Fighting to protect women’s genes and medical freedom of choice

3 April 2012

Rebecca Gilsenan, Sydney

The fundamental question of whether we own our genes when they're outside our body was recently considered in the Federal Court in Sydney. The groundbreaking test case focuses on whether isolated human genes are patentable started on Monday 20 February. A decision is yet to be handed down.

Who's involved

Maurice Blackburn is running the case pro bono through our Social Justice Practice, with support from barrister David Catterns QC and Professor Peter Cashman of Sydney University.  We've teamed up with national consumer organisation Cancer Voices Australia and Yvonne D'Arcy, a Brisbane woman with breast cancer, and we're challenging biotech companies Myriad Genetics Inc and Melbourne-based Genetic Technologies Ltd. Read our original media statement here.

What the case is about

The case focused on the patent over mutations to an isolated gene known as BRCA1.  When these mutations exist on the BRCA1 gene they are associated with an increased risk of hereditary breast and ovarian cancer.

The law states that patents protect "inventions", not "discoveries".  Myriad has isolated the gene from the human body.  We will argue this isolation cannot amount to a patentable invention.  Isolation of genes from the body can be done by any number of established laboratory techniques, and we will argue that the isolation of BRCA1 is no more than a medical or scientific discovery of a naturally occurring phenomenon.

Patents in Australia

The Federal Government's patents body, IP Australia, has been handing out patents over isolated human genes for some years. No laws have been passed to specifically allow this, and no Australian court has ever decided whether the practice is legal.  That's why this case is breaking new ground.

A patent is a monopoly right to control the use of an invention.  The law is clear that only inventions which constitute a "manner of manufacture" or "manner of new manufacture" can be patentable. For example, if a person invents a new type of car part, they can apply for a patent over it.  If the patent is granted it means that they can stop other people from producing that car part, or they can charge people money to produce it.

Myriad Genetics'  "invention" has been given the title of "In vivo mutations and polymorphisms in the 17q-linked breast and ovarian susceptibility gene".  This means a mutated gene known as BRCA1 which is associated with breast and ovarian cancer and has been isolated from the human body.

Monopoly over gene use

The granting of the patent means that Myriad Genetics and companies to which it sells licenses - such as Genetic Technologies in Australia - have a right to stop anyone else from isolating, testing, researching or otherwise using that gene.

Presently, the patent is not being enforced in Australia but there have been moves to do so. On 7 July 2008, Genetic Technologies announced to the Australian share market that it intended to enforce its exclusive rights.  Its CEO sent a letter to numerous medical, pathology and cancer centers in Australia alleging that they had infringed and were continuing to infringe its exclusive patent rights, by testing patients for the BRCA1 genetic mutation.  Genetic Technologies gave other testing facilities seven days to cease testing, and demanded that the facilities refer all of their patients to Genetic Technologies' services. The letters caused a public backlash, and Genetic Technologies did not follow through on this threat; but they could still do so at any time until the patent expires.

The US situation

In the United States, Myriad Genetics has taken legal action to enforce its patents in 1998, 1999 and 2000. Similar legal proceedings are currently in the US courts challenging Myriad Genetics' right to own a patent over a human gene.

The US experience illustrates the potential impact on cancer patients or people at risk of cancer.  Currently in the US, Myriad charges more than $3000 per test and does not allow any other laboratory to perform full diagnostic testing on patients who wish to know if they have an increased risk of breast or ovarian cancer.

The high cost means that many women are not tested and not able to make informed decisions about further screening and treatment. Myriad's monopoly also means that women in the US cannot get a second opinion from another laboratory.

Why this case is important

If Maurice Blackburn wins this case in Australia, it will enable Australian women to have the freedom of choice over their medical testing.  It will also allow for much more diverse research into gene mutations.  At the moment, anyone who wants to study patented gene mutations has to either gain permission from the patent owner, or run the risk of being sued.  Limiting these patents will allow researchers to focus on what they do best - coming up with cures and solutions, rather than worrying about the law.