This document deals with patent issues from the perspective of public health. It focuses on issues relating to access to medicines. It therefore concentrates on provisions and mechanisms in patent laws that may increase the affordability of medicines (including diagnostics, preventive and curative medicines) rather than those more relevant to the development of new drugs or the production of pharmaceuticals, though the three issues are often interlinked.
The purpose of this monograph, however, is not to provide specific provisions for health-related inventions, but to suggest more general principles and rules that could be instrumental in developing a health-sensitive national patent system.
One reason for this approach is that developing a public health-sensitive patent system requires consideration of many key general aspects (such as the criteria for patentability). A second reason is that article 27.1 of the TRIPs Agreement bans any discrimination, in either the recognition or exercise of patent rights, based on the field of technology. This means that both negative discrimination (e.g., reducing the rights available to pharmaceutical patent holders) and positive discrimination (broadening such rights) may be deemed TRIPs-inconsistent. In the latter case, broadening rights available to holders of pharmaceutical patents could be deemed inconsistent because it could discriminate against patent owners in other fields of technology19. However, differential treatment does not necessarily mean discriminatory treatment because different technologies might require different treatment.
19 Thus, a panel was requested by Canada against the European Union in the framework of the WTO dispute settlement mechanism, on the grounds that pharmaceutical patents can get in Europe an additional term of protection, which is excluded for other fields of technology (except agrochemicals). This request, however, has not been pursued so far.
A health-sensitive approach could aim to address short-term emergencies that could justify several sorts of temporary measures (for instance, for the supply of medicines in cases of epidemics or catastrophe), or be devised as part of an integrated medium or long-term patent policy and strategy. In the latter case, attention should be given to the diversity among developing countries, and to the possibility that countries with greater capacity may want stronger patent rights than those with less. Such countries may wish, for instance, to develop a patent system that fosters cooperation with firms from more advanced countries.
In some instances, a country may - within the limits permitted by its international obligations - opt for different levels of protection in different areas of intellectual property depending on its respective competitive position and the expected role of national and foreign investors and technology suppliers. It may, for instance, be possible to emphasize protection in the area of information technologies through high levels of copyright protection for computer programs and databases, while recognizing more moderate levels of protection in areas where local industrial and technological capabilities are low and unlikely to be significantly improved through high standards of protection.