Staving off death: A case study of the pharmaceutical industry's strategies to protect blockbuster franchises

Food and Drug Law Journal

Volumn 63, Issue 4, 2008, Pages

  Gorlin, Daniel I ^a  

^a BOSTON CONSULTING GROUP   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ASTEMIZOLE; CETIRIZINE; CHLORPHENIRAMINE MALEATE; CIMETIDINE; CLEMASTINE FUMARATE; DESLORATADINE; DIPHENHYDRAMINE; ESOMEPRAZOLE; FEXOFENADINE; GENERIC DRUG; HISTAMINE H2 RECEPTOR ANTAGONIST; LANSOPRAZOLE; LORATADINE; NEW DRUG; NON PRESCRIPTION DRUG; OMEPRAZOLE; OXAPROZIN; PANTOPRAZOLE; RABEPRAZOLE; TERFENADINE;

BIOEQUIVALENCE; CLINICAL TRIAL; DROWSINESS; DRUG APPROVAL; DRUG INDUSTRY; DRUG MARKETING; DRUG SAFETY; ENANTIOMER; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL REFLUX; GOOD MANUFACTURING PRACTICE; HEART DISEASE; HUMAN; LAW; LAW SUIT; NONHUMAN; PATENT; PEPTIC ULCER; RACEMIC MIXTURE; REFLUX ESOPHAGITIS; REVIEW;

DRUG APPROVAL; DRUG INDUSTRY; DRUGS, GENERIC; HUMANS; INTELLECTUAL PROPERTY; INVESTIGATIONAL NEW DRUG APPLICATION; LEGISLATION, DRUG; LORATADINE; NONPRESCRIPTION DRUGS; OMEPRAZOLE; PATENTS AS TOPIC; UNITED STATES;

EID: 58149168863     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

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13. The term of a patent was subsequently changed with the enactment of Uruguay Round Agreements Act to twenty years from the date of the patent filing. See infra note 68.
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26. Id.
27. Karki, supra note 11, at 607.
28. Mossinghoff, supra note 10, at 188.
29. ANNA COOK, CONG. BUDGET OFF., THE CONG. OF THE U.S., A CBO STUDY: HOW INCREASED COMPETITION FROM GENERIC DRUGS HAS AFFECTED PRICES AND RETURNS IN THE PHARMACEUTICAL INDUSTRY, XII (1998).
30. Representative Henry Waxman, Speech to the Generic Pharmaceutical Association (Jan. 28, 2003) (transcript available at http://www.house. gov/waxman/news_files/news_statements_gpha.htm).
31. Mossinghoff, supra note 10, at 188.
32. Id.
33. 572 F. Supp. 255 (E.D.N.Y (1983)).
34. Engelberg, supra note 22, at 396.
35. See Roche Products, Inc. v. Bolar Pharmaceutical Co., 733 F. 2d 858 (Fed. Cir. (1984)).
36. Engelberg, supra note 22, at 396.
37. Id.
38. Id.
39. Id.
40. Sayeed, supra note 9, at 11.
41. Title I of the Hatch-Waxman Act is codified under FDCA, 21 U.S.C. § 355(j) (2006).
42. ROBIN J. STRONGIN, HATCH-WAXMAN, GENERICS, AND PATENTS: BALANCING PRESCRIPTION DRUG INNOVATION, COMPETITION AND A FFORDABILITY 7, (National Health Policy Forum, Background Paper, (June 2000)).
43. See id. § 355(j)(2)(A).
44. See id. § 355(j)(2)(A)(vii).
45. See id.
46. See id.
47. See id. § 355(j)(5)(B)(iii); see also 35 U.S.C. §271(e)(2).
48. See id. § 355(j)(2)(B)(ii).
49. See id. § 355(j)(5)(B)(iii).
50. See id.
51. Engelberg, supra note 22, at 394.
52. Id. at 404.
53. 21 U.S.C § 355(c)(3)(C)(ii) (2006).
54. 35 U.S.C. § 271(e)(4)(C) (2006).
55. 21 U.S.C § 355(j)(5)(B) (2006).
56. Engelberg, supra note 22, at 398.
57. See 21 U.S.C § 355(j)(5)(F)(ii) (2006).
58. STRONGIN, supra note 42, at 11.
59. ParagraphFour.com, Paragraph IV Explained: An Emerging Trend, at http://www.paragraphfour. com/explained/emerging_trend.html (last visited Oct. 3, 2008).
60. See 21 U.S.C § 355(j)(5)(F)(iii) (2006).
61. Karki, supra note 11, at 611.
62. See 21 U.S.C § 355(j)(5)(F)(iii) (2006).
63. See 35 U.S.C. § 156(a) (2006).
64. See id. §156(c).
65. See id. §156(c)(3).
66. See id.
67. See 35 U.S.C. § 154(a)(1),(2) (2006).
68. Pub. L. No. 103-465 (1994), 108 Stat. 4809.
69. Food and Drug Administration Modernization Act (FDAMA), Pub. L. No. 105-115 (1997), 111 Stat. 2678.
70. PhRMA, 2006 Pharmaceutical Industry Profile, at http://www.phrma.org/files/2006%20Industry%20Profile.pdf (last visited Oct. 2008).
71. G. Richard Locke III et al., Prevalence and Clinical Spectrum of Gastroesophageal Reflux, 112 GASTROENTEROLOGY 1448, 1448 (1997).
72. American Chemical Society, Tagamet: A Medicine that Changed Peoples Lives, at http://acswe-bcontent.acs.org/landmarks/tagamet/tagamet.html
73. Barry Berkowitz & George Sachs, Life Cycle of a Blockbuster Drug: Discovery and Development of Omeprazole, 2 MOLECULAR INTERVENTIONS 6, 6 (2002).
74. American Chemical Society, supra note 72.
75. See id.
76. Berkowitz & Sachs, supra note 73, at 8.
77. See Astra Aktiebolag v. Andrx Pharm., Inc., 222 F. Supp. 2d 423, 435-438 (S.D.N.Y.2002).
78. Id. at 427.
79. Robert Langreth, Hard to Swallow, FORBES, May 13, 2002, available at http://www.forbes. com/forbes/2002/0513/199_print.html.
80. Id.
81. Id.
82. Id.
83. Id.
84. Id.
85. Astra Aktiebolag v. Andrx Pharms., Inc., 222 F. Supp. 2d. 423 (S.D.N.Y. (2002)).
86. Bruce Vanderhoff & Rundsarah Tahboub, Proton Pump Inhibitors: An Update, AM. FAMILY PHYSICIAN, (July 15, 2002), available at http://www.aafp.org/afp/20020715/273.html.
87. Neil Swidey, How the Drug Companies Deceive You - The Inside Story of Nexium, BOSTON GLOBE MAG., (NOV. 17, 2002) available at http://www.mercola.com/2002/dec/21/nexium2.htm.
88. See id.
89. Zeneca and Astra Merge to Form Drug Giant, BBC NEWS, (Dec. 9, 1998), available at http://news. bbc.co.uk/1/hi/business/ the_company_file/231213.stm.
90. Quarterly and annual sales figures for Prilosec and Nexium are found in tables that accompany AstraZeneca's quarterly earnings press releases. E.g., AstraZeneca PLC: 2001 Fourth Quarter and Full Year Results (2002), available at http://www.astrazeneca.eom/sites/7/imagebank/typeArticleparam11186/ full-year2001-figures.pdf.
91. Certificate Extending U.S. Patent No. 4,255,431 (issued Mar. 10, 1981), available at http.//www. uspto.gov/web/offices/pac/dapp/opla/term/certs/ 4255431.pdf
92. See supra note 69. See also Approved Active Moieties to Which FDA Has Granted Pediatric Exclusivity for Pediatric Studies under Section 505A of the FDCA, at http://www.fda.gov/cder/pediatric/exgrant.htm
93. A. Maureen Ruohi, Beyond Hatch-Waxman: Legislative Action Seeks to Close Loopholes in U.S. Law That Delay Entry of Generics to Market, CHEM. AND ENG'G NEWS, (Sept. 23, 2002), Vol. 80, No. 38, at 53.
94. EXPRESS SCRIPTS, INC., EXPRESS SCRIPTS 2001 DRUG TREND REPORTS: GENERICS (2002), available at http://www.express-scripts.com/ ourcompany/news/industryreports/drugtrendreport/2001/Generics.pdf.
95. Id.
96. Press Release, Business Communications Company, Generic Drug Industry Exhibiting High Growth Rates (January 1999), available at http://www.bccresearch.com/editors/RC-058N.html.
97. See supra Section 2, at p. 14.
98. A. Maureen Ruohi, Generic Tide is Rising, CHEM. AND ENG'G NEWS, Sept. 23, 2002, Vol. 80, No. 38, at 42.
99. EXPRESS SCRIPTS, supra note 94.
100. See id.
101. See id.
102. ASTRAZENECA PLC, 2000 ANNUAL REPORT (2001), at 96, available at http://www2.astrazeneca. com/annualrep2000/ annualreportpt2.pdf.
103. 21 U.S.C. § 355(j)(2)(A)(vii) (2006).
104. Id. § 355(j)(5)(B)(iii).
105. FDCA, 21 U.S.C. § 355(b) (2005).
106. Twin City Bakery Workers & Welfare Fund v. Astra Aktiebolag, 207 F. Supp. 2d 221, 224 (S.D.N.Y. (2002)).
107. See Examining Issues Related to Competition in the Pharmaceutical Marketplace: A Review of the FTC Report, "Generic Drug Entry Prior to Patent Expiration": Hearing Before the Subcomm. on Health of the Comm. on Energy and Commerce, 107th Cong. (2002) [Hearing Before Subcomm. On Health] (prepared statement of Business for Affordable Medicines).
108. Id.
109. Id.
110. Twin City Bakery Workers & Welfare Fund, 207 F. Supp. at 224.
111. Id.
112. PTO, General Information Concerning Patents, at http://www.uspto.gov/web/offices/pac/doc/general/index.html
113. Hearing Before Subcomm. On Health, supra note 107.
114. ANDRX CORP., 2001 SUMMARY ANNUAL REPORT 73 (2002).
115. See 35 U.S.C. § 284 (2006).
116. ANDRX CORP., supra note 114, at 53.
117. 35 U.S.C. § 271(e)(4)(C) (2006).
118. 21 U.S.C § 355 (2006).
119. In re Omeprazole Patent Litig., 258 F. Supp. 2d 221 (S.D.N.Y. (2001)).
120. Astra Aktiebolag v. Kremers Urban Dev. Co. (In re Omeprazole Patent Litig.), 2001 LEXIS 23879 (S.D.N.Y (2001)).
121. Lynne Peterson and Norman Bauman, The Outlook for Prilosec and other Proton Pump Inhibitors, TRENDS IN MED., (June 2002), at 4.
122. Astra Aktiebolag v. Andrx Pharms., Inc., 222 F. Supp. 2d. 423 (S.D.N.Y. (2002)).
123. Id. at 425.
124. Id.
125. Grant Ritter, Cindy Thomas & Stanley Wallack, Greater Use of Generics: A Prescription for Drug Costs Savings, Schneider Institute for Health Policy, Brandeis Univ., at 8 available at http://bcb- shealthissues.com/relatives/19385.pdf
126. FRANK SLOAN & CHEE-RUEY HSIEH, PHARMACEUTICAL INNOVATION: INCENTIVES, COMPETITION, AND COST-BENEFIT ANALYSIS IN INTERNATIONAL PERSPECTIVE 157 (Cambridge Univ. Press, (2007)).
127. Letter from Stuart Williams, Chief Legal Officer Mylan Pharmaceuticals to FDA, (Oct., 29, 2004) at http://www.fda.gov/ohrms/dockets/dockets/ 03p0366/03p-0366-c000004-01-vol1.pdf.
128. Id.
129. Letter from Paul Franz, Associate General Counsel Procter and Gamble to FDA, (Nov., 19, 2004) at http://www.fda.gov/ohrms/dockets/dockets/03p0366/03P- 0366_emc-000001-02.doc.
130. 21 U.S.C. § 355(j)(5)(F)(iii) (2006).
131. Id. As will be seen later in the article, FDA does not always deem studies included in an application for a new indication, presentation, or dose to be essential for approval and thus the studies do not serve as an obstacle for the approval of generic formulations.
132. Ernst Berndt et al., The Long Shadow of Patent Expiration: Do Rx to OTC Switches Provide an Afterlife?, paper presented at the National Bureau of Economic Research, (Sept. 15-16, 2000), at 5.
133. Id.
134. Id. at 25.
135. See Letter from Jonca Bull and Florence Houn to Linda Jones, Director, Regulatory Affairs at P&G (on file with author).
136. Press Release, AstraZeneca, Joint FDA Advisory Committee Confirms OTC Prilosec Safety and Efficacy (Oct. 20, 2000) available at http://www.astrazeneca.com/pressrelease/351.aspx.
137. Final Minutes, Joint Meeting of the Nonprescription Drugs and Gastrointestinal Advisory Committees, (Oct. 20, 2000) at http://www.fda.gov/ohrms/dockets/ac/00/minutes/3650m1.pdf.
138. Sarah Lueck, FDA Panel Advises Not to Sell Prilosec Over the Counter, WALL ST. J., (Oct. 23, 2000), at B8.
139. Prilosec 1 to Make Another Run for OTC Status, Executive Newsletter (Consumer Health Products Association) (Apr. 2002), at http://www.chpainfo.org/web/newsletter/archive/2002/4_26_02_XNL. html.
140. Peterson and Bauman, supra note 121, at 2.
141. Final Minutes, Joint Meeting of the Nonprescription Drugs and Gastrointestinal Advisory Committees, (June 21, 2002), available at http://www.fda.gov/ohrms/dockets/ac/02/minutes/3861M.htm
142. Sarah Ellison and Gardiner Harris, P&G Must Revise Prilosec Label Before FDA Gives Sales Approval, WALL ST. J., (Aug. 22, 2002), at A2.
143. Under 21 CFR 10.30, a citizen has the right to petition FDA to change or amend any policy and FDA must respond either approving or denying the petition within 180 days.
144. Citizens Petition for Denial of Over the Counter Status to Omeprazole Magnesium, Submitted on Behalf of Andrx Pharm. Corp., (Nov. 20, 2003), at 1.
145. Memorandum from Charles Ganley, FDA Director, Division of Over the Counter Drug Products, to John Bull, Director, Office of Drug Evaluation V and Florence Huon, Director, Office of Drug Evaluation V, (June 20, 2003), at http://www.fda.gov/cder/foi/appletter/2003/21229ltr_CitizenPetition. pdf.
146. John Faucher, Procter and Gamble: Prilosec Anniversary Should Not Cause Heartburn, JPM-ORGAN EQUITY RESEARCH, (Aug. 11, 2004), at 2.
147. Gardiner Harris, Drug Prices - Why They Keep Soaring, WALL ST. J., (June 6, 2002), at A1
148. [Harris, Drug Prices].
149. See Berndt et al., supra note 132.
150. Lars Olbe, Enar Carlsson & Per Lindberg, A Proton Pump Inhibitor Expedition: The Case Histories of Omeprazole and Esomeprazole, NATURE REVIEWS DRUG DISCOVERY (2003), at 132.
151. Harris, Drug Prices, supra note 147, at A1.
152. Olbe, supra note 149, at 138.
153. Id.
154. Id.
155. Id.
156. Harris, Drug Prices, supra note 147, at A1.
157. Id.
158. Olbe, supra note 149, at 138.
159. See MERRILL GOOZNER, $800 MILLION PILL: THE TRUTH BEHIND THE COST OF NEW DRUGS 222 (Univ. of California Press (2004)).
160. Id.
161. Id.
162. See supra note 112.
163. A. Maureen Rouhi, Chiralty at Work: Drug Developers Can Learn Much From Recent Successful and Failed Chiral Switches, CHEM. AND ENG'G NEWS, (May 5, 2003), Vol. 81, No. 18, at 58.
164. Eli Lilly & Co. vs. Generix Drug Sales Inc., 460 F.2nd 1096 (5th Cir. (1972)).
165. Enantiomere/ Hoechst. T 296/87 OJ (Official Journal) (1988) (decision of the European Technical Board of Appeals).
166. Declaration of Dr. Tommy Andersson, presented in letter from Bruce Radin, Counsel for Dr. Reddy's Laboratories Ltd, to Janet Woodcock, Director, FDA Center for Drug Evaluation and Research (CDER), (Aug. 27, 2002) available at http://www.fda.gov/ohrms/dockets/98fr/01e-0365-prc0001-01-vol1. pdf.
167. Id.
168. Id.
169. Israel Agranat, Hava Caner and John Caldwell, Putting Chiralty to Work: the Strategy of Chiral Switches, 1 NATURE REVIEWS DRUG DISCOVERY 748, 753 (2002).
170. Id.
171. The '431 patent officially expired on October 5, 2001 after AstraZeneca received a six month extension for undertaking pediatric studies with the compound.
172. Press Release, AstraZeneca, FDA Approves AstraZeneca's Nexium with Comprehensive Set of Indications (Feb. 21, 2001) available at http://www.astrazeneca.com/pressrelease/376.aspx [FDA Approves AstraZeneca's Nexium].
173. Swidey, supra note 87.
174. Harris, Drug Prices, supra note 147, at A1.
175. Id.
176. Id.
177. Gardiner Harris, Prilosec's Maker Switches Users to Nexium, Thwarting Generics, WALL ST. J., (June 6, 2002), at A1
178. [Harris, Prilosec's Maker].
179. Pa. Employee Benefit Trust Fund v. Zeneca Inc., Docket # 05-5340, 2005 WL 2993937 (D. Del. (Nov. 8, 2005)).
180. Id. at 16.
181. Id.
182. FDA Approves AstraZeneca's Nexium, supra note 171.
183. Generic Prilosec...Ready or Not Here it Comes, THE FORMULARY FILES, (Dec. 2002), available af http://www.managedcaremag.corn/archives/0212/0212.formulary.html
184. David Molowa, AstraZeneca: A Giant is Born, BEAR STEARNS EQUITY RESEARCH, (June 18, 1999), at 35.
185. All figures from AstraZeneca quarterly earnings and sales announcements available at http://www.astrazeneca.com/article/511679.aspx
186. Ian Sanderson, Specialty Pharma Pulse: Making the Turn, S.G. COWEN EQUITY RESEARCH, (Oct. 2005), at 284.
187. Stephen S. Hall, Claritin and Schering-Plough: A Prescription for Profit, N.Y. TIMES MAG., (Mar. 11, 2001), at 20.
188. James F. Peggs et al., Antihistamines: The Old and The New, AM. FAMILY PHYSICIAN, (Aug. 1995), available at http://www.findarticles.com/p/articles/mi_m3225/is_n2_v52/ai_17281999.
189. Id. at 22.
190. Brief for Plaintiff-Appellant, at 5, Schering Corp v. Geneva Pharms., Inc., 339 F. 3d 1373 (Fed. Cir. (2003)).
191. Schering Corp v. Geneva Pharms., Inc., 275 F. Supp.2d 534, 536 (D.N.J. (Aug. 8, 2002)).
192. Brief for Plaintiff-Appellant, supra note 188, at 5.
193. Hall, supra note 185, at 22.
194. See Goozner, supra note 158, at 224. Researchers at Schering-Plough chose to offer a 10 mg dose rather than a 20 mg dose because preclinical trials suggested that, at higher doses, loratadine might have some sedative effects on patients. However, concern existed that a 10 mg dose would only be minimally effective in treating allergy symptoms and that a higher dose would produce better antihistaminic results.
195. GOVERNMENT ACCOUNTABILITY OFF., THE CONG. OF THE U.S., PRESCRIPTION DRUGS: MANY FACTORS AFFECTED FDA'S APPROVAL OF SELECTED PIPELINE DRUGS, 32 (2000) [GAO REPORT].
196. See id. at 35. In May 1987, an FDA pharmacologist discovered indications of carcinogenicity in Schering-Plough's preclinical animal testing but after requesting, and receiving, additional and reformulated data, the pharmacologist concluded that from a toxicological perspective, the drug was safe enough to be approved but suggested that Schering-Plough disclose the carcinogenicity tests in its label.
197. See Hall, supra note 185, at 23. In Nov. 1987, Dr. Sherwin Strauss, FDA official in charge of reviewing loratadine, doubted the superiority of low-dose Claritin over a placebo. He believed that a 40 mg was the lowest possible dose that Claritin effectively treated allergy symptoms, and at such a dosage would need to be labeled as having sedative side effects.
198. GAO REPORT, supra note 193, at 41. In May and August of 1988, the official in charge of reviewing the bioequivalence of the capsule and tablet forms of loratadine concluded that the studies in Schering-Plough's application were not sufficient to show bioequivalence and demanded that Schering-Plough undertake additional tests to show that the capsule and tablet forms were in fact bioequivalent. According to the President of Schering-Plough's research institute however, "it was then common in the drug industry - and well known to FDA - that clinical trials could be conducted with a capsule. Having followed this accepted practice, we submitted data to the FDA to establish bioequivalence of the capsule to the tablet."
199. (see Patent Fairness Act of 1999: Hearing before the Subcomm. on Courts and Intellectual Prop. of Comm. on the Judiciary, 106th Cong. (1999) (statement of Jonathan Spicehandler, President, Schering-Plough Research Institute) [Patent Fairness Act of 1999]
200. GAO REPORT, supra note 193, at 37.
201. Id. at 46.
202. Id.
203. Goozner, supra note 158, at 226.
204. Press Release, FDA, The Manufacturer of the Seidane Terfenadine (July 7, 1992), available at http://www.fda.gov/bbs/topics/NEWS/NEW00286.html.
205. Press Release, FDA, The Use of Antihistamine Drug Hismanal Astemizole (Oct. 28, 1992), available at http://www.fda.gov/bbs/topics/NEWS/ NEW00302.html.
206. Michelle Meadows, Why Drugs Get Pulled Off the Market, FDA CONSUMER MAG., (Jan.-Feb. 2002), available at http://www.fda.gov/fdac/features/2002/102_drug.html.
207. Will Mitchell, Comparing Two Acquisitions: Marion Merrell Dow and Glaxo Wellcome, (Nov. 2002), at http://faculty.fuqua.duke.edu/~willm/ Classes/Pharma2005/Materials/11_ _Acquisitions/Case/ OnLine/ GW_MMD_A_Acquisitions2a.pdf.
208. 35 U.S.C. §156(g)(6)(A) (2006).
209. Id. §156(g)(6)(C) (2006).
210. Patent Fairness A et of 1999, supra note 196, (statement of Peter Barton Hutt, Partner, Covington & Burling).
211. Id. at 78.
212. Robert Merges et al., The Proper Scope of the Copyright and Patent Power, HARV. J. ON LEGISL, (Winter 2000), at 53.
213. Public Citizen, Schering-Plough Political Money Pushes Claritin Patent Extension and Distorts GAO Report, (Aug. 2000), at 1. Schering Plough hired, among others, Linda Daschle, Peter Knight and Vic Fazio for their close ties to the Democratic Party as well as Howard Baker and Bob Livingston for their close ties to the Republican Party.
214. Id. at 8-9.
215. Id.
216. Id. On at least five occasions between 1996 and 2000, influential Congressmen, including Senator Arlen Specter, Senator Frank Lautenberg, and Representative Ed Bryant, attempted and failed to pass a two year patent extension for Claritin.
217. Id.
218. Certificate Extending U.S. Patent No. 4,282,233 (issued Sept. 20,1994), available at http://www. uspto.gov/web/offices/pac/dapp/opla/term/certs/ 4282233.pdf.
219. FDA: CDER, Frequently Asked Questions on the Patent Restoration Program, http://www.fda. gov/cder/about/smallbiz/patent_term.htm.
220. Approved Active Moieties, supra note 92.
221. Schering Corp. v. Geneva Pharm., Inc., 275 F. Supp.2d 534 (D.N.J. (Aug. 8, 2002)).
222. See Steven Tighe, Oral Arguments on Claritin Patent Scheduled for Mid February 2002, MERRILL LYNCH EQUITY RESEARCH, (Sept. 10, 2001), at 1.
223. 35 U.S.C. § 2006).
224. See Schering Corp., 275 F. Supp.2d at 541.
225. 35 U.S.C. § 102 (2006).
226. Schering Corp., 275 F. Supp.2d at 541.
227. Id.
228. Id.
229. Id.
230. Tighe, supra note 219, at 1.
231. Steve Scala, Claritin Case Appears to be Delayed Again, SG COWEN EQUITY RESEARCH, (Apr. 19, 2002), at 3.
232. See Schering Corp., 275 F. Supp.2d at 542.
233. Schering Corp v. Geneva Pharm., Inc., 339 F. 3d 1373 (Fed. Cir. (2003)).
234. Wellmark Blue Cross Blue Shield, Third in a Series of Special Reports: Antihistamines, available at http://www.wellmark.com/health_improvement/ reports/antihistamines/about_antihistamines.htm
235. Petition from Rob Seidman, Vice President, Blue Cross of California, to FDA, (July 21, 1998) (Citizens Petition 98P-0610/CP1).
236. Sarah Lueck and Gardiner Harris, FDA Panel Recommends Switch of Allergy Drugs to OTC Status, WALL ST. J., NY, NY, (May 14, 2001), at A4.
237. Petition from Rob Seidman, supra note 232.
238. Letter from Burt Rein, Andrew Krulwich & Kristin Davis, Wiley Rein & Fielding LLP, to FDA, (Apr. 21, 2003), (responding to Citizens Petition No. 98P-0610/CP) [Wiley, Rein & Fielding Letter]
239. Krulwich, supra note 234, at 3.
240. Wiley, Rein & Fielding Letter, supra note 235, at 14.
241. Letter from Peter Safir, Richard Merrill & Scott Cunningham, Covington & Burling, to FDA, (July 11, 2003), (responding to Citizens Petition No. 98P-0610/CP) [Covington & Burling Letter].
242. Holly M. Spencer, The Rx-to-OTC Switch of Claritin, Allegra, and Zyrtec: An Unprecedented FDA Response to Petitioners and the Protection of the Public Health, 51 AM. U. L. REV. 999, 1026 (June 2002).
243. Public Hearing on FDA Regulation of Over the Counter Products before the Dep't of Health and Human Serv. (June 29, 2000), available at http://www.fda.gov/ohrms/dockets/dailys/00/Jul00/071800/tr00002.doc.
244. Id.
245. FDA panelists merely asked the company to explain the meta-data analysis it performed without asking any probing follow-up questions.
246. Transcript of FDA Joint Meeting of the Nonprescription Drugs Advisory Committee and Pulmonary-Allergy Drugs Advisory Committee, (May 11, 2001), 14, available at http://www.fda.gov/ohrms/dockets/ac/01/transcripts/ 3737t1.rtf [Transcript of FDA Joint Meeting - Antihistamines].
247. Id. at 16.
248. Michael Johnson, FDA-forced Switch: Does it Makes Cents?, DRUG STORE NEWS, (June 25, 2001), at 1.
249. Transcript of FDA Joint Meeting - Antihistamines, supra note 243, at 76.
250. Anthony Butler, Can Allergy Drugs Dodge the OTC Draft?, LEHMAN BROS. EQUITY RESEARCH, (May 17, 2001), at 8.
251. Schering-Plough's stance on making Claritin available without a prescription at the Joint Committee meeting diverged greatly from the stance taken by AstraZeneca regarding Prilosec at its FDA Advisory Panel meeting. The reason for the divergence was that when AstraZeneca met with FDA, it had already undertaken proprietary studies that, if used by FDA to approve the switch, could not be relied upon by generic versions for three years. With the exclusivity seemingly already in hand, AstraZeneca argued for the sufficiency of its data and touted the advantages of offering the drug without a prescription. Schering-Plough, on the other hand, had not yet undertaken any additional trials to prove the safety of the OTC form of Claritin. If FDA decided that the product was safe without mandating any additional trials, Schering-Plough would not need to undertake relatively cheap additional trials and thus would not have any proprietary data on which generic versions would have to rely upon for approval. However, Schering-Plough hoped to convince FDA that additional studies were necessary so it too could enjoy three years of exclusivity in the OTC market.
252. Transcript of FDA Joint Meeting - Antihistamines, supra note 243, at 78.
253. Id. at 274.
254. Id. at 276.
255. Carey Krause, Schering-Plough Vies to Quash Generic OTC Claritin, CHEM. MKT. REP., (Feb. 11, 2002), at 9.
256. Matthew Herper, Claritin Will be Sold Without a Prescription, FORBES, (Mar. 8, 2002).
257. Press Release, FDA, FDA Approves OTC Claritin (Nov. 27, 2002), available at http://www.fda. gov/bbs/topics/NEWS/2002/NEW00855.html.
258. Sepracor, About Sepracor, at http://www.sepracor.com/about/index. html.
259. Douglas Lind & Christopher Leonard, Sepracor: DCL Patent Licensed to Schering-Plough, MORGAN STANLEY DEAN WITTER EQUITY RESEARCH, (Dec. 10, 1997), at 1.
260. Id.
261. Id.
262. Id.
263. Glenis Scadding, Predicting and Establishing the Clinical Efficacy of Histamine H1-Receptor Antagonist, 25 CLIN. DRUG INVEST. 150, 162 (2005).
264. MARICA ANGELL, THE TRUTH ABOUT THE DRUG COMPANIES: HOW THEY DECEIVE YOU AND WHAT TO DO ABOUT IT? 79 (Random House, (2004)).
265. Press Release, Schering-Plough Corp., Schering-Plough Announces FDA Approval of CLARINEX(R) (Desloratadine) for Treatment of Seasonal Allergic Rhinitis (Dec. 2001), available at http://www.prnewswire.com/cgi-bin/ stories.pl?ACCT=104&STORY=/www/story/12-21-2001/0001638601&EDATE=.
266. Press Release, Schering-Plough Corp., Schering-Plough Announces CLARINEX(R) (Desloratadine) Tablets Approved for Allergic Rhinitis and Chronic Idiopathic Urticaria (Feb. 2002), available at http://www.sch-plough.com/ schering_plough/news/release.jsp?releaseID=257379
267. Melody Peterson, At Schering, Optimism and Problems, N.Y. TIMES, (Jan. 15, 2002).
268. American Family Physician, Desloratadine for Allergic Rhinitis, (Nov. 15, 2003), available at http://www.aafp.org/afp/20031115/steps. html.
269. Peterson, supra note 264.
270. SCHERING-PLOUGH CORP., 2001 ANNUAL REPORT FILED WITH THE SEC (2001).
271. Id.
272. Consent Decree of Permanent Injunction, United States v. Schering-Plough Corp., No. C-02-2397 (JAP) (D.N.J. (2002)).
273. See Jon Hess & Shannon Litauen, Battle for the Market: Branded Drug Companies' Secret Weapons Generic Drug Makers Must Know, 3 J. GENERIC MED. NO. 1, 20, 22 (Oct. 2005).
274. Jami Rubi, Santa Smiles of Schering-Plough, MORGAN STANLEY EQUITY RESEARCH, (Dec. 24, 2001), at 3.
275. Amy Tsao, Schering Puts on a Marketing Clinic, BUS. WEEK ONLINE, (Mar. 21, 2002) available at http://www.businessweek.com/bwdaily/dnflash/mar2002/nf20020321_9529.htm.
276. Nair Kavita et. al., Improving Formulary Compliance with Managed Care Members, 14 DRUG BENEFIT TRENDS, 7, 45 (2002).
277. SCHERING-PLOUGH CORP., 2002 ANNUAL REPORT (2003), at 4.
278. Jami Rubin, Schering-Plough Sales and Earnings Estimates, MORGAN STANLEY EQUITY RESEARCH, (Jan. 27, 2004), at 7.
279. Helen Brown, Dealing with the Generic Threat, PHARMAFOCUS, (Sept. 14, 2005) at http://www. prophet.com/news/ pressreleases/09-05Smith.htm
280. See Gardiner Harris, Schering-Plough's CEO Quest Narrows to Two, WALL ST. J., New York, NY, (Nov. 29, 2002), at A3.
281. SCHERING-PLOUGH CORP., 2007 ANNUAL REPORT (2008), at 13.