Patenting human biological materials and data: balancing the reward of innovation with the ordre public and morality exception

Abstract

The availability of human biological materials and data plays a key role in promoting biotechnological innovations and conducting biomedical research. While the function of patent rights in promoting innovation is widely discussed, there are still overarching concerns in patenting human biological materials and data, including triggering commercialization and commodification of the human body, precluding affordable access to the products or services and inducing interest extraction by patent holders to recoup investments and make excessive profits. This article aims to analyse the extent to which the ordre public and morality exclusion can protect the human being whose bodily material has been taken and prevent legal and ethical exploitation. We argue that the concept of ordre public and morality needs to be modified, sparking a new governance approach to better protecting human beings in a patent system that is more participatory, accountable and transparent in patent assessment.