The presentation will focus on how pharmaceutical companies have expertly navigated the confluence of patents with regulatory data protection to leverage the market in order to effectively create increased protection and financial rewards for materials that could otherwise be susceptible to generic competition. The focus of the presentation will be on the international trade obligations relating to providing data exclusivity, and the solution to alleviate the adverse impact of data exclusivity obligations on access to medication with a specific focus on developing countries while keeping the US regime as the vantage point to examine the issues.