Case 3:15-cv-00287-MAS-LHG Document 1 Filed 01/14/15 Page 1 of 50 PageID: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
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`
`Liza M. Walsh, Esq.
`CONNELL FOLEY LLP
`85 Livingston Avenue
`Roseland, New Jersey 07068-1765
`(973) 535-0500
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`
`
`Of Counsel:
`William E. Solander, Esq.
`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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`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and
`SANOFI
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`C.A. No.: _____________________
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`Electronically Filed
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`Plaintiffs,
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`v.
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`Defendants.
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`APOTEX CORP. and APOTEX INC.
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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 Apotex Corp. and Apotex Inc. (collectively “Defendants”), hereby allege as follows:
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`
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`AVENTIS EXHIBIT 2050
`Mylan v. Aventis
`IPR2016-00627
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`Case 3:15-cv-00287-MAS-LHG Document 1 Filed 01/14/15 Page 2 of 50 PageID: 2
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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, Apotex Corp. is a corporation organized and
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`existing under the laws of the State of Delaware, having its principal place of business at 2400
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`North Commerce Parkway, Suite 400, Weston, Florida 33326.
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`6.
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`On information and belief, Apotex Inc. is a corporation organized and
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`existing under the laws of Canada, having its principal place of business at 150 Signet Drive,
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`Toronto, Ontario, Canada M9L IT9.
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`Apotex Inc.
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`7.
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`8.
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`On information and belief, Apotex Corp. is a wholly-owned subsidiary of
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`On information and belief, Apotex Inc. 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. § 355(j)
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`(Section 505(j) of the Federal Food, Drug and Cosmetic Act), Abbreviated New Drug
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`2
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`Case 3:15-cv-00287-MAS-LHG Document 1 Filed 01/14/15 Page 3 of 50 PageID: 3
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`
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`Application (“ANDA”) No. 207736 (hereinafter “the Apotex ANDA”) concerning a proposed
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`drug product, Cabazitaxel Injection, 60 mg/1.5 mL (“Apotex’s Proposed ANDA Product”).
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`JURISDICTION AND VENUE
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`9.
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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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`10.
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`This Court has personal jurisdiction over Apotex Corp. On information
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`and belief, Apotex Corp. directly or through its subsidiaries, affiliates and agents develops,
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`formulates, manufactures, markets, imports and sells pharmaceutical products, including generic
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`drug 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, Apotex Corp. holds an active wholesale drug license for the State of New Jersey under
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`License No. 5003192.
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`11.
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`On
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`information and belief, Apotex Corp. is
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`in the business of
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`manufacturing, marketing, importing and selling pharmaceutical drug products, including
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`generic drug products. On information and belief, Apotex Corp. “has successfully secured FDA
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`approval for over 230 ANDAs” and “boast[s] over a billion dollars in salesand a new ranking
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`in the top 10 generic pharmaceutical companies according to recent IMS HEALTH data.”
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`Apotex Corp: A Global Leader Focused on Excellence, Pharmacy Times available at
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`http://www.pharmacytimes.com/publications/supplement/2013/Generic-Supplement-
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`2013/Apotex-Corp-A-Global-Leader-Focused-on-Excellence. (last visited January 6, 2015).
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`12.
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`On information and belief, Apotex Corp. has affiliations with the State of
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`New Jersey that are pervasive, continuous, and systematic. On information and belief, Apotex
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`3
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`Corp. 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.
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`13.
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`On information and belief, Apotex Corp. regularly conducts and/or solicits
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`business in the State of New Jersey, engages in other persistent courses of conduct in the State of
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`New Jersey, and/or derives substantial revenue from services or things used or consumed in the
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`State of New Jersey.
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`14.
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`On information and belief, Apotex Corp. 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. Apotex Inc. et al., Civil Action No. 2:12-cv-05574
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`(JLL)(MAH), D.I. 12 at 2-3, 10-12 (D.N.J. Feb. 11, 2013); Otsuka Pharmaceutical Co., Ltd. v.
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`Apotex Corp. et al., Civil Action No. 3:12-cv-05645 (MLC) (LHG), D.I. 27 at 3-5, 15-20 (D.N.J.
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`Dec. 11, 2012); Actelion Pharmaceuticals Ltd. et al. v. Apotex Inc. et al., Civil Action No. 1:12-
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`cv-05743 (NLH)(AMD), D.I. 24 at 13-33 (D.N.J. Nov. 27, 2012); and Hoffman-La Roche, Inc. v.
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`Apotex Inc. et al., Civil Action No. 2:10-cv-06241 (SRC)(MAS), D.I. 14 at 3-4, 20-24 (D.N.J.
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`Jan. 12, 2011).
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`15.
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`On information and belief, upon approval of the Apotex ANDA, Apotex
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`Corp. and/or its subsidiaries, affiliates or agents will market, sell and/or distribute Apotex’s
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`Proposed ANDA Product throughout the United States, including in this Judicial District, and
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`will derive substantial revenue therefrom.
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`16.
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`On information and belief, upon approval of the Apotex ANDA, Apotex
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`Corp. and/or its subsidiaries, affiliates or agents will place Apotex’s Proposed ANDA Product
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`4
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`into the stream of commerce with the reasonable expectation or knowledge and the intent that
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`such product will ultimately be purchased and used by consumers in this Judicial District.
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`17.
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`This Court has personal jurisdiction over Apotex Inc. On information and
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`belief, Apotex Inc. 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
`
`belief, Apotex Inc. is in the business of manufacturing, marketing, importing and selling
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`pharmaceutical drug products, including generic drug products.
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`18.
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`On information and belief, Apotex Inc. has affiliations with the State of
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`New Jersey that are pervasive, continuous, and systematic. On information and belief, Apotex
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`Inc. engages in direct marketing, distribution, and/or sale of generic pharmaceutical drugs within
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`the State of New Jersey and to the residents of the State of New Jersey.
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`19.
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`On information and belief, Apotex Inc. regularly conducts and/or solicits
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`business in the State of New Jersey, engages in other persistent courses of conduct in the State of
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`New Jersey, and/or derives substantial revenue from services or things used or consumed in the
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`State of New Jersey.
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`20.
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`On information and belief, Apotex Inc. 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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`Pharmaceutical Corporation v. Apotex Inc. et al., Civil Action No. 2:12-cv-05574 (JLL)(MAH),
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`D.I. 12 at 2-3, 10-12 (D.N.J. Feb. 11, 2013); Otsuka Pharmaceutical Co., Ltd. v. Apotex Corp. et
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`al., Civil Action No. 3:12-cv-05645 (MLC) (LHG), D.I. 27 at 3-5, 15-20 (D.N.J. Dec. 11, 2012);
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`5
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`
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`Actelion Pharmaceuticals Ltd. et al. v. Apotex Inc. et al., Civil Action No. 1:12-cv-05743
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`(NLH)(AMD), D.I. 24 at 13-33 (D.N.J. Nov. 27, 2012); and Hoffman-La Roche, Inc. v. Apotex
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`Inc. et al., Civil Action No. 2:10-cv-06241 (SRC)(MAS), D.I. 14 at 3-4, 20-24 (D.N.J. Jan. 12,
`
`2011).
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`21.
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`Apotex Inc. is also subject to personal jurisdiction in the State of New
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`Jersey because, inter alia, Apotex Inc. 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. Apotex Inc. sent its December 4,
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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 Apotex Inc.’s
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`contact with Sanofi U.S. in Bridgewater, New Jersey. Apotex Inc. states that it intends to engage
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`in the commercial manufacture, use, and/or sale of Apotex Inc.’s Proposed ANDA 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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`22.
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`In the alternative, Apotex Inc. is subject to jurisdiction in the United States
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`under the principles of general jurisdiction, and specially in the State of New Jersey pursuant to
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`Fed. R. Civ. P. 4(k)(2). Apotex Inc. has contacts with the United States by, inter alia, its having
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`filed an ANDA with the FDA.
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`23.
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`On information and belief, upon approval of the Apotex ANDA, Apotex
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`Inc. and/or its subsidiaries, affiliates or agents will market, sell and/or distribute Apotex’s
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`Proposed ANDA Product throughout the United States, including in this Judicial District, and
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`will derive substantial revenue therefrom.
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`6
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`24.
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`On information and belief, upon approval of the Apotex ANDA, Apotex
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`Inc. and/or its subsidiaries, affiliates or agents will place Apotex’s Proposed ANDA Product into
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`the stream of commerce with the reasonable expectation or knowledge and the intent that such
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`product will ultimately be purchased and used by consumers in this Judicial District.
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`25.
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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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`26.
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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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`27.
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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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`28.
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`The ’170 patent is owned by Aventis.
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`29.
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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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`30.
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`The ’907 patent is owned by Aventis.
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`CLAIMS FOR RELIEF  PATENT INFRINGEMENT
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`31.
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`On information and belief, Apotex Inc. submitted the Apotex ANDA to
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`the FDA seeking approval to engage in the commercial manufacture, use, offer for sale, sale,
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`and/or importation of Apotex’s Proposed ANDA Product.
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`32.
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`On information and belief, the Apotex ANDA seeks FDA approval of
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`Apotex’s Proposed ANDA Product for use in combination with prednisone for the treatment of
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`patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-
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`containing treatment regimen.
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`33.
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`On information and belief, Apotex Inc. actively collaborated with Apotex
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`Corp. and/or participated in and/or directed activities related to the submission of the Apotex
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`ANDA and the development of Apotex’s Proposed ANDA Product, was actively involved in
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`preparing the ANDA, and/or intends to directly benefit from and has a financial stake in the
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`approval of the ANDA. On information and belief, upon approval of the Apotex ANDA, Apotex
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`Inc. will be involved in the manufacture, distribution, and/or marketing of Apotex’s Proposed
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`ANDA Product.
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`34.
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`On information and belief, Apotex Corp. actively collaborated with
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`Apotex Inc. and/or participated in and/or directed activities related to the submission of the
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`Apotex ANDA and the development of Apotex’s Proposed ANDA Product, was actively
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`involved in preparing the ANDA, and/or intends to directly benefit from and has a financial stake
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`in the approval of the ANDA. On information and belief, upon approval of the Apotex ANDA,
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`Apotex Corp. will be involved in the manufacture, distribution, and/or marketing of Apotex’s
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`Proposed ANDA Product.
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`35.
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`By letter dated December 4, 2014 (the “December 4 Letter”), and pursuant
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`to 21 U.S.C. § 355(j)(2)(B)(ii) and 21 C.F.R. §314.95, Apotex Inc. notified Plaintiffs that it had
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`submitted to the FDA the Apotex ANDA, seeking approval to engage in the commercial
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`manufacture, use, or sale of Apotex’s Proposed ANDA Product before the expiration of the ’170
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`patent and the ’907 patent. The December 4 Letter was received by Plaintiffs on December 5,
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`2014.
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`36.
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`In its December 4 Letter, Apotex Inc. notified Plaintiffs, as part of the
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`Apotex ANDA,
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`it had filed a certification of the type described
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`in 21 U.S.C. §
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`355(j)(2)(A)(vii)(IV) (a “Paragraph IV Certification”) with respect to the ’170 patent and the
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`’907 patent. On information and belief, Apotex Inc. 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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`Apotex’s Proposed ANDA Product.
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`37.
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`The Apotex ANDA refers to and relies upon the Sanofi U.S.’s NDA No.
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`201023 for JEVTANA®.
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`38.
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`In the December 4 Letter, Apotex offered confidential access to portions
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`of the Apotex ANDA on terms and conditions set forth in paragraph 2 of the December 4 Letter
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`(“Apotex Offer”). Apotex requested that Plaintiffs accept the Apotex Offer before receiving
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`access to any portion of the Apotex ANDA. The Apotex Offer contained unreasonable
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`restrictions that would apply under a protective order. For example, the Apotex Offer required
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`that Plaintiffs’ outside counsel do not engage, formally or informally, in any patent prosecution
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`or any FDA counseling, litigation or other work before or involving the FDA on behalf of
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`Plaintiffs.
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`39.
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`Under 21 U.S.C. § 355(j)(5)(C)(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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`40.
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`Since rejecting the Apotex Offer, Plaintiffs attempted to negotiate with
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`Apotex to obtain a copy of excerpts of the Apotex ANDA under restrictions “as would apply had
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`a protective order been issued.” Those negotiations were unsuccessful. For example, Apotex’s
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`final proposal continued to unreasonably impose patent prosecution and FDA restrictions on
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`Plaintiffs’ outside counsel.
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`41.
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`Plaintiffs are not aware of any other means of obtaining information
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`regarding Apotex’s Proposed ANDA 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 Apotex’s Proposed ANDA 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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`42.
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`Plaintiff repeats and realleges paragraphs 1 through 41 above as if fully set
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`forth herein.
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`43.
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`By submitting the Apotex ANDA under 21 U.S.C. § 355(j) for the purpose
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`of obtaining approval to engage in the commercial manufacture, use or sale of Apotex’s
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`Proposed ANDA Product throughout the United States prior to the expiration of the ’170 patent,
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`Defendants committed an act of infringement of the ’170 patent under 35 U.S.C. § 271(e)(2). On
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`information and belief, Defendants were aware of the ’170 patent at the time the Apotex ANDA
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`was submitted.
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`44.
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`If Defendants commercially make, use, offer to sell, or sell Apotex’s
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`Proposed ANDA Product within the United States, or import Apotex’s Proposed ANDA Product
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`into the United States, or induce or contribute to any such conduct during the term of the ’170
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`patent, they would further infringe the ’170 patent under 35 U.S.C. §§ 271(a), (b), and/or (c).
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`45.
`
`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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`46.
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`Apotex Inc.’s certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) against
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`the ’170 patent was wholly unjustified, and thus this case is exceptional under 35 U.S.C. § 285.
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`COUNT II
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`INFRINGEMENT OF U.S. PATENT NO. 7,241,907
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`Plaintiffs repeat and reallege paragraphs 1 through 46 above as if fully set
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`By submitting the Apotex ANDA under 21 U.S.C. § 355(j) for the purpose
`
`forth herein.
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`47.
`
`48.
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`of obtaining approval to engage in the commercial manufacture, use or sale of Apotex’s
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`Proposed ANDA Product throughout the United States prior to the expiration of the ’907 patent,
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`Defendants committed an act of infringement of the ’907 patent under 35 U.S.C. § 271(e)(2). On
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`11
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`information and belief, Defendants were aware of the ’907 patent at the time the Apotex ANDA
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`was submitted.
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`49.
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`If Defendants commercially make, use, offer to sell, or sell Apotex’s
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`Proposed ANDA Product within the United States, or import Apotex’s Proposed ANDA Product
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`into the United States, or induce or contribute to any such conduct during the term of the ’907
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`patent, it would further infringe the ’907 patent under 35 U.S.C. §§ 271(a), (b), and/or (c).
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`50.
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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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`51.
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`Apotex Inc.’s certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) against
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`the ’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 ANDA No. 207736 relating to Apotex’s Proposed ANDA Product before the
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`expiration of the ’170 patent;
`
`B.
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`A judgment that the manufacture, use, offer for sale, sale and/or
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`importation of Apotex’s Proposed ANDA Product will infringe the ’170 patent;
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`C.
`
`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 Apotex’s Proposed ANDA Product until the expiration of
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`12
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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 Apotex’s ANDA No.
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`207736 relating to Apotex’s Proposed ANDA Product under Section 505(j) of the Federal Food,
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`Drug and Cosmetic Act (21 U.S.C. § 355(j)) shall be a date that is not earlier than the expiration
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`date of the ’170 patent or any later date of exclusivity to which Plaintiffs and/or the ’170 patent
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`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 ANDA No. 207736 relating to Apotex’s Proposed ANDA Product before the
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`expiration of the ’907 patent;
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`G.
`
`A judgment that the manufacture, use, offer for sale, sale and/or
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`importation of Apotex’s Proposed ANDA Product will infringe the ’907 patent;
`
`H.
`
`I.
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`A judgment declaring that the ’907 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 Apotex’s Proposed ANDA Product until the expiration of
`
`the ’907 patent or any later date of exclusivity to which Plaintiffs and/or the ’907 patent are or
`
`become entitled to;
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`J.
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`An order that the effective date of any approval of Apotex’s ANDA No.
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`207736 relating to Apotex’s Proposed ANDA Product under Section 505(j) of the Federal Food,
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`Drug and Cosmetic Act (21 U.S.C. § 355(j)) shall be a date that is not earlier than the expiration
`
`
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`13
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`

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`Case 3:15-cv-00287-MAS-LHG Document 1 Filed 01/14/15 Page 14 of 50 PageID: 14
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`date of the ’907 patent or any later date of exclusivity to which Plaintiffs and/or the ’907 patent
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`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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`
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`14
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`

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`Case 3:15-cv-00287-MAS-LHG Document 1 Filed 01/14/15 Page 15 of 50 PageID: 15
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`
`CONNELL FOLEY LLP
`
`
`
`
`
`By: s/Liza M. Walsh
`
`
`
`
`
`Liza M. Walsh, Esq.
`CONNELL FOLEY LLP
`85 Livingston Avenue
`Roseland, New Jersey 07068-1765
`(973) 535-0500
`
`Attorneys for Plaintiffs,
`SANOFI-AVENTIS U.S. LLC, AVENTIS
`PHARMA S.A. and SANOFI
`
`Of Counsel:
`
`William E. Solander, Esq.
`Jason A. Leonard, Esq.
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`(212) 218-2100
`
`
`
`
`15
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`January 14, 2015