Case 1:12-cv-00809-SLR Document 18 Filed 08/27/12 Page 1 of 17 PageID #: 71 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE PFIZER INC., WYETH LLC, WYETH PHARMACEUTICALS INC., and PF PRISM C.V., v. Plaintiffs, APOTEX INC. and APOTEX CORP., Defendants. C.A. No. 1:12-cv-809-SLR APOTEX INC. S AND APOTEX CORP. S ANSWER TO COMPLAINT FOR PATENT INFRINGEMENT AND COUNTERCLAIMS Apotex Inc. and Apotex Corp. (collectively, Defendants, by their attorneys, Cozen O Connor, for their Answer to the Complaint filed by Pfizer Inc., Wyeth LLC, Wyeth Pharmaceuticals Inc., and PF Prism C.V. (collectively, Plaintiffs, state as follows: GENERAL DENIAL Pursuant to Fed. R. Civ. P. 8(b(3, Defendants deny all allegations in Plaintiffs Complaint except those specifically admitted below. 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 Apotex 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 use. Defendants admit that Plaintiffs purport to bring this action under 35 U.S.C. 271 et seq., for infringement of U.S. Patent No. 6,673,838 ( the 838 patent. All other - 1 -
Case 1:12-cv-00809-SLR Document 18 Filed 08/27/12 Page 2 of 17 PageID #: 72 allegations of Paragraph 1 are denied. 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. Upon information and belief, Apotex admits that 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. Upon information and belief, Apotex admits that 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. Defendants lack knowledge or information sufficient to form a belief about the truth of the remaining allegations contained in Paragraph 3 and on that basis deny these allegations. 4. Plaintiff Wyeth Pharmaceuticals Inc. is a corporation organized and existing under the laws of the State of Delaware, having a place of business 500 Arcola Road, Collegeville, PA 19426. Pfizer Inc. is the ultimate parent of Wyeth Pharmaceuticals Inc. Upon information and belief, Apotex admits that Plaintiff Wyeth Pharmaceuticals Inc. is a corporation organized and existing under the laws of the State of Delaware, having a place of business 500 Arcola Road, Collegeville, PA 19426. Defendants lack knowledge or information sufficient to form a belief about the truth of the remaining allegations contained in Paragraph 4 and on that basis deny these allegations. 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 Netherlands, under number 51840456, with main - 2 -
Case 1:12-cv-00809-SLR Document 18 Filed 08/27/12 Page 3 of 17 PageID #: 73 offices at Blaak 40 basement, 3011 TA, Rotterdam, Netherlands. Pfizer Inc. is the ultimate parent of PF Prism C.V. Upon information and belief, Apotex admits that 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 Netherlands, under number 51840456, with main offices at Blaak 40 basement, 3011 TA, Rotterdam, Netherlands. Defendants lack knowledge or information sufficient to form a belief about the truth of the remaining allegations contained in Paragraph 5 and on that basis deny these allegations. 6. On information and belief, Defendant Apotex Corp. is a corporation organized and existing under the laws of the State of Delaware, having a principal place of business at 2400 North Commerce Parkway, Suite 400, Weston, Florida 33326. On information and belief, Apotex Corp. is a whollyowned subsidiary of Apotex Inc. that serves as Apotex Inc. s United States sales agent and distributor, and sells and offers for sale Apotex Inc. s drug products in the State of Delaware and throughout the United States. On information and belief, Apotex Corp. has previously consented to the jurisdiction of 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 Delaware. Paragraph 6 contains legal conclusions and allegations to which no answer is required. To the extent that an answer may be required, Defendants admit that Apotex Corp. is a corporation organized and existing under the laws of the State of Delaware, with a place of business at 2400 North Commerce Parkway, Suite 400, Weston, Florida, 33326. Defendants admit that Apotex Corp. distributes and sells pharmaceuticals in the United States, including quality generic medicines. Defendants deny all remaining allegations of Paragraph 6. 7. On information and belief, Defendant Apotex Inc. is a corporation organized and existing under the laws of Canada, having a principal place of business at 150 Signet Drive, Toronto, Ontario M9L 1T9, Canada. On information and belief, Apotex Inc. manufactures drug products for the purpose of - 3 -
Case 1:12-cv-00809-SLR Document 18 Filed 08/27/12 Page 4 of 17 PageID #: 74 sale within the State of Delaware and throughout the United Sates by Apotex Corp. On information and belief, Apotex Inc. derives substantial revenue from services or things used or consumed in the State of Delaware. On information and belief, Apotex Inc. has previously consented to the jurisdiction of 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 Delaware. Paragraph 7 contains legal conclusions and allegations to which no answer is required. To the extent that an answer may be required, Defendants admit that Apotex, Inc. is a corporation organized and existing under the laws of Canada, with a place of business at 150 Signet Drive, Toronto, Ontario, Canada M9L 1T9. Defendants admit that Apotex, Inc. develops and manufactures pharmaceuticals, including quality generic medicines. Defendants deny all remaining allegations of Paragraph 7. JURISDICTION AND VENUE 8. This Court has subject matter jurisdiction over this action pursuant to 28 U.S.C. 1331 and 1338(a. Paragraph 8 contains legal conclusions and allegations to which no answer is required. To the extent an answer may be required, Defendants admit that subject matter jurisdiction exists only for any claims asserted under 35 U.S.C. 271(e(2. Defendants deny all remaining allegations of Paragraph 8. 9. This Court has personal jurisdiction over Apotex by virtue of, inter alia, its presence in Delaware, having conducted business in Delaware, having availed itself of the rights and benefits of Delaware 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 Delaware. Paragraph 9 contains legal conclusions and allegations to which no answer is required. To the extent an answer may be required, solely to conserve the resources of the parties and the Court, Apotex, Inc. and Apotex Corp. do not contest personal jurisdiction in this Judicial District solely for the limited purposes of this action only. Defendants deny all - 4 -
Case 1:12-cv-00809-SLR Document 18 Filed 08/27/12 Page 5 of 17 PageID #: 75 remaining allegations of Paragraph 9. 10. Venue is proper in this District pursuant to 28 U.S.C. 1391 and 1400(b. Paragraph 10 contains legal conclusions and allegations to which no answer is required. To the extent an answer may be required, solely to conserve the resources of the parties and the Court, Apotex, Inc. and Apotex Corp. do not contest venue for the limited purposes of this action only. Defendants deny all remaining allegations of Paragraph 10. 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 known as 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. Paragraph 11 contains legal conclusions and allegations to which no answer is required. To the extent an answer may be required, Defendants admit that, according to the electronic records of the United States Patent and Trademark Office ( Patent Office, the Patent Office issued the 838 patent, entitled Succinate Salt of O-Desmethyl-Venlafaxine, on or about January 6, 2004, according to the electronic records of the Patent Office, Wyeth LLC is a purported assignee of the 838 patent, and what is purported to be a copy of the 838 patent was attached to the Complaint (D.I.1 as Exhibit A. Defendants deny all remaining allegations of Paragraph 11. 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. Paragraph 12 contains legal conclusions and allegations to which no answer is - 5 -
Case 1:12-cv-00809-SLR Document 18 Filed 08/27/12 Page 6 of 17 PageID #: 76 required. To the extent an answer may be required, Defendants admit that the electronic version of the FDA publication, Approved Drug Products With Therapeutic Equivalence Evaluations (commonly known as the Orange Book, identifies NDA No. 21-992 for Pristiq as being directed to O-desmethylvenlafaxine succinate extended release tablets in 50 and 100 mg dosage strengths, and lists Wyeth Pharms Inc as the approval holder for NDA No. 21-992. Defendants lack knowledge or information sufficient to form a belief as to the truth of all remaining allegations of Paragraph 12, and on that basis deny these allegations. 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. Paragraph 13 contains legal conclusions and allegations to which no answer is required. To the extent an answer may be required, Defendants admit that the electronic version of the FDA s Orange Book lists the 838 patent in connection with NDA No. 21-992 for Pristiq. Defendants lack knowledge or information sufficient to form a belief as to the truth of all remaining allegations of Paragraph 13, and on that basis deny these allegations. APOTEX S ANDA 14. On information and belief, Apotex submitted ANDA No. 204088 ( the Apotex ANDA to the FDA, pursuant to 21 U.S.C. 355, 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 Apotex ANDA are herein referred to as the Apotex Products. The contents of Defendants ANDA No. 204088 speak for itself. Defendants deny the remaining allegations of Paragraph 14. 15. The Apotex ANDA refers to and relies upon the Pristiq NDA and contains data that, according to Apotex, demonstrate the bioequivalence of the Apotex Products and Pristiq. The contents of Defendants ANDA No. 204088 speak for itself. Defendants - 6 -
Case 1:12-cv-00809-SLR Document 18 Filed 08/27/12 Page 7 of 17 PageID #: 77 deny the remaining allegations of Paragraph 15. 16. Pfizer has received from Apotex a letter, dated May 30, 2012 (the Apotex Notification, stating that Apotex had included a certification in the Apotex 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 Apotex Products (the Paragraph IV Certification. Defendants admit that by letter dated May 30, 2012, Defendants notified Plaintiffs that Defendants had submitted ANDA No. 204088 to the FDA under Section 505(j of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j. The content of Defendants Notice Letter speaks for itself. Except as expressly admitted herein, the allegations of Paragraph 16 are denied as stated. 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. Paragraph 17 contains legal conclusions and allegations to which no answer is required. Defendants incorporate their answers to Paragraphs 1 to 16 as if fully set forth herein. 18. Apotex has infringed the 838 patent, pursuant to 35 U.S.C. 271(e(2(A, by submitting the Apotex ANDA, by which Apotex seeks approval from the FDA to engage in the commercial manufacture, use, offer to sell, sale, or importation of the Apotex Products prior to the expiration of the 838 patent. Paragraph 18 contains legal conclusions and allegations to which no answer is required. To the extent that an answer may be required, Defendants deny the allegations of Paragraph 18. 19. Apotex s commercial manufacture, use, offer to sell, or sale of the Apotex Products within the United States, or importation of the Apotex 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. Paragraph 19 contains legal conclusions and allegations to which no answer is - 7 -
Case 1:12-cv-00809-SLR Document 18 Filed 08/27/12 Page 8 of 17 PageID #: 78 required. To the extent that an answer may be required, Defendants deny the allegations of Paragraph 19. 20. Plaintiffs will be substantially and irreparably harmed if Apotex is not enjoined from infringing the 838 patent. Defendants deny the allegations of Paragraph 20. 21. Plaintiffs have no adequate remedy at law. Defendants deny the allegations of Paragraph 21. 22. This case is an exceptional one, and Plaintiffs are entitled to an award of attorneys fees under 35 U.S.C. 285. Defendants deny the allegations of Paragraph 22. PRAYER FOR RELIEF Defendants deny that Plaintiffs are entitled to any of the relief requested in their Prayer for Relief. DEFENDANTS ADDITIONAL DEFENSES Defendants assert the following defenses without prejudice to the denials in this Answer, without admitting any allegations of the Complaint not otherwise admitted. FIRST DEFENSE (INVALIDITY The 838 patent and each of the claims thereof are invalid for failure to comply with one or more conditions for patentability set forth in one or more provisions of 35 U.S.C. 101, 102, 103, and/or 112, or under other judicially-created bases for invalidation. SECOND DEFENSE (NO DIRECT INFRINGEMENT Defendants do not infringe, either literally or under the doctrine of equivalents, any valid and enforceable claim of the 838 patent and if the products that are the subject of ANDA No. - 8 -
Case 1:12-cv-00809-SLR Document 18 Filed 08/27/12 Page 9 of 17 PageID #: 79 204088 were marketed, Defendants would not infringe any valid and enforceable claim of the 838 patent. THIRD DEFENSE (NO INDIRECT INFRINGEMENT Defendants have not, do not, and will not induce the infringement of, or contribute to the infringement of, any valid and enforceable claim of the 838 patent, and if the products that are the subject of ANDA No. 204088 were marketed, Defendants would not induce the infringement of, or contribute to the infringement of any valid and enforceable claim of the 838 patent. suit. FOURTH DEFENSE Plaintiffs are barred by 35 U.S.C. 288 from recovering any costs associated with this APOTEX, INC. S AND APOTEX CORP. S COUNTERCLAIMS Pursuant to Rule 13 of the Federal Rules of Civil Procedure, Apotex, Inc. and Apotex Corp. (collectively, Apotex, by way of its attorneys Cozen O Connor, hereby state for their Counterclaims against Pfizer Inc., Wyeth LLC, Wyeth Pharmaceuticals Inc., and PF Prism C.V. (collectively, Counterclaim Defendants, the following: 1. Apotex repeats and incorporates by reference each of the foregoing paragraphs of Apotex s Answer and Separate Defenses to the Complaint. 2. This is an action for a declaratory judgment of non-infringement and invalidity, of one or more claims of United States Patent No. 6,673,838 ( the 838 patent under 28 U.S.C. 2201 and 2202. Upon information and belief, a true and correct copy of the 838 patent was attached to the Complaint (D.I. 1 as Exhibit A. - 9 -
Case 1:12-cv-00809-SLR Document 18 Filed 08/27/12 Page 10 of 17 PageID #: 80 THE PARTIES 3. Apotex, Inc.is a corporation organized and existing under the laws of Canada, with a place of business at 150 Signet Drive, Toronto, Ontario, Canada M9L 1T9. 4. Apotex Corp. is a corporation organized and existing under the laws of the State of Delaware, with a place of business at 2400 North Commerce Parkway, Suite 400, Weston, Florida, 33326. 5. On information and belief, Counterclaim Defendant 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. 6. On information and belief, Counterclaim Defendant 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. 7. On information and belief, Counterclaim Defendant Wyeth Pharmaceuticals Inc. is a corporation organized and existing under the laws of the State of Delaware, having a place of business 500 Arcola Road, Collegeville, PA 19426. 8. On information and belief, Counterclaim Defendant 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 Netherlands, under number 51840456, with main offices at Blaak 40 basement, 3011 TA, Rotterdam, Netherlands. JURISDICTION 9. This court has subject matter jurisdiction over these Counterclaims for declaratory judgment pursuant to 28 U.S.C. 1331, 1337(a, 1338(a, 2201(a and (b, and 2202, based on - 10 -
Case 1:12-cv-00809-SLR Document 18 Filed 08/27/12 Page 11 of 17 PageID #: 81 an actual controversy between Apotex, on the one hand, and Counterclaim Defendant Allergan, on the other hand, arising under the Patent Laws of the United States, 35 U.S.C. 1 et seq. This court has personal jurisdiction over Counterclaim Defendant Pfizer Inc. based, inter alia, on the filing by Counterclaim Defendant Pfizer Inc. of this lawsuit in this jurisdiction and because Counterclaim Defendant Pfizer Inc. is doing business in this jurisdiction. This court has personal jurisdiction over Counterclaim Defendant Wyeth LLC based, inter alia, on the filing by Counterclaim Defendant Wyeth LLC of this lawsuit in this jurisdiction. This court has personal jurisdiction over Counterclaim Defendant Wyeth Pharmaceuticals Inc. based, inter alia, on the filing by Counterclaim Defendant Wyeth Pharmaceuticals Inc. of this lawsuit in this jurisdiction and because Counterclaim Defendant Wyeth Pharmaceuticals Inc. is doing business in this jurisdiction. This court has personal jurisdiction over Counterclaim Defendant PF Prism C.V. based, inter alia, on the filing by Counterclaim Defendant PF Prism C.V. of this lawsuit in this jurisdiction. 10. Venue is proper in this judicial district under 28 U.S.C. 1391(b and (c, and 1400(b. ORANGE BOOK LISTING OF THE 838 PATENT 11. On information and belief, on January 6, 2004, the United States Patent and Trademark Office ( Patent Office issued United States Patent No. 6,673,838 ( the 838 patent, entitled Succinate Salt of O-Desmethyl-Venlafaxine. According to the electronic records of the Patent Office, Wyeth LLC is the purported assignee of the 838 patent. 12. The Hatch-Waxman Amendments to the Food, Drug and Cosmetic Act require NDA holders to disclose to the FDA the patent numbers and expiration dates of those patents - 11 -
Case 1:12-cv-00809-SLR Document 18 Filed 08/27/12 Page 12 of 17 PageID #: 82 that the holder believes claim the drug for which their NDA is submitted, or patents covering a method of using such drug. 21 U.S.C. 355(b(1 and (c(2. 13. On information and belief, pursuant to 21 U.S.C. 355(b(1(G, Counterclaim Defendant Wyeth Pharmaceuticals Inc. caused the FDA to list the 838 patent in the Orange Book in connection with NDA No. 21-992 for PRISTIQ (the PRISTIQ NDA. 14. By maintaining the listing of the 838 patent in the Orange Book, Counterclaim Defendants Pfizer Inc., Wyeth LLC, Wyeth Pharmaceuticals Inc., and PF Prism C.V. represent that the 838 patent could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug. 21 U.S.C. 355(b(1(G. APOTEX S ABBREVIATED NEW DRUG APPLICATION 15. Apotex filed ANDA No. 204088 with the FDA seeking approval to market the O- desmethylvenlafaxine succinate extended release tablets in 50 and 100 mg dosage strengths described therein. THE PRESENCE OF A CASE OR CONTROVERSY 16. By maintaining the Orange Book listing of the 838 patent in connection with the PRISTIQ NDA, Counterclaim Defendants Pfizer Inc., Wyeth LLC, Wyeth Pharmaceuticals Inc., and PF Prism C.V. continue to represent that the 838 patent could reasonably be asserted against anyone making, using or selling generic O-desmethylvenlafaxine succinate extended release tablet products without a license from Pfizer Inc., Wyeth LLC, Wyeth Pharmaceuticals Inc., and PF Prism C.V. 17. Counterclaim Defendants Pfizer Inc., Wyeth LLC, Wyeth Pharmaceuticals Inc., and PF Prism C.V. have filed an infringement action under 35 U.S.C. 271(e(2(A and 35 U.S.C. 271(a, (b, and (c asserting the 838 patent against Apotex Inc. and Apotex Corp. There has been and is now an actual and justiciable controversy between Apotex Inc. and Apotex - 12 -
Case 1:12-cv-00809-SLR Document 18 Filed 08/27/12 Page 13 of 17 PageID #: 83 Corp. and Counterclaim Defendants Pfizer Inc., Wyeth LLC, Wyeth Pharmaceuticals Inc., and PF Prism C.V. as to whether the products disclosed in Apotex s ANDA No. 204088 infringes the 838 patent and whether any valid, enforceable claim of the 838 patent exists. 18. Apotex seeks to market the O-desmethylvenlafaxine succinate extended release tablet products that are the subject of ANDA No. 204088 in the United States. 19. If Apotex succeeds in proving that its O-desmethylvenlafaxine succinate extended release tablet products do not infringe the 838 patent or that the 838 patent is invalid, such a judgment will remove any uncertainty that may exist by virtue of Counterclaim Defendants Pfizer Inc., Wyeth LLC, Wyeth Pharmaceuticals Inc., and PF Prism C.V. maintenance of the listing of the 838 patent in the Orange Book in connection with the PRISTIQ NDA. 20. In light of all the circumstances, an actual substantial and continuing justiciable controversy having sufficient immediacy and reality to warrant the issuance of a declaration of rights by the Court exists between Counterclaim Defendants Pfizer Inc., Wyeth LLC, Wyeth Pharmaceuticals Inc., and PF Prism C.V. and Apotex as to whether the claims of the 838 patent are invalid and/or not infringed by Apotex. FIRST COUNT (DECLARATORY JUDGMENT OF NON-INFRINGEMENT OF UNITED STATES PATENT NO. 6,673,838 21. Apotex repeats and incorporates by reference each of the foregoing paragraphs of Apotex s Answer and Separate Defenses to the Complaint and of these Counterclaims. 22. This counterclaim arises under the Patent Laws of the United States, 35 U.S.C. 1 et seq., and the Declaratory Judgment Act, 28 U.S.C. 2201 and 2202. A case of actual, substantial, and continuing justiciable controversy having adverse legal interests of sufficient immediacy and reality to warrant the issuance of a declaration of rights by this Court exists - 13 -
Case 1:12-cv-00809-SLR Document 18 Filed 08/27/12 Page 14 of 17 PageID #: 84 between Apotex and Counterclaim Defendants Pfizer Inc., Wyeth LLC, Wyeth Pharmaceuticals Inc., and PF Prism C.V. concerning the infringement of the claims of the 838 patent. 23. Counterclaim Defendants Pfizer Inc., Wyeth LLC, Wyeth Pharmaceuticals Inc., and PF Prism C.V. assert that the commercial manufacture, use, offer for sale, or sale of the Apotex s O-desmethylvenlafaxine succinate extended release tablet products described in ANDA No. 204088 infringe the claims of the 838 patent. 24. Apotex asserts that no valid claim of the 838 patent is infringed by the manufacture, use, offer for sale, or sale of Apotex s O-desmethylvenlafaxine succinate extended release tablet products described in ANDA No. 204088. 25. Apotex is entitled to a declaration that the manufacture, use, offer for sale, and sale of Apotex s O-desmethylvenlafaxine succinate extended release tablet products described in ANDA No. 204088 do not infringe any valid claim of the 838 patent. SECOND COUNT (DECLARATORY JUDGMENT OF INVALIDITY OF UNITED STATES PATENT NO. 6,673,838 26. Apotex repeats and incorporates by reference each of the foregoing paragraphs of Apotex s Answer and Separate Defenses to the Complaint and of these Counterclaims. 27. This counterclaim arises under the Patent Laws of the United States, 35 U.S.C. 1 et seq., and the Declaratory Judgment Act, 28 U.S.C. 2201 and 2202. A case of actual, substantial and continuing justiciable controversy having adverse legal interests of sufficient immediacy and reality to warrant the issuance of a declaration of rights by this Court exists between Apotex and Counterclaim Defendants Pfizer Inc., Wyeth LLC, Wyeth Pharmaceuticals Inc., and PF Prism C.V. concerning the invalidity of the claims of the 838 patent. 28. Counterclaim Defendants Pfizer Inc., Wyeth LLC, Wyeth Pharmaceuticals Inc., and PF Prism C.V. assert that the commercial manufacture, use, offer for sale, or sale of - 14 -
Case 1:12-cv-00809-SLR Document 18 Filed 08/27/12 Page 15 of 17 PageID #: 85 Apotex s O-desmethylvenlafaxine succinate extended release tablet products described in ANDA No. 204088 do and will infringe claims of the 838 patent. 29. Apotex asserts that the manufacture, use, offer for sale, or sale of Apotex s O- desmethylvenlafaxine succinate extended release tablet products does not infringe any valid claim of the 838 patent, and that the claims of the 838 patent are invalid under one or more provisions of 35 U.S.C. 101, 102, 103 or 112, or other judicially-created bases for invalidation. 30. Apotex is entitled to a declaration that the claims of the 838 patent are invalid under one or more provisions of 35 U.S.C. 101, 102, 103, or 112, or other judicially-created bases for invalidation. PRAYER FOR RELIEF WHEREFORE, Defendants Apotex Inc. and Apotex Corp. respectfully request that the Court enter a Judgment and Order in their favor and against Plaintiffs and Counterclaim Defendants Pfizer Inc., Wyeth LLC, Wyeth Pharmaceuticals Inc., and PF Prism C.V. as follows: A. For a declaration that the claims of U.S. Patent No. 6,673,838 are invalid; B. For a declaration that the claims of U.S. Patent No. 6,673,838 are not and will not be infringed by Apotex Inc. and Apotex Corp.; C. Preliminarily and permanently enjoin Plaintiffs, their officers, agents, servants, employees, attorneys, and any person who acts in concert or participation with Plaintiffs, from utilizing U.S. Patent No. 6,673,838 to block, hamper, hinder or obstruct FDA approval of Defendants proposed products; D. Permanently enjoin Plaintiffs, their officers, agents, servants, employees, attorneys, and any person who acts in concert or participation with Plaintiffs, from asserting or - 15 -
Case 1:12-cv-00809-SLR Document 18 Filed 08/27/12 Page 16 of 17 PageID #: 86 otherwise seeking to enforce U.S. Patent No. 6,673,838 against Defendants or anyone in privity with Defendants; and Complaint; E. Granting Apotex Inc. and Apotex Corp. judgment in their favor on Plaintiffs F. Denying any request by Plaintiffs for injunctive relief; G. Dismissing Plaintiffs Complaint with prejudice; H. For an award of attorneys fees pursuant to 35 U.S.C. 285, other statutes or rules, or the general power of the Court; I. For an award of costs; J. Awarding any other such relief as is just and proper. Dated: August 27, 2012 /s/ Barry Klayman Barry M. Klayman, Esq. (#3676 COZEN O CONNOR 1201 N. Market Street, Suite 1400 Wilmington, DE 19801 Tel: (302 295-2035 Fax: (215 701-2209 E-mail: BKlayman@cozen.com Richard T. Ruzich COZEN O CONNOR 333 W. Wacker Drive, Suite 1900 Chicago, IL 60606-1293 (312 382-3100 (phone (312 382-8910 (facsimile E-mail: RRuzich@cozen.com Attorneys for Defendants APOTEX, INC. and APOTEX CORP. - 16 -
Case 1:12-cv-00809-SLR Document 18 Filed 08/27/12 Page 17 of 17 PageID #: 87 Barry Golob (pro hac vice Donald R. McPhail (pro hac vice pending Aaron S. Lukas (pro hac vice COZEN O CONNOR 1627 I Street N.W., Suite 1100 Washington, DC 20006 (202 912-4800 (phone (202 912-4830 (facsimile E-mail: BGolob@cozen.com E-mail: DMcPhail@cozen.com E-mail: ALukas@cozen.com - 17 -