Issues in the interpretation of 180-day exclusivity

Food and Drug Law Journal

Volumn 62, Issue 1, 2007, Pages 49-75

  Lietzan, Erika ^a   Korn, David E ^b  

^a Department of International Practice   (United States)

^b Pharmaceutical Research and Manufacturers of America   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CERTIFICATION; COURT; DECISION MAKING; DRUG APPROVAL; DRUG INDUSTRY; DRUG LEGISLATION; DRUG MARKETING; FOOD AND DRUG ADMINISTRATION; PATENT; REVIEW;

DRUGS, GENERIC; DRUGS, INVESTIGATIONAL; HUMANS; INVESTIGATIONAL NEW DRUG APPLICATION; LEGISLATION, DRUG; MARKETING OF HEALTH SERVICES; PATENTS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 33947226976     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (210)

1. Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585(1984).
2. Pub. L. No. 108-173, 117 Stat. 2066 (2003).
3. Erika Lietzan, A Brief History of 180-Day Exclusivity under the Hatch- Waxman Amendments, 59 FOOD & DRUG L.J. 287 (2004).
4. A subsequent update traced developments in 2004. Erika Lietzan, 2004 Update-180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act, 59 FOOD & DRUG L.J. 459 (2004).
5. The earlier article identified the cases by party and roman numeral (e.g., Purepac I, Purepac II, Mylan I, Mylan II). The growing number of disputes involving the same companies has rendered this system unwieldy. Where shorthand is called for, we generally refer to the case by the active ingredient of the innovator's drug.
6. 21 U.S.C. § 355(j)(5)(B)(iv) (1984) (amended 2003).
7. Although the statute refers to "previous" ANDAs, it has been interpreted over time to mean that only the first applicant is eligible.
8. Shortly after enactment of the 2003 amendments, Senator Hatch noted the "incongruity" of "awarding 180 days both for a successful invalidity challenge and a non-infringement action." The latter, he noted, benefits only a specific party, the non-infringing generic manufacturer, rather than clearing the way for generic market entry in general. 149 CONG. REC. S 16104 (daily ed., Dec. 9, 2003) (Sen. Hatch).
9. 21 U.S.C. § 355(j)(5)(B)(iv) (2003).
10. As discussed below, there can be more than one "first applicant" eligible for 180-day exclusivity.
11. 21 U.S.C. § 355(j)(5)(D).
12. 21 U.S.C. § 355(j)(5)(B)(iv)(II).
13. See Pub. L. No. 108-173 § 1102(b).
14. See FDA, Draft Guidance for Industry, Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Oct. 2004).
15. 54 Fed. Reg. 28872 (July 10,1989) (proposed rule);
16. Fed. Reg. 50338 (Oct. 3, 1994) (final rule).
17. The statute refers only to a decision holding the patent invalid or not infringed. FDA added "unenforceable." See 59 Fed. Reg. at 50339 ("The agency, on its own initiative, has also amended [the proposed regulations] to include a reference to unenforceable patents.... The alternative interpretation ... would be contrary to Congress' obvious intent in allowing patent challenges under section 505 of the act and would lead to absurd results.").
18. In the preamble to the proposed regulation, FDA had added that a "required bioequivalence study is one that meets any FDA guidance document or is otherwise reasonable in design and purports to show that the drug product for which the applicant seeks exclusivity is bioequivalent to the listed drug." 54 Fed. Reg. at 28895.
19. Rejecting concerns about so-called "file first fix later" practices on the part of generic manufacturers, however, FDA declined to establish criteria to determine whether changes to an ANDA have been so substantial that it can no longer be considered to have been the first filed. Instead, it would rely on its decision in 1992 to no longer accept ANDAs lacking complete bioequivalence study data (if such data are required for approval) and use a "case-by-case approach" to ANDA changes. 59 Fed. Reg. at 50354.
20. FDA added, however that "[a] decision by the agency after receipt of an application that the bioequivalence information is inadequate for approval does not necessarily mean that the application was not substantially complete at the time of submission." This effectively undermined the 1992 solution to what FDA itself referred to as a "significant and unwarranted expenditure of resources in reviewing applications that had little potential for approval." Id.
21. The phrase "lawfully maintain" was added in the Conference Report. One cannot "lawfully maintain" a patent challenge if one loses the ensuing litigation. And the failure-to-market forfeiture event applies only to patents for which a paragraph IV certification has been lawfully maintained. Thus, if an ANDA applicant loses a patent challenge (for example, to a drug substance patent), that patent challenge no longer qualifies the applicant for exclusivity. The 75-day forfeiture clock would begin to run as soon as the eligible applicant prevails on a different patent. Put another way, if the ANDA applicant challenges a formulation patent but adds a frivolous challenge to a drug substance patent, prevails on the formulation patent and loses on the substance patent, then the 75-day clock begins to run. This precludes parking exclusivity by challenging two patents, knowing the challenger will lose on the patent that is not due to expire for some time. Now the generic applicant forfeits exclusivity, if it cannot market within 75 days of the appellate decision on a patent it successfully challenged. For a discussion of this issue, see Eli Lilly, Hatch 180-Day Award Concerns May Slow Hatch-Waxman Deal" www.InsideHealthPolicy.com (Aug. 7, 2003);
22. CBO Says Generic Rx Language in Both Medicare Bills Could Delay Drug Competition, HEALTH CARE DAILY (Sept. 2, 2003);
23. Robert A. Armitage, Testimony on Behalf of Eli Lilly and Company Before the Committee on the Judiciary, United States Senate, on the "Greater Access to Affordable Pharmaceuticals Act" (Aug. 1, 2003).
24. Purepac Pharmaceutical Co. v. Thompson, 354 F.3d 877 (D.C. Cir. 2004), aff'g TorPharm, Inc. v. Thompson, 260 F.Supp.2d 69 (D.D.C. 2003);
25. see also TorPharm Rebuffed on Bid to Overturn FDA Decision Awarding Exclusivity to Purepac, BNA PHARMACEUTICAL LAW & INDUSTRY REPORT (Jan. 23, 2004);
26. Appeals Court Backs FDA: Purepac Gets Gabapentin 180-Day Award, FDA WEEK (Jan. 23, 2004).
27. See IVAX, Purepac Settle Metformin 180-Day Generic Drug Exclusivity Suit, FDA WEEK (Dec. 5, 2003);
28. Glucophage XR Settlement: Purepac, IVAX Split Generic Profits for 180 Days, HEALTH NEWS DAILY (Nov. 28, 2003).
29. 21 U.S.C. § 355(j)(2)(B)(ii)(II).
30. See 21 U.S.C. § 355(j)(2)(B)(ii)(I).
31. IVAX, Citizen Petition, Docket No. 2004P-0520 (Nov. 19, 2004) (arguing that the notice date should control in both cases) (withdrawn); Mylan Pharmaceuticals, Inc., Citizen Petition, Docket No. 2006P-0245 (June 12, 2006) (same) (pending).
32. Apotex v. Shalala, 53 F.Supp.2d 454 (D.D.C. 1999), aff'd, 1999 WL 956686 (D.C. Cir. 1999).
33. Id. at 456 (emphasis added).
34. See, e.g., Mylan Pharmaceuticals, Inc. v. Shalala, 81 F.Supp.2d at 30, 35 n.8 (D.D.C. 2000) ("The tablet and capsule forms of the drug, however, are distinct products for FDA purposes and are thus each eligible for their own exclusivity.").
35. See FDA, Response to APP and Pharmachemie Citizen Petitions, Docket No. 99P-1271 (Aug. 2, 1999) at 3.
36. FDA, Response to APP and Pharmachemie Citizen Petitions, Docket No. 99P-1271 (Aug. 2, 1999) at 3
37. TorPharm, Citizen Petition, Docket No. 99P-5317 (Dec. 7, 1999).
38. FDA, Response to APP and Pharmachemie Citizen Petitions, Docket No. 99P-1271 (Aug. 2, 1999), at 3.
39. 64 Fed. Reg. 42873 (Aug. 6, 1999).
40. Id. at 42876-42877.
41. Id. at 42881.
42. Id. at 42875.
43. 67 Fed. Reg. 66593 (Nov. 1, 2002).
44. Zenith Goldline Pharmaceutical, Citizen Petition, Docket No. OOP-1445 (Aug. 8, 2000).
45. Zenith Goldline Pharmaceutical, Petition for Stay of Action, Docket No. 00P-1443 (Aug. 8, 2000).
46. Ranbaxy Laboratories, Citizen Petition, Docket No. 03P-0217 (May 13, 2003).
47. FDA, Guidance for Industry, 180-Day Exclusivity when Multiple ANDAs Are Submitted on the Same Day (July 2003);
48. FDA, Letter to IVAX Pharmaceutical, Docket No. 00P-1443 (July 31, 2003);
49. FDA, Letter to IVAX Pharmaceuticals, Docket No. 00P-1445 (July 31, 2003);
50. FDA, Letter to Venable, Baetjer, Howard & Civiletti, Docket No. 03P-02171 (July 31, 2003).
51. See 21 U.S.C. § 355(j)(5)(B)(iv)((II)(bb)(defining "first applicant" to mean "an applicant that, on the first day on which a substantially complete application containing a [paragraph IV certification] is submitted for approval of a drug, submits a substantially complete application that contains and lawfully maintains a [paragraph IV certification] for the drug.");
52. see also 149 CONG. REC. S15584 (daily ed., Nov. 25, 2003) (Senator Kennedy) ("and the exclusivity is available to more than one generic applicant, if they all challenge patents on the same day");
53. U.S.C. § 355(j)(5)(D)(III)(if all first applicants forfeit exclusivity, "no applicant shall be eligible").
54. See TorPharm, Inc. v. FDA, 2004 WL 64064 (D.D.C. Jan. 8, 2004) (written order memorializing oral order and judgment issued on January 2);
55. Court Overturns FDA Decision that TorPharm Must Share Paxil 180-Day Exclusivity, INSIDE HEALTH POLICY (Jan. 5, 2004).
56. Apotex, Inc. v. FDA, Case No. 04-5046 (D.C. Cir., Notice of Appeal filed Feb. 13, 2004).
57. Apotex, Inc. v. FDA, Case No. 04-5046 (D.C. Cir., Judgment, Dec. 17, 2004).
58. See Appeals Court Backs FDA: Purepac Gets Gabapentin 180-day Award, INSIDE WASHINGTON'S FDA WEEK, (Jan. 23, 2004), at 3.
59. Apotex, Inc. v. Food and Drug Administration, 1:04-cv-00605-ESH (D.D.C. filed (Apr. 14, 2004)).
60. Apotex, Inc. v. Food and Drug Administration, 1:04-cv-00605-ESH (D.D.C., Order, (June 3, 2004));
61. see Court Split on FDA's Patent-by-Patent Approach to 180-Day Exclusivity, INSIDE WASHINGTON'S FDA WEEK (June 11, 2004).
62. See Court Split on FDA's Patent-by-patent Approach to 180-Day Exclusivity, INSIDE WASHINGTON'S FDA WEEK (June 11, 2004).
63. Apotex v. FDA, 393 F.3d 210 (D.C. Cir. 2004). The case giving rise to res judicata was TorPharm, Inc. v. Thompson, 260 F.Supp.2d 69 (D.D.C. 2003), discussed in section III-A above, which involved the same parties and the same ANDAs. That litigation related to FDA's decision to postpone the effective date of Purepac's certification to the second patent (rather than nullify it as TorPharm had argued). Although the causes of action were not the same, Apotex effectively accepted in the first case that exclusivity was patent-based and argued in the second case that it was not.
64. See also Appeals Court Says Apotex Cannot Relitigate Fight Over Gabapentin Exclusivity, BNA INC. PHARMACEUTICAL LAW & INDUSTRY (Dec. 31, 2004).
65. Apotex v. FDA, 414 F.Supp.2d 61 (D.D.C. 2006);
66. see also Federal Court Upholds FDA's Position on Patent-Based Exclusivity Periods, BNA INC. PHARMACEUTICAL LAW & INDUSTRY (Feb. 17, 2006).
67. See In re Omeprazole Patent Litigation, 222 F.Supp.2d 423 (S.D.N.Y (2002)), aff'd 84 Fed. Appx. 76 (Fed. Cir. Dec. 11, 2003).
68. 414 F.Supp. 2d at 74.
69. Chevron USA, Inc. v. Natural Resources Defense Council, 467 U.S. 83 (1984).
70. 21 U.S.C. § 355(j)(5)(D)(iii).
71. See also 149 CONG. REC. S 15884 (daily ed., (Nov. 25, 2003)) (Senator Kennedy) ("The Hatch-Waxman provisions in this bill also make the exclusivity available only with respect to the patent or patents challenged on the first day generic applicants challenge brand drug patents, which makes the exclusivity a product-by-product exclusivity rather than a patent-by-patent exclusivity.")
72. 54 Fed. Reg. at 50352-50353.
73. Inwood Laboratories, Inc. v. Young, 723 F.Supp. 1523, 1526 (D.D.C. 1989), vacated as moot, no. 89-5209 (D.C. Cir. Nov. 13, 1989).
74. Id.
75. Inwood asked the court of appeals to declare the case moot when six months had elapsed after the lower court enjoined FDA from approving another ANDA. See Inwood Case May Not Set Precedent on Exclusivity, WASHINGTON DRUG LETTER (Oct. 30, 1989), at 2.
76. See Mova Pharmaceutical Corp. v. Shalala, 140 F.3d 1060, 1069-1070 (D.C. Cir. 1998) (discussing FDA's interpretation).
77. 59 Fed. Reg. at 50353.
78. Mova Pharm. Corp. v. Shalala, 955 F.Supp. 128 (D.D.C. 1997).
79. Mova Pharm. Corp. v. Shalala, 140 F. 3d 1060 (D.C. Cir. 1998).
80. Id. at 1069.
81. Id. at 1069-70.
82. Id. at 1069.
83. The court reasoned that "if the first applicant begins marketing its product before it wins its infringement suit, the 180 days of exclusivity do not begin to run; other applicants remain eligible for FDA approval to begin marketing their products, at least up to the date that the first applicant wins the infringement action." Id. at 1070.
84. Id. at 1072.
85. Id. at 1074.
86. In dictum, the court also approved as "elegant and textually persuasive" an argument made by Teva (as amicus curiae) that the court decision trigger may be satisfied by any decision of a court holding the patent invalid or not infringed-including suits not brought by the patent holder, such as a declaratory judgment action by the second ANDA applicant. Id. at 1072-1073.
87. The court noted, however, that it "seems odd to reward the first applicant if some later applicant was the party that actually prevailed in the patent-infringement litigation." Id. at 1073.
88. 955 F.Supp. 128 (D.D.C. 1997).
89. Granutec, Inc. v. Shalala, 139 F.3d 889 (4th Cir. 1998) (unpublished).
90. 139 F.3d 889, at *4.
91. See id. at *5 (citing Glaxo, Inc. v. Boehringer Ingelheim Corp., 954 F.Supp. 469 (D.Conn. 1996), judgment entered by 962 F.Supp. 295 (D.Conn. 1997), aff'd, No. 97-1283, 1997 WL 355339 (Fed. Cir. June 4, 1997).
92. See FDA, Guidance for Industry, 180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the FDCA (June 1998).
93. Id. at 4.
94. Id.
95. Id. at 5.
96. 63 Fed. Reg. 59710 (Nov. 5, 1998).
97. Purepac Pharm. Co. v. Friedman, 162 F.3d 1201 (D.C. Cir. 1998).
98. 162 F.3d at 1204.
99. See Mylan Pharmaceuticals v. Henney, 94 F.Supp.2d 36 (D.D.C. 2000), vacated and dismissed as moot, 276 F.3d 627 (D.C. Cir. 2002).
100. 94 F.Supp.2d at 41.
101. Id.
102. Id. at 42.
103. Id. at 56-57. On May 24, 2001, Gary Buehler, Acting Director of FDA's Office of Generic Drugs, confirmed FDA's view by telling the Senate Judiciary Committee that "[o]nly an application containing a paragraph IV certification may be eligible for exclusivity. If an applicant changes from a paragraph IV certification to a paragraph III certification, for example upon losing its patent infringement litigation, the ANDA will no longer be eligible for exclusivity." Competition in the Pharmaceutical Marketplace: Antitrust Implications of Patent Settlements: Hearing Before the Senate Committee on the Judiciary, 107th Cong. 12 (2001) (Statement of Gary Buehler, RPh).
104. 64 Fed. Reg. 42873 (Aug. 6, 1999).
105. See the discussion below in section III-I.
106. Teva Pharmaceuticals, USA, Inc. v. FDA, 182 F.3d 1003 (D.C. Cir. 1999) ("The California court dismissed the complaint for lack of subject-matter jurisdiction after finding, based on the patent holder's admission of non-infringement, that Teva lacked a reasonable apprehension of suit by the patent holder."). The California decision was not published.
107. Teva Pharmaceutical, USA, Inc. v. FDA, 182 F.3d 1003 (D.C. Cir. 1999).
108. Id. at 1007-1008.
109. Id. at 1009.
110. Following this decision, FDA provided a rationale for refusing to recognize dismissal of Teva's declaratory judgment action as a triggering court decision. In essence, FDA explained, generic applicants seeking to avail themselves of the court decision trigger must submit a copy of the court decision in question. The agency will not review any additional papers from the underlying litigation. The reason for Teva's dismissal "was not evident from the face of the court order, the court did not issue a memorandum opinion explaining the basis for the order," and requiring staff in the Office of Generic Drugs to delve beyond these documents would "place an unbearable burden" on the office. On remand, the district court rejected FDA's explanation, noting-among other things-that "this is not a case where a great deal of sophisticated legal analysis is required." In addition, the court noted, FDA had not met the challenge of squaring its approach to the California dismissal with its handling of the Boehringer decision (a partial summary judgment on the basis of an admission of non-infringement) that triggered the exclusivity at issue in the Granutec case. FDA's claim that the California decision was not a "holding" failed, for example, because the term is open to interpretation. Teva Pharmaceuticals USA, Inc. v. United States Food & Drug Administration, 1999 WL 1042743 (D.D.C. Aug. 19, 1999), aff'd 254 F.3d 316 (D.C. Cir. 2000).
111. Teva v. FDA, 441 F.3d 1, 3 (D.C. Cir. 2006).
112. Id. at 6.
113. Id.
114. FDA, Letter to Pravastatin ANDA Applicant (Apr. 11, 2006), available at www.fda.gov/cder/ ogd/announce/Pravastatin-180Day-amend.pdf;
115. see also FDA Narrows Interpretation of Exclusivity Court Decision Triggers, [THE PINK SHEET] (Apr. 17, 2006).
116. FDA Approves Teva's Generic Pravastatin, As Court Denies Apotex Emergency Relief, BNA, INC. PHARMACEUTICAL LAW & INDUSTRY (Apr. 28, 2006). Apotex Inc. v. FDA, D.D.C, No. 06-00627 (April 19, 2006) (denying motions for temporary restraining order and preliminary injunction);
117. Apotex Inc. v. FDA, D.C. Cir., No. 06-5105 (April 20, 2006) (granting emergency motion for injunctive relief-issuing administrative injunction-pending further order of the court);
118. D.C. Cir., No. 06-5105 (April 24, 2006) (dissolving administrative injunction and denying motion for injunctive relief pending appeal).
119. Put simply, once the first generic obtains final approval of its ANDA, its exclusivity does not begin to run until it commercially markets, and-unless another forfeiture provision applies-that exclusivity is not forfeited until 75 days after a court decision on every patent qualifying it for exclusivity. Shortly after passage of the 2003 amendments, Senator Hatch pointed out that if the court decision in question involves a different ANDA applicant-i.e., if the second applicant, not the first, successfully challenged the innovator's patents-the first generic is still entitled to exclusivity, and, indeed, could launch on the 74th day after the court decision, thereby effectively blocking the second applicant for 254 days. In his view, at least in the winter of 2003, this inappropriately penalizes the successful patent challenger. 149 CONG. REC. S 16104 (daily ed., Dec. 9, 2003) (Sen. Hatch).
120. See 149 CONG. REC. S 15885 (daily ed., Nov. 25, 2003) (Sen. Kennedy) ("We do intend that a court decision like the one in the D.C. Circuit's 1999 decision in Teva v. Shalala-a decision dismissing a declaratory judgment action for lack of subject matter jurisdiction because the patent owner has represented that the patent is not infringed-will count as a court decision under the new 'failure to market' provision.").
121. 59 Fed. Reg. at 50354.
122. Mylan Pharmaceutical, Inc. v. Shalala, 81 F.Supp.2d 30 (D.D.C. 2000).
123. Id. at 41-42.
124. Id. at 47.
125. FDA, Guidance for Industry, Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the FDCA (Mar. 2000).
126. Id. at 4.
127. Id.
128. Id.
129. 65 Fed. Reg. 43233 (July 13, 2000).
130. Pub. L. No. 108-173 § 1101(b)(3). By way of contrast, when it amended the statute in 2003 Congress provided that 30-month stays for new ANDAs would end with a district court decision. Thus, under the MMA district court decisions will end 30-month stays but not trigger the running of the 180 days. If the 30-month stay ends, however, and FDA approves the ANDA, any commercial marketing under the ANDA will trigger 180-day exclusivity for old ANDAs or new ANDAs.
131. Dr. Reddy's Laboratories, Inc. v. Thompson, 302 F.Supp.2d 340 (D.N.J. 2003).
132. Id. at 345.
133. See 21 C.F.R. § 314.94(a)(12)(viii)(C).
134. Id. at 351,
135. citing 59 Fed. Reg. 50338, 50348 (Oct. 3, 1994) ("a patent is deemed to be relevant until the end of the term of the patent or applicable 180-day period, whichever occurs first") and FDA., Response to APP and Pharmachemie Citizen Petitions, 99P-1271 (Aug. 2, 1999). The court characterized the latter as stating that, "because exclusivity cannot extend beyond the expiration of a patent, an ANDA applicant who is first to file a paragraph IV certification on a patent loses its eligibility based upon that patent when the patent expires before either of the triggering events occurs."
136. Id. at 354-355.
137. 21 U.S.C. § 355(j)(5)(D)(i)(VI).
138. Purepac Pharmaceutical Co. v. Thompson, 2004 WL 76594 (D.C.Cir. Jan 20, 2004), aff'g TorPharm, Inc. v. Thompson, 260 F.Supp.2d 69 (D.D.C. 2003);
139. see also TorPharm Rebuffed on Bid to Overturn FDA Decision Awarding Exclusivity to Purepac, BNA PHARMACEUTICAL LAW & INDUSTRY REPORT (Jan. 23, 2004);
140. Appeals Court Backs FDA: Purepac Gets Gabapentin 180-Day Award, FDA WEEK (Jan. 23, 2004).
141. FDA clarified in its 2003 regulations that only patents claiming approved uses could be listed. This is confirmed in the 2003 amendments, which authorize a counterclaim to an infringement case on the grounds that a listed method of use patent does not claim an approved use of the product.
142. Purepac Pharmaceutical Co. v. Thompson, 238 F.Supp. 2d 191 (D.D.C. 2002). A section viii statement states that the patent in question has been listed but does not claim a use for which the ANDA applicant seeks approval. 21 U.S.C. § 355(j)(2)(A)(viii). Because it is not a paragraph IV certification, it does not entitle the innovator to notice, and it does not entitle the ANDA applicant to exclusivity.
143. 21 C.F.R. § 314.94(a)(12)(viii)(B).
144. Purepac Pharmaceutical Co. v. Thompson, 2004 WL 76594 (D.C.Cir. Jan 20, 2004), aff'g TorPharm, Inc. v. Thompson, 260 F.Supp.2d 69 (D.D.C. 2003).
145. 21 C.F.R. § 314.94(a)(12)(viii)(B).
146. Id.
147. The FTC characterized the substance as "related to" simvastatin. Federal Trade Commission, Response to Citizen Petition by IVAX Pharmaceuticals, Inc., Docket No. 2005P-0008 (April 5, 2005), at 4.
148. Ranbaxy characterized the compounds as "related compounds of simvastatin" that it believed to be "present in Zocor" and that were "a byproduct of Merck's manufacture of simvastatin." Ranbaxy Laboratories Limited, Citizen Petition, Docket No. 2005P-0046 (Feb. 1, 2005), at 2.
149. 68 Fed. Reg. 36676 (June 18, 2003).
150. IVAX Pharmaceuticals, Inc., Citizen Petition, Docket No. 2005P-0008 (Jan. 5, 2005).
151. Ranbaxy Laboratories Limited, Citizen Petition, Docket No. 2005P-0046 (Feb. 1, 2005).
152. Teva, Response, Docket No. 2005P-0046 (June 8, 2005), at 2.
153. FDA, Response, Docket Nos. 2005P-0008 and 2005P-0046 (Oct. 24, 2005).
154. Id. at 2.
155. Ranbaxy v. Leavitt, 2006 WL 1147797 (D.D.C. (April 30, 2006), at 7;
156. see also Ivax, Ranbaxy Score Win on Generic Zocor As Court Reverses FDA on Exclusivity Issue, BNA, INC. PHARMACEUTICAL LAW & INDUSTRY (May 5, 2006).
157. Id.
158. Id. at 8.
159. Id.
160. Id.
161. Ranbaxy v. Leavitt, No. 06-5154 (D.C. Cir. Nov. 14, 2006);
162. see also FDA Loses in Court on Delisting Patents, DICKINSON'S FDA WEBVIEW (Nov. 14, 2006). While the appeal was pending, Sandoz, which also sought to market generic simvastatin, separately challenged FDA's relisting of the patents in the Orange Book and its requirement that all pending ANDAs be updated with either a paragraph III certification or a paragraph IV certification to each patent. The district court denied its motion for a preliminary injunction, and the court of appeals summarily affirmed.
163. See Sandoz v. Food and Drug Administration, 439 F.Supp.2d 26(D.D.C. 2006), aff'd 2006 WL 2591087 (D.C. Cir. 2006) (unpublished). The district court noted that "FDA's refusal to give final approval to Sandoz's simvastatin application until Ivax and Ranbaxy have exhausted their 180 days of exclusivity is not a discretionary act to be reviewed again, but was compelled by [the] decision in Ranbaxy."
164. Id. at 30.
165. It also rejected the only new argument made by Sandoz-that it was not required to update its ANDA with respect to the relisted patents-as inconsistent with the plain language of the statute and regulations. Id. at 31.
166. 21 U.S.C. § 355(j)(5)(D)(i)(I)(bb)(CC).
167. Boehringer Ingelheim Corp. v. Shalala, 993 F.Supp.1 (D.D.C. 1997).
168. 993 F.Supp. at 2.
169. Id.
170. 64 Fed. Reg. 42873, 42881 (Aug. 6, 1999).
171. See Generic Drug Entry Prior to Patent Expiration: An FTC Study (July 2002), at 36 ("For 6 out of 68 drug products in which there was more than one generic applicant, the first and second generic applicant entered into agreements related to generic market entry. In 4 of these agreements, one of the main provisions specified which generic applicant had or retained rights to the 180-day exclusivity.");
172. id. ("In 1 agreement, the first generic applicant relinquished its rights to 180-day exclusivity for a $35 million license and royalty payment based on the second generic applicant's sales for a period of 7 years.").
173. Id. at 42.
174. 64 Fed. Reg. 42873 (Aug. 6, 1999).
175. Id. at 42878.
176. Id.
177. Id. at 42881.
178. Id.
179. Pfizer, Inc., Citizen Petition, 2004P-0227 (May 11, 2004).
180. FDA, Response to Pfizer Citizen Petition, 2004P-0227 (July 2, 2004).
181. Id. at n. 5.
182. 59 Fed. Reg. at 50367-50368.
183. 64 Fed. Reg. 42873 (Aug. 6, 1999).
184. Id. at 42873.
185. 21 U.S.C. § 355(j)(5)(D)(III).
186. Mylan Pharmaceuticals, Inc. v. Thompson, 207 F.Supp.2d 476 (N.D. W.Va. 2001).
187. 21 U.S.C. § 355(j)(5)(B)(iv)(I).
188. Mylan Pharmaceutical, Inc., Citizen Petition, 2004P-0075 (Feb. 17, 2004).
189. Id. at 2.
190. Teva Pharmaceutical USA, Inc., Citizen Petition, 2004P-0261 (June 9, 2004).
191. FDA, Response to Teva and Mylan Citizen Petitions, 2004P-0075 and 2004P-0261 (July 2, 2004).
192. Id. at 2.
193. Teva Pharms. Indus. v. Crawford, 355 F.Supp.2d 111 (D.D.C. 2004).
194. Teva Pharm. Indus. v. Crawford, 410 F.3d 41 (D.C. Cir. 2005).
195. Mylan Pharmaceuticals, Inc. v. Food and Drug Administration, Case No. 1:04cv174 (N.D. W.Va., filed Aug. 4, 2004).
196. Notice of Voluntary Dismissal without Prejudice, Mylan Pharmaceuticals, Inc. v. Food and Drug Administration, Case No. 1:04cv174 (N.D. W.Va., Aug. 30, 2004). Trade press reported that "[t]he judge seemed to indicate that Mylan might not be able to get FDA to act under the FDC Act because the law is silent on the issue." Mylan Drops Authorized Generics Suit Against FDA, INSIDE WASHINGTON'S FDA WEEK, (Sept. 3, 2004), at 2.
197. Mylan v. FDA, 454 F.3d 270 (4th Cir. 2006).
198. See Mylan Loses Fight Against Agency: Court Says Authorized Generics Policy Legal, BNA INC. PHARMACEUTICAL LAW & INDUSTRY (July 14, 2006). Legislation was, however, introduced in both houses during the 109th Congress apparently intending to prohibit the practice.
199. See S. 3695 (109th Cong.); H.R. 5993 (109th Cong.). The Senate bill was referred to the Committee on Health, Education, Labor and Pensions. The House bill was referred to the House Committee on Energy and Commerce Subcommittee on Health. Neither bill passed out of Committee before the end of the Congress. Congress also included a provision in the Deficit Reduction Act of 2005 requiring that, after Jan. 1, 2007, average manufacturer price (AMP) and best price include all drugs marketed under a single NDA. Deficit Reduction Act of 2005, Pub. L. No. 109-171. And at the request of Senators Grassley, Leahy, and Rockefeller, the FTC is examining the competitive effect of authorized generics.
200. See Congressional Research Service Report for Congress, Authorized Generic Pharmaceuticals: Effects on Innovation (Aug. 8, 2006) (CRS Report), at 16;
201. see also Grassley, Other Senators Want FTC Study on Market Effects of "Authorized Generics," BNA INC. PHARMACEUTICAL LAW & INDUSTRY (May 20, 2005). This report should be released in 2007. FTC Press Release, "FTC Proposes Study of Competitive Impacts of Authorized Generic Drugs) (March 29, 2006) ("With OMB approval, the Commission will likely issue the orders later this year, and prepare a final report in 2007.");
202. see also CRS Report, supra, at 16;
203. Fed. Reg. 16779 (Apr. 4, 2006). The HHS Office of Inspector General (OIG) also recently announced a study of the impact of authorized generics on Medicaid drug pricing and rebates.
204. See CRS Report, at 16.
205. 66 Fed. Reg. 27983 (May 21, 2001).
206. See [THE PINK SHEET] (Mar. 12, 2001), at 3.
207. Eli Lilly & Co. v. Barr Laboratories Inc., 222 F.3d 973 (Fed. Cir. 2000).
208. Pub. L. No. 107-109, 115 Stat. 1408 (2002).
209. Pediatric exclusivity is due for reauthorization in 2007.
210. See Mylan Pharmaceutical, Inc., Citizen Petition, Docket No. 2006P-0245 (June 12, 2006) (pending); IVAX, Citizen Petition, Docket No. 2004P-0520 (Nov. 19, 2004) (withdrawn).