Charles M. Lizza
`William C. Baton
`SAUL EWING LLP
`One Riverfront Plaza, Suite 1520
`Newark, New Jersey 07102-5426
`(973) 286-6700
`clizza@saul.com
`
`Attorneys for Plaintiffs
`Celgene Corporation and
`Children’s Medical Center Corporation
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`Civil Action No. ____________________
`
`COMPLAINT
`
`(Filed Electronically)
`
`))))))))))))))
`
`CELGENE CORPORATION and
`CHILDREN’S MEDICAL CENTER
`CORPORATION,
`
`Plaintiffs,
`
`v.
`
`LANNETT HOLDINGS, INC. and
`LANNETT COMPANY, INC.,
`
`Defendants.
`
`Plaintiffs Celgene Corporation (“Celgene”) and Children’s Medical Center Corporation
`
`(“CMCC”) (collectively, “Plaintiffs”), for their Complaint against Defendants Lannett Holdings,
`
`Inc. and Lannett Company, Inc. (collectively, “Lannett”), hereby allege as follows:
`
`NATURE OF THE ACTION
`This is an action for patent infringement under the patent laws of the United
`
`1.
`
`States, 35 U.S.C. §100, et seq., arising from Lannett’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 THALOMID® drug product prior
`
`CFAD VI 1041 - 0001
`CFAD VI v. CELGENE
`IPR2015-01103
`
`
`William C. Baton
`SAUL EWING LLP
`One Riverfront Plaza, Suite 1520
`Newark, New Jersey 07102-5426
`(973) 286-6700
`clizza@saul.com
`
`Attorneys for Plaintiffs
`Celgene Corporation and
`Children’s Medical Center Corporation
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`Civil Action No. ____________________
`
`COMPLAINT
`
`(Filed Electronically)
`
`))))))))))))))
`
`CELGENE CORPORATION and
`CHILDREN’S MEDICAL CENTER
`CORPORATION,
`
`Plaintiffs,
`
`v.
`
`LANNETT HOLDINGS, INC. and
`LANNETT COMPANY, INC.,
`
`Defendants.
`
`Plaintiffs Celgene Corporation (“Celgene”) and Children’s Medical Center Corporation
`
`(“CMCC”) (collectively, “Plaintiffs”), for their Complaint against Defendants Lannett Holdings,
`
`Inc. and Lannett Company, Inc. (collectively, “Lannett”), hereby allege as follows:
`
`NATURE OF THE ACTION
`This is an action for patent infringement under the patent laws of the United
`
`1.
`
`States, 35 U.S.C. §100, et seq., arising from Lannett’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 THALOMID® drug product prior
`
`CFAD VI 1041 - 0001
`CFAD VI v. CELGENE
`IPR2015-01103
`
`
`
`to the expiration of United States Patent Nos. 6,045,501 (the “’501 patent”), 6,315,720 (the “’720
`
`patent”), 6,561,976 (the “’976 patent”), 6,561,977 (the “’977 patent”), 6,755,784 (the “’784
`
`patent”), 6,869,399 (the “’399 patent”), 7,141,018 (the “’018 patent”), 7,230,012 (the “’012
`
`patent”), 7,435,745 (the “’745 patent”), 7,874,984 (the “’984 patent”), 7,959,566 (the “’566
`
`patent”), 8,204,763 (the “’763 patent”), 8,315,886 (the “’886 patent”), 8,589,188 (the “’188
`
`patent”), and 8,626,531 (the “’531 patent”) (collectively, “the patents-in-suit”). The ’745 patent
`
`is owned by CMCC and exclusively licensed to Celgene. All other patents-in-suit are owned by
`
`Celgene.
`
`THE PARTIES
`Plaintiff Celgene is a corporation organized and existing under the laws of the
`
`2.
`
`State of Delaware, having a principal place of business at 86 Morris Avenue, Summit, New
`
`Jersey 07901.
`
`3.
`
`Plaintiff CMCC is a Massachusetts not-for-profit corporation, having a principal
`
`place of business at 55 Shattuck Street, Boston, Massachusetts 02115.
`
`4.
`
`On information and belief, Defendant Lannett Holdings, Inc. is a corporation
`
`organized and existing under the laws of the State of Delaware, having its principal place of
`
`business at 103 Foulk Road, Suite 202, Wilmington, Delaware 19803.
`
`5.
`
`On information and belief, Defendant Lannett Company, Inc. is a corporation
`
`organized and existing under the laws of the State of Delaware, having its principal place of
`
`business at 13200 Townsend Road, Philadelphia, Pennsylvania 19154.
`
`6.
`
`On information and belief, Lannett Holdings, Inc. is a wholly owned subsidiary
`
`of Lannett Company, Inc.
`
`7.
`
`On information and belief, Lannett Holdings, Inc. and Lannett Company, Inc.
`
`2
`
`CFAD VI 1041 - 0002
`
`
`
`manufacture and/or distribute generic drugs for sale and use throughout the United States,
`
`including in this Judicial District. On information and belief, Lannett Holdings, Inc. and Lannett
`
`Company, Inc. also prepare and/or aid in the preparation and submission of ANDAs to the FDA.
`
`JURISDICTION AND VENUE
`This Court has jurisdiction over the subject matter of this action pursuant to 28
`
`8.
`
`U.S.C. §§ 1331, 1338(a), 2201, and 2202.
`
`9.
`
`This Court has personal jurisdiction over Lannett Holdings, Inc. by virtue of,
`
`inter alia, its systematic and continuous contacts with the State of New Jersey. On information
`
`and belief, Lannett Holdings, Inc. 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, Lannett Holdings, Inc. has committed, aided, abetted,
`
`induced, contributed to, and/or participated in the commission of, a tortious act of patent
`
`infringement that has led to foreseeable harm and injury to Plaintiffs in New Jersey. On
`
`information and belief, Lannett Holdings, Inc. has customers in the State of New Jersey. Further,
`
`Lannett Holdings, Inc. is a wholly owned subsidiary of Lannett Company, Inc., which has
`
`substantial contacts with the State of New Jersey.
`
`10.
`
`This Court has personal jurisdiction over Lannett Company, Inc. by virtue of,
`
`inter alia, its systematic and continuous contacts with the State of New Jersey. On information
`
`and belief, Lannett Company, Inc. 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 Jersey and deriving revenue from such activities.
`
`On information and belief, Lannett Company, Inc. has committed, aided, abetted, induced,
`
`3
`
`CFAD VI 1041 - 0003
`
`
`
`contributed to, and/or participated in the commission of, a tortious act of patent infringement that
`
`has led to foreseeable harm and injury to Plaintiffs in New Jersey. On information and belief,
`
`Lannett Company, Inc. has customers in the State of New Jersey. Further, on information and
`
`belief, Lannett Company, Inc. has previously consented to personal jurisdiction in this Court
`
`(see, e.g., Civil Action No. 05-4202), and purposefully availed itself of the benefits of this forum
`
`by filing counterclaims in at least one of those actions. Civil Action No. 05-4202.
`
`11.
`
`On information and belief, Lannett Holdings, Inc. and Lannett Company, Inc.
`
`operate as an integrated business.
`
`12.
`
`On information and belief, Lannett Holdings, Inc. and Lannett Company, Inc.
`
`share common officers and directors and are agents of each other and/or work in concert with
`
`each other with respect to the development, regulatory approval, marketing, sale, and distribution
`
`of pharmaceutical products throughout the United States, including in New Jersey.
`
`13.
`
`On information and belief, Lannett Holdings, Inc. and Lannett Company, Inc.
`
`together formulate, develop, market, and sell active pharmaceutical ingredients (“APIs”), solid
`
`dosage forms, pharmaceutical formulations, and/or pharmaceutical products containing such
`
`APIs or pharmaceutical formulations that they distribute in New Jersey and throughout the
`
`United States.
`
`14.
`
`On information and belief, Lannett Holdings, Inc. and Lannett Company, Inc.
`
`together routinely file, and/or aid, abet, contribute to, and/or participate in the filing of, ANDAs
`
`to seek FDA approval to market their products in the United States, including in New Jersey.
`
`15.
`
`On information and belief, Lannett Holdings, Inc. is a wholly owned subsidiary
`
`of Lannett Company, Inc. On information and belief, Lannett Company, Inc., acting either alone
`
`or in concert with Lannett Holdings, Inc., either directly or through one or more of its
`
`4
`
`CFAD VI 1041 - 0004
`
`
`
`subsidiaries, agents, and/or distributors, markets, sells, and/or distributes pharmaceutical
`
`products in New Jersey.
`
`16.
`
`On information and belief, Lannett Company, Inc. directs, authorizes,
`
`cooperates, participates, and/or assists Lannett Holdings, Inc. with the marketing, selling, and/or
`
`distributing pharmaceutical products in New Jersey. On information and belief, the acts of
`
`Lannett Holdings, Inc. complained of herein were done at the direction of, with the authorization
`
`of, and/or with the cooperation, participation, and assistance of Lannett Company, Inc.
`
`17.
`
`On information and belief, this Judicial District is a likely destination of
`
`products that will be manufactured and sold as a result of FDA approval of Lannett’s ANDA No.
`
`206-601, which is the subject of this lawsuit.
`
`18.
`
`On information and belief, Lannett Holdings, Inc. and Lannett Company, Inc.
`
`have committed, or aided, abetted, contributed to, and/or participated in the commission of the
`
`tortious act of patent infringement that has led to foreseeable harm and injury to Plaintiffs
`
`including Celgene Corporation, which has its principal place of business in New Jersey.
`
`19.
`
`Venue is proper in this judicial district pursuant to 28 U.S.C. §§ 1391 and
`
`1400(b).
`
`THE PATENTS-IN-SUIT
`On April 4, 2000, the United States Patent and Trademark Office (“USPTO”)
`
`20.
`
`duly and lawfully issued the ’501 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 ’501
`
`patent is attached hereto as Exhibit A.
`
`21.
`
`On November 13, 2001, the USPTO duly and lawfully issued the ’720 patent,
`
`5
`
`CFAD VI 1041 - 0005
`
`
`
`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 B.
`
`22.
`
`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 C.
`
`23.
`
`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 D.
`
`24.
`
`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 E.
`
`25.
`
`On March 22, 2005, the USPTO duly and lawfully issued the ’399 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 March 7, 2006, a certificate of correction was
`
`granted by the USPTO to correct typographical errors in claim 19 of the ’399 patent. A copy of
`
`6
`
`CFAD VI 1041 - 0006
`
`
`
`the ’399 patent and its certificate of correction is attached hereto as Exhibit F.
`
`26.
`
`On November 28, 2006, the USPTO duly and lawfully issued the ’018 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 ’018 patent is attached hereto as
`
`Exhibit G.
`
`27.
`
`On June 12, 2007, the USPTO duly and lawfully issued the ’012 patent, entitled
`
`“Pharmaceutical Compositions and Dosage Forms of Thalidomide” to Celgene as assignee of the
`
`inventors Paul D’Angio and John McCarty. A copy of the ’012 patent is attached hereto as
`
`Exhibit H.
`
`28.
`
`On October 14, 2008, the USPTO duly and lawfully issued the ’745 patent,
`
`entitled “Methods and Compositions for Inhibition of Angiogenesis,” to CMCC as assignee of
`
`the inventor Robert J. D’Amato. The ’745 patent is licensed exclusively to Celgene. On April 7,
`
`2009, a certificate of correction was granted by the USPTO to correct the name of the assignee
`
`from Celgene to CMCC. A copy of the ’745 patent and its certificate of correction is attached
`
`hereto as Exhibit I.
`
`29.
`
`On January 25, 2011, the USPTO duly and lawfully issued the ’984 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 ’984 patent is attached hereto as Exhibit J.
`
`30.
`
`On June 14, 2011, the USPTO duly and lawfully issued the ’566 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.
`
`7
`
`CFAD VI 1041 - 0007
`
`
`
`Williams and Joseph K. Kaminski. A copy of the ’566 patent is attached hereto as Exhibit K.
`
`31.
`
`On June 19, 2012, the USPTO duly and lawfully issued the ’763 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 ’763 patent is attached hereto as Exhibit L.
`
`32.
`
`On November 20, 2012, the USPTO duly and lawfully issued the ’886 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 ’886 patent is
`
`attached hereto as Exhibit M.
`
`33.
`
`On November 19, 2013, the USPTO duly and lawfully issued the ’188 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 ’188 patent is attached hereto as Exhibit N.
`
`34.
`
`On January 7, 2014, the USPTO duly and lawfully issued the ’531 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 ’531 patent is attached hereto as
`
`Exhibit O.
`
`THE THALOMID® DRUG PRODUCT
`Celgene holds an approved New Drug Application (“NDA”) under Section
`
`35.
`
`505(a) of the Federal Food Drug and Cosmetic Act (“FFDCA”), 21 U.S.C. § 355(a), for
`
`thalidomide capsules (NDA No. 20-785), which it sells under the trade name THALOMID®. The
`
`8
`
`CFAD VI 1041 - 0008
`
`
`
`claims of the patents-in-suit cover, inter alia, methods of use and delivery of pharmaceutical
`
`compositions containing the drug thalidomide.
`
`36.
`
`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 THALOMID®.
`
`ACTS GIVING RISE TO THIS ACTION
`Pursuant to Section 505 of the FFDCA, Lannett filed ANDA No. 206-601
`
`37.
`
`(“Lannett’s ANDA”) seeking approval to engage in the commercial use, manufacture, sale, offer
`
`for sale or importation into the United States of thalidomide capsules 50 mg, 100 mg, 150 mg,
`
`and 200 mg (“Lannett’s Proposed Products”), before the patents-in-suit expire.
`
`38.
`
`In connection with the filing of its ANDA as described in the preceding
`
`paragraph, Lannett 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 Lannett’s ANDA.
`
`39.
`
`On or about December 22, 2014, Plaintiffs received written notice of Lannett’s
`
`ANDA certification (“Lannett’s Notice Letter”). Lannett’s Notice Letter alleged that the claims
`
`of the ’501, ’720, ’976, ’977, ’784, ’399, ’018, ’012, ’745, ’984, ’566, ’763, ’886, ’188, and ’531
`
`patents are invalid, unenforceable, and/or will not be infringed by the activities described in
`
`Lannett’s ANDA. Lannett’s Notice Letter also informed Plaintiffs that Lannett seeks approval to
`
`market Lannett’s Proposed Products before the ’501, ’720, ’976, ’977, ’784, ’399, ’018, ’012,
`
`’745, ’984, ’566, ’763, ’886, ’188, and ’531 patents expire.
`
`COUNT I: INFRINGEMENT OF THE ’501 PATENT
`Plaintiffs repeat and reallege the allegations of the preceding paragraphs as if
`
`40.
`
`9
`
`CFAD VI 1041 - 0009
`
`
`
`fully set forth herein.
`
`41.
`
`Lannett’s submission of its ANDA to obtain approval to engage in the
`
`commercial use, manufacture, sale, offer for sale, or importation of thalidomide capsules into the
`
`United States, 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).
`
`42.
`
`There is a justiciable controversy between the parties hereto as to the
`
`infringement of the ’501 patent.
`
`43.
`
`Unless enjoined by this Court, upon FDA approval of Lannett’s ANDA, Lannett
`
`will infringe the ’501 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
`
`importing into the United States, and/or selling Lannett’s Proposed Products in the United States.
`
`44.
`
`Unless enjoined by this Court, upon FDA approval of Lannett’s ANDA, Lannett
`
`will induce infringement of the ’501 patent under 35 U.S.C. § 271(b) by making, using, offering
`
`to sell, importing into the United States, and/or selling Lannett’s Proposed Products in the United
`
`States. On information and belief, upon FDA approval of Lannett’s ANDA, Lannett will
`
`intentionally encourage acts of direct infringement with knowledge of the ’501 patent and
`
`knowledge that its acts are encouraging infringement.
`
`45.
`
`Unless enjoined by this Court, upon FDA approval of Lannett’s ANDA, Lannett
`
`will contributorily infringe the ’501 patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing into the United States, and/or selling Lannett’s Proposed Products in the United
`
`States. On information and belief, Lannett has had and continues to have knowledge that
`
`Lannett’s Proposed Products are especially adapted for a use that infringes the ’501 patent and
`
`that there is no substantial noninfringing use for Lannett’s Proposed Products.
`
`46.
`
`Plaintiffs will be substantially and irreparably damaged and harmed if Lannett’s
`
`10
`
`CFAD VI 1041 - 0010
`
`
`
`infringement of the ’501 patent is not enjoined.
`
`47.
`
`48.
`
`Plaintiffs do not have an adequate remedy at law.
`
`This case is an exceptional one, and Plaintiffs are entitled to an award of their
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`COUNT II: INFRINGEMENT OF THE ’720 PATENT
`Plaintiffs repeat and reallege the allegations of the preceding paragraphs as if
`
`49.
`
`fully set forth herein.
`
`50.
`
`Lannett’s submission of its ANDA to obtain approval to engage in the
`
`commercial use, manufacture, sale, offer for sale, or importation of thalidomide capsules into the
`
`United States, 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).
`
`51.
`
`There is a justiciable controversy between the parties hereto as to the
`
`infringement of the ’720 patent.
`
`52.
`
`Unless enjoined by this Court, upon FDA approval of Lannett’s ANDA, Lannett
`
`will infringe the ’720 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
`
`importing into the United States, and/or selling Lannett’s Proposed Products in the United States.
`
`53.
`
`Unless enjoined by this Court, upon FDA approval of Lannett’s ANDA, Lannett
`
`will induce infringement of the ’720 patent under 35 U.S.C. § 271(b) by making, using, offering
`
`to sell, importing into the United States, and/or selling Lannett’s Proposed Products in the United
`
`States. On information and belief, upon FDA approval of Lannett’s ANDA, Lannett will
`
`intentionally encourage acts of direct infringement with knowledge of the ’720 patent and
`
`knowledge that its acts are encouraging infringement.
`
`11
`
`CFAD VI 1041 - 0011
`
`
`
`54.
`
`Unless enjoined by this Court, upon FDA approval of Lannett’s ANDA, Lannett
`
`will contributorily infringe the ’720 patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing into the United States, and/or selling Lannett’s Proposed Products in the United
`
`States. On information and belief, Lannett has had and continues to have knowledge that
`
`Lannett’s Proposed Products are especially adapted for a use that infringes the ’720 patent and
`
`that there is no substantial noninfringing use for Lannett’s Proposed Products.
`
`55.
`
`Plaintiffs will be substantially and irreparably damaged and harmed if Lannett’s
`
`infringement of the ’720 patent is not enjoined.
`
`56.
`
`57.
`
`Plaintiffs do not have an adequate remedy at law.
`
`This case is an exceptional one, and Plaintiffs are entitled to an award of their
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`COUNT III: INFRINGEMENT OF THE ’976 PATENT
`Plaintiffs repeat and reallege the allegations of the preceding paragraphs as if
`
`58.
`
`fully set forth herein.
`
`59.
`
`Lannett’s submission of its ANDA to obtain approval to engage in the
`
`commercial use, manufacture, sale, offer for sale, or importation of thalidomide capsules into the
`
`United States, 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).
`
`60.
`
`There is a justiciable controversy between the parties hereto as to the
`
`infringement of the ’976 patent.
`
`61.
`
`Unless enjoined by this Court, upon FDA approval of Lannett’s ANDA, Lannett
`
`will infringe the ’976 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
`
`importing into the United States, and/or selling Lannett’s Proposed Products in the United States.
`
`12
`
`CFAD VI 1041 - 0012
`
`
`
`62.
`
`Unless enjoined by this Court, upon FDA approval of Lannett’s ANDA, Lannett
`
`will induce infringement of the ’976 patent under 35 U.S.C. § 271(b) by making, using, offering
`
`to sell, importing into the United States, and/or selling Lannett’s Proposed Products in the United
`
`States. On information and belief, upon FDA approval of Lannett’s ANDA, Lannett will
`
`intentionally encourage acts of direct infringement with knowledge of the ’976 patent and
`
`knowledge that its acts are encouraging infringement.
`
`63.
`
`Unless enjoined by this Court, upon FDA approval of Lannett’s ANDA, Lannett
`
`will contributorily infringe the ’976 patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing into the United States, and/or selling Lannett’s Proposed Products in the United
`
`States. On information and belief, Lannett has had and continues to have knowledge that
`
`Lannett’s Proposed Products are especially adapted for a use that infringes the ’976 patent and
`
`that there is no substantial noninfringing use for Lannett’s Proposed Products.
`
`64.
`
`Plaintiffs will be substantially and irreparably damaged and harmed if Lannett’s
`
`infringement of the ’976 patent is not enjoined.
`
`65.
`
`66.
`
`Plaintiffs do not have an adequate remedy at law.
`
`This case is an exceptional one, and Plaintiffs are entitled to an award of their
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`COUNT IV: INFRINGEMENT OF THE ’977 PATENT
`Plaintiffs repeat and reallege the allegations of the preceding paragraphs as if
`
`67.
`
`fully set forth herein.
`
`68.
`
`Lannett’s submission of its ANDA to obtain approval to engage in the
`
`commercial use, manufacture, sale, offer for sale, or importation of thalidomide capsules into the
`
`United States, prior to the expiration of the ’977 patent, constitutes infringement of one or more
`
`13
`
`CFAD VI 1041 - 0013
`
`
`
`of the claims of that patent under 35 U.S.C. § 271(e)(2)(A).
`
`69.
`
`There is a justiciable controversy between the parties hereto as to the
`
`infringement of the ’977 patent.
`
`70.
`
`Unless enjoined by this Court, upon FDA approval of Lannett’s ANDA, Lannett
`
`will infringe the ’977 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
`
`importing into the United States, and/or selling Lannett’s Proposed Products in the United States.
`
`71.
`
`Unless enjoined by this Court, upon FDA approval of Lannett’s ANDA, Lannett
`
`will induce infringement of the ’977 patent under 35 U.S.C. § 271(b) by making, using, offering
`
`to sell, importing into the United States, and/or selling Lannett’s Proposed Products in the United
`
`States. On information and belief, upon FDA approval of Lannett’s ANDA, Lannett will
`
`intentionally encourage acts of direct infringement with knowledge of the ’977 patent and
`
`knowledge that its acts are encouraging infringement.
`
`72.
`
`Unless enjoined by this Court, upon FDA approval of Lannett’s ANDA, Lannett
`
`will contributorily infringe the ’977 patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing into the United States, and/or selling Lannett’s Proposed Products in the United
`
`States. On information and belief, Lannett has had and continues to have knowledge that
`
`Lannett’s Proposed Products are especially adapted for a use that infringes the ’977 patent and
`
`that there is no substantial noninfringing use for Lannett’s Proposed Products.
`
`73.
`
`Plaintiffs will be substantially and irreparably damaged and harmed if Lannett’s
`
`infringement of the ’977 patent is not enjoined.
`
`74.
`
`75.
`
`Plaintiffs do not have an adequate remedy at law.
`
`This case is an exceptional one, and Plaintiffs are entitled to an award of their
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`14
`
`CFAD VI 1041 - 0014
`
`
`
`COUNT V: INFRINGEMENT OF THE ’784 PATENT
`Plaintiffs repeat and reallege the allegations of the preceding paragraphs as if
`
`76.
`
`fully set forth herein.
`
`77.
`
`Lannett’s submission of its ANDA to obtain approval to engage in the
`
`commercial use, manufacture, sale, offer for sale, or importation of thalidomide capsules into the
`
`United States, 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).
`
`78.
`
`There is a justiciable controversy between the parties hereto as to the
`
`infringement of the ’784 patent.
`
`79.
`
`Unless enjoined by this Court, upon FDA approval of Lannett’s ANDA, Lannett
`
`will infringe the ’784 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
`
`importing into the United States, and/or selling Lannett’s Proposed Products in the United States.
`
`80.
`
`Unless enjoined by this Court, upon FDA approval of Lannett’s ANDA, Lannett
`
`will induce infringement of the ’784 patent under 35 U.S.C. § 271(b) by making, using, offering
`
`to sell, importing into the United States, and/or selling Lannett’s Proposed Products in the United
`
`States. On information and belief, upon FDA approval of Lannett’s ANDA, Lannett will
`
`intentionally encourage acts of direct infringement with knowledge of the ’784 patent and
`
`knowledge that its acts are encouraging infringement.
`
`81.
`
`Unless enjoined by this Court, upon FDA approval of Lannett’s ANDA, Lannett
`
`will contributorily infringe the ’784 patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing into the United States, and/or selling Lannett’s Proposed Products in the United
`
`States. On information and belief, Lannett has had and continues to have knowledge that
`
`15
`
`CFAD VI 1041 - 0015
`
`
`
`Lannett’s Proposed Products are especially adapted for a use that infringes the ’784 patent and
`
`that there is no substantial noninfringing use for Lannett’s Proposed Products.
`
`82.
`
`Plaintiffs will be substantially and irreparably damaged and harmed if Lannett’s
`
`infringement of the ’784 patent is not enjoined.
`
`83.
`
`84.
`
`Plaintiffs do not have an adequate remedy at law.
`
`This case is an exceptional one, and Plaintiffs are entitled to an award of their
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`COUNT VI: INFRINGEMENT OF THE ’399 PATENT
`Plaintiffs repeat and reallege the allegations of the preceding paragraphs as if
`
`85.
`
`fully set forth herein.
`
`86.
`
`Lannett’s submission of its ANDA to obtain approval to engage in the
`
`commercial use, manufacture, sale, offer for sale, or importation of thalidomide capsules into the
`
`United States, prior to the expiration of the ’399 patent, constitutes infringement of one or more
`
`of the claims of that patent under 35 U.S.C. § 271(e)(2)(A).
`
`87.
`
`There is a justiciable controversy between the parties hereto as to the
`
`infringement of the ’399 patent.
`
`88.
`
`Unless enjoined by this Court, upon FDA approval of Lannett’s ANDA, Lannett
`
`will infringe the ’399 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
`
`importing into the United States, and/or selling Lannett’s Proposed Products in the United States.
`
`89.
`
`Unless enjoined by this Court, upon FDA approval of Lannett’s ANDA, Lannett
`
`will induce infringement of the ’399 patent under 35 U.S.C. § 271(b) by making, using, offering
`
`to sell, importing into the United States, and/or selling Lannett’s Proposed Products in the United
`
`States. On information and belief, upon FDA approval of Lannett’s ANDA, Lannett will
`
`16
`
`CFAD VI 1041 - 0016
`
`
`
`intentionally encourage acts of direct infringement with knowledge of the ’399 patent and
`
`knowledge that its acts are encouraging infringement.
`
`90.
`
`Unless enjoined by this Court, upon FDA approval of Lannett’s ANDA, Lannett
`
`will contributorily infringe the ’399 patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing into the United States, and/or selling Lannett’s Proposed Products in the United
`
`States. On information and belief, Lannett has had and continues to have knowledge that
`
`Lannett’s Proposed Products are especially adapted for a use that infringes the ’399 patent and
`
`that there is no substantial noninfringing use for Lannett’s Proposed Products.
`
`91.
`
`Plaintiffs will be substantially and irreparably damaged and harmed if Lannett’s
`
`infringement of the ’399 patent is not enjoined.
`
`92.
`
`93.
`
`Plaintiffs do not have an adequate remedy at law.
`
`This case is an exceptional one, and Plaintiffs are entitled to an award of their
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`COUNT VII: INFRINGEMENT OF THE ’018 PATENT
`Plaintiffs repeat and reallege the allegations of the preceding paragraphs as if
`
`94.
`
`fully set forth herein.
`
`95.
`
`Lannett’s submission of its ANDA to obtain approval to engage in the
`
`commercial use, manufacture, sale, offer for sale, or importation of thalidomide capsules into the
`
`United States, prior to the expiration of the ’018 patent, constitutes infringement of one or more
`
`of the claims of that patent under 35 U.S.C. § 271(e)(2)(A).
`
`96.
`
`There is a justiciable controversy between the parties hereto as to the
`
`infringement of the ’018 patent.
`
`97.
`
`Unless enjoined by this Court, upon FDA approval of Lannett’s ANDA, Lannett
`
`17
`
`CFAD VI 1041 - 0017
`
`
`
`will infringe the ’018 patent under 35 U.S.C. § 271(a) by making, using, offering to sell,
`
`importing into the United States, and/or selling Lannett’s Proposed Products in the United States.
`
`98.
`
`Unless enjoined by this Court, upon FDA approval of Lannett’s ANDA, Lannett
`
`will induce infringement of the ’018 patent under 35 U.S.C. § 271(b) by making, using, offering
`
`to sell, importing into the United States, and/or selling Lannett’s Proposed Products in the United
`
`States. On information and belief, upon FDA approval of Lannett’s ANDA, Lannett will
`
`intentionally encourage acts of direct infringement with knowledge of the ’018 patent and
`
`knowledge that its acts are encouraging infringement.
`
`99.
`
`Unless enjoined by this Court, upon FDA approval of Lannett’s ANDA, Lannett
`
`will contributorily infringe the ’018 patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing into the United States, and/or selling Lannett’s Proposed Products in the United
`
`States. On information and belief, Lannett has had and continues to have knowledge that
`
`Lannett’s Proposed Products are especially adapted for a use that infringes the ’018 patent and
`
`that there is no substantial noninfringing use for Lannett’s Proposed Products.
`
`100.
`
`Plaintiffs will be substantially and irreparably damaged and harmed if Lannett’s
`
`infringement of the ’018 patent is not enjoined.
`
`101.
`
`102.
`
`Plaintiffs do not have an adequate remedy at law.
`
`This case is an exceptional one, and Plaintiffs are entitled to an award of their
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`COUNT VIII
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