A Comparative Study on Human Embryonic Stem Cell Patent Law in the United States, the European Patent Organization, and China

Abstract

With the recent developments in biotechnology, associated patent law issues have been a growing concern since the 1980s. Among all the subcategories within the general field of biotechnology, human embryonic stem cell research, as one of the most controversial, is receiving different patent system treatment in different countries. China explicitly opposes the patentability of hESCs in its patent regulations on the basis that patenting hESCs is contrary to morality and the public interest. Similarly, the EPO, relying on ambiguous language in the European Patent Convention [EPC], excludes hESCs from patentability by broadly interpreting the morality clause of the EPC. In contrast, the United States has become the main progenitor of hESC patents. By analyzing the reasons to grant or deny patents on hESCs, and considering patent law doctrines and justifications, this dissertation reaches two conclusions. First, patent law should not include a morality clause and should only take into consideration technical concerns. Moral issues should be left to other mechanisms such as administrative law. This is an approach deeply rooted in the American patent system, but not in China or the EPO. Second, by reviewing the requirements of patentability such as novelty, non-obviousness and utility, it can be concluded that hESCs themselves are not patentable because they lack a specific concrete utility and, since they already exist in nature, they lack novelty as well. However, hESC production processes and derivative products are patentable.