Implications of Genetic Patents on Human Genetic Resources: Issues of Ownership, Benefit Sharing and Informed Consent

Abstract

With the increasing commercialization of human genetic research, human genetic material has become a source for patenting. The increased extension of patent rights to human genetic material has serious implications for research subjects and patients whose genetic material is used in the research. The ownership of human genetic material has become a controversial issue as a variety of proprietary rights are claimed over it such as patent rights, personal rights, sovereign rights and academic rights. Among these claims, the ownership rights claims of patients, researchers and research subjects has been contested in courts and started an open debate among legal scholars and policy makers. In genetic research, researchers and sponsors thereof are basically concerned to exploit the human genetic material to earn credit by claiming their exclusive rights. It raises the question, whether may researchers obtain patent rights through observation, isolation and manipulation of the human genetic material, without recognizing and admitting contribution of research subjects and patients who have given their genetic material for the research? The commercial exploitation of human genetic material is not confined to an individual but it also extends to human genetic resources of countries. Trade-Related Aspects of Intellectual Property Rights (TRIPS) does not contain any explicit reference to genetic material, and the laws that restrict access to genetic material to obtain remuneration for the nation such as Convention on Biological Diversity (CBD) exclude human genetic material from their ambit. This has led to a growing exploitation of human genetic resources for scientific or commercial purposes.