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Liza M. Walsh Rukhsanah L. Lighari Connell Foley LLP 85 Livingston Avenue Roseland, New Jersey 07068 Tel.: (973) 535-0500 Fax: (973) 535-9217 Attorneys 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. and APR APPLIED PHARMA RESEARCH SA, Plaintiffs, v. WOCKHARDT USA LLC, WOCKHARDT LTD., and EDICT PHARMACEUTICALS PVT. LTD., Defendants. COMPLAINT Plaintiffs Nautilus Neurosciences, Inc. (Nautilus) and APR Applied Pharma Research SA (APR) (collectively, Plaintiffs), by and through their attorneys, for their Complaint against Defendants Wockhardt USA LLC (Wockhardt USA), Wockhardt Ltd. (collectively, Wockhardt), and Edict Pharmaceuticals Pvt. Ltd. (Edict), hereby allege as follows: PARTIES 1. Nautilus is a Delaware corporation with its principal place of business at ) ) ) ) ) ) ) ) ) ) ) )

Civil Action No. _____________

135 Rte 202/206, Bedminster, New Jersey 07921.

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2.

APR is a corporation organized under the laws of Switzerland with its

principal place of business at Via Corti 5, CH-6828, Balerna, Switzerland. 3. On information and belief, Wockhardt USA is a Delaware corporation

with a principal place of business at 20 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey 07054. 4. On information and belief, Wockhardt Ltd. is a corporation organized and

existing under the laws of India with its principal place of business at Wockhardt Towers, Bandra-Kurla Complex, Bandra (East), Mumbai 400 051, Maharashtra, India. 5. On information and belief, Wockhardt USA is a subsidiary of Wockhardt

Ltd. and the two companies have common officers and directors. 6. On information and belief, Wockhardt USA is controlled and/or

dominated by Wockhardt Ltd. 7. On information and belief, Wockhardt Ltd. manufactures numerous

generic drugs for sale and use throughout the United States, including in this judicial district, through its subsidiary and agent, Wockhardt USA. 8. On information and belief, the acts of Wockhardt USA complained of

herein were done at the direction of, with the authorization of, and with the cooperation, 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 and existing

under the laws of India with its principal place of business at New No. 1/58, Pudupakkam Main Road, Kelambakkam, Chennai 603 103, Tamil Nadu, India. 10. On information and belief, Edict has maintained a U.S. office in this

judicial district at 9 Revere Road, Monmouth Junction, New Jersey 08852.

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11.

On information and belief, Edict authorized a U.S. agent in this district at

508 Elm Avenue, Moorestown, New Jersey 08057 to act on its behalf in corresponding with the United States Food and Drug Administration (FDA) regarding Edicts Abbreviated New Drug Application (Edicts ANDA) No. 20-2964. 12. On information and belief, Edict was acquired by Par Pharmaceutical

Companies, Inc. (Par) on February 17, 2012. 13. On information and belief, Par is a Delaware corporation with a principal

place of business at 300 Tice Boulevard, Woodcliff Lake, New Jersey 07677. 14. On information and belief, Edict develops and manufactures generic

pharmaceutical formulations for sale and use throughout the United States, including in this judicial district. NATURE OF THE ACTION 15. This is a civil action for infringement of U.S. Patent No. 8,097,651 (the

651 patent or the patent-in-suit), which is attached as Exhibit A. 16. The 651 patent is assigned to and/or exclusively licensed by Plaintiffs and

listed in the publication entitled Orange Book: Approved Drug Products with Therapeutic Equivalents. 17. This action is based upon the Patent Laws of the United States, 35 U.S.C.

1 et seq., and arises out of Wockhardts filing of ANDA No. 20-2430 seeking approval for Wockhardt to sell diclofenac potassium for oral solution 50 mg prior to the expiration of the patent-in-suit, and Edicts filing of ANDA No. 20-2964 seeking approval for Edict to sell diclofenac potassium for oral solution 50 mg prior to the expiration of the patent-in-suit.

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JURISDICTION AND VENUE 18. et seq. 19. 1338(a), and 2201(a). 20. Wockhardt USA is subject to personal jurisdiction in this District by virtue This Court has subject matter jurisdiction pursuant to 28 U.S.C. 1331, This action arises under the patent laws of the United States, 35 U.S.C. 1

of, inter alia, its conduct of business in this District, the location of its place of business in this District, its purposeful availment of the rights and benefits of New Jersey law, and its substantial and continuing contacts with the state of New Jersey. 21. Wockhardt Ltd. is subject to personal jurisdiction in this District by virtue

of, inter alia, its manufacture of numerous generic drugs for sale and use in this District through Wockhardt USA and its direction and control of the business of Wockhardt USA, through which it conducts business in this District, purposefully avails itself of the rights and benefits of New 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 virtue of, inter

alia, its manufacture of generic pharmaceutical formulations for sale and use in this District, its conduct of business in this District, the location of one of its offices in this District, the location of its U.S. agent in this District, its purposeful availment of the rights and benefits of New Jersey law, including its previous admissions that it is subject to personal jurisdiction in New Jersey, see, e.g., Orexo AB v. Edict Pharms. Pvt. Ltd., No. 3:10-cv-05548 (D.N.J. Oct. 26, 2010), and its substantial and continuing contacts with the state of New Jersey. 23. (d) and 1400(b). Venue is proper in this district pursuant to 28 U.S.C. 1391(b), (c), and

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24.

Wockhardt USA and Wockhardt Ltd. did not contest that they were

subject to personal jurisdiction or that venue was appropriate in New Jersey in another action brought against them by Plaintiffs in this Court, Nautilus Neurosciences, Inc. et al. v. Wockhardt 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 jurisdiction or that

venue was appropriate in New Jersey in another action brought against it by Plaintiffs in this Court, Nautilus Neurosciences, Inc. et al. v. Edict Pharmaceuticals Pvt. Ltd.., Civil Action No. 2:11-4183 (ES/CLW) (D.N.J. July 20, 2011). THE PATENT-IN-SUIT 26. The 651 patent, entitled Diclofenac Formulations and Methods of Use,

was duly and legally issued by the United States Patent and Trademark Office (USPTO) on January 17, 2012. 27. APR owns the entire right, title, and interest in the 651 patent. Nautilus is

the exclusive licensee of the 651 patent for the United States. 28. Nautilus is the holder of New Drug Application (NDA) No. 22-165 for

diclofenac potassium for oral solution 50 mg, sold in the United States under the trademark CAMBIA. The United States Food and Drug Administration (FDA) approved NDA No. 22165 on June 17, 2009. 29. The 651 patent is duly listed in the Orange Book: Approved Drug

Products with Therapeutic Equivalents for NDA No. 22-165 (the Orange Book listing). The claims of the 651 patent cover, inter alia, various methods of using diclofenac.

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ACTS GIVING RISE TO THIS ACTION 30. On information and belief, Wockhardt reviewed the Orange Book listing

for CAMBIA and certain commercial and economic information regarding CAMBIA and decided to file an ANDA seeking approval to market a generic version of CAMBIA. 31. On information and belief, Wockhardt Ltd. has designated Wockhardt

USA as its agent for the purpose of submitting and obtaining approval of ANDA No. 20-2430. 32. On information and belief Wockhardt Ltd. submitted ANDA No. 20-2430

to the FDA to seek approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation into the United States of generic diclofenac potassium for oral solution 50 mg. 33. Plaintiffs received a letter dated March 1, 2011 from Wockhardt

purporting to notify them that Wockhardt had filed ANDA No. 20-2430 with the FDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FDCA) seeking approval to market a generic version of CAMBIA prior to the expiry of U.S. Patent Nos. 6,974,595, 7,482,377, and 7,759,394. 34. The stated purpose of Wockhardts March 1, 2011 letter was to notify

Plaintiffs that ANDA No. 20-2430 included a certification under 21 U.S.C. 355(j)(2)(a)(vii)(IV) (Wockhardts Paragraph IV Certification) that the claims of U.S. Patent Nos. 6,974,595, 7,482,377, and 7,759,394 are invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use, sale, offer for sale, and/or importation into the United States of Wockhardts ANDA product. 35. Attached to the March 1, 2011 letter was a Detailed Statement setting

forth the factual and legal bases for Wockhardts opinion that U.S. Patent Nos. 6,974,595,

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7,482,377, and 7,759,394 are invalid and/or would not be infringed by the commercial manufacture, use, sale, offer for sale, and/or importation into the United States of Wockhardts product. 36. On April 8, 2011, Plaintiffs filed a complaint for infringement by

Wockhardt of U.S. Patent Nos. 6,974,595, 7,482,377, and 7,759,394 in this Court. The case is docketed as Civil Action No. 2:11-cv-01997-ES-CLW. 37. The 651 patent was duly and legally issued by the USPTO on January 17,

2012 and subsequently added to the Orange Book listing. 38. Plaintiffs received a letter dated January 30, 2012 from Wockhardt

purporting to notify them that Wockhardt had amended ANDA No. 20-2430 with the FDA under section 505(j) of the FDCA to seek approval to market a generic version of CAMBIA prior to the expiry of the 651 patent. 39. The stated purpose of Wockhardts January 30, 2012 letter was to notify

Plaintiffs that Wockhardts Paragraph IV Certification was amended to add that the claims of the 651 patent are invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use, sale, offer for sale, and/or importation into the United States of Wockhardts ANDA product. 40. Attached to the January 30, 2012 letter was a Detailed Statement setting

forth the factual and legal bases for Wockhardts opinion that the 651 patent is invalid and/or would not be infringed by the commercial manufacture, use, sale, offer for sale, and/or importation into the United States of Wockhardts product.

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41.

On information and belief, Edict reviewed the Orange Book listing for

CAMBIA and certain commercial and economic information regarding CAMBIA and decided to file an ANDA seeking approval to market a generic version of CAMBIA. 42. On information and belief, Edict submitted ANDA No. 20-2964 to the

FDA to seek approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation into the United States of generic diclofenac potassium for oral solution 50 mg. 43. Plaintiffs received a letter dated June 8, 2011 from Edict notifying them

that Edict had filed ANDA No. 20-2964 with the FDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FDCA) seeking approval to market a generic version of CAMBIA 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 notify Plaintiffs

that ANDA No. 20-2964 included a certification under 21 U.S.C. 355(j)(2)(a)(vii)(IV) (Edicts Paragraph IV Certification) that the claims of U.S. Patent Nos. 6,974,595, 7,482,377, and 7,759,394 are invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use, sale, offer for sale, and/or importation into the United States of Edicts ANDA product. 45. Attached to the June 8, 2011 letter was a Detailed Statement setting

forth the factual and legal bases for Edicts opinion that U.S. Patent Nos. 6,974,595, 7,482,377, and 7,759,394 are invalid and/or would not be infringed by the commercial manufacture, use, sale, offer for sale, and/or importation into the United States of Edicts product. 46. On July 20, 2011, Plaintiffs filed a complaint for infringement by Edict of

U.S. Patent Nos. 6,974,595, 7,482,377, and 7,759,394 in this Court. The case is docketed as Civil Action No. 2:11-cv-04183-ES-CLW.

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47.

The 651 patent was duly and legally issued by the USPTO on January 17,

2012 and subsequently added to the Orange Book listing. 48. Plaintiffs received a letter dated February 7, 2012 from Edict purporting to

notify them that Edict had amended its Paragraph IV Certifications in ANDA No. 20-2964 with the FDA under section 505(j) of the FDCA to seek approval to market a generic version of CAMBIA prior to the expiry of the 651 patent. 49. The stated purpose of Edicts February 7, 2012 letter was to notify

Plaintiffs that Edicts Paragraph IV Certification was amended to add that the claims of the 651 patent are invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use, sale, offer for sale, and/or importation into the United States of Edicts ANDA product. 50. Attached to the February 7, 2012 letter was a Detailed Statement setting

forth the factual and legal bases for Edicts opinion that the 651 patent is invalid and/or would not be infringed by the commercial manufacture, use, sale, offer for sale, and/or importation into the United States of Edicts product. FIRST CLAIM FOR RELIEF (Infringement of the 651 Patent by Wockhardt) 51. 52. Paragraphs 1 through 50 are incorporated herein as set forth above. Wockhardt submitted ANDA No. 20-2430 with a Paragraph IV

Certification, along with a subsequent amendment, to the FDA under section 505(j) of the FDCA to obtain approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation into the United States of diclofenac potassium for oral solution prior to the expiration of the 651 patent. By submitting this ANDA, Wockhardt has committed an act of infringement under 35 U.S.C. 271(e)(2).

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53.

Unless enjoined by this Court, Wockhardt, upon FDA approval of the

amended ANDA No. 20-2430, will manufacture, use, sell, offer for sale, and/or import into the United States the proposed generic diclofenac potassium product described in ANDA No. 202430, thereby actively inducing others to infringe or contributing to the infringement of the 651 patent under 35 U.S.C. 271(b) and/or (c). 54. Plaintiffs will be substantially and irreparably harmed if Wockhardt is not

enjoined from infringing the 651 patent. 55. 56. Plaintiffs do not have an adequate remedy at law. An actual and justiciable controversy exists between the parties with

respect to the 651 patent. 57. 285. SECOND CLAIM FOR RELIEF (Infringement of the 651 Patent by Edict) 58. 59. Paragraphs 1 through 57 are incorporated herein as set forth above. Edict submitted ANDA No. 20-2964 with a Paragraph IV Certification, Wockhardts actions render this an exceptional case under 35 U.S.C.

along with a subsequent amendment, to the FDA under section 505(j) of the FDCA to obtain approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation into the United States of diclofenac potassium for oral solution prior to the expiration of the 651 patent. By submitting this ANDA, Edict has committed an act of infringement under 35 U.S.C. 271(e)(2). 60. Unless enjoined by this Court, Edict, upon FDA approval of the amended

ANDA No. 20-2964, will manufacture, use, sell, offer for sale, and/or import into the United

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States the proposed generic diclofenac potassium product described in ANDA No. 20-2964, thereby actively inducing others to infringe or contributing to the infringement of the 651 patent under 35 U.S.C. 271(b) and/or (c). 61. Plaintiffs will be substantially and irreparably harmed if Edict is not

enjoined from infringing the 651 patent. 62. 63. the 651 patent. 64. Edicts actions render this an exceptional case under 35 U.S.C. 285. Plaintiffs do not have an adequate remedy at law. An actual justiciable controversy exists between the parties with respect to

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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 to the FDA,

along with a subsequent amendment, Wockhardt has infringed the 651 patent under 35 U.S.C. 271(e)(2); B. A declaration that, through the commercial manufacture, use, sale, offer

for sale, and/or importation into the United States of the proposed generic diclofenac potassium product described in ANDA No. 20-2430, Wockhardt will actively induce others to infringe or 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 the effective

date of any approval of ANDA No. 20-2430 be no earlier than the expiration date of the 651 patent including any applicable extensions; D. A preliminary and permanent injunction restraining and enjoining

Wockhardt, its officers, agents, attorneys, and employees and those acting in privity or concert with it, from engaging in the commercial manufacture, use, sale, and/or offer for sale within the United States and/or importation into the United States of the diclofenac product described in ANDA No. 20-2430 or any other product not colorably different from the product of ANDA No. 20-2430 until the expiration date of the 651 patent, including any applicable extensions; E. An order decreeing that, by submitting ANDA No. 20-2964 to the FDA,

along with a subsequent amendment, Edict has infringed the 651 patent under 35 U.S.C. 271(e)(2); F. A declaration that, through the commercial manufacture, use, sale, offer

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

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product described in ANDA No. 20-2964, Edict will actively induce others to infringe or 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 the effective

date of any approval of ANDA No. 20-2964 be no earlier than the expiration date of the 651 patent, including any applicable extensions; H. A preliminary and permanent injunction restraining and enjoining Edict,

its officers, agents, attorneys, and employees and those acting in privity or concert with it, from engaging in the commercial manufacture, use, sale, and/or offer for sale within the United States and/or importation into the United States of the diclofenac product described in ANDA No. 202964 or any other product not colorably different from the product of ANDA No. 20-2964 until the expiration date of the 651 patent, including any applicable extensions; I. J. A declaration that this case is exceptional under 35 U.S.C. 285; An award of attorney fees, costs, and expenses that Plaintiffs incur in

prosecuting this action; and K. Such other and further relief as the Court may deem just and proper.

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Dated: February 27, 2012

CONNELL FOLEY LLP Attorneys for Plaintiffs Nautilus Neurosciences, Inc. and APR Applied Pharma Research SA

By:

/s Liza M. Walsh_________ Liza M. Walsh Rukhsanah L. Lighari 85 Livingston Avenue Roseland, New Jersey 07068 Telephone: (973) 535-0500 Facsimile: (973) 535-9217

Of Counsel: Thomas J. Meloro Michael W. Johnson Ketan Pastakia Laurie N. Stempler Willkie Farr & Gallagher LLP 787 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 these parties is not the subject of any other pending or anticipated litigation in any court or arbitration proceeding, nor are there any non-parties known to Plaintiffs that should be joined to this action, with the exception that related patents are the subject of two other, coordinated actions pending in this Court which involve the same parties: Nautilus Neurosciences, Inc. et al. v. Wockhardt USA LLC et al., Civil Action No. 2:11-1997 (ES/CLW) (D.N.J. April 8, 2011); Nautilus Neurosciences, Inc. et al. v. Edict Pharmaceuticals Pvt. Ltd.., Civil Action No. 2:11-4183 (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 arbitration 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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