BRCA gene cannot be patented, says Australia's High Court

An isolated gene sequence cannot be patented, Australia's highest court has unanimously ruled. It is the latest and final decision in litigation that has lasted over five years.

Myriad Genetics was granted patents over isolated versions of the BRCA1 and BRCA2 genes in the 1990s. The patents effectively conferred a monopoly over the testing for certain gene sequences, which, if present in a patient, indicate an increased risk of developing ovarian and breast cancers.

Yvonne D'Arcy, who was twice treated for breast cancer, challenged the patents with the support of campaign group Cancer Voices Australia on the grounds that even it its isolated form, a human gene is not an invention.

Myriad contended, on the other hand, that isolated nucleic acid was chemically, structurally and functionally different from that found in a cell and was therefore patentable. Supporters argued that patent protection is necessary to encourage innovation in research and development for biological medicines.

Overturning two previous Federal Court decisions (see BioNews 693 and 770), the High Court ruled unanimously that an isolated nucleic acid coding for a BRCA1 protein was not a 'patentable invention' under Australian law.

The judges gave different reasons for their conclusion. The majority said that while the invention claimed might be, in a formal sense, a product of human action, it was the existence of the information stored in the relevant sequences that was an essential element. Other judges said that variations indicating increased risk of cancer was a 'matter of chance', and not something 'made' or 'artificially created'.

A broadly similar approach has been taken in Europe and Asia, and there is a challenge to gene patents yet to be heard in Canada. The High Court's decision also brings Australia's position in line with that in the USA, where Myriad Genetics lost their BRCA1 patent in 2013 (see BioNews 709).

The ruling means that other researchers and clinicians can now test for the gene without risk of infringing the patent. D'Arcy hopes that the decision will result in more affordable testing for patients.

Speaking after the court case, D'Arcy said: 'For all those people who do have the genetic footprint, it's a win for them, because now they're forewarned and forearmed.'