Hostname: page-component-586b7cd67f-vdxz6 Total loading time: 0 Render date: 2024-11-29T03:38:40.811Z Has data issue: false hasContentIssue false

The Health of eBay

The Impact of eBay on the Future of TRIPS-Like Pharmaceutical, Compulsory Licenses in the United States

Published online by Cambridge University Press:  06 January 2021

Jack Brodsky*
Affiliation:
J.D. Candidate 2016, Boston University School of Law. B.A. in Political Science, University of Michigan, 2013.

Abstract

Image of the first page of this content. For PDF version, please use the ‘Save PDF’ preceeding this image.'
Type
Notes and Comments
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2015

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1 See Baker, Tom, Health Insurance, Risk, and Responsibility After the Patient Protection and Affordable Care Act, 159 U. Pa. L. Rev. 1577, 1578-79 (2011).Google Scholar

2 King v. Burwell, 135 S.Ct. 2480 (2015); Brown, Caroline, Peisch, Philip & Barker, Shruti, Even After King, the Affordable Care Act Continues to Fact Litigation, 23 Health Care Pol. Rep. (BNA) 1083 (July 13, 2015), https://www.cov.com/~/media/files/corporate/publications/2015/07/even_after_king_the_affordable_care_act_continues_to_face_litigation.pdf [https://perma.cc/6ZME-92FB]Google Scholar; see Robert Pear, Next Health Law Battle: Insurance Exchanges, N.Y. Times, July 8, 2012, at A14.

3 eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388, 391 (2006); see, e.g., Elrefaie, Engey, Injunctive Relief Post eBay and the Various Applications of the Four-Factor Test in Differing Technological Industries, 2 Hastings Sci. & Tech. L.J. 219, 227 (2010)Google Scholar; Iancu, Andrei & Nichols, W. Joss, Balancing the Four Factors in Permanent Injunction Decisions: A Review of Post-eBay Case Law, 89 J. Pat. & Trademark Off. Soc'y 395, 395 (2007).Google Scholar

4 See Elrefaie, supra note 3, at 227.

5 See Stern-Dombal, Charlene A., Tripping Over TRIPS: Is Compulsory Licensing Under eBay at Odds with U.S. Statutory Requirements and TRIPS?, 41 Suffolk U. L. Rev. 249, 260-61, 261n.99 (2007).Google Scholar

6 See Helfer, Laurence R., Regime Shifting: The TRIPs Agreement and New Dynamics of International Intellectual Property Lawmaking, 29 Yale J. Int'l L. 1, 2 (2004).Google Scholar

7 See id.

8 See Abbott, Frederick M., The Doha Declaration on the TRIPS Agreement and Public Health: Lighting a Dark Corner at the WTO, 5 J. Int'l Econ. L. 469, 470 (2002)CrossRefGoogle Scholar; Otten, Adrian & Wager, Hannu, Compliance with TRIPS: The Emerging World View, 29 Vand. J. Transnat'l L. 391, 394 (1996).Google Scholar

9 See Helfer, supra note 6, at 3-4.

10 Abbott, supra note 8, at 480.

11 Id. at 488.

12 World Trade Organization, Ministerial Declaration of 14 November 2001, WTO Doc. WT/MIN(01)/DEC/2 [hereinafter Doha Declaration]; Carlos M. Correa, World Health Organization, Implications of the Doha Declaration on the Trips Agreement and Public Health 14-15 (2002).

13 Doha Declaration, supra note 12.

14 See Lauroesch, Mark W., General Compulsory Patent Licensing in the United States: Good in Theory, But Not Necessary in Practice, 6 Santa Clara High Tech. L.J. 41, 41 (1990)Google Scholar (“Unlike a number of foreign countries, no ‘general’ compulsory licensing statute, applicable to all patents that have not been practiced or have been used for anticompetitive purposes, exists in this country.”).

15 Barnes, David W., The Incentives/Access Tradeoff, 9 Nw J. Tech. & Intell. Prop. 96, 96 (2010).Google Scholar

16 Id. at 96-98.

17 Sony Corp. v. Universal City Studios, Inc., 464 U.S. 417, 429 (1984).

18 Id.

19 Kaiser Aetna v. United States, 444 U.S. 164, 176 (1979); see Merrill, Thomas W., Property and the Right to Exclude, 77 Neb. L. Rev. 730, 730 (1998).Google Scholar

20 See Elrefaie, supra note 3, at 227.

21 35 U.S.C. § 283 (2012).

22 See Stern-Dombal, supra note 5, at 260, 261 n.99.

23 See id.; Cont'l Paper Bag Co. v. E. Paper Bag Co., 210 U.S. 405, 429-30 (1908).

24 See, e.g., eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388, 391 (2006); Amoco Prod. Co. v. Village of Gambell, 480 U.S. 531, 542 (1987); Weinberger v. Romero-Barcelo, 456 U.S. 305, 311-13 (1982); Stern-Dombal, supra note 5, at 253.

25 See Schoenhard, Paul M., Who Took My IP?—Defending the Availability of Injunctive Relief for Patent Owners, 16 Tex. Intell. Prop. L.J. 187, 202 (2008).Google Scholar

26 Julian-Arnold, Gianna, International Compulsory Licensing: The Rationales and the Reality, 33 IDEA 349, 349-50 (1993).Google Scholar

27 Compulsory Licensing of Pharmaceuticals and TRIPS, World Trade Org. (Sept. 2006), https://www.wto.org/english/tratop_e/trips_e/public_health_faq_e.htm [https://perma.cc/9Z3Z-ZRQ3].

28 See Stern-Dombal, supra note 5, at 260.

29 Abbott, supra note 8, at 480-81.

30 See Helfer, supra note 6, at 2-3.

31 Kaminski, Margot, The Origins and Potential Impact of the Anti-Counterfeiting Trade Agreement (ACTA), 34 Yale. J. Int'l L. 247, 248 (2009).Google Scholar

32 Helfer, supra note 6, at 2.

33 Carlos M. Correa, Intellectual Property Rights, the WTO and Developing Countries 1–4 (2000).

34 Id.

35 Id. at 5.

36 Id.

37 Abbott, supra note 8, at 470.

38 Id. at 473.

39 Id. at 470.

40 Id. at 471-73.

41 See Correa, supra note 12, at 15; Bonadio, Enrico, Compulsory Licensing of Patents: The Bayer/Natco Case, 10 Eur. Intell. Prop. Rev. 719, 722 (2012).Google Scholar

42 See Abbott, supra note 8, at 472-73 (establishing the fact that the cost of pharmaceuticals developed by patent holders far exceeds the marginal cost of production so as to recoup the developer for the risk-taking and costly research involved in development).

43 See id. at 473. Decreased prices are also attributable to existence of competition and the elimination of monopoly pricing, for example. Cf. Schoenhard, supra note 25, at 202 (discussing how monopoly pricing and the absence of competitors are consequences of the right to exclude).

44 Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, 1869 U.N.T.S. 299, art. 31 (1994) [hereinafter TRIPS Agreement]; Abbott, supra note 8, at 498.

45 TRIPS Agreement, at art. 31; Abbott, supra note 8, at 498.

46 Although the language refers to “Other Use Without Authorization of the Right Holder,” compulsory licenses fall into the “use without authorization” category and are thus subject to the restrictive conditions set forth in the Article. TRIPS Agreement, at art. 31; Bartelt, Sandra, Compulsory Licenses Pursuant to TRIPS Article 31 in the Light of the Doha Declaration on the TRIPS Agreement and Public Health, 6 J. World Intell. Prop. 283, 288 (2003).CrossRefGoogle Scholar

47 See Bartelt, supra note 46, at 296.

48 Id. (“Paragraph 6 of the Doha TRIPS Declaration recognizes that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement with regard to patented pharmaceuticals.”); Correa, supra note 12, at 20.

49 See Bonadio, supra note 41.

50 Correa, supra note 12, at i.

51 Id. at 5.

52 Id. at i.

53 Doha Declaration, supra note 12.

54 General Council, Amendment of the TRIPS Agreement, WTO Doc. L/641 (Dec. 6, 2005); General Council, Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, WTO Doc. L/540 (Aug. 30, 2003); Correa, supra note 12, at 19.

55 See Correa, supra note 12, at 19-20.

56 Id. at 9.

57 Id. at 7.

58 See Natco Pharma Ltd. v. Bayer Corp., (2012) Compulsory License Application No. 1 of 2011, Controller of Patents, Mumbai, http://ipindia.nic.in/ipoNew/compulsory_License_12032012.pdf [http://perma.cc/EL9V-5UG5].

59 Id. at 40-41.

60 Bonadio, supra note 41, at 722.

61 Patents Act, §83(f), India Code “General Principles Applicable to Working of Patented Inventions” (1970); Bonadio, supra note 41, at 722.

62 The Patents Act, §83(c) “General Principles Applicable to Working of Patented Inventions” (1970); Bonadio, supra note 41, at 722.

63 Bonadio, supra note 41, at 721; Natco Pharma Ltd. v. Bayer Corp., Compulsory License Application No. 1 of 2011, at 54.

64 Bonadio, supra note 41, at 721 (stating that in its argument, Natco attested that “an Indian public sector worker would have to work for three and a half years to be able to buy a single month's treatment at the above price”).

65 See id.; Natco Pharma Ltd. v. Bayer Corp., Compulsory License Application No. 1 of 2011, at 15; Vikas Bajaj & Andrew Pollack, India Orders Bayer to License a Patented Drug, N.Y. Times, Mar. 13, 2012, at B2.

66 Natco Pharma Ltd. v. Bayer Corp., Compulsory License Application No. 1 of 2011, at 20.

67 Id. at 36.

68 TRIPS Agreement, supra note 44, at art. 31.

69 Id at art. 31(b).

70 Doha Declaration, supra note 12; Abbott, supra note 8, at 498.

71 Natco Pharma Ltd. v. Bayer Corp., Compulsory License Application No. 1 of 2011, Controller of Patents, Mumbai, at 20-24.

72 Id. at 13 (comparing the demand of roughly 16,000 bottles of Sorafenib for liver cancer patients and 7120 bottles of Sorafenib for kidney cancer patients with the zero bottles Bayer imported in 2008, the 200 bottles imported in 2009, and the unknown number of bottles imported in 2010).

73 India Grants First Compulsory License to Generic Drug Producer, 16 Bridges (Mar. 14, 2012), http://www.ictsd.org/bridges-news/bridges/news/india-grants-first-compulsory-license-to-generic-drug-producer [http://perma.cc/5LLD-LV96].

74 Zolotaryova, Vera, Are We There Yet? Taking “TRIPS” to Brazil and Expanding Access to HIV/AIDS Medication, 33 Brook J. Int'l L. 1099, 1110 (2008).Google Scholar

75 Id. at 1110-11 (offering that in August of 2001, Roche, a Swiss pharmaceutical producer, agreed to a 40% price reduction for its AIDS drug Viracept after Brazil's government threatened to issue a compulsory license).

77 Taylor, Ed, Brazilian President Breaks Patent on Merck Anti-AIDS Drug Stocrin, 1 LSLR (BNA) 176, No. 5, May 11, 2007.Google Scholar

78 Id.

79 Zolotaryova, supra note 74, at 1110.

80 Id.

81 Id. at 1113-14.

82 Id. at 1112 & n.87, 1114 (“Brazil informed Merck that it would accept a price [that is] the same price offered to Thailand, namely $0.65 per tablet. However, the lowest price Merck offered to Brazil was $1.10 per tablet.”) (footnotes omitted).

83 Id. at 1115-17.

84 Id. at 1115 (proposing this argument as a potential response to Brazil's use of the compulsory license).

85 Taylor, supra note 77.

86 Zolotaryova, supra note 74, at 1124 (“Brazil's recent use of compulsory licensing calls into question the scope and meaning of the provision by asking whether a large middle-income country like Brazil, with a relatively low rate of infection, should be able to use the provision in order to import generic HIV/AIDS medication.”) (footnote omitted). As Brazil claimed in its argument in favor of a compulsory license for Efavirenz, the Brazilian government would save $30 million annually as a result of the efforts. Id. at 1118.

87 Cont'l Paper Bag Co. v. E. Paper Bag Co., 210 U.S. 405, 429 (1908).

88 See Schwartz, Herbert F., Injunctive Relief in Patent Infringement Suits, 112 U. Pa. L. Rev. 1025, 1029 (1964)CrossRefGoogle Scholar; Stern-Dombal, supra note 5, at 253 & n.41; see, e.g., Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1247 (Fed. Cir. 1989) (“It is the general rule that an injunction will issue when infringement has been adjudged, absent a sound reason for denying it.”).

89 eBay v. MercExchange, 547 U.S. 388, 395 (2006) (Roberts, J., concurring).

90 See Lim, Lily & Craven, Sarah E., Injunctions Enjoined; Remedies Restructured, 25 Santa Clara Computer & High Tech. L.J., 787, 790 (2009).Google Scholar

91 Id.

92 See eBay, 547 U.S. at 393-94; Lim & Craven, supra note 90, at 788-89.

93 eBay, 547 U.S. at 394; see Lim & Craven, supra note 90, at 788-89.

94 Hybritech v. Abbot Labs., No. CV 86-7461/AK (PX), 1987 WL 123997 (C.D. Cal. Jul. 14. 1987).

95 Id. at *20-*21.

96 City of Milwaukee v. Activated Sludge, Inc., 69 F.2d 577, 593 (7th Cir. 1934).

97 Vitamin Techs. v. Wis. Alumni Research Found., 146 F.2d 941, 946 (9th Cir. 1944).

98 Chao, Bernard H., After eBay, Inc v. MercExchange: The Changing Landscape for Patent Remedies, 9 Minn. J.L. Sci. & Tech. 543, 543 (2008)Google Scholar; Lim & Craven, supra note 90, at 791.

99 Lim & Craven, supra note 90, at 789.

100 See, e.g., eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388, 391 (2006); Amoco Production Co. v. Village of Gambell, 480 U.S. 531, 542 (1987); Weinberger v. Romero-Barcelo, 456 U.S. 305, 311-313 (1982); Stern-Dombal, supra note 5, at 253.

101 eBay Inc., 547 U.S. at 391.

102 See Lim & Craven, supra note 90, at 789.

103 Iancu & Nichols, supra note 3, at 396.

104 Lim & Craven, supra note 90, at 798 & n.75 (“Before eBay, courts granted patentees injunctions 95% of the time after finding infringement, while after eBay, this number has dipped to 72%”) (citing FTI Consulting analysis of relevant publicly available court cases).

105 Mulder, Jeremy, The Aftermath of eBay: Predicting When District Courts Will Grant Permanent Injunctions in Patent Cases, 22 Berkeley Tech. L.J. 67, 80-83 (2007).Google Scholar

106 Id. at 82.

107 Id.

108 Chao, supra note 98, at 554.

109 See id. at 555.

110 Iancu & Nichols, supra note 3, at 397.

111 Elrefaie, supra note 3, at 236.

112 Id.

113 eBay v. MercExchange, 547 U.S. 388, 396 (2006) (Kennedy, J., concurring).

114 Elrefaie, supra note 3, at 238.

115 Streur, Stacy, The eBay Effect: Tougher Standards but Courts Return to the Prior Practice of Granting Injunctions for Patent Infringement, 8 Nw. J. Tech & Intell. Prop. 67, 79-80 (2009).Google Scholar

116 Id. (calculating that from May 2006-April 2007, 29% of cases addressing injunctive relief resulted in a denial of injunction based on failure to demonstrate irreparable harm; from May 2007-April 2008, no decision denying injunction was justified on a showing of irreparable harm or no adequate remedy at law; and from May 2008-April 2009, 10% of cases addressing injunctive relief resulted in denial of injunction due to a lack of irreparable harm).

117 Advanced Cardiovascular Sys., Inc. v. Medtronic Vascular, Inc., 579 F. Supp. 2d 554, 561 (D. Del. 2008); Streur, supra note 115, at 85.

118 Iancu & Nichols, supra note 3, at 403.

119 Smith & Nephew, Inc. v. Synthes, (U.S.A.), 466 F. Supp. 2d 978, 985 (W.D. Tenn. 2006) (emphasis added).

120 See Elrefaie, supra note 3, at 238; Iancu & Nichols, supra note 3, at 402; see also Amgen, Inc. v. F. Hoffman-La Roche Ltd., 581 F. Supp. 2d 160, 210 (D. Mass. 2008); O2 Micro Int'l Ltd. v. Beyond Innovation Tech. Co., No. 2-04-CV-32, 2007 WL 869576, at *3 (E.D. Tex. Mar. 21, 2007).

121 See Chao, supra note 98, at 555; see, e.g., Advanced Cardiovascular Sys., Inc., 579 F. Supp. 2d at 561.

122 Mulder, supra note 105, at 83.

123 Rozek, Richard P. & Berkowitz, Ruth, The Effects of Patent Protection on the Prices of Pharmaceutical Products: Is Intellectual Property Protection Raising the Drug Bill in Developing Countries?, 1 J. World Intell. Prop. 179, 179 (1998).CrossRefGoogle Scholar

124 See Bale, Harvey E. Jr., Patent Protection and Pharmaceutical Innovation, 29 N.Y.U. J. Int'l L. & Pol. 95, 95-96 (1996-1997).Google Scholar

125 See Bartelt, supra note 46, at 289.

126 See Richard Tren, Free the Industry, Not the Drugs, Wall St. J. Eur. (July 11, 2002, 1:13 AM), http://www.wsj.com/articles/SB1026341408941203720 (“[T]hreatening compulsory licensing … will only act as [a] disincentive[] to the development and marketing of new drugs.”).

127 Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1247 (Fed. Cir. 1989) (“It is the general rule that an injunction will issue when infringement has been adjudged, absent a sound reason for denying it.”); Schwartz, supra note 88, at 1029; Stern-Dombal, supra note 5, at 253 & n.41.

128 See Chien, Colleen, Cheap Drugs at What Price to Innovation: Does the Compulsory Licensing of Pharmaceuticals Hurt Innovation, 18 Berkeley Tech. L.J. 853, 855-56 (2003)Google Scholar (stating that one of the key reasons underlying the infrequent use of compulsory licenses is the “fundamental assumption” that “compulsory licenses harm the incentive for innovation”); Rozek, Richard P., The Effects of Compulsory Licensing on Innovation and Access to Health Care, 3 J. World Intell. Prop. 889, 909 (2000)CrossRefGoogle Scholar (“In theory, compulsory licensing is an inefficient policy since it undermines the incentive to conduct R&D and tends to undervalue technology by replacing voluntary negotiation over licensing with forced sales of technologies.”); Vaughan, Susan Vastano, Compulsory Licensing of Pharmaceuticals Under TRIPS: What Standard of Compensation?, 25 Hastings Int'l & Comp. L. Rev. 87, 109 (2001)Google Scholar (“Absent the limited monopoly granted under a patent, it is unlikely that the millions of dollars and years of research would be available for the development of new drugs.”).

129 Chien, supra note 128, at 873.

130 Id. at 873-74; Gillat, Adi, Compulsory Licensing to Regulated Licensing: Effects on the Conflict Between Innovation and Access in the Pharmaceutical Industry, 58 Food & Drug L.J. 711, 723 (2003).Google ScholarPubMed

131 See Bale, supra note 124, at 95; Levin, Richard C. et al., Appropriating the Returns from Industrial Research and Development, 3 Brookings Papers on Econ. Activity 783, 796-98 (1987)CrossRefGoogle Scholar; Stanton, Jerry, Comment, Lesson for the United States from Foreign Pricing Controls on Pharmaceuticals, 16 Conn. J. Int'l L. 149, 155 (2000)Google Scholar (noting that the average R&D cost for pharmaceuticals is roughly $500 million with an added $359 million to bring the new drug to the market: less than one out of ten drugs successfully recoups these costs).

132 Gillat, supra note 130, at 725.

133 Chien, supra note 128, at 870.

134 See Yosick, Joseph A., Compulsory Patent Licensing for Efficient Use of Inventions, 2001 U. Ill. L. Rev. 1275, 1303 (2001).Google Scholar

135 Id. It is worth noting that this relationship between pricing and costs for research and development, and thus the level of compensation necessary to drive incentives, is highly contested, as many argue that drug prices are often significantly above what is necessary to recoup for the costs to produce the drug. See, e.g., Ana Swanson, Big Pharmaceutical Companies are Spending Far More on Marketing Than Research, Wash. Post (Feb. 11, 2015), http://www.washingtonpost.com/news/wonkblog/wp/2015/02/11/big-pharmaceutical-companies-are-spending-far-more-on-marketing-than-research/ [http://perma.cc/XQ34-9P6Q].

136 When the market in which a compulsory license is granted is a target market that the pharmaceutical manufacturer intends to recoup its expenses, the compulsory license may have a significant adverse effect on innovation. See Chien, supra note 128, at 873.

137 A drug's target market are those countries where a pharmaceutical company focuses its sales efforts and expects to obtain most of its profits. See id.

138 Id.

139 See Borowski, Samuel Mark, Comment, Saving Tomorrow from Today: Preserving Innovation in the Face of Compulsory Licensing, 36 Fla. St. U. L. Rev. 275, 284-85 (2009).Google Scholar

140 Gillat, supra note 130, at 724.

141 “Conversely, if the license covers a market that is unimportant to the licensor, or it covers a product that has yet to be proven or for which the market is immature or untested, there is a good chance that the licensee and licensor will not compete head to head. The significance of this license may be relatively low.” Chien, supra note 128, at 873.

142 See Gillat, supra note 130, at 723 (“The existence of barriers to competitive entry other than patent protection diminishes the dependency of the innovating entity on the exclusivity granted under a patent right.”).

143 Borowski, supra note 139, at 286 (“[P]harmaceuticals find little protection as a trade secret because they are easily imitated and require extensive disclosure prior to regulatory approval. They are also not subject to copyright, and trademark law offers only a limited amount of protection after a significant period of time on the market.”) (footnotes omitted).

144 Id. at 284; Gillat, supra note 130, at 723; see U.S. Food & Drug Admin., How Drugs are Developed and Approved, http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ [http://perma.cc/5T4X-ECCU] (last updated Aug. 18, 2015) (stating that because of the extensive disclosure requirements “[n]ew drugs, like other new products, are frequently under patent protection during development.”).

145 See Borowski, supra note 139, at 284.

146 See Chien, supra note 128, at 874 (“The licensor may choose to redirect R&D investment, put off inventive activity until the license has expired, or choose trade secret over patent protection.”).

147 F. M. Scherer, The Economic Effects of Compulsory Patent Licensing 69, 75 (Edwin J. Elton & Martin J. Gruber eds., 1977) (finding that in the short-term, the largely unpredictable licenses studied did not appear to impact behavior on the year studied); Chien, supra note 128, at 875.

148 Chien, supra note 128, at 873-74.

149 Id.

150 Vaughan, supra note 128, at 103; John LaMattina, Does Pharma Only Develop Drugs for Those Who Can Pay?, Forbes (Dec. 5, 2013, 8:18 AM), http://www.forbes.com/sites/johnlamattina/2013/12/05/does-pharma-only-develop-drugs-for-those-who-can-pay/.

151 Pharmaceutical Chief Tries to Stop India Replicating its Cancer Treatment, Daily Mail UK (Jan. 24, 2014, 9:43 EST), http://www.dailymail.co.uk/news/article-2545360/Pharmaceutical-chief-tries-stop-India-replicating-cancer-treatment.html.

152 See John LaMattina, India's Solution to Drug Costs: Ignore Patents and Control PricesExcept for Home Grown Drugs, Forbes (Apr. 8, 2013, 8:38 AM), http://www.forbes.com/sites/johnlamattina/2013/04/08/indias-solution-to-drug-costs-ignore-patents-and-control-prices-except-for-home-grown-drugs/ (noting that “70% of Indians pay for healthcare expenses out of their own pockets”); WORLD BANK, Out-of-Pocket Health Expenditure (% of Private Expenditure on Health), http://data.worldbank.org/indicator/SH.XPD.OOPC.ZS/countries [http://perma.cc/ZX25-GQ4R] (citing an 85.9% out of pocket expenditure in India in 2013).

153 See Rein, Judy, International Governance Through Trade Agreements: Patent Protection for Essential Medicines, 21 Nw. J. Int'l L. & Bus. 379, 404 (2001)Google Scholar (“Diseases suffered by populations with no purchasing power are not going to be addressed by commercial producers.”).

154 See Vaughan, supra note 128, at 100-07, 108 (“Because developing countries cannot pay the monopoly prices that pharmaceutical companies may charge for their patented inventions, these countries are not a part of pharmaceutical companies' market.”).

155 Chien, supra note 128, at 873.

156 See Vaughan, supra note 128, at 100-07 (comparing the appropriate meaning of “adequate remuneration” under Article 31(h) in developing nations and developed nations).

157 See Rein, supra 153, at 404-05; Vaughan, supra note 128, at 103, 103 n.132 (arguing that profits from the sale of pharmaceuticals in developing countries are inconsequential to pharmaceutical companies, so fair compensation for the grant of a compulsory license in a developing country should be minimal as compared to the appropriate compensation warranted for a compulsory license in a developed country).

158 See Vaughan, supra note 128, at 102 (arguing that granting compulsory licenses in developing countries does not generate any injury for pharmaceutical manufacturers, and thus compensation for lost profits is excessive).

159 See id.

160 Id. at 105 (quoting United States v. Reynolds, 397 U.S. 14, 16 (1970)).

161 Id.

162 Gillat, supra note 130, at 725.

163 See Vaughan, supra note 128, at 105.

164 Halajian, Dina, Inadequacy of TRIPS & the Compulsory License: Why Broad Compulsory Licensing Is Not A Viable Solution to the Access to Medicine Problem, 38 Brook. J. Int'l L. 1191, 1193 (2013).Google Scholar

165 About PHRMA, Pharmaceutical Res. & Manufacturers of America, http://www.phrma.org/ about [http://perma.cc/3758-K4Y9].

166 2015 Ranking of the Global Top 10 Biotech and Pharmaceutical Companies Based on Revenue (in Billion U.S. Dollars), Statista, http://www.statista.com/statistics/272717/top-global-biotech-and-pharmaceutical-companies-based-on-revenue/ [http://perma.cc/HG6Z-4XMD] (Johnson & Johnson, U.S., $74.3 billion; Novartis, Switzerland, $49.6 billion; Pfizer, U.S., $49.6 billion; Roche, Switzerland, $47.7 billion; Merck, U.S., $42.2 billion; Sanofi, France, $41.2 billion; GlaxoSmithKline, UK, $35.8 billion; AstraZeneca, UK, $24.7 billion; Abbott Laboratories, U.S. $20.2 billion; Amgen, U.S., $20.1 billion).

167 Global Pharmaceutical Sales from 2012 to 2014, by Region (in Billion U.S. Dollars), Statista, http://www.statista.com/statistics/272181/world-pharmaceutical-sales-by-region/ [http://perma.cc/9MYE-PBHM].

168 See Borowski, supra note 139, at 284 (“In the pharmaceutical industry, the patent preserves this incentive because after developing a new drug, patenting it provides a substantial reward that offsets the high costs of success.”).

169 Pharmaceuticals/Health Products, Opensecrets.org, http://www.opensecrets.org/lobby/indusclient.php?id=H04&year=2014 [http://perma.cc/F74T-Q3GZ] (PhRMA spending almost $17 million, Phizer almost $8.5 million, Johnson & Johnson almost $6 million, and Bayer just over $6 million).

170 Long, Clarisa, Patents and Cumulative Innovation, 2 Wash. U. J.L. & Pol'y 229, 230-31 (2000).Google Scholar

171 See Kremer, Michael, Pharmaceuticals and the Developing World, 16 J. Econ. Persp., 67, 74 (2002).CrossRefGoogle ScholarPubMed

172 See id. at 74-75.

173 Chien, supra note 128, at 862.

174 Yosick, supra note 134, at 1292.

175 See Bonadio, supra note 41, at 727.

176 Khan, Kishore, Striking a Balance in Compulsory License Legislation, 5 Geo. Mason J. Int'l Com. L. 221, 250 (2014).Google Scholar

177 See id.

178 See id. at 251.

179 Id. at 257-58 (noting that negotiations can result in control over the distribution so as to not disrupt pricing in other markets, reputational advantages in the form of goodwill by engaging in voluntary licensing rather than a compulsory licensing, and mutually beneficial pricing).

180 See, e.g., H.R. 1708, 107th Cong. (2001).

181 Id. at § 158(a).

182 Id. at § 158(b).

183 See Bonadio, supra note 41, at 727.

184 Id.

185 Id.

186 Id. (“It is believed that this solution is efficient, as the patentee is in a privileged position to supply rapidly the goods covered by its patent, e.g. it might have large stocks ready to be distributed.”).

187 Chien, supra note 128, at 860-61; see Bonadio, supra note 41, at 727-28.