingly and willfully infringe the ’524
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`patent.
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`63.
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`Cephalon will be irreparably harmed if Hetero is not enjoined from infringing the
`
`’524 patent.
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`COUNT III FOR INFRINGEMENT OF U.S. PATENT NO. 8,791,270 BY HETERO
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`64.
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`The allegations of the preceding paragraphs 1-63 are re-alleged and incorporated
`
`herein by reference.
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`65.
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`The use of Hetero’s Bendamustine Product is covered by one or more claims of
`
`the ’27O patent.
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`66.
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`The commercial manufacture, use, offer for sale, sale, marketing, distribution
`
`and/or importation of Hetero’s Bendamustine Product would infringe one or more claims of the
`
`’27O patent.
`
`67.
`
`Under 35 U.S.C. § 27l(e)(2)(A), Hetero’s submission to FDA of the Hetero
`
`ANDA to obtain approval for Hetero’ s Bendamustine Product with a Paragraph IV Certification
`
`related thereto before the expiration of the ’27O patent constitutes an act of infringement, and if
`
`approved, the commercial manufacture, use, offer to sell, sale, or importation of Hetero’s
`
`Bendamustine Product containing bendamustine hydrochloride, would infringe one or more
`
`claims of the ’27O patent under 35 U.S.C. § 27l(a).
`
`68.
`
`Hetero was aware of the ’27O patent when engaging in these knowing and
`
`purposeful activities and were aware that filing the Hetero ANDA with Hetero’ s Paragraph IV
`
`Certification with respect to the ’27O patent constituted an act of infringement of the ’27O patent.
`
`ll
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`FRESENIUS KABI 1002-0011
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`

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`69.
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`On information and belief, Hetero’s Bendamustine Product contains the same
`
`active pharmaceutical ingredient, bendamustine hydrochloride, as that used in Cephalon’s
`
`TREANDA® products and claimed in the ’27O patent.
`
`70.
`
`On information and belief, Hetero’ 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 ’27O patent.
`
`7 1.
`
`On information and belief, Hetero’ s Bendamustine Product is the pharmaceutical
`
`composition of bendamustine hydrochloride, containing not more than the amount of the HPl
`
`degradant, recited in one or more claims of the ’27O patent.
`
`72.
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`On information and belief, Hetero’s Bendamustine Product infringes one or more
`
`claims of the ’27O patent.
`
`73.
`
`On information and belief, Hetero plans and intends to, and will, infringe the ’27O
`
`patent immediately and imminently upon approval of the Hetero ANDA.
`
`74.
`
`On information and belief, Hetero, under 35 U.S.C. § 27l(b), acted in concert,
`
`actively supported, participated in, encouraged, and/or induced the infringement of one or more
`
`claims of the ’27O patent.
`
`75.
`
`On information and belief, Hetero plans and intends to, and will, actively induce
`
`infringement of the ’27O patent when the Hetero ANDA is approved, and plans and intends to,
`
`and will, do so immediately and imminently upon approval.
`
`76.
`
`On information and belief, Hetero knows that Hetero’ s Bendamustine Product is
`
`especially made or adapted for use in infringing the ’27O patent and that Hetero’s Bendamustine
`
`Product is not suitable for substantial non-infringing uses. On information and belief, Hetero
`
`12
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`FRESENIUS KABI 1002-0012
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`

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`plans and intends to, and will, contribute to the infringement of the ’27O patent, under 35 U.S.C.
`
`§ 27 l(c), immediately and imminently upon approval of the Hetero ANDA.
`
`77.
`
`The foregoing actions by Hetero constitutes and/or would constitute infringement
`
`of the ’27O patent, active inducement of infringement of the ’27O patent and/or contribution to
`
`the infringement by others of the ’27O patent.
`
`78.
`
`On information and belief, Hetero acted without a reasonable basis for believing
`
`that they would not be liable for infringing the ’27O patent, actively inducing infringement of the
`
`’27O patent and/or contributing to the infringement by others of the ’27O patent.
`
`79.
`
`Cephalon will be substantially and irreparably harmed by Hetero’s infringing
`
`activities unless the Court enjoins those activities. Cephalon will have no adequate remedy at
`
`law if Hetero is not enjoined from the commercial manufacture, use, offer to sell, sale in and
`
`importation into the United States of Hetero’s Bendamustine Product.
`
`80.
`
`Hetero’s activities render this case an exceptional one, and Cephalon is entitled to
`
`an award of its reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`COUNT IV DECLARATORY JUDGMENT OF
`
`INFRINGEMENT OF U.S. PATENT NO. 8,791,270 BY HETERO
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`81.
`
`The allegations of the preceding paragraphs 1-80 are re-alleged and incorporated
`
`herein by reference.
`
`82.
`
`On information and belief, Hetero plans to begin manufacturing, marketing,
`
`selling, offering to sell and/or importing Hetero’s Bendamustine Product soon after FDA
`
`approval of the Hetero ANDA.
`
`83.
`
`Such conduct will constitute direct infringement of one or more claims on the
`
`’27O patent under 35 U.S.C. § 27l(a), inducement of infringement of the ’27O patent under 35
`
`U.S.C. § 27l(b), and contributory infringement under 35 U.S.C. § 27l(c).
`
`l3
`
`FRESENIUS KABI 1002-0013
`
`

`
`Case 1:13—cv—O2046—GMS Document 34 Filed 11/06/14 Page 14 of 16 Page|D #: 298
`
`84.
`
`Hetero’s infringing patent activity complained of herein is imminent and will
`
`begin following FDA approval of the Hetero ANDA.
`
`85.
`
`As a result of the foregoing facts, there is a real, substantial, and continuing
`
`justiciable controversy between Cephalon and Hetero as to liability for the infringement of the
`
`’27O patent. Hetero’s actions have created in Cephalon a reasonable apprehension of irreparable
`
`harm and loss resulting from Hetero’s threatened imminent actions.
`
`86.
`
`On information and belief, Hetero will knowingly and willfully infringe the 270
`
`patent.
`
`87.
`
`Cephalon will be substantially and irreparably harmed by Hetero’s infringing
`
`activities unless the Court enjoins those activities.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Cephalon respectfully requests the following relief:
`
`a.
`
`b.
`
`a judgment that the ’524 patent and the ’27O patent are valid and enforceable;
`
`a judgment that Hetero’s submission of the Hetero ANDA No. 204081 was an act
`
`of infringement of one or more claims of the ’524 patent and the ’27O patent and that the making,
`
`using, offering to sell, selling, marketing, distributing, or importing into the United States of
`
`Hetero’s Bendamustine Products prior to the expiration of the ’524 patent and the ’27O patent
`
`will infringe, actively induce infringement, and/or contribute to the infringement of one or more
`
`claims of the ’524 patent and the ’27O patent;
`
`c.
`
`an Order pursuant to 35 U.S.C. § 27l(e)(4)(A) providing that the effective date of
`
`any FDA approval of the Hetero ANDA No. 204081 or any product or compound the use of
`
`which infringes the ’524 patent or the ’27O patent shall be a date that is not earlier than the
`
`expiration of the ’524 patent and the ’27O patent;
`
`l4
`
`FRESENIUS KABI 1002-0014
`
`

`
`Case 1:13—cv—O2046—GMS Document 34 Filed 11/06/14 Page 15 of 16 Page|D #: 299
`
`d.
`
`an Order pursuant to 35 U.S.C. § 271(e)(4)(B) permanently enjoining Hetero and
`
`all persons acting in concert with Hetero from commercially manufacturing, using, offering for
`
`sale, selling, marketing, distributing, or importing into the United States Hetero’s Bendamustine
`
`Products, or any product or compound the use of which infringes the ’524 patent or the ’270
`
`patent, or inducing or contributing to the infringement of the ’524 patent or the ’27O patent until
`
`after the expiration of the ’524 patent and the ’27O patent;
`
`e.
`
`an Order pursuant to 35 U.S.C. 283 permanently enjoining Hetero and all persons
`
`acting in concert with Hetero from commercially manufacturing, using, offering for sale, selling,
`
`marketing, distributing, or importing Hetero’s Bendamustine Products, or any product or
`
`compound the use of which infringes the ’524 patent or the ’27O patent, or inducing or
`
`contributing to the infringement of the ’524 patent or the ’270 patent until after the expiration of
`
`the ’524 patent or the ’27O patent;
`
`f.
`
`an Order enjoining Hetero and all persons acting in concert with Hetero from
`
`seeking, obtaining, or maintaining approval of the Hetero ANDA No. 204081 before the
`
`expiration of the ’524 patent or the ’27O patent;
`
`g.
`
`an award of Cephalon’s damages or other monetary relief to compensate
`
`Cephalon if Hetero engages in the commercial manufacture, use, offer to sell, sale or marketing
`
`or distribution in, or importation into the United States of Hetero’ s Bendamustine Products, or
`
`any product or compound the use of which infringes the ’524 patent or the ’27O patent, or the
`
`inducement or contribution of the foregoing, prior to the expiration of the ’524 patent and the
`
`’27O patent in accordance with 35 U.S.C. § 27l(e)(4)(C);
`
`h.
`
`an award of Cephalon’s damages or other monetary relief to compensate
`
`Cephalon if Hetero engages in the commercial manufacture, use, offer to sell, sale or marketing
`
`15
`
`FRESENIUS KABI 1002-0015
`
`

`
`Case 1:13—cv—O2046—GMS Document 34 Filed 11/06/14 Page 16 of 16 Page|D #: 300
`
`or distribution in, or importation into the United States of Hetero’ s Bendamustine Products, or
`
`any product or compound the use of which infringes the ’524 patent or the ’270 patent, or the
`
`inducement or contribution of the foregoing, prior to the expiration of the ’524 patent and the
`
`’270 patent;
`
`i.
`
`a judgment that this is an exceptional case and awarding Cephalon its attorneys’
`
`fees under 35 U.S.C. §285;
`
`an award of Cephalon’s reasonable costs and expenses in this action; and
`
`an award of any further and additional relief to Cephalon as this Court deems just
`
`j.
`
`k.
`
`and proper.
`
`Respectfully submitted,
`
`/s/ John W. Shaw
`John w. Shaw (No. 3362)
`Karen E. Keller (No. 4489)
`Stephanie E. O’Byrne (No. 4446)
`SHAW KELLER LLP
`300 Delaware AVe., Suite 1 120
`Wilmington) DE 19801
`
`j shaw@shawkeller.com
`kkeller@shawkeller.com
`sobyrne@shawkeller.com
`Attorneysfor PlamlzflCephalon, Inc.
`
`OF COUNSEL
`DaV1_d M Héshmall
`Cam“ E Wmgfield 1“
`Jonathan A. Auerbach
`GOODWIN PROCTER LLP
`The New York Times Building
`AVCIILIC
`New Y°rk= NY 10018
`(212) 813'8800
`
`Paul F" Ware
`Emily L. Rapalino
`Nicholas K. Mitrokostas
`
`GOODWIN PROCTER LLP
`
`Exchange Place
`Boston, MA 02109
`(617) 570-1000
`
`Dated: November 6, 2014
`
`16
`
`FRESENIUS KABI 1002-0016