Abstract not available

This dissertation is the compilation of three separate works of research revolving around the theme of regulation of biomedical technologies that are either emerging or that have undergone significant developments over the past decade or so. Each of these three research works examines a legal response to a technological development in the areas of biotechnology and/or medicine and addresses one or more challenges - ethical, constitutional, legal or one that is related to public policy - created by that response. The first work of research, which was published in the Administrative Law Review in March 2008, examines the legality of the restrictions imposed by the administration of President George W. Bush on the funding of research involving human embryonic stem cells. Reaching the conclusion that the Bush Administration's actions were outright illegal in more than one way, the research highlights existing tensions in the division of decision-making power between the President and executive agencies and between Congress and the President. The second work of research, which was published in the Columbia Science and Technology Law Review in August 2010, reviews the regulation of genetic screening and testing of donated reproductive tissue in the United States. Analyzing the regulation in the federal, state and industry level, the research highlights significant shortcomings of the regulation of this area and, drawing on the experience of other countries, advocates the regulation of this area by the FDA. The third and last work of research of which this dissertation consists is dedicated to the examination of the newly created regime of statutory exclusivities afforded to biological pharmaceuticals under the Biologics Price Competition and Innovation Act (BPCIA) as it compares to the protection afforded to such products under patent law. The research concludes that allowing biological pharmaceuticals to benefits from parallel protection under both patent law and the statutory exclusivities regime established under BPCIA does not contribute to incentivizing innovation and might have undesirable ramifications from a public policy perspective. Hence, the research proposes limiting the protection afforded to biological pharmaceutical products, namely to the protection under either patent law or BPCIA, by suspending the ability to enforce patents covering biological pharmaceuticals against generic applicants under BPCIA. In addition, the research examines the proposition that under some circumstances it would be possible to substitute patent protection for statutory exclusivities.

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.