This document focuses on issues in patent law most relevant from a public-health perspective. The intention is not, however, to ignore or downplay the relevance of issues that are not specifically addressed here, such as:
• procedures followed by patent offices and for the enforcement of rights;
• the interface between patent and competition law;
• issues relating to the use of trademarks in relation to medicines;
• the protection of test data submitted for the approval of medicines for commercialization20.
20 See, however, a brief consideration of this issue in Section X on “Compulsory licensing”.
A number of issues considered in this document may need to be addressed in implementing regulations and guidelines for patent offices, as well as in patent laws. Training of personnel in charge of patent law and regulation application is also an essential component of a patent policy. Developing a cadre of skilled personnel is particularly important, for instance, for applying patentability requirements, which depends on case-by-case evaluations.
The legal options presented in this document are intended to provide elements for national legislation which are compatible with the TRIPs Agreement. Though this Agreement may be reviewed21, the model options presented here are based on its existing provisions.
21 Several developing countries have submitted proposals to review the TRIPs Agreement. See, e.g., Correa, 2000.
The way in which such options are implemented should be consistent with the level of development of each country and, in particular, with its research and manufacturing capabilities in the pharmaceutical sector. Understandably, the options followed by a large developing country with significant capabilities in that sector may differ from those preferred by a small economy which is totally or substantially dependent on foreign supplies of pharmaceuticals. Likewise, patent laws may evolve as a country develops. It should be borne in mind, however, that problems of access to drugs caused by poverty and low income are common to most developing countries.
The document provides a brief discussion of the main issues to be considered with respect to the patentability of health-related products and processes. For each item, there is an explanation of the concept, the treatment found in comparative law and the implications of the TRIPs Agreement. For each of the various issues, this document presents key principles and options for the development of provisions in national patent laws. These principles aim to provide the basic concept on which more detailed provisions could be fashioned, after careful deliberation and consideration of the characteristics of each national legal system and patent law.