El alambrado situado sobre un conjunto piso/cielo raso o tejado/cielo raso no clasificado como resistente al fuego, no debe sujetar ni apoyar en los cielos rasos, ni siquiera en las

The lack of consensus between WTO Members over the use of public health related TRIPS flexibilities became apparent shortly after the establishment of the WTO. After 1995, developing countries soon began to re-assess the Agreement with the intention of identifying the ambiguities that existed as well as any manoeuvring room which remained for domestic intellectual property policy making.92 India interpreted to Article 70 of the TRIPS Agreement in a manner which brought it into dispute with the US, resulting in the first use of the WTO Dispute Settlement Mechanism93 to resolve an intellectual property dispute. The dispute originated from the claim by the US that India had not complied with its obligations under Article 70.8 which, inter alia, included a requirement to implement a mailbox mechanism to receive and preserve applications pending the availability of patent protection for pharmaceutical and agricultural chemical products94 _{and that India had failed to establish a legal mechanism for the granting of exclusive}

89 _{See Matthews 2002 at 28.} 90 _{Ibid Matthews 2002 at 34.} 91 _WT/GC/W/302.

92 _{Reichman J, (1998) ‘Securing Compliance with the TRIPS Agreement after US v India’, JIEL, Oxford University}

Press 585-601 [Online] Available:

http://scholarship.law.duke.edu/cgi/viewcontent.cgi?article=2226&context=faculty_scholarship

93 _{See the first Dispute Settlement Panel (DSP) Report India - Patent Protection for Pharmaceutical and Agricultural}

Chemical Products WT/DS50/R, 5 September 1997 and the Appellate Body (AB) Report India-Patent Protection for Pharmaceutical and Agricultural Chemical Products (India- Mailbox) WT/DS50/AB/R. 19 December 1997.

94 _{Article 70.8 required countries like India that were making use of transitional arrangements to establish a means by}

which applications for patents could be filed, to apply the same criteria of patentability as contained in Article 27.1 and to provide patent protection for the 20 year minimum period prescribed under Article 33, from the date of filing of the patent.

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marketing rights. On the issue of exclusive marketing rights, according to India’s interpretation of Article 70.9, it was not obliged to create the legal mechanism for exclusive marketing rights until such need arose. Both the Panel and the Appellate Body found that India had not met its obligations under Articles 70.8 and 70.9 with the AB finding that India’s textual obligation under TRIPS was to provide a means to implement its mailbox obligations and the establishment of a mechanism to grant exclusive marketing rights.95

This decision together with a potentially unclear understanding of an LDC’s minimum obligations under the TRIPS Agreement reportedly led to Ugandan officials debating whether to include a mailbox in a draft patent Act in September 2009 96 despite LDCs not having to comply with the provisions of the TRIPS Agreement except articles 3, 4, and 5 until 1 July 2013, at the time, an exemption which has been further extended to 1 July 2021.

The next public health related intellectual property dispute involved the US and Brazil and related to the local working provisions in Brazil’s Industrial Property Law.97 _{Article 68 of the Brazilian} Industrial Property Law authorises the government to issue compulsory licenses when manufactured goods are not being produced locally three years or more after a patent has been granted by the authorities. The US took issue with Article 68 on the grounds that it was overly broad in its scope and that Brazil could have issued a compulsory license under Article 71 on the grounds of national health emergency.98

95 _{Ortino F, and Petersmann E, (2004) “The WTO Dispute Settlement system: 1995-2003” Kluwer Law}

International, 422.

96 _{Discussion with Sisule Musungu, 17 February 2010. Subsequently, the Ugandan Parliament passed an Industrial}

Property Act in 2013. The Act came into force in January 2014 upon assent by the President does not contain a provision for a mailbox.

97 _{Amendments to Brazil’s patent law were enacted in 1996 and came into force on 1 January 1997.}

98 _{See ICTSD Report of 8 May 2001 entitled ‘US-Brazil War of words over pharmaceutical s and intellectual property’}

[Online] available: http://ictsd.org/i/ip/39980/. For more on the US position, refer to the USTR, 2001, ‘Special 301 Report’, Washington DC: United States Trade Representative [Online] Available:

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Although the US requested consultations99 and the establishment of a panel100 with Brazil under the WTO Dispute Settlement Understanding, (DSU) on 30 May 2000, the matter was resolved through a “settlement agreement” between the parties, resulting in the US withdrawing its complaint. Shadlen101 _{believes that intense pressure from AIDS activists both domestically and} internationally (who believed that the US complaint was an attack on Brazil’s national public health care programme which provided free ARVs to anyone in need) played a role in the matter being resolved between the parties. He also asserts that there was also a fear on the part of the US that a DSP might find against the US, thereby creating an undesirable precedent. It was therefore in the interests of both parties to resolve the dispute without the risk of a precedent going against them. Considerable pressure was also placed on the US through the tabling of a resolution at the United Nations Human Rights Commission which called for the availability of appropriate medicines for the treatment of AIDS to be made available at accessible prices and which reminded UN Member States that access to ART was a fundamental human rights issue.102 The resolution was adopted by every member of the Commission except the US, which led to its further isolation on the issue.103

The next dispute between developed and developing countries over the interpretation of the TRIPS Agreement captured the attention not only of governments in eastern and southern Africa, of but that of the media, patient groups and civil society activists worldwide. The reasons for this are linked to the fact that an African country was involved in the dispute, and because South Africa had become the global epicentre of AIDS epidemic.

While the first antiretroviral medicines had begun to emerge in the mid-1990s, their prohibitive cost, in excess of US$ 12 000 per patient per year, combined with the large number of people in

99 _{Request for Consultations by the United States, Brazil – Measures Affecting Patent Protection, WT/DS199/1,}

G/L/385, IP/D/23, 8 June 2000.

100 _{Request for the Establishment of a Panel by the United States, Brazil- Measures affecting Patent Protection}

WT/DS199/39, January 2001.

101 _{See Shadlen K, (2007) ‘The political economy of AIDS treatment: intellectual property and the transformation of}

generic supply’ International Studies Quarterly, 51: 559–581

102 _{Commission on Human Rights resolution 2001/33, Access to medication in the context of pandemics such as}

HIV/AIDS, UN Doc. E/CN.4/RES/2001/33, 20 April 2001.

103 _{For more on the various strategies employed by the Brazilian government in its dispute with the US, see Bird R,}

and Cahoy D, (2008) ‘The Impact of Compulsory Licensing on Foreign Direct Investment: A Collective Bargaining Approach’, American Business Law Journal, Volume 45, Issue 2.

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need of treatment made a national sponsored treatment programme un-feasible. In a bid to make use of the limited policy space the TRIPS Agreement still afforded it, on 30 October 1997, the South African Parliament passed the Medicines Control and Related Substances Amendment Act.104 _{The Act contained provisions including Section 15 (C), which appeared to allow a Minister} of State,105 _{broad discretionary powers to authorise parallel importation as a means of reducing} essential medicine prices.106 _{The South African chapter of the Pharmaceutical Manufacturers’} Association (PMA) launched a High Court application to suspend the Act from coming into operation because of what it perceived to be the presence of unfair wide-ranging powers which could be improperly used. One of the contentions was that, in addition to parallel importation, Section 15(C) could be utilised for compulsory licensing and that, in its present form, it was contrary to Articles 6, 27, 28 and Article 31 of the TRIPS Agreement. Interestingly, the US government opted not to bring the matter before the WTO Dispute Settlement Mechanism. Two reasons are offered for this. The first relates to the strong emotions the case evoked and the potential public relations disaster which eventually led to the application being dropped by the PMA and a settlement being reached in April 2001.107 The second may explain the settlement the US reached with the Brazilian government in an earlier dispute. A DSP precedent in favour of the South African government might have prompted other countries to adopt similarly wide-ranging provisions.108

Although the disputes between Brazil and South Africa were resolved without either country having to amend or renounce legislation, developing countries remained concerned that attempts to utilise intellectual property legislation to alleviate public health crises were being met with stiff resistance. Meanwhile, a combination of factors including the court case brought against the South

104 _{Act 90 of 1997.}

105 _{It can be argued that the phrase ‘a minister of state’ as opposed to ‘the minister of state” enables the Minister of}

Trade and Industry, Health or indeed, any government minister to use Section 15(c).

106 _{See Watal (1999).}

107 _{See Tickell S, (2001) ‘Cutting the Cost of Drugs’, Managing Intellectual Property, March 3. No case since has}

gad a greater impact on the reputation of the originator pharmaceutical industry. See also Baker and Avafia.

108 _{Abbott F, (2002), ‘The Doha Declaration on the TRIPS Agreement and Public Health: Lighting a Dark Corner at}

the WTO, 5 (2), Journal of International Economic Law 469 at 486, has suggested that the reason for the US government withdrawing its support for the pharmaceutical companies was to some degree, related to the NGO protesters threatening to disrupt the presidential campaign of then Vice President Al Gore unless the US withdrew its support to the pharmaceutical industry on this and similar public health disputes.

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African government,109 the rapidly growing HIV epidemic in sub-Saharan Africa, a realization that the US was prepared to use the WTO Dispute Settlement Mechanism to enforce intellectual property rights as well as continued unilateral pressure imposed by the US by placing countries on watch-lists through Section 301 propelled the African Group at the WTO110 _{to more actively begin} seeking clarification on the use of TRIPS flexibilities to increase access to more affordable health technologies.111 _{These initiatives include the adoption of a resolution by the 57}th _{Session of the} United Nations Human rights Commission calling, inter alia, on UN Member States to refrain from taking measures which would impede access to medicines and encouraging countries to adopt legislation and regulations to facilitate medicine access in their countries.112 Two World Health Assembly Resolutions113 in May 2001 which referred to access to essential medicines were also initiated to support the agenda of the African Group and developing country allies.