Listen to the BBC World Service interview with Dr Gareth Williams on this ruling at www.bbc.co.uk/programmes/p034mby7 (from 12:45 in).
The long-running saga of Myriad Genetics’ patents on the breast cancer gene BRCA1 has reached another conclusion with the High Court of Australia finally ruling that isolated nucleic acids embodying naturally occurring sequences are not patentable subject matter in Australia. Myriad’s Australian patent was granted with claims covering “isolated nucleic acids” coding for the BRCA1 polypeptide and including one or more mutations or polymorphisms which were associated with increased risks of developing breast cancer. The appellant, Yvonne D’Arcy, had argued that such claims were not patentable in Australia.
Despite the lower courts siding with Myriad, the High Court overturned the initial rulings on the basis that an isolated nucleic acid was not a “manner of manufacture” within the meaning of the Statute of Monopolies; the Australian Patents Act requires that an invention fall within this definition. The Court’s reasoning was primarily that the substance of the claim was to the information inherent in the gene sequence; that information would be present in the nucleic acid as found in cells as well as in the isolated form. As the Court put it, “that information is not 'made' by human action”.
This decision was made despite the Australian Parliament rejecting proposed amendments to the Patents Act to exclude gene sequences from patentability; and indeed the argument that gene sequences were deemed patentable by Parliament (and those of other jurisdictions, such as the EU) was raised by Myriad.
Although isolated nucleic acids are not considered patentable, the ruling is not all bad news for biotech innovation. The Court was at pains to point out that Myriad’s patent contained many other claims based on the BRCA1 research which were not at issue – in particular, claims to probes for use in detecting the mutations; or to polypeptides embodying the mutated proteins. Such products appear to properly fall within the definition of a “manner of manufacture”, as they do indeed result from human action. Even though the sequences of such nucleic acid probes or polypeptides may be found in nature, they nonetheless embody the contribution made by Myriad that certain mutations do predispose patients to cancer.
It seems therefore that the High Court have managed to avoid the sweeping ruling made by the US Supreme Court in the BRCA1 case heard there (see our previous article) which threw the biotech and healthcare industries into shock by declaring that “naturally occurring products” or “products of nature” were inherently unpatentable in the USA. Our view is that, although it may be a disappointment to industry, this ruling sends a clear signal that biotech and healthcare innovation will continue to be protected in Australia, in particular for therapeutic applications arising from genetic research, and for other naturally-occurring products such as antibiotics or antibodies.