Case 3:15-cv-00289-MAS-LHG Document 1 Filed 01/14/15 Page 1 of 49 PageID: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`
`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
`
`
`
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and
`SANOFI
`
`
`
`C.A. No.: _____________________
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`
`
`Electronically Filed
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`
`
`
`
`
`
`Plaintiffs,
`
`v.
`
`Defendant.
`
`
`
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`
`
`
`
`
`
`
`
`BRECKENRIDGE PHARMACEUTICAL,
`INC.
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiffs Sanofi-Aventis U.S. LLC (hereinafter “Sanofi U.S.”), Aventis Pharma S.A.
`
`(hereinafter “Aventis”) and Sanofi (collectively, “Plaintiffs”) for their Complaint against
`
`defendant Breckenridge Pharmaceutical, Inc. (hereinafter “Breckenridge” or “Defendant”),
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`AVENTIS EXHIBIT 2048
`Mylan v. Aventis
`IPR2016-00627
`
`

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`Case 3:15-cv-00289-MAS-LHG Document 1 Filed 01/14/15 Page 2 of 49 PageID: 2
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`hereby allege as follows:
`
`THE PARTIES
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`1.
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`Plaintiff Sanofi U.S. is a U.S. subsidiary of Sanofi and is a company
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`organized and existing under the laws of the State of Delaware, having commercial headquarters
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`at 55 Corporate Drive, Bridgewater, New Jersey 08807.
`
`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.
`
`On information and belief, Breckenridge is a corporation organized and
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`existing under the laws of Florida, having its principal place of business at 6111 Broken Sound
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`Parkway, NW, Suite 170, Boca Raton, Florida 33487.
`
`6.
`
`On information and belief, Breckenridge assembled and caused to be filed
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`with the United States Food and Drug Administration (“FDA”), pursuant to 21 U.S.C. § 355(j)
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`(Section 505(j) of the Federal Food, Drug and Cosmetic Act), Abbreviated New Drug
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`Application (“ANDA”) No. 207619 (hereinafter “the Breckenridge ANDA”) concerning a
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`proposed drug product, cabazitaxel solution, IV, 60 mg/1.5 mL (40 mg/mL) (“Breckenridge’s
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`Proposed ANDA Product”).
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`
`
`2
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`

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`Case 3:15-cv-00289-MAS-LHG Document 1 Filed 01/14/15 Page 3 of 49 PageID: 3
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`JURISDICTION AND VENUE
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`7.
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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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`8.
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`This Court has personal jurisdiction over Breckenridge. On information
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`and belief, Breckenridge maintains a sales office at 1 Passaic Avenue, Fairfield, New Jersey
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`07004. On information and belief, Breckenridge’s New Jersey office is registered as a domestic
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`business entity with the New Jersey Department of Treasury under the business entity
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`identification number 0100189565 under entity name Breckenridge Inc. On information and
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`belief, Breckenridge Inc. maintains a corporate agent for service of process at 600 College Road
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`East, Princeton, New Jersey 08540. On information and belief, Breckenridge Inc. conducts
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`business in New Jersey under the alternate name Breckenridge Pharmaceutical Inc. On
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`information and belief, Breckenridge Pharmaceutical Inc. is registered as a foreign business
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`entity with the New Jersey Department of Treasury under the business entity identification
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`number 0100973602. On information and belief, Breckenridge Pharmaceutical Inc. maintains a
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`corporate agent for service of process at 811 Church Road #105, Cherry Hill, New Jersey 08002.
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`On information and belief, Breckenridge Inc. is an agent, affiliate or subsidiary of Breckenridge.
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`On information and belief, Breckenridge Pharmaceutical Inc. is an agent, affiliate or subsidiary
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`of Breckenridge.
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`9.
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`On
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`information and belief, Breckenridge
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`is
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`in
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`the business of
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`manufacturing and marketing “a broad range of generic prescription products in many
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`therapeutic
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`categories.”
`
`Breckenridge
`
`Home
`
`Page
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`available
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`at
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`http://www.bpirx.com/html/index.aspx?page=home. (last visited December 18, 2014). On
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`information and belief, Breckenridge “plan(s) to file more than 12 ANDA’s . . . on an annual
`3
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`

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`Case 3:15-cv-00289-MAS-LHG Document 1 Filed 01/14/15 Page 4 of 49 PageID: 4
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`basis.”
`
`Breckenridge
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`Business
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`Development
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`Page
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`available
`
`at
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`http://www.bpirx.com/html/index.aspx?p32sda=businessdevelopment&psdge87d=295&tl97abi=
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`16. (last visited December 18, 2014). On information and belief, Breckenridge conducts “sales
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`marketing and distribution to all classes of trade in all 50 states” Breckenridge Business
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`Development
`
`Page
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`available
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`at
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`http://www.bpirx.com/html/index.aspx?p32sda=businessdevelopment&psdge87d=295&tl97abi=
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`16. (last visited December 18, 2014).
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`10.
`
`On information and belief, Breckenridge directly or through its affiliates
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`and agents develops, formulates, manufactures, markets, imports and sells pharmaceutical
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`products, including generic drug products, which are copies of products invented and developed
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`by innovator pharmaceutical companies, throughout the United States, including in this Judicial
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`District. On information and belief, Breckenridge holds an active wholesale drug and medical
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`device license for the State of New Jersey under License No. 5002974.
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`11.
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`On information and belief, Breckenridge has affiliations with the State of
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`New Jersey that are pervasive, continuous, and systematic. On information and belief,
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`Breckenridge engages in direct marketing, distribution, and/or sale of generic pharmaceutical
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`drugs within the State of New Jersey and to the residents of the State of New Jersey, and
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`maintenance of corporate agents in the State of New Jersey.
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`12.
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`On information and belief, Breckenridge regularly conducts and/or solicits
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`business in the State of New Jersey, engages in other persistent courses of conduct in the State of
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`New Jersey, and/or derives substantial revenue from services or things used or consumed in the
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`State of New Jersey.
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`4
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`13.
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`On information and belief, Breckenridge has previously submitted to the
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`jurisdiction of this Court and has availed itself of the legal protections of the State of New Jersey,
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`having asserted claims
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`in
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`this
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`jurisdiction,
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`including
`
`in
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`the matter of Breckenridge
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`Pharmaceutical, Inc. v. Sonar Products, Inc., Civil Action No. 2:10-cv-03921 (WHM)(MCA)
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`(D.N.J. Aug. 2, 2010). On information and belief, Breckenridge has previously submitted to the
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`jurisdiction of this Court and has availed itself of the legal protections of the State of New Jersey,
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`having asserted counterclaims in this jurisdiction, including in the matters of Everett
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`Laboratories, Inc. v. Breckenridge Pharmaceutical, Inc., Civil Action No. 2:09-cv-00177
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`(JLL)(CCC), D.I. 28 at 1-2, 7-9 (D.N.J. Mar. 20, 2009); Everett Laboratories, Inc. v.
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`Breckenridge Pharmaceutical, Inc., Civil Action No. 2:08-cv-03156 (JLL)(CCC), D.I. 21 at 1-2,
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`7-11 (D.N.J. Aug. 1, 2008); Novartis Pharmaceuticals Corp. et al. v. Breckenridge
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`Pharmaceutical, Inc., Civil Action No. 2:06-cv-04199 (FSH), D.I. 3 at 2, 5-8 (D.N.J. Sep. 26,
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`2006); and Bradley Pharmaceuticals, Inc. v. Breckenridge Pharmaceutical, Inc., Civil Action
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`No. 2:06-cv-02442 (SDW)(MCA), D.I. 5 at 3-6 (D.N.J. Aug. 24, 2006).
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`14.
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`Breckenridge is also subject to personal jurisdiction in the State of New
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`Jersey because, inter alia, Breckenridge 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. Breckenridge sent its December 2,
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`2014 Paragraph IV Notice Letter to Sanofi U.S.’s commercial headquarters at 55 Corporate
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`Drive, Bridgewater, New Jersey 08807. Plaintiffs’s cause of action arose from Breckenridge’s
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`contact with Sanofi U.S. in Bridgewater, New Jersey. Breckenridge states that it intends to
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`engage in the commercial manufacture, use, and/or sale of Breckenridge’s Proposed ANDA
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`
`
`5
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`

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`Case 3:15-cv-00289-MAS-LHG Document 1 Filed 01/14/15 Page 6 of 49 PageID: 6
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`Product before the expiration of U.S Patent Nos. 5,847,170 (“’170 patent”) and 7,241,907 (“’907
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`patent”) throughout the United States, including in this Judicial District.
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`15.
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`On information and belief, upon approval of the Breckenridge ANDA,
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`Breckenridge and/or its affiliates or agents will market, sell and/or distribute Breckenridge’s
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`Proposed ANDA Product throughout the United States, including in this Judicial District, and
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`will derive substantial revenue therefrom.
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`16.
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`On information and belief, upon approval of the Breckenridge ANDA,
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`Breckenridge and/or its affiliates or agents will place Breckenridge’s Proposed ANDA Product
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`into the stream of commerce with the reasonable expectation or knowledge and the intent that
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`such product will ultimately be purchased and used by consumers in this Judicial District.
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`17.
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`Venue is proper in this Court at least pursuant to 28 U.S.C. §§ 1391(b),
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`(c), and/or (d), and 1400(b).
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`THE PATENTS-IN-SUIT
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`18.
`
`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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`19.
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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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`6
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`Case 3:15-cv-00289-MAS-LHG Document 1 Filed 01/14/15 Page 7 of 49 PageID: 7
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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).
`
`20.
`
`21.
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`The ’170 patent is owned by Aventis.
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`United States Patent No. 7,241,907 (the “’907 patent,” copy attached as
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`Exhibit B) is entitled “Acetone Solvate of Dimethoxy Docetaxel and its Process of Preparation”
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`and was duly and legally issued by the United States Patent and Trademark Office (“USPTO”)
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`on July 10, 2007. The ’907 patent claims, inter alia, an acetone solvate of cabazitaxel. The ’907
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`patent is listed in the FDA’s Orange Book for JEVTANA® (NDA No. 201023).
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`22.
`
`The ’907 patent is owned by Aventis.
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`CLAIMS FOR RELIEF − PATENT INFRINGEMENT
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`23.
`
`On information and belief, Breckenridge submitted the Breckenridge
`
`ANDA to the FDA seeking approval to engage in the commercial manufacture, use, offer for
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`sale, sale, and/or importation of Breckenridge’s Proposed ANDA Product.
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`24.
`
`On information and belief, the Breckenridge ANDA seeks FDA approval
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`of Breckenridge’s Proposed ANDA Product for use in combination with prednisone for the
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`treatment of patients with hormone-refractory metastatic prostate cancer previously treated with
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`a docetaxel-containing treatment regimen.
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`25.
`
`On information and belief, Breckenridge actively participated in and/or
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`directed activities related to the submission of the Breckenridge ANDA and the development of
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`Breckenridge’s Proposed ANDA Product, was actively involved in preparing the ANDA, and/or
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`intends to directly benefit from and has a financial stake in the approval of the ANDA. On
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`7
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`information and belief, upon approval of the Breckenridge ANDA, Breckenridge will be
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`involved in the manufacture, distribution, and/or marketing of Breckenridge’s Proposed ANDA
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`Product.
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`26.
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`By letter dated December 2, 2014 (the “December 2 Letter”), and pursuant
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`to 21 U.S.C. § 355(j)(2)(B)(ii) and 21 C.F.R. §314.95, Breckenridge notified Plaintiffs that it had
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`submitted to the FDA the Breckenridge ANDA, seeking approval to engage in the commercial
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`manufacture, use, or sale of Breckenridge’s Proposed ANDA Product before the expiration of
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`the ’170 patent and the ’907 patent. The December 2 Letter was received by Plaintiffs on
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`December 3, 2014.
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`27.
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`In its December 2 Letter, Breckenridge notified Plaintiffs, as part of the
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`Breckenridge ANDA, it had filed a certification of the type described in 21 U.S.C. §
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`355(j)(2)(A)(vii)(IV) (a “Paragraph IV Certification”) with respect to the ’170 patent and the
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`’907 patent. On information and belief, Breckenridge certified that, the ’170 patent and the ’907
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`patent are invalid, unenforceable and/or will not be infringed by the manufacture, use or sale of
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`Breckenridge’s Proposed ANDA Product.
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`28.
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`The Breckenridge ANDA refers to and relies upon the Sanofi U.S.’s NDA
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`No. 201023 for JEVTANA®.
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`29.
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`In the December 2 Letter, Breckenridge offered confidential access to
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`portions of the Breckenridge ANDA on terms and conditions set forth in paragraph VII of the
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`December 2 Letter (“Breckenridge Offer”). Breckenridge requested that Plaintiffs accept the
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`Breckenridge Offer before receiving access to any portion of the Breckenridge ANDA. The
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`Breckenridge Offer contained unreasonable restrictions that would apply under a protective
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`order. For example, the Breckenridge Offer required that Plaintiffs’ outside counsel do not
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`8
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`engage, formally or informally, in any patent prosecution or any FDA counseling, litigation or
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`other work before or involving the FDA on behalf of Plaintiffs.
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`30.
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`Under 21 U.S.C. § 355(j)(5)(C)(i)(III), an “offer of confidential access
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`shall contain such restrictions . . . on the use and disposition of any information accessed, as
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`would apply had a protective order been entered for the purpose of protecting trade secrets and
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`other confidential business information.”
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`31.
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`Since rejecting the Breckenridge Offer, Plaintiffs attempted to negotiate
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`with Breckenridge to obtain a copy of excerpts of the Breckenridge ANDA under restrictions “as
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`would apply had a protective order been issued.” Those negotiations were unsuccessful. For
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`example, Breckenridge’s final proposal continued to unreasonably impose patent prosecution
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`and FDA restrictions on Plaintiffs’ outside counsel.
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`32.
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`Plaintiffs are not aware of any other means of obtaining information
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`regarding Breckenridge’s Proposed ANDA Product within the 45-day statutory period. Without
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`such information, Plaintiffs will use the judicial process and the aid of discovery to obtain, under
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`appropriate judicial safeguards such information as is required to confirm its allegations of
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`infringement and to present to the Court evidence that Breckenridge’s Proposed ANDA Product
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`falls within the scope of one or more claims of the ’170 and ’907 patents.
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`COUNT I
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`INFRINGEMENT OF U.S. PATENT NO. 5,847,170
`
`33.
`
`Plaintiff repeats and realleges paragraphs 1 through 32 above as if fully set
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`forth herein.
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`34.
`
`By submitting the Breckenridge ANDA under 21 U.S.C. § 355(j) for the
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`purpose of obtaining approval to engage in the commercial manufacture, use or sale of
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`9
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`Breckenridge’s Proposed ANDA Product throughout the United States prior to the expiration of
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`the ’170 patent, Breckenridge committed an act of infringement of the ’170 patent under 35
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`U.S.C. § 271(e)(2). On information and belief, Breckenridge was aware of the ’170 patent at the
`
`time the Breckenridge ANDA was submitted.
`
`35.
`
`If Breckenridge commercially makes, uses, offers to sell, or sells
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`Breckenridge’s Proposed ANDA Product within the United States, or imports Breckenridge’s
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`Proposed ANDA Product into the United States, or induces or contributes to any such conduct
`
`during the term of the ’170 patent, it would further infringe the ’170 patent under 35 U.S.C. §§
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`271(a), (b), and/or (c).
`
`36.
`
`Plaintiffs will be irreparably harmed if Breckenridge 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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`37.
`
`Breckenridge’s certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV)
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`against the ’170 patent was wholly unjustified, and thus this case is exceptional under 35 U.S.C.
`
`§ 285.
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`forth herein.
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`COUNT II
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`INFRINGEMENT OF U.S. PATENT NO. 7,241,907
`
`38.
`
`Plaintiffs repeat and reallege paragraphs 1 through 37 above as if fully set
`
`39.
`
`By submitting the Breckenridge ANDA under 21 U.S.C. § 355(j) for the
`
`purpose of obtaining approval to engage in the commercial manufacture, use or sale of
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`Breckenridge’s Proposed ANDA Product throughout the United States prior to the expiration of
`
`the ’907 patent, Breckenridge committed an act of infringement of the ’907 patent under 35
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`10
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`Case 3:15-cv-00289-MAS-LHG Document 1 Filed 01/14/15 Page 11 of 49 PageID: 11
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`U.S.C. § 271(e)(2). On information and belief, Breckenridge was aware of the ’907 patent at the
`
`time the Breckenridge ANDA was submitted.
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`40.
`
`If Breckenridge commercially makes, uses, offers to sell, or sells
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`Breckenridge’s Proposed ANDA Product within the United States, or imports Breckenridge’s
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`Proposed ANDA Product into the United States, or induces or contributes to any such conduct
`
`during the term of the ’907 patent, it would further infringe the ’907 patent under 35 U.S.C. §§
`
`271(a), (b), and/or (c).
`
`41.
`
`Plaintiffs will be irreparably harmed if Breckenridge is not enjoined from
`
`infringing the ’907 patent. Plaintiffs do not have an adequate remedy at law.
`
`42.
`
`Breckenridge’s certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV)
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`against the ’907 patent was wholly unjustified, and thus this case is exceptional under 35 U.S.C.
`
`§ 285.
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`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiffs respectfully request the following relief:
`
`A.
`
`A judgment that Breckenridge Pharmaceutical, Inc. has infringed one or
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`more claims of the ’170 patent by filing ANDA No. 207619 relating to Breckenridge’s Proposed
`
`ANDA Product before the expiration of the ’170 patent;
`
`B.
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`A judgment that the manufacture, use, offer for sale, sale and/or
`
`importation of Breckenridge’s Proposed ANDA Product will infringe the ’170 patent;
`
`C.
`
`D.
`
`A judgment declaring that the ’170 patent remains valid and enforceable;
`
`A permanent
`
`injunction
`
`restraining and enjoining Breckenridge
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`Pharmaceutical, Inc., and its officers, agents, attorneys and employees, and those acting in
`
`privity or concert with them, from engaging in the commercial manufacture, use, offer for sale,
`
`
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`11
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`

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`or sale within the United States, or importation into the United States, of Breckenridge’s
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`Proposed ANDA Product until the expiration of the ’170 patent or any later date of exclusivity to
`
`which Plaintiffs and/or the ’170 patent are or become entitled to;
`
`E.
`
`An order that the effective date of any approval of Breckenridge’s ANDA
`
`No. 207619 relating to Breckenridge’s Proposed ANDA Product under Section 505(j) of the
`
`Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j) shall be a date that is not earlier than
`
`the expiration date of the ’170 patent or any later date of exclusivity to which Plaintiffs and/or
`
`the ’170 patent are or become entitled;
`
`F.
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`A judgment that Breckenridge Pharmaceutical, Inc. has infringed one or
`
`more claims of the ’907 patent by filing ANDA No. 207619 relating to Breckenridge’s Proposed
`
`ANDA Product before the expiration of the ’907 patent;
`
`G.
`
`A judgment that the manufacture, use, offer for sale, sale and/or
`
`importation of Breckenridge’s Proposed ANDA Product will infringe the ’907 patent;
`
`H.
`
`I.
`
`A judgment declaring that the ’907 patent remains valid and enforceable;
`
`A permanent
`
`injunction
`
`restraining and enjoining Breckenridge
`
`Pharmaceutical, Inc., and its officers, agents, attorneys and employees, and those acting in
`
`privity or concert with them, from engaging in the commercial manufacture, use, offer for sale,
`
`or sale within the United States, or importation into the United States, of Breckenridge’s
`
`Proposed ANDA Product until the expiration of the ’907 patent or any later date of exclusivity to
`
`which Plaintiffs and/or the ’907 patent are or become entitled to;
`
`J.
`
`An order that the effective date of any approval of Breckenridge’s ANDA
`
`No. 207619 relating to Breckenridge’s Proposed ANDA Product under Section 505(j) of the
`
`Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j)) shall be a date that is not earlier than
`
`
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`12
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`Case 3:15-cv-00289-MAS-LHG Document 1 Filed 01/14/15 Page 13 of 49 PageID: 13
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`the expiration date of the ’907 patent or any later date of exclusivity to which Plaintiffs and/or
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`the ’907 patent are or become entitled;
`
`K.
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`A declaration that this case is “exceptional” within the meaning of 35
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`U.S.C. § 285 and an award of reasonable attorney fees, costs, expenses, and disbursements of
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`this action; and
`
`L.
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`Such other and further relief as the Court may deem just and proper.
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`
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`13
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`Case 3:15-cv-00289-MAS-LHG Document 1 Filed 01/14/15 Page 14 of 49 PageID: 14
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`CONNELL FOLEY LLP
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`By:_s/Liza M. Walsh________
`
`
`
`
`
`Liza M. Walsh, Esq.
`CONNELL FOLEY LLP
`85 Livingston Avenue
`Roseland, New Jersey 07068-1765
`(973) 535-0500
`
`Attorneys for Plaintiffs,
`SANOFI-AVENTIS U.S. LLC, AVENTIS
`PHARMA S.A. and SANOFI
`
`Of Counsel:
`
`William E. Solander, Esq.
`Jason A. Leonard, Esq.
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`(212) 218-2100
`
`
`
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`14
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`January 14, 2015