Concern over gene patents

Eleanor Walton reports on a ruling on a gene patent in Australia that could change the landscape of patent law and genetic research

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The code of life is patentable; according to a recent ruling by the Australian federal court. On 15th February, Justice John Nicholas ruled that Myriad Genetics would be able to keep and enforce their Australian patent of a gene linked to breast and ovarian cancer, BRCA1, much to the furore of many cancer charities and scientists worldwide.

The patenting of genes has caused great divide between those that believe that companies should be able to protect their investment in genetics and those that believe that being able to patent something that naturally occurs in the human body is unpractical, and in the case of BRCA1, can lead to patient harm.

Myriad first filed for US patents on BRCA1 and the closely related BRCA2 back in 1999, and have also filed patents in Europe and Australia, most of which have been granted by the relevant patent offices.

Charities and patient groups have been trying to overturn these ever since. The result of the Australia court case is likely to reflect the outcome of outstanding appeals against Myriad across the globe. This issue will be played out again in America's Supreme Court on 15 April, between Myriad Genetics Inc. and the Association for Molecular Pathology.

The result of this patent gives the company the monopoly on genetic screening in countries where they enforce their patent. It is this fact which is the most worrying for cancer charities. So far, public outcry has prevented Myriad enforcing this in Australia, although there is no legal reason why they cannot. In countries like America, where Myriad do impose their legal rights, all tests are performed in their Salt Lake City lab and can cost between $300 and $3000 for each test, depending on the level of scrutiny. Without any competition for tests, these prices may be inflated.

However, genetic testing is still fallible and it has been reported that tests provided by Myriad Genetics still misses 10-20% of BRCA mutations. Myriad's monopoly means that people cannot get a second opinion on inconclusive tests, leaving those considering prophylactic mastectomy more confused.

So why is BRCA so important? DNA is a form of nucleic acid which codes all of the information necessary to build and orchestrate the day-to-day running of cells. Damage to DNA can cause all kinds of chaos for cells and trigger the death of that cell to protect the rest of the organism. Cancer is the result of failure of multiple safe guards leading to uncontrolled cell division.

BRCA1 encodes a protein that helps to fix damaged DNA. Eradicating it increases the risk that DNA damage will go unchecked resulting in cancers. According to Myriad's website, a damaged or mutant copy of BRCA genes give a person an "87% chance of developing breast cancer and up to 44% for developing ovarian cancer by age 70."

The main reason Justice John Nicholas upheld the patent is because what they have patented is the isolated nucleic acid, something that could not exist without human intervention. This was despite his statement that the nucleic acid has "precisely the same chemical composition and structure as that found in the cells of some human beings" and that the techniques used to extract the gene are not unique.

New Scientist described isolating DNA in this way as "snapping a leaf from a tree" as the "process is so commonplace, it doesn't represent a substantially artificial state of affairs".

The patent covers all forms of isolated nucleic acid, including naturally modified forms and shorter versions. This means the patents affect both rights to screening tests and external scientific research into BRAC mutations. Although the Australian government has had the fortitude to add an "experimental use defence" to shield research, this protection is not universal.

While Myriad Genetics is not currently stopping researchers from working on BRCA1 & BRCA2, it no longer shares its own information with the scientific community, slowing down the research process. Additionally, if another group were to identify a detrimental mutation of BRCA in the course of their research they cannot inform the individual due to patent law (providing that the samples have not been anonymised under ethic laws).

If the trend in international patent law continues as predicted, the issue of who owns your genes is likely to become increasing complicated.

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