The High Court today overturned the rulings of lower courts in D’Arcy v Myriad Genetics Inc  HCA 35, determining that the breast cancer gene BRCA-1 cannot be patented. The High Court ruled that merely isolating naturally occurring genes in the artificial environment of a laboratory is not an invention as it is not a “manner of manufacture” within the meaning of s6 Statute of Monopolies 1624 – one of the tests for patentability of inventions under section 18(1)(a) of the Patents Act 1990 (Cth). The overall concern was that ownership of the gene patent could stifle the research and development of treatments for genetic diseases.
Myriad Genetics had already been to the US Supreme Court which also ruled against the patent. The US Supreme Court ruled that naturally occurring DNA was a product of nature and not patentable subject matter merely by virtue of being isolated (Association for Molecular Pathology v Myriad Genetics Inc 596 US 12-398 (2013)).
The High Court has followed what was generally thought to be the case in Australian law prior to the findings of the lower courts.
The seminal authority on the “manner of manufacture” in Australia is the NRDC decision: National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252. There, the High Court held that the key elements in determining whether an alleged invention is a “manner of manufacture” are whether the invention resulted in an “artificially created state of affairs”, and whether it produced an economically useful result.
The decision will reinvigorate the debate as to the overall economic advantages of having less rather than more lenient approaches to patentability.
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