The U.S. Supreme Court issued a unanimous decision Thursday morning saying that biotech companies and pharmaceutical manufacturers cannot patent configurations of Deoxyribonucleic Acid, also known as DNA. According to the decision in the case of Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al., companies cannot own DNA, even if they are the first to discover and isolate it.
The decision, a rare Justice Clarence Thomas-authored brief, stated that the company Myriad Genetics is not within its rights to patent the cancer-linked genes BRCA1 and BRCA2, which both have been found to occur in women who are hereditarily more likely to develop breast, ovarian and other cancers. Myriad developed a test to detect the genes and patented the test.
The BRCA1 and BRCA2 test is the one taken by actress Angelina Jolie, who recently went public with her decision to have a double mastectomy after testing positive for the cancer genes. Jolie said she based her decision on a positive test and the experiences she had watching her own mother struggle with breast cancer for a decade before her death in 2007.
The Court ruled that companies cannot patent naturally occurring DNA, and even though BRCA1 and BRCA2 are mutations, they still naturally occur. The ruling, in effect, denies Myriad a monopoly on the detection test, meaning that other companies can now create tests to offer a second opinion. It also means that Myriad can no longer keep the cost of the test artificially inflated at $3,000.
The ACLU challenged Myriad's right to patent the genes, saying that such a monopoly will stifle research and testing and hold back the battle against cancers affecting women. On Thursday, the rights group proclaimed victory on its website. Susan Park, director of the ACLU Women's Rights project said, "Today, the court struck down a major barrier to patient care and medical innovation. 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."
Myriad had previously scoffed at those concerns on its website, writing, "No one can patent anyone’s genes. Genes consist of DNA that is naturally occurring in a person’s body and as products of nature are not patentable." The company argued that what it is actually patenting are the laboratory copies it has created of BRCA1 and BRCA2, "isolated DNA," which it says does not occur in nature and is therefore a patentable product.
Legal experts have called this hair-splitting, in that all genes and chromosomes have to be isolated and copied in order to be studied in the laboratory at all.
The battle has gone back and forth since 2010, when a federal district court invalidated all of the challenged patents on isolated DNA. In 2011, a federal appeals court reinstated the patents. Thursday's Supreme Court ruling overturned that appeal.
[image of scientist studying DNA molecule via Shutterstock.com]