Extending the Limits of Protection of Pharmaceutical Patents and Data Outside the EU – Is There a Need to Rebalance?

Abstract

The European Union (EU) has instituted internal and external measures aimed at protecting and enforcing intellectual property rights. In the area of pharmaceutical patents, the Union has also sought to protect its industries through patent term extension and data exclusivity. Recent EU Free Trade Agreements (FTAs) with developing countries contain chapters on intellectual property that extend patent terms and data exclusivity for pharmaceutical products. Such acts further prolong the lifespan of protection given to existing products and limit generic market entry. This article identifies the issue as one of “cross-pollination” of laws and argues that since similar laws exist in the internal regime of the EU, incorporating them into the EU would not be technically too difficult. However, to an extent this regime is simulated in developing countries, implementation will bring major difficulties to the health sector and economies of these countries. The article thus proposes that developing countries should not be forced to adopt such laws through FTAs, and if they are, there should be the compulsory inclusion of both (1) a clause on transitional arrangements for developing countries specific to intellectual property; and (2) a clause that clearly links the objectives for intellectual property protection and enforcement (in this context, patent term extension and data exclusivity) to balancing between the promotion of technological innovation and access to medicines.