Four things you should know about gene patents
Posted: September 10, 2014 at 5:42 am
By Rodney Scott
The Federal Courts decision that gene patenting is permitted in Australia will have ramifications for all gene patents, even though the case involved only one gene associated with breast cancer.
A gene patent means only the patent-holder has the right to undertake research and development involving that gene. These patents generally last for 20 years.
The full bench of the Federal Court heard the appeal against a ruling that private companies could patent genes in August 2013, after a Federal Court justice dismissed a challenge to the patent for a breast cancer gene, BRCA1, in February.
A landmark ruling by the US Supreme Court in June 2012 declared that naturally occurring DNA sequences were ineligible for patents in a case that involved the same breast cancer gene, and the same patent holder.
Its about 20 years since Myriad Genetics patented two genes associated with a significantly increased risk of developing breast cancer. Known as BRCA1 and BRCA2, the genes are also associated with an increased risk of ovarian cancer.
When functional, BRCA1 and BRCA2 produce tumour suppressor proteins that help repair damaged DNA. But when they are altered, the protein is either not made or doesnt function correctly, leaving DNA damage unrepaired. The cells may then develop additional genetic alterations that can lead to cancer.
Breast cancer affects approximately one in ten women at some time in their lives, although not all cases result from these genetic mutations. Studies have estimated that the frequency of BRCA1 and BRCA2 changes in the community is approximately one in 500.
Identifying these gene carriers is an important step in reducing disease in the community and in preventing transmission into subsequent generations. Indeed, any measure that can reduce breast cancer figures and help women avoid an incurable disease is something any reasonable society would aim for.
The BRCA1 and BRCA2 patents have generated significant controversy because Myriad has effectively monopolised the market for screening these genes to identify the alterations, or mutations, that render them non-functional.