The Full Federal Court of Australia has confirmed in D’Arcy v. Myriad Genetics that isolated nucleic acids can be the subject matter of a patent application.

The court dismissed the appeal and unanimously upheld Justice John Nicholas’s first-instance decision in the Federal Court in February 2013 that a “valid patent may be granted for a claim that covers naturally occurring nucleic acid that has been isolated.”

Claire Gregg, a patent scientist at Spruson & Ferguson, said that the judgment is an important one. “While the Full Federal Court’s decision in Myriad has maintained the status quo in Australia when it comes to gene patenting, this decision now represents precedent by which the Federal Court and the patent office must abide in future matters relating to the patentability of isolated nucleic acids,” she said.

According to the judgment, the invention encompasses the “methods and materials used to isolate and detect the BRCA1 gene, some alleles of which cause susceptibility to cancer,” as well as “the use of the gene in the diagnosis of predisposition to breast and ovarian cancer.” The mutation of the BRCA1 gene is believed to account for about 45% of occurrences of familial breast cancer and more than 80% of ovarian cancer, the judgment said.

Under Section 18(1)(a) of the Patents Act 1990, any claimed invention must consist of “a manner of manufacture” to constitute patentable subject matter.

According to the Australian Law Reform Commission, for an invention to be a “manner of manufacture,” “it must belong to the ‘useful arts’ rather than the ‘fine arts’; it must provide a material advantage; and its value to the country must be in the field of economic endeavour.”

This was based on the decision in National Research Development Council v. Commissioner of Patents. In that case, which involved a newly developed treatment for killing weeds in crops, it was held that a claim which had as its subject matter “a product found in nature” could satisfy the “manner of manufacture” requirement if the product “involves and artificially created of affairs and has utility in a field of economic significance,” according to Spruson & Ferguson.

The Full Federal Court in Myriad took the NRDC principles into account and held that a gene sequence which is isolated is “different to the gene comprising the nucleic acid sequence as it exists in nature.” The court agreed that the challenged claims in the patent application did consist of a “manner of manufacture,” saying that the case was not about “the wisdom of the patent system” but rather “the application of Australian patent law, as set out in the Act and as developed by the courts.”

According to Gregg, the “manner of manufacture” requirement causes some to believe that genes such as the one in question do not make valid patent applications.

“The argument that genes should not be patentable stems from the notion that isolated nucleic acids represent mere discoveries in nature,” she says. “Concerns that the rights afforded by a patent for isolated nucleic acids extend to genetic information itself add an emotive aspect to this argument. However, the Full Federal Court was careful to emphasise that the claims at issue are directed to isolated compounds and not to information.”

She also explained why many think that genes should be patentable. “On the other hand, patents attract funding to support research efforts and provide a means of recovering costs for these efforts, encouraging innovation where it may not otherwise be financially viable,” she said. “Patents also make certain technologies available to the public so that they may be used to support other research efforts.”

The court said that it was not for judges to make a decision as to “whether, for policy or moral or social reasons, patents for gene sequences should be excluded form patentability.” That question, it said, should be left to the Australian Parliament.

Myriad’s application was reportedly being opposed by Yvonne D’Arcy because she thought that every female should be able to undergo testing for breast and ovarian cancer at an affordable price, something which she believed would not be possible if the technology were to be patented.

The gene patent market is a lucrative one. According to a recent report commissioned by IP Australia, the governmental IP agency, approximately A$795 million (US$697 million) were invested in health-related gene technologies in financial year 2011.

Counsel for D’Arcy said that they would fight the Full Federal Court’s decision “to the end,” but it is not known whether the High Court will grant leave for an appeal.