On June 13, the US Supreme Court ruled unanimously that natural human genes cannot be patented.
Human genes may not be patented, but artificially copied DNA however can be claimed as intellectual property, according to the decision. The ruling concerns a challenge to patents held by biotechnology company, Myriad Genetics Inc., on two genes that can signal if a woman faces greater risk of developing breast cancer or ovarian cancer. The Supreme Court has reviewed the earlier decision by the U.S. Court of Appeals for the Federal Circuit, which declared that Myriad’s composition of matter claims covering isolated DNA of the BRCA 1 and BRCA 2 genes are patent eligible under Section 101 of the United States Patent Act.
The Supreme Court has found that it is not enough to isolate a gene from its natural environment in order to patent it. As a result, the earlier praxis will be altered and Myriad Genetics will thus lose the sole right to the DNA that makes up the natural breast cancer genes BRCA 1 and BRCA 2. However, the Supreme Courts finds that the patent is valid for cDNA, the synthetically developed DNA without non-coded regions, as this is not a natural phenomena. Following the decision, Myriad has more than 500 valid and enforceable claims in 24 different patents conferring strong patent protection for its BRACAnalysis test, states the company.
“We believe the Court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward. More than 250,000 patients rely upon our BRACAnalysis test annually, and we remain focused on saving and improving peoples’ lives and lowering overall healthcare costs,” said Peter D. Meldrum, president and CEO in a press release on June 13.
There has been some concern that a negative outcome for Myriad Genetics would have an influence on the industry. According to Anders Wirén, patent consultant at legal firm Kransell & Wennborg, the decision “will not have particularly large consequences for the industry.” Wirén states that the issue that the court ruled in is especially interesting from an ethical and political perspective.
Patients, cancer organizations, medical groups and geneticists, all represented by the American Civil Liberties Union, have been challenging the company’s right to the patents. They won a trial court ruling in 2010, but a federal appeals court has twice sided with the Salt Lake City-based company. According to Myriad Genetics, the BRACAnalysis test detects the presence of the BRCA1 and BRCA2 genetic mutations that can help determine a patient’s risk of breast and ovarian cancer and inform about treatment options. In a petition to the Supreme Court, Myriad’s opponents stated that the company’s breast-cancer-gene patents have allowed it to dictate the cost of genetic testing, stopped other laboratories from creating and offering new and improved testing procedures, and made it impossible to obtain second opinions that could better inform patients of their cancer risk.