The implementation of intellectual property protection for pharmaceutical products in developing countries have led to concerns on access to medicine, and some countries, such as India, have tailored their legislation to limit the effect of intellectual property (IP) rights, in particular to prevent patents on incremental innovations. However, this strategy might not be yielding the desired effect, according to this study. The author examined all patent applications during the transition period allowed under the Agreement of Trade-related Aspects of IP Rights (TRIPS) before the implementation of the agreement in 2005. India is the main provider of generic medicines to developing countries, and production is legislatively supported by the prevention of patents on incremental innovations and the use of flexibilities to TRIPS rules. The laws on the book do not map neatly with laws in practice, the author found, as it appeared that, in complex cases, the Indian Patent Office lacked resources and expertise to determine whether or not a patent may be granted. He argues that the tailoring of Indian patent standards to limit patents on incremental innovations, which dominate drug patenting in the developed world, can be seen as an institutional innovation. However, in practice, resource constraints and other pressures may lead to institutional imitation, where the Indian Patent Office would simply copy developed-country practices and standards. The author predicts that the impact of TRIPS in India will be determined by the extent to which India sticks to, or departs from, international patentability standards.
Health equity in economic and trade policies
The boundaries between scientific and technological knowledge are nebulous in some technical fields, such as the biological sciences and their applications. This has led to the appropriation under patents of knowledge (such as on specific genes) of scientific nature, which may not only have negative effects for the further development of science and new technological contributions, but also encroach on the fundamental right of access to science. The South Centre argues in this paper that the patenting policies adopted by some universities and other research institutions may aggravate this problem. Court decisions in the USA and Australia and some national laws (e.g. Brazil) have limited the possibility of that appropriation, but this is still feasible in many jurisdictions. The authors argues that other measures – such as a well formulated research exception, the limitation of the patent claims’ scope, and legislation mandating open access to research results achieved with public funding – may mitigate the effects of the exclusivity granted by patent rights, but more fundamental policy changes may be necessary in order to preserve scientific outcomes in the public domain for free use and follow-on research.
According to this booklet, media has a crucial role to play in shaping the intellectual property (IP) rights reform agenda in East Africa. As far as IP issues are concerned, CEHURD makes a number of recommendations. Media should aim to build their own capacity to understand IP issues, which tend to be technical and dynamic. It is important to understand the World Trade Organisation system and how it functions, as well as the ongoing negotiations, and to assess which position is in the best interest of Uganda and the region. The media should also follow ongoing policy and legislative processes and report and evaluate them at every stage. They should show support for progressive decisions by government actors in the negotiations, generate community support to promote social and economic change, and persuade the public and Parliament to demand that the president and Cabinet act in public and national interest. Media can further play a role in empowering ordinary citizens through civic education, information and mobilisation to participate more directly in the discussion and debate of ongoing IP reforms and their impact the different aspects of social life.
Based on the outcome of a meeting that took place from 22-26 November in Switzerland, the World Intellectual Property Organization (WIPO) has initiated an intellectual property (IP) project aimed at developing countries. The New Platform for Technology Transfer and IP Collaboration addresses WIPO Development Agenda recommendations 19, 25, 26 and 28 regarding developing countries. These recommendations require WIPO to facilitate access to knowledge and technology for developing countries and least-developed countries, to promote the transfer and dissemination of technology to benefit developing countries, and to foster research co-operation between developed and developing countries. The project consists of five phases: the organisation of five regional technology transfer consultation meetings, the commissioning of peer-reviewed analytic studies, the organisation of a High-Level International Expert Forum, the creation of a web forum on technology transfer and IP, and ‘the incorporation of any adopted set of recommendations resulting from the above activities into the WIPO programmes’.
Intellectual property (IP) issues were raised at the 124th Session of the World Health Organization’s (WHO) Executive Board in January in respect of the following technical and health matters: pandemic influenza preparedness (sharing of influenza viruses, access to vaccines and other benefits); the role and responsibility of WHO in health research; counterfeit medical products; and a global strategy and plan of action for the Intergovernmental Working Group on Public Health, Innovation and IP. A draft of the ‘WHO Strategy on Research for Health’ was presented.
Although technology transfer and innovation feature in the final outcome of the Rio+20 United Nations Conference on Sustainable Development (UNCSD), held 20-22 June 2012, intellectual property rights (IPRs) - which are closely related to them - are barely mentioned, according to this brief. While the mention of IPRs in the Rio+20 outcome document signals their relevance for efforts to achieve sustainable development, no consensus was reached on how to ensure they are equitable and relevant to green technology. However, the stalemate may be addressed in several ways, the author proposes. Clear parameters are needed to foster a more constructive and pragmatic dialogue. Intellectual property should be seen in a broader context of appropriate policies, adequate institutions and human resources to both encourage green innovation and to ensure that its benefits are widely diffused. Other recommendations include improving access to technological information on green technologies, facilitating licensing of green technologies, fast-tracking green patents and ensuring open innovation for sustainability.
The legitimacy of the intellectual property (IP) system depends on the correct balance between the public interest and the private privilege given to the IP holders. This balance has been disrupted by a one-size-fits-all global regime in the TRIPS agreement. Yet TRIPS has some flexibilities that can be used. Recently, developed countries have been promoting a TRIPS-Plus agenda that reduces or removes TRIPS flexibilities. Their IP enforcement programme has resulted in legitimate generic drugs of developing countries being seized in European ports while in transit to other developing countries. At the World Intellectual Property Organization (WIPO), developing countries have not accepted the TRIPS-Plus proposals and are protesting against the actions on generic medicines. Issues covered here include the row over generic drug seizures, the recent controversies at the WIPO meeting on Patent Cooperation Treaty, the TRIPS-Plus enforcement agenda, and the move towards a ‘global IP infrastructure’.
Recent media focus on intellectual property rules has led many to believe that the entire debate centers around the issues of piracy of films, videos and DVDs. There is a constant refrain that a watertight regime of intellectual property rules is essential to protect the rights of those who devised, developed and produced innovative goods, be it art or health cures. Under GATT and the WTO, the latter created in 1995, the rules protecting and harmonising intellectual property have been enhanced to principally benefit corporate and neo-colonial interests, under the Trade Related Intellectual Property (TRIPS) regime. TRIPS is extremely controversial in its failure to recognise traditional and communal knowledge systems and rights while at the same time insisting on strong protection, enforcement and regulation of corporate aligned intellectual property rules.
International intellectual property (IP) rights are increasingly serving the needs of the global pharmaceutical industry, the authors of this article argue. IP constitutes the most substantial class of intangible assets. They are geographically mobile sources of vast corporate income that remain difficult to financially evaluate via arms length transfer pricing. This is especially true concerning transactions between subsidiaries of the same corporation. Intangible assets are often shifted to secrecy jurisdictions that specialise in IP holding companies that provide 100% tax exemption on royalty income as one of several tax holidays. The authors report that the Anti-Counterfeiting Trade Agreement (ACTA), drawn up by an ad-hoc group of high income countries and endorsed in March 2010, seeks to further lock down any loopholes on IP that may diminish the power of big pharmaceutical companies. Vessels passing through rich countries carrying generic goods for poor countries - irrespective of whether such goods are legal at source and destination jurisdictions - may be held up for seemingly as long as the intermediary nation deems fit.
By the end of 2007, only eighteen African states (including most non-LDCs and some LDCs) had initialled interim EPAs, as had two Pacific non-LDCs (Fiji and Papua New Guinea), while Caribbean countries went further and approved full EPAs. What have they agreed to? What are the main implementation challenges, some of which will require support from Europe? And for those that remain committed to this process, what are the options for the completion of negotiations towards full EPAs? The Overseas Development Institute (ODI) and the European Centre for Development Policy Management (ECDPM) study attempts to analyse these questions as comprehensively as possible, with a focus on Africa. This article summarises some of the main findings.