Legislative changes are urgently needed to stop patents being granted over human genetic material, according to Sally Crossing AM, from Cancer Voices Australia.

Below is a summary of her recent presentation on this issue to a Coalition Backbench Policy Committee, on behalf of Cancer Voices, representing people affected by cancer.


Making a difference for people with cancer: it only needs 1.5 pages of legislative action
Sally Crossing writes:

There is a pressing need to amend Australia’s Patents Act (1990) –  to clearly exclude the ability to grant patents over human genetic material.

We need this to improve and save lives by freeing research from this encumbrance.

A recent American Supreme Court decision makes this even more pressing.

In the US naturally occurring human genetic materials that have been ‘isolated’ from their natural environments are no longer patentable.  They now have certainty of freedom to use human genetic material – which we in Australia do not have.  This has major short and long-term impacts for health consumers and researchers.

That decision has overturned an interpretation that the Australian community finds abhorrent – ask anyone if they think bits of their bodies, inside or outside them, should be patentable.  The unequivocal, usually unbelieving, answer is always NO.

We are encouraged to note that most MPs of all parties are of a similar mind, and in fact have made numerous attempts – since 1996, to amend our Patent Act.

Removing the ability to patent biological materials that have simply been removed from their natural environment is enormously important – ethically and economically – and in the areas of diagnosis, treatment and research.

We think the stars are now aligned for a commitment by the next Australian Government to make such an amendment one of its first legislative acts.

Why is Cancer Voices Australia concerned about this issue – and what are we doing? 

We were concerned enough to have been a plaintiff in the single judge Federal Court case which gave a negative decision in February this year.  Concerned enough to launch a Say NO to Gene Patents campaign, to continue talking to MPs, to continue  talking to the media, by raising a formal Petition – to doing anything we can to gain your attention to the mounting public concern over this very big issue.

AND it’s bigger than a couple of breast cancer genetic mutations – it’s even bigger than cancer – which itself now annually causes more Australians deaths than any other disease.

Diagnostic testing and treatment of all kinds of disease and conditions increasingly rely on genetic profiling – this is the necessary step before we can benefit from true personalised medicine.

We people with cancer are hoping we live long enough so that more of us will benefit from treatment that directly addresses our own particular genetic profiles.  This coming era is recognised by the clinical and research worlds as the next big advance in medicine.  And we consumers of their services recognise it too!

A little history:

2002 Genetic Technologies’ first threat to enforce its breast cancer gene patents caused media and community outcry

2003  Genetic Technologies “gifts” its patent rights to the Australian people

2008  Genetic Technologies threatens to sue Australian laboratories using BrCa tests and calls for transfer of all genetic material to them.  Further public outcry and another withdrawal of threat / ie more “gifts” to us of our own DNA

2009  Senate Community Affairs Committee holds an Inquiry into gene patents

2010  Cancer Voices Australia & Yvonne D’Arcy challenge Myriad’s patent over isolated Br Ca 1 DNA

2010  Bill to ban gen patents introduced to Parliament and referred to a Senate Committee

2013  Australian Federal Court decides patent claims on isolated DNA are patentable (Feb)

2013 US Supreme Court decides they are not patentable (June) on Appeal

2013 Full Federal Court of Aust. of 5 judges will hear an Appeal re the Feb decision (Aug)

You can see that 2013 has proved to be a stellar year for the debate, with a little help from Angelina Jolie (“Court wipes patent on  Angelina Jolie genes”, The Australian 15 /06).

Hopefully your decision will turn sustained, thoughtful debate into positive history via a one and a half page amendment to the Patents Act.

How does the US decision impact on Australia?  Now & future

The Supreme Court of the United States delivered its decision on patenting genetic testing for breast cancer and ovarian cancer in Association for Molecular Pathology v. Myriad Genetics.

In the lead judgment, Justice Thomas commented:  “Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention”.

Informed commentators, including Cancer Voices, have welcomed the example of the US decision and recognise it will have a far-reaching impact.

A 15 June SMH Editorial summed it up like this: “the new parliament should revive the lapsed 2010 proposals – this time without timidity and with a clear understanding that people’s lives can be saved without cruelling biotech research”.

The US decision gives our legislators the impetus to ensure we in Australia have certainty regardless of the reading of present patent law by Australian courts.

If Parliament acts soon, this will ensure certainty is gained quite quickly.  Australia needs to be aligned on such a fundamental issue as this, with the US – one of our major trading and research partners – or we will lose out to a freer market.

Free, unencumbered access to genetic information cannot be achieved when patents are used to suppress competition, innovation, research and testing – and treatment as well.

What do we want?

Cancer Voices Australia and the many people living with cancer today are calling for an Amendment to the Patents Act 1990, which would, as a minimum, clearly exclude the ability to grant patents over any human genetic material.

We now seek your commitment to this in the lead up to the Federal Election.




Q:  Haven’t we addressed this in 2011?

“Raising the Bar” legislation was limited to pure research, not to commercial or clinical use, hence did not address the main problem – the patentability of biological materials that no one invented.

Q: How will industry react?

Industry argued they need patents on human genetic material protect their investment.  This was the argument put vigorously by the US biotechs to their Supreme Court.  It was not upheld by the Court, although synthetic DNA (cDNA patents) remains so – the basis of much of their business.  Interestingly, Myriad itself is not complaining.  In the few hours after the decision, the price of testing fell by 2/3 as competitors moved in.  Share prices fluctuated up and down – and that part of the industry became competitive again. Industry would do well to watch happens in the US before threatening the falling in of the sky again.

Q: Why is CVA interested?

We care because personalised treatment depends on access to genetic profiling.

We also think the moral issue is an important one for the community.

It’s not just for one or two genes or one disease – it’s a public good.

Cancer patients and their health professionals also want full certainty of access, quality of testing and interpretation, appropriate counselling and ability to gain second opinions.

Q:  Aren’t patents expiring anyway?

Thousands (40%) of our genes have patents on them, patents expiring at different times – but more can be applied for at any time.  We are entering a new era of personalised medicine that depends on easy, fast and free access, to be able to target a range of genetic mutations and their combinations.

Q:  Why not wait till Australian Federal Court decision?

It could be a long wait and may again be negative.  But mainly we need certainty and ASAP.

Q:  Who else supports your position?

Cancer Council Australia, Royal Australian College of Pathologists, Human Genetics Society of Australia, Ian Frazer and other eminent researchers, Australian Medical Association, National Breast Cancer Foundation of Australia – for starters.

I feel confident we can add “the people of Australia” to that list.




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