Case 3:15-cv-00776-MAS-LHG Document 1 Filed 02/02/15 Page 1 of 18 PageID: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
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`
`Of Counsel:
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`William E. Solander, Esq.
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`(212) 218-2100
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`
`
`
`C.A. No.: _____________________
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`
`
`
`
`
`
`Jason A. Leonard, Esq.
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`(212) 218-2100
`
`Attorneys for Plaintiffs
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and SANOFI
`
`
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and
`SANOFI
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`
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`
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`Electronically Filed
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`
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`Plaintiffs,
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`v.
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`ACTAVIS LLC and
`ACTAVIS ELIZABETH LLC
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`Defendants.
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`
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`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiffs Sanofi-Aventis U.S. LLC (hereinafter “Sanofi U.S.”), Aventis Pharma S.A.
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`(hereinafter “Aventis”) and Sanofi (collectively, “Plaintiffs”) for their Complaint against
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`defendants Actavis LLC and Actavis Elizabeth LLC (collectively “Defendants”), hereby allege
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`as follows:
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`AVENTIS EXHIBIT 2051
`Mylan v. Aventis
`IPR2016-00627
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`THE PARTIES
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`1.
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`Plaintiff Sanofi U.S. is a U.S. subsidiary of Sanofi and is a company
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`organized and existing under the laws of the State of Delaware, having commercial headquarters
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`at 55 Corporate Drive, Bridgewater, New Jersey 08807.
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`2.
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`Plaintiff Aventis is a corporation organized and existing under the laws of
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`France, having its principal place of business at 20 avenue Raymond Aron, 92160 Antony,
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`France.
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`3.
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`Plaintiff Sanofi is a corporation organized and existing under the laws of
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`France, having its principal place of business at 54 rue La Boétie, 75008 Paris, France.
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`4.
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`Plaintiff Sanofi is a global research-driven pharmaceutical company that
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`discovers, develops, manufactures and markets a broad range of innovative products to improve
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`human and animal health.
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`5.
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`On information and belief, Actavis LLC is a corporation organized and
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`existing under the laws of the State of Delaware, having principal places of business at 60
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`Columbia Road, Building B, Morristown, New Jersey 07960 and Morris Corporate Center III,
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`400 Interspace Parkway, Parsipanny, New Jersey 07054. On information and belief, Actavis
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`LLC was formerly known as Actavis Inc., a Delaware corporation.
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`6.
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`On information and belief, Actavis Elizabeth LLC is a corporation
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`organized and existing under the laws of the State of Delaware, having a principal place of
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`business at 200 Elmora Avenue, Elizabeth, New Jersey 07202.
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`7.
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`On information and belief, Actavis Elizabeth LLC is a wholly-owned
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`subsidiary of Actavis LLC.
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`8.
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`On information and belief, Actavis LLC is a wholly-owned subsidiary of
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`Actavis, Inc. On information and belief, Actavis, Inc. is a corporation organized and existing
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`under the laws of the State of Nevada, having its principal place of business at Morris Corporate
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`Center III, 400 Interspace Parkway, Parsipanny, New Jersey 07054.
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`9.
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`On information and belief, Actavis LLC assembled and caused to be filed
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`with the United States Food and Drug Administration (“FDA”), pursuant to 21 U.S.C. §
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`355(b)(2) (Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act), New Drug
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`Application (“NDA”) No. 207970 (hereinafter “the Actavis 505(b)(2) application”) concerning a
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`proposed drug product, Cabazitaxel Injection, 10 mg/mL (“Actavis’s Proposed Generic
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`Product”).
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`JURISDICTION AND VENUE
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`10.
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`This action arises under the patent laws of the United States of America.
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`This Court has jurisdiction over the subject matter of this action under 28 U.S.C. §§ 1331 and
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`1338(a).
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`11.
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`This Court has personal jurisdiction over Actavis LLC. On information
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`and belief, Actavis LLC regularly conducts and/or solicits business in the State of New Jersey,
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`engages in other persistent courses of conduct in the State of New Jersey, and/or derives
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`substantial revenue from services or things used or consumed in the State of New Jersey. On
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`information and belief, Actavis LLC, formerly as Actavis Inc., a Delaware corporation,
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`maintains principal places of business at 60 Columbia Road, Building B, Morristown, New
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`Jersey 07960 and Morris Corporate Center III, 400 Interspace Parkway, Parsipanny, New Jersey
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`07054. On information and belief, Actavis LLC, formerly as Actavis Inc., a Delaware
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`corporation, is registered with the New Jersey Department of Treasury under the business entity
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`identification number 0101005391. On information and belief, Actavis LLC, formerly as
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`Actavis Inc., a Delaware corporation, maintains a corporate agent for service of process at 80
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`Main Street, 5th Floor, West Orange, New Jersey 07052.
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`12.
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`On information and belief, Actavis LLC has affiliations with the State of
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`New Jersey that are pervasive, continuous, and systematic. On information and belief, Actavis
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`LLC engages in direct marketing, distribution, and/or sale of generic pharmaceutical drugs
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`within the State of New Jersey and to the residents of the State of New Jersey. On information
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`and belief, Actavis LLC is in the business of manufacturing, marketing, importing and selling
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`pharmaceutical drug products, including generic drug products. On information and belief,
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`Actavis LLC directly or through its subsidiaries, affiliates and agents develops, formulates,
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`manufactures, markets, imports and sells pharmaceutical products, including generic drug
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`products, which are copies of products invented and developed by innovator pharmaceutical
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`companies, throughout the United States, including in this Judicial District. On information and
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`belief, Actavis, Inc. as the parent company and Actavis LLC as the trade name holds an active
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`wholesale drug license for the State of New Jersey under License No. 5003899.
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`13.
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`On information and belief, Actavis LLC has previously submitted to the
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`jurisdiction of this Court and have availed themselves of the legal protections of the State of New
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`Jersey, having asserted counterclaims in this jurisdiction, including in the matters of Novartis
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`Pharmaceuticals Corporation v. Actavis LLC. et al., Civil Action No. 2:12-cv-03967
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`(SDW)(SCM), D.I. 354 at 8, 15-19 (D.N.J. May 16, 2014); and Novartis Pharmaceuticals
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`Corporation v. Actavis LLC. et al., Civil Action No. 2:13-cv-01028 (SDW)(MCA), D.I. 119 at 9,
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`15-18 (D.N.J. Mar. 13, 2013).
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`14.
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`Actavis LLC is also subject to personal jurisdiction in the State of New
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`Jersey because, inter alia, Actavis LLC has committed, aided, abetted, contributed to, and/or
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`participated in the commission of a tortious act of patent infringement under 35 U.S.C. §
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`271(e)(2) that has led and/or will lead to foreseeable harm and injury to Plaintiff Sanofi U.S.,
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`having commercial headquarters in the State of New Jersey. Actavis LLC sent its December 22,
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`2014 Paragraph IV Notice Letter to Sanofi U.S.’s commercial headquarters at 55 Corporate
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`Drive, Bridgewater, New Jersey 08807. Plaintiffs’s cause of action arose from Actavis LLC’s
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`contact with Sanofi U.S. in Bridgewater, New Jersey. Actavis LLC states that it intends to
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`engage in the commercial manufacture, use, and/or sale of Actavis’s Proposed Generic Product
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`before the expiration of U.S Patent Nos. 5,847,170 (“’170 patent”) and 7,241,907 (“’907 patent”)
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`throughout the United States, including in this Judicial District.
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`15.
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`On information and belief, upon approval of the Actavis 505(b)(2)
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`application, Actavis LLC and/or its subsidiaries, affiliates or agents will market, sell and/or
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`distribute Actavis’s Proposed Generic Product throughout the United States, including in this
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`Judicial District, and will derive substantial revenue therefrom.
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`16.
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`On information and belief, upon approval of the Actavis 505(b)(2)
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`application, Actavis LLC and/or its subsidiaries, affiliates or agents will place Actavis’s
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`Proposed Generic Product into the stream of commerce with the reasonable expectation or
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`knowledge and the intent that such product will ultimately be purchased and used by consumers
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`in this judicial district.
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`17.
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`This Court has personal jurisdiction over Actavis Elizabeth LLC. On
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`information and belief, Actavis Elizabeth LLC regularly conducts and/or solicits business in the
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`State of New Jersey, engages in other persistent courses of conduct in the State of New Jersey,
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`and/or derives substantial revenue from services or things used or consumed in the State of New
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`Jersey. On information and belief, Actavis Elizabeth LLC maintains a principal place of
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`business at 200 Elmora Avenue, Elizabeth, New Jersey 07202. On information and belief,
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`Actavis Elizabeth LLC is registered with the New Jersey Department of Treasury under the
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`business entity identification number 0600272818. On information and belief, Actavis Elizabeth
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`LLC, formerly as Actavis Inc., a Delaware corporation, maintains a corporate agent for service
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`of process at 80 Main Street, 5th Floor, West Orange, New Jersey 07052.
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`18.
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`On information and belief, Actavis Elizabeth LLC has affiliations with the
`
`State of New Jersey that are pervasive, continuous, and systematic. On information and belief,
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`Actavis Elizabeth LLC engages in direct marketing, distribution, and/or sale of generic
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`pharmaceutical drugs within the State of New Jersey and to the residents of the State of New
`
`Jersey. On information and belief, Actavis Elizabeth LLC is in the business of manufacturing,
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`marketing, importing and selling pharmaceutical drug products, including generic drug products.
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`On information and belief, Actavis Elizabeth LLC directly or through its subsidiaries, affiliates
`
`and agents develops, formulates, manufactures, markets, imports and sells pharmaceutical
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`products, including generic drug products, which are copies of products invented and developed
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`by innovator pharmaceutical companies, throughout the United States, including in this Judicial
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`District. On information and belief, Actavis, Inc. as the parent company and Actavis Elizabeth
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`LLC as the trade name holds an active wholesale drug license for the State of New Jersey under
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`License No. 5003329.
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`19.
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`On information and belief, Actavis Elizabeth LLC has previously
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`submitted to the jurisdiction of this Court and have availed themselves of the legal protections of
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`the State of New Jersey, having asserted counterclaims in this jurisdiction, including in the
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`matters of Janssen Pharmaceuticals, Inc. et al. v. Actavis Elizabeth LLC. et al., Civil Action No.
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`2:13-cv-04507 (CCC)(MF), D.I. 150 at 10, 23-38 (D.N.J. Sep. 3, 2014); Shire LLC et al. v.
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`Actavis Elizabeth LLC. et al., Civil Action No. 2:11-cv-03781 (SRC)(CLW), D.I. 231 at 5, 40-47
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`(D.N.J. Jan. 17, 2013); and Depomed, Inc. v. Actavis Elizabeth LLC. et al., Civil Action No.
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`3:12-cv-01358 (JAP)(TJB), D.I. 40 at 3, 23-27 (D.N.J. Apr. 13, 2012).
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`20.
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`On information and belief, upon approval of the Actavis 505(b)(2)
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`application, Actavis Elizabeth LLC and/or its subsidiaries, affiliates or agents will market, sell
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`and/or distribute Actavis’s Proposed Generic Product throughout the United States, including in
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`this Judicial District, and will derive substantial revenue therefrom.
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`21.
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`On information and belief, upon approval of the Actavis 505(b)(2)
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`application, Actavis Elizabeth LLC and/or its subsidiaries, affiliates or agents will place
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`Actavis’s Proposed Generic Product into the stream of commerce with the reasonable
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`expectation or knowledge and the intent that such product will ultimately be purchased and used
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`by consumers in this judicial district.
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`22.
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`Venue is proper in this Court at least pursuant to 28 U.S.C. §§ 1391(b),
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`(c), and/or (d), and 1400(b).
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`THE PATENTS-IN-SUIT
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`23.
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`Sanofi U.S. holds approved New Drug Application (“NDA”) No. 201023
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`for cabazitaxel injection, 60 mg/ 1.5 mL (40 mg/mL), which is prescribed and sold in the United
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`States under the trademark JEVTANA® KIT (hereinafter “JEVTANA®”). The U.S. Food and
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`Drug Administration (“FDA”) approved NDA No. 201023 on June 17, 2010. JEVTANA® is
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`approved for use in combination with prednisone for the treatment of patients with hormone-
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`refractory metastatic prostate cancer previously treated with a docetaxel-containing treatment
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`regimen.
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`24.
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`United States Patent No. 5,847,170 (the “’170 patent,” copy attached as
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`Exhibit A) is entitled “Taxoids, Their Preparation And Pharmaceutical Compositions Containing
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`Them” and was duly and legally issued by the United States Patent and Trademark Office
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`(“USPTO”) on December 8, 1998. The ’170 patent claims, inter alia, cabazitaxel and
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`pharmaceutical compositions containing cabazitaxel. The ’170 patent is listed in the FDA’s
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`Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”) for
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`JEVTANA® (NDA No. 201023).
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`25.
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`26.
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`The ’170 patent is owned by Aventis.
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`United States Patent No. 7,241,907 (the “’907 patent,” copy attached as
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`Exhibit B) is entitled “Acetone Solvate of Dimethoxy Docetaxel and its Process of Preparation”
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`and was duly and legally issued by the United States Patent and Trademark Office (“USPTO”)
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`on July 10, 2007. The ’907 patent claims, inter alia, an acetone solvate of cabazitaxel. The ’907
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`patent is listed in the FDA’s Orange Book for JEVTANA® (NDA No. 201023).
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`27.
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`The ’907 patent is owned by Aventis.
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`CLAIMS FOR RELIEF -
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` PATENT INFRINGEMENT
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`28.
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`On information and belief, Actavis LLC submitted the Actavis 505(b)(2)
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`application to the FDA seeking approval to engage in the commercial manufacture, use, offer for
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`sale, sale, and/or importation of Actavis’s Proposed Generic Product.
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`29.
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`On information and belief, the Actavis 505(b)(2) application seeks FDA
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`approval of Actavis’s Proposed Generic Product for use in combination with prednisone for the
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`treatment of patients with hormone-refractory metastatic prostate cancer previously treated with
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`a docetaxel-containing treatment regimen.
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`30.
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`On information and belief, Actavis LLC actively collaborated with
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`Actavis Elizabeth LLC participated in and/or directed activities related to the submission of the
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`Actavis 505(b)(2) application and the development of Actavis’s Proposed Generic Product, was
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`actively involved in preparing the NDA, and/or intends to directly benefit from and has a
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`financial stake in the approval of the NDA. On information and belief, upon approval of the
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`Actavis 505(b)(2) application, Actavis LLC will be involved in the manufacture, distribution,
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`and/or marketing of Actavis’s Proposed Generic Product.
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`31.
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`On information and belief, Actavis Elizabeth LLC actively collaborated
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`with Actavis LLC participated in and/or directed activities related to the submission of the
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`Actavis 505(b)(2) application and the development of Actavis’s Proposed Generic Product, was
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`actively involved in preparing the NDA, and/or intends to directly benefit from and has a
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`financial stake in the approval of the NDA. On information and belief, upon approval of the
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`Actavis 505(b)(2) application, Actavis Elizabeth LLC will be involved in the manufacture,
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`distribution, and/or marketing of Actavis’s Proposed Generic Product.
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`32.
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`By letter dated December 22, 2014 (the “December 22 Letter”), and
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`pursuant to 21 U.S.C. §355(b)(3)(B) and 21 C.F.R. §314.52(c), Actavis LLC notified Plaintiffs
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`that it had submitted to the FDA the Actavis 505(b)(2) application, seeking approval to engage in
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`the commercial manufacture, use, or sale of Actavis’s Proposed Generic Product before the
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`expiration of the ’170 patent and the ’907 patent. The December 22 Letter was received by
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`Plaintiffs on December 23, 2014.
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`33.
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`In its December 22 Letter, Actavis LLC notified Plaintiffs, as part of the
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`Actavis 505(b)(2) application, it had filed certification of the type described in 21 U.S.C. §
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`355(b)(2)(A)(iv) (a “Paragraph IV Certification”) with respect to the ’170 patent and the ’907
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`patent. On information and belief, Actavis LLC certified that, the ’170 patent and the ’907
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`patent are invalid, unenforceable and/or will not be infringed by the manufacture, use or sale of
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`Actavis’s Proposed Generic Product.
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`34.
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`The Actavis 505(b)(2) application refers to and relies upon the Sanofi
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`U.S.’s NDA No. 201023 for JEVTANA®.
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`35.
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`In the December 22 Letter, Actavis LLC offered confidential access to
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`portions of the Actavis 505(b)(2) application on terms and conditions set forth in paragraph VIII
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`of the December 22 Letter (“Actavis Offer”). Actavis LLC requested that Plaintiffs accept the
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`Actavis Offer before receiving access to any portion of the Actavis 505(b)(2) application. The
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`Actavis Offer contained unreasonable restrictions that would apply under a protective order.
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`36.
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`Under 21 U.S.C. § 355(c)(3)(D)(i)(III), an “offer of confidential access
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`shall contain such restrictions . . . on the use and disposition of any information accessed, as
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`would apply had a protective order been entered for the purpose of protecting trade secrets and
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`other confidential business information.”
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`37.
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`Despite further negotiations, the parties were unable to arrive at
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`reasonable terms.
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`38.
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`Plaintiffs are not aware of any other means of obtaining information
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`regarding Actavis’s Proposed Generic Product within the 45-day statutory period. Without such
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`information, Plaintiffs will use the judicial process and the aid of discovery to obtain, under
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`appropriate judicial safeguards such information as is required to confirm its allegations of
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`infringement and to present to the Court evidence that Actavis’s Proposed Generic Product falls
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`within the scope of one or more claims of the ’170 and ’907 patents.
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`COUNT I
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`INFRINGEMENT OF U.S. PATENT NO. 5,847,170
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`39.
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`Plaintiffs repeat and reallege paragraphs 1 through 38 above as if fully set
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`forth herein.
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`40.
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`By submitting the Actavis 505(b)(2) application under 21 U.S.C. §
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`355(b)(2) for the purpose of obtaining approval to engage in the commercial manufacture, use or
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`sale of Actavis’s Proposed Generic Product throughout the United States prior to the expiration
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`of the ’170 patent, Defendants committed an act of infringement of the ’170 patent under 35
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`U.S.C. § 271(e)(2). On information and belief, Defendants were aware of the ’170 patent at the
`
`time the Actavis 505(b)(2) application was submitted.
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`41.
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`If Defendants commercially make, use, offer to sell, or sell Actavis’s
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`Proposed Generic Product within the United States, or import Actavis’s Proposed Generic
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`Product into the United States, or induces or contributes to any such conduct during the term of
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`the ’170 patent, they would further infringe the ’170 patent under 35 U.S.C. §§ 271(a), (b),
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`and/or (c).
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`42.
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`Plaintiffs will be irreparably harmed if Defendants are not enjoined from
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`infringing the ’170 patent. Plaintiffs do not have an adequate remedy at law.
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`43.
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`Actavis LLC’s certification under 21 U.S.C. § 355(b)(2)(A)(iv) against the
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`’170 patent was wholly unjustified, and thus this case is exceptional under 35 U.S.C. § 285.
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`forth herein.
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`COUNT II
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`INFRINGEMENT OF U.S. PATENT NO. 7,241,907
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`44.
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`Plaintiffs repeat and reallege paragraphs 1 through 43 above as if fully set
`
`45.
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`By submitting the Actavis 505(b)(2) application under 21 U.S.C. §
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`355(b)(2) for the purpose of obtaining approval to engage in the commercial manufacture, use or
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`sale of Actavis’s Proposed Generic Product throughout the United States prior to the expiration
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`of the ’907 patent, Defendants committed an act of infringement of the ’907 patent under 35
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`U.S.C. § 271(e)(2). On information and belief, Defendants were aware of the ’907 patent at the
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`time the Actavis 505(b)(2) application was submitted.
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`46.
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`If Defendants commercially make, use, offer to sell, or sell Actavis’s
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`Proposed Generic Product within the United States, or import Actavis’s Proposed Generic
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`Product into the United States, or induces or contributes to any such conduct during the term of
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`the ’907 patent, they would further infringe the ’907 patent under 35 U.S.C. §§ 271(a), (b),
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`and/or (c).
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`47.
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`Plaintiffs will be irreparably harmed if Defendants are not enjoined from
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`infringing the ’907 patent. Plaintiffs do not have an adequate remedy at law.
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`48.
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`Actavis LLC’s certification under 21 U.S.C. § 355(b)(2)(A)(iv) against the
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`’907 patent was wholly unjustified, and thus this case is exceptional under 35 U.S.C. § 285.
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`PRAYER FOR RELIEF
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`WHEREFORE, Plaintiffs respectfully request the following relief:
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`A.
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`A judgment that Defendants have infringed one or more claims of the ’170
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`patent by filing NDA No. 207970 relating to Actavis’s Proposed Generic Product before the
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`expiration of the ’170 patent;
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`B.
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`A judgment that the manufacture, use, offer for sale, sale and/or
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`importation of Actavis’s Proposed Generic Product will infringe the ’170 patent;
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`C.
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`D.
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`A judgment declaring that the ’170 patent remains valid and enforceable;
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`A permanent injunction restraining and enjoining Defendants, and their
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`officers, agents, attorneys and employees, and those acting in privity or concert with them, from
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`engaging in the commercial manufacture, use, offer for sale, or sale within the United States, or
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`importation into the United States, of Actavis’s Proposed Generic Product until the expiration of
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`the ’170 patent or any later date of exclusivity to which Plaintiffs and/or the ’170 patent are or
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`become entitled to;
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`E.
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`An order that the effective date of any approval of Actavis LLC’s NDA
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`No. 207970 relating to Actavis’s Proposed Generic Product under Section 505(b)(2) of the
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`Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(b)(2)) shall be a date that is not earlier
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`than the expiration date of the ’170 patent or any later date of exclusivity to which Plaintiffs
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`and/or the ’170 patent are or become entitled;
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`F.
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`A judgment that Defendants have infringed one or more claims of the ’907
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`patent by filing NDA No. 207970 relating to Actavis’s Proposed Generic Product before the
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`expiration of the ’907 patent;
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`G.
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`A judgment that the manufacture, use, offer for sale, sale and/or
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`importation of Actavis’s Proposed Generic Product will infringe the ’907 patent;
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`H.
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`A judgment declaring that the ’907 patent remains valid and enforceable;
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`I.
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`A permanent injunction restraining and enjoining Defendants, and their
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`officers, agents, attorneys and employees, and those acting in privity or concert with them, from
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`engaging in the commercial manufacture, use, offer for sale, or sale within the United States, or
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`importation into the United States, of Actavis’s Proposed Generic Product until the expiration of
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`the ’907 patent or any later date of exclusivity to which Plaintiffs and/or the ’907 patent are or
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`become entitled to;
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`J.
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`An order that the effective date of any approval of Actavis LLC’s NDA
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`No. 207970 relating to Actavis’s Proposed Generic Product under Section 505(b)(2) of the
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`Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(b)(2)) shall be a date that is not earlier
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`than the expiration date of the ’907 patent or any later date of exclusivity to which Plaintiffs
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`and/or the ’907 patent are or become entitled;
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`K.
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`A declaration that this case is “exceptional” within the meaning of 35
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`U.S.C. § 285 and an award of reasonable attorney fees, costs, expenses, and disbursements of
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`this action; and
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`L.
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`Such other and further relief as the Court may deem just and proper.
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`14
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`Case 3:15-cv-00776-MAS-LHG Document 1 Filed 02/02/15 Page 15 of 18 PageID: 15
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`February 2, 2015
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`Respectfully submitted,
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`
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`By: s/ Jason A. Leonard
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`
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`Jason A. Leonard, Esq.
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`(212) 218-2100
`
`Attorneys for Plaintiffs,
`SANOFI-AVENTIS U.S. LLC, AVENTIS
`PHARMA S.A. and SANOFI
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`Of Counsel:
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`William E. Solander, Esq.
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`(212) 218-2100
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`15