Is isolated DNA patentable?

DNA patent

A patent is a right granted for a device, substance, method or process that you have invented which is new, inventive and useful. This differs from a trademark, which is a method used to distinguish your goods and services from those of another trader.

In the recent case of D’Arcy v Myriad Genetics Inc & Anor, the High Court discussed whether the genetic material isolated from the BRCA1 protein met the requirements of a patentable invention under s 18 of the Patents Act 1990 (Cth).

The BRCA1 gene is comprised of a sequence of DNA which contains the code used to produce the BRCA1 protein. In its ordinary form, BRCA1 protein is responsible for suppressing the growth of tumours in the human body by helping to repair damaged DNA.

However, some versions of the BRCA1 gene contain abnormalities in the sequence of DNA (known as mutations). This causes the production of a mutated form of the BRCA1 protein, which can no longer help to repair DNA in the body. Individuals who have this mutated BRCA1 gene and protein are at a greater risk of developing breast and ovarian cancer. It is this mutated sequence which Myriad claims to have ‘invented’.

For an invention to be patentable under the Act, it must be “a manner of manufacture”. The High Court held that the isolated DNA is not a product of human action and therefore does not qualify as patentable. While human action may have allowed the sequence to be discovered, Myriad did not create, make or alter the genetic code in any way as the information was already naturally occurring. “Discovering” a naturally existing material is considered distinct from “inventing” it.

With the sequence unable to be patented, Myriad will be unable to exercise a monopoly over the availability of the sequence. This could enable more researchers to access the sequence and lower the costs of genetic testing.

The High Court deemed any extension of the ‘manner of manufacture’ requirement “not appropriate for judicial determination”. It is likely that in the coming years, legislation will be passed to deal more specifically with DNA-based discoveries and patents as this is an area of scientific discovery which is rapidly evolving beyond current law.