High Court to Hear Landmark Dispute over Breast Cancer Gene Patent

Friday 3 July 2015 @ 11.57 a.m. | IP & Media

The High Court is currently presiding over one of the largest genetics patent cases in Australian history. As recently reported, Queensland breast cancer survivor Yvonne D’Arcy brought the case against US genetics research company Myriad Genetics after the company was granted a patent in Australia to a hereditary gene associated with the increased risk of breast cancer. Previous to the High Court hearing, the Full Federal Court had already ruled in favour of the Genetics company stating that the isolated nucleic acid, including DNA, has resulted in an artificially created state of affairs for economic benefit.

Background to the Case

Myriad Genetics owns Australian Patent Number 686004, being a patent over the invention of certain methods of detecting the gene BRCA1 and of using components and mutations of that gene in the diagnosis of predisposition to breast cancer and ovarian cancer. D’Arcy challenged the patent on the ground that the claim involved naturally occurring nucleic acids that was merely isolated by Myriad without the necessary “manner of manufacture” as prescribed in s18(1)(a) of the Patents Act 1990 (Cth).

Previous Decision

The matter originally appeared before the Federal Court where Justice Nicholas dismissed D’Arcy’s argument. His Honour found that the disputed claims pertained not to nucleic acids as they existed within human cells but to nucleic acids which had been extracted from such cells and purged of associated biological materials. In this respect, it was ruled that the disputed claims satisfied a “manner of manufacture” for the purposes of Australia law.

The matter subsequently appeared before the Full Federal Court where it was unanimously dismissed. The Court found that the isolated nucleic acids, as described in the disputed claims, were chemically and functionally different from those which occurred in nature. Only once those acids had been isolated could they be used for the described comparison with tables of coding determine the presence of any mutations in BRCA1 polypeptides that would indicate a likelihood of cancer. This was thus an artificially created state of affairs for the purpose of the Act.

Current Hearing

D’Arcy continues to argue that the genes existed in nature so were discovered rather than invented by the company. A ruling reflecting that, D'Arcy says:

 "is going to enable research, whereas at the moment it is stymied because you can't research…We need to find out what turns these genes on, what makes them go rogue and what can turn them off…And for people who have a genetic disorder then that is a plus for them because forewarned is forearmed."

Myriad Genetics is expected to tell the High Court that the patent applies to a product, an isolated nucleic acid, that is chemically, structurally and functionally different to naturally occurring DNA. Historically, the disputed claim had already failed in the USA where the US Supreme Court had ruled that naturally occurring DNA was a product of nature is cannot be patented.

However, the test in the USA is simply where the disputed claim ‘is a product of nature.’ The test in Australia is significantly less strict than its US counterpart. In Australia, the manufacture test applies. Myriad argues under Australian law the emphasis was on the differences in the structure and function of the genetic material and not the similarities as it would be in the US.

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