Patent Term Extension for Pharmaceutical Products in Free Trade Agreements and Policy Options for Mitigation of Health Implications

Pei-kan Yang

 

ABSTRACT: The patent term extension/adjustment for pharmaceutical products is one of the controversial issues in the negotiation of free trade agreements. Given the immense commercial and public interests involved in extending the regular patent term for pharmaceutical products, the implementation of patent term extension system should be cautiously evaluated for its potential impact on the access to affordable medicines. While the patent term extension system has been adopted domestically in the US and EU, it continues to proliferate globally through the free trade agreements. This paper will examine relevant patent term extension provisions in selected FTAs concluded by the US or EU, and discuss the policy considerations and options for mitigation of implications on public health. This paper argues that states could make use of flexible options to mitigate the impact on public health despite the proliferation of patent term extension system prescribed in the free trade agreements.