ABSTRACT

Among developing World Trade Organization (WTO) Member Countries, most major pharmaceutical-producing countries had already introduced pharmaceutical product patent protection before 2005. Shifts in the supply market based on those changes may largely have taken place. India was the notable exception. It only introduced pharmaceutical product patent protection at the beginning of 2005. The Indian pharmaceutical sector until then had operated largely free of patent impediments in its domestic market. India is a major supplier of generic pharmaceuticals to the developing world (Fink, 2001; Shah, 2004). Its introduction of pharmaceutical product patents is likely to have a significant impact upon the world supply market, although the precise effect is difficult to predict. It will depend, among other things, upon how changes to India’s existing patent system are implemented. India’s parliament took steps to ameliorate the short-term impact of the transition (in legislation that became effective on 5 April 2005) by providing that patents granted on the basis of mailbox applications may not be used to prevent generic producers from continuing to produce drugs already in manufacture before 1 January 2005 on payment of a reasonable royalty. It also sought to limit the granting of patents on minor improvements to existing products in a provision addressing new forms of the same substance and new uses of

known substances. Nonetheless, the short-, medium-and long-term impacts may vary (see Box 2.1).