25 February 2013
The Australian Federal Court has ruled that genes isolated from the human body may be patented.
The Court concluded that an isolated nucleic acid molecule is patentable, even where the sequence of the molecule is identical to that of the native molecule within the body. The decision was based on its view that removal of the material from its natural environment and separation from other cellular components constitutes an “artificial state of affairs”, which is one of the threshold requirements for patentability under Australian law.
The Court also considered the expense, skill and intellectual effort required to isolate nucleic acid molecules to be relevant, and commented that it would be an odd state of affairs if this could not be rewarded by granting a patent. The validity of gene patents had not previously been tested in court in Australia, but this decision is consistent with positions that have been taken by Australian legislative bodies.
Critics of the ruling fear it could restrict access to genetic tests and hinder new research. The case had been brought by patient advocacy group Cancer Voices Australia in partnership with an individual breast cancer survivor, Yvonne D'Arcy (see previous news). It was defended by the company Myriad Genetics and their exclusive Australian licence holder for BRCA1 and BRCA2 testing, Genetic Technologies, which caused controversy in 2008 when it attempted to enforce its patents by preventing hospitals and laboratories performing tests on the genes. Some worry the ruling could lead them to repeat this stance, this time with legal backing.
The Australian ruling is in alignment with that of the US Federal Court of Appeals last year, and which will be reconsidered by the US Supreme Court later this year (see previous news).