Comparative Legal Review: Reassessing the Social Contract in Europe and the United States for Patenting Human Genetic Materials

Abstract

In 2013, the US Supreme Court declared isolated gene sequences as ‘products of nature’ and hence, unpatentable subject matter. Paradoxically, the European Patent Office (EPO), relying on the EU Biotech Directive 98/44/EC, does not perceive a problem with patents on isolated human genetic sequences. However, the EPO excludes human embryonic stem cells (hESCs) from being patentable subject matter on the grounds of morality and ordre public. The controversy arises from an understanding that gene patents create a de facto tragedy of the anti-commons. This, in turn, is based on a wider belief that the current statutory regime governing the patent protection of human genetic materials creates expansive property rights, without a proper consideration of the public interest. This thesis tests this proposition by examining and revealing the contextual genesis of these bifurcated reactions by the United States and European jurists. First, it reframes the historical evolution of patented inventions within the biotechnology sector. By adopting the concept of patents as a social contract between the inventor and society, the research reasserts the fundamental aspects of patent law. Second, the subsequent chapters employ this primary premise in order to map out the theoretical arguments for propertizing genetic materials. Finally, the thesis investigates the possibility of policy guidelines by gathering an empirical dataset through questionnaires and interviews directed at key stakeholders. This work maintains that the current statutory regimes in Europe and the US governing the patent protection of human genetic materials can create acceptable property rights. But this is only possible if the regime adopts a purpose-bound approach for human genetic materials. Such an enhanced status quo approach, as adopted in some European jurisdictions, would entail the consideration of public interest values, as articulated through the empirical research, and which has been set out as a draft manifesto.