This Article draws upon the international relations theory of regimes to analyze the growing chorus of challenges to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs), and to the expansion of intellectual property rights more generally. The few years since TRIPs entered into force have seen nothing less than an explosion of interest in intellectual property issues in international fora not previously concerned with the products of human creativity or innovation. Intellectual property is now at or near the top of the agenda in intergovernmental organizations such as the World Health Organization and the Food and Agriculture Organization, in international negotiating fora such as the Convention on Biological Diversity's Conference of the Parties and the Commission on Genetic Resources for Food and Agriculture, and in expert and political bodies such as the United Nations Commission on Human Rights and its Sub-Commission on the Protection and Promotion of Human Rights. In some of these venues, intellectual property lawmaking has led to the negotiation of new treaties; in others, challenges to TRIPs are framed through reinterpretation of existing agreements and the creation of nonbinding declarations, recommendations, and other forms of soft law. The theoretical and practical consequences of these new developments have yet to be fully explored. I argue in this Article that the expansion of intellectual property lawmaking into these diverse international fora is the result of a strategy of "regime shifting" by developing countries and NGOs that are dissatisfied with many of the provisions in TRIPs and are actively seeking ways to recalibrate, revise, or supplement them. State and non-state actors shift lawmaking initiatives from one international regime to another for many reasons. In the case of intellectual property rights, developing countries and their allies have shifted negotiations and hard and soft lawmaking initiatives to four international regimes - those governing biodiversity, plant genetic resources, public health and human rights - whose institutions, actors, and subject matter mandates are more closely aligned with these countries' interests. Within these four regimes, developing countries are questioning established legal prescriptions and generating new principles, norms, and rules of intellectual property protection for states and private parties to follow. Intellectual property regime shifting thus heralds the rise of a more complex international environment in which seemingly settled treaty bargains are contested and new dynamics of lawmaking and dispute settlement must be considered.
Laurence R. Helfer, Regime Shifting: The TRIPs Agreement and New Dynamics of International Intellectual Property Lawmaking, 29 Yale Journal of International Law 1-83 (2004)