Beyond Patents: Global Challenges to Affordable Medicine

This chapter deals with the way academic writing and policy analysis has missed something important in its articulation of the way patent law impedes making low-cost generic versions of essential medicines desperately needed in the developing world. A summary of solutions that may serve to reduce the harm likely to occur in developing countries that are forced to adopt regulatory regimes is presented. The data exclusivity and patent linkage act as regulatory protections for drugs. As with data exclusivity, patent linkage operates independently of patent defenses and exceptions. It can also offer an independent bar to marketing a generic drug even when there are no underlying patent problems. However, the possible harms of data exclusivity and patent linkage for developing countries have been noticed. Thus, although the effect of data exclusivity and patent linkage can be predicted, whether developing countries will adopt such measures is yet to be determined.