Guidelines for the Examination of Pharmaceutical Patents: Developing a Public Health Perspective. A Working Paper
(2007; 65 pages)

Abstract

The criteria for patentability require that a product or manufacturing process fulfils the conditions of novelty, inventiveness and industrial applicability (or utility).

In order to develop new drugs, mechanisms will have to be put in place that foster innovation and the development of new products, while at the same time ensuring that patients have rapid access to the fruits of such research.

The guidelines contained in this document are intended to be a contribution to the improvement of transparency and efficiency of the patent system for pharmaceuticals, particularly in developing countries. These countries should pay more attention to the way in which patents are examined and granted to avoid the negative effects resulting from the granting of patents on developments lacking inventiveness.

This working document should be understood in the context of two major issues:

  1. The accessibility of medicines to the world’s population as a key element of public health policy; and
  2. Innovation as an essential prerequisite for the existence of medicines. In relation to these two issues we should see how to manage the patent system for pharmaceuticals, and more specifically the “strengthened patent system” emerging from the TRIPS and current bilateral trade agreements. Patents are a social contract between the patent owner and the society; this is why it is necessary to explore, identify and implement mechanisms to improve the functioning and transparency of the patent system in the interest of public health. In order to develop a legal and normative framework for patent protection for pharmaceuticals that ensures a balance between the interests of the patent holders and the users of technology (as required by Articles 7 and 8 of the TRIPS Agreement) several issues should be carefully examined and considered at the national level. These Guidelines are a contribution to this important task.
 
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