Liza M. Walsh 

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 and 

WOCKHARDT LTD., 

 Defendants. 

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Civil Action No. _____________ 

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”) and Wockhardt Ltd. (collectively 

“Defendants”), hereby allege as follows: 

PARTIES

1. Nautilus is a Delaware corporation with its principal place of business at 

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. 

NATURE OF THE ACTION

9. This is a civil action for infringement of U.S. Patent Nos. 6,974,595 (the 

“’595 patent”), 7,482,377 (the “’377 patent”), and 7,759,394 (the “’394 patent”) (collectively, 

the “patents-in-suit”), which are attached as Exhibits A, B, and C, respectively. 

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10. This action is based upon the Patent Laws of the United States, 35 U.S.C. 

§ 1 et seq., and arises out of Defendants’ filing of an Abbreviated New Drug Application 

(“ANDA”) No. 20-2430 seeking approval to sell diclofenac potassium for oral solution 50 mg 

prior to the expiration of the patents-in-suit, which are assigned to and/or exclusively licensed by 

Plaintiffs and listed in the publication entitled “Orange Book: Approved Drug Products with 

Therapeutic Equivalents.” 

JURISDICTION AND VENUE

11. This action arises under the patent laws of the United States, 35 U.S.C. § 1 

et seq.

12. This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331, 

1338(a), and 2201(a). 

13. Wockhardt USA is subject to personal jurisdiction in this District by virtue 

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. 

14. 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. 

15. Venue is proper in this district pursuant to 28 U.S.C. §§ 1391(b), (c), and 

(d) and 1400(b). 

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THE PATENTS-IN-SUIT

16. The ’595 patent, entitled “Pharmaceutical Compositions Based on 

Diclofenac,” was duly and legally issued by the United States Patent and Trademark Office 

(“USPTO”) on December 13, 2005. 

17. APR owns the entire right, title, and interest in the ’595 patent. Nautilus is 

the exclusive licensee of the ’595 patent for the United States. 

18. The ’377 patent, entitled “Pharmaceutical Compositions and Methods of 

Treatment Based on Diclofenac,” was duly and legally issued by the USPTO on January 27, 

2009. 

19. APR owns the entire right, title, and interest in the ’377 patent. Nautilus is 

the exclusive licensee of the ’377 patent for the United States. 

20. The ’394 patent, entitled “Diclofenac Formulations and Methods of Use,” 

was duly and legally issued by the USPTO on July 10, 2010. 

21. APR owns the entire right, title, and interest in the ’394 patent. Nautilus is 

the exclusive licensee of the ’394 patent for the United States. 

22. 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. 22-

165 on June 17, 2009. 

23. The patents-in-suit are duly listed in the Orange Book: Approved Drug 

Products with Therapeutic Equivalents for NDA No. 22-165. The claims of the patents-in-suit 

cover, inter alia, various methods of using diclofenac. 

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ACTS GIVING RISE TO THIS ACTION

24. On information and belief, Defendants reviewed each of the patents-in-suit 

and certain commercial and economic information regarding CAMBIA and decided to file an 

ANDA seeking approval to market a generic version of CAMBIA. 

25. 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. 

26. 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. 

27. Plaintiffs received a letter dated March 1, 2011 from Defendants 

purporting to notify them that Defendants 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 the patents-in-suit. 

28. The stated purpose of Defendants’ 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) 

(“Paragraph IV Certification”) that the claims of the patents-in-suit 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 Defendants’ ANDA product. 

29. On information and belief, Defendants were necessarily aware of each of 

the patents-in-suit when Wockhardt Ltd. filed ANDA No. 20-2430 with a Paragraph IV 

Certification. 

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30. Attached to the March 1, 2011 letter was a “Detailed Statement” 

purporting to set forth the factual and legal bases for Defendants’ opinion that the patents-in-suit 

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 Defendants’ product. 

31. The subject line of Defendants’ March 1, 2011 letter reads “Notice of 

Paragraph IV Certification Regarding ANDA No. 202430 (Diclofenac Potassium Tablets) with 

respect to U.S. Patent Nos. 6,974,595, 7,482,377, and 7,759,394.” 

32. Defendants’ March 1, 2011 letter states that “Wockhardt’s proposed drug 

product is in the form of a tablet, which contains the equivalent of 50 mg per tablet of Diclofenac 

Potassium as the active ingredient.” 

33. The Detailed Statement states that “Wockhardt’s diclofenac product is a 

powder for solution.” 

34. On information and belief, ANDA No. 20-2430 seeks approval for 

diclofenac potassium powder for oral solution 50 mg. 

35. Nautilus received the March 1, 2011 letter no earlier than March 1, 2011. 

APR received the March 1, 2011 letter no earlier than March 1, 2011. Plaintiffs commenced this 

action within 45 days of the date upon which they received Defendants’ March 1, 2011 letter. 

FIRST CLAIM FOR RELIEF

(Infringement of the ’595 Patent by Defendants) 

36. Paragraphs 1 through 35 are incorporated herein as set forth above. 

37. Defendants submitted ANDA No. 20-2430 with a Paragraph IV 

Certification 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 

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diclofenac potassium for oral solution prior to the expiration of the ’595 patent. By submitting 

this ANDA, Defendants have committed an act of infringement under 35 U.S.C. § 271(e)(2). 

38. Unless enjoined by this Court, Defendants, upon FDA approval of 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. 20-2430, thereby 

actively inducing others to infringe or contributing to the infringement of the ’595 patent under 

35 U.S.C. § 271(b) and/or (c). 

39. Plaintiffs will be substantially and irreparably harmed if Defendants are 

not enjoined from infringing the ’595 patent. 

40. Plaintiffs do not have an adequate remedy at law. 

41. An actual and justiciable controversy exists between the parties with 

respect to the ’595 patent. 

42. Defendants were aware of the existence of the ’595 patent prior to the 

filing of ANDA No. 20-2430 but took such action knowing that it would constitute infringement 

of the ’595 patent. 

43. Defendants’ actions render this an exceptional case under 35 U.S.C. § 285. 

SECOND CLAIM FOR RELIEF

(Infringement of the ’377 Patent by Defendants) 

44. Paragraphs 1 through 43 are incorporated herein as set forth above. 

45. Defendants submitted ANDA No. 20-2430 with a Paragraph IV 

Certification 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 

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diclofenac potassium for oral solution prior to the expiration of the ’377 patent. By submitting 

this ANDA, Defendants have committed an act of infringement under 35 U.S.C. § 271(e)(2). 

46. Unless enjoined by this Court, Defendants, upon FDA approval of 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. 20-2430, thereby 

actively inducing others to infringe or contributing to the infringement of the ’377 patent under 

35 U.S.C. § 271(b) and/or (c). 

47. Plaintiffs will be substantially and irreparably harmed if Defendants are 

not enjoined from infringing the ’377 patent. 

48. Plaintiffs do not have an adequate remedy at law. 

49. An actual justiciable controversy exists between the parties with respect to 

the ’377 patent. 

50. Defendants were aware of the existence of the ’377 patent prior to the 

filing of ANDA No. 20-2430 but took such action knowing that it would constitute infringement 

of the ’377 patent. 

51. Defendants’ actions render this an exceptional case under 35 U.S.C. § 285. 

THIRD CLAIM FOR RELIEF

(Infringement of the ’394 patent by Defendants) 

52. Paragraphs 1 through 51 are incorporated herein as set forth above. 

53. Defendants submitted ANDA No. 20-2430 with a Paragraph IV 

Certification 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 

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diclofenac potassium for oral solution prior to the expiration of the ’394 patent. By submitting 

this ANDA, Defendants have committed an act of infringement under 35 U.S.C. § 271(e)(2). 

54. Unless enjoined by this Court, Defendants, upon FDA approval of 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. 20-2430, thereby 

actively inducing others to infringe or contributing to the infringement of the ’394 patent under 

35 U.S.C. § 271(b) and/or (c). 

55. Plaintiffs will be substantially and irreparably harmed if Defendants are 

not enjoined from infringing the ’394 patent. 

56. Plaintiffs do not have an adequate remedy at law. 

57. An actual justiciable controversy exists between the parties with respect to 

the ’394 patent. 

58. Defendants were aware of the existence of the ’394 patent prior to the 

filing of ANDA No. 20-2430 but took such action knowing that it would constitute infringement 

of the ’394 patent. 

59. Defendants’ actions render this an exceptional case under 35 U.S.C. § 285. 

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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, 

Defendants have infringed the patents-in-suit 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, Defendants will actively induce others to infringe or 

contribute to the infringement of the patents-in-suit 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 last to 

expire of the patents-in-suit, including any applicable extensions; 

 D. A preliminary and permanent injunction restraining and enjoining 

Defendants, their officers, agents, attorneys, and employees and those acting in privity or concert 

with them, 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 of the last to expire of the patents-in-suit, including any applicable 

extensions; 

 E. A declaration that this case is exceptional under 35 U.S.C. § 285; 

 F. An award of attorney fees, costs, and expenses that Plaintiffs incur in 

prosecuting this action; and 

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

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Dated: April 8, 2011 CONNELL FOLEY LLP

 Attorneys for Plaintiffs 

Nautilus Neurosciences, Inc. and 

APR Applied Pharma Research SA 

 By:___/s Liza M. Walsh ______________ 

 Liza M. Walsh 

 85 Livingston Avenue 

 Roseland, New Jersey 07068 

 Telephone: (973) 535-0500 

 Facsimile: (973) 535-9217 

Of Counsel: 

Thomas J. Meloro 

Michael W. Johnson 

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 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. In addition, I recognize a 

continuing obligation during the course of this litigation to file and to serve on all other parties 

and with the Court an amended certification if there is a change in the facts stated in this original 

certification. 

Dated: April 8, 2011 _____/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: April 8, 2011 ___/s Liza M. Walsh______________ 

 Liza M. Walsh 

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