Supreme Court Declared BRCA Gene Patents No Longer Valid

By Vera Viner

It is distressing to think that one company – Myriad Genetics – held the patent rights to two genes that, if mutated, increased women’s risk of breast cancer. These patents forced all medical laboratories to pay for the right to perform a genetic analysis on the BRCA1 and BRCA2 genes. However, women around the nation recently celebrated a major decision by the U.S. Supreme Court that struck down the right of a corporation to hold patents to human genes.

USA Today reported that this decision would benefit the lives of breast cancer and ovarian cancer patients because health insurance companies would no longer be compromised when covering the costs of these genetic tests. Women who have been diagnosed with breast or ovarian cancer or are at high risk of these diseases would be able to get a second opinion or adequate information before performing any invasive procedures based on just one test.

“Myriad did not create anything,” Justice Clarence Thomas wrote in the final 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 was unanimous on striking down the gene patent. This outcome will lead to lower costs and greater access for women in need of genetic testing. Instead of insurers and patients spending approximately $3,300 to have this genetic test, the costs will be slashed to less than $1,000.

The Supreme Court did, however, allow Myriad Genetics to have patent rights to cDNA, a synthetic type of DNA that is not naturally occurring. In the past, the Supreme Court ruled that forces of nature are not patent eligible and this decision may invalidate more than 40,000 patents related to genetic substances granted since 1984.

The court battle against Myriad Genetics has actually been going on since May of 2009 when the American Civil Liberties Union and the Public Patent Foundation filed a lawsuit in a New York Federal Court, according to Medscape News. Myriad began appealing the process once their patents were declared invalid. The case went as far as the Supreme Court and patenting of the BRCA genes was still found null and void.

“This ruling makes a huge and immediate difference for women with a known or suspected inherited risk of breast cancer,” Karuna Jaggar, executive director of Breast Cancer Action, told USA Today. “And it is a tremendous victory for all people everywhere. The Supreme Court has taken a significant stand to limit the rights of companies to own human genes by striking down Myriad’s monopoly.”

An editorial in the Boston Globe illuminated the essence of the Supreme Court ruling – nobody can own a product of nature. We are all a part of the natural world and our genes cannot be patented by companies.

“Maybe it takes a decision like this one to remember why it matters so much, in the end, to be just a ‘product of nature’ after all — imperfect, vulnerable, subject to all the vicissitudes and issues that are part and parcel of the natural world. Not everything, in the end, is man-made. At the same time, sometimes it takes human beings to uphold the right to be part of something bigger than we are, something we can’t own — and that can’t be controlled by patents,” The Globe reported.