Patently a Problem? Human Gene Patenting and Its Ethical and Practical Implications

Abstract

The issue of gene patenting has received renewed interest 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 highlighted the wider implications of gene patenting within Australia. This article examines the legal issues arising from that judgment with respect to the ‘manner of manufacture’ requirement for patentability. Additionally, it 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 services, industry investment and the dissemination of research results. It will further consider community concerns regarding limitations in access to genetic testing and treatment and will suggest means of redressing such concerns.

Keywords: patent law, gene patenting, healthcare ethics, genetic testing, biotechnology, intellectual property, manner of manufacture, gene patenting in international law, common heritage of mankind, TRIPS Agreement, Statute of Monopolies, market monopolies, Myriad Genetics, Patents Act 1900 (Cth)

JEL Classification: K10, K30