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In the United States District Court for the Middle District of Pennsylvania Harrisburg Division

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In the United States District Court for the Middle District of Pennsylvania Harrisburg Division CaseCase 3:02-at-06000-UN 1:05-cv-01416-SHR Document Document 483-1 1 FiledFiled 07/14/0507/14/2005 Page Page 1 of 133 of 33 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF PENNSYLVANIA HARRISBURG DIVISION MYLAN PHARMACEUTICALS INC., ) ) Plaintiff, ) Civil Action No. ) v. ) JURY TRIAL DEMANDED ) MERCK & CO., INC., ) ) FILED ELECTRONICALLY Defendant. ) COMPLAINT FOR DECLARATORY JUDGMENT The Plaintiff, Mylan Pharmaceuticals Inc. (“Mylan”), for its Complaint against the Defendant, Merck & Co., Inc. (“Merck”), alleges as follows: Nature of the Action 1. Mylan brings—and is entitled by statute to maintain—this action for declaratory judgment of patent non-infringement under, inter alia, 21 U.S.C. § 355(j)(5)(C)(i), as amended by Title XI of the Medicare Prescription Drug, CaseCase 3:02-at-06000-UN 1:05-cv-01416-SHR Document Document 483-1 1 FiledFiled 07/14/0507/14/2005 Page Page 2 of 233 of 33 Improvement, and Modernization Act of 2003, Pub. L. No. 108-173, 117 Stat. 2066 (2003) (“the MMA”). 2. This action arises out of, inter alia, Mylan’s submission of an Abbreviated New Drug Application (“ANDA”) to the U.S. Food and Drug Administration (“FDA”) seeking approval to market a generic version of Merck’s brand-name prescription drug Proscar®, otherwise known as finasteride. Merck also markets finasteride under the brand-name Propecia®. 3. Merck owns several United States patents purportedly relating to finasteride, including U.S. Patent Nos. 5,886,184 (“the ‘184 patent”), 6,046,183 (“the ‘183 patent”), and 5,942,519 (“the ‘519 patent”). Merck has listed these patents in FDA’s “Orange Book,” a compilation of approved drugs and their patents, in connection with finasteride. 4. As a consequence of the Orange Book-listing of these patents, Merck maintains, and has affirmatively represented to the world, that the ‘184, ‘183, and ‘519 patents claim finasteride, or an approved method of using finasteride, and that a claim for patent infringement could reasonably be asserted against any generic ANDA applicant, including Mylan, that attempts to manufacture, use, or sell a generic finasteride drug product. Merck also vigorously enforces its intellectual property rights on blockbuster prescription drugs like finasteride against generic drug manufacturers. In fact, Merck already has sued one generic company - 2 - CaseCase 3:02-at-06000-UN 1:05-cv-01416-SHR Document Document 483-1 1 FiledFiled 07/14/0507/14/2005 Page Page 3 of 333 of 33 (Mylan’s competitor, Dr. Reddy’s Laboratories) for patent infringement for attempting to manufacture, use, or sell a generic finasteride product to compete with Merck’s Propecia®. 5. Mylan’s ANDA contains a so-called “paragraph IV certification” stating that Merck’s ‘183 and ‘184 patents are invalid, unenforceable, and/or will not be infringed by the manufacture, use, or sale of Mylan’s generic finasteride drug product. Mylan’s Paragraph IV ANDA filing constitutes an act of patent infringement that puts Mylan at considerable risk of being sued by Merck either before or after market entry. In fact, this regulatory submission alone created the necessary case or controversy and subject matter jurisdiction for Merck to sue Mylan for patent infringement. 6. Mylan is prepared to begin marketing its generic finasteride drug product in competition with Merck upon receipt of FDA approval to do so. As required by statute, Mylan notified Merck of its ANDA filing and the detailed legal and factual basis for Mylan’s paragraph IV certification. In response to that notice, Merck requested information from Mylan’s ANDA and samples of Mylan’s generic finasteride drug product. After receiving Mylan’s ANDA information and product samples, Merck has neither informed Mylan that Mylan does not infringe nor covenanted not to sue Mylan for infringement of Merck’s patents. Rather, Merck cryptically informed Mylan only that it was not Merck’s “intention to bring - 3 - CaseCase 3:02-at-06000-UN 1:05-cv-01416-SHR Document Document 483-1 1 FiledFiled 07/14/0507/14/2005 Page Page 4 of 433 of 33 suit . within the 45 day period from service of Mylan’s Notice.” The 45-day period from service of Mylan’s notice has expired. Merck impliedly reserved the right to sue Mylan after that 45-day period, just as Merck did when it sued Mylan’s generic competitor, Dr. Reddy’s Laboratories, for infringement of other Merck finasteride patents. Merck has created in Mylan a reasonable apprehension of being sued for infringement of Merck’s finasteride patents. 7. On information and belief, Merck believes that a claim for patent infringement could be reasonably asserted against Mylan and Merck intends to sue Mylan for such infringement. There is an actual, substantial, and continuing justiciable case and controversy between Mylan and Merck regarding infringement of Merck’s patents, over which this Court can and should exercise jurisdiction and declare the rights of the parties. 8. Mylan is entitled by law to bring and maintain this action for declaratory judgment of patent non-infringement under the MMA where, as here, Merck did not sue Mylan within 45 days of receipt of Mylan’s notice of paragraph IV certification to the ‘184 and ‘183 patents, and Mylan has offered Merck an Offer of Confidential Access to Mylan’s ANDA for generic finasteride. 9. Mylan is entitled to a judicial declaration that the manufacture, use, sale, offer for sale, or importation of Mylan’s generic finasteride drug product does not and will not infringe the ‘184, ‘183, and ‘519 patents. Absent the exercise of - 4 - CaseCase 3:02-at-06000-UN 1:05-cv-01416-SHR Document Document 483-1 1 FiledFiled 07/14/0507/14/2005 Page Page 5 of 533 of 33 jurisdiction by this Court and such declaratory relief, Mylan and the American public will be irreparably harmed by the indefinite delay in the market entry, and greater availability, of lower-priced generic finasteride drug products. The Parties 10. Plaintiff Mylan is a West Virginia corporation with a place of business at 781 Chestnut Ridge Road, Morgantown, West Virginia 26505, and an authorized agent in this District. Mylan is engaged in the research, development, manufacture, and distribution of quality generic pharmaceutical products in the United States and in this District. 11. On information and belief, Defendant Merck is a New Jersey corporation with a place of business at One Merck Drive, Whitehouse Station, New Jersey 08889. On information and belief, Merck is registered to do, and conducts substantial, business in the Commonwealth of Pennsylvania and in this District. On information and belief, Merck also maintains offices in the Commonwealth of Pennsylvania and in this District. Jurisdiction and Venue 12. This action arises under, inter alia, the Patent Laws of the United States, 35 U.S.C. § 1 et seq.; the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202; and the MMA, 21 U.S.C. § 355(j)(5)(C)(i) and 35 U.S.C. § 271(e)(5). - 5 - CaseCase 3:02-at-06000-UN 1:05-cv-01416-SHR Document Document 483-1 1 FiledFiled 07/14/0507/14/2005 Page Page 6 of 633 of 33 13. This Court has original jurisdiction over the subject matter of this action under 28 U.S.C. §§ 1331 and 1338(a), because this action involves substantial claims arising under the United States Patent Act, 35 U.S.C. § 1 et seq.; under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202, because this action is an actual controversy concerning the infringement of the patents-in-suit; and under the MMA, 21 U.S.C. § 355(j)(5)(C)(i) and 35 U.S.C. § 271(e)(5), because Congress has directed that district courts maintain and exercise jurisdiction in such cases. 14. There exists an actual, substantial, and continuing justiciable case or controversy between Mylan and Merck regarding infringement of the ‘184, ‘183, and ‘519 patents. 15. This Court can and should declare the rights and legal relations of the parties regarding non-infringement of the ‘184, ‘183, and ‘519 patents pursuant to, inter alia, the Declaratory Judgment Act, 28 U.S.C. §§ 2201, 2202, and the MMA, 21 U.S.C. § 355(j)(5)(C)(i) and 35 U.S.C. § 271(e)(5). 16. Mylan has the statutory right to bring and maintain this declaratory judgment action under 21 U.S.C. § 355(j)(5)(C)(i), as amended by the MMA. This Court can and should exercise its declaratory judgment jurisdiction over Mylan’s claims pursuant to 35 U.S.C. § 271(e)(5), as amended by the MMA. - 6 - CaseCase 3:02-at-06000-UN 1:05-cv-01416-SHR Document Document 483-1 1 FiledFiled 07/14/0507/14/2005 Page Page 7 of 733 of 33 17. This Court has personal jurisdiction over Merck because Merck is registered to do business in the Commonwealth of Pennsylvania and because Merck maintains offices and conducts substantial business in, and has regular and systematic contact with, the Commonwealth of Pennsylvania and this District. 18. Venue is proper in this District under 28 U.S.C. §§ 1391(b) and 1400(b). Background Allegations Common to all Counts I. Statutory Scheme for Approval of New and Generic Drugs. 19. The approval of new and generic drugs is governed by the applicable provisions of the Federal Food, Drug, and Cosmetic Act (the “FFDCA”), 21 U.S.C. § 301 et seq., as amended by the Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (1984) (commonly known as the “Hatch-Waxman Amendments” or “Hatch-Waxman”), and the MMA (codified as amended in relevant part at 21 U.S.C.
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