1. See UNAIDS, Report on the Global HIV/AIDS Epidemic 125, 129, 133 (UNAIDS 2000).


2. M.D. Nair, Compromising TRIPS: Brazil’s Approach to Tackle the HIV/AIDS Imbroglio, Journal of Intellectual Property Rights, vol. 13, Sept. 2008, p. 457.


3. World Health Organization, Essential Medicines: Definition, available at http://www.who.int/medicines/services/essmedicines_def/en/. See also MDG Gap Task Force, Millennium Development Goal 8: Delivering on the Global Partnership for Achieving the Millennium Development Goals: MDG Gap Task Force Report 2008 (New York: United Nations, 2008), 36.


4. Ibid, at 35.


5. Supra, at note 2.


6. James Thou Gathii, “Construing Intellectual Property Rights and Competition Policy Consistency with Facilitating Access to Affordable AIDS Drugs to Low-End Consumers,” Florida Law Review 53 (2001): 727-734; Anna-Marie Tabor, “Recent Development: AIDS Crisis”, 38 Harvard Journal on Legislation (2001): 514-525.


7. See for e.g. Universal Declaration of Human Rights, 1948 (Article 25); International Convention on the Elimination of All Forms of Racial Discrimination, 1965 (Article 5(e)(1)); The Convention on the Elimination of All Forms of Racial Discrimination Against Women, 1979 (Articles 11.1(f) and 12); The Convention on the Rights of the Child, 1989 (Article 24); The European Social Charter (Article 11); The African Charter on Human and People’s Rights, 1981 (Article 16); The Additional Protocol to the American Convention on Human Rights in the Area of Economic, Social and Cultural Rights, 1988 (Article 10); Human Rights Commission Resolution 1989/11; The Principles for the Protection of Persons with Mental Illness and for the improvement of Mental Health Care adopted by the UN General Assembly in 1991 (Resolution 46/1190 and the ICESCRs General Comment no. 5 on Persons with Disabilities; The Programme of Action of the International Conference on Population and Development, Cairo, 1994; The Declaration and Programme of Action of the Fourth World Conference on Women, Beijing, 1995, among others.


8. Article 25 (1), UDHR, 1948.


9. International Covenant on Economic, Social and Cultural Rights, adopted 16 December 1966; CA Res, 2200 (XXL), UNGAOR, 21st Session Supp. No. 16, UN Doc. A 16316 1966; 993 UNTS 3.


10. Article 12, ICESCR, 1966.


11. Article 253 of the Constitution of India reads – "Legislation for giving effect to international agreements: Notwithstanding anything in the foregoing provisions of this Chapter (Part XI, Chapter 1-Legislative Relations), Parliament has power to make any law for the whole or any part of the territory of India for implementing any treaty, agreement or convention with any other country or countries or any decision made at any international conference, association or other body".


12. Article 39(e) provides that "the health and strength of workers, men and women, and the tender age of children are not abused and that citizens are not forced by economic necessity to enter avocations unsuited to their age or strength."


13. Article 39(f) states that "children are given opportunities and facilities to develop in a healthy manner and in conditions of freedom and dignity and that childhood and youth are protected against exploitation and against moral and material abandonment."


14. Article 42 provides that "the State shall make provision for securing just and humane conditions of work and for maternity relief."


15. Article 47 provides that "The State shall regard the raising of the level of nutrition and the standard of living of its people and the improvement of public health as among its primary duties and, in particular, the State shall endeavour to bring about prohibition of the consumption except for medicinal purposes of intoxicating drinks and of drugs which are injurious to health."


16. (1995) 3 SCC 42.


17. AIR 1989 SC 2039.


18. See for e.g. W.B. Khet Mazdoor Samiti v. Union of India, AIR (1996) SC 2426; Murali Deora v. Union of India & Ors. (2001) 8 SCC 765.


19. Tufts Center for the Study of Drug Development, Backgrounder: How New Drugs Move through the Development and Approval Process (Nov 1, 2001). http://csdd.tufts.edu/files/uploads/how_new_drugs_move.pdf (accessed February 5, 2011).


20. Joseph A. DiMasi, Ronald W. Hansen, and Henry G. Grabowski, "The Price of Innovation: New Estimates of Drug Development Costs," Journal of Health Economics 22 (2003):151-185.


21. Henry G. Grabowski, John Vernon, and Joseph A. DiMasi, "Returns on Research and Development for 1990s New Drug Introductions," PharmacoEconomics 20, no. 3 (2002): 11.


22. Shanker A. Singham, "Competition Policy and the Stimulation of Innovation: TRIPS and the Interface Between Competition and Patent Protection in the Pharmaceutical Industry," 26 Brooklyn Journal of International Law 26 (2000): 363, 373 .


23. Médecins Sans Frontières (2001), Prescriptions for Action, MSF Briefing for the European Parliament - Accelerated Action Targeted at Major Communicable Diseases within the Context of Poverty Reduction, Paris.


24. Figures quoted in the annual reports of Merck, available at http://www.merck.com (accessed January 30, 2011) and Pfizer, at http://www.pfizer.com (accessed January 30, 2011).


25. Shanker A. Singham, "Competition Policy and the Stimulation of Innovation: TRIPS and the Interface Between Competition and Patent Protection in the Pharmaceutical Industry," 26 Brooklyn Journal of International Law 26 (2000): 363, 373.


26. Health Action International (1998), HAI News, No. 100, April 1998.


27. Jean O. Lanjouw , "The Introduction of Pharmaceutical Product Patents in India: "Heartless Exploitation of the Poor and Suffering" ?," Working Paper 6366, National Bureau of Economic Research, Cambridge (1988).


28. C. Andrade, N. Shah and S. Chandra, "The New Patent Regime: Implications for Patients in India," Indian Journal of Psychiatry 49, no. 1 (2007): 312-316.


29. Quoted in Stuart Macdonald, "Exploring the Hidden Costs of Patents" in Peter Drahos and Ruth Mayne (eds.) Global Property Rights (2002): 34.


30. B. Zorina Khan, The Democratization or Invention: Patents and Copyright in American Economic Development, 1790-1920 (New York: Cambridge University Press, 2005).


31. Brodly Condon and Tapen Sinha, "Global Diseases, Global Patents and Differential Treatment in WTO Law: Criteria for Suspending Obligations in Developing Countries," Northwestern Journal of International Law and Business 26 (2005): 27.


32. Graham Dutfield, Intellectual Property Rights and the Life Science Industries(Hampshire: Ashgate Publishing Ltd., 2003), 239.


33. Pharmaceutical Research and Manufacturers of America, Pharmaceutical Industry Profile (2002), cited in Condon and Sinha, Northwestern Journal of International Law and Business 26 (2005): 20.


34. Peter Drahos, A Philosophy of Intellectual Property Rights (Aldershot: Dartmouth, 1996), 202.


35. According to Article 27 of the TRIPS, patents must be available for any inventions, whether products or processes, in all fields of technology. Until TRIPS, India excluded patents on products such as pharmaceuticals and foods.


36. World Trade Organization, "Understanding the WTO: The Organization, Least-developed Countries." http://www.wto.org/english/thewto_e/whatis_e/tif_e/org7_e.htm (accessed January 25, 2011).


37. Vide, The Patents (Amendment) Act, 1999 (Act No. 17 of 1999), The Patents (Amendment) Act, 2002 (Act No. 38 of 2002) and The Patents (Amendment) Act, 2005 (Act No. 15 of 2005).


38. Sudip Chaudhuri, "TRIPS Agreement and Amendment of the Patents Act in India," Economic and Political Weekly, (August 10, 2002).


39. See, most notably, Section 92A(1) which reads as: Compulsory license shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems, provided compulsory license has been granted by such country or such country has, by notification or otherwise, allowed importation of the patented pharmaceutical products from India.


40. Article 6, TRIPS Agreement.


41. Carlos M. Correa, "Pro-Competitive Measures under TRIPS to Promote Technology Diffusion in Developing Countries," (2002): 43 in Global Intellectual Property Rights: Knowledge, Access and Development. Drahos and Mayne (eds.). New York: Palgrave: 40-57.


42. For an in depth discussion of data exclusivity, see Médecins Sans Frontières, "Data Exclusivity in International Trade Agreements: What Consequences for Access to Medicines?," (2004).


43. TRIPS Agreement, Annex. 1C, Article 39 Section 3 (entered into force 1994).


44. Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (codified at 15 U.S.C. §§ 68b-68c, 70b (1994); 21 U.S.C. §§ 301 note, 355, 360cc (1994); 28 U.S.C. § 2201 (1994); 35 U.S.C. §§ 156, 271, 282 (1994)).


45. Article 10, Directive 2004/27/EC (March 31, 2004) (Directive 2004/27/EC of the European Parliament and Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use).


46. TRIPS Agreement, Annex. 1C, Article 39 Section 3 (entered into force 1994).


47. Padmini Jayshree, Consultative Committee Recommends Data Protection, Express Pharma Pulse (March 24, 2005) (available at http://www.expresspharmapulse.com/20050324/coverstory01.shtml).


48. Ibid.


49. Médecins Sans Frontières, "Data Exclusivity in International Trade Agreements: What Consequences for Access to Medicines?,"(2004).


50. In the newly established Indian patent regime, the 'Bolar' exception has been provided under Section 107A(a), Patents (Amendment) Act, 2005.


51. WHO Drug Information, World Health Organization 19, no. 3 (2005).