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Supreme Court Invalidates Patents on Human Genes

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In a rare unanimous decision, the Supreme Court ruled today that naturally occurring pieces of human DNA cannot be patented.

The justices found that Utah-based biotech company Myriad Genetics' patents on the BRCA1 and BRCA2 genes fell outside the scope of the U.S. Patent Act, which states that “laws of nature, natural phenomena, and abstract ideas” are “basic tools of scientific and technological work."

"Myriad did not create anything,” Justice Clarence Thomas wrote in the court’s 18-page decision. “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."

The court did, however, rule that Myriad’s patents on the specific process they used to isolate the BRCA genes and on a man-made version of genes, called cDNA, fall within patent guidelines.

Myriad lawyer Gregory Castanias argued that because the process of isolating the genes required hard work and ingenuity the resulting genes should be patent protected. The court did not accept this argument, but, by allowing for patents on other parts of the process, the court did recognize the need to encourage companies to invest money in research and development for genetic diseases.

How the Ruling Will Affect Woman

Mutations on the BRCA 1 and 2 genes can greatly increase a woman’s chances of developing breast and ovarian cancer. Last month, actress Angelina Jolie discovered through genetic testing that she carries a high-risk BRCA mutation and underwent a preventative double mastectomy. She also plans to have her ovaries removed.

Myriad says that about seven percent of breast cancer cases and 15 percent of ovarian cancer cases are caused by mutations on the BRCA1 or 2 genes. According to Myriad, patients with BRCA mutations have "risks of up to 87 percent for breast cancer and up to 44 percent for ovarian cancer by age 70." Jolie’s doctors put her risk at 87 percent for breast cancer and 50 percent for ovarian cancer.

Until today, Myriad was the only company legally allowed to study and test for mutations on BRCA 1 and 2. The American Civil Liberties Union (ACLU) and the Association for Molecular Pathology, who originally brought the lawsuit against Myriad in 2009, argued that gene patents discourage scientific research and that by giving one company the exclusive right to test for these mutations, the test could be made prohibitively expensive. Jolie agreed.

“It has got to be a priority to ensure that more women can access gene testing and lifesaving preventive treatment, whatever their means and background, wherever they live. The cost of testing for BRCA1 and BRCA2, at more than $3,000 in the United States, remains an obstacle for many women,” Jolie wrote in a New York Times editorial.

“I choose not to keep my story private because there are many women who do not know that they might be living under the shadow of cancer,” she added. “It is my hope that they, too, will be able to get gene tested, and that if they have a high risk they, too, will know that they have strong options.”

The ACLU applauded the court’s ruling, expressing their hope that by allowing other researchers to study the genes, someone will soon develop a faster, cheaper, and more sensitive test for these cancer-causing mutations.

“We celebrate the Court's ruling as a victory for civil liberties, scientific freedom, patients, and the future of personalized medicine,” said attorney Sandra Park of the ACLU.

Should Companies Be Allowed to Patent Breast Cancer Genes?

Far-reaching Consequences

According to a news release from the ACLU, “The U.S. Patent and Trademark Office (PTO) has granted thousands of patents on human genes—in fact, about 20 percent of our genes are patented. A gene patent holder has the right to prevent anyone from studying, testing or even looking at a gene.”

By ruling that genes cannot be patented, the Supreme Court has effectively invalidated thousands of these existing patents. Only time will tell what effect this will have on the biotechnology and agricultural industries.

The final piece of the BRCA puzzle is a proprietary database that Myriad maintains of what each BRCA mutation means in terms of increased cancer risk. The ACLU argues that Myriad should be compelled to release this information so that doctors have the data they need to assess each patient’s risk based on her specific genetic profile.

It’s unlikely Myriad will give the public access to their database, but a group of researchers is now amassing their own database by asking women who’ve had Myriad’s BRCAnalysis test and their doctors to submit their results.

The Supreme Court ruling and the move to create an open-source database of BRCA mutations should make this type of genetic testing faster, less expensive, and more accessible to women around the world. By giving women access to the information contained in their genes, they can find out if they too are at risk, seek a second opinion, and ultimately make personal health decisions that could save their lives.

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