Secrecy, Monopoly, and Access to Pharmaceuticals in International Trade Law: Protection of Marketing Approval Data Under the TRIPs Agreement

摘要

Among the many trade conflicts that divide the postindustrial economies of Europe, the United States, Japan, and the Commonwealth from the less information-driven economies of the rest of the world, one of the most consequential is the debate over how to balance access to medicines with the intellectual property protection demanded by their developers. Among the many facets of this debate is the question of whether pharmaceuticals, vaccines, biologies, and other therapeutic or preventative health consumables (to which this article will refer collectively as "drugs") should be patentable in developing countries. This debate was partly resolved by the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs Agreement), which allows signatories to exclude from patentability "diagnostic, therapeutic and surgical methods for the treatment of humans or animals" yet requires the patenting of pharmaceuticals after a transition period. Nonetheless, disagreement about access to medicines has plagued subsequent negotiations. The economically developed states, led by the United States, have demanded that WTO members cease liberal compulsory licensing practices and adopt patent protection regimes equivalent in most significant respects to those of the United States and Europe.