Court rules cancer gene patent invalid

Experts said the Australian decision could impact access to genetic testing, medical research and treatments in the country.

As ABC News explained, Australian inventions are subject to something called the “manufacture test”, in which the differences in structure and function of genetic substances is emphasized, not the similarities as is the case in the States.

They contended that allowing corporations to own patents over human genes stifles cancer research and allows them to charge exorbitant rates for patients who wish to be tested for the BRCA1 mutation.

The High Court of Australia [official website] ruled [order, PDF] Wednesday that the genetic material, BRCA1 [NCI backgrounder], is not a “patentable invention” under §18(1)(a) of the Patents Act 1990 [text].

The Court held that, having regard to the relevant factors, an isolated nucleic acid, coding for the BRCA1 protein, with specified variations, is not a manner of manufacture. Critics argued that this was aimed at heading off a legal challenge in Australia.

D’Arcy and her lawyers from Maurice Blackburn had successfully argued that BRCA1 was a naturally occurring gene and was not a patentable invention.

The High Court of Australia today ruled in favour of a cancer survivor in a landmark judgment against a USA biotech firm. As such, they should have exclusive commercial rights to the gene (even though it occurs naturally in the human body…finders keepers and all of that).

ANN FULLER: It seems to set a pretty significant global trend, so we’re optimistic and hopeful of what this can mean for our case in Canada, which is quite similar.

Myriad, whose ownership of BRCA-1 and BRCA-2 had previously been overturned by the US Supreme Court, successfully won the case twice in Australian Federal Courts.

“Myriad did not create, make or alter those specific mutations and polymorphisms. Those sorts of inventions should not be affected by this decision”, Dr Davies said.

“These sorts of patents for things like BRCA, they were coming out in the 1990s when people were making these really broad claims”, she says. “What is important is its effect on the availability of patents in new areas of technology more generally”.

“It shifts the balance a bit away from the more substantial entitles in the space and opens up opportunities for others”, Mr Lee said.

Mr Shoebridge said without patent protection there was a risk companies would not invest the money required to commercialise innovations that governments could not afford to.

The court decision in Australia is yet another setback for Myriad in its efforts to patent the gene.

“Moreover, the fact of the matter is that companies like Myriad never enforce their patents against researchers”, Dr Shoebridge said.

Unsurprisingly, individuals who have devoted their lives to fighting breast cancer are also jubilant over this decision.