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    Liza M. WalshRukhsanah L. Lighari

    Connell Foley LLP85 Livingston AvenueRoseland, New Jersey 07068

    Tel.: (973) 535-0500

    Fax: (973) 535-9217Attorneys for Plaintiffs

    Nautilus Neurosciences, Inc.

    and APR Applied Pharma

    Research SA

    IN THE UNITED STATES DISTRICT COURT

    FOR THE DISTRICT OF NEW JERSEY

    NAUTILUS NEUROSCIENCES, INC. andAPR APPLIED PHARMA RESEARCH

    SA,

    Plaintiffs,

    v.

    WOCKHARDT USA LLC,

    WOCKHARDT LTD., and EDICTPHARMACEUTICALS PVT. LTD.,

    Defendants.

    ))

    )

    ))

    )

    )

    ))

    ))

    )

    Civil Action No. ___________

    COMPLAINT

    Plaintiffs Nautilus Neurosciences, Inc. (Nautilus) and APR Applied Pharm

    SA (APR) (collectively, Plaintiffs), by and through their attorneys, for their Com

    against Defendants Wockhardt USA LLC (Wockhardt USA), Wockhardt Ltd. (co

    Wockhardt), and Edict Pharmaceuticals Pvt. Ltd. (Edict), hereby allege as follo

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    2. APR is a corporation organized under the laws of Switzerlandprincipal place of business at Via Corti 5, CH-6828, Balerna, Switzerland.

    3. On information and belief, Wockhardt USA is a Delaware cowith a principal place of business at 20 Waterview Boulevard, 3rd Floor, Parsippany

    07054.

    4. On information and belief, Wockhardt Ltd. is a corporation oexisting under the laws of India with its principal place of business at Wockhardt To

    Bandra-Kurla Complex, Bandra (East), Mumbai 400 051, Maharashtra, India.

    5. On information and belief, Wockhardt USA is a subsidiary ofLtd. and the two companies have common officers and directors.

    6. On information and belief, Wockhardt USA is controlled anddominated by Wockhardt Ltd.

    7. On information and belief, Wockhardt Ltd. manufactures numgeneric drugs for sale and use throughout the United States, including in this judicia

    through its subsidiary and agent, Wockhardt USA.

    8. On information and belief, the acts of Wockhardt USA compherein were done at the direction of, with the authorization of, and with the coopera

    participation, and awareness of, and at least in part for the benefit of, Wockhardt Ltd

    9. On information and belief, Edict is a corporation organized aunder the laws of India with its principal place of business at New No. 1/58, Pudupa

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    11. On information and belief, Edict authorized a U.S. agent in th508 Elm Avenue, Moorestown, New Jersey 08057 to act on its behalf in correspond

    United States Food and Drug Administration (FDA) regarding Edicts Abbreviate

    Application (Edicts ANDA) No. 20-2964.

    12. On information and belief, Edict was acquired by Par PharmaCompanies, Inc. (Par) on February 17, 2012.

    13. On information and belief, Par is a Delaware corporation withplace of business at 300 Tice Boulevard, Woodcliff Lake, New Jersey 07677.

    14. On information and belief, Edict develops and manufactures pharmaceutical formulations for sale and use throughout the United States, includin

    judicial district.

    NATURE OF THE ACTION

    15. This is a civil action for infringement of U.S. Patent No. 8,09651 patent or the patent-in-suit), which is attached as Exhibit A.

    16. The 651 patent is assigned to and/or exclusively licensed by listed in the publication entitled Orange Book: Approved Drug Products with Ther

    Equivalents.

    17. This action is based upon the Patent Laws of the United State 1 et seq., and arises out of Wockhardts filing of ANDA No. 20-2430 seeking app

    Wockhardt to sell diclofenac potassium for oral solution 50 mg prior to the expiratio

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    JURISDICTION AND VENUE

    18. This action arises under the patent laws of the United States, 3et seq.

    19. This Court has subject matter jurisdiction pursuant to 28 U.S.1338(a), and 2201(a).

    20. Wockhardt USA is subject to personal jurisdiction in this Disof, inter alia, its conduct of business in this District, the location of its place of busin

    District, its purposeful availment of the rights and benefits of New Jersey law, and i

    and continuing contacts with the state of New Jersey.

    21. Wockhardt Ltd. is subject to personal jurisdiction in this Distof, inter alia, its manufacture of numerous generic drugs for sale and use in this Dis

    Wockhardt USA and its direction and control of the business of Wockhardt USA, th

    it conducts business in this District, purposefully avails itself of the rights and benef

    Jersey law, and has substantial and continuing contacts with the state of New Jersey

    22. Edict is subject to personal jurisdiction in this District by virtalia, its manufacture of generic pharmaceutical formulations for sale and use in this

    conduct of business in this District, the location of one of its offices in this District,

    of its U.S. agent in this District, its purposeful availment of the rights and benefits o

    law, including its previous admissions that it is subject to personal jurisdiction in Ne

    see, e.g., Orexo AB v. Edict Pharms. Pvt. Ltd., No. 3:10-cv-05548 (D.N.J. Oct. 26, 2

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    24. Wockhardt USA and Wockhardt Ltd. did not contest that theysubject to personal jurisdiction or that venue was appropriate in New Jersey in anoth

    brought against them by Plaintiffs in this Court, Nautilus Neurosciences, Inc. et al.

    USA LLC et al., Civil Action No. 2:11-1997 (ES/CLW) (D.N.J. April 8, 2011).

    25. Edict did not contest that it was subject to personal jurisdictiovenue was appropriate in New Jersey in another action brought against it by Plaintif

    Court,Nautilus Neurosciences, Inc. et al. v. Edict Pharmaceuticals Pvt. Ltd.., Civil

    2:11-4183 (ES/CLW) (D.N.J. July 20, 2011).

    THE PATENT-IN-SUIT

    26. The 651 patent, entitled Diclofenac Formulations and Methwas duly and legally issued by the United States Patent and Trademark Office (US

    January 17, 2012.

    27. APR owns the entire right, title, and interest in the 651 patenthe exclusive licensee of the 651 patent for the United States.

    28. Nautilus is the holder of New Drug Application (NDA) Nodiclofenac potassium for oral solution 50 mg, sold in the United States under the tra

    CAMBIA. The United States Food and Drug Administration (FDA) approved ND

    165 on June 17, 2009.

    29. The 651 patent is duly listed in the Orange Book: ApprovedProducts with Therapeutic Equivalents for NDA No. 22-165 (the Orange Book list

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    ACTS GIVING RISE TO THIS ACTION

    30. On information and belief, Wockhardt reviewed the Orange Bfor CAMBIA and certain commercial and economic information regarding CAMBI

    decided to file an ANDA seeking approval to market a generic version of CAMBIA

    31. On information and belief, Wockhardt Ltd. has designated WUSA as its agent for the purpose of submitting and obtaining approval of ANDA No

    32. On information and belief Wockhardt Ltd. submitted ANDA to the FDA to seek approval to engage in the commercial manufacture, use, sale, off

    and/or importation into the United States of generic diclofenac potassium for oral so

    mg.

    33. Plaintiffs received a letter dated March 1, 2011 from Wockhapurporting to notify them that Wockhardt had filed ANDA No. 20-2430 with the FD

    section 505(j) of the Federal Food, Drug, and Cosmetic Act (FDCA) seeking appr

    market a generic version of CAMBIAprior to the expiry of U.S. Patent Nos. 6,974,5

    7,482,377, and 7,759,394.

    34. The stated purpose of Wockhardts March 1, 2011 letter was Plaintiffs that ANDA No. 20-2430 included a certification under 21 U.S.C. 355(j)(2

    (Wockhardts Paragraph IV Certification) that the claims of U.S. Patent Nos. 6,97

    7,482,377, and 7,759,394 are invalid, unenforceable, and/or will not be infringed by

    commercial manufacture, use, sale, offer for sale, and/or importation into the United

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    7,482,377, and 7,759,394 are invalid and/or would not be infringed by the commerc

    manufacture, use, sale, offer for sale, and/or importation into the United States of W

    product.

    36. On April 8, 2011, Plaintiffs filed a complaint for infringemenWockhardt of U.S. Patent Nos. 6,974,595, 7,482,377, and 7,759,394 in this Court.

    docketed as Civil Action No. 2:11-cv-01997-ES-CLW.

    37. The 651 patent was duly and legally issued by the USPTO o2012 and subsequently added to the Orange Book listing.

    38. Plaintiffs received a letter dated January 30, 2012 from Wockpurporting to notify them that Wockhardt had amended ANDA No. 20-2430 with th

    section 505(j) of the FDCA to seek approval to market a generic version of CAMBI

    expiry of the 651 patent.

    39. The stated purpose of Wockhardts January 30, 2012 letter wPlaintiffs that Wockhardts Paragraph IV Certification was amended to add that the

    651 patent are invalid, unenforceable, and/or will not be infringed by the commerci

    manufacture, use, sale, offer for sale, and/or importation into the United States of W

    ANDA product.

    40. Attached to the January 30, 2012 letter was a Detailed Statemforth the factual and legal bases for Wockhardts opinion that the 651 patent is inva

    would not be infringed by the commercial manufacture, use, sale, offer for sale, and

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    41. On information and belief, Edict reviewed the Orange Book lCAMBIA and certain commercial and economic information regarding CAMBIA a

    file an ANDA seeking approval to market a generic version of CAMBIA.

    42. On information and belief, Edict submitted ANDA No. 20-29FDA to seek approval to engage in the commercial manufacture, use, sale, offer for

    importation into the United States of generic diclofenac potassium for oral solution

    43. Plaintiffs received a letter dated June 8, 2011 from Edict notithat Edict had filed ANDA No. 20-2964 with the FDA under section 505(j) of the Fe

    Drug, and Cosmetic Act (FDCA) seeking approval to market a generic version of

    prior to the expiry of U.S. Patent Nos. 6,974,595, 7,482,377, and 7,759,394.

    44. The stated purpose of Edicts June 8, 2011 letter was to notifythat ANDA No. 20-2964 included a certification under 21 U.S.C. 355(j)(2)(a)(vii)(

    Paragraph IV Certification) that the claims of U.S. Patent Nos. 6,974,595, 7,482,37

    7,759,394 are invalid, unenforceable, and/or will not be infringed by the commercia

    manufacture, use, sale, offer for sale, and/or importation into the United States of Ed

    product.

    45. Attached to the June 8, 2011 letter was a Detailed Statementforth the factual and legal bases for Edicts opinion that U.S. Patent Nos. 6,974,595

    and 7,759,394 are invalid and/or would not be infringed by the commercial manufac

    sale, offer for sale, and/or importation into the United States of Edicts product.

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    47. The 651 patent was duly and legally issued by the USPTO o2012 and subsequently added to the Orange Book listing.

    48. Plaintiffs received a letter dated February 7, 2012 from Edict notify them that Edict had amended its Paragraph IV Certifications in ANDA No. 2

    the FDA under section 505(j) of the FDCA to seek approval to market a generic ver

    CAMBIA prior to the expiry of the 651 patent.

    49. The stated purpose of Edicts February 7, 2012 letter was to nPlaintiffs that Edicts Paragraph IV Certification was amended to add that the claim

    patent are invalid, unenforceable, and/or will not be infringed by the commercial ma

    use, sale, offer for sale, and/or importation into the United States of Edicts ANDA

    50. Attached to the February 7, 2012 letter was a Detailed Statemforth the factual and legal bases for Edicts opinion that the 651 patent is invalid an

    not be infringed by the commercial manufacture, use, sale, offer for sale, and/or imp

    the United States of Edicts product.

    FIRST CLAIM FOR RELIEF

    (Infringement of the 651 Patent by Wockhardt)

    51. Paragraphs 1 through 50 are incorporated herein as set forth a52. Wockhardt submitted ANDA No. 20-2430 with a Paragraph I

    Certification, along with a subsequent amendment, to the FDA under section 505(j)

    to obtain approval to engage in the commercial manufacture, use, sale, offer for sale

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    53. Unless enjoined by this Court, Wockhardt, upon FDA approvamended ANDA No. 20-2430, will manufacture, use, sell, offer for sale, and/or imp

    United States the proposed generic diclofenac potassium product described in AND

    2430, thereby actively inducing others to infringe or contributing to the infringemen

    patent under 35 U.S.C. 271(b) and/or (c).

    54. Plaintiffs will be substantially and irreparably harmed if Wocenjoined from infringing the 651 patent.

    55. Plaintiffs do not have an adequate remedy at law.56. An actual and justiciable controversy exists between the parti

    respect to the 651 patent.

    57. Wockhardts actions render this an exceptional case under 35285.

    SECOND CLAIM FOR RELIEF

    (Infringement of the 651 Patent by Edict)

    58. Paragraphs 1 through 57 are incorporated herein as set forth a59. Edict submitted ANDA No. 20-2964 with a Paragraph IV Ce

    along with a subsequent amendment, to the FDA under section 505(j) of the FDCA

    approval to engage in the commercial manufacture, use, sale, offer for sale, and/or i

    into the United States of diclofenac potassium for oral solution prior to the expiratio

    patent. By submitting this ANDA, Edict has committed an act of infringement unde

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    States the proposed generic diclofenac potassium product described in ANDA No. 2

    thereby actively inducing others to infringe or contributing to the infringement of th

    under 35 U.S.C. 271(b) and/or (c).

    61. Plaintiffs will be substantially and irreparably harmed if Edicenjoined from infringing the 651 patent.

    62. Plaintiffs do not have an adequate remedy at law.63. An actual justiciable controversy exists between the parties w

    the 651 patent.

    64. Edicts actions render this an exceptional case under 35 U.S.C

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    PRAYER FOR RELIEF

    WHEREFORE, Plaintiffs pray for judgment as follows:

    A. An order decreeing that, by submitting ANDA No. 20-2430 t

    along with a subsequent amendment, Wockhardt has infringed the 651 patent unde

    271(e)(2);

    B. A declaration that, through the commercial manufacture, use,

    for sale, and/or importation into the United States of the proposed generic diclofena

    product described in ANDA No. 20-2430, Wockhardt will actively induce others to

    contribute to the infringement of the 651 patent under 35 U.S.C. 271(b) and (c);

    C. An order pursuant to 35 U.S.C. 271(e)(4)(A) decreeing that

    date of any approval of ANDA No. 20-2430 be no earlier than the expiration date of

    patent including any applicable extensions;

    D. A preliminary and permanent injunction restraining and enjoi

    Wockhardt, its officers, agents, attorneys, and employees and those acting in privity

    with it, from engaging in the commercial manufacture, use, sale, and/or offer for sal

    United States and/or importation into the United States of the diclofenac product de

    ANDA No. 20-2430 or any other product not colorably different from the product o

    20-2430 until the expiration date of the 651 patent, including any applicable extens

    E. An order decreeing that, by submitting ANDA No. 20-2964 t

    along with a subsequent amendment, Edict has infringed the 651 patent under 35 U

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    C 3 33 00001 D t 4484 Fil d 02/27/12 P 13 f 33 P

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    product described in ANDA No. 20-2964, Edict will actively induce others to infrin

    contribute to the infringement of the651 patent under 35 U.S.C. 271(b) and (c);

    G. An order pursuant to 35 U.S.C. 271(e)(4)(A) decreeing that

    date of any approval of ANDA No. 20-2964 be no earlier than the expiration date of

    patent, including any applicable extensions;

    H. A preliminary and permanent injunction restraining and enjoi

    its officers, agents, attorneys, and employees and those acting in privity or concert w

    engaging in the commercial manufacture, use, sale, and/or offer for sale within the U

    and/or importation into the United States of the diclofenac product described in AN

    2964 or any other product not colorably different from the product of ANDA No. 20

    the expiration date of the 651 patent, including any applicable extensions;

    I. A declaration that this case is exceptional under 35 U.S.C. 2

    J. An award of attorney fees, costs, and expenses that Plaintiffs

    prosecuting this action; and

    K. Such other and further relief as the Court may deem just and

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    Dated: February 27, 2012 CONNELL FOLEY LLPAttorneys for Plaintiffs

    Nautilus Neurosciences, Inc. anAPR Applied Pharma Research

    By: /s Liza M. Walsh______

    Liza M. Walsh

    Rukhsanah L. Lighari85 Livingston Avenue

    Roseland, New Jersey 0

    Telephone: (973) 535-0Facsimile: (973) 535-9

    Of Counsel:

    Thomas J. MeloroMichael W. Johnson

    Ketan Pastakia

    Laurie N. Stempler

    Willkie Farr & Gallagher LLP787 Seventh Avenue

    New York, NY 10019-6099(T) 212.728.8000

    (F) 212.728.8111

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    LOCAL CIVIL RULE 11.2 CERTIFICATION

    I certify that, to the best of my knowledge, the matter in controversy between

    parties is not the subject of any other pending or anticipated litigation in any court o

    proceeding, nor are there any non-parties known to Plaintiffs that should be joined t

    with the exception that related patents are the subject of two other, coordinated actio

    in this Court which involve the same parties: Nautilus Neurosciences, Inc. et al. v. W

    USA LLC et al., Civil Action No. 2:11-1997 (ES/CLW) (D.N.J. April 8, 2011);Nau

    Neurosciences, Inc. et al. v. Edict Pharmaceuticals Pvt. Ltd.. , Civil Action No. 2:11

    (ES/CLW) (D.N.J. July 20, 2011).

    Dated: February 27, 2012 /s Liza M. Walsh____________Liza M. Walsh

    LOCAL CIVIL RULE 201.1 CERTIFICATION

    I hereby certify that the above-captioned matter is not subject to compulsory

    in that declaratory and injunctive relief is sought.

    Dated: February 27, 2012 /s Liza M. Walsh____________Liza M. Walsh

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    Exhibit A

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    Case 3:33-av-00001 Document 4484 Filed 02/27/12 Page 17 of 33 PageID: 80366

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    Case 3:33-av-00001 Document 4484 Filed 02/27/12 Page 18 of 33 PageID: 80367

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    Case 3:33-av-00001 Document 4484 Filed 02/27/12 Page 19 of 33 PageID: 80368

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    Case 3:33-av-00001 Document 4484 Filed 02/27/12 Page 21 of 33 PageID: 80370

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    Case 3:33-av-00001 Document 4484 Filed 02/27/12 Page 26 of 33 PageID: 80375

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    Case 3:33-av-00001 Document 4484 Filed 02/27/12 Page 27 of 33 PageID: 80376

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    Case 3:33-av-00001 Document 4484 Filed 02/27/12 Page 29 of 33 PageID: 80378

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    Case 3:33-av-00001 Document 4484 Filed 02/27/12 Page 31 of 33 PageID: 80380

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