1 Ryan, Michael P., Knowledge Diplomacy: Global Competition and the Politics of Intellectual Property 110 (Brookings Institution Press 1998)Google Scholar; Drahos, Peter with John Braithwaite, Information Feudalism: Who Owns the Knowledge Economy? 160 (The New Press 2002)Google Scholar; Matthews, Duncan, Globalising Intellectual Property Rights: The Trips Agreement (Higgott, Richard ed., Routledge 2002)Google Scholar; Sell, Susan K., Private Power, Public Law: the Globalization of Intellectual Property Rights 146 (Smith, Steve ed., Cambridge University Press 2003)CrossRefGoogle Scholar.

2 Global Intellectual Property Rights: Knowledge Access and Development (Peter Drahos & Ruth Mayne eds., 2002); Odell, John S. & Sell, Susan K., Reframing the Issue: The WTO Coalition on Intellectual Property and Public Health, 2001, in Negotiating Trade: Developing Countries in the WTO and NAFTA 85 (Odell, John S. ed., 2006)Google Scholar.

3 For an overview, see Negotiating Health: Intellectual Property And Access To Medicines (Pedro Roffe, Geoff Tansey and David Vivas-Eugui eds., 2006).

4 Sisule F. Musungu et al., Utilizing TRIPS Flexibilities for Public Health Protection Through South-South Regional Frameworks (2004), http://www.who.int/medicinedocs/collect/medicinedocs/pdf.s4968e/s4968e.pdf.

5 For an overview, see Abbott, Frederick M., The Cycle of Action and Reaction: Developments and Trends in Intellectual Property and Health, in Negotiating Health: Intellectual Property and Access to Medicines, 27 (Roffe, Pedro et al. eds., 2006)Google Scholar.

6 Such structural approaches tend to rely on treaties. See, e.g., Hubbard, Tim & Love, James, A New Trade Framework for Global Healthcare R&D, 2 PloS Biology 147 (2004)Google Scholar.

7 See, e.g., Outterson, Kevin, Patent Buy-Outs for Global Disease Innovations for Low- and Middle-Income Countries, 32 Am. J.L. & Med. 159 (2006)Google Scholar.

8 Based on US and European figures it seems that between and 1–2% of patents will be litigated. The opposition rate at the EPO for 1981–1998 was 8.3%. See Graham, Stuart J. H. et al., Patent Quality Control: A Comparison of U.S. Patent Re-examinations and European Patent Oppositions, in Patents in the Knowledge-Based economy, 74, 89–91 (Cohen, Wesley M. & Merrill, Stephen A. eds., 2001)Google Scholar.

9 Patenting in the drugs and medical area is one of the big winners in terms of numbers of patents granted. By the end of the 1990s, this area accounted for 10% of all patents granted in the US. See Hall, Bronwyn et al., The NBER Patent Citation Data File: Lessons, Insights and Methodological Tools, 13 (Nat’l Bureau of Econ. Research, Working Paper No. 8498, 2001)CrossRefGoogle Scholar, http://papers.nber.org/papers/w8498.pdf.

10 The EPO describes each year's technical assistance in its annual reports. European Patent Office Annual Reports, http://www.epo.org/about-us/publications/generalinformation/annual-reports.html. (last visited March 11, 2008).

11 The Japanese Patent Office website describes an extensive technical assistance program. Intellectual Property Cooperation in The Asia-Pacific Region, http://www.jpo.go.jp/torikumi_e/kokusai_e/asia_ip_e/apip_tope.htm (last visited March 15, 2008).

12 The USPTO lists its technical assistance in its annual reports. See USPTO Annual Reports, http://www.uspto.gov/web/offices/com/annual/index.html.

13 See infra Part II.

14 See Lanjouw, Jean O., A New Global Patent Regime For Diseases: U.S. and International Legal Issues, 16 Harv. J.L. & Tech. 85, 88–89 (2002)Google Scholar; Kettler, Hannah E., Using Intellectual Property Regimes to Meet Global Health R&D Needs, 5 J. World Intell. Prop. 655, 656-59 (2002)Google Scholar.

15 Utton, Michael A., Market Dominance and Antitrust Policy 29–30 (Edward Elgar Publishing Ltd. 2003)CrossRefGoogle Scholar.

16 Studies reveal a high degree of market concentration in the markets of major therapeutic categories, suggesting little or no drug substitutability. See Schwartzman, David, Innovation in the Pharmaceutical Industry 108–112 (Johns Hopkins University Press 1976)Google Scholar. Vernon's study of 18 therapeutic markets suggests that a relatively small number of companies dominate sales in the individual therapeutic markets. See Vernon, John M. Concentration, Promotion, and Market Share Stability in the Pharmaceutical Industry, 19 J. Indus. Econ., 249, 249-54 (1971)Google Scholar.

17 For concerns about the quality of the work of the USPTO see King, John L., Patent Examination Procedures and Patent Quality, in Patents in the Knowledge-Based Economy 54 (Cohen, Wesley M. & Merrill, Stephen A. eds., 2001)Google Scholar. Within the EPO itself, there are considerable doubts about the quality of its work. See Staff Union of the European Patent Office, Quality of Examination at the EPO (2004), http://www.suepo.org/public/zb0404e.pdf. National patent offices in Europe have suggested that improving patent quality through the introduction of a European Quality Management System is a key priority. See European Patent Office, Dutch Paper on the Strategy Debate 1-2 (2006), http://ac.european-patent-office.org/strategy_debate/documentation/pdf/ec06068.pdf.

18 Drahos, Peter, Developing Countries and International Intellectual Property Standard-Setting, 5 J. World Intell. Prop. 765, 765 (2002)Google Scholar.

19 For example, the Trilateral Offices accounted for approximately 57% of total number of patents granted worldwide in 2004. The Trilateral Co-operation, Trilateral Statistical Report: 2004 Edition 3 (2004), http://www.trilateral.net/tsr/tsr_2004/tsr2004.pdf. For USPTO and JPO statistics, see The Website of the Trilateral Co-operation, Trilateral Statisitcal Reports, http://www.trilateral.net/tsr/ (last visited March 16, 2008). For EPO statistics, see European Patent Organisation, Statistics, http://www.epo.org/about-us/office/annual-reports/2004/statistics.html. (last visited March 15, 2008). For patents granted worldwide, see World Intellectual Property Organization, WIPO Patent Report: Statistics on Worldwide Patent Activities 12 (2007), http://www.wipo.int/export/sites/www/freepublications/en/patents/931/wipo_pub_931.pdf. For the historical background of the Trilateral Offices, see The Website of the Trilateral Co-operation, Historical Background, http://www.trilateral.net/background/ (last visited March 16, 2008).

20 See The Trilateral Co-operation, Trilateral Statistical Report: 2005 Edition 5 (2005), http://www.trilateral.net/tsr/tsr_2005/.

21 The Trilateral Offices held their first annual conference in 1983. See The Website of the Trilateral Co-operation, Historical Timeline, http://www.trilateral.net/background/timeline/.

22 See The Website of the Trilateral Co-operation, Most Significant Achievements, http://www.trilateral.net/background/achievements/.

23 See European Patent Office, IP and International Relations, http://www.epo.org/aboutus/office/annual-reports/2005/business-report/international-relations.html.num;trilat.

24 For a description of the EPO's links with the Chinese Patent Office for 2006 see European Patent Office, 2006 Annual Report 45, http://www.epo.org/about-us/office/annualreports/2006.html.

25 The European Patent Office, Annual Report(s) include information on expenditure on travel, meetings and technical co-operation. For example in 1990 it was 6 million DEM (German Mark) and in 1997 it was 16.6 DEM. See European Patent Office, 1990 Annual Report 28 (1991); European Patent Office, 1997 Annual Report 48 (1998).

26 A discussion paper that shows how the Trilaterals identify differences and work towards common ground is the paper written by the EPO as part of the Trilateral Working Group. Substantive Harmonization of Patent Law (SPLT) The European Perspective (2003), http://www.aipla.org/Content/ContentGroups/Meetings_and_Events1/International_Symposia1/EPOTrilateral.pdf.

27 Work on substantive patent law harmonization is being carried out by WIPO's Standing Committee on the Law of Patents. See World Intellectual Property Organization, Substantive Patent Law Harmonization, http://www.wipo.int/patent-law/en/harmonization.htm.

28 European Patent Office, 1989 Annual Report 36 (1990).

29 Id.

30 On this politics see Sell, supra note 1, at 173-79.

31 Bogsch, Arpad, Brief History of the First 25 Years of the World Intellectual Property Organization 36 (World Intellectual Property Organization 1996) (1992)Google Scholar.

32 This includes representation from UNICE, Japan Intellectual Property Association, Intellectual Property Owners Association, and American Intellectual Property Law Association. See Intellectual Property Owners Association, Industry Trilateral Report: Global Patent Application 1 (2006), http://www.ipo.org/AM/Template.cfm?Section=Home&TEMPLATE=/CM/ContentDisplay.cfm&CONTENTID=9075.

33 Id. at 1.

34 See European Patent Office, 2006 Annual Report 45 (2007).

35 In its 1997 EPO Annual Report at p.48 the figures for these categories are given in millions of DEM as 323.2, 426.4 and 282.5. European Patent Office, 1997 Annual Report 48. In 2006 the EPO reported that its revenue from patent and procedural fees was 982,011,000 euro. European Patent Office, 2006 Annual Report, http://www.epo.org/aboutus/office/annual-reports/2006/financial-report.html.num;2.

36 In 1997 this was 687 million DEM of a total budget of 1173.4 million DEM. See European Patent Office, 1997 Annual Report 48.

37 See Ullrich, Hanns, Patent Protection in Europe: Integrating Europe into the Community or the Community into Europe? 8 Eur. L. J. 433, 443 (2002)Google Scholar.

38 European Patent Office, 1989 Annual Report 21 (1990).

39 See id. at 45.

40 The EPO began accepting patent applications in 1978.

41 European Patent Office, 1996 Annual Report 64 (1997).

42 See id. at 55-56.

43 See, e.g., European Patent Office, 1997 Annual Report (1998) at 41 (describing activities with the African Regional Intellectual Property Office and the Brazilian Patent Office), European Patent Office, 2006 Annual Report (2007) at 46 (describing technical support activities with these offices).

44 Interview in Malaysian Patent Office, in Kuala Lumpar, Malay. (Aug. 30, 2005).

45 Interview at National Office of Industrial Property, in Hanoi, Vietnam (June 3, 2004).

46 Interview in the Thai Patent Office, Department of Intellectual Property, Ministry of Commerce, in Bangkok, Thail. (June 5, 2006).

47 European Patent Office, 1996 Annual Report 56 (1997).

48 For more details see Hardin, Russell, Trust in Government, in Trust and Governance 9, 12–13 (Braithwaite, Valerie & Levi, Margaret eds., 1998)Google Scholar.

49 The European Commission takes this view of the patent institution. See Green Paper on the Community Patent and the Patent System in Europe, at 3, COM (1997) 314 final (June 24, 1997); Promoting Innovation Through Patents: The Follow-Up to the Green Paper on the Community Patent and the Patent System in Europe, at 8, COM (1999) 42 final (Feb. 5, 1999).

50 There were, for example, real tensions between the US and Japan over the way in which Japan administered its patent law during the 1980s. See Helfand, Michael Todd, How Valid are U.S. Criticisms of the Japanese Patent System?, 15 Hastings Comm. & Ent. L.J. 123, 125 (1992)Google Scholar.

51 The importance of automating its systems is a regular item in the EPO's annual reports. See European Patent Office, 1989 Annual Report 26 (1990), European Patent Office, 1997 Annual Report 25 (1998). Online filing is increasingly becoming the norm. The online filing of PCT applications at the EPO rose to 50% in 2006. See European Patent Office, 2006 Annual Report 16 (2007).

52 European Patent Office, 1996 Annual Report 37 (1997).

53 Id.

54 Interview with Michael Dela Cruel (President of PCPI), Ed Ocampo, Marilou Buensucesco, Esther E. Velarde, Philippine Chamber of Pharmaceutical Industry, in Manila, Phil. (May 6, 2004).

55 Interview at the Department of Intellectual Property, in Vientiane, Laos (May 12, 2004).

56 Interview in the Sub-Directorate of Patent Administration and Technical Services, in Jakarta, Indon. (Jan. 24, 2006).

57 Id.

58 European Patent Office, 1996 Annual Report 10 (1997).

59 Id.

60 For those for whom seeing is believing, see the photo of some of this shelving in the European Patent Office, 1989 Annual Report 40–41 (1990).

61 A description of the EPO's activities in Vietnam is available in the European Patent Office, 1996 Annual Report 56 (1997) and in the European Patent Office, 1997 Annual Report 41 (1998).

62 Interview, National Office of Industrial Property, Hanoi, Vietnam, supra note 45.

63 This decision tree was explained to the author during the course of the interview. Id.

64 For an overview of the issues see Maskus, Keith E. & Reichman, Jerome H., Globalization of Private Knowledge Goods and the Privatization of Global Public Goods, in International Public Goods and Transfer of Technology Under a Globalized Intellectual Property Regime 3 (Maskus, Keith E. & Reichman, Jerome H. eds., 2005)Google Scholar. See also Commission on Intellectual Property Rights, Integrating Intellectual Property Rights and Development Policy (2002), http://www.iprcommission.org/papers/pdf./final_report/CIPRfullfinal.pdf.

65 See European Patent Office, 1995 Annual Report 62 (1996). This figure excludes Vietnam. Id.

66 Id.

67 Id.

68 On the rent transfer from developing to developed countries as a result of TRIPS see Michael Finger, J., The Doha Agenda and Development: A View from the Uruguay Round 12 (Asian Development Bank, ERD Working Paper No. 21, Sept. 2002)Google Scholar.

69 See Cheek, Marney L., The Limits of Informal Regulatory Cooperation in International Affairs: A Review of the Global Intellectual Property Regime, 33 Geo. Wash. Int'l L. Rev. 277, 315 (2001)Google Scholar.

70 For an overview, see Atkinson, Michael M. & Coleman, William D., Strong States and Weak States: Sectoral Policy Networks in Advanced Capitalist Economies, 19 Brit. J. Pol. Sci. 47 (1989)Google Scholar.

71 This is the case for example in the free trade negotiations that Malaysia is having with the US and Australia. Interview in Malaysian Patent Office, in Kuala Lumpar, Malay., supra note 44.

72 See Abbott, Frederick M., The WTO Medicines Decision: World Pharmaceutical Trade and the Protection of Public Health, 99 Am. J. Int’l L, 317, 349–354 (2005)Google Scholar.

73 See supra Fig. 1 and the discussion in Section 2.

74 See supra Section 2 and accompanying notes.

75 In most developing countries, the number of patent applications and grants to nonresidents exceeds the number of patent applications and grants to residents. The World Intellectual Property Organization keeps these statistics. See World Intellectual Property Organization, Patent Grant by Office Table, http://www.wipo.int/ipstats/en/statistics/patents/source/wipo_pat_grant_by_office_table.csv. Unfortunately, WIPO does not have statistics on the proportion of patents that are granted to non-residents in developing countries that are foreign multinational companies.

76 A country that demonstrates this is Vietnam. See Figure 2.

77 The direct connection between the reduction in patent fees and a rise in patenting is rarely commented upon. For an exception see Klaus Boehm with Aubrey Silbertson, The British Patent System 37 (vol. 1 1967).

78 Thompson, Dennis, The Draft Convention For A European Patent, 22 Int’l & Comp. L.Q. 51, 62 (1973)Google Scholar.

79 European Patent Office, 1996 Annual Report 15 (1997).

80 JPO reported 408,674 for 2006. 2006 Japan Patent Office Annual Report 6 (2007), http://www.jpo.go.jp/shiryou_e/toukei_e/report_a_r_e.htm.

81 At the USPTO, the Office of Initial Patent Examination (OIPE) received over 417,000 patent applications. See United States Patent and Trademark Office, 2006 Performance and Accountability Report, http://www.uspto.gov/web/offices/com/annual/2006/3020100_patentperfrm.html.

82 European Patent Office, Strategy Debate Documentation, http://www.epo.org/aboutus/epo/consultation-processes/strategy-debate.html. (last visited Apr. 29, 2008).

83 See German, Danish & Dutch Delegation, Notes on the patenting situation in Europe, CA/92/05, at 2 (May 18, 2005).

84 Id. at 3.

85 See Netherland Delegation, Dutch paper on the strategy debate, CA/68/06, at 5-7, (Feb. 15, 2006).

86 See Staff Union of the European Patent Office, Position Paper, Quality of Examination at the EPO 5 (May 2004).

87 A comprehensive analysis of the EPO's workload problems is to be found in President of the European Patent Office, Mastering the workload, CA/132/02, at 43-50 (Oct. 8, 2002). In the USPTO, first action pendency for 2006 was 22.6 months. See United States Patent and Trademark Office, 2006 Performance and Accountability Report, http://www.uspto.gov/web/offices/com/annual/2006/3020100_patentperfrm.html.

88 See supra note 9.

89 The EPO, JPO and the USPTO are all International Search Authorities for the purposes of the PCT. See World Intellectual Property Organization, Quality Reports, 2006, http://www.wipo.int/pct/en/quality/authorities.html.

90 Id.

91 See Susan Farquhar, A Regional International Property Rights Office for the South Pacific: Cost-Benefit Analysis, Pacific Studies Series, Toward a New Pacific Regionalism 22 (Asian Dev. Bank – Commonwealth Secretariat vol. 3, Working Paper 16, n.d.).

92 See id. at 20.

93 Designation in a PCT application of all states that are members of the PCT is now automatic. World Intellectual Property Organization, Regulations Under the Patent Cooperation Treaty, Rule 4.9(a)(i), June 19, 1970 (last revised Oct. 3, 2006), available at http://www.wipo.int/pct/en/texts/index.htm.

94 Information provided by IP Australia.

95 See UK Intellectual Property Office, Kiribati, http://www.ipo.gov.uk/abroad/abroadextend/abroad-extend-kiribati.htm.

96 His Majesty's Stationary Office, Report of the Department Committee on the Patents and Designs Acts and Practice of the Patent Office 71 (1931).

97 For the full list see European Patent Office, Official J. EPO, March 2004, at 179.

98 See AusAID, Commonwealth of Australia, Final Report of HIV Epidemiological Modelling and Impact Study, Impacts of HIV/AIDS 2005–2025 in Papua New Guinea, Indonesia and East Timor (2006).

99 Didanosine (ddl) is important in second line treatment. See Medecins Sans Frontieres, Untangling the web of price reductions: a pricing guide for the purchase of ARVs for developing countries, 15 (9th ed., 2006), http://www.accessmed-msf.org.

100 Thailand's experience with the ddl patent is described in ASEAN Secretariat, Regional Report: The ASEAN-Rockefeller Foundation Project on Intellectual Property Laws Review and Capacity Building on Intellectual Property Rights Related to Public Health in the ASEAN Region 267–71 (2005).

101 Id.

102 Id.

103 Id.

104 Id. at 270.

105 Luhmann, Niklas, A Sociological Theory of Law (Elizabeth King & Martin Albrow trans., Routledge & Kegan Paul 1985)Google Scholar.

106 For an overview see Scott, Colin, Regulation in the Age of Governance: The Rise of the Post-Regulatory State, in The Politics of Regulation: Institutions and Regulatory Reforms for the Age of Governance 145, 151–54 (Jordana, Jacint & Levi-Faur, David eds., 2004)Google Scholar.

107 Drahos, Peter & Parker, Stephen, Rule Following, Rule Scepticism and Indeterminacy in Law: A Conventional Account, 5 Ratio Juris. 109, 116 (1992)Google Scholar.

108 On the application of the theory to law see, e.g., Hugh Collins, Regulating Contracts, (1999); Regulating Law (Christine Parker et al. eds., 2004).

109 For details as to how the patent community operates in an isolated fashion see Drahos, Peter, Biotechnology Patents, Markets and Morality, 21 Eur. Intell. Prop. L. R. 441 (1999)Google Scholar.

110 As an aside, it should be said that systems thinking is not especially optimistic about regulatory interventions. For the reasons why see Gunther Teubner, Juridification: Concepts, Aspects, Limits, Solutions, in Juridification of Social Spheres: A Comparative Analysis of the Areas of Labor, Corporate, Antitrust and Social Welfare Law 3–48 (Gunther Teubner ed., 1987).

111 States have much less discretion when it comes to choosing standards of patent protection because of international agreements. See Braithwaite, John & Drahos, Peter, Global Business Regulation (Cambridge University Press 2000)CrossRefGoogle Scholar.

112 Work undertaken for the ASEAN Secretariat and reported in Regional Report. See ASEAN Secretariat, supra note 100.

113 On the complexities of patent litigation and its costs in the US see Bessen, James & Meurer, Michael J., Lessons for Patent Policy from Empirical Research on Patent Litigation, in 2 Intellectual Property and Information Wealth 199 (Yu, Peter K. ed., 2007)Google Scholar.

114 Interview in the Sub-Directorate of Patent Administration and Technical Services in Jakarta, Indon., supra note 56.

115 Interview with Michael Dela Cruel (President of PCPI), Ed Ocampo, Marilou Buensucesco, Esther E. Velarde, Philippine Chamber of Pharmaceutical Industry in Manila, Phil., supra note 54.

116 Interview with Malaysian generic firms (Kotra Industries, Pharmaniaga, AHealth Properties, Braun, Y.S.P. Industries, and Hovid) in Kuala Lumpur, Malay. (Aug. 30, 2004).

117 The measure was consolidated in Article 229-C of the Law 10.196/01. It reads as follows: “229-C The allowance of patents to pharmaceutical products and processes will depend upon previous consent of the Brazilian Sanitary Surveillance Agency – ANVISA.” Brazilian Industrial Property Law, Art. 229-C, Law 10.196/01, Dec. 15, 1999.

118 Letter from Ms Ana Paula Jucá Silva, ANVISA, to Lu Guoliang (on file with author).

119 Id.

120 Other countries in South America are studying the Brazilian model. E-mail from Ana Paula Jucá Silva, ANVISA (July 11, 2007).

121 This has led to complaints in a number of countries about the problem of evergreening. See, e.g., Edward Hore, Patently Absurd: Evergreening of pharmaceutical patent protection under the Patented Medicines (Notice of Compliance) Regulations of Canada's Patent Act (2004), http://www.canadiangenerics.ca/en/issues/patently_absurd_04.pdf. Somogyi, A. et al., Inside the Isomers: The Tale of Chiral Switches, 27 Austl. Prescriber 24 (2004)Google Scholar; Kesselheim, Aaron S., Intellectual Property Policy in the Pharmaceutical Sciences: The Effect of Inappropriate Patents and Market Exclusivity Extensions on the Health Care System, 9 The AAPS J. L. E306 (2007)CrossRefGoogle Scholar.

122 I am indebted to Professor Peter Yu who pointed out these two problems to me in a discussion of this paper at the American Journal of Law & Medicine's Symposium Conference held at Boston University School of Law on February 2, 2008. I also thank him for the discussion over the coffee break that helped lead me to the solutions suggested above.

123 In the words of the US Court of Appeals for the Federal Circuit, the “whole purpose of a patent specification is to disclose one's invention to the public. It is the quid pro quo for the grant of the period of exclusivity.” LizardTech, Inc. v. Earth Res. Mapping, Inc., 433 F.3d 1373, 1375 (Fed. Cir. 2006).

124 See World Intellectual Property Organization, IPC/R 1/99 Rev. 1 Annex 10, 1-2 (1999), http://www.wipo.int/edocs/mdocs/classifications/en/ipc_ref_2/ipc_r_1_99_rev_1.pdf.

125 Lokuge, Buddhima et al., Pandemics, Antiviral Stockpiles and Biosecurity in Australia: What about the Generic Option?, 184 Med. J. Austl. 16, 20 (2006)Google Scholar.

126 For a philosophical defence of simple rules for dealing with complexity see Epstein, Richard A., Simple Rules for a Complex World (Harvard University Press 1995)Google Scholar.

127 Agreement on Trade-Related Aspects of Intellectual Property Rights, art. 27(a), effective January 1, 1995, 1869 U.N.T.S. 311

128 See Federal Trade Commission, Generic Drug Entry Prior to Patent Expiration iii-iv (2002), http://www.ftc.gov/os/2002/07/genericdrugstudy.pdf.

129 See id. at 16.

130 See generally Suzanne Scotchmer, Patent Quality, Patent Design, and Patent Politics (2004), http://socrates.berkeley.edu/scotch/Scotchmer_epo.pdf.

131 For the suggestion that companies in the US do not need the notice function of the Orange Book because of private search techniques see Federal Trade Commission, supra note 128, at 54.