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

Home , Generic 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 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

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(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

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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

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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).

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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.

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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. § 355 and 35 U.S.C. § 271).

A. New drugs and patent listing requirements.

20. Before marketing a new or previously unapproved drug (i.e., not a

generic drug), such as finasteride, in the United States, the FFDCA, as amended by

Hatch-Waxman and the MMA, requires that an applicant, like Merck, submit, and

that FDA approve, a new drug application (“NDA”) under 21 U.S.C. § 355(b).

The NDA must include, inter alia, technical data on the composition of the drug,

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the means for manufacturing it, clinical trial results to establish the safety and efficacy of the drug, and labeling relating to the use of the drug for which approval is requested.

21. An NDA applicant, like Merck, is required, within its NDA, to submit information (e.g., the patent number and expiration date) for each patent that claims the drug or method of using the drug that is the subject of the NDA and for which a claim of patent infringement could be reasonably asserted if a person not licensed by the patent owner engaged in the manufacture, use, or sale of the drug.

21 U.S.C. § 355(b)(1).

22. FDA publishes patent information submitted by an NDA-holder in the

Patent and Exclusivity Information Addendum of FDA’s publication, Approved

Drug Products with Therapeutic Equivalence Evaluations (commonly known as the “Orange Book”).

23. By filing an NDA and submitting a patent for listing in the Orange

Book, the NDA-holder/patent owner (here, Merck), by law, necessarily maintains that the listed patent claims the approved NDA drug, or an approved method of using such drug, and that an infringement suit could reasonably be asserted against anyone who engages in the manufacture, use, or sale of the drug, and in particular against any company (here, Mylan) that is seeking to make a generic version of the

NDA drug.

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24. The NDA-holder/patent owner, like Merck here, necessarily puts all prospective generic ANDA applicants, like Mylan, on notice that a suit for infringement can and will be asserted against any ANDA applicant that attempts to seek approval for and market a competing generic version of the NDA drug.

25. Such conduct by the NDA-holder/patent owner gives rise to a reasonable apprehension on the generic ANDA applicant’s part that it will face an infringement suit or the threat of one if it attempts to seek approval for or to market a generic version of the NDA drug.

B. Generic drugs and patent certification requirements. 26. The FFDCA, as amended by Hatch-Waxman and the MMA, provides for an ANDA approval process that enables generic pharmaceutical manufacturers to obtain regulatory approval of lower-priced generic versions of previously approved brand-name or NDA drugs on an expedited basis, thereby benefiting the

U.S. health-care system and American consumers. The ANDA process is a streamlined version of the full NDA procedure and results in a generic drug product that is normally marketed under the chemical name of the active drug ingredient (e.g., finasteride).

27. An applicant, like Mylan here, may invoke this procedure for

expedited FDA approval of a generic version of an already approved NDA drug by

submitting an ANDA to FDA under 21 U.S.C. § 355(j).

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28. Instead of repeating the comprehensive, extensive clinical studies of safety and efficacy conducted for the previously-approved NDA drug, a generic applicant submitting an ANDA only is required to establish, among other things, that its generic drug is bioequivalent to the already-approved NDA drug (i.e., has

no significant difference in rate and extent of absorption) and that it has the same

active ingredient, dosage form, dosage strength, route of administration, and

labeling (with certain exceptions) as the approved NDA drug. 21 U.S.C.

§ 355(j)(2)(A).

29. An ANDA applicant also is required to address each patent listed in

the Orange Book in connection with the approved NDA drug. In particular, an

ANDA applicant generally must submit one of four types of patent certifications

for each listed patent: (I) that the NDA-holder/patent owner has not submitted any

patent information to FDA; (II) that the listed patent has expired; (III) that the

patent will expire on a future date, and that the generic applicant will not market its

drug product until after the expiration date (commonly referred to as a “paragraph

III certification”); or, (IV) that the listed patent is invalid, unenforceable, and/or

will not be infringed by the manufacture, use, or sale of the generic drug for which

the ANDA is submitted (commonly referred to as a “paragraph IV certification”).

21 U.S.C. § 355(j)(2)(A)(vii)(I-IV). This last type of certification, a paragraph IV

certification, signifies that the generic ANDA applicant intends to market its

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generic drug prior to expiration of the subject patent. The submission of an ANDA with a paragraph IV certification, like Mylan’s ANDA here, constitutes an act of infringement under the patent laws.

30. When an ANDA applicant submits a paragraph IV certification for a listed patent, as Mylan did here, the generic applicant must notify the NDA- holder/patent owner that it has filed an ANDA to obtain regulatory approval of a generic version of the NDA drug, and that the ANDA contains a paragraph IV certification for a listed patent (indicating that the ANDA applicant intends to market its generic product before expiration of the listed patent). 21 U.S.C.

§ 355(j)(2)(B). This notice must contain a detailed statement of the factual and legal basis for the ANDA applicant’s certification that the listed patent is invalid, unenforceable, and/or will not be infringed by the manufacture, use, or sale of the

ANDA applicant’s generic drug product. 21 U.S.C. § 355(j)(2)(B)(ii).

31. The submission of a paragraph IV certification has two important effects.

C. 180-day exclusivity.

32. First, a generic applicant that is first to submit an ANDA containing a paragraph IV certification for a listed patent is entitled to 180 days of generic market exclusivity during which no other competing generic drug products may be

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marketed. 21 U.S.C. § 355(j)(5)(B)(iv). This statutory benefit is commonly known as “180-day exclusivity.”

33. In particular, section 355(j)(5)(B)(iv) of the FFDCA provides that

“[i]f the application contains a certification described in subclause (IV) of paragraph (2)(A)(vii) and is for a drug for which a previous application has been submitted under this section [containing] such a certification, the application shall be made effective not earlier than one hundred and eighty days after” the earlier of:

(a) the first commercial marketing of that ANDA applicant’s proposed drug; or, (b) any court decision—whether it involves the first applicant or not—that the particular patent that is the subject of the paragraph IV certification is invalid or not infringed. 21 U.S.C. § 355(j)(5)(B)(iv).

D. Artificial act of infringement. 34. Second, the submission of a paragraph IV certification for a listed patent constitutes an act of infringement that creates the necessary case or controversy and subject matter jurisdiction to enable an NDA-holder/patent owner to file, and a district court to resolve, an action for patent infringement—before the generic drug is actually made, used, or sold—to determine whether the generic drug, if marketed and sold in accordance with the ANDA, would infringe the relevant patent.

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35. The submission of an ANDA with a paragraph IV certification creates the necessary case or controversy and subject matter jurisdiction for an ANDA applicant to file a declaratory judgment action against the NDA-holder/patent owner if the ANDA applicant is not sued within the applicable 45-day period, as set forth below.

36. Upon receiving notice of a paragraph IV certification for a listed patent submitted by an ANDA applicant, such as Mylan here, the NDA- holder/patent owner, like Merck here, may file suit for infringement of the listed patent under 35 U.S.C. § 271(e)(2)(A). If such a suit is filed within 45 days of receiving such notification, FDA will delay issuing final approval of the ANDA for up to thirty (30) months. 21 U.S.C. § 355(j)(5)(B)(iii).

37. An NDA-holder/patent owner is not precluded from suing after expiration of the 45-day period. In fact, NDA-holders/patent owners, like Merck here, can and often do file suit after expiration of the 45-day period.

38. If the NDA-holder/patent owner does not file such a suit within the

45-day period, the ANDA applicant can file and maintain a suit for declaratory judgment against the NDA-holder/patent owner to obtain patent certainty in the form of a judicial declaration of patent non-infringement and/or invalidity.

39. Congress enacted Hatch-Waxman and the MMA in order to expedite the marketing of lower-priced generic drug products.

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40. Congress intended that the manufacturing and marketing of a generic drug should be allowed as soon as it is determined that the particular generic drug does not violate patent rights, and should not be delayed just because the NDA- holder/patent owner has not sued the generic applicant first, but rather has merely held its patents over the generic applicant like a modern-day “Sword of

Damocles,” as Merck is doing here.

41. Congress intended that a generic ANDA applicant be permitted to trigger the 180-day exclusivity of another applicant by obtaining a favorable court decision in order to open up the generic market. Otherwise, the market could be bottle-necked indefinitely by an ANDA applicant’s 180-day exclusivity, and other generic applicants that may have successfully designed around the listed patent(s), as Mylan has done here, could never get on the market.

42. Congress did not intend for NDA-holders/patent owners to be able to manipulate the market and delay generic competition by delaying suit, as Merck has done here.

43. Congress contemplated that ANDA applicants must obtain a favorable court decision on the patent in order to market the generic drug. This can be accomplished by either being sued by the NDA-holder/patent owner within the 45- day period or by the generic ANDA applicant seeking a declaratory judgment of patent non-infringement and/or invalidity.

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44. The FFDCA, as amended by Hatch-Waxman and the MMA, prohibits an ANDA from seeking a declaratory judgment during the 45-day period in which the NDA-holder/patent owner may bring suit after receiving notification of the

ANDA and paragraph IV certification. Congress, however, clearly intended that a declaratory judgment action be available for ANDA applicants who are not sued by the NDA-holder/patent owner within the 45-day period.

45. The acts of an NDA-holder/patent owner listing a patent in the Orange

Book through the filing of an NDA and a generic manufacturer filing an ANDA together meet the case or controversy requirement for a declaratory judgment action of noninfringement and/or invalidity.

46. In fact, as explained below, Congress explicitly mandated that an

ANDA applicant is entitled to file and maintain a declaratory judgment action when the applicant is not sued.

E. Congress explicitly mandated that an ANDA applicant may file and maintain a declaratory judgment action when it is not sued. 47. Title XI of the MMA, entitled “Access to Affordable

Pharmaceuticals,” amended provisions of the FFDCA and, in particular, Hatch-

Waxman.

48. Under the MMA, an ANDA applicant who has filed a paragraph IV certification is statutorily entitled to file and maintain an action for declaratory judgment against an NDA-holder/patent owner if: (a) the 45-day period has passed

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since notice of the paragraph IV certification was received; (b) neither the patent owner nor the NDA-holder brought an action for infringement of the patent within the 45-day period; and, (c) the NDA-holder/patent owner has been granted an

Offer of Confidential Access to the ANDA. 21 U.S.C. § 355(j)(5)(C)(i)(I)(aa-cc), as amended.

49. Once these three conditions are met, the MMA specifically and unequivocally provides that an ANDA applicant “may, in accordance with section

2201 of title 28, United States Code, bring a civil action under such section against the owner or holder referred to in such subclause . . . for a declaratory judgment that the patent is invalid or will not be infringed by the drug for which the applicant seeks approval . . . .” 21 U.S.C. § 355(j)(5)(C)(i)(II), as amended.

50. An ANDA applicant may exercise its right to file and maintain a declaratory judgment action under the MMA regardless of whether or not the Offer of Confidential Access is accepted.

51. The MMA’s declaratory judgment provision applies to all ANDAs pending on or after December 8, 2003, which includes these proceedings. Section

1102 of the MMA, 117 Stat. 2066, 2456.

52. Congress’s intent in amending 21 U.S.C. § 355(j)(5)(C)(i) and 35

U.S.C. § 271(e)(5) was to extend to ANDA applicants, like Mylan here, the right to file and maintain a declaratory judgment action for patent non-infringement and/or

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invalidity against an NDA-holder/patent owner, like Merck, and to grant the district courts subject matter jurisdiction in such an action.

53. The purpose of this provision was to allow generic ANDA applicants to obtain patent certainty before marketing their generic products, thus avoiding potential ruinous infringement liability and damages.

II. Merck’s Finasteride Tablets (Brand-Names Proscar® and Propecia®) and Listed Patents. 54. Merck holds approved NDA No. 20-180 for 5 mg finasteride tablets,

which Merck markets and sells under the brand-name Proscar® for, among other things, the treatment of symptomatic benign prostatic hyperplasia (BHP) in men with an enlarged prostate.

55. Merck holds approved NDA No. 20-788 for 1 mg finasteride tablets, which Merck markets and sells under the brand-name Propecia® for, among other

things, the treatment of male pattern hair loss.

56. Merck began selling finasteride in the United States in or about June

1992, and even today Merck’s brand-name products are the only finasteride drug

products available to American consumers. Merck’s 2004 sales for finasteride

totaled nearly $500 million (USD).

57. Merck owns a number of United States patents, which purportedly

relate to finasteride, for which Merck seeks to protect and preserve its lucrative

finasteride monopoly from lower-priced generic competition.

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58. Merck purports to own, and have the right to enforce, U.S. Patent No.

4,760,071 (“the ‘071 patent”), entitled “17β-N-Monosubstituted Carbamoyl-4-Aza-

5α-Androst-1-En-3-Ones Which Are Active As Testosterone 5α-Reductase

Inhibitors,” the term of which allegedly expires on or about June 19, 2006, according to FDA’s Orange Book.

59. Merck purports to own, and have the right to enforce, the ‘184 patent, entitled “Finasteride Processes,” the term of which allegedly expires on or about

November 19, 2012, according to FDA’s Orange Book. A true and correct copy of the ‘184 patent is submitted with this Complaint as Exhibit A.

60. Merck purports to own, and to have the right to enforce, the ‘183 patent, entitled “Method Of Synergistic Treatment For Benign Prostatic

Hyperplasia,” the term of which allegedly expires on or about March 20, 2011, according to FDA’s Orange Book. A true and correct copy of the ‘183 patent is submitted with this Complaint as Exhibit B.

61. Merck purports to own, and have the right to enforce, the ‘519 patent, entitled “Prevention Of Precipitated Acute Urinary Retention,” the term of which allegedly expires on or about October 23, 2018, according to FDA’s Orange Book.

A true and correct copy of the ‘519 patent is submitted with this Complaint as

Exhibit C.

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62. On information and belief, Merck submitted information on the ‘071,

‘184, ‘183, and ‘519 patents to FDA for listing in the Orange Book, and certified that such patents claim finasteride, or a method of using finasteride, and that a claim for patent infringement could be reasonably asserted against any generic

ANDA applicant that attempts to seek approval for, and market, a generic version of finasteride.

63. By virtue of that submission, FDA listed the ‘071, ‘184, ‘183, and

‘519 patents in the Orange Book in connection with Merck’s approved NDA No.

20-180 for 5 mg finasteride tablets (brand-name Proscar®).

64. By listing the ‘071, ‘184, ‘183, and ‘519 patents in the Orange Book,

Merck maintains, and has affirmatively represented to the world, that such patents claim finasteride, or a method of using finasteride, and that an infringement suit could reasonably be asserted against any generic ANDA applicant, including

Mylan, that attempts to seek approval for, and market, a generic version of finasteride.

65. The listing of the ‘184, ‘183, and ‘519 patents in the Orange Book creates a reasonable apprehension in the ANDA applicant that it will be sued by

Merck for infringement.

66. The listing of the ‘184, ‘183, and ‘519 patents in the Orange Book objectively creates the necessary case or controversy and subject matter

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jurisdiction for an ANDA-filer to file and maintain a declaratory judgment action if it is not sued by Merck within the requisite 45-day period.

67. Merck has listed a number of other patents in the Orange Book in connection with 1 mg finasteride tablets (brand-name Propecia®), including the

‘071 and ‘184 patents.

III. Mylan’s ANDA for Generic Finasteride Tablets. 68. Mylan submitted an ANDA to FDA seeking approval to market generic 5 mg finasteride tablets to compete with Merck’s Proscar® (finasteride) tablets.

69. Mylan devoted years and millions of dollars in research, development and testing of its generic finasteride drug product, all toward compiling the information necessary to submit an ANDA for generic finasteride tablets.

70. As part of its ANDA, Mylan appropriately addressed the listed patents for 5 mg finasteride tablets (brand-name Proscar®).

71. Mylan submitted a “paragraph III certification,” pursuant to 21 U.S.C.

§ 355(j)(2)(A)(vii)(III), to the ‘071 patent, signifying that Mylan will not market its generic finasteride drug product until after the expiration of that patent.

72. Mylan submitted a “paragraph IV certification,” pursuant to 21 U.S.C.

§ 355(j)(2)(A)(vii)(IV), to the ‘184 and ‘183 patents, stating that such patents are

invalid, unenforceable, and/or will not be infringed by the manufacture, use, or sale

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of Mylan’s generic finasteride drug product. This certification signifies that Mylan intends to market and commercialize its generic finasteride drug product prior to expiration of the ‘184 and ‘183 patents.

73. Mylan submitted a “section (viii) statement,” pursuant to 21 U.S.C.

§ 355(j)(2)(A)(viii), to the ‘519 patent, stating that such patent claims a method of using finasteride for which Mylan is not seeking approval. This statement signifies that Mylan intends to market and commercialize its generic finasteride drug product prior to expiration of the ‘519 patent.

74. Mylan’s finasteride ANDA is substantially complete and was accepted for filing by FDA. Mylan has satisfied all substantive requirements for approval of its generic finasteride drug product.

75. Mylan intends, and is prepared, to market its generic finasteride drug product before expiration of the ‘184, ‘183, and ‘519 patents.

F. Mylan’s notice and offer of confidential access to ANDA. 76. In accordance with 21 U.S.C. § 355(j)(2)(B)(i-ii), Mylan provided

Merck with notice of its ANDA and paragraph IV certification to the ‘184 and

‘183 patents. This notice included a detailed statement setting forth the factual and legal bases why the ‘184 and ‘183 patents are invalid, unenforceable, and/or will not be infringed by the manufacture, use, or sale of Mylan’s generic finasteride tablets.

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77. With the notice of its ANDA, as required under 21 U.S.C.

§ 355(j)(5)(C)(i), Mylan extended to Merck an Offer of Confidential Access to

Mylan’s ANDA for the purpose of determining whether a suit for infringement can be brought.

78. In response to that Offer and for purposes of determining whether an infringement action can be brought, Merck requested that Mylan produce confidential information from its ANDA as well as samples of Mylan’s finasteride drug product.

79. Mylan in good faith complied with Merck’s request for confidential

ANDA information and product samples.

80. Mylan voluntarily provided information and product samples to

Merck so Merck could determine for itself that Mylan does not infringe Merck’s patents and, as a result, so inform Mylan and/or provide Mylan with a covenant not to sue.

81. Despite Mylan’s production of ANDA information and product samples, Merck has never informed or represented to Mylan that Mylan’s finasteride drug product does not infringe Merck’s patents. Nor has Merck covenanted or otherwise promised not to sue Mylan for infringement of Merck’s patents.

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82. Instead, Merck sent Mylan a cryptic two-line letter stating only that “it is not our intention to bring suit pursuant to 35 U.S.C. 271(e)(2) within the 45 day period from service of Mylan’s Notice on the patents discussed with respect to the product of the ANDA.”

83. Merck said nothing about its intentions after expiration of the 45-day period. Nor did Merck inform Mylan that it does not infringe and/or provide

Mylan with a covenant not to sue.

84. Merck’s carefully worded and cryptic letter impliedly reserves the right to sue Mylan some time after the 45-day period expires.

85. The 45-day period has expired and, with it, so has Merck’s purported intention not to sue Mylan.

86. On information and belief, Merck intends to sue Mylan for infringement of the ‘184, ‘183, and ‘519 patents sometime after the 45-day period expires, just as Merck sued Dr. Reddy’s Laboratories for infringement of Merck’s finasteride patents after expiration of the 45-day period, as discussed below.

G. Merck’s litigious conduct and vigorous enforcement of its intellectual property rights, including Merck’s finasteride patents. 87. Merck has a policy and history of vigorously enforcing its patents against generic drug applicants seeking to compete with Merck.

88. As recently as May 2005, Merck released public statements that it

“intends to vigorously defend its patents, which it believes are valid, against

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infringement by generic companies attempting to market products prior to the expiration dates of such patents.” Merck’s 10-Q for quarterly period ended March

31, 2005, at 10; Merck’s Form 10K for fiscal year ended December 31, 2004, at

22, both available at http://phx.corporate-ir.net/phoenix.zhtml?c=73184&p=irol-

sec&localSecCat01v1_rs=11&localSecCat01v1_rc=10.

89. In that statement, Merck was referring specifically to its patents for the drugs alendronate and finasteride.

90. Merck has filed numerous actions for patent infringement in the

United States and abroad against generic companies seeking to market generic alendronate products in competition with Merck’s own alendronate (brand-name

Fosomax®) product.

91. Merck has demonstrated a willingness and intent to enforce its finasteride patents against a similarly-situated generic pharmaceutical company that has filed an ANDA to market generic finasteride.

92. Merck filed suit against one of Mylan’s generic competitors, Dr.

Reddy’s Laboratories, in Merck & Co., Inc. v. Dr. Reddy’s Laboratories, Ltd., No.

04-1313 (GMS) (D. Del.), alleging infringement of two of Merck’s finasteride patents relating to male pattern hair loss. That litigation is still pending.

93. Notably, Merck sued Dr. Reddy’s Laboratories for infringement of

Merck’s finasteride patents almost two years after the 45-day period expired.

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94. In fact, other brand-name pharmaceutical companies have, like

Merck, similarly demonstrated an intent to enforce their patents against, and essentially ambush, generic applicants after the 45-day period expires. For example, with respect to the prescription drug quinapril hydrochloride (brand- name Accupril®), Pfizer Inc. delayed suing generic ANDA applicant Ranbaxy until after the 45-day period expired and Ranbaxy began marketing its generic quinapril drug. Pfizer obtained a preliminary injunction against Ranbaxy, thus exposing

Ranbaxy to potentially catastrophic infringement damages.

95. Congress did not intend for generic ANDA applicants to be subjected to such risks and delays. Rather, Congress intended that generic ANDA applicants be permitted to obtain court decisions through declaratory judgment actions in order to obtain patent certainty and avoid potentially catastrophic infringement damages and to allow for exclusivity triggering court decisions that expedite the market entry of lower-priced generic drugs.

IV. There Is a Substantial and Continuing Justiciable Controversy Between Mylan and Merck Regarding Infringement of the ‘184, ‘183, and ‘519 Patents.

96. By submitting the ‘184, ‘183, and ‘519 patents to FDA for listing in the Orange Book, Merck has affirmatively represented to the world, including

Mylan, that “a claim of patent infringement could reasonably be asserted if a

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person not licensed by the owner engaged in the manufacture, use, or sale of the drug.” 21 U.S.C. § 355(b)(1).

97. By preparing and filing an ANDA, Mylan has invested millions of dollars and substantially prepared to make, use, or sell generic finasteride tablets in the United States.

98. By submitting its ANDA with a paragraph IV certification to engage in the commercial manufacture, use, or sale of generic finasteride tablets before the expiration of the ‘184, ‘183, and ‘519 patents, Mylan has committed an act of infringement sufficient to create case or controversy jurisdiction under 35 U.S.C.

§ 271(e)(2)(A) and Article III of the Constitution.

99. Merck did not sue Mylan for infringement of the ‘184 and ‘183

patents within 45 days of receipt of Mylan’s notice of paragraph IV certification.

In compliance with 21 U.S.C. § 355(j)(5)(C)(i), as amended, Mylan extended

Merck an Offer of Confidential Access to Mylan’s ANDA for generic finasteride

tablets. As such, Mylan is statutorily entitled to institute—and this Court has

constitutional authority to adjudicate—a declaratory judgment action against

Merck. See 35 U.S.C. § 271(e)(5), as amended.

100. Merck has never communicated to Mylan that Mylan does not

infringe or that Merck does not intend to bring a lawsuit against Mylan for

infringement of the ‘184, ‘183, and ‘519 patents. Mylan thus faces enormous

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potential infringement liability if Mylan commences marketing before the ‘184,

‘183, and ‘519 patents expire.

101. Merck’s cryptic statements about not suing within the 45-day period, which has now expired, reveal Merck’s true intention to sue Mylan for infringement of the ‘184, ‘183, and ‘519 patents, just as Merck sued Dr. Reddy’s

Laboratories after expiration of the 45-day period.

102. Merck has demonstrated a willingness and further an intention to enforce its patents related to finasteride against similarly-situated finasteride

ANDA applicants after expiration of the 45-day period.

103. Based on the totality of at least these facts, Mylan is under a reasonable apprehension that Merck will sue Mylan for infringement of the ‘184,

‘183, and ‘519 patents.

104. These facts, either alone or together, give rise to a substantial and continuing case or controversy under Article III of the Constitution over which this

Court has subject matter jurisdiction.

105. To avoid legal uncertainty, to protect its substantial investment, to protect its anticipated future investments in the manufacture of Mylan’s generic finasteride tablets, and to open the generic finasteride market, Mylan has instituted this action under the MMA and is entitled to a declaration of its rights with respect to the ‘184, ‘183, and ‘519 patents.

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First Claim for Relief (Declaratory Judgment of Non-Infringement of the ‘184 Patent)

106. Mylan asserts and realleges paragraphs 1 through 105 above as if fully set forth herein.

107. Mylan is entitled by statute to seek a judicial declaration of non- infringement of the ‘184 patent.

108. Mylan has committed an act of infringement by submitting an ANDA with a paragraph IV certification. Mylan also has produced an allegedly infringing finasteride drug product and intends and is prepared to market and sell that product before expiration of the ‘184 patent.

109. Merck has affirmatively represented that an action for patent infringement could be asserted against any generic finasteride applicant, which includes Mylan.

110. Merck has engaged, and continues to engage, in conduct giving rise to a reasonable and objective apprehension on Mylan’s part that Mylan will face an infringement suit.

111. There is an actual, substantial, and continuing justiciable case or controversy between Mylan and Merck regarding infringement of the ‘184 patent.

112. The manufacture, use, sale, offer for sale, or importation of Mylan’s generic finasteride drug product, that is the subject of Mylan’s ANDA, does not

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and will not infringe (either literally or under the doctrine of equivalents), directly or indirectly (either by inducement or contributorily), any valid or enforceable claim of the ‘184 patent.

113. Mylan is entitled to a judicial declaration that the manufacture, use, sale, offer for sale, or importation of Mylan’s generic finasteride drug product, that is the subject of Mylan’s ANDA, does not and will not infringe (either literally or under the doctrine of equivalents), directly or indirectly (either by inducement or contributorily), any valid or enforceable claim of the ‘184 patent.

Second Claim for Relief (Declaratory Judgment of Non-Infringement of the ‘183 Patent)

114. Mylan asserts and re-alleges paragraphs 1 through 105 above as if

fully set forth herein.

115. Mylan is entitled by statute to seek a judicial declaration of non-

infringement of the ‘183 patent.

116. Mylan has committed an act of infringement by submitting an ANDA

with a paragraph IV certification. Mylan has produced an allegedly infringing

finasteride drug product and intends and is prepared to market and sell that product

before expiration of the ‘183 patent.

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117. Merck has affirmatively represented that an action for patent infringement could be asserted against any generic finasteride applicant, which includes Mylan.

118. Merck has engaged, and continues to engage, in conduct giving rise to a reasonable and objective apprehension on Mylan’s part that Mylan will face an infringement suit.

119. There is an actual, substantial, and continuing justiciable case or controversy between Mylan and Merck regarding infringement of the ‘183 patent.

120. The manufacture, use, sale, offer for sale, and importation of Mylan’s generic finasteride drug product, that is the subject of Mylan’s ANDA, does not and will not infringe (either literally or under the doctrine of equivalents), directly or indirectly (either by inducement or contributorily), any valid or enforceable claim of the ‘183 patent.

121. Mylan is entitled to a judicial declaration that the manufacture, use, sale, offer for sale, or importation of Mylan’s generic finasteride drug product, that is the subject of Mylan’s ANDA, does not and will not infringe (either literally or under the doctrine of equivalents), directly or indirectly (either by inducement or contributorily), any valid or enforceable claim of the ‘183 patent.

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Third Claim for Relief (Declaratory Judgment of Non-Infringement of the ‘519 Patent)

122. Mylan asserts and re-alleges paragraphs 1 through 105 above as if

fully set forth herein.

123. Mylan is entitled by statute to seek a judicial declaration of non-

infringement of the ‘519 patent.

124. Mylan has committed an act of infringement by submitting an ANDA

with a paragraph IV certification. Mylan has produced an allegedly infringing

finasteride drug product and intends and is prepared to market and sell that product

before expiration of the ‘519 patent.

125. Merck has affirmatively represented that an action for patent

infringement could be asserted against any generic finasteride applicant, which

includes Mylan.

126. Merck has engaged, and continues to engage, in conduct giving rise to

a reasonable and objective apprehension on Mylan’s part that Mylan will face an

infringement suit.

127. There is an actual, substantial, and continuing justiciable case or

controversy between Mylan and Merck regarding infringement of the ‘519 patent.

128. The manufacture, use, sale, offer for sale, or importation of Mylan’s generic finasteride product, that is the subject of Mylan’s ANDA, does not and will

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not infringe (either literally or under the doctrine of equivalents), directly or indirectly (either by inducement or contributorily), any valid or enforceable claim of the ‘519 patent.

129. Mylan is entitled to a judicial declaration that the manufacture, use, sale, offer for sale, or importation of Mylan’s generic finasteride drug product, that is the subject of Mylan’s ANDA, does not and will not infringe (either literally or under the doctrine of equivalents), directly or indirectly (either by inducement or contributorily), any valid or enforceable claim of the ‘519 patent.

Prayer For Relief

WHEREFORE, Mylan respectfully prays for judgment in its favor and against Merck:

(a) Declaring that the manufacture, use, sale, offer for sale, or

importation of Mylan’s generic finasteride drug product, that is

the subject of Mylan’s ANDA, does not and will not infringe

(either literally or under the doctrine of equivalents), directly or

indirectly (either by inducement or contributorily), any valid or

enforceable claim of the ‘184, ‘183, and ‘519 patents; and,

(b) Awarding Mylan its reasonable attorneys’ fees and costs of this

action; and,

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deem just and proper.

Jury Demand

The Plaintiff, Mylan Pharmaceuticals Inc., hereby demands a trial by jury on

all issues so triable.

Dated: July 14, 2005. Respectfully submitted,

KEEFER WOOD ALLEN & RAHAL, LLP

By: s/ Charles W. Rubendall II Charles W. Rubendall II (PA 23172) Donald M. Lewis III (PA 58510) 210 Walnut Street, P.O. Box 11963 Harrisburg, PA 17108-1963 Telephone: (717) 255-8010 and 8038 Facsimile: (717) 255-8003 [email protected] [email protected]

Attorneys for Plaintiff, Mylan Pharmaceuticals Inc.

Of Counsel William A. Rakoczy Amy D. Brody RAKOCZY MOLINO MAZZOCHI SIWIK LLP 6 West Hubbard Street, Suite 500 Chicago, Illinois 60610 Telephone: (312) 222-6301 Facsimile: (312) 222-6321 [email protected] [email protected]

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