Patently a problem? Recent developments in human gene patenting and their wider ethical and practical implications

Abstract

The issue of gene patenting has become re-enlivened with the recent decisions of both the Supreme Court of the United States and the Federal Court of Australia in regards to the patentability of isolated genetic material. The latter case, Cancer Voices Australia v Myriad Genetics Inc, upheld the validity of a patent over the isolated BRCA1 gene and has highlighted the wider implications of gene patenting in Australia. This article examines the legal issues arising from that judgment in respect of the ‘manner of manufacture’ requirement for patentability. It also analyses the ethical consequences of gene patenting and the impact of the monopolistic market control that is facilitated by patents upon the delivery of biogenetic healthcare, industry investment and the dissemination of research results. It will further consider community concerns regarding possible limitations in access to genetic testing and treatment and suggest means of redressing such concerns.