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.
Highlights
The emergence of genetic medicine as well as advancements in biotechnology have been accompanied by a significant proliferation in the number of patents granted over biological materials
This debate surrounding the patentability of genetic materials has been recently re-enlivened by the judgment of Nicholas J in Cancer Voices Australia v Myriad Genetics Inc (Myriad Genetics),[2] which upheld the validity of a patent over isolated human genetic material
As the first Australian case to uphold the practice of granting patents over human genetic material, Myriad Genetics has raised legal, and significant ethical issues regarding the suitability of human genetic material for patentability
Summary
The emergence of genetic medicine as well as advancements in biotechnology have been accompanied by a significant proliferation in the number of patents granted over biological materials. Recent debates in Australia regarding the patenting of such substances, in particular human genomic materials, have raised concerns about the ethical and practical implications of patenting in the biotechnology sector. This debate surrounding the patentability of genetic materials has been recently re-enlivened by the judgment of Nicholas J in Cancer Voices Australia v Myriad Genetics Inc (Myriad Genetics),[2] which upheld the validity of a patent over isolated human genetic material. The article will further provide a balanced view of the practical, and ethical implications of gene patenting. The wider bioethical implications of patenting human biological materials under the Patents Act 1990 (Cth) (‘Patents Act’) will be explored to determine whether the rationale behind patenting human genetic material is supported by compelling justifications
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