Case 3:12-cv-03893-PGS-LHG Document 1 Filed 06/25/12 Page 1 of 41 PageID: 1 Liza M. Walsh CONNELL FOLEY LLP 85 Livingston Avenue Roseland, New Jersey 07068 (973) 535-0500 Of Counsel: Dimitrios T. Drivas Adam Gahtan Brendan G. Woodard Jayashree Mitra WHITE & CASE LLP 1155 Avenue of the Americas New York, NY 10036 (212) 819-8200 Attorneys for Pfizer Inc., Wyeth LLC, Wyeth Pharmaceuticals Inc. and PF Prism C.V. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY PFIZER INC., WYETH LLC, WYETH PHARMACEUTICALS INC., and PF PRISM C.V., v. Plaintiffs, ZYDUS PHARMACEUTICALS (USA), INC., and CADILA HEALTHCARE LTD. d/b/a ZYDUS CADILA, Defendants. ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) Civil Action No. COMPLAINT Plaintiffs Pfizer Inc., Wyeth LLC, Wyeth Pharmaceuticals Inc., and PF Prism C.V. (collectively Plaintiffs ), by their undersigned attorneys, for their Complaint against Defendants
Case 3:12-cv-03893-PGS-LHG Document 1 Filed 06/25/12 Page 2 of 41 PageID: 2 Cadila Healthcare Ltd. d/b/a Zydus Cadila and Zydus Pharmaceuticals (USA), Inc. (collectively, Zydus ) herein allege: NATURE OF THE ACTION 1. This is an action for patent infringement under the patent laws of the United States, Title 35 of the United States Code, arising from Zydus s filing of an Abbreviated New Drug Application ( ANDA ) with the United States Food and Drug Administration ( FDA ) seeking approval to market a generic version of Pfizer s pharmaceutical product Pristiq prior to the expiration of United States Patent No. 6,673,838 ( the 838 patent ) which covers Pristiq and its uses. THE PARTIES 2. Plaintiff Pfizer Inc. is a corporation organized and existing under the laws of the State of Delaware, having a place of business at 235 East 42nd Street, New York, New York. 3. Plaintiff Wyeth LLC is a limited liability company organized and existing under the laws of the State of Delaware, having a place of business at 5 Giralda Farms, Madison, NJ 07940. Pfizer Inc. is the ultimate parent of Wyeth LLC. 4. Plaintiff Wyeth Pharmaceuticals Inc. is a corporation organized and existing under the laws of the State of Delaware, having a place of business at 500 Arcola Road, Collegeville, PA 19426. Pfizer Inc. is the ultimate parent of Wyeth Pharmaceuticals Inc. 5. Plaintiff PF Prism C.V. is a Netherlands limited partnership (commanditaire vennootschap) having its registered seat in Rotterdam, the Netherlands, and registered at the Trade Register held by the Chamber of Commerce of Rotterdam, the -2-
Case 3:12-cv-03893-PGS-LHG Document 1 Filed 06/25/12 Page 3 of 41 PageID: 3 Netherlands, under number 51840456, with main offices at Blaak 40 basement, 3011 TA, Rotterdam, Netherlands. Pfizer Inc. is the ultimate parent of PF Prism C.V. 6. On information and belief, Zydus Pharmaceuticals (USA), Inc. is a corporation organized and existing under the laws of the State of New Jersey, with its principal place of business at 73 Route 31 N., Pennington, NJ 08534. On information and belief, Zydus Pharmaceuticals (USA), Inc. manufactures and/or distributes numerous generic drug products for marketing, sale, and/or use throughout the United States, including in this judicial district. Zydus Pharmaceuticals (USA), Inc. has previously submitted to jurisdiction in this Court, and has purposefully availed itself of the jurisdiction of this Court by filing lawsuits and asserting counterclaims in lawsuits filed in the United States District Court for the District of New Jersey. On information and belief, Zydus Pharmaceuticals (USA), Inc. is a wholly-owned subsidiary of Cadila Healthcare Ltd. d/b/a Zydus Cadila ( Zydus Cadila ). 7. On information and belief, Zydus Cadila is a corporation organized and existing under the laws of India, having a principal place of business at Zydus Tower, Satellite Cross Roads, Ahmedabad, 380015 Gujarat, India. On information and belief, Zydus Cadila is in the business of, among other things, developing, manufacturing, and selling generic versions of branded pharmaceutical products for the U.S. market through various directly or indirectly owned operating subsidiaries, including its wholly-owned subsidiary, Zydus Pharmaceuticals (USA), Inc. On information and belief, Zydus Cadila established Zydus Pharmaceuticals (USA), Inc. for the purposes of distributing, marketing, offering for sale and/or selling its generic drug products throughout the United States, including this judicial district. On information and belief Zydus Cadila and Zydus Pharmaceuticals (USA), Inc. work in concert with one another for purposes of developing, manufacturing, marketing, and selling generic drug products throughout -3-
Case 3:12-cv-03893-PGS-LHG Document 1 Filed 06/25/12 Page 4 of 41 PageID: 4 JURISDICTION AND VENUE 8. This Court has subject matter jurisdiction over this action pursuant to 28 U.S.C. 1331 and 1338(a). 9. This Court has personal jurisdiction over Zydus by virtue of, inter alia, its presence in New Jersey, having conducted business in New Jersey, having availed itself of the rights and benefits of New Jersey law, previously consenting to personal jurisdiction in this Court, availing itself of the jurisdiction of this Court, and having engaged in systematic and continuous contacts with the State of New Jersey. 10. Venue is proper in this District pursuant to 28 U.S.C. 1391 and 1400(b). THE PATENT-IN-SUIT 11. On January 6, 2004, the United States Patent and Trademark Office issued the 838 patent, entitled Succinate Salt of O-Desmethyl Venlafaxine. At the time of its issue, the 838 patent was assigned to Wyeth (now Wyeth LLC), Madison NJ, and Wyeth LLC currently holds title to the 838 patent. A copy of the 838 patent is attached hereto as Exhibit A. PRISTIQ 12. Pfizer Inc., itself and through its wholly owned indirect subsidiary Wyeth Pharmaceuticals, Inc., holds approved New Drug Application No. 21-992 ( the Pristiq NDA ) for O-desmethylvenlafaxine succinate extended release tablets in 50 and 100 mg dosage strengths, which are sold by Pfizer Inc. under the trade name Pristiq. -4-
Case 3:12-cv-03893-PGS-LHG Document 1 Filed 06/25/12 Page 5 of 41 PageID: 5 13. Pursuant to 21 U.S.C. 355(b)(1), and attendant FDA regulations, the 838 patent is listed in the FDA publication, Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book ), with respect to Pristiq. ZYDUS S ANDA 14. On information and belief, Zydus submitted ANDA No. 204020 ( the Zydus ANDA ) to the FDA, pursuant to 21 U.S.C. 355(j), seeking approval to market O- desmethylvenlafaxine succinate extended release tablets in 50 and 100 mg dosage strengths. The O-desmethylvenlafaxine succinate extended release tablets described in the Zydus ANDA are herein referred to as the Zydus Products. 15. The Zydus ANDA refers to and relies upon the Pristiq NDA and contains data that, according to Zydus, demonstrate the bioequivalence of the Zydus Products and Pristiq. 16. Pfizer has received from Zydus a letter, dated May 14, 2012 (the Zydus Notification ), stating that Zydus had included a certification in the Zydus ANDA, pursuant to 21 U.S.C. 355(j)(2)(A)(vii)(IV), that the 838 patent is invalid, or will not be infringed by the commercial manufacture, use, or sale of the Zydus Products (the Paragraph IV Certification ). COUNT FOR INFRINGEMENT OF U.S. PATENT NO. 6,673,838 17. Plaintiffs reallege and incorporate by reference the allegations of paragraphs 1-16 of this Complaint. 18. Zydus has infringed the 838 patent, pursuant to 35 U.S.C. 271(e)(2)(A), by submitting the Zydus ANDA, by which Zydus seeks approval from the FDA to engage in the commercial manufacture, use, offer to sell, sale, or importation of the Zydus Products prior to the expiration of the 838 patent. -5-
Case 3:12-cv-03893-PGS-LHG Document 1 Filed 06/25/12 Page 6 of 41 PageID: 6 19. Zydus s commercial manufacture, use, offer to sell, or sale of the Zydus Products within the United States, or importation of the Zydus Products into the United States during the term of the 838 patent would further infringe the 838 patent under 35 U.S.C. 271(a), (b), and/or (c). 20. Plaintiffs will be substantially and irreparably harmed if Zydus is not enjoined from infringing the 838 patent. 21. Plaintiffs have no adequate remedy at law. 22. This case is an exceptional one, and Plaintiffs are entitled to an award of attorneys fees under 35 U.S.C. 285. PRAYER FOR RELIEF WHEREFORE, Pfizer Inc., Wyeth LLC, Wyeth Pharmaceuticals Inc. and PF Prism C.V. pray for a judgment in their favor and against Defendants Zydus Pharmaceuticals (USA), Inc. and Cadila Healthcare Ltd. d/b/a Zydus Cadila and respectfully request the following relief: A. A judgment declaring that Zydus has infringed U.S. Patent No. 6,673,838; B. A judgment pursuant to 35 U.S.C. 271(e)(4)(B) preliminarily and permanently enjoining Zydus, its officers, agents, servants, and employees, and those persons in active concert or participation with any of them, from manufacturing, using, offering to sell, or selling the Zydus Products within the United States, or importing the Zydus Products into the United States, prior to the expiration date of the 838 patent; C. A judgment ordering that pursuant to 35 U.S.C. 271(e)(4)(A), the effective date of any approval of ANDA No. 204020 under 505(j) of the Federal Food, Drug -6-
Case 3:12-cv-03893-PGS-LHG Document 1 Filed 06/25/12 Page 7 of 41 PageID: 7 and Cosmetic Act (21 U.S.C. 355(j)) shall not be earlier than the expiration date of the 838 patent, including any extensions; D. If Zydus commercially manufactures, uses, offers to sell, or sells the Zydus Products within the United States, or imports the Zydus Products into the United States, prior to the expiration date of 838 patent, including any extensions, a judgment awarding Plaintiffs monetary relief together with interest; E. Attorneys fees in this action as an exceptional case pursuant to 35 U.S.C. 285; F. Costs and expenses in this action; and G. Such other relief as the Court deems just and proper. -7-
Case 3:12-cv-03893-PGS-LHG Document 1 Filed 06/25/12 Page 8 of 41 PageID: 8 CONNELL FOLEY s/liza M. Walsh Liza M. Walsh 85 Livingston Avenue Roseland, New Jersey 07068 (973) 535-0500 lwalsh@connellfoley.com Attorneys for Pfizer Inc., Wyeth LLC, Wyeth Pharmaceuticals Inc. and PF Prism C.V. Of Counsel: Dimitrios T. Drivas Adam Gahtan Brendan G. Woodard Jayashree Mitra WHITE & CASE LLP 1155 Avenue of the Americas New York, NY 10036 (212) 819-8200 June 25, 2012-8-
Case 3:12-cv-03893-PGS-LHG Document 1 Filed 06/25/12 Page 9 of 41 PageID: 9 LOCAL CIVIL RULE 11.2 CERTIFICATION I certify that, to the best of my knowledge, the matter in controversy between these parties is the subject of a pending litigation involving the same patent-in-suit in the United States District Court for the District of Delaware, Case 1:12-cv-00818, filed on June 22, 2012. I further 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 of that action disclosed above and with the exception that the patent at issue in this Complaint is the subject of the following actions: Pfizer Inc. et al. v. Sandoz Inc., Civ. Action No. (D.N.J.) (filed June 25, 2012); Pfizer Inc. et al. v. Sandoz Inc., Case 1:12-cv-00814 (D. Del.) (filed June 22, 2012); Pfizer Inc. et al. v. Lupin Ltd. et al., Case 1:12-cv-00811 (D. Del.) (filed June 22, 2012); Pfizer Inc. et al. v. Teva Pharmaceuticals USA, Inc. et al., Case 1:12-cv-00815 (D. Del.) (filed June 22, 2012); Pfizer Inc. et al. v. Wockhardt, Ltd. et al., Case 1:12-cv-00817 (D. Del.) (filed June 22, 2012); Pfizer Inc. et al. v. Apotex Inc. et al., Case 1:12-cv-00809 (D. Del.) (filed June 22, 2012); Pfizer Inc. et al. v. Watson Laboratories, Inc. - Florida et al., Case 1:12-cv-00816 (D. Del.) (filed June 22, 2012); Pfizer Inc. et al. v. Anchen Pharmaceuticals, Inc. et al., Case 1:12-cv-00808 (D. Del.) (filed June 22, 2012); Pfizer Inc. et al. v. Mylan Pharmaceuticals Inc. et al., Case 1:12-cv-00812 (D. Del.) (filed June 22, 2012); -9-
Case 3:12-cv-03893-PGS-LHG Document 1 Filed 06/25/12 Page 10 of 41 PageID: 10 Pfizer Inc. et al. v. Roxane Laboratories, Inc. et al., Case 1:12-cv-00813 (D. Del.) (filed June 22, 2012); and Pfizer Inc. et al. v. Breckenridge Pharmaceuticals, Inc. et al., Case 1:12-00810 (D. Del.) (filed June 22, 2012). Dated: June 25, 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: June 25, 2012 s/liza M. Walsh Liza M. Walsh -10-
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