Case 1:11-cv-01105-RGA Document 10 Filed 01/13/12 Page 1 of 14 PageID #: 47 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE WARNER CHILCOTT COMPANY, LLC, v. Plaintiff, ZYDUS PHARMACEUTICALS (USA INC., and CADILA HEALTHCARE LIMITED (d/b/a ZYDUS CADILA Defendants. Civil Action No. 1:11-cv-Ol105-RGA DEFENDANTS ZYDUS PHARMACEUTICALS (USA INC. AND CADILA HEAL THCARE LIMITED'S ANSWER, AFFIRMATIVE DEFENSES, AND COUNTERCLAIMS TO PLAINTIFF'S COMPLAINT Defendants Zydus Pharmaceuticals (USA Inc. ("Zydus USA" and Cadila Healthcare Limited ("Cadila" (collectively, "Defendants", for their Answer, Affirmative Defenses, and Counterclaims to the Complaint of Warner Chilcott Company, LLC ("Plaintiff', state as follows: All averments not expressly admitted are denied. THE PARTIES 1. Defendants lack knowledge or information sufficient to form a belief about the truth of the allegations in paragraph 1 and therefore deny them. 2. Defendants lack knowledge or information sufficient to form a belief about the truth of the allegations in paragraph 2 and therefore deny them. 3. Admitted. 4. Admitted. 1
Case 1:11-cv-01105-RGA Document 10 Filed 01/13/12 Page 2 of 14 PageID #: 48 5. Defendants admit that Zydus USA markets, sells, and distributes drugs, including drugs manufactured by Cadila, in the United States, including in this judicial district. Defendants deny all other allegations in paragraph 5. 6. Denied. 7. Defendants admit that Cadila assisted Zydus USA in the preparation and submission of ANDA No. 203-286. Defendants deny all other allegations in paragraph 7. 8. Denied. JURISDICTION AND VENUE 9. The allegations in paragraph 9 are legal conclusions to which no response is required. To the extent a response is required, Defendants admit that Plaintiff's Complaint purports to be a civil action arising under the patent laws of the United States, Title 35 of the United States Code, alleging infringement of United States Patent No. 6,893,662 ("the '662 patent", but deny that Defendants have infringed the '662 patent or that Plaintiff is entitled to the relief requested. Defendants do not contest subject-matter jurisdiction in this Court for purposes of Plaintiff's claims against Defendants in this case. Defendants deny all other allegations in paragraph 9. 10. The allegations in paragraph 10 are legal conclusions to which no response is required. To the extent a response is required, Defendants deny the allegations in paragraph 10. Defendants do not contest personal jurisdiction in this Court for purposes of Plaintiff s claims against Defendants in this case. 11. Defendants admit that the language quoted in the first sentence can be found at 2
Case 1:11-cv-01105-RGA Document 10 Filed 01/13/12 Page 3 of 14 PageID #: 49 http://www.zyduscadila.com. but deny that the quoted language completely and accurately sets forth the information available on that website. Defendants further admit that the language quoted in the second sentence can be found at http://www.zyduscadila.comlkeyfacts.html. but deny that the quoted language completely and accurately set forth the information available on that website. Defendants admit that Cadila's 2010-11 Annual Report states that posted sales in the United States were "up by 44% y-y, with launch of 11 new products," but deny that the allegations in the third sentence completely and accurately set forth the information in that document. Defendants admit that the language quoted in the fourth sentence appears in Cadila's 2010-11 Annual Report, but deny that the quoted language completely and accurately sets forth the information in that document. Defendants admit that the website http://www.zyduscadila.comis accessible in the State of Delaware and in this judicial district. Defendants deny all other allegations in paragraph 11. 12. Defendants admit that Zydus USA has more than seventy authorized distributors for its drug products, including Walgreens Co., Rite Aid, Wal-Mart, and CVS Pharmacy. Defendants further admit that Zydus USA sells pharmaceutical products, including paroxetine tablets, ribavirin tablets, and famotidine for oral suspension, to distributors. Defendants deny all other allegations in paragraph 12. 13. The allegations in paragraph 13 are legal conclusions to which no response is required. To the extent a response is required, Defendants lack knowledge or information sufficient to form a belief about the truth of the allegations in paragraph 13 and therefore deny them. 14. The allegations in paragraph 14 are legal conclusions to which no response is 3
Case 1:11-cv-01105-RGA Document 10 Filed 01/13/12 Page 4 of 14 PageID #: 50 required. To the extent a response is required, Defendants admit that Zydus Healthcare (USA LLC is incorporated under the laws of the State of Delaware. Defendants deny all other allegations in paragraph 14. 15. Defendants admit that a document submitted to the FDA on April 3, 2007 erroneously refers to Zydus Pharmaceuticals USA, Inc. as a Delaware corporation. Defendants further admit that a document submitted to the FDA on June 16,2006 erroneously refers to Zydus Pharmaceuticals USA, Inc. as a Delaware corporation. Defendants deny all other allegations in paragraph 15. 16. The allegations in paragraph 16 are legal conclusions to which no response is required. To the extent a response is required, Defendants admit that they have asserted counterclaims in Somaxon Pharmaceuticals, Inc. v. Zydus Pharmaceuticals USA, Inc., Case No. ll-cv-00537-slr (D. Del., Shire Development Inc., et al. v. Cadila Healthcare Limited, Case No. 10-cv-00581-KAJ (D. Del., and Wyeth v. Cadila Healthcare Limited, Case No. 09-cv- 00239-JJF (D. Del.. Defendants deny all other allegations in paragraph 16. 17. The allegations in paragraph 17 are legal conclusions to which no response is required. To the extent a response is required, Defendants do not contest venue in this judicial district for purposes of Plaintiff s claims against Defendants in this case. REGULATORY REQUIREMENTS FOR APPROVAL OF NEW DRUGS AND GENERIC DRUGS 18. The allegations in paragraph 18 are legal conclusions to which no response is required. To the extent that a response is required, Defendants deny that paragraph 18 completely and accurately sets forth the requirements for a New Drug Application or the 4
Case 1:11-cv-01105-RGA Document 10 Filed 01/13/12 Page 5 of 14 PageID #: 51 language of21 U.S.C. 355(a, and therefore deny the allegations of paragraph 18. 19. The allegations in paragraph 19 are legal conclusions to which no response is required. To the extent that a response is required, Defendants deny that paragraph 19 completely and accurately sets forth the requirements for an Abbreviated New Drug Application or the language of21 U.S.C. 355G(2(A(iv, and therefore deny the allegations of paragraph 19. 20. The allegations in paragraph 20 are legal conclusions to which no response is required. To the extent that a response is required, Defendants deny that paragraph 20 completely and accurately sets forth the requirements for an Abbreviated New Drug Application or the language of21 U.S.C. 3550, and therefore deny the allegations of paragraph 20. 21. The allegations in paragraph 21 are legal conclusions to which no response is required. To the extent that a response is required, Defendants deny that paragraph 21 completely and accurately sets forth the requirements for an Abbreviated New Drug Application or the language of21 U.S.C. 3550(2(A(i, and therefore deny the allegations of paragraph 21. 22. The allegations in paragraph 22 are legal conclusions to which no response is required. To the extent that a response is required, Defendants deny that paragraph 22 completely and accurately sets forth the requirements for a New Drug Application or an Abbreviated New Drug Application or the language of21 U.S.C. 355(a, and therefore deny the allegations of paragraph 22. WARNER CIDLCOTT'S APPROVED DRUG PRODUCT 5
Case 1:11-cv-01105-RGA Document 10 Filed 01/13/12 Page 6 of 14 PageID #: 52 23. Defendants admit upon information and belief that Warner Chilcott is the holder ofnda No. 02-1830, for a delayed-release oral tablet containing 800 mg of mesal amine, and that FDA lists ASACOL HD as the brand name associated with NDA No. 02-1830. Defendants further admit upon information and belief that the package insert for ASACOL HD states that it is indicated for the treatment of moderately active ulcerative colitis. Defendants lack knowledge or information sufficient to form a belief about the truth of the remaining allegations in paragraph 23 and therefore deny them. 24. Defendants admit that the '662 patent, the' 170 patent, and the' 171 patent are currently listed in the electronic version of the Orange Book at http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfin? Appl_ N 0=02183 O&Product No=001&table1=OB Rx in connection with NDA No. 02-1830. Defendants deny all other - - allegations in paragraph 24. 25. The allegations in paragraph 25 state legal conclusions to which no response is required. To the extent that a response is required, Defendants lack knowledge or information sufficient to form a belief about the truth of the allegations in the first sentence of paragraph 25 and therefore deny them. With respect to the second sentence, Defendants admit only that there is currently no independent cause of action challenging the propriety of the listing of the '662 patent, the' 170 patent, and the' 171 patent in the Orange Book. Defendants deny all other allegations in paragraph 25. ANDA NO. 203-286 26. Defendants admit that on July 12,2011 Zydus USA submitted to FDA ANDA No. 203-286 seeking FDA approval to engage in the commercial manufacture and sale of the 6
Case 1:11-cv-01105-RGA Document 10 Filed 01/13/12 Page 7 of 14 PageID #: 53 proposed 800 mg mesalamine delayed-release oral tablet described therein. Defendants further admit that, in connection with the submission of ANDA No. 203-286, Zydus USA submitted a paragraph III certification under section 505G(2(A(vii(III of the Federal Food, Drug, and Cosmetic Act ("FDCA", 21 U.S.C. 355G(2(A(vii(III, and a paragraph IV certification under section 505G(2(A(vii(IV of the FDCA, 21 U.S.C. 355G(2(A(vii(IV. Defendants deny all other allegations in paragraph 26. 27. Defendants admit that the proposed labeling submitted in ANDA No. 203-286 states that the proposed 800 mg mesalamine delayed-release oral tablet described therein is indicated for the treatment of moderately active ulcerative colitis. Defendants further admit upon information and belief that the package insert for ASACOL HD states that it is indicated for the treatment of moderately active ulcerative colitis. Defendants deny all other allegations in paragraph 27. 28. Defendants admit that Zydus USA transmitted a letter dated September 26,2011 to Plaintiff. Defendants further admit that the letter notified Plaintiff that Zydus USA submitted to FDA ANDA No. 203-286 under 21 U.S.C. 3550, which identified ASACOL HD as the Reference Listed Drug and included a certification pursuant to 21 U.S.C. 355G(2(A(vii(IV with respect to the '662 patent and a certification pursuant to 21 U.S.C. 355G(2(A(vii(III with respect to the' 170 and '171 patents. Defendants deny all other allegations in paragraph 28. 29. Defendants admit that Zydus USA submitted to FDA ANDA No. 203-286 seeking FDA approval to engage in the commercial manufacture and sale of the proposed 800 mg mesalamine delayed-release oral tablet described therein. Defendants deny all other allegations in paragraph 29. 7
Case 1:11-cv-01105-RGA Document 10 Filed 01/13/12 Page 8 of 14 PageID #: 54 30. Defendants admit that Zydus USA transmitted a letter dated September 26,2011 to Plaintiff pursuant to 21 U.S.C. 3550 regarding ANDA No. 203-286. Defendants deny that the allegations in paragraph 30 completely and accurately set forth the terms of that confidential letter. Defendants deny all other allegations in paragraph 30. COUNT I: PATENT INFRINGEMENT UNDER 35 U.S.C. 271(E AGAINST DEFENDANTS 31. Defendants repeat and reassert their answers to the allegations in paragraphs 1 through 30 above as though fully set forth herein. 32. Defendants admit that the document attached to the Complaint as Exhibit A purports to be a copy of the '662 patent and is entitled "Phannaceutical Dosage Form with Multiple Coatings for Reduced Impact of Coating Fractures." Defendants further admit that Exhibit A lists an issue date on its face of May 17, 2005. Defendants lack knowledge or information sufficient to form a belief about the truth of the remaining allegations in paragraph 32 and therefore deny them. 33. Defendants lack knowledge or information sufficient to form a belief about the truth of the allegations in paragraph 33 and therefore deny them. 34. Defendants deny the first sentence. With respect to the second sentence of paragraph 34, Defendants admit upon information and belief that Warner Chilcott is the holder ofnda No. 02-1830 for a delayed-release oral tablet containing 800 mg of mesal amine and that FDA lists ASACOL HD as the brand name associated with NDA No. 02-1830. The third sentence in paragraph 34 states a legal conclusion to which no response is required. To the extent that a response is required, Defendants lack knowledge or information sufficient to form a 8
Case 1:11-cv-01105-RGA Document 10 Filed 01/13/12 Page 9 of 14 PageID #: 55 belief about the truth of the allegations in that sentence and therefore deny them. Defendants deny all other allegations in paragraph 34. 35. The allegations in paragraph 35 are legal conclusions to which no response is required. To the extent that a response is required, Defendants lack knowledge or information sufficient to form a belief about the truth of the allegations in paragraph 35 and therefore deny them. 36. Denied. 37. Denied. 38. Denied. COUNTH: PATENT INFRINGEMENT UNDER 35 U.S.C. 271(A, (B & (C AGAINST DEFENDANTS 39. Defendants repeat and reassert their answers to the allegations in paragraphs 1 through 38 above as though fully set forth herein. 40. Defendants admit that Zydus USA submitted to FDA ANDA No. 203-286 seeking FDA approval to engage in the commercial manufacture and sale of the proposed 800 mg mesalamine delayed-release oral tablet described therein. Defendants deny all other allegations in paragraph 40. 41. Denied. 42. Denied. 43. Denied. 9
Case 1:11-cv-01105-RGA Document 10 Filed 01/13/12 Page 10 of 14 PageID #: 56 44. Denied. PRAYER FOR RELIEF Defendants specifically deny that Plaintiff is entitled to the general or specific relief requested against Defendants, or to any relief whatsoever, and pray for judgment in favor of Defendants dismissing this action with prejudice, and awarding Defendants their reasonable attorneys' fees pursuant to 35 U.S.C. 285, interest, and costs ofthis action, and such other or further relief as this Court may deem just and proper. AFFIRMATIVE DEFENSES Without prejudice to the denials set forth in their Answer and without admitting any allegations of the Complaint not otherwise admitted, Zydus Pharmaceuticals (USA Inc. and Cadila Healthcare Limited (collectively, "Defendants" aver and assert the following Affirmative Defenses to PlaintiffWamer Chilcott Company, LLC's Complaint. FIRST AFFIRMATIVE DEFENSE (Noninfringement of U.S. Patent No. 6,893,662 Plaintiff will not and cannot meet the burden of proof required to show that the manufacture, use, sale, offer to sell, or importation into the United States of the proposed 800 mg mesalamine delayed-release oral tablets which are the subject of ANDA No. 203-286 will directly or indirectly infringe, either literally or under the doctrine of equivalents, any valid claim of the '662 patent. SECOND AFFIRMATIVE DEFENSE (Invalidity of U.S. Patent No. 6,893,662 Upon information and belief, the claims of the '662 patent are invalid for failure to comply with one or more of the provisions of Title 35 of the United States Code, including, but not limited to, 101, 102, 103 andlor 112. 10
Case 1:11-cv-01105-RGA Document 10 Filed 01/13/12 Page 11 of 14 PageID #: 57 RESERVATION OF DEFENSES Defendants hereby reserve any and all defenses that are available under the Federal Rules of Civil Procedure and the U.S. Patent Laws and any other defenses, at law or in equity, that may now exist or become available later as a result of discovery and further factual investigation during this litigation. COUNTERCLAIMS Zydus Pharmaceuticals (USA Inc. and Cadila Healthcare Limited (collectively, "Counterclaimants", by their attorneys, allege the following counterclaims against Warner Chilcott Company, LLC: 1. Zydus Pharmaceuticals (USA Inc. ("Zydus USA" is a corporation organized and existing under the laws of the State of New Jersey, having a principal place of business at 73 Route 31 North, Pennington, New Jersey 08534. 2. Cadila Healthcare Limited ("Cadila" is a company organized and existing under the laws of India, having a principal place of business at Zydus Tower, Satellite Cross Roads, Ahmedabad-380015 Gujarat, India. 3. Upon information and belief, Warner Chilcott Company, LLC ("Warner Chilcott" is a corporation organized and existing under the laws of Puerto Rico and has its principal place of business at Union Street, Road 195 Km. 1.1, Fajardo, Puerto Rico 00738. 4. As a consequence of Warner Chilcott's Complaint against Counterclaimants, there is now an existing and continuing actual controversy between Warner Chilcott and Counterclaimants concerning the alleged infringement and the validity of the '662 patent. 5. This action arises under, and this Court has jurisdiction pursuant to, 28 U.S.C. 11
Case 1:11-cv-01105-RGA Document 10 Filed 01/13/12 Page 12 of 14 PageID #: 58 1331, 1338,2201, and 2202 as well as the U.S. patent laws, 35 U.S.C. 1, et seq. TIllS Court has jurisdiction over the subject matter of the Counterclaims asserted here pursuant to 28 U.S.C. 1331 and 1338. 6. Thls Court may declare the rights and legal relation ofthe parties pursuant to 2201 and 2202 of Title 28 of the U.S. Code and 271 (e(5 of Title 35 of the U.S. Code because the Counterclaims present an actual controversy within the Court's jurisdiction concerning the alleged infringement and the validity of the patent asserted by Warner Chllcott against Counterclaimants. 7. Venue for these counterclaims is proper within thls District in whlch Warner Chilcott's Complaint is pending under 28 U.S.C. 1391 (b & (c and 1400(b. COUNT I (Declaratory Judgment of Noninfringement of the '662 Patent 8. Counterclaimants repeat and reassert the allegations in paragraphs 1 through 7 above as though fully set forth herein. 9. By asserting its claim against Counterclaimants for infringement of the '662 patent, Warner Chllcott has created a case or controversy regarding the noninfringement of the '662 patent. 10. The manufacture, use, sale, offer to sell or importation into the United States of the proposed 800 mg mesalamine delayed-release oral tablets which are the subject matter of ANDA No. 203-286 would not and will not directly or indirectly infringe, either literally or under the doctrine of equivalents, any valid claim of the '662 patent. 12
Case 1:11-cv-01105-RGA Document 10 Filed 01/13/12 Page 13 of 14 PageID #: 59 COUNTU (Declaratory Judgment of Invalidity of the '662 Patent 11. Counterclaimants repeat and reassert the allegations in paragraphs 1 through 10 above as though fully set forth herein. 12. By asserting its claim against Counterclaimants for infringement of the '662 patent, Warner Chilcott has created a case or controversy regarding the validity of the '662 patent for failure to comply with one or more of the provisions of Title 35 of the United States Code, including, but not limited to, 101, 102, 103 and/or 112. 13. Upon information and belief, the claims ofthe '662 patent are invalid for failure to comply with one or more of the provisions of Title 35 of the United States Code, including, but not limited to, 101, 102, 103 and/or 112. PRAYER FOR RELIEF WHEREFORE, Counterclaimants Zydus Pharmaceuticals (USA Inc. and Cadila Healthcare Limited respectfully request the Court to enter judgment against Counterclaim Defendant Warner Chilcott Company, LLC as follows: A. A declaration that Counterclaimants have not and will not directly or indirectly infringe, either literally or under the doctrine of equivalents, any valid claim of the '662 patent; B. A declaration that the claims of the '662 patent are invalid for failure to comply with one or more of the provisions of35 U.S.C. 100 et seq., including 101,102, 103 and/or 112; C. A declaration that Counterclaim-Defendant Warner Chilcott Company, LLC takes nothing by its Complaint; 13
Case 1:11-cv-01105-RGA Document 10 Filed 01/13/12 Page 14 of 14 PageID #: 60 E. A dismissal of Counterclaim-Defendant Warner Chilcott Company, LLC's Complaint with prejudice; F. An award to Counterclaimants of their reasonable costs and attorneys' fees incurred in this action pursuant to 35 U.S.C. 285; and G. An award of any other and further relief that this Court may deem just and proper. Respectfully submitted, Dated: January 13,2012 PHILLIPS GOLDMAN & SPENCE, P.A. IslJohn C. Phillips, Jr. John C. Phillips, Jr. (#110 Megan C. Haney (#5016 1200 North Broom Street Wilmington, DE 19806 Tel. (302 655-4200 Fax (302 655-4210 jcp@pgslaw.com Of Counsel Michael J. Gaertner Keith D. Parr P.C. James T. Peterka Locke Lord LLP 111 South Wacker Drive Chicago, IL 60606 (312 443-0700 Counsel for Zydus Pharmaceuticals (USA Inc. and Cadila Healthcare Limited 14