Case 3:16-cv-02259-MAS-LHG Document 1 Filed 04/21/16 Page 1 of 43 PageID: 1
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`
`
`
`Liza M. Walsh
`Tricia B. O’Reilly
`Katelyn O’Reilly
`CONNELL FOLEY LLP
`One Newark Center
`1085 Raymond Boulevard, 19th Floor
`Newark, New Jersey 07102
`(973) 757-1100
`
`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
`
`Attorneys for Plaintiffs,
`SANOFI-AVENTIS U.S. LLC, AVENTIS PHARMA S.A. and SANOFI
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
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`
`
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and
`SANOFI
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`
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`
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`C.A. No.: _____________________
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`
`
`Plaintiffs,
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`v.
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`Defendants.
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`
`
`
`
`
`
`DR. REDDY’S LABORATORIES, INC., and
`DR. REDDY’S LABORATORIES, LTD.
`
`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 Dr. Reddy’s Laboratories, Inc., and Dr. Reddy’s Laboratories, Ltd. (collectively,
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`
`
`AVENTIS EXHIBIT 2052
`Mylan v. Aventis
`IPR2016-00627
`
`

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`Case 3:16-cv-02259-MAS-LHG Document 1 Filed 04/21/16 Page 2 of 43 PageID: 2
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`“DRL” or “Defendants”), hereby allege as 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, defendant Dr. Reddy’s Laboratories, Inc. is a
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`corporation organized and existing under the laws of the State of New Jersey, having its principal
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`place of business at 107 College Road East, Princeton, New Jersey 08540.
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`6.
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`On information and belief, defendant Dr. Reddy’s Laboratories, Ltd. is a
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`company organized and existing under the laws of India, having its principal place of business at
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`8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, India.
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`7.
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`On information and belief, defendant Dr. Reddy’s Laboratories, Inc. is a
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`subsidiary of Dr. Reddy’s Laboratories, Ltd.
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`8.
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`On information and belief, defendant Dr. Reddy’s Laboratories, Inc., as
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`United States agent for Dr. Reddy’s Laboratories, Ltd., assembled and caused to be filed with the
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`
`2
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`

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`Case 3:16-cv-02259-MAS-LHG Document 1 Filed 04/21/16 Page 3 of 43 PageID: 3
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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. 207718 (hereinafter “the DRL ANDA”) concerning a proposed drug product,
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`cabazitaxel injection, 60 mg/1.5 mL (40 mg/mL), for intravenous infusion (“DRL’s Proposed
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`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 Dr. Reddy’s Laboratories, Inc.
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`On information and belief, Dr. Reddy’s Laboratories, Inc. is a corporation organized and existing
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`under the laws of the State of New Jersey, having its principal place of business at 107 College
`
`Road East, Princeton, New Jersey 08540. On information and belief, Dr. Reddy’s Laboratories,
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`Inc. is registered as a domestic business entity with the New Jersey Department of Treasury
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`under the business entity identification number 0100518911. On information and belief, Dr.
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`Reddy’s Laboratories, Inc. conducts business in the State of New Jersey under the alternate name
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`Reddy-Cheminor, Inc. On information and belief, Reddy-Cheminor, Inc. is also registered as a
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`domestic business entity with the New Jersey Department of Treasury under the business entity
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`identification number 0100518911. On information and belief, Reddy-Cheminor, Inc. is
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`registered to conduct business activity of distributing generic pharmaceuticals. On information
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`and belief, Reddy-Cheminor, Inc. maintains a corporate agent for service of process at 66 South
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`Maole Avenue, Ridgewood, New Jersey 07450. On information and belief, Reddy-Cheminor,
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`Inc. is an agent, affiliate or subsidiary of Dr. Reddy’s Laboratories, Inc.
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`3
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`11.
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`On information and belief, Dr. Reddy’s Laboratories, Inc. directly or
`
`through its affiliates and agents develops, formulates, manufactures, markets, imports and sells
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`pharmaceutical products, including generic drug products, which are copies of products invented
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`and developed by innovator pharmaceutical companies, throughout the United States, including
`
`in this Judicial District. On information and belief, Dr. Reddy’s Laboratories, Inc. holds an
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`active wholesale drug and medical device license for the State of New Jersey under License No.
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`5002312.
`
`12.
`
`On information and belief, Dr. Reddy’s Laboratories, Inc. has affiliations
`
`with the State of New Jersey that are pervasive, continuous, and systematic. On information and
`
`belief, Dr. Reddy’s Laboratories, Inc. engages in direct marketing, distribution, and/or sale of
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`generic pharmaceutical drugs within the State of New Jersey and to the residents of the State of
`
`New Jersey, and maintenance of corporate agents in the State of New Jersey.
`
`13.
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`On information and belief, Dr. Reddy’s Laboratories, Inc. regularly
`
`conducts and/or solicits business in the State of New Jersey, engages in other persistent courses
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`of conduct in the State of New Jersey, and/or derives substantial revenue from services or things
`
`used or consumed in the State of New Jersey.
`
`14.
`
`On information and belief, Dr. Reddy’s Laboratories, Inc. has previously
`
`submitted to the jurisdiction of this Court and has availed itself of the legal protections of the
`
`State of New Jersey, having asserted claims in this jurisdiction, including in the matter of Dr.
`
`Reddy’s Laboratories, Inc. et al. v. Purdue Pharmaceutical Products L.P. et al., Civil Action No.
`
`14-3230 (JLL)(JAD) (D.N.J. May 20, 2014). On information and belief, Dr. Reddy’s
`
`Laboratories, Inc. has previously submitted to the jurisdiction of this Court and has availed itself
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`of the legal protections of the State of New Jersey, having asserted counterclaims in this
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`
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`4
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`

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`Case 3:16-cv-02259-MAS-LHG Document 1 Filed 04/21/16 Page 5 of 43 PageID: 5
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`
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`jurisdiction, including in the related matter of Sanofi-Aventis U.S. LLC et al. v. Dr. Reddy’s
`
`Laboratories, Inc. et al., Civil Action No. 15-2522 (MAS)(LHG), D.I. 15 at 4-8, 15-20 (D.N.J.
`
`Jun. 26, 2015), and in the matters of Sucampo AG et al. v. Dr. Reddy’s Laboratories, Inc. et al.,
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`Civil Action No. 14-7144 (MAS)(DEA), D. I. 16 at 2-3, 18-25 (D.N.J. Jan. 26, 2015); Helsinn
`
`Healthcare S.A. et al. v. Dr. Reddy’s Laboratories, Inc. et al., Civil Action No. 14-4274
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`(MLC)(DEA), D.I. 13 at 3, 8-12 (D.N.J. Sep. 5, 2014); Amarin Pharma, Inc. et al. v. Dr. Reddy’s
`
`Laboratories, Inc. et al., Civil Action No. 14-2760 (MLC)(DEA), D.I. 27 at 3, 34-48 (D.N.J. Jul.
`
`31, 2014); Genzyme Corp. et al. v. Dr. Reddy’s Laboratories, Inc. et al., Civil Action No. 13-
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`6827 (JEI)(KMW), D.I. 17 at 6, 16-21 (D.N.J. Jan. 21, 2014).
`
`15. Dr. Reddy’s Laboratories, Inc. is also subject to personal jurisdiction in the
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`State of New Jersey because, inter alia, it 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. Dr. Reddy’s Laboratories, Inc. sent
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`its March 10, 2016 Paragraph IV Notice Letter to Sanofi U.S.’s commercial headquarters at 55
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`Corporate Drive, Bridgewater, New Jersey 08807. Plaintiffs’ cause of action arose from Dr.
`
`Reddy’s Laboratories, Inc.’s contact with Sanofi U.S. in Bridgewater, New Jersey. Dr. Reddy’s
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`Laboratories, Inc. states that it intends to engage in the commercial manufacture, use, and/or sale
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`of DRL’s Proposed ANDA Product before the expiration of U.S Patent No. 5,847,170
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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 DRL ANDA, Dr. Reddy’s
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`Laboratories, Inc. and/or its subsidiaries, affiliates or agents will market, sell and/or distribute
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`
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`5
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`DRL’s Proposed ANDA Product throughout the United States, including in this Judicial District,
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`and will derive substantial revenue therefrom.
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`17.
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`On information and belief, upon approval of the DRL ANDA, Dr. Reddy’s
`
`Laboratories, Inc. and/or its subsidiaries, affiliates or agents will place DRL’s Proposed ANDA
`
`Product into the stream of commerce with the reasonable expectation or knowledge and the
`
`intent that such product will ultimately be purchased and used by consumers in this Judicial
`
`District.
`
`18.
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`This Court has personal jurisdiction over Dr. Reddy’s Laboratories, Ltd.
`
`On information and belief, Dr. Reddy’s Laboratories, Ltd. directly or through its affiliates and
`
`agents develops, formulates, manufactures, markets, imports and sells pharmaceutical products,
`
`including generic drug products, which are copies of products invented and developed by
`
`innovator pharmaceutical companies, throughout the United States, including in this Judicial
`
`District. On information and belief, Dr. Reddy’s Laboratories, Ltd. is in the business of
`
`manufacturing, marketing, importing and selling pharmaceutical drug products, including
`
`generic drug products.
`
`19.
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`On information and belief, Dr. Reddy’s Laboratories, Ltd. has affiliations
`
`with the State of New Jersey that are pervasive, continuous, and systematic. On information and
`
`belief, Dr. Reddy’s Laboratories, Ltd. engages in direct marketing, distribution, and/or sale of
`
`generic pharmaceutical drugs within the State of New Jersey and to the residents of the State of
`
`New Jersey, and maintenance of corporate agents in the State of New Jersey.
`
`20.
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`On information and belief, Dr. Reddy’s Laboratories, Ltd. regularly
`
`conducts and/or solicits business in the State of New Jersey, engages in other persistent courses
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`6
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`of conduct in the State of New Jersey, and/or derives substantial revenue from services or things
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`used or consumed in the State of New Jersey.
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`21.
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`On information and belief, Dr. Reddy’s Laboratories, Ltd. has previously
`
`submitted to the jurisdiction of this Court and has availed itself of the legal protections of the
`
`State of New Jersey, having asserted claims in this jurisdiction, including in the matter of Dr.
`
`Reddy’s Laboratories, Inc. et al. v. Purdue Pharmaceutical Products L.P. et al., Civil Action No.
`
`14-3230 (JLL)(JAD) (D.N.J. May 20, 2014). On information and belief, Dr. Reddy’s
`
`Laboratories, Ltd. has previously submitted to the jurisdiction of this Court and has availed itself
`
`of the legal protections of the State of New Jersey, having asserted counterclaims in this
`
`jurisdiction, including in the related matter of Sanofi-Aventis U.S. LLC et al. v. Dr. Reddy’s
`
`Laboratories, Inc. et al., Civil Action No. 15-2522 (MAS)(LHG), D.I. 15 at 4-8, 15-20 (D.N.J.
`
`Jun. 26, 2015), and in the matters of Sucampo AG et al. v. Dr. Reddy’s Laboratories, Inc. et al.,
`
`Civil Action No. 14-7144 (MAS)(DEA), D. I. 16 at 2-3, 18-25 (D.N.J. Jan. 26, 2015); Helsinn
`
`Healthcare S.A. et al. v. Dr. Reddy’s Laboratories, Inc. et al., Civil Action No. 14-4274
`
`(MLC)(DEA), D.I. 13 at 3, 8-12 (D.N.J. Sep. 5, 2014); Amarin Pharma, Inc. et al. v. Dr. Reddy’s
`
`Laboratories, Inc. et al., Civil Action No. 14-2760 (MLC)(DEA), D.I. 27 at 3, 34-48 (D.N.J. Jul.
`
`31, 2014); Genzyme Corp. et al. v. Dr. Reddy’s Laboratories, Inc. et al., Civil Action No. 13-
`
`6827 (JEI)(KMW), D.I. 17 at 6, 16-21 (D.N.J. Jan. 21, 2014).
`
`22.
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`In the alternative, Dr. Reddy’s Laboratories, Ltd. is subject to jurisdiction
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`in the United States under the principles of general jurisdiction, and specially in the State of New
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`Jersey pursuant to Fed. R. Civ. P. 4(k)(2). Dr. Reddy’s Laboratories, Ltd. has contacts with the
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`United States by, inter alia, its having filed an ANDA with the FDA.
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`7
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`23.
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`On information and belief, upon approval of the DRL ANDA, Dr. Reddy’s
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`Laboratories, Ltd. and/or its subsidiaries, affiliates or agents will market, sell and/or distribute
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`DRL’s Proposed ANDA Product throughout the United States, including in this Judicial District,
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`and will derive substantial revenue therefrom.
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`24.
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`On information and belief, upon approval of the DRL ANDA, Dr. Reddy’s
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`Laboratories, Ltd. and/or its subsidiaries, affiliates or agents will place DRL’s Proposed ANDA
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`Product into the stream of commerce with the reasonable expectation or knowledge and the
`
`intent that such product will ultimately be purchased and used by consumers in this Judicial
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`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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`JEVTANA®
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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 FDA approved
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`NDA No. 201023 on June 17, 2010. JEVTANA® is approved for use in combination with
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`prednisone for the treatment of patients with hormone-refractory metastatic prostate cancer
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`previously treated with a docetaxel-containing treatment regimen.
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`THE PATENT-IN-SUIT
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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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`8
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`Case 3:16-cv-02259-MAS-LHG Document 1 Filed 04/21/16 Page 9 of 43 PageID: 9
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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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`CLAIMS FOR RELIEF  PATENT INFRINGEMENT
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`29.
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`On information and belief, Dr. Reddy’s Laboratories, Inc. submitted the
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`DRL ANDA to the FDA seeking approval to engage in the commercial manufacture, use, offer
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`for sale, sale, and/or importation of DRL’s Proposed ANDA Product.
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`30.
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`On information and belief, the DRL ANDA seeks FDA approval of DRL’s
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`Proposed ANDA Product for use in combination with prednisone for the treatment of patients
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`with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-
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`containing treatment regimen.
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`31.
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`On information and belief, Dr. Reddy’s Laboratories, Inc. actively
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`collaborated with Dr. Reddy’s Laboratories, Ltd. and/or participated in and/or directed activities
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`related to the submission of the DRL ANDA and the development of DRL’s Proposed ANDA
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`Product, was actively involved in preparing the ANDA, and/or intends to directly benefit from
`
`and has a financial stake in the approval of the ANDA. On information and belief, upon
`
`approval of the DRL ANDA, Dr. Reddy’s Laboratories, Inc. will be involved in the manufacture,
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`distribution, and/or marketing of DRL’s Proposed ANDA Product.
`
`32.
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`On information and belief, Dr. Reddy’s Laboratories, Ltd. actively
`
`collaborated with Dr. Reddy’s Laboratories, Inc. and/or participated in and/or directed activities
`
`related to the submission of the DRL ANDA and the development of DRL’s Proposed ANDA
`
`Product, was actively involved in preparing the ANDA, and/or intends to directly benefit from
`
`
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`9
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`Case 3:16-cv-02259-MAS-LHG Document 1 Filed 04/21/16 Page 10 of 43 PageID: 10
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`and has a financial stake in the approval of the ANDA. On information and belief, upon
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`approval of the DRL ANDA, Dr. Reddy’s Laboratories, Ltd. will be involved in the
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`manufacture, distribution, and/or marketing of DRL’s Proposed ANDA Product.
`
`33.
`
`By letter dated March 10, 2016 (the “March 10, 2016 Notice Letter”), and
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`pursuant to 21 U.S.C. § 355(j)(2)(B)(ii) and 21 C.F.R. §314.95, Dr. Reddy’s Laboratories, Inc.
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`notified Plaintiffs that it had submitted to the FDA the DRL ANDA, seeking approval to engage
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`in the commercial manufacture, use, or sale of DRL’s Proposed ANDA Product before the
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`expiration of the ’170 patent. The March 10, 2016 Notice Letter was received by Plaintiff
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`Aventis Pharma S.A. on March 16, 2016.
`
`34.
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`In its March 10, 2016 Notice Letter, Dr. Reddy’s Laboratories, Inc.
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`notified Plaintiffs that it had filed a certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (a
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`“Paragraph IV Certification”) with respect to the ’170 patent in support of the DRL ANDA. On
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`information and belief, Dr. Reddy’s Laboratories, Inc. certified that the ’170 patent is invalid,
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`unenforceable and/or will not be infringed by the manufacture, use or sale of DRL’s Proposed
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`ANDA Product.
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`35.
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`The DRL ANDA refers to and relies upon Sanofi U.S.’s NDA No. 201023
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`for JEVTANA®.
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`COUNT I
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`INFRINGEMENT OF U.S. PATENT NO. 5,847,170
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`36.
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`Plaintiffs repeat and reallege 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 DRL ANDA under 21 U.S.C. § 355(j) for the purpose
`
`of obtaining approval to engage in the commercial manufacture, use or sale of DRL’s Proposed
`
`
`
`10
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`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).
`
`38.
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`If Defendants commercially make, use, offer to sell, or sell DRL’s
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`Proposed ANDA Product within the United States, or import DRL’s Proposed ANDA Product
`
`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).
`
`39.
`
`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.
`
`40.
`
`Dr. Reddy’s Laboratories, Inc.’s certification under 21 U.S.C. §
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`355(j)(2)(A)(vii)(IV) against the ’170 patent was wholly unjustified, and thus this case is
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`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:
`
`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. 207718 relating to DRL’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
`
`importation of DRL’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 DRL’s Proposed ANDA Product until the expiration of the
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`11
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`Case 3:16-cv-02259-MAS-LHG Document 1 Filed 04/21/16 Page 12 of 43 PageID: 12
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`’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 DRL’s ANDA No.
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`207718 relating to DRL’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
`
`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
`
`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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`
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`12
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`Case 3:16-cv-02259-MAS-LHG Document 1 Filed 04/21/16 Page 13 of 43 PageID: 13
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`
`CONNELL FOLEY LLP
`
`
`
`By: s/Liza M. Walsh
`
`
`
`
`
`
`Liza M. Walsh
`Tricia B. O’Reilly
`Katelyn O’Reilly
`CONNELL FOLEY LLP
`One Newark Center
`1085 Raymond Boulevard, 19th Floor
`Newark, New Jersey 07102
`(973) 757-1100
`
`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
`
`
`
`
`
`13
`
`
`
`Dated: April 21, 2016