This chapter provides a summary of the key arguments made in this book. Crucially, the regulatory theory of patent law, which adopts a socio-centric approach to patent law, permits the incorporation of a model of human rights into a country’s patent law system. The model of human rights demands that any regulatory instrument implemented by a state must not constitute a breach of its international human rights obligations. The incorporation of a model of human rights into the design, implementation, interpretation, and enforcement of their national patent laws will help developing countries to preserve their patent policy space and secure access to affordable medicines for poor patients in their countries.

This chapter begins by introducing the problem of access to affordable medicines in developing countries. It describes the patent policy space available to states prior to the adoption of the TRIPS Agreement and the attempts made by developing countries to reclaim their patent policy space after the adoption of the TRIPS Agreement via the Doha Declaration on the TRIPS Agreement and Public Health. It notes that the Doha Declaration only yielded marginal gains in the form of the confirmation of the flexibilities that are already contained in the TRIPS Agreement and the introduction of a waiver system that is more burdensome and less beneficial. Nevertheless, the chapter contends that paragraph 4 of the Doha Declaration provides a linchpin that developing countries can use to preserve their patent policy space as it sanctions the incorporation of a right to health perspective, and invariably the incorporation of a model of human rights, into the design, implementation, interpretation, and enforcement of their national patent laws. The chapter also presents a roadmap for the rest of the book.