`William C. Baton
`SAUL EWING LLP
`One Riverfront Plaza, Suite 1520
`Newark, New Jersey 07102-5426
`(973) 286-6700
`clizza@saul.com
`
`Attorneys for Plaintiff
`Celgene Corporation
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`
`Civil Action No. ____________________
`
`COMPLAINT FOR
`PATENT INFRINGEMENT
`
`
`
`(Filed Electronically)
`
`CELGENE CORPORATION,
`
`
`
`
`
`
`
`v.
`
`Plaintiff,
`
`NATCO PHARMA LIMITED,
`
`
`
`
`
`
`
`Defendant.
`
`Plaintiff Celgene Corporation (“Celgene”), by its undersigned attorneys, for its
`
`Complaint against defendant Natco Pharma Limited (“Natco” or “Defendant”), alleges as
`
`follows:
`
`Nature of the Action
`
`1.
`
`This is an action for patent infringement under the patent laws of the United
`
`States, 35 U.S.C. §100, et seq., arising from Natco’s filing of an Abbreviated New Drug
`
`Application (“ANDA”) with the United States Food and Drug Administration (“FDA”) seeking
`
`approval to commercially market a generic version of Celgene’s REVLIMID® drug product prior
`
`to the expiration of United States Patent Nos. 5,635,517 (the “’517 patent”), 6,045,501 (the
`
`“’501 patent”), 6,281,230 (the “’230 patent”), 6,315,720 (the “’720 patent”), 6,555,554 (the
`
`“’554 patent”), 6,561,976 (the “’976 patent”), 6,561,977 (the “’977 patent”), 6,755,784 (the
`
`CFAD VI 1040 - 0001
`CFAD VI v. CELGENE
`IPR2015-01103
`
`
`
`“’784 patent”), 7,119,106 (the “’106 patent”), and 7,465,800 (the “’800 patent”) owned by
`
`Celgene (collectively, “the patents-in-suit”).
`
`The Parties
`
`2.
`
`Plaintiff Celgene is a corporation organized and existing under the laws of the
`
`State of Delaware, having a principal place of business at 86 Morris Avenue, Summit, New
`
`Jersey 07901.
`
`3.
`
`On information and belief, defendant Natco is a corporation organized and
`
`existing under the laws of India, having a principal place of business at Natco House, Road
`
`No. 2, Banjara Hills, Hyderabad 500 033 India.
`
`4.
`
`On information and belief, Natco is registered to do business in the State of
`
`New Jersey. On information and belief, Natco also regularly transacts business within this
`
`judicial district. Further, on information and belief, Natco develops numerous generic drugs
`
`for sale and use throughout the United States, including in this judicial district. On information
`
`and belief, Natco also prepares and/or aids in the preparation and submission of ANDAs to the
`
`FDA. Additionally, on information and belief, Natco has partnered with an unknown generic
`
`pharmaceutical company based in the United States (“Natco’s Unknown Partner”) to market
`
`and distribute Natco’s generic drug products complained of herein, including in this district.
`
`On information and belief, Natco’s Unknown Partner regularly conducts business in this
`
`judicial district, including marketing and selling pharmaceutical products. Prior to filing suit,
`
`Celgene asked counsel for Natco to identify Natco’s Unknown Partner. Natco’s counsel
`
`refused, but did not deny that such partner exists.
`
`Jurisdiction and Venue
`
`5.
`
`This Court has jurisdiction over the subject matter of this action pursuant to 28
`
`U.S.C. §§ 1331, 1338(a), 2201, and 2202.
`
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`CFAD VI 1040 - 0002
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`6.
`
`This Court has personal jurisdiction over Natco by virtue of, inter alia, its
`
`systematic and continuous contacts with the State of New Jersey. On information and belief,
`
`Natco has purposefully availed itself of this forum by, among other things, making, shipping,
`
`using, offering to sell or selling, or causing others to use, offer to sell, or sell, pharmaceutical
`
`products in the State of New Jersey and deriving revenue from such activities. On information
`
`and belief, Natco also has purchased retail pharmacies in the State of New Jersey. Further, on
`
`information and belief, Natco has customers in the State of New Jersey. Additionally, on
`
`information and belief, Natco’s Unknown Partner makes, ships, uses, offers to sell or sells, or
`
`causes others to use, offer to sell, or sell, pharmaceutical products in the State of New Jersey
`
`and derives revenue from such activities. On information and belief, Natco’s Unknown Partner
`
`also has customers in the State of New Jersey.
`
`7.
`
`8.
`
`Venue is proper in this District pursuant to 28 U.S.C. §§ 1391 and 1400(b).
`
`The Patents in Suit
`
`On June 3, 1997, the United States Patent and Trademark Office (“USPTO”)
`
`duly and lawfully issued the ’517 patent, entitled “Method of Reducing TNFα Levels with
`
`Amino Substituted 2-(2,6-dioxopiperidin-3-yl)-1-oxo-and 1,3-dioxoisoindolines” to Celgene as
`
`assignee of the inventors George W. Muller, David I. Stirling, and Roger Shen-Chu Chen. On
`
`June 29, 1999, the USPTO duly and lawfully issued a reexamination certificate for the ’517
`
`patent. On March 27, 2008, the USPTO extended the term of the ’517 patent under 35 U.S.C.
`
`§ 156 for a period of 1,167 days. A copy of the ’517 patent and its reexamination certificate
`
`are attached hereto as Exhibit A.
`
`9.
`
`On April 4, 2000, the USPTO duly and lawfully issued the ’501 patent, entitled
`
`“Methods for Delivering a Drug to a Patient While Preventing the Exposure of a Foetus or
`
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`CFAD VI 1040 - 0003
`
`
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`Other Contraindicated Individual to the Drug” to Celgene as assignee of the inventors Marc
`
`Elsayed and Bruce Williams. A copy of the ’501 patent is attached hereto as Exhibit B.
`
`10.
`
`On August 28, 2001, the USPTO duly and lawfully issued the ’230 patent,
`
`entitled “Isoindolines, Method of Use, and Pharmaceutical Compositions” to Celgene as
`
`assignee of the inventors George W. Muller, David I. Stirling, and Roger Shen-Chu Chen. A
`
`copy of the ’230 patent is attached hereto as Exhibit C.
`
`11.
`
`On November 13, 2001, the USPTO duly and lawfully issued the ’720 patent,
`
`entitled “Methods for Delivering a Drug to a Patient While Avoiding the Occurrence of an
`
`Adverse Side Effect Known or Suspected of Being Caused by the Drug” to Celgene as
`
`assignee of the inventors Bruce A. Williams and Joseph K. Kaminski. A copy of the ’720
`
`patent is attached hereto as Exhibit D.
`
`12.
`
`On April 29, 2003, the USPTO duly and lawfully issued the ’554 patent,
`
`entitled “Isoindolines, Method of Use, and Pharmaceutical Compositions” to Celgene as
`
`assignee of the inventors George W. Muller, David I. Stirling, and Roger Shen-Chu Chen. A
`
`copy of the ’554 patent is attached hereto as Exhibit E.
`
`13.
`
`On May 13, 2003, the USPTO duly and lawfully issued the ’976 patent, entitled
`
`“Methods for Delivering a Drug to a Patient While Preventing the Exposure of a Foetus or
`
`Other Contraindicated Individual to the Drug” to Celgene as assignee of the inventors Marc
`
`Elsayed and Bruce Williams. A copy of the ’976 patent is attached hereto as Exhibit F.
`
`14.
`
`On May 13, 2003, the USPTO duly and lawfully issued the ’977 patent, entitled
`
`“Methods for Delivering a Drug to a Patient While Restricting Access to the Drug by Patients
`
`for Whom the Drug May be Contraindicated” to Celgene as assignee of the inventors Bruce A.
`
`Williams and Joseph K. Kaminski. A copy of the ’977 patent is attached hereto as Exhibit G.
`
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`CFAD VI 1040 - 0004
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`15.
`
`On June 29, 2004, the USPTO duly and lawfully issued the ’784 patent, entitled
`
`“Methods for Delivering a Drug to a Patient While Restricting Access to the Drug by Patients
`
`for Whom the Drug May be Contraindicated” to Celgene as assignee of the inventors Bruce A.
`
`Williams and Joseph K. Kaminski. On May 3, 2005, a certificate of correction was granted by
`
`the USPTO to correct a typographical error in claim 29 of the ’784 patent. A copy of the ’784
`
`patent and its certificate of correction are attached hereto as Exhibit H.
`
`16.
`
`On October 10, 2006, the USPTO duly and lawfully issued the ’106 patent,
`
`entitled “Pharmaceutical Compositions of 1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-
`
`aminoisoindoline” to Celgene as assignee of the inventors George W. Muller, David I. Stirling,
`
`and Roger Shen-Chu Chen. A copy of the ’106 patent is attached hereto as Exhibit I.
`
`17.
`
`On December 16, 2008, the USPTO duly and lawfully issued the ’800 patent,
`
`entitled “Polymorphic Forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-
`
`dione” to Celgene as assignee of the inventors Markian S. Jaworsky, Roger Shen-Chu Chen
`
`and George W. Muller. A copy of the ’800 patent is attached hereto as Exhibit J.
`
`The REVLIMID® Drug Product
`
`18.
`
`Celgene holds an approved New Drug Application (“NDA”) under Section
`
`505(a) of the Federal Food Drug and Cosmetic Act (“FFDCA”), 21 U.S.C. § 355(a), for
`
`lenalidomide capsules (NDA No. 21-880), which it sells under the trade name REVLIMID®.
`
`The claims of the patents-in-suit cover, inter alia, lenalidomide, solid forms of lenalidomide,
`
`pharmaceutical compositions containing lenalidomide, and methods of use and administration
`
`of lenalidomide or pharmaceutical compositions containing lenalidomide.
`
`19.
`
`Pursuant to 21 U.S.C. § 355(b)(1) and attendant FDA regulations, the patents-
`
`in-suit are listed in the FDA publication, “Approved Drug Products with Therapeutic
`
`Equivalence Evaluations” (the “Orange Book”), with respect to REVLIMID®.
`
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`CFAD VI 1040 - 0005
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`Acts Giving Rise to this Suit
`
`20.
`
`Pursuant to Section 505 of the FFDCA, Natco filed ANDA No. 201-452
`
`(“Natco’s ANDA”) seeking approval to engage in the commercial use, manufacture, sale, offer
`
`for sale or importation of lenalidomide capsules 5 mg, 10 mg, 15 mg and 25 mg (“Natco’s
`
`Proposed Products”), before the patents-in-suit expire.
`
`21.
`
`In connection with the filing of its ANDA as described in the preceding
`
`paragraph, Natco has provided a written certification to the FDA, as called for by Section 505
`
`of the FFDCA, alleging that the claims of the patents-in-suit are invalid, unenforceable, and/or
`
`will not be infringed by the activities described in Natco’s ANDA.
`
`22.
`
`No earlier than August 30, 2010, Natco sent written notice of its ANDA
`
`certification to Celgene (“Natco’s Notice Letter”). Natco’s Notice Letter alleged that the
`
`claims of the ’517, ’501, ’720, ’554, ’976, ’977, ’784, ’106 and ’800 patents are invalid,
`
`unenforceable, and/or will not be infringed by the activities described in Natco’s ANDA.
`
`Natco’s Notice Letter also informed Celgene that Natco seeks approval to market Natco’s
`
`Proposed Products before the ’517, ’501, ’720, ’554, ’976, ’977, ’784, ’106 and ’800 patents
`
`expire.
`
`23.
`
`In its Notification Letter, Natco offered to provide access to certain confidential
`
`information and materials within Natco’s ANDA that would allow Celgene to confirm Natco’s
`
`infringement of the patents-in-suit. The parties did not reach agreement on the terms of such
`
`confidential access. To date, Natco has not provided any portion of its ANDA to counsel for
`
`Celgene.
`
`24.
`
`On information and belief, Natco has entered into an agreement with Natco’s
`
`Unknown Partner, under which Natco’s Unknown Partner will market and distribute Natco’s
`
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`CFAD VI 1040 - 0006
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`Proposed Products upon FDA approval of Natco’s ANDA throughout the United States,
`
`including within the State of New Jersey.
`
`Count I: Infringement of the ’517 Patent
`
`25.
`
`Plaintiff repeats and realleges the allegations of paragraphs 1-24 as though fully
`
`set forth herein.
`
`26.
`
`Natco’s submission of its ANDA to obtain approval to engage in the
`
`commercial use, manufacture, sale, offer for sale, or importation of lenalidomide capsules,
`
`prior to the expiration of the ’517 patent, constitutes infringement of one or more of the claims
`
`of that patent under 35 U.S.C. § 271(e)(2)(A).
`
`27.
`
`There is a justiciable controversy between the parties hereto as to the
`
`infringement of the ’517 patent.
`
`28.
`
`Unless enjoined by this Court, upon FDA approval of Natco’s ANDA, Natco
`
`will infringe the ’517 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
`
`importing, and/or selling Natco’s Proposed Products in the United States.
`
`29.
`
`Unless enjoined by this Court, upon FDA approval of Natco’s ANDA, Natco
`
`will induce infringement of the ’517 patent under 35 U.S.C. § 271(b) by making, using,
`
`offering to sell, importing, and/or selling Natco’s Proposed Products in the United States. On
`
`information and belief, upon FDA approval of Natco’s ANDA, Natco will intentionally
`
`encourage acts of direct infringement with knowledge of the ’517 patent and knowledge that its
`
`acts are encouraging infringement.
`
`30.
`
`Unless enjoined by this Court, upon FDA approval of Natco’s ANDA, Natco
`
`will contributorily infringe the ’517 patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing, and/or selling Natco’s Proposed Products in the United States. On
`
`information and belief, Natco has had and continues to have knowledge that Natco’s Proposed
`
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`CFAD VI 1040 - 0007
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`Products are especially adapted for a use that infringes the ’517 patent and that there is no
`
`substantial non-infringing use for Natco’s Proposed Products.
`
`31.
`
`Celgene will be substantially and irreparably damaged and harmed if Natco’s
`
`infringement of the ’517 patent is not enjoined.
`
`32.
`
`33.
`
`Celgene does not have an adequate remedy at law.
`
`This case is an exceptional one, and Celgene is entitled to an award of its
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`Count II: Infringement of the ’501 Patent
`
`34.
`
`Plaintiff repeats and realleges the allegations of paragraphs 1-33 as though fully
`
`set forth herein.
`
`35.
`
`Natco’s submission of its ANDA to obtain approval to engage in the
`
`commercial use, manufacture, sale, offer for sale, or importation of lenalidomide capsules,
`
`prior to the expiration of the ’501 patent, constitutes infringement of one or more of the claims
`
`of that patent under 35 U.S.C. § 271(e)(2)(A).
`
`36.
`
`There is a justiciable controversy between the parties hereto as to the
`
`infringement of the ’501 patent.
`
`37.
`
`Unless enjoined by this Court, upon FDA approval of Natco’s ANDA, Natco
`
`will infringe the ’501 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
`
`importing, and/or selling Natco’s Proposed Products in the United States.
`
`38.
`
`Unless enjoined by this Court, upon FDA approval of Natco’s ANDA, Natco
`
`will induce infringement of the ’501 patent under 35 U.S.C. § 271(b) by making, using,
`
`offering to sell, importing, and/or selling Natco’s Proposed Products in the United States. On
`
`information and belief, upon FDA approval of Natco’s ANDA, Natco will intentionally
`
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`CFAD VI 1040 - 0008
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`encourage acts of direct infringement with knowledge of the ’501 patent and knowledge that its
`
`acts are encouraging infringement.
`
`39.
`
`Unless enjoined by this Court, upon FDA approval of Natco’s ANDA, Natco
`
`will contributorily infringe the ’501 patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing, and/or selling Natco’s Proposed Products in the United States. On
`
`information and belief, Natco has had and continues to have knowledge that Natco’s Proposed
`
`Products are especially adapted for a use that infringes the ’501 patent and that there is no
`
`substantial non-infringing use for Natco’s Proposed Products.
`
`40.
`
`Celgene will be substantially and irreparably damaged and harmed if Natco’s
`
`infringement of the ’501 patent is not enjoined.
`
`41.
`
`42.
`
`Celgene does not have an adequate remedy at law.
`
`This case is an exceptional one, and Celgene is entitled to an award of its
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`Count III: Infringement of the ’230 Patent
`
`43.
`
`Plaintiff repeats and realleges the allegations of paragraphs 1-42 as though fully
`
`set forth herein.
`
`44.
`
`Natco’s submission of its ANDA to obtain approval to engage in the
`
`commercial use, manufacture, sale, offer for sale, or importation of lenalidomide capsules,
`
`prior to the expiration of the ’230 patent, constitutes infringement of one or more of the claims
`
`of that patent under 35 U.S.C. § 271(e)(2)(A).
`
`45.
`
`There is a justiciable controversy between the parties hereto as to the
`
`infringement of the ’230 patent.
`
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`CFAD VI 1040 - 0009
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`46.
`
`Unless enjoined by this Court, upon FDA approval of Natco’s ANDA, Natco
`
`will infringe the ’230 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
`
`importing, and/or selling Natco’s Proposed Products in the United States.
`
`47.
`
`Unless enjoined by this Court, upon FDA approval of Natco’s ANDA, Natco
`
`will induce infringement of the ’230 patent under 35 U.S.C. § 271(b) by making, using,
`
`offering to sell, importing, and/or selling Natco’s Proposed Products in the United States. On
`
`information and belief, upon FDA approval of Natco’s ANDA, Natco will intentionally
`
`encourage acts of direct infringement with knowledge of the ’230 patent and knowledge that its
`
`acts are encouraging infringement.
`
`48.
`
`Unless enjoined by this Court, upon FDA approval of Natco’s ANDA, Natco
`
`will contributorily infringe the ’230 patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing, and/or selling Natco’s Proposed Products in the United States. On
`
`information and belief, Natco has had and continues to have knowledge that Natco’s Proposed
`
`Products are especially adapted for a use that infringes the ’230 patent and that there is no
`
`substantial non-infringing use for Natco’s Proposed Products.
`
`49.
`
`Celgene will be substantially and irreparably damaged and harmed if Natco’s
`
`infringement of the ’230 patent is not enjoined.
`
`50.
`
`51.
`
`Celgene does not have an adequate remedy at law.
`
`This case is an exceptional one, and Celgene is entitled to an award of its
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`Count IV: Infringement of the ’720 Patent
`
`52.
`
`Plaintiff repeats and realleges the allegations of paragraphs 1-51 as though fully
`
`set forth herein.
`
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`CFAD VI 1040 - 0010
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`53.
`
`Natco’s submission of its ANDA to obtain approval to engage in the
`
`commercial use, manufacture, sale, offer for sale, or importation of lenalidomide capsules,
`
`prior to the expiration of the ’720 patent, constitutes infringement of one or more of the claims
`
`of that patent under 35 U.S.C. § 271(e)(2)(A).
`
`54.
`
`There is a justiciable controversy between the parties hereto as to the
`
`infringement of the ’720 patent.
`
`55.
`
`Unless enjoined by this Court, upon FDA approval of Natco’s ANDA, Natco
`
`will infringe the ’720 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
`
`importing, and/or selling Natco’s Proposed Products in the United States.
`
`56.
`
`Unless enjoined by this Court, upon FDA approval of Natco’s ANDA, Natco
`
`will induce infringement of the ’720 patent under 35 U.S.C. § 271(b) by making, using,
`
`offering to sell, importing, and/or selling Natco’s Proposed Products in the United States. On
`
`information and belief, upon FDA approval of Natco’s ANDA, Natco will intentionally
`
`encourage acts of direct infringement with knowledge of the ’720 patent and knowledge that its
`
`acts are encouraging infringement.
`
`57.
`
`Unless enjoined by this Court, upon FDA approval of Natco’s ANDA, Natco
`
`will contributorily infringe the ’720 patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing, and/or selling Natco’s Proposed Products in the United States. On
`
`information and belief, Natco has had and continues to have knowledge that Natco’s Proposed
`
`Products are especially adapted for a use that infringes the ’720 patent and that there is no
`
`substantial non-infringing use for Natco’s Proposed Products.
`
`58.
`
`Celgene will be substantially and irreparably damaged and harmed if Natco’s
`
`infringement of the ’720 patent is not enjoined.
`
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`CFAD VI 1040 - 0011
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`59.
`
`60.
`
`Celgene does not have an adequate remedy at law.
`
`This case is an exceptional one, and Celgene is entitled to an award of its
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`Count V: Infringement of the ’554 Patent
`
`61.
`
`Plaintiff repeats and realleges the allegations of paragraphs 1-60 as though fully
`
`set forth herein.
`
`62.
`
`Natco’s submission of its ANDA to obtain approval to engage in the
`
`commercial use, manufacture, sale, offer for sale, or importation of lenalidomide capsules,
`
`prior to the expiration of the ’554 patent, constitutes infringement of one or more of the claims
`
`of that patent under 35 U.S.C. § 271(e)(2)(A).
`
`63.
`
`There is a justiciable controversy between the parties hereto as to the
`
`infringement of the ’554 patent.
`
`64.
`
`Unless enjoined by this Court, upon FDA approval of Natco’s ANDA, Natco
`
`will infringe the ’554 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
`
`importing, and/or selling Natco’s Proposed Products in the United States.
`
`65.
`
`Unless enjoined by this Court, upon FDA approval of Natco’s ANDA, Natco
`
`will induce infringement of the ’554 patent under 35 U.S.C. § 271(b) by making, using,
`
`offering to sell, importing, and/or selling Natco’s Proposed Products in the United States. On
`
`information and belief, upon FDA approval of Natco’s ANDA, Natco will intentionally
`
`encourage acts of direct infringement with knowledge of the ’554 patent and knowledge that its
`
`acts are encouraging infringement.
`
`66.
`
`Unless enjoined by this Court, upon FDA approval of Natco’s ANDA, Natco
`
`will contributorily infringe the ’554 patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing, and/or selling Natco’s Proposed Products in the United States. On
`
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`information and belief, Natco has had and continues to have knowledge that Natco’s Proposed
`
`Products are especially adapted for a use that infringes the ’554 patent and that there is no
`
`substantial non-infringing use for Natco’s Proposed Products.
`
`67.
`
`Celgene will be substantially and irreparably damaged and harmed if Natco’s
`
`infringement of the ’554 patent is not enjoined.
`
`68.
`
`69.
`
`Celgene does not have an adequate remedy at law.
`
`This case is an exceptional one, and Celgene is entitled to an award of its
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`Count VI: Infringement of the ’976 Patent
`
`70.
`
`Plaintiff repeats and realleges the allegations of paragraphs 1-69 as though fully
`
`set forth herein.
`
`71.
`
`Natco’s submission of its ANDA to obtain approval to engage in the
`
`commercial use, manufacture, sale, offer for sale, or importation of lenalidomide capsules,
`
`prior to the expiration of the ’976 patent, constitutes infringement of one or more of the claims
`
`of that patent under 35 U.S.C. § 271(e)(2)(A).
`
`72.
`
`There is a justiciable controversy between the parties hereto as to the
`
`infringement of the ’976 patent.
`
`73.
`
`Unless enjoined by this Court, upon FDA approval of Natco’s ANDA, Natco
`
`will infringe the ’976 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
`
`importing, and/or selling Natco’s Proposed Products in the United States.
`
`74.
`
`Unless enjoined by this Court, upon FDA approval of Natco’s ANDA, Natco
`
`will induce infringement of the ’976 patent under 35 U.S.C. § 271(b) by making, using,
`
`offering to sell, importing, and/or selling Natco’s Proposed Products in the United States. On
`
`information and belief, upon FDA approval of Natco’s ANDA, Natco will intentionally
`
`
`
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`CFAD VI 1040 - 0013
`
`
`
`encourage acts of direct infringement with knowledge of the ’976 patent and knowledge that its
`
`acts are encouraging infringement.
`
`75.
`
`Unless enjoined by this Court, upon FDA approval of Natco’s ANDA, Natco
`
`will contributorily infringe the ’976 patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing, and/or selling Natco’s Proposed Products in the United States. On
`
`information and belief, Natco has had and continues to have knowledge that Natco’s Proposed
`
`Products are especially adapted for a use that infringes the ’976 patent and that there is no
`
`substantial non-infringing use for Natco’s Proposed Products.
`
`76.
`
`Celgene will be substantially and irreparably damaged and harmed if Natco’s
`
`infringement of the ’976 patent is not enjoined.
`
`77.
`
`78.
`
`Celgene does not have an adequate remedy at law.
`
`This case is an exceptional one, and Celgene is entitled to an award of its
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`Count VII: Infringement of the ’977 Patent
`
`79.
`
`Plaintiff repeats and realleges the allegations of paragraphs 1-78 as though fully
`
`set forth herein.
`
`80.
`
`Natco’s submission of its ANDA to obtain approval to engage in the
`
`commercial use, manufacture, sale, offer for sale, or importation of lenalidomide capsules,
`
`prior to the expiration of the ’977 patent, constitutes infringement of one or more of the claims
`
`of that patent under 35 U.S.C. § 271(e)(2)(A).
`
`81.
`
`There is a justiciable controversy between the parties hereto as to the
`
`infringement of the ’977 patent.
`
`
`
`- 14 -
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`CFAD VI 1040 - 0014
`
`
`
`82.
`
`Unless enjoined by this Court, upon FDA approval of Natco’s ANDA, Natco
`
`will infringe the ’977 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
`
`importing, and/or selling Natco’s Proposed Products in the United States.
`
`83.
`
`Unless enjoined by this Court, upon FDA approval of Natco’s ANDA, Natco
`
`will induce infringement of the ’977 patent under 35 U.S.C. § 271(b) by making, using,
`
`offering to sell, importing, and/or selling Natco’s Proposed Products in the United States. On
`
`information and belief, upon FDA approval of Natco’s ANDA, Natco will intentionally
`
`encourage acts of direct infringement with knowledge of the ’977 patent and knowledge that its
`
`acts are encouraging infringement.
`
`84.
`
`Unless enjoined by this Court, upon FDA approval of Natco’s ANDA, Natco
`
`will contributorily infringe the ’977 patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing, and/or selling Natco’s Proposed Products in the United States. On
`
`information and belief, Natco has had and continues to have knowledge that Natco’s Proposed
`
`Products are especially adapted for a use that infringes the ’977 patent and that there is no
`
`substantial non-infringing use for Natco’s Proposed Products.
`
`85.
`
`Celgene will be substantially and irreparably damaged and harmed if Natco’s
`
`infringement of the ’977 patent is not enjoined.
`
`86.
`
`87.
`
`Celgene does not have an adequate remedy at law.
`
`This case is an exceptional one, and Celgene is entitled to an award of its
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`Count VIII: Infringement of the ’784 Patent
`
`88.
`
`Plaintiff repeats and realleges the allegations of paragraphs 1-87 as though fully
`
`set forth herein.
`
`
`
`- 15 -
`
`CFAD VI 1040 - 0015
`
`
`
`89.
`
`Natco’s submission of its ANDA to obtain approval to engage in the
`
`commercial use, manufacture, sale, offer for sale, or importation of lenalidomide capsules,
`
`prior to the expiration of the ’784 patent, constitutes infringement of one or more of the claims
`
`of that patent under 35 U.S.C. § 271(e)(2)(A).
`
`90.
`
`There is a justiciable controversy between the parties hereto as to the
`
`infringement of the ’784 patent.
`
`91.
`
`Unless enjoined by this Court, upon FDA approval of Natco’s ANDA, Natco
`
`will infringe the ’784 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
`
`importing, and/or selling Natco’s Proposed Products in the United States.
`
`92.
`
`Unless enjoined by this Court, upon FDA approval of Natco’s ANDA, Natco
`
`will induce infringement of the ’784 patent under 35 U.S.C. § 271(b) by making, using,
`
`offering to sell, importing, and/or selling Natco’s Proposed Products in the United States. On
`
`information and belief, upon FDA approval of Natco’s ANDA, Natco will intentionally
`
`encourage acts of direct infringement with knowledge of the ’784 patent and knowledge that its
`
`acts are encouraging infringement.
`
`93.
`
`Unless enjoined by this Court, upon FDA approval of Natco’s ANDA, Natco
`
`will contributorily infringe the ’784 patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing, and/or selling Natco’s Proposed Products in the United States. On
`
`information and belief, Natco has had and continues to have knowledge that Natco’s Proposed
`
`Products are especially adapted for a use that infringes the ’784 patent and that there is no
`
`substantial non-infringing use for Natco’s Proposed Products.
`
`94.
`
`Celgene will be substantially and irreparably damaged and harmed if Natco’s
`
`infringement of the ’784 patent is not enjoined.
`
`
`
`- 16 -
`
`CFAD VI 1040 - 0016
`
`
`
`95.
`
`96.
`
`Celgene does not have an adequate remedy at law.
`
`This case is an exceptional one, and Celgene is entitled to an award of its
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`Count IX: Infringement of the ’106 Patent
`
`97.
`
`Plaintiff repeats and realleges the allegations of paragraphs 1-96 as though fully
`
`set forth herein.
`
`98.
`
`Natco’s submission of its ANDA to obtain approval to engage in the
`
`commercial use, manufacture, sale, offer for sale, or importation of lenalidomide capsules,
`
`prior to the expiration of the ’106 patent, constitutes infringement of one or more of the claims
`
`of that patent under 35 U.S.C. § 271(e)(2)(A).
`
`99.
`
`There is a justiciable controversy between the parties hereto as to the
`
`infringement of the ’106 patent.
`
`100. Unless enjoined by this Court, upon FDA approval of Natco’s ANDA, Natco
`
`will infringe the ’106 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
`
`importing, and/or selling Natco’s Proposed Products in the United States.
`
`101. Unless enjoined by this Court, upon FDA approval of Natco’s ANDA, Natco
`
`will induce infringement of the ’106 patent under 35 U.S.C. § 271(b) by making, using,
`
`offering to sell, importing, and/or selling Natco’s Proposed Products in the United States. On
`
`information and belief, upon FDA approval of Natco’s ANDA, Natco will intentionally
`
`encourage acts of direct infringement with knowledge of the ’106 patent and knowledge that its
`
`acts are encouraging infringement.
`
`102. Unless enjoined by this Court, upon FDA approval of Natco’s ANDA, Natco
`
`will contributorily infringe the ’106 patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing, and/or selling Natco’s Proposed Products in the United States. On
`
`
`
`- 17 -
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`CFAD VI 1040 - 0017
`
`
`
`information and belief, Natco has had and continues to have knowledge that Natco’s Proposed
`
`Products are especially adapted for a use that infringes the ’106 patent and that there is no
`
`substantial non-infringing use for Natco’s Proposed Products.
`
`103. Celgene will be substantially and irreparably damaged and harmed if Natco’s
`
`infringement of the ’106 patent is not enjoined.
`
`104. Celgene does not have an adequate remedy at law.
`
`105. This case is an exceptional one, and Celgene is entitled to an award of its
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`Count X: Infringement of the ’800 Patent
`
`106. Plaintiff repeats and realleges the allegations of paragraphs 1-105 as though
`
`fully set forth herein.
`
`107. Natco’s submission of its ANDA to obtain approval to engage in the
`
`commercial use, manufacture, sale, offer for sale, or importation of lenalidomide capsules,
`
`prior to the expiration of the ’800 patent, constitutes infringement of one or more of the claims
`
`of that patent under 35 U.S.C. § 271(e)(2)(A).
`
`108. There is a justiciable controversy between the parties hereto as to the
`
`infringement of the ’800 patent.
`
`109. Unless enjoined by this Court, upon FDA approval of Natco’s ANDA, Natco
`
`will infringe the ’800 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
`
`importing, and/or selling Natco’s Proposed Products in the United States.
`
`110. Unless enjoined by this Court, upon FDA approval of Natco’s ANDA, Natco
`
`will induce infringement of the ’800 patent under 35 U.S.C. § 271(b) by making, using,
`
`offering to sell, importing, and/or selling Natco’s Proposed Products in the United States. On
`
`information and belief, upon FDA approval of Natco’s ANDA, Natco will intentionally
`
`
`
`- 18 -
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`CFAD VI 1040 - 0018
`
`
`
`encourage acts of direct infringement with knowledge of the ’800 patent and knowledge that its
`
`acts are encouraging infringement.
`
`111. Unless enjoined by this Court, upon FDA approval of Natco’s ANDA, Natco
`
`will contributorily infringe the ’800 patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing, and/o