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Volumn 91, Issue 2, 2012, Pages 283-330

Solving the patent settlement puzzle

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EID: 84871726945     PISSN: 00404411     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article
Times cited : (48)

References (85)
  • 1
    • 84871820719 scopus 로고    scopus 로고
    • note
    • These are sometimes called "pay-for-delay" settlements, but we avoid that terminology because it presupposes that the settlement entry date does "delay" entry compared to the expected entry date, which is generally the disputed issue.
  • 2
    • 84871784029 scopus 로고    scopus 로고
    • note
    • The literature often instead compares the settlement entry date to the "expected entry date" from litigation, but the latter term is imprecise in cases where, absent settlement, the entrant would have entered at risk and thus could have been excluded well after entry if it had later lost the patent litigation. So we use the more precise term "expected litigation exclusion period." For example, suppose the entrant would enter at risk, the remaining patent term is 10 years, the patent litigation will last two years, and the entrant has a 20% chance of losing and being excluded. The expected entry date is immediate and thus would be exceeded by any settlement that excludes entry for any period at all. But this does not accurately determine whether the settlement harms consumer welfare because the expected litigation exclusion period is 20% of 8 years or 1.6 years. Thus, a settlement that excludes entry for less than 1.6 years does not harm consumer welfare.
  • 3
    • 84871723950 scopus 로고    scopus 로고
    • note
    • Delaying entry through a reverse patent settlement is profit maximizing whenever entry reduces the joint profits of the patent holder and entrant, which is true whenever the patent holder has market power that the entrant would constrain to some degree. Further, we show below that if the reverse payment amount exceeds the patent holder's anticipated litigation costs, then the patent holder must have believed it had market power that the settling entrant would uniquely constrain.
  • 4
    • 84871747458 scopus 로고    scopus 로고
    • note
    • In re Cardizem CD Antitrust Litig., 332 F.3d 896, 907-08 (6th Cir. 2003). In this case, Professor Elhauge filed an expert declaration for a generic defendant in which he opposed application of the per se rule.
  • 5
    • 84871723549 scopus 로고    scopus 로고
    • note
    • Schering-Plough Corp. v. FTC, 402 F.3d 1056, 1065-66, 1075-76 (11th Cir. 2005); id. at 1071 (finding the evidence unrebutted that the settlement "entry date reasonably reflected the strength of [the patent holder's] case"); Valley Drug Co. v. Geneva Pharm., Inc., 344 F.3d 1294, 1312 (11th Cir. 2003) (requiring inquiry into whether the settlement terms exceeded patent protections, "considered in light of the likelihood of [the patent holder] obtaining such protections").
  • 6
    • 84871801906 scopus 로고    scopus 로고
    • note
    • Valley Drug, 344 F.3d at 1306-07 (holding that such a settlement could thus be proper even if the patent were later held invalid).
  • 7
    • 84871797691 scopus 로고    scopus 로고
    • note
    • In re Tamoxifen Citrate Antitrust Litig., 466 F.3d 187, 203-04 (2d Cir. 2006).
    • (2006)
  • 8
    • 84871821130 scopus 로고    scopus 로고
    • note
    • Id. at 212-13.
    • (2006) , pp. 212-213
  • 9
    • 84871756812 scopus 로고    scopus 로고
    • note
    • id. at 213-16 (holding that the settlement did not exceed the scope of the patent because it did not preclude "non-infringing products," did not delay other potential entrants, and allowed entry before the patent term expired); Ark. Carpenters Health & Welfare Fund v. Bayer AG, 604 F.3d 98, 106 (2d Cir. 2010) (stressing that a "settlement agreement did not exceed the scope of the patent where (1) there was no restriction on marketing non-infringing products; (2) a generic version of the branded drug would necessarily infringe the branded firm's patent; and (3) the agreement did not bar other generic manufacturers from challenging the patent"). 9. In re Ciprofloxacin Hydrochloride Antitrust Litig., 544 F.3d 1323, 1336-37 (Fed. Cir. 2008); id. at 1335 (indicating that if a reverse payment settlement created a bottleneck effect "delaying the entry of other generic manufacturers" or covered "non-infringing" products, then it would clearly lie "outside the exclusion zone of the patent"); FTC v. Watson Pharm., Inc., 677 F.3d 1298, 1312 (11th Cir. 2012). The Eleventh Circuit panel in Watson claimed its conclusion was consistent with prior Eleventh Circuit panels, but it never addressed the language in Valley Drug saying that the exclusionary scope of a patent turned on "the likelihood of [the patent holder] obtaining [patent] protections." Valley Drug, 344 F.3d at 1312. The Watson panel's effort to reconcile Schering-Plough relied on the dubious assertion that Schering-Plough's references to evaluating the "strength of the patent" merely meant the temporal length of the patent. Watson, 677 F.3d at 1311 n.8. But the Watson panel was reasonably concerned that the FTC's proposed standard in that case (whether patent victory was unlikely) failed to reliably identify whether the settlement was anticompetitive and required difficult inquiries into the probability that the patent holder would have won.
    • (2006) , pp. 213-216
  • 10
    • 84871724456 scopus 로고    scopus 로고
    • note
    • Id. at 1312-15.
    • (2006) , pp. 1312-1315
  • 11
    • 84871801754 scopus 로고    scopus 로고
    • note
    • In re K-Dur Antitrust Litig., 686 F.3d 197, 218 (3d Cir. 2012).
    • (2012)
  • 12
    • 84871805237 scopus 로고    scopus 로고
    • note
    • Brief for the United States in Response to the Court's Invitation at 10, 22, 28-32, Ark. Carpenters Health & Welfare Fund, 604 F.3d 98 (Nos. 05-2851-cv(L), 05-2852-cv (CON), 05- 2863-cv (CON)), 2009 WL 8385027, at *10, *22, *28-32. The Antitrust Division used to favor a case-by-case inquiry into whether the patent holder actually would likely have won, but now rejects that sort of objective probabilistic approach in favor of the perceived probabilistic approach described in the text above. Id. at 24-27, 26 n.9.
  • 13
    • 84871746795 scopus 로고    scopus 로고
    • note
    • Schering-Plough Corp., 136 F.T.C. 956, 987-91, 1000-03 (2003), vacated, 402 F.3d 1056 (11th Cir. 2005).
    • (2005)
  • 14
    • 84871743488 scopus 로고    scopus 로고
    • note
    • Id. at 992-98.
    • (2005) , pp. 992-998
  • 15
    • 84871796612 scopus 로고    scopus 로고
    • note
    • See FED. TRADE COMM'N, GENERIC DRUG ENTRY PRIOR TO PATENT EXPIRATION: AN FTC STUDY vi (2002) ("Generic applicants have prevailed in 73 percent of the cases in which a court has resolved the patent dispute."); ADAM GREENE & D. DEWEY STEADMAN, RBC CAPITAL MKTS., PHARMACEUTICALS: ANALYZING LITIGATION SUCCESS RATES 1 (2010) (noting that patent holders lose 48% of the cases with generic entrants); Paul M. Janicke & LiLan Ren, Who Wins Patent Infringement Cases?, 34 AIPLA Q.J. 1, 20 (2006) (providing data that demonstrates that patent holders lose approximately 70% of the time).
  • 16
    • 84871727829 scopus 로고    scopus 로고
    • note
    • This difficulty might be particularly acute because the Federal Circuit has exclusive jurisdiction over patent cases, while antitrust cases can go to any appellate panel. Thus, the appellate panel hearing the antitrust case might worry it lacks the expertise to predict how the Federal Circuit would decide any patent issues. See FTC v. Watson Pharm., Inc., 677 F.3d 1298, 1314-15 (11th Cir. 2012) (expressing concern that "[t]his Court and the other non-specialized circuit courts have no expertise or experience in the area" of patent law and thus "are ill-equipped to make a judgment about the merits of a patent infringement claim").
  • 17
    • 84871792431 scopus 로고    scopus 로고
    • note
    • However, our proof below shows this possibility exists only when the reverse payment amount is lower than the patent holder's anticipated litigation costs, absent a judgment-proof entrant or a separate procompetitive justification.
  • 18
    • 84871745631 scopus 로고    scopus 로고
    • note
    • In re Tamoxifen Citrate Antitrust Litig., 466 F.3d 187, 211 (2d Cir. 2006).
    • (2006)
  • 19
    • 84871808123 scopus 로고    scopus 로고
    • note
    • Ark. Carpenters Health & Welfare Fund v. Bayer AG, 604 F.3d 98, 108-10 (2d Cir. 2010).
    • (2010)
  • 20
    • 84871780916 scopus 로고    scopus 로고
    • note
    • Schering-Plough Corp., 136 F.T.C. 956, 987 (2003), vacated, 402 F.3d 1056 (11th Cir. 2005); Brief for the United States, supra note 13, at 21-22.
  • 21
    • 0031511862 scopus 로고    scopus 로고
    • Patents and antitrust: A rethinking in light of patent breadth and sequential innovation
    • note
    • See John H. Barton, Patents and Antitrust: A Rethinking in Light of Patent Breadth and Sequential Innovation, 65 ANTITRUST L.J. 449, 450 (1997) ("The patent-antitrust analysis has always had to take into account and balance benefit to consumers by maintaining the competitive structure of existing markets against benefit to consumers by permitting the intellectual property rights system to provide an incentive for research toward new and improved products.").
    • (1997) Antitrust L.J , vol.65
    • Barton, J.H.1
  • 22
    • 84871764564 scopus 로고    scopus 로고
    • note
    • See SUZANNE SCOTCHMER, INNOVATION AND INCENTIVES 100-03 (2004); Partha Dasgupta & Joseph Stiglitz, Uncertainty, Industrial Structure, and the Speed of R&D, 11 BELL J. ECON. 1, 18 (1980); Pankaj Tandon, Rivalry and the Excessive Allocation of Resources to Research, 14 BELL J. ECON. 152, 152, 156-57 (1983). Such a system will also maximize overall total welfare because competing innovators will keep spending on ex ante investments until their investment costs equal their expected ex post profits, so that the profits to patent holders wash out ex ante.
  • 23
    • 84871803438 scopus 로고    scopus 로고
    • note
    • See supra note 24.
  • 24
    • 73849090211 scopus 로고    scopus 로고
    • A model of discovery
    • note
    • For a theoretical model proving that this is possible, see generally Michele Boldrin & David K. Levine, A Model of Discovery, 99 AM. ECON. REV. 337 (2009).
    • (2009) Am. Econ. Rev , vol.99 , pp. 337
    • Boldrin, M.1    Levine, D.K.2
  • 25
    • 73849141604 scopus 로고    scopus 로고
    • note
    • For empirical work showing that expanding patent protections have had net negative effects on patent filings and suppressed later innovations, see generally Josh Lerner, The Empirical Impact of Intellectual Property Rights on Innovation: Puzzles and Clues, 99 AM. ECON. REV. 343 (2009); Fiona Murray et al., Of Mice and Academics: Examining the Effect of Openness on Innovation (Nat'l Bureau of Econ. Research, Working Paper No. 14819, 2009); Heidi L. Williams, Intellectual Property Rights and Innovation: Evidence from the Human Genome (Nat'l Bureau of Econ. Research, Working Paper No. 16213, 2010).
    • (2010) The Empirical Impact of Intellectual Property Rights on Innovation: Puzzles and Clues
  • 26
    • 84871813960 scopus 로고    scopus 로고
    • note
    • In re Tamoxifen Citrate Antitrust Litig., 466 F.3d 187, 211 (2d Cir. 2006).
    • (2006)
  • 27
    • 40749086384 scopus 로고    scopus 로고
    • note
    • See, e.g., Ian Ayres & Gideon Parchomovsky, Tradable Patent Rights, 60 STAN. L. REV. 863, 864 (2007) (arguing that issuance of too many patents chills innovation).
  • 28
    • 84871788842 scopus 로고    scopus 로고
    • note
    • See, e.g., Joshua L. Sohn, Can't the PTO Get a Little Respect?, 26 BERKLEY TECH. L.J. 1603, 1605 (2011) (arguing that federal courts do not give PTO decisions enough deference during invalidity contests).
  • 29
    • 84871820103 scopus 로고    scopus 로고
    • note
    • For the same reasons, we think antitrust law should assume the optimality of the Hatch-Waxman Act, which gives pharmaceutical patent holders the additional exclusion right of an automatic 30-month stay on generic entry, which helps incentivize patent holders to incur the costs of new drug applications that can secure FDA approval. 21 U.S.C. § 355(j)(5)(D)(i)-(ii) (2006). Thus, in a Hatch-Waxman case, we would treat the residual patent period as starting once that 30- month stay expires because monopoly profits before the stay expires are part of the special intellectual property reward for investing in new drug applications, which are valuable even if the patent proves invalid. Although the Hatch-Waxman Act provides this limited exclusion right, it nowhere approves anticompetitive settlements that extend beyond that 30-month exclusion right.
  • 30
    • 84871810162 scopus 로고    scopus 로고
    • note
    • Altering the model to include discount rates, make profitability differ over time, or both would not change any of the conclusions in the proof but would significantly complicate the mathematical formulas. In fact, adding either of these complications would only strengthen our proof. Adding discount rates would reduce the net present value of the patent holder's anticipated litigation costs but would not reduce the net present value of any reverse payment made at time 0. Discounting future profit streams would only increase the extent to which an entrant would be willing to delay entry in exchange for an upfront settlement payment and reduce the extent to which a patent holder is willing to speed up entry.
  • 31
    • 84871768986 scopus 로고    scopus 로고
    • note
    • See, e.g., Timothy F. Bresnahan & Peter C. Reiss, Entry and Competition in Concentrated Markets, 99 J. POL. ECON. 977, 984 (1991); Richard G. Frank & David S. Salkever, Generic Entry and the Pricing of Pharmaceuticals, 6 J. ECON. & MGMT. STRATEGY 75, 84 (1997); David Reiffen & Michael R. Ward, Generic Drug Industry Dynamics, 87 REV. ECON. & STAT. 37, 43 (2005).
    • (2005)
  • 32
    • 84871820015 scopus 로고    scopus 로고
    • note
    • For example, if the remaining patent term is 100 months, and the parties expect the patent litigation to last 10 months, then L = 0.1. We assume both parties share the same expected litigation duration L because it makes the mathematical model easier to understand but does not change any of the relevant conclusions. If we instead assumed that the entrant was relatively pessimistic about litigation length (so that LE > LP), that would only widen the range of possible settlement entry dates that (without any reverse payment) can provide settlement payoffs to both the entrant and patent holder that exceed their litigation payoffs. If we instead assumed the entrant was relatively optimistic about litigation length (so that LE < LP), that would only increase the extent to which a settlement exclusion period that exceeds the patent holder's estimate of the expected litigation exclusion period will exceed the entrant's estimate of that expected litigation exclusion period.
  • 33
    • 84871776396 scopus 로고    scopus 로고
    • note
    • This formula assumes that the entrant has sufficient assets to pay damages, i.e., that it is not judgment proof. We discuss below the case of a judgment-proof entrant. See infra section II(B)(2).
  • 34
    • 84871784845 scopus 로고    scopus 로고
    • note
    • Our model assumes firms are risk neutral, but as we show below, our conclusions do not depend on this assumption.
  • 35
    • 84871752162 scopus 로고    scopus 로고
    • note
    • The formula in the above text assumes the entrant has sufficient assets to pay any patent damages. If the entrant does not, then it is judgment proof to some extent, which does provide a possible ground for rebuttal that we discuss below in section II(B)(2). The formula in the text also assumes that damages are not trebled for willful infringement. Because we are talking here about a weak patent, where by definition the odds are relatively low that a court would sustain the patent claims, it is very unlikely willful infringement would ever be found, especially because willful infringement is found in only 2.1% of all patent disputes. Kimberly A. Moore, Empirical Statistics on Willful Patent Infringement, 14 FED. CIR. B.J. 227, 234 (2005). In any event, the prospect that damages might be trebled would either: (1) raise damages high enough to deter entry, in which case the strong patent proof would apply; or (2) raise the patent-holder returns from litigation if the patent remained too weak to deter entry, which would make the patent holder demand an even larger settlement exclusion period, worsening all the effects predicted by the model.
  • 36
    • 85071386618 scopus 로고    scopus 로고
    • Antitrust policy toward agreements that settle patent litigation
    • note
    • See, e.g., Robert D. Willig & John P. Bigelow, Antitrust Policy Toward Agreements That Settle Patent Litigation, 49 ANTITRUST BULL. 655, 659-62, 667-77 (2004).
    • (2004) Antitrust Bull , vol.49
    • Willig, R.D.1    Bigelow, J.P.2
  • 37
    • 84871733850 scopus 로고    scopus 로고
    • note
    • 21 U.S.C. § 355(j) (2006).
    • (2006)
  • 38
    • 71949088939 scopus 로고    scopus 로고
    • Unsettling drug patent settlements: A framework for presumptive illegality
    • note
    • See, e.g., Michael A. Carrier, Unsettling Drug Patent Settlements: A Framework for Presumptive Illegality, 108 MICH. L. REV. 37, 71 (2009).
    • (2009) Mich. L. Rev , vol.108
    • Carrier, M.A.1
  • 39
    • 84871758301 scopus 로고    scopus 로고
    • note
    • See AIPLA, REPORT OF THE ECONOMIC SURVEY 2011, at 35 (2011) [hereinafter 2011 AIPLA REPORT] (stating that, as of 2011, median litigation costs for a patent infringement suit with more than $25 million at stake were $3 million through the end of discovery and $5 million in total); Meredith Addy, Appellate Strategy Before the U.S. Court of Appeals for the Federal Circuit, in PATENT LITIGATION, NEGOTIATION, AND SETTLEMENT: LEADING LAWYERS ON STRATEGIES FOR EFFECTIVELY RESOLVING PATENT DISPUTES 7, 8 (2006), available at http://www.brinkshofer.com/files/201.pdf ("Generally, once a patent case has gone through a district court trial, it has already cost, on average, $3 to $5 million, or more. Comparatively, the cost of appeal is far less: perhaps a few hundred thousand dollars for an easy case, a few million for a complicated one, but almost always exponentially less than the initial litigation.").
  • 41
    • 84871727216 scopus 로고    scopus 로고
    • note
    • 2011 AIPLA REPORT, supra note 40, at 35-36, I-154.
    • (2011)
  • 42
    • 84871797617 scopus 로고    scopus 로고
    • note
    • Id. at I-154.
    • (2011)
  • 43
    • 84871777990 scopus 로고    scopus 로고
    • note
    • The reports from previous years have similar figures, with the highest 75th percentile reported in any year being $11.5 million for cases in the Los Angeles region in 2009. See AIPLA, REPORT OF THE ECONOMIC SURVEY 2009, at I-129 (2009) [hereinafter 2009 AIPLA REPORT].
  • 44
    • 84871757395 scopus 로고    scopus 로고
    • note
    • In re Tamoxifen Citrate Antitrust Litig., 466 F.3d 187, 190, 194 (2d Cir. 2006) (noting the $66.4 million total given to two generics).
  • 45
    • 84871809275 scopus 로고    scopus 로고
    • note
    • The patent holder agreed to pay one generic $6 million every three months and the other generic $4.5 million per month for the period from March 31, 1998 to March 1, 2000. Valley Drug Co. v. Geneva Pharm., Inc., 344 F.3d 1294, 1300-01 (11th Cir. 2003). Because of an FTC investigation, the parties terminated this settlement agreement early on August 13, 1999, so $39 million of this was not actually paid out, but that was not part of the original settlement agreement and thus not relevant to the inference at issue here. Id.
  • 46
    • 84871753679 scopus 로고    scopus 로고
    • note
    • The patent holder agreed to pay $60 million to one generic and $19-$30 million annually to another generic for the 10.75 years from January 2006 to September 2015. FTC v. Watson Pharm., Inc., 677 F.3d 1298, 1304-05 (11th Cir. 2012). The patent holder also agreed to pay one generic $12 million for backup manufacturing assistance, but if we assume that this $12 million constituted fair consideration for that assistance, then it should be excluded from the calculation of the reverse payment amount. Id.
  • 47
    • 84871800177 scopus 로고    scopus 로고
    • note
    • Ark. Carpenters Health & Welfare v. Bayer AG, 604 F.3d 98, 102 n.8 (2d Cir. 2010).
    • (2010)
  • 48
    • 84871810516 scopus 로고    scopus 로고
    • Cost and duration of patent litigation
    • note
    • See Richard D. Margiano, Cost and Duration of Patent Litigation, MANAGING INTELL. PROP., Feb. 2009, at 150, 150.
    • (2009) Managing Intell. Prop
    • Margiano, R.D.1
  • 50
    • 84871741999 scopus 로고    scopus 로고
    • note
    • The Third Circuit has recognized the need to allow this sort of rebuttal for other procompetitive justifications. In re K-Dur Antitrust Litig., 686 F.3d 197, 218 (3d Cir. 2012).
    • (2012)
  • 51
    • 84871790396 scopus 로고    scopus 로고
    • note
    • 21 U.S.C. § 355(j)(5)(D)(i)-(ii) (2006).
    • (2006)
  • 52
    • 84871732231 scopus 로고    scopus 로고
    • note
    • Aiding this sort of rebuttal evidence was other evidence in that case that minimized the possible anticompetitive effects that needed to be rebutted. The Cardizem settlement differed from the sort we model in this Article because it did not end the patent litigation and set a fixed settlement entry date. Rather, it was an interim settlement that required the parties to continue the patent litigation, precluded entry only during the litigation and only if the litigation did not last too long, and allowed the generic to keep the reverse payment only if it won the litigation. Further, in that case anticompetitive effects were undermined by strong evidence that: (1) the entrant would not have entered at risk anyway, so that such a purely interim settlement did not preclude any entry by the settling generic; and (2) no other generic entry was delayed because (a) under the rules that then prevailed, the settling generic had to win the patent litigation to preclude other generics and (b) no other generic received FDA approval in time to enter any earlier anyway. Given this evidence, the FTC concluded that the settlement had not actually delayed any generic entry. FED. TRADE COMM'N, DOCKET NO. 9293, ANALYSIS TO AID PUBLIC COMMENT 4 (2001), available at http://www.ftc.gov/os/2001/04/hoechstanalysis.pdf.
    • (2001)
  • 53
    • 84871767065 scopus 로고    scopus 로고
    • note
    • See FTC v. Ind. Fed'n of Dentists, 476 U.S. 447, 460-61 (1986) ("'[P]roof of actual detrimental effects, such as a reduction of output,' can obviate the need for an inquiry into market power, which is but a 'surrogate for detrimental effects.'"); Toys "R" Us, Inc. v. FTC, 221 F.3d 928, 937 (7th Cir. 2000) (Wood, J.) ("[T]he share a firm has in a properly defined relevant market is only a way of estimating market power, which is the ultimate consideration. The Supreme Court has made it clear that there are two ways of proving market power. One is through direct evidence of anticompetitive effects." (citations omitted)); Allen-Myland, Inc. v. Int'l Bus. Machs. Corp., 33 F.3d 194, 209 (3d Cir. 1994) (Easterbrook, J.) ("Market share is just a way of estimating market power, which is the ultimate consideration. When there are better ways to estimate market power, the court should use them." (quoting Ball Mem'l Hosp., Inc. v. Mut. Hosp. Ins., Inc., 784 F.2d 1325, 1336 (7th Cir. 1986))); United States v. Baker Hughes Inc., 908 F.2d 981, 992 (D.C. Cir. 1990) (Thomas, J., joined by Ruth Bader Ginsburg, J.) (same); see also IIB PHILLIP E. AREEDA, HERBERT HOVENKAMP & JOHN L. SOLOW, ANTITRUST LAW: AN ANALYSIS OF ANTITRUST PRINCIPLES AND THEIR APPLICATION 108 (3d ed. 2007) ("'[D]irect' indicators of market power. can be independent of market definition and are sometimes superior to it. [M]arket definition may not be necessary to prove market power.").
  • 54
    • 84871795896 scopus 로고    scopus 로고
    • note
    • See FTC v. Watson Pharm., Inc., 677 F.3d 1298, 1315 (11th Cir. 2012) (making such a claim).
  • 55
    • 84871724578 scopus 로고    scopus 로고
    • note
    • See supra note 22; see infra Part IV.
  • 56
    • 67249133979 scopus 로고    scopus 로고
    • note
    • This data is drawn from Professor Scott Hemphill's invaluable survey of 143 patent settlements from 1984 to 2008. See generally C. Scott Hemphill, An Aggregate Approach to Antitrust: Using New Data and Rulemaking to Preserve Drug Competition, 109 COLUM. L. REV. 629 (2009); C. Scott Hemphill, Drug Patent Settlements Between Rivals: A Survey (March 12, 2007) (unpublished manuscript), available at http://academiccommons.columbia.edu/catalog/ac%3A129331. We use the date of the settlement agreement, rather than the expiration of the 30-month Hatch-Waxman stay, as the best indicator of when generic entry was first possible because sometimes the Hatch-Waxman stay gets extended for other reasons, like pediatric exclusivity. If one instead uses the expiration of the 30-month stay, the residual patent period would be 93.2 months. Because our focus is on the prospective issue of how likely it is that settlements that exclude entry would be anticompetitive if no reverse payment were allowed, we combine results from settlements that did and did not have a reverse payment. If one instead wanted to ask about the likelihood that past settlements without any reverse payment were anticompetitive, then the residual patent period for only those settlements would be 75.4 months and the average monthly sales figure would be $42.4 million. This would not alter our qualitative conclusions. See infra section III(A)(3) (showing that cutting the residual patent period and annual profit level in half would actually make it somewhat more likely that settlements without reverse payments are anticompetitive).
  • 57
    • 84871806670 scopus 로고    scopus 로고
    • note
    • See GREENE & STEADMAN, supra note 17, app. C.
  • 58
    • 84871743320 scopus 로고    scopus 로고
    • note
    • Frank & Salkever, supra note 32, at 84 fig.3 (reporting 70%); Reiffen & Ward, supra note 32, at 43-44 (reporting 88%).
  • 59
    • 84871798448 scopus 로고    scopus 로고
    • note
    • In fact, incumbents increase their drug prices slightly in response to generic entry, but because the price increase is only 0.7% with one generic entrant, we treat it as unchanged. Frank & Salkever, supra note 32, at 87. Apparently, the incumbent makes more money by keeping its price high and selling only to price-insensitive customers than the incumbent would make if it lowered its price to compete with the generic for price-sensitive customers.
  • 60
    • 84871786470 scopus 로고    scopus 로고
    • note
    • Reiffen & Ward, supra note 32, at 43.
    • Reiffen1    Ward2
  • 61
    • 84871797209 scopus 로고    scopus 로고
    • note
    • Frank & Salkever, supra note 32, at 89.
    • Frank1    Salkever2
  • 62
    • 84859267668 scopus 로고    scopus 로고
    • note
    • See Gautier Duflos & Frank R. Lichtenberg, Does Competition Stimulate Drug Utilization? The Impact of Changes in Market Structure on US Drug Prices, Marketing and Utilization, 32 INT'L REV. L. & ECON. 95, 106-07 (2012) (concluding that net volume is unchanged by entry into drug markets because entry leads to a decline in both prices and marketing expenditures, which "approximately offset" each other's effects on output).
  • 63
    • 84871747085 scopus 로고    scopus 로고
    • note
    • Because the patent holder profit per sale is unchanged, PY = 55% of PN. The generic who is a single entrant has a price that is 79% of the patent holder's with the same marginal cost of 20%, and thus earns 59% of the patent holder gross sales for 45% of volume, which means average monthly profits of 59% of 45% of $72.46 million = $19.2 million. Thus, if it could obtain those profits for the entire residual patent period, it would get $1.732 billion.
  • 64
    • 84871768411 scopus 로고    scopus 로고
    • note
    • Because the suggestion is to allow only buyer patent actions to invalidate the patent prospectively, one need not worry that a risk of paying damages in such a buyer class action would deter the patent holder from ever entering into a settlement with the rival.
  • 65
    • 71949088939 scopus 로고    scopus 로고
    • Unsettling drug patent settlements: A framework for presumptive illegality
    • note
    • See Michael A. Carrier, Unsettling Drug Patent Settlements: A Framework for Presumptive Illegality, 108 MICH. L. REV. 37, 75-76 (2009).
    • (2009) Mich. L. Rev , vol.108
    • Carrier, M.A.1
  • 66
    • 0038159320 scopus 로고    scopus 로고
    • Anticompetitive settlement of intellectual property disputes
    • Herbert Hovenkamp, Mark Janis & Mark A. Lemley, Anticompetitive Settlement of Intellectual Property Disputes, 87 MINN. L. REV. 1719, 1720, 1759 (2003).
    • (2003) Minn. L. Rev , vol.87
    • Hovenkamp, H.1    Janis, M.2    Lemley, M.A.3
  • 67
    • 0043246455 scopus 로고    scopus 로고
    • Antitrust limits to patent settlements
    • Carl Shapiro, Antitrust Limits to Patent Settlements, 34 RAND J. ECON. 391, 408 (2003).
    • (2003) Rand J. Econ , vol.34
    • Shapiro, C.1
  • 68
    • 84871759664 scopus 로고    scopus 로고
    • note
    • Professor Shapiro does present proofs on other issues but not on this conjecture.
  • 70
    • 0043246455 scopus 로고    scopus 로고
    • Antitrust limits to patent settlements
    • note
    • Shapiro, supra note 65, at 408.
    • (2003) Rand J. Econ , vol.34 , pp. 408
    • Shapiro, C.1
  • 71
    • 71949088939 scopus 로고    scopus 로고
    • Unsettling drug patent settlements: A framework for presumptive illegality
    • note
    • Carrier, supra note 65, at 77.
    • (2009) Mich. L. Rev , vol.108 , pp. 77
    • Carrier, M.A.1
  • 72
    • 84871779129 scopus 로고    scopus 로고
    • note
    • Professor Carrier would also allow rebuttal if a cash-strapped generic needs cash quickly. Id. To the extent he means to rely on varying risk aversion, we would not allow rebuttal. To the extent he means that the generic might be judgment-proof, we agree with that possible ground for rebuttal, as limited by the conditions we prove are necessary to establish it.
  • 73
    • 0043246455 scopus 로고    scopus 로고
    • Antitrust limits to patent settlements
    • note
    • Shapiro, supra note 65, at 396, 407-08.
    • (2003) Rand J. Econ , vol.34
    • Shapiro, C.1
  • 74
    • 84871759662 scopus 로고    scopus 로고
    • note
    • Shapiro mistakenly conflates the expected litigation exclusion period with the optimal patent exclusion period, id. at 396, but as we show above, the former can be less than the latter when at-risk entry would have occurred without settlement.
  • 75
    • 84871754581 scopus 로고    scopus 로고
    • note
    • Id. at 397.
  • 76
    • 0038159320 scopus 로고    scopus 로고
    • Anticompetitive settlement of intellectual property disputes
    • note
    • Hovenkamp, Janis & Lemley, supra note 65, at 1762-63. They do suggest another possible rebuttal consisting of evidence that a reverse payment was actually made, but such evidence would mean that this presumption does not apply in the first place.
    • (2003) Minn. L. Rev , vol.87 , pp. 1762-1763
    • Hovenkamp, H.1    Janis, M.2    Lemley, M.A.3
  • 77
    • 22144484363 scopus 로고    scopus 로고
    • Antitrust analysis of patent settlements between rivals
    • Carl Shapiro, Antitrust Analysis of Patent Settlements Between Rivals, ANTITRUST, Summer 2003, at 70, 72.
    • (2003) Antitrust , Issue.Summer
    • Shapiro, C.1
  • 78
    • 71949088939 scopus 로고    scopus 로고
    • Unsettling drug patent settlements: A framework for presumptive illegality
    • note
    • Carrier, supra note 65, at 76-77.
    • (2009) Mich. L. Rev , vol.108 , pp. 76-77
    • Carrier, M.A.1
  • 79
    • 73449141177 scopus 로고    scopus 로고
    • Exit payments in settlement of patent infringement lawsuits: Antitrust rules and economic implications
    • Daniel A. Crane, Exit Payments in Settlement of Patent Infringement Lawsuits: Antitrust Rules and Economic Implications, 54 FLA. L. REV. 747, 779-96 (2002).
    • (2002) Fla. L. Rev , vol.54
    • Crane, D.A.1
  • 80
    • 0037821592 scopus 로고    scopus 로고
    • Refining the "presumptive illegality" approach to settlements of patent disputes involving reverse payments: A commentary on hovenkamp, janis & lemley
    • Thomas F. Cotter, Refining the "Presumptive Illegality" Approach to Settlements of Patent Disputes Involving Reverse Payments: A Commentary on Hovenkamp, Janis & Lemley, 87 MINN. L. REV. 1789, 1807, 1812 & n.92 (2003).
    • (2003) Minn. L. Rev , vol.87 , Issue.92
    • Cotter, T.F.1
  • 81
    • 84871788333 scopus 로고    scopus 로고
    • Are settlements of patent disputes illegal per se?
    • note
    • Roger D. Blair & Thomas F. Cotter, Are Settlements of Patent Disputes Illegal Per Se?, 47 ANTITRUST BULL. 491, 533-34 (2002) (reporting the views of just Professor Blair).
    • (2002) Antitrust Bull , vol.47
    • Blair, R.D.1    Cotter, T.F.2
  • 84
    • 84871757457 scopus 로고    scopus 로고
    • note
    • Much of their analysis actually addresses a different question: whether a reverse payment might be necessary for patent settlement without showing that settlement would actually be desirable. Our proof shows that although this is true, a reverse payment that exceeds litigation costs is necessary only for undesirable settlements.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.