Landmark patent ruling over breast cancer gene BRCA1

Amy Corderoy
Sydney Morning Herald

More patents over human genetic material could be granted after a landmark ruling in the federal court in Sydney on Friday morning.

Federal court Justice John Nicholas has ruled that a private company can continue to hold a patent over the so-called breast cancer gene BRCA1, in a decision that has devastated cancer victims.

The decision is the first in Australia to rule on whether isolated genes can be patented, and will set a precedent in favour of commercial ownership of genetic material.

Women with certain mutations in the BRCA genes have a 65 per cent increased risk for breast cancer, and a 40 per cent increased risk of ovarian cancer.

The case was fought by the law firm Maurice Blackburn, on behalf of Cancer Voices Australia and a Brisbane woman with a history of breast cancer, Yvonne D’Arcy.

Rebecca Gilsenan, the principal lawyer at Maurice Blackburn, said the company had argued that isolating a gene did not constitute manufacturing a new invention, and so should not qualify for a patent.

“We argued that isolated genetic material is not an invention but is naturally occurring,” Ms Gilsenan said. “The ruling … has far reaching consequences for future medical research and genetic testing.”

Ms D’Arcy was in tears as she left court this morning.

“To tell the truth I’m very disappointed,” she said. “We were doing this for future generations, and I’m just so disappointed.”

Ms Gilsenan said Maurice Blackburn would not rule out appealing against the decision.

“We will consider what the judgment says and consider our options,” she said.

Justice Nicholas also awarded costs against the applicants.

The BRCA1 patent is granted to a US biotechnology company, Myriad Genetics, which in Australia has granted an exclusive licence to the patent to a company called Genetic Technologies Limited.

In 2008, Genetic Technologies attempted to enforce its patent rights over the gene, and threatened pathology and cancer centres with legal action.

After a public backlash it did not follow through with its threat, and it has not actively defended the case in Australia.

But Myriad Genetics had defended its patent rights in the Australian case.

In the US, where the case against the BRCA1 patent is also being fought, there have been several decisions and appeals.

The US Supreme Court will again consider the case in its current session, meaning a hearing is expected before the middle of the year.

Correction: The original version of this story said that women with the BRCA genes have a 65 per cent increased risk for breast cancer, and a 40 per cent increased risk of ovarian cancer. It has been corrected to say that women with certain mutations in the BRCA genes have the increased risk.

Comments are closed.