July-December 2019
ISSN 2516-1210 (Print), 2515-9887 (Online)
Moral and economic dilemmas are often caused by the patent system as new drugs enter the market. This is because patents are mostly centred on economic profit, regardless of the possible negative consequences on public health.(fn) Some of the consequences include the difficulty for the less economically-advantaged classes to access particular drugs(fn) and that a drug is often isolated from competition as a result of a 20-year mandated monopoly. Competition would contribute to a proliferation of medical products and, therefore, reduce the holistic medication price.(fn) Access to effective and affordable medicines is regarded as a prerequisite for global public health. At the same time, the pharmaceutical industries deserved remuneration for the product and its value which they produce. The current system is flawed and must be restructured.
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1. The Agreement on Trade-related Aspects of Intellectual property Rights 1994 (TRIPS) Article 27(1).
2. Lionel Bently & Brad Sherman, *Intellectual Property Law* (Oxford, Oxford University Press 2014) 357.
3. TRIPS Article 33.
4. Bently & Sherman (n 2) 375.
5. Valbona Muzaka, ‘Prizes for Pharmaceuticals? Mitigating the Social ineffectiveness of the current Pharmaceutical Patent Arrangement’ (2013) 34(1) *Third World Quarterly* 151.
6. Rory Horner, ‘The Impact of Patents on Innovation, Technology Transfer and Health: A Pre- and Post-Trips Analysis of India’s Pharmaceutical Industry’ (2014) 19(3) *New Political Economy* 384, 399.
7. Muzaka (n 6) 154.
8. Bently & Sherman (n 2) 379.
9. Ibid 379.
10. TRIPS Article 27(2).
11. Reaches nine years, Alan Devlin, ‘Systemic Bias in Patent Law’ (2012) 61 *DePaul Law Review* 57, 67.
12. Ibid 59.
13. Richard Hosmer Blum, *Pharmaceuticals and Health Policy* (New York: Holmes & Meier Publishers 1981) 63.
14. Elias Mossialos; Monique Mrazek & Tom Maidenhead, *Regulating Pharmaceuticals in Europe: Striving for Efficiency, Equity and Quality* (Berkshire: Open University Press 2004) 354.
15. Jay Mattappally, ‘Goliath Beats David: Undoing the Leahy-Smith America Invents Act’s Harmful Effects on Small Businesses Comment’ (2012) 58 *Loyola Law Review* 981, 1013.
16. United States Code 2000 Title 35 para 251.
17. Charlie Lisherness, ‘Patent Reissue Genus Claims: Harmful Evolution’ (2003) 26 *Thomas Jefferson Law Review* 85, 86 & 98.
18. Mattappally (n 19) 1021.
19. Ibid 1021.
20. America Invents Act (2011) Sec. 5(a) para 273.
21. Mattappally (n 19) 1023-1024.
22. Dong-Churl Suh; Willard Manning; Stephen Schondelmeyer & Ronald Hadsall, ‘‘Effect of Multiple-Source Entry on Price Competition after Patent Expiration in the Pharmaceutical Industry’’ (2000) 35(2) *Health Services Research* 529, 533.
23. Srividhya Ragavan, *Patent and Trade Disparities in Developing Countries* (Oxford: Oxford University Press 2012) 197-198
24. Ibid 197-198.
25. Ibid 197-198.
26. World Health Organization, ‘Update 61 – WHO extends its SARS related travel advice to all of Taiwan province, China’’ (21 May 2003) <http://www.who.int/csr/don/2003_05_21a/en/> accessed 20 April 2016
27. Ragavan (n 28) 197-198.
28. Avert, ‘‘HIV And AIDS in South Africa’ (2017) <https://www.avert.org/professionals/hiv-around-world/sub-saharan-africa/south-africa> accessed 20 April 2016
29. Ragavan (n 28) 197-198.
30. Ragavan (n 28) 193-194.
31. Arman Kirim, ‘Reconsidering Patents and Economic Development: A Case Study of the Turkish Pharmaceutical Industry’ (1985) 13(2) *World Development* 219, 221.
32. Ibid 221.
33. Ibid 221.
34. StopFakes, ‘What is a Patent?’ (7 July 2016) <http://www.stopfakes.gov/learn-about-ip/patents/about> accessed 12 December 2015.
35. Janice Mueller, ‘Taking TRIPS to India — Novartis, Patent Law, and Access to Medicines’ (2007) 356(6) *The New England Journal of Medicine* 541, 543.
36. KSR International Co. v Teleflex Inc. (2007) 550 US 398 (US Supreme Court)
37. Laura Pedraza-Farina, ‘Patent Law and the Sociology of Innovation’ (2013) 2 *Wisconsin Law Review* 813, 815-818.
38. Ibid 817.
39. Blum (n 17) 192.
40. World Health Organization, ‘Schistosomiasis: WHO reports substantial treatment progress for school-age Children’ (8 December 2017) <http://www.who.int/neglected_diseases/news/WHO_schistosomiasis_reports_substantial_treatment_progress_sac/en/> accessed 18 April 2018.
41. NHS, Schistosomiasis (bilharzia) <https://www.nhs.uk/conditions/schistosomiasis/> accessed 18 April 2018.
42. World Health Organization, (n 44).
43. Antara Dutta, ‘From Free Entry to Patent Protection: Welfare Implications ing 2008) 163.
44. Doha Declaration on the TRIPS Agreement and Public Health 2001 (Doha Declaration) para 5(b) & (c).
45. Doha Declaration, para 6.
46. Bently & Sherman (n 2) 379.
47. Morten Tvedt, ‘One Worldwide Patent System: What’s in it for Developing Countries?’ (2010) 31(2) *Third World Quarterly* 277, 281.
48. Ibid 280 & 288.
49. Muzaka (n 6) 156.
50. Ragavan (n 28) 36.
51. Ibid 36.
52. Ibid 195.
53. Ibid.
54. International Covenant on Civil and Political Rights (1966) Article 6. It also mentions that the right to life should not be arbitrarily deprived. See also: The International Covenant on Economic, Social and Cultural Rights (ICESCR) (1966) Article 12.
55. The Action Programme on Essential Drugs (1979) Article 2(1).
56. Phoebe Li, *Health Technologies and International Intellectual Property* (London: Routledge 2014) 22.
57. World Health Organization, ‘Saving Lives through the Promotion of Quality Medicines’ <http://www.who.int/medicines/services/expertcommittees/pharmprep/qual_med_promo_save-lives/en/> accessed 13 December 2016.
58. Johanna Gibson, *Patenting Lives: Life Patents, Culture and Development* (Cornwall: TJ international 2008) 65-66.
59. The Universal Declaration of Human Rights (UDHR) (1948) Article 27(2).
60. UDHR Article 25(1).
61. Gibson (n 68) 65-66.
62. Ibid.
63. UN Declaration on the Rights of Indigenous Peoples (2008) Article 31(1).
64. That was in 2004. Chalmers (n 52) 160.
65. The Pharma Letter, UAE’s Julphar Inks Five-year Deal to Market Merck & Co Drugs (11 April 2014).
66. Dutta (n 48) 177.
67. Jakkrit Kuanpoth, *Patent Rights in Pharmaceuticals in Developing Countries* (Cheltenham: Edward Elgar 2010) 181-184.
68. Ibid.
69. Devlin (n 15) 68.
70. Ibid.
71. Ibid 68.
72. USTR identifies countries which do not provide effective protection of intellectual property rights. Office of the United States Trade Representative, ‘Intellectual Property’ <https://ustr.gov/issue-areas/intellectual-property> accessed 23 December 2015.
73. It provides opportunities for many of the Third world’s countries to trade in order to grow their economies. Office of the United States Trade Representative, ‘Generalized System of Preferences’ <https://ustr.gov/issue-areas/trade-development/preference-programs/generalized-system-preferencegsp> accessed 23 December 2015.
74. Kuanpoth (n 77) 181-184.
75. It is an annual report on the effectiveness of U.S. trade partners’ protection of intellectual property rights. Office of the United States Trade Representative, ‘USTR Releases Annual Special 301 Report on Intellectual Property Rights’ <https://ustr.gov/about-us/policy-offices/press-office/press-releases/2015/april/ustr-releases-annual-special-301> accessed 23 December 2015.
76. Muzaka (n 6) 156.
77. H Knight, *Patent Strategy: For Researchers and Research Managers* (Chichester: John Wiley & Sons 1996) 91.
78. Bureau of Industry Economics, *The Economics of Patents* (Canberra: Australian Government Publishing Service 1994) 8.
79. Horner (n 7) 391-392.
80. Ibid 399.
81. Bureau of Industry Economics (n 86) 8.
82. Horner (n 7) 399.
83. M Bloche & Elizabeth Jungman, ‘Patent Immorality?’ (2002) 2(3) *The American Journal of Bioethics* 48, 49.
84. Kellogg v Wyeth, (2010) 762 F Supp 2d 694 (District Court).
85. Amanda Fachler, ‘The Need for Reform in Pharmaceutical Protection: The Inapplicability of the Patent System to the Pharmaceutical Industry and the Recommendation of a Shift towards Regulatory Exclusivities’ (2014) 24 *Fordham Intellectual Property, Media & Entertainment Law J* 1059, 1078-1085.
86. Dutta (n 48) 177.
87. Bureau of Industry Economics (n 86) 26.
88. One of the world’s premier biopharmaceutical corporation.
89. Christopher Holman, ‘Unpredictability in Patent Law and Its Effect on Pharmaceutical Innovation’ (2011) 76 *Missouri Law Review* 645, 646.
90. Ibid 646.
91. Fachler (n 95) 1066.
92. Ibid 1065.
93. Ibid.
94. Ibid 1066.
95. Ibid 1067.
96. Ibid 1075.
97. Mattappally (n 19) 996.
98. Fachler (n 95) 1075-1076.
99. Morten Tvedt (n 56) 278-279.
100. R S Crespi, *Patenting in the Biological Sciences*, (Chichester: John Wiley & Sons 1982) 78-79.
101. Muzaka (n 6) 152 & 158.
102. Bureau of Industry Economics (n 86) 41.
103. Ragavan (n 28) 195.
104. Mrazek et al (n 17) 337.
105. Amitava Banerjee; Aidan Hollis & Thomas Pogge, ‘The Health Impact Fund: Incentives for Improving Access to Medicines’ (2010) 375(9709) *The Lancet* 166, 166-167.
106. Ibid. See also Li (n 66) 23.
107. Blum (n 17) 201.
108. Andrew Jones, *The Elgar Companion to Health Economics* (Cheltenham: Edward Elgar 2012) 98.
109. Muzaka (n 6) 152.
110. Ragavan (n 28) 197-198.
111. Muzaka (n 6) 151.
112. Ibid 152.
113. Ragavan (n 28) 35.
114. Devlin (n 15) 65.
115. Blum (n 17) 201.
116. Andrew Jones, The Elgar Companion to Health Economics (Cheltenham: Edward Elgar 2012) 98.
117. Muzaka (n 6) 152.
118. Ragavan (n 28) 197-198.
119. Muzaka (n 6) 151.
120. Ibid 152.
121. Ragavan (n 28) 35.
122. Devlin (n 15) 65.
1 Email: bosha_mhd@yahoo.com.
2 Muzaka (n 6) 156.
3 Yvette Madrid ; Germán Velásquez & Enrique Fefer, ‘The Economics of Pharmaceuticals and Health Sector Reform in the Americas’ (1998) 3(5) Revista Panamericana de Salud Pública 343.
4 Ibid 344.
(2019). Is there a Justification for the Existence of Patent Law in the International Pharmaceutical Industry?. Legal issues Journal, 7 (2), https://www.legalissuesjournal.com/article/07-02-12072019/
