Case 3:14-cv-08079-MAS-LHG Document 1 Filed 12/29/14 Page 1 of 42 PageID: 1
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`Liza M. Walsh, Esq.
`CONNELL FOLEY LLP
`85 Livingston Avenue
`Roseland, New Jersey 07068-1765
`(973) 535-0500
`
`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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`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
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`
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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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`
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`Plaintiffs,
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`v.
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`Defendant.
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`ACCORD HEALTHCARE, 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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`defendant Accord Healthcare, Inc. (hereinafter “Accord” or “Defendant”), hereby allege as
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`follows:
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`
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`AVENTIS EXHIBIT 2047
`Mylan v. Aventis
`IPR2016-00627
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`

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`Case 3:14-cv-08079-MAS-LHG Document 1 Filed 12/29/14 Page 2 of 42 PageID: 2
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`THE PARTIES
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`1.
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`Plaintiff Sanofi U.S. is a wholly owned U.S. subsidiary of Sanofi and is a
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`company organized and existing under the laws of the State of Delaware, having commercial
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`headquarters 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, defendant Accord is a corporation organized
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`and existing under the laws of North Carolina, having its principal place of business at 1009
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`Slater Road, Suite 210B, Durham, North Carolina 27703.
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`6.
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`On information and belief, Accord is a wholly-owned subsidiary of Intas
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`Pharmaceuticals Ltd. (hereinafter “Intas”). On information and belief, Intas is a corporation
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`organized under the laws of India, with its principal place of business at 2nd Floor, Chinubai
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`Centre, Off. Nehru Bridge, Ashram Road, Ahmedabad 380009, Gujarat, India.
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`ACCORD ANDA
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`7.
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`On information and belief, Accord assembled and caused to be filed with
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`the United States Food and Drug Administration (“FDA”), Abbreviated New Drug Application
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`(“ANDA”) No. 207693 pursuant to 21 U.S.C. § 355(j) (§ 505(j) of the Federal Food, Drug and
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`2
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`Cosmetic Act) (hereinafter “the Accord ANDA”) concerning a proposed drug product,
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`Cabazitaxel Injection, 60 mg/1.5 mL (hereinafter “Accord’s Proposed ANDA Product”).
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`ACCORD B2 NDA
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`8.
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`On information and belief, Accord assembled and caused to be filed with
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`the FDA, New Drug Application (“NDA”) No. 207949 pursuant to 21 U.S.C. § 355(b)(2) (§
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`505(b)(2) of the Federal Food, Drug and Cosmetic Act) (hereinafter “the Accord B2 NDA”)
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`concerning a proposed drug product, Cabazitaxel Injection, 20 mg/mL, 3 mL (hereinafter
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`“Accord’s Proposed B2 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 Accord. On information and
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`belief, Accord directly or through its alter ego, 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, Intas as parent company and Accord as trade name are the holders of Registration No.
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`5003815 active wholesale drug and medical device license with the New Jersey Department of
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`Health, available at http://web.doh.state.nj.us/apps2/FoodDrugLicense/fdList.aspx (last visited
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`December 11, 2014).
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`11.
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`On information and belief, “Accord has been servicing the needs of the
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`US healthcare industry since 2009,” and its “business in the USA . . . currently accounts for more
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`3
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`that [sic] USD 100 million in revenue.” Accord Healthcare, Global Presence – USA site
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`available at http://www.accord-healthcare.com/global-presence-usa.html (last visited December
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`11, 2014). On information and belief, Accord is “the preferred supplier for leading distributors
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`and retail pharma chains” in the United States. Intas, International Operations, USA site
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`available
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`at
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`http://www.intaspharma.com/index.php?option=com_content&view=article&id=56&Itemid=63
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`(last visited December 11, 2014).
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`12.
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`On information and belief, Accord 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 Otsuka
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`Pharmaceutical Co., Ltd. v. Intas Pharmaceuticals Ltd. et al., Civil Action No. 1:14-cv-06158
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`(JBS)(KMW), D.I. 38, 3, 7-11 (D.N.J. Dec. 8, 2014); Otsuka Pharmaceutical Co., Ltd. v. Intas
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`Pharmaceuticals Ltd. et al., Civil Action No. 1:14-cv-03996 (JBS)(KMW), D.I. 45, 3, 10-14
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`(D.N.J. Dec. 8, 2014); Novartis Pharmaceuticals Corp. et al. v. Wockhardt USA LLC et al., Civil
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`Action No: 2:12-cv-03967 (SDW)(SCM), D. I. 89, 5, 9-13 (D.N.J. Jun. 6, 2013); Merck Sharp &
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`Dohme Corp. v. Accord Healthcare, Inc. et al., Civil Action No: 3:12-cv-03324 (PGS)(LHG), D.
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`I. 27, 5, 14-17 (D.N.J. Sep. 24, 2012); Hoffman-LaRoche Inc. v. Accord Healthcare, Inc. et al.,
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`Civil Action No: 2:11-cv-03663 (ES)(CLW), D. I. 7, 4, 11-15 (D.N.J. Nov. 28, 2011); Hoffman-
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`LaRoche Inc. v. Accord Healthcare, Inc. et al., Civil Action No: 2:11-cv-01192 (ES)(CLW), D.
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`I. 11, 4-5, 11-14 (D.N.J. May 31, 2011); AstraZeneca Pharmaceuticals LP et al. v. Accord
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`Healthcare, Inc. et al., Civil Action No: 3:09-cv-00619 (JAP)(TJB), D. I. 9, 2, 8-11 (D.N.J. Mar.
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`20, 2009); and AstraZeneca Pharmaceuticals LP et al. v. Accord Healthcare, Inc. et al., Civil
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`Action No: 3:08-cv-04804 (JAP)(TJB), D. I. 15, 3, 7-11 (D.N.J. Oct. 28, 2008).
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`4
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`13.
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`On information and belief, Accord has affiliations with the State of New
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`Jersey that are pervasive, continuous, and systematic. On information and belief, Accord
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`engages in direct marketing, distribution, and/or sale of generic pharmaceutical drugs within the
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`State of New Jersey and to the residents of the State of New Jersey, and maintenance of
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`corporate agents in the State of New Jersey.
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`14.
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`On information and belief, Accord regularly conducts and solicits business
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`in the State of New Jersey, engages in other persistent courses of conduct in the State of New
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`Jersey, and/or derives substantial revenue from services or things used or consumed in the State
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`of New Jersey.
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`15.
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`Accord is also subject to personal jurisdiction in the State of New Jersey
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`because, inter alia, Accord has committed, aided, abetted, contributed to, and/or participated in
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`the commission of a tortious act of patent infringement under 35 U.S.C. § 271(e)(2) that has led
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`and/or will lead to foreseeable harm and injury to Plaintiff Sanofi U.S., having commercial
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`headquarters in the State of New Jersey. By letter dated November 24, 2014 (“November 24
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`ANDA Notice Letter”), Accord notified Plaintiffs that it had filed a certification of the type
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`described in 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“ANDA Paragraph IV Certification”) with
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`respect to U.S Patent No. 5,847,170 (“’170 patent”). By letter dated November 25, 2014
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`(“November 25 B2 Notice Letter”), Accord notified Plaintiffs that it had filed a certification
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`pursuant to 21 U.S.C. §355(b)(2)(A)(iv) (“B2 Paragraph IV Certification”) with respect to the
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`’170 patent. Accord sent its November 24 ANDA Notice Letter and its November 25 B2 Notice
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`Letter to Sanofi U.S.’s commercial headquarters at 55 Corporate Drive, Bridgewater, New Jersey
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`08807. Plaintiffs’s cause of action arose from Accord’s contacts with Sanofi U.S. in
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`Bridgewater, New Jersey. In its November 24 ANDA Notice Letter, Accord states that it intends
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`5
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`to engage in the manufacture, use, and/or sale of Accord’s Proposed ANDA Product before the
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`expiration of the ’170 patent throughout the United States, including in this Judicial District. In
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`its November 25 B2 Notice Letter, Accord states that it intends to engage in the manufacture,
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`use, and/or sale of Accord’s Proposed B2 Product before the expiration of the ’170 patent
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`throughout the United States, including in this Judicial District.
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`16.
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`On information and belief, upon approval of the Accord ANDA, Accord
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`and/or its affiliates or agents will market, sell and/or distribute Accord’s Proposed ANDA
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`Product throughout the United States, including in this Judicial District, and will derive
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`substantial revenue therefrom.
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`17.
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`On information and belief, upon approval of the Accord ANDA, Accord
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`and/or its affiliates or agents will place Accord’s Proposed ANDA Product into the stream of
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`commerce with the reasonable expectation or knowledge and the intent that such product will
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`ultimately be purchased and used by consumers in this Judicial District.
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`18.
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`On information and belief, upon approval of the Accord B2 NDA, Accord
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`and/or its affiliates or agents will market, sell and/or distribute Accord’s Proposed B2 Product
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`throughout the United States, including in this Judicial District, and will derive substantial
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`revenue therefrom.
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`19.
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`On information and belief, upon approval of the Accord B2 NDA, Accord
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`and/or its affiliates or agents will place Accord’s Proposed B2 Product into the stream of
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`commerce with the reasonable expectation or knowledge and the intent that such product will
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`ultimately be purchased and used by consumers in this Judicial District.
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`20.
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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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`6
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`THE PATENT-IN-SUIT
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`21.
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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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`22.
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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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`23.
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`The ’170 patent is owned by Aventis.
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`CLAIMS FOR RELIEF  PATENT INFRINGEMENT BY ACCORD ANDA
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`24.
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`On information and belief, Accord submitted the Accord ANDA to the
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`FDA seeking approval to engage in the commercial manufacture, use, offer for sale, sale, and/or
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`importation of Accord’s Proposed ANDA Product.
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`25.
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`On information and belief, the Accord ANDA seeks FDA approval of
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`Accord’s Proposed ANDA Product for use in combination with prednisone for the treatment of
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`7
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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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`26.
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`On information and belief, Accord actively participated in and/or directed
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`activities related to the submission of the Accord ANDA and the development of Accord’s
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`Proposed ANDA Product, was actively involved in preparing the Accord ANDA, and/or intends
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`to directly benefit from and has a financial stake in the approval of the Accord ANDA. On
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`information and belief, upon approval of the Accord ANDA, Accord will be involved in the
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`manufacture, distribution, and/or marketing of Accord’s Proposed ANDA Product.
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`27.
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`In its November 24 ANDA Notice Letter, Accord notified Plaintiffs that it
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`had submitted to the FDA the Accord ANDA, seeking approval to engage in the commercial
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`manufacture, use, or sale of Accord’s Proposed ANDA Product before the expiration of the ’170
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`patent, and that it had filed an ANDA Paragraph IV Certification with respect to the ’170 patent.
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`The November 24 ANDA Notice Letter was received by Plaintiffs on November 26, 2014.
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`28.
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`On information and belief, in its November 24 ANDA Notice Letter,
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`Accord certified that the ’170 patent is invalid, unenforceable and/or will not be infringed by the
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`manufacture, use or sale of Accord’s Proposed ANDA Product.
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`29.
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`The Accord ANDA refers to and relies upon the Sanofi U.S.’s NDA No.
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`201023 for JEVTANA®.
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`CLAIMS FOR RELIEF  PATENT INFRINGEMENT BY ACCORD B2 NDA
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`30.
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`On information and belief, Accord submitted the Accord B2 NDA to the
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`FDA seeking approval to engage in the commercial manufacture, use, offer for sale, sale, and/or
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`importation of Accord’s Proposed B2 Product.
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`8
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`31.
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`On information and belief, the Accord B2 NDA seeks FDA approval of
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`Accord’s Proposed B2 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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`32.
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`On information and belief, Accord actively participated in and/or directed
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`activities related to the submission of the Accord B2 NDA and the development of Accord’s
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`Proposed B2 Product, was actively involved in preparing the Accord B2 NDA, and/or intends to
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`directly benefit from and has a financial stake in the approval of the Accord B2 NDA. On
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`information and belief, upon approval of the Accord B2 NDA, Accord will be involved in the
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`manufacture, distribution, and/or marketing of Accord’s Proposed B2 Product.
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`33.
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`In its November 25 B2 Notice Letter, Accord notified Plaintiffs that it had
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`submitted to the FDA the Accord B2 NDA, seeking approval to engage in the commercial
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`manufacture, use, or sale of Accord’s Proposed B2 Product before the expiration of the ’170
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`patent and that it had filed a B2 Paragraph IV Certification with respect to the ’170 patent. The
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`November 25 B2 Notice Letter was received by Plaintiffs on December 1, 2014.
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`34.
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`On information and belief, in its November 25 B2 Notice Letter, Accord
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`certified that the ’170 patent is invalid, unenforceable and/or will not be infringed by the
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`manufacture, use or sale of Accord’s Proposed B2 Product.
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`35.
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`The Accord B2 NDA refers to and relies upon the Sanofi U.S.’s NDA No.
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`201023 for JEVTANA®.
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`9
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`COUNT I
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`INFRINGEMENT OF U.S. PATENT NO. 5,847,170 BY ACCORD ANDA
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`36.
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`Plaintiff repeats and realleges paragraphs 1 through 35 above as if fully set
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`forth herein.
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`37.
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`By submitting the Accord 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 Accord’s
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`Proposed ANDA Product throughout the United States prior to the expiration of the ’170 patent,
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`Accord 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, Accord was aware of the ’170 patent at the time the Accord ANDA was
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`submitted.
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`38.
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`If Accord commercially makes, uses, offers to sell, or sells Accord’s
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`Proposed ANDA Product within the United States, or imports Accord’s Proposed ANDA
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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, it would further infringe the ’170 patent under 35 U.S.C. §§ 271(a), (b), and/or
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`(c).
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`39.
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`Plaintiffs will be irreparably harmed if Accord is not enjoined from
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`infringing the ’170 patent. Plaintiffs do not have an adequate remedy at law.
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`40.
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`Accord’s certification under 21 U.S.C. § 355(j)(2)(A)(vii)(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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`COUNT II
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`INFRINGEMENT OF U.S. PATENT NO. 5,847,170 BY ACCORD B2 NDA
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`41.
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`Plaintiff repeats and realleges paragraphs 1 through 40 above as if fully set
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`forth herein.
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`10
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`42.
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`By submitting the Accord B2 NDA under 21 U.S.C. § 355(b)(2) for the
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`purpose of obtaining approval to engage in the commercial manufacture, use or sale of Accord’s
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`Proposed B2 Product throughout the United States prior to the expiration of the ’170 patent,
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`Accord 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, Accord was aware of the ’170 patent at the time the Accord B2 NDA was
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`submitted.
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`43.
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`If Accord commercially makes, uses, offers to sell, or sells Accord’s
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`Proposed B2 Product within the United States, or imports Accord’s Proposed B2 Product into the
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`United States, or induces or contributes to any such conduct during the term of the ’170 patent, it
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`would further infringe the ’170 patent under 35 U.S.C. §§ 271(a), (b), and/or (c).
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`44.
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`Plaintiffs will be irreparably harmed if Accord is not enjoined from
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`infringing the ’170 patent. Plaintiffs do not have an adequate remedy at law.
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`45.
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`Accord’s certification under 21 U.S.C. § 355(b)(2)(A)(iv) against the ’170
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`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 Accord Healthcare, Inc. has infringed one or more claims
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`of the ’170 patent by filing ANDA No. 207693 relating to Accord’s Proposed ANDA Product
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`before the expiration of the ’170 patent;
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`B.
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`A judgment that Accord Healthcare, Inc. has infringed one or more claims
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`of the ’170 patent by filing NDA No. 207949 relating to Accord’s Proposed B2 NDA Product
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`before the expiration of the ’170 patent;
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`Case 3:14-cv-08079-MAS-LHG Document 1 Filed 12/29/14 Page 12 of 42 PageID: 12
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`C.
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`A judgment that the manufacture, use, offer for sale, sale and/or
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`importation of Accord’s Proposed ANDA Product and/or Accord’s Proposed B2 NDA Product
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`will infringe the ’170 patent;
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`D.
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`E.
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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 Accord Healthcare, Inc.,
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`and its officers, agents, attorneys and employees, and those acting in privity or concert with
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`them, from engaging in the commercial manufacture, use, offer for sale, or sale within the United
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`States, or importation into the United States, of Accord’s Proposed ANDA Product and/or
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`Accord’s Proposed B2 NDA Product until the expiration of the ’170 patent or any later date of
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`exclusivity to which Plaintiffs and/or the ’170 patent are or become entitled to;
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`F.
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`An order that the effective date of any approval of Accord’s ANDA No.
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`207693 relating to Accord’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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`G.
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`An order that the effective date of any approval of Accord’s NDA No.
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`207949 relating to Accord’s Proposed B2 Product under Section 505(b)(2) of the Federal Food,
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`Drug and Cosmetic Act (21 U.S.C. 355(b)(2)) shall be a date that is not earlier than the
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`expiration date of the ’170 patent or any later date of exclusivity to which Plaintiffs and/or the
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`’170 patent are or become entitled;
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`H.
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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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`12
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`Case 3:14-cv-08079-MAS-LHG Document 1 Filed 12/29/14 Page 13 of 42 PageID: 13
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`I.
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`Such other and further relief as the Court may deem just and proper.
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`CONNELL FOLEY LLP
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`13
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`
`By: 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
`
`
`December 29, 2014