nautilus neurosciences et. al. v. wockhardt et. al
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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.
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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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