Compulsory licences: recent experiences in developing countries

International Journal of Intellectual Property Management

Volumn 1, Issue 1-2, 2006, Pages 22-36

  Oh, Cecilia ^a  

^a WORLD HEALTH ORGANIZATION   (Switzerland)

Author keywords

access to medicines; compulsory licences; developing countries; Doha Declaration; government use; patent protection; pharmaceuticals; public health; the TRIPS agreement; TRIPS flexibilities

Indexed keywords

EID: 79957996948     PISSN: 14789647     EISSN: 14789655     Source Type: Journal    
DOI: 10.1504/ijipm.2006.011020     Document Type: Article

References (53)

1. Commission on Intellectual Property Rights (CIPR) (2002) Integrating Intellectual Property Rights and Development Policy, IPR Commission, London.
2. Love, J. (2001) Compulsory Licensing: Models for State Practice in Developing Countries, Access to Medicines and Compliance with WTO TRIPS Accord, UNDP, New York.
3. Maonera, F. and Chifamba, C. (2003) Developing a Regional Legal Framework on Access to Medicines for Protecting Public Health Needs in the COMESA Region, COMESA, Lusaka.
4. Médicins Sans Frontières (2003) ‘Drug patents under the spotlight: sharing practical knowledge about pharmaceutical patents’, Médicins Sans Frontières, Geneva.
5. Reichman, J. and Hazendahl, C. (2002) Non-Voluntary Licensing of Patented Inventions: Historical Perspective, Legal Framework under TRIPS and An Overview of the Practice in Canada and the United States of America, Issues Paper No. 5, UNCTAD and ICTSD, Geneva.
6. Sisule, M. and Oh, C. (2005) ‘The use of flexibilities in TRIPS by developing countries: can they promote access to medicines?’, Study Commissioned by the Who Commission on Intellectual Property Rights, Innovation and Public Health (Cipih), available at http://www.who.int/intellectualproperty/studies/en/index.html.
7. Task Force on Trade (2005) Trade for Development, UN Millennium Project, New York.
8. Third World Network (2003) Manual on Good Practices in Public-Health-Sensitive Policy Measures and Patent Laws, Third World Network, Penang.
9. World Bank (2004) HIV/AIDS Medicines and Related Supplies: Contemporary Context and Procurement – Technical Guide, World Bank, Washington DC.
10. See for e.g., Correa (2002) and Task Force on Trade, UN Millennium Project (2005).
11. Although some developed countries argue that the Chairman’s Statement that accompanies the August Decision also has legal standing, current negotiations on the amendment of the TRIPS Agreement indicate that WTO Members have widely diverging views on this point; with developing countries on the whole asserting that the Statement does not have legal status.
12. In Article 31(b) of TRIPS.
13. See for example, World Bank (2004) and UNCTAD-ICTSD Resource Book (2005) for further discussion and analysis on the concept of ‘public, non-commercial use’.
14. See Love (2001) and Reichman and Hasenzahl (2002) for discussion on the US government use provision, 28 USC 1498 (1997).
15. UK Patents Act 1977.
16. See Watal (2001) and Reichman and Hasenzahl (2002).
17. Article 31(b) of the TRIPS agreement.
18. Declaration of Period of Emergency (HIV/AIDS) Notice 2002, General Notice 240 of 2002.
19. Section 34(1) of the Patent Acts: Notwithstanding anything in this Act, any department of the State or any person authorised in writing by the Minister may make, use or exercise any invention disclosed in any specification lodged at the Patent Office for the service of the State in accordance with this section.
20. Section 35(1): During any period of emergency the powers exercisable in relation to an invention by a department of the State or a person authorised by the Minister under section thirty-four shall include power to make, use, exercise and vend the invention for any purpose which appears to the Minister necessary or expedient- (a) for the efficient prosecution of any war in which Zimbabwe may be engaged; or (b) for the maintenance of supplies and services essential to the life of the community; or (c) for securing a sufficiency of supplies and services essential to the well-being of the community; or (d) for promoting the productivity of industry, commerce or agriculture; or (e) for fostering and directing exports and reducing imports or imports of any classes, from all or any countries and for redressing the balance of trade; or (f) generally, for ensuring that the whole resources of the community are available for use, and are used, in a manner best calculated to serve the interests of the community; or (g) for assisting the relief of suffering and the restoration and distribution of essential supplies and services in any part of Zimbabwe or any foreign country that is in grave distress as the result of war; and any reference in that section or in Section 36 to the service of the State shall be construed as including a reference to the purposes referred to in paragraphs (a)-(g).
21. In Statutory Instrument 32 of 2003.
22. Letter of authorisation signed by the Minister of Justice, Legal and Parliamentary Affairs, Patrick Anthony Chinamasa, dated 8th April 2003.
23. Sources and prices of selected medicines and diagnostics for people living with HIV/AIDS: June 2004, UNICEF-UNAIDS Secretariat-WHO-MSF.
24. Information from Chris Chitemere of Varichem Pvt Ltd., presented during the African Regional Workshop on the WTO TRIPS Agreement and Access to Medicines, Addis Ababa (1—4 March 2005). The Varichem ARV portfolio is as follows: (a) Varivar tablets 60s at US$ 13.95 (this is the generic version of Combivir – the trade name of the double fixed dose combination of zidovudine and lamivudine, produced by GlaxoSmithKline, which holds the relevant patent on Combivir in Zimbabwe); (b) nevirapine 200 mg tablets 60s at US$ 7.15; (c) Stanalev-40 (fixed dose combination of stavudine 40mg, lamivudine 150 mg and nevirapine 200 mg) tablets 60s at US$ 14.45; (d) Stanalev-30 (as Stanalev-40 except for stavudine 30 mg) tablet 60s at US$ 14.25; (e) stavudine 30 mg capsules 60s at US$ 2.40; (f) stavudine 40 mg capsules 60s at US$ 3.25; and (g) lamivudine 100 mg tablets 60s at US$ 5.25.
25. According to the information presented by Mrs. Ropafadzai Hove, Principal Regulatory Officer, Legal Affairs and Narcotics, Medicines Control Authority of Zimbabwe, at the African Regional Workshop on the WTO TRIPS Agreement and Access to Medicines, Addis Ababa, 1–4 March 2005.
26. The medicines were didanosine/ddI, zidovudine and Combivir (lamivudine+zidovudine fixed-dose combination).
27. Section 84(1) of Patents Act of 1983, amended as at 15th May 2002 provides that: “Notwithstanding anything containing in this Act- (a) Where there is national emergency or where the public interest, in particular, national security, nutrition, health or the development of other vital sectors of the national economy as determined by the Government, so requires; or (b) Where a judicial or relevant authority has determined that the manner of exploitation by the owner of the patent or his licensee is anti-competitive, … The Minister may decide that, even without the agreement of the owner of the patent, a Government agency, or a third person designated by the Minister may exploit a patented invention.”
28. MOH Malaysia asked for price reductions as follows: 10% price reduction for ritonavir, 10–40% reduction for stavudine, didanosine, zidovudine and Combivir/zidovudine+lamivudine, 60–79% reduction for indinavir, efavirenz and nevirapine.
29. The Minister of Health, Dato’ Chua Jui Meng, invited independent trade, intellectual property and public health experts – Carlos Correa, James Love, Dr. K. Balasubramaniam and Martin Khor – to brief officials from the Ministries of Health, International Trade and Industry, Domestic Trade and Consumer Affairs, and the Attorney-General’s Chambers.
30. Section 84 of the Patents Act 1983.
31. For example, the affected originator companies, in meetings between their legal representatives at the Malaysian Embassy in New York and High Commission in London, questioned the legality of the proposed importation, alleging that it would be a violation of the TRIPS obligations. One company suggested that the proposal would affect their investment decisions in relation to Malaysia.
32. Notice No. DC 01/2004 Ministry of Commerce, Trade and Industry, dated 21st September 2004.
33. See WHO-UNAIDS-MSF (2004) for the priority dates of the patents granted on the ARVs.
34. The Sri Lankan patent law of 1979 did not appear to provide for compulsory licensing nor did Brunei’s Emergency (Patents) Order 1999.
35. Abbott, F. (2004) ‘The Doha declaration on the TRIPS agreement and public health and the contradictory trend in bilateral and regional trade agreements’, Occasional Paper 14, QUNO, Geneva.
36. Baker, B. (2004) Processes and Issues for Improving Access to Medicines: Willingness and Ability to Utilize TRIPS Flexibilities in Non-producing Countries, DFID Health Systems Resource Centre, London.
37. Chaudhuri, S. (2005) TRIPS and Changes in Pharmaceutical Patent Regime in India, Working Paper No. 535/2005, Indian Institute of Management Calcutta, Calcutta.
38. Correa, C. (1999) Intellectual Property and the use of Compulsory Licenses: Options for Developing Countries, T.R.A.D.E Working Papers 5, South Centre, Geneva.
39. Correa, C. (2000) Integrating Public Health Concerns into Patent Legislation in Developing Countries, South Centre, Geneva.
40. Correa, C. (2002) Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the TRIPS Agreement, South Centre and WHO, Geneva.
41. Correa, C. (2004) Protecting Test Data for Pharmaceutical and Agrochemical Products under Free Trade Agreements, mimeo.
42. Dhar, B. and Rao, C. (2002) Transfer of Technology for Successful Integration into the Global Economy: A Case study of the Pharmaceutical Industry in India, UNCTAD, Geneva.
43. Keayla, B.K. (2004) Review of Patent Legislation of India, Indonesia, Sri Lanka and Thailand: Measures to Safeguard Public Health, WHO Regional Office for South-East Asia, New Delhi.
44. Lettington, R. and Banda, C. (2004) A Survey of Policy and Practice on the Use of Access to Medicines-related TRIPS Flexibilities in Malawi, DFID Health Systems Resource Centre, London.
45. Lettington, R. and Munyi, P. (2004) Willingness and Ability to Use TRIPS Flexibilities: Kenya Case Study, DFID Health Systems Resource Centre, London.
46. Musungu, S., Villanueva, S. and Blasetti, R. (2004) Utilizing TRIPS Flexibilities for Public Health Protection Through South-South Regional Frameworks, South Centre, Geneva.
47. Task Force on HIV/AIDS, Malaria, TB, and Access to Essential Medicines, Working Group on Access to Essential Medicines (2005) Prescription for Healthy Development: Increasing Access to Medicines, UN Millennium Project, New York.
48. UNCTAD (1996) The TRIPS Agreement and Developing Countries, UNCTAD, New York and Geneva.
49. UNCTAD and ICTSD (2005) Resource Book on TRIPS and Development, Cambridge University Press, Cambridge.
50. UNDP (2001) Human Development Report 2001: Making New Technologies Work for Human Development, Oxford University Press, New York.
51. Vandoren, P. and van Eeckhaute, J.V. (2003) ‘The WTO decision on Paragraph 6 of the Doha Declaration on the TRIPS agreement and public health’, The Journal of World Intellectual Property, November, Vol. 6, No. 6, pp.779–793.
52. Velasquez, G. and Boulet, P. (1999) ‘Globalisation and access to drugs: perspectives on the WTO/TRIPS agreement’, Health Economics and Drugs Series, EDM Series No. 7, WHO, Geneva.
53. Watal, J. (2001) Intellectual Property Rights in the WTO and Developing Countries, Kluwer Law International, The Hague/London/Boston.