A fundamental rights perspective on the patentability of diagnostic genes

Abstract

Technological advances in the medical domain are critical in finding effective diagnostic and therapeutic instruments for curing genetic conditions. These advances include developing diagnostic tools used to diagnose such conditions. Diagnostic gene tests are an example of such a tool. These tests are developed using a gene that corresponds with identified disease-causing genes. The creation and development of diagnostic tests results in the patenting of genetic material becoming a general occurrence which raises the question on whether genetic material, being part of the human body and naturally occurring, could in fact qualify as patentable subject-matter. Several global intellectual property systems do accept and include genes, more specifically, diagnostic genes, as patentable subject matter. This results in overpriced diagnostic gene tests being put on the market remaining economically unavailable to most of the public. The discussion observes the benefits and limitations of patents in the field of biotechnology and explores alternative options including but not limited to patent exemptions and licences. The study then seeks to address the issue by analysing the right to property and health care, in order to find a universal application that allows for both the protection of, and accessibility to, innovation. Despite the public having the right to access health care, including access to diagnostic tests, inventors also have a right to property and seek to protect their invention. The discussion suggests that intellectual property laws, specifically those relating to diagnostic gene tests, should be observed and interpreted with the aim to balance the rights to access to health care and property, in order for the public to fully benefit from scientific development. The study also examines this aspect in selecting foreign jurisdictions and providing a comparative analysis that may provide global guidance around intellectual property and health in this regard.