Case 2:07-cv-05485-SDW-MCA Document 1 Filed 11/14/07 Page 1 of 14 PageID: 40
`
`Charles M. Lizza
`William C. Baton
`SAUL EWING LLP
`One Riverfront Plaza
`Newark, New Jersey 07102-5490
`(973) 286-6700
`clizza@saul.com
`
`
`
`Attorneys for Plaintiff
`Celgene Corporation
`
`
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`
`CELGENE CORPORATION,
`
`Plaintiff,
`
`v.
`
`BARR LABORATORIES, INC. and
`BARR PHARMACEUTICALS, INC.,
`
`Defendants.
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`Civil Action No. _____________
`
`COMPLAINT FOR PATENT
`INFRINGEMENT
`
`(Filed Electronically)
`
`
`Plaintiff Celgene Corporation ((cid:147)Celgene(cid:148)), by its undersigned attorneys, brings this
`
`action against defendants, Barr Laboratories, Inc. and Barr Pharmaceuticals, Inc., for patent
`
`infringement and alleges as follows:
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`Nature of the Action
`
`1.
`
`This is an action for patent infringement under the patent laws of the United
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`States, 35 United States Code, arising from Barr Laboratories, Inc.(cid:146)s filing of an Abbreviated
`
`New Drug Application ((cid:147)ANDA(cid:148)) with the United States Food and Drug Administration
`
`((cid:147)FDA(cid:148)) seeking approval to commercially market a generic version of Celgene(cid:146)s Thalomidfi
`
`brand drug prior to the expiration of certain patents owned by Celgene that cover that product(cid:146)s
`
`
`
`

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`Case 2:07-cv-05485-SDW-MCA Document 1 Filed 11/14/07 Page 2 of 14 PageID: 41
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`use, i.e., United States Patent Nos. 6,045,501 ((cid:147)the (cid:146)501 patent(cid:148)), 6,315,720 ((cid:147)the (cid:146)720 patent(cid:148)),
`
`6,561,976 ((cid:147)the (cid:146)976 patent(cid:148)), 6,561,977 ((cid:147)the (cid:146)977 patent(cid:148)), 6,755,784 ((cid:147)the (cid:146)784 patent(cid:148)),
`
`6,869,399 ((cid:147)the (cid:146)399 patent(cid:148)), and 7,141,018 ((cid:147)the (cid:146)018 patent(cid:148)) (collectively, (cid:147)the patents-in-
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`suit(cid:148)).
`
`The Parties
`
`2.
`
`Plaintiff Celgene is a corporation organized and existing under the laws of the
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`State of Delaware, having a principal place of business at 86 Morris Avenue, Summit, New
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`Jersey 07901.
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`3.
`
`On information and belief, defendant Barr Laboratories, Inc. is a corporation
`
`having its principal place of business at 223 Quaker Road, Pomona, New York 10970.
`
`4.
`
`On information and belief, defendant Barr Pharmaceuticals, Inc. is a corporation
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`organized and existing under the laws of the State of Delaware, having a place of business at 400
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`Chestnut Ridge Road, Woodcliff Lake, NJ 07677.
`
`5.
`
`On information and belief, defendant Barr Laboratories, Inc. is a subsidiary of
`
`defendant Barr Pharmaceuticals, Inc.
`
`6.
`
`On information and belief, Barr Laboratories, Inc. and Barr Pharmaceuticals, Inc.
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`are registered to do business in New Jersey. Further, on information and belief, Barr
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`Laboratories, Inc. and Barr Pharmaceuticals, Inc. maintain executive offices and a manufacturing
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`facility and otherwise transact business within this District.
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`7.
`
`On information and belief, the acts of Barr Laboratories, Inc. complained of
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`herein were done at the direction of, with the authorization of, or with the cooperation,
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`participation, or assistance of, or at least in part for the benefit of, Barr Pharmaceuticals, Inc.
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`Case 2:07-cv-05485-SDW-MCA Document 1 Filed 11/14/07 Page 3 of 14 PageID: 42
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`8.
`
`Barr Laboratories, Inc. and Barr Pharmaceuticals, Inc. are referred to hereinafter,
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`collectively, as (cid:147)Barr.(cid:148)
`
`Jurisdiction and Venue
`
`9.
`
`This Court has jurisdiction over the subject matter of this action pursuant to 28
`
`U.S.C. §§ 1331 and 1338(a) and 2201 and 2202.
`
`10.
`
`This Court has personal jurisdiction over Barr by virtue of the fact that Barr has
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`availed itself of the laws of New Jersey and conducts business in New Jersey.
`
`11.
`
`Venue is proper in this District pursuant to 28 U.S.C. §§ 1391 and 1400(b).
`
`The Patents in Suit
`
`12.
`
`On April 4, 2000, the United States Patent and Trademark Office ((cid:147)USPTO(cid:148))
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`duly and lawfully issued the (cid:146)501 patent, entitled (cid:147)Methods for Delivering a Drug to a Patient
`
`While Preventing the Exposure of a Foetus or Other Contraindicated Individual to the Drug(cid:148) to
`
`Celgene as assignee of the inventors Marc Elsayed and Bruce Williams. A copy of the (cid:146)501
`
`patent is attached hereto as Exhibit A.
`
`13.
`
`On November 13, 2001, the USPTO duly and lawfully issued the (cid:146)720 patent,
`
`entitled (cid:147)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(cid:148) to Celgene as assignee
`
`of the inventors Bruce A. Williams and Joseph K. Kaminski. A copy of the (cid:146)720 patent is
`
`attached hereto as Exhibit B.
`
`14.
`
`On May 13, 2003, the USPTO duly and lawfully issued the (cid:146)976 patent, entitled
`
`(cid:147)Methods for Delivering a Drug to a Patient While Preventing the Exposure of a Foetus or Other
`
`Contraindicated Individual to the Drug(cid:148) to Celgene as assignee of the inventors Marc Elsayed
`
`and Bruce Williams. A copy of the (cid:146)976 patent is attached hereto as Exhibit C.
`
`
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`15.
`
`On May 13, 2003, the USPTO duly and lawfully issued the (cid:146)977 patent, entitled
`
`(cid:147)Methods for Delivering a Drug to a Patient While Restricting Access to the Drug by Patients for
`
`Whom the Drug May be Contraindicated(cid:148) to Celgene as assignee of the inventors Bruce A.
`
`Williams and Joseph K. Kaminski. A copy of the (cid:146)977 patent is attached hereto as Exhibit D.
`
`16.
`
`On June 29, 2004, the USPTO duly and lawfully issued the (cid:146)784 patent, entitled
`
`(cid:147)Methods for Delivering a Drug to a Patient While Restricting Access to the Drug by Patients for
`
`Whom the Drug May be Contraindicated(cid:148) 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 (cid:146)784 patent. A copy of the (cid:146)784
`
`patent and its certificate of correction is attached hereto as Exhibit E.
`
`17.
`
`On March 22, 2005, the USPTO duly and lawfully issued the (cid:146)399 patent, entitled
`
`(cid:147)Methods for Delivering a Drug to a Patient While Restricting Access to the Drug by Patients for
`
`Whom the Drug May be Contraindicated(cid:148) to Celgene as assignee of the inventors Bruce A.
`
`Williams and Joseph K. Kaminski. On March 7, 2006, a certificate of correction was granted by
`
`the USPTO to correct typographical errors in claim 19 of the (cid:146)399 patent. A copy of the (cid:146)399
`
`patent and its certificate of correction is attached hereto as Exhibit F.
`
`18.
`
`On November 28, 2006, the USPTO duly and lawfully issued the (cid:146)018 patent,
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`entitled (cid:147)Methods for Delivering a Drug to a Patient While Restricting Access to the Drug by
`
`Patients for Whom the Drug May be Contraindicated(cid:148) to Celgene as assignee of the inventors
`
`Bruce A. Williams and Joseph K. Kaminski. A copy of the (cid:146)018 patent is attached hereto as
`
`Exhibit G.
`
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`Case 2:07-cv-05485-SDW-MCA Document 1 Filed 11/14/07 Page 5 of 14 PageID: 44
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`The THALOMID® Drug Product
`
`19.
`
`Celgene holds an approved New Drug Application ((cid:147)NDA(cid:148)) under Section 505(a)
`
`of the Federal Food Drug and Cosmetic Act ((cid:147)FFDCA(cid:148)), 21 U.S.C. § 355(a) for thalidomide
`
`capsules (NDA No. 20-785), which it sells as THALOMIDfi brand drug. The claims of the (cid:146)501,
`
`(cid:146)720, (cid:146)976, (cid:146)977, (cid:146)784, (cid:146)399, and (cid:146)018 patents cover, inter alia, methods of use and delivery of
`
`pharmaceutical compositions containing the drug thalidomide.
`
`20.
`
`Pursuant to 21 U.S.C. § 355(b)(1) and attendant FDA regulations, the (cid:146)501, (cid:146)720,
`
`(cid:146)976, (cid:146)977, (cid:146)784, (cid:146)399, and (cid:146)018 patents are listed in the FDA publication, (cid:147)Approved Drug
`
`Products with Therapeutic Equivalence Evaluations(cid:148) (the (cid:147)Orange Book(cid:148)), with respect to
`
`THALOMIDfi brand drug.
`
`Acts Giving Rise to this Suit
`
`21.
`
`Pursuant to Section 505 of the FFDCA, Barr filed ANDA No. 78-505 for
`
`thalidomide capsules, seeking approval to engage in the commercial use, manufacture, sale, offer
`
`for sale or importation into the United States of thalidomide capsules before the patents-in-suit
`
`expire.
`
`22.
`
`On October 4, 2007, Barr amended its ANDA to seek approval to engage in the
`
`commercial use, manufacture, sale, offer for sale or importation into the United States of 150 mg
`
`thalidomide capsules ((cid:147)Barr(cid:146)s Proposed Product(cid:148)) before the patents-in-suit expire.
`
`23.
`
`After amending its ANDA, Barr was required to send Celgene notification
`
`pursuant to 21 U.S.C. § 355(j)(2)(B)(ii).
`
`24.
`
`No earlier than October 4, 2007, Barr sent written notice of its amended ANDA to
`
`Celgene ((cid:147)Barr(cid:146)s Notice Letter(cid:148)). In its Notice Letter, Barr alleged that the patents-in-suit are
`
`invalid, unenforceable, and/or will not be infringed by Barr. Barr(cid:146)s Notice Letter also informed
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`Case 2:07-cv-05485-SDW-MCA Document 1 Filed 11/14/07 Page 6 of 14 PageID: 45
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`Celgene that Barr seeks approval to market Barr(cid:146)s Proposed Product before the expiration of the
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`patents-in-suit.
`
`Count I: Barr’s Filing of the ANDA Infringes the ’501 Patent
`
`25.
`
`Plaintiffs repeat and reallege the allegations of paragraphs 1-24 as though fully set
`
`forth herein.
`
`26.
`
`Barr(cid:146)s submission of its ANDA to obtain approval to engage in the commercial
`
`use, manufacture, sale, offer for sale or importation of thalidomide capsules, prior to the
`
`expiration of the (cid:146)501 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 infringement of
`
`the (cid:146)501 patent.
`
`28.
`
`Unless enjoined by this Court, Barr, upon FDA approval of Barr(cid:146)s ANDA, will
`
`infringe the (cid:146)501 patent by making, using, offering to sell, importing, and selling Barr(cid:146)s Proposed
`
`Product in the United States.
`
`29.
`
`Celgene will be substantially and irreparably damaged and harmed if Barr(cid:146)s
`
`infringement of the (cid:146)501 patent is not enjoined.
`
`30.
`
`31.
`
`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 attorney(cid:146)s fees under 35 U.S.C. § 285.
`
`Count II: Barr’s Filing of the ANDA Infringes the ’720 Patent
`
`32.
`
`Plaintiffs repeat and reallege the allegations of paragraphs 1-31 as though fully set
`
`forth herein.
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`33.
`
`Barr(cid:146)s submission of its ANDA to obtain approval to engage in the commercial
`
`use, manufacture, sale, offer for sale or importation of thalidomide capsules, prior to the
`
`expiration of the (cid:146)720 patent, constitutes infringement of one or more of the claims of that patent
`
`as issued under 35 U.S.C. § 271(e)(2)(A).
`
`34.
`
`There is a justiciable controversy between the parties hereto as to infringement of
`
`the (cid:146)720 patent.
`
`35.
`
`Unless enjoined by this Court, Barr, upon FDA approval of Barr(cid:146)s ANDA, will
`
`infringe the (cid:146)720 patent by making, using, offering to sell, importing, and selling Barr(cid:146)s Proposed
`
`Product in the United States.
`
`36.
`
`Celgene will be substantially and irreparably damaged and harmed if Barr(cid:146)s
`
`infringement of the (cid:146)720 patent is not enjoined.
`
`37.
`
`38.
`
`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 attorney(cid:146)s fees under 35 U.S.C. § 285.
`
`Count III: Barr’s Filing of the ANDA Infringes the ’976 Patent
`
`39.
`
`Plaintiffs repeat and reallege the allegations of paragraphs 1-38 as though fully set
`
`forth herein.
`
`40.
`
`Barr(cid:146)s submission of its ANDA to obtain approval to engage in the commercial
`
`use, manufacture, sale, offer for sale or importation of thalidomide capsules, prior to the
`
`expiration of the (cid:146)976 patent, constitutes infringement of one or more of the claims of that patent
`
`as issued under 35 U.S.C. § 271(e)(2)(A).
`
`41.
`
`There is a justiciable controversy between the parties hereto as to infringement of
`
`the (cid:146)976 patent.
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`42.
`
`Unless enjoined by this Court, Barr, upon FDA approval of Barr(cid:146)s ANDA, will
`
`infringe the (cid:146)976 patent by making, using, offering to sell, importing, and selling Barr(cid:146)s Proposed
`
`Product in the United States.
`
`43.
`
`Celgene will be substantially and irreparably damaged and harmed if Barr(cid:146)s
`
`infringement of the (cid:146)976 patent is not enjoined.
`
`44.
`
`45.
`
`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 attorney(cid:146)s fees under 35 U.S.C. § 285.
`
`Count IV: Barr’s Filing of the ANDA Infringes the ’977 Patent
`
`46.
`
`Plaintiffs repeat and reallege the allegations of paragraphs 1-45 as though fully set
`
`forth herein.
`
`47.
`
`Barr(cid:146)s submission of its ANDA to obtain approval to engage in the commercial
`
`use, manufacture, sale, offer for sale or importation of thalidomide capsules, prior to the
`
`expiration of the (cid:146)977 patent, constitutes infringement of one or more of the claims of that patent
`
`as issued under 35 U.S.C. § 271(e)(2)(A).
`
`48.
`
`There is a justiciable controversy between the parties hereto as to infringement of
`
`the (cid:146)977 patent.
`
`49.
`
`Unless enjoined by this Court, Barr, upon FDA approval of Barr(cid:146)s ANDA, will
`
`infringe the (cid:146)977 patent by making, using, offering to sell, importing, and selling Barr(cid:146)s Proposed
`
`Product in the United States.
`
`50.
`
`Celgene will be substantially and irreparably damaged and harmed if Barr(cid:146)s
`
`infringement of the (cid:146)977 patent is not enjoined.
`
`51.
`
`Celgene does not have an adequate remedy at law.
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`52.
`
`This case is an exceptional one, and Celgene is entitled to an award of its
`
`reasonable attorney(cid:146)s fees under 35 U.S.C. § 285.
`
`Count V: Barr’s Filing of the ANDA Infringes the ’784 Patent
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`53.
`
`Plaintiffs repeat and reallege the allegations of paragraphs 1-52 as though fully set
`
`forth herein.
`
`54.
`
`Barr(cid:146)s submission of its ANDA to obtain approval to engage in the commercial
`
`use, manufacture, sale, offer for sale or importation of thalidomide capsules, prior to the
`
`expiration of the (cid:146)784 patent, constitutes infringement of one or more of the claims of that patent
`
`as issued under 35 U.S.C. § 271(e)(2)(A).
`
`55.
`
`There is a justiciable controversy between the parties hereto as to infringement of
`
`the (cid:146)784 patent.
`
`56.
`
`Unless enjoined by this Court, Barr, upon FDA approval of Barr(cid:146)s ANDA, will
`
`infringe the (cid:146)784 patent by making, using, offering to sell, importing, and selling Barr(cid:146)s Proposed
`
`Product in the United States.
`
`57.
`
`Celgene will be substantially and irreparably damaged and harmed if Barr(cid:146)s
`
`infringement of the (cid:146)784 patent is not enjoined.
`
`58.
`
`59.
`
`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 attorney(cid:146)s fees under 35 U.S.C. § 285.
`
`Count VI: Barr’s Filing of the ANDA Infringes the ’399 Patent
`
`60.
`
`Plaintiffs repeat and reallege the allegations of paragraphs 1-59 as though fully set
`
`forth herein.
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`61.
`
`Barr(cid:146)s submission of its ANDA to obtain approval to engage in the commercial
`
`use, manufacture, sale, offer for sale or importation of thalidomide capsules, prior to the
`
`expiration of the (cid:146)399 patent, constitutes infringement of one or more of the claims of that patent
`
`as issued under 35 U.S.C. § 271(e)(2)(A).
`
`62.
`
`There is a justiciable controversy between the parties hereto as to infringement of
`
`the (cid:146)399 patent.
`
`63.
`
`Unless enjoined by this Court, Barr, upon FDA approval of Barr(cid:146)s ANDA, will
`
`infringe the (cid:146)399 patent by making, using, offering to sell, importing, and selling Barr(cid:146)s Proposed
`
`Product in the United States.
`
`64.
`
`Celgene will be substantially and irreparably damaged and harmed if Barr(cid:146)s
`
`infringement of the (cid:146)399 patent is not enjoined.
`
`65.
`
`66.
`
`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 attorney(cid:146)s fees under 35 U.S.C. § 285.
`
`Count VII: Barr’s Filing of the ANDA Infringes the ’018 Patent
`
`67.
`
`Plaintiffs repeat and reallege the allegations of paragraphs 1-66 as though fully set
`
`forth herein.
`
`68.
`
`Barr(cid:146)s submission of its ANDA to obtain approval to engage in the commercial
`
`use, manufacture, sale, offer for sale or importation of thalidomide capsules, prior to the
`
`expiration of the (cid:146)018 patent, constitutes infringement of one or more of the claims of that patent
`
`as issued under 35 U.S.C. § 271(e)(2)(A).
`
`69.
`
`There is a justiciable controversy between the parties hereto as to infringement of
`
`the (cid:146)018 patent.
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`70.
`
`Unless enjoined by this Court, Barr, upon FDA approval of Barr(cid:146)s ANDA, will
`
`infringe the (cid:146)018 patent by making, using, offering to sell, importing, and selling Barr(cid:146)s Proposed
`
`Product in the United States.
`
`71.
`
`Celgene will be substantially and irreparably damaged and harmed if Barr(cid:146)s
`
`infringement of the (cid:146)018 patent is not enjoined.
`
`72.
`
`73.
`
`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 attorney(cid:146)s fees under 35 U.S.C. § 285.
`
`Count VIII: Inducing Infringement
`
`74.
`
`Plaintiffs repeat and reallege the allegations of paragraphs 1-73 as though fully set
`
`forth herein.
`
`75.
`
`Upon information and belief, Barr Pharmaceuticals, Inc. has infringed each of the
`
`patents-in-suit under 35 U.S.C. § 271(b) by actively inducing Barr Laboratories, Inc. to infringe
`
`each of the patents-in-suit.
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`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiff Celgene Corporation respectfully requests the following relief:
`
`(A) A Judgment that Defendants have infringed the (cid:146)501, (cid:146)720, (cid:146)976, (cid:146)977, (cid:146)784, (cid:146)399,
`
`and (cid:146)018 patents by submitting the aforementioned ANDA;
`
`(B) A Judgment that Defendants have infringed, and that Defendants(cid:146) making, using,
`
`selling, offering to sell, or importing Barr(cid:146)s Proposed Product will infringe one or more claims of
`
`the (cid:146)501, (cid:146)720, (cid:146)976, (cid:146)977, (cid:146)784, (cid:146)399, and (cid:146)018 patents;
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`(C) An Order that the effective date of FDA approval of ANDA No. 78-505 be a date
`
`which is not earlier than the later of the expiration of the (cid:146)501, (cid:146)720, (cid:146)976, (cid:146)977, (cid:146)784, (cid:146)399, and
`
`(cid:146)018 patents, or any later expiration of exclusivity to which Plaintiff is or becomes entitled;
`
`(D)
`
`Preliminary and permanent injunctions enjoining Defendants and their officers,
`
`agents, attorneys and employees, and those acting in privity or concert with them, from making,
`
`using, selling, offering to sell, or importing Barr(cid:146)s Proposed Product until after the expiration of
`
`the (cid:146)501, (cid:146)720, (cid:146)976, (cid:146)977, (cid:146)784, (cid:146)399, and/or (cid:146)018 patents, or any later expiration of exclusivity
`
`to which Plaintiff is or becomes entitled;
`
`(E) A permanent injunction be issued, pursuant to 35 U.S.C. § 271(e)(4)(B),
`
`restraining and enjoining Defendants, their officers, agents, attorneys and employees, and those
`
`acting in privity or concert with them, from practicing any methods or compositions as claimed
`
`in the (cid:146)501, (cid:146)720, (cid:146)976, (cid:146)977, (cid:146)784, (cid:146)399, and/or (cid:146)018 patents, or from actively inducing or
`
`contributing to the infringement of the (cid:146)501, (cid:146)720, (cid:146)976, (cid:146)977, (cid:146)784, (cid:146)399, and/or (cid:146)018 patents, or
`
`any later expiration of exclusivity to which Plaintiff is or becomes entitled;
`
`(F)
`
`A declaration that the commercial manufacture, use, importation into the United
`
`States, sale, or offer for sale of Barr(cid:146)s Proposed Product will directly infringe or induce and/or
`
`contribute to infringement of the (cid:146)501, (cid:146)720, (cid:146)976, (cid:146)977, (cid:146)784, (cid:146)399, and/or (cid:146)018 patents or any
`
`later expiration of exclusivity to which Plaintiff is or becomes entitled;
`
`(G)
`
`To the extent that Defendants have committed any acts with respect to the
`
`methods or compositions claimed in the (cid:146)501, (cid:146)720, (cid:146)976, (cid:146)977, (cid:146)784, (cid:146)399, and/or (cid:146)018 patents,
`
`other than those acts expressly exempted by 35 U.S.C. § 271(e)(1), Plaintiff be awarded damages
`
`for such acts;
`
`
`
`- 12 -
`
`

`

`Case 2:07-cv-05485-SDW-MCA Document 1 Filed 11/14/07 Page 13 of 14 PageID: 52
`
`(H)
`
`If Defendants engage in the commercial manufacture, use, importation into the
`
`United States, sale, or offer for sale of Barr(cid:146)s Proposed Product prior to the expiration of the
`
`(cid:146)501, (cid:146)720, (cid:146)976, (cid:146)977, (cid:146)784, (cid:146)399, and (cid:146)018 patents, a Judgment awarding damages to Plaintiff
`
`resulting from such infringement, together with interest;
`
`(I)
`
`(J)
`
`Attorney(cid:146)s fees in this action as an exceptional case pursuant to 35 U.S.C. § 285;
`
`Costs and expenses in this action; and
`
`(K)
`
`Such further and other relief as this Court may deem just and proper.
`
` Respectfully submitted,
`
`
`By:
`
` s/ Charles M. Lizza .
`Charles M. Lizza
`William C. Baton
`SAUL EWING LLP
`One Riverfront Plaza
`Newark, New Jersey 07102-5490
`(973) 286-6700
`clizza@saul.com
`
`Attorneys for Plaintiff
`Celgene Corporation
`
`
`
`
`
`
`Dated: November 14, 2007
`
`
`
`
`
`
`
`
`
`OF COUNSEL:
`
`F. Dominic Cerrito
`Daniel L. Malone
`JONES DAY
`222 East 41st Street
`New York, New York 10017-6702
`(212) 326-3939
`
`Daniel E. Reidy
`JONES DAY
`77 West Wacker
`Chicago, Illinois 60601-1692
`(312) 269-4140
`
`Richard G. Greco
`Benjamin C. Hsing
`KAYE SCHOLER LLP
`425 Park Avenue
`New York, New York 10022-3598
`(212) 836-8500
`
`
`
`- 13 -
`
`

`

`Case 2:07-cv-05485-SDW-MCA Document 1 Filed 11/14/07 Page 14 of 14 PageID: 53
`
`
`
`LOCAL CIVIL RULE 11.2 CERTIFICATION
`
`I hereby certify that the matter captioned, Celgene Corporation v. Barr Laboratories,
`
`Inc., et al., Civil Action No. 07-286 (SDW)(MCA), is related to the matter in controversy
`
`because the matter in controversy involves the same plaintiffs, the same defendants and seven of
`
`the same patents as the related matter, and in both cases, the defendants are seeking FDA
`
`approval to market a generic version of the same thalidomide drug product.
`
`I further certify that, to the best of my knowledge, the matter in controversy is not the
`
`subject of any other action pending in any court, or of any pending arbitration or administrative
`
`proceeding.
`
`Dated: November 14, 2007
`
`
`
`
`
`OF COUNSEL:
`
`F. Dominic Cerrito
`Daniel L. Malone
`JONES DAY
`222 East 41st Street
`New York, New York 10017-6702
`(212) 326-3939
`
`Daniel E. Reidy
`JONES DAY
`77 West Wacker
`Chicago, Illinois 60601-1692
`(312) 269-4140
`
`Richard G. Greco
`Benjamin C. Hsing
`KAYE SCHOLER LLP
`425 Park Avenue
`New York, New York 10022-3598
`(212) 836-8500
`
`
`
`
`By:
`
`
`
` s/ Charles M. Lizza .
`Charles M. Lizza
`William C. Baton
`SAUL EWING LLP
`One Riverfront Plaza
`Newark, New Jersey 07102-5490
`(973) 286-6700
`clizza@saul.com
`
`Attorneys for Plaintiff
`Celgene Corporation
`
`
`
`
`
`- 14 -
`
`