Earning exclusivity: Generic drug incentives and the Hatch-Waxman Act

Antitrust Law Journal

Volumn 77, Issue 3, 2011, Pages 947-989

  Hemphill, C Scott ^a   Lemley, Mark A ^b  

^a The Earth Institute at Columbia University   (United States)

^b STANFORD LAW SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84855401729     PISSN: 00036056     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (128)

1. Caraco Pharm. Labs., Ltd. v. Forest Labs., Ltd., 527 F.3d 1278, 1283 (Fed. Cir. 2008) (point of 180-day period is "to incentivize ANDA filers to challenge the validity of listed patents or design around those patents as early as possible").
2. Teva Pharm. Indus, v. Crawford, 410 F.3d 51, 53-54 (D.C. Cir. 2005) (noting that Congress "clearly" "intended to create an incentive to challenge branddrug patents" by means of the 180-day period).
3. Sandoz, Inc. v. FDA, 439 F. Supp. 2d 26, 29, 33-34 (D.D.C. 2006)
4. Daniel F. Coughlin & Rochelle A. Dede, Hatch-Waxman Game-Playing from a Generic Manufacturer Perspective, 25 BIOTECH. L. REP. 525, 525-526 (2006).
5. See also MARTIN A. VOET, THE GENERIC CHALLENGE: UNDERSTANDING PATENTS, F D A AND PHARMACEUTICAL LIFE-CYCLE MANAGEMENT 61 ( 2 0 0 5 ) (stating that the 180-day period often provides the majority of total profits).
6. See, e.g., Lear, Inc. v. Adkins, 395 U.S. 653, 670 (1969) (emphasizing the "public interest in permitting full and free competition in the use of ideas," and holding that a licensee was not estopped from attacking patent validity).
7. Wembley, Inc. v. Superba Cravats, Inc., 315 F.2d 87, 89 (2d Cir. 1963) (quoting Hand, J., Bresnick v. U.S. Vitamin Corp., 139 F.2d 239, 242 (2d Cir. 1943)) (noting the potential "scarecrow" effect of an invalid patent, even where not litigated, on potential entrants).
8. Christopher R. Leslie, The Anticompetitive Effects of Unenforced Invalid Patents, 91 MINN. L. REV. 101, 113-39 (2006) (analyzing the mechanism and consequences of this scarecrow effect).
9. See, e.g., C. Scott Hemphill, Collusive and Exclusive Settlements of Intellectual Property Litigation, 2010 COLUM. Bus. L. REV. 685, 703 (endorsing term-division settlements as properly reflecting the inherent strength of the patent).
10. Herbert Hovenkamp et al., Anticompetitive Settlement of Intellectual Property Disputes, 87 MINN. L. REV. 1719, 1762 (2003).
11. Valley Drug Co. v. Geneva Pharms., 344 F.3d 1295, 1306 n.18 (11th Cir. 2003).
12. In re Cardizem CD Antitrust Litig., 332 F.3d 896, 907-08 (6th Cir. 2003).
13. King Drug Co. of Florence, Inc. v. Cephalon, Inc., 702 F. Supp. 2d 514, 534, 535-536 (E.D. Pa. 2010).
14. Joseph A. DiMasi et al., The Price of Innovation: New Estimates of Drug Development Costs, 22 J. HEALTH ECON. 151 (2003) (estimating that the costs of clinical tests constitute more than half the total cost of drug development).
15. C. Scott Hemphill & Bhaven N. Sampat, When Do Generics Challenge Drug Patents?, 8 J. EMPIRICAL LEGAL STUD. 613 (forthcoming 2011), available at http://ssrn.com/abstract=1640512.
16. Marc Goodman et al., Quantifying the Impact from Authorized Generics 9 (Morgan Stanley Research Report 2004). Nonetheless, challenging patents frequently pays quite handsomely, either in profits from sales in the market or in the form of reverse payments to stay out of the market.
17. Sarah Rubenstein, Why Generic Doesn't Always Mean Cheap, WALL ST. J., Mar. 13, 2007, at D1.
18. Murray Aitken, Ernst R. Berndt & David M. Cutler, Prescription Drug Spending Trends in the United States: Looking Beyond the Turning Point, 28 HEALTH AFF., wl51, wl56-wl58, exh. 5 (2009).
19. See Frank R. Lichtenberg & Gautier Duflos, The Effect of Patent Expiration on U.S. Drug Prices, Marketing, and Utilization by the Public (Manhattan Inst, for Policy Research, Medical Progress Report No. 11, Oct. 2009), available at http://www.manhattan-institute.org/html/mpr-11.htm.
20. Darius Lakdawalla et al., Intellectual Property and Marketing (Nat'l Bureau of Econ. Research Working Paper No. 12577, 2006).
21. Cf. Gideon Parchomovsky & Peter Siegelman, Towards an Integrated Theory of Intellectual Property, 88 VA. L. REV. 1455, 1516-1517 (2002) (observing that brand-name drug makers sometimes raise prices upon generic entry, relying on the brand to drive a few sales at the higher price).
22. Blonder-Tongue Labs., Inc. v. Univ. of 111. Found., 402 U.S. 313, 349 (1971).
23. Joseph Scott Miller, Building a Better Bounty: Litigation-Stage Rewards for Defeating Patents, 19 BERKELEY TECH. L.J. 667, 687-88 (2004) (recognizing public-good characteristic of patent challenges).
24. Joseph Farrell & Robert P. Merges, Incentives to Challenge and Defend Patents: Why Litigation Won't Reliably Fix Patent Office Errors and Why Administrative Patent Review Might Help, 19 BERKELEY TECH. L.J. 943, 952 (2004) (similar).
25. John R. Thomas, Collusion and Collective Action in the Patent System: A Proposal for Patent Bounties, 2001 U. III. L. REV. 305, 333 (similar). Noninfringement claims are more complicated, because they may be specific to the strategy pursued by a particular generic firm.
26. Gardiner Harris & Joanna Slater, Bitter Pills: Drug Makers See "Branded Generics" Eating into Profits, WALL ST. J., Apr. 17, 2003, at Al (reporting that Barr's generic version of Prozac had revenue of $366 million during the 180-day period, and $4 million in subsequent six months).
27. Food & Drug Admin., Generic Competition and Drug Prices (Mar. 3, 2010), http://www. fda.gov/AboutFDA/CentersOffices/CDER/ucm129385.htm.
28. Shannon Pettypiece & Justin Blum, Merck's Zocor Gets Additional Generic Competition, BLOOMBERG NEWS, Dec. 27, 2006 (noting, at the end of the exclusivity period, that 20-milligram Zocor sold for $4.53 per pill, compared to $4.16 for Teva's generic version).
29. see Ron A. Bouchard et al., The Pas de Deux of Pharmaceutical Regulation and Innovation: Who's Leading Whom?, 24 BERKELEY TECH. L.J. 1461 (2009).
30. See also FED. TRADE COMM'N, GENERIC DRUG ENTRY PRIOR TO PATENT EXPIRATION vi (2002) [hereinafter GENERIC DRUG ENTRY] (reporting three awards between 1984 and 1992), available at http://www.ftc.gov/os/2002/07/genericdrugstudy.pdf.
31. Mova Pharm. Corp. v. Shalala, 955 F. Supp. 128, 130 (D.D.C. 1997).
32. Ctr. for Drug Evaluation & Research, FDA, Guidance for Industry: 180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act 4 (1998) (stating that "FDA will not enforce the 'successful defense' provisions" and "intends to formally remove" them from Code of Federal Regulations), available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/ucm079342.pdf.
33. see, e.g., Mark A. Lemley & Kimberly A. Moore, Ending Abuse of Patent Continuations, 84 B.U. L. REV. 63, 81-83 (2004).
34. See also Lara J. Glasgow, Stretching the Limits of Intellectual Property Rights: Has the Pharmaceutical Industry Gone Too Far?, 41 IDEA 227, 233-235 (2001).
35. Christine S. Paine, Brand-Name Drug Manufacturers Risk Antitrust Violations By Slowing Generic Production Through Patent Layering, 33 SETON HALL L. REV. 479, 497 (2003).
36. Frederick Tong, Widening the Bottleneck of Pharmaceutical Patent Exclusivity, 24 WHITHER L. REV. 775, 787-788 (2003).
37. See Nichols v. SmithKline Beecham Corp., No. Civ. A. 00-6222, 2005 WL 950616, at 1, 26-27 (E.D. Pa. Apr. 22, 2005) (indirect).
38. Stop & Shop Supermarket Co. v. SmithKline Beecham Corp., No. Civ. A. 03-4578, 2005 WL 1213926, at 1 (E.D. Pa. May 19, 2005) (direct).
39. see 1 HERBERT HOVENKAMP ET AL., IP AND ANTITRUST § 15.3cl (2d ed. 2010).
40. Stacey L. Dogan & Mark A. Lemley, Antitrust Law and Regulatory Gaming, 87 TEX. L. REV. 685, 709-717 (2009).
41. Steve D. Shadowen et al., Anticompetitive Product Changes in the Pharmaceutical Industry, 41 RUTGERS L.J. 1 (2009).
42. ROBIN FELDMAN, RETHINKING PATENT RIGHTS ch. 5 (forthcoming 2012).
43. See Second Amended Answer, Affirmative Defenses, and Counterclaims, Abbott Labs. v. Teva Pharms. USA, Inc., No. 02-1512, 2005 WL 6155984 (D. Del. July 29, 2005).
44. First Amended Counterclaims at 9, Abbott Labs. v. Impax Labs., Inc., No. 03-120, 2005 WL 6155872 (D. Del. Sept. 30, 2005).
45. Teva Pharms. USA, Inc. v. Abbott Labs., 580 F. Supp. 2d 345, 355 (D. Del. 2008)
46. Compare id. with Walgreen Co. v. AstraZeneca Pharms., 534 F. Supp. 2d 146 (D.D.C. 2008)
47. Teva Pharms. USA, Inc. v. Abbott Labs., 580 F. Supp. 2d 345, 369 (D. Del. 2008).
48. C. Scott Hemphill, An Aggregate Approach to Antitrust: Using New Data and Rulemaking to Preserve Drug Competition, 109 COLUM. L. REV. 629, 651-55 (2009) [hereinafter Aggregate Approach].
49. ROBIN FELDMAN, THE ROLE OF SCIENCE IN LAW 167 (2009).
50. Jeremy Bulow , The Gaming of Pharmaceutical Patents, in 4 INNOVATION POLICY AND THE ECONOMY 145 (Adam B. Jaffe et al. eds., 2004).
51. Roger D. Blair & Thomas F. Cotter, Are Settlements of Patent Disputes Illegal Per Se?, 47 ANTITRUST BULL. 491 (2002).
52. Michael A. Carrier, Unsettling Drug Patent Settlements: A Framework for Presumptive Illegality, 108 MICH. L. REV. 37 (2009).
53. Daniel A. Crane, Exit Payments in Settlement of Patent Infringement Lawsuits: Antitrust Rules and Economic Implications, 54 FLA. L. REV. 747 (2002).
54. Bret Dickey et al., An Economic Assessment of Patent Settlements in the Pharmaceutical Industry, 19 ANNALS HEALTH L. 367 (2010).
55. Joseph Farrell & Carl Shapiro, How Strong Are Weak Patents?, 98 AM. ECON. REV. 1347 (2008).
56. C. Scott Hemphill, Paying for Delay: Pharmaceutical Patent Settlement as a Regulatory Design Problem, 81 N.Y.U. L. REV. 1553 (2006) [hereinafter Paying for Delay].
57. Mark A. Lemley & Carl Shapiro, Probabilistic Patents, 19 J. ECON. PERSPS., Spring 2005, at 75.
58. Kevin D. McDonald, Hatch-Waxman Patent Settlements and Antitrust: On "Probabilistic" Patent Rights and False Positives, ANTITRUST, Spring 2003, at 68.
59. Maureen A. O'Rourke & Joseph F. Brodley, An Incentives Approach to Patent Settlements, 87 MINN. L. REV. 1767 (2003).
60. Catherine J.K. Sandoval, Pharmaceutical Reverse Payment Settlements: Presumptions, Procedural Burdens, and Covenants Not to Sue Generic Drug Manufacturers, 26 SANTA CLARA COMPUTER & HIGH TECH. L.J. 141 (2009).
61. Marc G. Schildkraut, Patent-Splitting Settlements and the Reverse Payment Fallacy, 71 ANTITRUST L.J. 1033 (2004).
62. Carl Shapiro, Antitrust Limits to Patent Settlements, 34 RAND J. ECON. 391 (2003).
63. Robert D. Willig & John P. Bigelow, Antitrust Policy Toward Agreements that Settle Patent Litigation, 49 ANTITRUST BULL. 655 (2004).
64. See Dey, L.P. v. Sepracor, Inc., 595 F. Supp. 2d 355, 357 n.1 (D. Del. 2009).
65. Teva Pharms. USA, Inc. v. Novartis Pharms. Corp., 482 F.3d 1330, 1334 (Fed. Cir. 2007) (same).
66. Pfizer Inc. v. Apotex Inc., 726 F. Supp. 2d 921 (N.D. III. 2010) (same).
67. Merck & Co. v. Apotex, Inc., 488 F. Supp. 2d 418 (D. Del. 2007).
68. See also Dr. Reddy's Labs., Ltd. v. AstraZeneca AB, No. 08-2496, 2008 WL 4056533 (D.N.J. 2008) (generic firm lacks standing as to some patents), order vacated on reconsideration, 2009 WL 3241699 (D.N.J. 2009) (denying dismissal).
69. Ivax Pharms., Inc. v. AstraZeneca AB, No. 08-2165, 2008 WL 4056518 (D.N.J. 2008).
70. For analyses, see Scott A. Backus, Reversing Course on Reverse Payment Settlements in the Pharmaceutical Industry: Has Schering-Plough Created the Blueprint for Defensible Antitrust Violations?, 60 OKLA. L. REV. 375, 414-416 (2007).
71. Michael A. Carrier, A Real-World Analysis of Pharmaceutical Settlements: The Missing Dimension of Product Hopping, 62 FLA. L. REV. 1009, 1032-1033 (2010).
72. Michael A. Carrier, Solving the Drug Settlement Problem: The Legislative Approach, 41 RUTGERS L.J. 83, 93 (2009).
73. Joshua P. Davis, Applying Litigation Economics to Patent Settlements: Why Reverse Payments Should Be Per Se Illegal, 41 RUTGERS L.J. 255, 304-305 (2009).
74. Ankur N. Patel, Comment, Delayed Access to Generic Medicine: A Comment on the Hatch-Waxman Act and the "Approval Bottleneck," 78 FORDHAM L. REV. 1075, 1096 (2009).
75. s e e FED. TRADE COMM'N, AUTHORIZED GENERICS: AN INTERIM REPORT c h . 2, 1 - 1 0 (2009), available at http://www.ftc.gov/os/2009/06/ P062105authorizedgenericsreport.pdf.
76. See, e.g., King Drug Co. of Florence, Inc. v. Cephalon, Inc., 702 F. Supp. 2d 514, 535-536 (E.D. Pa. 2010) (denying motion to dismiss, in part, because plaintiffs alleged that agreement created a bottleneck that blocked subsequent filers).
77. See Ark. Carpenters Health & Welfare Fund v. Bayer AG, 604 F.3d 98, 110 (2d Cir. 2010) (per curiam).
78. Valley Drug Co. v. Geneva Pharms., Inc., 344 F.3d 1294 (11th Cir. 2003).
79. Teva Pharms. USA, Inc. v. Sebelius, 595 F.3d 1303, 1318 (D.C. Cir. 2010).
80. Mylan Pharms., Inc. v. Thompson, 139 F. Supp. 2d 1, 10-11 (D.D.C. 2001).
81. Mark A. Lemley, Rational Ignorance at the Patent Office, 95 Nw. U. L. REV. 1495 (2001).
82. For a proposal along these lines, see Gregory Dolin, Reverse Settlements as Patent Invalidity Signals (SSRN Working Paper Series, 2010), available at http://ssrn.com/abstract=1675947.
83. See, e.g., Doug Lichtman & Mark A. Lemley, Rethinking Patent Law's Presumption of Validity, 60 STAN. L. REV. 45 (2007).
84. Mark A. Lemley et al., What to Do About Bad Patents, REG., Winter 2005-2006, at 10.
85. Alfred B. Engelberg, Special Patent Provisions for Pharmaceuticals: Have They Outlived Their Usefulness?, 39 IDEA 389, 425 (1999).
86. See, e.g., FDA, Guidance for Industry 1 (1988) [hereinafter 1988 FDA Guidance] (taking view that Congress intended 180-day provision to be limited to instances of successful litigation), available at http://www.fda.gov/downloads/ Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075007.pdf.
87. Letter from Gary Buehler, Dir. of Office of Generic Drugs, FDA, to [Unnamed] ANDA Applicant (Oct. 28, 2008) (interpreting "lawfully maintains" in the course of determining 180- day exclusivity for generic version of Cosopt), available at http://www.fda.gov/downloads/AboutFDA/ CentersOffices/CenterforDrugEvaluationandResearch/ucml19602.pdf.
88. see David E. Korn et al., A New History and Discussion of 180-Day Exclusivity, 64 FOOD & DRUG L.J. 335, 346-47 (2009).
89. See, e.g., David Bickart, The Hatch-Waxman Act, in DEVELOPMENTS IN PHARMACEUTICAL AND BIOTECH PATENT LAW 205, 274 (Practising Law Institute 2008) (noting this "conceivablfe]" interpretation).
90. Erica N. Andersen, Note, Schering the Market: Analyzing the Debate over Reverse- Payment Settlements in the Wake of the Medicare Modernization Act of 2003 and In re Tamoxifen Citrate Litigation, 93 IOWA L. REV. 1015, 1051-52 (2008) (advocating this approach).
91. See Letter from Gary J. Buehler, Dir., Office of Generic Drugs, FDA, to Marc A. Goshko, Executive Dir., Teva N. Am. 5 (Jan. 17, 2008), available at http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/ HowDrugsareDevelopedandApproved/ApprovalApplications/ AbbreviatedNewDrugApplicationANDAGenerics/UCM151237.pdf.
92. See SHASHANK UPADHYE, GENERIC PHARMACEUTICAL PATENT AND F D A LAW § 14.11 (2010) (arguing that the provision, "while verbose, has no teeth because . . . the forfeit will only occur after a ridiculously long period of time").
93. Richard A. Posner, The Federal Trade Commission: A Retrospective, 72 ANTITRUST L.J. 761,766 (2005).
94. see Bruce H. Kobayashi & Joshua D. Wright, Federalism, Substantive Preemption, and Limits on Antitrust: An Application to Patent Holdup, 5 J. COMPETITION L. & ECON. 469 (2009).
95. See Frank H. Easterbrook, The Limits of Antitrust, 63 TEX. L. REV. 1 (1984) (proposing a set of threshold filters to minimize false positives, on the grounds that the cost of condemning a beneficial practice is much higher than the harm of allowing an anticompetitive practice to continue).
96. See, e.g., Peter C. Carstensen, False Positives in Identifying Liability for Exclusionary Conduct: Conceptual Error, Business Reality, and Aspen, 2008 Wis. L. REV. 295, 295 (2008).
97. See Leegin Creative Leather Prods., Inc. v. PSKS, Inc., 551 U.S. 877, 907 (2007) (overruling precedent to hold that the per se rule is inapplicable to vertical agreements to fix minimum resale prices).
98. Tool Works, Inc. v. Indep. Ink, Inc., 547 U.S. 28, 42-43 (2006) (requiring proof of market power in patent tying cases).
99. NYNEX Corp. v. Discon, Inc., 525 U.S. 128, 135 (1998) (declining to apply the per se rule to a boycott case involving only a single buyer).
100. State Oil Co. v. Khan, 522 U.S. 3, 18 (1997) (overturning precedent to remove vertical agreements on maximum prices from the scope of the per se rule).
101. Bus. Elecs. Corp. v. Sharp Elecs. Corp., 485 U.S. 717, 735-736 (1988) (holding that the per se rule does not apply to non-price-related forms of vertical agreement).
102. See Texaco, Inc. v. Dagher, 547 U.S. 1, 5-6 (2006) (determining that a joint venture that set the prices its members would charge was not per se illegal).
103. Nw. Wholesale Stationers, Inc. v. Pac. Stationery & Printing Co., 472 U.S. 284, 298 (1985) (holding that an act of expulsion from a wholesale cooperative does not fall under the per se rule).
104. NCAA v. of Regents of Univ. of Okla., 468 U.S. 85, 100-01 (1984) (refusing to apply the per se rule to the NCAA's footballtelevising plan because horizontal restraints were necessary for the product to be available at all).
105. Broad. Music, Inc. v. CBS, Inc., 441 U.S. 1, 7 (1979) (holding that the per se rule should not be used when analyzing blanket licenses issued by performing rights organizations).
106. See Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007) (imposing a heightened pleading requirement on a plaintiff attempting to use parallel conduct as the initial basis for a claim of anticompetitive conspiracy).
107. Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 595 (1986) (requiring more direct evidence for a conspiracy claim to survive summary judgment, including evidence showing a rational motive to conspire).
108. Monsanto Co. v. Spray- Rite Serv. Corp., 465 U.S. 752,764 (1984) (holding that a conspiracy case must be supported by evidence that tends to exclude the possibility of independent action and indicates a conscious commitment to an unlawful common scheme).
109. Brooke Group Ltd. v. Brown & Williamson Tobacco Corp., 509 U.S. 209, 222-27 (1993) (requiring proof of below-cost pricing and probability of recoupment in predatory pricing claims).
110. see also Weyerhaeuser Co. v. Ross-Simmons Hardwood Lumber Co., Inc., 549 U.S. 312, 326 (2007) (holding that the stringent standard for predatory pricing also applies to predatory bidding claims).
111. See Peter J. Hammer & William M. Sage, Antitrust, Health Care Quality, and the Courts, 102 COLUM. L. REV. 545, 575 (2002) (concluding that plaintiffs win only 14 percent of antitrust cases in the health care industry).
112. But see Daniel A. Crane, Rules Versus Standards in Antitrust Adjudication, 64 WASH. & LEE L. REV. 49, 65 (2007) (contending that the rule of reason has become "reinvigorated" in recent years, leading to more wins for plaintiffs).
113. See Atl. Richfield Co. v. USA Petroleum Co., 495 U.S. 328, 3 4 1 ^ 5 (1990) (holding that antitrust plaintiffs must prove that their injury resulted from harm to the competitive process).
114. Brunswick Corp. v. Pueblo Bowl-O-Mat, Inc., 429 U.S. 477, 489 (1977) ("Plaintiffs must prove antitrust injury, which is to say injury of the type the antitrust laws were intended to prevent and that flows from that which makes defendants' acts unlawful.").
115. See William Kolasky, Reinvigorating Antitrust Enforcement in the United States: A Proposal, ANTITRUST, Spring 2008, at 85, 85 (2008) (recording this streak of plaintiff losses).
116. Am. Needle, Inc. v. Nat'l Football League, 130 S. Ct. 2201 (2010). 115 This is controversial.
117. See Robert H. Lande, Are Antitrust "Treble" Damages Really Single Damages?, 54 OHIO ST. L.J. 115 (1993).
118. see Thomas C. Arthur, A Workable Rule of Reason: A Less Ambitious Antitrust Role for the Federal Courts, 68 ANTITRUST L.J. 337, 384-85 n.285 (2000) ("While the FTC cannot afford compensation to the private parties favored by non-Chicagoans, it may be more likely than the current federal judiciary to prohibit the practices that concern Chicago's critics.").
119. Teva Pharms. USA, Inc. v. Sebelius, 595 F.3d 1303, 1318 (D.C. Cir. 2010).
120. King, Aventis, Cobalt Agree to Dismiss Patent Litigation Regarding ACE Inhibitor Altace, HEART DISEASE WKLY., Apr. 9, 2006.
121. James DeGuilio, Impax Settles Amrix Patent Suit with Cephalon, PATENT Docs (Oct. 14, 2010) (same, as to Amrix), http://www.patentdocs.org/2010/10/ biotechpharma-docket-2.html.
122. Ernst R. Berndt, Richard Mortimer & Andrew Parece, Do Authorized Generic Drugs Deter Paragraph IV Certifications? Recent Evidence 1 (Analysis Group Working Paper, 2007), http://www.analysisgroup.com/uploadedFiles/ Publishing/Articles/PhRMA-Authorized-Generic-Entry.pdf.
123. see, e.g., Rebecca S. Eisenberg, The Role of the FDA in Innovation Policy, 13 MICH. TELECOMM. & TECH. L. REV. 345, 359-364 (2007).
124. Benjamin N. Roin, Unpatentable Drugs and the Standards of Patentability, 87 TEX. L. REV. 5 0 3 , 565-567 (2009).
125. Ashlee B. Mehl, Note, The Hatch-Waxman Act and Market Exclusivity for Generic Drug Manufacturers: An Entitlement or an Incentive, 81 CHI.-KENT L. REV. 649, 672-677 (2006).
126. See, e.g., King Drug Co. of Florence, Inc. v. Cephalon, Inc., 702 F. Supp. 2d 514, 532-33 (E.D. Pa. 2010) (noting such clauses in settlements between Cephalon and four generic firms).
127. See, e.g., James C. Morrison, Update on the Waxman-Hatch Amendment Implementation, 43 FOOD DRUG & COSMETIC L.J. 553, 554 (1988) (article by FDA official describing an early controversy involving the exclusivity period, and noting that "[t]his section has not been highlighted in any speeches or guidance letters because the agency did not expect it to be of much significance").
128. See, e.g., King Drug Co. of Florence, Inc. v. Cephalon, Inc., 702 F. Supp. 2d 514, 534, 535-536 (E.D. Pa. 2010).