Case 3:15-cv-03392-MAS-LHG Document 1 Filed 05/15/15 Page 1 of 13 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:
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`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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`C.A. No.: _____________________
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`(Filed Electronically)
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`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
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`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and
`SANOFI
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`ONCO THERAPIES LIMITED,
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`Plaintiffs,
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`v.
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`Defendant.
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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 Onco Therapies Limited (hereinafter “Onco” or “Defendant”), hereby allege as
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`follows:
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`THE PARTIES
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`1.
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`Plaintiff Sanofi U.S. is an indirectly wholly owned U.S. subsidiary of
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`Sanofi and is a company organized and existing under the laws of the State of Delaware, having
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`commercial 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, Onco is a corporation organized and existing
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`under the laws of India, having its principal place of business at Strides House, Bilekahalli,
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`Bannerghatta Road, Bangalore, Karnataka 560076, India.
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`6.
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`On information and belief, Onco is a wholly-owned subsidiary of Strides
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`Arcolab Limited (hereinafter “Arcolab”). On information and belief, Arcolab is a corporation
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`organized and existing under the laws of India, having its principal place of business at Strides
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`House, Bilekahalli, Bannerghatta Road, Bangalore, Karnataka 560076, India.
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`7.
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`On information and belief, Onco conducts business through and with
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`Agila Specialties Inc. (hereinafter “Agila”), formerly known as Strides, Inc. On information and
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`belief, Agila is a corporation organized and existing under the laws of New Jersey, having its
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`2
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`principal place of business at 201 South Main Street, Suite 3, Lambertville, New Jersey 08530.
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`On information and belief, Agila is an agent or affiliate of Onco.
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`8.
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`On information and belief, Onco conducts business through and with
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`Strides Pharma Inc. (hereinafter “Strides Pharma”). On information and belief, Strides Pharma is
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`a corporation organized and existing under the laws of New Jersey, having its principal place of
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`business at 201 South Main Street, Suite 3, Lambertville, New Jersey 08530. On information
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`and belief, Strides Pharma is a wholly-owned subsidiary of Arcolab. On information and belief,
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`Strides Pharma is an agent or affiliate of Onco.
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`9.
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`On information and belief, Onco assembled and caused to be filed with the
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`United States Food and Drug Administration (“FDA”), pursuant to 21 U.S.C. § 355(j) (Section
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`505(j) of the Federal Food, Drug and Cosmetic Act), Abbreviated New Drug Application
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`(“ANDA”) No. 207381 (hereinafter “the Onco ANDA”) concerning a proposed drug product,
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`cabazitaxel injection [60 mg/1.5 mL] [40 mg/mL] (“Onco’s Proposed ANDA 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 Onco. On information and
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`belief, Onco conducts business through and with Agila. On information and belief, Agila is a
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`corporation organized and existing under the laws of New Jersey, having its principal place of
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`business at 201 South Main Street, Suite 3, Lambertville, New Jersey 08530. On information
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`and belief, Agila is registered with the New Jersey Department of Treasury under entity
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`identification number 0100791546. On information and belief, Agila maintains a registered
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`3
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`corporate agent at 37 Veronica Avenue, Somerset, New Jersey 08873. On information and
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`belief, Agila is an agent or affiliate of Onco. On information and belief, Onco conducts business
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`through and with Strides Pharma. On information and belief, Strides Pharma is a corporation
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`organized and existing under the laws of New Jersey, having its principal place of business at
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`201 South Main Street, Suite 3, Lambertville, New Jersey 08530. On information and belief,
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`Strides Pharma is registered with the New Jersey Department of Treasury under entity
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`identification number 0400580219. On information and belief, Strides Pharma maintains a
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`registered corporate agent at 201 South Main Street, Suite 3, Lambertville, New Jersey 08530.
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`On information and belief, Strides Pharma holds an active wholesale drug and medical device
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`license for the State of New Jersey under License No. 5004572.
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`12.
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`On information and belief, Onco directly or through its affiliates and
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`agents develops, formulates, manufactures, markets, imports and sells pharmaceutical products,
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`including generic drug products, which are copies of products invented and developed by
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`innovator pharmaceutical companies, throughout the United States, including in this Judicial
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`District.
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`13.
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`On information and belief, Onco has affiliations with the State of New
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`Jersey that are pervasive, continuous, and systematic. On information and belief, Onco engages
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`in direct marketing, distribution, and/or sale of generic pharmaceutical drugs within the State of
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`New Jersey and to the residents of the State of New Jersey.
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`14.
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`On information and belief, Onco regularly conducts and/or solicits
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`business, directly, or throught its parent company, Arcolab, and/or affiliate or subsidiary
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`companies, Agila, and Strides Pharma, in the State of New Jersey. On information and belief,
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`Onco engages in other persistent courses of conduct, directly, or throught its parent company,
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`4
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`Arcolab, and/or affiliate or subsidiary companies, Agila, and Strides Pharma, 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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`Onco is also subject to personal jurisdiction in the State of New Jersey
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`because, inter alia, Onco has committed, aided, abetted, contributed to, and/or participated in the
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`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. In its May 5, 2015 Paragraph IV Notice Letter, Onco
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`states that it intends to engage in the commercial manufacture, use, and/or sale of Onco’s
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`Proposed ANDA Product before the expiration of U.S Patent No. 8,927,592 (the “’592 patent,”
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`copy attached as Exhibit A) throughout the United States, including in this Judicial District.
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`16.
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`In the alternative, Onco is subject to jurisdiction in the United States under
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`the principles of general jurisdiction, and specially in the State of New Jersey pursuant to Fed. R.
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`Civ. P. 4(k)(2). Onco has contacts with the United States by, inter alia, its having filed an
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`ANDA with the FDA.
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`17.
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`On information and belief, upon approval of the Onco ANDA, Onco
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`and/or its affiliates, agents or subisdiaries will market, sell and/or distribute Onco’s Proposed
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`ANDA Product throughout the United States, including in this Judicial District, and will derive
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`substantial revenue therefrom.
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`18.
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`On information and belief, upon approval of the Onco ANDA, Onco
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`and/or its affiliates, agents or subsidiaries will place Onco’s Proposed ANDA Product into the
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`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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`5
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`19.
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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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`JEVTANA®
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`20.
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`Sanofi U.S. holds approved NDA No. 201023 for cabazitaxel injection, 60
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`mg/ 1.5 mL (40 mg/mL), which is prescribed and sold in the United States under the trademark
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`JEVTANA® KIT (hereinafter “JEVTANA®”). The FDA approved NDA No. 201023 on June
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`17, 2010. JEVTANA® is approved 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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`THE PATENT-IN-SUIT
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`21.
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`The ’592 patent is entitled “Antitumoral Use of Cabazitaxel” and was duly
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`and legally issued by the United States Patent and Trademark Office (“USPTO”) on January 6,
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`2015. The ’592 patent claims, inter alia, methods for treating or increasing the survival of
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`patients with prostate cancer, including the use of JEVTANA® in accordance with the labeling
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`approved by the FDA. The ’592 patent is listed in the FDA’s Approved Drug Products with
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`Therapeutic Equivalence Evaluations (the “Orange Book”) for JEVTANA® (NDA No. 201023).
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`22.
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`The ’592 patent is owned by Aventis.
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`CLAIMS FOR RELIEF − PATENT INFRINGEMENT
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`23.
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`On information and belief, Onco submitted the Onco ANDA to the FDA
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`seeking approval to engage in the commercial manufacture, use, offer for sale, sale, and/or
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`importation of Onco’s Proposed ANDA Product.
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`24.
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`On information and belief, the Onco ANDA seeks FDA approval of
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`Onco’s Proposed ANDA Product for use in combination with prednisone for the treatment of
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`6
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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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`25.
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`On information and belief, Onco actively participated in and/or directed
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`activities related to the submission of the Onco ANDA and the development of Onco’s Proposed
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`ANDA Product, was actively involved in preparing the ANDA, and/or intends to directly benefit
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`from and has a financial stake in the approval of the ANDA. On information and belief, upon
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`approval of the Onco ANDA, Onco will be involved in the manufacture, distribution, and/or
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`marketing of Onco’s Proposed ANDA Product.
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`26.
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`By letter dated May 5, 2015 (the “May 5 Letter”), and pursuant to 21
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`U.S.C. § 355(j)(2)(B)(ii) and 21 C.F.R. §314.95, Onco notified Plaintiffs that it had amended the
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`Onco ANDA to indicate that Onco seeks approval to engage in the commercial manufacture, use,
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`or sale of Onco’s Proposed ANDA Product before the expiration of the ’592 patent. The May 5
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`Letter was received by Plaintiffs on May 6, 2015.
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`27.
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`In its May 5 Letter, Onco notified Plaintiffs, as part of the Onco ANDA,
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`that it had filed a certification of the type described in 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (a
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`“Paragraph IV Certification”) with respect to the ’592 patent. On information and belief, Onco
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`certified that, the ’592 patent is invalid, unenforceable and/or will not be infringed by the
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`manufacture, use or sale of Onco’s Proposed ANDA Product.
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`28.
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`The Onco ANDA refers to and relies upon Sanofi U.S.’s NDA No.
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`201023 for JEVTANA®.
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`COUNT I
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`INFRINGEMENT OF U.S. PATENT NO. 8,927,592
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`29.
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`Plaintiffs repeat and reallege paragraphs 1 through 28 above as if fully set
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`forth herein.
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`30.
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`By submitting the Onco 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 Onco’s Proposed
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`ANDA Product throughout the United States prior to the expiration of the ’592 patent, Onco
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`committed an act of infringement of the ’592 patent under 35 U.S.C. § 271(e)(2). On
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`information and belief, Onco was aware of the ’592 patent at the time the Onco ANDA was
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`submitted.
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`31.
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`If Onco commercially makes, uses, offers to sell, or sells Onco’s Proposed
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`ANDA Product within the United States, or imports Onco’s Proposed ANDA Product into the
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`United States, or induces or contributes to any such conduct during the term of the ’592 patent, it
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`would further infringe the ’592 patent under 35 U.S.C. §§ 271(a), (b), and/or (c).
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`32.
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`Plaintiffs will be irreparably harmed if Onco is not enjoined from
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`infringing the ’592 patent. Plaintiffs do not have an adequate remedy at law.
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`33.
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`Onco’s certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) against the
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`’592 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 Onco Therapies Limited has infringed one or more claims
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`of the ’592 patent by filing ANDA No. 207381 relating to Onco’s Proposed ANDA Product
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`before the expiration of the ’592 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 Onco’s Proposed ANDA Product will infringe the ’592 patent;
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`C.
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`D.
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`A judgment declaring that the ’592 patent remains valid and enforceable;
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`A permanent injunction restraining and enjoining Onco Therapies
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`Limited, and its officers, agents, attorneys and employees, and those acting in privity or concert
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`with them, from engaging in the commercial manufacture, use, offer for sale, or sale within the
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`United States, or importation into the United States, of Onco’s Proposed ANDA Product until the
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`expiration of the ’592 patent or any later date of exclusivity to which Plaintiffs and/or the ’592
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`patent are or become entitled;
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`E.
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`An order that the effective date of any approval of Onco Therapies
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`Limited’s ANDA No. 207381 relating to Onco’s Proposed ANDA Product under Section 505(j)
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`of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j)) shall be a date that is not
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`earlier than the expiration date of the ’592 patent or any later date of exclusivity to which
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`Plaintiffs and/or the ’592 patent are or become entitled;
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`F.
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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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`G.
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`Such other and further relief as the Court may deem just and proper.
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`9
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`Dated: May 15, 2015
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`Respectfully submitted,
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`By: s/Liza M. Walsh
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`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
`
`
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`10
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`Case 3:15-cv-03392-MAS-LHG Document 1 Filed 05/15/15 Page 11 of 13 PageID: 11
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`RULE 11.2 CERTIFICATION
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`I, Liza M. Walsh, admitted to the bars of the State of New Jersey and this Court, and a
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`Partner in the law firm of Connell Foley LLP representing Plaintiffs Sanofi-Aventis U.S. LLC,
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`Aventis Pharma S.A., and Sanofi in the above-captioned matter, hereby certify pursuant to L.
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`Civ. R. 11.2 that the matter in controversy in this action is related to the following actions that
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`are pending in the United States District Court for the District of New Jersey: Sanofi-Aventis
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`U.S. LLC et al. v. Fresenius Kabi USA, LLC, C. A. No. 14-7869 (MAS)(LHG); Sanofi-Aventis
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`U.S. LLC et al. v. Accord Healthcare, Inc., C. A. No. 14-8079 (MAS)(LHG); Sanofi-Aventis U.S.
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`LLC et al. v. BPI Labs, LLC et al., C. A. No. 14-8081 (MAS)(LHG); Sanofi-Aventis U.S. LLC et
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`al. v. Fresenius Kabi USA, LLC, C. A. No. 14-8082 (MAS)(LHG); Sanofi-Aventis U.S. LLC et
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`al. v. Apotex Corp. et al., C. A. No. 15-0287 (MAS)(LHG); Sanofi-Aventis U.S. LLC et al. v.
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`Breckenridge Pharmaceutical, Inc., C. A. No. 15-0289 (MAS)(LHG); Sanofi-Aventis U.S. LLC
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`et al. v. Onco Therapies Limited, C. A. No. 15-0290 (MAS)(LHG); Sanofi-Aventis U.S. LLC et
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`al. v. Actavis LLC et al., C. A. No. 15-0776 (MAS)(LHG); Sanofi-Aventis U.S. LLC et al. v.
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`Apotex Corp. et al., C. A. No. 15-1835 (MAS)(LHG); Sanofi-Aventis U.S. LLC et al. v.
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`Breckenridge Pharmaceutical, Inc., C. A. No. 15-1836 (MAS)(LHG); Sanofi-Aventis U.S. LLC
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`et al. v. Accord Healthcare, Inc., C. A. No. 15-02520 (MAS)(LHG); Sanofi-Aventis U.S. LLC et
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`al. v. BPI Labs, LLC et al., C. A. No. 15-02521 (MAS)(LHG); Sanofi-Aventis U.S. LLC et al. v.
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`Dr. Reddy Laboratories, Inc. et al., C. A. No. 15-02522 (MAS)(LHG); Sanofi-Aventis U.S. LLC
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`et al. v. Glenmark Generics Inc. et al., C. A. No. 15-02523 (MAS)(LHG); Sanofi-Aventis U.S.
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`LLC et al. v. Fresenius Kabi USA, LLC, C. A. No. 15-02631 (MAS)(LHG); and Sanofi-Aventis
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`U.S. LLC et al. v. Actavis LLC et al., C. A. No. 15-3107 (MAS)(LHG).
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` certify under penalty of perjury that the foregoing is true and correct.
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`Dated: May 15, 2015
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`CONNELL FOLEY LLP
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`By: s/Liza M. Walsh
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`
`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
`
`
`
`
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`12
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`Case 3:15-cv-03392-MAS-LHG Document 1 Filed 05/15/15 Page 13 of 13 PageID: 13
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`RULE 201.1 CERTIFICATION
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`We hereby certify that the above-captioned matter is not subject to compulsory
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`arbitration in that the plaintiffs seek, inter alia, injunctive relief.
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`May 15, 2015
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`CONNELL FOLEY LLP
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`s/Liza M. Walsh
`By:
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`
`
`Liza M. Walsh
`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
`Jason A. Leonard
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`(212) 218-2100
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`13
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`FCHS_WS 11361091v1.doc
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