Attorneys for Defendants Watson Laboratories, Inc. and Watson Pharmaceuticals, Inc.

Case 2:10-cv-00080-FSH -PS Document 15 Filed 03/01/10 Page 1 of 14 HELLRING LINDEMAN GOLDSTEIN & SIEGAL LLP Matthew E. Moloshok, Esq. Robert S. Raymar, Esq. One Gateway Center Newark, New Jersey 07102-5386 Telephone: (973 621-9020 Facsimile: (973 621-7406 mmoloshok@hlgslaw.com rsraymar@hlgslaw.com Attorneys for Defendants Watson Laboratories, Inc. and Watson Pharmaceuticals, Inc. UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY TEVA WOMEN'S HEALTH, INC., Plaintiff, v. Civil Action No. 2:10-CV-00080-FSH-PS LUPIN, LTD., LUPIN PHARMACEUTICALS, INC., WATSON LABORATORIES, INC. AND ELECTRONICALLY FILED WATSON PHARMACEUTICALS, INC., Defendants. ANSWER, AFFIRMATIVE DEFENSES AND COUNTERCLAIMS OF DEFENDANTS WATSON LABORATORIES, INC. AND WATSON PHARMACEUTICALS, INC. TO TEVA WOMEN S HEALTH, INC. S COMPLAINT Defendants Watson Laboratories, Inc. ( Watson Laboratories and Watson Pharmaceuticals, Inc. ( Watson Pharmaceuticals (collectively, Watson, by and through the undersigned attorneys, answer the complaint for patent infringement ( Complaint of plaintiff, Teva Women s Health, Inc. ( Teva Women s Health, as follows: NATURE OF THE ACTION 1. Responding to paragraph 1 of the Complaint, Watson admits only that this action for alleged patent infringement purports to arise under the Patent Laws of the United States. All other allegations of paragraph 1 of the Complaint are denied.

Case 2:10-cv-00080-FSH -PS Document 15 Filed 03/01/10 Page 2 of 14 THE PARTIES 2. Watson lacks sufficient knowledge or information to form a belief as to the truth of the allegations of paragraph 2 of the Complaint and, therefore, denies them. 3. Watson lacks sufficient knowledge or information to form a belief as to the truth of the allegations of paragraph 3 of the Complaint and, therefore, denies them. 4. Watson lacks sufficient knowledge or information to form a belief as to the truth of the allegations of paragraph 4 of the Complaint and, therefore, denies them. 5. Watson lacks sufficient knowledge or information to form a belief as to the truth of the allegations of paragraph 5 of the Complaint and, therefore, denies them. 6. Responding to paragraph 6 of the Complaint, Watson admits only that Watson Pharmaceuticals is a corporation organized and existing under the laws of the State of Nevada. All other allegations of paragraph 6 of the Complaint are denied. 7. Responding to paragraph 7 of the Complaint, Watson admits only that Watson Laboratories is a corporation organized and existing under the laws of the State of Nevada. All other allegations of paragraph 7 of the Complaint are denied. 8. Responding to paragraph 8 of the Complaint, Watson admits only that Watson Laboratories is a wholly-owned subsidiary of Watson Pharmaceuticals and the two have common officers and a common director. All other allegations of paragraph 8 of the Complaint are denied. 9. Responding to paragraph 9 of the Complaint, Watson admits that Watson Laboratories develops and manufactures generic pharmaceutical products, including generic contraceptive products. All other allegations of paragraph 9 of the Complaint are denied. JURISDICTION AND VENUE 10. Responding to paragraph 10 of the Complaint, Watson admits this Court has subject matter jurisdiction pursuant to 28 U.S.C. 1331, 1338(a. 11. Responding to paragraph 11 of the Complaint, Watson lacks sufficient knowledge or information to form a belief as to the truth of the allegations relating to co-defendants Lupin 2

Case 2:10-cv-00080-FSH -PS Document 15 Filed 03/01/10 Page 3 of 14 Ltd. and Lupin Pharmaceuticals, Inc. (collectively, Lupin and, therefore, denies them. All other allegations of paragraph 11 of the Complaint are denied. 12. Responding to paragraph 12 of the Complaint, Watson lacks sufficient knowledge or information to form a belief as to the truth of the allegations relating to Lupin and, therefore, denies them. All other allegations of paragraph 12 of the Complaint are denied. BACKGROUND 13. Responding to paragraph 13 of the Complaint, Watson admits only that a copy of U.S. Patent No. 7,615,545 B2 ( the 545 patent is attached to Teva Women s Health s Complaint as Exhibit A; that the cover page of the 545 patent recites Oral Contraceptives to Prevent Pregnancy and Diminish Premenstrual Symptomatology and identifies Robert G. Bell, Carole Ben-Maimon, and Beata Iskold as the inventors, and Duramed Pharmaceuticals, Inc. as the assignee; and that the cover page further recites an issuance date of November 10, 2009. Watson denies that the 545 patent was duly and legally issued. Watson further denies that [t]he 545 patent is valid and enforceable. As to the remainder of the allegations in paragraph 13 of the Complaint, Watson lacks sufficient knowledge or information to form a belief as to the truth of the allegations and, therefore, denies them. 14. Responding to paragraph 14 of the Complaint, the 545 patent speaks for itself. As to the characterizations and remaining allegations in paragraph 14 of the Complaint, Watson lacks sufficient knowledge or information to form a belief as to the truth of the allegations and, therefore, denies them. 15. Responding to paragraph 15 of the Complaint, the LoSeasonique product speaks for itself with respect to the contents of its active ingredients. As to the characterizations and remaining allegations in paragraph 15 of the Complaint, Watson lacks sufficient knowledge or information to form a belief as to the truth of the allegations and, therefore, denies them. 16. Responding to paragraph 16 of the Complaint, Watson admits only that the 545 patent is listed in the FDA publication titled Approved Drug Products with Therapeutic 3

Case 2:10-cv-00080-FSH -PS Document 15 Filed 03/01/10 Page 4 of 14 Equivalence Evaluations (known as the Orange Book in connection with NDA No. 22-262 for LoSeasonique. All other allegations of paragraph 16 of the Complaint are denied. LUPIN S ACTS GIVING RISE TO THIS ACTION 17. Watson lacks sufficient knowledge or information to form a belief as to the truth of the allegations of paragraph 17 of the Complaint and, therefore, denies them. 18. Watson lacks sufficient knowledge or information to form a belief as to the truth of the allegations of paragraph 18 of the Complaint and, therefore, denies them. 19. Watson lacks sufficient knowledge or information to form a belief as to the truth of the allegations of paragraph 19 of the Complaint and, therefore, denies them. 20. Watson lacks sufficient knowledge or information to form a belief as to the truth of the allegations of paragraph 20 of the Complaint and, therefore, denies them. 21. Watson lacks sufficient knowledge or information to form a belief as to the truth of the allegations of paragraph 21 of the Complaint and, therefore, denies them. 22. Watson lacks sufficient knowledge or information to form a belief as to the truth of the allegations of paragraph 22 of the Complaint and, therefore, denies them. 23. Watson lacks sufficient knowledge or information to form a belief as to the truth of the allegations of paragraph 23 of the Complaint and, therefore, denies them. 24. Watson lacks sufficient knowledge or information to form a belief as to the truth of the allegations of paragraph 24 of the Complaint and, therefore, denies them. WATSON S ACTS GIVING RISE TO THIS ACTION 25. Responding to paragraph 25 of the Complaint, Watson Laboratories admits that it submitted ANDA No. 200407 to the FDA seeking approval to manufacture, sell and distribute a generic version of LoSeasonique. Watson Laboratories admits that it provided a letter dated November 23, 2009 to Duramed Pharmaceuticals, Inc., the holder of NDA No. 22-262 for LoSeasonique ( Notice Letter, as required by 21 U.S.C. 355(j(2(B. All other allegations of paragraph 25 of the Complaint are denied. 4

Case 2:10-cv-00080-FSH -PS Document 15 Filed 03/01/10 Page 5 of 14 26. Responding to paragraph 26 of the Complaint, Watson Laboratories Notice Letter speaks for itself and any additional characterizations thereof beyond the plain language are denied. All other allegations of paragraph 26 of the Complaint are denied. 27. Responding to paragraph 27 of the Complaint, Watson Laboratories admits that its ANDA No. 200407 contains a certification, pursuant to 21 U.S.C. 355(j(2(A(vii(IV, that the 545 patent is invalid, unenforceable and/or will not be infringed by the manufacture, use or sale of its proposed ANDA product. Watson Laboratories denies that the commercial manufacture, use, offer for sale, sale and/or importation of its proposed ANDA product would infringe any valid and enforceable claim of the 545 patent. All other allegations of paragraph 27 of the Complaint are denied. 28. Responding to paragraph 28 of the Complaint, Watson Laboratories Notice Letter speaks for itself and additional characterizations thereof beyond the plain language are denied. All other allegations of paragraph 28 of the Complaint are denied. 29. Responding to paragraph 29 of the Complaint, Watson Laboratories Notice Letter speaks for itself and additional characterizations thereof beyond the plain language are denied. All other allegations of paragraph 29 of the Complaint are denied. 30. Responding to paragraph 30 of the Complaint, Watson Laboratories admits that it submitted ANDA No. 200407 to the FDA seeking approval to engage in the commercial manufacture, use or sale of its proposed ANDA product. All other allegations of paragraph 30 of the Complaint are denied. 31. Responding to paragraph 31 of the Complaint, Watson admits only that it was aware of the 545 patent when Watson Laboratories submitted its Paragraph IV certification directed to this patent. All other allegations of paragraph 31 of the Complaint are denied. 32. Watson lacks sufficient knowledge or information to form a belief as to the truth of the allegations of paragraph 32 of the Complaint and, therefore, denies them. 5

Case 2:10-cv-00080-FSH -PS Document 15 Filed 03/01/10 Page 6 of 14 ANSWERING COUNT I: PATENT INFRINGEMENT OF U.S. PATENT NO. 7,615,545 Answering Lupin s Infringement 33. Responding to paragraph 33 of the Complaint, Watson hereby incorporates by reference its answers, in their entirety, set forth in paragraphs 1-32 of this Answer. 34. Watson lacks sufficient knowledge or information to form a belief as to the truth of the allegations of paragraph 34 of the Complaint and, therefore, denies them. 35. Watson lacks sufficient knowledge or information to form a belief as to the truth of the allegations of paragraph 35 of the Complaint and, therefore, denies them. 36. Watson lacks sufficient knowledge or information to form a belief as to the truth of the allegations of paragraph 36 of the Complaint and, therefore, denies them. 37. Watson lacks sufficient knowledge or information to form a belief as to the truth of the allegations of paragraph 37 of the Complaint and, therefore, denies them. 38. Watson lacks sufficient knowledge or information to form a belief as to the truth of the allegations of paragraph 38 of the Complaint and, therefore, denies them. 39. Watson lacks sufficient knowledge or information to form a belief as to the truth of the allegations of paragraph 39 of the Complaint and, therefore, denies them. 40. Watson lacks sufficient knowledge or information to form a belief as to the truth of the allegations of paragraph 40 of the Complaint and, therefore, denies them. Answering Watson s Infringement 41. Watson denies each and every allegation of paragraph 41 of the Complaint. 42. Watson denies each and every allegation of paragraph 42 of the Complaint. 43. Watson denies each and every allegation of paragraph 43 of the Complaint. 44. Watson denies each and every allegation of paragraph 44 of the Complaint. 45. Watson denies each and every allegation of paragraph 45 of the Complaint. 46. Watson denies each and every allegation of paragraph 46 of the Complaint. 47. Watson denies each and every allegation of paragraph 47 of the Complaint. 6

Case 2:10-cv-00080-FSH -PS Document 15 Filed 03/01/10 Page 7 of 14 Answering PRAYER FOR RELIEF Except as specifically admitted herein, Watson denies each and every allegation contained in the Complaint, and denies that Teva Women s Health is entitled to any of the relief requested or to any relief whatsoever. AFFIRMATIVE DEFENSES First Affirmative Defense (Lack of Subject Matter Jurisdiction This Court lacks subject matter jurisdiction because Watson Pharmaceuticals, Inc. is not a proper party to this Complaint as it did not submit ANDA No. 200470, which is the ANDA at issue. Second Affirmative Defense (Failure to State a Claim for Relief The Complaint fails to state a claim for relief against Watson Pharmaceuticals, Inc., as it did not submit ANDA No. 200407, which is the ANDA at issue. Third Affirmative Defense (The Claims of the 545 Patent Are Not Infringed Watson Laboratories submission of its ANDA No. 200407 for the purpose of obtaining approval to market a generic version of LoSeasonique did not and does not infringe any valid and enforceable claim of the 545 patent under 35 U.S.C. 271(e(2, nor would the manufacture, use, sale, offer of sale in and/or importation into the United States of Watson Laboratories proposed generic version of LoSeasonique that is the subject of ANDA No. 200407 infringe any valid and enforceable claim of the 545 patent. Fourth Affirmative Defense (The Claims of the 545 Patent Are Invalid for Anticipation The claims of the 545 patent are invalid because the alleged inventions claimed therein are anticipated in view of the prior art to one having ordinary skill in the art and thus fail to satisfy the conditions for patentability set forth in 35 U.S.C. 102. 7

Case 2:10-cv-00080-FSH -PS Document 15 Filed 03/01/10 Page 8 of 14 Fifth Affirmative Defense (The Claims of the 545 Patent Are Invalid For Obviousness The claims of the 545 patent are invalid because the alleged inventions claimed therein are obvious in view of the prior art to one having ordinary skill in the art and thus fail to satisfy the conditions for patentability set forth in 35 U.S.C. 103. Sixth Affirmative Defense (Failure to State a Claim for Relief To the extent Teva Women s Health alleges that Watson Laboratories submission of ANDA No. 200407 makes this an exceptional case under 35 U.S.C. 285, the Complaint fails to state a claim upon which relief can be granted and it must be dismissed. COUNTERCLAIM FOR DECLARATORY JUDGMENT Defendant/Counter-Plaintiff, Watson Laboratories, Inc. ( Watson Laboratories, conditionally brings the following Counterclaims against Plaintiff/Counter-Defendant Teva Women s Health ( Teva Women s Health : PARTIES 1. Defendant/Counter-Plaintiff Watson Laboratories is a corporation organized and existing under the laws of the State of Nevada, having a principal place of business at 311 Bonnie Circle, Corona, California 92880. 2. Upon information and belief, Plaintiff/Counter-Defendant Teva Women s Health is a corporation organized and existing under the laws of the State of Delaware, having an established place of business at 400 Chestnut Ridge Road, Woodcliff Lake, New Jersey 07677. 8

Case 2:10-cv-00080-FSH -PS Document 15 Filed 03/01/10 Page 9 of 14 BACKGROUND A. FDA Approval of Brand-Name Drugs 3. The Federal Food, Drug, and Cosmetic Act ( FFDCA, 21 U.S.C. 301 et seq., as amended by the Hatch-Waxman Act (described below as further amended by the Medicare Prescription Drug, Improvement and Modernization Act ( MMA, sets forth the rules that the U.S. Food and Drug Administration ( FDA follows when considering whether to approve the marketing of both brand-name and generic drugs. 4. Under the FFDCA, an applicant seeking to market a new brand-name drug must prepare a New Drug Application ( NDA for consideration by the FDA. See 21 U.S.C. 355. 5. A NDA must include, inter alia, the number of any patent that claims the drug or a method of using such drug for which the NDA was submitted and for which a claim of patent infringement could reasonably be asserted against a person not licensed by the patent owner to engage in the manufacture, use, or sale of the drug. See 21 U.S.C. 355(b(1, (c(2; 21 C.F.R. 314.53(b, (c(2. 6. Upon approval of the NDA, the FDA publishes patent information for the approved drug in the Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the Electronic Orange Book or Orange Book. See 21 U.S.C. 355(j(7(A(iii. B. Generic Competition Approval of Abbreviated New Drug Applications 7. Generic drugs are versions of brand-name drugs that contain the same active ingredients, but not necessarily the same inactive ingredients, as the brand-name original. 8. In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act, known as the Hatch-Waxman Act, to the FFDCA. See Pub. L. No. 98-417, 98 Stat. 1585 (1984 (codified at 21 U.S.C. 355 and 35 U.S.C. 156, 271(e. The Hatch- Waxman Act simplified the process for obtaining approval of generic drugs, for at least the purpose of decreasing the cost of pharmaceuticals through early market entry of generic drugs. 9

Case 2:10-cv-00080-FSH -PS Document 15 Filed 03/01/10 Page 10 of 14 Under the Hatch-Waxman Act, a generic manufacturer submits what is called an Abbreviated New Drug Application ( ANDA. 9. To receive approval of its ANDA, a generic manufacturer must show, inter alia, that its generic drug is bioequivalent to the listed reference drug. See 21 U.S.C. 355(j(4(F. 10. An ANDA must also contain a certification as to every patent that the NDA holder caused to be listed in the Orange Book with respect to the particular approved drug for which the ANDA is being submitted. See 21 U.S.C. 355(j(2(A(vii; 21 C.F.R. 314.94(a(12. 11. If the generic manufacturer seeks to market its proposed generic product that is the subject of its ANDA prior to the expiration of any patent listed in the Orange Book, it must submit with its ANDA a so-called paragraph IV certification directed to the listed patent. A paragraph IV certification directed to a patent listed in the Orange Book asserts that the patent is invalid, unenforceable, and/or will not be infringed and, on that basis, the generic manufacturer seeks FDA approval for commercial marketing of the generic product prior to expiration of the patent as to which the certification is made. See 21 U.S.C. 355(j(2(A(vii(IV. 12. The generic manufacturer must also notify both the patent owner and NDA holder of its paragraph IV certification. See 21 U.S.C. 355(j(2(B(i. 13. Upon receiving notice of the paragraph IV certification, the NDA holder/patent owner can file a patent infringement suit against the generic manufacturer. See 21 U.S.C. 355(j(5(B(iii. C. Watson Laboratories, Inc. s ANDA 14. Watson Laboratories submitted an ANDA No. 200407 with the FDA seeking approval to market an oral contraceptive product, referencing NDA No. 22-262 for LoSeasonique. 15. The holder of NDA No. 22-262 caused the FDA to list U.S. Patent No. 7,615,545 B2 ( the 545 patent in the Orange Book in connection with NDA No. 22-262, after the patent issued on or about November 10, 2009. 10

Case 2:10-cv-00080-FSH -PS Document 15 Filed 03/01/10 Page 11 of 14 16. Because Watson Laboratories seeks FDA approval to market its generic version of LoSeasonique before expiration of the 545 patent, Watson s ANDA includes a paragraph IV certification against the 545 patent, and Watson Laboratories provided the patent owner and holder of NDA No. 22-262 with the required Notice under 21 U.S.C. 355(j(2(B(i on or about November 23, 2009. 17. Watson Laboratories Notice of its paragraph IV certification provided the holder of NDA No. 22-262 with statutory authority, under 35 U.S.C. 271(e(2, to sue Watson Laboratories for alleged infringement of the 545 patent. 18. On information and belief, Duramed Pharmaceuticals, Inc. ( Duramed is the assignee of the 545 patent. 19. On information and belief, Teva Women s Health is the successor to, and/or was formerly known as Duramed, and Teva Women s Health is also the current holder of NDA No. 22-262. 20. Teva Women s Health has filed in this Court a patent infringement action against Watson Laboratories and others alleging infringement of the 545 patent. JURISDICTION AND VENUE 21. Watson Laboratories realleges and incorporates by reference the allegations of paragraphs 1-20 of this Counterclaim. 22. This is an action under the Declaratory Judgment Act, 28 U.S.C. 2201 and 2202, and the Patent Laws of the United States, based upon an actual controversy between the parties. 23. This is a compulsory counterclaim under Rule 13(a of the Federal Rules of Civil Procedure and the Court has jurisdiction pursuant to 28 U.S.C. 1331, 1338(a, 2201 and 2202. COUNTERCLAIM FOR DECLARATION OF NONINFRINGEMENT OF UNITED STATES PATENT NO. 7,615,545 B2 24. Watson Laboratories realleges and incorporates by reference the allegations of paragraphs 1-23 of this Counterclaim. 11

Case 2:10-cv-00080-FSH -PS Document 15 Filed 03/01/10 Page 12 of 14 25. Watson Laboratories submission of its ANDA No. 200407 for the purpose of obtaining approval to market a generic version of LoSeasonique did not and does not infringe any valid and enforceable claim of the 545 patent under 35 U.S.C. 271(e(2, nor would the manufacture, use, sale, offer of sale in and/or importation into the United States of Watson Laboratories proposed generic version of LoSeasonique that is the subject of ANDA No. 200407 infringe any valid and enforceable claim of the 545 patent. 26. Watson Laboratories is entitled to a declaration that the manufacture, use, sale, offer of sale in and/or importation into the United States of the product that is the subject of Watson Laboratories ANDA No. 200407 would not infringe any valid and enforceable claim of the 545 patent. COUNTERCLAIM FOR DECLARATION OF INVALIDITY OF UNITED STATES PATENT NO. 7,615,545 B2 27. Watson Laboratories realleges and incorporates by reference the allegations of paragraphs 1-26 of this Counterclaim. 28. The 545 patent is invalid for failure to meet one or more of the requirements of patentability under 35 U.S.C. 101, et seq., including but not limited to 35 U.S.C. 102 and 103. 29. The claims of the 545 patent are invalid because the alleged inventions claimed therein are anticipated in view of the prior art to one having ordinary skill in the art and thus fail to satisfy the conditions for patentability set forth in 35 U.S.C. 102. 30. The claims of the 545 patent are invalid because the alleged inventions claimed therein are obvious in view of the prior art to one having ordinary skill in the art and thus fail to satisfy the conditions for patentability set forth in 35 U.S.C. 103. 31. Therefore, Watson Laboratories is entitled to a declaration that the claims of the 545 patent are invalid, including for anticipation and/or obviousness in view of the prior art. 12

Case 2:10-cv-00080-FSH -PS Document 15 Filed 03/01/10 Page 13 of 14 REQUEST FOR RELIEF WHEREFORE, Defendant/Counter-Plaintiff Watson Laboratories respectfully requests that this Court enter a Judgment and Order in its favor against Plaintiff/Counter-Defendant Teva Women s Health: (a (b (c Dismissing the Complaint herein in its entirety with prejudice; Declaring that the claims of the 545 patent are invalid; Declaring that no valid and enforceable claim of the 545 patent has been infringed; (d Permanently enjoining Teva Women s Health, its officers, agents, directors, servants, employees, subsidiaries, and assigns, and all those acting under the authority of or in privy with them or with any of them, from asserting or otherwise seeking to enforce the 545 patent against either Watson Laboratories or its proposed generic version of the LoSeasonique product; (e Declaring that this case is an exceptional case under 35 U.S.C. 285 and awarding Watson Laboratories its attorney s fees, costs, and expenses; and (f Awarding Watson Laboratories any further additional relief as the Court may deem just, proper and equitable. Dated: March 1, 2010 HELLRING LINDEMAN GOLDSTEIN & SIEGAL LLP By:/s/ Matthew E. Moloshok Matthew E. Moloshok, Esq. Robert S. Raymar, Esq. One Gateway Center Newark, New Jersey 07102-5386 Telephone: (973 621-9020 Facsimile: (973 621-7406 mmoloshok@hlgslaw.com rsraymar@hlgslaw.com 13

Case 2:10-cv-00080-FSH -PS Document 15 Filed 03/01/10 Page 14 of 14 Of Counsel: Mark T. Jansen, Esq. TOWNSEND AND TOWNSEND AND CREW LLP Two Embarcadero Center, 8 th Floor San Francisco, CA 94111 Telephone: (415 576-0200 Facsimile: (415 576-0300 Cedric C.Y. Tan, Esq. Kristin M. Cooklin, Esq. TOWNSEND AND TOWNSEND AND CREW LLP 1301 K Street, N.W. Ninth Floor, East Towner Washington, D.C. 20005 Telephone: (202 481-9900 Facsimile: (202 481-3972 Attorneys for Watson Pharmaceuticals, Inc. and Watson Laboratories, Inc. 14