Case 3:15-cv-00290-MAS-LHG Document 1 Filed 01/14/15 Page 1 of 48 PageID: 1
`
`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.: _____________________
`
`Electronically Filed
`
`
`
`
`
`
`
`
`
`Plaintiffs,
`
`v.
`
`Defendant.
`
`
`
`
`
`
`
`
`
`
`
`
`ONCO THERAPIES LIMITED
`
`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 Onco Therapies Limited (hereinafter “Onco” or “Defendant”), hereby allege as
`
`follows:
`
`MYLAN - EXHIBIT 1023
`
`

`
`Case 3:15-cv-00290-MAS-LHG Document 1 Filed 01/14/15 Page 2 of 48 PageID: 2
`
`THE PARTIES
`
`1.
`
`Plaintiff Sanofi U.S. is a U.S. subsidiary of Sanofi and is a company
`
`organized and existing under the laws of the State of Delaware, having commercial headquarters
`
`at 55 Corporate Drive, Bridgewater, New Jersey 08807.
`
`2.
`
`Plaintiff Aventis is a corporation organized and existing under the laws of
`
`France, having its principal place of business at 20 avenue Raymond Aron, 92160 Antony,
`
`France.
`
`3.
`
`Plaintiff Sanofi is a corporation organized and existing under the laws of
`
`France, having its principal place of business at 54 rue La Boétie, 75008 Paris, France.
`
`4.
`
`Plaintiff Sanofi is a global research-driven pharmaceutical company that
`
`discovers, develops, manufactures and markets a broad range of innovative products to improve
`
`human and animal health.
`
`5.
`
`On information and belief, Onco is a corporation organized and existing
`
`under the laws of India, having its principal place of business at Strides House, Bilekahalli,
`
`Bannerghatta Road, Bangalore, Karnataka 560076, India.
`
`6.
`
`On information and belief, Onco is a wholly-owned subsidiary of Strides
`
`Arcolab Limited (hereinafter “Arcolab”). On information and belief, Arcolab is a corporation
`
`organized and existing under the laws of India, having its principal place of business at Strides
`
`House, Bilekahalli, Bannerghatta Road, Bangalore, Karnataka 560076, India.
`
`7.
`
`On information and belief, Onco conducts business through and with
`
`Agila Specialties Inc. (hereinafter “Agila”), formerly known as Strides, Inc. On information and
`
`belief, Agila is a corporation organized and existing under the laws of New Jersey, having its
`
`principal place of business at 201 South Main Street, Suite 3, Lambertville, New Jersey 08530.
`
`On information and belief, Agila is an agent or affiliate of Onco.
`2
`
`
`
`

`
`Case 3:15-cv-00290-MAS-LHG Document 1 Filed 01/14/15 Page 3 of 48 PageID: 3
`
`8.
`
`On information and belief, Onco conducts business through and with
`
`Strides Pharma Inc. (hereinafter “Strides Pharma”). On information and belief, Strides Pharma is
`
`a corporation organized and existing under the laws of New Jersey, having its principal place of
`
`business at 201 South Main Street, Suite 3, Lambertville, New Jersey 08530. On information
`
`and belief, Strides Pharma is a wholly-owned subsidiary of Arcolab. On information and belief,
`
`Strides Pharma is an agent or affiliate of Onco.
`
`9.
`
`On information and belief, Onco assembled and caused to be filed with the
`
`United States Food and Drug Administration (“FDA”), pursuant to 21 U.S.C. § 355(j) (Section
`
`505(j) of the Federal Food, Drug and Cosmetic Act), Abbreviated New Drug Application
`
`(“ANDA”) No. 207381 (hereinafter “the Onco ANDA”) concerning a proposed drug product,
`
`cabazitaxel injection [60 mg/1.5 mL] [40 mg/mL] (“Onco’s Proposed ANDA Product”).
`
`JURISDICTION AND VENUE
`
`10.
`
`This action arises under the patent laws of the United States of America.
`
`This Court has jurisdiction over the subject matter of this action under 28 U.S.C. §§ 1331 and
`
`1338(a).
`
`11.
`
`This Court has personal jurisdiction over Onco. On information and
`
`belief, Onco conducts business through and with Agila. On information and belief, Agila is a
`
`corporation organized and existing under the laws of New Jersey, having its principal place of
`
`business at 201 South Main Street, Suite 3, Lambertville, New Jersey 08530. On information
`
`and belief, Agila is registered with the New Jersey Department of Treasury under entity
`
`identification number 0100791546. On information and belief, Agila maintains a registered
`
`corporate agent at 37 Veronica Avenue, Somerset, New Jersey 08873. On information and
`
`belief, Agila is an agent or affiliate of Onco. On information and belief, Onco conducts business
`
`
`
`3
`
`

`
`Case 3:15-cv-00290-MAS-LHG Document 1 Filed 01/14/15 Page 4 of 48 PageID: 4
`
`through and with Strides Pharma. On information and belief, Strides Pharma is a corporation
`
`organized and existing under the laws of New Jersey, having its principal place of business at
`
`201 South Main Street, Suite 3, Lambertville, New Jersey 08530. On information and belief,
`
`Strides Pharma is registered with the New Jersey Department of Treasury under entity
`
`identification number 0400580219. On information and belief, Strides Pharma maintains a
`
`registered corporate agent at 201 South Main Street, Suite 3, Lambertville, New Jersey 08530.
`
`On information and belief, Strides Pharma holds an active wholesale drug and medical device
`
`license for the State of New Jersey under License No. 5004572.
`
`12.
`
`On information and belief, Onco 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.
`
`13.
`
`On information and belief, Onco has affiliations with the State of New
`
`Jersey that are pervasive, continuous, and systematic. On information and belief, Onco 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.
`
`14.
`
`On information and belief, Onco regularly conducts and/or solicits
`
`business, directly, or through its parent company, Arcolab, and/or affiliate or subsidiary
`
`companies, Agila, and Strides Pharma, in the State of New Jersey. On information and belief,
`
`Onco engages in other persistent courses of conduct, directly, or throught its parent company,
`
`Arcolab, and/or affiliate or subsidiary companies, Agila, and Strides Pharma, in the State of New
`
`
`
`4
`
`

`
`Case 3:15-cv-00290-MAS-LHG Document 1 Filed 01/14/15 Page 5 of 48 PageID: 5
`
`Jersey, and/or derives substantial revenue from services or things used or consumed in the State
`
`of New Jersey.
`
`15.
`
`Onco is also subject to personal jurisdiction in the State of New Jersey
`
`because, inter alia, Onco has committed, aided, abetted, contributed to, and/or participated in the
`
`commission of a tortious act of patent infringement under 35 U.S.C. § 271(e)(2) that has led
`
`and/or will lead to foreseeable harm and injury to Plaintiff Sanofi U.S., having commercial
`
`headquarters in the State of New Jersey. In its December 4, 2014 Paragraph IV Notice Letter,
`
`Onco states that it intends to engage in the commercial manufacture, use, and/or sale of Onco’s
`
`Proposed ANDA Product before the expiration of U.S Patent Nos. 5,847,170 (“’170 patent”) and
`
`7,241,907 (“’907 patent”) throughout the United States, including in this Judicial District.
`
`16.
`
`In the alternative, Onco is subject to jurisdiction in the United States under
`
`the principles of general jurisdiction, and specially in the State of New Jersey pursuant to Fed. R.
`
`Civ. P. 4(k)(2). Onco has contacts with the United States by, inter alia, its having filed an
`
`ANDA with the FDA.
`
`17.
`
`On information and belief, upon approval of the Onco ANDA, Onco
`
`and/or its affiliates, agents or subisdiaries will market, sell and/or distribute Onco’s Proposed
`
`ANDA Product throughout the United States, including in this Judicial District, and will derive
`
`substantial revenue therefrom.
`
`18.
`
`On information and belief, upon approval of the Onco ANDA, Onco
`
`and/or its affiliates, agents or subsidiaries will place Onco’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.
`
`
`
`5
`
`

`
`Case 3:15-cv-00290-MAS-LHG Document 1 Filed 01/14/15 Page 6 of 48 PageID: 6
`
`19.
`
`Venue is proper in this Court at least pursuant to 28 U.S.C. §§ 1391(b),
`
`(c), and/or (d), and 1400(b).
`
`THE PATENTS-IN-SUIT
`
`20.
`
`Sanofi U.S. holds approved New Drug Application (“NDA”) No. 201023
`
`for cabazitaxel injection, 60 mg/ 1.5 mL (40 mg/mL), which is prescribed and sold in the United
`
`States under the trademark JEVTANA® KIT (hereinafter “JEVTANA®”). The U.S. Food and
`
`Drug Administration (“FDA”) approved NDA No. 201023 on June 17, 2010. JEVTANA® is
`
`approved for use in combination with prednisone for the treatment of patients with hormone-
`
`refractory metastatic prostate cancer previously treated with a docetaxel-containing treatment
`
`regimen.
`
`21.
`
`United States Patent No. 5,847,170 (the “’170 patent,” copy attached as
`
`Exhibit A) is entitled “Taxoids, Their Preparation And Pharmaceutical Compositions Containing
`
`Them” and was duly and legally issued by the United States Patent and Trademark Office
`
`(“USPTO”) on December 8, 1998. The ’170 patent claims, inter alia, cabazitaxel and
`
`pharmaceutical compositions containing cabazitaxel. The ’170 patent is listed in the FDA’s
`
`Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”) for
`
`JEVTANA® (NDA No. 201023).
`
`22.
`
`23.
`
`The ’170 patent is owned by Aventis.
`
`United States Patent No. 7,241,907 (the “’907 patent,” copy attached as
`
`Exhibit B) is entitled “Acetone Solvate of Dimethoxy Docetaxel and its Process of Preparation”
`
`and was duly and legally issued by the United States Patent and Trademark Office (“USPTO”)
`
`on July 10, 2007. The ’907 patent claims, inter alia, an acetone solvate of cabazitaxel. The ’907
`
`patent is listed in the FDA’s Orange Book for JEVTANA® (NDA No. 201023).
`
`
`
`6
`
`

`
`Case 3:15-cv-00290-MAS-LHG Document 1 Filed 01/14/15 Page 7 of 48 PageID: 7
`
`24.
`
`The ’907 patent is owned by Aventis.
`
`CLAIMS FOR RELIEF − PATENT INFRINGEMENT
`
`25.
`
`On information and belief, Onco submitted the Onco ANDA to the FDA
`
`seeking approval to engage in the commercial manufacture, use, offer for sale, sale, and/or
`
`importation of Onco’s Proposed ANDA Product.
`
`26.
`
`On information and belief, the Onco ANDA seeks FDA approval of
`
`Onco’s Proposed ANDA Product for use in combination with prednisone for the treatment of
`
`patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-
`
`containing treatment regimen.
`
`27.
`
`On information and belief, Onco actively participated in and/or directed
`
`activities related to the submission of the Onco ANDA and the development of Onco’s Proposed
`
`ANDA 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 Onco ANDA, Onco will be involved in the manufacture, distribution, and/or
`
`marketing of Onco’s Proposed ANDA Product.
`
`28.
`
`By letter dated December 4, 2014 (the “December 4 Letter”), and pursuant
`
`to 21 U.S.C. § 355(j)(2)(B)(ii) and 21 C.F.R. §314.95, Onco notified Plaintiffs that it had
`
`submitted to the FDA the Onco ANDA, seeking approval to engage in the commercial
`
`manufacture, use, or sale of Onco’s Proposed ANDA Product before the expiration of the ’170
`
`patent and the ’907 patent. The December 4 Letter was received by Plaintiffs on December 5,
`
`2014.
`
`29.
`
`In its December 4 Letter, Onco notified Plaintiffs, as part of the Onco
`
`ANDA, it had filed a certification of the type described in 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (a
`
`
`
`7
`
`

`
`Case 3:15-cv-00290-MAS-LHG Document 1 Filed 01/14/15 Page 8 of 48 PageID: 8
`
`“Paragraph IV Certification”) with respect to the ’170 patent and the ’907 patent. On
`
`information and belief, Onco certified that, the ’170 patent and the ’907 patent are invalid,
`
`unenforceable and/or will not be infringed by the manufacture, use or sale of Onco’s Proposed
`
`ANDA Product.
`
`30.
`
`The Onco ANDA refers to and relies upon the Sanofi U.S.’s NDA No.
`
`201023 for JEVTANA®.
`
`31.
`
`In the December 4 Letter, Onco offered confidential access to portions of
`
`the Onco ANDA on terms and conditions set forth in paragraph 2 of the December 4 Letter
`
`(“Onco Offer”). Onco requested that Plaintiffs accept the Onco Offer before receiving access to
`
`any portion of the Onco ANDA. The Onco Offer contained unreasonable restrictions that would
`
`apply under a protective order. For example, the Onco Offer required that Plaintiffs’ outside
`
`counsel do not engage, formally or informally, in any patent prosecution or any FDA counseling,
`
`litigation or other work before or involving the FDA on behalf of Plaintiffs.
`
`32.
`
`Under 21 U.S.C. § 355(j)(5)(C)(i)(III), an “offer of confidential access
`
`shall contain such restrictions . . . on the use and disposition of any information accessed, as
`
`would apply had a protective order been entered for the purpose of protecting trade secrets and
`
`other confidential business information.”
`
`33.
`
`Since rejecting the Onco Offer, Plaintiffs attempted to negotiate with
`
`Onco to obtain a copy of excerpts of the Onco ANDA under restrictions “as would apply had a
`
`protective order been issued.” Those negotiations were unsuccessful. For example, Onco’s final
`
`proposal continued to unreasonably impose patent prosecution and FDA restrictions on
`
`Plaintiffs’ outside counsel.
`
`
`
`8
`
`

`
`Case 3:15-cv-00290-MAS-LHG Document 1 Filed 01/14/15 Page 9 of 48 PageID: 9
`
`34.
`
`Plaintiffs are not aware of any other means of obtaining information
`
`regarding Onco’s Proposed ANDA Product within the 45-day statutory period. Without such
`
`information, Plaintiffs will use the judicial process and the aid of discovery to obtain, under
`
`appropriate judicial safeguards such information as is required to confirm its allegations of
`
`infringement and to present to the Court evidence that Onco’s Proposed ANDA Product falls
`
`within the scope of one or more claims of the ’170 and ’907 patents.
`
`COUNT I
`
`INFRINGEMENT OF U.S. PATENT NO. 5,847,170
`
`35.
`
`Plaintiff repeats and realleges paragraphs 1 through 34 above as if fully set
`
`forth herein.
`
`36.
`
`By submitting the Onco ANDA under 21 U.S.C. § 355(j) for the purpose
`
`of obtaining approval to engage in the commercial manufacture, use or sale of Onco’s Proposed
`
`ANDA Product throughout the United States prior to the expiration of the ’170 patent, Onco
`
`committed an act of infringement of the ’170 patent under 35 U.S.C. § 271(e)(2). On
`
`information and belief, Onco was aware of the ’170 patent at the time the Onco ANDA was
`
`submitted.
`
`37.
`
`If Onco commercially makes, uses, offers to sell, or sells Onco’s Proposed
`
`ANDA Product within the United States, or imports Onco’s 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. §§ 271(a), (b), and/or (c).
`
`38.
`
`Plaintiffs will be irreparably harmed if Onco is not enjoined from
`
`infringing the ’170 patent. Plaintiffs do not have an adequate remedy at law.
`
`
`
`9
`
`

`
`Case 3:15-cv-00290-MAS-LHG Document 1 Filed 01/14/15 Page 10 of 48 PageID: 10
`
`39.
`
`Onco’s certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) against the
`
`’170 patent was wholly unjustified, and thus this case is exceptional under 35 U.S.C. § 285.
`
`COUNT II
`
`INFRINGEMENT OF U.S. PATENT NO. 7,241,907
`
`40.
`
`Plaintiffs repeat and reallege paragraphs 1 through 39 above as if fully set
`
`forth herein.
`
`41.
`
`By submitting the Onco ANDA under 21 U.S.C. § 355(j) for the purpose
`
`of obtaining approval to engage in the commercial manufacture, use or sale of Onco’s Proposed
`
`ANDA Product throughout the United States prior to the expiration of the ’907 patent, Onco
`
`committed an act of infringement of the ’907 patent under 35 U.S.C. § 271(e)(2). On
`
`information and belief, Onco was aware of the ’907 patent at the time the Onco ANDA was
`
`submitted.
`
`42.
`
`If Onco commercially makes, uses, offers to sell, or sells Onco’s Proposed
`
`ANDA Product within the United States, or imports Onco’s 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).
`
`43.
`
`Plaintiffs will be irreparably harmed if Onco is not enjoined from
`
`infringing the ’907 patent. Plaintiffs do not have an adequate remedy at law.
`
`44.
`
`Onco’s certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) against the
`
`’907 patent was wholly unjustified, and thus this case is exceptional under 35 U.S.C. § 285.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiffs respectfully request the following relief:
`
`
`
`10
`
`

`
`Case 3:15-cv-00290-MAS-LHG Document 1 Filed 01/14/15 Page 11 of 48 PageID: 11
`
`A.
`
`A judgment that Onco Therapies Limited has infringed one or more claims
`
`of the ’170 patent by filing ANDA No. 207381 relating to Onco’s Proposed ANDA Product
`
`before the expiration of the ’170 patent;
`
`B.
`
`A judgment that the manufacture, use, offer for sale, sale and/or
`
`importation of Onco’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 Onco Therapies
`
`Limited, 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 Onco’s 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 Onco’s ANDA No.
`
`207381 relating to Onco’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.
`
`A judgment that Onco Therapies Limited has infringed one or more claims
`
`of the ’907 patent by filing ANDA No. 207381 relating to Onco’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 Onco’s Proposed ANDA Product will infringe the ’907 patent;
`
`H.
`
`A judgment declaring that the ’907 patent remains valid and enforceable;
`
`
`
`11
`
`

`
`Case 3:15-cv-00290-MAS-LHG Document 1 Filed 01/14/15 Page 12 of 48 PageID: 12
`
`I.
`
`A permanent injunction restraining and enjoining Onco Therapies
`
`Limited, 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 Onco’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 Onco’s ANDA No.
`
`207381 relating to Onco’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 ’907 patent or any later date of exclusivity to which Plaintiffs and/or the ’907 patent
`
`are or become entitled;
`
`K.
`
`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
`
`this action; and
`
`L.
`
`Such other and further relief as the Court may deem just and proper.
`
`
`
`12
`
`
`
`
`
`

`
`Case 3:15-cv-00290-MAS-LHG Document 1 Filed 01/14/15 Page 13 of 48 PageID: 13
`
`Respectfully submitted,
`
`
`
`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
`
`
`
`
`13
`
`January 14, 2015
`
`
`
`
`
`
`
`

`
`Case 3:15-cv-00290-MAS-LHG Document 1 Filed 01/14/15 Page 14 of 48 PageID: 14
`
`RULE 11.2 CERTIFICATION
`
`
`
`I, Liza M. Walsh, admitted to the bars of the State of New Jersey and this Court, and a
`
`Partner in the law firm of Connell Foley LLP representing Plaintiffs Sanofi-Aventis U.S. LLC,
`
`Aventis Pharma S.A. and Sanofi in the above-captioned matter, hereby certify pursuant to L.
`
`Civ. R. 11.2 that the matter in controversy in this action is related to the following actions that
`
`are pending before the District Court for the District of New Jersey: Sanofi-Aventis U.S. LLC et
`
`al. v. Fresenius Kabi USA, LLC, C. A. No. 14-7869 (MAS)(LHG); Sanofi-Aventis U.S. LLC et
`
`al. v. Accord Healthcare, Inc., C. A. No. 14-8079 (MAS)(LHG); Sanofi-Aventis U.S. LLC et al.
`
`v. BPI Labs, LLC et al., C. A. No. 14-8081 (MAS)(LHG); Sanofi-Aventis U.S. LLC et al. v.
`
`Fresenius Kabi USA, LLC, C. A. No. 14-8082 (MAS)(LHG); the following actions pending
`
`before the District Court for the District of Delaware: Sanofi-Aventis U.S. LLC et al. v. Fresenius
`
`Kabi USA, LLC, C. A. No. 14-1496 (LPS); and Sanofi-Aventis U.S. LLC et al. v. Fresenius Kabi
`
`USA, LLC, C. A. No. 14-1533 (LPS); one pending litigation in the District Court for the Middle
`
`District of Florida: Sanofi-Aventis U.S. LLC et al. v. BPI Labs, LLC et al., C. A. No. 14-3233
`
`(EAK)(TGW); and one pending litigation in the District Court for the Middle District of North
`
`Carolina: Sanofi-Aventis U.S. LLC et al. v. Accord Healthcare, Inc., C. A. No. 15-0018
`
`(NCT)(LPA).
`
` I
`
` certify under penalty of perjury that the foregoing is true and correct.
`
`14
`
`
`
`
`
`

`
`Case 3:15-cv-00290-MAS-LHG Document 1 Filed 01/14/15 Page 15 of 48 PageID: 15
`
`CONNELL FOLEY LLP
`
`
`
`
`
`By:__ s/Liza M. Walsh_______
`
`
`
`
`
`Liza M. Walsh, Esq.
`CONNELL FOLEY LLP
`85 Livingston Avenue
`Roseland, New Jersey 07068-1765
`(973) 535-0500
`
`Attorneys for Plaintiffs,
`SANOFI-AVENTIS U.S. LLC, AVENTIS
`PHARMA S.A. and SANOFI
`
`Of Counsel:
`
`William E. Solander, Esq.
`Jason A. Leonard, Esq.
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`(212) 218-2100
`
`
`
`
`15
`
`January 14, 2015
`
`
`
`
`
`
`
`

`
`Case 3:15-cv-00290-MAS-LHG Document 1 Filed 01/14/15 Page 16 of 48 PageID: 16
`
`RULE 201.1 CERTIFICATION
`
`
`
`We hereby certify that the above-captioned matter is not subject to compulsory
`
`arbitration in that the plaintiffs seek, inter alia, injunctive relief.
`
`January 14, 2015
`
`CONNELL FOLEY LLP
`
`
`
`
`
`
`
`
`
`
`
`By:_ s/Liza M. Walsh_________
`
`
`
`
`
`Liza M. Walsh, Esq.
`CONNELL FOLEY LLP
`85 Livingston Avenue
`Roseland, New Jersey 07068-1765
`(973) 535-0500
`
`Attorneys for Plaintiffs,
`SANOFI-AVENTIS U.S. LLC, AVENTIS
`PHARMA S.A. and SANOFI
`
`Of Counsel:
`
`William E. Solander, Esq.
`Jason A. Leonard, Esq.
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`(212) 218-2100
`
`
`FCHS_WS 11039355v1.doc
`
`16
`
`

`
`Case 3:15-cv-00290-MAS-LHG Document 1 Filed 01/14/15 Page 17 of 48 PageID: 17
`Case 3:l5—cv—OO290—MAS—LHG Document 1 Filed 01/14/15 Page 17 of 48 Page|D: 17
`
`
`
`EXHIBIT A
`EXHIBIT A
`
`
`
`

`
`Case 3:15-cv-00290-MAS-LHG Document 1 Filed 01/14/15 Page 18 of 48 PageID: 18
`
`United States Patent [19]
`Bouchard et al.
`
`[54]
`
`[75]
`
`TAXOIDS, THEIR PREPARATION AND
`PHARMACEUTICAL COMPOSITIONS
`CONTAINING THEM
`
`Inventors: Hervé Bouchard, Ivry-sur-Seine;
`J ean-Dominique Bourzat, Vincennes;
`Alain Commergon, Vitry-sur-Seine, all
`of France
`
`Assignee: Rhone-Poulenc Rorer, S.A., Antony
`CedeX, France
`
`Appl. No.:
`
`Filed:
`
`622,011
`Mar. 26, 1996
`
`Related US. Application Data
`
`Provisional application No. 60/010,144, Jan. 17, 1996.
`Foreign Application Priority Data
`
`[60]
`[30]
`Mar. 27, 1995 [FR]
`Dec. 22, 1995 [FR]
`
`US005847170A
`Patent Number:
`Date of Patent:
`
`[11]
`[45]
`
`5,847,170
`Dec. 8, 1998
`
`OTHER PUBLICATIONS
`Greene et al, “Protective Groups in Organic Synthesis”, pp.
`10—14, 2”“ edition, 1991.
`M.L. Shelanski et al., “Microtubule Assembly in the
`Absence of Added Nucleotides”, Proc. Natl. Acad. Sci. vol.
`70, No. 3,pp. 765—768 (1973).
`G. Chauviere et al., “Analyse structurable et etude bio
`chimique de produits isoles de l’if: TaXus baccata L. (Tax
`aces)”, CR. Acad. Sc. Paris, t.293, pp. 501—503 (1981).
`J. Kant et al., “A Chemoselective Approach to FunctionaliZe
`the C—10 Position of 10—Deacetylbaccatin III. Synthesis and
`Biological Properties of Novel C—10 TaXol Analogues”,
`Tetrahedron Letters, vol. 35, No. 31, pp. 5543—5546, 1994.
`Primary Examiner—Ba K. Trinh
`Attorney, Agent, or Firm—Finnegan, Henderson, FaraboW,
`Garrett & Dunner, L.L.P.
`[57]
`ABSTRACT
`
`NeW taXoids of general formula (I):
`
`France ................................. .. 95 03545
`France ................................. .. 95 15381
`
`R4
`
`0
`
`(I)
`
`Int. Cl.6 ................................................. .. C07D 305/14
`[51]
`[52] US. Cl. ................ ..
`549/510; 549/511
`[58] Field of Search
`.......... .. 549/510, 511
`
`[56]
`
`References Cited
`
`US. PATENT DOCUMENTS
`
`5,229,526
`5,319,112
`5,486,601
`5,739,362
`
`7/1993 Holton et al. ......................... .. 549/213
`6/1994 Kingston et al.
`549/510
`1/1996 Holton et al.
`514/337
`4/1998 Holton et al. ......................... .. 549/510
`
`FOREIGN PATENT DOCUMENTS
`
`0 336 841 10/1989 European Pat. Off. .
`604910 7/1994 European Pat. Off. .
`0 639 577 2/1995 European Pat. Off. .
`694539
`1/1996 European Pat. Off. .
`WO 92/09589
`6/1992 WIPO .
`WO 94/07878 4/1994 WIPO .
`WO 94/18164 8/1994 WIPO .
`WO96/00724 1/1996 WIPO .
`
`COCH3
`
`their preparation and pharmaceutical compositions contain
`ing them, and the neW products of general formula (I) in
`Which Z represents a radical of general formula (II):
`
`<11)
`
`OH
`display noteWorthy antitumour and antileukaemic proper
`ties.
`
`22 Claims, No Drawings
`
`

`
`Case 3:15-cv-00290-MAS-LHG Document 1 Filed 01/14/15 Page 19 of 48 PageID: 19
`
`1
`TAXOIDS, THEIR PREPARATION AND
`PHARMACEUTICAL COMPOSITIONS
`CONTAINING THEM
`
`5,847,170
`
`This application claims the priority of US. provisional
`application 60/010,144 ?led Jan. 17, 1996.
`The present invention relates to neW taXoids of general
`formula (I)
`
`(I)
`
`15
`
`in Which:
`Z represents a hydrogen atom or a radical of general
`formula (II):
`
`20
`
`RINH
`
`o
`
`R3
`
`(11)
`
`25
`
`in Which:
`R1 represents
`a benZoyl radical optionally substituted With one or more
`identical or different atoms or radicals selected from
`halogen atoms, alkyl radicals containing 1 to 4 carbon
`atoms, alkoXy radicals containing 1 to 4 carbon atoms
`and tri?uoromethyl radicals,
`a thenoyl or furoyl radical or
`a radical R2—O—CO— in Which R2 represents:
`an alkyl radical containing 1 to 8 carbon atoms,
`an alkenyl radical containing 2 to 8 carbon atoms,
`an alkynyl radical containing 3 to 8 carbon atoms,
`a cycloalkyl radical containing 3 to 6 carbon atoms,
`a cycloalkenyl radical containing 4 to 6 carbon atoms
`or
`a bicycloalkyl radical containing 7 to 10 carbon atoms,
`these radicals being optionally substituted With one or
`more substituents selected from halogen atoms,
`hydroXyl radicals, alkoXy radicals containing 1 to 4
`carbon atoms, dialkylamino radicals in Which each
`alkyl portion contains 1 to 4 carbon atoms, piperi
`dino radicals, morpholino radicals, 1-piperaZinyl
`radicals, said piperaZinyl radicals being optionally
`substituted at position 4 With an alkyl radical con
`taining 1 to 4 carbon atoms or With a phenylalkyl
`radical in Which the alkyl portion contains 1 to 4
`carbon atoms, cycloalkyl radicals containing 3 to 6
`carbon atoms, cycloalkenyl radicals containing 4 to
`6 carbon atoms, phenyl radicals, said phenyl radicals
`being optionally substituted With one or more atoms
`or radicals selected from halogen atoms, alkyl radi
`cals containing 1 to 4 carbon atoms, and alkoXy
`radicals containing 1 to 4 carbon atoms, cyano
`radicals, carboXyl radicals and alkoXycarbonyl radi
`cals in Which the alkyl portion contains 1 to 4 carbon
`atoms,
`a phenyl or ot- or [3-naphthyl radical optionally substi
`tuted With one or more atoms or radicals selected
`from halogen atoms, alkyl radicals containing 1 to 4
`
`30
`
`35
`
`40
`
`45
`
`55
`
`60
`
`65
`
`2
`carbon atoms, and alkoXy radicals containing 1 to 4
`carbon atoms,
`a S-membered aromatic heterocyclic radical preferably
`selected from furyl and thienyl radicals,
`or a saturated heterocyclic radical containing 4 to 6
`carbon atoms, optionally substituted With one or
`more alkyl radicals containing 1 to 4 carbon atoms,
`R3 represents
`an unbranched or branched alkyl radical containing 1 to 8
`carbon atoms,
`an unbranched or branched alkenyl radical containing 2 to
`8 carbon atoms,
`an unbranched or branched alkynyl radical containing 2 to
`8 carbon atoms,
`a cycloalkyl radical containing 3 to 6 carbon atoms,
`a phenyl or ot- or [3-naphthyl radical optionally substituted
`With one or more atoms or radicals selected from
`halogen atoms, alkyl, alkenyl, alkynyl, aryl, aralkyl,
`alkoXy, alkylthio, aryloXy, arylthio, hydroXyl,
`hydroXyalkyl, mercapto, formyl, acyl, acylamino,
`aroylamino, alkoXycarbonylamino, amino, alkylamino,
`dialkylamino, carboXyl, alkoXycarbonyl, carbamoyl,
`alkylcarbamoyl, dialkylcarbamoyl, cyano, nitro and
`tri?uoromethyl radicals,
`or a S-membered aromatic heterocycle containing one or
`more identical or different hetero atoms selected from
`nitrogen, oXygen and sulphur atoms and optionally
`substituted With one or more identical or different
`substituents selected from halogen atoms, alkyl, aryl,
`amino,
`alkylamino,
`dialkylamino,
`alkoXycarbonylamino, acyl, arylcarbonyl, cyano,
`carboXyl, carbamoyl, alkylcarbamoyl, dialkylcarbam
`oyl and alkoxycarbonyl radicals,
`With the understanding that, in the substituents of the
`phenyl, ot- or [3-naphthyl and aromatic heterocyclic
`radicals, the alkyl radicals and the alkyl portions of the
`other radicals contain 1 to 4 carbon atoms, the alkenyl
`and alkynyl radicals contain 2 to 8 carbon atoms, and
`the aryl radicals are phenyl or ot- or [3-naphthyl radicals,
`R4 represents
`an alkoXy radical containing 1 to 6 carbon atoms in an
`unbranched or branched chain,
`an alkenyloXy radical containing 3 to 6 carbon atoms in an
`unbranched or branched chain,
`an alkynyloXy radical containing 3 to 6 carbon atoms in
`an unbranched or branched chain,
`a cycloalkyloXy radical containing 3 to 6 carbon atoms or
`a cycloalkenyloXy radical containing 4 to 6 carbon atoms,
`these radicals being optionally substituted With one or
`more substituents selected from halogen atoms, an
`alkoXy radical containing 1 to 4 carbon atoms, an
`alkylthio radical containing 1 to 4 carbon atoms, a
`carboXyl radical, an alkyloXycarbonyl radical in Which
`the alkyl portion contains 1 to 4 carbon atoms, a cyano
`radical, a carbamoyl radical, an N-alkylcarbamoyl radi
`cal and a N,N-dialkylcarbamoyl radical in Which each
`alkyl portion contains 1 to 4 carbon atoms, or both alkyl
`portions, together With the nitrogen atom to Which they
`are linked, form a saturated 5- or 6-membered he