Allens insights

Patent case a win for everyone

By Dr Trevor Davies (view CV) and Sarah Matheson (view CV)

There has been a long-standing public debate as to whether genes and their biological products should be patented. The Australian Patent Office has consistently recognised isolated DNA and RNA as patentable but that hasn't quietened debate.

The oft-cited concern is gene patents will restrict both research and public access to diagnostic tests and medical procedures by awarding monopolies to companies that detect a new gene and its biological function. These are not to be confused with naturally occurring genes; DNA or RNA as they exist inside the cells of the human body are not covered by gene patents.

This month the Federal Court went a long way to settling the debate with a landmark decision that confirmed isolated nucleic acids encoding genes and their biological products are patentable subject matter.

The decision sends a clear message to innovation companies in this space that they can continue to protect and commercialise their biological innovations in Australia, and that they will be rewarded for their extensive investment and efforts.

In turn, the public will benefit from improvements to diagnostic testing, new treatments and medical care.

The decision related to an Australian patent held by American biotech company Myriad Genetics for isolated nucleic acid encoding mutations of the human gene BRCA1 and uses of the nucleic acid in diagnostic tests for elevated risk of breast and ovarian cancers. Cancer Voices Australia, which represents people affected by cancer, challenged three claims of this patent directed to the isolated nucleic acid.

The court found isolated nucleic acid is patentable because it consists of an artificially created state of affairs that is of economic significance. In handing down his judgment, Justice John Nicholas explained that nucleic acids encoding genes, isolated from their natural cells in which they were found, constituted a 'manner of manufacture' and therefore were suitable subject matter for patent protection.

Though lawyers for Cancer Voices have suggested an appeal is in the offing, the ruling is a win for innovators and users of Australia's medical system. Medicine is more reliant than any other industry on innovation to drive better care and efficiencies. This invention was made in 1994 and has resulted in new tests to detect predisposition to breast and ovarian cancers and improved the clinical outcome of many patients throughout the world. Without patent protection, it is unclear whether these tests would have been commercialised by Myriad Genetics.

This is an important decision for Australia's $48 billion biotechnology industry.

Greater certainty in this field is likely to encourage future investment, offering growth opportunities and further cementing Australia's position as a leading location for biotechnology companies in the Asia region.

An edited version of this article was published in the Australian Financial Review on 21 February 2013.

For further information, please contact:

Share or Save for later

What are these?


To save this publication on your smartphone or
tablet for off-line reading (eg on a plane flight),
we recommend Pocket.