During the last two decades, there have been a number of policy and legislative changes in respect of South Africa’s intellectual property (IP) and the national system of innovation (NSI). In 2012, a Ministerial Review of the Science, Technology and Innovation (STI) landscape in South Africa made recommendations to improve the STI landscape and effectively the national system of innovation. The study provides a critical review of drafts of the national IP policy published in 2013 as well as the IP Framework released in 2016 for public comment. The review of the IP and the NSI are within the context of the National Development Plan (NDP), which outlines South Africa’s desired developmental goals. South Africa is part of the BRICS group of countries (Brazil, Russia, India, China and South Africa). The South African economy is characterised by a desire to move away from being dependent on resources and commodities, to becoming a more knowledge based and innovation driven economy. It is hoped that such a move would assist the country to address some of the social and economic development challenges facing South Africa, as captured in the NDP. South Africa has a functioning IP system, but its relationship with South Africa’s development trajectory is not established. More particularly, the extent to which the IP system relates to the innovation system and how these two systems must be aligned to enable South Africa to transition successfully from a country based on the production of primary resources and associated commodity-based industries to a viable knowledge-based economy is unclear. The Trade-related Aspects of Intellectual Property Rights (TRIPS Agreement) of the World Trade Organisation (WTO) provides that IP must contribute to innovation and to transfer of technology and knowledge in a manner that is conducive to social and economic welfare. Certain provisions set out the foundations of intellectual property systems within the context of each member state. This study has thus explored the complex, complementary and sometimes contested relationships between IP and innovation, with particular emphasis on the potential of an intellectual property system to stimulate innovation and foster social and economic development. The study has also analysed the interconnectivity of IP and innovation with other WTO legal instruments, taking into account South Africa’s positioning within the globalised economy and in particular the BRICS group of countries. The research involved a critical review of South Africa’s IP and innovation policies, as well as relevant legislation, instruments, infrastructure, IP and innovation landscape, and relationship with international WTO legal instruments, in addition to its performance, given the developmental priorities and the globalised economy. The research documents patenting trends by South Africans using European Patent Office (EPO), Patent Cooperation Treaty (PCT), United States Patents and Trademarks Office (USPTO) databases over the period 1996-2015. A comparative analysis of patenting trends amongst BRICS group of countries has also been documented. The study also documents new findings, observations and insights regarding South Africa’s IP and innovation systems. Some of these, particularly in relation to higher education and research institutions, are directly attributable to the Intellectual Property Rights from Publicly Financed Research and Development Act. More particularly, the public institutions are becoming relevant players in the NSI and are responsible for growth of certain technology clusters, in particular, biotechnology. At the same time, the study makes findings of a decline of private sector participation in patenting as well as R&D investment over the 20-year period. Recommendations are included regarding specific interventions to ensure coherence between the IP and innovation systems. Such coherence and alignment should strengthen the systems’ ability to stimulate innovation and foster inclusive development and competitiveness, which are relevant for addressing South Africa’s socio-economic development priorities. / Mercantile Law / LL. D.

In 2001 the Declaration on the TRIPS Agreement and Public Health (‘Doha Declaration’), affirmed the right of member states of the World Trade Organisation (‘WTO’) to interpret and implement the TRIPS Agreement as supportive of the protection of public health and, in particular, access to medicines. While initially well-received, consternation soon arose over the interpretation of a specific paragraph in the Doha Declaration dealing with compulsory licensing. After a further two years of deliberation, the WTO Decision on the Interpretation of Paragraph 6 (‘Paragraph-6 Decision’) was announced in August 2003 specifying when countries can import drugs produced elsewhere under compulsory licence. With one third of the world's population is still denied access to essential medicines - a figure which rises to over 50 per cent in Asia and Africa - the problems facing the public health community are two-fold. The first is the capacity of developing countries (‘DCs’) actually to use the flexibilities afforded under the TRIPS Agreement, the Doha Declaration, and the Paragraph- 6 Decision amid stark inequalities in health resources and the world trading system as a whole. These include provisions for compulsory licensing, parallel importation, and addressing imbalances in research and development (‘R&D’). The pending ratification of the Paragraph-6 Decision, from an interim solution to a permanent amendment, is accompanied by considerable uncertainty: will the protections be accessible under the system currently proposed? The second problem concerns the undermining of the above hard-won flexibilities by provisions adopted under various bilateral and regional trade agreements. Known as ‘TRIPS-plus’- or ‘WTO-plus’- measures, the level of intellectual property rights (‘IPRs’) rights protection being negotiated and even adopted under other trade agreements are more restrictive as regards public health protection. These two sources of concern have led to an increase in rather than a lessening of tensions between the public health and trade policy communities. The thesis opens with a brief analysis of the interplay between patents and medicines. This includes an overview of the human rights framework and the right of access to medicines as a manifestation of human rights. The historical development of the TRIPS Agreement, its legitimacy, and the effect of the introduction of patents for pharmaceuticals are critically analysed. The terms of the Doha Declaration as it relates to public health, the Paragraph-6 Decision and its system, the December 2005 Amendment, and the progress made to date on the public health protections available under the TRIPS Agreement are reviewed and discussed in detail. The thesis describes how, despite these important clarifications, concerns as to the capacity of DCs to implement specific measures persist. This thesis further addresses the development of compulsory licensing in India and South Africa, and the legal framework for compulsory licensing in these countries. The role of competition law and constraints faced by DCs in implementing the flexibilities offered by the TRIPS Agreement and Doha Declaration are considered before turning to the threat posed by TRIPS-plus measures and calls for their critical reassessment. The thesis considers the role of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG), the WHO Commission on IPRs, Innovation and Public Health (CIPIH), Patent Pools, and international and multilateral donors in access to medicines. The thesis concludes by reviewing potential ways forward to ensure that access to medicines by the poor living in DCs is secured in all trade agreements. / Mercantile Law / LL.D.

In 2001 the Declaration on the TRIPS Agreement and Public Health (‘Doha Declaration’), affirmed the right of member states of the World Trade Organisation (‘WTO’) to interpret and implement the TRIPS Agreement as supportive of the protection of public health and, in particular, access to medicines. While initially well-received, consternation soon arose over the interpretation of a specific paragraph in the Doha Declaration dealing with compulsory licensing. After a further two years of deliberation, the WTO Decision on the Interpretation of Paragraph 6 (‘Paragraph-6 Decision’) was announced in August 2003 specifying when countries can import drugs produced elsewhere under compulsory licence. With one third of the world's population is still denied access to essential medicines - a figure which rises to over 50 per cent in Asia and Africa - the problems facing the public health community are two-fold. The first is the capacity of developing countries (‘DCs’) actually to use the flexibilities afforded under the TRIPS Agreement, the Doha Declaration, and the Paragraph- 6 Decision amid stark inequalities in health resources and the world trading system as a whole. These include provisions for compulsory licensing, parallel importation, and addressing imbalances in research and development (‘R&D’). The pending ratification of the Paragraph-6 Decision, from an interim solution to a permanent amendment, is accompanied by considerable uncertainty: will the protections be accessible under the system currently proposed? The second problem concerns the undermining of the above hard-won flexibilities by provisions adopted under various bilateral and regional trade agreements. Known as ‘TRIPS-plus’- or ‘WTO-plus’- measures, the level of intellectual property rights (‘IPRs’) rights protection being negotiated and even adopted under other trade agreements are more restrictive as regards public health protection. These two sources of concern have led to an increase in rather than a lessening of tensions between the public health and trade policy communities. The thesis opens with a brief analysis of the interplay between patents and medicines. This includes an overview of the human rights framework and the right of access to medicines as a manifestation of human rights. The historical development of the TRIPS Agreement, its legitimacy, and the effect of the introduction of patents for pharmaceuticals are critically analysed. The terms of the Doha Declaration as it relates to public health, the Paragraph-6 Decision and its system, the December 2005 Amendment, and the progress made to date on the public health protections available under the TRIPS Agreement are reviewed and discussed in detail. The thesis describes how, despite these important clarifications, concerns as to the capacity of DCs to implement specific measures persist. This thesis further addresses the development of compulsory licensing in India and South Africa, and the legal framework for compulsory licensing in these countries. The role of competition law and constraints faced by DCs in implementing the flexibilities offered by the TRIPS Agreement and Doha Declaration are considered before turning to the threat posed by TRIPS-plus measures and calls for their critical reassessment. The thesis considers the role of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG), the WHO Commission on IPRs, Innovation and Public Health (CIPIH), Patent Pools, and international and multilateral donors in access to medicines. The thesis concludes by reviewing potential ways forward to ensure that access to medicines by the poor living in DCs is secured in all trade agreements. / Mercantile Law / LL.D.