BRCA Gene Patent Struck Down By Supreme Court

First Posted: Jun 13, 2013 03:06 PM EDT
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An unanimous Supreme Court ruling today decided that isolated genes of humans cannot be patented in the U.S.

Many believe this decision marks a victory for cancer patients, geneticists and researchers throughout the country, who believe that raised costs and possibly forced medical decisions could harm overall health. 

Justice Clarence Thomas wrote the decision for a unanimous court, stating that "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." 

Myriad acknowledged the court's ruling that five of its claims that looked at isolated DNA would not be patent eligible. The Salt Lake City company "has more than 500 valid and enforceable claims in 24 different patents conferring strong patent protection for its BRACAnalysis test," according to a statement made by the company today. 

The Mayo Clinic notes that the BRCA gene test uses DNA analysis to identify mutations relating to breast cancer susceptibility genes-including the aforementioned BRCA1 and BRCA2 genes. "Women who have inherited mutations in these genes face a much higher risk of developing breast cancer and ovarian cancer compared with the general population," the website writes. "The BRCA gene test is offered only to people who are likely to have an inherited mutation, based on personal or family history, or who have specific types of breast cancer."

However, the courts also noted that the possibility to patent synthetic genetic material would be acceptable. 

"Today, the court struck down a major barrier to patient care and medical innovation," said Sandra Park, via The Associated Press, senior staff attorney with Women's Rights Project of the American Civil Liberties Union, which had challenged the patents.

"Myriad did not invent the BRCA genes and should not control them. Because of this ruling, patients will have greater access to genetic testing and scientists can engage in research on these genes without fear of being sued."

Recent news surrounding popular actress and celebrity Angelina Jolie shows that women with these gene mutations including BRCA1 or BRCA2 are five times more likely to be diagnosed with breast cancer, according to the National Cancer Institute. However, less than 1 percent of women actually have either gene, which many feel would make genetic testing ridiculously and unnecessarily expensive.

Other opponents of the patent also note that this would have allowed Myriad to set various cost parameters for testing and created added difficulties for treatments.

"The court rightfully found that patents cannot be awarded for something so fundamental to nature as DNA," said Daniel B Ravicher, executive director of Public Patent Foundation and co-counsel in the lawsuit, via The Guardian.

With the patents, Myriad is the only place in the United States where diagnostic testing can be received at $3,340. 

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