Delayed Access to Generic Medicine: A Comment on the Hatch-Waxman Act and the "Approval Bottleneck

Fordham Law Review Volume 78 | Issue 2 Article 16 2009 Delayed Access to Generic Medicine: A Comment on the Hatch-Waxman Act and the "Approval Bottleneck Ankur N. Patel Recommended Citation Ankur N. Patel, Delayed Access to Generic Medicine: A Comment on the Hatch-Waxman Act and the "Approval Bottleneck, 78 Fordham L. Rev. 1075 (2009). Available at: http://ir.lawnet.fordham.edu/flr/vol78/iss2/16 This Article is brought to you for free and open access by FLASH: The Fordham Law Archive of Scholarship and History. It has been accepted for inclusion in Fordham Law Review by an authorized editor of FLASH: The Fordham Law Archive of Scholarship and History. For more information, please contact . COMMENT DELAYED ACCESS TO GENERIC MEDICINE: A COMMENT ON THE HATCH-WAXMAN ACT AND THE "APPROVAL BOTTLENECK" Ankur N. Patel* Prescription drug costs can be astronomical. The advent of generic drugs, which sell at substantially lower prices than their brand-name counterparts,can save consumers billions of dollarsper year. The HatchWaxman Act, which governs the introduction of generic pharmaceuticals into the marketplace, produces an undesired side effect-the "approval bottleneck." This Comment examines the "approval bottleneck"-a potential roadblock to the generic drug approvalprocess, and comments on attempts to alleviate the problem. This Comment suggests that developments in statutes and case law have made leaps in attempting to alleviate the "approval bottleneck" problem. The Comment evaluates these developments, which include (1) the ability of a subsequent Abbreviated New Drug Application (ANDA) filer to trigger the generic exclusivity period of the first ANDA filer; (2) the forfeiture provisions; (3) declaratory judgments and the relaxed declaratory judgment test; and (4) the rulings on covenants not to sue. Despite these attempts, however, the potential harm to consumers resultingfrom delayed access to generic medicines remains. TABLE OF CONTENTS IN TRO DU CTION ........................................................................................ 1076 I. DEVELOPING THE "APPROVAL BOTTLENECK". .................................. 1078 A . Drug Approval Process.......................................................... 1079 1. New Drug Application ..................................................... 2. Abbreviated New Drug Application ................................ 3. 180-D ay Exclusivity ........................................................ 1079 1080 1082 a. 180-Day Exclusivity: Pre-MMA Triggering Provisions.................................................................. 1085 * JD. Candidate, 2010, Fordham University School of Law; Pharm.D., 2004, Rutgers, The State University of New Jersey-Ernest Mario School of Pharmacy. I would like to thank Professor George W. Conk for his invaluable guidance, feedback, and support throughout the process. I would also like to thank my fianc6e, Sanam, for her support and patience. 1075 1076 FORDHAM LA W REVIEW [Vol. 78 b. 180-Day Exclusivity: Post-MMA Triggering and ForfeitureProvisions ...................................... 1086 B. D eclaratoryJudgments ........................................... 1090 1. Overview of Declaratory Judgments .............................. 1091 2. Civil Action To Obtain Patent Certainty .......................... 1091 3. Reasonable-Apprehension-of-Suit Test ........................... 1093 4. A ll-the-Circumstances Test .................................... 1093 C. "ApprovalBottleneck ........................................... 1094 II. EVOLUTION OF LAW THAT DIRECTLY OR INDIRECTLY ADDRESSES CONQUERING THE "APPROVAL BOTTLENECK" ........................... 1098 A. Subsequent ANDA Filers Can Trigger the Exclusivity ........... 1098 B. MedicarePrescriptionDrug, Improvement, and M odernization Act of 2003........................................ 1098 1. M M A Forfeiture Provisions .................................... 1099 2. MMA Civil Action To Obtain Patent Certainty ............... 1101 C. MedImmune, Inc. v. Genentech, Inc .................................. 1102 D . Covenants N ot To Sue ............................................ 1103 III. THE STATUS OF THE "APPROVAL BOTTLENECK" AND A POSSIBLE SO LU TIO N ....................................................... 1109 A. No PresentIdeal Solution To Overcome or Eliminate the "ApprovalBottleneck". .......................................... 1110 B. A Permanent,Though Not Ideal, Solution to the "Approval Bottleneck" Problem............................................ 1113 C O NCLU SION .......................................................... 1114 INTRODUCTION Prescription drug costs can be daunting to consumers. The advent of generic drugs, which sell at "substantially lower prices than their brandname counterparts," can save consumers "tens of billions of dollars per year."' The average price per dose of a generic drug can be drastically less than its brand-name counterpart, especially as more generic competitors enter the market. 2 A generic drug can cost as low as less than ten percent of the price of its brand-name counterpart. 3 Therefore, innovator companies, who develop brand-name drugs, will often try to delay the introduction of generic versions of their brand-name drugs. As a brief example, consider the following real-life situation. Sepracor, an innovator pharmaceutical 1. Richard G. Frank, The Ongoing Regulation of Generic Drugs, 357 NEW ENG. J. MED. 1993, 1993 (2007); see FDA, What Are Generic Drugs?, http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/Unde rstandingGenericDrugs/ucm144456.htm (last visited Oct. 19, 2009) ("According to the Congressional Budget Office, generic drugs save consumers an estimated $8 to $10 billion a year at retail pharmacies. Even more billions are saved when hospitals use generics."). 2. See Frank, supra note 1, at 1995. 3. See id. 2009) APPROVAL BOTTLENECK 1077 company, holds the six patents for the brand-name drug Xopenex. 4 In accordance with the Hatch-Waxman Act, 5 which encourages generic pharmaceutical companies to bring cheaper generic versions of brand-name drugs to market, Breath, a generic pharmaceutical company, filed an Abbreviated New Drug Application (ANDA) in June 2005 to market a generic version of Xopenex. 6 As the first Paragraph IV ANDA filer, Breath is entitled to a 180-day exclusivity period during which no other generic version of Xopenex may enter the marketplace. 7 Sepracor brought a patent infringement suit against Breath for all six patents in October 2005.8 However, Sepracor and Breath settled their lawsuit in early 2008, before a decision had been made as to the validity of Sepracor's patents or infringement by Breath. 9 The settlement allows Breath to enter the market with a generic version of Xopenex in August 2012.10 In the meantime, in July 2005, Dey also filed an ANDA to market a generic version of Xopenex."l Sepracor, however, sued De (...truncated)